Antibody sales are predicted to reach $50 billion this year. This Insight
Pharma Report focuses on recent developments in the therapeutic antibody field
and new technologies built on the foundations of previously successful and
unsuccessful strategies.
Following a review of the business environment and market forces, this report
examines:
The state of the art, and the needs and direction, of antibody technology
today
Antibody conjugates and other payloads: construction, clinical
development, and corporate activity
Multispecific and multifunctional antibodies: construction, clinical
development, and corporate activity
Development of biosimilars and biobetters: commercial and regulatory issues
Advances in product development technologies and overcoming
biomanufacturing challenges
IP challenges, deal structures, mergers and acquisitions
Marketed and clinical pipeline products, current status and future forecast
Strategies, technologies, and pipelines of selected new-generation
antibody companies
Future potential impact of systems biology and nanotechnology
Strategic issues, economic outlook, and opportunities for future products
Insights from thought leaders interviewed for this report
The commercial clinical pipeline for antibodies is growing at a rate of 50 -
55 new mAbs per year. Today, about 314 mAb products are in clinical trials
worldwide. ‘The New Generation of Antibody Therapeutics: Current Status and
Future Prospects’ reviews antibodies in clinical development, profiles
selected companies that may contribute to the next generation of cutting-edge
antibody technology, and discusses notable collaborations within the antibody
industry.
A number of immunotoxins currently in clinical trials are antibody-based
reagents. As discussed in this Insight Pharma Report, a number of targets,
drugs, and linkers are being evaluated. The last few years have seen striking
improvements in the development of antibody-drug conjugate technology; it is
clear that in the next few years a wave of such products will gain approval.
Firms that profess expertise in the synthesis of immunoconjugates are
discussed in this report.
Bispecific antibodies present unique possibilities for disease treatment.
There is substantial interest in bispecific antibodies as a means to overcome
some of the shortcomings of conventional recombinant antibodies that have
slowed their successful performance and prevented FDA approval. Today,
numerous bispecific antibodies are in clinical trials and may provide a new
generation of antibody technologies. This Insight Pharma Report profiles
selected bispecific antibody companies and cutting-edge concepts in bispecific
antibody development.
‘The New Generation of Antibody Therapeutics: Current Status and Future
Prospects’ discusses recent developments in bioprocessing relevant to the
needs of the antibody sector. Also discussed are biosimilar antibody drugs,
which are the subject of much interest with many patent expirations taking
place. While the FDA has yet to approve a biosimilar, many large companies
have been moving forward aggressively on such products. We review challenges
and opportunities, commercial development and the marketplace, as well as
regulatory issues concerning biosimilars.
Predictions for the future of cutting-edge antibody technologies are that
robust growth will continue despite the many roadblocks and uncertainties in
the overall picture of drug development. While the market will continue to be
dominated by whole antibody molecules, it is anticipated that bispecific
antibodies and antibody-drug conjugates will be a growing component of the
overall market.
About the Author
K. John Morrow, Jr., PhD, is a writer and consultant for the
biotechnology industry. He obtained his PhD in genetics from the University of
Washington in Seattle, and completed his training with post-doctoral studies
in Italy at the Universita di Pavia and in Philadelphia at the Fox Chase
Cancer Institute. He has held faculty positions at the University of Kansas
and at Texas Tech University Health Sciences Center. His writings include over
200 peer-reviewed journal papers, non - peer-reviewed coverage of the
biotechnology industry, books, and marketing reports. A number of companies,
including Meridian Bioscience, Affitech, Henderson-Morley Biotechnology,
Brandwidth Communications, and Emergent Technologies have taken advantage of
his consultancy services, provided through Newport Biotechnology Consultants.
He resides in Newport, KY.
Table of Contents
Table of Contents
Chapter - 1
Introduction, Scope, and Objectives
1.1. Introduction
A Long History of Biotherapeutics
The Rise of Antibodies
The FDA Approval Process
Is the FDA Moving Too Slowly?
