Market Research Report
Genetics Reports Bundle
Published by
Trimark Publications
Published
June 1, 2012 Product code
193678
Content info
10 Reports: 1,807 Pages
Price
Genetics Reports Bundle
Published: June 1, 2012
From USD 25327
10 Reports: 1,807 Pages
Abstract The Genetics Reports Bundle includes the following TriMark Publications reports:
Bioinformatics Markets
DNA Sequencing and PCR Markets
Gene Expression Reagents Markets
Genomics World Markets
Microarray Markets
Personalized Medicine
Pharmacogenomics for Clinical Use and in Drug Development
Regenerative Medicine Markets
RNA Interference Markets
Stem Cell Markets
Below are summaries of each report: Bioinformatics Markets
The life science informatics marketplace--known as bioinformatics--is set to
expand as high-tech companies infiltrate this arena and biopharmaceutical
companies incorporate key informatic solutions into their business strategies.
TriMark Publications believes that many of the segments of bioinformatics
described in this report offer an unusual opportunity for accelerated
expansion within the coming years. This study is arranged to provide an
overview of bioinformatics market segments and offer evidence that these
segments are poised for significant future growth. Each segment is accompanied
by analysis and forecasts by product type and application. This analysis
surveys the bioinformatics market and the latest information regarding
emerging new products and industry trends. The study will quantify and qualify
the bioinformatics market segments as an area of research, product development
and investment. Forecasts of the bioinformatics market and an analysis of
products in the worldwide information-processing market will provide a basis
for understanding the significance of past developments and future
possibilities within this market category.
DNA Sequencing and PCR Markets
The focus of this TriMark Publications report is to describe the specific
segment of the life sciences market called DNA sequencing. This analysis
includes all of the generally-accepted DNA-oriented analytical activities that
are currently used today, such as enabling technologies like polymerase chain
reaction (PCR). It examines these measurement technology platforms and their
reagents and supplies as utilized in biotechnology research, pharmacology and
healthcare. Generally, diagnostic tests which are marketed primarily as
over-the-counter products directly to patients are not included in this study,
although there is inevitably some overlap. This examination will: 1) identify
viable technology drivers through a comprehensive look at various platform
technologies for molecular sequencing, including immunoassays electrophoretic
methods, probe-based nucleic acid assays, microarrays and non-PCR sequencing;
2) obtain a complete understanding of the chief molecular sequencing tests for
predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic
applications; 3) discover feasible market opportunities via an identification
of high-growth applications in different therapeutic areas, with a focus on
the biggest and expanding markets-communicable diseases, cardiology and
oncology; and 4) focus on global industry development through an in-depth
analysis of the major world markets for molecular sequencing, including
forecasts for growth.
Gene Expression Reagents Markets
The area of gene expression reagents is one of the newest and most important
sectors of pharmaceutical and bioscience research and development. The term
gene expression reagents refers to chemicals that are used in gene expression
experiments that are performed to determine whether a particular gene is
expressed--i.e., present--and in some cases at what levels, in a biological
sample. The purpose of this TriMark Publications report is to describe the
specific segments of the global gene expression reagents market. Within this
area, the study covers those segments that are highly active in terms of
innovation and growth. Specifically, this review examines the markets for gene
expression reagents and small lab equipment all the way up to highly automated
platforms. Emphasis is on those companies that are actively developing and
marketing gene expression reagents for genomics research in the academic
sector and the pharmaceutical, bioscience industry. This study concentrates on
the laboratory reagent market segment and the companion gene expression
reagents sector in the U.S. and around the world that use materials for
genetic research. Particular attention is paid to those areas of the gene
expression reagents sector that are showing the greatest growth or the most
innovation.
Genomics World Markets
Genomics is transforming the pharmaceutical industry. Companies are moving
from drug discovery and development based on medicinal chemistry to the design
of drugs based on information provided by genomics. Virtually all of the major
pharmaceutical houses have either formed partnerships with genomics firms that
began to emerge in the early 1990s or have created in house genomics
divisions. The aim of this TriMark Publications study is to provide in depth
information on the developing market for genomics products and services. The
report will include detailed market analyses and discussions of industry
trends in order to assess the impact of genomics on the current and emerging
pharmaceutical and diagnostic markets. Forecasts and trends were developed
from interviews with industry sources, as well as from an assessment of
available and emerging technologies. The report focuses on how researchers are
applying new genomic approaches to drug discovery and development, and on how
these technologies can be used most effectively and in a high throughput
capacity. Case studies analyzing particular applications of genomic
technologies to specific disease related research are provided, and future
trends and developments are forecasted. Information to prepare this study was
derived from interviews with product managers, marketing strategists, research
executives and others. These individuals are employed at leading genomics
firms or in pharmaceutical and biotechnology companies that either contract
with these firms or have developed in house genomics capabilities.
Microarray Markets
A microarray is an arrangement of miniaturized test sites or "spots" on a
surface. Each spot is usually no more than 250 micrometers in diameter and
contains biological molecules--usually DNA or protein--which act as probes for
a test sample applied to the array. The surface may be a glass slide, a
plastic plate with wells or a polymer bead. The microarray format allows many
tests or experiments to be performed simultaneously, in parallel, leading to
the generation of huge amounts of biological information for the application
of only a tiny amount of sample. Microarrays are often also known as
"biochips". The purpose of this TriMark Publications report is to describe the
specific segment of the microarray market aimed at analysis of proteins and
DNA. Protein microarray applications include: 1) expression profiling; 2)
serum-based diagnostics; 3) protein-protein binding assays; 4 drug-target
binding; and 5) receptor epitope binding. It examines the market for DNA and
protein array testing equipment and supplies using screening reagents and
instruments for analysis of individual components in blood, serum or plasma.
It defines the dollar volume of sales, both worldwide and in the U.S., and
analyzes the factors that influence the size and the growth of the market
segments. Also examined are the subsections of each market segment, including
the research labs, hospital labs, and commercial laboratories. Additionally,
the numbers of institutions using this type of testing and the factors that
influence purchases are discussed. The report surveys almost all of the
companies known to be marketing, manufacturing or developing instruments and
reagents for the protein array market in the U.S. Each company is discussed in
depth with a section on its history, product line, business and marketing
analysis, and a subjective commentary of the company's market position.
Personalized Medicine
Personalized medicine and pharmacogenomics are inextricably linked.
Pharmacogenomics is the use of genetic variations (such as SNPs, gene
expression variability, or other molecular signatures) to understand and
correlate with differential response to pharmaceutical agents (drugs).
Pharmacogenomics can be deployed clinically to stratify patients into
responders and non-responders and this practice is termed personalized
medicine. The purpose of this TriMark Publications report is to describe the
specific market segment of the diagnostics market called personalized
medicine. To frame the context of current approaches, pharmacogenomics seeks
to identify and validate the signature(s) of molecular analytes and these are
converted to assays using the tools of molecular diagnostics. The deployment
of these molecular diagnostics assays on defining and targeting patient
populations is the domain of personalized medicine. This study includes all of
the generally-accepted imaging activities that are currently used in
personalized medicine, including pharmacogenomics, genomics and theranostics.
It examines associated clinical market segments in which personalized medicine
has taken a prominent role including cancer treatment, cardiology and
neurology markets.
Pharmacogenomics for Clinical Use and in Drug Development
Pharmacogenomics, the science of individualizing drug therapy based on the
genetic makeup of individual patients, offers an unusual opportunity for
future market growth. Applying pharmacogenomics would allow doctors to treat
specific segments of the population based on their particular responses to a
drug. The knowledge of the likely effectiveness of a drug in a patient makes
the drug more reliable, and fewer drugs would have to be taken off the market
due to adverse reactions in some, but not all, of the patients to whom they
were administered. Additionally, reducing the occurrence of adverse effects to
a drug effectually reduces the cost of patient care overall. This TriMark
Publications study examines the market for diagnostic tests based on this
science and the clinical measurement methods, the reagents and supplies being
utilized in clinical medicine and the pharmaceutical industry. This report
presents an overview of the latest information regarding emerging new products
and industry trends and will not only quantify, but also, qualify the
pharmacogenomic market segments as an area of research, product development
and investment opportunity. Forecasts of the pharmacogenomic market and an
analysis of products in the worldwide diagnostics market will provide a basis
for understanding the significance of past developments and the immense
possibilities of the future.
Regenerative Medicine Markets
Regenerative medicine is a way of treating injured and diseased human tissue
by using laboratory-grown or therapeutically-induced human tissue as a
replacement. As such, astounding new advancements in the ability to repair or
replace damaged human tissue and organ functions are being made. Whereas
before, remedies for damaged tissue or organ functions due to congenital
deformities, injuries, diseases or simple wear-and-tear relied upon either the
body's ability to repair itself (or not), or a surgeon's skilled hands. Now,
the area of regenerative medicine promises to revolutionize humanity's ability
to remediate countless physical maladies that have perpetually afflicted
humans and other animals. Compared to a select few life forms--like the
starfish--man-made solutions for tissue repair and organ replacement haven't
come close to nature's solutions. And where there once was no solution even
offered by nature, researchers are now at the cusp of overcoming such
limitations by literally regrowing damaged tissue and restoring organ
functions through the use of tissue engineering and stem cell therapy. This is
the promise of regenerative medicine. This TriMark Publications report
discusses the current state of regenerative medicine. The study provides a
thorough overview of regenerative medicine sector together with analyses of
the funding trends, intellectual property, market opportunities, therapeutic
pipeline, research collaborations, partnership activities, and guidelines for
establishing new ventures. The report enables the reader gain in-depth
knowledge about ongoing tissue engineering and stem cell therapy research
programs carried out in universities and other research centers. Moreover,
this analysis profiles the leading companies developing regenerative medicine
solutions.
RNA Interference Markets
Since its discovery, the naturally occurring RNA (ribonucleic acid)
interference effect has been acclaimed as the most exciting technical
breakthrough in biological research in the last decade. Some industry analysts
predict that RNA interference (RNAi) may even surpass PCR as a top technology.
RNAi allows scientists to silence the expression or effect of a gene under
study. This is known as gene knockdown. This field has rapidly emerged as a
fast-growing new market. The purpose of this TriMark Publications report is to
review the market for RNAi testing equipment and supplies. RNAi is a mechanism
in molecular biology where the presence of certain fragments of
double-stranded RNA (dsRNA) interferes with the expression of a particular
gene which shares a similar sequence with the dsRNA. This study defines the
dollar volume of sales, both worldwide and in the U.S., and analyzes the
factors that influence market size and growth for RNAi testing. The main
objectives of this study are to: 1) understand the different sectors of RNAi
testing market and to look at a description of the instruments, reagents and
supplies marketed by major companies in each segment; 2) obtain a complete
understanding of the individual RNAi-testing platforms--from basic principles
to clinical applications; 3) discover feasible market opportunities by
identifying high-growth applications in different analytical diagnostic areas,
with a focus on the biggest and expanding markets; 4) focus on global industry
developments and trends through an in-depth analysis of the major world
markets for RNAi measurement technology, including growth forecasts; and 5)
present market figures related to the current value of RNAi testing, market
projections, market share, key players and sector growth rates.
Stem Cell Markets
A stem cell is an extraordinary type of cell that has the ability to
self-renew for long periods of time and to differentiate into specialized
cells under appropriate physiological or experimental conditions.
Traditionally, stem cells have been classified as either embryonic, adult
(tissue-specific or cord blood) stem cells. Recent understanding of stem cell
biology may provide new approaches for the treatment of a number of diseases
as well as tissue/organ injuries, including cardiovascular disease,
neurological disease, musculoskeletal disease, diabetes and hematopoietic
disorders. Stem cell fate is determined by both intrinsic regulators and the
extra-cellular environment (niche), and their expansion and differentiation ex
vivo are generally controlled by growing them in a specific configuration
(monolayer or three-dimensional culture). This process, which is vital to
enable stem cells to be used for therapeutic purposes, is called
differentiation. Differentiation is a process involving unspecialized cells
progressing to become specialized cells with restricted developmental
potential. The purpose of this TriMark Publications report is to describe the
specific market segments of the medical research space using stem cells for
research and development purposes. This study reviews all of the generally
accepted analytical methods that are currently in use today for preparing and
using stem cells. It examines the use of stem cells in developing new
therapies for disease.
