Biomarkers & Related Tests for Molecular Diagnostics & Pharma/ Biotech R&D

Companies, Products & Worldwide Market, 2004-2009

Publication Date	July 2005
Publisher	Takeda Pacific
Product Type	Report
Pages	168
ISBN Number	not applicable
Product Code	TKD00004

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Summary

One of the big ideas that emerged since the completion of the human genome project involves new biomarkers and tests used for tailoring new drugs that match an individual's genetic makeup. This report is about the market for genomic, metabolomic and protein biomarkers and the related tests. The tests are used as molecular diagnostics and as pharmacogenomic assays to measure drug safety or effectiveness.

Takeda Pacific's report maps out the major areas of the market ecosystem for biomarkers and related tests. This insightful study shows that this market is big business and reached $7.1 billion in 2004. The study reveals that molecular diagnostic companies are poised for continued strong growth. The mix of pharma/ biotech companies doing biomarker related R&D is also beginning to show gains.

The study projects the 5-year trends for biomarkers, molecular diagnostics and pharmacogenomic tests used by the drug makers. The report charts the developments of more than 50 companies involved in this dynamic industry.

This report discusses new FDA initiatives to accelerate the approvals of emerging diagnostics and new drugs by integrating biomarkers and pharmacogenomic tests drug development from pre-clinical through the end of clinical trial phases. Companies have responded with new products. Roche's new microarray test, targets certain gene variants, and tests if patients respond well to 30 or more currently marketed drugs. Tailored therapies such as Herceptin, Gleevec, Erbitux, or Irressa are among a new class of marketed products. They work very effectively, but just for a sub-set of individuals that pass special genetic tests designed for each product. These products signal that the era of personalized medicine has begun.

This study is packed with interesting data and includes more than 66 figures and tables. The tables provide data about technologies, companies, product pipelines, partnerships and more. The study also has additional data such as the worldwide incidence and prevalence of major diseases. The report analyzes partnering deals and includes several years of alliance and M&A data.

Twenty-two selected companies are profiled, with details including contact information, business and product overviews, alliances and patent or other financial details. This 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.

