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 bioMérieux 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
INDEX OF FIGURES
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
INDEX OF TABLES
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 |
