Table of Contents
1. Overview of Molecular Diagnostic Tests
- 1.1 Gene-Based and ' Omics' -Based Biomarkers Enable Molecular Diagnostics
- 1.1.1 Molecular Diagnostics (J added)
- 1.2 Diagnostic Industry Competitive Overview
- 1.2.1 WW Molecular Diagnostics IVD Business
- 1.2.2 WW Molecular Diagnostics Lab Services
- 1.2.3 Leading Molecular Diagnostics IVD Makers
- 1.2.4 Leading Molecular Diagnostics IVD Lab Services
- 1.3 Advances in Molecular Diagnostics
- 1.3.1 FDA View of Biomarkers for Molecular Diagnostic Field
- 1.3.2 Genetic Tests for Multiple Gene Based Diseases
- 1.3.3 Multiplexed Protein Patterns Become Molecular Diagnostics
- 1.3.4 DNA Methylation Tests
- 1.4 Developing Molecular Diagnostics
- 1.4.2 Esoteric ' Home Brew' Molecular Diagnostics Marketed as Services
- 1.4.3 Developing a Test into an In Vitro Diagnostic
- 1.4.4 Product Prices and the $3,200 Test!
- 1.4.5 Healthcare Reimbursement Issues
2. Company Activities and Strategies
- 2.1 Major Market Participants by Disease Segments
- 2.2 Important Findings or Special Notes
- 2.2.1 Findings of Companies in Molecular Diagnostics by Sample Material
- 2.2.2 Findings of Companies in Molecular Diagnostics by Major Disease
- 2.2.3 Findings of Companies in Molecular Diagnostics by Product ' Status'
3. Technologies Used in Developing Molecular Diagnostics
- 3.1 Technologies: Current Status & Next Stage Development Status
- 3.2 Overview of Technologies Used in Molecular Diagnostics
- 3.3 Technologies and Molecular Diagnostics Products: Current and Next Stage
Development
- 3.4 Commercial Implications of Clinical Molecular Diagnostics
4. Alliances and R&D Activity in Molecular Diagnostics
- 4.1 Overview of Strategic Alliances & R&D in Molecular Diagnostics
- 4.1.1 Alliance Types
- 4.1.2 Molecular Diagnostic Alliances for R&D at a Glance
- 4.1.3 Alliances in Molecular Diagnostics Gained Momentum in 2006
- 4.2 Summary of Molecular Diagnostics in Medical Research
- 4.3 R&D Activity by Diseases or Applications
- 4.3.1 Summary of R&D Activity
- 4.3.2 Details of R&D Activity
5. Market Size and Forecast for Molecular Diagnostics
- 5.1 Market Overview: Molecular Diagnostic (MDx) Products & Clinical Lab
Servic
- 5.2 WW Molecular Diagnostic (MDx) Product/ Market Trends
- 5.2.1 Examples of Selected MDx Equipment and Consumable Products
- 5.2.2 Examples of Selected MDx Lab Services
- 5.3 Molecular Diagnostic (MDx) Total WW Market Size
- 5.3.1 Total WW MDx Market Size, 2006-2011
- 5.3.2 Market Size by Major Segments
- 5.4 Leading Molecular Diagnostic Manufacturers' Shares
- 5.5 WW Molecular Diagnostic Product Market Size by Disease Segments
- 5.6 WW Molecular Diagnostic Product Market Size by Test Material Segments
- 5.7 WW Molecular Diagnostic Product Market Size by Technologies
- 5.8 WW Molecular Diagnostic Product Market Size by Region
- 5.9 WW Molecular Diagnostic Lab Services Market Size by Disease and Regions
- 5.9.1 MDx Lab Services Market Size by Disease
- 5.9.2 WW Molecular Diagnostic Lab Services Market Size by Regions
6. Future Directions
- 6.1 Key Trends for Molecular Diagnostics
- 6.1.1 Infectious Disease Testing
- 6.1.2 Interest in Cancer Tests Growing
- 6.1.3 Future Direction for CNS Disease Tests
- 6.1.4 Future Direction of Genetic Testing and PGx Tests
- 6.2 Top Opportunities for the Future
- 6.2.1 Government Regulators Driving Future Opportunities
- 6.2.2 Emerging Personalized Medicine and Timeline
- 6.3 Main Challenges
- 6.3.1 High Costs of Molecular Diagnostics
- 6.3.2 Acute Shortages of Diagnostics in the Developing World
- 6.3.3 Worldwide Regulatory Delays in Approving New Tests
- 6.3.4 Insurance Reimbursement Issues
7. Activities of Molecular Diagnostics Companies
- 7.1 Large Diagnostic Lab Services
- 7.1.1 BML, Inc.
- 7.1.2 Diagnosticos Da America S.A. (DASA)
- 7.1.3 LabCorp
- 7.1.4 Quest Diagnostics, Inc.
- 7.1.5 Unilabs Group
- 7.2 Small Diagnostic Lab Services
- 7.2.1 diaDexus, Inc.
- 7.2.2 Myriad Genetics, Inc.
