miniddy5的部落格

NEW YORK, Aug.儲存 19, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:Molecular Diagnostics in Infectious Disease Testing.reportlinker.com/p0368860/Molecular-Diagnostics-in-Infectious-Disease-Testing.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_DiagnosticThis TriMark Publications report describes the specific segment of the in vitro diagnostics market known as molecular diagnostics testing for infectious disease. In the current medical diagnostics market, molecular diagnostics in infectious disease testing offers one of the most promising areas for growth and innovation. The confluence of breakthroughs in genomics and proteomics--along with the development of microarray devices to measure analytes in the blood--has led to this revolutionary market development. Specifically, molecular diagnostics offers the power of advanced analytical techniques to diagnose infectious diseases. Whereas before, the detection of many infectious 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 the emerging field of molecular diagnostics in infectious disease testing. The infectious disease space is the most dominant and profitable sector of molecular diagnostics. Topics covered in this study include: 1) the existing and emerging technologies in the field, 2) the U.S. and global market size for molecular diagnostic products and 3) the profiles of companies that are focusing on the molecular diagnostic sector. The research examines drivers and restraints for sales growth, market share and technical trends. In addition, an in-depth analysis of the competitive situation of prominent market venders is provided with five-year sales forecasts.1. Overview 161.1 Statement of Report 161.2 About This Report 171.3 Scope of the Report 171.4 Objectives 191.5 Methodology 191.6 Executive Summary 212. Introduction to Molecular Diagnostics for Infectious Disease Testing 292.1 Molecular Diagnostics Testing and Opportunities in the Infectious Disease Sector 292.2 The Infectious Disease Problem 332.3 Impact of the Human Genome Project on Molecular Diagnostics 372.4 Opportunities for Molecular and Clinical Diagnostics 382.4.1 Companion Diagnostics 392.5 Development of Molecular Diagnostics Testing Markets 392.6 Target-Based Gene Amplification 412.6.1 Polymerase Chain Reaction 412.6.2 Real-Time PCR 412.6.3 Nucleic Acid Sequence-Based Amplification 422.6.4 Market Drivers and Restraints 462.6.4.1 Market Drivers 462.6.4.2 Market Restraints 462.6.5 Market and Technology Trends 462.6.5.1 Market Trends 462.6.5 2 Technology Trends 472.6.6 Strategic Recommendations 482.7 PCR Reagents for Clinical Diagnostics 483. Infectious Disease Diagnostics Molecular Testing Market 503.1 Market Overview 503.1.1 Overall Infectious Disease Market Analysis 553.2 NAT Molecular Diagnostics Market 673.3 Infectious Disease Molecular Diagnostic Testing Markets 693.3.1 HIV 693.3.1.1 Disease Background and Statistics 693.3.1.2 Measuring Viral Loads 763.3.1.3 Instruments and MD Reagents 773.3.1.4 Method Comparisons 833.3.1.5 Market Size 853.3.1.5.1 HIV Diagnostic Testing 863.3.1.6 HIV Market Challenges and Strategic Recommendations 903.3.1.6.1 HIV Molecular Diagnostic Market History 903.3.1.7 Market Drivers and Restraints 913.3.1.7.1 Market Drivers 913.3.1.7.2 Market Restraints 923.3.1.8 Market and Technology Trends 923.3.1.8.1 Market Trends 923.3.1.8.2 Technology Trends 933.3.1.9 Strategic Recommendations 943.3.2 Hepatitis 943.3.2.1 Hepatitis B Virus 953.3.2.1.1 Hepatitis B Disease Background and Statistics 953.3.2.1.2 Instruments and Reagents for Hepatitis B Detection 973.3.2.1.3 Method Comparisons 993.3.2.1.4 Hepatitis B Market Size 1013.3.2.1.5 HBV Market Challenges and Strategic Recommendations 1033.3.2.1.5.1 Market Drivers and Restraints 1033.3.2.1.5.1.1 Market Drivers 1033.3.2.1.5.1.2 Market Restraints 1033.3.2.1.6 Market and Technology Trends 1043.3.2.1.6.1 Market Trends 1043.3.2.1.6.2 Technology Trends 1043.3.2.1.7 Strategic Recommendations 1053.3.2.2 Hepatitis C Virus Testing 1063.3.2.2.1 Disease Background and Statistics 1063.3.2.2.2 Instruments and Reagents for Hepatitis C Detection 1123.3.2.2.3 