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

SUMMARY

Executive Summary

This report reviews, analyzes and sizes the combined molecular diagnostics product and clinical lab services markets. The study uncovers interesting information about key equipment, IVD consumables, reagents, software and services that are marketed to clinical diagnostic labs located at independent companies, hospitals, HMOs, doctors cooperatives and healthcare centers of all kinds in the developed and developing worldwide regions.

This report assesses the market and maps the competitors in this market landscape with more than 85 companies identified. The financial section sizes the market and discusses the five-year revenue projection to 2011. This study segments the market by major product and service areas, by technology, by disease/ application, and by test sample material. The report also segments the market by major world regions to see the growth opportunity.

This study reviews and analyzes major company alliances, M&As during the last two years. Large data tables summarize the alliances and M&As. The alliance table presents a large amount of partnering information. This report reviews the molecular diagnostic technology and business trends over the next three to five years. Large and small analytical tables help the reader quicky understand the trend information.

The study methodolgy uses primary information that was gathered from numerous sources including in-person interviews and discussions, telephone interviews, and surveys, attendance at business presentations at healthcare technical and financial conferences as well a through secondary research. This research report is designed for people that include marketers, business development, top executives, investors, VCs, consultants, R&D managers, entrepreneurs and the like. More than 51 detailed tables or figures provide key data about items such as strategic alliances, M&As, market size, segments and the like.

This report includes 30 company profiles that provide the reader a snapshot of the companies' focus or activities. The provided Internet links help readers access companies' own web sites for further review.

TABLE OF CONTENTS

1. Overview of Molecular Diagnostic Tests

• 1.1Gene-Based and 'Omics'-Based Biomarkers Enable Molecular Diagnostics
  • 1.1.1Molecular Diagnostics (J added)
• 1.2Diagnostic Industry Competitive Overview
  • 1.2.1WW Molecular Diagnostics IVD Business
  • 1.2.2WW Molecular Diagnostics Lab Services
  • 1.2.3Leading Molecular Diagnostics IVD Makers
  • 1.2.4Leading Molecular Diagnostics IVD Lab Services
• 1.3Advances in Molecular Diagnostics
  • 1.3.1FDA View of Biomarkers for Molecular Diagnostic Field
  • 1.3.2Genetic Tests for Multiple Gene Based Diseases
  • 1.3.3Multiplexed Protein Patterns Become Molecular Diagnostics
  • 1.3.4DNA Methylation Tests
• 1.4Developing Molecular Diagnostics
  • 1.4.2Esoteric 'Home Brew' Molecular Diagnostics Marketed as Services
  • 1.4.3Developing a Test into an In Vitro Diagnostic
  • 1.4.4Product Prices and the $3,200 Test!
  • 1.4.5Healthcare Reimbursement Issues

2. Company Activities and Strategies

• 2.1Major Market Participants by Disease Segments
• 2.2Important Findings or Special Notes
  • 2.2.1Findings of Companies in Molecular Diagnostics by Sample Material
  • 2.2.2Findings of Companies in Molecular Diagnostics by Major Disease
  • 2.2.3Findings of Companies in Molecular Diagnostics by Product 'Status'

3. Technologies Used in Developing Molecular Diagnostics

• 3.1Technologies: Current Status & Next Stage Development Status
• 3.2Overview of Technologies Used in Molecular Diagnostics
• 3.3Technologies and Molecular Diagnostics Products: Current and Next Stage Development
• 3.4Commercial Implications of Clinical Molecular Diagnostics

4. Alliances and R&D Activity in Molecular Diagnostics

• 4.1Overview of Strategic Alliances & R&D in Molecular Diagnostics
  • 4.1.1Alliance Types
  • 4.1.2Molecular Diagnostic Alliances for R&D at a Glance
  • 4.1.3Alliances in Molecular Diagnostics Gained Momentum in 2006
• 4.2Summary of Molecular Diagnostics in Medical Research
• 4.3R&D Activity by Diseases or Applications
  • 4.3.1Summary of R&D Activity
  • 4.3.2Details of R&D Activity

