Pharma/ Biotech R&D – Companies, Products and
WW Market, 2004-2009
Published: July 2005
168 pages;
Can be printed; fully searchable PDF format; TOC hyperlinks and Internet hyperlinks
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Description
One of the big ideas that emerged since the
completion of the human genome project involves new biomarkers and tests used for tailoring new drugs that match an individual’s genetic makeup. This report is
about the market for genomic, metabolomic and protein biomarkers and the related tests. The tests are used as molecular diagnostics and as pharmacogenomic
assays to measure drug safety or effectiveness.
Takeda Pacific’s report maps out the major
areas of the market ecosystem for biomarkers and related tests. This insightful study shows that this market is big business and reached $7.8 billion in 2004.
The study reveals that molecular diagnostic companies are poised for continued strong growth. The mix of pharma/ biotech companies doing biomarker related R&D
is also beginning to show gains.
The study projects the 5-year trends for
biomarkers, molecular diagnostics and pharmacogenomic tests used by the drug makers. The report charts the developments of more than 50 companies involved in
this dynamic industry.
This report discusses new FDA initiatives to
accelerate the approvals of emerging diagnostics and new drugs by integrating biomarkers and pharmacogenomic tests drug development from pre-clinical through
the end of clinical trial phases. Companies have responded with new products. Roche’s new microarray test, targets certain gene variants, and tests if patients
respond well to 30 or more currently marketed drugs. Tailored therapies such as Herceptin, Gleevec, Erbitux, or Irressa are among a new class of marketed
products. They work very effectively, but just for a sub-set of individuals that pass special genetic tests designed for each product. These products signal
that the era of personalized medicine has begun.
This study is packed with interesting data and
includes more than 66 figures and tables. The tables provide data about technologies, companies, product pipelines, partnerships and more. The study also has
additional data such as the worldwide incidence and prevalence of major diseases. The report analyzes partnering deals and includes several years of alliance
and M&A data.
Twenty-two selected companies are profiled,
with details including contact information, business and product overviews, alliances and patent or other financial details. 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.Market for Biomarkers & Related Tests
Pharmaceutical Industry Productivity
Personalizing Medicine with Genomics
`Modern' Biomarkers
Government Agencies, Biomarkers and PGx
Market Ecosystem
2.Overview of Biomarkers and Related Tests
Defining Biomarkers
Traditional Biomarkers
Modern Biomarkers: Genomic, Proteomic and
more
Government Regulatory Definition of
Biomarkers for Diagnostics
and Drug R&D
Commercializing New In-Vitro Diagnostics
Molecular Diagnostics
The Leading Molecular Diagnostics
Companies
Modern Biomarkers and Related Tests
Nucleic Acids, Proteins and Patterns are
Biomarkers
Pharmacogenomics and Personalized
Medicine
Biomarkers Gain FDA Mindshare
FDA's Biomarker-Related Initiatives
(2003-2005)
Molecular Patterns and Profiles Measure
Complex Diseases
The Goal of `1-Cent-Per-SNP' Studies
Protein Patterns Demonstrated as
Biomarkers
Making Diagnostics from Biomarkers
Commercializing Biomarker Tests
Home Brew Diagnostic Test Service
Directly Developing an IVD
Pending Pricing Decisions
Planning for Government or Insurance
Reimbursement
3.Biomarker-Based Diagnostic Technologies
Technologies for Biomarker Analysis
Direct Methods
PCR-based Target Amplification Technology
Non-PCR Target Amplification and Signal
Amplification
Boosting Signals
Microarrays
Lab-on-a-chip Systems
Proteomics
Metabolomics
Bioinformatic Software
Biomarkers and Pharmacogenomic Assays for
Pharma/ Biotech Drug R&D
Commercializing Biomarker-Based Diagnostics
