Molecular Diagnostics Markets

Table of Contents

1. Overview

• 1.1 Statement of Report
• 1.2 About This Report
• 1.3 Scope of the Report
• 1.4 Objectives
• 1.5 Methodology
• 1.6 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
  • 2.7.1 Gene-based Amplification Technologies
  • 2.7.2 Detection of Amplified Gene Products
  • 2.7.3 Target-Based Gene Amplification
    • 2.7.3.1 Polymerase Chain Reaction
    • 2.7.3.2 Real-time PCR
    • 2.7.3.3 Nucleic Acid Sequence-Based Amplification
  • 2.7.4 Probe-Based Amplification
    • 2.7.4.1 Ligase Chain Reaction
    • 2.7.4.2 Strand Displacement Amplification
    • 2.7.4.3 Qβ-replicase Amplified Probe Assay
  • 2.7.5 Signal-Based Amplification
    • 2.7.5.1 Branched DNA (bDNA)
  • 2.7.6 Other Gene Amplification Technologies
    • 2.7.6.1 Immuno-PCR
    • 2.7.6.2 Bio-Barcode Assay

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 A Sampling of 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 Methicillin-resistant Staphylococcus Aureus
  • 3.2.6 Blood Screening
• 3.3 SNPs in Clinical Diagnostics
  • 3.3.1 Functional Genomics
  • 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
  • 3.11.1 Coumadin
• 3.12 Thrombic Disorders

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 Pharmaceutical 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
  • 4.6.6 Reimbursement Issues
    • 4.6.6.1 Cystic Fibrosis
    • 4.6.6.2 Viral Load Testing
    • 4.6.6.3 NMP22
    • 4.6.6.4 iFOB Reimbursement

5. Molecular Diagnostics Automated Instrumentation Approved for Market by the FDA

• 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 in 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 Pre-implantation Diagnosis
• 6.21 FISH-Based Tests on Fetal Cells
• 6.22 Companion Therapeutic/Diagnostic Approach
• 6.23 Sample Preparation Market

7. Corporate Directory

• 7.1 Abbott Laboratories
• 7.2 Affymetrix
• 7.3 Agendia
• 7.4 Agilent Technologies
• 7.5 Ambion
• 7.6 Applied Biosystems Group
• 7.7 Beckman Coulter
• 7.8 BioGenex
• 7.9 bioMérieux
• 7.10 Bio-Rad Laboratories
• 7.11 Biotage
• 7.12 Biotest
• 7.13 Caliper Life Sciences
• 7.14 Celera Group
• 7.15 Cellomics
• 7.16 Cepheid
• 7.17 Chiron (Novartis)
• 7.18 Ciphergen Biosystems
• 7.19 CuraGen
• 7.20 Cytocell Technologies
• 7.21 Dako A/S (formerly DakoCytomation A/S)
• 7.22 DiaDexus
• 7.23 Digene
• 7.24 Enzo Biochem
• 7.25 Epigenomics
• 7.26 Epoch Biosciences
• 7.27 EraGen Biosciences
• 7.28 Eurogentec
• 7.29 Exiqon
• 7.30 Gene Link
• 7.31 Gene Logic
• 7.32 GeneOhm Sciences
• 7.33 Genisphere
• 7.34 Gen-Probe
• 7.35 Genzyme
• 7.36 Hamilton Thorne Biosciences
• 7.37 ID Biomedical
• 7.38 Illumina
• 7.39 Incyte
• 7.40 Innogenetics
• 7.41 Interleukin Genetics
• 7.42 Invitrogen
• 7.43 Kreatech Biotechnology
• 7.44 LabCorp
• 7.45 LI-COR Biosciences
• 7.46 Matritech
• 7.47 Meridian Bioscience
• 7.48 Monogram Biosciences
• 7.49 Motorola
• 7.50 MWG Biotech
• 7.51 Myriad Genetics
• 7.52 Nanogen
• 7.53 Nanosys
• 7.54 NimbleGen Systems
• 7.55 Nuvelo
• 7.56 Nymox Pharmaceutical
• 7.57 Orchid BioSciences
• 7.58 Orchid Cellmark
• 7.59 Organon International
• 7.60 Ortho-Clinical Diagnostics
• 7.61 Ostex International
• 7.62 PerSeptive Biosystems
• 7.63 PharMingen
• 7.64 PPD
• 7.65 PPGx (DNA Sciences Laboratories)
• 7.66 Prodesse
• 7.67 Professional Genetics Laboratory
• 7.68 Promega
• 7.69 QIAGEN
• 7.70 Quantum Biotechnologies
• 7.71 Quidel
• 7.72 Response Biomedical
• 7.73 Roche Diagnostics
• 7.74 Siemens
• 7.75 Sequenom
• 7.76 SurModics
• 7.77 Tepnel Life Sciences
• 7.78 Thermo Fisher Scientific
• 7.79 Third Wave Technologies
• 7.80 Tm Bioscience
• 7.81 Visible Genetics
• 7.82 VisiGen Biotechnologies
• 7.83 Vysis
• 7.84 Alternative Sequencing Companies
• 7.84.1 Callida Genomics, Inc.
• 7.84.2 Mobious Genomics, Ltd.
• 7.84.3 Perlegen Sciences, Inc.
• 7.84.4 Solexa, Ltd.
• 7.84.5 U.S. Genomics, Inc.

