Biomarkers, Tests and Trends for Drug R&D

Published: February 2010

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

 

SKU: TPR3179 

 

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Description

 

This report is about the world market for biomarkers and tests used for drug R&D. The study reviews and analyzes the market by examining biomarker related drug R&D spending, trends, major diseases, applications, M&As, alliances, tools & technologies, products and R&D services. This report provides a detailed outlook of the market for biomarkers and related genomic, proteomic, or other tests used in drug R&D programs. The research report also touches on metabolomic and imaging biomarkers. This study sizes the world market and growth rate of biomarkers and tests for drug R&D spending to 2014.

 

The major drug makers face many daunting challenges that are being mitigated by the companies using key business and technical strategies that utilize biomarkers.  Despite the recent severe recession, this business area is set for strong continued double-digit growth as biomarkers and tests in drug/therapeutic R&D enable emerging opportunities, potentially worth billions of dollars. 

 

This business report updates our current view about biomarkers for drug R&D. The study discusses ongoing government initiatives that foster worldwide development in biomarkers and personalized medicine opportunities. Their expectation is to streamline commercializing new, safer, drugs and co-developed companion predictive tests by integrating biomarkers and pharmacogenomic (PGx) tests into the critical path of drug R&D.  The study discusses how clinical trials are undergoing important emerging changes that integrate biomarkers and assays into the drug development process to provide more useful information in order for drug makers to make better product development decisions.

 

This study uses more than 51 figures and tables to illustrate its insightful findings.  The report offers detailed information including data tables about key technologies, M&As, alliances and so on. More than thirty selected companies are profiled with details such as contact information, business overview, financial details and product information. 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.

 

 

 

Table of Contents

 

1.Biomarker Market for Drug R&D

   Drug Industry R&D Spending and New Products

   Limited Drug Safety, Effectiveness and Unmet Medical

   Needs

     Common Drug Types Are Not Very Effective

     Drug-Related Adverse Events (AEs) Create Health

          Risks for Large Patient Populations

     Key Unmet Medical Needs

   Tools for Biomarker Discovery and Qualification

   Enables Personalized Medicine

   Pharmacogenomic and ‘Omic Biomarkers

   Government, 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

     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)

     First-, Second- and Third-Generation DNA Sequencing

          for Biomarker R&D

     Proteomic Biomarker Testing

     Metabolomics Biomarker Testing

     Imaging Biomarker Testing

     Bioinformatic Software is Key to Biomarker Analysis

5.Market Size and Outlook for Drug Industry 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.Selected Companies Working in Biomarker R&D

   Abbott Molecular

   Affymetrix, Inc.

   Asuragen, Inc.

   Beckman Coulter, Inc.

   bioMérieux SA

   Celera Corporation

   Cepheid

   Dako A/S

   Epigenomics AG

   Expression Analysis, Inc.

   Gen-Probe, Inc.

   Helicos Biosciences Corporation

   Hologic, Inc.

   Illumina, Inc.

   Ingenuity Systems, Inc.

   KineMed

   LabCorp

   Life Technologies, Inc.

   Luminex Corporation

   Nanosphere, Inc.

   Nymox Pharmaceutical Corporation

   Orion Genomics LLC

   QIAGEN N.V.

   Quest Diagnostics, Inc.

   Rules-Based Medicine, Inc.

   Sequenom, Inc.

   454 Life Sciences (Roche)

   Banyan Biomarkers, Inc.

   Combimatrix Molecular Diagnostics, Inc.

   Protagen AG

   Singulex

7.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 FDA’s 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

8.Appendices

   WW 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

Table 8. Alliances in Biomarkers and Pharma-Biotech R&D by

        Major Disease

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,

        1H/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. First-, Second- and Third-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 or Applications to 2014

Table 20. Global Drug Makers’ Biomarker R&D Spending Market

        Shares by Disease, 2008 & 2014

Table 21. Global Drug Makers’ Biomarker R&D by Application/

        Clinical Phase

Table 22. Global Drug Makers’ Biomarker R&D Spending by

        Tools and Services, 2008-2014

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 Selected Government 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 2014

Figure 8. Global Drug Makers’ Biomarker R&D Spending Market

        Shares by Disease, 2008 & 2014

Figure 9. Global Drug Makers’ Biomarker R&D by Application/

        Clinical Phase

Figure 10 Global Drug Makers’ Biomarker R&D Spending by

        Tools and Services, 2008-2014

Figure 11. Global Drug Makers’ Biomarker R&D Spending by

        Region

Figure 12. Biomarkers and the FDA Critical Path

 


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