Table of Contents
Bioinformatics Markets 1. Overview
1.1. Statement of Report
1.2. About this Report
1.3. Scope of this Report
1.4. Methodology
1.5. Executive Summary
2. Introduction
2.1. Global Bioinformatics Products Industry
2.2. Computers and Biology
2.3. Bioinformatics and the Internet
2.4. Company Evaluation Overview
2.5. Market Outlook
2.6. Competitive Structure
2.7. Applications of Bioinformatics
2.7.1. Medicine
2.7.2. Microbial Genomics
2.7.3. Agriculture
2.8. R&D
2.8.1. Allocation of R&D
2.8.2. Traditional Drug Discovery Process
2.8.3. Drug Discovery and Bioinformatics
2.8.4. Collaborative Agreements
2.9. The Human Genome Project (HGP)
2.9.1. Goals of the Human Genome Project
2.9.2. Benefits of the Human Genome Project
2.10. Barriers to Entry
2.11. Proteomics and Databases
2.11.1. Protein Database Standards
2.11.2. Future Trends
3. The U.S. Bioinformatics Market
3.1. Overview
3.2. Market Restraints and Drivers
3.2.1. Market Restraints
3.2.2. Market Drivers
4. Genomics
4.1. The Biotechnology Industry
4.2. The Development of a Genomics Market
4.2.1. Market Drivers
4.2.2. Market Restraints
4.2.3. Market Size and Growth Projections
4.2.4. The U.S. Genomics Market
4.3 Biochips and DNA Microarrays
4.3.1. Key Challenges
4.3.2. Freeware
4.3.3. New Tools
4.4. Bioinformatics
4.5. Disease Targets
4.6. Functional Genomics
4.7. Gene Sequencing
4.8. Gene Sequence Variation Detection
4.9. Comparative Genomics
4.10. Genome Database Arrays
4.11. High-throughput Genomics
4.11.1. High-throughput Technology
4.11.2. Lab on a Chip
4.12. Pharmacogenomics
4.13. Probe Arrays
4.13.1. Gene Expression Monitoring Arrays
4.13.2. DNA Analysis Arrays
4.14. Proteomics
4.15. Sequencing
4.16. Single Nucleotide Polymorphisms (SNPs)
4.17. Structural Genomics
4.18. Photolithography
4.19. Instrumentation
5. The Bioinformatics Industry
5.1. Definition and Role of Bioinformatics
5.1.1. Bioinformatics Sector Overview
5.1.2. The Future Status of Bioinformatics
5.1.3. Barriers to Growth
5.2. Types of Data and Bioinformatics Applications
5.2.1. Validated Core Modeling Technology
5.2.2. Broad Applicability
5.2.3. Data Management Compliant with Industry Standards
5.2.4. Open Architecture
5.2.5. Ease of Use
5.2.6. Increased Access
5.3. Functions of Bioinformatics Software
5.3.1. Data Management
5.3.2. Data Transformation
5.3.3. Data Collaboration
5.3.4. Interface for Online Data Sources
5.4. Target Markets for Informatics Software
5.5. Steps Involved in Bringing a Drug to Market
5.6. Costs Incurred in Developing a New Drug
5.7. Industry Drivers and Challenges
5.8. Industry Risks
5.9. Products of Bioinformatics
5.10. Bioinformatics Processes
5.11. Informatics Tools and Functionalities
5.11.1. Sequence to Structure
5.11.2. Lead Identification and Optimization
5.11.3. Development and Formulation
5.11.4. Improving Materials and Processes
5.11.5. Other Materials-Based Industries
5.12. Role of Bioinformatics in the Biotechnology Value Chain
5.13. Bioinformatics Market Segment
5.13.1. Databases
5.13.2. Hardware
5.13.3. Software
5.13.4. Bioinformatics Services
5.14. Bioinformatics Market Size
5.14.1. Sales and R&D
5.14.2. IT Budget
5.14.3. Projected Bioinformatics Market Size
5.15. Global Market Perspective
6. Bioinformatics Business
6.1. Bioinformatics Business Models
6.1.1. Changing Business Models
6.1.2. Competition for Pure Play Informatics Companies
6.1.3. Non-Profit Organizations
6.1.4. In-House Bioinformatics Solutions
6.1.5. Large IT Companies
6.2. Bioinformatics Target Disciplines
6.2.1. Comparative Genomics
6.2.2. Pharmacogenomics
6.2.3. Functional Genomics
6.2.4. Proteomics
6.2.5. Structural Genomics
6.2.6. Image Informatics
6.2.7. Clinical Trial Informatics
6.2.8. Cheminformatics
6.3. Bioinformatics Architecture
6.4. Bioinformatics Applications
6.4.1. Data Search Tools
6.4.2. Data Visualization Tools
6.4.3. Data Mining and Clustering
6.4.4. Enterprise Solutions
6.4.5. Data Warehousing
6.5. Evaluation of Bioinformatics Solutions
6.5.1. Requirements of Study
6.5.2. Shortlisting the Options
6.5.3. Scoring Patterns
6.5.4. Performance
6.5.5. Data Storage
6.5.6. Data Management in Drug Discovery
6.5.7. Key Issues in Bioinformatics Data Storage
6.6. Convergence of Industries
6.7. Proteins as a Driver
6.8. Current Bioinformatics Research
6.9. New Bioinformatics Modeling Algorithms
6.10. 3D Modeling
6.11. Patenting Bioinformatics Algorithms
7. Recent Industry Activity
7.1. Collaborations and Acquisitions
7.2. Product Development and Launches
8. Corporate Profiles
8.1. Abbott Laboratories
8.2. Abgenix
8.3. Ablynx
8.4. Accelrys
8.5. Affimed Therapeutics
8.6. Affitech
8.7. Affymetrix
8.8. Agencourt Bioscience Corporation
8.9. Agensys
8.10. Agilent Technologies
8.11. Alexion Pharmaceuticals
8.12. AlgoNomics
8.13. ALLEZ Software
8.14. Amgen
8.15. Antisoma
8.16. Applied Biosystems
8.17. Arana Therapeutics
8.18. Ariadne Genomics
8.19. Array Genetics
8.20. Astellas Pharma
8.21. AstraZeneca
8.22. Automated Handling Systems
8.23. Avesthagen, Limited
8.24. Bioalma
8.25. BIOBASE Biological Databases
8.26. BioCarta
8.27. Biodatabases (AMITA Corporation)
8.28. BioDiscovery
8.29. Biogen Idec
8.30. BioInformatics
8.31. BioInformatics Services
8.32. BioInformatics Solutions
8.33. Biomax Informatics
8.34. BioServe Technologies
8.35. Biosiris
8.36. BioSoftSolutions
8.37. Biotique Systems
8.38. BioInvent International
8.39. Biosite Discovery
8.40. BioWa
8.41. BioWisdom
8.42. Bio-Xtal
8.43. Boehringer Ingelheim
8.44. Cambridge Antibody Technology Group
8.45. Capital Genomix
8.46. Celera Group
8.47. Cellectis
8.48. Cellomics
8.49. CeuticalSoft
8.50. Chemical Computing Group
8.51. Cimarron Software
8.52. CLONDIAG Chip Technologies
8.53. CodonCode Corporation
8.54. CompuDrug International
8.55. Compugen USA
8.56. Corimbia
8.57. Crucell
8.58. CSIRO Bioinformatics
8.59. CuraGen Corporation
8.60. CyberGene
8.61. Cytogen
8.62. Data Unlimited International
8.63. deCODE Genetics
8.64. Decodon
8.65. Deltagen
8.66. Digilab
8.67. DNA Software
8.68. DNAPrint Genomics
8.69. DNA Star
8.70. DxS
8.71. Dyax Corp.
8.72. Eisai
8.73. Elan Corporation
8.74. Electric Genetics Corporation
8.75. Elusys Therapeutics
8.76. Entagen
8.77. Entelos
8.78. Enzon Pharmaceuticals
8.79. Epigenomics
8.80. ePitope Informatics
8.81. EraGen Biosciences
8.82. European Bioinformatics Institute (EBI) Industry Programme
8.83. Evolutionary BioInformatics
8.84. Genamics
8.85. GeneData
8.86. Gene Logic
8.87. Genentech
8.88. Geneva Bioinformatics (GeneBio)
8.89. Genmab
8.90. GenOdyssee
8.91. Genolyze
8.92. Genomatica
8.93. GenomeQuest
8.94. Genomic Solutions
8.95. Genomining
8.96. Genovac
8.97. Genzyme
8.98. Geospiza
8.99. GlaxoSmithKline
8.100. Glycominds
8.101. Health Discovery Corporation
8.102. Hitachi Corporate Technology Group
8.103. IBM Life Sciences
8.104. ImClone Systems
8.105. ImmunoGen
8.106. Immunomedics
8.107. Improved Outcomes Software
8.108. INCOGEN
8.109. Incyte Corporation
8.110. Informagen
8.111. Ingenuity Systems
8.112. InNexus Biotechnology
8.113. Insilicos
8.114. Intrexon Corporation
8.115. Invitrogen Corporation
8.116. IO Informatics
8.117. Johnson & Johnson
8.118. LabVantage Solutions
8.119. Lexigen
8.120. Lifespan Biosciences
8.121. Lion Bioscience
8.122. MathEcology
8.123. Matrix Science
8.124. Medarex
8.125. Medicel
8.126. MedImmune
8.127. Merus
8.128. METabolic Explorer
8.129. Metahelix Life Sciences
8.130. Metalife
8.131. Micromet
8.132. Millennium Pharmaceuticals
8.133. Molecular Connections
8.134. Molecular Networks
8.135. Molecularware
8.136. MorphoSys
8.137. Nexus Genomics
8.138. Nonlinear Dynamics
8.139. Novartis
8.140. Ocimum Biosolutions
8.141. OmniViz
8.142. Partek
8.143. PDL BioPharma
8.144. Perlegen Sciences
8.145. Philogen
8.146. Philotec
8.147. Prokaria
8.148. Quantiom Bioinformatics
8.149. Relevant Software
8.150. Roche
8.151. Rosetta Inpharmatics
8.152. Sanofi-Aventis
8.153. SBI Science
8.154. Seascape Learning
8.155. Seattle Genetics
8.156. Scil Proteins
8.157. Simulations Plus
8.158. Spotfire
8.159. Strand Life Sciences
8.160. Sun Microsystems
8.161. Symphogen
8.162. Syngene
8.163. Tahoe Informatics
8.164. Tanox
8.165. 3rd Millennium
8.166. ThromboGenics
8.167. Thomson Reuters
8.168. TIB MOLBIOL
8.169. Trion Pharma
8.170. Tripos
8.171. UBI Life Sciences
8.172. Viventia Biotech
8.173. VizX Labs
8.174. Wyeth
8.175. Xcellerex
8.176. Xencor
8.177. Xoma
8.178. Xpogen
INDEX OF FIGURES
Figure 4.1: Representation of Biotechnology Market, Geographically, 2008
Figure 5.1: Informatics Applications along the Drug-Discovery Value Chain
Figure 5.2: Functions of Bioinformatics Software in Research
Figure 5.3: EMBL Database Growth, 1995-2008
Figure 5.4: The Steps Involved in Bringing a Drug to Market
Figure 5.5: The Breakdown of Total Costs in New Drug Development, 2007
Figure 5.6: The Role of Bioinformatics in the Biotechnology Value Chain
Figure 5.7: Worldwide Pharmaceutical Sales and R&D Expenditures, 2000-2013
Figure 5.8: Worldwide Growth in IT Budget, 2000-2013
Figure 5.9: Worldwide Bioinformatics Market, 2000-2013
Figure 6.1: Steps of a Proteomics Experiment
Figure 6.2: Bioinformatics Architecture
INDEX OF TABLES
Table 2.1: Leading Biotechnology Companies
Table 2.2: Total of Domestic U.S. R&D, 2006-2013
Table 2.3: Global Biotechnology Market, 2007
Table 2.4: SIB Informatics Databases
Table 4.1: The U.S. Biotechnology Industry Size and Revenue, 2000-2007
Table 4.2: Global Biotechnology Industry Major Segments
Table 4.3: Genomics Sector Market Size, 2006-2013
Table 4.4: Total Biochip Market, 2007-2013
Table 4.5: Selected Competitors in the Biochip Market
Table 4.6: Biochip Microarray Products
Table 4.7: Bioinformatics Tools
Table 4.8: Functional Genomics Companies Building Advanced Integrated
Platforms and Substantial Databases
Table 4.9: Companies Using New Genomic Tools
Table 4.10: Non-DNA-Based Chip Suppliers
Table 4.11: Robotics or "Lab-on-a-Chip" Market Sector
Table 4.12: Key High-throughput and Systemic Approaches in Genomic Analysis
Table 4.13: Pharmacogenomics Segment Players
Table 4.14: The Worldwide Market for Pharmacogenomics, 2006-2013
Table 4.15: Competitors in the SNP Genotyping Segment
Table 4.16: Scanning and Detection Technology Suppliers
Table 5.1: Data Sources and Bioinformatic Investigations
Table 5.2: Drivers and Challenges of the Bioinformatics Industry
Table 5.3: Bioinformatics Activities, Sub-Activities and Key Players
Table 5.4: Bioinformatics Market Size, 2006-2013
Table 5.5: Cheminformatics Market Size, 2006-2013
Table 5.6: In-silico Informatics Market Size, 2006-2013
Table 5.7: Bioinformatics Hardware and Systems Market Size, 2006-2013
Table 6.1: Alliances between IT/Telecom and Biotechnology Firms
Table 6.2: Types of Intellectual Property Protection for Bioinformatics
Tools
DNA Sequencing and PCR Markets 1. Overview
1.1. Statement of Report
1.2. About This Report
1.3. Scope of the Report
1.4. Methodology
1.5. Executive Summary
2. Introduction to DNA Sequencing and PCR Technology
2.1. Science Overview: Introduction to DNA
2.1.1. DNA Sequencing and PCR Applications Space
2.1.2. DNA Sequencing Technologies
2.1.3. DNA Sequencing Applications
2.1.4. Proteomics
2.1.5. Products for the Genomics Market
2.2. The Impact of the Human Genome Project on Molecular Biology
2.3. Impact of DNA Sequencing Techniques on Biotechnology, Pharmaceutical
and Healthcare Industries
2.4. Molecular Diagnostics in the Post-genomic Era The Role of SNPs
2.5. Advances in Molecular Diagnostic Technologies
2.6. The Use of PCR Technology
2.7. Genetic Variability and Disease
3. DNA Sequencing Technologies and Market Analysis
3.1. Overview of the Sequencing Market
3.1.1. Market Opportunity
3.1.2. Highlights of DNA Sequencing Market
3.1.3. Genomic Analysis Market Development
3.1.4. Companies Offering Sequencing Technology Platforms
3.1.5. Competition
3.1.6. Markets for DNA Sequencing
3.1.7. Market Opportunity
3.1.8. Market Dynamics
3.1.9. Overview of Current DNA Sequencing Technology Platforms and Players
3.1.10. Limitations of Current Sequencing Technologies
3.1.11. Next Generation sequencing software
3.1.12. Sequencing Services Industry: Market Size and Outlook
3.2. Overview of the Life Science Marketplace
3.2.1. Research Laboratories
3.2.2. Market Share
3.2.3. Paradigm Shift in Drug Discovery and Development
3.2.4. Systems Biology and the Need for More Effective Tools
3.2.5. Molecular Medicine and the New Therapeutics
3.2.6. Pharmacogenomics Using Genotyping and Phenotyping Clinical
Biomarkers
3.3. The Market for Genetic Analysis Products
4. PCR and DNA Amplification Technologies and Markets
4.1. Technology Overview
4.1.1. Nucleic Acid Amplification Methods
4.1.2. Overview of PCR Technology
4.1.2.1. PCR Components
4.1.2.2. Primers for PCR
4.1.2.3. Equipment for PCR
4.1.2.4. Sources of DNA for PCR
4.1.2.5. PCR Primer Sequence
4.1.2.6. Thermostable DNA Polymerases
4.1.2.7. PCR Protocols
4.2. Overview of Current PCR Technology Platforms and Players
4.3. DNA Amplification Market
4.3.1. Market Size and Growth Projections in DNA Amplification
Instrumentation, 2010-2018
4.3.1.1. U.S. Market
4.3.1.2. European Market
4.3.2. Market Share of Key Players in DNA Amplification
4.3.3. Markets for Emerging Amplification Technologies
4.3.4. The Drivers for Amplification Technologies
4.4. Instrumentation Outlook for the Life Sciences Industry
4.5. Products for the Genomics Market
5. Technical Trends in Nucleic Acid Analysis
5.1. Amplification of Nucleic Acids
5.1.1. Overview
5.1.2. Quality Control Issues in PCR
5.1.3. Detection of the Amplified Product
5.1.4. Novel Nucleic Acid Amplification Techniques
5.2. Alternatives to PCR Amplification
5.2.1. Locked Nucleic Acids (LNAs)
5.2.2. Multiplexed Nuclease-Protection Assay and ArrayPlate
5.2.3. Biosensor Technologies
5.2.3.1. DNA Hybridization Biosensor Chips
5.2.3.2. PNA-Based Biosensors
5.3. Microplate Readers
5.4. DNA Sequencing Technologies
5.4.1. Capillary-Based Sequencers
5.4.2. Pyrosequencing
5.4.3. High-throughput Sequencing
5.4.5. Emerging Markets for Next-Generation Sequencing
5.5. Nucleic Acid Sample Prep Platforms
5.6. RNA Isolation Kits
5.7. DNA Microarrays
5.7.1. The Technique
5.7.2. The Market
5.7.3. Advantages of Microarrays
5.7.4. Gene Expression Monitoring Arrays
6. Corporate Directory
6.1. Abbott Laboratories
6.2. Affymetrix
6.3. Agilent Technologies
6.4. AgriGen Biotech Pty
6.5. Avesthagen Gengraine Technologies, Pvt. Ltd.
6.6. BD Biosciences
6.7. BGI Life Tech
6.8. bioMerieux
6.9. Bioneer
6.10. Bio-Rad Laboratories
6.11. BioServe
6.12. Caliper LifeSciences (A Perkin-Elmer Company)
6.13. Cepheid
6.14. Cogenics (A Subsidiary of Danaher Corp.)
6.15. CombiMatrix Corporation
6.16. Commonwealth Biotechnologies
6.17. Complete Genomics
6.18. Comprehensive Biomarker Center GmbH
6.19. CuraGen Corporation
6.20. Cytocell
6.21. DiaDexus
6.22. DNA LandMarks
6.23. DNAVision
6.24. DNASTAR, Inc.
6.25. ELITech Molecular Diagnostics
6.26. Enigma Diagnostics Limited
6.27. Enzo Biochem
6.28. Eppendorf AG
6.29. Eurofins Medigenomix
6.30. Exiqon
6.31. FASMAC Co. Ltd.
6.32. GE Healthcare
6.33. GeneticTechnologies
6.34. GeneWorks
6.35. Genia
6.36. Genisphere
6.37. Genovoxx
6.38. Gen-Probe Incorporated
6.39. Genset
6.40. GnuBIO Incorporated.
6.41. GVK BIO
6.42. Helicos BioSciences Corporation
6.43. High Throughput Genomics
6.44. Hokkaido System Science
6.45. Hy Laboratories
6.46. Illumina
6.47. Inqaba Biotechnical Industries
6.48. IntegenX Inc.
6.49. Integrated DNA Technologies
6.50. Intelligent Biosystems (IBS)
6.51. Kreatech Holding BV
6.52. LaserGen Inc.
6.53. LI-COR
6.54. Life Technologies Corporation
6.55. Lucigen
6.56. Luminex Corporation
6.57. Meridian Biosciences
6.58. Microsynth AG
6.59. MilleGen SA
6.60. MWG Biotech AG
6.61. NanoString Technologies
6.62. NobleGen Biosciences
6.63. Orchid Cellmark
6.64. Oxford Nanopore Technologies Ltd.
6.65. Pacific Biosciences
6.66. PamGene
6.67. PPD
6.68. PrimmBiotech
6.69. Promega
6.70. QIAGEN
6.71. RainDance Technologies
6.72. Research Biolabs Pte
6.73. Roche Diagnostics
6.74. Rubicon Genomics
6.75. Saturn Biotech
6.76. SeeGene
6.77. Sequenom
6.78. Sequetech
6.79. SeqWright
6.80. Shanghai Sangon Biological Engineering Technology and Services Co.
6.81. Shimadzu Biotech
6.82. Siemens AG
6.83. SolGent Inc.
6.84. Stratos Genomics Inc
6.85. TATAA Biocenter
6.86. Thermo Fisher Scientific Inc.
6.87. Third Wave Technologies
6.88. Wellcome Trust Sanger Institute
6.89. ZS Genetics
6.90. ZyGEM Corporation Limited
7. Market Trends and Forecasts
7.1. Market Dynamics
7.2. Future Considerations for Molecular Diagnostics
7.2.1. How Genomics is Transforming Pharmaceutical R&D
7.2.2. Genetic Markers for Disease
7.2.3. NAT and Personalized Medicine
7.2.4. Three Growth Areas of Molecular Diagnostics
7.3. RNA Detection
7.4. Ramification Amplification Method
7.5. Invader Assays/Third Wave Technologies
7.6. Molecular Beacons
7.7. ChIP Sequencing
7.8. Methylation Analysis
7.9. Digital Polymerase Chain Reaction (dPCR)
7.10. Personal or Desktop Sequencers
8. Major Product Innovations/Launches in DNA Sequencing and PCR Markets
8.1. Major Product Innovations/Launches in DNA Sequencing and PCR Industries
8.2. Major Activities in DNA Sequencing Industry
LIST OF FIGURES
Figure 2.1: Segment of Double-Stranded DNA Showing the Base-Pair
Relationship
Figure 3.1: Cost of Sequencing a Human Genome, 2001-2013
Figure 3.2: Number of Sequencing Machines by Continent
Figure 3.3: Factors influencing Researchers Choice of Next Generation
Sequencing Platform
Figure 3.4: Next-Generation Sequencing Platforms Market Share, 2012.
Figure 3.5: Applications for Next Generation Sequencing in the Research
Laboratory
Figure 3.6: Consumables in Research Laboratories: Market Breakdown and
Corresponding Growth Rates, 2012-2015
Figure 4.1: Cepheid's I-CORE Module
Figure 4.2: Market Share for Thermal Cycler Manufacturers
Figure 7.1: Evolution of the Market for Benchtop Sequencers, Predicted
Market Shares for 2014.
LIST OF TABLES
Table 2.1: First and Second (Next) Generation Sequencers
Table 2.2: Third Generation Sequencing Platforms
Table 2.3: Applications of Next Generation Sequencing
Table 3.1: Global Market for Next-Generation Sequencing
Table 3.2: DNA Sequencing Market Players
Table 3.3: Major DNA Product Companies in Europe
Table 3.4: Major DNA Product Companies in Asia and Australia
Table 3.5: Major DNA Product Companies in Japan
Table 3.6: Major DNA Product Companies in Rest of the World
Table 3.7: Comparison on Pricing of Current NGS Platforms
Table 3.8: Number of Sequencers Currently in use at Academic and
Sequencing Centers Worldwide, by Platform
Table 3.9: Comparison of Established Genomic Analysis Technologies
Table 3.10: Integrated Software Solutions for Next Generation Sequencing
Table 3.11: Software Solutions for Resequencing
Table 3.12: Software Solutions for de novo Alignment/Assembly
Table 3.13: Software Solutions for SNP/Indel Discovery
Table 3.14: Software Solutions for Genome Annotation
Table 3.15: Software Solutions for ChIP-Sequencing and Methylome-Sequencing
Table 3.16: Software Solutions for Transcriptomics
Table 3.17: Sequencing Services Market Size, 2010-2018
Table 3.18: Top 25 Genome Centers Worldwide
Table 3.19: Genome Centers by Country
Table 3.20: Frequently Used Life Science Techniques
Table 3.21: Reagents Used by Life Science Researchers
Table 3.22: The Most Commonly Used Instruments and Apparatus in Life
Science Research
Table 3.23: The Most Widely Reported Categories of Software in Life
Science Research
Table 3.24: Global Market Size for Life Science Research Tools, 2011-2018
Table 3.25: Key Bioassay Technologies in the Life Sciences Industry
Table 4.1: Nucleic Acid Amplification Methods
Table 4.2: Properties of Various Acid Amplification Techniques
Table 4.3: Global Market Size for DNA Amplification Instrumentation,
2010-2018
Table 4.4: Global Market Size for Reagents and Consumables in the DNA
Amplification Segment, 2010-2018
Table 4.5: Market Share of Key Players in DNA Amplification Thermostable
Enzymes
Table 4.6: Leading Manufacturers of Thermal Cyclers and Market Share
Table 4.7: High Growth in the Global Market for digital PCR; Market Size
2012-2017
Table 5.1: Next-Generation Sequencing Platforms
Table 5.2: Comparative Benefits of Next-Generation Sequencing over
Microarray Technology
Table 8.1: The Key Bioassay Technologies in the Life Sciences Industry
Gene Expression Reagents Markets 1. Overview
1.1. Objectives of the Report
1.2. Methodology
1.3. Scope of the Report
1.4. Executive Summary
2. Gene Expression
2.1. The Genomics Revolution
2.2. Basic Principles of Gene Expression
2.3.1. Quantitative Real-Time PCR (qRT-PCR)
2.3.2. PCR Labeling Chemistries
2.3.3. TaqMan Probes
2.3.4. SYBR Green
2.4. Microarray Technology
2.5. Microarray Target Preparation and Hybridization
2.6. RNA Sample Preparation and Assessment
3. Gene Expression Reagents
3.1. Kit Format vs. Home-Brew Assays
3.2. Whole Product Solutions
3.3. Emerging Technologies
4. Market Environment
4.1. Institutional and Government Budgeting
4.2. Worldwide Investment in Genomics Technologies and Research
4.3. Industry Consolidation and Acquisitions
5. Market Drivers
5.1. Improved Assay Performance
5.2. Cost Effective Systems
5.3. Automation
5.4. Bioinformatics Solutions
6. Worldwide Market for Gene Expression Reagents
6.1. Life Science Research
6.2. Drug Discovery and Development, Molecular Diagnostics
6.3. Commercial Production
6.4. Gene Expression Market Size
6.4.1. Real-Time PCR Revenue
6.4.2. Commercial Microarray Revenue
6.4.3. RNA Sample Preparation Revenue
6.5. Gene Expression Reagent Market by Region
6.6. Users of Gene Expression Products
6.6.1. Core Laboratories
6.6.2. Consortia
6.6.3. Pharmaceutical and Biotechnology Companies
6.7. Affiliation
6.8. Job Function and Decision Makers
7. Key Applications
7.1. BioMarker Identification and Pharmacogenomics
7.2. Toxicogenomics
7.3. Molecular Diagnostics
8. Vendor and Product Selection
8.1. Product Adoption
8.2. Drivers for Product Switching
9. Leading Vendors
10. Marketing Strategies
10.1. e-Marketing and e-Commerce
10.2. Catalog
10.3. On-Site Cabinet Programs
11. Pricing Strategies
11.1. Price Elasticity
11.2. Strategies
12. Distribution Channels
13. Competitive Situation
14. Opportunities
15. Market Strategy Profiles, Leading and Selected Vendors
15.1. Applied Biosystems
15.1.1. Applera Corporation-Corporate History and Structure
15.1.2. Molecular Biology Technology and Products
15.1.3. Acquisitions, Partnerships and Collaborations, 2006
15.1.4. Product Portfolio Summary
15.1.5. Real-Time PCR/Genomics Products and Consumables
15.1.6. Real-Time PCR/Genomics New Product Introductions, 2006
15.1.7. End-Users
15.1.8. Distribution Channels
15.1.9. Competition-Gene Expression Products
15.1.10. Competitive Analysis
15.1.11. Business Model
15.2. Affymetrix
15.2.1. Corporate History and Structure
15.2.2. Technology
15.2.3. Partnerships and Collaborations
15.2.4. Product Portfolio Summary
15.2.5. Complementary Services
15.2.6. New Product Introductions
15.2.7. End-Users
15.2.8. Distribution Channels
15.2.9. Competition
15.2.10. Competitive Analysis
15.2.11. Business Model
15.3. Invitrogen
15.3.1. Corporate History and Structure
15.3.2. Technology
15.3.3. Acquisitions
15.3.4. Partnerships and Collaborations
15.3.5. Product Profile Summary
15.3.6. Gene Expression Product Portfolio
15.3.7. New Product Introductions
15.3.8. End-Users
15.3.9. Distribution Channels
15.3.10. Competition
15.3.11. Competitive Analysis
15.3.12. Business Model
15.4. Qiagen
15.4.1. Corporate History and Structure
15.4.2. Technology
15.4.3. Acquisitions, Partnerships and Collaborations
15.4.4. Collaborations and Partnerships
15.4.5. Product Portfolio Summary
15.4.6. Complementary Services
15.4.7. New Product Introductions
15.4.8. End-Users
15.4.9. Distribution Channels
15.4.10. Competition
15.4.11. Competitive Analysis
15.4.12. Business Model
15.5. GE Healthcare (Formerly Amersham Biosciences)
15.5.1. Corporate History and Structure
15.5.2. Technology
15.5.3. Product Portfolio Summary
15.5.4. Complementary Services
15.5.5. Genomics New Product Introductions
15.5.6. Amersham Biosciences End-Users
15.5.7. Distribution Channels
15.5.8. Competition
15.5.9. Competitive Analysis
15.5.10. Business Model
15.6. Stratagene
15.6.1. Corporate History and Structure
15.6.2. Technology
15.6.3. Acquisitions, Collaborations, Alliances and Partnerships
15.6.4. Product Portfolio Summary-Research Products Division
15.6.5. New Product Introductions
15.6.6. Complementary Services
15.6.7. End-Users
15.6.8. Distribution Channels
15.6.9. Competition
15.6.10. Competitive Analysis
15.6.11. Business Model
Appendix I: Leading Vendor's Gene Expression Products
Appendix II: Gene Expression Product Groups
Appendix III: Companies Offering Gene Expression Products
LIST OF FIGURES
Figure 2.1: Gene Expression Process
Figure 2.2: qRT-PCR Workflow
Figure 2.3: Microarray Workflow
Figure 6.1: Gene Expression Market by Region
Figure 6.2: Researchers Using Gene Expression Technologies Worldwide, 2005
Figure 6.3: Distribution of Laboratory Workers by Organization in North
America
Figure 6.4: Laboratory Job Function
Figure 6.5: Product Selection and Purchasing Decision Makers
LIST OF TABLES
Table 5.1: Microarray Analysis Cost per Sample
Table 5.2: Cost of qRT-PCR Research Reagents and Systems
Table 6.1: Five-Year Forecast-Gene Expression Reagents, Instruments
Table 6.2: RNA Sample Preparation Revenue
Table 6.3: Forecasted Annual Revenue-qRT-PCR, 2005-2010
Table 6.4: Forecasted Annual Revenue-Commercial Microarrays, Reagents,
Instruments, 2005-2010
Table 6.5: Forecasted Annual Revenue-Gene Expression Reagents,
Instruments, 2005-2010
Table 6.6: Forecasted Annual Revenue-RNA Sample Preparation, 2005-2010
Table 6.7: Projected Revenue Growth of Microarrays and Related Products
Table 6.8: Major Players' Distribution of Revenue by Region, 2005
Table 6.9: Decision Makers Profile
Table 9.1: Major Vendors-Gene Expression Reagents and RNA Sample
Preparation
Table 9.2: Vendors' Key Statistics, 2005
Table 9.3: Vendors' Technology and Products
Table 11.1: RNA Sample Preparation-Vendors Prices
Table 11.2: qPCR Kits-Vendor's Prices
Table 11.3: Reverse Transcriptase-Vendor's Prices
Table 12.1: Distribution Channels
Table 15.1: Applied Biosystems Revenue, 2005
Table 15.2: Affymetrix Revenue, 2005
Table 15.3: Invitrogen Revenue, 2005
Table 15.4: Qiagen Revenue, 2005
Table 15.5: GE Healthcare Revenue, 2005
Table 15.6: Stratagene Revenue, 2005
Genomics World Markets 1. Introduction
1.1. Statement of Report
1.2. Objectives and Goals of Study
1.3. Methodology
1.4. Executive Summary
1.4.1. Market Drivers
1.4.2. Market Restraints
1.4.3. Market Size and Growth Projections
1.5. What Is a Gene?
1.6. Gene Expression
1.7. Genetic Variability
1.8. The Human Genome Project (HGP)
1.9. Gene Databases
1.10. Sequencing and Resequencing
1.11. RNA Interference (RNAi)
1.12. DNA Tags
2. Genomics Technology and Industry
2.1. The Development of a Genomics Market
2.1.1. Market Size and Growth Projections
2.1.2. The U.S. Genomics Market
2.2. DNA Microarray Technology
2.2.1. Biochips
2.2.2. Photolithography
2.2.3. Instrumentation for DNA Microarray Analysis
2.2.4. Lab-on-a-Chip
2.2.5. DNA Microarrays
2.3. Applications of DNA Microarrays
2.3.1. DNA Sequence Analysis
2.3.2. Gene Expression Analysis
2.3.3. Effect of DNA Sequence and Gene Expression Monitoring on the
Genomics Market
2.4. Bioinformatics
2.5. Functional Genomics
2.5.1. Gene Knockdown
2.5.2. Protein-Protein Interactions
2.5.3. Bioinformatics
2.5.4. Strategies of Functional Genomics Companies
2.5.5. Frontiers in Functional Genomics
2.6. Comparative Genomics
2.7. Pharmacogenomics
2.8. Proteomics
2.9. Structural Genomics
2.10. Disease Targets
2.10.1. Paradigm Shift in Drug Development: The Evolution of Targeted
Therapies
2.10.2. Personalized Warfarin Therapy
3. How Genomics Is Revolutionizing Healthcare
3.1. Pharmaceutical Applications
3.2. Diagnostics
3.3. Toxicogenomics
3.4. The Market for DNA Microarrays
3.5. DNA Chip Technology Competition
3.6. Expression Profiling
3.7. Gene Sequencing-Advantages of Chip Array Technology
3.8. Applied Markets for Genomics
3.9. Genomics and the Pharmaceutical Companies
3.10. Cancer Markets
3.11. Agricultural Markets
3.11.1. Plant Genomics
3.11.2. Food Processing
3.11.3. Animal Husbandry
4. Proprietary Applications and Patents
4.1. What is Patentable?
4.2. Patents and Litigation
5. Business Analysis
5.1. Facilitation and Capitalization of the Convergence of Gene Expression
Analysis and Proteomics
5.2. Competition
5.3. Market Opportunities for Functional Genomics
5.3.1. Metabolic Profiling
5.3.2. Anti-Fungal Targets
5.3.3. Nutrition
5.3.4. Crop Production
5.4. The Highly-Competitive Nature of the Genomics Industry
5.4.1. First-Generation Biotech
5.4.2. Second-Generation Genomics Companies
5.4.3. Next-Generation DNA Sequencing Companies
5.5. Strategic Alliances
6. Genomics Company Profiles
6.1. Affymetrix, Inc.
6.2. Agendia
6.3. Agilent Technologies, Inc.
6.4. Applied Biosystems Group
6.5. Bayer, AG
6.6. Biotage
6.7. Caliper Life Sciences
6.8. Celera Group
6.9. Cepheid
6.10. CLC bio
6.11. Clinical Data, Inc.
6.12. CuraGen Corporation
6.13. Cytocell Ltd.
6.14. diaDexus, Inc.
