Molecular Diagnostics Markets

Molecular Diagnostics Markets

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 TriMark Publications 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;

4) focusing on global industry development through an in-depth analysis of the major world markets for molecular diagnostics, including growth forecasts.

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

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
3.2.5 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 Motorola 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 Growth in Viral Load Testing
4.3.6 Development of Emerging Markets for NAT Technology
4.3.7 Cancer
4.3.8 Human Leukocyte Antigen Typing
4.3.9 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 Three 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
Abbott Laboratories
Affymetrix
Agilent Technologies
Ambion
Applied Biosystems Group
Bayer
Beckman Coulter
BioMérieux
Bio-Rad Laboratories
Biotage
Biotest
Caliper Life Sciences
Cellomics
Cepheid
Chiron
Ciphergen Biosystems
CuraGen
Cytocell Technologies
DakoCytomation A/S
DiaDexus
Digene
Enzo Biochem
Epigenomics
Epoch Biosciences
EraGen Biosciences
Eurogentec
Exiqon
Gene Link
Gene Logic
GeneOhm Sciences
Genisphere
Gen-Probe
Genzyme General
Hamilton Thorne Biosciences
ID Biomedical
Illumina
Incyte
Innogenetics
InnoGenex
Interleukin Genetics
Invitrogen
Kreatech Biotechnology
LabCorp
LI-COR Biosciences
Matritech
Meridian Bioscience
Millennium Predictive Medicine
Monogram Biosciences
Motorola
MWG Biotech
Myriad Genetics
Nanogen
Nanosys
NimbleGen Systems
Nuvelo
Nymox Pharmaceutical
Orchid BioSciences
Orchid Cellmark
Organon International
Ortho-Clinical Diagnostics
Ostex International
PerSeptive Biosystems
PharMingen
PPD
PPGx (DNA Sciences Laboratories)
Prodesse
Professional Genetics Laboratory
Promega
QIAGEN
Quantum Biotechnologies
Quidel
Response Biomedical
Roche Molecular Systems
Sequenom
SurModics
Tepnel Life Sciences
Thermo Electron
Third Wave Technologies
Tm Bioscience
Visible Genetics
Vysis
VisiGen Biotechnologies
Callida Genomics Inc.
Mobious Genomics Ltd.
Perlegen Sciences Inc.
Solexa Ltd.
U.S. Genomics Inc.

8. Market Overview
8.1 Global Molecular Diagnostics Testing Market
8.2 U.S. Molecular Diagnostics Testing Market
8.4 Japanese Molecular Diagnostics Testing Market
8.5 Rest-of-World (ROW) Molecular Diagnostics Testing Market
8.6 Overview of the Asian Healthcare Market
8.6.1 Singapore
8.6.2 Malaysia
8.6.3 Thailand
8.6.4 Indonesia
8.6.5 Philippines
8.6.6 South Korea
8.6.7 India
8.6.8 Hong Kong
8.6.9 Taiwan
8.6.10 China

Appendix 1. Roche Molecular Diagnostics: Chronology of PCR Technology
Appendix 2. Roche Diagnostics’ Recent Partnerships and Strategic Alliances
Appendix 3. Roche Molecular Diagnostics Licensing Programs
Appendix 4. Roche Molecular Diagnostics Patent Portfolio
Appendix 5. 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 1. Segment of Double-Stranded DNA Showing the Base-Pair Relationship
Figure 2: Applications of Molecular Diagnostics Technology Platforms
Figure 3: Overall Structure of Nucleic Acid Testing Market
Figure 4: Serologic and Clinical Course of Acute HBV Infection
Figure 5: Primary Causes of Chronic Liver Disease
Figure 6: Time Course of Markers in Typical HCV Infection
Figure 7: Bacillus anthracis