5. Market Size and Forecast for Molecular Diagnostics

• 5.1Market Overview: Molecular Diagnostic (MDx) Products & Clinical Lab Servic
• 5.2WW Molecular Diagnostic (MDx) Product/ Market Trends
  • 5.2.1Examples of Selected MDx Equipment and Consumable Products
  • 5.2.2Examples of Selected MDx Lab Services
• 5.3Molecular Diagnostic (MDx) Total WW Market Size
  • 5.3.1Total WW MDx Market Size, 2006-2011
  • 5.3.2Market Size by Major Segments
• 5.4Leading Molecular Diagnostic Manufacturers' Shares
• 5.5WW Molecular Diagnostic Product Market Size by Disease Segments
• 5.6WW Molecular Diagnostic Product Market Size by Test Material Segments
• 5.7WW Molecular Diagnostic Product Market Size by Technologies
• 5.8WW Molecular Diagnostic Product Market Size by Region
• 5.9WW Molecular Diagnostic Lab Services Market Size by Disease and Regions
  • 5.9.1MDx Lab Services Market Size by Disease
  • 5.9.2WW Molecular Diagnostic Lab Services Market Size by Regions

6. Future Directions

• 6.1Key Trends for Molecular Diagnostics
  • 6.1.1Infectious Disease Testing
  • 6.1.2Interest in Cancer Tests Growing
  • 6.1.3Future Direction for CNS Disease Tests
  • 6.1.4Future Direction of Genetic Testing and PGx Tests
• 6.2Top Opportunities for the Future
  • 6.2.1Government Regulators Driving Future Opportunities
  • 6.2.2Emerging Personalized Medicine and Timeline
• 6.3Main Challenges
  • 6.3.1High Costs of Molecular Diagnostics
  • 6.3.2Acute Shortages of Diagnostics in the Developing World
  • 6.3.3Worldwide Regulatory Delays in Approving New Tests
  • 6.3.4Insurance Reimbursement Issues

7. Activities of Molecular Diagnostics Companies

• 7.1Large Diagnostic Lab Services
  • 7.1.1BML, Inc.
  • 7.1.2Diagnosticos Da America S.A. (DASA)
  • 7.1.3LabCorp
  • 7.1.4Quest Diagnostics, Inc.
  • 7.1.5Unilabs Group
• 7.2Small Diagnostic Lab Services
  • 7.2.1diaDexus, Inc.
  • 7.2.2Myriad Genetics, Inc.
  • 7.2.3Veridex, LLC (J&J Co.)
  • 7.2.4Genomic Health, Inc.
  • 7.2.5Agendia B.V.
• 7.3Large MDx Company
  • 7.3.1Abbott Molecular
  • 7.3.2BD Diagnostics
  • 7.3.3Digene Corporation
  • 7.3.4Beckman Coulter, Inc.
  • 7.3.5bioMerieux SA
  • 7.3.6Gen-Probe, Inc.
  • 7.3.7Roche Molecular Diagnostics
  • 7.3.8Siemens Medical Solutions Diagnostics
• 7.4Point of Care MDx
  • 7.4.1BioSite, Inc.
  • 7.4.2Cepheid
• 7.5Pure Play MDx
  • 7.5.1Celera Group
  • 7.5.2Chiron Corporation (Novartis)
  • 7.5.3Dako A/S
  • 7.5.4Exact Sciences Corporation
  • 7.5.5Innogenetics NV
• 7.6DNA Methylation MDx
  • 7.6.1Orion Genomics LLC
  • 7.6.2Epigenomics AG
• 7.7Array Platforms
  • 7.7.1Affymetrix, Inc.
  • 7.7.2Luminex Corporation
  • 7.7.3Nanogen, Inc.

8. Appendix

• 8.1Major Disease Population Sizes
• 8.2Companies Mentioned in This Report

LIST OF TABLES

• 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

LIST OF ILLUSTRATIONS

• 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