1.1 List of Tables 7
1.2 List of Figures 8
2 Biomarkers in Drug Discovery – Introduction 10
2.1 Introduction 10
2.2 GBI Research Report Guidance 11
3 Biomarkers in Drug Discovery – Overview 12
3.1 History of Biomarkers 12
3.2 Biomarker Classification 14
3.2.1 Biomarker Categories 15
3.2.2 Types of Biomarkers 16
3.2.3 Example of Type 0, I and II Biomarker 17
3.2.4 Reasons Surrogate Endpoints ‘Fail’ 17
3.3 Biomarker Discovery and the Validation Process 19
3.3.1 Product Development Process from Discovery to Launch 20
3.4 General Application of Biomarkers 21
3.4.1 Biomarkers in Drug Discovery and Drug Development 22
3.4.2 Role of Biomarkers in the Drug Discovery Process 23
3.4.3 Application of Biomarkers in Disease Diagnosis and Prognosis 23
3.4.4 Potential Impact of Biomarkers on Disease States 25
3.4.5 Population Genetics Study 26
3.4.6 Environmental Health and Risk Assessment 27
3.4.7 Role of Biomarkers in Environmental Health and Risk Assessment 28
3.4.8 Toxicology Studies in Dietary Items or Nutraceuticals 28
3.5 Application of Biomarkers in Drug Discovery 29
3.5.1 Lead Identification and Optimization 29
3.5.2 Potential Role of Biomarkers in Lead Identification and Optimization 30
3.5.3 Target Validation 30
3.5.4 Toxicological Assay (Preclinical and Clinical) 30
3.5.5 Mechanism of Action 31
3.5.6 Monitor Therapy and Dose Response 31
3.5.7 Stratify Patient Population 31
3.5.8 Filing and Post Marketing Surveillance 32
3.6 Benefits of Biomarker Utilization 32
3.6.1 Disease Understanding 32
3.6.2 Project Prioritization through Early Attrition 32
3.6.3 Streamlining Clinical Trials 32
3.6.4 Reducing Cost of Drug Development 33
3.6.5 Speeding Drug Development 33
3.6.6 Avoiding Adverse Drug Reactions (ADR) and Rationalizing Dosing Regimen 33
3.6.7 Drug Repositioning 33
3.7 Challenges in Biomarker Utilization 34
3.7.1 Variability 34
3.7.2 Validity 34
3.7.3 Measurement Errors 34
4 Biomarkers in Drug Discovery – Case Study 35
4.1 Cell Signaling Technology Enters Into Co-Marketing Agreement with Astellas Pharma 35
4.1.1 Definition 35
4.1.2 About Lung Cancer 35
4.1.3 Company Profile 35
4.1.4 Technology Used 36
4.1.5 Market Information 36
4.1.6 Advantages 36
4.1.7 Future Prospect 36
5 Biomarkers in Drug Discovery – Market Characterization 37
5.1 Market Overview 37
5.2 Market Size and Forecasts 37
5.2.1 Global Biomarkers Market Size 37
5.2.2 Global Biomarkers Drug Discovery Market 39
5.2.3 Global Biomarker’s Molecular Diagnostics Market 40
5.2.4 Global Biomarkers Others Market 41
5.2.5 Global Biomarkers Market Segmentation 42
5.2.6 Drivers and Restraints 43
5.2.7 Drivers for the Global Biomarkers Market 43
5.2.8 Barriers for the Global Biomarkers Market 46
5.3 Unmet Needs – Biomarkers Fulfilling the Unmet Needs of Drug Discovery 47
5.3.1 High Attrition Rates 48
5.3.2 High Drug Discovery Cost 48
5.3.3 Time Consuming 49
5.3.4 Safety and Efficacy 49
5.3.5 Invasiveness, Selectivity and Sensitivity 49
6 Biomarkers in Drug Discovery – Trends Analysis 50
6.1 Regulatory Landscape (Current and Future) 50
6.1.1 Investigative/Exploratory Biomarker 50
6.1.2 Probable Valid Biomarker 50
6.1.3 Known Valid Biomarker 50
6.1.4 Regulatory Biomarker 50
6.1.5 Letter Of Intent to Propose Biomarker Qualification 50
6.1.6 Structure of Biomarker Qualification Briefing Document 51
6.2 Validated Biomarker 53
6.3 Regulatory Acceptance of Valid Biomarkers 55
