Executive Summary
This report is about the market for molecular biomarkers for clinical diagnostics and for drug discovery and development. The research reviews the market segments by major diseases, by application areas, and by technologies.
This study surveyed the activities of more than 60 companies that are participating in this industry. The report analyzed the future direction of biomarkers, molecular diagnostics and pharmaco-genomic tests used in drug discovery and development.
This new report has found that the worldwide market size for molecular biomarkers, diagnostics and related molecular clinical lab services in 2003 was about $6.1 billion. The diagnostics and pharmaceutical industries each face numerous challenges that could be helped with newer business approaches that are discussed in this report. The molecular diagnostics companies are set for strong growth.
The report discusses new FDA initiatives to accelerate the approvals of diagnostics and new drugs by integrating biomarkers and pharmacogenomic tests into the drug discovery and development steps including clinical trials. The report discusses these important items with interesting and useful findings.
This study uses more than 23 figures and 47 tables to illustrate the findings. Detailed information includes several large tables about company activities, strategic alliances, technologies and so on. Twenty-three companies are profiled including details about contact information, business overview, financial details and product pipelines.
Molecular Biomarker and Diagnostic Test Market
TABLE OF CONTENTS
1. Major Diseases, Biomarkers and Diagnostics
1.1 The Size of Major Disease Populations
2. What Biomarkers and Tests Are
2.1 Biomarker Definitions
2.1.1 Pre-Genome
2.1.2 Post Genome
2.1.3 FDA Definition
2.2 The In-Vitro Diagnostics (IVD) Industry
2.2.1 Molecular IVD industry
2.2.2 Top Molecular IVD Industry Players
2.3 Biomarkers and Genetic Diagnostic Tests
2.3.1 Post-Genomic Biomarkers Are Molecular
2.3.2 Pharmacogenomic Tests for Drug Discovery and Development
2.4 Biomarker Advances
2.4.1 FDA Enters Biomarker And Pharmacogenomics Field In 2003
2.4.2 Biomarkers in Multiple Gene Based Diseases
2.4.3 Cost Reducing SNP Genotyping - Disease Association Studies
2.4.4 Multiplexed Protein Patterns Become Biomarkers
2.5 Developing Molecular Biomarker Tests
2.5.1 Development Path To Commercializing Molecular Biomarker Tests
2.5.2 Make A Home Brew Test and Market The Test as a Service
2.5.3 Develop Test Into An In Vitro Diagnostic
2.5.4 Typical Product Prices
2.5.5 Healthcare Reimbursement Issues
3. Company Activities: Molecular Biomarker Tests in Clinical
Diagnostics
3.1 Major Participants by Disease Segment
3.2 Important Findings or Special Notes
3.2.1 Findings of Companies in Molecular Biomarker Tests by Major Disease
3.2.2 Findings of Companies in Molecular Biomarker Tests by Product 'Status'
4. Technology: Developing Molecular Biomarker Tests for Clinical Diagnostics &
Commercial Implication
4.2 Recent Important Molecular Biomarker Test Discoveries
4.2.1 Nucleic Acid Technologies
4.2.1.1 Direct Probe
4.2.1.2 Target Amplification Technology
