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  • the detection of manyinfectious agents was slow and expensive due to reliance upon culturing methods,researchers are now at the cusp of overcoming such limitations via the use of nucleic acid-mediated molecular diagnostics testing. medical supplies in Malaysia
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    Molecular diagnostics in infectious disease testing Molecular diagnostics in infectious disease testing Document Transcript

    • Molecular Diagnostics in Infectious Disease TestingThis TriMark Publications report describes the specific segment of the in vitro diagnosticsmarket known as molecular diagnostics testing for infectious disease. In the current medicaldiagnostics market, molecular diagnostics in infectious disease testing offers one of themost promising areas for growth and innovation.Buy Now: Molecular Diagnostics in Infectious Disease TestingBrowse All: Latest Market Research ReportsThe confluence of breakthroughs in genomics and proteomics–along with the developmentof microarray devices to measure analytes in the blood–has led to this revolutionary marketdevelopment. Specifically, molecular diagnostics offers the power of advanced analyticaltechniques to diagnose infectious diseases. Whereas before, the detection of manyinfectious agents was slow and expensive due to reliance upon culturing methods,researchers are now at the cusp of overcoming such limitations via the use of nucleic acid-mediated molecular diagnostics testing. The purpose of this report is to describe theemerging field of molecular diagnostics in infectious disease testing.The infectious disease space is the most dominant and profitable sector of moleculardiagnostics. Topics covered in this study include: 1) the existing and emerging technologiesin the field, 2) the U.S. and global market size for molecular diagnostic products and 3) theprofiles of companies that are focusing on the molecular diagnostic sector. The researchexamines drivers and restraints for sales growth, market share and technical trends. Inaddition, an in-depth analysis of the competitive situation of prominent market venders isprovided with five-year sales 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 for Infectious Disease Testing2.1 Molecular Diagnostics Testing and Opportunities in the Infectious Disease Sector2.2 The Infectious Disease Problem2.3 Impact of the Human Genome Project on Molecular Diagnostics2.4 Opportunities for Molecular and Clinical Diagnostics2.4.1 Companion Diagnostics2.5 Development of Molecular Diagnostics Testing Markets2.6 Target-based Gene Amplification2.6.1 Polymerase Chain Reaction (PCR)2.6.2 Real-time PCR (RT-PCR)
    • 2.6.3 Nucleic Acid Sequence-based Amplification (NASBA)2.6.4 Market Drivers and Restraints2.6.4.1 Market Drivers2.6.4.2 Market Restraints2.6.5 Market and Technology Trends2.6.5.1 Market Trends2.6.5 2 Technology Trends2.6.6 Strategic Recommendations2.7 PCR Reagents for Clinical Diagnostics3. Infectious Disease Diagnostics Molecular Testing Market3.1 Market Overview3.1.1 Overall Infectious Disease Market Analysis3.2 NAT Molecular Diagnostics Market3.3 Infectious Disease Molecular Diagnostic Testing Markets3.3.1 HIV3.3.1.1 Disease Background and Statistics3.3.1.2 Measuring Viral Loads3.3.1.3 Instruments and MD Reagents3.3.1.4 Method Comparisons3.3.1.5 Market Size3.3.1.5.1 HIV Diagnostic Testing3.3.1.6 HIV Market Challenges and Strategic Recommendations3.3.1.6.1 HIV Molecular Diagnostic Market History3.3.1.7 Market Drivers and Restraints3.3.1.7.1 Market Drivers3.3.1.7.2 Market Restraints3.3.1.8 Market and Technology Trends3.3.1.8.1 Market Trends3.3.1.8.2 Technology Trends3.3.1.9 Strategic Recommendations3.3.2 Hepatitis3.3.2.1 Hepatitis B Virus3.3.2.1.1 Hepatitis B Disease Background and Statistics3.3.2.1.2 Instruments and Reagents for Hepatitis B Detection3.3.2.1.3 Method Comparisons3.3.2.1.4 Hepatitis B Market Size3.3.2.1.5 HBV Market Challenges and Strategic Recommendations3.3.2.1.5.1 Market Drivers and Restraints3.3.2.1.5.1.1 Market Drivers3.3.2.1.5.1.2 Market Restraints3.3.2.1.6 Market and Technology Trends3.3.2.1.6.1 Market Trends3.3.2.1.6.2 Technology Trends3.3.2.1.7 Strategic Recommendations3.3.2.2 Hepatitis C Virus (HCV) Testing3.3.2.2.1 Disease Background and Statistics3.3.2.2.2 Instruments and Reagents for Hepatitis C Detection3.3.2.2.3 Method Comparisons for HCV Tests
