This publication has been discontinued on September 9, 2011.
Abstract
Description
GBI Research' s new report “Biomarkers in Drug Discovery - Optimizing
Drug Discovery Timeline and Cost” provides an in-depth analysis on the
potential applications of biomarkers in pharmaceutical drug discovery and
clinical services. The report suggests investment decisions in biomarker based
drug research by providing information on valid biomarkers, pipelines, case
studies, competitive landscape, geographical dominance, mergers and
acquisitions and market potential. It also provides an analysis on the trends
prevailing in the global biomarkers market. In addition to this, the report
also covers market drivers and Restrains for the global biomarkers market.
Increasing Acceptance and Application of Biomarkers in Drug Discover by
Pharmaceutical Companies
GBI Research analyzed the increasing application of Biomarkers in drug
discovery process and how it facilitates the Pharmaceutical Companies to
overcome the challenges posed by conventional drug discovery processes which
are time consuming and expensive. High drug attrition rates, safety and
efficacy concerns and time consuming methods have encouraged the
pharmaceuticals sector to adopt the use of biomarkers in drug discovery
process on a large scale. According to the FDA the biomarkers are 10% more
efficient in predicting drug failures and hence can save approximately $100m
and three to four years in each drug discovery process. Application of the
biomarkers in the pharmaceuticals sector can revolutionize the drug discovery
process by facilitating treatment decision and introduction of preventive and
personalized medicines.
Application of Biomarkers in Each Stage of Drug Discovery
Biomarkers have wide spread applications and are used in several sectors
including pharmaceuticals due to their high sensitivity and efficacy. In the
pharmaceuticals sector biomarkers have applications in each phase of drug
discovery. In drug discovery processes biomarkers are used mainly to monitor
the disease progression with the therapy. The reason for their popularity in
the pharmaceuticals sector constitutes its ability to detect and monitor
disease progression. Biomarkers techniques are non-invasive and robust and
have helped them gain popularity over the conventional drug discovery methods.
From the early lead and target identification and optimization stages to late
stage drug discovery process biomarkers are applicable for target validation,
determination of mechanism of action of drug (MOA), drug safety and efficacy
and most importantly the therapy response. Biomarkers are applicable in
efficiently and accurately studying dosage response during clinical trials
stratifying patient population and facilitating faster filings and post
marketing surveillance. The efficient integration of biomarkers in each drug
discovery stage allows pharmaceutical companies to save time and money on R&D
to enhance their pipeline. Pharmaceutical companies wanting to reduce their
drug discover cost and time are widely applying novel and validated
biomarkers.
Biomarkers in Drug Discovery, Global, Biomarker application in each stage of
Drug discovery process, 2008
Source: GBI Research
Wide Spread Use, Flexible FDA Regulations and Integration of
‘Omics’ Drive Biomarkers Market towards Growth
GBI Research has analyzed the factors driving the Biomarkers market towards
steady growth. Biomarkers have widespread application in the pharmaceuticals
and Disease diagnosis sector. The FDA is somehow flexible in regulating the
application of biomarkers in the drug discovery process. This is the key
factor contributing to the growth of the biomarkers market. Also the fact that
biomarkers application in the drug discovery process involves the integration
of the ‘Omics’ technologies like the proteomics, genomics,
transcriptomics and others is causing tremendous growth of the biomarkers
market. The fact that biomarkers predict accurate safety profile are cost
effective and time consuming are those factors open wide scope for the growth
of the biomarker application by the pharmaceuticals companies.
Biomarkers Facilitating Quick Turnover of Drugs
Conventional Drug discovery methods are expensive and time consuming. Each
drug discovery requires approximately 12-15 years and an expenditure of $800M.
According to the FDA biomarkers facility in reducing the over all drug
discovery time span to 8-12 years and cut down developmental cost by $100M.
Faster and efficient disease progression in each drug discovery stage have
caused quick turn over of drugs and helped the pharmaceuticals sector and also
the diseased population.
Biomarkers in Drug Discovery, Global, Biomarkers facilitating quick turn over
of drugs,2008
Source: GBI Research
Biomarkers Market Expects Significant Growth
GBI Research concludes the advantages of biomarker applications in the drug
discovery process by the pharmaceuticals sector and their increased growth.
