ReportsnReports – Molecular Diagnostics in Infectious Disease Testing

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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.

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  • 1.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. The confluence of breakthroughs ingenomics and proteomicsalong with the development of microarray devices to measureanalytes in the bloodhas led to this revolutionary market development. Specifically,molecular diagnostics offers the power of advanced analytical techniques to diagnoseinfectious diseases. Whereas before, the detection of many infectious agents was slow andexpensive due to reliance upon culturing methods, researchers are now at the cusp ofovercoming such limitations via the use of nucleic acid-mediated molecular diagnosticstesting.Buy Now: Molecular Diagnostics in Infectious Disease Testing MarketBrowse All: Latest Market Research ReportsThe purpose of this report is to describe the emerging field of molecular diagnostics ininfectious disease testing. The infectious disease space is the most dominant and profitablesector of molecular diagnostics. Topics covered in this study include: 1) the existing andemerging technologies in the field, 2) the U.S. and global market size for moleculardiagnostic products and 3) the profiles of companies that are focusing on the moleculardiagnostic sector. The research examines drivers and restraints for sales growth, marketshare and technical trends. In addition, an in-depth analysis of the competitive situation ofprominent market venders is provided 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. 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 Detection 3. 3.3.2.2.3 Method Comparisons for HCV Tests3.3.2.2.4 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 Forecasts 4. 3.3.5.1.7.1 Revenue Forecasts3.3.5.1.8 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 Trends 5. 3.3.8.8.1 Market Trends3.3.8.8.2 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 Tests 6. 4.5 Next Generation Sequencing4.6 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 Exceptions 7. 6.4.2 Three Areas for Denial of Claims6.5 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 Tests 8. 8.16 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 bioMrieux10.10 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 NV 9. 10.32 Roche Ltd.10.33 Seegene10.34 SIRS-Lab10.35 Source MDx10.36 TrimGen10.37 TrovaGene10.38 Veredus Laboratories10.39 VeridexAppendix 1: Draft Guidance for Industry and Food and Drug Administration StaffEstablishing 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 Microassa...

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