    • 3.3.2.2.4 Hepatitis C Market Size3.3.2.2.4.1 HCV Market Share3.3.2.2.5 HCV Market Challenges and Strategic Recommendations3.3.2.2.5.1 Market Drivers and Restraints3.3.2.2.5.1.1 Market Drivers3.3.3.2.2.5.1.2 Market Restraints3.3.2.2.5.2 Market and Technology Trends3.3.2.2.5.2.1 Market Trends3.3.2.2.5.2.2 Technology Trends3.3.2.2.6 Strategic Recommendations3.3.3 Human Papillomavirus (HPV)3.3.3.1 Disease Background and Statistics3.3.3.2 Instruments and Reagents for HPV Detection3.3.3.3 Method Comparison3.3.3.4 HPV Market Size3.3.3.4.1 North American Market3.3.3.4.2 European Market3.3.3.5 Market Challenges and Strategic Recommendations3.3.3.5.1 Market Drivers and Restraints3.3.3.5.1.1 Market Drivers3.3.3.5.1.2 Market Restraints3.3.3.5.2 Market and Technology Trends3.3.3.5.2.1 Market Trends3.3.3.5.2.2 Technology Trends3.3.3.5.3 Strategic Recommendations3.3.4 Influenza Viruses3.3.4.1 Disease Background and Statistics3.3.4.2 Instruments and Reagents for Influenza Detection3.3.4.3 Method Comparisons3.3.4.4 Influenza Market Size3.3.4.5 Influenza Market Challenges and Strategic Recommendations3.3.4.5.1 Market Drivers and Restraints3.3.4.5.1.1 Market Drivers3.3.4.5.1.2 Market Restraints3.3.4.5.2 Market and Technology Trends3.3.4.5.2.1 Market Trends3.3.4.5.2.2 Technology Trends3.3.4.5.3 Strategic Recommendations3.3.5 STD Testing3.3.5.1 Chlamydia3.3.5.1.1 Disease Background and Description3.3.5.1.2 Product Analysis: Instruments and Reagents for Testing Chlamydia3.3.5.1.3 Method Comparison3.3.5.1.4 Chlamydia/Gonorrhea Molecular Diagnostic Testing Market Size3.3.5.1.5 Competitive Structure and Market Share Analysis3.3.5.1.6 Market Forecasts3.3.5.1.6.1 Revenue Forecasts3.3.5.1.7 Market Forecasts3.3.5.1.7.1 Revenue Forecasts
    • 3.3.5.1.8 Market Challenges3.3.5.1.8.1 Market Drivers3.3.5.1.8.2 Market Restraints3.3.5.1.9 Market and Technology Trends3.3.5.1.9.1 Market Trends3.3.5.1.9.2 Technology Trends3.3.5.1.10 Strategic Recommendations3.3.6 Gonorrhea3.3.6.1 Disease Background and Description3.3.6.2 Product Analysis: Instruments and Reagents3.3.6.3 Method Comparison3.3.6.4 Competitive Structure and Market Share Analysis3.3.6.5 Market Forecasts3.3.6.5.1 Revenue Forecasts3.3.6.6 Market Challenges3.3.6.6.1 Market Drivers3.3.6.6.2 Market Restraints3.3.6.7 Market and Technology Trends3.3.6.7.1 Market Trends3.3.6.7.2 Technology Trends3.3.6.8 Strategic Recommendations3.3.7 Tuberculosis (TB)3.3.7.1 Disease Background and Description3.3.7.2 Product Analysis: Instruments and Reagents3.3.7.3 Method Comparison3.3.7.4 Tuberculosis Market Size3.3.7.5 Competitive Structure and Market Share Analysis3.3.7.6 Market Forecasts3.3.7.6.1 Revenue Forecasts3.3.7.7 Market Challenges3.3.7.7.1 Market Drivers3.3.7.7.2 Market Restraints3.3.7.8 Market and Technology Trends3.3.7.8.1 Market Trends3.3.7.8.2 Technology Trends3.3.7.9 Strategic Recommendations3.3.8 Methicillin-resistant Staphylococcus Aureus (MRSA)3.3.8.1 Disease Background and Description3.3.8.2 Product Analysis: Instruments and Reagents3.3.8.3 Method Comparison3.3.8.4 MRSA Market Size3.3.8.5 Competitive Structure and Market Share Analysis3.3.8.6 Market Forecasts3.3.8.6.1 Revenue Forecasts3.3.8.7 Market Challenges3.3.8.7.1 Market Drivers3.3.8.7.2 Market Restraints3.3.8.8 Market and Technology Trends3.3.8.8.1 Market Trends
    • 3.3.8.8.2 Technology Trends3.3.8.9 Strategic Recommendations3.3.9 Vancomycin-resistant Enterococci (VRE)3.3.9.1 Disease Background and Description3.3.9.2 Product Analysis: Instruments and Reagents3.3.9.3 Method Comparison3.3.9.4 Competitive Structure and Market Share Analysis3.3.9.5 Market Forecasts3.3.9.5.1 Revenue Forecasts3.3.9.6 Market Challenges3.3.9.6.1 Market Drivers3.3.9.6.2 Market Restraints3.3.9.7 Market and Technology Trends3.3.9.7.1 Market Trends3.3.9.7.2 Technology Trends3.3.9.8 Strategic Recommendations3.3.10 Herpes Simplex Virus (HSV)3.3.11 C. difficile3.3.12 Cytomegalovirus3.4 Blood Screening3.4.1 Product Analysis: Instruments and Reagents3.4.2 Method Comparison3.4.3 Blood Screening Market Size3.4.4 Competitive Positions3.4.5 Market Challenges and Strategic Recommendations3.4.5.1 Market Drivers and Restraints3.4.5.1.1 Market Drivers3.4.5.1.2 Market Restraints3.4.5.2 Market and Technology Trends3.4.5.2.1 Market Trends3.4.5.2.2 Technology Trends3.4.5.3 Strategic Recommendations4. Molecular Diagnostic Testing Technology for Infectious Disease Testing4.1 Infectious Disease Diagnostic Tests4.1.2 Molecular Diagnostic Tools Solutions4.1.3 Technology of Gene Expression Analysis4.1.3.1 Amplification and Detection of RNA4.1.3.2 Analysis of Multiple Genes4.1.3.3 Advanced Information Technology4.2 Use of Molecular Tests in Infectious Disease4.2.1 Molecular Screening4.2.2 Early Detection4.2.3 Detection of Specific Resistance Genes and Viral Loading Tests4.2.4 Pharmacogemomics and Personalized Medicine in MD Infectious Disease Testing4.2.5 Molecular Strain Typing4.3 Cost of Molecular Diagnostic Testing4.4 Use of Multiplex PCR Tests4.5 Next Generation Sequencing