Method Comparisons for HCV Tests 1183.3.2.2.4 Hepatitis C Market Size 1203.3.2.2.4.1 HCV Market Share 1223.3.2.2.5 HCV Market Challenges and Strategic Recommendations 1233.3.2.2.5.1 Market Drivers and Restraints 1233.3.2.2.5.1.1 Market Drivers 1233.3.2.2.5.1.2 Market Restraints 1243.3.2.2.5.2 Market and Technology Trends 1243.3.2.2.5.2.1 Market Trends 1243.3.2.2.5.2.2 Technology Trends 1253.3.2.2.6 Strategic Recommendations 1263.3.3 Human Papillomavirus 1273.3.3.1 Disease Background and Statistics 1273.3.3.2 Instruments and Reagents for HPV Detection 1323.3.3.3 Method Comparison 1393.3.3.4 HPV Market Size 1393.3.3.4.1 North American Market 1413.3.3.4.2 European Market 1433.3.3.5 Market Challenges and Strategic Recommendations 1453.3.3.5.1 Market Drivers and Restraints 1453.3.3.5.1.1 Market Drivers 1453.3.3.5.1.2 Market Restraints 1453.3.3.5.2 Market and Technology Trends 1453.3.3.5.2.1 Market Trends 1453.3.3.5.2.2 Technology Trends 1473.3.3.5.3 Strategic Recommendations 1493.3.4 Influenza Viruses 1493.3.4.1 Disease Background and Statistics 1493.3.4.2 Instruments and Reagents for Influenza Detection 1553.3.4.3 Method Comparisons 1583.3.4.4 Influenza Market Size 1583.3.4.5 Influenza Market Challenges and Strategic Recommendations 1593.3.4.5.1 Market Drivers and Restraints 1593.3.4.5.1.1 Market Drivers 1593.3.4.5.1.2 Market Restraints 1593.3.4.5.2 Market and Technology Trends 1603.3.4.5.2.1 Market Trends 1603.3.4.5.2.2 Technology Trends 1603.3.4.5.3 Strategic Recommendations 1613.3.5 STD Testing (Chlamydia/Gonorrhea Molecular Diagnostic Testing) 1613.3.5.1 Chlamydia/Gonorrhea Molecular Diagnostic Testing Market Size 1633.3.5.2 Competitive Structure and Market Share Analysis 1633.3.5.2.1 Market Forecasts 1653.3.5.2.1.1 Revenue Forecasts 1653.3.5.3 Chlamydia Molecular Diagnostic Testing 1653.3.5.3.1 Disease Background and Description 1653.3.5.3.2 Product Analysis: Instruments and Reagents for Testing Chlamydia 1693.3.5.3.3 Method Comparison 1713.3.5.3.4 Chlamydia Molecular Diagnostic Testing 1723.3.5.3.4.1 Revenue Forecasts 1723.3.5.3.4.2 Market Challenges 1733.3.5.3.4.2.1 Market Drivers 1733.3.5.3.4.2.2 Market Restraints 1733.3.5.3.5 Market and Technology Trends 1743.3.5.3.5.1 Market Trends 1743.3.5.3.5.2 Technology Trends 1743.3.5.3.5.3 Strategic Recommendations 1753.3.5.4 Gonorrhea Molecular Diagnostic Testing 1753.3.5.4.1 Disease Background and Description 1753.3.5.4.2 Product Analysis: Instruments and Reagents 1783.3.5.4.3 Method Comparison 1803.3.5.4.4 Competitive Structure and Market Share Analysis 1813.3.5.4.5 Market Forecasts 1823.3.5.4.5.1 Revenue Forecasts 1823.3.5.4.6 Market Challenges 1823.3.5.4.6.1 Market Drivers 1823.3.5.4.6.2 Market Restraints 1823.3.5.4.7 Market and Technology Trends 1823.3.5.4.7.1 Market Trends 1823.3.5.4.7.2 Technology Trends 1833.3.5.4.8 Strategic Recommendations 1833.3.6 Tuberculosis 1833.3.6.1 Disease Background and Description 1833.3.6.2 Product Analysis: Instruments and Reagents 1923.3.6.3 Method Comparison 1933.3.6.4 Tuberculosis Market Size 1943.3.6.5 Competitive Structure and Market Share Analysis 1953.3.6.6 Market Forecasts 1973.3.6.6.1 Revenue Forecasts 1973.3.6.7 Market Challenges 1983.3.6.7.1 Market Drivers 1983.3.6.7.2 Market Restraints 1983.3.6.8 Market and Technology Trends 1993.3.6.8.1 Market Trends 1993.3.6.8.2 Technology Trends 2003.3.6.9 Strategic Recommendations 2003.3.7 Methicillin-Resistant Staphylococcus aureus (MRSA) 2013.3.7.1 Disease Background and Description 2013.3.7.2 Product Analysis: Instruments and Reagents 2043.3.7.3 Method Comparison 2053.3.7.4 MRSA Market Size 2063.3.7.5 Competitive Structure and Market Share Analysis 2073.3.7.6 Market Forecasts 2093.3.7.6.1 Revenue Forecasts 2093.3.7.7 Market Challenges 2103.3.7.7.1 Market Drivers 2103.3.7.7.2 Market Restraints 2103.3.7.8 Market and Technology Trends 2103.3.7.8.1 Market Trends 2103.3.7.8.2 Technology Trends 2113.3.7.9 Strategic Recommendations 2113.3.8 Vancomycin-resistant Enterococci 2123.3.8.1 Disease Background and Description 2123.3.8.2 Product Analysis: Instruments and Reagents 2153.3.8.3 Method Comparison 2153.3.8.4 Competitive Structure