Biomarkers and Tests for Pharma/ Biotech R&D – Companies Products and WW Market, 2006-2011

Published: June 2007

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This report focuses on the market for biomarkers and tests used in pharma/ biotech drug R&D.  The study reviews the market by looking at key alliances, pharma/ biotech research and development spending, trends, major diseases, applications and technologies. The research analyzed the future direction of biomarkers and related ‘-omic’ or pharmacogenomic (PGx) tests used in drug R&D. This report estimates the worldwide market value and growth (CAGR) of biomarkers and tests for pharma/ biotech R&D for the next five years.


Research-based pharma/ biotech companies face numerous challenges that are being overcome with newer business strategies or approaches that are discussed in this report.  This business area is set for strong continued growth as biomarkers and tests in drug R&D enable new opportunities. 


The report discusses ongoing government initiatives that foster worldwide development in targeted therapeutics, biomarkers and personalized medicine opportunities. Their expectation is to streamline commercializing new, safer, drugs and co-developed tests by integrating biomarkers and PGx tests into the critical path of drug R&D.  


Traditional clinical trial designs will undergo key changes that integrate biomarkers and tests to provide more useful information in order for drug makers to make better product decisions. Some drug company executives expect biomarkers to enable a ‘sea change’ in how new drugs are developed as the blockbuster business model fades and transitions to new focused therapeutic approaches that gain traction in a few years.


Targeted therapies such as Herceptin, Gleevec, Erbitux, or Irressa are among new drug products that work in just a sub-set of patients that pass special pharmcogenomic tests designed for each product. Many drug companies are routinely using biomarkers in R&D and are increasingly adding drug-test projects to their product pipelines. The era of personalized medicine has arrived.


This study uses more than 42 figures and tables to illustrate its useful findings.  The report offers detailed information including data tables about strategic alliances, technologies and so on. Thirty-one leading companies are profiled with details such as contact information, business overview, financial details and product information.


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.The Biomarker Market for Pharma/ Biotech Drug R&D

   Drug Industry R&D Spending and Productivity

   Limited Drug Effectiveness, Safety and Unmet Medical Needs

     Many Drug Types Do Not Work Well for Patients

     Drug- Related ADRs Impact Large Populations

     Key Unmet Medical Needs

   Personalizing Medicine with Biomarkers and Key Technologies

   Molecular Biomarkers and Pharmaco-genomics (PGx)

   Government Agencies, Biomarkers and PGx

   Market Ecosystem

2.Biomarkers For Drug R&D

   Defining Biomarkers

     Healthcare and Biomarkers

     Evolving Definition of Biomarkers

     The Regulatory Definition of Biomarkers and Tests for

          Drug R&D

   Biomarkers and Tests

     Nucleic Acids, Proteins, Profiles and Metabolites

     Biomarkers, Pharmacogenomics (PGx) and Personalized


     New Clinical Trial Designs and Patient Stratification

     Drug-Test Synergies for Companion Tests

   Biomarkers Generate Industry Buzz

     FDA's Biomarker Activities (2004-2007)

     FDA's VXDS Program and International Participation

     Other US Government Initiatives in Personalized Medicine

     SNPs, Molecular Patterns and Gene Expression Profiles

          Measure Complex Diseases

     The Goal to Drive Down the Cost of SNP Tests

     Using RNA Interference For Screening for Biomarkers

     Protein Patterns Demonstrated as Biomarkers

   Developing Biomarkers and Tests

3.Alliances and M&As in Biomarker R&D

   Alliances in Biomarkers and Drug R&D

   Alliances in Biomarkers By Major Diseases

   Alliance Details 2005 to May-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


         Signal Amplification

     Microarrays and Microfluidic Systems


         Microfluidic Systems (Lab-on-a-chips)

