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

Table of 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.
• bioMerieux 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