or Assays
4.Companies Developing Biomarker-Based
Molecular Diagnostics
Companies and Product Pipelines
Company Research Results
Companies and Biomarker Tests by Disease
Segment
Companies and Biomarker Tests by Product
Status
5.Companies Developing Biomarker-Based PGx
Assays for Pharma/ Biotech R&D
Companies and Product Pipelines
Company Research Results
Company Output by Disease Segment
Company Output by Product Status
6.Biomarker Alliances and R&D Trends
Alliances and R&D Overview
Alliances and Drug Discovery R&D
7.Market Size and Forecast for
Biomarker-Based Clinical Molecular
Diagnostics & Lab Services
Market Overview: Biomarker-Based Molecular
Diagnostics & Clinical Lab
Services
WW Biomarker-Based Clinical Molecular
Diagnostic Product Market Trends
Biomarker-Based Clinical Molecular
Diagnostic Product Market Shares
Biomarker-Based Clinical Molecular
Diagnostic Market Size by Application
Segment
Biomarker-based Clinical Molecular
Diagnostic Product Market Size by
Region
Biomarker-Based Clinical Molecular
Diagnostic Lab Services Market Size
By Applications and Regions
Biomarker-Based Clinical Molecular
Diagnostic Lab Services Market Size
by Applications
Biomarker-Based Clinical Molecular
Diagnostic Lab Services Market Size
by WW Regions
8.Market Size and Forecast for Pharma/
Biotech Biomarker/ PGx R&D Spending
Pharma/ Biotech Biomarker R&D Spending
Trends
Pharma/ Biotech Biomarker R&D Spending
Market Shares
Pharma/ Biotech Biomarker R&D Market Size
by Application Segments
Pharma/ Biotech Biomarker R&D Market Size
by Application/ Clinical Phase
Pharma/ Biotech Biomarker R&D by R&D Tools
and R&D Services
Pharma/ Biotech Biomarker R&D Spending by
WW Region
9.Emerging Trends and Opportunities
Trends in Biomarkers and Related Molecular
Tests
Testing Infectious Diseases
Growing Interest in Cancer Biomarker
Tests
Measuring Alzheimer's Disease Progression
Drug Response Assays: Biomarkers for
Safety and Efficacy
Future Opportunities
Government Regulators Fostering Future
Opportunities
Pharmacogenomics Can Save Time and
Expense
Personalizing Medicine Has Arrived For
Some
Hurdles
Pricey Molecular Diagnostics
Developing World Needs Diagnostics Too
Fastest Regulatory Route to
Commercializing Tests
Roche and Affymetrix First to Get
Clearance to Market
Microarray-Based Pharmacogenetic Test
System
Insurance Reimbursement
10.Highlights of Selected Companies
Axis-Shield, Inc.
BioMarker Pharmaceuticals, Inc.
BioSite, Inc.
CeMines, Inc.
Chiron Corporation
DakoCytomation A/S
diaDexus, Inc.
Diagnostics Products Corporation
DxS Ltd.
Exact Sciences Corporation
Genaissance Pharmaceuticals, Inc.
Gen-Probe, Inc.
Icoria
Illumina, Inc.
Jurilab Ltd.
Matritech, Inc.
Millennium Pharmaceuticals, Inc.
Myriad Genetics, Inc.
Nanosphere, Inc.
Perlegen Sciences, Inc.
Samaritan Pharmaceuticals
SurroMed, Inc.
11.Appendix A - WW Populations by Diseases
12.Appendix B - Goals and Uses of Biomarker
Tests for Pharma/ Biotech R&D
New Genetic Tests for Pharma/ Biotech R&D
Foster Personalized Medicine
Clinical Pharmacogenomics in Pharma/
Biotech R&D
Biomarker Diagnostic Products Can Reach
Market Quickly
Biomarker Tests for Pharma/ Biotech
13.Appendix C - Alliance Tables
14.About the Publisher and Authors
About Takeda Pacific
About the Authors
List of Tables
Table 1. Molecular IVD Test Applications
Table 2. The Leading Molecular Diagnostics
Companies
Table 3. Path to Commercialize Molecular
Diagnostics
Table 4. Technology for Biomarker-Based
Diagnostics by Disease
Table 5. Target Amplification Technologies
Table 6. Target Signal Amplification
Technologies
Table 7. Microarray and Lab-on-a-chip
Technologies
Table 8. Proteomic Technologies for Diagnostics
Table 9. Metabolomic Technologies and
Biomarkers
Table 10. Competitors for Nucleic Acid
Amplification Technologies for
Clinical Diagnostics
Table 11. Commercializing Biomarker-Based
Diagnostics by Disease
Table 12. Company Output by Major Disease
Totals and Shares
Table 13. Company Output by Product `Status'
Segment Totals & Shares
