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ReportsnReports – Molecular Diagnostics Markets

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The technologies that constitute molecular diagnostics–like first-generation amplification, DNA probes, fluorescent in situ hybridization (FISH), second-generation biochips and microfluidics, …

The technologies that constitute molecular diagnostics–like 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.

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  • 1. Molecular Diagnostics MarketsThe technologies that constitute molecular diagnostics–like first-generation amplification,DNA probes, fluorescent in situ hybridization (FISH), second-generation biochips andmicrofluidics, next-generation signal detection, biosensors, and molecular labels–areinfluencing 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 hasseen several fascinating developments.Buy Now: Molecular Diagnostics MarketsBrowse All: Latest Market Research ReportsThis TriMark Publications report describes the specific market segment of the in vitrodiagnostics market known as molecular diagnostics and includes all of the generallyaccepted 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 asover-the-counter are generally not included in this report, although there is inevitably someoverlap.The main objectives of this analysis are: 1) identifying viable technology drivers through acomprehensive look at platform technologies for molecular diagnostics, including probe-based nucleic acid assays, microarrays and sequencing; 2) obtaining a completeunderstanding of the chief molecular diagnostics tests–i.e., predictive, screening,prognostic, monitoring, pharmacogenomic and theranostic–from their basic principles totheir applications; 3) discovering feasible market opportunities by identifying high-growthapplications in different clinical diagnostic areas and by focusing on expanding markets,such as communicable diseases, cardiology and oncology; and 4) focusing on globalindustry development through an in-depth analysis of the major world markets formolecular diagnostics, including growth forecasts.Table Of Contents1. Overview1.1 Statement of Report1.2 About This Report1.3 Scope of the Report1.4 Objectives1.5 Methodology1.6 Executive Summary2. Introduction to Molecular Diagnostics and PCR Technology2.1 Introduction to Genomics and Its Opportunity2.2 Impact of the Human Genome Project on Molecular Diagnostics2.3 Key Considerations for Molecular Diagnostics2.4 Molecular Diagnostics in the Post-Genomic Era
  • 2. 2.5 Advances in Molecular Diagnostics Technologies2.6 Genetic Variability and Disease2.7 Major Technology Platforms2.7.1 Gene-based Amplification Technologies2.7.2 Detection of Amplified Gene Products2.7.3 Target-based Gene Amplification2.7.3.1 Polymerase Chain Reaction (PCR)2.7.3.2 Real-Time PCR2.7.3.3 Nucleic Acid Sequence-based Amplification (NASBA)2.7.4 Probe-based Amplification2.7.4.1 Ligase Chain Reaction (LCR)2.7.4.2 Strand Displacement Amplification (SDA)2.7.4.3 QB-Replicase Amplified Probe Assay2.7.5 Signal-based Amplification2.7.5.1 Branched DNA (bDNA)2.7.6 Other Gene Amplification Technologies2.7.6.1 Immuno-PCR (IPCR)2.7.6.2 Bio-Barcode Amplification Assay (BCA)2.7.6.3 Hybrid Capture2.7.7 Next Generation Sequencing2.8 PCR Reagents for Clinical Diagnostics3. Nucleic Acid Test Applications3.1 Molecular Diagnostic Testing and Infectious Diseases3.1.1 Genomics Molecular Diagnostics Market3.1.1.1 Methods