6.15. Enzo Biochem, Inc.
6.16. Exiqon A/S
6.17. GE Healthcare
6.18. Gene Link, Inc.
6.19. Gene Logic, Inc.
6.20. Genentech, Inc.
6.21. Genisphere, Inc.
6.22. Genomatix Software, Inc.
6.23. Genomic Solutions, Inc.
6.24. Gen-Probe, Inc.
6.25. Harvard Bioscience, Inc.
6.26. Helicos Biosciences Corporation
6.27. Human Genome Sciences, Inc.
6.28. Illumina, Inc.
6.29. Interleukin Genetics
6.30. LI-COR Biosciences
6.31. Luminex Corporation
6.32. Millennium Pharmaceuticals, Inc.
6.33. Monogram Biosciences, Inc.
6.34. Motorola, Inc.
6.35. MWG Biotech AG
6.36. Myriad Genetics, Inc.
6.37. Nanogen, Inc.
6.38. Nuvelo, Inc.
6.39. Orchid Cellmark
6.40. Pacific Biosciences, Inc.
6.41. QIAGEN, Inc.
6.42. Roche Diagnostics
6.43. Sequenom, Inc.
6.44. Third Wave Technologies, Inc.
6.45. Verenium Corporation
6.46. Visigen Technologies, Inc.
6.47. Brief Profiles of Companies Marketing Personalized Genomics Products
6.47.1. 23andMe, Inc.
6.47.2. deCODE Genetics, Inc.
6.47.3. Navigenics, Inc.
6.48. Brief Profiles of Other Selected Genomics Firms
6.48.1. Aber Genomic Computing
6.48.2. Spotfire, Inc.
7. Genomics Challenges and Growth Factors
7.1. Market Drivers
7.1.1. Product Pipeline: Need for More Drug Candidates
7.1.2. Need for Increased Research and Development Productivity
7.2. A Genomics Market Bottleneck-Bioinformatics
7.3. Strategic Recommendations-Market Opportunities
7.3.1. More Comprehensive Tools Are Needed
7.3.2. Resolving Bottlenecks in Functional Genomics Market
7.4. Key Trends of Recent Mergers and Acquisition Deals
7.5. Chemogenomics
7.6. Pharmacogenomics
7.7. Biomarkers
7.8. Additional Genomics Market Opportunities
8. Bioinformatics
8.1. Types of Data and Bioinformatics Applications
8.1.1. Validated Core Modeling Technology
8.1.2. Broad Applicability
8.1.3. Data Management Compliant with Industry Standards
8.1.4. Open Architecture
8.1.5. Ease of Use
8.1.6. Increased Access
8.2. Functions of Informatics Software
8.2.1. Data Management
8.2.2. Transformation of Data into Knowledge
8.2.3. Collaboration Among Researchers
8.2.4. Interface for Online Data Sources
8.3. Target Markets for Informatics Software
8.3.1. Pharmaceutical Companies
8.3.2. Biotechnology Companies
8.3.3. Academic and Government Research Institutions
8.3.4. Agricultural, Environmental and Industrial Biotechnology Companies
8.4. Products of Bioinformatics
8.4.1. Sequences and Structure of Genes and Proteins
8.4.2. 3-D Molecular Structures
8.4.3. Genome Structures and Functions
8.4.4. Bibliographic Data
8.5. Bioinformatics Processes
8.6. Informatics Tools and Functionalities
8.6.1. Sequence to Structure
8.6.2. Lead Identification and Optimization
8.6.3. Development and Formulation
8.6.4. Improving Materials and Processes in the Chemicals Industry
8.6.5. Other Materials-Based Industries
8.7. Role of Bioinformatics in the Value Chain
8.8. Bioinformatics Market Segments
8.8.1. Database
8.8.2. Hardware
8.8.3. Software
8.8.4. Bioinformatics Services
8.9. Bioinformatics Business Models
8.9.1. Changing Business Models
8.9.2. Selected Business Strategies
Glossary
INDEX OF FIGURES
Figure 2.1: Major Areas of Functional Genomics and Their Relationship to
Bioinformatics and Industry
Figure 8.1: Role of Bioinformatics in the Biotechnology Value Chain
INDEX OF TABLES
Table 2.1: Genomics Sector Global Market Size, 2001 to 2010
Table 2.2: Companies Marketing DNA Microarray Software
Table 2.3: Selected Competitors in the DNA Microarray Market
Table 2.4: Companies Offering DNA Sequencing Products
Table 2.5: Competitors in the SNP-Genotyping Segment
Table 2.6: Companies that Market MAQC-tested Gene Expression Microarrays
Table 2.7: Worldwide Market for Bioinformatics, 2005 to 2010
Table 2.8: Selected Companies Marketing New Functional Genomics Tools
Table 3.1: Genomics Pharmaceutical Market Sector Leaders and Promising
Newcomers
Table 3.2: Summary of Assays for HIV Viral Load Testing
Table 3.3: Global Market for HIV Diagnostic Testing, 2000 to 2012
Table 3.4: Summary of Molecular Diagnostics Testing
Table 3.5: Global Market for Molecular Diagnostics Testing, 2000 to 2012
Table 3.6: U.S. Market for Molecular Diagnostics Testing, 2004 to 2012
Table 3.7: Applied Markets for Genomics
Table 3.8: Competitors in the Field of Identity Genomics Testing
Table 3.9: Opportunities for Molecular-Targeting Therapeutics for Cancer
Table 3.10: Emerging Companies in the Anti-Cancer Sector
Table 8.1: Data Source and Bioinformatic Investigations
Table 8.2: Bioinformatics Activities, Subactivities and Key Players
Microarray Markets 1. Overview
1.1. Statement of Report
1.2. About This Report
1.3. Scope of the Report
1.4. Objectives
1.5. Methodology
1.6. Executive Summary
2. Overview of Microarrays
2.1. History of Microarrays
2.2. Genomics and Proteomics
2.2.1. Genetic Variability and Disease
2.3. General Theory of Microarrays
2.4. DNA Microarrays
2.5. Protein Microarrays
2.6. Tissue Microarrays
3. DNA Microarrays
3.1. Advantages and Drivers
3.2. Limitations and Barriers to Commercialization
3.3. DNA Microarray Technology Platforms
3.3.1. Reasons Why Researchers Utilize DNA Microarrays
3.3.2. Factors for Difficulties Applying DNA Microarrays Technology
3.4. Key Attributes of DNA Microarray Software
3.5. Applications
3.6. Future Directions for DNA Microarray Technology
3.6.1. High-Throughput Array Technology
3.6.2. Emerging Microarray Trends
3.6.3. Emerging Microarray Applications
3.6.4. Key Points for Developing Microarray Based Applications
3.7. Competitive Landscape for DNA Microarrays
4. Protein Microarrays
4.1. Critical Factors for Microarray Content
4.2. Key Findings on Use of Microarrays
4.3. Advantages and Drivers
4.4. Limitations and Barriers to Commercialization
4.5. Key Experimental Parameters of Protein Microarray Technology for
Current and Future Users
4.6. Reasons Why Researchers Utilize Protein Microarrays
4.7. Factors for Adoption of Protein Microarrays Technology
4.8. Top Suppliers of Protein Microarray Slides and Products
4.9. Factors that Influence Sale Decisions
4.10. Future Innovations in Protein Microarray Technology
5. Current DNA Microarrays
5.1. Key Players
5.2.1. Microarray-Based Commercial Genotyping Activity
5.2.2. Location Analysis
5.3. Future Innovations in DNA Microarray Technology
6. Current Protein Microarrays
6.1. Protein Profiling Microarrays-Antibody Arrays
6.2. Protein Profiling Microarrays-Reverse Phase Microarrays
6.3. Multiplex Sandwich Microarrays-Planar
6.4. Multiplex Sandwich Immunoassays-Bead Based
6.5. Microarrays for Protein Function Studies
6.6. High Growth Applications
6.6.1. Cytokine Arrays
6.6.2. Whole Proteome Arrays
6.6.3. Microarray-Based Commercial Genotyping Activity
6.6.3.1. Microarray-Based Genotyping Applications
6.6.3.2. Microbial Applications
6.6.3.3. The Market for Microbial Genotyping Products
6.6.3.4. Comparative Genomic Hybridization (CGH)
6.6.4 ChIP-on-Chip Analysis
7. Technology
7.1. Production of Microarrays
7.2. 2-D Versus 3-D Technology
7.3. Substrates and Surface Chemistries
7.4. Detection Methods
7.5. Instruments
7.6. Data Management and Informatics in Gene Expression
8. Applications
8.1. DNA Microarrays in Gene Expression
8.2. DNA Microarrays in SNP Analysis
8.3. DNA Microarrays in Cancer
8.4. Protein Expression
8.4.1. Cytokine Applications
8.4.2. Protein Function
8.4.3. Protein-Protein Interactions
8.5. Target /Biomarker Discovery
8.6. Drug Discovery and Development (Gene and Protein Microarrays)
8.7. Clinical Diagnostics (Gene and Protein Microarrays)
8.8. RNA Microarrays
8.9. Oligo Microarrays
8.10. Yeast Microarrays
8.11. Antibody Arrays
8.12. Arrays for Toxicogenomics
9. The Commercial Opportunity for Microarrays
9.1. Market Drivers for Microarrays
9.2. Market Restraints for Microarrays
9.3. Key Players
9.4. Market Size, Strategic Trends and Competitive Landscape for Protein
Arrays
9.5. Marketing and Distribution
9.6. Protein Arrays Market Analysis
9.7. Genes Associated with Major Diseases
9.8. Software and Data Analysis
9.8.1. Supplier of DNA Microarray Analysis Software
9.8.2. Satisfaction with Software Features
9.8.3. Satisfaction with Software
9.8.4. Supplier Factors in Software Purchase Decision
9.8.5. Suppliers' Role in Improving Data Sharing for DNA Microarrays
10. Company Profiles
LIST OF FIGURES
Figure 6.1: Cytokines and Growth Factors: Sources of Microarrays for
Cytokine Research
Figure 8.1: Microbial Genotyping: Applications for DNA Microarrays
Figure 8.2: Source of Variation in Microarray Data
Figure 8.3: Toxicogenomics: DNA Microarrays
LIST OF TABLES
Table 3.1: Microarray Product Revenue: Arrays, Reagents and Instruments,
2005 and 2010
Table 3.2: Microarray Market Drivers
Table 3.3: Microarray Market Barriers
Table 3.4: Unit Pricing of DNA Microarrays, 2000-2010
Table 3.5: Steps in the Design and Implementation of a DNA Microarray
Experiment
Table 3.6: Microarray Applications
Table 3.7: List of DNA Array Manufacturers
Table 4.1: Critical Factors for Microarray Content
Table 4.2: Top Three Suppliers of Treated Protein Microarray Surfaces for
Self-Printing
Table 4.3: Top Suppliers of Commercially Available Protein Microarrays
Table 4.4: Top Suppliers of Protein Microarray Readers
Table 5.1: Affymetrix Sales of Probe Arrays, 2000-2007
Table 5.2: Affymetrix Total Product Sales, 1999-2007
Table 5.3: Affymetrix Instrument Sales, 2000-2007
Table 6.1: Microarray Genetic Testing
Table 6.2: ChIP-on-Chip Microarray Market Size Projections, 2005-2011
Table 8.1: Applications of Biochips by Class
Table 8.2: Diagnostics Microarray Market Size Projections, 2005-2011
Table 8.3: HTS Microarray Market Size Projections, 2005-2011
Table 8.4: Pharmacogenomics Microarray Market Size Projections, 2005-2011
Table 8.5: Toxicology Screening Microarray Market Size Projections,
2005-2011
Table 8.6: Expression Profiling Microarray Market Size Projections,
2005-2011
Table 9.1: Market Share of Microarray Products, 2006
Table 9.2: Affymetrix Product Sales
Table 9.3: Leading Microarray Companies
Table 9.4: Worldwide Microarray Market Size, 2004-2012
Table 9.5: Microarray Market Share by Technology Type
Table 9.6: DNA Microarray U.S. Market Size, 2005-2011
Table 9.7: DNA Microarray Worldwide Market Size, 2002-2011
Table 9.8: Biochip Market by Usage, 2003 and 2007
Personalized Medicine 1. Overview
1.1. Statement of Report
1.2. Scope of this Report
1.3. Methodology
1.4. Executive Summary
2. The Case for Pharmacogenomics and Personalized Medicine: Biology, Approaches, Pipeline and Regulatory Trends
2.1. Scope of this Section
2.2. Introduction to Pharmacogenomics/Personalized Medicine
2.3. The Compelling Case for Personalized Medicine
2.4. The Process of Drug Metabolism and Implications for
Pharmacogenomics/Personalized Medicine
2.5. Examples of Personalized Medicine
2.5.1. Herceptin
2.5.2. Ziagen
2.5.3. Iressa
2.5.4. Erbitux
2.6. Personalized Medicine Product Pipeline
2.7. The Personalized Medicine Coalition
2.8. Regulatory Trends and Guidelines in the Personalized Medicine Space
2.9. FDA Approved Agendia's MammaPrint Diagnostic-The First IVDMIA to be
Approved
2.10. A Changing Regulatory Landscape for Personalized Medicine
2.11. Patenting Personalized Medicine
2.11.1. U.S. Supreme Court Dismisses LabCorp Appeal
2.12. The Leading Edge of Personalized Medicine: Specific Examples of
Clinical Situations Where Personalized Medicine is Appropriate and Being Used
2.12.1. EGFR Assay
2.12.2. Individualized Warfarin Therapy
2.12.3. UGT1A1 Molecular Assay for Camptosar
2.12.4. Response to Gleevec in Gastrointestinal Stromal Tumors
2.12.5. LabCorp, ARCA Personalized Medicine Deal for Cardiovascular
Diseases
2.12.6. Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to
Push into Pharmacogenomics
3. Pharmacogenomics/Personalized Medicine: Qualitative and Quantitative Market Analysis
3.1. Scope of this Section
3.2. Market Analysis of Molecular Diagnostics as it Relates to
Pharmacogenomics/Personalized Medicine
3.3. Snapshot of Diagnostics Industry Structure
3.4. The Case for Theranostics (Therapeutic/Companion Diagnostic)
3.5. Classification of Diagnostics by Risk
3.6. Personalized Medicine Market Analysis-Market Survey Data
Characterizing the Qualitative and Quantitative Industry Parameters
3.7. Segmentation of the Personalized Medicine Marketplace
3.8. Timeline for Impact of Various Segments in Personalized Medicine
3.9. Challenges for Personalized Therapeutics Development
3.10. Molecular Diagnostics Technology Platforms and Their Impact on
Personalized Medicine
3.11. Macro Trends in Personalized Medicine
3.12. Personalized Medicine: Industry SWOT Analysis
4. Company Profiles
4.1. Abbott Molecular, Inc./Vysis
4.2. Affymetrix, Inc.
4.3. Agendia
4.4. Celera Diagnostics
4.5. Cepheid
4.6. Clinical Data, Inc.
4.7. Dakocytomation
4.8. deCODE Genetics
4.9. DNA Direct, Inc.
4.10. DxS Ltd.
4.11. Exact Sciences Corp.
4.12. Exagen Diagnostics, Inc.
4.13. Gen-Probe
4.14. Genelex Corp.
4.15. Gene Logic, Inc.
4.16. Genentech, Inc.
4.17. Genomic Health, Inc.
4.18. Genzyme Genetics
4.19. Illumina
4.20. Luminex Corporation/Tm Biosciences
4.21. Monogram Biosciences
4.22. Myriad Genetics, Inc.
4.23. Nanogen
4.24. Osmetech plc
4.25. Perlegen Sciences, Inc.
4.26. PGxl Laboratories
4.27. Prometheus Laboratories, Inc.
4.28. Roche Diagnostics
4.29. Siemens Medical Solutions Diagnostics
4.30. Target Discovery, Inc.
4.31. Third Wave Technologies
4.32. Ventana Medical Systems
4.33. XDx, Inc.
Appendix 1: Qualitative Market Responses
LIST OF FIGURES
Figure 2.1: Phase I and II Processes of Drug Metabolism
Figure 2.2: Human Phase I Enzymes
Figure 2.3: Human Phase II Enzymes
Figure 2.4: Hepatic Distribution of Human CYP450
Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism
Figure 2.6: Genetic Components Determine Drug Metabolism
Figure 3.1: From Genetic Content to Personalized Medicine
Figure 3.2: The Lopsided Remuneration for Diagnostics
Figure 3.3: Breakout of the Molecular Diagnostics Marketplace
Figure 3.4: Molecular Diagnostics Market Segmentation
Figure 3.5: Molecular Diagnostics Market Segmentation by Technology
Figure 3.6: Market Survey Respondent Demographics
Figure 3.7: Breakout of the Respondent Pool by Affiliation
Figure 3.8: Segmentation of the Personalized Medicine Market
Figure 3.9: Personalized Medicine Market Drivers
Figure 3.10: Challenges in the Personalized Medicine Space
LIST OF TABLES
Table 2.1: Personalized Medicine at the Nexus Point
Table 2.2: Percentage of Non-Responders in Various Drug Classes
Table 2.3: High Profile Drug Withdrawals from the Marketplace
Table 2.4: Drug Metabolism Drives Drug Efficacy/Toxicity
Table 2.5: Population Frequency of the Various Cytochromes
Table 2.6: List of Personalized Medicine Tests
Table 2.7: Personalized Medicine Product Pipeline
Table 2.8: Marketed Personalized Therapies, 2006
Table 2.9: Current Targets, Drugs and Disease Areas Classified by their
Clinical Applications
Table 3.1: Areas in Personalized Medicine-Timeline of Impact
Table 3.2: Impact of Personalized Medicine on Various Therapeutic Areas
Table 3.3: Hurdles in Personalized Medicine Development in Various
Therapeutic Areas
Table 3.4: Various Molecular Diagnostics Technologies: Timeline for Impact
Table 3.5: Various Molecular Diagnostics Technologies: Impact on Different
Therapeutic Areas in Personalized Medicine
Table 3.6: Various Molecular Diagnostics Technologies: Technical
Challenges in the Deployment for Personalized Medicine
Table 3.7: Market Opportunities in Personalized Medicine
Table 3.8: Challenges for Market Adoption of the Various Personalized
Medicine Tests
Table 3.9: Personalized Medicine Industry SWOT
Pharmacogenomics for Clinical Use and in Drug Development 1. Overview
1.1. Statement of Report
1.2. Objectives of this Report
1.3. Scope of the Study
1.4. Methodology
1.5. Executive Summary
2. Introduction
2.1. Pharmacogenomic Testing Overview
2.1.1. Clinical Applications
2.1.2. Technologies for Pharmacogenomic Diagnostic Tools
2.1.3. Drug and Diagnostic Combinations
2.1.4. Economic Impact of Healthcare Costs
2.2. Genetic Variation among Individuals
2.2.1. Population Genomics
2.2.2. SNPs and Haplotypes
2.2.3. HapMap
2.2.3.1. The International HapMap Project
2.2.3.2. HapMap Participants and Funding Sources
2.3. Drug Metabolism
2.3.1. Adverse Drug Reactions (ADRs)
2.3.2. Drug-Test Combinations
2.4. Impact of Pharmacogenomics
2.4.1. How Will Gene Variation Be Used in Predicting Drug Response?
2.4.2. How Will Drug Development and Testing Benefit from
Pharmacogenomics?
2.4.3. Advantages of Pharmacogenomics
2.4.4. The Diagnostics-Therapeutics Fusion
2.4.5. Potential Challenges
2.4.6. Poor Metabolizer Phenotype Testing
2.4.7. Drug Repositioning
2.5. Pharmacogenomic Tests
2.5.1. CYP2D6
2.5.2. CYP2C19 and CYP2C9
2.5.3. CYP3A4 and CYP3A5 Genotyping
2.5.4. CYP1A2 and CYP2B6
2.5.5. NAT2, DPD, and UGT1A1
2.6. HercepTest
2.7. Drivers of Pharmacogenomic Testing
2.8. Pharmacogenomics and Drug Discovery
2.8.1. Business Implications of Pharmacogenomics in Drug Discovery
2.8.2. Impact of Pharmacogenomics on Drug Sales
2.8.3. Pressure to Optimize Drug Discovery Drives Use of Pharmacogenomics
3. Pharmacogenomic Testing Market: Size, Growth and Share
3.1. Global Pharmacogenomic Testing Markets by Technology Segments
3.1.1. Market Structure
3.1.2. Market Drivers in the Pharmacogenomic Diagnostics Testing Sector
3.1.3. Market Restraints in Pharmacogenomic Diagnostic Testing Segment
3.1.4. Principal Market Segments for Genomics Testing
3.1.4.1. Diagnostic Testing
3.1.4.2. Pharmacogenomic Testing
3.1.4.3. SNP Identification
3.1.5. Key Players in the Pharmacogenomic Diagnostics Testing Segment
3.1.6. Pharmacogenomic Testing Sector Analysis
3.2 U.S. Pharmacogenomic Testing Market
3.2.1. Market Overview
3.2.2. Diagnostic Testing Categories
3.3. European Pharmacogenomic Diagnostic Testing Market
3.4. Japanese Diagnostic Testing Market
4. Pharmacogenomic Disease Markers
4.1. SNPs
4.1.1. SNP Identification Market
4.1.2. Overview of SNP Identification
4.1.3. Strategies for SNP Identification
4.1.4. Candidate Gene Selection
4.1.5. Whole-Genome Linkage Disequilibrium Mapping
4.1.6. SNP Databases
4.1.7. Computational Tools for SNP Identification
4.1.8. SNPbrowser, Applied Biosystems
4.1.9. Progeny Suite, Progeny Software, LLC
4.1.10. Sentrix Array Matrix, Illumina
4.1.11. Third Wave Technologies (a Hologic Company)
4.2. Predictive Pharmacogenomics
4.2.1. Cancer Testing
4.2.2. Breast Cancer
4.2.3. Melanoma
4.2.4. Colon Cancer
4.2.5. Predictive Cancer Testing Market Size
4.2.6. Prostate Cancer
4.2.7. Lung Cancer
4.2.8. Acute Myelocytic Leukemia (AML)
4.2.9. Cystic Fibrosis
4.2.10. Genetic Test for Cardiac Ion Channel Mutations (Cardiac
Channelopathies)
4.2.11. Cardiac Transplants
4.2.12. Thiopurine S-methyltransferase (TPMT) Genetic Test
4.2.13. CARING Study
4.2.14. Vilazodone
4.2.15. STRENGTH Trials (Statin Response Examined by Genetic HAP Markers)
4.2.16. HIV and AIDS
4.2.17. Herceptin and Tykerb
4.2.18. Asthma
4.2.19. Hepatitis C Viral Load
4.3. Examining the Impact of Pharmacogenomics in Specific Disease
Application
4.3.1. The Impact of Pharmacogenomics in Bipolar and Other Psychiatric
Disorders
4.3.2. Pharmacogenomics in Warfarin Treatment
4.3.3. Pharmacogenomics and Breast Cancer Treatment
4.3.4. Pharmacogenomics of Depression
4.3.4.1. Tricyclic Antidepressants
4.3.4.2. Serotonin Re-uptake Inhibitors
4.3.4.3. Mirtazapine and Venlafaxine
4.3.4.4 Nefazodone, Moclobemide, Reboxetine and Trazodone
4.3.5. Pharmacogenomics of Cardiovascular Disease
4.3.5.1. Beta-blockers
4.3.5.2. Angiotensin II Type 1 Receptor Antagonists and AT1 Receptor
Antagonists (Sartans)
