Report: Molecular Diagnostics Markets TOC

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

Molecular Diagnostics Markets

Table of Contents

1. Overview

2. Introduction to Molecular Diagnostics and PCR Technology

3. Nucleic Acid Test Applications

4. Trends in Molecular Diagnostics

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

6. Market Trends and Forecasts

7. Corporate Directory

8. Market Overview

LIST OF FIGURES

LIST OF TABLES