4.2.1.3 Non-PCR Target Amplification and Signal Amplification
4.2.1.4 Signal Amplification
4.2.2 Microarrays and Labchips
4.2.2.1 Microarrays
4.2.2.2 Labchips
4.2.3 Proteomic Technologies
4.2.4 Metabolomic Technologies
4.2.5 Bioinformatic Software
4.3 Drug Discovery Research & Development
4.4 Commercial Implications of Biomarker based Assays or Diagnostics
5. Company Activities: Biomarkers and Tests in Drug Discovery and Development
5.1 Major Participants by Disease Segment
5.2 Important Findings or Special Notes
5.2.1 Findings About Company Activities by Major Disease.
5.2.2 Findings About Company Activities by Product Status
6. R&D Activity and Alliances for Biomarkers/ Molecular Diagnostics
6.1 Overview of R&D & Alliances in Biomarker/ Molecular Diagnostics and in Drug Discovery R&D
6.2 R&D Activity and Strategic Alliances
7. The Market Size and Forecast for Biomarker Clinical Diagnostics
7.1 Market Overview: Biomarker Clinical Diagnostics & Lab Services
7.2 WW Biomarker Clinical Diagnostic Product Market Trends
7.3 Molecular Biomarker Clinical Diagnostic Product Market Share
7.4 WW Biomarker Clinical Diagnostic Market Size by Application Segment
7.5 WW Biomarker Diagnostic Market Size by Region
7.6 WW Biomarker Diagnostic Lab Services Market Size by Applications and Regions
7.6.1 Biomarker Diagnostic Lab Services Market Size by Applications
7.6.2 WW Biomarker Diagnostic Lab Services Market Size by Regions
8. Future Directions
8.1 Major Trends for Molecular Biomarkers and Diagnostics
8.1.1 Infectious Disease Testing
8.1.2 Interest in Cancer Tests Growing
8.1.3 CNS Disease Progression
8.1.4 Drug Response Assays: Biomarkers for Safety and Efficacy
8.2 Best Opportunities for the Future
8.2.1 Government Regulators Fostering Future Opportunities
8.2.2 Pharmacogenomics Opportunity Cuts Drug R&D Timeline
8.2.3 Emerging Personalized Medicine
8.3 Main Challenges
8.3.1 High Costs of Molecular Diagnostics Today
8.3.2 Acute Shortages of Diagnostics in the Developing World
8.3.3 Regulatory Delays in Approving New Tests
8.3.4 Insurance Reimbursement Issues
9. The Market Size and Forecast for Biomarkers in Drug Discovery and Development
9.1 WW Biomarkers in Drug Discovery and Development Market Trends
9.2 WW Biomarkers in Drug Discovery and Development, Disease Market Shares
9.3 WW Biomarker in Drug Discovery and Development Market Size by Application Segments
9.3.1 WW Biomarkers in Drug Discovery and Development by Application/ Clinical Phase
9.3.2 WW Biomarkers in Drug Discovery and Development by R&D Tools and R&D Services
9.4 WW Biomarker in Drug Discovery and Development Market Size by Region
10. Company Activities and Profiles In Biomarker Test R&D
10.1 Company Activities at a Glance
10.2 BioContent
10.2.1 BioMarker Pharmaceuticals, Inc.
10.2.2 Jurilab Ltd.
10.2.3 Millennium Pharmaceuticals, Inc.
10.2.4 Myriad Genetics, Inc.
10.2.5 Samaritan Pharmaceuticals
10.2.6 SurroMed, Inc.
10.3 Chemistry
10.3.1 Axis-Shield, Inc.
10.3.2 Gen-Probe, Inc.
10.3.3 Matritech, Inc.
10.4 IVD Manufacturer
10.4.1 BioSite, Inc.
10.4.2 CeMines, Inc.
10.4.3 Chiron Corporation
10.4.4 DakoCytomation A/S
10.4.5 diaDexus, Inc.
