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


Description: 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. This report shows the major areas of this dynamic market landscape, including the 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 such as: 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 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

List of Illustrations

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


Companies Mentioned 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.)


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