6.4 Regulatory Guidance from the FDA, EMEA, and MHLW (Japan) 55
7 Biomarkers in Drug Discovery – Technology Adoptions 56
7.1 Unmet Need - Drug Discovery 57
7.1.1 Biomarkers Technology Exists to Fulfill Unmet Drug Discovery Needs 57
7.2 Increased Awareness among Pharmaceutical and Research Sector 57
7.3 Increasing Adoption Due to Wide Application 57
7.4 Biomarkers’ Future – Drug Discovery Unmet Needs Fulfilled 57
8 Biomarkers in Drug Discovery – Competitive Landscape 59
8.1 Key Biomarkers Players 59
8.1.1 Quest Diagnostics 60
8.1.2 Life Technologies Corporation 62
8.1.3 Vermillion 64
8.1.4 BG Medicine 66
8.1.5 Menarini 68
8.1.6 Abbott 70
8.1.7 Roche 72
8.1.8 Genentech 74
8.1.9 Affymetrix 76
8.1.10 Amgen 78
8.2 Global Biomarkers Market – Geographic Landscape 80
9 Biomarkers in Drug Discovery – Pipeline Analysis 82
9.1 Pipeline Analysis 82
9.1.1 Biomarkers in Discovery Phase 82
9.1.2 Biomarkers in Phase I 83
9.1.3 Biomarkers in Phase II 84
9.1.4 Biomarkers in Phase III 84
9.1.5 Biomarkers in Phase IV 84
9.1.6 Pipeline Analysis by Phase 85
9.1.7 Pipeline Analysis – Therapeutic Class 86
9.1.8 Pipeline Analysis by Geography 87
10 Biomarkers in Drug Discovery – Strategic Consolidations 88
10.1 Strategic Consolidations by Deal Type 88
10.2 Mergers and Acquisitions 89
10.2.1 Mergers and Acquisitions by Geography 91
10.2.2 Major M&A Deals 91
10.3 Licensing Agreement Deals 93
10.3.1 Licensing Agreement Deals by Geography 94
10.3.2 Major Licensing Agreements 95
10.4 Partnership Deals 97
10.4.1 Major Partnership Deals 98
11 Biomarkers in Drug Discovery – Appendix 100
11.1 Market Definitions 100
11.2 Abbreviations 100
11.3 Research Methodology 100
11.3.1 Biomarkers in Drug Discovery- Overview 101
11.3.2 Biomarkers in Drug Discovery- Case Study 101
11.3.3 Biomarkers in Drug Discovery- Market Characterisation 101
11.3.4 Biomarkers in Drug Discovery- Trends Analysis 101
11.3.5 Biomarkers in Drug Discovery- Technology Adoptions 101
11.3.6 Biomarkers in Drug Discovery- Competitive Landscape 101
11.3.7 Biomarkers in Drug Discovery- Pipeline Analysis 101
11.3.8 Biomarkers in Drug Discovery- Strategic Consolidations 102
11.3.9 Coverage 102
11.3.10 Secondary Research 102
11.3.11 Primary Research 102
11.3.12 Expert Panel Validation 103
11.4 Contact Us 103
11.5 Disclaimer 103
11.6 Sources 103
1.1 List of Tables
Table 1: Biomarkers in Drug Discovery, Global Biomarkers Market, Revenue ($bn), 2010-2017 37
Table 2: Biomarkers in Drug Discovery, Global Biomarkers Market, Revenue Forecasts ($bn), 2010-2017 38
Table 3: Biomarkers in Drug Discovery, Global Biomarkers Market, Market Segmentation by Therapy Area, 2009-2017 38
Table 4: Biomarkers in Drug Discovery, Global Biomarker’s Drug Discovery Market, Revenue ($bn), 2002-2010 39
Table 5: Biomarkers in Drug Discovery, Global Biomarker’s Drug Discovery Market, Revenue Forecast ($bn), 2010-2017 39
Table 6: Biomarkers in Drug Discovery, Global Biomarker’s Molecular Diagnostics Market, Historical Revenue, ($bn), 2002-2010 40
Table 7: Biomarkers in Drug Discovery, Global Biomarker’s Molecular Diagnostics Market, Revenue Forecast, ($bn), 2010-2017 40
Table 8: Biomarkers in Drug Discovery, Global Others Market, Historical Revenue ($bn), 2002-2010 41
Table 9: Biomarkers in Drug Discovery, Global Others Market, Revenue Forecast ($bn), 2010-2017 41
