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Molecular Diagnostics in Infectious Disease Testing
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| Inhalt der Studie: |
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 mar.....
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. [Studien Infos ausblenden] |
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1. Overview 14 1.1 Statement of Report 14 1.2 About This Report 15 1.3 Scope of the Report 15 1.4 Objectives 17 1.5 Methodology 17 1.6 Executive Summary 19 2. Introduction to Molecular Diagnostics for Infectious Disease Testing 27 2.1 Molecular Diagnostics Testing and Opportunities in the Infectious Disease Sector 27 2.2 The Infectious Disease Problem 31 2.3 Impact of the Human Genome Project on Molecular Diagnostics 35 2.4 Opportunities for Molecular and Clinical Diagnostics 35 2.4.1 Companion Diagnostics 36 2.5 Development of Molecular Diagnostics Testing Markets 37 2.6 Target-based Gene Amplification 38 2.6.1 Polymerase Chain Reaction (PCR) 38 2.6.2 Real-time PCR (RT-PCR) 39 2.6.3 Nucleic Acid Sequence-based Amplification (NASBA) 39 2.6.4 Market Drivers and Restraints 46 2.6.4.1 Market Drivers 46 2.6.4.2 Market Restraints 46 2.6.5 Market and Technology Trends 46 2.6.5.1 Market Trends 46 2.6.5 2 Technology Trends 47 2.6.6 Strategic Recommendations 47 2.7 PCR Reagents for Clinical Diagnostics 48 3. Infectious Disease Diagnostics Molecular Testing Market 50 3.1 Market Overview 50 3.1.1 Overall Infectious Disease Market Analysis 53 3.2 NAT Molecular Diagnostics Market 65 3.3 Infectious Disease Molecular Diagnostic Testing Markets 66 3.3.1 HIV 66 3.3.1.1 Disease Background and Statistics 66 3.3.1.2 Measuring Viral Loads 74 3.3.1.3 Instruments and MD Reagents 75 3.3.1.4 Method Comparisons 81 3.3.1.5 Market Size 83 3.3.1.5.1 HIV Diagnostic Testing 83 3.3.1.6 HIV Market Challenges and Strategic Recommendations 88 3.3.1.6.1 HIV Molecular Diagnostic Market History 88 3.3.1.7 Market Drivers and Restraints 89 3.3.1.7.1 Market Drivers 89 3.3.1.7.2 Market Restraints 89 3.3.1.8 Market and Technology Trends 89 3.3.1.8.1 Market Trends 89 3.3.1.8.2 Technology Trends 90 3.3.1.9 Strategic Recommendations 91 3.3.2 Hepatitis 91 3.3.2.1 Hepatitis B Virus 91 3.3.2.1.1 Hepatitis B Disease Background and Statistics 91 3.3.2.1.2 Instruments and Reagents for Hepatitis B Detection 93 3.3.2.1.3 Method Comparisons 95 3.3.2.1.4 Hepatitis B Market Size 97 3.3.2.1.5 HBV Market Challenges and Strategic Recommendations 98 3.3.2.1.5.1 Market Drivers and Restraints 98 3.3.2.1.5.1.1 Market Drivers 98 3.3.2.1.5.1.2 Market Restraints 99 3.3.2.1.6 Market and Technology Trends 99 3.3.2.1.6.1 Market Trends 99 3.3.2.1.6.2 Technology Trends 99 3.3.2.1.7 Strategic Recommendations 100 3.3.2.2 Hepatitis C Virus (HCV) Testing 101 3.3.2.2.1 Disease Background and Statistics 101 3.3.2.2.2 Instruments and Reagents for Hepatitis C Detection 107 3.3.2.2.3 Method Comparisons for HCV Tests 112 3.3.2.2.4 Hepatitis C Market Size 115 3.3.2.2.4.1 HCV Market Share 116 3.3.2.2.5 HCV Market Challenges and Strategic Recommendations 117 3.3.2.2.5.1 Market Drivers and Restraints 117 3.3.2.2.5.1.1 Market Drivers 117 3.3.2.2.5.1.2 Market Restraints 118 3.3.2.2.5.2 Market and Technology Trends 118 3.3.2.2.5.2.1 Market Trends 118 3.3.2.2.5.2.2 Technology Trends 119 3.3.2.2.6 Strategic Recommendations 120 3.3.3 Human Papillomavirus (HPV) 120 3.3.3.1 Disease Background and Statistics 120 3.3.3.2 Instruments and Reagents for HPV Detection 125 3.3.3.3 Method Comparison 131 3.3.3.4 HPV Market Size 132 3.3.3.4.1 North American Market 134 3.3.3.4.2 European Market 135 3.3.3.5 Market Challenges and Strategic Recommendations 137 3.3.3.5.1 Market Drivers and Restraints 137 3.3.3.5.1.1 Market Drivers 137 3.3.3.5.1.2 Market Restraints 138 3.3.3.5.2 Market and Technology Trends 138 3.3.3.5.2.1 Market Trends 138 3.3.3.5.2.2 Technology Trends 139 3.3.3.5.3 Strategic Recommendations 140 3.3.4 Influenza Viruses 141 3.3.4.1 Disease Background and Statistics 141 3.3.4.2 Instruments and Reagents for Influenza Detection 147 3.3.4.3 Method Comparisons 149 3.3.4.4 Influenza Market Size 149 3.3.4.5 Influenza Market Challenges and Strategic Recommendations 151 3.3.4.5.1 Market Drivers and Restraints 151 3.3.4.5.1.1 Market Drivers 151 3.3.4.5.1.2 Market Restraints 151 3.3.4.5.2 Market and Technology Trends 151 3.3.4.5.2.1 Market Trends 151 3.3.4.5.2.2 Technology Trends 152 3.3.4.5.3 Strategic Recommendations 153 3.3.5 STD Testing 153 3.3.5.1 Chlamydia 154 3.3.5.1.1 Disease Background and Description 154 3.3.5.1.2 Product Analysis: Instruments and Reagents for Testing Chlamydia 157 3.3.5.1.3 Method Comparison 159 3.3.5.1.4 Chlamydia/Gonorrhea Molecular Diagnostic Testing Market Size 