Commercializing Molecular Diagnostics: Products, Services,

Companies and Global Market

Published: July 2008

175 pages; Can be printed; fully searchable PDF format; TOC hyperlinks and Internet hyperlinks

 

SKU: TPR3174

 

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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 Ď-omicí biomarkers.

 

The detailed study shows that molecular diagnostic companies are expecting continued strong growth. Takeda Pacificís 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.  Rocheís 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.

 

 

 

Table of 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 Figures

 

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

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