Cost Factors in Antibody Therapeutics
1.2. Current Products
Avastin (bevacizumab)
Cimzia (certolizumab pegol)
SIMPONI (golimumab)
ILARIS (canakinumab)
STELARA (ustekinumab)
ARZERRA (ofatumumab)
Prolia (denosumab)
Actemra (tocilizumab)
Benlysta (belimumab)
YERVOY (ipilimumab)
ADCETRIS (brentuximab)
1.3. Business Environment and Market Forces
World Economic Outlook
Economic Outlook for Antibody Technologies
Drug Development Costs
1.4. Opportunities for Future Products Antibodies in Development
Phase III Antibody Studies
Elotuzumab
Naptumomab estafenatox
AMG 386
Itolizumab
Factor VIII-Fc and Factor XI-Fc
CINQUIL (reslizumab)
Obinutuzumab
Bosatria (mepolizumab)
Necitumumab
Ramucirumab
Epratuzumab
Tabalumab
Solanezumab
Farletuzumab
Secukinumab
Vedolizumab
Bapineuzumab
Inotuzumab (CMC-544)
Sarilumab
Zanolimumab (HuMax-CD4)
Girentuximab
Otelixizumab
Other Antibodies in Earlier Stages of Development
IL-1 - Blocking Therapies
Adimab Antibodies: MM-151
Daratumumab
Alzheimer's Disease: Therapeutic Antibodies
A Delivery Strategy That Overcomes the Blood-Brain Barrier
A New Trial Will Follow Progression from the Preclinical State to
Expression of the Full-Blown Disease
New Antibody Selection Technologies
Novartis and AnaptysBio
Ylanthia (MorphoSys)
Small Engineered Bispecific Antibodies
Improving Efficacy and Druggability of mAbs
A New Yeast Display Technology
1.5. Summary, Objectives, and Outlook
Chapter - 2
Antibody Conjugates and Other Payloads
2.1. Past and Present
2.2. General Methodology of Construction
2.3. Notable Antibody-Toxin Conjugates
AGS-16M8F
AGS-5ME
Glembatumumab Vedotin-Auristatin E
Ontak/DT
Trastuzumab-Emtansine
Lorvotuzumab-Mertansine (IMGN901)
Cintredekin Besudotox
MR1-1 - PE
MEDI547-mcMMAF
CAT-8015 - PE
BL22-PE
LMB-2 - PE
SS1P-PE
Inotuzumab-Ozogamicin
PSMA ADC/PSMA ADC-Auristatin E
SAR-3419
Brentuximab-Vedotin
2SGN-75 - Auristatin F
HuM195/rGel-rGelonin
RFT-5 - dgA
Moxetumomab Pasudotox (CAT-8015 - PE38)
CDX-011
2.4. Clinical Trials HuM-195/rGel: A Unique Immunoconjugate
2.5. Commercial Development
Aldevron (Formerly GENOVAC)
GenScript
Maine Biotechnology Services
Ambrx
Seattle Genetics
Genentech
Philogen
2.6. Summary and Future Directions for Antibody-Drug Conjugates
Chapter - 3
Multispecific and Multifunctional Antibodies
3.1. Challenges and Opportunities
3.2. The Rundown on Bispecific Antibody Companies Ablynx
Affimed
Fresenius
MacroGenics
Merrimack
Micromet
Pfizer
Sanofi
Trion
Zyngenia
3.3. Methods of Construction
3.4. Recombinant Polyclonal Antibodies
3.5. Anti-Angiogenic Antibodies: Boom or Bust
3.6. Challenges and Opportunities in Immunocytokines
Provenance
3.7. Cutting-Edge Concepts in Bispecific Antibody Development
DuoBody Technology
Chemically Programmed Antibodies: CovX
3.8. Summary and Conclusions
Chapter - 4
Biosimilars and Biobetters: Opportunities and Challenges
4.1. Biosimilars: Challenges and Opportunities
An Uncertain Period
A Rundown on Biosimilars
Will Biosimilar Cost Savings Materialize?