LIST OF TABLES 

Table 1: Global Market for Molecular Diagnostics Testing
Table 2: Global Market for Nucleic Acid Testing
Table 3: Summary of Molecular Diagnostics Testing, 2004
Table 4: Annual U.S. Market for DNA Probe Diagnostics
Table 5: Annual Global Market for DNA Probe Diagnostics
Table 6: Estimated Market Share of Major Competitors in U.S. DNA/PCR Kit Research Market
Table 7: Estimated Market Share of Major Competitors in U.S. DNA/PCR Kit Diagnostics Market
Table 8: Roche PCR Licenses
Table 9: DNA Probe Market Segments in the U.S.
Table 10: Companies Marketing Products Using DNA Probes
Table 11: Global Sales of DNA Probe Kits
Table 12: Companies Marketing DNA Detection Platforms
Table 13: Companies Marketing Genotyping Technologies
Table 14: Companies Marketing Clinical Genotyping Technologies
Table 15: Summary of Assays for HIV Viral Load Testing
Table 16: Global Market for HIV Diagnostic Testing
Table 17: U.S. Market for HIV Diagnostic Testing
Table 18: Serologic Diagnosis of HBV Infections*
Table 19: Unusual HBV Serologic Profiles Requiring Further Evaluation
Table 20: Recommendations for HBV Diagnostic Testing
Table 21: Lower Detection Limits of HBV DNA Assays
Table 22: Recommendations for HBV Testing
Table 23: Recommendations for HCV Diagnostic Testing
Table 24: Important HCV Statistics
Table 25: Gen-Probe Clinical Diagnostic Products for the Detection of Viral Microorganisms
Table 26: Global Market for HAV Diagnostic Testing
Table 27: U.S. Market for HAV Diagnostic Testing
Table 28: Global Market for HBV Diagnostic Testing
Table 29: U.S. Market for HBV Diagnostic Testing
Table 30: Global Market for HCV Diagnostic Testing
Table 31: U.S. Market for HCV Diagnostic Testing
Table 32: Global Market for SARS Diagnostics Testing
Table 33: U.S. Market for SARS Diagnostics Testing
Table 34: Global Market for Molecular Diagnostics Cancer Testing
Table 35: Annual Volume of Infectious Disease NAT Testing
Table 36: Global Market Dollar Volume of NAT STD Testing
Table 37: U.S. Market Dollar Volume of NAT STD Testing
Table 38: U.S. Market Share of NAT STD Testing
Table 39: Global Market for Chlamydia Diagnostic Testing
Table 40: U.S. Market for Chlamydia Diagnostic Testing
Table 41: Global Market for Gonorrhea Diagnostic Testing
Table 42: Global Market for TB Diagnostic Testing
Table 43: Global Market for DNA Group B Streptococcus Diagnostic Testing
Table 44: U.S. Market for Group B Streptococcus Diagnostic Testing
Table 45: Gen-Probe Clinical Diagnostic Products for the Detection of Non-Viral Microorganisms
Table 46: Global Market for Blood-Screening Diagnostic Testing
Table 47: U.S. Market for Blood-Screening Diagnostic Testing
Table 48: Gen-Probe Blood-Screening Products
Table 49: Leading Players in SNP Genotyping
Table 50: Global Market for SNP Genotyping
Table 51: DNA-Analysis Market Competitors
Table 52: Leading Companies in Medical Utility of SNPs
Table 53: Competitors in the Field of Identity Genomics Testing
Table 54: U.S. Market for Food-Screening Diagnostic Testing Using Molecular Diagnostics Techniques
Table 55: Methods for Detection of Salmonella in Food Using Molecular Diagnostics Methods
Table 56: U.S. Market for Forensic Analytical Testing Products, Instruments and Supplies, 2004, 2005 and 2010
Table 57: U.S. Market for Forensic Diagnostics Testing
Table 58: U.S. Market for Biological Threat Detection Testing
Table 59: Biotest Reagents
Table 60: Variation of CF Carrier Risks by Ethnic Group
Table 61: Reasons for CF Testing
Table 62: CF Testing Methodology
Table 63: Variation of CF Detection Rates by Ethnic Background
Table 64: Global Market for CF Diagnostic Testing
Table 65: U.S. Market for CF Diagnostic Testing
Table 66: Commercial CF-Screening Products
Table 67: Emerging CF-Screening Products
Table 68: CF Screening Technology Summary
Table 69: U.S. Market for HLA Type Testing
Table 70: Competitors in HLA Testing
Table 71: U.S. Market for NAT Genetic-Disease Testing
Table 72: Non-U.S. Market for NAT Genetic-Disease Testing
Table 73: U.S. Market for NAT Cytogenetic-Disease Testing
Table 74: Non-U.S. Market for NAT Cytogenetic-Disease Testing
Table 75: Carrier Rates of Common HFE Mutations in Caucasians
Table 76: Results and Diagnosis for Fragile X Syndrome
Table 77: Principal Competitors in Pharmacogenetics R&D for Personalized Medicine
Table 78: Principal Competitors in Pharmacogenetics Patient Testing
Table 79: DNA-Sequencing Market Players
Table 80: Global Market for DNA Chips, 2000 to 2007
Table 81: Top Ten Companies for Molecular Diagnostics Patents
Table 82: Companies Licensed to Sell Custom Molecular Beacon Probes
Table 83: Products Marketed by Abbott in the Diagnostics Market
Table 84: Summary of Selected Affymetrix Expression-Profiling Customers
Table 85: Summary of Selected Affymetrix Collaborators and Licensees
Table 86: Summary of Selected Affymetrix GeneChip® Collaborators
Table 87: CuraGen Products and Applications
Table 88: PACE Product Sales as a Percentage of Total Company Revenue, 2000 to 2003
Table 89: Innogenetics HLA Products for Genetic Testing and Transplantation
Table 90: Nanogen Product Sales
Table 91: Rarely-Expressed Genes as Therapeutic Product Candidates
Table 92: Roche Key Products
Table 93: Number of Molecular Diagnostics Tests in the U.S.
Table 94: Ten Largest Diagnostics Companies Worldwide, 2004
Table 95: Global Molecular Diagnostics Testing Revenues
Table 96: Global Distribution of Molecular Diagnostics Testing, 2004
Table 97: U.S. Molecular Diagnostics Testing Market
Table 98: Japanese Molecular Diagnostics Testing Market
Table 99: ROW Molecular Diagnostics Testing Market
Table 100: Chinese Molecular Diagnostics Products Market Sales