Molecular Diagnostics 2007 Technologies, Companies, Products, Applications and Worldwide Outlook

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

• 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

• 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