Biomarkers: The Future of Next-Generation Drug R&D

Product Code TKD00012
Publication Date September 2008
Publisher Takeda Pacific
Product Type Report
Pages 147
ISBN Number not applicable
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Biomarkers: The Future of Next-Generation Drug R&D

This report analyzes the hot global market for biomarkers and related assays or tests used in drug R&D. The study reviews this dynamic market by looking at drug research and development spending trends, M&As, alliances, major diseases, applications, tools, technologies, products and services. This report suggests the future direction of the market for biomarkers and related '-omic' or pharmacogenomic (PGx) assays or tests used in the next-generation of drug R&D. This study sizes the world market and growth rate of biomarkers and assays for drug R&D spending to 2012.

Drug and biopharmaceutical developers face numerous challenges that are being helped with emerging business and technical strategies or approaches that utilize biomarkers to improve their chances of success. This business area is set for strong continued growth as biomarkers and assays in drug R&D enable new opportunities. This report estimates that this potential multi-billion dollar market will grow at strong double-digit rates over the five-year study period.

The study discusses ongoing regional government initiatives that are fostering worldwide development in biomarkers and personalized medicine opportunities. With the current group of more than 20-marketed personalized medicines and companion tests as a model, government drug regulators have already begun to change the labels of selected marketed drugs to use specific companion tests to predict patient drug response. Drug regulators are asking that drug makers use certain kidney safety biomarker assays in drug R&D. Their goal is to streamline commercializing new, safer, more effective drugs and co-developed companion predictive tests by integrating biomarkers and related pharmacogenomic (PGx), protein, imaging or other tests into the drug R&D critical path. The study discusses how clinical trials are undergoing important changes that integrate biomarkers and assays into the drug R&D process to provide more meaningful information in order for drug makers to make better product development decisions.

This study uses more than 51 figures and tables to illustrate its useful findings. The report offers detailed information including data tables about strategic technologies, M&As, alliances and so on. Thirty-four selected companies are profiled with details such as business overview, contacts, financial details and product information. This fully searchable PDF report helps busy readers save time. This report uses hyperlinks to help readers jump to Table of Content items or to text-linked Internet sites.

This must-have report would benefit people with job titles including CEO, VPs, Director of Business Development, Research Directors, Entrepreneurs, Venture Capitalists, Investment Planners, Research Scientists, Consultants or Industry Analysts.