4.3.6. Pharmacogenomics of Thromboembolic Disorders
4.3.6.1. Warfarin
4.3.6.2. Acenocoumarol
4.3.6.3. Phenprocoumon
4.4. Gene Chips to Detect Cytochrome Variations
4.4.1. AmpliChip CYP450-Roche Diagnostics
4.4.2. GeneChip System-Affymetrix
4.4.3. NanoChip Molecular Biology Workstation-Nanogen, Inc.
5. Pharmacogenomic Testing: Development Issues
5.1. Adoption of Pharmacogenomic Testing
5.1.1. Pharmacogenomics Gatekeepers
5.1.1.1. Industry
5.1.1.1.1. Use of Pharmacogenomics in Drug Development
5.1.1.1.2. Co-development of Pharmacogenomics Diagnostics and Drugs
5.1.1.2. FDA as a Gatekeeper of Pharmacogenomics
5.2. Factors Influencing the Integration of Pharmacogenomics into Clinical
Trials
5.3. Moderators of Growth
5.3.1. Classification of Extensive vs. Poor Metabolizer
5.3.2. Genetic Testing
5.3.3. Cost-Benefit of Pharmacogenomic Testing
5.3.4. Workforce Issues
5.3.5. Reimbursement
5.3.6. New CPT Test Codes and Payment Amounts
5.3.7. CMS and Other Third-party Payers
5.3.7.1. Reimbursement Challenges to Pharmacogenomic Testing
5.3.7.2. CMS Regulatory Responsibilities
5.3.7.3. Costs Associated with Pharmacogenomic Testing
5.4. Clinical Guidelines and Pharmacogenomic Testing
5.5. Good Laboratory Practice (GLP)
5.6. Quality Assurance Issues
5.6.1. Criteria Required to Establish a Genomic Test for Clinical Use
5.6.2. Microarrays in Clinical Diagnostic Use
5.7. Pre-therapeutic Pharmacogenomic Testing
5.8. Regulatory Requirements
5.9. Screening
5.10. Cost of Phenotyping vs. Genotyping
5.11. Pharmacogenomic Tests: New Product Development
5.12. Underutilization of Pharmacogenomic Tests
6. Business Trends in the Industry
6.1. Pharmacogenomic Initiatives within Pharmaceutical Companies
6.2. Pharmacogenomic Testing Growth Factors
6.3. Acquisition, License Agreements, Internal Development and Partnerships
6.4. Product Testing Depth in Pharmacogenomic Testing
6.5. Government Regulation
6.5.1. U.S. Regulations
6.5.2. U.K. Regulations
6.5.3. E.U. Regulations
6.5.4. Japanese Regulations
6.6. Increased Market Penetration in Pharmacogenomic Testing
6.7. Legal Issues
6.7.1. Federal Policy History
6.7.2. State Policy History
6.7.3. Federal Anti-Discrimination Laws and How They Apply to Genetics
6.7.3.1. The Genetic Information Nondiscrimination Act of 2008 (GINA)
6.7.4. Prescription Drug User Fee Act (PDUFA)
6.7.5. Liability Concerns for Pharmacogenomics Drug and Diagnostic
Developers
6.8. Barriers to Growth
6.9. Drivers of Growth
6.10. Product Launches and Developments
6.11. Investment Parameters for Diagnostic Companies
6.12. Key Elements of the Pharmaceutical Value Chain
6.13. An Evaluation of Successful Pharmacogenomic Business Models
6.14. Ethical Considerations for Pharmacogenomic Applications
6.15. Drug Repositioning Services
6.16. Patent Protection of Pharmacogenomic Technology
6.17. FDA Product Submission and Review Process
6.18. FDA Pipeline for Pharmacogenomic Tests
6.19. Adaptive Clinical Trial Design
7. Important Technology Trends in Pharmacogenomics
7.1. Trends in Pharmacogenomic Testing
7.2. Drug Metabolism
7.3. Personalized Medicine: the Genomic and Proteomic Approach
7.4. Biomarkers
7.4.1. Cancer
7.4.1.1. Leukemia: Gleevec and Dasatinib (BMS-354825)
7.4.1.2. Gefitinib (Iressa)
7.4.1.3. Colorectal Cancer
7.5. Cardiovascular Drugs
7.5.1. Arrhythmia
7.5.2. Hypertension
7.5.3. Hyperlipidemia
7.5.4. Myocardial Infarction
7.5.5. Heart Failure
7.6. Future Developments
7.6.1. GSK's Pharmacogenomic Program
7.6.2. Roche's Biomarker Strategy
7.6.3. Hypertension Markets
7.6.4. Expression Data to Integrate Pharmacology and Chemistry Data
7.6.5. Metabolomics
7.6.6. Theranostics
8. Overview and Conclusions
8.1. The Unrealized Promise of Pharmacogenomics
8.2. The New Drug Pipeline
8.3. Pharmacogenomics and Regulation
8.4. Pharmacogenomics and Reimbursement
8.5. Key Considerations for Realizing the Promise of Pharmacogenomics
8.6. Development of Easy to Use Point of Care Pharmacogenomic Tests
8.7. Development of Pharmacogenomic Tests during Drug Development
8.8. Pharmacogenomics' Impact on Commercial Strategies
8.9. Pharmacogenomics' Impact on the Blockbuster Model of Drug Development
8.10. Pharmacogenomics' Impact on Clinical Trials
8.11. Pharmacogenomic Business Models
8.12. Structure of Pharmacogenomic Deals and Alliances
8.13. Challenges to Pharmacogenomics
9. Company Profiles
9.1. Abbott Laboratories
9.2. Affymetrix
9.3. Agilent Technologies, Inc.
9.4. Ambry Genetics
9.5. ARCA Biopharma, Inc.
9.6. Asper Biotech
9.7. AstraZeneca
9.8. Bayer
9.9. BioTrove, Inc.
9.10. Bristol-Myers Squibb
9.11. Celera Group
9.12. Clinical Data
9.13. CombinatoRx, Inc.
9.14. Complement Genomics Ltd.
9.15. Covance Inc.
9.16. CuraGen Corporation
9.17. Cypress Bioscience, Inc.
9.18. Dako (formerly DakoCytomation)
9.19. deCODE Genetics
9.20. DNAPrint Genomics
9.21. DxS
9.22. EraGen Biosciences
9.23. EXACT Sciences
9.24. Expression Analysis
9.25. FivePrime Therapeutics
9.26. GE Healthcare
9.27. Gene Express, Inc.
9.28. GeneGO Inc.
9.29. Genelex Corporation
9.30. Genentech
9.31. Genizon Biosciences Inc.
9.32. Genomic Health
9.33. Gentris
9.34. Genzyme
9.35. GlaxoSmithKline
9.36. g-Nostics Ltd.
9.37. Hologic
9.38. Human Genome Sciences
9.39. Illumina
9.40. Incyte, Inc.
9.41. InterGenetics Inc.
9.42. Interleukin Genetics
9.43. Iris BioTechnologies Inc.
9.44. Johnson & Johnson
9.45. Lab21
9.46. Life Technologies Corporation
9.47. Luminex Corp.
9.48. MediBIC Group
9.49. Melior Discovery Inc.
9.50. Merck & Co.
9.51. Merck Serano
9.52. Millennium Pharmaceuticals
9.53. Monogram Biosciences, Inc.
9.54. Myriad Genetics, Inc.
9.55. Nanogen
9.56. Nanosphere
9.57. Nitromed
9.58. Ocimum Biosolutions
9.59. Orchid Cellmark
9.60. Ore Pharmaceuticals
9.61. PharmaSeq
9.62. Prediction Sciences
9.63. Predictive Biosciences
9.64. Prometheus Laboratories
9.65. Progeny Software, LLC
9.66. Roche Diagnostics
9.67. Response Genetics, Inc.
9.68. Sequenom
9.69. SimuGen Ltd.
9.70. Sosei Group Corporation
9.71. Transgenomic, Inc.
9.72. TrimGen Corp.
9.73. Tripos International
9.74. Vertex Pharmaceuticals
9.75. VIA Pharmaceuticals, Inc.
9.76. Warnex
9.77. Wyeth
9.78. XDx, Inc.
INDEX OF FIGURES
Figure 2.1: Roche AmpliChip
Figure 2.2: FDA Approval Rates for NME Drug Applications vs. R&D
Expenditures, 1998-2008
Figure 2.3: Steps Involved in Bringing a Drug to Market
Figure 2.4: CYP2C9
Figure 6.1: Total Spending on Healthcare in the U.S., 1960-2008
Figure 6.2: The Healthcare Dollar, 2008
INDEX OF TABLES
Table 1.1: The Success of Pharmacogenomics: Drugs that Utilize Companion
Tests, 2008
Table 2.1: The Difference between Pharmacogenomics and Pharmacogenetics
Table 2.2: Clinical Applications of Diagnostic Pharmacogenomic Testing
Table 2.3: Comparison of New Molecular Entity Outcomes for FDA and EMEA
(Jan 2006 - October 2008)
Table 2.4: Timeline for Development of Companion Diagnostics
Table 2.5: Valid Genomic Biomarkers in the Context of FDA-Approved Drug
Labels
Table 2.6: Potential Benefits of Biomarkers as Companion Diagnostics in
Drug Development
Table 2.7: Groups Participating in the International HapMap Project
Table 2.8: High-Profile Drug Withdrawals from the Marketplace
Table 2.9: Response Rates of Patients to a Major Drug for Selected
Therapeutic Areas
Table 2.10 Factors That Determine a Successful Pharmacogenomic Test
Table 2.11: Pharmacogenomics' Influence on Drug Sales
Table 2.12: Pharmacogenomics' Effect on Maximizing R&D Productivity
Table 2.13: Prevalence of Metabolically-Active Enzymes
Table 2.14: Pharmacogenomics in Phase II and Phase III Trials
Table 2.15: Drug Testing
Table 2.16: Factors Affecting Variability in Individual Response to Drug
Therapy
Table 2.17: CYP2D6 Characteristics
Table 2.18: CYP2D6 Metabolism of Drug Types
Table 2.19: CYP2C19
Table 2.20: CYP2C19 Metabolism of Drug Types
Table 2.21: CYP2C9 Characteristics
Table 2.22: CYP2C9 Metabolism of Drug Types
Table 2.23: CYP3A4/5/7 Metabolism of Drug Types
Table 2.24: CYP1A2 Metabolism of Drug Types
Table 2.25: CYP2B6 Metabolism of Drug Types
Table 2.26: Drivers of Pharmacogenomic Testing
Table 2.27: Markets for Pharmacogenomic Testing
Table 3.1: Worldwide Pharmacogenomic Market Size by Technology Segments,
2004-2012
Table 3.2: Total Pharmacogenomic Testing Market Size, 2001-2012
Table 3.3: Diagnostic Pharmacogenomic Testing Market Size, 2001-2012
Table 3.4: Benefits of Pharmacogenomic Diagnostics in Patient Care
Table 3.5: Genotyping Pharmacogenomic Testing Market Size, 2001-2012
Table 3.6: Benefits of Pharmacogenomics in Clinical Trials and Drug
Development
Table 3.7: Five Key Action Points for Pharmaceutical Companies
Table 3.8: Global SNP Identification Tools Market Size, 2004-2012
Table 3.9: Pharmacogenomic Testing Market Structure
Table 3.10: P450 Isozymes and Pharmaceuticals
Table 3.11: List of Companies that Market Pharmacogenomic Tests
Table 3.12: Key Collaborations in the Pharmacogenomics Industry
Table 3.13: Prominent Drugs Withdrawn from the Market
Table 3.14: Key Elements in the Drug Development Process
Table 3.15: Major Suppliers of PCR-based Assays and PCR-based Technologies
Table 4.1: Methods for Performing NAT
Table 4.2: SNP Databases
Table 4.3: Myriad Genetics Predictive Medicine Sales, 2001-2008
Table 4.4: DNA-based Predictive Medicine Product Sales for Cancer,
2006-2010
Table 4.5: Developmental Atherosclerosis Drugs
Table 4.6: Summary of Assays for HIV Viral Load Testing
Table 4.7: U.S. Market Share of HIV Testing Kits
Table 4.8: Global HIV Statistics, 2007
Table 4.9: List of Approved HIV/AIDS Rapid Test Kits, 2009
Table 4.10: Monogram Bioscience, Inc. Products for HIV Testing
Table 4.11: CCR-5 Receptor Agonists in Development, 2009
Table 4.12: Asthma Therapeutic Drug Pipeline
Table 4.13: Psychiatric Case Studies, Organized Pharmacokinetically
Table 4.14: Antidepressant Drugs Decreased Clearance with DME CYP2D6
Table 4.15: Antidepressant Drugs with No Effect Clearance with DME CYP2D6
Table 5.1: Examples of Gene-Drug Pharmacogenomic Relationships
Table 5.2: Estimated Cost and Time for Typing of the BRCA1 Gene by Direct
Sequencing vs. SNP Array
Table 5.3: Average Cost of Resistance Testing, 2007
Table 6.1: U.S. Prescription Drug Expenditures, 2003-2015
Table 6.2: U.S. Pharmaceutical Market, 1996-2009
Table 6.3: Top Ten Global Pharmaceutical Companies by Global Sales, 2007
Table 6.4: Pharmaceutical Companies Ranked by Total R&D Expenditures, 2007
Table 6.5: Leading Therapy Classes for R&D, 2008
Table 6.6: Leading Therapy Classes by Global Pharmaceutical Sales (Audited
Market), 2007
Table 6.7: Number of NME Approvals and Mean Approval Times, 1984-2008
Table 6.8: Global Market for Tools and Consumables Used in Drug Discovery
and Development, 1999-2010
Table 6.9: Leading Therapeutic Classes by U.S. Sales, 2006 and 2007
Table 6.10: Top Ten Therapeutic Classes by U.S. Dispensed Prescriptions,
2006 and 2007
Table 6.11: Top Ten Brand Drugs by U.S. Retail, 2007
Table 7.1: Select Companies Developing Cancer Diagnostics Available as
Analyte Specific Reagents (ASRS)
Table 7.2: Emerging Fields in Biological Science with the Potential to
Impact Personalized Medicine
Regenerative Medicine Markets 1. Overview
1.1. Statement of Report
1.2. Scope of this Report
1.3. Methodology
1.4. Executive Summary
2. Regenerative Medicine: An Overview of Segments
2.1. Tissue Engineering
2.1.1. Tissue-Engineered Skin
2.1.2. Tissue-Engineered Cartilage
2.1.3. Tissue-Engineered Bone
2.1.4. Tissue-Engineered Peripheral Nerves
2.1.5. Tissue-Engineered Cornea
2.1.6. Tissue-Engineered Blood Vessels
2.2 An Overview of Tissue Engineering and Regenerative Medicine (TERM)
2.2.1. Tissue-Engineered Products and Their Applications
2.2.1.1. Skin, Cartilage, Bone and Urological Applications
2.2.1.2. Cardiovascular Applications
2.2.1.3. Neurological Applications
2.2.1.4. Pancreas, Liver and Kidney Applications
2.2.1.5. Ophthalmic Applications
2.2.1.6. Dental Applications
2.2.1.7. Autologous and Allogeneic Products
2.2.2. Geographic Distribution of TERM Firms in the Five Focus Countries
2.3. Cell Therapy
2.3.1. Number of Patients Treated between 1988 and 2010 by Regenerative
Medicine Therapies
2.3.2. Cell Culture Products
2.3.2.1. In Vitro Test Kits
2.3.2.2. Suppliers of Cells and Tissues
2.3.2.3. Suppliers of Culture Media and Reagents
2.3.2.4. Equipments for Stem Cell Research
2.3.2.5. Computer Software for Stem Cell Research
2.3.3. Overall Picture of Cell Therapy Industry
2.3.3.1. The Size of Cell Therapy Industry
2.3.3.2. The Age, Size and Location of Firms
2.3.3.3. Technology and Disease Focus
2.3.4. Cell Therapy Products and Companies
2.3.4.1. First Generation (Non-Stem Cell-based) Primary Products
2.3.4.2. Second Generation (Stem Cell-Based) Primary Products
2.3.4.3. Secondary Products
2.3.4.4. Products in Development
2.3.5. The Disease Focus of Clinical Trials
2.3.5.1. Stem Cell Industry Pipeline
2.3.6. Industry Collaboration in Stem Cell Space
2.3.6.1. Commercial Success in Stem Cell Industry
2.3.6.2. Major Shift to Stem Cells from Non-Stem Cell Technologies
2.3.6.3. Challenges to Commercial Development of Cell Therapies
2.3.6.4. Partnership of Stem Cell Companies with Large Pharmaceutical
Companies
2.3.6.5. Strategic Approaches for Cell-Based Companies
2.3.6.6. The Need for Support from Large Pharmaceuticals
2.4 Scaffolding Biomaterials
2.4.1. Biomaterial Scaffolds in Regenerative Medicine
2.5. Growth Factors
3. Regenerative Medicine: The Next Evolution of Medical Treatments
3.1. Scope of this Chapter
3.2. Need for Regenerative Medicine
3.3. Current State of Regenerative Medicine
3.4. Future of Regenerative Medicine
3.5. Number of Products in Pipeline
3.6. Projected Timeline for Regenerative Medicine
3.7. Regenerative Medicine Products in the Market
3.7.1. Medtronic's Infuse Bone Graft and the LT-Cage Device
3.7.2. Genzyme's Carticel
3.7.3. Stryker's OP-1
3.7.4. Osyris/Nuvasive's Osteocel
3.7.5. RTI's Spinal Implants
3.7.6. Organogenesis' Apligraf
3.7.7. Advanced BioHealing's Dermagraft
3.7.8. Integra's Bilayer Matrix Wound Dressing
3.7.9. LifeCell's Alloderm
3.7.10. Cytori Therapeutics' Celution
3.8. Other Products of Importance in Regenerative Medicine
3.8.1. Tissue-Engineered Wound Healing Products
3.8.1.1. Oasis
3.8.1.2. Permacol
3.8.1.3. EZ-Derm
3.8.1.4. Matriderm
3.8.1.5. TransCyte
3.8.1.6. ICX-SKN
3.8.1.7. OrCel
3.8.1.8. Epicel
3.8.1.9. Myskin
3.8.1.10. VCT01
3.8.2. ICX-TRC-Hair Regeneration Therapy
3.8.3. Cartilage Regeneration
3.8.3.1. Novocart
3.8.3.2. BioSeed-C
3.8.3.3. BioSeed-Oral Bone
3.8.3.4. Chondrotissue
3.8.3.5. co.don Chondrotransplant
3.8.3.6. co.don Chondrotransplant DISC
3.8.3.7. co.don Chondrosphere
3.8.3.8. co.don Osteotransplant DENT
3.8.3.9. MACI Implant
3.8.3.10. Cartilink-3
3.8.3.11. Accell Evo3 Demineralized Bone Matrix
3.8.3.12. OsSatura BCP
3.8.4. Mozobil
4. Market Analysis of Regenerative Medicine Sector
4.1. Scope of this Chapter
4.1.1. Market for Regenerative Medicine Products
4.1.2. The Different Characteristics of Regenerative Medicine Industry in
the Recent Past
4.1.3. Potential Market for Regenerative Medicine in the U.S.
4.2. Global Market for Stem Cells
4.3. Market for Cell Therapy in the U.S.
4.4. Global Market for Cord Blood Stem Cells
4.4.1. Public Cord Blood Banks
4.4.2. Private Cord Blood Banks
5. Business Models and Requirements for a Successful Regenerative Medicine Industry
5.1. Scope of this Chapter
5.1.1. The Limited Success Achieved by the Regenerative Medicine Products
5.1.2. Business Models in Regenerative Medicine
5.1.3. Current Model for Autologous Cell Therapies
5.1.4. Current Models for Allogeneic Cell Therapies
5.1.5. Key Factors for Successful Business Models for Cell Therapies
5.2. Commercial Manufacturing of Cell Therapy Products: Requirements
5.2.1. Elements of Commercial Manufacturing
5.2.1.1. Regulatory Requirements
5.2.1.2. Manufacturing Process Scale
5.2.1.3. In-House Manufacturing
5.2.1.4. Contract Manufacturing: Commercial and Academic
6. Diseases with Potential Applications for Regenerative Medicine
6.1. Regenerative Medicine and Diabetes
6.2. Regenerative Medicine for Cardiac Repair
6.3. Regenerative Medicine in Orthopedics
6.3.1. Orthobiologics in Orthopedics
6.3.2. Growth Factor Therapies in Orthopedics
6.3.3. Stem Cell Therapies in Orthopedics
6.4. Regenerative Medicine in Liver Diseases
6.4.1. Hepatocyte-Like Cells for Liver Disease
6.4.2. Cell Therapy for Liver Cirrhosis
6.4.3. CD 34+ Cells
6.5. Regenerative Medicine in Retinal Replacement Therapy
6.5.1. Retinal Transplantation
6.6. Regenerative Medicine in Central Nervous System (CNS) Disorders
6.6.1. Clinical Activity for Stem Cell Transplantation into the CNS
7. Current Stem Cell Research and Federal Funding in the U.S.
7.1. Scope of this Chapter
7.2. Stem Cell Policies in North America
7.3. Stem Cell Policies in South America
7.4. Stem Cell Policies in Europe
7.5. Stem Cell Policies in Asia/Oceania
7.6. Stem Cell Policies in Africa
7.7. Stem Cell Research and California Institute for Regenerative Medicine
(CIRM)