    • 4.6 Patient Flow Software4.7 Digital PCR5. Business5.1 Technology and Market Trends5.1.1 Technology Trends5.2 M&A Activity5.3 Partnerships5.4 Competitive Analysis5.4.1 Primary Competitors5.4.2 Industry Challenges and Strategic Recommendations5.4.3 Commercialization of Molecular Diagnostic Products5.5 Intellectual Property Rights5.5.1 New Patents5.5.2 Current Patent Disputes5.6 Opportunities and Strategic Recommendations5.6.1 The Key Technical Opportunities with Significant Market Appeal in the MolecularDiagnostic Space in the Next Five Years5.6.2 Developments for Molecular Diagnostic Instrumentation Products5.6.3 Market Penetration Strategies for Infectious Disease Testing5.7 Business Models and Requirements for a Successful Molecular Diagnostics InfectiousDisease Products Industry5.7.1 Scope of This Section5.7.2 The Success Achieved by the Molecular Diagnostics Infectious Disease Products5.7.3 Business Models in Molecular Diagnostics Infectious Disease Products5.7.4 SWOT Comparison of Business Models for MD Infectious Disease Diagnostic Testing5.7.5 Commercial Manufacturing of Molecular Diagnostics Infectious Disease Products:Requirements5.7.5.1 Elements of Commercial Manufacturing5.7.5.1.1 Regulatory Requirements5.7.5.1.2 Manufacturing Process Scale5.7.5.1.3 In-House Manufacturing5.7.5.2 Contract Manufacturing: Commercial and Academic5.7.6 Sales and Marketing Strategies for Infectious Disease Tests5.8 Companion Diagnostics Development in Partnership with a Pharmaceutical Company5.8.1 Description of Business Model5.8.2 Anti-infective Pharmaceutical Market6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing forInfectious Disease6.1 Overview6.2 Trends in Reimbursement Practice6.2.1 Medicare Reimbursement Threats6.2.2 Analysis of ROI for Molecular Diagnostic Tests for Infectious Disease Using CurrentMedicare Reimbursement Rules6.3 Trends in Patient Care and Reimbursement6.4 Revenue threats6.4.1 Medicare Payment Exceptions6.4.2 Three Areas for Denial of Claims
    • 6.5 Billing Rules6.5.1 Medicare Billing Procedures6.5.2 Medicare CPT Coding Rules for MD Infectious Disease Testing6.5.3 Infectious Disease Billing Strategies7. Regulatory Requirements7.1 U.S. Food and Drug Administration7.2 CLIA Regulations7.3 Clinical Laboratory Improvement Act (CLIA)7.4 State Licensing for Service Laboratories7.5 IVDMIAs7.6 510(k) Clearance7.7 Pre-Market Approval (PMA)7.7.1 Pre-Market Approval Application7.8 Analyte Specific Reagents (ASRs)7.8.1 Laboratory Developed Tests7.9 What Regulatory Guidance is Needed for Companion Biomarkers?7.10 U.S. Patent and Trademark Office (USPTO)7.11 IRB Approval in Clinical Trials7.12 CE Marking and the IVDD (European In Vitro Diagnostic Device Directive)7.13 De Novo Classification7.14 Research Use Only Reagents7.15 FDA Recommendations on MRSA Testing8. Business Decisions using Molecular Diagnostic Tests in Infectious DiseaseTesting8.1 What are Key Opportunities in Infectious Disease Testing Development andCommercialization?8.2 What are the Current Obstacles for MD Infectious Disease TestingImplementation?8.3 How do Business Strategies, such as those relating to Acquisition, Drive MD Strategies?8.4 How Might Novel Infectious Disease MD Test Development Lead to AcquisitionStrategies and their Implications for Deal Making?8.5 How can Molecular Diagnostic Tests Increase Value in an Associated Drug MarketingPlan?8.6 Which Types of Infectious Disease MD Testing should be Developed by DiagnosticCompanies at Various Stages in the Development Pipeline?8.7 How can Regulatory Oversight Drive Approval and Adoption of New Technologies?8.8 What are the Noteworthy Deals?8.9 Who are the Acquirers?8.10 Who are the Target Companies?8.11 How will Platform Technology Companies Enter the Space?8.12 Will Pharma Integrate with Diagnostics?8.13 How do Platform Technology Companies Position themselves for DiagnosticsDevelopment?8.14 Evaluate how Partnering and M&As will Alter the Competitive Landscape8.15 Predict how FDA Regs will Impact New Diagnostic Tests8.16 How can Big Pharma and Diagnostic Companies Co-develop Biomarkers in aModel for Regulatory Acceptance?
