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Diagnostics

Molecular Diagnostics Markets


Publication Date   March 2008
Publisher   TriMark Publications
Product Type   Strategic Report
Pages   282
ISBN Number   not applicable
Product Code   TRI019
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Summary


The technologies that constitute molecular diagnostics-first-generation amplification, DNA probes, fluorescent in situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors, and molecular labels-are influencing the discovery of therapeutic molecules, the screening and diagnosis of patients, and the optimization of drug therapy. In the past few years, this rapidly evolving field has seen several fascinating developments. This report describes the specific market segment of the in vitro diagnostics market known as molecular diagnostics and includes all of the generally accepted clinical analytical activities in use today. It examines the prevalent clinical-measurement devices, as well as their reagents and supplies as utilized in hospitals, clinics, large reference laboratories and doctor's offices. Diagnostic tests marketed primarily as over-the-counter are generally not included in this report, although there is inevitably some overlap. The main objectives of this analysis are: 1) identifying viable technology drivers through a comprehensive look at platform technologies for molecular diagnostics, including probe-based nucleic acid assays, microarrays and sequencing; 2) obtaining a complete understanding of the chief molecular diagnostics tests-i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic-from their basic principles to their applications; 3) discovering feasible market opportunities by identifying high-growth applications in different clinical diagnostic areas and by focusing on expanding markets, such as communicable diseases, cardiology and oncology; and 4) focusing on global industry development through an in-depth analysis of the major world markets for molecular diagnostics, including growth forecasts.

Content


  • 1. Overview
    • 1.1 Statement of Report
    • 1.2 About This Report
    • 1.3 Scope of the Report
    • 1.4 Methodology
    • 1.5 Executive Summary
  • 2. Introduction to Molecular Diagnostics and PCR Technology
    • 2.1 Science Overview: Introduction to Genomics and Its Opportunity
    • 2.2 Impact of the Human Genome Project on Molecular Diagnostics
    • 2.3 Considerations for Molecular and Clinical Diagnosis
    • 2.4 Molecular Diagnosis in the Post-Genomic Era
    • 2.5 Advances in Molecular Diagnostics Technologies
    • 2.6 Genetic Variability and Disease
    • 2.7 Major Technology Platforms
  • 3. Nucleic Acid Test Applications
    • 3.1 Blood Testing and Infectious Diseases
      • 3.1.1 Molecular Diagnostics Market
        • 3.1.1.1 Methods for DNA Detection and Gene Sequencing
        • 3.1.1.2 Products and Applications
        • 3.1.1.3 Oncology
      • 3.1.2 SNPs and Genes: Medical Utility (Clinical Applications)
        • 3.1.2.1 Clinical Application Initiatives
