TABLE OF CONTENTS
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 43
2.6.4.1 Market Drivers 43
2.6.4.2 Market Restraints 43
2.6.5 Market and Technology Trends 43
2.6.5.1 Market Trends 43
2.6.5 2 Technology Trends 44
2.6.6 Strategic Recommendations 44
2.7 PCR Reagents for Clinical Diagnostics 45
3. Infectious Disease Diagnostics Molecular Testing Market 47
3.1 Market Overview 47
3.1.1 Overall Infectious Disease Market Analysis 52
3.2 NAT Molecular Diagnostics Market 64
3.3 Infectious Disease Molecular Diagnostic Testing Markets 65
3.3.1 HIV 65
3.3.1.1 Disease Background and Statistics 65
3.3.1.2 Measuring Viral Loads 72
3.3.1.3 Instruments and MD Reagents 73
3.3.1.4 Method Comparisons 79
3.3.1.5 Market Size 81
3.3.1.5.1 HIV Diagnostic Testing 82
3.3.1.6 HIV Market Challenges and Strategic Recommendations 86
3.3.1.6.1 HIV Molecular Diagnostic Market History 86
3.3.1.7 Market Drivers and Restraints 87
3.3.1.7.1 Market Drivers 87
3.3.1.7.2 Market Restraints 88
3.3.1.8 Market and Technology Trends 88
3.3.1.8.1 Market Trends 88
3.3.1.8.2 Technology Trends 89
3.3.1.9 Strategic Recommendations 89
3.3.2 Hepatitis 90
3.3.2.1 Hepatitis B Virus 90
3.3.2.1.1 Hepatitis B Disease Background and Statistics 90
3.3.2.1.2 Instruments and Reagents for Hepatitis B Detection 92
3.3.2.1.3 Method Comparisons 93
3.3.2.1.4 Hepatitis B Market Size 96
3.3.2.1.5 HBV Market Challenges and Strategic Recommendations 97
3.3.2.1.5.1 Market Drivers and Restraints 97
3.3.2.1.5.1.1 Market Drivers 97
3.3.2.1.5.1.2 Market Restraints 97
3.3.2.1.6 Market and Technology Trends 98
3.3.2.1.6.1 Market Trends 98
3.3.2.1.6.2 Technology Trends 98
3.3.2.1.7 Strategic Recommendations 99
3.3.2.2 Hepatitis C Virus (HCV) Testing 99
3.3.2.2.1 Disease Background and Statistics 99
3.3.2.2.2 Instruments and Reagents for Hepatitis C Detection 105
3.3.2.2.3 Method Comparisons for HCV Tests 110
3.3.2.2.4 Hepatitis C Market Size 113
3.3.2.2.4.1 HCV Market Share 114
3.3.2.2.5 HCV Market Challenges and Strategic Recommendations 115
3.3.2.2.5.1 Market Drivers and Restraints 115
3.3.2.2.5.1.1 Market Drivers 115
3.3.2.2.5.1.2 Market Restraints 116
3.3.2.2.5.2 Market and Technology Trends 116
3.3.2.2.5.2.1 Market Trends 116
3.3.2.2.5.2.2 Technology Trends 117
3.3.2.2.6 Strategic Recommendations 118
3.3.3 Human Papillomavirus (HPV) 118
3.3.3.1 Disease Background and Statistics 118
3.3.3.2 Instruments and Reagents for HPV Detection 123
3.3.3.3 Method Comparison 129
3.3.3.4 HPV Market Size 130
3.3.3.4.1 North American Market 132
3.3.3.4.2 European Market 133
3.3.3.5 Market Challenges and Strategic Recommendations 135
3.3.3.5.1 Market Drivers and Restraints 135
3.3.3.5.1.1 Market Drivers 135
3.3.3.5.1.2 Market Restraints 136
3.3.3.5.2 Market and Technology Trends 136
3.3.3.5.2.1 Market Trends 136
3.3.3.5.2.2 Technology Trends 137
3.3.3.5.3 Strategic Recommendations 139
3.3.4 Influenza Viruses 139
3.3.4.1 Disease Background and Statistics 139
3.3.4.2 Instruments and Reagents for Influenza Detection 145
3.3.4.3 Method Comparisons 147