Contents

  • 1.The Biomarker Market for Drug R&D
    • Drug Industry R&D and Output
    • Limited Drug Safety, Effectiveness and Unmet Medical
    • Needs
    • Common Drug Types Are Not Very Effective
    • Drug-Related Adverse Events (AEs) Impose Health
    • Risks on Large Populations of Patients
    • Key Unmet Medical Needs
    • Technologies for Biomarker Discovery and Qualification
    • Enables Personalized Medicine
    • Pharmacogenomic (PGx) Biomarkers
    • Government Agencies, Biomarkers and PGx
    • Market Ecosystem
  • 2.Biomarkers For Drug R&D
    • Definitions of What Biomarkers Are
    • Healthcare and Biomarkers
    • The Definition of Biomarkers Continues to Evolve
    • The FDA's Definitions of Biomarkers and Tests for
    • Drug R&D
    • Updated Definitions And Biomarker Qualification
    • FDA's International Harmonization Progress
    • Biomarkers, Assays and Tests
    • Nucleic Acids, Proteins, Profiles and Metabolites
    • Pharmacogenomic (PGx) Biomarkers and Personalized
    • Medicine
    • New Clinical Trial Designs and Patient
    • Stratification
    • Drug-Test Synergies for Rx/ Dx Companion Tests
    • Biomarkers Generate Industry Buzz
    • FDA's Biomarker Activities (2005-2008)
    • FDA vXDS Program and International Harmonization
    • Other Government Initiatives in Personalized
    • Medicine
    • SNPs, CNVs, Haplotyping, Molecular Patterns and
    • Gene Expression Profiles Measure Complex
    • Diseases
    • The Goal to Drive Down the Cost of SNP Tests
    • MicroRNAs are Biomarkers; shRNAs Can Screen for
    • Biomarkers
    • Multiplexed Protein Patterns Can Be Biomarkers
    • Developing Biomarkers, Assays and Dx
  • 3.Alliances and M&As in Biomarker R&D
    • Alliances in Biomarkers and Drug R&D
    • Alliances in Biomarkers By Major Diseases
    • Alliance Deals to Mid-2007
  • 4.Technologies for Biomarkers and Drug R&D
    • PGx Tests for Drug R&D
    • Biomarker Testing and Analysis Technologies
    • Genomic Biomarker Testing
    • Direct Detection with Blots and ELISAs
    • PCR-based Target Amplification Technology
    • Non-PCR Target Amplification and Signal Amplification
    • Signal Amplification
    • Microarrays and Microfluidic Systems
    • Microarrays
    • Microfluidic Systems (Lab-on-a-chips)
    • CE and Next-Generation DNA Sequencing for Biomarker R&D
    • Proteomic Biomarker Testing
    • Metabolomics Biomarker Testing
    • Bioinformatic Software Enables Biomarker Analysis
  • 5.Market Size and Forecast for Drug Maker Biomarker R&D Spending
    • Global Drug Makers' Biomarker R&D Spending Trends
    • Global Drug Makers' Biomarker R&D Spending Market Shares
    • Global Drug Makers' Biomarker R&D Market Size by Application
    • Segments
    • Global Drug Makers' Biomarker R&D Market Size by Application/ Clinical
    • Phase
    • Global Drug Makers' Biomarker R&D by Tools and Services
    • Drug Makers' Biomarker R&D Spending by World Region
  • 6.Trends and Future Directions
    • Biomarkers for Drug R&D
    • Government Initiatives Foster Drug R&D + Biomarker/
    • Test Co-development
    • Biomarkers, a Key Opportunity on the Critical Path
    • to Personalized Medicine
    • The Critical Path Linked to vXDS Program
    • Biomarkers Enable New Clinical Trial Designs
    • Future Direction of PGx Tests and Targeted Therapies
    • Personalized Medicine is Here and is Set for Growth
    • Cancer Biomarkers and Tests
    • Future Direction for CNS Disease Tests
    • Infectious Disease Testing
  • 7.Companies Linked to Biomarker R&D
    • 454 Life Sciences (Roche)
    • Abbott Molecular
    • Affymetrix, Inc.
    • Applied Biosystems
    • Asuragen, Inc.
    • BD Diagnostics
    • Beckman Coulter, Inc.
    • bioMrieux SA
    • Celera Corporation
    • Cepheid
    • Cogenics (Clinical Data)
    • Combimatrix Molecular Diagnostics, Inc.
    • Dako A/S
    • Decision Biomarkers, Inc.
    • Epigenomics AG
    • Expression Analysis, Inc.
    • Gen-Probe, Inc.
    • Helicos Biosciences Corporation
    • Illumina, Inc.
    • Innogenetics NV
    • LabCorp
    • Luminex Corporation
    • Nanosphere, Inc.
    • Nymox Pharmaceutical Corporation
    • Orion Genomics LLC
    • Pathway Diagnostics Corporation
