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U.S. Market for Molecular Diagnostics, 2nd Edition

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 One: Executive Summary

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


Chapter Two: Introduction

  • Background
  • Market Erosion
  • Clinical Relevance
  • Cost-Benefit Relationships
  • Scientific Limitations
  • Major Influencing Technologies
  • Genomics
  • Genes, Functional Genomics and Disease
  • Proteomics


Chapter Three: Molecular Diagnostics Technologies

  • Background
  • Amplification Technologies
  • Gene Amplification
  • Signal Amplification
  • Probe Technologies
  • Microchip Technologies
  • Electrophoretic Technologies
  • Blotting Technologies
  • Single Nucleotide Polymorphism (SNP) Analysis
  • Restriction Fragment Length Polymorphism (RFLP) Analysis
  • RNA Inhibition (RNAi) Analysis



Chapter Four: Applications of Molecular Diagnostics

  • The Testing Environment
  • Commercial Laboratories
  • University/Hospital Laboratories
  • Blood Banking Analysis
  • Genetic Diseases
  • Cancer
  • Pharmacogenetics
  • Infectious Disease Testing
    • Chlamydia trachomatis
    • Neisseria gonorrhoeae
    • Pneumonia
    • Human Immunodeficiency Virus (HIV)
    • Tuberculosis
    • Hepatitis B (HBV)
    • Hepatitis C (HCV)
    • Human Papillomavirus (HPV)
    • Herpes Simplex (HSV)
    • West Nile Virus (WNV)


Chapter Five: The Market for Molecular Diagnostics

  • Market Size and Trending
  • Blood Bank and Plasmapheresis Center Testing
  • Gene and Chromosome Testing
  • Oncology Testing
  • Pharmacogenetic Testing
  • Infectious Disease Testing
  • Competitive Picture and Industry Structure
  • Future Prospects


Chapter Six: Company Profiles

  • Overview
  • Abbott Diagnostics Division of Abbott Laboratories
  • Affymetrix, Inc.
  • Agilent Technologies, Inc. Division of Hewlett-Packard

  • Alnylam Pharmaceuticals
  • Ambion RNA Diagnostics Division of Ambion, Inc.
  • Applied Biosystems Group Division of Applera Corporation
  • Celera Genomics/Celera Diagnostics Division of Applera Corporation
  • Cenetron Diagnostics
  • Cenix BioScience GmbH
  • Cepheid, Inc.
  • Chiron Corporation
  • Dharmacon, Inc.
  • diaDexus, LLC
  • Digene Corporation
  • Gene Logic, Inc.
  • Gen-Probe Incorporated
  • Illumina, Inc.
  • Innogenetics NV
  • Invitrogen Corporation
  • Mirus Corporation
  • Myriad Genetics, Inc.
  • Nanogen, Inc.
  • Orchid BioSciences, Inc.
  • Perkin-Elmer Corp.
  • Roche Diagnostics Division/Roche Molecular Systems F. Hoffmann-LaRoche Ltd.
  • Sequenom Genetic Systems Division Of Sequenom
  • Sirna Therapeutics (Formerly Ribozyme Pharmaceuticals)
  • Vysis Subsidiary of Abbott Laboratories


Chapter Seven: Conclusions & Strategic Implications

  • First Conclusion
  • Second Conclusion
  • Third Conclusion
  • Fourth Conclusion
  • Fifth Conclusion
  • Sixth Conclusion
  • Seventh Conclusion
  • Eighth Conclusion
  • Ninth Conclusion
  • Tenth Conclusion


APPENDIX A: Company Names and Addresses

APPENDIX B: Glossary





List of Exhibits



Chapter One: Executive Summary

  • Table 1-1: Molecular Diagnostics Technologies
  • Table 1-2: Projected Molecular Diagnostics Market Potential in the United States by Applications Segment: 2003-2013
  • Figure 1-1: Trending in the Projected Molecular Diagnostics Market Potential in the United States by Applications Segment: 2003-2013
  • Figure 1-2: Trending in the Composition of the Projected Molecular Diagnostics Market Potential in the United States by Applications Segment: 2003-2013
  • Table 1-3: Key Active Competitors in the United States for Molecular Diagnostics Products and Technologies


