Biomarkers in Late Stage Clinical Trials

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Biomarkers in Late Stage Clinical Trials
Published on April 2010

Report Summary

The pharmaceuticals and biotechnology sectors are currently facing increasing time and cost issues related to clinical trials in drug
discovery. The cost of developing a new drug can reach $2 billion; clinical trials, regulatory approval and subsequent launch may take
up to a decade.
Biomarkers reduce the attrition rate of late stage clinical trials by assessing drug potential in terms of efficacy and toxicity at the early
stages of the clinical development. Thus, biomarkers significantly increase productivity, lower the cost and duration of the clinical trial,
and help researchers complete drug development process at a faster pace.
This report reviews various biomarker technologies and therapy area applications. Market drivers and restraints are viewed in the
context of biomarker activity of leading innovator companies as well as contract research organizations.

Key features of this report

' ' The report analyzes revenues of late stage biomarker technology and services in North America, Europe, Asia and rest of the
world.
' ' Provides key market drivers and restraints of the biomarker market.
' Covers microarrays, immunoassay, LC/MS and GC/MS, flow cytometry, imaging, PCR and services
' Provides patent analysis with respect to competitors and geography.

Scope of this report

' ' Understand and evaluate the growth potential of emerging technologies.
' Understand biomarker activity in clinical trials of leading market players.
' Gain knowledge about the relative importance of the biomarker late stage clinical trials technologies in the next five years for
investment opportunities.
' Learn which therapy areas leading market players in the late stage biomarker clinical trials market.
' Determine the collaborations and partnerships of the major market players.

Key Market Issues

' The pharmaceutical and biotech sectors are currently facing increasing duration and cost issues related to clinical trials in drug
discovery.
' Funding from government sources such as the National Institutes of Health (NIH) has not increased significantly over the last few
years.
' Late stage failures are much more expensive than early ones.
' The rising demand for better safety data has put a considerable amount of regulatory and economic pressure on pharmaceutical
companies.
' The current average approval rate of cancer drugs is as low as 5%, while the development period can reach 15 years.
' More than 50% of clinical trials fail in Phase III due to a host of reasons, greater disease complexity, stiffer clinical endpoints, and
the inability of the data to prove drug effectiveness.

Key findings from this report

Biomarkers in Late Stage Clinical Trials (From Slideshare) Page 1/9


' The biomarkers in late stage clinical trials market is largest in North American and European region, with Europe having the second
largest market.
' North America constitutes the major market share with the immunoassay, flow cytometry and GC/MS and LC/MS having high market
growth.
' Caprion proteomics, Applied BioSystems, BG Medicine, Covance, Eli Lilly, Pfizer and Astra Zeneca are some of the major
companies engaged in collaborative partnerships in the past three years.
' A number of market players have formed strategic alliances for the development and sharing of technology for biomarker
applications in the late stage clinical trials.
' Pharmaceutical companies are focusing mainly on cancer biomarkers for use in late stage (Phase III and IV) clinical trials.

Key questions answered

' How is the biomarker late stage clinical trials market segmented and what will growth be to 2014'
' What are the major technologies that have emerged such as microarrays, PCR, LC/MS and GC/MS'
' In which areas are the companies focusing while forming strategic alliances with other industrial players'
' What is the competitive landscape and what is the strategic focus of innovator companies, CROs and biomarker specialists'
' What applications are pharmaceutical companies focusing on while conducting late stage biomarker clinical trials'

Table of Content

TABLE OF CONTENTS
Executive Summary 12
Market dynamics 12
Biomarker activity at leading pharma companies 13
Applications of biomarkers in clinical trials 13
Biomarker market for late stage clinical trials by tools and services 14
Company profiles 15
Chapter 1 Market dynamics 18
Summary 18
Introduction 19
Factors influencing biomarker adoption in clinical trials 22
Investment scenario for late stage clinical trials 22
Cost of clinical trials: early stage vs. late stage 23
Impact of drug failure in last stage clinical trials 24
Case 1: Vicriviroc - Merck 25
Case 2: Flurizon ' Myriad Pharmaceutical 26
Technologies influencing drug success ratio 26
Genomics 26
Proteomics 26
Pharmacogenomics 27
Nanotechnology 27
Emerging technology integration (biomarker and bioinformatics) 27
Impact of omics and increasing adoption of biomarkers in clinical trials 28



