Published: June 2007
130 pages;
Can be printed; fully searchable PDF format; TOC hyperlinks and Internet hyperlinks
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Description
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
Medicine
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
Amplification
Signal Amplification
Microarrays and Microfluidic Systems
Microarrays
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
Forecast
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
Segments
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
Co-development
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
Cepheid
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.
Sigma-Aldrich
Spotfire, Inc.
Third Wave Technologies, Inc.
Veridex, LLC (J&J Co.)
8.Appendices
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
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. 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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