    • Protagen AG
    • QIAGEN N.V.
    • Quest Diagnostics, Inc.
    • Roche Nimblegen, Inc.
    • Rules-Based Medicine, Inc.
    • Sequenom, Inc.
    • Siemens Healthcare Diag. (MDx)
    • Third Wave Technologies, Inc.
  • 8.Appendices
    • World Populations by Diseases
    • Examples of Uses of Biomarker Tests for Drug R&D
    • Clinical PGx Biomarker Tests in the Drug R&D Paths
    • Biomarker Tests for Drug R&D
    • Links to Organizations Mentioned in this Report
    • About Takeda Pacific
    • About the Authors
  • List of Tables
    • Table 1. Annual Drug R&D Spending Estimates
    • Table 2. Common Drug Types and Low Drug Response Rates (%)
    • Table 3. Large Disease Populations with Unmet Medical Need
    • Table 4. Areas of Drug R&D Interest for vXDSs Sent to FDA
    • Table 5. Examples of Biomarker Topics For FDA vXDS Submissions
    • Table 6. Path to Commercialize Biomarker Tests
    • Table 7. Summary of Alliances in Biomarker Pharma-Biotech R&D by Alliance Type and Year
    • Table 8. Alliances in Biomarkers and Pharma-Biotech R&D by Major Disease (2005-2Q/2007)
    • Table 9. Analysis of the 'Others' (Drug Response) Biomarker Alliances By Indication/ Application
    • Table 10. Key Alliances in Biomarkers and Pharma-Biotech
      • R&D by Major Disease and Indication/ Application, as of 2Q/2007
    • Table 11. Key Alliances in Biomarkers and Pharma-Biotech
      • R&D by Major Disease and Indication/ Application, 2006
    • Table 12. Key Alliances in Biomarkers and Pharma-Biotech
      • R&D by Major Disease and Indication/ Application, 2005
    • Table 13. Target Amplification Technologies
    • Table 14. Target Signal Amplification Technologies
    • Table 15. Microarray and Lab-on-a-chip Technologies
    • Table 16. CE & Next-Generation DNA Sequencing Platforms
    • Table 17. Proteomic Technologies for Biomarker Testing or R&D
    • Table 18. Metabolomic Technologies and Biomarkers
    • Table 19. Global Drug Makers' Biomarker R&D Spending by Major Diseases to 2012
    • Table 20. Global Drug Makers' Biomarker R&D Spending Market Shares by Disease, 2007 & 2012
    • Table 21. Global Drug Makers' Biomarker R&D by Application/Clinical Phase
    • Table 22. Global Drug Makers' Biomarker R&D Spending by Services and Tools
    • Table 23. Global Drug Makers' Biomarker R&D Spending by Region
    • Table 24. Six Major FDA Critical Path Topics
    • Table 25. Future Direction of PGx Tests
    • Table 26. Future Direction for Risk Prediction Genetic Tests
    • Table 27. Highlights of Biomarkers, Targeted Therapies, and Tests (PGx)
    • Table 28. Cancer Companion Tests and Targeted Therapies
    • Table 29. Future Direction of Cancer Companion Tests
    • Table 30. CNS Tests Likely in Five Years
    • Table 31. Future Direction of Infectious Disease Tests
    • Table 32. Major Diseases by Mortality, Incidence and Prevalence
    • Table 33. Top Health Risk Factors Leading to Death in the Developed World
    • Table 34. Path For Prediction of Drug Response Safety Risk
    • Table 35. Path For Drug Efficacy Testing v. Disease State
    • Table 36. Summary of PGx Biomarker Test Focus in Drug R&D
    • Table 37. Weblinks to Companies Mentioned in this Report
    • Table 38. Weblinks to Government Regulatory Organizations
    • Table 39. Weblinks to Biomarker Consortium Industry Members
    • Table 40. Weblinks to Biomarker Consortium Non-Profit Members
  • List of Illustrations
    • Figure 1. The Biomarker Pharma/ Biotech R&D/ PGx Market Ecosystem
    • Figure 2. Microarrays and Microfluidic Chips Used in Drug R&D
    • Figure 3. Affymetrix Microarray System
    • Figure 4. A Microfluidics Instrument for Drug R&D
    • Figure 5. Diagram of a Protein Capture Microarray
    • Figure 6. Analytical Software
    • Figure 7. Global Drug Makers' R&D Spending by Major Diseases to 2012
    • Figure 8. Global Drug Makers' Biomarker R&D Spending Market Shares by Disease
    • Figure 9. Global Drug Makers' Biomarker R&D by Application/Clinical Phase
    • Figure 10 Global Drug Makers' Biomarker R&D Spending by Services and Tools, 2007-2012
    • Figure 11. Global Drug Makers' Biomarker R&D Spending by Region
    • Figure 12. Biomarkers and the FDA Critical Path