160 3.3.5.1.5 Competitive Structure and Market Share Analysis 161 3.3.5.1.6 Market Forecasts 162 3.3.5.1.6.1 Revenue Forecasts 162 3.3.5.1.7 Market Forecasts 163 3.3.5.1.7.1 Revenue Forecasts 163 3.3.5.1.8 Market Challenges 163 3.3.5.1.8.1 Market Drivers 163 3.3.5.1.8.2 Market Restraints 164 3.3.5.1.9 Market and Technology Trends 164 3.3.5.1.9.1 Market Trends 164 3.3.5.1.9.2 Technology Trends 165 3.3.5.1.10 Strategic Recommendations 165 3.3.6 Gonorrhea 166 3.3.6.1 Disease Background and Description 166 3.3.6.2 Product Analysis: Instruments and Reagents 168 3.3.6.3 Method Comparison 170 3.3.6.4 Competitive Structure and Market Share Analysis 171 3.3.6.5 Market Forecasts 171 3.3.6.5.1 Revenue Forecasts 171 3.3.6.6 Market Challenges 171 3.3.6.6.1 Market Drivers 171 3.3.6.6.2 Market Restraints 172 3.3.6.7 Market and Technology Trends 172 3.3.6.7.1 Market Trends 172 3.3.6.7.2 Technology Trends 172 3.3.6.8 Strategic Recommendations 172 3.3.7 Tuberculosis (TB) 173 3.3.7.1 Disease Background and Description 173 3.3.7.2 Product Analysis: Instruments and Reagents 179 3.3.7.3 Method Comparison 180 3.3.7.4 Tuberculosis Market Size 181 3.3.7.5 Competitive Structure and Market Share Analysis 182 3.3.7.6 Market Forecasts 185 3.3.7.6.1 Revenue Forecasts 185 3.3.7.7 Market Challenges 185 3.3.7.7.1 Market Drivers 185 3.3.7.7.2 Market Restraints 186 3.3.7.8 Market and Technology Trends 186 3.3.7.8.1 Market Trends 186 3.3.7.8.2 Technology Trends 187 3.3.7.9 Strategic Recommendations 187 3.3.8 Methicillin-resistant Staphylococcus aureus (MRSA) 188 3.3.8.1 Disease Background and Description 188 3.3.8.2 Product Analysis: Instruments and Reagents 191 3.3.8.3 Method Comparison 192 3.3.8.4 MRSA Market Size 193 3.3.8.5 Competitive Structure and Market Share Analysis 194 3.3.8.6 Market Forecasts 196 3.3.8.6.1 Revenue Forecasts 196 3.3.8.7 Market Challenges 196 3.3.8.7.1 Market Drivers 196 3.3.8.7.2 Market Restraints 197 3.3.8.8 Market and Technology Trends 197 3.3.8.8.1 Market Trends 197 3.3.8.8.2 Technology Trends 198 3.3.8.9 Strategic Recommendations 198 3.3.9 Vancomycin-resistant Enterococci (VRE) 199 3.3.9.1 Disease Background and Description 199 3.3.9.2 Product Analysis: Instruments and Reagents 201 3.3.9.3 Method Comparison 202 3.3.9.4 Competitive Structure and Market Share Analysis 204 3.3.9.5 Market Forecasts 205 3.3.9.5.1 Revenue Forecasts 205 3.3.9.6 Market Challenges 205 3.3.9.6.1 Market Drivers 205 3.3.9.6.2 Market Restraints 206 3.3.9.7 Market and Technology Trends 206 3.3.9.7.1 Market Trends 206 3.3.9.7.2 Technology Trends 207 3.3.9.8 Strategic Recommendations 207 3.3.10 Herpes Simplex Virus (HSV) 207 3.3.11 C. difficile 207 3.3.12 Cytomegalovirus 208 3.4 Blood Screening 208 3.4.1 Product Analysis: Instruments and Reagents 210 3.4.2 Method Comparison 212 3.4.3 Blood Screening Market Size 213 3.4.4 Competitive Positions 214 3.4.5 Market Challenges and Strategic Recommendations 219 3.4.5.1 Market Drivers and Restraints 219 3.4.5.1.1 Market Drivers 219 3.4.5.1.2 Market Restraints 219 3.4.5.2 Market and Technology Trends 219 3.4.5.2.1 Market Trends 219 3.4.5.2.2 Technology Trends 220 3.4.5.3 Strategic Recommendations 220 4. Molecular Diagnostic Testing Technology for Infectious Disease Testing 221 4.1 Infectious Disease Diagnostic Tests 221 4.1.1 Molecular Diagnostic Tools Solutions 223 4.1.2 Technology of Gene Expression Analysis 223 4.1.2.1 Amplification and Detection of RNA 223 4.1.2.2 Analysis of Multiple Genes 224 4.1.2.3 Advanced Information Technology 225 4.2 Use of Molecular Tests in Infectious Disease 225 4.2.1 Molecular Screening 225 4.2.2 Early Detection 226 4.2.3 Detection of Specific Resistance Genes and Viral Loading Tests 226 4.2.4 Pharmacogemomics and Personalized Medicine in MD Infectious Disease Testing 226 4.2.5 Molecular Strain Typing 227 4.3 Cost of Molecular Diagnostic Testing 229 4.4 Use of Multiplex PCR Tests 229 4.5 Next Generation Sequencing 231 4.6 Patient Flow Software 232 4.7 Digital PCR 232 4.8 LAMP 233 5. Business 234 5.1 Technology and Market Trends 234 5.1.1 Technology Trends 234 5.2 M&A Activity 237 5.3 Partnerships 239 5.4 Competitive Analysis 242 5.4.1 Primary Competitors 242 5.4.2 Industry Challenges and Strategic Recommendations 243 5.4.3 Commercialization of Molecular Diagnostic Products 243 5.5 Intellectual Property Rights 244 5.5.1 New Patents 245 5.5.2 Current Patent Disputes 246 5.6 Opportunities and Strategic Recommendations 246 5.6.1 The Key Technical Opportunities with Significant Market Appeal in the Molecular Diagnostic Space in the Next Five Years 246 5.6.2 Developments for Molecular Diagnostic Instrumentation Products 246 5.6.3 Market Penetration Strategies for Infectious Disease Testing 247 5.7 Business Models and Requirements