10.4.6 Diagnostics Products Corporation
10.4.7 Exact Sciences
10.4.8 Nanosphere, Inc.
10.5 R&D Service Provider
10.5.1 DxS Ltd.
10.5.2 Illumina, Inc.
10.5.3 Perlegen Sciences, Inc.
10.6 Software
10.6.1 Paradigm Genetics, Inc.
10.7 Tech Platform
10.7.1 Genaissance Pharmaceuticals, Inc.
10.7.2 Molecular Staging, Inc.
LIST OF TABLES
Table 1. Summary of Patient Populations Sorted by New Patients
Table 2. Summary of Patient Populations Sorted by Total Existing Patients
Table 4. Top Health Risk Factors Leading to Death in the Developed World
Table 5. Molecular IVD Test Applications
Table 6. Top Molecular Diagnostics IVD Manufacturers
Table 7. Typical Molecular Biomarker Diagnostic Development Path
Table 8. Key Companies in Molecular Biomarker Tests by Major Disease
Table 9. Company Activities by Major Disease Totals and Shares
Table 10. Company Activities by Product 'Status' Segment Totals and Shares
Table 11. Technology Overview for Developing Molecular Biomarker Tests by Disease
Table 12. Target Amplification Technologies
Table 13. Target Signal Amplification Technologies
Table 14. Microarray and Labchip Technologies
Table 15. Proteomic Technologies for Diagnostics
Table 16. Metabolomic Technologies and Biomarkers
Table 17. Competitive Environment for Nucleic Acid Amplification Technologies for
Clinical Diagnostics
Table 18. Activities of Major Biomarker Drug Discovery & Development Participants
by Major Disease
Table 19. Company Activities by Major Disease Segment Total and Share
Table 20. Company Activities by Product Status
Table 21. Summary of Strategic Alliances for Biomarker/ Molecular Diagnostics and
Drug Discovery R&D by Major Disease (2000-2004)
Table 22. Summary Analysis of 'Others' Alliances
Table 23. Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery
R&D by Major Disease,
1Q/2004
Table 24. Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery
R&D by Major Disease,
2003
Table 25. Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery
R&D by Major Disease,
2002
Table 26. Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery
R&D by Major Disease,
2001
Table 27. Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery
R&D by Major Disease,
2Q/2000
Table 28. Summary of Strategic Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery
R&D by Type and Year
Table 29. WW Molecular Biomarker Clinical Diagnostic, Tests, Tools, & Lab Services, 2003 & 2007
Table 30. WW Molecular Biomarker Clinical Diagnostics (ASR/ IVD) Products by Disease Area,
2003-2007
Table 31. WW Molecular Biomarker Clinical Diagnostic Product Market Share, 2003 & 2007
Table 32. WW Molecular Biomarker-based Clinical Diagnostic Products by Application, 2003-2007
Table 33. WW Molecular Biomarker-based Clinical Diagnostic Products by Regions, 2003-2007
Table 34. WW Molecular Biomarker Clinical Diagnostic Lab Services by Applications, 2003-2007
Table 35.WW Est. Molecular Biomarker Clinical Diagnostic Lab Services by World Regions,
2003-200
Table 36. Future Direction of Infectious Disease Tests
Table 37. Future Direction of Cancer Companion Tests
Table 38. Future Direction of Cancer Disease Progression Tests
Table 39. CNS Tests Likely in Five Years
Table 42. WW Biomarkers in Drug Discovery and Development, Revenues by Major Diseases
Table 43. Biomarker in Drug Discovery and Development Market Share, 2004 & 2007
Table 44. WW Biomarkers in Drug Discovery and Development by Application/ Clinical Phase,
2003-2007
Table 45. WW Biomarkers in Drug Discovery and Development by R&D Tools and R&D Services,
2003-2007
Table 46. WW Biomarker in Drug Discovery and Development Market Size by World Region
Table 47. Company Activities at a Glance and Disease Areas
LIST OF ILLUSTRATIONS
Figure 1. Molecular Biomarker and Diagnostic Test Market
Figure 2. Company Activities by Major Disease Segment Totals
Figure 3. Company Activities by Major Disease Segment Shares
Figure 4. Company Activities by Product 'Status' Totals
Figure 5. Company Activities by Product Status Shares
Figure 6. Company Activities by Major Disease Segment Total
Figure 7. Company Activities by Major Disease Segment Share
Figure 8. Company Activities by Product Status Total
Figure 9. Company Activities by Product Status Share
Figure 10. Summary of Strategic Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery
R&D by Major Disease (2000-2004)
Figure 11. Summary Analysis of the 'Others' Alliances
Figure 12. Summary of Strategic Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery
R&D by Type and Year
Figure 13. WW Molecular Biomarker Clinical Diagnostic, Tests, Tools, & Lab Services, 2003 & 2007
Figure 14. WW Molecular Biomarker Clinical Diagnostics (ASR/ IVD) Products by Disease Area,
2003-2007
Figure 15. WW Molecular Biomarker Clinical Diagnostic Product Market Share, 2004 & 2007
Figure 16. WW Molecular Biomarker-based Clinical Diagnostic Products by Application, 2003-2007
Figure 17. WW Molecular Biomarker-based Clinical Diagnostic Products by Regions, 2003-2007
Figure 18. WW Molecular Biomarker Clinical Diagnostic Lab Services by Applications, 2003-2007
Figure 19. WW Est. Molecular Biomarker Clinical Diagnostic Lab Services by World Regions,
2003-2007
Figure 20. WW Biomarker in Drug Discovery and Development Revenues by Major Diseases
Figure 21. Biomarker in Drug Discovery and Development by Disease and Market Shares,
2004-2007
Figure 22. WW Biomarkers in Drug Discovery and Development by Application/ Clinical Phase,
2003-2007
Figure 23. WW Biomarkers in Drug Response and Development by R&D Tools, 2003-2007
Figure 24. WW Biomarker in Drug Discovery and Development Market Size by World Region
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