        • 3.1.2.2 Clinical Application Collaborations
        • 3.1.2.3 Collaborative Relationships
    • 3.2 Diagnostic Testing Using DNA
      • 3.2.1 HIV
      • 3.2.2 Hepatitis Serologic Markers and Nucleic Acid Testing
        • 3.2.2.1 Hepatitis A Virus (HAV)
        • 3.2.2.2 Hepatitis B Virus (HBV)
        • 3.2.2.3 Hepatitis C Virus (HCV)
        • 3.2.2.4 Hepatitis D Virus (HDV)
        • 3.2.2.5 Hepatitis E Virus (HEV)
        • 3.2.2.6 HBV/HCV Viral Load and Drug Resistance
      • 3.2.3 Severe Acute Respiratory Syndrome (SARS)
        • 3.2.3.1 New Approach to Diagnosing Avian Influenza
        • 3.2.3.2 Microarray or DNA Chip-Based Tests
      • 3.2.4 Cancer Detection Using PCR
        • 3.2.4.1 Lung Cancer
        • 3.2.4.2 Oral Cancer
        • 3.2.4.3 Prostate Cancer
        • 3.2.4.4 Chronic Myelogenous Leukemia
        • 3.2.4.5 Malignant Gliomas
        • 3.2.4.6 Colorectal Cancer
        • 3.2.4.7 Breast Cancer
        • 3.2.4.8 Bladder Cancer
      • 3.2.5 Microbiology Testing
        • 3.2.5.1 Chlamydia
        • 3.2.5.2 Gonorrhea
        • 3.2.5.3 Tuberculosis
        • 3.2.5.4 Group B Streptococcus
        • 3.2.5.5 Pathogenic Enteric Bacteria
        • 3.2.5.6 Bordetella Pertussis
        • 3.2.5.7 Legionella Pneumophila
        • 3.2.5.8 Peridontal Bacteria
        • 3.2.5.9 Pneumocystis Carinii
        • 3.2.5.10 Staphylococcus Aureus
      • 3.2.6 Blood Screening
    • 3.3 SNPs in Clinical Diagnostics
      • 3.3.1 The Market
      • 3.3.2 Paternity Testing
    • 3.4 Industrial Testing and Food Diagnostics
      • 3.4.1 The Market
      • 3.4.2 Detection of H. pylori by PCR
      • 3.4.3 Detection of E. coli 0157
      • 3.4.4 Detection of Enteric Viruses
    • 3.5 Forensics Market
      • 3.5.1 Isolation of DNA for PCR Profiling
      • 3.5.2 Analysis by PCR-Based DNA Typing
      • 3.5.3 Rapid Isolation of DNA for RFLP and PCR
      • 3.5.4 DNA for PCR-STR Typing
    • 3.6 Bioterrorism and Molecular Diagnostics
      • 3.6.1 Introduction
        • 3.6.1.1 Current Biological Threat Detection Systems
        • 3.6.1.2 Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWA
        • 3.6.1.3 Advantages and Disadvantages of Host Gene Expression Profiling as a Biothreat Detection System
      • 3.6.2 Biological Warfare Agents
        • 3.6.2.1 Anthrax
        • 3.6.2.2 Botulinum Toxin
        • 3.6.2.3 Ricin
        • 3.6.2.4 IVD Industry and Bioterrorism Preparedness
        • 3.6.2.4.1 Brucellosis
        • 3.6.2.4.2 Cholera
        • 3.6.2.5 Rapid Lateral Flow Immunoassays
        • 3.6.2.6 Biosensors
        • 3.6.2.6.1 Antibody and Synthetic Receptor-Based Sensors
        • 3.6.2.6.2 DNA Sensors
        • 3.6.2.6.3 Reagentless Sensors
      • 3.6.3 Anthrax in Clinical Samples
        • 3.6.3.1 Overview of Anthrax and Its Infectivity
        • 3.6.3.2 Rapid Tests
        • 3.6.3.2.1 PCR Tests
    • 3.7 Cystic Fibrosis Testing
    • 3.8 HLA Sequencing-Based Typing Kits
    • 3.9 Cytogenetic Testing
      • 3.9.1 Hereditary Hemochromatosis
      • 3.9.2 Apolipoprotein E (ApoE) Genotyping