and Market Share Analysis 2173.3.8.5 Market Forecasts 2183.3.8.5.1 Revenue Forecasts 2183.3.8.6 Market Challenges 2193.3.8.6.1 Market Drivers 2193.3.8.6.2 Market Restraints 2193.3.8.7 Market and Technology Trends 2193.3.8.7.1 Market Trends 2193.3.8.7.2 Technology Trends 2203.3.8.8 Strategic Recommendations 2203.3.9 Herpes Simplex Virus 2213.3.10 C. difficile 2213.3.11 Cytomegalovirus 2223.4 Blood Screening 2223.4.1 Product Analysis: Instruments and Reagents 2243.4.2 Method Comparison 2263.4.3 Blood Screening Market Size 2273.4.4 Competitive Positions 2283.4.5 Market Challenges and Strategic Recommendations 2333.4.5.1 Market Drivers and Restraints 2333.4.5.1.1 Market Drivers 2333.4.5.1.2 Market Restraints 2333.4.5.2 Market and Technology Trends 2343.4.5.2.1 Market Trends 2343.4.5.2.2 Technology Trends 2353.4.5.3 Strategic Recommendations 2354. Molecular Diagnostic Testing Technology for Infectious Disease Testing 2364.1 Infectious Disease Diagnostic Tests 2364.1.1 Molecular Diagnostic Tools Solutions 2384.1.2 Technology of Gene Expression Analysis 2384.1.2.1 Amplification and Detection of RNA 2384.1.2.2 Analysis of Multiple Genes 2394.1.2.3 Advanced Information Technology 2404.2 Use of Molecular Tests in Infectious Disease 2404.2.1 Molecular Screening 2404.2.2 Early Detection 2414.2.3 Detection of Specific Resistance Genes and Viral Loading Tests 2414.2.4 Pharmacogenomics and Personalized Medicine in MD Infectious Disease Testing 2414.2.5 Molecular Strain Typing 2434.3 Cost of Molecular Diagnostic Testing 2454.4 Use of Multiplex PCR Tests 2454.4.1 Advantages of Multiplex PCR 2454.4.2 Applications of Multiplex PCR 2464.5 Next-Generation Sequencing 2474.6 Patient Flow Software 2494.7 Digital PCR 2494.8 LAMP 2494.9 Ion Proton System for Gene Sequencing 2505. Business 2525.1 Technology and Market Trends 2525.1.1 Technology Trends 2525.2 M&A Activity 2555.3 Partnerships 2585.4 Competitive Analysis 2615.4.1 Primary Competitors 2615.4.2 Industry Challenges and Strategic Recommendations 2625.4.3 Commercialization of Molecular Diagnostic Products 2635.5 Intellectual Property Rights 2635.5.1 New Patents 2655.5.2 Current Patent Disputes 2655.6 Opportunities and Strategic Recommendations 2665.6.1 The Key Technical Opportunities with Significant Market Appeal in the Molecular Diagnostic Space in the Next Five Years 2665.6.2 Developments for Molecular Diagnostic Instrumentation Products 2665.6.3 Market Penetration Strategies for Infectious Disease Testing 2675.7 Business Models and Requirements for a Successful Molecular Diagnostics Infectious Disease Products Industry 2675.7.1 Scope of This Section 2675.7.2 The Success Achieved by the Molecular Diagnostics Infectious Disease Products 2675.7.3 Business Models in Molecular Diagnostics Infectious Disease Products 2685.7.4 SWOT Comparison of Business Models for MD Infectious Disease Diagnostic Testing 2695.7.5 Commercial Manufacturing of Molecular Diagnostics Infectious Disease Products: Requirements 2825.7.5.1 Elements of Commercial Manufacturing 2825.7.5.1.1 Regulatory Requirements 2825.7.5.1.2 Manufacturing Process Scale 2825.7.5.1.3 In-House Manufacturing 2835.7.5.2 Contract Manufacturing: Commercial and Academic 2835.7.6 Sales and Marketing Strategies for Infectious Disease Tests 2845.8 Companion Diagnostics Development in Partnership with a Pharmaceutical Company 2885.8.1 Description of Business Model 2885.8.2 Anti-Infective Pharmaceutical Market 2926. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for Infectious Disease 2996.1 Overview 2996.1.1 Gap Filling 3006.2 Trends in Reimbursement Practice 3006.2.1 Medicare Reimbursement Threats 3026.2.2 Analysis of ROI for Molecular Diagnostic Tests for Infectious Disease Using Current Medicare Reimbursement Rules 3056.3 Trends in Patient Care and Reimbursement 3056.4 Revenue Threats 3076.4.1 Medicare Payment Exceptions 3086.4.2 Three Areas for Denial of Claims 3086.5 Billing Rules 3096.5.1 Medicare Billing Procedures 3096.5.2 Medicare CPT Coding Rules for MD Infectious Disease Testing 3106.5.3 Infectious Disease Billing Strategies 3117. Regulatory Requirements 3137.1 U.S. Food and Drug Administration 3137.2 CLIA Regulations 3137.3 Clinical Laboratory Improvement Act 3157.4 State Licensing for Service Laboratories 3167.5 IVDMIAs 3167.6 FDA Draft Guidance on In Vitro Companion Diagnostic Devices 3177.7 510(k) Clearance 3177.8 Pre-Market Approval (PMA) 3187.8.1 Pre-Market Approval Application 3197.9 Analyte Specific Reagents (ASRs) 3197.9.1 Laboratory Developed Tests (LDT) 3207.10 What Regulatory Guidance is Needed for Companion Biomarkers? 