    • 8.17 How to Maximize Business Development through Biomarker Strategies?8.18 What is the Best Type of Business Model for Developing Genetic Biomarkersfor Infectious Disease?8.19 How Best have Genetic Biomarkers Provided the Most Benefit in Infectious DiseaseTesting?8.20 What are the Most Innovative Methods in Development of Molecular DiagnosticBiomarkers?8.21 What are the Best Values for Genetic Biomarkers in Drug Development and inDiagnostics?9. Economics of Anti-microbial Drug Resistance: The Persistent need for Anti-bacterials9.1 Resistance and Antibiotic Usage9.2 Infection Control Programs10. Company Profiles10.1 Abbott Laboratories10.2 AdvanDx10.3 Arcxis Biotechnologies10.4 Atlas Genetics10.5 AutoGenomics, Inc.10.6 Becton, Dickinson and Company10.7 BioGenex Laboratories, Inc.10.8 BioHelix Corporation10.9 bioMérieux10.10 Biocartis10.11 bioTheranostics10.12 Celera10.13 Cepheid10.14 EraGen Biosciences10.15 Exiqon A/S10.16 Genera Biosystems10.17 GenMark Diagnostics, Inc.10.18 Genomix Biotech10.19 Gen-Probe10.20 Gene Express10.21 Genomica10.22 Great Basin Scientific10.23 Hologic10.24 Illumina, Inc.10.25 Innogenetics NV10.26 Life Technologies10.27 Mobidiag10.28 Myconostica10.29 Nanosphere10.30 NorDiag ASA10.31 Qiagen NV10.32 Roche Ltd.10.33 Seegene
    • 10.34 SIRS-Lab10.35 Source MDx10.36 TrimGen10.37 TrovaGene10.38 Veredus Laboratories10.39 VeridexAppendix 1: Draft Guidance for Industry and Food and Drug Administration Staff—Establishing the Performance Characteristics of Nucleic Acid-based In vitro DiagnosticDevices for the Detection and Differentiation of Methicillin-resistant Staphylococcus aureus(MRSA) and Staphylococcus aureus (SA)LIST OF FIGURESFigure 2.1: Relationship of DNA Testing to Key Areas of Clinical DiagnosisFigure 2.2: Finding Genes with MicroassaysFigure 2.3: The Use of Microassays for Studying Gene ExpressionFigure 2.4: Overall Structure of Nucleic Acid Testing MarketFigure 2.5: Global Market for Molecular Diagnostics, 2002-2016Figure 3.1: Global Market for Molecular Diagnostics Testing, 2010Figure 3.2: Share of Molecular Diagnostics Testing by Testing Type, 2009Figure 3.3: Key Players Market Share in Global Molecular Diagnostics Testing MarketsFigure 3.4: Global Market for Infectious Disease Treatments, 2008-2014Figure 3.5: Global Revenue Forecast for Molecular Diagnostics Testing for InfectiousDisease, 2009-2016Figure 3.6: Global Market Revenue Share Forecasts for Molecular Diagnostics InfectiousDisease Testing Markets by Region, 2009 and 2015Figure 3.7: Infectious Disease Testing Revenue Market Share of Total U.S. MD Market, 2009and 2015Figure 3.8: European Market Revenue Forecast for Molecular Diagnostics Testing forInfectious Disease, 2009-2015Figure 3.9: Infectious Disease Testing Revenue Market Share of Total European MD Market,2009 and 2015Figure 3.10: Japanese Market Revenue Forecast for Molecular Diagnostics Testing forInfectious Disease, 2009-2016Figure 3.11: Infectious Disease Testing Revenue Market Share of Total Japanese MD Market,2009 and 2015Figure 3.12: Total Global Infectious Disease Molecular Diagnostics Markets, 2010Figure 3.13: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2010Figure 3.14: Total Global Infectious Disease Molecular Diagnostics Markets, 2016Figure 3.15: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2016Figure 3.16: Global Trend of HIV Infection, 1991-2007Figure 3.17: Number of People Living with HIV, Newly Infected with HIV and Number ofAIDS Deaths in the World, 1990-2008Figure 3.18: Worldwide Rate of New HIV Cases, 1990-2007Figure 3.19: Percentage of Adult Population in African Countries with HIV, 2007Figure 3.20: Global View of HIV Infection, 2008Figure 3.21: Ethnic Distribution of AIDS Patients in the U.S., 2007Figure 3.22: Ten Best Selling AIDS Drugs in the U.S., 2008Figure 3.23: U.S. Rates for New HIV Cases, 2008
    • Figure 3.24: U.S. Rates for New HIV Cases in Men, 2008Figure 3.25: U.S. Rates for New HIV Cases in Women, 2008Figure 3.26: Global Trend of HIV Infections, 1991-2007Figure 3.27: Proposed HIV Testing AlgorithmFigure 3.28: Distribution of HIV Molecular Diagnostic Testing by PurposeFigure 3.29: Estimated Market Forecast for Global HIV Molecular Diagnostic Testing, 2011-2016Figure 3.30: Estimated Market Forecast for U.S. HIV Molecular Diagnostic Testing, 2011-2016Figure 3.31: Market Share Viral Load HIV MD Diagnostic TestingFigure 3.32: Geographic Distribution of Chronic HBV InfectionFigure 3.33: Rate of New Hepatitis A, B and C Infections in the U.S., 1982-2006Figure 3.34: Global Prevalence of Hepatitis CFigure 3.35: Primary Causes of Chronic Liver DiseaseFigure 3.36: HCV Infection PrevalenceFigure 3.37: Hepatitis C Infection by SourceFigure 3.38: Growth and Projections of HCV Therapies by Drug Class, 2008 and 2013Figure 3.39: U.S. Market Share of HCV Molecular Diagnostic Market, 2010Figure 3.40: Global Market Share (Excluding U.S.) of HCV Molecular Diagnostic Market,2010Figure 3.41: Rate of New Cases and Deaths of Cervical Cancer by