for DNA Detection and Gene Sequencing3.1.1.2 Products and Applications3.1.1.3 Oncology3.1.2 SNPs and Genes: Medical Utility (Clinical Applications)3.1.2.1 Clinical Application Initiatives3.1.2.2 Sampling of Affymetrix’s Clinical Application Collaborations3.2 Infectious Disease Testing Using Molecular Diagnostics3.2.1 HIV3.2.2 Hepatitis Serologic Markers and Nucleic Acid Testing3.2.2.1 Hepatitis A Virus (HAV)3.2.2.2 Hepatitis B Virus (HBV)3.2.2.2.1 Hepatitis B Market Size3.2.2.3 Hepatitis C Virus (HCV)3.2.2.4 Hepatitis D Virus (HDV)3.2.2.5 Hepatitis E Virus (HEV)3.2.3 Human Papillomavirus (HPV)3.2.4 Influenza Viruses3.2.4.1 H5N1 Influenza Virus3.2.4.2 H1N1 Influenza Virus3.2.5 Cancer Detection Using Molecular Diagnostics3.2.5.1 Lung Cancer3.2.5.2 Oral Cancer3.2.5.3 Prostate Cancer3.2.5.3.1 PCA3
  • 3. 3.2.5.3.2 Companies Active in Molecular Diagnostics and Prostate Cancer Analysis3.2.5.4 Chronic Myelogenous Leukemia3.2.5.5 Malignant Gliomas3.2.5.6 Colorectal Cancer3.2.5.6.1 Background on KRAS Mutation3.2.5.7 Breast Cancer3.2.5.8 Bladder Cancer3.2.5.9 Ovarian Cancer3.2.5.10 Molecular Diagnostic Screening Test for Cancer3.2.5.11 Cervical Cancer3.2.6 Microbiology Testing Using Molecular Diagnostics3.2.6.1 Chlamydia3.2.6.1.1 Revenue Forecasts3.2.6.2 Gonorrhea3.2.6.3 Tuberculosis (TB)3.2.6.4 Group B Streptococcus (GBS)3.2.6.5 Bordetella pertussis3.2.6.6 Legionella pneumophila3.2.6.7 Periodontal Bacteria3.2.6.8 Pneumocystis carinii3.2.6.9 Methicillin-resistant Staphylococcus Aureus (MRSA)3.2.6.10 Clostridium difficile3.2.6.11 Vancomycin-resistant Enterococci (VRE)3.2.6.12 Fungal Infections3.2.6.13 Herpes3.2.6.14 Other Infectious Diseases3.2.7 Blood Screening Using Molecular Diagnostics3.2.7.1 Blood Screening Competitive Positions3.3 Genetics Testing in Molecular Diagnostics3.3.1 Functional Genomics3.3.2 Genetic and Paternity Testing3.4 Molecular Diagnostics Uses in Industrial Testing and Food Diagnostics3.4.1 The Market3.4.2 Detection of Helicobacter pylori by PCR3.4.3 Detection of Escherichia coli 01573.4.4 Detection of Enteric Viruses3.4.5 Industrial Microorganisms3.5 Molecular Diagnostics Forensics Testing Market3.5.1 Analysis by PCR-based DNA Typing3.5.2 Rapid Isolation of DNA for Restriction Fragment Length Polymorphism (RFLP)and PCR3.5.3 DNA for PCR-STR Typing3.6 Bioterrorism and Molecular Diagnostics3.6.1 Introduction3.6.1.1 Current Biological Threat Detection Systems3.6.1.2 Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWAs3.6.1.3 Advantages and Disadvantages of Host Gene Expression Profiling as a BiothreatDetection3.6.2 Biological Warfare Agents (BWAs)3.6.2.1 Anthrax
  • 4. 3.6.2.2 Botulinum Toxin3.6.2.3 Ricin3.6.2.4 IVD Industry and Bioterrorism Preparedness3.6.2.4.1 Brucellosis3.6.2.4.2 Cholera3.6.2.5 Rapid Lateral Flow Immunoassays3.6.2.6 Biosensors3.6.3 Anthrax in Clinical Samples3.6.3.1 Overview of Anthrax and its Infectivity3.6.3.2 Rapid Tests3.7 Cystic Fibrosis Testing3.8 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits3.8.1 Transplantation of Tissues3.9 Molecular Cytogenetic Testing3.9.1 Hereditary Hemochromatosis3.9.2 Apolipoprotein E (ApoE) Genotyping3.9.3 Fragile X Syndrome (FXS)3.9.4 Methylenetetrahydrofolate Reductase (MTHFR) Carrier Testing3.9 5 Other Genetic Testing Procedures3.10 Developments in DNA Biochips for Clinical Applications3.10.1 Product Analysis3.10.2 Breast Cancer DNA Arrays3.10.3 eSensor DNA Detection System3.11 Personalized Medicine, Pharmacogenomics and Molecular Diagnostics Testing3.11.1 