Key market drivers & restraints 29
Increasing presence of CROs 29
Biomarkers in oncology clinical trials 30
Genomics and proteomics developments 30
Cost and reliability issues 30
Patent analysis 30
Competitive landscape 32
Regulatory environment 35
Introduction 35
Role of FDA 35
European Medicines Agency 37
Regulatory impact on drug safety 38
Chapter 2 Biomarker activity at leading pharma companies 40
Summary 40
Trends in the biomarker market for late stage clinical trials 41
Ongoing biomarker late stage clinical trials 43
Abbott 43
Astra Zeneca 45
Bristol-Myers Squibb 47
Eli Lilly 48
GlaxoSmithKline 49
Merck & Co., Inc. 51
Novartis 52
Pfizer 53
Roche 54
Sanofi-Aventis 55
Overview of pharmaceutical sector and biomarker use 57
Overview of contract research organizations and biomarker use 58
Overview of biomarker industry and biomarker use 59
Chapter 3 Applications of biomarkers in clinical trials 62
Summary 62
Early stage clinical trials 63
Toxicity determination 63
Dosage level 66
Drug efficacy 68
Late stage clinical trials 68
Phase III 68
Phase IV 69
Competitive landscape for late stage clinical trials 69
Application by therapy area 72
Oncology 72
Cardiovascular 73
Neurological disorders 74
Autoimmune diseases 75
Selected applications 76
Synta - Elesclomol 76
HGS ' Benlysta 77
Roche ' Herceptin 77



Eli Lilly - Alzheimer's Phase III trial 77
Chapter 4 Biomarker market for late stage clinical trials by tools and services 80
Summary 80
Service 82
Technology 83
Immunoassay 85
Biochip/microarray 85
GC/MS and LC/MS 86
Flow cytometry 87
Imaging 88
PCR (Polymerase Chain Reaction) 89
Chapter 5 Company profiles 92
Summary 92
Pharmaceutical companies 93
Abbott Laboratories Inc 93
Astellas Pharma Inc. 94
AstraZeneca Ltd 95
Bayer Schering Pharma AG 96
Boehringer Ingelheim GmbH 98
Bristol-Myers Squibb Co 99
Daiichi Sankyo Company, Ltd 100
Eisai Co. Ltd. 102
Eli Lilly and Company 103
GlaxoSmithKline Ltd 104
Johnson & Johnson Ltd 106
Merck & Co., Inc. 107
Novartis AG 109
Pfizer Inc 110
Roche Ltd 111
Sanofi-Aventis 112
Takeda Pharmaceuticals Ltd 114
Teva Pharmaceutical Industries Ltd. 115
Contract Research Organizations 117
Charles River Laboratories International, Inc. 117
Clininvent Research Pvt. Ltd. 118
Covance Inc. 120
ICON plc 121
Kendle International 122
MDS Pharma Services Inc 123
Parexel International Corp 124
PharmaNet Development Group, Inc. 125
PPD, Inc. 126
Pharsight Corp 127
PRA International Inc 129
Quintiles Inc 130
ReSearch Pharmaceutical Services, Inc. 132
Biomarker companies 133
Affymetrix, Inc. 133



Banyan Biomarkers, Inc. 134
BG Medicine, Inc. 135
Biophysical Corp 136
BioSystems International Inc 137
Caprion Proteomics Inc 138
Clinical Data, Inc 139
Correlogic Systems, Inc. 140
Epigenomics AG 141
Genedata AG 143
GeneGo, Inc. 144
GeneNews Ltd 145
Appendix 147