Age Group Worldwide,2008Figure 3.42: U.S. Market Share of HPV Molecular Diagnostic Market, 2010Figure 3.43: Global Market Share (Excluding U.S.) of HPV Molecular Diagnostic Market,2010Figure 3.44: Market Share Estimates for Molecular Diagnostic HPV Testing, 2009Figure 3.45: Number of Reported and Confirmed Cases of Influenza H1N1 Strain Worldwide,2009Figure 3.46: Distribution of H1N1 Flu in the U.S., 2009Figure 3.47: H1N1 Confirmed and Probable Case Rate in the U.S., By Age GroupFigure 3:48: U.S. Rates of Sexually-transmitted Diseases, 1940-2007Figure 3.49: Chlamydia Infection Rates: Total and by Gender: U.S., 1989-2009Figure 3.50: Chlamydia U.S. Prevalence by Age Group and Race/EthnicityFigure 3.51: U.S. Market Share of CT/NG Molecular Diagnostic Market, 2010Figure 3.52: Global Market Share (Excluding U.S.) of CT/NG Molecular Diagnostic Market,2010Figure 3.53: U.S. Gonorrhea Infection Rates, 1941-2006Figure 3.54: U.S. Gonorrhea Infection Rates by Race/Ethnicity, 1999-2008Figure 3.55: Pipeline for TB DiagnosticsFigure 3.56: Number of Tuberculosis (TB) Cases Among U.S.- and Foreign-born Persons inthe U.S., 1993-2008Figure 3.57: Rate of Tuberculosis (TB) Cases Among U.S.- and Foreign-born Persons in theU.S., 1993-2008Figure 3.58: Rate of Tuberculosis (TB) Cases by State/Area in the U.S., 2008Figure 3.59: U.S.-born Tuberculosis (TB) Cases by Ethnicity, 2008Figure 3.60: Reported Tuberculosis (TB) Cases in the U.S., 1983-2007Figure 3.61: Global Market Share of MD TB TestingFigure 3.62: Global Market Share of MD TB Testing by Region, 2010Figure 3.63: Incidence Rates of Invasive MRSA Infections by Age
    • Figure 3.64: MRSA Trends According to Patient Location, 1998-2005Figure 3.65: Incidence of Healthcare-associated MRSA Infections, 2005-2008Figure 3.66: U.S. Market Share of MRSA Molecular Diagnostic Market, 2010Figure 3.67: Global Market Share (Excluding U.S.) of MRSA Molecular Diagnostic Market,2010Figure 3.68: Global Frequency of Vancomycin-resistant Enterococci, 2006Figure 3.69: U.S. Market Share of VRE Molecular Diagnostic Market, 2010Figure 3.70: Estimated Market for Global Blood Screening Product Sales, 2007-2016Figure 3.71: Gen-Probe Blood Screening Product Market Share, 2005-2009Figure 3.72: Blood Screening Product Market Share by Company, 2010Figure 4.1: Using DNA Microassays to Measure Gene ExpressionFigure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in PatientsFigure 5.1: FDA Co-developed Products as a Model for CollaborationFigure 5.2: Market Growth of MD Infectious Disease TestsFigure 5.3: Segmentation of the Biomarker Development MarketFigure 5.4: Global Distribution of Anti-infective Agent Sales by GeographyFigure 5.5: Leading Companies in Anti-infectives Market Share, 2008Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision MakingFigure 9.1: Global Multidrug Susceptibility in Pseudomonas aeruginosaFigure 9.2: Global Frequency of Vancomycin-resistant Enterococci, 2006Figure 10.1: Gen-Probe Key AcquisitionsFigure 10.2: Gen-Probe Projected R&D ExpendituresLIST OF TABLESTable 1.1: Market Trends in Infectious Disease DNA TestingTable 1.2: Molecular Diagnostics Infectious Disease Market: Market Drivers Ranked in Orderof ImpactTable 1.3: Molecular Diagnostics Infectious Disease Market: Market Restraints Ranked inOrder of ImpactTable 1.4: Strategic Recommendations on Molecular Diagnostic Sector Business FunctionsTable 2.1: Nucleic Acid-based Tests for Clinically Important Viral and Bacterial PathogensTable 2.2: Top Ten Causes of Death WorldwideTable 2.3: The Most Prevalent Infectious Diseases WorldwideTable 2.4: Annual Rates of Global Infectious DiseasesTable 2.5: Emerging Molecular Diagnostic TechnologiesTable 2.6: Global Market for Molecular Diagnostics Testing, 2000-2016Table 2.7: U.S. Market for Molecular Diagnostics Testing, 2004-2016Table 2.8: Automated Molecular Diagnostics Platforms for Infectious Disease TestingTable 2.9: Companies Marketing Products using DNA ProbesTable 2.10: Companies Marketing Multiple Products in Molecular Diagnostics SectorTable 2.11: FDA-approved Molecular Diagnostic Commercial Kits for the Detection ofInfectious AgentsTable 2.12: Global and U.S. Major Infectious Disease Market Size (Estimated InfectedPersons)Table 2.13: Molecular Diagnostics Market: Market Drivers Ranked in Order of ImpactTable 2.14: Molecular Diagnostics Market: Market Restraints Ranked in Order of ImpactTable 2.15: Attractive Growth Areas for Molecular Diagnostic TestingTable 2.16: NAT Labs in U.S. and Five European MarketsTable 3.1: European Market for Molecular Diagnostics Testing, 2005-2015