      • 3.9.3 Fragile X Syndrome
      • 3.9.4 Methylenetetrahydrofolate Reductase (MTHFR) Carrier Testing
    • 3.10 Developments in Biochips for Clinical Applications
      • 3.10.1 Roche AmpliChip Microarray
      • 3.10.2 Breast Cancer DNA Chips
      • 3.10.3 eSensor DNA Detection System
    • 3.11 Pharmacogenomics
  • 4. Trends in Molecular Diagnostics
    • 4.1 Pharmacogenomics
      • 4.1.1 The Market
        • 4.1.1.1 Oncology
        • 4.1.1.2 Toxicogenomics
      • 4.1.2 Market Influences and Forecast
    • 4.2 DNA Microarrays
      • 4.2.1 Techniques
      • 4.2.2 The Market
      • 4.2.3 Identification of Sequence SNPs
      • 4.2.4 Determining Gene Expression Levels
        • 4.2.4.1 Hybridization Tests
        • 4.2.4.2 Oligonucleotide Probes
      • 4.2.5 Molecular Diagnostics Entry into Point-of-Care Testing
    • 4.3 Emerging Markets of DNA Arrays
      • 4.3.1 Pharmacogenomics
      • 4.3.2 Adoption of Amplified Screening Technology
      • 4.3.3 Advances in Automated Testing
      • 4.3.4 Increased Focus on Safety of Blood Supply
      • 4.3.5 Development of Emerging Markets for NAT Technology
      • 4.3.6 Cancer
      • 4.3.7 Human Leukocyte Antigen Typing
      • 4.3.8 Neonatal Screening
    • 4.4 Drivers and Restraints
    • 4.5 Market Forecast
    • 4.6 Business Trends in the Industry
      • 4.6.1 Molecular Diagnostics Industry Trends
        • 4.6.1.1 Adoption of Amplified Screening Technology
        • 4.6.1.2 Advances in Automated Testing
        • 4.6.1.3 Responsiveness to Newly Emerging Threats
        • 4.6.1.4 Increased Focus on Safety of Blood Supply
        • 4.6.1.5 Growth in Viral Load Testing
        • 4.6.1.6 Development of Emerging Markets for NAT Technology
        • 4.6.1.7 Improvements in Detection Technologies
      • 4.6.2 Pharmaceuticals Industry Trends
      • 4.6.3 Acquisitions, License Agreements and Partnerships
      • 4.6.4 Ethical, Legal and Social Issues Related to the Use of Genetic Information
      • 4.6.5 Regulatory Issues
  • 5. New Products Under Development
    • 5.1 Gene Expression Profiling
    • 5.2 Proteomic Multiplex Assays
    • 5.3 Solution-Phase Multiplexing
    • 5.4 RNA Interference (RNAi)
      • 5.4.1 Role of RNAi in Drug Target Validation
      • 5.4.2 Other Companies Involved in the RNAi Market
    • 5.5 DNA Tags
  • 6. Market Trends and Forecasts
    • 6.1 Market Dynamics
      • 6.1.1 Technological Perspective on Molecular Diagnostics
      • 6.1.2 Molecular Diagnostics Market Opportunities
      • 6.1.3 Market Forces
        • 6.1.3.1 Adoption of Amplified Screening Technology
        • 6.1.3.2 Advances in Automated Testing
        • 6.1.3.3 Responsiveness to Newly Emerging Threats
        • 6.1.3.4 Increased Focus on Safety of Blood Supply
        • 6.1.3.5 Growth in Viral Load Testing
        • 6.1.3.6 Development of Emerging Markets for NAT Technology
        • 6.1.3.7 Improvements in Detection Technologies
    • 6.2 Future Considerations for Molecular Diagnosis
    • 6.3 Role of Genomics in Transforming Pharmaceutical R&D
    • 6.4 Cancer Markers