Coumadin (Warfarin)3.12 Thrombic Disorders3.13 Respiratory Virus Panel3.14 HFE (Hemochromatosis)3.15 Lupus3.16 Down’s Syndrome and Prenatal Screening3.17 Molecular Diagnostics Technology Platforms and their Impact on Personalized Medicine4. Trends in Molecular Diagnostics4.1 Pharmacogenomics4.1.1 The Market4.1.1.1 Oncology4.1.1.2 Toxicogenomics4.1.2 Market Influences and Forecast4.2 DNA Microarrays4.2.1 Techniques4.2.2 The Market4.2.3 Identification of Sequence SNPs4.2.4 Determining Gene Expression Levels4.2.4.1 Hybridization Tests4.2.4.2 Oligonucleotide Probes4.2.5 Molecular Diagnostics Entry into Point-of-Care (POC) Testing4.3 Emerging Markets of DNA Arrays4.3.1 Pharmacogenomics4.3.2 Adoption of Amplified Screening Technology
  • 5. 4.3.3 Advances in Automated Testing4.3.4 Increased Focus on Safety of Blood Supply4.3.5 Development of Emerging Markets for NAT Technology4.3.6 Cancer4.3.7 Human Leukocyte Antigen (HLA) Typing4.3.8 Neonatal Screening4.4 Drivers and Restraints4.5 Market Forecast4.6 Business Trends in the Industry4.6.1 Molecular Diagnostics Industry Trends4.6.1.1 Adoption of Amplified Screening Technology4.6.1.2 Advances in Automated Testing4.6.1.3 Responsiveness to Newly Emerging Threats4.6.1.4 Increased Focus on Safety of Blood Supply4.6.1.5 Growth in Viral Load Testing4.6.1.6 Development of Emerging Markets for NAT Technology4.6.1.7 Improvements in Detection Technologies4.6.1.8 Use of Multiplex PCR Tests4.6.2 Pharmaceutical Industry Trends4.6.3 Acquisitions, License Agreements and Partnerships4.6.4 Ethical, Legal and Social Issues Related to the Use of Genetic Information4.6.5 Regulatory Issues4.6.5.1 U.S. Food and Drug Administration4.6.5.2 CLIA Regulations4.6.5.3 Clinical Laboratory Improvement Act (CLIA)4.6.5.4 State Licensing for Service Laboratories4.6.5.5 Multivariate Index Assays (IVDMIAs)4.6.5.6 510(k) Clearance4.6.5.6.1 Pre-Market Approval (PMA)4.6.5.7 PMAs4.6.5.8 ASRs4.6.5.9 Laboratory Developed Tests4.6.5.10 What Regulatory Guidance is needed for Companion Biomarkers?4.6.5.11 U.S. Patent and Trademark Office (USPTO)4.6.5.12 IRB Approval in Clinical Trials4.6.5.13 CE marking and the IVDD (European In Vitro Diagnostic Device Directive)4.6.5.14 De Novo Classification4.6.5.15 Research Use Only Reagents4.6.6 Reimbursement Issues and Billing Landscape for Molecular Diagnostics Testing4.6.6.1 Cystic Fibrosis4.6.6.2 Viral Load Testing4.6.6.3 NMP224.6.6.4 Trends in Reimbursement Practice4.6.6.5 Medicare Reimbursement Threats4.7 Patent Protection and Intellectual Property Rights4.7.1 New Patents4.7.2 BRCA1 and BRCA2 Gene Patents4.7.3 Current Patent Disputes4.8 Micoarray Quality Control (MAQC)
  • 6. 5. Molecular Diagnostics Automated Instrumentation Approved for Market by theFDA5.1 Gene Expression Profiling5.2 Proteomic Multiplex Assays5.3 Solution-Phase Multiplexing5.4 RNA Interference (RNAi)5.4.1 Role of RNAi in Drug Target Validation5.4.2 Other Companies involved in the RNAi Market5.5 DNA Tags5.6 Follow-on Optical Technologies6. Market Trends and Forecasts6.1 Market Dynamics6.1.1 Molecular Diagnostics Market Opportunities6.1.2 Market Forces6.2 Future Considerations for Molecular Diagnosis6.3 Role of Genomics in Transforming Pharmaceutical R&D6.4 Cancer Markers6.5 Cytology Markers6.6 RNA Detection6.7 Diagnosis of Inherited Disease6.8 Ethical Considerations6.9 NAT and Personalized Medicine6.10 Five Molecular Diagnostics Growth Areas6.11 Specific Commercial Nucleic Acid Probes6.12 Novel Amplification Techniques in