for a Successful Molecular Diagnostics Infectious Disease Products Industry 247 5.7.1 Scope of This Section 247 5.7.2 The Success Achieved by the Molecular Diagnostics Infectious Disease Products 247 5.7.3 Business Models in Molecular Diagnostics Infectious Disease Products 248 5.7.4 SWOT Comparison of Business Models for MD Infectious Disease Diagnostic Testing 249 5.7.5 Commercial Manufacturing of Molecular Diagnostics Infectious Disease Products: Requirements 260 5.7.5.1 Elements of Commercial Manufacturing 260 5.7.5.1.1 Regulatory Requirements 260 5.7.5.1.2 Manufacturing Process Scale 260 5.7.5.1.3 In-House Manufacturing 261 5.7.5.2 Contract Manufacturing: Commercial and Academic 261 5.7.6 Sales and Marketing Strategies for Infectious Disease Tests 262 5.8 Companion Diagnostics Development in Partnership with a Pharmaceutical Company 266 5.8.1 Description of Business Model 266 5.8.2 Anti-infective Pharmaceutical Market 270 6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for Infectious Disease 275 6.1 Overview 275 6.2 Trends in Reimbursement Practice 275 6.2.1 Medicare Reimbursement Threats 277 6.2.2 Analysis of ROI for Molecular Diagnostic Tests for Infectious Disease Using Current Medicare Reimbursement Rules 279 6.3 Trends in Patient Care and Reimbursement 280 6.4 Revenue threats 281 6.4.1 Medicare Payment Exceptions 282 6.4.2 Three Areas for Denial of Claims 283 6.5 Billing Rules 283 6.5.1 Medicare Billing Procedures 284 6.5.2 Medicare CPT Coding Rules for MD Infectious Disease Testing 284 6.5.3 Infectious Disease Billing Strategies 285 7. Regulatory Requirements 287 7.1 U.S. Food and Drug Administration 287 7.2 CLIA Regulations 287 7.3 Clinical Laboratory Improvement Act (CLIA) 289 7.4 State Licensing for Service Laboratories 290 7.5 IVDMIAs 290 7.6 510(k) Clearance 291 7.7 Pre-Market Approval (PMA) 292 7.7.1 Pre-Market Approval Application 292 7.8 Analyte Specific Reagents (ASRs) 293 7.8.1 Laboratory Developed Tests 294 7.9 What Regulatory Guidance is Needed for Companion Biomarkers? 295 7.10 U.S. Patent and Trademark Office (USPTO) 296 7.11 IRB Approval in Clinical Trials 296 7.12 CE Marking and the IVDD (European In Vitro Diagnostic Device Directive) 296 7.13 De Novo Classification 296 7.14 Research Use Only Reagents 297 7.15 FDA Recommendations on MRSA Testing 297 8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease Testing 299 8.1 What are Key Opportunities in Infectious Disease Testing Development and Commercialization? 299 8.2 What are the Current Obstacles for MD Infectious Disease Testing Implementation? 299 8.3 How do Business Strategies, such as those relating to Acquisition, Drive MD Strategies? 299 8.4 How might Novel Infectious Disease MD Test Development Lead to Acquisition Strategies and their Implications for Deal Making? 300 8.5 How can Molecular Diagnostic Tests Increase Value in an Associated Drug Marketing Plan? 300 8.6 Which Types of Infectious Disease MD Testing should be Developed by Diagnostic Companies at Various Stages in the Development Pipeline? 301 8.7 How can Regulatory Oversight Drive Approval and Adoption of New Technologies? 301 8.8 What are the Noteworthy Deals? 301 8.9 Who are the Acquirers? 302 8.10 Who are the Target Companies? 302 8.11 How will Platform Technology Companies Enter the Space? 302 8.12 Will Pharma Integrate with Diagnostics? 303 8.13 How do Platform Technology Companies Position themselves for Diagnostics Development? 303 8.14 Evaluate how Partnering and M&As will Alter the Competitive Landscape 303 8.15 Predict how FDA Regs will Impact New Diagnostic Tests 304 8.16 How can Big Pharma and Diagnostic Companies Co-develop Biomarkers in a Model for Regulatory Acceptance? 305 8.17 How to Maximize Business Development through Biomarker Strategies? 305 8.18 What is the Best Type of Business Model for Developing Genetic Biomarkers for Infectious Disease? 305 8.19 How Best have Genetic Biomarkers Provided the Most Benefit in Infectious Disease Testing? 305 8.20 What are the Most Innovative Methods in Development of Molecular Diagnostic Biomarkers? 306 8.21 What are the Best Values for Genetic Biomarkers in Drug Development and in Diagnostics? 306 9. Economics of Anti-microbial Drug Resistance: The Persistent need for Anti-bacterials 309 9.1 Resistance and Antibiotic Usage 312 9.2 Infection Control Programs 313 10. Company Profiles 314 10.1 Abbott Laboratories 314 10.2 AdvanDx 314 10.3 Arcxis Biotechnologies 315 10.4 Atlas Genetics 315 10.5 AutoGenomics, Inc. 315 10.6 Becton, Dickinson and Company 317 10.7 BioGenex Laboratories, Inc. 317 10.8 BioHelix Corporation 318 10.9 bioM�rieux 318 10.10 Biocartis 318 10.11 bioTheranostics 319 10.12 Celera 319 10.13 Cepheid 321 10.14 EraGen Biosciences 322 10.15 Exiqon A/S 322 10.16 Genera Biosystems 323 10.17 GenMark Diagnostics, Inc. 323 10.18 Genomix Biotech 323 10.19 Gen-Probe 323 10.20 Gene Express 326 10.21 Genomica 326 10.22 Great Basin Scientific 326 10.23 Hologic 326 10.24 Illumina, Inc. 327 10.25 Innogenetics NV 328 10.26 Life Technologies 328 10.27 Mobidiag 329 10.28 Myconostica 329 10.29 Nanosphere 329 10.30 NorDiag ASA 330 10.31 Qiagen NV 330 10.32 Roche Ltd. 333 10.33 Seegene 334 10.34 SIRS-Lab 334 10.35 Source MDx 335 10.36 TrimGen 335 10.37 TrovaGene 335 10.38 Veredus Laboratories 335 10.39 Veridex 336 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) 337 [Inhaltsverzeichnis ausblenden] |