     Proteomic Biomarker Testing

     Metabolomic Biomarker Testing

     Bioinformatic Software Enables Biomarker Analysis

5.WW Pharma/ Biotech Biomarker R&D Spending, Market Size and


   WW Pharma/ Biotech Biomarker R&D Spending Trends

   WW Pharma/ Biotech Biomarker R&D Spending Market Shares

   WW Pharma/ Biotech Biomarker R&D Market Size by Application


     WW Pharma/ Biotech Biomarker R&D Market Size by

          Application/ Clinical Phase

     WW Pharma/ Biotech Biomarker R&D by Tools and Services

   Pharma/ Biotech Biomarker R&D Spending by WW Region

6.Trends and Future Directions

   Biomarkers for Drug R&D

     Government Initiatives Foster Drug R&D - Biomarker/ Test


     Biomarkers, a Key Opportunity on the Critial 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.Selected Companies Working in Biomarker-Related Drug R&D

   Affymetrix, Inc.

   Agendia B.V.

   Agilent Technologies, Inc., LSCA group

   Applied Biosystems

   BioSite, Inc.

   Caliper Life Sciences, Inc.

   Celera Group


   CombiMatrix Corp (Acacia Research)

   Dako A/S

   diaDexus, Inc.

   Epigenomics AG

   Fluidigm Corporation

   Gene Logic, Inc.

   Illumina, Inc.

   Innogenetics NV

   Invitrogen Corporation

   Luminex Corporation

   Myriad Genetics, Inc.

   Nanogen, Inc.

   Nanosphere, Inc.

   NimbleGen Systems, Inc.

   Nymox Pharmaceutical Corporation

   Orion Genomics LLC

   Qiagen NV

   Roche Molecular Diagnostics

   Sequenom, Inc.


   Spotfire, Inc.

   Third Wave Technologies, Inc.

   Veridex, LLC (J&J Co.)


   WW Populations by Diseases

   Goals and Uses of Biomarker Tests for Pharma/ Biotech R&D

     New PGx Tests for Pharma/ Biotech R&D Enable

          Personalized Medicine

     Clinical PGx in the Pharma/ Biotech R&D Path

     Biomarker Tests for Pharma/ Biotech

     Biomarker Test Products Can Reach Market Quickly

   About Takeda Pacific

   About the Authors 



List of Tables


Table 1. Annual Drug R&D Spending Estimate

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. Proteomic Technologies for Biomarker Testing

Table 17. Metabolomic Technologies and Biomarkers

Table 18. WW Pharma/ Biotech Biomarker R&D Spending by Major

        Diseases to 2011

Table 19. WW Pharma/ Biotech Biomarker R&D Spending Market

        Shares by Disease, 2006 & 2011

Table 20. WW Pharma/ Biotech Biomarker R&D Spending by

        Application/ Clinical Phase

Table 21. WW Pharma/ Biotech Biomarker R&D Spending by Services

        and Tools

Table 22. WW Pharma-Biotech Biomarker R&D Spending by Region

Table 23. Six Major Critical Path Topics

Table 24. Future Direction of PGx Tests

Table 25. Future Direction for Risk Prediction Genetic Tests

Table 26. Highlights of Biomarkers, Targeted Therapies, and

        Tests (PGx)

Table 27. Cancer Companion Tests and Targeted Therapies

Table 28. Future Direction of Cancer Companion Tests

Table 29. CNS Tests Likely in Five Years

Table 30. Future Direction of Infectious Disease Tests

Table 31. Major Diseases by Mortality, Incidence and Prevalence


List of Figures


Figure 1. The Biomarker Pharma/ Biotech R&D/ PGx Market


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. WW Pharma/ Biotech Biomarker R&D Spending by Major

        Diseases to 2011

Figure 8. WW Pharma/ Biotech Biomarker R&D Spending Market

        Shares by Disease

Figure 9. WW Pharma/ Biotech Biomarker R&D by Application/

        Clinical Phase

Figure 10 WW Pharma/ Biotech Biomarker R&D Spending by Services

        and Tools, 2006-2011

Figure 11. WW Pharma-Biotech Biomarker R&D Spending by Region

Figure 12. Biomarkers and the Critical Path

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