the Market6.13 Ramification Amplification Method (RAM)6.14 Invader Assays/Third Wave Technologies (Hologic)6.15 Molecular Beacons6.16 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits6.17 Prenatal Diagnosis6.18 Newborn Screening6.19 NAT and Preventive Medicine: NAT-based Assays6.20 Prenatal and Pre-Implantation Diagnosis6.21 FISH-based Tests on Fetal Cells6.22 Companion Therapeutic/Diagnostic Approach6.23 Sample Preparation Market6.24 Emerging Amplification Techniques6.24.1 Gold Nanoparticle Molecular Probes6.24.2 Real-Time Microfluidic PCR Using Magnetic Affinity Beads6.25 ASRs (Analyte-Specific Reagents)7. Company Profiles7.1 Abbott Laboratories7.2 Adnavance Technologies, Inc.7.3 AdvanDx7.4 Agendia7.5 Agilent Technologies
  • 7. 7.6 Asuragen7.7 Ambry Genetics7.8 American Diagnostica7.9 Applied Biosystems, Inc. (now Life Technologies)7.10 ARCA biopharma7.11 ArcticDx, Inc.7.12 Arcxis Biotechnologies7.13 Atlas Genetics7.14 Aureon Laboratories7.15 AutoGenomics, Inc.7.16 Beckman Coulter, Inc.7.17 Becton, Dickinson and Company7.18 BG Medicine7.19 Biocartis7.20 BioGenex Laboratories, Inc.7.21 Biohelix Corporation7.22 bioMerieux7.23 Bio-Rad Laboratories7.24 Biotage AB7.25 Biotest AG7.26 Caliper Life Sciences, Inc.7.27 Celera7.28 Cepheid7.29 CombiMatrix Corporation7.30 Cytocell Technologies Ltd.7.31 CytoCore, Inc.7.32 DiagnoCure, Inc.7.33 DxS (Acquired by QIAGEN)7.34 Enzo Biochem7.35 Epigenomics7.36 EraGen Biosciences7.37 Eurogentec7.38 EXACT Sciences Corporation7.39 Exiqon A/S7.40 GeneOhm Sciences7.41 Genera Biosystems7.42 Genzyme Corporation7.43 GenMark Diagnostics, Inc.7.44 Genomix Biotech7.45 Gen-Probe7.46 Gene Express7.47 Genomica7.48 Hologic7.49 Illumina, Inc.7.50 Innogenetics NV7.51 Invitrogen (Life Technologies)7.52 Life Technologies7.53 Luminex7.54 Inverness Medical Innovations
  • 8. 7.55 Monogram Biosciences, Inc.7.56 Myconostica7.57 Nanogen7.58 Nanosphere7.59 NorDiag ASA7.60 PharMingen7.61 QIAGEN N.V.7.62 Roche Diagnostics7.63 SABiosciences Corporation7.64 Seegene7.65 Siemens Healthcare Diagnostics (Siemens)7.66 SIRS-Lab7.67 Source MDx7.68 Targeted Molecular Diagnostics7.69 Thermo Fisher Scientific7.70 Thorne Diagnostics7.71 TrimGen7.72 TrovaGene7.73 U.S. Genomics, Inc.7.74 Veredus Laboratories7.75 Veridex8. Market Overview8.1 Snapshot of Molecular Diagnostics Industry Structure8.2 Global Molecular Diagnostics Testing Market8.3 U.S. Molecular Diagnostics Testing Market8.4 European Molecular Diagnostics Market8.5 Japanese Molecular Diagnostics Testing Market8.6 Overview of the European Molecular Diagnostics Country Markets8.6.1 France8.6.2 Germany8.6.3 U.K.8.6.4 Italy8.6.5 Spain8.7 Strategic Assessment and Business Development in the Molecular Diagnostics Sector8.7.1 Industry Background8.7.2 Competition8.7.3 Business Strategy8.7.4 Corporate Examples8.7.4.1 Gen-Probe8.7.4.2 Osmetech8.7.4.3 Combimatrix8.7.4.4 Sekisui Chemical Co. Ltd.8.7.4.5 Myriad Genetics8.7.4.6 Luminex8.7.5 IVD Manufacturers’ Goals in Detection Technology Development8.7.5.1 New Developments in Molecular Diagnostic Markers are driven by Corporate JointVentures8.7.5.2 Factors for Growth in Molecular Diagnostics