Chapter Three: Molecular Diagnostics Technologies

  • Table 3-1: Molecular Diagnostics Technologies
  • Table 3-2: Gene Amplification Technologies
  • Table 3-3: Commonly Used Signal Amplification Technologies for Genetic Analysis


Chapter Four: Applications of Molecular Diagnostics

  • Table 4-1: Commercially Available Molecular Diagnostics Tests
  • Table 4-2: Key "Home-Brew" Molecular Diagnostics Assays
  • Figure 4-1a: Distribution of Molecular Diagnostics Testing in the
    United States: 2004
  • Table 4-3: Projected Blood Banking and Plasmapheresis Testing by Molecular Diagnostics in the United States: 2003-2013
  • Figure 4-1: Trending in the Projected Number of Blood Banking and Plasmapheresis Tests by Molecular Diagnostics in the United States: 2003-2013
  • Figure 4-2: Trending in the Percentage Distribution of Blood Banking and Plasmapheresis Tests by Molecular Diagnostics in the United States: 2003-2013
  • Table 4-4: Commercially Available Molecular (Nucleic Acid) Tests for Blood,
    Plasma and Organ Donor Screening in the United States: 2004
  • Table 4-5: Key Hereditary Diseases
  • Table 4-6: Projected Genetic Disease Testing by Molecular Diagnostics in the
    United States: 2003-2013
  • Figure 4-3: Trending in the Projected Number of Genetic Disease Tests by Molecular Diagnostics in the United States: 2003-2013
  • Figure 4-4: Trending in the Percentage Distribution of Genetic Disease Tests by Molecular Diagnostics in the United States: 2003-2013
  • Table 4-7: Projected Oncology Testing by Molecular Diagnostics in the United
    States: 2003-2013
  • Figure 4-5: Trending in the Projected Number of Oncology Tests by Molecular Diagnostics in the United States: 2003-2013
  • Figure 4-6: Trending in the Percentage Distribution of Oncology Tests by Molecular Diagnostics in the United States: 2003-2013
  • Table 4-8: Drugs Affected by the Cytochrome p450 System
  • Table 4-9: Projected Pharmacogenetic Testing by Molecular Diagnostics in the
    United States: 2003-2013
  • Figure 4-7: Trending in the Projected Number of Pharmacogenetic Tests by
    Molecular Diagnostics in the United States: 2003-2013
  • Figure 4-8: Trending in the Percentage Distribution of Pharmacogenetic Tests by Molecular Diagnostics in the United States: 2003-2013
  • Table 4-10: Projected Infectious Disease Testing by Molecular Diagnostics in the
    United States: 2003-2013