    • Table 3.2: Japanese Market for Molecular Diagnostics Testing, 2009-2016Table 3.3: Summary of Molecular Diagnostics Testing SectorsTable 3.4: Share of Molecular Diagnostics Testing by Testing Type, 2009Table 3.5: Key Players and Market Share in Global Molecular Diagnostics Testing MarketTable 3.6: Revenue Model for Molecular Diagnostics TestingTable 3.7: Molecular Infectious Disease Diagnostics Market: Market Drivers Ranked in Orderof ImpactTable 3.8: Molecular Infectious Disease Diagnostics Market: Market Restraints Ranked inOrder of ImpactTable 3.9: Global Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease,2009-2016Table 3.10: U.S. Market Revenue Forecast for Molecular Diagnostics Testing for InfectiousDisease, 2009-2016Table 3.11: European Market Revenue Forecast for Molecular Diagnostics Testing forInfectious Disease, 2009-2015Table 3.12: Japanese Market Revenue Forecast for Molecular Diagnostics Testing forInfectious Disease, 2009-2016Table 3.13: Molecular Diagnostic Markets for Infectious Disease Testing, 2010Table 3.14: Molecular Diagnostic Markets for Infectious Disease Testing, 2016Table 3.15: Business Factors Influencing Advanced Infectious Disease MD Testing ServicesTable 3.16: Global Summary of the HIV/AIDS Epidemic, 2008Table 3.17: Global HIV Statistics, 2008Table 3.18: HIV Resistance Testing RecommendationsTable 3.19: Summary of Assays for HIV Viral Load TestingTable 3.20: Commercially Available Molecular Diagnostic Products for HIV AssayTable 3.21: Global Market for Molecular Diagnostic HIV Testing, 2007-2010Table 3.22: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2010Table 3.23: Global Market Forecast for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016Table 3.24: U.S. Market Forecast for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016Table 3.25: Global Market for HIV Viral Load Diagnostic Testing, 2007-2010Table 3.26: U.S. Market for HIV Viral Load Diagnostic Testing, 2007-2010Table 3.27: Global Market Forecast for HIV Viral Load Diagnostic Testing, 2011-2016Table 3.28: U.S. Market Forecast for HIV Viral Load Diagnostic Testing, 2011-2016Table 3.29: Global Market for HIV Genotyping Testing, 2007-2010Table 3.30: U.S. Market for HIV Genotype Testing, 2007-2010Table 3.31: Global Market Forecast for HIV Genotyping Testing 2011-2015Table 3.32: U.S. Market Forecast for HIV Genotyping Testing, 2011-2016Table 3.33: HIV Molecular Diagnostics Market: Market Drivers Ranked in Order of ImpactTable 3.34: HIV Molecular Diagnostics Market: Market Restraints Ranked in Order of ImpactTable 3.35: Clinical Application of Quantitative HBV DNA TestingTable 3.36: Lower Detection Limits of HBV DNA AssaysTable 3.37: Summary of Molecular Diagnostic Assays for Testing HBVTable 3.38: Global Market for HBV Diagnostic Testing, 2000-2010Table 3.39: U.S. Market for HBV Diagnostic Testing, 2000-2010Table 3.40: Global Market Forecast for HBV Diagnostic Testing, 2011-2016Table 3.41: U.S. Market Forecast for HBV Diagnostic Testing, 2011-2016Table 3.42: HBV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
    • Table 3.43: HBV Molecular Diagnostics Market: Market Restraints Ranked in Order of ImpactTable 3.44: Hepatitis B FactsTable 3.45: U.S. HCV StatisticsTable 3.46: Worldwide Rate of HCV CasesTable 3.47: Efficiency of Available HCV Screening TestsTable 3.48: Commercially Available Molecular Diagnostic Products for HCV AssayTable 3.49: Global Market for DNA HCV Diagnostic Testing, 2005-2010Table 3.50: U.S. Market for DNA HCV Diagnostic Testing, 2005-2010Table 3.51: Global Market Forecast for NAT HCV Diagnostic Testing, 2011-2016Table 3.52: U.S. Market Forecast for NAT HCV Diagnostic Testing, 2011-2016Table 3.53: Major Companies Marketing HCV Molecular Diagnostic Tests: Market Size andShare, 2010Table 3.54: HCV Molecular Diagnostics Market: Market Drivers Ranked in Order of ImpactTable 3.55: HCV Molecular Diagnostics Market: Market Restraints Ranked in Order of ImpactTable 3.56: Recommendations for HCV Diagnostic TestingTable 3.57: Number of Pap Smears Performed by Country, 2009Table 3.58: Qiagen’s Digene HC2 High-risk HPV DNA TestTable 3.59: Commercially Available Molecular Diagnostic Products for HPV AssayTable 3.60: Major Companies Marketing HPV Molecular Diagnostic Tests: Market Size andShare, 2010Table 3.61: Global Market for HPV Molecular Diagnostic Testing, 2007-2010Table 3.62: U.S. Market for HPV Molecular Diagnostic Testing, 2007-2010Table 3.63: Global Market Forecast for HPV Molecular Diagnostic Testing, 2011-2016Table 3.64: U.S. Market Forecast for HPV Molecular Diagnostic Testing, 2011-2016Table 3.65: HPV Molecular Diagnostics Market: Market Drivers Ranked in Order of ImpactTable 3.66: HPV Molecular Diagnostics Market: Market Restraints Ranked in Order of ImpactTable 3.67: Commercially Available Molecular Diagnostic Products for Influenza AssayTable 3.68: Global Market for Molecular Influenza Diagnostic Testing, 2007-2010Table 3.69: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2010Table 3.70: Global Market Forecast for Influenza Molecular Diagnostic Testing, 2010-2016Table 3.71: U.S. Market Forecast for Influenza Molecular Diagnostic Testing, 2010-2016Table 3.72: Influenza Molecular Diagnostics Market: Market Drivers Ranked in Order ofImpactTable 3.73: Influenza Molecular Diagnostics Market: Market Restraints Ranked in Order ofImpactTable 3.74: U.S. Chlamydia Infection Rates, 1985-2008Table 3.75: U.S. Chlamydia StatisticsTable 3.76: Commercially Available Molecular Diagnostic Products for Chlamydia AssayTable 3.77: Global Market for Molecular Diagnostic Chlamydia/NG Diagnostic Testing, 2000-2010Table 3.78: U.S. Market for Molecular Diagnostic Chlamydia/NG Diagnostic Testing, 2000-2010Table 3.79: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic Tests:Market Size and Share, 2010Table 3.80: Global Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing, 2011-2016Table 3.81: U.S. Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing, 2010-2016Table 3.82: Global Market Forecast for Chlamydia Molecular Diagnostic Testing, 2011-2016Table 3.83: U.S. Market Forecast for Chlamydia Molecular Diagnostic Testing, 2011-2016Table 3.84: Chlamydia Molecular Diagnostics Market: Market Drivers Ranked in Order of
    • ImpactTable 3.85: Chlamydia Molecular Diagnostics Market: Market Restraints Ranked in Order ofImpactTable 3.86: U.S. Gonorrhea StatisticsTable 3.87: Commercially Available Molecular Diagnostic Products for Gonorrhea AssayTable 3.88: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic Tests:Market Size and Share, 2010Table 3.89: Gonorrhea Molecular Diagnostics Market: Market Drivers Ranked in Order ofImpactTable 3.90: Gonorrhea Molecular Diagnostics Market: Market Restraints Ranked in Order ofImpactTable 3.91: Commercially Available Molecular Diagnostic Assays for Testing TBTable 3.92: Global Market for MD TB Diagnostic Testing, 2005-2010Table 3.93: U.S. Market for MD TB Diagnostic Testing, 2005-2010Table 3.94: Global Market Share of MD TB Testing by Region, 2010Table 3.95: Global Unit Sales of MD TB Testing by Region, 2010Table 3.96: Comparative U.S. Claim Charges for TB Testing by Type, 2010Table 3.97: Global Testing for TB by Testing Type, 2010Table 3.98: Global Testing for TB by Testing Reason, 2010Table 3.99: Global Market Forecast for MD TB Diagnostic Testing, 2011-2016Table 3.100: U.S. Market Forecast for MD TB Diagnostic Testing, 2011-2016Table 3.101: Tuberculosis Molecular Diagnostics Market: Market Drivers Ranked in Order ofImpactTable 3.102: Tuberculosis Molecular Diagnostics Market: Market Restraints Ranked in Orderof ImpactTable 3.103: Leading Tuberculosis Therapeutic R&D CandidatesTable 3.104: Commercially Available Molecular Diagnostic Products for MRSA AssayTable 3.105: Global Market for MRSA Diagnostic Testing, 2005-2010Table 3.106: U.S. Market for MRSA Diagnostic Testing, 2005-2010Table 3.107: Major Companies Marketing HCV Molecular Diagnostic Tests: Market Size andShare, 2010Table 3.108: Global Market Forecast for MD MRSA Diagnostic Testing, 2011-2016Table 3.109: U.S. Market Forecast for MD MRSA Diagnostic Testing, 2011-2016Table 3.110: MRSA Molecular Diagnostics Market: Market Drivers Ranked in Order of ImpactTable 3.111: MRSA Molecular Diagnostics Market: Market Restraints Ranked in Order ofImpactTable 3.112: In vitro Susceptibility of Staphylococci to New Agents in DevelopmentTable 3.113: Commercially Available Molecular Diagnostic Products for VRE AssayTable 3.114: Global Market for VRE Diagnostic Testing, 2005-2010Table 3.115: U.S. Market for VRE Diagnostic Testing, 2005-2010Table 3.116: Major Companies Marketing VRE Molecular Diagnostic Tests: Market Size andShare, 2010Table 3.117: Global Market Forecast for MD VRE Diagnostic Testing, 2011-2016Table 3.118: U.S. Market Forecast for MD VRE Diagnostic Testing, 2011-2016Table 3.119: VRE Molecular Diagnostics Market: Market Drivers Ranked in Order of ImpactTable 3.120: VRE Molecular Diagnostics Market: Market Restraints Ranked in Order ofImpactTable 3.121: Transmission-related Disease Screening from Blood Donor PoolsTable 3.122: Principal Blood Screening Products of Gen-Probe for HIV Assay
    • Table 3.123: Global Market for Blood Screening Product Sales, 2007-2016Table 3.124: Global Revenue and Forecast for Blood-Screening Market, 2000-2016Table 3.125: U.S. Market and Forecast for Blood-Screening Market, 2000-2016Table 3.126: Major Companies Marketing Blood Screening Molecular Diagnostic Tests:Market Size and Share, 2010Table 3.127: Blood Screening Molecular Diagnostics Market: Market Drivers Ranked in Orderof ImpactTable 3.128: Blood Screening Molecular Diagnostics Market: Market Restraints Ranked inOrder of ImpactTable 4.1: Key Elements for Business Competition in Molecular Diagnostic Testing forInfectious DiseaseTable 4.2: Key Elements for Future Success in Molecular Testing for Infectious DiseaseTable 4.3: Examples of Personalized Medicine in Treatment of Infectious DiseaseTable 4.4: Molecular Methods for Epidemiologic Typing of MicroorganismsTable 4.5: Drivers of Molecular Diagnostic Methods for Infectious Disease Testing in theClinical SettingTable 4.6: Barriers to Molecular Diagnostic Methods for Infectious Disease Testing in theClinical SettingTable 5.1: Technology Trends in Molecular Diagnostic Infectious Disease TestingTable 5.2: Clinical Testing Trends in Molecular Diagnostic Infectious Disease TestingTable 5.3: Business Market