Commercializing Molecular Diagnostics:

Summary

This report is about the molecular diagnostics market, including systems, consumables and clinical lab services. These key medical products and services use technologies that can detect single or multiple genomic, protein, metabolomic or other '-omic' biomarkers.

The detailed study shows that molecular diagnostic companies are expecting continued strong growth. Takeda Pacific's report shows the major areas of this dynamic market landscape. This report shows various views of this growing multi-billion dollar market. The study sizes the market and projects the 5-year trend. The report charts the developments of more than 80 companies involved in this dynamic industry.

This report discusses government regulatory initiatives to accelerate the approvals of emerging molecular diagnostics by integrating biomarkers and companion pharmacogenomic tests. Myriad, Veridex, Genomic Health, Agendia and others are gaining traction detecting cancers. Roche's Affymetrix-based tests measure how patients respond to 30 or more currently marketed drugs. These products enable the emerging field of personalized medicine. The passing of the GINA law in the US might foster the growth of more molecular diagnostics, clinical lab services and other related genetic testing services.

This study is full of interesting data and includes more than 43 figures and tables. The tables provide data about technologies, companies, product pipelines, partnerships and more. The study also has additional data such as the global incidence and prevalence of major diseases. The report analyzes partnering deals and includes several years of alliance and M&A data.

Thirty-eight 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.

Contents

• 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
• List of Tables
  • 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
  • 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