Commercializing Molecular Diagnostics: Products,Services,Companies and Global Market

1.Molecular Diagnostics Market Landscape

• Biomarkers, ‘Omics' and Molecular Tests
  • An Expanding Definition of Molecular Diagnostic Tests
  • The Global In Vitro Diagnostic Product and Clinical
  • Lab Service Business
    • Global Molecular Diagnostics IVD Business
    • Global Molecular Diagnostic Clinical Lab Services
    • Major Manufacturers of Molecular Diagnostic IVDs
    • Major Molecular Diagnostic IVD Lab Services
  • Advancing Molecular Diagnostics
    • Government Initiatives, Biomarkers and Molecular Diagnostics
    • MDx Test Panels Detect Multi-Gene Diseases
    • Protein Pattern Detection
    • Epigenetics: DNA Methylation Tests Detect Cancer
  • Commercializing Molecular Diagnostic Tests
    • Application Specific Reagents (‘Home Brew' ) MDx Lab Services
    • Commercialize Biomarker Tests into a Molecular IVD
    • High MDx Prices and Healthcare Insurance Challenges

2.Alliances and M&As in Molecular Diagnostics

• Highlights of Alliances & M&As
  • Alliance Types
  • Molecular Diagnostic Alliances at a Glance
  • Recent Molecular Diagnostics Alliances Show Growth
• Technical Development Applications
  • Summary of Development Activities
  • Details of Development Activity

3.Manufacturer Strategies

• MDx Manufacturers by Disease Areas
• Notable Findings
  • Molecular Diagnostics by Sample Material
  • Molecular Diagnostics by Major Disease
  • Molecular Diagnostics by Product ‘Status'

4.Detection Technologies Used in Developing Molecular

• Diagnostics
  • Current and Next Generation Technology Development
  • Overview of Technologies Used in Molecular Diagnostics
    • Technologies Market Share: Current vs. Next-Gen. vs. Future
    • Technologies, Companies and Relationship
  • Technologies and Molecular Diagnostic Products:
  • Current and Next Generation Development
  • Business Implications of Clinical Molecular
  • Diagnostics

5.Market Size and Forecast

• Molecular Diagnostic (MDx) Product & Clinical Lab
• Service Market Sizes
• Market Trends for Global Molecular Diagnostic (MDx) Products
  • Selected MDx Equipment and Consumable Products
  • Selected MDx Clinical Lab Services
• MDx Total Global Market Size
  • Total Global MDx Market Size to 2012
  • Market Size by Major Segments
  • Leading Molecular Diagnostic Manufacturers' Shares
  • Global Molecular Diagnostic Product Market by Disease Segments
  • Global Molecular Diagnostic Product Market by Test Sample Segments
  • Global Molecular Diagnostic Product Market by Technologies
  • Global Molecular Diagnostic Product Market by Region
  • Global Molecular Diagnostic Clinical Lab Services
  • Market by Disease and Regions
• MDx Lab Services Market Size by Disease
• Global MDx Clinical Lab Services Market Size by Regions

6.Trends, Opportunities and Challenges

• Key Trends for Molecular Diagnostics
  • Infectious Disease Testing
  • Cancer Tests Growing
  • CNS Disease Tests
  • Genetic Testing and PGx Tests
• Top Opportunities for the Future
  • Government Regulators Driving Future Opportunities
  • Emerging Personalized Medicine and Timeline
• Main Challenges
  • High Costs of Molecular IVDs and Lab Services
  • Worldwide Regulatory Delays in Approving New Tests
  • Insurance Reimbursement Issues
  • Acute Shortages of Diagnostics in the Developing World