- 7.2.3 Veridex, LLC (J&J Co.)
- 7.2.4 Genomic Health, Inc.
- 7.2.5 Agendia B.V.
- 7.3 Large MDx Company
- 7.3.1 Abbott Molecular
- 7.3.2 BD Diagnostics
- 7.3.3 Digene Corporation
- 7.3.4 Beckman Coulter, Inc.
- 7.3.5 bioMerieux SA
- 7.3.6 Gen-Probe, Inc.
- 7.3.7 Roche Molecular Diagnostics
- 7.3.8 Siemens Medical Solutions Diagnostics
- 7.4 Point of Care MDx
- 7.4.1 BioSite, Inc.
- 7.4.2 Cepheid
- 7.5 Pure Play MDx
- 7.5.1 Celera Group
- 7.5.2 Chiron Corporation (Novartis)
- 7.5.3 Dako A/S
- 7.5.4 Exact Sciences Corporation
- 7.5.5 Innogenetics NV
- 7.6 DNA Methylation MDx
- 7.6.1 Orion Genomics LLC
- 7.6.2 Epigenomics AG
- 7.7 Array Platforms
- 7.7.1 Affymetrix, Inc.
- 7.7.2 Luminex Corporation
- 7.7.3 Nanogen, Inc.
8. Appendix
- 8.1 Major Disease Population Sizes
- 8.2 Companies Mentioned in This Report
LIST OF TABLES
- Table 1. Molecular IVD Test Applications
- Table 2. Top Molecular Diagnostics IVD Players
- Table 3. Top Independent MDx IVD Lab Services Players
- Table 4. Typical Molecular Diagnostic IVD Development Path
- Table 5. Market Participants by Disease, Company, MDx Products (n=356)
- Table 6. Company Activities by Sample Material Totals and Shares
- Table 7. Company Activities by Major Disease Totals and Shares
- Table 8. Company Activities by ' Product Status' Segment Totals and Shares
- Table 9. Technologies: Current Status & Next Stage Development by Count
- Table 10. Technologies Market Share: 2006 vs. 2009 vs. 2011 by Product
Pipelines
- Table 11. Technologies, Major Companies and Relationship
- Table 12. Technologies and MDx Products: Current and Next Stage Development
- Table 13. Vendor Competition by Nucleic Acid Amplification Technologies
for Clinical Molecular Diagnostics and by Estimated Shares and Revenues
- Table 14. Strategic Alliances Summary by Alliance Type, 2004 to 2007
- Table 15. Summary of M&As by Year, Buyer, Alliance Type, Size, 2004 to 2007
- Table 16. Alliances Summary by Major Diseases, Jan-2004 to Mar-2007
- Table 17. Alliances for Molecular Diagnostics by Major Disease, 2007
- Table 18. Alliances for Molecular Diagnostics by Major Disease, 2006
- Table 19. Alliances for Molecular Diagnostics by Major Disease, 2005
- Table 20. Alliances for Molecular Diagnostics by Major Disease, 2004
- Table 21. Examples of Selected MDx Equipment and Consumable Products
- Table 22. Examples of Selected MDx Lab Services and Prices
- Table 23. Total WW MDx Market Size, 2006-2011
- Table 24. WW MDx Market Size and Forecast by Major Segments
- Table 25. Molecular Diagnostic Manufacturer Revenues ($M) & Shares (%)
- Table 26. MDx Products by Major Diseases/ Applications & Revenues
- Table 27. MDx Products by Test Material & Revenues
- Table 28. MDx Products by Technology & Revenues
- Table 29. MDx Product Market Size by WW Regions
- Table 30. Molecular Diagnostic Lab Services by Disease Segments
- Table 31. MDx Clinical Lab Services by WW Regions and Revenues
- Table 32. Future Direction of Infectious Disease Tests
- Table 33. Future Direction of Cancer Companion Tests and Targeted Medicine
- Table 34. Future Direction of Cancer Tests
- Table 35. CNS Tests Likely in Five Years
- Table 36. Future Direction of Pharmacogenomics (PGx) Tests
- Table 37. Future Genetic Tests for Risk Prediction
- Table 38. Selected Companion Diagnostics (PGx) and Targeted Therapies
- Table 39. Estimated Patient Populations by Disease in the Developed World
- Table 40. Top Health Risk Factors Leading to Death in the Developed World
- Table 41. Companies Mentioned in This Report
LIST OF ILLUSTRATIONS
- Figure 1. WW Molecular Diagnostics Business
- Figure 2. The Fastest Growing IVD and Lab Services Businesses
- Figure 3. Total WW MDx Market Size, 2006-2011
- Figure 4. WW MDx Market Size by Major Segments
- Figure 5. MDx Products by Major Diseases/ Applications & Revenues
- Figure 6. MDx Products by Test Material & Revenues
- Figure 7. MDx Products by Technology & Revenues
- Figure 8. MDx Product Market Size by WW Regions
- Figure 9. Molecular Diagnostic Lab Services by Disease Segments
- Figure 10. MDx Clinical Lab Services by WW Regions and Revenues
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