8. Market Overview

• 8.1 Snapshot of Molecular Diagnostics Industry Structure
• 8.2 Global Molecular Diagnostics Testing Market
• 8.3 U.S. Molecular Diagnostics Testing Market
• 8.4 European Molecular Diagnostics Market
• 8.5 Japanese Molecular Diagnostics Testing Market
• 8.6 Overview of the European Molecular Diagnostics Country Markets
  • 8.6.1 France
  • 8.6.2 Germany
  • 8.6.3 The United Kingdom
  • 8.6.4 Italy
  • 8.6.5 Spain

• Appendix 1: Biowarfare Agents

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: Combination Therapy in Typical HCV Infection
• Figure 3.6: Time Course of Markers in Typical HCV Infection
• Figure 3.7: Bacillus anthracis
• Figure 8.1: Molecular Diagnostics Market Segmentation
• Figure 8.2: Molecular Diagnostics Market Segmentation by Technology
• Figure 8.3: Breakout of the Molecular Diagnostics Marketplace
• Figure 8.4: U.S. Molecular Diagnostics Market Segments 2007

LIST OF TABLES

• Table 3.1: Global Market for Molecular Diagnostics Testing, 2000 to 2012
• Table 3.2: U.S. Market for Molecular Diagnostics Testing, 2004 to 2012
• Table 3.3: Global Market for Nucleic Acid Testing, 2000 to 2012
• Table 3.4: Summary of Molecular Diagnostics Testing
• Table 3.5: Annual U.S. Market for DNA Probe Diagnostics, 1998 to 2012
• Table 3.6: Annual Global Market for DNA Probe Diagnostics, 1998 to 2009
• Table 3.7: Estimated Market Share of Major Competitors in U.S. DNA/PCR Kit Research Market
• Table 3.8: Estimated Market Share of Major Competitors in U.S. DNA/PCR Kit Diagnostics Market
• Table 3.9: Roche PCR Licenses
• Table 3.10: DNA Probe Market Segments in the U.S.
• Table 3.11: Companies Marketing Products Using DNA Probes
• Table 3.12: Companies Marketing Multiple Products in Molecular Diagnostics Sector
• Table 3.13: Global Sales of DNA Probe Kits, 1998 to 2005
• Table 3.14: Companies Marketing DNA Detection Platforms
• Table 3.15: Companies Marketing Genotyping Technologies
• Table 3.16: Companies Marketing Clinical Genotyping Technologies
• Table 3.17: Summary of Assays for HIV Viral Load Testing
• Table 3.18: Global Market for HIV Diagnostic Testing, 2000 to 2012
• Table 3.19: U.S. Market for HIV Diagnostic Testing, 2000 to 2012
• Table 3.20: Serologic Diagnosis of HBV Infections*
• Table 3.21: Unusual HBV Serologic Profiles Requiring Further Evaluation
• Table 3.22: Recommendations for HBV Diagnostic Testing
• Table 3.23: Lower Detection Limits of HBV DNA Assays
• Table 3.24: Recommendations for HCV Diagnostic Testing
• Table 3.25: Important HCV Statistics
• Table 3.26: Global Market for HAV Diagnostic Testing, 2000 to 2008
• Table 3.27: U.S. Market for HAV Diagnostic Testing, 2000 to 2008
• Table 3.28: Global Market for HBV Diagnostic Testing, 2000 to 2008
• Table 3.29: U.S. Market for HBV Diagnostic Testing, 2000 to 2008
• Table 3.30: Global Market for HCV Diagnostic Testing, 2000 to 2008
• Table 3.31: U.S. Market for HCV Diagnostic Testing, 2000 to 2008
• Table 3.32: Global Market for SARS Diagnostics Testing, 2002 to 2008
• Table 3.33: U.S. Market for SARS Diagnostics Testing, 2002 to 2008
• Table 3.34: Global Market for Molecular Diagnostics Cancer Testing, 2000 to 2008
• Table 3.35: Annual Volume of NAT Infectious Disease Testing, 2000 to 2008
• Table 3.36: Global Market Dollar Volume of NAT STD Testing, 2000 to 2008
• Table 3.37: U.S. Market Dollar Volume of NAT STD Testing, 2000 to 2009
• Table 3.38: U.S. Market Share of NAT STD Testing
• Table 3.39: Global Market for Chlamydia Diagnostic Testing, 2000 to 2009