3.3.4.4 Influenza Market Size 147
3.3.4.5 Influenza Market Challenges and Strategic Recommendations 149
3.3.4.5.1 Market Drivers and Restraints 149
3.3.4.5.1.1 Market Drivers 149
3.3.4.5.1.2 Market Restraints 149
3.3.4.5.2 Market and Technology Trends 149
3.3.4.5.2.1 Market Trends 149
3.3.4.5.2.2 Technology Trends 150
3.3.4.5.3 Strategic Recommendations 151
3.3.5 STD Testing (Chlamydia/Gonorrhea Molecular Diagnostic Testing) 151
3.3.5.1 Chlamydia/Gonorrhea Molecular Diagnostic Testing Market Size 152
3.3.5.2 Competitive Structure and Market Share Analysis 153
3.3.5.2.1 Market Forecasts 154
3.3.5.2.1.1 Revenue Forecasts 154
3.3.5.3 Chlamydia Molecular Diagnostic Testing 155
3.3.5.3.1 Disease Background and Description 155
3.3.5.3.2 Product Analysis: Instruments and Reagents for Testing Chlamydia 158
3.3.5.3.3 Method Comparison 160
3.3.5.3.4 Chlamydia Molecular Diagnostic Testing 161
3.3.5.3.4.1 Revenue Forecasts 161
3.3.5.3.4.2 Market Challenges 162
3.3.5.3.4.2.1 Market Drivers 162
3.3.5.3.4.2.2 Market Restraints 162
3.3.5.3.5 Market and Technology Trends 162
3.3.5.3.5.1 Market Trends 162
3.3.5.3.5.2 Technology Trends 163
3.3.5.3.5.3 Strategic Recommendations 164
3.3.5.4 Gonorrhea Molecular Diagnostic Testing 164
3.3.5.4.1 Disease Background and Description 164
3.3.5.4.2 Product Analysis: Instruments and Reagents 166
3.3.5.4.3 Method Comparison 169
3.3.5.4.4 Competitive Structure and Market Share Analysis 170
3.3.5.4.5 Market Forecasts 170
3.3.5.4.5.1 Revenue Forecasts 170
3.3.5.4.6 Market Challenges 170
3.3.5.4.6.1 Market Drivers 170
3.3.5.4.6.2 Market Restraints 171
3.3.5.4.7 Market and Technology Trends 171
3.3.5.4.7.1 Market Trends 171
3.3.5.4.7.2 Technology Trends 171
3.3.5.4.8 Strategic Recommendations 171
3.3.6 Tuberculosis (TB) 172
3.3.6.1 Disease Background and Description 172
3.3.6.2 Product Analysis: Instruments and Reagents 179
3.3.6.3 Method Comparison 180
3.3.6.4 Tuberculosis Market Size 181
3.3.6.5 Competitive Structure and Market Share Analysis 181
3.3.6.6 Market Forecasts 184
3.3.6.6.1 Revenue Forecasts 184
3.3.6.7 Market Challenges 185
3.3.6.7.1 Market Drivers 185
3.3.6.7.2 Market Restraints 185
3.3.6.8 Market and Technology Trends 185
3.3.6.8.1 Market Trends 185
3.3.6.8.2 Technology Trends 186
3.3.6.9 Strategic Recommendations 187
3.3.7 Methicillin-resistant Staphylococcus aureus (MRSA) 187
3.3.7.1 Disease Background and Description 187
3.3.7.2 Product Analysis: Instruments and Reagents 190
3.3.7.3 Method Comparison 191
3.3.7.4 MRSA Market Size 192
3.3.7.5 Competitive Structure and Market Share Analysis 193
3.3.7.6 Market Forecasts 195
3.3.7.6.1 Revenue Forecasts 195
3.3.7.7 Market Challenges 195
3.3.7.7.1 Market Drivers 195
3.3.7.7.2 Market Restraints 196
3.3.7.8 Market and Technology Trends 196
3.3.7.8.1 Market Trends 196
3.3.7.8.2 Technology Trends 197
3.3.7.9 Strategic Recommendations 197
3.3.8 Vancomycin-resistant Enterococci (VRE) 198
3.3.8.1 Disease Background and Description 198
3.3.8.2 Product Analysis: Instruments and Reagents 200
3.3.8.3 Method Comparison 201