Content

1.Market for Biomarkers & Related Tests
- Pharmaceutical Industry Productivity
- Personalizing Medicine with Genomics
- `Modern' Biomarkers
- Government Agencies, Biomarkers and PGx
- Market Ecosystem
2.Overview of Biomarkers and Related Tests
- Defining Biomarkers
- Traditional Biomarkers
- Modern Biomarkers: Genomic, Proteomic and more
- Government Regulatory Definition of Biomarkers for Diagnostics and Drug R&D
- Commercializing New In-Vitro Diagnostics
- Molecular Diagnostics
- The Leading Molecular Diagnostics Companies
- Modern Biomarkers and Related Tests
- Nucleic Acids, Proteins and Patterns are Biomarkers
- Pharmacogenomics and Personalized Medicine
- Biomarkers Gain FDA Mindshare
- FDA's Biomarker-Related Initiatives (2003-2005)
- Molecular Patterns and Profiles Measure Complex Diseases
- The Goal of `1-Cent-Per-SNP' Studies
- Protein Patterns Demonstrated as Biomarkers
- Making Diagnostics from Biomarkers
- Commercializing Biomarker Tests
- Home Brew Diagnostic Test Service
- Directly Developing an IVD
- Pending Pricing Decisions
- Planning for Government or Insurance Reimbursement
3.Biomarker-Based Diagnostic Technologies
- Technologies for Biomarker Analysis
- Direct Methods
- PCR-based Target Amplification Technology
- Non-PCR Target Amplification and Signal Amplification
- Boosting Signals
- Microarrays
- Lab-on-a-chip Systems
- Proteomics
- Metabolomics
- Bioinformatic Software
- Biomarkers and Pharmacogenomic Assays for Pharma/ Biotech Drug R&D
- Commercializing Biomarker-Based Diagnostics or Assays
4.Companies Developing Biomarker-Based Molecular Diagnostics
- Companies and Product Pipelines
- Company Research Results
- Companies and Biomarker Tests by Disease Segment
- Companies and Biomarker Tests by Product Status
5.Companies Developing Biomarker-Based PGx Assays for Pharma/ Biotech R&D
- Companies and Product Pipelines
- Company Research Results
- Company Output by Disease Segment
- Company Output by Product Status
6.Biomarker Alliances and R&D Trends
- Alliances and R&D Overview
- Alliances and Drug Discovery R&D
7.Market Size and Forecast for Biomarker-Based Clinical Molecular
- Diagnostics & Lab Services
- Market Overview: Biomarker-Based Molecular Diagnostics & Clinical Lab Services
- WW Biomarker-Based Clinical Molecular Diagnostic Product Market Trends
- Biomarker-Based Clinical Molecular Diagnostic Product Market Shares
- Biomarker-Based Clinical Molecular Diagnostic Market Size by Application Segment
- Biomarker-based Clinical Molecular Diagnostic Product Market Size by Region
- Biomarker-Based Clinical Molecular Diagnostic Lab Services Market Size By Applications and Regions
- Biomarker-Based Clinical Molecular Diagnostic Lab Services Market Size by Applications
- Biomarker-Based Clinical Molecular Diagnostic Lab Services Market Size by WW Regions
8.Market Size and Forecast for Pharma/ Biotech Biomarker/ PGx R&D Spending
- Pharma/ Biotech Biomarker R&D Spending Trends
- Pharma/ Biotech Biomarker R&D Spending Market Shares
- Pharma/ Biotech Biomarker R&D Market Size by Application Segments
- Pharma/ Biotech Biomarker R&D Market Size by Application/ Clinical Phase
- Pharma/ Biotech Biomarker R&D by R&D Tools and R&D Services
- Pharma/ Biotech Biomarker R&D Spending by WW Region
9.Emerging Trends and Opportunities
- Trends in Biomarkers and Related Molecular Tests
- Testing Infectious Diseases
- Growing Interest in Cancer Biomarker Tests
- Measuring Alzheimer's Disease Progression
- Drug Response Assays: Biomarkers for Safety and Efficacy
- Future Opportunities
- Government Regulators Fostering Future Opportunities
- Pharmacogenomics Can Save Time and Expense
- Personalizing Medicine Has Arrived For Some
- Hurdles
- Pricey Molecular Diagnostics
- Developing World Needs Diagnostics Too
- Fastest Regulatory Route to Commercializing Tests
- Roche and Affymetrix First to Get Clearance to Market
- Microarray-Based Pharmacogenetic Test System
- Insurance Reimbursement
10.Highlights of Selected Companies
- Axis-Shield, Inc.
- BioMarker Pharmaceuticals, Inc.
- BioSite, Inc.
- CeMines, Inc.
- Chiron Corporation
- DakoCytomation A/S
- diaDexus, Inc.
- Diagnostics Products Corporation
- DxS Ltd.
- Exact Sciences Corporation
- Genaissance Pharmaceuticals, Inc.
- Gen-Probe, Inc.
- Icoria
- Illumina, Inc.
- Jurilab Ltd.
- Matritech, Inc.
- Millennium Pharmaceuticals, Inc.
- Myriad Genetics, Inc.
- Nanosphere, Inc.
- Perlegen Sciences, Inc.
- Samaritan Pharmaceuticals
- SurroMed, Inc.
11.Appendix A - WW Populations by Diseases
12.Appendix B - Goals and Uses of Biomarker Tests for Pharma/ Biotech R&D
- New Genetic Tests for Pharma/ Biotech R&D Foster Personalized Medicine
- Clinical Pharmacogenomics in Pharma/ Biotech R&D
- Biomarker Diagnostic Products Can Reach Market Quickly
- Biomarker Tests for Pharma/ Biotech
13.Appendix C - Alliance Tables
14.About the Publisher and Authors