  • 9. 8.7.5.3 How has the IVD Industry Changed?8.7.5.4 What are the Challenges for the Future?8.7.5.5 What New Trends are in the Future?8.7.5.5.1 Market and Technology Trends8.7.5.5.1.1 Market Trends8.7.5.5.1.2 Technology Trends8.7.5.5.1.3 Strategic RecommendationsLIST OF FIGURESFigure 2.1: Segment of Double-stranded DNA Showing the Base-Pair RelationshipFigure 3.1: Overall Structure of Nucleic Acid Testing MarketFigure 3.2: Global Market for Molecular Diagnostics Testing, 2010Figure 3.3: Share of Molecular Diagnostics Testing by Testing Type, 2009Figure 3.4: Key Players Market Share in Global Molecular Diagnostics Testing MarketsFigure 3.5: Revenue Mix from BioChipsFigure 3.6: Global Revenue Forecast for Molecular Diagnostics Testing for InfectiousDisease, 2009-2016Figure 3.7: Global Market Revenue Share Forecasts for Molecular Diagnostics InfectiousDisease Testing Markets by Region, 2009 and 2016Figure 3.8: Forecast for Total Global Infectious Disease Molecular Diagnostics Markets, 2016Figure 3.9: Forecast for Total U.S. Infectious Disease Molecular Diagnostics Markets, 2016Figure 3.10: Key Players Market Share in Global Molecular Diagnostics Infectious DiseaseTesting MarketsFigure 3.11: Estimated Market Forecast for Global HIV Molecular Diagnostic Testing, 2011-2016Figure 3.12: Markers of Acute HBV Infection as a Function of Time after Exposure toInfectionFigure 3.13: Primary Causes of Chronic Liver DiseaseFigure 3.14: Markers of Acute HCV Infection as a Function of Time after Exposure toInfectionFigure 3.15: U.S. Market Share for Molecular Diagnostic HPV Testing, 2010Figure 3.16: Analysis of Cancer Tissue by MicroarrayFigure 3.17: Number of Genomic Health Oncotype DX Tests Performed, 1991-2006Figure 3.18: U.S. Total Infectious Disease Molecular Diagnostics Markets, 2009Figure 3.19: Estimated Market for Global Blood Screening Product Sales, 2007-2016Figure 3.20: Blood Screening Market Share, 2010Figure 3.21: Bacillus anthracisFigure 4.1: Reimbursement for Diagnostics in Healthcare Decision MakingFigure 7.1: Gen-Probe Projected R&D ExpendituresFigure 8.1: Molecular Diagnostics Market Segmentation by Testing TypeFigure 8.2: Molecular Diagnostics Market Segmentation by TechnologyFigure 8.3: Global Market for Molecular Diagnostics, 2002-2016Figure 8.4: Global Distribution of Molecular Diagnostics Testing by Geographic Region, 2010LISTOF TABLESTable 2.1: Key Assay Technologies for Molecular DiagnosticsTable 2.2: Emerging Molecular Diagnostic TechnologiesTable 2.3: Companies involved in Next Generation Sequencing TechnologyTable 3.1: Applications of Molecular Diagnostics Technology Platforms
  • 10. Table 3.2: Global Market for Molecular Diagnostics Testing, 2000-2016Table 3.3: U.S. Market for Molecular Diagnostics Testing, 2004-2016Table 3.4: Summary of Molecular Diagnostics Testing Clinical Focus and DetectionTable 3.5: Share of Molecular Diagnostics Testing by Testing Type, 2009Table 3.6: Key Players and Market Share in Global Molecular Diagnostics Testing MarketTable 3.7: Revenue Model for Molecular Diagnostics TestingTable 3.8: Annual U.S. Market for DNA Probe Diagnostics, 1998-2012Table 3.9: Annual Global Market for DNA Probe Diagnostics, 1998-2010Table 3.10: Roche PCR LicensesTable 3.11: Companies Marketing Products Using DNA ProbesTable 3.12: Companies Marketing Multiple Products in Molecular Diagnostics SectorTable 3.13: Global Sales of DNA Probe Kits, 1998-2009Table 3.14: Companies Marketing DNA Detection PlatformsTable 3.15: Companies Marketing Genotyping TechnologiesTable 3.16: Companies Marketing Clinical Genotyping TechnologiesTable 3.17: Global Revenues and Forecast for Molecular Diagnostics Testing for InfectiousDisease, 2009-2016Table 3.18: Molecular Diagnostic Markets for Infectious Disease Testing, 2010Table 3.19: Molecular Diagnostic Markets for Infectious Disease