Dallas, TX (PressExposure) April 21, 2010 -- ReportsandReports announce it will carry Biomarkers in Late Stage Clinical Trials: Applications, opportunities and activities of leading players Market Research Report in its Store.
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?
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 - 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
Browse the complete Report on: http://www.reportsandreports.com/market-reports/biomarkers-in-late-stage-clinical-trials-applications-opportuni/
Related Reports: http://www.reportsandreports.com/market-reports/biomarkers-advanced-technologies-and-global-market-2009-2014/ http://www.reportsandreports.com/market-reports/biomarkers-in-drug-discovery-optimizing-drug-discovery-timeline/ http://www.reportsandreports.com/market-reports/stakeholder-opinions-biomarkers-in-rheumatology-awaiting-the-n/
About Us ReportsandReports comprises an online library of 10,000 reports, in-depth market research studies of over 5000 micro markets, and 25 industry specific websites. Our client list boasts almost all well-known publishers of such reports across the globe. We as a third-party reseller of market research reports employ a number of marketing tools, such as press releases, email-marketing and effective search-engine optimization techniques to drive revenues for our clients. We also provide 24/7 online and offline support service to our customers.