3217.11 U.S. Patent and Trademark Office (USPTO) 3237.12 IRB Approval in Clinical Trials 3237.13 CE Marking and the European In Vitro Diagnostic Device Directive 3237.14 De Novo Classification 3237.15 Research Use Only Reagents 3247.16 FDA Recommendations on Methicillin-Resistant Staphylococcus aureus and Staphylococcus aureus Testing 3248. Business Decisions using Molecular Diagnostic Tests in Infectious Disease Testing 3288.1 What are Key Opportunities in Infectious Disease Testing Development and Commercialization? 3288.3 How do Business Strategies, Such as Those Relating to Acquisition, Drive MD Strategies? 3298.4 How Might Novel Infectious Disease MD Test Development Lead to Acquisition Strategies and Their Implications for Deal Making? 3298.5 How can Molecular Diagnostic Tests Increase Value in an Associated Drug Marketing Plan? 3308.6 Which Types of Infectious Disease MD Testing Should be Developed by Diagnostic Companies at Various Stages in the Development Pipeline? 3308.7 How can Regulatory Oversight Drive Approval and Adoption of New Technologies? 3318.8 What are the Noteworthy Deals? 3318.9 Who are the Acquirers? 3328.10 Who are the Target Companies? 3328.11 How will Platform Technology Companies Enter the Space? 3328.12 Will Pharma Integrate with Diagnostics? 3348.13 How do Platform Technology Companies Position Themselves for Diagnostics Development? 3348.14 Evaluate How Partnering and M&As will Alter the Competitive Landscape 3358.15 Predict How FDA Regulations will Impact New Diagnostic Tests 3358.16 How can Big Pharma and Diagnostic Companies Co-Develop Biomarkers in a Model for Regulatory Acceptance? 3368.17 How to Maximize Business Development Through Biomarker Strategies? 3368.18 What is the Best Type of Business Model for Developing Genetic Biomarkers for Infectious Disease? 3378.19 How Best have Genetic Biomarkers Provided the Most Benefit in Infectious Disease Testing? 3378.20 What are the Most Innovative Methods in Development of Molecular Diagnostic Biomarkers? 3378.21 What are the Best Values for Genetic Biomarkers in Drug Development and in Diagnostics? 338FDA Clears Gen-Probe's PANTHERAE System for use with APTIMA Combo 2AE Assay in May 2012 3389. Economics of Anti-Microbial Drug Resistance: The Persistent Need for Antibacterials 3419.1 Resistance and Antibiotic Usage 3459.2 Infection Control Programs 34710. Company Profiles 34810.1 Abbott Laboratories 34810.2 AdvanDx 35110.3 Arcxis Biotechnologies 35210.4 Atlas 35210.5 AutoGenomics, Inc. 35310.6 Becton, Dickinson and Company 35410.7 bioMErieux 35610.8 Biocartis 35610.9 bioTheranostics 35710.10 Cepheid 35810.11 EraGen Biosciences 35910.12 GenMark Diagnostics, Inc. 36010.13 Genomix Biotech 36010.14 Hologic Gen-Probe 36110.15 Genomica S.A.U. 36610.16 Great Basin Corporation 36710.17 Illumina, Inc. 36710.18 Innogenetics NV 36810.19 Life Technologies 37010.20 Mobidiag 37210.21 Myconostica 37210.22 Myriad Genetics, Inc. 37210.23 Nanosphere 37410.24 NorDiag ASA (The DiaSorin Group) 37610.25 Qiagen NV 37610.26 Roche Ltd. 37910.27 Seegene 38010.28 SIRS-Lab 38110.29 TrimGen 38110.30 TrovaGene 38110.31 Veredus Laboratories 38110.32 Veridex 382Appendix 1: Draft Guidance for Industry and Food and Drug Administration StaffoEstablishing the Performance Characteristics of Nucleic Acid-based In Vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) 383Appendix 2: Molecular Diagnostic Instruments with Combined Functions - Draft Guidance for Industry and Food and Drug Administration Staff 406Appendix 3: Applications for Molecular Testing 411INDEX OF FIGURESFigure 2.1: Relationship of DNA Testing to Key Areas of Clinical Diagnosis 