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Figure 2.1: Relationship of DNA Testing to Key Areas of Clinical Diagnosis 27 Figure 2.2: Finding Genes with Microassays 28 Figure 2.3: The Use of Microassays for Studying Gene Expression 29 Figure 2.4: Overall Structure of Nucleic Acid Testing Market 41 Figure 2.5: Global Market for Molecular Diagnostics, 2002-2016 45 Figure 3.1: Global Market for Molecular Diagnostics Testing, 2010 51 Figure 3.2: Share of Molecular Diagnostics Testing by Testing Type, 2009 52 Figure 3.3: Key Players Market Share in Global Molecular Diagnostics Testing Markets 53 Figure 3.4: Global Market for Infectious Disease Treatments, 2008-2014 54 Figure 3.5: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2016 55 Figure 3.6: Global Market Revenue Share Forecasts for Molecular Diagnostics Infectious Disease Testing Markets by Region, 2009 and 2015 56 Figure 3.7: Infectious Disease Testing Revenue Market Share of Total U.S. MD Market, 2009 and 2015 57 Figure 3.8: European Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2015 58 Figure 3.9: Infectious Disease Testing Revenue Market Share of Total European MD Market, 2009 and 2015 58 Figure 3.10: Japanese Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2016 59 Figure 3.11: Infectious Disease Testing Revenue Market Share of Total Japanese MD Market, 2009 and 2015 60 Figure 3.12: Total Global Infectious Disease Molecular Diagnostics Markets, 2010 61 Figure 3.13: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2010 61 Figure 3.14: Total Global Infectious Disease Molecular Diagnostics Markets, 2016 62 Figure 3.15: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2016 63 Figure 3.16: Global Trend of HIV Infection, 1991-2007 67 Figure 3.17: Number of People Living with HIV, Newly Infected with HIV and Number of AIDS Deaths in the World, 1990-2008 67 Figure 3.18: Worldwide Rate of New HIV Cases, 1990-2007 68 Figure 3.19: Percentage of Adult Population in African Countries with HIV, 2007 69 Figure 3.20: Global View of HIV Infection, 2008 71 Figure 3.21: Ethnic Distribution of AIDS Patients in the U.S., 2007 71 Figure 3.22: Ten Best Selling AIDS Drugs in the U.S., 2008 72 Figure 3.23: U.S. Rates for New HIV Cases, 2008 72 Figure 3.24: U.S. Rates for New HIV Cases in Men, 2008 73 Figure 3.25: U.S. Rates for New HIV Cases in Women, 2008 73 Figure 3.26: Global Trend of HIV Infections, 1991-2007 74 Figure 3.27: Proposed HIV Testing Algorithm 81 Figure 3.28: Distribution of HIV Molecular Diagnostic Testing by Purpose 83 Figure 3.29: Estimated Market for Global HIV Molecular Diagnostic Testing, 2011-2016 84 Figure 3.30: Estimated Market for U.S. HIV Molecular Diagnostic Testing, 2011-2016 84 Figure 3.31: Market Share Viral Load HIV MD Diagnostic Testing 85 Figure 3.32: Geographic Distribution of Chronic HBV Infection 92 Figure 3.33: Rate of New Hepatitis A, B and C Infections in the U.S., 1982-2006 92 Figure 3.34: Global Prevalence of Hepatitis C 102 Figure 3.35: Primary Causes of Chronic Liver Disease 104 Figure 3.36: HCV Infection Prevalence, 1988-2008 104 Figure 3.37: Hepatitis C Infection by Source 105 Figure 3.38: Growth and Projections of HCV Therapies by Drug Class, 2008 and 2013 106 Figure 3.39: U.S. Market Share of HCV Molecular Diagnostic Market, 2010 116 Figure 3.40: Global Market Share (Excluding U.S.) of HCV Molecular Diagnostic Market, 2010 117 Figure 3.41: Rate of New Cases and Deaths of Cervical Cancer by Age Group Worldwide, 2008 123 Figure 3.42: U.S. Market Share of HPV Molecular Diagnostic Market, 2010 133 Figure 3.43: Global Market Share (Excluding U.S.) of HPV Molecular Diagnostic Market, 2010 133 Figure 3.44: Market Share Estimates for Molecular Diagnostic HPV Testing, 2009 133 Figure 3.45: Number of Reported and Confirmed Cases of Influenza H1N1 Strain Worldwide, 2009 145 Figure 3.46: Distribution of H1N1 Flu in the U.S., 2009 146 Figure 3.47: H1N1 Confirmed and Probable Case Rate in the U.S., By Age Group 146 Figure 3:48: U.S. Rates of Sexually-transmitted Diseases, 1940-2007 154 Figure 3.49: Chlamydia Infection Rates: Total and by Gender: U.S., 1989-2009 156 Figure 3.50: Chlamydia U.S. Prevalence by Age Group and Race/Ethnicity 157 Figure 3.51: U.S. Market Share of CT/NG Molecular Diagnostic Market, 2010 161 Figure 3.52: Global Market Share (Excluding U.S.) of CT/NG Molecular Diagnostic Market, 2010 162 Figure 3.53: U.S. Gonorrhea Infection Rates, 1941-2006 166 Figure 3.54: U.S. Gonorrhea Infection Rates by Race/Ethnicity, 1999-2008 167 Figure 3.55: Pipeline for TB Diagnostics, 2006-2013 174 Figure 3.56: Number of Tuberculosis (TB) Cases Among U.S.