    • 6.5 Cytology Markers
    • 6.6 RNA Detection
    • 6.7 Diagnosis of Inherited Disease
    • 6.8 Ethical Considerations
    • 6.9 NAT and Personalized Medicine
    • 6.10 Five Molecular Diagnostics Growth Areas
    • 6.11 Specific Commercial Nucleic Acid Probes
    • 6.12 Novel Amplification Techniques on the Market
    • 6.13 Ramification Amplification Method (RAM)
    • 6.14 Invader Assays/Third Wave Technologies
    • 6.15 Molecular Beacons
    • 6.16 HLA Sequencing-Based Typing Kits
    • 6.17 Prenatal Diagnosis
    • 6.18 Newborn Screening
    • 6.19 NAT and Preventive Medicine: NAT-Based Assays
    • 6.20 Prenatal and Preimplantation Diagnosis
    • 6.21 FISH-Based Tests on Fetal Cells
    • 6.22 Companion Therapeutic/Diagnostic Approach
  • 7. Corporate Directory
    • 7.1 Abbott Laboratories
    • 7.2 Affymetrix
    • 7.3 Agilent Technologies
    • 7.4 Ambion
    • 7.5 Applied Biosystems Group
    • 7.6 Bayer
    • 7.7 Beckman Coulter
    • 7.8 BioMrieux
    • 7.9 Bio-Rad Laboratories
    • 7.10 Biotage
    • 7.11 Biotest
    • 7.12 Caliper Life Sciences
    • 7.13 Cellomics
    • 7.14 Cepheid
    • 7.15 Chiron
    • 7.16 Ciphergen Biosystems
    • 7.17 CuraGen
    • 7.18 Cytocell Technologies
    • 7.19 Dako A/S (formerly DakoCytomation A/S)
    • 7.20 DiaDexus
    • 7.21 Digene
    • 7.22 Enzo Biochem
    • 7.23 Epigenomics
    • 7.24 Epoch Biosciences
    • 7.25 EraGen Biosciences
    • 7.26 Eurogentec
    • 7.27 Exiqon
    • 7.28 Gene Link
    • 7.29 Gene Logic
    • 7.30 GeneOhm Sciences
    • 7.31 Genisphere
    • 7.32 Gen-Probe
    • 7.33 Genzyme
    • 7.34 Hamilton Thorne Biosciences
    • 7.35 ID Biomedical
    • 7.36 Illumina
    • 7.37 Incyte
    • 7.38 Innogenetics
    • 7.39 BioGenex
    • 7.40 Interleukin Genetics
    • 7.41 Invitrogen
    • 7.42 Kreatech Biotechnology
    • 7.43 LabCorp
    • 7.44 LI-COR Biosciences
    • 7.45 Matritech
    • 7.46 Meridian Bioscience
    • 7.47 Monogram Biosciences
    • 7.48 Motorola
    • 7.49 MWG Biotech
    • 7.50 Myriad Genetics
    • 7.51 Nanogen
    • 7.52 Nanosys
    • 7.53 NimbleGen Systems
    • 7.54 Nuvelo
    • 7.55 Nymox Pharmaceutical
    • 7.56 Orchid BioSciences
    • 7.57 Orchid Cellmark
    • 7.58 Organon International
    • 7.59 Ortho-Clinical Diagnostics
    • 7.60 Ostex International
    • 7.61 PerSeptive Biosystems
    • 7.62 PharMingen
    • 7.63 PPD
    • 7.64 PPGx (DNA Sciences Laboratories)
    • 7.65 Prodesse
    • 7.66 Professional Genetics Laboratory
    • 7.67 Promega
    • 7.68 QIAGEN
    • 7.69 Quantum Biotechnologies
    • 7.70 Quidel
    • 7.71 Response Biomedical
    • 7.72 Roche Diagnostics
    • 7.73 Sequenom
    • 7.74 SurModics
    • 7.75 Tepnel Life Sciences
    • 7.76 Thermo Electron
    • 7.77 Third Wave Technologies
    • 7.78 Tm Bioscience
    • 7.79 Visible Genetics
    • 7.80 Vysis
    • 7.81 VisiGen Biotechnologies
    • 7.9 Alternative Sequencing Companies
      • 7.9.1 Callida Genomics Inc.
      • 7.9.2 Mobious Genomics Ltd.
      • 7.9.3 Perlegen Sciences Inc.
      • 7.9.4 Solexa Ltd.
      • 7.9.5 U.S. Genomics Inc.
