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Molecular Diagnostics in Infectious Disease Testing

TriMark Publications
February 1, 2012
366 Pages - SKU: TRI6822548

Abstract Table of Contents Related Reports

Molecular Diagnostics in Infectious Disease Testing

This 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: 1.1 Statement of Report; 1.2 About This Report; 1.3 Scope of the Report; 1.4 Objectives; 1.5 Methodology; 1.6 Executive Summary
2. Introduction to Molecular Diagnostics for Infectious Disease Testing: 2.1 Molecular Diagnostics Testing and Opportunities in the Infectious Disease Sector; 2.2 The Infectious Disease Problem; 2.3 Impact of the Human Genome Project on Molecular Diagnostics; 2.4 Opportunities for Molecular and Clinical Diagnostics; 2.5 Development of Molecular Diagnostics Testing Markets; 2.6 Target-based Gene Amplification; 2.7 PCR Reagents for Clinical Diagnostics
3. Infectious Disease Diagnostics Molecular Testing Market: 3.1 Market Overview; 3.2 NAT Molecular Diagnostics Market; 3.3 Infectious Disease Molecular Diagnostic Testing Markets; 3.4 Blood Screening
4. Molecular Diagnostic Testing Technology for Infectious Disease Testing: 4.1 Infectious Disease Diagnostic Tests; 4.2 Use of Molecular Tests in Infectious Disease; 4.3 Cost of Molecular Diagnostic Testing; 4.4 Use of Multiplex PCR Tests; 4.5 Next Generation Sequencing; 4.6 Patient Flow Software; 4.7 Digital PCR; 4.8 LAMP
5. Business: 5.1 Technology and Market Trends; 5.2 M&A Activity; 5.3 Partnerships; 5.4 Competitive Analysis; 5.5 Intellectual Property Rights; 5.6 Opportunities and Strategic Recommendations; 5.7 Business Models and Requirements for a Successful Molecular Diagnostics Infectious Disease Products Industry; 5.8 Companion Diagnostics Development in Partnership with a Pharmaceutical Company
6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for Infectious Disease: 6.1 Overview; 6.2 Trends in Reimbursement Practice; 6.3 Trends in Patient Care and Reimbursement; 6.4 Revenue threats; 6.5 Billing Rules
7. Regulatory Requirements: 7.1 U.S. Food and Drug Administration; 7.2 CLIA Regulations; 7.3 Clinical Laboratory Improvement Act (CLIA); 7.4 State Licensing for Service Laboratories; 7.5 IVDMIAs; 7.6 510(k) Clearance; 7.7 Pre-Market Approval (PMA); 7.7.1 Pre-Market Approval Application; 7.8 Analyte Specific Reagents (ASRs); 7.8.1 Laboratory Developed Tests; 7.9 What Regulatory Guidance is Needed for Companion Biomarkers?; 7.10 U.S. Patent and Trademark Office (USPTO); 7.11 IRB Approval in Clinical Trials; 7.12 CE Marking and the IVDD (European In Vitro Diagnostic Device Directive); 7.13 De Novo Classification; 7.14 Research Use Only Reagents; 7.15 FDA Recommendations on MRSA Testing
8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease Testing: 8.1 What are Key Opportunities in Infectious Disease Testing Development and Commercialization?; 8.2 What are the Current Obstacles for MD Infectious Disease Testing; Implementation?; 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 Acquisition Strategies and their Implications for Deal Making?; 8.5 How can Molecular Diagnostic Tests Increase Value in an Associated Drug Marketing Plan?; 8.6 Which Types of Infectious Disease MD Testing should be Developed by Diagnostic Companies 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 Diagnostics Development?; 8.14 Evaluate how Partnering and M&As will Alter the Competitive Landscape; 8.15 Predict how FDA Regs will Impact New Diagnostic Tests; 8.16 How can Big Pharma and Diagnostic Companies Co-develop Biomarkers in a Model 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 Biomarkers for Infectious Disease?; 8.19 How Best have Genetic Biomarkers Provided the Most Benefit in Infectious Disease Testing?; 8.20 What are the Most Innovative Methods in Development of Molecular Diagnostic Biomarkers?; 8.21 What are the Best Values for Genetic Biomarkers in Drug Development and in Diagnostics?