- and Foreign-born Persons in the U.S., 1993-2008 175 Figure 3.57: Rate of Tuberculosis (TB) Cases Among U.S.- and Foreign-born Persons in the U.S., 1993-2008 175 Figure 3.58: Rate of Tuberculosis (TB) Cases by State/Area in the U.S., 2008 177 Figure 3.59: U.S.-born Tuberculosis (TB) Cases by Ethnicity, 2008 178 Figure 3.60: Reported Tuberculosis (TB) Cases in the U.S., 1983-2007 181 Figure 3.61: Global Market Share of MD TB Testing 182 Figure 3.62: Global Market Share of MD TB Testing by Region, 2010 183 Figure 3.63: Incidence Rates of Invasive MRSA Infections by Age 189 Figure 3.64: MRSA Trends According to Patient Location, 1998-2005 190 Figure 3.65: Incidence of Healthcare-associated MRSA Infections, 2005-2008 191 Figure 3.66: U.S. Market Share of MRSA Molecular Diagnostic Market, 2010 195 Figure 3.67: Global Market Share (Excluding U.S.) of MRSA Molecular Diagnostic Market, 2010 195 Figure 3.68: Global Frequency of Vancomycin-resistant Enterococci, 2006 200 Figure 3.69: U.S. Market Share of VRE Molecular Diagnostic Market, 2010 204 Figure 3.70: Estimated Market for Global Blood Screening Product Sales, 2007-2016 214 Figure 3.71: Gen-Probe Blood Screening Product Market Share, 2005-2009 215 Figure 3.72: Blood Screening Product Market Share by Company, 2010 217 Figure 4.1: Using DNA Microassays to Measure Gene Expression 221 Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients 222 Figure 5.1: FDA Co-developed Products as a Model for Collaboration 240 Figure 5.2: Market Growth of MD Infectious Disease Tests 263 Figure 5.3: Segmentation of the Biomarker Development Market 267 Figure 5.4: Global Distribution of Anti-infective Agent Sales by Geography 270 Figure 5.5: Leading Companies in Anti-infectives Market Share, 2008 271 Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision Making 276 Figure 9.1: Global Multidrug Susceptibility in Pseudomonas aeruginosa 311 Figure 9.2: Global Frequency of Vancomycin-resistant Enterococci, 2006 312 Figure 10.1: Gen-Probe Key Acquisitions 325 Figure 10.2: Gen-Probe Projected R&D Expenditures 325 Table 1.1: Market Trends in Infectious Disease DNA Testing 20 Table 1.2: Molecular Diagnostics Infectious Disease Market: Market Drivers Ranked in Order of Impact 22 Table 1.3: Molecular Diagnostics Infectious Disease Market: Market Restraints Ranked in Order of Impact 22 Table 1.4: Strategic Recommendations on Molecular Diagnostic Sector Business Functions 22 Table 2.1: Nucleic Acid-based Tests for Clinically Important Viral and Bacterial Pathogens 30 Table 2.2: Top Ten Causes of Death Worldwide 32 Table 2.3: The Most Prevalent Infectious Diseases Worldwide 32 Table 2.4: Annual Rates of Global Infectious Diseases 34 Table 2.5: Emerging Molecular Diagnostic Technologies 38 Table 2.6: Global Market for Molecular Diagnostics Testing, 2000-2016 40 Table 2.7: U.S. Market for Molecular Diagnostics Testing, 2004-2016 41 Table 2.8: Automated Molecular Diagnostics Platforms for Infectious Disease Testing 42 Table 2.9: Companies Marketing Products using DNA Probes 42 Table 2.10: Companies Marketing Multiple Products in Molecular Diagnostics Sector 43 Table 2.11: FDA-approved Molecular Diagnostic Commercial Kits for the Detection of Infectious Agents 44 Table 2.12: Global and U.S. Major Infectious Disease Market Size (Estimated Infected Persons) 45 Table 2.13: Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 46 Table 2.14: Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 46 Table 2.15: Attractive Growth Areas for Molecular Diagnostic Testing 48 Table 2.16: NAT Labs in U.S. and Five European Markets 48 Table 3.1: European Market for Molecular Diagnostics Testing, 2005-2015 50 Table 3.2: Japanese Market for Molecular Diagnostics Testing, 2009-2016 51 Table 3.3: Summary of Molecular Diagnostics Testing Sectors 51 Table 3.4: Share of Molecular Diagnostics Testing by Testing Type, 2009 52 Table 3.5: Key Players and Market Share in Global Molecular Diagnostics Testing Market 52 Table 3.6: Revenue Model for Molecular Diagnostics Testing 53 Table 3.7: Molecular Infectious Disease Diagnostics Market: Market Drivers Ranked in Order of Impact 54 Table 3.8: Molecular Infectious Disease Diagnostics Market: Market Restraints Ranked in Order of Impact 54 Table 3.9: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2016 55 Table 3.10: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2016 56 Table 3.11: European Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2015 57 Table 3.12: Japanese Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2016 59 Table 3.13: Molecular Diagnostic Markets for Infectious Disease Testing, 2010 61 Table 3.14: Molecular Diagnostic Markets for Infectious Disease Testing, 2016 62 Table 3.15: Business Factors Influencing Advanced Infectious Disease MD Testing Services 64 Table 3.16: Global Summary of the HIV/AIDS Epidemic, 2008 68 Table 3.17: Global HIV Statistics, 2008 70 Table 3.18: HIV Resistance Testing Recommendations 74 Table 3.19: Summary of Assays for HIV Viral Load Testing 75 Table 3.20: Commercially Available Molecular Diagnostic Products for HIV Assay 80 Table 3.21: Global Market for Molecular Diagnostic HIV Testing, 2007-2010 83 Table 3.22: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2010 84 Table 3.23: Global Market for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016 85 Table 3.24: U.S. Market for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016 85 Table 3.25: Global Market for HIV Viral Load Diagnostic Testing, 2007-2010 86 Table 3.26: U.S. Market for HIV Viral Load Diagnostic Testing, 2007-2010 86 Table 3.27: Global Market for HIV Viral Load Diagnostic Testing, 2011-2016 86 Table 3.28: U.S. Market for HIV Viral Load Diagnostic Testing, 2011-2016 86 Table 3.29: Global Market for HIV Genotyping Testing, 2007-2010 87 Table 3.30: U.S. Market for HIV Genotype Testing, 2007-2010 87 Table 3.31: Global Market for HIV Genotyping Testing 2011-2015 87 Table 3.32: U.S. Market for HIV Genotyping Testing, 2011-2016 87 Table 3.33: HIV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 89 Table 3.34: HIV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 89 Table 3.35: Clinical Application of Quantitative HBV DNA Testing 93 Table 3.36: Lower Detection Limits of HBV DNA Assays 95 Table 3.37: Summary of Molecular Diagnostic Assays for Testing HBV 97 Table 3.38: Global Market for HBV Diagnostic Testing, 2000-2010 97 Table 3.39: U.S. Market for HBV Diagnostic Testing, 2000-2010 97 Table 3.40: Global Market for HBV Diagnostic Testing, 2011-2016 98 Table 3.41: U.S. Market for HBV Diagnostic Testing, 2011-2016 98 Table 3.42: HBV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 98 Table 3.43: HBV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 99 Table 3.44: Hepatitis B Facts 100 Table 3.45: U.S. HCV Statistics 106 Table 3.46: Worldwide Rate of HCV Cases 106 Table 3.47: Efficiency of Available HCV Screening Tests 108 Table 3.48: Commercially Available Molecular Diagnostic Products for HCV Assay 114 Table 3.49: Global Market for DNA HCV Diagnostic Testing, 2005-2010 115 Table 3.50: U.S. Market for DNA HCV Diagnostic Testing, 2005-2010 115 Table 3.51: Global Market for NAT HCV Diagnostic Testing, 2011-2016 115 Table 3.52: U.S. Market for NAT HCV Diagnostic Testing, 2011-2016 116 Table 3.53: Major Companies Marketing HCV Molecular Diagnostic Tests: Market Size and Share, 2010 116 Table 3.54: HCV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 117 Table 3.55: HCV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 118 Table 3.56: Recommendations for HCV Diagnostic Testing 120 Table 3.57: Number of Pap Smears Performed by Country, 2009 121 Table 3.58: Qiagen�s Digene HC2 High-risk HPV DNA Test 126 Table 3.59: Commercially Available Molecular Diagnostic Products for HPV Assay 131 Table 3.60: Major Companies Marketing HPV Molecular Diagnostic Tests: Market Size and Share, 2010 132 Table 3.61: Global Market for HPV Molecular Diagnostic Testing, 2007-2011 136 Table 3.62: U.S. Market for HPV Molecular Diagnostic Testing, 2007-2011 136 Table 3.63: Global Market for HPV Molecular Diagnostic Testing, 2011-2016 137 Table 3.64: U.S. Market for HPV Molecular Diagnostic Testing, 2011-2016 137 Table 3.65: HPV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 137 Table 3.66: HPV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 138 Table 3.67: Commercially Available Molecular Diagnostic Products for Influenza Assay 149 Table 3.68: Global Market for Molecular Influenza Diagnostic Testing, 2007-2010 149 Table 3.69: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2010 150 Table 3.70: Global Market for Influenza Molecular Diagnostic Testing, 2010-2016 150 Table 3.71: U.S. Market for Influenza Molecular Diagnostic Testing, 2010-2016 150 Table 3.72: Influenza Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 151 Table 3.73: Influenza Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 151 Table 3.74: U.S. Chlamydia