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市場調査レポート
分子診断：急速に変化する商業的および技術的動向
Molecular Diagnostics: A Rapidly Shifting Commercial and Technology Landscape
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Abstract
Molecular diagnostic tests are now used for a wide range of applications,
including:
- Human clinical molecular diagnostic testing
- Veterinary molecular diagnostic testing
- Identity testing
- Forensic testing
- Histocompatibility testing
Within these broad disease areas, molecular diagnostics tests have a wide
range of applications, including:
- Identification of individuals who are at increased risk of developing
certain disorders
- Screening apparently healthy populations
- Diagnosis
- Determining prognosis, such as with cancer
- Personalized medicine applications, including pharmacogenetic tests such
as drug metabolism tests to avoid adverse drug effects and companion
diagnostics to identify patients who will respond to a specific drug
- Monitoring response to therapy
Molecular Diagnostics: A Rapidly Shifting Commercial and Technology
Landscape focuses on human clinical molecular diagnostics. Even within
this field, molecular diagnostics is being applied to a wide range of diseases
and applications. The first molecular diagnostics tests to reach the market
were for infectious diseases, and this remains the largest segment of the
molecular diagnostics market. Molecular oncology tests have been emerging as a
second significant-and rapidly growing-market segment. Molecular diagnostics
is also starting to emerge as an important tool for inherited disorders,
cardiovascular disorders, and other disease areas.
This report provides a thorough discussion of the many companies involved in
molecular diagnostics and their commercial products either on the market or in
development for these applications. Molecular diagnostics has emerged as a
significant segment of the overall clinical diagnostics market. Overall, the
molecular diagnostics market is growing rapidly, although some segments are
growing more rapidly than others. This report provides an overview of the
molecular diagnostics market, and discusses many of the trends in this
market-including factors that are driving the growth.
This report also includes results from a Web survey of individuals involved in
molecular diagnostics research, development, and use. More than 250 people
responded to the survey, pointing out in a question what they think will be
the biggest growth areas over the next 5 years:
As molecular diagnostics moves into the future, companies in this market will
face a number of challenges. Selected examples of the challenges are
discussed. The molecular diagnostics market is changing rapidly and is
becoming highly competitive. The market shows considerable promise for new
tests to improve the diagnosis and treatment of a wide range of diseases and
disorders.
Table of Contents
Chapter 1 BACKGROUND AND SCOPE
Chapter 2 CURRENT AND EMERGING TECHNOLOGIES
- 2.1. Nonamplified Probe-Based Assays
- 2.2. Cytogenetics and FISH
- 2.3. PCR and Other Amplification Technologies
- 2.4. Microarrays
- 2.5. DNA Methylation Assays
- Companies Focusing on Methylation and Cancer Diagnostics
- Epigenomics
- OncoMethylome Sciences
- Orion Genomics
- Rubicon Genomics
- 2.6. Other Current and Emerging Technologies
Chapter 3 CURRENT AND EMERGING APPLICATIONS OF MOLECULAR DIAGNOSTICS
- 3.1. Infectious Disease Diagnostics
- Human Immunodeficiency Virus
- Hepatitis C Virus
- Hepatitis B Virus
- Molecular Tests for Blood Screening
- Chlamydia and Gonorrhea
- Human Papillomavirus and Cervical Cancer
- Methicillin-Resistant Staphylococcus aureus
- Other Current and Emerging Infectious Disease Diagnostics Tests