7.7.1. CIRM Collaborative Funding
7.7.2. CIRM's funding for Clinical Applications
7.7.3. Early Translational Awards
7.7.4. CIRM's Disease Team Awards
7.8. Stem Cell Research Programs in Connecticut Department of Public Health
7.8.1. Seed Grant Awards from Connecticut Stem Cell Research Program in
2010
7.8.2. Established Investigator Awards from Connecticut Stem Cell
Research Program in 2010
7.8.3. Group Project Awards from Connecticut Stem Cell Research Program
in 2010
7.8.4. Core Facility Awards from Connecticut Stem Cell Research Program
in 2010
7.8.5. Maryland Technology Development Corporation (TEDCO)
7.8.6. TEDCO's Fort Detrick Technology Transfer Initiative (FDTTI)
7.8.7. Johnson & Johnson Investment Fund
7.8.8. TEDCO's NAVAIR Technology Insertion (NAVTI) Program
7.8.9. TEDCO's TechStart Program
7.8.10. TEDCO's University Technology Development Fund (UTDF)
7.8.11. TEDCO's Working Capital Loan Fund
7.8.12. Maryland Technology Transfer and Commercialization Fund (MTTCF)
7.8.13. Maryland Stem Cell Research Fund
7.9. The New Jersey Commission on Science and Technology (NJCST)
7.9.1. Investigator Initiated Research Projects (IIRP) and Innovative,
Developmental or Exploratory Activities (IDEA) in Stem Cell Research
7.9.2. Targeted Request for Applications for Investigation of iPS and
Other Derivation Approaches
7.9.3. Shared Facilities/Resources and Equipment/Instrumentation for Stem
Cell Research
7.9.4. Consortia Planning Awards
7.9.5. Institutional Development
7.10. Center for Stem Cell and Regenerative Medicine
7.11. Global Funding for Regenerative Medicine
7.12. Federal Funding of Stem Cell Research in the U.S.: Past and Present
7.12.1. The U.S. National Institute of Health (NIH) Guidelines to hESC
Research
7.12.2. Types of Research Ineligible for NIH Funding
7.12.3. NIH's Leadership in Providing Funds for Stem Cell Research
7.12.4. NIH Guidelines Addressing the Projected Growth of Stem
Cell-related Clinical Trials
7.12.5. Federal Agencies Providing Funds for Stem Cell Research
8. Company Profiles
8.1. Aastrom Biosciences, Inc.
8.1.1. Aastrom's Clinical Trial Programs
8.1.1.1. Dilated Cardiomyopathy
8.1.1.2. Critical Limb Ischemia
8.1.1.3. Osteonecrosis of the Femoral Head
8.1.1.4. Other Bone Disorders
8.1.2. Product Development
8.1.3. Aastrom's Cell Manufacturing
8.1.4. Aastrom's Business Performance
8.2. Advanced Cell Technology, Inc. (ACT)
8.2.1. ACT's Cellular Reprogramming
8.2.2. ACT's Stem Cell Differentiation
8.2.2.1. ACT's Retinal Pigment Epithelium (RPE) Program
8.2.2.2. ACT's Hemangioblast Program
8.2.2.3. ACT's Adult Stem Cell Program
8.2.3. ACT's Intellectual Property
8.2.4. ACT's Business Performance
8.2.5. ACT's Investment in Research and Development
8.3. Aldagen, Inc.
8.3.1. Aldagen's ALD-201
8.3.2. Aldagen's ALD-301
8.4. Altrika Ltd.
8.4.1. Myskin
8.4.2. Cryoskin
8.4.3. Altrika's Future Products
8.4.3.1. Lyphoderm
8.4.3.2. Corneal Bandage
8.4.3.3. Leukodepletion Filters
8.5. Alseres Pharmaceuticals, Inc.
8.5.1. Alseres' Product Pipeline
8.5.1.1. Celthrin-A Rho Inhibitor
8.5.1.2. Inosine
8.5.1.3. Oncomodulin and ALSE-100
8.5.1.4. Altropane-PD
8.5.2. Alseres' Science and Technology
8.5.2.1. Nerve Repair Pathways
8.5.2.2. The Pro-Regenerative Pathway
8.5.2.3. The Anti-Regenerative Pathway
8.5.2.4. Molecular Imaging
8.5.2.5. Dopamine Transporter
8.6. Amgen, Inc.
8.6.1. Amgen's Marketed Products
8.6.1.1. Aranesp (Darbepoetin Alfa)
8.6.1.2. Epogen (Epoetin Alfa)
8.6.1.3. Neulasta (Pegfilgrastim)/Neupogen (Filgrastim)
8.6.1.4. Enbrel (Etanercept)
8.6.1.5. Sensipar (Cinacalcet)
8.6.1.6. Vectibix (Panitumumab)
8.6.1.7. Nplate (Romiplostim)
8.6.2. Amgen's Marketing and Distribution
8.6.3. Amgen's Overall Business Performance
8.7. Amorcyte, Inc.
8.7.1. Amorcyte's Technology
8.8. AnGes MG, Inc.
8.8.1. AnGes' Genetic Medicine
8.8.2. HGF Genetic Medicine
8.8.3. Hemagglutinating Virus of Japan (HVJ) Envelope Vector
8.8.4. NF-kB Decoy Oligodeoxynucleotide
8.9. Angioblast Systems, Inc.
8.9.1. Angioblast's Technology and Applications
8.9.1.1. Allogenic Adult Stem Cells
8.9.1.2. Protein Therapeutics
8.9.1.3. Gene Slicing
8.10. Angion Biomedica, Corp.
8.10.1. HGF and c-Met Signaling in Tissue Repair and Organ Regeneration
8.10.2. PARP-1
8.10.3. TGFB1
8.11. Ars Arthro Biotechnology, Inc.
8.11.1. CaReS
8.11.2. Fibrocell
8.11.3. Fibroplus
8.12. Arteriocyte Medical Systems, Inc.
8.12.1. Blood Pharming
8.12.2. Cardiac Ischemia
8.12.3. Critical Limb Ischemia
8.12.4. Malaria Research
8.12.5. Orthopedic Regenerative Medicine
8.12.6. Proliferative Diabetic Retinopathy
8.12.7. Wound Healing
8.13. Athersys, Inc.
8.13.1. Athersys' Pipeline
8.13.2. MultiStem for Stem Cell Therapy
8.13.3. MultiStem for Bone Marrow (BM) Transport Support
8.13.4. MultiStem for Acute Myocardial Infarction
8.13.5. MultiStem for Stroke
8.13.6. Treatments for Obesity
8.13.7. Histamine H3 Receptor Antagonists
8.13.8. Athersys' Collaborations and Partnerships
8.13.8.1. Collaboration with Pfizer
8.13.8.2. Collaboration with Angiotech
8.13.8.3. Collaboration with Bristol-Myers Squibb
8.13.9. Athersys' Research and Development
8.13.10. Athersys' Business Performance
8.14. BeFutur Biotechnologies
8.14.1. BeFutur's Technologies
8.14.1.1. Cells and Tissue Engineering
8.14.1.2. Serum-Free Technology
8.15. BioE, Inc.
8.16. Bioheart, Inc.
8.16.1. Bioheart's Product Candidates
8.16.1.1. MyoCell
8.16.1.2. MyoCell SDF-1
8.16.1.3. TGI 1200 Cell Isolation System
8.16.1.4. Bioheart 3370
8.16.2. Bioheart's Patents and Proprietary Rights
8.17. BioLine Rx
8.17.1. BioLine's Product Pipeline
8.17.1.1. BL-1020 Schizophrenia
8.17.1.2. BL-1040 for Acute Myocardial Infarction
8.17.1.3. BL-5010 for Skin Lesions
8.17.1.4. BL-1021 for Neuropathic Pain
8.17.1.5. BL-2030 for Inflammation
8.17.1.6. BL-1023 for Parkinson's Disease
8.17.1.7. BL-4010 for Cancer
8.17.1.8. BL-4040 for Acute Kidney Failure
8.17.1.9. BL-5030 for Thromboembolic Diseases
8.17.1.10. BL-5040 for Cachexia and Inflammatory Bowel Disease
8.18. BIOMET
8.18.1. BIOMET 3i
8.18.2. Clotalyst Autologous Serum Collection System
8.18.3. BioCUE Platelet Concentration System
8.19. BioMimetic Therapeutics, Inc.
8.19.1. BioMimetic's Product Candidates
8.19.2. BioMimetic's Research and Development
8.20. BioSafe Group SA
8.20.1. Sepax
8.20.2. Sepax System in Adult Stem Cell Banking
8.20.3. Coolmix
8.20.4. SepaxNet
8.21. BioTime, Inc.
8.21.1. BioTime's Stem Cell Products for Regenerative Medicine
8.21.2. BioTime's Embryome Database
8.21.3. BioTime's Progenitor and hES Cell Lines
8.21.4. BioTime's hES Cells Carrying Genetic Diseases
8.21.5. BioTime's ESpan Cell Growth Media
8.21.6. BioTime's ESpy Cell Lines
8.21.7. BioTime's Licensed Stem Cell Technology and Stem Cell Product
Development Agreements
8.21.7.1. Wisconsin Alumni Research Foundation
8.21.7.2. ACTCellerate Technology
8.21.7.3. The iPS Technology
8.21.7.4. Lifeline
8.21.7.5. BioTime's Stem Cell Agreement with Reproductive Genetics
Institute
8.21.8. BioTime's Plasma Volume Expanders and Related Products
8.21.8.1. Hextend
8.21.8.2. PentaLyte
8.22. Biovest International, Inc.
8.22.1. BiovaxID Cancer Vaccine
8.23. BrainStorm Cell Therapeutics, Inc.
8.23.1. BrainStorm's Technology
8.23.2. BrainStorm's Stem Cell Therapy
8.23.3. BrainStorm Technology-NurOwn
8.24. Cardio3 BioSciences
8.24.1. Cardio3's Product Pipeline
8.24.1.1. C-Cure
8.24.1.2. C-Cure2
8.24.1.3. Allo-Cure
8.24.1.4. G-Cure
8.24.1.5. C-Cath
8.24.2. Cardio3's Investors
8.25. CardioPolymers, Inc.
8.25.1. CardioPolymer's Products
8.25.1.1. Algisyl-LVR
8.25.1.2. Plexisyl-AF
8.25.2. CardioPolymer's Investors
8.26. CaridianBCT
8.26.1. Trima Accel Automated Blood Collection System
8.26.2. Spectra Optia Apheresis System
8.26.3. COBE Spectra Apheresis System
8.26.4. Elutra Cell Separation System
8.26.5. Atreus Whole Blood Processing System
8.26.6. OrbiSac System
8.26.7. COBE 2991 Cell Processor
8.27. Cardium Therapeutics, Inc.
8.27.1. Cardium Biologics
8.27.2. Cardium's Tissue Repair Company
8.27.3. Cardium's Gene Activated Matrix (GAM) Technology
8.27.4. Cardium's Biologics and Stem Cells for Regenerative Medicine
8.28. Cellartis AB
8.28.1. Cellartis' Products
8.28.1.1. The hES-CMC 2D: Cardiomyocyte Monolayers
8.28.1.2. The hES-CMC 002: Cardiomyocyte Clusters
8.28.1.3. The hES-HEO 002: Hepatocyte-like Cells
8.28.1.4. The hES-MP 002.5: Mesenchymal Progenitors
8.28.1.5. The hES Cell Lines
8.28.1.6. SCED 461: Human ES Cells
8.28.1.7. Monoclonal Antibodies
8.28.2. Cellartis' Licensing Activities
8.29. Cellerix
8.29.1. Ontaril
8.29.2. Cx501
8.30. Celgene Corporation
8.30.1. Celgene's Business Performance
8.30.2. Celgene's Commercial Stage Products
8.30.2.1. Revlimid (Lenalidomide)
8.30.2.2. Thalomid (Thalidomide)
8.30.2.3. Vidaza (Azacitidine for Injection)
8.30.2.4. Ritalin Family of Drugs
8.30.2.5. Alkeran (Melphalan)
8.30.2.6. IMiDs Compounds
8.30.2.7. Oral Anti-Inflammatory Agents
8.30.2.8. Kinase Inhibitors
8.30.2.9. Cellular Therapies
8.31. CellSeed, Inc.
8.31.1. CellSeed's Epithelial Cell Sheet for Corneal Regeneration
8.31.2. CellSeed's Regenerated Cardiac Patch
8.31.3. CellSeed's Epithelial Cell Sheet for Esophageal Regeneration
8.31.4. CellSeed's Cell Sheet for Periodontal Tissue Regeneration
8.31.5. CellSeed's Regenerated Cartilage Sheet
8.32. Cellular Dynamics International
8.32.1. The iCell Cardiomyocytes
8.32.2. Cellular Dynamics' Technology
8.33. Celltrix
8.34. Cerco Medical
8.34.1. Cerco Medical's Concept
8.34.2. Bio-Artificial Endocrine Pancreas
8.35. Cook Biotech, Inc.
8.35.1. Cook's Technology
8.35.2. Biodesign Dural Graft
8.35.3. Dynamatrix Oral Graft
8.35.4. SiS Ophthalmic
8.35.5. Oasis Wound Matrix
8.35.6. Biodesign Staple Line Reinforcement
8.35.7. Biodesign Hiatal Hernia Graft
8.35.8. ECM for Pericardial Closure
8.35.9. ECM for Cardiac Tissue Repair
8.35.10. Biodesign 8-Layer Tissue Graft
8.35.11. Biodesign Abdominal Lock Graft
8.35.12. Biodesign Hernia Graft
8.35.13. Biodesign Inguinal Hernia Graft
8.35.14. Biodesign Umbilical Hernia Graft
8.35.15. Biodesign Anterior Pelvic Floor Graft
8.35.16. Biodesign Fistula Plug
8.35.17. Biodesign Posterior Pelvic Floor Graft
8.35.18. Surgisis Biodesign Peyronie's Repair Graft
8.35.19. Biodesign Tension-Free Urethral Sling
8.35.20. Biodesign Vaginal Erosion Repair Graft
8.35.21. AxoGuard Nerve Protector
8.35.22. AxoGuard Nerve Connector
8.35.23. FISH Femoral Introducer Sheath and Hemostasis Device
8.36. Cord Blood America (CBAI), Inc.
8.37. Cryo-Cell International, Inc.
8.37.1. Cryo Cell's License Agreements
8.37.1.l. Cryo-Cell De Mexico
8.37.1.2. Asia Cryo-Cell Private Limited
8.37.1.3. Venezuela
8.37.1.4. China
8.37.1.5. Germany
8.37.1.6. Nicaragua
8.37.1.7. Pakistan
8.37.2. Uses of Cord Blood Stem Cells
8.38. Curis, Inc.
8.38.1. Curis' Business Performance
8.38.2. Curis' Research and Development
8.39. Cytori Therapeutics, Inc.
8.39.1. Cytori's Cosmetic and Reconstructive Surgery Market
8.39.2. Cytori StenSource Cell Banking Market
8.40. Develogen AG
8.40.1. Develogen's Pipeline
8.40.1.1. DG3173-Somatostatin Analog
8.40.1.2. Insulin Sensitizers
8.40.1.3. Beta Cell Regeneration Factor
8.41. Effector Cell Institute, Inc (ECI)
8.41.1. ECI's Cell-based Drug Discovery (CDD)
8.41.2. ECI's Regenerative Medicine
8.41.3. ECI's Cancer Therapeutic Agent Development Project (EC1301)
8.41.4. ECI's Anti-Inflammatory Drug Development Project (FROUNT)
8.41.5. ECI's High Throughput Screening by Automatic TAXIScan System
8.41.6. ECI's Products
8.41.6.1. TAXIScan System
8.41.6.2. Cytorecon
8.41.6.3. TAXIScan-FL
8.42. Epistem plc
8.42.1. Epistem's Cotract Research Services in Oncology
8.42.2. Epistem's Xenografting Models
8.42.3. Epistem's Cancer Cell Assays
8.42.4. Epistem's Angiogenesis Models
8.42.5. Epistem's Colon Cancer Models (Min/+)
8.42.6. Epistem's Histology, IHC, ISH and Gene Expression Profiling
8.42.7. Epistem's In Vitro Cytotoxicity Testing
8.42.8. Epistem's Plucked Hair Immunohistochemistry
8.42.9. Epistem's Emerging Protein Therapeutics
8.42.10. Epistem's Biomarker Technology
8.43. FivePrime Therapeutics, Inc.
8.43.1. FivePrime's Technology
8.43.2. FivePrime's Collaborations
8.44. Forticell Bioscience, Inc.
8.45. Gamidia Cell Ltd.
8.45.1. Gamidia's Technology
8.46. GeneGrafts Ltd.
8.46.1. GeneGrafts's Technology
8.47. GenVec, Inc.
8.47.1. GenVec's Product Programs
8.47.1.1. TNFerade
8.47.1.2. Hearing and Balance
8.48. Genzyme Corporation
8.48.1. Genzyme's Business Performance
8.48.2. Genzyme's Genetic Diseases Segment
8.48.3. Genzyme's Hematology Oncology Segment
8.48.4. Genzyme's Cardiometabolic and Renal Segment
8.48.5. Genzyme's Biosurgery Segment
8.48.6. Genzyme's Genetics and Diagnostics Segment
8.48.7. Genzyme's Pipeline
8.49. Geron Corporation
8.49.1. Geron's Major Technology Platforms
8.49.1.1. Role of Telomere in Cancer and Aging
8.49.1.2. Human Embryonic Stem Cells: Source for the Manufacturing of
Therapeutic Cells
8.49.2. Commercial Opportunities for Geron's Major Technology Platforms
8.49.3. Geron's Human Embryonic Stem Cell Therapies
8.49.4. Geron's Patents and Proprietary Technology
8.49.5. Geron's Business Performance
8.49.6. Geron's Investment in Research and Development
8.50. Harvest Technologies Corporation
8.50.1. Harvest Technologies' Products
8.50.1.1. SmartPReP2 APC+
8.50.1.2. SmartPReP2 BMAC
8.51. HemaStem Therapeutics, Inc.
8.51.1. Cord Blood Program
8.52. HepaLife Technologies, Inc.
8.53. Humacyte, Inc.
8.53.1. Humacyte's Products
8.54. Hydra Biosciences, Inc.
8.55. Intercytex Group plc
8.55.1. Vavelta-Skin Repair and Rejuvenation
8.55.2. SHEF-1-Stem Cell Line
8.55.3. CX-SKN-Skin Graft Replacement for Burns and Acute Wounds
8.55.4. ICX-TRC-Hair Regeneration
8.55.5. Cyzact-Chronic Wound Repair
8.56. Integra Lifesciences Holdings Corporation
8.56.1. Integra's Products
8.56.1.1. Integra's Orthopedic Product Portfolio
8.56.1.2. Dermal Regeneration and Engineered Wound Dressings
8.56.1.3. Nerve and Tendon
8.56.1.4. Bone Graft Substitutes for Extremity Reconstruction
8.56.1.5. Integra's OrthoBiologics
8.56.1.6. Duraplasty Products
8.56.2. Integra's Investment in Research and Development
8.56.3. Integra's Business Performance
8.57. International Stem Cell Corporation (ISCO)
8.57.1. Lifeline Cell Technology
8.57.2. Universal Stem Cell Bank
8.57.3. ISCO's Technology
8.58. Japan Tissue Engineering, Co., Ltd.
8.58.1. Autologous Cultured Epidermis
8.58.2. Autologous Cultured Cartilage
8.58.3. Autologous Cultured Corneal Epithelium
8.59. Karocell Tissue Engineering AB
8.59.1. Karocell's Autologous Cells
8.59.1.1. Keratinocytes
8.59.1.2. Melanocytes
8.59.1.3. Fibroblasts
8.59.1.4. Chondrocytes
8.59.1.5. Urothelial Cells
8.59.1.6. Karoskin
8.59.1.7. Karoderm
8.59.1.8. Cell Bank
8.59.2. Karocell's Research and Development
8.60. Kensey Nash Corporation
8.60.1. Biomaterials from Kensey
8.60.2. Kensey's Collagen Technology
8.60.3. Porous Tissue Matrix Technology
8.60.4. Kensey's Products
8.60.4.1. The Angio-Seal Vascular Closure Device
8.60.4.2. Vitoss Scaffold Foam
8.60.4.3. OsseoFit Porous Tissue Matrix
8.60.4.4 Epi-Guide Bioresorbable Barrier Matrix
8.61. Kiadis Pharma, BV
8.62. LifeCell
8.62.1. AlloDerm Regenerative Tissue Matrix
8.62.2. Strattice Reconstructive Tissue Matrix
8.62.3. Cymetra Micronized AlloDerm Tissue
8.63. MaxCyte, Inc.
8.63.1. Advantages of MaxCyte Platform System
8.63.2. MaxCyte's Collaborations
8.63.3. MaxCyte's Application in Immunotherapy
8.63.4. MaxCyte's Application in Regenerative Medicine
8.63.5. MaxCyte's Viral Vectors and Vaccines
8.63.6. MaxCyte XTS Scalable Transfection System
8.64. Mesoblast Ltd.
8.64.1. Mesoblast's Intervertebral Spinal Fusion
8.64.2. Lumbar Fusion
8.64.3. Cervical Fusion
8.64.4. Mesoblast's Intervertebral Disc Repair and Regeneration
8.64.5. Mesoblast's Product for Knee Osteoarthritis
8.64.6. Mesoblast's Investment in Angioblast Systems, Inc.
8.64.7. Angioblast's Product Candidate for Congestive Heart Failure
8.64.8 Angioblast's Product Candidate for Bone Marrow Transplantation
8.65. NanoCor Therapeutics, Inc.
8.65.1. NanoCor's Products
8.66. NeuralStem, Inc.
8.66.1. NeuralStem's Technology
8.66.2. NeuralStem's Research and Programs
8.66.3. NeuralStem's Intellectual Property
8.67. NeuroNova AB
8.67.1. NeroNova's Neurogenesis Qualifier-Technology
8.67.2. The sNN0029
8.67.3. The sNN0031
8.67.4. NeuroNova's Investors
8.68. Olympus Terumo Biomaterials Corporation
8.68.1. OSferion 60
8.68.2. Terudermis
8.68.3. Teruplug
8.68.4. Osferion
8.68.5. Boneceram P
8.69. Opexa Therapeutics, Inc.
8.69.1. Opexa's T-Cell Platform
8.69.2. Opexa's Stem Cell Platform
8.70. Organogenesis, Inc.
8.70.1. Products from Organogenesis
8.70.1.1. Apligraf
8.70.1.2. VCT01
8.70.1.3. CelTx for Oral Soft Tissue Regeneration
8.70.1.4. FortaGen
8.70.1.5. FortaPerm
8.70.1.6. BioSTAR
8.71. Orthovita, Inc.
8.71.1. Orthovita's Products
8.71.1.1. Vitoss
8.71.1.2. Vitoss and Bone Defect Grafting
8.71.1.3. Vitoss in Spinal Fusion and Grafting
8.71.1.4. Vitoss and Trauma
8.71.1.5. Vitomatrix and Dental, Periodontal, Oral and
Craniomaxillofacial Defects
8.71.1.6. Cortoss Bone Augmentation Material
8.71.1.7. Cortoss and Vertebral Augmentation of Vertical Compression
Fractures (VCFs)
8.71.1.8. Cortoss and Screw Augmentation
8.71.1.9. Orthovita's Aliquot Delivery System
8.71.2. Orthovita's Biosurgery Products
8.71.3. Partnership with Kensey for Vitoss Foam
8.71.4. Partnership with Angiotech for Vitagel and CellPaker
8.71.5. Partnership with Medafor for Vitasure
8.71.6. Orthovita's Business Performance
8.72. Osiris Therapeutics, Inc.
8.72.1. Osiris' Partnerships
8.72.2. Osiris' Technologies
8.72.3. Prochymal
8.72.4. Chondrogen
8.73. Osteotech, Inc.
8.73.1. Osteotech's Products
8.74. Pervasis Therapeutics, Inc.
8.74.1. Pervasis' Clinical Focus
8.74.2. Power of Endothelium
8.74.3 Therapeutic Applications of Pervasis' Products
8.74.3.1. Arteriovenous (AV) Access for Hemodialysis
8.74.3.2. Peripheral Arterial Disease
8.75. Pleuron
8.75.1. Pleuron's Technology
8.76. Pluristem Therapeutics, Inc.
8.76.1. Pluristem's PluriX 3D Bioreactor
8.76.2. Pluristem's PLacental eXpanded (PLX) Cells
8.76.3. PLX-PAD for Peripheral Artery Disease
8.76.4. PLX-IBD for Inflammatory Bowel Disease
8.76.5. PLX-MS for Multiple Sclerosis
8.76.6. PLX-STROKE for Ischemic Stroke
8.77. RegeneRx
8.78. ReNeuron Group plc
8.78.1. ReNeuron's Platform Technologies
8.78.2. ReNeuron's Cell Therapy Programs
8.78.3. ReNeuron's ReN001 for Stroke
8.78.4. ReNeuron's ReNcell Products
8.79. Revivicor, Inc.
8.79.1. Revivicor's Xenografting Technology
8.79.2. Revivicor's Islet Transplantation Technology
8.79.3. Revivicor's Infectious Disease Platform Technologies
8.80. Saneron CCEL Therapeutics, Inc.
8.80.1. Saneron's U-Cord-Cell Program
8.80.2. Saneron's Sert-Cell Program
8.81. Sangamo BioSciences, Inc.
8.81.1. Sangamo's ZFP Therapeutic Product Development Programs
8.81.2. ZFP Therapeutic Pre-Clinical Stage Programs
8.81.2.1. Neuropathic Pain (Cancer Pain)
8.81.2.2. Nerve Regeneration-Spinal Cord Injury (SCI) and Traumatic
Brain Injury (TBI)
