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Gene Amplification Technologies: End Users, Marketers, and Markets

Published by: Kalorama Information

Published: Aug. 1, 2002 - 156 Pages

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Table of Contents


Chapter One: Executive Summary


    Introduction


    Scope and Methodology


    Summary of Major Findings


Chapter Two: The Technologies


    Target vs. Signal Amplification

    • Target Amplification Technology Glossary
    • Signal Amplification Technology Glossary
    • Other Amplification Technology Glossary


    Isothermal vs. Cycling Temperature

    • Isothermal DNA Amplification Technologies
    • Cycling Temperature DNA Amplification Technologies
    • Isothermal Signal Amplification Technologies
    • Cycling Temperature Signal Gene Amplification Technologies
    • Isothermal Other Gene Amplification Technologies
    • Cycling Other Gene Amplification Technologies


    Exponential vs. Linear DNA Amplification Techniques

    • Exponential Gene Amplification
    • Linear Gene Amplification


    Trends in Gene Amplification Technologies Development

    • Additional Properties: Sensitivity, Range, Specificity


    Amplification Technology Market Players


Chapter Three: The Markets


    Amplification Technology Revenue


    Amplification Technology Market Share


    • Market Share by Competitor
    • Target vs Signal Gene Amplification Technology
    • Cycling vs Isothermal Gene Amplification Technology Revenue
    • Exponential vs Linear Gene Amplification Technology Revenue


Chapter Four: The Applications


    Introduction


    Medical Applications


    • FDA-Regulated Molecular Diagnostic Tests
    • FDA-Approved Clinical Molecular Diagnostic Tests by Disease


    Forensics, Paternity, Identity


    Food Safety, Agri-Diagnostics


    Veterinary


Chapter Five: The Reign Of PCR—The PCR Patent Fort


Chapter Six: DNA Amplification Technologies End-User Survey


  • Summary of Results
  • Conclusions


Chapter Seven: Next Generation: DNA Amplification On A Chip


Chapter Eight: Conclusions And Strategic Implications


  • First Conclusion
  • Second Conclusion
  • Third Conclusion
  • Fourth Conclusion


Chapter Nine: Company Profiles

  • Abbott Laboratories
  • Agilent Technologies
  • Ambion, Inc.
  • Amersham Biosciences, Inc.
  • Axcell Biosciences
  • Bayer Corporation
  • Becton, Dickinson, and Co.
  • Biogenex
  • Biotecon Diagnostics
  • Bio Merieux
  • Caliper Technology Corporation
  • Cepheid
  • Chugai Biopharmaceuticals, Inc.
  • Cytocell, Ltd.
  • Cytogen Corporation
  • Digene Corporation
  • Eragen Biosciences, Inc.
  • Exiqon, Inc.
  • Genisphere 3DNA
  • Gen-Probe
  • Hamilton Thorne Biosciences
  • Hibergen Limited
  • ID Biomedical Corporation
  • ImClone Systems, Inc.
  • Linco Research, Inc.
  • Molecular Sensing, PLC
  • Molecular Staging, Inc.
  • Nanogen, Inc.
  • Orchid Biosciences, Inc.
  • PerkinElmer Life Sciences
  • Phylogenetix Laboratories, Inc.
  • Qbiogene
  • Rubicon Genomics
  • SignalGene, Inc.
  • Takara Shuzo Co., Ltd.
  • Third Wave Technologies
  • Tm Bioscience Corporation
  • U.S. Genomics
  • Xtrana, Inc.


Appendix A: DNA Amplification Techniques End-User Questionnaire


Appendix B: Company Directory






List of Exhibits

    Table 2-1: Gene Amplification Technology Summary

    Table 2-2: Comparison of RCAT with PCR by Feature

    Table 2-3: Summary of Isothermal & Cycling Gene Amplification Technologies

    Table 2-4: Advantages/Disadvantages of Isothermal and Cycling DNA Amplification Techniques

    Table 2-5: Advantages & Disadvantages: Exponential versus Linear DNA Amplification Techniques

    Table 2-6: Gene Amplification Technologies Physical Characteristic and Development Date Summary

    Table 2-7: Range, Sensitivity & Specificity Gene Amplification Properties

    Table 2-8: Amplification Technology Research-Only Companies

    Table 2-9: Amplification Technology Application-Only Companies

    Table 2-10: Amplification Technology Research & Application Companies

    Table 3-1: Gene Amplification Technology Sales

    Table 3-2: Gene Amplification Technology Market Share by Competitor

    Table 3-3: Target vs. Signal Gene Amplification Technology Revenue

    Table 3-4: Cycling vs Isothermal Gene Amplification Technology Revenue

    Table 3-5: Exponential vs Linear Gene Amplification Technology Revenue

    Table 4-1: Technology Used in FDA Approved Molecular Diagnostic Tests

    Table 4-2: FDA-Approved Clinical Molecular Diagnostic Test by Technology and Company

    Table 4-3: PCR FDA-Approved Molecular Diagnostic Tests and Companies

    Table 4-4: TMA FDA-Approved Molecular Diagnostic Tests and Companies

    Table 4-5: Hybrid Capture FDA-Approved Molecular Diagnostic Tests and
    Companies

    Table 4-6: NASBA FDA-Approved Molecular Diagnostic Tests and Companies

    Table 4-7: FDA-Approved Clinical Molecular Diagnostic Tests by Disease

    Table 4-8: FDA-Approved Chlamydia Tests

    Table 4-9: FDA-Approved Gonorrhea Tests

    Table 4-10: FDA-Approved HIV & HCV Tests



    Figure 2-1: Kinetic Classification of Gene Amplification Technologies

    Figure 2-2: Number of Competitors by DNA Amplification Technology Use

    Figure 3-1: Gene Amplification Technology, Competitive Market Share, 2002

    Figure 3-2: Gene Amplification Technology, Competitive Market Share, 2007

    Figure 4-1: Percentage of Laboratories Using a Direct Detection Amplification Procedure for M. tuberculosis, 1997, 1999, 2001


    Survey Results Figures


Abstract

Gene amplification technology has been a backbone technology for the Human Genome Project and is vital in other fields, such as diagnostics. There are more than 50 biotech and diagnostic companies with DNA amplification technology and approximately 30 different gene- and signal-amplification technologies, from polymerase chain reaction to ligase chain reaction, transcription mediated amplification, and dendritic polymers. And these many technologies are being used for an ever-increasing variety of applications in research and clinical settings.

The market for amplification technology is currently in the hundreds of millions of dollars, but as the need for information about genes in genomics and other research progresses, and as clinical diagnostic tools develop, the market for amplification technology will continue to grow. Although PCR is currently the dominant amplification technology, other technologies are emerging to challenge PCR in many areas. Patents, costs, and ease of use of a technique are forces that drive the development of amplification technology and will shape this dynamic market.

This study reviews the landscape in this emerging sector, discussing technologies, applications, competitors, and regulation. In addition, Kalorama has conducted the first ever end-user survey, to determine the preferences of actual researchers using various amplification technologies in various settings and for various applications.

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