Testing, 2016Table 3.20: Key Players and Market Share in Global Molecular Diagnostics InfectiousDisease Testing MarketTable 3.21: Commercially Available Molecular Diagnostic Products for HIV AssayTable 3.22: Summary of Assays for HIV Viral Load TestingTable 3.23: Global Market for Molecular Diagnostic HIV Testing, 2007-2010Table 3.24: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2010Table 3.25: Global Market Forecast for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016Table 3.26: U.S. Market Forecast for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016Table 3.27: Markers for Diagnosis of HBV InfectionsTable 3.28: Recommendations for HBV Diagnostic TestingTable 3.29: Lower Detection Limits of HBV DNA AssaysTable 3.30: Summary of Molecular Diagnostic Assays for Testing HBVTable 3.31: Global Market for HBV Diagnostic Testing, 2000-2010Table 3.32: U.S. Market for HBV Diagnostic Testing, 2000-2010Table 3.33: Global Market Forecast for HBV Diagnostic Testing, 2011-2016Table 3.34: U.S. Market Forecast for HBV Diagnostic Testing, 2011-2016Table 3.35: Recommendations for HCV Diagnostic TestingTable 3.36: Important HCV StatisticsTable 3.37: Commercially Available Molecular Diagnostic Products for HCV AssayTable 3.38: Global Market for DNA HCV Diagnostic Testing, 2005-2010Table 3.39: U.S. Market for DNA HCV Diagnostic Testing, 2005-2010Table 3.40: Global Market Forecast for NAT HCV Diagnostic Testing, 2011-2016Table 3.41: U.S. Market Forecast for NAT HCV Diagnostic Testing, 2011-2016Table 3.42: Global Market for DNA HAV Diagnostic Testing, 2000-2008Table 3.43: U.S. Market for DNA HAV Diagnostic Testing, 2000-2008Table 3.44: Global Market for DNA HBV Diagnostic Testing, 2000-2008Table 3.45: U.S. Market for DNA HBV Diagnostic Testing, 2000-2008Table 3.46: Global Market for DNA HCV Diagnostic Testing, 2000-2008
  • 11. Table 3.47: U.S. Market for DNA HCV Diagnostic Testing, 2000-2008Table 3.48: Commercially Available Molecular Diagnostic Products for HPV AssayTable 3.49: Major Companies Marketing HPV Molecular Diagnostic Tests: Market Size andShare, 2010Table 3.50: Global Market for HPV Molecular Diagnostic Testing, 2007-2010Table 3.51: U.S. Market for HPV Diagnostic Testing, 2007-2010Table 3.52: Global Market Forecast for HPV Molecular Diagnostic Testing, 2011-2016Table 3.53: U.S. Market Forecast for HPV Diagnostic Testing, 2011-2016Table 3.54: Commercially Available Molecular Diagnostic Products for Influenza AssayTable 3.55: Global Market for Molecular Influenza Diagnostic Testing, 2007-2010Table 3.56: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2010Table 3.57: Global Market Forecast for Influenza Molecular Diagnostic Testing, 2010-2016Table 3.58: U.S. Market Forecast for Influenza Molecular Diagnostic Testing, 2010-2016Table 3.59: Global Market for Molecular Diagnostics Cancer Testing, 2008-2016Table 3.60: Leading Segments of the Molecular Diagnostic Testing MarketTable 3.61: KRAS Assays by Analytical TypeTable 3.62: KRAS Mutation Assay from Exiqon DiagnosticsTable 3.63: Players in the Breast Cancer Molecular Diagnostic SpaceTable 3.64: U.S. Molecular Diagnostic Markets for Infectious Disease Testing, 2009Table 3.65: Commercially Available Molecular Diagnostic Products for Chlamydia AssayTable 3.66: Global Market for Molecular Diagnostic Chlamydia/Gonorrhea DiagnosticTesting, 2000-2010Table 3.67: U.S. Market for Chlamydia/Gonorrhea Diagnostic Testing, 2000-2010Table 3.68: Global Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing, 2011-2016Table 3.69: U.S. Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing, 2010-2016Table 3.70: CPT Code1 Description National Limitation AmountTable 3.71: Global Market for MD TB Diagnostic Testing, 2005-2010Table 3.72: U.S. Market for MD TB Diagnostic Testing, 2005-2010Table 3.73: Global Market for DNA Group B Streptococcus Diagnostic Testing, 2000-2009Table 3.74: U.S. Market for DNA Group B Streptococcus Diagnostic Testing, 2000-2009Table 3.75: Gen-Probe Clinical Diagnostic Products for the Detection of Non-Viral Micro-OrganismsTable 3.76: Commercially Available Molecular Diagnostic Products for MRSA AssayTable 3.77: Global Market for MRSA Diagnostic Testing, 2005-2010Table 3.78: U.S. Market for MRSA Diagnostic Testing, 2005-2010Table 3.79: Global Market Forecast for MD MRSA Diagnostic Testing, 2011-2016Table 3.80: U.S. Market Forecast for MD MRSA Diagnostic Testing, 2011-2016Table 3.81: Commercially Available Molecular Diagnostic Products for VRE AssayTable 3.82: Global Market for VRE Diagnostic Testing, 2005-2010Table 3.83: U.S. Market for VRE Diagnostic Testing, 2005-2010Table 3.84: Global Market Forecast for MD VRE Diagnostic Testing, 2011-2016Table 3.85: U.S. Market for MD VRE Diagnostic Testing, 2011-2016Table 3.86: Global Market for Blood Screening Product Sales, 2007-2016Table 3.87: Blood Screening Molecular Diagnostics Market: Market Drivers Ranked in Orderof ImpactTable 3.88: Blood Screening Molecular Diagnostics Market: Market Restraints Ranked inOrder of ImpactTable 3.89: Drivers of the Genetic Analysis MarketTable 3.90: Leading Players in the SNP Genotyping Space
  • 12. Table 3.91: Global Market for SNP and Genotyping, 2009-2015Table 3.92: InstrumentationTable 3.93: ConsumablesTable 3.94: DNA Analysis Market CompetitorsTable 3.95: Leading Companies in Medical Utility of SNPsTable 3.96: Competitors in the Field of Identity, Family and Paternity TestingTable 3.97: Competitors in the Field of Forensic TestingTable 3.98: U.S. Market for Food-Screening Diagnostic Testing Using MD Techniques, 2000-2016Table 3.99: Molecular Diagnostics Methods for Detection of Salmonella in FoodTable 3.100: U.S. Market for Forensic Diagnostics Testing, 2000-2016Table 3.101: Barriers for Biologics Warfare Monitoring SystemsTable 3.102: U.S. Market for Biological Threat Detection Testing, 2000-2010Table 3.103: Technical Problems for PCR Assays for Pathogen Genotyping and DetectionTable 3.104: Biological Warfare Agents Identified by PCR MethodsTable 3.105: Companies Developing Detection Devices for Biological Warfare AgentsTable 3.106: Variation of CF Carrier Risks by Ethnic GroupTable 3.107: Reasons for CF TestingTable 3.108: Variation of CF Detection Rates by Ethnic BackgroundTable 3.109: Global Market for CF Diagnostic Testing, 2000-2008Table 3.110: U.S. Market for CF Diagnostic Testing, 2000-2008Table 3.111: Projected Global Market for CF Diagnostic Testing, 2009-2013Table 3.112: Projected U.S. Market for CF Diagnostic Testing, 2009-2013Table 3.113: Commercial CF-Screening ProductsTable 3.114: CF Screening Technology SummaryTable 3.115: U.S. Market for HLA Type Testing, 2000-2009Table 3.116: Competitors in HLA TestingTable 3.117: Carrier Rates of Common HFE Mutations in CaucasiansTable 3.118: Results and Diagnosis for Fragile X SyndromeTable 3.119: Other Genetic Testing Procedures by Molecular DiagnosticsTable 3.120: DNA Chip Market Drivers and RestraintsTable 3.121: DNA Chip Major PlayersTable 3.122: Applications