8.81.2.3. Parkinson's Disease (PD)
8.81.2.4. Stroke
8.81.2.5. ZFP Therapeutic Research Programs
8.81.3. Funding from Research Foundations
8.81.3.1. The Juvenile Diabetes Research Foundation International
8.81.3.2. The Michael J. Fox Foundation
8.81.3.3. The Bill and Melinda Gates Foundation
8.81.4. Sangamo's Research and Development Expenses
8.81.5. Sangamo's Business Performance
8.82. StemCells, Inc.
8.82.1. StemCell's Cellular Medicine Programs
8.82.2. StemCells' Enabling Technologies Program
8.82.3. StemCells' Patents, Proprietary Rights and Licenses
8.83. Stem Cell Authority Ltd.
8.83.1. The “Miracle” Mesenchymal Stem Cell-Mirachymal Stem
Cells
8.84. Stem Cell Innovations (SCI)
8.84.1. SCI's Research and Development
8.84.2. SCI's Services
8.84.3. PluriCells and Derivatives
8.84.4. ACTIVTox
8.84.5. PredictivTox
8.84.6. Endogenous Protein Production
8.85. Stem Cell Sciences KK
8.85.1. SCS KK's Product/Service
8.85.1.1. CultiCell Medium for Embryonic Stem Cells
8.85.1.2. Contract/Sponsored Research on ES-derived Functional Cells
8.86. SyntheMed, Inc.
8.86.1. Repel-CVAdhesion Barrier
8.86.2. Resolve Adhesion Barrier Instillate
8.86.3. Repel Adhesion Barrier
8.86.4. SpineShield Adhesion Barrier Film
8.86.5. Relieve Adhesion Barrier Gel
8.86.6. SinusShield Adhesion Prevention Film
8.87. t2cure GmbH
8.87.1. BMCs in Regenerative Therapies
8.87.2. t2cure's Product Development Pipeline
8.88. Tengion
8.88.1. Tengion's Pipeline Overview
8.89. TiGenix
8.89.1. ChondroCelect
8.89.2. Chondromimetic
8.89.3. TGX002
8.89.4. TGX003
8.90. Thermogenesis Corp.
8.90.1. Products from Thermogenesis
8.90.1.1. AutoXpress Platform or AXP
8.90.1.2. MarrowXpress
8.90.1.3. BioArchive System
8.90.1.4. Res-Q
8.90.1.5. Thermoline
8.90.1.6. CryoSeal Fibrin Sealant (CryoSeal) System
8.90.2. Thermogenesis' Business Performance
INDEX OF FIGURES
Figure 2.1: Geographic Distribution of 73 TERM Firms in the Five Focus
Countries, 2009
Figure 2.2: Geographic Distribution of the 15 TERM Firms in Germany, 2009
Figure 2.3: Geographic Distribution of the Five TERM Companies in the
U.K., 2009
Figure 2.4: The Potential Uses of Embryonic Stem Cells
Figure 2.5: Cell Culture Products by Market Segment
Figure 2.6: Estimated Global Market for Cell and Tissue Analysis Products,
2008-2014
Figure 2.7: Growth in Size of Cell Therapy Industry, 2000, 2002, 2003, 2008
Figure 2.8: Percent Break-Up of Cell Therapy Companies by Product Type,
2008
Figure 2.9: Location of Primary Tissue Engineering Companies by Geography,
2008-2009
Figure 2.10: Breakdown of Primary Cell Therapy Products on Market by
Geography, 2008-2009
Figure 2.11: The Geographical Distribution of Clinical Trials, 2008-2009
Figure 2.12: Implantation of a Hydrogel at the Site of an Injured Tissue
Figure 2.13: Implantation of CS-PEG Hydrogel
Figure 2.14: Implantation of CMP-PEG Scaffold
Figure 4.1: Global Market for Regenerative Medicine Products, 2008-2013
Figure 4.2: Estimated Market for Regenerative Cell Therapy Products for
Orthopedics, 2008-2012
Figure 4.3: Estimated U.S. Market for Regenerative Medicine Products,
2009-2014
Figure 4.4: Estimated U.S. Market for Bone Grafting/Bone Replacement,
2009-2014
Figure 4.5: Estimated U.S. Market for Bone Growth Stimulating Substances,
2009-2014
Figure 4.6: Estimated U.S. Market for Regenerative Products for Cartilage
Repair, 2009-2014
Figure 4.7: Estimated Market for Stem Cells, 2008-2012
Figure 4.8: Estimated Market for Cell Therapy Products in the U.S.,
2009-2018
Figure 4.9: Estimated Global Market for Cord Blood Stem Cells, 2010-2015
Figure 4.10: Worldwide Growth of Public Cord Blood Banks, 2005-2009
Figure 4.11: Worldwide Growth of Private Cord Blood Banks, 2005-2009
Figure 5.1: Cell-Based Business Models
Figure 5.2: Current Autologous Business Models
Figure 5.3: Current Allogeneic Business Models
Figure 7.1: CIRM's Grant Awards by Category, 2009
Figure 7.2: CIRM's funding by Disease Application, 2009
Figure 7.3: CIRM's Funding by Disease Category
Figure 7.4: Estimated Increase in Worldwide Funding for RM Research,
2008-2018
Figure 8.1: Aastrom's Investment in Research and Development, 2007-2009
Figure 8.2: Aastrom's Business Performance, 2005-2009
Figure 8.3: ACT's Business Performance, 2008 and 2009
Figure 8.4: ACT's Investment in Research and Development, 2008 and 2009
Figure 8.5: Aranesp (Darbepoetin Alfa)'s Sales in the U.S. and
International Market, 2007-2009
Figure 8.6: U.S. Market for Epogen, 2007-2009
Figure 8.7: Global Market for Neulasta, 2007-2009
Figure 8.8: Global Market for Enbrel (Etanercept), 2007-2009
Figure 8.9: Global Market for Sensipar (Cinacalcet), 2007-2009
Figure 8.10: Global Market for Vectibix (Panitumumab), 2007-2009
Figure 8.11: Global Market for Nplate (Romiplostim), 2007-2009
Figure 8.12: Amgen's Three Large Wholesale Customers, 2007-2009
Figure 8.13: Amgen's Overall U.S. and International Market, 2007-2008
Figure 8.14: Athersys' Investment and Development, 2007-2009
Figure 8.15: Athersys' Business Performance, 2005-2009
Figure 8.16: Current Capitalization of Cardio3's Investors, 2009
Figure 8.17: Celgene's Business Performance, 2005-2009
Figure 8.18: Curis' Business Performance, 2005-2009
Figure 8.19: Genzyme's Business Performance, 2005-2009
Figure 8.20: Genzyme's Percent of Revenue by Business Group, 2009
Figure 8.21: Geron's Business Performance, 2005-2009
Figure 8.22: Geron's Investment in Research and Development, 2005-2009
Figure 8.23: Integra's Investment in Research and Development, 2007-2009
Figure 8.24: Integra's Business Performance, 2005-2009
Figure 8.25: NeuroNova's Share Holders as of June, 2009
Figure 8.26: Orthovita's Business Performance, 2005-2009
Figure 8.27: Sangamo's Investment in Research and Development, 2007-2009
Figure 8.28: Sangamo's Business Performance, 2005-2009
INDEX OF TABLES
Table 2.1: Number of TERM Companies Identified in the Five Focus
Countries, 2009
Table 2.2: Number of TERM Companies Developing Stem Cells Seeded to
Scaffolds, 2009
Table 2.3: Number of Firms with Focus on Skin, Cartilage, Bone and
Urological Applications, 2009
Table 2.4: Number of Firms Focusing on Cardiovascular Applications, 2009
Table 2.5: Number of Firms with a Focus on Neurological Applications, 2009
Table 2.6: Number of Firms Focused on Pancreas, Liver and Kidney
Applications, 2009
Table 2.7: Number of Companies Focused on Autologous and Allogeneic
Products, 2009
Table 2.8: Geographic Distribution of U.S. TERM Firms, 2009
Table 2.9: Geographic Location of 11 Out of 13 TERM Firms in Japan, 2009
Table 2.10: Geographic Distribution of the Three TERM Firms in Sweden, 2009
Table 2.11: Number of Patients Treated with Cell Therapeutics, 1988-2010
Table 2.12: Some Selected Suppliers of In Vitro Test Kits and Their
Products
Table 2.13: Suppliers of Cells and Tissues
Table 2.14: Selected Suppliers of Media and Reagents
Table 2.15: Selected Providers of Equipments in Stem Cell Research
Table 2.16: Selected Providers of Computer Software for Stem Cell Research
Table 2.17: Geographical Distribution of Stem Cell-Related Tissue
Engineering Companies, 2008
Table 2.18: Breakdown of Cell Therapy Firms by Country, 2008-2009
Table 2.19: Cell Therapy Products on the Market by Type and Application
Area, 2008-2009
Table 2.20: Data on Sales and Application for Skin and Cartilage Products,
2006-2008
Table 2.21: Reagent Sales by Selected Stem Cell Companies, 2008
Table 2.22: Sales of Secondary Products, 2007
Table 2.23: Disease Focus of Clinical Trials, 2008-2009
Table 2.24: Stem Cell Products in Phase II/III Trials, 2008-2009
Table 2.25: Licensing Activities in Pharmaceutical and Cell Therapy
Industries
Table 2.26: Investment Activity in Cell Therapy Sector
Table 2.27: Novel Partnership by Large Pharmaceuticals with Universities
Table 2.28: Cell Therapy Companies with Greater than Ten Million by Market
Cap, 2008
Table 3.1: Regenerative Medicine Product Development Status, 2008
Table 3.2: Top Ten Regenerative Medicine Products, 2008
Table 3.3: Wound Healing Products
Table 4.1: Worldwide Estimates of Key Industry Parameters, 2007
Table 4.2: Potential U.S. Populations for Cell-Based Therapies
Table 5.1: The Required Elements of a Manufacturing Facility
Table 5.2: Cell Therapy CMO Qualification Audit: Points to Investigate
Table 6.1: Diseases with Potential Applications for Regenerative Medicine
Table 7.1: Stem Cell Policies in North America
Table 7.2: Stem Cell Policies in South America
Table 7.3: Stem Cell Policies in Europe
Table 7.4: Stem Cell Policies in Asia/Oceania
Table 7.5: CIRM Funded Grants To-Date
Table 7.6: List of Upcoming Request for Applications (RFAs) Showing
Commitments from Funding Partners
Table 7.7: Recipients of Funds from Connecticut Stem Cell Research
Program, 2009
Table 7.8: Maryland Stem Cell Research Fund, 2008
Table 7.9: NJCST's Award of Grants for Stem Cell Research, 2008
Table 7.10: NYSTEM's IIRP Awards, 2008
Table 7.11: NIH Funding for Regenerative Medicine and Stem Cell Research,
2003-2009
Table 7.12: NIH Funding for Various Types of Stem Cell Research, 2004-2009
Table 8.1: Patents Owned by ACT
Table 8.2: Patents Owned by ACT's Subsidiary Mytogen, Inc.
Table 8.3: Patents Licensed to ACT by the University of Massachusetts
Table 8.4: Alseres' Product Pipeline, 2009
Table 8.5: Amgen's Pipeline of Products
Table 8.6: Amgen's Approved Products
Table 8.7: AnGes' Current Pipeline Status, 2010
Table 8.8: Angioblast's Product Development Overview
Table 8.9: Angion's Product Pipeline
Table 8.10: Angion's Product Pipeline
Table 8.11: Arteriocyte's Product Pipeline
Table 8.12: Developmental Status of Athersys' Key Programs, 2010
Table 8.13: Bioheart's Pipeline Product Candidates
Table 8.14: BioLine's Product Pipeline, 2010
Table 8.15: BioMimetic's Current Product Candidates and Target Indications
Table 8.16: BioMimetic's Clinical Studies
Table 8.17: BioMimetic's Investment in Research and Development, 2005-2009
Table 8.18: BrainStorm's Intellectual Property
Table 8.19: Cardio3's promising Product Pipeline
Table 8.20: Cellerix's Product Pipeline
Table 8.21: Celgene's Leading Product Candidates
Table 8.22: Private Cord Blood Banking vs. Public Donation
Table 8.23: Curis' Current Research and Development Programs and Their
Status
Table 8.24: Curis' Revenues from Research and Development, 2008 and 2009
Table 8.25: Regulatory Status of Celution System
Table 8.26: Regulatory Status of PureGraft and CelBrush
Table 8.27: Develogen's Pipeline Overview
Table 8.28: Epistem's Emerging Pipeline of Protein Therapeutics
Table 8.29: FivePrime's Product Pipeline
Table 8.30: FivePrime's Collaborations
Table 8.31: Gamidia's Pipeline Products
Table 8.32: Genzyme's Pipeline of Products
Table 8.33: Cancer Therapeutics and Diagnostic Products being Developed by
Geron
Table 8.34: The hESC-derived Product Candidates Developed by Geron and its
Collaborators
Table 8.35: Geron's Patent Portfolio
Table 8.36: Hydra's Product Pipeline
Table 8.37: Intercytex' Product Pipeline
Table 8.38: Kiadis' Product Pipeline
Table 8.39: NeuralStem's Issued and Pending Patents
Table 8.40: NeuroNova's Product Pipeline
Table 8.41: Orthovita's Existing Orthobiologic and Biosurgery Products
Table 8.42: Orthovita's Biosurgery Products
Table 8.43: Osiris' Therapeutic Product Pipeline
Table 8.44: Pervasis' Product Pipeline
Table 8.45: RegeneRx's Product Development Pipeline
Table 8.46: Summary of Sangamo's Current Clinical Programs
Table 8.47: Current Status of StemCells' Therapeutic Product Development
Programs
Table 8.48: StemCells' Cell Culture Products
Table 8.49: StemCells' Patents Covering Stem and Progenitor Cells and
Research Tools
Table 8.50: t2cure's Product Development Pipeline
Table 8.51: Tengion's Product Candidates Pipeline
Table 8.52: Thermogenisis' Business Performance by Geographic Area,
2007-2009
RNA Interference Markets 1. Overview
1.1. Objectives
1.2. Scope
1.3. Methodology
1.4. Executive Summary
2. RNA Interference (RNAi)
2.1. Introduction
2.2. Overview of RNA Interference
2.2.1. Classes of Endogenous Small RNAs: siRNA, rasiRNA and miRNA
2.2.2. Mechanism of RNAi In Vivo
2.3. Glossary
2.4. What Areas of Research Does RNAi Impact?
2.4.1. RNAi Technology in Life Sciences Research, Drug Discovery and
Development
2.4.2. RNAi Technology in Agriculture
3. Technology Trends in RNAi Space
3.1. Overview
3.2. End-User Segmentation
3.3. Technologies for Inducing RNAi
3.3.1. Methods for Detecting Gene Silencing
3.3.2. Comparison of Strategies for Target Validation
3.3.3. Libraries of siRNAs/shRNAs to Knock Down Genes En Masse
3.4. miRNA-Based RNAi: The Leading Edge of RNAi Space
3.4.1. Biological Function of miRNAs
3.4.2. Role of miRNAs in Disease
3.4.3. miRNA-based Diagnostics
3.4.4. miRNA-based Therapeutics
3.5. Market Shifts in RNAi Space: Where Is It Headed?
3.5.1. Intellectual Property and Patent Issues
3.5.2. Patents Covering the Molecular Characteristics of the RNAi Agent
3.5.3. Funding in RNAi Space: Grants, Venture Capital and IPOs
3.5.4. Partnerships, Alliances, Mergers and Acquisitions
3.6. SWOT Analysis of Technologies and Vendors in RNAi Space
4. RNAi Market Analysis
4.1. Overview
4.2. Market Data Collection and Respondent Pool
4.2.1. Respondent Pool Characteristics
4.3. RNAi Technologies / Products in Research Applications
4.4. RNAi Technologies/Products: Market Shares (Quantitative)
4.5. Quantitative Metrics of RNAi Usage: Market Opportunity and Growth
4.5.1. Growth of Various Segments in RNAi Space
4.5.2. Product Formats and Representation in RNAi Marketplace
4.6v RNAi Marketplace: Challenges, Unmet Needs and Drivers
4.6.1. Unmet Needs in RNAi Space
4.6.2. RNAi Market: Qualitative Growth Drivers
5. The RNAi Landscape
5.1. Overview
5.2. Market Segmentation of RNAi and Segment Characteristics
5.3. Quantitative Market Opportunities in RNAi Space
5.3.1. Opportunities in miRNA Space
5.3.2. Opportunities in siRNA/shRNA Space
5.4. RNAi Product Offerings and Associated Business Models
5.5. Challenges for RNAi Therapeutic Development
6. RNAi-Based Therapeutics: The Emerging Industry Landscape
6.1. Factors Contributing to the Success of RNAi Therapeutics
6.2. Advantages and Disadvantages of siRNA-based Drugs
6.3. Opportunities and Challenges with RNAi-based Therapeutics
6.4. The Gene Therapy Precedent
6.5. The Antisense Precedent
6.6. Interferon Response
6.7. Delivery of RNAi-based Therapeutics
6.8. Off-Target Effects
6.9. Overwhelming the Endogenous RNAi System-Affecting the microRNA Pathway
6.10. RNAi-based Therapeutics
6.10.1. Cancer
6.10.2. Cardiac Disease
6.10.3. Immunologic Disease
6.10.4. Infectious Disease
6.10.5. Inflammation
6.10.6. Lifestyle Therapeutics
6.10.7. Metabolic Disease
6.10.8. Neurologic Disease
6.10.9. Ophthalmic Disease
6.10.10. Renal Disease
6.10.11. Respiratory Disease
7. Company Profiles-U.S.
7.1. Alfacell Corporation
7.2. Allele Biotechnology and Pharmaceuticals, Inc.
7.3. Alnylam Pharmaceuticals
7.4. Ambion
7.5. Asuragen, Inc.
7.6. Avalon Pharmaceuticals, Inc.
7.7. B-Bridge International, Inc.
7.8. Bio-Rad Laboratories
7.9. Calando Pharmaceuticals, Inc.
7.10. Cepheid
7.11. Cequent
7.12. Clontech Laboratories, Inc.
7.13. CombiMatrix Corporation
7.14. Cyntellect, Inc.
7.15. CytRx Corp.
7.16. Dharmacon
7.17. Dicerna
7.18. Galenea Corporation
7.19. GeneCopoeia, Inc.
7.20. GeneThera, Inc.
7.21. Genlantis
7.22. GenoSensor
7.23. GRL, Inc.
7.24. IDT
7.25. Imgenex Corporation
7.26. Ingenuity Systems
7.27. Intradigm Corporation
7.28. Invitrogen
7.29. InvivoGen
7.30. Isis Pharmaceuticals, LLC
7.31. LC Sciences
7.32. Lentigen Corporation
7.33. MDRNA
7.34. Merck & Co., Inc.
7.35. Mirus Bio Corporation (Acquired by Roche)
7.36. Monsanto
7.37. Nastech Pharmaceutical Company, Inc.
7.38. New England BioLabs
7.39. Nucleonics, Inc.
7.40. Open Biosystems, Inc.
7.41. OPKO Health, Inc.
7.42. OriGene
7.43. Panomics, Inc.
7.44. PhaseRx
7.45. Promega Corp.
7.46. Quark Pharmaceuticals, Inc.
7.47. RXi Pharmaceuticals Corporation
7.48. Senetek PLC
7.49. Sigma-Aldrich
7.50. Sirna Therapeutics
7.51. Sirnaomics, Inc.
7.52. SomaGenics, Inc.
7.53. System Biosciences
7.54. Tacere Therapeutics
7.55. Targeted Genetics Corporation
7.56. Third Wave Technologies
7.57. Traversa
8. Company Profiles-Europe
8.1. Actigenics SA
8.2. Amaxa
8.3. AstraZeneca PLC
8.4. Cenix Bioscience GmbH
8.5. deVGen N.V.
8.6. DNAVision
8.7. Exiqon
8.8. Genovis
8.9. genOway
8.10. imaGenes GmbH
8.11. MWG Biotech AG
8.12. OZ Biosciences
8.13. Prosensa Holding
8.14. QIAGEN
8.15. RNAx GmbH (Germany)
8.16. Roche
8.17. Rosetta Genomics, Ltd.
8.18. Santaris Pharma A/S
8.19. Silence Therapeutics PLC
8.20. TaconicArtemis GmbH
8.21. TRANSAT
9. Company Profiles-Asia-Pacific
9.1. alphaGEN Co., Ltd.
9.2. Benitec, Ltd.
9.3. Bioneer
9.4. CytoPathfinder, Inc.
9.5. Genesis Research & Development Corp.
9.6. GeneDesign, Inc.
9.7. GNI Pharmaceutical Corporation
9.8. Koken Co., Ltd.
9.9. NanoCarrier Co., Ltd.
9.10. Oncolys Biopharma, Inc.
9.11. RealGene Bio-Technologies, Inc.
9.12. Samchully Pharmaceuticals
9.13. Samyang Corp.
9.14. Shanghai Biochip
9.15. Shanghai GenePharma Co.
9.16. Shanghai Genomics, Inc.
9.17. Transgene Biotek, Ltd.
10. Company Profiles-Rest of the World
10.1. Benitec, Ltd.
10.2. Tekmira
INDEX OF TABLES
Table 2.1: Advantages/Disadvantages of siRNAs and shRNAs as Inducers of
RNAi in Mammalian Cells
Table 2.2: Prevalence of siRNA-mediated RNAi in Disease Models, as
Reported in Scientific Literature
Table 2.3: RNAi-based Therapeutics in Clinical Trials
Table 2.4: Suppliers of Enabling Technologies and Tools in RNAi Space
Table 2.5: Suppliers of siRNA/shRNA Products (by Product/Service Class)
Table 3.1: Currently-Utilized Technologies for Inducing RNAi-Mediated
Knockdown
Table 3.2: Comparison of mRNA Detection Technologies
Table 3.3: Strategies for Target Validation by Pharma/Biotech: RNAi and
Others
Table 3.4: Comparison of Formats for Library-Based Gene Knockdown
Table 3.5: Characteristics of Various Publicly-Available Mouse and Human
RNAi Libraries
Table 3.6: Disease-Related miRNAs
Table 3.7: Publicly-Available Computational Programs for Identifying miRNA
Sequences/Targets
Table 3.8: Seminal Patents in RNAi
Table 3.9: Venture Capital Raised by Selected Companies in the RNAi Space
Table 3.10: List of Public Biotech Companies in RNAi Space
Table 3.11: SWOT Analysis of siRNA Oligonucleotides
Table 3.12: Transfection Reagents (Lipid-Mediated Delivery)
Table 3.13: shRNA Plasmid Constructs
Table 3.14: shRNA Pooled Libraries or Arrayed Collections
(Retroviral/Lentiviral Delivery)
Table 5.1: RNAi Market Segmentation and Research Settings
Table 5.2: Segment 1: Basic Life Science Research Utilizing RNAi Tools and
Technologies
Table 5.3: Segment 2: RNAi for Drug Discovery and Development
Table 5.4: Segment 3: RNAi Research for Development of RNAi Therapeutics
Table 5.5: Segment 4: RNAi Fee-for-Service Business
Table 5.6: Grants Awarded and Research Spending in miRNA Space, 2005 to
2008
Table 5.7: RNAi Opportunity and Market Size: Quantitative Model, 2006 to
2009
Table 5.8: Challenges for RNAi Therapeutic Development
Table 5.9: Technology Platforms used in RNAi Research
Table 6.1 : Similarities Between Antisense Oligonucleotides and siRNAs
Table 6.2: Disadvantages of siRNA Versus Antisense Oligonucleotides
Table 6.3: Delivery Vectors for siRNA and Hairpin-Encoding DNA for In Vivo
Experiments.
Table 6.4: Delivery Systems for siRNA and Hairpin-Encoding DNA for In Vivo
Experiments.