Table 10: Biomarkers in Drug Discovery, Global, Validated Biomarkers Applied in FDA Approved Drugs, 2011 53
Table 11: Biomarkers in Drug Discovery, Global, Biomarkers in Discovery Phase, 2011 82
Table 12: Biomarkers in Drug Discovery, Global, Biomarkers in Phase I, 2011 83
Table 13: Biomarkers in Drug Discovery, Global, Biomarkers in Phase II, 2011 84
Table 14: Biomarkers in Drug Discovery, Global, Biomarkers in Phase III, 2011 84
Table 15: Biomarkers in Drug Discovery, Global, Biomarkers in Phase IV, 2011 84
Table 16: Biomarkers in Drug Discovery, Global, Strategic Consolidations, Mergers and Acquisitions, 2010-2011 89
Table 17: Biomarkers in Drug Discovery, Global, Strategic Consolidations, Mergers and Acquisitions, Top Three Deals, 2010-2011 90
Table 18: Biomarkers in Drug Discovery, Global, Strategic Consolidations, Licensing Agreement Deals, 2010-2011 93
Table 19: Biomarkers in Drug Discovery, Global, Strategic Consolidations, Partnerships Deals, 2010-2011 97
1.2 List of Figures
Figure 1: Biomarkers in Drug Discovery, Global, Commonly Identified Biomarkers, 2011 10
Figure 2: Biomarkers in Drug Discovery, Global, History of Biomarkers, 2011 13
Figure 3: Biomarkers in Drug Discovery, Global, Biomarkers Classification, Disease and Drug-related Biomarkers, 2011 14
Figure 4: Biomarkers in Drug Discovery, Global, Biomarker Categories, 2011 15
Figure 5: Biomarkers in Drug Discovery, Global, Types of Biomarkers, 2011 16
Figure 6: Biomarkers in Drug Discovery, Global, Reasons Surrogate Endpoint Fail (False Positive), 2011 17
Figure 7: Biomarkers in Drug Discovery, Global, Reasons Surrogate Endpoint Fail (False Positive), 2011 17
Figure 8: Biomarkers in Drug Discovery, Global, Reasons Surrogate Endpoint Fail (False Negative), 2011 18
Figure 9: Biomarkers in Drug Discovery, Global, Reasons Surrogate Endpoint Fail (False Negative or Positive), 2011 18
Figure 10: Biomarkers in Drug Discovery, Global, Reasons Surrogate Endpoint Fail , 2011 18
Figure 11: Biomarkers in Drug Discovery, Global, Biomarker Discovery and Validation Process, 2009 19
Figure 12: Biomarkers in Drug Discovery, Global, General Application of Biomarkers, 2010 21
Figure 13: Biomarkers in Drug Discovery, Global, Role of Biomarkers in Drug Discovery and Development, 2011 22
Figure 14: Biomarkers in Drug Discovery, Global, Drug Discovery Process, 2011 23
Figure 15: Biomarkers in Drug Discovery, Global, Application of Biomarkers in Diagnosis, 2011 24
Figure 16: Biomarkers in Drug Discovery, Global, Potential Impact of Biomarkers on Disease States, 2011 25
Figure 17:Biomarkers in Drug Discovery, Global, Application of Biomarkers in Population Genetic Studies, 2011 26
Figure 18:Biomarkers in Drug Discovery, Global, Role of Biomarkers in Risk Assessment, 2011 27
Figure 19:Biomarkers in Drug Discovery, Global, Biomarkers Accelerate the Drug Discovery Process, 2011 29
Figure 20: Biomarkers in Drug Discovery, Global, Adoption of Biomarkers by Top Companies in Drug Discovery, 2011 31
Figure 21: Biomarkers in Drug Discovery, Global, Case Study, 2011 35
Figure 22 Biomarkers in Drug Discovery, Global Biomarkers Market, Revenue Forecast ($bn), 2002-2017 37
Figure 23: Biomarkers in Drug Discovery, Global Biomarkers Market, Market Segmentation by Therapy Area, 2011 38
Figure 24: Biomarkers in Drug Discovery, Global Biomarkers Drug Discovery Market, Revenue Forecast ($bn), 2002-2017 39