3.3.8.4 Competitive Structure and Market Share Analysis 203
3.3.8.5 Market Forecasts 204
3.3.8.5.1 Revenue Forecasts 204
3.3.8.6 Market Challenges 204
3.3.8.6.1 Market Drivers 204
3.3.8.6.2 Market Restraints 205
3.3.8.7 Market and Technology Trends 205
3.3.8.7.1 Market Trends 205
3.3.8.7.2 Technology Trends 206
3.3.8.8 Strategic Recommendations 206
3.3.9 Herpes Simplex Virus (HSV) 206
3.3.10 C. difficile 206
3.3.11 Cytomegalovirus 207
3.4 Blood Screening 207
3.4.1 Product Analysis: Instruments and Reagents 209
3.4.2 Method Comparison 211
3.4.3 Blood Screening Market Size 212
3.4.4 Competitive Positions 213
3.4.5 Market Challenges and Strategic Recommendations 218
3.4.5.1 Market Drivers and Restraints 218
3.4.5.1.1 Market Drivers 218
3.4.5.1.2 Market Restraints 218
3.4.5.2 Market and Technology Trends 218
3.4.5.2.1 Market Trends 218
3.4.5.2.2 Technology Trends 219
3.4.5.3 Strategic Recommendations 219
4. Molecular Diagnostic Testing Technology for Infectious Disease Testing 220
4.1 Infectious Disease Diagnostic Tests 220
4.1.1 Molecular Diagnostic Tools Solutions 222
4.1.2 Technology of Gene Expression Analysis 222
4.1.2.1 Amplification and Detection of RNA 222
4.1.2.2 Analysis of Multiple Genes 223
4.1.2.3 Advanced Information Technology 224
4.2 Use of Molecular Tests in Infectious Disease 224
4.2.1 Molecular Screening 224
4.2.2 Early Detection 225
4.2.3 Detection of Specific Resistance Genes and Viral Loading Tests 225
4.2.4 Pharmacogemomics and Personalized Medicine in MD Infectious Disease
Testing 225
4.2.5 Molecular Strain Typing 226
4.3 Cost of Molecular Diagnostic Testing 228
4.4 Use of Multiplex PCR Tests 228
4.5 Next Generation Sequencing 230
4.6 Patient Flow Software 231
4.7 Digital PCR 231
4.8 LAMP 232
4.9 Ion Proton System for Gene Sequencing 232
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 247
5.6.1 The Key Technical Opportunities with Significant Market Appeal in the
Molecular Diagnostic Space in the Next Five Years 247
5.6.2 Developments for Molecular Diagnostic Instrumentation Products 247
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 248
5.7.1 Scope of This Section 248
5.7.2 The Success Achieved by the Molecular Diagnostics Infectious Disease
Products 248
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 261
5.7.5.1 Elements of Commercial Manufacturing 261
5.7.5.1.1 Regulatory Requirements 261
5.7.5.1.2 Manufacturing Process Scale 261
5.7.5.1.3 In-House Manufacturing 261
5.7.5.2 Contract Manufacturing: Commercial and Academic 262
5.7.6 Sales and Marketing Strategies for Infectious Disease Tests 263
5.8 Companion Diagnostics Development in Partnership with a Pharmaceutical
Company 267
5.8.1 Description of Business Model 267
5.8.2 Anti-infective Pharmaceutical Market 271
6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for
Infectious Disease 278
6.1 Overview 278
6.2 Trends in Reimbursement Practice 279
6.2.1 Medicare Reimbursement Threats 280
6.2.2 Analysis of ROI for Molecular Diagnostic Tests for Infectious Disease