Table 6.5: Delivery Systems for RNAi-based Therapeutics
Table 6.6: Diseases for RNAi Therapeutics
Table 6.7: RNAi-Based Therapeutics Pipeline-Broken Out by
Disease/Therapeutic Area
Table 6.8: RNAi-Based Therapeutics Pipeline-Broken Out by Stage of
Development
Table 6.9: Most Common Types of Cancer
Table 6.10: RNAi Therapeutics for Cancer in Phase I
Table 6.11: RNAi Therapeutics for Cancer in IND
Table 6.12: RNAi Therapeutics for Cardiac Disease in IND
Table 6.13: RNAi Therapeutics for Cardiac Disease in Pre-clinical/Research
Table 6.14: RNAi Therapeutics for Immunologic Disease in Pre-clinical /
Research
Table 6.15: RNAi Therapeutics for Infectious Disease in Phase II
Table 6.16: RNAi Therapeutics for Infectious Disease in Phase I
Table 6.17: RNAi Therapeutics for Infectious Disease in IND
Table 6.18: RNAi Therapeutics for Infectious Disease in
Pre-clinical/Research
Table 6.19: RNAi Therapeutics for Inflammatory Disease in
Pre-clinical/Research
Table 6.20: RNAi Therapeutics for Life Style Therapies in IND
Table 6.21: RNAi Therapeutics for Metabolic Disease in
Pre-clinical/Research
Table 6.22: RNAi Therapeutics for Neurologic Disease in
Pre-clinical/Research
Table 6.23: RNAi Therapeutics for Ophthalmic Disease in Phase III
Table 6.24: RNAi Therapeutics for Ophthalmic Disease in Phase II
Table 6.25: RNAi Therapeutics for Ophthalmic Disease in Phase I
Table 6.26: RNAi Therapeutics for Ophthalmic Disease in
Pre-clinical/Research
Table 6.27: RNAi Therapeutics for Renal Disease in Phase I
Table 6.28: RNAi Therapeutics for Respiratory Disease in
Pre-clinical/Research
Table 7.1: Nucleonics Products and Programs Ongoing/Pipeline
Table 7.2: Quark's Product Pipeline
Table 8.1: Santaris' Product Pipeline
Table 8.2: Silence Therapeutics' Product Pipeline
INDEX OF FIGURES
Figure 2.1: The miRNA Processing Pathway
Figure 2.2: Growth of Scientific Publications Addressing miRNAs, 2001 to
2008
Figure 2.3: Mechanisms of Small RNA-induced Gene Regulation
Figure 2.4: Types of RNAi Compounds
Figure 2.5: Breakdown of Scientific Publications Related to RNAi by
Geographic Region, 2007 to 2008
Figure 3.1: End-User Segmentation of RNAi Space
Figure 3.2: RNAi Patents Filed Globally, by Geographical Origin
Figure 3.3: Selected Deals in RNAi Space
Figure 4.1: Geographical Breakdown of RNAi End-User Survey Respondents
Figure 4.2: Affiliation of RNAi End-User Survey Respondents
Figure 4.3: Utilization of RNAi Technologies/Products by Respondent Pool
Figure 4.4: RNAi Utilization Period: Breakdown of Respondent Pool
Figure 4.5: Research Applications Using RNAi Technologies/Products
Figure 4.6: Types of RNAi Technologies Currently Utilized
Figure 4.7: RNAi Technologies Most Commonly Utilized Currently by End-Users
Figure 4.8: Types of RNAi Technologies: Expected Use in Six to 18 Months
Figure 4.9: Evolution of Market Shares of RNAi-Inducing Technologies
Figure 4.10: Number of Experiments Involving RNAi Conducted per Week
Figure 4.11: Range of Research Dollars Spent Monthly on RNAi Research
Figure 4.12: RNAi Experiment Throughput Correlated with Type of RNAi
Technology Used
Figure 4.13: Current RNAi Market Share by Segments
Figure 4.14: Growth/Decline Rate of RNAi Marketplace Segments (Six to 18
Months)
Figure 4.15: Product Formats Utilization for RNAi Research (Current and
Six to 18 Months)
Figure 4.16: Companies Offering Product Formats for Currently-Used RNAi
Products
Figure 4.17: RNAi Product Offerings/Formats Use (Projections-Six to 18
Months)