The global biomarkers market is a relatively mature market with approximately
$6.3 billion worth revenues in the year 2008. Since 2000 the market has seen
extensive growth due to increase in application of biomarkers in molecular
diagnostics and clinical services. But its application in drug discovery has
been recently realized by the pharmaceutical sector and has a share of 44% in
2008 of the global biomarkers market. By 2015 the market is expected to attain
revenues worth $22.2 billion due to expected regulatory and validation
procedures for biomarkers to be done by the regulatory bodies. Also rise in
awareness and ability to fulfill unmet needs posed by the conventional drug
discovery approaches will drive market towards significant growth.
Biomarkers in Drug Discovery - Optimizing Drug Discovery Timeline and Costs
Summary
GBI Research, the leading business intelligence provider, has released its
latest research, “Biomarkers In Drug Discovery - Optimizing Drug
Discovery Timeline and Costs”. The report provides an in-depth analysis
of the potential applications of biomarkers in pharmaceutical drug discovery
and clinical services. This pharmaceutical and healthcare report suggests
investment decisions in biomarker-based drug research by providing information
on valid biomarkers, pipelines, case studies, competitive landscape,
geographical trends, mergers and acquisitions and market potential. It also
provides an analysis on the trends prevailing in the global biomarkers market.
In addition to this, the report covers drivers and restrains for the global
biomarkers market.
This report is built using data and information sourced from proprietary
databases, primary and secondary research and in-house analysis by GBI
Research’s team of industry experts.
Scope
The scope of this report includes:
- Market Potential and Pipeline
Analysis of biomarkers by phase of development, therapeutic class and
geography.
- Market Size and forecast of global biomarkers market and
biomarkers drug discovery market from 2000 to 2008, forecast forward to
2015.
- Analysis of Key geographies including the US (United States),
Europe the UK (United Kingdom), France, Germany, Italy and Spain), Australia
and Southeast Asia.
- Investments and Funding Analysis for top companies
(Quest Diagnostics, Applied Biosystems, Vermillion, BGMedical, Menarini,
Abbott, Roche, Genetech, Affymetrix and Amgen) in the biomarker-based assay
development arena. This includes biomarker research on the application and
development of novel biomarkers by the top companies and analysis of the
competitive factors affecting the global biomarkers market.
- Qualitative
analysis of market drivers, market trends, and challenges.
- M&A
landscape in the biomarkers space segmented by deal value, geography and
phase.
Reasons to buy
The report will improve decision making and will enable you to:
- Develop
business strategies by understanding the trends and developments that are
driving the biomarkers-based drug research and development.
