Biomarkers, Tests and Trends for Drug R&D

Summary

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.

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.
bioMieux 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