9. Economics of Anti-microbial Drug Resistance: The Persistent need for Anti-bacterials: 9.1 Resistance and Antibiotic Usage; 9.2 Infection Control Programs
10. Company Profiles: 10.1 Abbott Laboratories; 10.2 AdvanDx; 10.3 Arcxis Biotechnologies; 10.4 Atlas Genetics; 10.5 AutoGenomics, Inc.; 10.6 Becton, Dickinson and Company; 10.7 BioGenex Laboratories, Inc.; 10.8 BioHelix Corporation; 10.9 bioMérieux; 10.10 Biocartis; 10.11 bioTheranostics; 10.12 Celera; 10.13 Cepheid; 10.14 EraGen Biosciences; 10.15 Exiqon A/S; 10.16 Genera Biosystems; 10.17 GenMark Diagnostics, Inc.; 10.18 Genomix Biotech; 10.19 Gen-Probe; 10.20 Gene Express; 10.21 Genomica; 10.22 Great Basin Scientific; 10.23 Hologic; 10.24 Illumina, Inc.; 10.25 Innogenetics NV; 10.26 Life Technologies; 10.27 Mobidiag; 10.28 Myconostica; 10.29 Nanosphere; 10.30 NorDiag ASA; 10.31 Qiagen NV; 10.32 Roche Ltd.; 10.33 Seegene; 10.34 SIRS-Lab; 10.35 Source MDx; 10.36 TrimGen; 10.37 TrovaGene; 10.38 Veredus Laboratories; 10.39 Veridex
Appendix 1: Draft Guidance for Industry and Food and Drug Administration: Staff—Establishing 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)
INDEX OF FIGURE: Figure 2.1: Relationship of DNA Testing to Key Areas of Clinical Diagnosis; Figure 2.2: Finding Genes with Microassays; Figure 2.3: The Use of Microassays for Studying Gene Expression; Figure 2.4: Overall Structure of Nucleic Acid Testing Market; Figure 2.5: Global Market for Molecular Diagnostics, 2002-2016; Figure 3.1: Global Market for Molecular Diagnostics Testing, 2010; Figure 3.2: Share of Molecular Diagnostics Testing by Testing Type, 2009; Figure 3.3: Key Players Market Share in Global Molecular Diagnostics Testing Markets; Figure 3.4: Global Market for Infectious Disease Treatments, 2008-2014; Figure 3.5: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2016; Figure 3.6: Global Market Revenue Share Forecasts for Molecular Diagnostics Infectious Disease Testing Markets by Region, 2009 and 2015; Figure 3.7: Infectious Disease Testing Revenue Market Share of Total U.S. MD Market, 2009 and 2015; Figure 3.8: European Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2015; Figure 3.9: Infectious Disease Testing Revenue Market Share of Total European MD Market, 2009 and 2015; Figure 3.10: Japanese Market Revenue for Molecular Diagnostics Testing for Infectious Disease,; 2009-2016; Figure 3.11: Infectious Disease Testing Revenue Market Share of Total Japanese MD Market, 2009 and 2015; Figure 3.12: Total Global Infectious Disease Molecular Diagnostics Markets, 2010; Figure 3.13: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2010; Figure 3.14: Total Global Infectious Disease Molecular Diagnostics Markets, 2016; Figure 3.15: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2016; Figure 3.16: Global Trend of HIV Infection, 1991-2007; Figure 3.17: Number of People Living with HIV, Newly Infected with HIV and; Number of AIDS Deaths in the World, 1990-2008; Figure 3.18: Worldwide Rate of New HIV Cases, 1990-2007; Figure 3.19: Percentage of Adult Population in African Countries with HIV, 2007; Figure 3.20: Global View of HIV Infection, 2008; Figure 3.21: Ethnic Distribution of AIDS Patients in the U.S., 2007; Figure 3.22: Ten Best Selling AIDS Drugs in the U.S., 2008; Figure 3.23: U.S. Rates for New HIV Cases, 2008; Figure 3.24: U.S. Rates for New HIV Cases in Men, 2008; Figure 3.25: U.S. Rates for New HIV Cases in Women, 2008; Figure 3.26: Global Trend of HIV Infections, 