29Figure 2.2: Finding Genes with Microassays 30Figure 2.3: The Use of Microassays for Studying Gene Expression 31Figure 2.4: Overall Structure of Nucleic Acid Testing Market 42Figure 3.1: Global Market fo新蒲崗迷你倉 Molecular Diagnostics, 2002-2017 50Figure 3.2: Global Market for Molecular Diagnostics Testing, 2012 53Figure 3.3: Share of Molecular Diagnostics Testing by Testing Type, 2012 54Figure 3.4: Key Players Market Share in Global Molecular Diagnostics Testing Markets, 2012 55Figure 3.5: Global Market for Infectious Disease Treatments, 2008-2014 56Figure 3.6: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018 57Figure 3.7: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018 58Figure 3.8: Infectious Disease Testing Revenue Market Share of Total U.S. MD Market, 2012 and 2018 59Figure 3.9: European Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018 60Figure 3.10: Japanese Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018 61Figure 3.11: Rest of World (ROW) Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018 61Figure 3.12: Infectious Disease Testing Revenue Market Share by Region, 2012 and 2018 62Figure 3.13: Total Global Infectious Disease Molecular Diagnostics Markets, 2012 63Figure 3.14: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2012 63Figure 3.15: Total Global Infectious Disease Molecular Diagnostics Markets, 2018 65Figure 3.16: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2018 65Figure 3.17: Global Trend of HIV Infection, 1991-2011 69Figure 3.18: Number of People Living with HIV, Newly Infected with HIV and Number of AIDS Deaths in the World, 1990-2011 70Figure 3.19: Worldwide Rate of New HIV Cases, 1990-2011 71Figure 3.20: Percentage of Adult Population in African Countries with HIV, 2010 72Figure 3.21: Global View of HIV Infection, 2009 74Figure 3.22: Ethnic Distribution of AIDS Patients in the U.S., 2011 74Figure 3.23: Ten Best Selling AIDS Drugs in the U.S., 2011 75Figure 3.24: U.S. Rates for New HIV Cases, 2011 75Figure 3.25: U.S. Rates for New HIV Cases in Men, 2010 76Figure 3.26: U.S. Rates for New HIV Cases in Women, 2010 76Figure 3.27: Proposed HIV Testing Algorithm 84Figure 3.28: Distribution of HIV Molecular Diagnostic Testing by Purpose 86Figure 3.29: Estimated Market for Global HIV Molecular Diagnostic Testing, 2011-2016 87Figure 3.30: Estimated Market for U.S. HIV Molecular Diagnostic Testing, 2011-2018 88Figure 3.31: Market Share Viral Load HIV MD Diagnostic Testing 89Figure 3.32: Geographic Distribution of Chronic HBV Infection 96Figure 3.33: Reported Cases of Acute Hepatitis A, B and C Infections in the U.S., 2005-2010 97Figure 3.34: Global Prevalence of Hepatitis C 107Figure 3.35: Primary Causes of Chronic Liver Disease 109Figure 3.36: Incidence of Acute Hepatitis C by Age Group o United States, 1992n2009 110Figure 3.37: Hepatitis C Infection by Source 110Figure 3.38: Growth and Projections of HCV Therapies by Drug Class, 2008 and 2013 111Figure 3.39: U.S. Market Share of HCV Molecular Diagnostic Market, 2012 122Figure 3.40: Global Market Share (Excluding U.S.) of HCV Molecular Diagnostic Market, 2012 122Figure 3.41: Rate of New Cases and Deaths of Cervical Cancer by Age Group Worldwide, 1980-2010 130Figure 3.42: Hybrid Capture 2 (HC2) versus PCR - Analytical Sensitivity and Clinical Sensitivity 134Figure 3.43: Basic Steps in Hybrid Capture 2 Technology 135Figure 3.44: U.S. Market Share of HPV Molecular Diagnostic Market, 2012 140Figure 3.45: Global Market Share (Excluding U.S.) of HPV Molecular Diagnostic Market, 2012 140Figure 3.46: Market Share Estimates for Molecular Diagnostic HPV Testing, 2012 141Figure 3.47: Number of Reported and Confirmed Cases of Influenza by Virus Sub-Type Worldwide, 2013 153Figure 3.48: Distribution of H1N1 Flu in the U.S., 2013 154Figure 3.49: H1N1 Confirmed and Probable Case Rate in the U.S., By Age Group 155Figure 3.50: U.S. Rates of Sexually-transmitted Diseases, 1940-2010 162Figure 3.51: U.S. Market Share of Chlamydia/Gonorrhea Molecular Diagnostic Market, 2012 164Figure 3.52: Global Market Share (Excluding U.S.) of Chlamydia/Gonorrhea Molecular Diagnostic Market, 2012 164Figure 3.53: Chlamydia Infection Rates: Total and by Gender: U.S., 1989-2010 168Figure 3.54: Chlamydia U.S. Prevalence by Age Group and Race/Ethnicity 169Figure 3.55: U.S. and Outlying Areas Gonorrhea Infection Rates, 1941-2011 176Figure 3.56: U.S. Gonorrhea Infection Rates by Race/Ethnicity, 1999-2011 177Figure 3.57: Pipeline for TB Diagnostics, 2005-2015 186Figure 3.58: The Development Pipeline for New TB Drugs, July 2012 186Figure 3.59: Number of Tuberculosis Cases Among U.S.