急速に拡大する分子診断業界における最新動向

Abstract

Introduction

Molecular diagnostics (MDx) is becoming increasingly entwined with the development of pharmaceutical drugs. Initially, it was used in clinical settings to aid diagnosis, prognosis, and optimal treatment, but now, backed by regulatory authorities, it is becoming important in the development and commercialization of new and existing therapies. As a result, the MDx industry, already a multibillion-dollar market, will continue to expand at a significant pace.

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The MDx market can be segmented into three phases: infectious diseases; blood screening; and pharmacogenomic testing, genetic testing, predictive testing, and companion diagnostics. Why does scope for greater innovation and greater sales potential lie in the third phase?

According to industry experts, polymerase chain reaction (PCR) technology will have the greatest impact on the MDx market. PCR enables researchers to amplify minute amounts of genetic material to billions of copies in a matter of hours through repeated cycles of duplication via the use of an enzyme called DNA polymerase or Taq polymerase. What big pharma company used PCR to become one of the most powerful leaders in the field of MDx?

Pharmaceutical companies have traditionally been reluctant to employ MDx (e.g., to identify biomarkers) to screen drug candidates during the R&D process for fear of reducing the potential target population. Why is this attitude changing?

Big pharmaceutical companies and smaller MDx companies are teaming up to produce MDx technologies. What alliances have been formed, and what products have been the result?

Scope

• The three phases of MDx: infectious diseases; blood screening; and pharmacogenomic testing, genetic testing, predictive testing, and companion diagnostics.
• MDx technologies: PCR, DNA methylation, and RNAi validation.
• MDx platforms: Microarrays, nanoarrays, microfluidics, and multiplex assays.
• Major players: Roche Diagnostics, Abbott Diagnostics, and Siemens Medical Solutions Group.
• Expert Commentary: Dr. John Sninsky, vice president of discovery research at Celera, and Dr.David Speechly, Media and Investor Relations at Celera, discuss Celera’s involvement in MDx.

Companies Mentioned in This Spectrum Report

• Abbott Diagnostics
• Affymetrix
• Alnylam Pharmaceuticals
• Applera
• Applied Biosystems
• Benitec
• BioForce Nanosciences
• Biosite
• Celera
• Cepheid
• Cetus
• Chiron
• deCode
• Epigenomics AD
• Genaco Biomedical Products
• Genzyme
• Illumina
• International Therapeutics
• Johns Hopkins University
• School of Medicine
• Johnson & Johnson
• MetriGenix
• Nanogen
• Nanolink
• Oncomethylome Sciences
• Orion Genomics
• Osmetech
• PamGene
• Qiagen
• Randox
• Roche Diagnostics
• Siemens Medical Solutions
• Group
• Tepnel (formerly Orchid
• Biosciences)
• Third Wave Technologies

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Overview
• The Evolution of the MDx Industry
• The Three Phases of the MDx Industry
  • Phase One: Infectious Diseases
  • Phase Two: Blood Screening
  • Phase Three: Pharmacogenomic Testing, Genetic Testing, Predictive Testing, and
  • Companion Diagnostics
    • Pharmacogenomic Testing
    • Predictive Testing
    • Genetic Testing
• Expert Commentary-MDx: Looking Ahead
  • Companion Diagnostics
• MDx Technologies and Platforms
  • MDx Technologies
    • PCR
    • DNA Methylation
    • RNA Interference
  • MDx Platforms
    • Microarrays and Nanoarrays
    • Microfl uidics
    • Multiplex Assays
• Changing Trends
  • Pharmaceutical/MDx Alliances and Acquisitions
  • Support from Regulatory Authorities
  • Alliances Between Diagnostics and Technology-Based Companies
• Regulatory Environment and Advances in MDx
• Key Players in the MDx Field
  • Roche Diagnostics
  • Abbott Diagnostics
  • Bayer Diagnostics/Siemens Medical Solutions Group
• Market Outlook

Tables:

• 1. Select Molecular Diagnostics for Infectious Agents
• 2. The Third Phase of the MDx Industry
• 3. Recent Alliances Between Research Organizations and Pharmaceutical/Biotech Companies
• 4. AmpliChip CYP450 Test
• 5. Select PGx-Based Diagnostic Tests
• 6. Comparison of Molecular Tests
• 7. Select Pharma-Diagnostics Industry Alliances
• 8. Recent Alliances Between Diagnostic and Technology Companies
• 9. Key Mergers and Acquisitions in the MDx Market
• 10. Likely Impact of Increased Uptake of MDx Tests
• 11. Global Market Opportunities for Molecular Diagnostics, 2005-2010
• A. Current and Planned MDx Products at Celera Diagnostics

Figures:

• 1. The Three Phases of the Molecular Diagnostic Industry
• 2. Growth in Alliances Between Academia/Research Organizations and Pharmaceutical/Biotech Companies, 2002-2006
• 3. Select Molecular Diagnostic Technologies and Platforms
• 4. Interrelationship Between Pharmaceutical/Biotech and Molecular Diagnostics Companies
• 5. Future Diversifi cation of the MDx Market