- Design,
develop and expand your product development, marketing and sales strategies
based on forecast of global biomarkers and biomarkers drug discovery market
till 2015
- Develop business strategies to exploit biomarkers-based drug
discovery market in emerging geographies
- Identify the key players
positioned to take advantage of the emerging market opportunities
-
Exploit M&A opportunities by identifying key market players with the most
novel pipeline
Table of Contents
1 Table of Contents
1 Table of Contents 3
1.1 List of Tables 6
1.2
List of Figures 7
2 Biomarkers in Drug Discovery - Facilitating a Quick
Turnaround Time: Overview 8
2.1 Introduction 8
2.2 GBI Research
Report Guidance 8
2.3 History of Biomarkers 9
2.4 Biomarker Discovery
and the Validation Process 10
2.4.1 Product Development Process from
Discovery to Launch 11
2.5 General Application of Biomarkers 12
2.5.1
Biomarkers in Drug Discovery and Drug Development 13
2.5.2 Role of
Biomarkers in the Drug Discovery Process 13
2.5.3 Application of
Biomarkers in Disease Diagnosis and Prognosis 13
2.5.4 Potential Impact of
Biomarkers on Disease States 15
2.5.5 Population Genetics Study 15
2.5.6 Environmental Health and Risk Assessment 17
2.5.7 Role of Biomarkers
in Environmental Health and Risk Assessment 17
2.5.8 Toxicology Studies in
Dietary Items or Nutraceuticals 18
2.6 Application of Biomarkers in Drug
Discovery 18
2.6.1 Lead Identification & Optimization 19
2.6.2
Potential Role of Biomarkers in Lead Identification and Optimization 19
2.6.3 Target Validation 20
2.6.4 Toxicological Assay (Preclinical &
Clinical) 20
2.6.5 Mechanism of Action 20
2.6.6 Monitor Therapy and
Dose Response 21
2.6.7 Stratify Patient Population 21
2.6.8 Filing and
Post Marketing Surveillance 21
3 Biomarkers in Drug Discovery - Case
Studies 23
3.1 Vermillion’s Hepcidin Biomarker for Ovarian Oancer
23
3.1.1 Definition 23
3.1.2 Hepcidin Biomarker 23
3.1.3 About
Ovarian Cancer 23
3.1.4 Company Profile 24
3.1.5 Technology Used
25
3.1.6 Market Information 25
3.1.7 Advantages 25
3.1.8 Future
Prospect 26
3.2 Epigenomic’s Septin 9 Biomarker for Colorectal
Cancer 26
3.2.1 DNA Methylation 26
3.2.2 Septin 9 27
3.2.3 Septin
Biomarker 27
3.2.4 About Colorectal Cancer 27
3.2.5 Advantages 27
3.2.6 Future Perspective 28
3.2.7 Clinical Study 28
3.2.8 Company
Profile 28
3.2.9 Technology Overview 29
3.2.10 Market Information
29
3.3 BiPar Science’s PARP 1 Gene Biomarker for Multiple Cancer
Types 29
3.3.1 PARP 1 Gene 29
3.3.2 PARP 1 Inhibitors 30
3.3.3
BSI-201 30
3.3.4 TNBC (Triple Negative Breast Cancer) 31
3.3.5
Technology 31
3.3.6 Advantage 31
3.3.7 Company Profile 31
3.3.8
Market Information 31
3.3.9 Clinical Study 31
4 Biomarkers in Drug
Discovery - Market Characterization 33
4.1 Market Overview 33
4.2 Market Size and Forecasts 33
4.2.1 Driver and Restraints 37
4.2.2
Drivers for the Global Biomarkers Market 38
4.2.3 Barriers for the Global
Biomarkers Market 40
4.3 Unmet Needs - Biomarkers Fulfilling the Unmet
Needs of Drug Discovery 40
4.3.1 High Attrition Rates 41
4.3.2 High
Drug Discovery Cost 41
4.3.3 Time consuming 42
4.3.4 Safety and
Efficacy 42
4.3.5 Invasiveness, Selectivity and Sensitivity 42
5
Trends Analysis 43
5.1 Regulatory Landscape (Current and Future) 43
5.1.1 Investigative/ Exploratory Biomarker 43
5.1.2 Probable Valid
Biomarker 43
5.1.3 Known Valid Biomarker 43
5.1.4 Regulatory Biomarker
43
5.2 Validated Biomarker 43
5.2.1 Validated Biomarkers Applied by
Top Pharmaceuticals Players in their FDA Approved
Drugs 44
5.3 Regulatory Acceptance of Valid Biomarkers 45
5.4
Regulatory Guidance from the FDA, EMEA, and MHLW (Japan) 46
6 Technology
Adoptions 47
6.1 Unmet Need - Drug Discovery 47
6.1.1 Biomarkers
Technology Exists to Fulfill Unmet Drug Discovery Needs 47
6.2 Increased
Awareness Among Pharmaceutical and Research Sector 48