- and Foreign-Born Persons in the U.S., 1993-2011 187Figure 3.60: Rate of Tuberculosis Cases Among U.S.- and Foreign-Born Persons in the U.S., 1993-2011 187Figure 3.61: Rate of Tuberculosis Cases by State/Area in the U.S., 2011 189Figure 3.62: U.S.-Born Tuberculosis Cases by Ethnicity, 2011 190Figure 3.63: Reported Tuberculosis Cases in the U.S., 1983-2011 194Figure 3.64: Global Market Share of MD TB Testing 195Figure 3.65: Global Market Share of MD TB Testing by Region, 2012 196Figure 3.66: Incidence Rates of Invasive MRSA Infections by Age 203Figure 3.67: MRSA Trends According to Patient Location, 1998-2005 203Figure 3.68: Incidence of Healthcare-Associated MRSA Infections, 2005-2008 204Figure 3.69: U.S. Market Share of MRSA Molecular Diagnostic Market, 2012 208Figure 3.70: Global Market Share (Excluding U.S.) of MRSA Molecular Diagnostic Market, 2012 208Figure 3.71: Global Frequency of Vancomycin-Resistant Enterococci, 2006 214Figure 3.72: U.S. Market Share of VRE Molecular Diagnostic Market, 2012 218Figure 3.73: Estimated Market for Global Blood Screening Product Sales, 2007-2019 228Figure 3.74: Hologic Gen-Probe Blood Screening Product Net Sales, 2005-2009 229Figure 3.75: Blood Screening Product Market Share by Company, 2012 231Figure 4.1: Using DNA Microassays to Measure Gene Expression 236Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients 237Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients 242Figure 5.1: FDA Co-developed Products as a Model for Collaboration 259Figure 5.2: Market Growth of MD Infectious Disease Tests 285Figure 5.3: Segmentation of the Biomarker Development Market 289Figure 5.4: Global Distribution of Anti-infective Agent Sales by Geography 292Figure 5.5: Leading Companies in Anti-infectives Market Share, 2011 294Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision Making 302Figure 9.1: Global Multidrug Susceptibility in Pseudomonas aeruginosa 343Figure 9.2: Global Frequency of Vancomycin-Resistant Enterococci, 2006 344INDEX OF TABLESTable 1.1: Market Trends in Infectious Disease DNA Testing 22Table 1.2: Molecular Diagnostics Infectious Disease Market: Market Drivers Ranked in Order of Impact 23Table 1.3: Molecular Diagnostics Infectious Disease Market: Market Restraints Ranked in Order of Impact 23Table 1.4: Strategic Recommendations on Molecular Diagnostic Sector Business Functions 23Table 2.1: Top Ten Causes of Death Worldwide 33Table 2.2: The Most Prevalent Infectious Diseases Worldwide 34Table 2.3: Annual Rates of Global Infectious Diseases 37Table 2.4: Emerging Molecular Diagnostic Technologies 40Table 2.5: Automated Molecular Diagnostics Platforms for Infectious Disease Testing 43Table 2.6: Companies Marketing Multiple Products in Molecular Diagnostics Infectious Disease Sector 43Table 2.7: FDA-Approved Molecular Diagnostic Commercial Kits for the Detection of Infectious Agents 45Table 2.8: Global and U.S. Major Infectious Disease Market Size (Estimated Infected Persons) 45Table 2.9: Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 46Table 2.10: Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 46Table 2.11: Attractive Growth Areas for Molecular Diagnostic Testing 48Table 2.12: NAT Labs in U.S. and Five European Markets 48Table 3.1: Global Market for Molecular Diagnostics Testing, 2000-2017 51Table 3.2: U.S. Market for Molecular Diagnostics Testing, 2004-2018 51Table 3.3: European Market for Molecular Diagnostics Testing, 2005-2018 52Table 3.4: Japanese Market for Molecular Diagnostics Testing, 2009-2018 52Table 3.5: Summary of Molecular Diagnostics Testing Sectors 53Table 3.6: Share of Molecular Diagnostics Testing by Testing