  • 8. Market Overview
    • 8.1 Global Molecular Diagnostics Testing Market
    • 8.2 U.S. Molecular Diagnostics Testing Market
    • 8.3 Japanese Molecular Diagnostics Testing Market
    • 8.4 Rest-of-World (ROW) Molecular Diagnostics Testing Market
    • 8.5 Overview of the Asian Healthcare Market
      • 8.5.1 Singapore
      • 8.5.2 Malaysia
      • 8.5.3 Thailand
      • 8.5.4 Indonesia
      • 8.5.5 Philippines
      • 8.5.6 South Korea
      • 8.5.7 India
      • 8.5.8 Hong Kong
      • 8.5.9 Taiwan
      • 8.5.10 China
    • Appendix 1. Biowarfare Agents
    • Anthrax
    • Botulinum Toxins
    • Brucellosis
    • Cholera
    • Clostridium Perfringens Toxins
    • Congo-Crimean Hemorrhagic Fever
    • Ebola Haemorrhagic Fever
    • Melioidosis
    • Plague
    • Q Fever
    • Ricin
    • Rift Valley Fever
    • Saxitoxin
    • Smallpox
    • Staphylococcal Enterotoxin B (SEB)
    • Trichothecene Mycotoxins
    • Tularemia
    • Venezuelan Equine Encephalitis (VEE)
  • LIST OF FIGURES
    • Figure 2.1: Segment of Double-Stranded DNA Showing the Base-Pair Relationship
    • Figure 3.1: Applications of Molecular Diagnostics Technology Platforms
    • Figure 3.2: Overall Structure of Nucleic Acid Testing Market
    • Figure 3.3: Serologic and Clinical Course of Acute HBV Infection
    • Figure 3.4: Primary Causes of Chronic Liver Disease
    • Figure 3.5: Time Course of Markers in Typical HCV Infection
    • Figure 3.6: Bacillus anthracis
  • LIST OF TABLES
    • Table 3.1: Global Market for Molecular Diagnostics Testing
    • Table 3.2: Global Market for Nucleic Acid Testing
    • Table 3.3: Summary of Molecular Diagnostics Testing, 2004
    • Table 3.4: Annual U.S. Market for DNA Probe Diagnostics
    • Table 3.5: Annual Global Market for DNA Probe Diagnostics
    • Table 3.6: Estimated Market Share of Major Competitors in U.S. DNA/PCR Kit Research Market
    • Table 3.7: Estimated Market Share of Major Competitors in U.S. DNA/PCR Kit Diagnostics Market
    • Table 3.8: Roche PCR Licenses
    • Table 3.9: DNA Probe Market Segments in the U.S.
    • Table 3.10: Companies Marketing Products Using DNA Probes
    • Table 3.11: Global Sales of DNA Probe Kits
    • Table 3.12: Companies Marketing DNA Detection Platforms
    • Table 3.13: Companies Marketing Genotyping Technologies
    • Table 3.14: Companies Marketing Clinical Genotyping Technologies
    • Table 3.15: Summary of Assays for HIV Viral Load Testing
    • Table 3.16: Global Market for HIV Diagnostic Testing
    • Table 3.17: U.S. Market for HIV Diagnostic Testing
    • Table 3.18: Serologic Diagnosis of HBV Infections*
    • Table 3.19: Unusual HBV Serologic Profiles Requiring Further Evaluation
    • Table 3.20: Recommendations for HBV Diagnostic Testing
    • Table 3.21: Lower Detection Limits of HBV DNA Assays
    • Table 3.22: Recommendations for HBV Testing
    • Table 3.23: Recommendations for HCV Diagnostic Testing
    • Table 3.24: Important HCV Statistics
    • Table 3.25: Gen-Probe Clinical Diagnostic Products for the Detection of Viral Microorganisms
    • Table 3.26: Global Market for HAV Diagnostic Testing
    • Table 3.27: U.S. Market for HAV Diagnostic Testing
    • Table 3.28: Global Market for HBV Diagnostic Testing
    • Table 3.29: U.S. Market for HBV Diagnostic Testing
    • Table 3.30: Global Market for HCV Diagnostic Testing
    • Table 3.31: U.S. Market for HCV Diagnostic Testing
    • Table 3.32: Global Market for SARS Diagnostics Testing
    • Table 3.33: U.S. Market for SARS Diagnostics Testing
    • Table 3.34: Global Market for Molecular Diagnostics Cancer Testing
    • Table 3.35: Annual Volume of Infectious Disease NAT Testing
    • Table 3.36: Global Market Dollar Volume of NAT STD Testing
    • Table 3.37: U.S. Market Dollar Volume of NAT STD Testing
    • Table 3.38: U.S. Market Share of NAT STD Testing
    • Table 3.39: Global Market for Chlamydia Diagnostic Testing