Table 14. Biomarker/ Pharmacogenomic Product
Pipeline by Disease
Table 15. Company Output by Disease Segment
Total and Share
Table 16. Company Output by Product Status
Table 17. Alliances in Molecular Diagnostics
and Pharma/ Biotech R&D (2000-2004)
Table 18. Review of the 'Others' Alliances
Table 19. Summary of Alliances in Molecular
Diagnostics and Pharma/ Biotech
R&D by Indication by Type and Year
Table 20. Biomarker-Based Clinical Molecular
Diagnostic Products & Lab
Services, 2004 & 2009
Table 21. Biomarker-Based Clinical Molecular
Diagnostic (ASR/ IVD*) Products
by Disease Area, 2004-2009
Table 22. Biomarker-Based Clinical Molecular
Diagnostic Product Market Share,
2005 & 2009
Table 23. Biomarker-based Clinical Molecular
Diagnostic Products by
Application, 2004-2009
Table 24. Biomarker-based Clinical Molecular
Diagnostic Products by WW
Region, 2004-2009
Table 25. Biomarker-Based Clinical Molecular
Diagnostic Lab Services by
Applications, 2004-2009
Table 26. Biomarker-Based Clinical Molecular
Diagnostic Lab Services by World
Regions, 2004-2009
Table 27. Pharma/ Biotech Biomarker R&D
Spending by Major Diseases
Table 28. Pharma/ Biotech Biomarker R&D
Spending Market Shares by Disease,
2005 & 2009
Table 29. Pharma/ Biotech Biomarker R&D by
Application/ Clinical Phase, 2004-
2009
Table 30. Pharma/ Biotech Biomarker R&D
Spending by Services and Tools, 2004-
2009
Table 31. Pharma/ Biotech Biomarker R&D
Spending by World Region
Table 32. Trend for Infectious Disease Tests
Table 33. Trend for Cancer Companion Tests
Table 34. Trend for Cancer Disease Progression
Tests
Table 35. Trend for CNS Tests Likely in Five
Years
Table 36. Trend for Genetic Tests
Table 37. Trend for Risk Prediction Genetic
Tests
Table 38. Major Diseases by Mortality,
Incidence and Prevalence
Table 39. Alliances in Molecular Diagnostics
and Pharma/ Biotech R&D, 1Q/2004
Table 40. Alliances in Molecular Diagnostics
and Pharma/ Biotech R&D, 2003
Table 41. Alliances in Molecular Diagnostics
and Pharma/ Biotech R&D, 2002
Table 42. Alliances in Molecular Diagnostics
and Pharma/ Biotech R&D, 2001
Table 43. Alliances in Molecular Diagnostics
and Pharma/ Biotech R&D, 2Q/2000
List of Figures
Figure 1. Biomarker, Molecular Diagnostics and
Pharma/ Biotech PGx Market
Ecosystem
Figure 2. Company Output by Major Disease
Segment
Figure 3. Company Output by Major Disease
Segment Shares
Figure 4. Company Output by Product `Status'
Totals
Figure 5. Company Output by Product Status
Shares
Figure 6. Company Output by Disease Segment
Total
Figure 7. Company Output by Disease Segment
Share
Figure 8. Company Output by Product Status
Total
Figure 9. Company Output by Product Status
Share
Figure 10. Summary of Alliances in Molecular
Diagnostics and Pharma/ Biotech
R&D by Indication (2000-2004)
Figure 11. Summary Analysis of the 'Others'
Alliances
Figure 12. Summary of Alliances in Molecular
Diagnostics and Pharma/ Biotech
R&D by Indication, Type and Year
Figure 13. Biomarker-Based Clinical Molecular
Diagnostic Products & Lab
Services, 2004 & 2009
Figure 14. Biomarker-Based Clinical Molecular
Diagnostic Products & Lab
Services by Disease Area, 2004-2009
Figure 15. Biomarker-Based Clinical Molecular
Diagnostic Product Market
Shares, 2005 & 2009
Figure 16. Biomarker-based Clinical Molecular
Diagnostic Products by
Application, 2004-2009
Figure 17. Biomarker-based Clinical Molecular
Diagnostic Products by WW
Region, 2004-2009
Figure 18. Biomarker-Based Clinical Molecular
Diagnostic Lab Services by
Applications, 2004-2009
Figure 19. Biomarker-Based Clinical Molecular
Diagnostic Lab Services by
World Regions, 2004-2009
Figure 20. Pharma/ Biotech Biomarker R&D
Spending by Major Diseases
Figure 21. Pharma/ Biotech Biomarker R&D
Spending Market Shares by Disease,
2005 & 2009
Figure 22. Pharma/ Biotech Biomarker R&D by
Application/ Clinical Phase,
2004-2009
Figure 23. Pharma/ Biotech Biomarker R&D
Spending by Services and Tools,
2004-2009
Figure 24. Pharma/ Biotech Biomarker R&D
Spending by WW Region
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