Infection Rates, 1985-2008 156 Table 3.75: U.S. Chlamydia Statistics 157 Table 3.76: Commercially Available Molecular Diagnostic Products for Chlamydia Assay 160 Table 3.77: Global Market for Molecular Diagnostic Chlamydia/NG Diagnostic Testing, 2000-2010 160 Table 3.78: U.S. Market for Molecular Diagnostic Chlamydia/NG Diagnostic Testing, 2000-2010 160 Table 3.79: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic Tests: Market Size and Share, 2010 161 Table 3.80: Global Market for Chlamydia/Gonorrhea Diagnostic Testing, 2011-2016 162 Table 3.81: U.S. Market for Chlamydia/Gonorrhea Diagnostic Testing, 2010-2016 162 Table 3.82: Global Market for Chlamydia Molecular Diagnostic Testing, 2011-2016 163 Table 3.83: U.S. Market for Chlamydia Molecular Diagnostic Testing, 2011-2016 163 Table 3.84: Chlamydia Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 163 Table 3.85: Chlamydia Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 164 Table 3.86: U.S. Gonorrhea Statistics 167 Table 3.87: Commercially Available Molecular Diagnostic Products for Gonorrhea Assay 170 Table 3.88: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic Tests: Market Size and Share, 2010 171 Table 3.89: Gonorrhea Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 171 Table 3.90: Gonorrhea Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 172 Table 3.91: Commercially Available Molecular Diagnostic Assays for Testing TB 180 Table 3.92: Global Market for MD TB Diagnostic Testing, 2005-2010 182 Table 3.93: U.S. Market for MD TB Diagnostic Testing, 2005-2010 182 Table 3.94: Global Market Share of MD TB Testing by Region, 2010 183 Table 3.95: Global Unit Sales of MD TB Testing by Region, 2010 183 Table 3.96: Comparative U.S. Claim Charges for TB Testing by Type, 2010 184 Table 3.97: Global Testing for TB by Testing Type, 2010 184 Table 3.98: Global Testing for TB by Testing Reason, 2010 184 Table 3.99: Global Market for MD TB Diagnostic Testing, 2011-2016 185 Table 3.100: U.S. Market for MD TB Diagnostic Testing, 2011-2016 185 Table 3.101: Tuberculosis Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 185 Table 3.102: Tuberculosis Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 186 Table 3.103: Leading Tuberculosis Therapeutic R&D Candidates 188 Table 3.104: Commercially Available Molecular Diagnostic Products for MRSA Assay 192 Table 3.105: Global Market for MRSA Diagnostic Testing, 2005-2010 193 Table 3.106: U.S. Market for MRSA Diagnostic Testing, 2005-2010 193 Table 3.107: Major Companies Marketing HCV Molecular Diagnostic Tests: Market Size and Share, 2010 194 Table 3.108: Global Market for MD MRSA Diagnostic Testing, 2011-2016 196 Table 3.109: U.S. Market for MD MRSA Diagnostic Testing, 2011-2016 196 Table 3.110: MRSA Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 196 Table 3.111: MRSA Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 197 Table 3.112: In vitro Susceptibility of Staphylococci to New Agents in Development 199 Table 3.113: Commercially Available Molecular Diagnostic Products for VRE Assay 203 Table 3.114: Global Market for VRE Diagnostic Testing, 2005-2010 203 Table 3.115: U.S. Market for VRE Diagnostic Testing, 2005-2010 204 Table 3.116: Major Companies Marketing VRE Molecular Diagnostic Tests: Market Size and Share, 2010 204 Table 3.117: Global Market for MD VRE Diagnostic Testing, 2011-2016 205 Table 3.118: U.S. Market for MD VRE Diagnostic Testing, 2011-2016 205 Table 3.119: VRE Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 205 Table 3.120: VRE Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 206 Table 3.121: Transmission-related Disease Screening from Blood Donor Pools 209 Table 3.122: Principal Blood Screening Products of Gen-Probe for HIV Assay 211 Table 3.123: Global Market for Blood Screening Product Sales, 2007-2016 213 Table 3.124: Global Revenue and for Blood-Screening Market, 2000-2016 215 Table 3.125: U.S. Market and for Blood-Screening Market, 2000-2016 216 Table 3.126: Major Companies Marketing Blood Screening Molecular Diagnostic Tests: Market Size and Share, 2010 216 Table 3.127: Blood Screening Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 219 Table 3.128: Blood Screening Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 219 Table 4.1: Key Elements for Business Competition in Molecular Diagnostic Testing for Infectious Disease 225 Table 4.2: Key Elements for Future Success in Molecular Testing for Infectious Disease 225 Table 4.3: Examples of Personalized Medicine in Treatment of Infectious Disease 226 Table 4.4: Molecular Methods for Epidemiologic Typing of Microorganisms 228 Table 4.5: Drivers of Molecular Diagnostic Methods for Infectious Disease Testing in the Clinical Setting 229 Table 4.6: Barriers to