1991-2007; Figure 3.27: Proposed HIV Testing Algorithm; Figure 3.28: Distribution of HIV Molecular Diagnostic Testing by Purpose; Figure 3.29: Estimated Market for Global HIV Molecular Diagnostic Testing, 2011-2016; Figure 3.30: Estimated Market for U.S. HIV Molecular Diagnostic Testing, 2011-2016; Figure 3.31: Market Share Viral Load HIV MD Diagnostic Testing; Figure 3.32: Geographic Distribution of Chronic HBV Infection; Figure 3.33: Rate of New Hepatitis A, B and C Infections in the U.S., 1982-2006; Figure 3.34: Global Prevalence of Hepatitis C; Figure 3.35: Primary Causes of Chronic Liver Disease; Figure 3.36: HCV Infection Prevalence, 1988-2008; Figure 3.37: Hepatitis C Infection by Source; Figure 3.38: Growth and Projections of HCV Therapies by Drug Class, 2008 and 2013; Figure 3.39: U.S. Market Share of HCV Molecular Diagnostic Market, 2010; Figure 3.40: Global Market Share (Excluding U.S.) of HCV Molecular Diagnostic Market, 2010; Figure 3.41: Rate of New Cases and Deaths of Cervical Cancer by Age Group Worldwide, 2008; Figure 3.42: U.S. Market Share of HPV Molecular Diagnostic Market, 2010; Figure 3.43: Global Market Share (Excluding U.S.) of HPV Molecular Diagnostic Market, 2010; Figure 3.44: Market Share Estimates for Molecular Diagnostic HPV Testing, 2009; Figure 3.45: Number of Reported and Confirmed Cases of Influenza H1N1 Strain Worldwide, 2009; Figure 3.46: Distribution of H1N1 Flu in the U.S., 2009; Figure 3.47: H1N1 Confirmed and Probable Case Rate in the U.S., By Age Group; Figure 3:48: U.S. Rates of Sexually-transmitted Diseases, 1940-2007; Figure 3.49: Chlamydia Infection Rates: Total and by Gender: U.S., 1989-2009; Figure 3.50: Chlamydia U.S. Prevalence by Age Group and Race/Ethnicity; Figure 3.51: U.S. Market Share of CT/NG Molecular Diagnostic Market, 2010; Figure 3.52: Global Market Share (Excluding U.S.) of CT/NG Molecular Diagnostic Market, 2010; Figure 3.53: U.S. Gonorrhea Infection Rates, 1941-2006; Figure 3.54: U.S. Gonorrhea Infection Rates by Race/Ethnicity, 1999-2008; Figure 3.55: Pipeline for TB Diagnostics, 2006-2013; Figure 3.56: Number of Tuberculosis (TB) Cases Among U.S.- and Foreign-born Persons in the U.S.,; 1993-2008; Figure 3.57: Rate of Tuberculosis (TB) Cases Among U.S.- and Foreign-born Persons in the U.S., 1993-2008; Figure 3.58: Rate of Tuberculosis (TB) Cases by State/Area in the U.S., 2008; Figure 3.59: U.S.-born Tuberculosis (TB) Cases by Ethnicity, 2008; Figure 3.60: Reported Tuberculosis (TB) Cases in the U.S., 1983-2007; Figure 3.61: Global Market Share of MD TB Testing; Figure 3.62: Global Market Share of MD TB Testing by Region, 2010; Figure 3.63: Incidence Rates of Invasive MRSA Infections by Age; Figure 3.64: MRSA Trends According to Patient Location, 1998-2005; Figure 3.65: Incidence of Healthcare-associated MRSA Infections, 2005-2008; Figure 3.66: U.S. Market Share of MRSA Molecular Diagnostic Market, 2010; Figure 3.67: Global Market Share (Excluding U.S.) of MRSA Molecular Diagnostic Market, 2010; Figure 3.68: Global Frequency of Vancomycin-resistant Enterococci, 2006; Figure 3.69: U.S. Market Share of VRE Molecular Diagnostic Market, 2010; Figure 3.70: Estimated Market for Global Blood Screening Product Sales,; 2007-2016; Figure 3.71: Gen-Probe Blood Screening Product Market Share, 2005-2009; Figure 3.72: Blood Screening Product Market Share by Company, 2010; Figure 4.1: Using DNA Microassays to Measure Gene Expression; Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients; Figure 