Figure 4.18: Percentage Change of RNAi Product Offerings/Formats (Six to
18 Months)
Figure 4.19: Key Challenges Faced by End-Users in RNAi Space
Figure 4.20: Unmet Needs in RNAi Space Ranked by Importance to End-Users
Figure 5.1: Growth and Evolution of miRNA Space
Figure 5.2: Elements of RNAi Value Chain
Figure 5.3: Growth and Evolution of RNAi (siRNA/shRNA) Space
Figure 5.4: Market Revenues Based on Components of siRNA Experimental
Paradigm
Stem Cell Markets 1. Overview
1.1. Statement of Report
1.2. Scope of the Report
1.3. Methodology
1.4. Executive Summary
1.4.1. Toxicity Screening for Drug Discovery and Development
1.4.2. Autologous Cell Therapy
1.4.2.1. Current Range of Applications for Autologous Cell Therapy (ACT)
1.4.2.2. Commercially Available Autologous Treatments
1.4.2.3. Autologous Treatment for Neurodegenerative Diseases
1.4.2.4. Autologous Cell Therapy and Wound Healing
1.4.2.5. Autologous Cell Therapy and Cosmetic Surgery
1.4.3. Allogeneic Cell Therapy
1.4.3.1. Allogeneic First Generation (Non-Stem Cell) Products
1.4.3.2. Second Generation (Stem Cell-Based) Products
1.4.3.3. Secondary Products
1.4.4. Three Basic Types of Allogeneic Stem Cell Products
1.4.4.1. Hematopoietic Stem Cells
1.4.4.2. Neural Stem Cells
1.4.4.3. Mesenchymal Stem Cells, Pancreatic Islet Stem Cells
1.5. Current State of Stem Cell Market
2. Biology of Stem Cells
2.1. Scope of this Chapter
2.2. Basic Properties of Stem Cells
2.3. Classification of Stem Cells, Stem Cell Lineages and their Derivation
2.3.1. Embryonic Stem Cells
2.3.1.1. Embryonic Germ Cells
2.3.1.1. Fetal Stem Cells
2.3.1.2. Umbilical Cord Stem Cells
2.3.2. Adult Stem Cells
2.3.2.1. Hematopoietic Stem Cells (Bone Marrow and Peripheral Blood)
2.3.2.2. Mesenchymal Stem Cells (Bone Marrow Stroma)
2.3.2.3. Gut Stem Cells
2.3.2.4. Liver Stem Cells
2.3.2.5. Bone and Cartilage Stem Cells
2.3.2.6. Epidermal Stem Cells (Skin and Hair)
2.3.2.7. Neuronal Stem Cells
2.3.2.8. Pancreatic Stem Cells
2.3.2.9. Eye Stem Cells
2.4. Stem Cell Lineage
2.5. Stem Cell Derivations
2.6. Sources of Stem Cells
2.7. Differentiation of Stem Cells
2.8. Self-Renewal of Stem Cells
2.9. Dedifferentiation of Cells
2.10. Nuclear Reprogramming of Stem Cells
3. Stem Cell Therapy
3.1. Scope of this Chapter
3.2. Diseases with Unmet Clinical Need: Primary Driver of Stem Cell Therapy
Market
3.3. Leading Healthcare Segments Offering Scope for Easy Entry into Stem
Cell Market
3.3.1. Stem Cell Therapy in Orthopedics
3.3.1.1. Stem Cells for the Repair of Tendons, Cartilages and Bone
3.3.2. Stem Cell Therapy for Cardiac Diseases
3.3.3. Stem Cell Therapy for Wound Healing
3.3.4. Stem Cell Therapy for Diabetes
3.3.5. Stem Cell Therapy for Neurodegenerative Diseases
3.3.5.1. Clinical Activity for Cell Therapy into CNS
3.3.6. Stem Cell Retinal Replacement Therapy
3.3.7. Stem Cell Therapy for Liver Diseases
3.3.7.1. Hepatocyte-like Cells for Liver Disease
3.3.7.2. Cell Therapy for Liver Cirrhosis
3.3.8. Cell Therapy for Peripheral Vascular Diseases
3.3.9. Cell Therapy for Blood Disorders
3.3.10. Biomaterials and Stem Cell Therapy
3.3.11. Stem Cell Application in Drug Discovery
3.4. Stem Cell Products in Development
3.5. Stem Cell and Related Products in the Global Market
3.5.1. Medtronic's Infuse Bone Graft and the LT-Cage Device
3.5.2. GenZyme's Carticel
3.5.3. Stryker's OP-1
3.5.4. Osyris/Nuvasive's Osteocel
3.5.5. RTI's Spinal Implants
3.5.6. Organogenesis' Apligraf
3.5.7. Advanced Biohealing's Dermagraft
3.5.8. Integra's Bilayer Matrix Wound Dressing
3.5.9. LifeCell's AlloDerm
3.5.10. Gytori's Celution
3.6. Other Products of Importance in the Global Market
3.6.1. Tissue-Engineered Wound Healing Products
3.6.1.1. Oasis
3.6.1.2. Permacol
3.6.1.3. EZ-Derm
3.6.1.4. Matriderm
3.6.1.5. Alloderm
3.6.1.6. TransCyte
3.6.1.7. ICX-SKN
3.6.1.8. OrCel
3.6.1.9. Epicel
3.6.1.10. Myskin
3.6.1.11. EpiDex
3.6.1.12. Genzyme's MACI Implant
3.6.1.13. Genzyme's Epicel
3.6.1.14. ICX-TRC-Hair Regeneration Therapy
3.6.1.15. VCT01
3.6.2. Cartilage Regeneration
3.6.2.1. ChondroCelect/TGX001
3.6.2.2. TGX002
3.6.2.3. TGX003
3.6.2.4. NOVOCART
3.6.3. BioTissue Technologies' Products
3.6.3.1. BioSeed-S
3.6.3.2. MelanoSeed
3.6.3.3. Oral Mucosa BioSeed-M
3.6.3.4. BioSeed-Oral Bone
3.6.3.5. BioSeed-C
3.6.4. co.don's Autologous Cell Transplant Products
3.6.5. Fidia Advanced Biopolymers' Regenerative Medicine Products
3.6.5.1. Hyalograft 3D
3.6.5.2. Laserskin
3.6.5.3. TISSUEtech autograft system
3.6.5.4. Hyalograft C
3.6.6. Genzyme Biosurgery's Tissue Engineering Products
3.6.6.1. Carticel
3.6.6.2. Epicel
3.6.7. Interface Biotech AS' Tissue Engineered Products
3.6.7.1. Cartilink-1
3.6.7.2. Cartilink-2
3.6.8. Isotis S.A's Tissue Engineered Products
3.6.8.1. OsSatura
3.6.8.2. EpiDex
3.6.8.3. AcuDress
3.6.9. Karocell Tissue Engineering AB's Tissue-Engineered Products
3.6.9.1. Skin Cells
3.6.9.2. Cartilage Cells
3.6.9.3. Melanocytes
3.6.9.4. Urothelial Tissue
3.6.10. Smith & Nephew's Tissue Engineering Products
3.6.10.1. TransCyte
3.6.10.2. Dermagraft
3.6.11. Tetec Tissue Engineering Technologies AG's Tissue Engineered
Product
3.6.12. Verigen Transplantation Service International (VTSI)'s
Tissue-Engineered Products
3.6.12.1. CACI
3.6.12.2. MACI
3.6.12.3. MACI (A)
3.6.13. XCELLentis' Tissue-Engineered Products
3.6.13.1. Ceal Platform
3.6.13.2. LyphoDerm
4. Market Analysis of the Stem Cell Space
4.1. Scope of this Chapter
4.1.1. Various Market Segments in Stem Cell Space
4.1.2. Market for Cell Therapy in the U.S.
4.2. Market Segmentation by Source of Stem Cell Used
4.2.1. Human Embryonic Stem Cells (hESCs) in Cell Therapy
4.2.1.1. Investing Companies in hESCs
4.2.1.2. Engineered Cartilage using hESCs
4.2.1.3. Lung Tissue Differentiated from hESCs
4.2.1.4. Human Mesenchymal Stem Cells (MSCs)
4.2.2. Neural Stem Cells
4.2.3. Human Hematopoietic Stem Cells
4.2.4. Cord Blood Stem Cells
4.2.5. Cancer Stem Cells
4.3. Cord Blood Banking Market
4.3.1. Cord Blood Stem Cell Applications
4.3.1.1. Repairing Blood Vessels Using Cord Blood Stem Cells
4.3.1.2. Cardiomyocetes and Cord Blood Stem Cells
4.3.1.3. Congenital Heart Defects and Cord Blood Stem Cells
4.3.1.4. Peripheral Vascular Disease and Cord Blood Stem Cells
4.3.2. Growth of Public and Private Cord Blood Banks
4.3.2.1. Public Cord Blood (CB) Banks
4.3.2.2. Private Cord Blood Banks
4.3.2.3. The Collection Process of Cord Blood Cells
4.4. Cell Culture Products
4.4.1. In Vitro Test Kits
4.4.2. Suppliers of Cells and Tissues
4.4.3. Suppliers of Culture Media and Cell Reagents
4.4.4. Equipments for Stem Cell Research
4.4.5. Computer Software for Stem Cell Research
4.5. Cell Therapy Market
4.5.1. The Size of the Cell Therapy Industry
4.5.2. The Age, Size and Location of Firms
4.5.3. Firm Technology and Disease Focus
4.5.4. Cell Therapy Products and Companies
4.5.5. Products on the Market
4.5.5.1. First Generation (Non-Stem Cell Based) Primary Products
4.5.5.2. Second Generation (Stem Cell Based) Primary Products
4.5.5.3. Secondary Products
4.5.5.4. Products in Development
4.5.5.5. The Disease Targets of Trials
4.5.5.6. Stem Cell Industry Pipeline
4.6. Industry Collaboration in Stem Cell Space
4.7. Increasing Commercial Success in Stem Cell Industry
4.8. Transition from Tissue Engineering to Regenerative Medicine
4.9. Challenges to Commercial Development of Cell Therapies
4.9.1. Problems of Commercial Viability and Sustainability
4.9.2. Poor Sales and Limited Prospects for Some Forms of Cell Therapy
4.9.3. Lack of Investment from Large Companies
4.9.4. Lack of Clinical Demand and Uptake
4.10. Partnership of Stem Cell Companies with Large Pharmaceutical Companies
4.10.1. Strategic Approaches for Cell-based Companies
4.10.2. The Need for Support from Large Pharmaceuticals
5. Strategic Roadmap to Cell Therapy Industry
5.1. Scope of this Chapter
5.2. Options for the Commercial Manufacturing of Stem Cell Products
5.3. Regulatory Requirements for a Cell Therapy Industry
5.4. In-House Manufacturing of Cell Therapy Products
5.5. Contract Manufacturing
5.6. Effective Clinical Delivery Plan for Cell Therapies
5.7. Business Models in Stem Cell Therapy Sector
5.8. Current Models for Autologous Cell Therapies
5.9. Current Models for Allogeneic Cell Therapies
5.10. Value Chain Considerations and Developmental Path
5.11. Stem Cells: From the Laboratory to the Market
5.11.1. Value Analysis
5.11.2. Clinical Study Development
5.11.3. Product Commercialization
5.11.4. Importance of Specialty Society Support
5.11.5. Payor Coverage
6. Funding for Regenerative Medicine Research
6.1. Scope of this Chapter
6.2. The Intense Competitive Pressure for Funding
6.3. History of Stem Cell Research, Tissue-Engineering and Regenerative
Medicine
6.4. The Story of Federal Funding of Stem Cell Research
6.4.1. Policy Changes
6.4.2. Types of Research Ineligible for NIH Funding
6.4.3. NIH Guidelines Addressing the Projected Growth of Stem
Cell-Related Clinical Trials
6.4.4. CIRM Funding for Stem Cell Research and Regenerative Medicine
6.5. The Strong Financial Case for Stem Cell Research and Regenerative
Medicine
6.5.1. Regenerative Medicine Cost vs. Existing Treatments
7. Current Stem Cell Research
7.1. Scope of this Chapter
7.2. Stem Cell Policies in North America
7.3. Stem Cell Policies in South America
7.4. Stem Cell Policies in Europe
7.5. Stem Cell Policies in Asia/Oceania
7.6. California Institute for Regenerative Medicine (CIRM)
7.6.1. CIRM Collaborative Funding
7.6.2. CIRM's Funding for Clinical Applications
7.6.3. Early Translational Awards
7.6.4. Disease Team Awards
7.7. Stem Cell Research Programs in Connecticut Department of Public Health
7.7.1. Types of Awards by Connecticut Stem Cell Research Program, 2010
7.7.1.1. Seed Grant Awards
7.7.1.2. Established Investigator Awards
7.7.1.3. Group Project Awards
7.7.1.4. Core Facilities Awards
7.8. Maryland Technology Development Corporation (TEDCO)
7.8.1. TEDCO's Programs: Funding Opportunities
7.8.1.1. Fort Detrick Technology Transfer Initiative (FDTTI)
7.8.1.2. J&J Investment Fund
7.8.1.3. NAVAIR Technology Insertion (NAVTI) Program
7.8.1.4. The TechStart Program
7.8.1.5. University Technology Development Fund (UTDF)
7.8.1.6. Working Capital Loan Fund
7.9. Maryland Technology Transfer and Commercialization Fund (MTTCF)
7.9.1. Maryland Stem Cell Research Fund
7.10. The New Jersey Commission on Science and Technology (NJCST)
7.10.1. Stem Cell Research in New Jersey
7.10.2. Stem Cell Research Grant Program
7.11. New York State Stem Cell Science (NYSTEM)
7.11.1. Investigator Initiated Research Projects and Innovative (IIRP),
Developmental or Exploratory Activities (IDEA) in Stem Cell Research
7.11.2. Targeted RFA for Investigation of iPS and Other Derivation
Approaches
7.11.3. Shared Facilities/Resources and Equipment/Instrumentation for
Stem Cell Research
7.11.4. Consortia Planning Awards
7.11.5. Institutional Development
7.11.6. Center for Stem Cell and Regenerative Medicine
7.11.7. Funding
8. Company Profiles
8.1. Aastrom Biosciences, Inc.
8.1.1. Aastrom's TRC Technology
8.1.2. Aastrom's Patents
8.1.3. Aastrom's Clinical Development Programs
8.2. Advanced Cell Technology, Inc.
8.2.1. ACT's Human ES Cell Technologies
8.2.2. ACT's Cellular Reprogramming
8.2.3. ACT's Stem Cell Differentiation
8.2.4. ACT's Adult Stem Cell Program
8.2.5. ACT's Intellectual Property
8.3. Aldagen, Inc.
8.4. Asterand plc
8.4.1. Asterand's Models and Methods to Improve Drug Discovery
8.4.2. Asterand's Product Offerings
8.4.2.1. Asterand's Frozen and Fixed Tissues
8.4.2.2. Asterand Cell Lines
8.5. Alseres Pharmaceuticals, Inc.
8.5.1. Alseres' Product Pipeline
8.5.1.1. Cethrin, a Rho Inhibitor
8.5.1.2. Inosine
8.5.1.3. Oncomodulin and ALSE-100
8.5.1.4. Altropane - PD
8.5.2. Alseres' Science and Technology
8.5.2.1. Nerve Repair Pathways
8.5.2.2. The Pro-Regenerative Pathway
8.5.2.3. The Anti-Regenerative Pathway
8.5.2.4. Molecular Imaging
8.6. Amgen, Inc.
8.6.1. Amgen's Clinical Developments
8.6.1.1. Amgen's Clinical Developments in Osteoporosis
8.6.1.2. Amgen's Clinical Developments in Oncology
8.6.2. Amgen's Select Product Candidates
8.6.2.1. Amgen's New Product Candidates
8.7. Amorcyte, Inc.
8.7.1. Amorcyte's Technology
8.7.1.1. AMR-001: A Cell Therapy for Acute Myocardial Infarction
8.8. Angioblast Systems, Inc.
8.8.1. Angioblast's Technology
8.8.1.1. Angioblast's Allogenic Adult Stem Cells
8.8.1.2. Angioblast's Protein Therapeutics
8.8.1.3. Angioblast's Gene Silencing
8.9. Athersys, Inc.
8.9.1. Athersys' Current Programs
8.9.2. Athersys' Regenerative Medicine Programs
8.9.2.1. Multistem for Heart Attack
8.9.2.2. HSC Transplant Support in Hematologic Malignancy
8.9.2.3. Stroke
8.10. BeFutur Biotechnologies
8.10.1. BeFutur's Serum Free Technology
8.10.2. BeFutur's Stem Cells
8.11. BD Biosciences
8.12. BioE, Inc.
8.12.1. BioE's Cell Technologies
8.12.1.1. Application of BioE's Multi-Lineage Progenitor Cell
8.12.1.2. Application of the MLPC in Regenerative Medicine
8.12.1.3. Application of PrepaCyte for Cord Blood
8.12.2. BioE's Products
8.12.2.1. Multi-Lineage Progenitor Cell (MLPC)
8.12.2.2. PrepaCyte-CB
8.12.2.3. PrepaCyte-WBC
8.12.2.4. ActiCyte
8.12.2.5. VitaLyse
8.13. Bioheart, Inc.
8.13.1. Bioheart's Product Candidates
8.13.1.1. MyoCell
8.13.1.2. MyoCell SDF-1
8.13.1.3. The TGI 1200 Cell Isolation system
8.13.1.4. Bioheart 3370
8.13.1.5. MyoCath
8.14. BioMimetic Therapeutics, Inc.
8.14.1. BioMimetic's Products
8.14.1.1. Augment Bone Graft
8.14.1.2. Augment Injectable Bone Graft
8.15. Biosafe Group SA
8.15.1. Biosafe's Sepax System
8.15.2. Coolmix
8.15.3. SepaxNet
8.16. Brainstorm Cell Therapeutics, Inc.
8.16.1. BrainStorm Technology-NurOwn
8.17. Cardio3 BioSciences
8.17.1. C-Cure
8.17.2. Dopamine Transporter (DAT)
8.18. CaridianBCT
8.18.1. Caridian's Products
8.18.1.1. Trima Accel Collection System
8.18.1.2. Spectra Optia Apheresis System
8.18.1.3. COBE Spectra Apheresis System
8.18.1.4. Elutra Cell Separation System
8.18.1.5. Atreus Whole Blood Processing System
8.18.1.6. OrbiSac System
8.18.1.7. COBE 2991 Cell Processor
8.19. Cellartis AG
8.19.1. Cellartis' Products
8.19.1.1. Cardiomyocyte Monolayers
8.19.1.2. Cardiomyocyte Clusters
8.19.1.3. Hepatocyte-like Cells
8.19.1.4. Mesenchymal Progenitors
8.19.1.5. The hES Cell Lines
8.19.1.6. Monoclonal Antibodies
8.19.1.7. VitroHES
8.19.1.8. Stem Culture Tools
8.20. Cellerant Therapeutics, Inc.
8.20.1. Cellerant's Pipeline
8.21. CellCyte Genetics Corporation
8.21.1. CellCyte's Product Candidates
8.21.2. CellCyte's Therapeutic Pipeline
8.21.2.1. Heart Repair
8.21.2.2. Cells for Use in the Liver
8.21.2.3. Delivery of Stem Cells to the Bone Marrow
8.21.2.4. Oncology-Adenocarcinoma Tumor Detection
8.21.3. CellCyte's Device Division
8.21.3.1. Cell Expansion
8.21.3.2. Stem Cell Purification
8.22. Cellerix
8.22.1. Cellerix's Products
8.22.1.1. Ontaril
8.22.1.2. Cx501
8.23. CellSeed, Inc.
8.23.1. Regenerative Cornea Product from CellSeed
8.23.2. Regenerative Living Cardiac Patch
8.24. Cellular Dynamics International, Inc. (CDI)
8.24.1. Induced Pluripotent Stem (iPS) Cell Technology
8.24.2. Cardiomyocytes
8.24.3. Mastocytes
8.25. CellTran Ltd.
8.25.1. Myskin
8.25.2. Lyphoderm
8.25.3. Products in Development
8.25.3.1. Vitiligo Treatment
8.25.3.2. Corneal Epithelial Treatment
8.25.3.3. Cell Migration Dressing
8.26. Cerco Medical
8.27. Cellular Engineering Technologies, Inc.
8.27.1. CET's Human Amniotic Epithelial Stem Cells
8.27.2. CET's Cryopreservation Media
8.27.3. CET's Adipogenic Differentiation Media
8.27.4. CET's Cardiomyocyte Differentiation Media
8.27.5. CET's Chondrogenic Differentiation Media
8.27.6. CET's Neural Differentiation Media
8.27.7. CET's Osteogenic Differentiation Media
8.27.8. CET's Amniotic Epithelial Stem Cell Expansion Media
8.27.9. CET's Cord Blood Multipotent Unrestricted Somatic Stem Cell
Expansion Media
8.27.10. CET's Mesenchymal Stem Cell Expansion Media
8.27.11. CET's Human Immunological Cells
8.27.12. CET's Human Foreskin Fibroblast Cells
8.27.13. CET's Human Umbilical Vein Endothelial Cell Expansion Media
8.27.14. CET's Cryopreservation Media
8.27.15. CET's Bioelectrode Cell-based Assays
8.27.16. CET's Hepatic Drug Screening
8.27.17. CET's Neural Drug Screening
8.27.18. CET's Contract Research Services
8.28. Cord Blood America, Inc.
8.29. CorMatrix Cardiovascular, Inc.
8.30. Cryo-Cell International, Inc.
8.31. Cytori Therapeutics, Inc.
8.31.1. Market for Clinical-Grade Cells
8.31.2. StemSource and Cell Banking
8.31.3. Celution System Pipeline
8.31.3.1. Cardiovascular Disease
8.32. CryoLife, Inc.
8.32.1. CryoLife's Services and Products
8.32.1.1. Tissue Preservation Services
8.32.1.2. Human Cardiac Tissue
8.32.1.3. Human Vascular Tissue
8.32.1.4. Human Orthopedic Tissue
8.32.1.5. ProPatch Soft Tissue Repair Matrix
8.33. Epistem PLC
8.33.1. Xenografting
8.33.2. Cancer Stem Cell Assays
8.33.3. Angiogenesis Models
8.33.4. Colon Cancer Models
8.33.5. Oncology Biomarker Models
8.33.6. In Vitro Cytotoxicity Testing
8.33.7. Target Validation-Oncology
8.33.8. Inflammatory Bowel Disease
8.33.9. Dermatology
8.33.10. Histology and Molecular Services
8.33.11. Epistem's Biomarkers
8.33.12. Epistem's New Therapies
8.34. ES Cell International Pvt, Ltd.
8.34.1. ESI's Technology
8.34.2. ESI's Intellectual Property
8.35. Forticell Bioscience, Inc.
8.36. OrCel
8.37. Gamida Cell
8.37.1. Gamida's Technology
8.38. GenVec, Inc.
8.39. Geron Corporation
8.39.1. Geron and Human Embryonic Stem Cell Therapies
8.39.2. Geron's Oligodendrocyte Progenitor Cells for Spinal Cord Injury
(GRNOPC1)
8.39.3. Geron's Cardiomyocytes for Heart Disease (GRNCM1)
8.39.4. Geron's Islet Cells for Diabetes (GRNIC1)
8.39.5. Geron's Osteoblasts for Osteoporosis and Non-Union Bone Fractures
8.39.6. Geron's Chondrocytes for Osteoarthritis
8.39.7. Geron's Dendritic Cells for Cancer Immunotherapy and to enable
Therapeutic Graft Acceptance
8.39.8. Geron's Immortalized Cells for Research
8.39.9. Geron's hESC-derived Cells for Drug Screening and Toxicology
8.40. Glycosan Biosystems, Inc.
8.40.1. Extracel Hydrogel Kit
8.40.2. Extracel-X Hydrogel Kit
8.40.3. Extracel-HP Hydrogel Kit
8.40.4. Extracel-SS Hydrogel Kit
8.40.5. HyStem Hydrogel Kit
8.40.6. HyStem-C Hydrogel Kit
8.40.7. HyStem-HP Hydrogel Kit
8.40.8. HyStem-CSS Hydrogel Kit
8.40.9. PEGDA
8.40.10. PEGTA
8.40.11. PEGSSDA (PEGSSDA)
8.41. Humacyte, Inc.
8.41.1. Humacyte's Technologies
8.41.1.1. Vascular Products
8.41.1.2. Injectable Products
8.41.1.3. Human Embryonic Stem Cell Therapies
8.42. Intercytex Group plc
8.42.1. Intercytex's Pipeline
8.42.1.1. VAVELTA - Skin Repair and Rejuvenation
8.42.1.2. SHEF-1 - Stem Cell Line
8.42.1.3. ICX-SKN-Skin Graft Replacement for Burns and Acute Wounds
8.42.1.4. ICX-TRC - Hair Regeneration
8.42.1.5. Cyzact-Chronic Wound Repair
8.43. Integra LifeSciences Holding, Corp.
8.43.1. Integra's Duraplasty Products
8.43.2. Integra's Collagen for Spine
8.43.3. Integra's Dermal Regeneration and Engineered Wound Dressings
8.43.4. Integra's Nerve and Tendon Products
8.43.5. Human Cells, Tissues and Cellular and Tissue-Based Products from
Integra
8.44. International Stem Cell Corporation
8.44.1. ISCO's Technology
8.44.1.1. Somatic Cell Nuclear Transfer
8.44.1.2. Parthenogenesis
8.44.1.3. ISCO's Therapeutic Focus
8.44.1.4. Retinal Degeneration
8.44.1.5. Diabetes Therapies
8.44.1.6. Liver Therapies
8.44.2. ISCO's Products
8.45. Japan Tissue Engineering Co., Ltd.
8.45.1. Cultured Epidermis
8.45.2. Cultured Cartilage
8.45.3. Cultured Corneal Epithelium
8.46. LifebankUSA
8.46.1. Cord Blood Banking
8.47. Life Technologies Corporation
8.47.1. Life Technologies' Customers
8.47.1.1. Life Science Researchers
8.47.1.2. Commercial Producers of Biopharmaceutical and Other
High-Valued Proteins
8.47.1.3. Applied Markets
8.47.2. Life Technologies' Products
8.48. Lonza
8.48.1. Lonza's Products and Applications
8.49. MedCell Bioscience, Ltd.
8.49.1. MedCell's MS-ten Technology
8.50. Medistem, Inc.
8.50.1. Method for Expansion of Stem Cells
8.50.2. Compositions of Placentally-derived Stem Cells for the Treatment
of Cancer
8.50.3. Transcatheter Tumor Immunoembolization
8.50.4. Stem Cell Therapy for Cardiac Valvular Dysfunction
8.50.5. Treatment of Erectile Dysfunction by Stem Cell Therapy
8.50.6. Allogeneic Stem Cell Transplants in Non-Conditioned Recipients
8.50.7. Stem Cell Mediated Treg Activation/Expansion for Therapeutic
Immune Modulation
8.50.8. Cellular Therapy for Lower Back Pain
8.50.9. Compositions and Methods of Stem Cell Therapy for Autism
8.50.10. Stem Cell Therapy for Weight Loss
8.50.11. Menstrual Blood Cellular Populations, Isolation, and Use Thereof
8.50.12. Endometrial Derived Reparative/Regenerative Cells
8.50.13. Treatment of Insulin Resistance and Diabetes
8.50.14. Combination Treatment of Cardiovascular Disease
8.50.15. Stem Cell Therapy for Autism
8.50.16. Endometrial Regenerative Stem Cell Line
8.50.17. Medistem's Angiostem Platform
8.51. Mesoblast Limited
8.51.1. Mesoblast's Technologies
8.51.2. Mesoblast's Applications in Bone Repair
8.51.2.1. Cartilage Regeneration
8.51.2.2. Disc Regrowth
8.51.3. Mesoblast's Application in Heart Attack
8.51.3.1. Congestive Heart Failure
8.51.3.2. Peripheral Arterial Disease
8.51.4. Mesoblast's Application in Wound Ulcers
8.51.5. Mesoblast's Process and Product Development
8.51.5.1. GMP Process Development
8.51.5.2. Proof of Principle Models
8.52. Millipore Corporation
8.52.1. Millipore's Drug Discovery and Development Services
8.52.2. Millipore's Research and Development
8.53. Miltenyi Biotec
8.53.1. Miltenyi Biotec's MACS Technology
8.53.2. MACS Cell Analysis
8.53.3. MACS Cell Culture product line
8.54. Neostem, Inc.
8.54.1. NeoStem's Services
8.55. NeuralStem, Inc.
8.55.1. NeuralStem's Focus on Regenerative Medicine
8.55.2. The Potential of NeuralStem's Tissue-Derived Stem Cell-based
Therapy
8.55.3. Potential Markets
8.55.4. NeuralStem's Technology
8.55.5. NeuralStem's Research Programs
8.56. NeuroGeneration
8.56.1. NeuroGeneration's Stem Cell Therapy
8.57. Novocell, Inc.
8.57.1. Novocell and Stem Cell Engineering
8.57.2. Novocell and Cell Encapsulation
8.57.3. Novocell's Clinical Trials
8.58. Opexa Therapeutics, Inc.
8.58.1. Opexa's Products
8.58.1.1. Tovaxin
8.58.1.2. Current MS Treatments
8.59. Organogenesis, Inc.
8.59.1. Products from Organogenesis
8.59.1.1. Apligraf
8.59.1.2. VCT01
8.59.1.3. CelTx for Oral Soft Tissue Regeneration
8.59.2. Bio-surgery
8.59.3. Licensing Opportunities
8.59.3.1. FortaFlex Collagen Biomaterial Technology
8.60. Orthovita, Inc.
8.60.1. Orthovita's Products and Product Candidates
8.60.1.1. Orthovita's Bone Defect Grafting Products
8.60.1.2. Orthovita's Spinal Fusion and Grafting Products
8.60.1.3. Orthovita's Trauma Products
8.60.1.4. Orthovita's Dental, Periodontal, Oral and
Cranio-Maxillofacial Products
8.61. Osiris Therapeutics, Inc.
8.62. Pervasis Therapeutics, Inc.
8.62.1. Vascugel
8.62.2. PVS-10200 - Minimally Invasive
8.63. Pleuron Corp.
8.63.1. Plureon's Technology
8.64. Pluristem Therapeutics, Inc.
8.64.1. Pluristem's PluriX 3D Bioreactor
8.64.2. Pluristem's PLacental eXpanded (PLX) Cells
8.64.3. PLX-PAD for Peripheral Artery Disease
8.64.4. PLX-IBD for Inflammatory Bowel Disease (Crohn's Disease and
Ulcerative Colitis)
8.64.5. PLX-MS for Multiple Sclerosis
8.64.6. PLX-STROKE for Ischemic Stroke
8.65. Reinnervate LLC
8.65.1. Reinnervate's Technology
8.65.2. Reinnervate's Culture Apparatus for Three Dimensional Cell Growth
8.65.3. Production of Synthetic Retinoids to Control Cell Differentiation
8.66. Regenocyte Therapeutic
8.66.1. Regenocyte's Adult Stem Cell Therapy
8.67. ReNeuron Group Plc
8.67.1. ReNeuron's Platform Technologies
8.67.2. ReNeuron's Cell Therapy Programs
8.67.3. ReNcell Products
8.68. Saneron Therapeutics, Inc.
8.68.1. Saneron's U-CORD-CELL Program
8.68.2. Saneron's SERT-CELL Program
8.69. Scikon Innovation, Inc.
8.69.1. Scikon's Human Cell Products
8.70. Stem Cells, Inc.
8.70.1. StemCell's Specialty Cell Culture Products
8.70.2. StemCell's Patents
8.71. StemCell Technologies, Inc.
8.71.1. SCT's Products
8.71.2. Hematopoietic Stem Cell Research
8.71.3. SCT's Mesenchymal Stem Cell Products for Human Cells
8.71.4. SCT's Products for Neural Stem Cells Research
8.71.5. Stem Cell Innovations (SCI)
8.71.6. SCI's Research and Development
8.71.7. SCI's Services
8.71.7.1. PluriCells and Derivatives
8.71.7.2. ACTIVTox
8.71.7.3. PREDICTIVTox
8.71.7.4. Endogenous Protein Production
8.72. Stem Cell Sciences KK
8.72.1. Cell-Based Therapy
8.72.2. SCS KK's Product/Service
8.72.2.1. CultiCell Medium for Embryonic Stem Cells
8.72.3. Contract/Sponsored Research on ES-Derived Functional Cells
8.73. Stem Cell Therapy International, Inc.
8.73.1. Biological Preparations
8.73.2. Treatment of Patients with Diabetes
8.73.3. Treatment of Patients with Diabetic Retinopathy
8.73.4. Atherosclerosis Coronary Heart Disease and Cerebral Ischemia
8.73.5. Liver Cirrhosis
8.73.6. Non-Specific Ulcerative Colitis (Crohn's Disease)
8.73.7. Immunomodulation before Capital Surgical Operations Wound
Dystrophy
8.73.8. Acute Surgical Complications
8.73.9. Peritoneal Commissures of the Abdominal Cavity
8.73.10. Immunodeficient States in Children
8.73.11. Sickle-Cell Anemia Therapy
8.73.12. Complex Therapy of Down's Disease
8.73.13. Complex Therapy of Cosmetic Problems
8.73.14. Diseases and Disorders of Nervous System
8.74. Stempeutics Research Private Limited
8.74.1. Research: Mesenchymal Stem Cells Derived from Wharton's Jelly
8.74.2. Research: Mesenchymal Stem Cells Derived from Adipose Tissue
8.74.3. Research: Mesenchymal Stem Cells Derived from Dental Pulp
8.74.4. Research: Large Scale Upscaling of Mesenchymal Stem Cells
8.74.5. Research: Human Embryonic Stem Cells
8.74.6. Stempeutics' Clinical Trials
8.74.6.1. Acute Myocardial Infarction (AMI)
8.74.6.2. Critical Limb Ischemia (CLI)
8.74.6.3. Chronic Obstructive Pulmonary Disease
8.74.6.4. Liver Cirrhosis
8.74.6.5. Osteoarthritis
8.74.6.6. Diabetes Mellitus - Type II
8.74.6.7. Cerebral Stroke (This Trial is being Conducted in Malaysia)
8.75. Tengion, Inc.
8.75.1. Tengion's Technology
8.75.2. Tengion's Pipeline
8.76. TheraVitae
8.76.1. TheraVitae's Stem Cell Technology
8.76.2. TheraVitae's Products
8.76.2.1. VesCell for Heart Disease
8.76.2.2. VesCell for Peripheral Artery Disease (PAD)
8.76.2.3. Future Products
8.77. VistaGen Therapeutics, Inc.
8.77.1. VistaGen's Embryonic Stem Cell Technologies
8.77.2. Tools for Drug Discovery and Regenerative Medicine
8.77.3. New Generation Drug Screening Assays for Neurological Drugs
8.77.4. New Generation Drug Screening Assays for Metabolic Diseases
8.77.5. Toxicity Screening
8.78. ZenBio, Inc.
8.78.1. ZenBio's Culture Media
Appendix 1: Clinical Trials in Stem Cell Space
Appendix 2: Stem Cell Glossary
Appendix 3: Consultants in Cell Therapy Sector
INDEX OF FIGURES
Figure 2.1: Derivation of Human Embryonic Stem Cells (hESC)
Figure 2.2: Differentiation of Embryonic Stem Cells into Specialized Cell
Types
Figure 2.3: Hematopoietic and Stromal Cell Differentiation
Figure 2.4: Somatic Cell Nuclear Transfer (SCNT)
Figure 3.1: Percent Population of Patient Pool with Unmet Clinical Need
Figure 3.2: Implantation of a Hydrogel at the Site of an Injured Tissue
Figure 3.3: Implantation of CS-PEG Hydrogel
Figure 3.4: Implantation of CMP-PEG Scaffold
Figure 4.1: Market for the Three Major Segments of Stem Cell Market,
2008-2012
Figure 4.2: Market for Cell Therapy Products in the U.S., 2009-2018
Figure 4.3: Utilization of Stem Cell Types in Stem Cell Market Place, 2008
Figure 4.4: Potential Uses of Human Embryonic Stem Cells (hESCs)
Figure 4.5: Global Market for Cord Blood Stem Cells, 2010-2015
Figure 4.6: Worldwide Growth of Public Cord Blood Banks, 2005-2009
Figure 4.7: Worldwide Growth of Private Cord Blood Banks, 2005-2009
Figure 4.8: Standard Procedure for Cord Blood Processing
Figure 4.9: Cell Culture Products by Market Segment
Figure 4.10: Global Market for Cell and Tissue Analysis Products, 2008-2014
Figure 4.11: Growth in Size of Cell Therapy Industry, 2000-2008
Figure 4.12: Percent Break-Up of Cell Therapy Companies by Product Type,
2008
Figure 4.13: Location of Primary Tissue Engineering Companies (%) by
Geography, 2008/2009
Figure 4.14: Breakdown (%) of Primary Cell Therapy Products on Market by
Geography, 2008/2009
Figure 4.15: Geographical Distribution of Clinical Trials, 2008/2009
Figure 5.1: Value Chain of Mesenchymal Stem Cell Therapeutics
Figure 5.2: Use of Coverage and Reimbursement Knowledge in the Product
Life Cycle
Figure 6.1: Increase in Worldwide Funding for Cell Therapy Products,
2008-2018
Figure 7.1: CIRM's Grant Awards (%) by Category, 2009
Figure 7.2: CIRM's Funding (%) by Disease Application, 2009
Figure 7.3: CIRM's Funding (%) by Disease Category, 2009
Figure 8.1: Cardio3 Biosciences' Investors, 2008
Figure 8.2: Relative Success of Cord Blood Stem Cells from Autogenic Donor
Figure A1.1: Clinical Studies on Cell Therapy related Products by Country,
2010
INDEX OF TABLES
Table 2.1: Different Types of Stem Cells and Their Properties
Table 2.2: Adult Stem Cell (ASC) Differentiation Properties
Table 2.3: HSC Sources and Their Properties
Table 3.1: Stem Cell Therapeutics for Orthopedic Disease in Development
Table 3.2: Stem Cell-based Therapeutics for Cardiac and Ischemic Diseases
in Development
Table 3.3: Stem Cell Therapeutics for Type I Diabetes in Development
Table 3.4: Stem Cell Therapeutics for Neurological Disease in Development
Table 3.5: Stem Cell-based Therapeutics for Vascular Diseases in
Development
Table 3.6: Stem Cell Therapeutics for Hematological Diseases in Development
Table 3.7: Products in Development: Target Indications, 2008
Table 3.8: Top Ten Regenerative Medicine Products, 2008
Table 3.9: Wound Healing Products
Table 3.10: Autologous Tissue-Engineering Products from BioTissue
Technologies AG
Table 3.11: co.don's Product Portfolio
Table 4.1: Entities Developing hSCs
Table 4.2: Biotech and Pharmaceutical Companies Investing in hESC Research
Table 4.3: Selected Cord Blood Banks Worldwide
Table 4.4: Selected Cord Blood Banks in the U.S.
Table 4.5: Companies in the Cord Blood Stem Cell Technology and
Therapeutics Development Space
Table 4.6: Some Selected Suppliers of In Vitro Test Kits and their Products
Table 4.7: Suppliers of Cells and Tissues
Table 4.8: Suppliers of Media and Cell Reagents
Table 4.9: Providers of Equipments for Stem Cell Research
Table 4.10: Providers of Computer Software for Stem Cell Research
Table 4.11: Geographical Distribution of Stem Cell-Related Tissue
Engineering Companies, 2008
Table 4.12: Breakdown of Cell Therapy Firms by Country, 2008/2009
Table 4.13: Cell Therapy Products on the Market by Type and Application
Area
Table 4.14: Data on Sales and Application for Skin and Cartilage Products,
2006-2008
Table 4.15: Reagent Sales by Selected Stem Cell Companies, 2008
Table 4.16: Sales of Secondary Products, 2007
Table 4.17: Disease Focus of Clinical Trials, 2008/2009
Table 4.18: Stem Cell Products in Phase II/III and Phase III Trials,
2008/2009
Table 4.19: Licensing Activity in Pharmaceutical and Cell Therapy
Industries
Table 4.20: Investment Activity in Cell Therapy Sector
Table 4.21: Novel Partnership by Large Pharmaceuticals with Universities
Table 4.22: Cell Therapy Companies with Greater Than $10 Million by Market
Cap, 2008
Table 5.1: Elements of a Manufacturing Facility
Table 5.2: Cell Therapy CMO Qualification Audit: Points to Investigate
Table 5.3: Areas for Coverage and Reimbursement Competency and Planning
Table 6.1: Cell-Based Regenerative Medicine Companies
Table 6.2: NIH Funding for Regenerative Medicine and Stem Cell Research,
2003-2009
Table 6.3: NIH Funding for Various Types of Stem Cell Research, 2004-2009
Table 6.4: CIRM Funded Grants To-Date
Table 6.5: Economic Costs of Major Illnesses in the U.S. and the Number of
Patients
Table 6.6: Costs per Quality-Adjusted Life Year for Various Interventions
Table 7.1: Stem Cell Policies in North America
Table 7.2: Stem Cell Policies in South America
Table 7.3: Stem Cell Policies in Europe
Table 7.4: Stem Cell Policies in Asia/Oceania
Table 7.5: List of Upcoming Request for Applications (RFAs) Showing
Commitments from Funding Partners
Table 7.6: Recipients of Funds from Connecticut Stem Cell Research
Program, 2009
Table 7.7: Maryland Stem Cell Research Fund, 2008
Table 7.8: NJCST's Award of Grants for Stem Cell Research, 2008
Table 7.9: NYSTEM's IIRP Awards, 2008
Table 8.1: Aastrom's Patents, 2010
Table 8.2: Aastrom's Product Pipeline, 2010
Table 8.3: Patents Owned by Advanced Cell Technologies, Inc., 2009
Table 8.4: Asterand's Frozen and Fixed Tissue Products, 2010
Table 8.5: Alseres' Product Pipeline, 2009
Table 8.6: Amgen's Outstanding Material Patents for Darbepoetin Alfa
Table 8.7: Amgen's Outstanding Material Patents for Epoietin Alfa
Table 8.8: Amgen's Outstanding Material Patents for Pegfilgrastim
Table 8.9: Amgen's Product Candidates
Table 8.10: Amgen's Product Candidates by Phase of Development
Table 8.11: Angioblast's Product Development
Table 8.12: BD Biosciences' Customers and Products
Table 8.13: BD Biosciences' Revenue by Segment, 2008 and 2009
Table 8.14: Bioheart's Patents, 2009
Table 8.15: Bioheart's Pending Patent Applications, 2009
Table 8.16: Bioheart's Clinical Trials, 2009
Table 8.17: BioMimetic's Clinical Data, 2010
Table 8.18: Cellerant's Pipeline
Table 8.19: Private Cord Blood Banking vs. Public Donation
Table 8.20: Cytori's Celution System Family and its Regulatory Status, 2009
Table 8.21: ESI's Patents in Stem Cell Field, 2009
Table 8.22: Gamida's Pipeline, 2009
Table 8.23: hESC-derived Product Candidates Being Developed by Geron or
Its Collaborators
Table 8.24: Intercytex' Product Pipeline, 2009
Table 8.25: LifebankUSA's Cord Blood Units Released for Transplant
Standard Therapies
Table 8.26: Medistem's Patent Applications
Table 8.27: Millipore's Products in Apoptosis and Cell Biology
Table 8.28: Millipore's Products in Biomarkers
Table 8.29: Millipore's Products in Cell Culture and Stem Cell Biology
Table 8.30: Millipore's Products in Cell Signaling and Epigenetics
Table 8.31: Millipore's Drug Discovery and Development Services
Table 8.32: Potential Target Markets for Stem Cell Therapies in the U.S.
Table 8.33: Issued and Pending Patents Owned by NeuralStem, Inc.
Table 8.34: Opexa's Pipeline, 2009
Table 8.35: Orthovita's Bone Graft Products, 2009
Table 8.36: Orthovita's Bone Marrow Aspiration Tools, 2009
Table 8.37: Osiris' Biologic Drug Candidates, 2010
Table 8.38: Pervasive's Product Pipeline
Table 8.39: Scikon's Media for Cell seeding and Culture, 2010
Table 8.40: Current Status of StemCell's Two Therapeutic Product
Development Programs
Table 8.41: StemCell's Specialty Cell Culture Products
Table 8.42: StemCell's U.S. Patents, 2009
Table 8.43: Cell Types Separated by SCT's Four Solutions
Table 8.44: Products Offered by SCT for Hematopoietic Stem Cell Research
Table 8.45: SCT's Products for Human Embryonic Stem Cell Research
Table 8.46: SCT's Products for Mesenchymal Stem Cell Research
Table 8.47: SCT's Products for Neural Stem Research
Table 8.48: SCT's Other Products for Stem Cell Related Research
Table 8.49: Tengion's Pipeline
Table 8.50: ZenBio's Products
Table A1.1: Stem Cells in Clinical Trials
Table A3.1: Consultants in Cell Therapy Sector
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