- About Takeda Pacific
- About the Authors
- Table 1. Molecular IVD Test Applications
- Table 2. The Leading Molecular Diagnostics Companies
- Table 3. Path to Commercialize Molecular Diagnostics
- Table 4. Technology for Biomarker-Based Diagnostics by Disease
- Table 5. Target Amplification Technologies
- Table 6. Target Signal Amplification Technologies
- Table 7. Microarray and Lab-on-a-chip Technologies
- Table 8. Proteomic Technologies for Diagnostics
- Table 9. Metabolomic Technologies and Biomarkers
- Table 10. Competitors for Nucleic Acid Amplification Technologies for Clinical Diagnostics
- Table 11. Commercializing Biomarker-Based Diagnostics by Disease
- Table 12. Company Output by Major Disease Totals and Shares
- Table 13. Company Output by Product `Status' Segment Totals & Shares
- Table 14. Biomarker/ Pharmacogenomic Product Pipeline by Disease
- Table 15. Company Output by Disease Segment Total and Share
- Table 16. Company Output by Product Status
- Table 17. Alliances in Molecular Diagnostics and Pharma/ Biotech R&D (2000-2004)
- Table 18. Review of the 'Others' Alliances
- Table 19. Summary of Alliances in Molecular Diagnostics and Pharma/ Biotech R&D by Indication by Type and Year
- Table 20. Biomarker-Based Clinical Molecular Diagnostic Products & LabServices, 2004 & 2009
- Table 21. Biomarker-Based Clinical Molecular Diagnostic (ASR/ IVD*) Products by Disease Area, 2004-2009
- Table 22. Biomarker-Based Clinical Molecular Diagnostic Product Market Share,2005 & 2009
- Table 23. Biomarker-based Clinical Molecular Diagnostic Products by Application, 2004-2009
- Table 24. Biomarker-based Clinical Molecular Diagnostic Products by WW Region, 2004-2009
- Table 25. Biomarker-Based Clinical Molecular Diagnostic Lab Services by Applications, 2004-2009
- Table 26. Biomarker-Based Clinical Molecular Diagnostic Lab Services by World Regions, 2004-2009
- Table 27. Pharma/ Biotech Biomarker R&D Spending by Major Diseases
- Table 28. Pharma/ Biotech Biomarker R&D Spending Market Shares by Disease,2005 & 2009
- Table 29. Pharma/ Biotech Biomarker R&D by Application/ Clinical Phase, 2004-2009
- Table 30. Pharma/ Biotech Biomarker R&D Spending by Services and Tools, 2004-2009
- Table 31. Pharma/ Biotech Biomarker R&D Spending by World Region
- Table 32. Trend for Infectious Disease Tests
- Table 33. Trend for Cancer Companion Tests
- Table 34. Trend for Cancer Disease Progression Tests
- Table 35. Trend for CNS Tests Likely in Five Years
- Table 36. Trend for Genetic Tests
- Table 37. Trend for Risk Prediction Genetic Tests
- Table 38. Major Diseases by Mortality, Incidence and Prevalence
- Table 39. Alliances in Molecular Diagnostics and Pharma/ Biotech R&D, 1Q/2004
- Table 40. Alliances in Molecular Diagnostics and Pharma/ Biotech R&D, 2003
- Table 41. Alliances in Molecular Diagnostics and Pharma/ Biotech R&D, 2002
- Table 42. Alliances in Molecular Diagnostics and Pharma/ Biotech R&D, 2001
- Table 43. Alliances in Molecular Diagnostics and Pharma/ Biotech R&D, 2Q/2000
- Figure 1. Biomarker, Molecular Diagnostics and Pharma/ Biotech PGx Market Ecosystem
- Figure 2. Company Output by Major Disease Segment
- Figure 3. Company Output by Major Disease Segment Shares
- Figure 4. Company Output by Product `Status' Totals
- Figure 5. Company Output by Product Status Shares
- Figure 6. Company Output by Disease Segment Total
- Figure 7. Company Output by Disease Segment Share
- Figure 8. Company Output by Product Status Total
- Figure 9. Company Output by Product Status Share
- Figure 10. Summary of Alliances in Molecular Diagnostics and Pharma/ Biotech R&D by Indication (2000-2004)
- Figure 11. Summary Analysis of the 'Others' Alliances
- Figure 12. Summary of Alliances in Molecular Diagnostics and Pharma/ Biotech R&D by Indication, Type and Year
- Figure 13. Biomarker-Based Clinical Molecular Diagnostic Products & Lab Services, 2004 & 2009
- Figure 14. Biomarker-Based Clinical Molecular Diagnostic Products & Lab Services by Disease Area, 2004-2009
- Figure 15. Biomarker-Based Clinical Molecular Diagnostic Product Market Shares, 2005 & 2009
- Figure 16. Biomarker-based Clinical Molecular Diagnostic Products by Application, 2004-2009
- Figure 17. Biomarker-based Clinical Molecular Diagnostic Products by WW Region, 2004-2009
- Figure 18. Biomarker-Based Clinical Molecular Diagnostic Lab Services by Applications, 2004-2009
- Figure 19. Biomarker-Based Clinical Molecular Diagnostic Lab Services by World Regions, 2004-2009
- Figure 20. Pharma/ Biotech Biomarker R&D Spending by Major Diseases
- Figure 21. Pharma/ Biotech Biomarker R&D Spending Market Shares by Disease, 2005 & 2009
- Figure 22. Pharma/ Biotech Biomarker R&D by Application/ Clinical Phase, 2004-2009
- Figure 23. Pharma/ Biotech Biomarker R&D Spending by Services and Tools, 2004-2009
- Figure 24. Pharma/ Biotech Biomarker R&D Spending by WW Region