5.1: FDA Co-developed Products as a Model for Collaboration; Figure 5.2: Market Growth of MD Infectious Disease Tests; Figure 5.3: Segmentation of the Biomarker Development Market; Figure 5.4: Global Distribution of Anti-infective Agent Sales by Geography; Figure 5.5: Leading Companies in Anti-infectives Market Share, 2008; Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision Making; Figure 9.1: Global Multidrug Susceptibility in Pseudomonas aeruginosa; Figure 9.2: Global Frequency of Vancomycin-resistant Enterococci, 2006; Figure 10.1: Gen-Probe Key Acquisitions; Figure 10.2: Gen-Probe Projected R&D Expenditures
INDEX OF TABLE: Table 1.1: Market Trends in Infectious Disease DNA Testing; Table 1.2: Molecular Diagnostics Infectious Disease Market: Market Drivers; Ranked in Order of Impact; Table 1.3: Molecular Diagnostics Infectious Disease Market: Market Restraints; Ranked in Order of; Impact; Table 1.4: Strategic Recommendations on Molecular Diagnostic Sector Business Functions; Table 2.1: Nucleic Acid-based Tests for Clinically Important Viral and Bacterial Pathogens; Table 2.2: Top Ten Causes of Death Worldwide; Table 2.3: The Most Prevalent Infectious Diseases Worldwide; Table 2.4: Annual Rates of Global Infectious Diseases; Table 2.5: Emerging Molecular Diagnostic Technologies; Table 2.6: Global Market for Molecular Diagnostics Testing, 2000-2016; Table 2.7: U.S. Market for Molecular Diagnostics Testing, 2004-2016; Table 2.8: Automated Molecular Diagnostics Platforms for Infectious Disease; Testing; Table 2.9: Companies Marketing Products using DNA Probes; Table 2.10: Companies Marketing Multiple Products in Molecular Diagnostics Sector; Table 2.11: FDA-approved Molecular Diagnostic Commercial Kits for the Detection of Infectious Agents; Table 2.12: Global and U.S. Major Infectious Disease Market Size (Estimated Infected Persons); Table 2.13: Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact; Table 2.14: Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact; Table 2.15: Attractive Growth Areas for Molecular Diagnostic Testing; Table 2.16: NAT Labs in U.S. and Five European Markets; Table 3.1: European Market for Molecular Diagnostics Testing, 2005-2015; Table 3.2: Japanese Market for Molecular Diagnostics Testing, 2009-2016; Table 3.3: Summary of Molecular Diagnostics Testing Sectors; Table 3.4: Share of Molecular Diagnostics Testing by Testing Type, 2009; Table 3.5: Key Players and Market Share in Global Molecular Diagnostics Testing Market; Table 3.6: Revenue Model for Molecular Diagnostics Testing; Table 3.7: Molecular Infectious Disease Diagnostics Market: Market Drivers Ranked in Order of Impact; Table 3.8: Molecular Infectious Disease Diagnostics Market: Market Restraints Ranked in Order of Impact; Table 3.9: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2016; Table 3.10: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2016; Table 3.11: European Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2015; Table 3.12: Japanese Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2016; Table 3.13: Molecular Diagnostic Markets for Infectious Disease Testing, 2010; Table 3.14: Molecular Diagnostic Markets for Infectious Disease Testing, 2016; Table 3.15: Business Factors Influencing Advanced Infectious Disease MD Testing Services; Table 3.16: Global Summary of the HIV/AIDS Epidemic, 2008; Table 3.17: Global HIV Statistics, 2008; Table 3.18: HIV Resistance Testing