Aarkstore Enterprise -biomarkers In Late Stage Clinical Trials-aarkstore Enterprise Market Research
Biomarkers in Late Stage Clinical Trials: Applications
, opportunities and activities of leading players
Table of Contents :
Biomarkers 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 - Alzheimers 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: Abbotts biomarker-based late stage clinical trials 44
Figure 2.15: Astra Zenecas biomarker-based late stage clinical trials 46
Figure 2.16: Bristol-Myers Squibbs biomarker-based late stage clinical trials 47
Figure 2.17: Eli Lilly biomarker-based late stage clinical trials 48
Figure 2.18: GSKs 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: Pfizers late stage clinical trials 53
Figure 2.22: Roches 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 Lillys 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
Published By :Business Insights
Delivery Details
PDF Format Reports will be
delivered by email within
12 to 24 hours after placing
the order (Mon-Fri IST)
Latest Reports
Opportunities in Human Embryonic Stem Cell (hESC) Products
Profitable Opportunities in Pharmacodynamic Assay Development
Capitalizing on Opportunities in Cord Blood Industry Growth
2009 Brokerage Process Services Outsourcing, Black Book Survey 2009 Results
The Top 10 Flavor and Fragrance Companies
Opportunity Analysis of H1N1 (swine flu) Vaccination Market
Impact of Counterfeits on Parallel Trade & Pharmaceutical Distribution: Issues, initiatives and insights for supply chain integrity
Post-Recession Outlook of the Electronics Industry and Connectors Roadmap 2009-2019
Connector Industry Forecast
Special Report on Year 2009 Vegetable Seed Market in China
Research Report of Chinese Telecommunication Operation Industry, 2008-2009
Pharmaceutical Speaker Programs : Measuring ROI and Communicating Value
LEDs Used in Signage & Professional Displays Global Market Forecast (2008-2013)
LEDs Used in Test/Measurement & Medical Science Devices Global Market Forecast
The Future of the Diabetes Care Devices Market to 2015
Global Membrane Market for Water and Wastewater Treatment Forecasts and Analysis to 2015
Global LNG Industry to 2015: Investment Opportunities Analysis and Forecasts of All Active and Planned Liquefaction and Regasification Terminals
Distribution and Patient Support for Speciality Medicines in Europe
US Denim Jeans Market Report: 2009 Edition
Power Sector in India: An Analysis
Global Milk & Dairy Products Market Report: 2009 Edition
The Market for Wellness Programs and Their Impact on Pharmaceutical, Diagnostic and Device Product Markets
United States LNG Export and Import Markets to 2015- Analysis and Forecasts of Terminal wise Capacity and Associated Contracts, LNG Trade movements and Prices
Mobile Applications Stores: Asia - Market Analysis and Business Assessment
Disposable Syringe Markets
Infectious Diseases Drugs Markets
Global Biofuels Market: Opportunities, Emerging Technologies and Production
UK Home Delivery and Fulfilment 2009
Mobile Film Content Forecasts & Analysis 2008-2013
Mobile ID Fraud
Worldwide Services Oriented Architecture (SOA) Infrastructure Market Shares, Strategies, and Forecasts, 2009 to 2015
Worldwide SOA Component Services Market Shares Strategies, and Forecasts, 2009 to 2015
The Military Aircraft Avionics Market 2009-2019
Military Energy, Fuels and Power Sources Market 2009-2019
UK Neighbourhood Retailing 2008
Report From the Frontier: A Global View of the Key Issues Confronting Higher Education
The Asian Banker Journal
The History of Wireless: How Creative Minds Produced Technology for the Masses
Patient Monitoring Markets
Energy-Efficient Home Renovations Market, Part 3: HVAC & Roofing
The Global Animation Industry
2009-10 Broadcast/Pro Video Marketplace Micro Quantitative Product Data Report
China industry research and investment analysis: iron ore mining industry, 2008
Feasibility Research Report on China C-Si Non C-Si Solar Cell and Module Project
2009-2013 Deep Research Report on China Solar Grade Polysilicon Industry
Boosting Immunity Through Digestion: The Relation Among Probiotics, Prebiotics and Digestive Enzymes
Worldwide Gas Processing Survey
Oil Sands Projects
VimpelCom-IT Sales Opportunities-2008
Deutsche Telekom (wholesale)
LNG to 2030:A Detailed Review of Future Volumes & Trends
Offshore Rigs: Global Prospects to 2020
Emerging Lighting Technologies and Global Market(2009-2014)
Global Stem Cell and Advanced Technologies Market
Annual Report on China's Banking Industry, 2008
Mobile Applications Stores: Europe - Market Analysis and Business Assessment
Medical Imaging Markets: Contrast Agents
Point of Care Diagnostics 2010 and Beyond: Rapid Testing at a Crossroads
United Kingdom LNG Export and Import Markets to 2015- Analysis and Forecasts of Terminal wise Capacity and Associated Contracts, LNG Trade movements and Prices
China: Education & Training Industry Overview of Emerging Tier II Markets 2008/2009 Update
Transparent Conductive Films for Flexible Electronics 2010-2020
Energy Harvesting & Micro Batteries: Market Forces and Demand Characteristics, Third Edition
Pharmaceutical Mergers and Acquisitions
Get your FREE
Newsletters Subscription
Receive an email alerts of
New Market Research Report.
Subscribe Now!!
For more information, please contact :
http://www.aarkstore.com/reports/Biomarkers-in-Late-Stage-Clinical-Trials-Applications-opportunities-and-activities-of-leading-players-45546.html
by: aarkstore enterprise
Web Marketing: A Route to Success for SMEs Aarkstore Enterprise - Hikma Pharmaceuticals Plc (hik) Swot Profile - Market Research Aarkstore Enterprise - International Power Plc (ipr) Swot Profile - Market Research Retail Pricing Strategy to Maximize the Profit Ecommerce Marketing Today- Big Three And Others Bulk Wholesale Clothing to Make Profit Effective Online Marketing Strategy - Product Reviews Pipeline Insight: Leukemias Underserved Patient Populations Offer Potential For Market Growth Aarkstore Enterprise--pet Supplies And Pet Care Products Market Research Aggregator The Future Of Payment Card Loyalty - Market Research Reports On Aarkstore Enterprise HTC Wildfire Deals: the wildest handset Available in the market Aarkstore Enterprise - Enzo Biochem Swot Profile - Market Research Anxiety 2 Rest Scam
Aarkstore Enterprise -biomarkers In Late Stage Clinical Trials-aarkstore Enterprise Market Research Anaheim