• Table 3.40: U.S. Market for Chlamydia Diagnostic Testing, 2000 to 2009
• Table 3.41: Global Market for Gonorrhea Diagnostic Testing, 2000 to 2008
• Table 3.42: Global Market for TB Diagnostic Testing, 2000 to 2008
• Table 3.43: Global Market for DNA Group B Streptococcus Diagnostic Testing, 2000 to 2009
• Table 3.44: U.S. Market for Group B Streptococcus Diagnostic Testing, 2000 to 2009
• Table 3.45: Gen-Probe Clinical Diagnostic Products for the Detection of Non-Viral Micro-organisms
• Table 3.46: Global Market for Blood-Screening Diagnostic Testing, 2000 to 2008
• Table 3.47: U.S. Market for Blood-Screening Diagnostic Testing, 2000 to 2008
• Table 3.48: Leading Players in SNP Genotyping
• Table 3.49: Global Market for SNP Genotyping, 2000 to 2011
• Table 3.50: DNA-Analysis Market Competitors
• Table 3.51: Leading Companies in Medical Utility of SNPs
• Table 3.52: Competitors in the Field of Identity Genomics Testing
• Table 3.53: U.S. Market for Food-Screening Diagnostic Testing Using Molecular Diagnostics Techniques, 2000 to 2008
• Table 3.54: Methods for Detection of Salmonella in Food Using Molecular Diagnostics Methods
• Table 3.55: U.S. Market for Forensic Diagnostics Testing, 2000 to 2010
• Table 3.56: U.S. Market for Biological Threat Detection Testing, 2000 to 2010
• Table 3.57: Biotest Reagents
• Table 3.58: Variation of CF Carrier Risks by Ethnic Group
• Table 3.59: Reasons for CF Testing
• Table 3.60: Variation of CF Detection Rates by Ethnic Background
• Table 3.61: Global Market for CF Diagnostic Testing, 2000 to 2008
• Table 3.62: U.S. Market for CF Diagnostic Testing, 2000 to 2008
• Table 3.63: Commercial CF-Screening Products
• Table 3.64: Emerging CF-Screening Products
• Table 3.65: CF Screening Technology Summary
• Table 3.66: U.S. Market for HLA Type Testing, 2000 to 2008
• Table 3.67: Competitors in HLA Testing
• Table 3.68: U.S. Market for NAT Genetic-Disease Testing, 2000 to 2008
• Table 3.69: Non-U.S. Market for NAT Genetic-Disease Testing, 2000 to 2008
• Table 3.70: U.S. Market for NAT Cytogenetic-Disease Testing, 2000 to 2008
• Table 3.71: Non-U.S. Market for NAT Cytogenetic-Disease Testing, 2000 to 2008
• Table 3.72: Carrier Rates of Common HFE Mutations in Caucasians
• Table 3.73: Results and Diagnosis for Fragile X Syndrome
• Table 3.74: Principal Competitors in Pharmacogenetics R&D for Personalized Medicine
• Table 3.75: 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 6.2: U.S. Sample Preparation Market, 2005 to 2012
• Table 7.1: Products Marketed by Abbott in the Diagnostics Market
• Table 7.2: Summary of Selected Affymetrix Expression-Profiling Customers
• Table 7.3: PACE Product Sales as a Percentage of Total Company Revenue, 2000 to 2005
• Table 7.4: Innogenetics HLA Products for Genetic Testing and Transplantation
• Table 7.5: Nanogen Product Sales, 2000 to 2006
• Table 7.6: Rarely-Expressed Genes as Therapeutic Product Candidates
• Table 7.7: Roche Diagnostics Key Products
• Table 7.8: Sales by Region
• Table 7.9: Sales by Business Area
• Table 7.10: Product Line Sales 2005
• Table 7.11: Growth Drivers
• Table 8.1: Number of Molecular Diagnostics Tests in the U.S., 2000 to 2008
• Table 8.2: Global Molecular Diagnostics Testing Revenues, 2000 to 2012
• Table 8.3: Global Distribution of Molecular Diagnostics Testing
• Table 8.4: U.S. Molecular Diagnostics Testing Market, 2004 to 2012
• Table 8.5: European Molecular Diagnostics Testing Market, 2005 to 2012
• Table 8.6: Japanese Molecular Diagnostics Testing Market, 2005 to 2012