Molecular Diagnostic Methods for Infectious Disease Testing in the Clinical Setting 229 Table 5.1: Technology Trends in Molecular Diagnostic Infectious Disease Testing 234 Table 5.2: Clinical Testing Trends in Molecular Diagnostic Infectious Disease Testing 234 Table 5.3: Business Market Trends in Molecular Diagnostics Infectious Disease Testing 235 Table 5.4: Expected Changes in Healthcare 235 Table 5.5: Customer Feedback for Automated Molecular Diagnostic Instruments 235 Table 5.6: Molecular Diagnostics Infectious Disease Market: Market Drivers Ranked in Order of Impact 236 Table 5.7: Molecular Diagnostics Infectious Disease Market: Market Restraints Ranked in Order of Impact 236 Table 5.8: Advantages of European Markets for Molecular Diagnostic Testing 237 Table 5.9: European Sales Percentage of Most Common Molecular Diagnostic Tests by Analyte Type 237 Table 5.10: Disadvantages of European Markets for Molecular Diagnostic Testing 237 Table 5.11: Summary of Recent M&A Activity in the Molecular Diagnostics Sector 238 Table 5.12: High Value Opportunities in Collaborative and Strategic Partnerships 239 Table 5.13: Principal Competitive Factors in the Molecular Diagnostics Infectious Disease Testing Market 242 Table 5.14: Molecular Diagnostics Infectious Disease Testing Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions 243 Table 5.15: Molecular Diagnostics Infectious Disease Market: Impact of Top Industry Challenges in the U.S. 243 Table 5.16: Documents for Protecting Intellectual Property Rights 244 Table 5.17: Recent Patents Related to PCR, Nucleic Acid Amplification, and Sample Prep 245 Table 5.18: Specific Opportunities for Automated Instrumentation and Reagent Systems in Molecular Diagnostics for Infectious Disease Testing 246 Table 5.19: Roche PCR Licenses 251 Table 5.20: Global Sales of Gen-Probe by Geographic Area, 2008-2010 253 Table 5.21: The Required Elements of a Manufacturing Facility 261 Table 5.22: CMO Qualification Audit: Points to Investigate 262 Table 5.23: Strategies and POA for Marketing Infectious disease Diagnostic Products 263 Table 5.24: Key Elements of Molecular Diagnostic Companies Marketing Plan 264 Table 5.25: Utility of Biomarkers as Companion Diagnostics to Drug Development 269 Table 5.26: Leading Pharmaceutical Companies in the Anti-infective Market�Total Global Sales, 2008 271 Table 6.1: Factors Determining Third-Party Payment for Molecular Diagnostic Tests for Infectious Disease 281 Table 6.2: CPT Codes for Molecular Diagnostic Infectious Disease Testing 286 Table 7.1: Regulatory Rules that Affect the Ability of a Diagnostic Testing Reagent Company to Conduct Business 287 Table 7.2: Strengths of the 510k Process 291 Table 7.3: Drawbacks of the 510k Process 291 Table 7.4: Focus Areas for the FDA Critical Path Initiative 296 Table 8.1: Effect of Regulation on MD Infectious Disease Market Technology Platforms, 2007 and 2015 301 Table 8.2: Companies Utilizing New, Cutting-edge Technologies to Develop, Validate and Market Molecular Tests for Clinical Use in Infectious Disease Management 306 Table 8.3: Impediments to Incorporating Promising Molecular Tests into Clinical Practice 306 Table 8.4: New Molecular Diagnostics Tests Showing the Most Promise for Approval 307 Table 8.5: Alliances Showing the Greatest Synergy in bringing Molecular Diagnostics Tests to Market 308 Table 8.6: Shared Technologies Driving the Most Encouraging MD Development 308 Table 10.1: Gen-Probe Key Acquisitions 325 Table A1: MRSA/SA Strains for Analytical Sensitivity (LoD) and Inclusivity Studies obtained from the CDC 345 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 346 Table A3: MRSA Strains (Clinical Isolates and Isolates obtained from Public and Private Collections) for Analytical Sensitivity (LoD) and Inclusivity Studies 347 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 349 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 351 Table A6: Examples of Substances Recommended for an Interference Study for Nasal Swab Specimens 352 Table A7: Examples of Substances Recommended for an Interference Study for Skin and Soft Tissue Infection Swab Specimens 353 Table A8: FDA-approved Molecular Diagnostic Tests for Infectious Diseases 360 Table A9: Noncommercial Nucleic Acid-based Tests for Clinically Important Viral and Bacterial Pathogens 361 Table A10: Molecular Methods for Detecting Antimicrobial Resistance 364 Table A11: Genotypic Methods for Epidemiologic Typing of Microorganisms 365 Table A12: Reduction in Number and Cost of Nosocomial Infections through Collaborative Efforts of Infection Control, Clinical Microbiology, and Molecular Typing Laboratories 367 [Tabellenverzeichnis ausblenden] |
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