Type, 2012 54Table 3.7: Key Players and Market Share in Global Molecular Diagnostics Testing Market 2012 54Table 3.8: Revenue Model for Molecular Diagnostics Testing 55Table 3.9: Molecular Infectious Disease Diagnostics Market: Market Drivers Ranked in Order of Impact 56Table 3.10: Molecular Infectious Disease Diagnostics Market: Market Restraints Ranked in Order of Impact 56Table 3.11: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018 57Table 3.12: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018 58Table 3.13: European Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018 59Table 3.14: Japanese Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018 60Table 3.15: Rest of World (ROW) Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018 60Table 3.16: Molecular Diagnostic Markets for Infectious Disease Testing, 2012 63Table 3.17: Molecular Diagnostic Markets for Infectious Disease Testing, 2018 64Table 3.18: Business Factors Influencing Advanced Infectious Disease MD Testing Services 66Table 3.19: Global Summary of the HIV/AIDS Epidemic, 2011 70Table 3.20: Global HIV Statistics, 2011 73Table 3.21: HIV Resistance Testing Recommendations 77Table 3.22: Summary of Assays for HIV Viral Load Testing 77Table 3.23: Commercially Available Molecular Diagnostic Products for HIV Assay 83Table 3.24: Global Market for Molecular Diagnostic HIV Testing, 2007-2012 86Table 3.25: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2012 87Table 3.26: Global Market for Molecular Diagnostic HIV Diagnostic Testing, 2013-2018 88Table 3.27: U.S. Market for Molecular Diagnostic HIV Diagnostic Testing, 2013-2018 88Table 3.28: Global Market for HIV Viral Load Diagnostic Testing, 2007-2012 89Table 3.29: U.S. Market for HIV Viral Load Diagnostic Testing, 2007-2012 89Table 3.30: Global Market for HIV Viral Load Diagnostic Testing, 2013-2018 90Table 3.31: U.S. Market for HIV Viral Load Diagnostic Testing, 2013-2018 90Table 3.32: HIV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 91Table 3.33: HIV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 92Table 3.34: Clinical Application of Quantitative HBV DNA Testing 97Table 3.35: Lower Detection Limits of HBV DNA Assays 99Table 3.36: Summary of Molecular Diagnostic Assays for Testing HBV 101Table 3.37: Global Market for HBV Diagnostic Testing, 2000-2012 101Table 3.38: U.S. Market for HBV Diagnostic Testing, 2000-2012 102Table 3.39: Global Market for HBV Diagnostic Testing, 2013-2018 102Table 3.40: U.S. Market for HBV Diagnostic Testing, 2013-2018 102Table 3.41: HBV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 103Table 3.42: HBV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 103Table 3.43: Hepatitis B Facts 106Table 3.44: U.S. HCV Statistics 111Table 3.45: Worldwide Rate of HCV Cases 112Table 3.46: Efficiency of Available HCV Screening Tests 113Table 3.47: Commercially Available Molecular Diagnostic Products for HCV Assay 120Table 3.48: Global Market for DNA HCV Diagnostic Testing, 2005-2012 121Table 3.49: U.S. Market for DNA HCV Diagnostic Testing, 2005-2012 121Table 3.50: Global Market for NAT HCV Diagnostic Testing, 2013-2018 121Table 3.51: U.S. Market for NAT HCV Diagnostic Testing, 2013-2018 121Table 3.52: Major Companies Marketing HCV Molecular Diagnostic Tests: Market Size and Share, 2012 122Table 3.53: HCV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 123Table 3.54: HCV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 124Table 3.55: Recommendations for HCV Diagnostic Testing 126Table 3.56: Number of Pap Smears Performed by Country, 2009 128Table 3.57: Deaths in Thousands from Cervical Cancer by Region and by Age Group in 2011 130Table 3.58: Qiagenis Digene HC2 High-risk HPV DNA Test 133Table 3.59: Commercially Available Molecular Diagnostic Products for HPV Assay 138Table 3.60: Major Companies Marketing HPV Molecular Diagnostic Tests: Market Size and Share, 2012 140Table 3.61: Global Market for HPV Molecular Diagnostic Testing, 2007-2012 144Table 3.62: U.S. Market for HPV Molecular Diagnostic Testing, 2007-2012 144Table 3.63: Global Market for HPV Molecular Diagnostic Testing, 2013-2018 144Table 