Recommendations; Table 3.19: Summary of Assays for HIV Viral Load Testing; Table 3.20: Commercially Available Molecular Diagnostic Products for HIV Assay; Table 3.21: Global Market for Molecular Diagnostic HIV Testing, 2007-2010; Table 3.22: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2010; Table 3.23: Global Market for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016; Table 3.24: U.S. Market for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016; Table 3.25: Global Market for HIV Viral Load Diagnostic Testing, 2007-2010; Table 3.26: U.S. Market for HIV Viral Load Diagnostic Testing, 2007-2010; Table 3.27: Global Market for HIV Viral Load Diagnostic Testing, 2011-2016; Table 3.28: U.S. Market for HIV Viral Load Diagnostic Testing, 2011-2016; Table 3.29: Global Market for HIV Genotyping Testing, 2007-2010; Table 3.30: U.S. Market for HIV Genotype Testing, 2007-2010; Table 3.31: Global Market for HIV Genotyping Testing 2011-2015; Table 3.32: U.S. Market for HIV Genotyping Testing, 2011-2016; Table 3.33: HIV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact; Table 3.34: HIV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact; Table 3.35: Clinical Application of Quantitative HBV DNA Testing; Table 3.36: Lower Detection Limits of HBV DNA Assays; Table 3.37: Summary of Molecular Diagnostic Assays for Testing HBV; Table 3.38: Global Market for HBV Diagnostic Testing, 2000-2010; Table 3.39: U.S. Market for HBV Diagnostic Testing, 2000-2010; Table 3.40: Global Market for HBV Diagnostic Testing, 2011-2016; Table 3.41: U.S. Market for HBV Diagnostic Testing, 2011-2016; Table 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 Impact; Table 3.44: Hepatitis B Facts; Table 3.45: U.S. HCV Statistics; Table 3.46: Worldwide Rate of HCV Cases; Table 3.47: Efficiency of Available HCV Screening Tests; Table 3.48: Commercially Available Molecular Diagnostic Products for HCV Assay; Table 3.49: Global Market for DNA HCV Diagnostic Testing, 2005-2010; Table 3.50: U.S. Market for DNA HCV Diagnostic Testing, 2005-2010; Table 3.51: Global Market for NAT HCV Diagnostic Testing, 2011-2016; Table 3.52: U.S. Market for NAT HCV Diagnostic Testing, 2011-2016; Table 3.53: Major Companies Marketing HCV Molecular Diagnostic Tests: Market Size and Share, 2010; Table 3.54: HCV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact; Table 3.55: HCV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact; Table 3.56: Recommendations for HCV Diagnostic Testing; Table 3.57: Number of Pap Smears Performed by Country, 2009; Table 3.58: Qiagen’s Digene HC2 High-risk HPV DNA Test; Table 3.59: Commercially Available Molecular Diagnostic Products for HPV Assay; Table 3.60: Major Companies Marketing HPV Molecular Diagnostic Tests: Market Size and Share, 2010; Table 3.61: Global Market for HPV Molecular Diagnostic Testing, 2007-2011; Table 3.62: U.S. Market for HPV Molecular Diagnostic Testing, 2007-2011; Table 3.63: Global Market for HPV Molecular Diagnostic Testing, 2011-2016; Table 3.64: U.S. Market for HPV Molecular Diagnostic Testing, 2011-2016; Table 3.65: HPV Molecular Diagnostics Market: Market Drivers Ranked in Order of; Impact; Table 3.66: HPV Molecular Diagnostics Market: Market Restraints Ranked in Order; of Impact; Table 3.67: Commercially Available Molecular Diagnostic Products for Influenza; Assay; Table 3.68: Global Market for Molecular Influenza Diagnostic Testing, 2007-2010; Table 3.69: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2010; Table 