米国の分子診断市場：第 2 版

Molecular diagnostics are seen as being a major breakthrough in medical science. While the technology itself has broad applications to such areas as agricultural bioterrorism and environmental science, medical and medical research applications have provided the primary focus. As a result, great things have been predicted for the development and use of new therapeutics based on molecular testing approaches.

The primary molecular diagnostics approaches are based on two major database sciences (genomics and proteomics) and their relationship to disease and metabolic processes (functional genomics and functional proteomics). The genome or proteome that forms the basis for these tests is very often of human origins, but may also be from a pathogen. As a result, the breadth of application for molecular diagnostic is virtually unlimited. With all this opportunity, however, progress has been slow in the development, introduction and commercialization of molecular diagnostics. This has been related to the difficulty and expense of performing such assays, and the utility of the test procedures in the absence of substantive therapeutic options based on the additional data provided by these assays.

This study looks at the basis for molecular diagnostics in the fields of genomics and proteomics; the technologies that are used to apply genomic and proteomic data to the diagnosis of disease; the diseases and conditions that are primary and secondary targets for this technology; the economics of molecular diagnostic testing; and its potential impacts on medical practice and the diagnostics markets over the next ten years. Number of tests, market potential, and estimated cost per test is provided for each test for each of the 10 years.

Chapter I: Executive Summary

• Background
• Scope and Methodology
• Size and Growth of Market
• Competitive Picture
• Market Trends and Factors

Chapter II: Introduction

• Background
• Diagnostics and Their Use
  • Clinical relevance
  • Scientific Limitations
  • Cost-Benefit Relationships
• Major Influencing Technologies
  • Genetics
  • Genomics
  • Proteomics

Chapter III: Molecular Diagnostics Technologies

• Background
• Amplification Technologies
• Blotting Technologies
• Electrophoretic Technologies
• Microchip Technologies
• Probe Technologies
• RNAi Analysis
• Single Nucleotide Polymorphism (SNP) Analysis

Chapter IV: Applications of Molecular Diagnostics

• The Testing Environment
  • Commercial Laboratories
  • University/Hospital Laboratories
• Blood Banking Analysis
• Cancer Diagnosis and Treatment Selection
• Genetic Diseases
• Pharmacogenetics
• Pharmacogenomics

Chapter V: The Market for Molecular Diagnostics

• Market Size and Trending
• Competitive Picture and Industry Structure
• Future Prospects
• Chapter VI: Company Profiles
• Abbott Diagnostics
• Affymetrix Inc.
• Agilent Technologies, Inc.
• Applied Biosystems Group
• Cepheid, Inc.
• Chiron Corporation
• diaDexus LLC
• Digene Corp.
• Gene Logic, Inc.
• Gen-Probe Incorporated
• Innogenetics NV
• MitoKor, Inc.
• Molecular Diagnostics, Inc.
• Myriad Genetics, Inc.
• Nanogen, Inc.
• Orchid Biosciences, Inc.
• Perkin-Elmer Corp.
• Roche Diasgnostics Division/Roche Molecular Systems
• Sangtec AB
• Visible Genetics

Chapter VII: Conclusions and Strategic Implications

APPENDIX A: Glossary

APPENDIX B: Company Names and Addresses