Examine the Molecular Diagnostics Markets
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Molecular Diagnostics Markets
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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 BioMA-A?A 1/2rieux 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 GeneticsVysis 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(r) 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
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Molecular Diagnostics Markets
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