3.70: Global Market for Influenza Molecular Diagnostic Testing, 2010-2016; Table 3.71: U.S. Market for Influenza Molecular Diagnostic Testing, 2010-2016; Table 3.72: Influenza Molecular Diagnostics Market: Market Drivers Ranked in; Order of Impact; Table 3.73: Influenza Molecular Diagnostics Market: Market Restraints Ranked in; Order of Impact; Table 3.74: U.S. Chlamydia Infection Rates, 1985-2008; Table 3.75: U.S. Chlamydia Statistics; Table 3.76: Commercially Available Molecular Diagnostic Products for Chlamydia Assay; Table 3.77: Global Market for Molecular Diagnostic Chlamydia/NG Diagnostic Testing, 2000-2010; Table 3.78: U.S. Market for Molecular Diagnostic Chlamydia/NG Diagnostic Testing, 2000-2010; Table 3.79: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic; Tests: Market Size and Share, 2010; Table 3.80: Global Market for Chlamydia/Gonorrhea Diagnostic Testing, 2011-2016; Table 3.81: U.S. Market for Chlamydia/Gonorrhea Diagnostic Testing, 2010-2016; Table 3.82: Global Market for Chlamydia Molecular Diagnostic Testing, 2011-2016; Table 3.83: U.S. Market for Chlamydia Molecular Diagnostic Testing, 2011-2016; Table 3.84: Chlamydia Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact; Table 3.85: Chlamydia Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact; Table 3.86: U.S. Gonorrhea Statistics; Table 3.87: Commercially Available Molecular Diagnostic Products for Gonorrhea Assay; Table 3.88: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic; Tests: Market Size and Share, 2010; Table 3.89: Gonorrhea Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact; Table 3.90: Gonorrhea Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact; Table 3.91: Commercially Available Molecular Diagnostic Assays for Testing TB; Table 3.92: Global Market for MD TB Diagnostic Testing, 2005-2010; Table 3.93: U.S. Market for MD TB Diagnostic Testing, 2005-2010; Table 3.94: Global Market Share of MD TB Testing by Region, 2010; Table 3.95: Global Unit Sales of MD TB Testing by Region, 2010; Table 3.96: Comparative U.S. Claim Charges for TB Testing by Type, 2010; Table 3.97: Global Testing for TB by Testing Type, 2010; Table 3.98: Global Testing for TB by Testing Reason, 2010; Table 3.99: Global Market for MD TB Diagnostic Testing, 2011-2016; Table 3.100: U.S. Market for MD TB Diagnostic Testing, 2011-2016; Table 3.101: Tuberculosis Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact; Table 3.102: Tuberculosis Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact; Table 3.103: Leading Tuberculosis Therapeutic R&D Candidates; Table 3.104: Commercially Available Molecular Diagnostic Products for MRSA Assay; Table 3.105: Global Market for MRSA Diagnostic Testing, 2005-2010; Table 3.106: U.S. Market for MRSA Diagnostic Testing, 2005-2010; Table 3.107: Major Companies Marketing HCV Molecular Diagnostic Tests: Market Size and Share, 2010; Table 3.108: Global Market for MD MRSA Diagnostic Testing, 2011-2016; Table 3.109: U.S. Market for MD MRSA Diagnostic Testing, 2011-2016; Table 3.110: MRSA Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact; Table 3.111: MRSA Molecular Diagnostics Market: Market Restraints Ranked in; Order of Impact; Table 3.112: In vitro Susceptibility of Staphylococci to New Agents in Development; Table 3.113: Commercially Available Molecular Diagnostic Products for VRE Assay; Table 3.114: Global Market for VRE Diagnostic Testing, 2005-2010; Table 3.115: U.S. Market for VRE