7.Selected Molecular Diagnostic Companies

• Abbott Molecular
• Affymetrix, Inc.
• Agendia B.V.
• Asuragen, Inc.
• Becton Dickinson Diagnostics
• Beckman Coulter, Inc.
• bioMerieux SA
• BioSite, Inc. (Inverness Medical Innovations)
• BML, Inc.
• Celera Corporation
• Cepheid
• Chiron Corporation (Novartis)
• Combimatrix Molecular Diagnostics, Inc.
• Dako A/S
• diaDexus, Inc.
• Diagnosticos Da America S.A. (DASA)
• Digene Corporation (Qiagen)
• Epigenomics AG
• Exact Sciences Corporation
• Genomic Health, Inc.
• Gen-Probe, Inc.
• Illumina, Inc.
• Innogenetics NV
• LabCorp
• Luminex Corporation
• Myriad Genetics, Inc.
• Nanogen, Inc.
• Nanosphere, Inc.
• Nymox Pharmaceutical Corporation
• Orion Genomics LLC
• Quest Diagnostics, Inc.
• Roche Molecular Diagnostics
• Sequenom, Inc.
• Siemens Healthcare Diagnostics (MDx business)
• Sonic Healthcare Limited
• Third Wave Technologies, Inc.
• Unilabs Group
• Veridex, LLC (J&J Co.)

8.Appendix

• Major Disease Population Sizes
• Companies Mentioned in This Report
• Molecular Diagnostics in Medical R&D
• About Takeda Pacific
• About the Authors

• Table 1. Molecular IVD Test Applications
• Table 2. Top 10 Molecular Diagnostics IVD Players
• Table 3. Leading Global Independent MDx IVD Clinical Lab Services
• Table 4. A Path to Developing a Molecular Diagnostic IVD
• Table 5. Strategic Alliances Summary by Alliance Type, 2004 to 2007
• Table 6. Summary of M&As by Year, Buyer, Alliance Type, Size, 2004 to 2007
• Table 7. Alliances Summary by Major Diseases, Jan-2004 to Mar-2007
• Table 8. Alliances for Molecular Diagnostics by Major Disease, 2007
• Table 9. Alliances for Molecular Diagnostics by Major Disease, 2006
• Table 10. Alliances for Molecular Diagnostics by Major Disease, 2005
• Table 11. Alliances for Molecular Diagnostics by Major Disease, 2004
• Table 12. Manufacturers by Disease Area, Company and Products
• Table 13. Company Activities by Sample Material Totals and Shares
• Table 14. Company Activities by Major Disease Totals and Shares
• Table 15. Company Activities by ‘Product Status' Segment Totals and Shares
• Table 16. Current and Next Generation MDx Technology Development
• Table 17. Technologies Market Share: Current vs. Next-Gen. vs. Future by Product Pipelines
• Table 18. Technologies, Companies and Relationship
• Table 19. Technologies and MDx Products: Current and Next Generation Development
• Table 20. Vendor Competition by Nucleic Acid Amplification Technologies for Clinical Molecular Diagnostics and by Estimated Shares and Revenues
• Table 21. Examples of Selected MDx Equipment and Consumable Products
• Table 22. Examples of MDx Clinical Lab Services and Prices
• Table 23. Total Global MDx Market Size to 2012
• Table 24. Global MDx Market Size and Forecast by Major Segments to 2012
• Table 25. Molecular Diagnostic Manufacturer Revenues & Shares
• Table 26. MDx Products by Major Diseases/ Applications & Revenues
• Table 27. MDx Products by Test Material Segments & Revenues
• Table 28. MDx Products by Technology Segments & Revenues
• Table 29. MDx Product Market Size by Global Regions
• Table 30. Molecular Diagnostic Lab Services by Disease Segments
• Table 31. MDx Clinical Lab Services by Global 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 Trends of Pharmacogenomics (PGx) Tests
• Table 37. Genetic Tests for Risk Prediction
• Table 38. Selected Companion Diagnostics (PGx) and Targeted Therapies
• Table 39. Estimated Incidence and Prevalence of 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
• Table 42. Summary of Molecular Diagnostics Technical Focus in Medical R&D

• Figure 1. Global Molecular Diagnostics Business
• Figure 2. The Fastest Growing IVD and Lab Services Businesses
• Figure 3. Total Global MDx Market Size to 2012
• Figure 4. Global MDx Market Size by Major Segments to 2012
• Figure 5. MDx Products by Major Diseases/ Applications & Revenues
• Figure 6. MDx Products by Test Material Segments & Revenues
• Figure 7. MDx Products by Technology Segments & Revenues
• Figure 8. MDx Product Market Size by Global Regions
• Figure 9. MDx Clinical Lab Services by Disease Segments
• Figure 10. MDx Clinical Lab Services by Global Regions and Revenues