6.3 Increasing
Adoption Due to Wide Application 48
6.4 Biomarkers’ Future - Drug
Discovery Unmet Needs Fulfilled 48
7 Global Biomarkers Market-
Competitive Landscape 49
7.1 Key Biomarkers Players 49
7.1.1 Quest
Diagnostics 50
7.1.2 Applied Biosystems 51
7.1.3 Vermillion 52
7.1.4 BGMedical 53
7.1.5 Menarini 54
7.1.6 Abbott 55
7.1.7 Roche
56
7.1.8 Genentech 57
7.1.9 Affymetrix 58
7.1.10 Amgen 59
7.2
Global Biomarkers Market - Geographic Landscape 60
8 Biomarkers in
Drug Discovery - Pipeline Analysis 62
8.1 Pipeline Analysis 62
8.1.1 Pipeline analysis by Phase 65
8.1.2 Pipeline Analysis -
Therapeutic class 66
8.1.3 Pipeline Analysis by Geography 67
9 Global
Biomarkers market - Strategic Consolidations 68
9.1 Mergers and
Acquisitions 68
9.1.1 Thermo Fisher Scientific Inc. Merges with
B.R.A.H.M.S. AG 68
9.1.2 Clinical Data Inc to Acquire Avlon
Pharmaceuticals 68
9.1.3 OSI Pharmaceuticals and AVEO Enter Collaborative
Alliance 68
9.1.4 PEP Products Inc. and Interleukin Genetics Inc. Enter
Collaborative Alliance 69
9.1.5 Pfizer Canada signs Alliance Deal with the
Centre of Excellence For The Prevention of Organ Failure (Proof) 69
9.1.6
Millipore Corporation Acquires Guava Technologies 69
9.1.7 SuperGen Inc.
Acquires Montigen Pharmaceuticals, Inc. 69
9.1.8 National Institute of
Allergy and Infectious Diseases (NIAID) Enters Collaborative Alliance with
Caprion Proteomics Inc. 69
9.1.9 Entelos Inc Acquires Iconix Biosciences
69
9.1.10 Vermillion Inc Acquires Ciphergen Biosystems 69
9.1.11
Cleveland Biolabs, Inc. Enters Collaborative Alliance with CBMS-MITS JPMO
69
9.2 Mergers and Acquisition Analysis by Deal Type 70
9.3 Mergers
and Acquisition by Year of Consolidations 71
9.4 Mergers and Acquisitions
by Geography 72
9.5 Mergers and Acquisitions by Deal value 72
10
Appendix 74
10.1 Abbreviations 74
10.2 Research Methodology 74
10.2.1 Coverage 75
10.2.2 Secondary Research 75
10.2.3 Primary
Research 76
10.2.4 Expert Panel Validation 76
10.3 Contact Us 76
10.4 Disclaimer 76
1.1 List of Tables
Table 1: Biomarkers in
Drug Discovery, Historical Revenue, Global Biomarkers Market,
($bn,
2000-2008) 33
Table 2: Biomarkers in Drug Discovery, Historical
Revenue, Global Biomarkers Market,
($bn, 2008-2015) 34
Table 3:
Biomarkers in Drug Discovery, Historical Revenue, Biomarker’s Drug
Discovery Market Revenue ($bn), 2000-2008 34
Table 4: Biomarkers in Drug
Discovery, Historical Revenue, Global Biomarkers Drug Discovery Market Revenue
($bn), 2008-2015 34
Table 5: Biomarkers in Drug Discovery, Historical
Revenues, Biomarker’s Molecular Diagnostics Market Revenue ($bn),
2000-2008 35
Table 6: Biomarkers in Drug Discovery, Historical Revenue,
Biomarkers Molecular Diagnostics Market Revenue ($bn), 2008-2015 35
Table
7: Biomarkers in Drug Discovery, Historical Revenue, Others Market Revenue
($bn), 2000-2008 36
Table 8: Biomarkers in Drug Discovery, Historical
Revenue, Others Market Revenue ($bn), 2008-2015 36
Table 9: Biomarkers in
Drug Discovery, Global, Regulatory Filings for Biomarkers, 2009 43
Table
10: Biomarkers in Drug Discovery, Global, Validated Biomarkers Applied in
FDA Approved Drugs, 2009 44
Table 11: Biomarkers in Drug Discovery,
Global,Biomarkers in Discovery Phase, 2009 62
Table 12: Biomarkers in
Drug Discovery, Global, Biomarkers in Preclinical Phase, 2009 64
Table 13:
Biomarkers in Drug Discovery, Global, Biomarkers in Phase I, 2009 65
Table 14: Biomarkers in Drug Discovery, Global, Biomarkers in Phase II,
2009 65
Table 15: Biomarkers in Drug Discovery, Global, Biomarkers in
Phase III, 2009 65
Table 16: Biomarkers in Drug Discovery, Global,
Merger and Acquisitions, 2009 68
1.2 List of Figures
Figure 1:
Biomarkers in Drug Discovery, Global, History of Biomarkers, 2009 10
Figure 2: Biomarkers in Drug Discovery, Global, Biomarker Discovery and
Validation Process, 2009 11