Chapter Five: The Market for Molecular Diagnostics

  • Table 5-1: Projected Molecular Diagnostics Market Potential in the United
    States by Applications Segment: 2003-2013 ($Millions)
  • Figure 5-1: Trending in the Projected Molecular Diagnostics Market
    Potential in the United States by Applications Segment: 2003-2013
  • Figure 5-2: Composition of the Projected Molecular Diagnostics Market
    Potential in the United States by Applications Segment: 2003-2013
  • Table 5-2: Projected Molecular Diagnostics Market Potential in the United
    States by Application Segment - Detailed Analysis: 2003 - 2013
  • Figure 5-3: Trending in the Projected Molecular Diagnostics Test Volume
    Potential in the United States by Applications Segment: 2003-2013
  • Figure 5-4: Composition of the Projected Molecular Diagnostics Test Volume
    Potential in the United States by Applications Segment: 2003-2013
  • Figure 5-5: Trending in the Projected Molecular Diagnostics Average Cost Per
    Test in the United States by Applications Segment: 2003-2013
  • Table 5-3: Projected Blood Banking and Plasmapheresis Molecular Diagnostics
    Testing Market Potential in the United States: 2003-2013
  • Figure 5-6: Trending in the Projected Test Volume for Molecular Diagnostics in
    Blood Banking Applications in the United States: 2003-2013
  • Figure 5-7: Trending in the Projected Test Volume Composition for Molecular Diagnostics in Blood Banking Applications in the United States: 2003-2013
  • Figure 5-8: Trending in the Projected Market Potential for Molecular Diagnostics in Blood Banking Applications in the United States: 2003-2013
  • Figure 5-9: Trending in the Projected Market Potential Composition for
    Molecular Diagnostics in Blood Banking Applications in the
    United States: 2003-2013
  • Figure 5-10: Trending in the Projected Average Cost Per Test for Molecular
    Diagnostics in Blood Banking Applications in the United States: 2003-2013
  • Table 5-4: Projected Gene and Chromosome Molecular Diagnostics Testing
    Market Potential in the United States: 2003-2013
  • Figure 5-11: Trending in the Projected Test Volume for Molecular Diagnostics in
    Gene and Chromosome Testing in the United States: 2003-2013
  • Figure 5-12: Trending in the Projected Test Volume Composition for Molecular Diagnostics in Gene and Chromosome Testing in the United States: 2003-2013
  • Figure 5-13: Trending in the Projected Market Potential for Molecular
    Diagnostics in Gene and Chromosome Testing in the United States: 2003-2013
  • Figure 5-14: Trending in the Projected Market Potential Composition for
    Molecular Diagnostics in Gene and Chromosome Testing in the United
    States: 2003-2013
  • Figure 5-15: Trending in the Projected Average Cost Per Test for Molecular
    Diagnostics in Gene and Chromosome Testing in the United States: 2003-2013
  • Table 5-5: Projected Molecular Diagnostics Oncology Testing Market
    Potential in the United States: 2003-2013
  • Figure 5-16: Trending in the Projected Test Volume for Molecular Diagnostics in Oncology Testing in the United States: 2003-2013
  • Figure 5-17: Trending in the Projected Test Volume Composition for Molecular Diagnostics in Oncology Testing in the United States: 2003-2013
  • Figure 5-18: Trending in the Projected Market Potential for Molecular
    Diagnostics in Oncology Testing in the United States: 2003-2013
  • Figure 5-19: Trending in the Projected Market Potential Composition for
    Molecular Diagnostics in Oncology Testing in the United States: 2003-2013
  • Figure 5-20: Trending in the Projected Average Cost Per Test for Molecular
    Diagnostics in Oncology Testing in the United States: 2003-2013
  • Table 5-6: Projected Molecular Diagnostics Pharmacogenetic Testing Market
    Potential in the United States: 2003-2013
  • Figure 5-21: Trending in the Projected Test Volume for Molecular Diagnostics in Pharmacogenetic Testing in the United States: 2003-2013
  • Figure 5-22: Trending in the Projected Test Volume Composition for Molecular Diagnostics in Pharmacogenetic Testing in the United States: 2003-2013
  • Figure 5-23: Trending in the Projected Market Potential for Molecular
    Diagnostics in Pharmacogenetic Testing in the United States: 2003-2013
  • Figure 5-24: Trending in the Projected Market Potential Composition for
    Molecular Diagnostics in Pharmacogenetic Testing in the United
    States: 2003-2013
  • Figure 5-25: Trending in the Projected Average Cost Per Test for Molecular
    Diagnostics in Pharmacogenetic Testing in the United States: 2003-2013
  • Table 5-7: Projected Molecular Diagnostics Infectious Disease Testing Market
    Potential in the United States: 2003-2013
  • Figure 5-26: Trending in the Projected Test Volume for Molecular Diagnostics in Infectious Disease Testing in the United States: 2003-2013
  • Figure 5-27: Trending in the Projected Test Volume for Molecular Diagnostics in Infectious Disease Testing in the United States: 2003-2013
  • Figure 5-28: Trending in the Projected Market Potential for Molecular
    Diagnostics in Infectious Disease Testing in the United States: 2003-2013
  • Figure 5-29: Trending in the Projected Market Potential Composition for
    Molecular Diagnostics in Infectious Disease Testing in the United
    States: 2003-2013
  • Figure 5-30: Trending in the Projected Average Cost Per Test (ECPT) for
    Molecular Diagnostics in Infectious Disease Testing in the United
    States: 2003-2013
  • Table 5-8: Key Active Competitors in the United States for Molecular
    Diagnostics Products and Technologies


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