    • Table 3.40: U.S. Market for Chlamydia Diagnostic Testing
    • Table 3.41: Global Market for Gonorrhea Diagnostic Testing
    • Table 3.42: Global Market for TB Diagnostic Testing
    • Table 3.43: Global Market for DNA Group B Streptococcus Diagnostic Testing
    • Table 3.44: U.S. Market for Group B Streptococcus Diagnostic Testing
    • Table 3.45: Gen-Probe Clinical Diagnostic Products for the Detection of Non-Viral Microorganisms
    • Table 3.46: Global Market for Blood-Screening Diagnostic Testing
    • Table 3.47: U.S. Market for Blood-Screening Diagnostic Testing
    • Table 3.48: Gen-Probe Blood-Screening Products
    • Table 3.49: Leading Players in SNP Genotyping
    • Table 3.50: Global Market for SNP Genotyping
    • Table 3.51: DNA-Analysis Market Competitors
    • Table 3.52: Leading Companies in Medical Utility of SNPs
    • Table 3.53: Competitors in the Field of Identity Genomics Testing
    • Table 3.54: U.S. Market for Food-Screening Diagnostic Testing Using Molecular Diagnostics Techniques
    • Table 3.55: Methods for Detection of Salmonella in Food Using Molecular Diagnostics Methods
    • Table 3.56: U.S. Market for Forensic Analytical Testing Products, Instruments and Supplies, 2004, 2005 and 2010
    • Table 3.57: U.S. Market for Forensic Diagnostics Testing
    • Table 3.58: U.S. Market for Biological Threat Detection Testing
    • Table 3.59: Biotest Reagents
    • Table 3.60: Variation of CF Carrier Risks by Ethnic Group
    • Table 3.61: Reasons for CF Testing
    • Table 3.62: Variation of CF Detection Rates by Ethnic Background
    • Table 3.63: Global Market for CF Diagnostic Testing
    • Table 3.64: U.S. Market for CF Diagnostic Testing
    • Table 3.65: Commercial CF-Screening Products
    • Table 3.66: Emerging CF-Screening Products
    • Table 3.67: CF Screening Technology Summary
    • Table 3.68: U.S. Market for HLA Type Testing
    • Table 3.69: Competitors in HLA Testing
    • Table 3.70: U.S. Market for NAT Genetic-Disease Testing
    • Table 3.71: Non-U.S. Market for NAT Genetic-Disease Testing
    • Table 3.72: U.S. Market for NAT Cytogenetic-Disease Testing
    • Table 3.73: Non-U.S. Market for NAT Cytogenetic-Disease Testing
    • Table 3.74: Carrier Rates of Common HFE Mutations in Caucasians
    • Table 3.75: Results and Diagnosis for Fragile X Syndrome
    • Table 3.76: Principal Competitors in Pharmacogenetics R&D for Personalized Medicine
    • Table 3.77: Principal Competitors in Pharmacogenetics Patient Testing
    • Table 4.1: DNA-Sequencing Market Players
    • Table 4.2: Global Market for DNA Chips, 2000 to 2007
    • Table 4.3: Top Ten Companies for Molecular Diagnostics Patents
    • Table 6.1: Companies Licensed to Sell Custom Molecular Beacon Probes
    • Table 7.1: Products Marketed by Abbott in the Diagnostics Market
    • Table 7.2: Summary of Selected Affymetrix Expression-Profiling Customers
    • Table 7.3: CuraGen Products and Applications
    • Table 7.4: PACE Product Sales as a Percentage of Total Company Revenue, 2000 to 2003
    • Table 7.5: Innogenetics HLA Products for Genetic Testing and Transplantation
    • Table 7.6: Nanogen Product Sales
    • Table 7.7: Rarely-Expressed Genes as Therapeutic Product Candidates
    • Table 7.8: Roche Diagnostics Key Products
    • Table 7.9: Sales by Region
    • Table 7.10: Sales by Business Area
    • Table 7.11: Product Line Sales 2005
    • Table 7.12: Growth Drivers
    • Table 8.1: Number of Molecular Diagnostics Tests in the U.S.
    • Table 8.2: Ten Largest Diagnostics Companies Worldwide, 2004
    • Table 8.3: Global Molecular Diagnostics Testing Revenues
    • Table 8.4: Global Distribution of Molecular Diagnostics Testing, 2004
    • Table 8.5: U.S. Molecular Diagnostics Testing Market
    • Table 8.6: Japanese Molecular Diagnostics Testing Market
    • Table 8.7: ROW Molecular Diagnostics Testing Market
    • Table 8.8: Chinese Molecular Diagnostics Products Market Sales