- 3.2. Molecular Oncology Tests
- Analysis of the Expression of Multiple Genes and Cancer Prognosis
- Analysis of Lymph Nodes to Detect Metastasis of Breast Cancer
- Screening for Colorectal Cancer: Stool-Based DNA Screening
- Leukemias and Lymphomas
- DNA Methylation Tests and Cancer
- Other Emerging Molecular Diagnostics Tests for Oncology
- Abbott Molecular
- DiagnoCure
- ExonHit Therapeutics
- Gen-Probe
- Roche Diagnostics
- 3.3. Genetic Testing: Tests for Inherited Disorders and Prenatal
Diagnostics
- Cystic Fibrosis
- Prenatal Diagnosis
- Ashkenazi Jewish Genetic Panel
- Other Current and Emerging Molecular Tests - Inherited Disorders
- 3.4. Genetic Testing: Predicting Risk of Disease
- Risk of Venous Thromboembolism
- Predicting Risk of Developing Cancer
- Other Emerging Molecular Tests for Predicting Risk of Disease
- 3.5. Personalized Medicine: Pharmacogenomics and Companion Diagnostics
- Cytochrome P450 and Drug Metabolism
- Targeted Cancer Therapies and Companion Diagnostics Tests
- Testing for HER2/neu Overexpression in Breast Cancer
- Testing for Epidermal Growth Factor Receptor (EGFR)
- UGT1A1 Genetic Variants
- Pharmacogenetics and Response to Antiretroviral Therapy
- Thiopurine Methyltransferase and Metabolism of Thiopurine Drugs
- Other Molecular Diagnostics Personalized Medicine Tests
- AutoGenomics
- DxS
- Myriad Genetics
- OncoMethylome Sciences
- PGxHealth (part of Clinical Data)
Chapter 4 BUSINESS CONSIDERATIONS IN MOLECULAR DIAGNOSTICS
- 4.1. Molecular Diagnostics Market
- 4.2. Major Trends in the Molecular Diagnostics Market
- Rapidly Growing Market; Growth Rates Vary by Segment
- Automation, Ease of Use
- Moving Molecular Diagnostics Tests Nearer to the Patient
- Growth in Number of New Biomarkers; Efforts to Demonstrate Clinical
Utility
- Increasing Number of Tests Commercially Available
- Growing Number of FDA-Cleared and FDA-Approved Tests
- Consolidation in IVD
- 4.3. Personalized Medicine and Molecular Diagnostics: Impact on the
Pharmaceutical Industry
- Treatment of Infectious Diseases
- Companion Diagnostics and Targeted Therapies
- Prevention of Adverse Drug Reactions
- 4.4. Major Challenges Facing Molecular Diagnostics Companies
- Regulatory Issues and Considerations
- Regulatory Issues and Considerations for Molecular Diagnostics Clinical
- Laboratories
- Regulatory Issues and Considerations for Molecular Diagnostics
- Companies
- Regulatory Issues and Considerations for Pharmaceutical Companies
- Developing Pharmacogenomic Therapies
- Reimbursement of Molecular Diagnostics
- Patient and Physician Education
- Identification of New Biomarkers; Validation of Biomarkers and
Diagnostics Tests
Chapter 5 EXPERT INTERVIEWS
- Fareed Kureshy, MBA
- Chairman, President and CEO
- AutoGenomics, Carlsbad, CA
- David H. Persing, MD, PhD
- Executive Vice President, Chief Medical and Technical Officer
- Cepheid, Sunnyvale, CA
- Geert Walther Nygaard
- CEO
- Epigenomics AG, Berlin, Germany and Oliver Schacht
- CFO and CEO
- Epigenomics, Seattle, WA
- Shuqi Chen, PhD
- President, CEO, and Chairman
- IQuum, Marlborough, MA
- Jorge Leon, PhD
- President, Leomics Associates
- Former Acting Chief Scientific Officer
- Orion Genomics, St. Louis, MO
- James White
- Chief Executive Officer
- Osmetech, Pasadena, CA
Chapter 6 SELECTED COMPANY PROFILES
- Abbott Molecular (aka Vysis)
- Agendia
- AutoGenomics
- BD and BD GeneOhm
- Cepheid
- Digene
- Genomic Health
- Gen-Probe
- Luminex
- Nanogen
- Osmetech and Osmetech Molecular Diagnostics
- Prodesse
- Qiagen
- Roche Molecular Systems
- Third Wave Technologies
Appendix
- CHI INSIGHT PHARMA REPORTS - MOLECULAR DIAGNOSTICS SURVEY ANALYSIS
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