3.64: U.S. Market for HPV Molecular Diagnostic Testing, 2013-2018 144Table 3.65: HPV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 145Table 3.66: HPV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 145Table 3.67: Commercially Available Molecular Diagnostic Products for Influenza Assay 157Table 3.68: Global Market for Molecular Influenza Diagnostic Testing, 2007-2012 158Table 3.69: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2012 158Table 3.70 Global Market for Influenza Molecular Diagnostic Testing, 2013-2018 158Table 3.71: U.S. Market for Influenza Molecular Diagnostic Testing, 2013-2018 159Table 3.72: Influenza Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 159Table 3.73: Influenza Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 159Table 3.74: Global Market for Molecular Diagnostic Chlamydia/Gonorrhea Diagnostic Testing, 2000-2012 163Table 3.75: U.S. Market for Molecular Diagnostic Chlamydia/Gonorrhea Diagnostic Testing, 2000-2012 163Table 3.76: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic Tests: Market Size and Share, 2012 164Table 3.77: Global Market for Chlamydia/Gonorrhea Diagnostic Testing, 2013-2018 165Table 3.78: U.S. Market for Chlamydia/Gonorrhea a Diagnostic Testing, 2013-2018 165Table 3.79: U.S. Chlamydia Infection Rates, 1985-2011 167Table 3.80: U.S. Chlamydia Statistics 168Table 3.81: Commercially Available Molecular Diagnostic Products for Chlamydia Assay 171Table 3.82: Global Market for Chlamydia Molecular Diagnostic Testing, 2012-2018 172Table 3.83: U.S. Market for Chlamydia Molecular Diagnostic Testing, 2012-2018 172Table 3.84: Chlamydia Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 173Table 3.85: Chlamydia Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 173Table 3.86: U.S. Gonorrhea Statistics 178Table 3.87: Commercially Available Molecular Diagnostic Products for Gonorrhea Assay 181Table 3.88: Major Companies Marketing /Gonorrhea Molecular Diagnostic Tests: Market Size and Share, 2012 181Table 3.89: Gonorrhea Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 182Table 3.90: Gonorrhea Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 182Table 3.91: Commercially Available Molecular Diagnostic Assays for Testing TB 193Table 3.92: Global Market for MD TB Diagnostic Testing, 2005-2012 194Table 3.93: U.S. Market for MD TB Diagnostic Testing, 2005-2012 195Table 3.94: Global Market Share of MD TB Testing by Region, 2012 195Table 3.95: Global Unit Sales of MD TB Testing by Region, 2012 196Table 3.96: Comparative U.S. Claim Charges for TB Testing by Type, 2012 197Table 3.97: Global Testing for TB by Testing Type, 2012 197Table 3.98: Global Testing for TB by Testing Reason, 2012 197Table 3.99: Global Market for MD TB Diagnostic Testing, 2013-2018 197Table 3.100: U.S. Market for MD TB Diagnostic Testing, 2013-2018 198Table 3.101: Tuberculosis Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 198Table 3.102: Tuberculosis Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 198Table 3.103: Leading Tuberculosis Therapeutic R&D Candidates 201Table 3.104: Commercially Available Molecular Diagnostic Products for MRSA Assay 206Table 3.105: Global Market for MRSA Diagnostic Testing, 2005-2012 206Table 3.106: U.S. Market for MRSA Diagnostic Testing, 2005-2012 207Table 3.107: Major Companies Marketing MRSA Molecular Diagnostic Tests: Market Size and Share, 2012 207Table 3.108: Global Market for MD MRSA Diagnostic Testing, 2013-2018 209Table 3.109: U.S. Market for MD MRSA Diagnostic Testing, 2013-2018 209Table 3.110: MRSA Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 210Table 3.111: MRSA Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 210Table 3.112: In Vitro Susceptibility of Staphylococci to New Agents in Development 212Table 3.113: Commercially Available Molecular Diagnostic Products for VRE Assay 216Table 3.114: Global Market for VRE Diagnostic Testing, 2005-2To order this report:In_Vitro_Diagnostic Industry: Molecular Diagnostics in Infectious Disease TestingContact Clare: clare@reportlinker.comUS:(339) 368 6001Intl:+1 339 368 6001ReportlinkerWeb site: .reportlinker.com/mini storage