Diagnostic Testing, 2005-2010; Table 3.116: Major Companies Marketing VRE Molecular Diagnostic Tests: Market Size and Share, 2010; Table 3.117: Global Market for MD VRE Diagnostic Testing, 2011-2016; Table 3.118: U.S. Market for MD VRE Diagnostic Testing, 2011-2016; Table 3.119: VRE Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact; Table 3.120: VRE Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact; Table 3.121: Transmission-related Disease Screening from Blood Donor Pools; Table 3.122: Principal Blood Screening Products of Gen-Probe for HIV Assay; Table 3.123: Global Market for Blood Screening Product Sales, 2007-2016; Table 3.124: Global Revenue and for Blood-Screening Market, 2000-2016; Table 3.125: U.S. Market and for Blood-Screening Market, 2000-2016; Table 3.126: Major Companies Marketing Blood Screening Molecular Diagnostic; Tests: Market Size and Share, 2010; Table 3.127: Blood Screening Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact; Table 3.128: Blood Screening Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact; Table 4.1: Key Elements for Business Competition in Molecular Diagnostic Testing for Infectious Disease; Table 4.2: Key Elements for Future Success in Molecular Testing for Infectious; Disease; Table 4.3: Examples of Personalized Medicine in Treatment of Infectious Disease; Table 4.4: Molecular Methods for Epidemiologic Typing of Microorganisms; Table 4.5: Drivers of Molecular Diagnostic Methods for Infectious Disease Testing in the Clinical Setting; Table 4.6: Barriers to Molecular Diagnostic Methods for Infectious Disease Testing in the Clinical Setting; Table 5.1: Technology Trends in Molecular Diagnostic Infectious Disease Testing; Table 5.2: Clinical Testing Trends in Molecular Diagnostic Infectious Disease Testing; Table 5.3: Business Market Trends in Molecular Diagnostics Infectious Disease Testing; Table 5.4: Expected Changes in Healthcare; Table 5.5: Customer Feedback for Automated Molecular Diagnostic Instruments; Table 5.6: Molecular Diagnostics Infectious Disease Market: Market Drivers; Ranked in Order of Impact; Table 5.7: Molecular Diagnostics Infectious Disease Market: Market Restraints Ranked in Order of Impact; Table 5.8: Advantages of European Markets for Molecular Diagnostic Testing; Table 5.9: European Sales Percentage of Most Common Molecular Diagnostic Tests; by Analyte Type; Table 5.10: Disadvantages of European Markets for Molecular Diagnostic Testing; Table 5.11: Summary of Recent M&A Activity in the Molecular Diagnostics Sector; Table 5.12: High Value Opportunities in Collaborative and Strategic Partnerships; Table 5.13: Principal Competitive Factors in the Molecular Diagnostics Infectious Disease Testing Market; Table 5.14: Molecular Diagnostics Infectious Disease Testing Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions; Table 5.15: Molecular Diagnostics Infectious Disease Market: Impact of Top Industry Challenges in the U.S.; Table 5.16: Documents for Protecting Intellectual Property Rights; Table 5.17: Recent Patents Related to PCR, Nucleic Acid Amplification, and Sample Prep; Table 5.18: Specific Opportunities for Automated Instrumentation and Reagent Systems in Molecular Diagnostics for Infectious Disease Testing; Table 5.19: Roche PCR Licenses; Table 5.20: Global Sales of Gen-Probe by Geographic Area, 2008-2010; Table 5.21: The Required Elements of a Manufacturing Facility; Table 5.22: CMO Qualification Audit: Points to Investigate; Table 