Trends in Molecular Diagnostics Infectious Disease TestingTable 5.4: Expected Changes in HealthcareTable 5.5: Customer Feedback for Automated Molecular Diagnostic InstrumentsTable 5.6: Molecular Diagnostics Infectious Disease Market: Market Drivers Ranked in Orderof ImpactTable 5.7: Molecular Diagnostics Infectious Disease Market: Market Restraints Ranked inOrder of ImpactTable 5.8: Advantages of European Markets for Molecular Diagnostic TestingTable 5.9: European Sales Percentage of Most Common Molecular Diagnostic Tests byAnalyte TypeTable 5.10: Disadvantages of European Markets for Molecular Diagnostic TestingTable 5.11: Summary of Recent M&A Activity in the Molecular Diagnostics SectorTable 5.12: High Value Opportunities in Collaborative and Strategic PartnershipsTable 5.13: Principal Competitive Factors in the Molecular Diagnostics Infectious DiseaseTesting MarketTable 5.14: Molecular Diagnostics Infectious Disease Testing Market: StrategicRecommendations on Molecular Diagnostic Sector Business FunctionsTable 5.15: Molecular Diagnostics Infectious Disease Market: Impact of Top IndustryChallenges in the U.S.Table 5.16: Documents for Protecting Intellectual Property RightsTable 5.17: Recent Patents Related to PCR, Nucleic Acid Amplification, and Sample PrepTable 5.18: Specific Opportunities for Automated Instrumentation and Reagent Systems inMolecular Diagnostics for Infectious Disease TestingTable 5.19: Roche PCR LicensesTable 5.20: Global Sales of Gen-Probe by Geographic Area, 2008-2010Table 5.21: The Required Elements of a Manufacturing FacilityTable 5.22: CMO Qualification Audit: Points to InvestigateTable 5.23: Strategies and POA for Marketing Infectious disease Diagnostic ProductsTable 5.24: Key Elements of Molecular Diagnostic Companies Marketing Plan
    • Table 5.25: Utility of Biomarkers as Companion Diagnostics to Drug DevelopmentTable 5.26: Leading Pharmaceutical Companies in the Anti-infective Market—Total GlobalSales, 2008Table 6.1: Factors Determining Third Party Payment for Molecular Diagnostic Tests forInfectious DiseaseTable 6.2: CPT Codes for Molecular Diagnostic Infectious Disease TestingTable 7.1: Regulatory Rules that Affect the Ability of a Diagnostic Testing Reagent Companyto Conduct BusinessTable 7.2: Strengths of the 510k ProcessTable 7.3: Drawbacks of the 510k ProcessTable 7.4: Focus Areas for the FDA Critical Path InitiativeTable 8.1: Effect of Regulation on MD Infectious Disease Market Technology Platforms, 2007and 2015Table 8.2: Companies Utilizing New, Cutting-edge Technologies to Develop, Validate andMarket Molecular Tests for Clinical Use in Infectious Disease ManagementTable 8.3: Impediments to Incorporating Promising Molecular Tests into Clinical PracticeTable 8.4: New Molecular Diagnostics Tests Showing the Most Promise for ApprovalTable 8.5: Alliances Showing the Greatest Synergy in bringing Molecular Diagnostics Teststo MarketTable 8.6: Shared Technologies Driving the Most Encouraging MD DevelopmentTable 10.1: Gen-Probe Key AcquisitionsTable A1: MRSA/SA Strains for Analytical Sensitivity (LoD) and Inclusivity Studies obtainedfrom the CDCTable A2: MRSA Strains (known Clinical Associated Strains) obtained from the Network onAntimicrobial Resistance in Staphylococcus aureus (NARSA) for Analytical Sensitivity (LoD)and Inclusivity StudiesTable A3: MRSA Strains (Clinical Isolates and Isolates obtained from Public and PrivateCollections) for Analytical Sensitivity (LoD) and Inclusivity StudiesTable A4: Examples of Microorganisms (Non-Staphylococci Strains of Various Bacterial andYeast Species and Viruses) Recommended for Analytical Specificity (Cross-reactivity)Studies for Devices that are Indicated for Testing Nasal Swab Specimens Collected fromPatients at Risk for MRSA ColonizationTable A5: Examples of Coagulase Negative Staphylococci (CNS) from Public and PrivateCollections (including Methicillin-resistant Staphylococcus epidermidis (MRSE), Methicillin-resistant Coagulase Negative Staphylococci (MRCoNS) and Methicillin-sensitive CoagulaseNegative Staphylococci (MSCoNS) Recommended for Analytical Specificity (Cross-reactivity)Studies for Devices that are Indicated for Testing Nasal Swab Specimens Collected fromPatients at Risk for MRSA ColonizationTable A6: Examples of Substances Recommended for an Interference Study for Nasal SwabSpecimensTable A7: Examples of Substances Recommended for an Interference Study for Skin andSoft Tissue Infection Swab SpecimensTable A8: FDA-approved Molecular Diagnostic Tests for Infectious DiseasesTable A9: Noncommercial Nucleic Acid-based Tests for Clinically Important Viral andBacterial PathogensTable A10: Molecular Methods for Detecting Antimicrobial ResistanceTable A11: Genotypic Methods for Epidemiologic Typing of MicroorganismsTable A12: Reduction in Number and Cost of Nosocomial Infections through CollaborativeEfforts of Infection Control, Clinical Microbiology, and Molecular Typing Laboratories
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