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Biomarkers in Late Stage Clinical Trials: Applications, Opportunities and Activities of Leading Players
Date:11/8/2010

NEW YORK, Nov. 8, 2010 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Biomarkers in Late Stage Clinical Trials: Applications, opportunities and activities of leading players

http://www.reportlinker.com/p0189378/Biomarkers-in-Late-Stage-Clinical-Trials-Applications-opportunities-and-activities-of-leading-players.html

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• 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?

Companies mentionedAbbott , Astra Zeneca , Bayer Schering Pharma , Boehringer Ingelheim , Bristol-Myers Squibb , Covance , Eisai Co. Ltd , Eli Lilly , GSK , ICON plc , Merck and Co. Inc. , Novartis , Pfizer , Roche , Sanofi-Aventis , Takeda Pharmaceuticals

Table of ContentsBiomarkers in Late Stage Clinical Trials

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 FiguresFigure 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 TablesTable 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 6.38: US patents (Contd.) 149

Table 6.39: US patents (Contd.) 150

Table 6.40: US patents (Contd.) 151

Table 6.41: US patents (Contd.) 152

Table 6.42: US patents (Contd.) 153

Table 6.43: US patents (Contd.) 154

Table 6.44: US patents (Contd.) 155

Table 6.45: US patents (Contd.) 156

Table 6.46: US patents (Contd.) 157

Table 6.47: US patents (Contd.) 158

Table 6.48: US patents (Contd.) 159

Table 6.49: US patents (Contd.) 160

Table 6.50: US patents (Contd.) 161

Table 6.51: European patents 162

Table 6.52: European patents (Contd) 163

Table 6.53: European patents (Contd) 164

Table 6.54: European patents (Contd) 165

Table 6.55: European patents (Contd) 166

Table 6.56: European patents (Contd) 167

Table 6.57: European patents (Contd) 168

Table 6.58: European patents (Contd) 169

Table 6.59: European patents (Contd) 170

Table 6.60: Japan patents 171

Table 6.61: Japan patents (Contd) 172

Table 6.62: Japan patents (Contd) 173

Table 6.63: Japan patents (Contd) 174

Table 6.64: Japan patents (Contd) 175

Table 6.65: Japan patents (Contd) 176

Table 6.66: Japan patents (Contd) 177

Table 6.67: FDA Guidelines 178

To order this report:Biotechnology Industry: Biomarkers in Late Stage Clinical Trials: Applications, opportunities and activities of leading players

More  Market Research Report

Check our  Company Profile, SWOT and Revenue Analysis!Nicolas BombourgReportlinkerEmail: nbo@reportlinker.comUS: (805)652-2626Intl: +1 805-652-2626
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