Figure 3: Biomarkers in Drug Discovery,
Global, General Application of Biomarkers, 2010 12
Figure 4: Biomarkers
in Drug Discovery, Global, Application of Biomarkers in Diagnosis, 2009 14
Figure 5: Biomarkers in Drug Discovery, Global, Potential Impact of
Biomarkers on Disease States, 2009 15
Figure 6: Biomarkers in Drug
Discovery, Global, Application of Biomarkers in Population Genetic Studies,
2009 16
Figure 7: Biomarkers in Drug Discovery, Global, Role of
Biomarkers in Risk Assessment, 2009 17
Figure 8: Biomarkers in Drug
Discovery, Global, Biomarkers Accelerate the Drug Discovery Process, 2009
19
Figure 9: Biomarkers in Drug Discovery, Global, Adoption of
Biomarkers by Top Companies in Drug Discovery, 2009 21
Figure 10:
Biomarkers in Drug Discovery, Global, Case Studies, 2009 23
Figure 11:
Biomarkers in Drug Discovery, Global, Hepicidine Biomarker Case Study, 2009
24
Figure 12: Biomarkers in Drug Discovery, Global, Septin 9 Biomarker
Case Study, 2009 26
Figure 13: Biomarkers in Drug Discovery, Global, PARP1
Gene Biomarker Case Study, 2009 30
Figure 14: Biomarkers in Drug
Discovery, Global, Global Biomarkers Market Revenues ($bn), 2000-2015 33
Figure 15: Biomarkers in Drug Discovery, Global, Biomarker’s Drug
Discovery Market Revenues ($bn), 2000-2015 34
Figure 16: Biomarkers in
Drug Discovery, Historical Revenue, Biomarkers Molecular Diagnostics Market
Revenue ($bn), 2000-2008 35
Figure 17: Biomarkers in Drug Discovery,
Global, Others Market Revenues ($bn), 2000-2015 36
Figure 18: Biomarkers
in Drug Discovery, Global, Global Biomarkers Market Segmentation, 2009
37
Figure 19: Biomarkers in Drug Discovery, Global, Market Drivers and
Restrains, 2009 37
Figure 20:Biomarkers in Drug Discovery, Global,
Integration of ‘Omics’ Drive Global Biomarker Market, 2009 39
Figure 21: Biomarkers in Drug Discovery, Global, Biomarkers Fulfill Unmet
Needs of Conventional Drug Discovery Methods, 2009 41
Figure 22:
Biomarkers in Drug Discovery, Global, Validated Biomarkers Applied by
Pharmaceutical Companies in Drug Discovery, 2009 45
Figure 23: Biomarkers
in Drug Discovery, Global, Biomarkers Technology Adoption Framework, 2009
47
Figure 24: Biomarkers in Drug Discovery, Global, Company Profile -
Quest Diagnostics, 2009 50
Figure 25: Biomarkers in Drug Discovery,
Global, Company Profile - Applied Biosystems, 2009 51
Figure 26:
Biomarkers in Drug Discovery, Global, Company Profile - Vermillion, 2009
52
Figure 27: Biomarkers in Drug Discovery, Global, Company Profile-
BGMedical, 2009 53
Figure 28: Biomarkers in Drug Discovery, Global,
Company Profile - Menarini, 2009 54
Figure 29: Biomarkers in Drug
Discovery, Global, Company Profile- Abbott, 2009 55
Figure 30:
Biomarkers in Drug Discovery, Global, Company Profile-Roche, 2009 56
Figure 31: Biomarkers in Drug Discovery, Global, Company Profile-Genentech,
2009 57
Figure 32: Biomarkers in Drug Discovery, Global, Company
Profile- Affymetrix, 2009 58
Figure 33: Biomarkers in Drug Discovery,
Global, Company Profile- Amgen, 2009 59
Figure 34: Biomarkers in Drug
Discovery, Global, Geographic Landscape-Global Biomarkers Market, 2009 60
Figure 35: Biomarkers in Drug Discovery, Global, Pipeline Analysis by Phase,
2009 65
Figure 36: Biomarkers in Drug Discovery, Global, Pipeline Analysis
by Therapeutic Class, 2009 66
Figure 37: Biomarkers in Drug Discovery,
Global, Pipeline Analysis by Geography, 2009 67
Figure 38: Biomarkers in
Drug Discovery, Global, Global Biomarkers Market - Deal Analysis, 2009
70
Figure 39: Biomarkers in Drug Discovery, Global, Mergers and
Acquisition by Year of Consolidation, 2009 71
Figure 40: Biomarkers in
Drug Discovery, Global, Mergers and Acquisitions - Geographical
Distribution, 2009 72
Figure 41: Biomarkers in Drug Discovery, Global,
Mergers and Acquisitions - Deal Value ($m), 2009 72
Figure 42: GBI
Research Methodology 75