4.2. Commercial Development and Marketplace
4.3. Role of the EMA and FDA in Approval and Regulation of
Biosimilars
EU Initiative
Canadian Biologics Regulatory Guidelines
US Regulation and the Affordable Healthcare Act
4.4. Biobetters: Unique Products or Improved Biosimilars?
Chapter - 5
Advances in Product Development Technologies
5.1. Overview
5.2. Biomanufacturing Challenges
5.3. Overview of Bioprocessing Technology
Escherichia coli
Other Bacterial Hosts
Yeast
Saccharomyces cerevisiae
Pichia pastoris
Insect Cells
Dictyostelium discoideum
5.4. Downstream Processing: Improvements in Product Purification
5.5. New Emerging TechnologiesMore and Better Disposables
Dealing with Inclusion Bodies
Modifying Proteins to Improve Their Stability
New Wrinkles in Bioprocessing
Wanted: Very Rapid Micropurification Strategies
Non-Natural Amino Acids
Improvements in Product Purification from Plant Material
5.6. Failed Technologies and Lessons Learned Failed Therapeutics
Inclusion Bodies
Host Cell Proteases, Endotoxins, and Pyrogens
Chapter - 6
IP Challenges, Deal Structures, Mergers & Acquisitions, and Future
Opportunities
6.1. IP Thicket for Biosimilars
6.2. Collaboration and Partnering
Symphogen
Activartis Biotech
MorphoSys
ImmunGene
BioInvent
Eli Lilly
Apexigen and Gansu Duyiwei Biological Pharmaceutical
GlaxoSmithKline-Tolerx Collaboration
b>6.3. Mergers and Acquisitions
Bristol-Myers Squibb Completes Acquisition of Inhibitex
Biogen Idec to Pay Up to $562.5 Million for Stromedix
Sanofi Signs Rare Disease Pact with CRG
Illumina Rejects Roche Tender Offer
Chapter - 7
Marketed and Pipeline Products
7.1. Marketed Products: Current Status and Future Forecast
7.2. Clinical Development: Lessons Learned From Successes and
Failures
7.3. The Centocor Experience with Centoxin
Chapter - 8
Profiles of Selected New-Generation Antibody Companies
8.1. Overview
MacroGenics
Micromet
Bicycle Therapeutics
8.2. Business Strategy
8.3. Technology and Product Pipeline Zyngenia
Philogen
T2 Biosystems
Molecular Partners
Tolerx
Crescendo Biologics
Haptogen
Trion, MacroGenics, and Micromet
Chapter - 9
Strategic Issues
9.1. Outlook for the Future
Why Do Antibodies Fail?
Naked or Nattily Dressed: Which Is Best?
Escape from the Valley of Death
Next Five Years
Alternative Affinity Tools
Technologies, 10 Years Plus
Intracellular Immunity
Demands, Needs, Directions
New Target Search
Cost Containment
We Need to Quit Overpromising
Systems Biology Is Not the Holy Grail
There Are No Surprises
9.2. Systems Biology and Design of Innovative Therapies Building
More Antibodies
Future of the Proteome
Systems Biology Companies
9.3. Immunotherapeutics and Vaccines
9.4. Impact of Nanotechnology in Antibody Therapeutics Development
Magnetic Nanoparticles
Antibody-Conjugated Nanoparticles
Nanodelivery Systems for Antibodies
Nanotechnology and Regulatory Concerns
References
Appendix
List of Consultants
Company Index
FIGURES
Figure 1.1. A Slow Rate of Approval for Antibodies
Figure 1.2. Structure of the Akt Molecule
Figure 1.3. Anti-TNF Agents Infliximab, Adalimumab, and Certolizumab Pegol
Figure 1.4. STELARA Molecule
Figure 1.5. Zoledronic Acid
Figure 1.6. Global GDP Growth
Figure 1.7. R&D Expenditures Continue an Upward Trend, While Approval
Rates Keep Dropping
Figure 1.8. CD38 Molecule
Figure 1.9. Structure of the Three-Helical Albumin-Binding Domain (ABD)
from Streptococcal Protein G (PDB: 1GJT)
Figure 2.1. Chemical Structures of mAb-Drug Conjugates
Figure 2.2. An Antibody-Drug Conjugate
Figure 2.3. Denileukin Diftitox (Ontak)
Figure 2.4. Recombinant Immunotoxin BL22 and LMB-2
Figure 2.5. How the PSMA ADC Works
Figure 3.1. A Conventional Antibody and Its Derived Fragments
Figure 3.2. The Scaffold Antibody and the Bispecific CVX-241 Antibody
Figure 3.3. Structure and Size Comparison of Tetravalent Antibodies and
Native Divalent Antibodies With Western Blot Analysis of the Purified
Anti-CD20 mAbs Separated by SDS-PAGE
Figure 3.4. Symphogen's Sym004 mAb Mixture Enables Novel Mechanism of
Action
Figure 3.5. Peregrine Clinical Trials in Progress
Figure 8.1. Display of Philogen Technology
Figure 8.2. Iron Oxide Nanoparticles (Orange) Coated With a Dextran
Polymer and Bound to a Detector Antibody
