Published: February 2010
144 pages;
Can be printed; fully searchable PDF format; TOC hyperlinks and Internet hyperlinks
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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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