of DNA BiochipsTable 3.123: Technology Trends in the DNA Microarray MarketTable 3.124: Molecular Diagnostic Personalized Medicine TestsTable 3.125: Global Revenue Forecasts for Prenatal and Newborn Testing Segment, 2007-2015Table 3.126: Various Molecular Diagnostics Technologies: Timeline for ImpactTable 3.127: Various Molecular Diagnostics Technologies: Impact on Different TherapeuticAreas in Personalized MedicineTable 3.128: Various Molecular Diagnostics Technologies: Technical Challenges in theDeployment for Personalized MedicineTable 4.1: DNA-Sequencing Molecular Diagnostics Market PlayersTable 4.2: U.S. Market for DNA Chips, 2000-2015Table 4.3: Affymetrix DNA Analysis ProductsTable 4.4: PCR Segmentation by SectorTable 4.5: Impediments to Incorporating Promising Molecular Tests into Clinical PracticeTable 4.6: Largest Market Opportunities in PCR TestingTable 4.7: PCR Real-Time Applications
  • 13. Table 4.8: Advantages of Using Real-Time PCRTable 4.9: Pharmaceutical Company ChallengesTable 4.10: Molecular Diagnostic Sector Acquisitions, Agreements and PartnershipsTable 4.11: Regulatory Rules that Affect the Ability of a Diagnostic Testing ReagentCompany to Conduct BusinessTable 4.12: Strengths of the 510k ProcessTable 4.13.: Focus Areas for the FDA Critical Path InitiativeTable 4.14: Medicare Pricing MethodsTable 4.15: Factors Affecting Third-Party Reimbursement for Molecular Diagnostic TestsTable 4.16: Documents for Protecting Intellectual Property RightsTable 4.17: Recent Patents Related to PCR, Nucleic Acid Amplification, and Sample PrepTable 5.1: Molecular Diagnostic High-throughput Automated Testing SystemsTable 6.1: Five Molecular Diagnostics Growth AreasTable 6.2: Limitations of Nucleic Acid Chip ProbesTable 6.3: Companies Licensed to Sell Custom Molecular Beacon ProbesTable 6.4: U.S. Sample Preparation Market, 2005-2012Table 7.1: Products Marketed by Abbott in the Diagnostics MarketTable 7.2: Gen-Probe Key AcquisitionsTable 7.3: Roche Diagnostics Key ProductsTable 7.4: Sales by RegionTable 7.5: Sales by Business AreaTable 7.6: Product Line SalesTable 7.7: Growth DriversTable 8.1: Number of Molecular Diagnostics Tests in the U.S., 2008-2015Table 8.2: Global Molecular Diagnostics Testing Revenues, 2000-2016Table 8.3: Global Distribution of Molecular Diagnostics Testing by Geographic Region, 2010Table 8.4: U.S. Molecular Diagnostics Testing Market, 2004-2016Table 8.5: European Molecular Diagnostics Testing Market, 2005-2016Table 8.6: Japanese Molecular Diagnostics Testing Market, 2005-2016Table 8.7: Molecular Diagnostics Market: Market Drivers Ranked in Order of ImpactTable 8.8: Molecular Diagnostics Market: Market Restraints Ranked in Order of ImpactTable 8.9: Large General Diagnostic Lab ServicesTable 8.10: Small Specialized Diagnostic Lab ServicesTable 8.11: MDx Sector LeadersTable 8.12: Point-of-Care MDx LeadersTable 8.13: Pure Play MDx CompaniesTable 8.14: Array PlatformsTable 8.15: Molecular Diagnostic Testing Market TrendsTable 8.16: Molecular Diagnostic Testing Technology TrendsTable 8.17: Molecular Diagnostics Market: Strategic Recommendations on MD SectorBusiness FunctionsLatest Market Research Reports:Cancer Diagnostic Testing World MarketsCompanion Diagnostics in Personalized Medicine and Cancer TherapyMolecular Diagnostics in Cancer TestingMolecular Diagnostics MarketsPoint of Care Diagnostic Testing World MarketsPositron Emission Tomography (PET) Markets
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