Figure 8.3. A 4-Repeat DARPin Molecule
Figure 9.1. Outline of the Immune Surveillance Theory
Figure 9.2. Mechanism of Action of Whole IgG mAbs
Figure 9.3. Antibody Fab Fragments Complexed with Peptide Epitopes
Figure 9.4. Structure of the Armadillo Repeat Region of Beta-Catenin
Figure 9.5. A Biosensor Platform
Figure 9.6. Honeycombed Particles Filled with Cancer Drugs Act like
Time-Release Capsules at Tumor Site
TABLES
Table 1.1. FDA-Approved Recombinant Antibodies
Table 1.2. Costs of the Most Expensive Drugs
Table 1.3. Various Estimates of Pharma Sales
Table 1.4. Phase III Antibody Trials
Table 1.5. IL-1 - Blocking Therapies Marketed or In Development for the
Treatment of Autoimmune Disorders
Table 1.6. Many Antibodies Are Directed Against the Same Target
Table 2.1. Immunotoxins: Current Status of Clinical Trials
Table 3.1. Bispecific Antibodies in Clinical Trials
Table 4.1. EMA-Approved Biosimilars
Table 5.1. Non-Microbial Protein Production Platforms
Table 5.2. Important Approved Therapeutic Protein-Based Products From E.
coli
Table 5.3. Various Polishing Options
Table 6.1. Notable Antibody Collaborations
Table 9.1. Properties of Affinity Molecules
Table 9.2. Systems Biology Companies
Table 9.3. Antibodies Against Infectious Disease Agents in Current Trials
The New Generation of Antibody Therapeutics: Current Status and Future Prospects published by Insight Pharma Reports in June 1, 2012. This report price starts from US $ 2495.
Press Release
Antibody Sales Predicted to Reach $50 Billion in 2012
June 4th, 2012
Global Information Inc. would like to present a new market research report, "The New Generation of Antibody Therapeutics: Current Status and Future Prospects" by Insight Pharma Reports.
With antibody sales projected to reach $50 billion this year, predictions for the future of cutting-edge antibody technologies are that robust growth will continue despite the many roadblocks and uncertainties in the overall picture of drug development. While the market will continue to be dominated by whole antibody molecules, it is anticipated that bispecific antibodies and antibody-drug conjugates will be a growing component of the overall market.
The commercial clinical pipeline for antibodies is growing at a rate of 50 55 new mAbs per year. Today, about 314 mAb products are in clinical trials worldwide. The New Generation of Antibody Therapeutics: Current Status and Future Prospects reviews antibodies in clinical development, profiles selected companies that may contribute to the next generation of cutting-edge antibody technology, and discusses notable collaborations within the antibody industry.
Report highlights:
Current state of the art, and the needs and direction of antibody technology
Antibody conjugates and other payloads: construction, clinical development, and corporate activity
Multispecific and multifunctional antibodies: construction, clinical development, and corporate activity
Development of biosimilars and biobetters: commercial and regulatory issues
Advances in product development technologies and overcoming biomanufacturing challenges
IP challenges, deal structures, mergers and acquisitions
Marketed and clinical pipeline products, current status and future forecast
Strategies, technologies, and pipelines of selected new-generation antibody companies
Future potential impact of systems biology and nanotechnology
Strategic issues, economic outlook, and opportunities for future products
Insights from thought leaders interviewed for this report
This Insight Pharma report focuses on recent developments in the therapeutic antibody field and new technologies built on the foundations of previously successful and unsuccessful strategies. The new report discusses recent developments in bioprocessing relevant to the needs of the antibody sector. Also discussed are biosimilar antibody drugs, which are the subject of much interest with many patent expirations taking place. While the FDA has yet to approve a biosimilar, many large companies have been moving forward aggressively on such products. Insight Pharma reviews challenges and opportunities, commercial development and the marketplace, as well as regulatory issues concerning biosimilars.
