Biomarkers and Related Tests for Molecular Diagnostics and

Pharma/ Biotech R&D Ė Companies, Products and WW Market, 2004-2009

Published: July 2005

168 pages; Can be printed; fully searchable PDF format; TOC hyperlinks and Internet hyperlinks

 

SKU: TPR3157 

 

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Description

 

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 individualís 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 Pacificís 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 $7.8 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. Rocheís 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.

 

 

 

Table of Contents

 

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

 

List of Tables

 

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 & Lab

          Services, 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

 

List of Figures

 

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

 


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