5.23: Strategies and POA for Marketing Infectious disease Diagnostic Products; Table 5.24: Key Elements of Molecular Diagnostic Companies Marketing Plan; Table 5.25: Utility of Biomarkers as Companion Diagnostics to Drug Development; Table 5.26: Leading Pharmaceutical Companies in the Anti-infective Market—Total Global Sales, 2008; Table 6.1: Factors Determining Third-Party Payment for Molecular Diagnostic Tests for Infectious Disease; Table 6.2: CPT Codes for Molecular Diagnostic Infectious Disease Testing; Table 7.1: Regulatory Rules that Affect the Ability of a Diagnostic Testing Reagent Company to Conduct Business; Table 7.2: Strengths of the 510k Process; Table 7.3: Drawbacks of the 510k Process; Table 7.4: Focus Areas for the FDA Critical Path Initiative; Table 8.1: Effect of Regulation on MD Infectious Disease Market Technology; Platforms, 2007 and 2015; Table 8.2: Companies Utilizing New, Cutting-edge Technologies to Develop, Validate and Market Molecular Tests for Clinical Use in Infectious Disease Management; Table 8.3: Impediments to Incorporating Promising Molecular Tests into Clinical Practice; Table 8.4: New Molecular Diagnostics Tests Showing the Most Promise for Approval; Table 8.5: Alliances Showing the Greatest Synergy in bringing Molecular Diagnostics Tests to Market; Table 8.6: Shared Technologies Driving the Most Encouraging MD Development; Table 10.1: Gen-Probe Key Acquisitions; Table A1: MRSA/SA Strains for Analytical Sensitivity (LoD) and Inclusivity Studies obtained from the CDC; Table A2: MRSA Strains (known Clinical Associated Strains) obtained from the Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA) for Analytical Sensitivity (LoD) and Inclusivity Studies Table A3: MRSA Strains (Clinical Isolates and Isolates obtained from Public and Private Collections) for Analytical Sensitivity (LoD) and Inclusivity Studies; Table A4: Examples of Microorganisms (Non-Staphylococci Strains of Various Bacterial and Yeast Species and Viruses) Recommended for Analytical Specificity (Cross-reactivity) Studies for Devices that are Indicated for Testing Nasal Swab Specimens Collected from Patients at Risk for MRSA Colonization Table A5: Examples of Coagulase Negative Staphylococci (CNS) from Public and Private Collections (including Methicillin-resistant Staphylococcus epidermidis (MRSE), Methicillin-resistant Coagulase Negative Staphylococci (MRCoNS) and Methicillin-sensitive Coagulase Negative Staphylococci (MSCoNS) Recommended for Analytical Specificity (Cross-reactivity) Studies for Devices that are Indicated for Testing Nasal Swab Specimens Collected from Patients at Risk for MRSA Colonization; Table A6: Examples of Substances Recommended for an Interference Study for Nasal Swab Specimens; Table A7: Examples of Substances Recommended for an Interference Study for Skin and Soft Tissue Infection Swab Specimens; Table A8: FDA-approved Molecular Diagnostic Tests for Infectious Diseases; Table A9: Noncommercial Nucleic Acid-based Tests for Clinically Important Viral and Bacterial Pathogens; Table A10: Molecular Methods for Detecting Antimicrobial Resistance; Table A11: Genotypic Methods for Epidemiologic Typing of Microorganisms; Table A12: Reduction in Number and Cost of Nosocomial Infections through; Collaborative Efforts of Infection Control, Clinical Microbiology, and Molecular Typing Laboratories

Molecular Diagnostics in Infectious Disease Testing

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