Figure 25: Biomarkers in Drug Discovery, Biomarkers Molecular Diagnostics Market, Revenue Forecast ($bn), 2002-2010 40
Figure 26: Biomarkers in Drug Discovery, Global Others Market, Revenue Forecast ($bn), 2002-2017 41
Figure 27: Biomarkers in Drug Discovery, Global Biomarkers Market Segmentation, 2011 42
Figure 28: Biomarkers in Drug Discovery, Global, Market Drivers and Restrains, 2011 43
Figure 29:Biomarkers in Drug Discovery, Global, Integration of ‘Omics’ Drive Global Biomarker Market, 2011 45
Figure 30:Biomarkers in Drug Discovery, Global, Biomarkers Fulfill Unmet Needs of Conventional Drug Discovery Methods, 2011 47
Figure 31: Biomarkers in Drug Discovery, Global, Reasons for Attrition, 2011 48
Figure 32: Biomarkers in Drug Discovery, Global, Biomarkers Technology Adoption Framework, 2011 56
Figure 33: Biomarkers in Drug Discovery, Global, Company Profile – Quest Diagnostics, 2011 60
Figure 34: Biomarkers in Drug Discovery, Quest Diagnostics, SWOT Analysis, 2011 61
Figure 35: Biomarkers in Drug Discovery, Global, Company Profile – Life Technologies, 2011 62
Figure 36: Biomarkers in Drug Discovery, Life Technologies, SWOT Analysis, 2011 63
Figure 37: Biomarkers in Drug Discovery, Global, Company Profile – Vermillion, 2011 64
Figure 38: Biomarkers in Drug Discovery, Vermillion, SWOT Analysis, 2011 65
Figure 39: Biomarkers in Drug Discovery, Global, Company Profile – BGMedicine, 2011 66
Figure 40: Biomarkers in Drug Discovery, BGMedicine, SWOT Analysis, 2011 67
Figure 41: Biomarkers in Drug Discovery, Global, Company Profile – Menarini, 2011 68
Figure 42: Biomarkers in Drug Discovery, Menarini, SWOT Analysis, 2011 69
Figure 43: Biomarkers in Drug Discovery, Global, Company Profile – Abbott, 2011 70
Figure 44: Biomarkers in Drug Discovery, Abbott, SWOT Analysis, 2011 71
Figure 45: Biomarkers in Drug Discovery, Global, Company Profile – Roche, 2011 72
Figure 46: Biomarkers in Drug Discovery, Roche, SWOT Analysis, 2011 73
Figure 47: Biomarkers in Drug Discovery, Global, Company Profile-Genentech, 2011 74
Figure 48: Biomarkers in Drug Discovery, Genentech, SWOT Analysis, 2011 75
Figure 49: Biomarkers in Drug Discovery, Global, Company Profile – Affymetrix, 2011 76
Figure 50: Biomarkers in Drug Discovery, Affymetrix, SWOT Analysis, 2011 77
Figure 51: Biomarkers in Drug Discovery, Global, Company Profile Amgen, 2011 78
Figure 52: Biomarkers in Drug Discovery, Amgen, SWOT Analysis, 2011 79
Figure 53: Biomarkers in Drug Discovery, Global, Geographic Landscape – Global Biomarkers Market, 2011 80
Figure 54: Biomarkers in Drug Discovery, Global, Pipeline Analysis by Phase, 2010 85
Figure 55: Biomarkers in Drug Discovery, Global, Pipeline Analysis by Therapeutic Class, 2011 86
Figure 56: Biomarkers in Drug Discovery, Global, Pipeline Analysis by Geography, 2011 87
Figure 57: Biomarkers in Drug Discovery, Global, Strategic Consolidations by Deal Type, 2010-2011 88
Figure 58: Biomarkers in Drug Discovery, Global, Strategic Consolidations, Mergers and Acquisitions by Geography (%), 2010-2011 91
Figure 59: Biomarkers in Drug Discovery, Global, Strategic Consolidations, Licensing Agreement Deals by Geography (%), 2010-2011 94
Companies Mentioned
Quest Diagnostics
Life Technologies Corporation
Vermillion
BG Medicine
Menarini
Abbott
Roche
Genentech
Affymetrix
Amgen
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