List of Figures
Figure 1.1: Biomarker applications in clinical stages 20
Figure 1.2: Disease specific biomarkers as surrogate end points 21
Figure 1.3: Role of biomarkers in cost saving 23
Figure 1.4: Average cost of clinical trials (per patient basis) 24
Figure 1.5: Approximation of time taken for clinical trial phases 25
Figure 1.6: Important elements in new biomarker discovery and role of bioinformatics 28
Figure 1.7: Functions of omics in the drug development process 29
Figure 1.8: Patent analysis by geography 2006 vs. 2008 31
Figure 1.9: Patent analysis by competitors 2008 32
Figure 1.10: Therapy areas focus of major market players (2007-2009) 33
Figure 7.11: Biomarker classification by FDA 37
Figure 2.12: Biomarker late stage clinical trials by disease 41
Figure 2.13: Biomarker late stage clinical trials by phase 42
Figure 2.14: Abbott's biomarker-based late stage clinical trials 44
Figure 2.15: Astra Zeneca's biomarker-based late stage clinical trials 46
Figure 2.16: Bristol-Myers Squibb's biomarker-based late stage clinical trials 47
Figure 2.17: Eli Lilly biomarker-based late stage clinical trials 48
Figure 2.18: GSK's biomarker-based late stage clinical trials 50
Figure 2.19: Merck & Co. biomarker-based late stage clinical trials 51
Figure 2.20: Novartis' biomarker-based late stage clinical trials 52
Figure 2.21: Pfizer's late stage clinical trials 53
Figure 2.22: Roche's biomarker-based late stage clinical trials 54
Figure 2.23: Sanofi-Aventis' biomarker-based late stage clinical trials 56
Figure 3.24: Biomarker types for toxicity 64
Figure 3.25: Major focus areas for the late stage clinical trials by pharmaceutical companies (2008- 2009) 70
Figure 3.26: Applications of biomarkers in late stage clinical trials 71

List of Tables
Table 1.1: Agreements & Collaborations (2007 ' 2009) 34
Table 1.2: New product launches (2007 ' 2009) 35
Table 2.3: Late stage clinical trial scenario by top players 43
Table 2.4: Key late stage clinical trials - Abbott 45
Table 2.5: Key late stage clinical trials ' Astra Zeneca 46
Table 2.6: Key late stage clinical trials ' Bristol-Myers Squibb 48



Table 2.7: Key late stage clinical trials ' Eli Lilly's 49
Table 2.8: Key late stage clinical trials ' GlaxoSmithKline 50
Table 2.9: Key late stage clinical trials ' Merck & Co. 51
Table 2.10: Key late stage clinical trials ' Novartis 52
Table 2.11: Key late stage clinical trials ' Pfizer 53
Table 2.12: Key late stage clinical trials ' Roche 55
Table 2.13: Key late stage clinical trials ' Sanofi-Aventis 56
Table 2.14: Developments by pharmaceutical companies for biomarker applications 57
Table 2.15: Developments by contract research organizations for biomarker applications 58
Table 2.16: Developments by biomarker companies for biomarker applications 59
Table 3.17: Clinical trials for biomarker toxicity 65
Table 3.18: Clinical trials for biomarker dose range 67
Table 3.19: Clinical trials for biomarker validation 68
Table 3.20: Global biomarker late stage clinical trials applications market, by diseases 2007-2014f ($m) 72
Table 3.21: Ongoing biomarker late stage clinical trials in oncology 73
Table 3.22: Ongoing biomarker late stage clinical trials in cardiovascular diseases 74
Table 3.23: Ongoing biomarker late stage clinical trials in neurological diseases 75
Table 3.24: Ongoing biomarker late stage clinical trials in autoimmune diseases 76
Table 4.25: Global biomarker market in late stage clinical trials, by services and technologies
2007-2014f ($m) 81
Table 4.26: Global biomarker market in late stage clinical trials, by geography 2007-2014f ($m) 82
Table 4.27: Global biomarker services market in late stage clinical trials, by geography 2007-2014f ($m) 83
Table 4.28: Global biomarker technology market in late stage clinical trials, by products 2007- 2014f ($m) 84
Table 4.29: Global biomarker technology market in late stage clinical trials, by products 2007- 2014f ($m) 84
Table 4.30: Global immunoassay market, by geography 2007-2014f ($m) 85
Table 4.31: Global Biochip/microarray market, by geography 2007-2014f ($m) 86
Table 4.32: Global Biochip/Microarray market, by geography 2007-2014f ($m) 87
Table 4.33: Global flow cytometry market by geography 2007-2014f ($m) 88
Table 4.34: Global imaging market by geography 2007-2014f ($m) 89
Table 4.35: Global PCR market by geography 2007-2014f ($m) 90
Table 6.36: US patents 147
Table 6.37: US patents (Contd.) 148
Table 6.51: European patents 162
Table 6.52: European patents (Contd) 163



Table 6.60: Japan patents 171
Table 6.61: Japan patents (Contd) 172
Table 6.67: FDA Guidelines 178


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