Using Current Medicare Reimbursement Rules 283
6.3 Trends in Patient Care and Reimbursement 283
6.4 Revenue Threats 284
6.4.1 Medicare Payment Exceptions 286
6.4.2 Three Areas for Denial of Claims 286
6.5 Billing Rules 287
6.5.1 Medicare Billing Procedures 287
6.5.2 Medicare CPT Coding Rules for MD Infectious Disease Testing 288
6.5.3 Infectious Disease Billing Strategies 289
7. Regulatory Requirements 290
7.1 U.S. Food and Drug Administration 290
7.2 CLIA Regulations 290
7.3 Clinical Laboratory Improvement Act (CLIA) 292
7.4 State Licensing for Service Laboratories 293
7.5 IVDMIAs 293
7.6 FDA Draft Guidance on In Vitro Companion Diagnostic Devices 294
7.7 510(k) Clearance 294
7.8 Pre-Market Approval (PMA) 295
7.8.1 Pre-Market Approval Application 296
7.9 Analyte Specific Reagents (ASRs) 296
7.9.1 Laboratory Developed Tests (LDT) 297
7.10 What Regulatory Guidance is Needed for Companion Biomarkers? 298
7.11 U.S. Patent and Trademark Office (USPTO) 300
7.12 IRB Approval in Clinical Trials 300
7.13 CE Marking and the IVDD (European In Vitro Diagnostic Device Directive) 300
7.14 De Novo Classification 300
7.15 Research Use Only (RUO) Reagents 301
7.16 FDA Recommendations on MRSA Testing 301
8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease
Testing 303
8.1 What are Key Opportunities in Infectious Disease Testing Development and
Commercialization? 303
8.2 What are the Current Obstacles for MD Infectious Disease Testing
Implementation? 303
8.3 How do Business Strategies, such as those relating to Acquisition, Drive MD
Strategies? 303
8.4 How might Novel Infectious Disease MD Test Development Lead to Acquisition
Strategies and their Implications for Deal Making? 304
8.5 How can Molecular Diagnostic Tests Increase Value in an Associated Drug
Marketing Plan? 305
8.6 Which Types of Infectious Disease MD Testing should be Developed by
Diagnostic Companies at Various Stages in the Development Pipeline? 305
8.7 How can Regulatory Oversight Drive Approval and Adoption of New
Technologies? 305
8.8 What are the Noteworthy Deals? 306
8.9 Who are the Acquirers? 307
8.10 Who are the Target Companies? 307
8.11 How will Platform Technology Companies Enter the Space? 307
8.12 Will Pharma Integrate with Diagnostics? 308
8.13 How do Platform Technology Companies Position themselves for Diagnostics
Development? 309
8.14 Evaluate how Partnering and M&As will Alter the Competitive Landscape 309
8.15 Predict how FDA Regulations will Impact New Diagnostic Tests 310
8.16 How can Big Pharma and Diagnostic Companies Co-develop Biomarkers in a
Model for Regulatory Acceptance? 311
8.17 How to Maximize Business Development through Biomarker Strategies? 311
8.18 What is the Best Type of Business Model for Developing Genetic Biomarkers
for Infectious
Disease? 311
8.19 How Best have Genetic Biomarkers Provided the Most Benefit in Infectious
Disease Testing? 312
8.20 What are the Most Innovative Methods in Development of Molecular Diagnostic
Biomarkers? 312
8.21 What are the Best Values for Genetic Biomarkers in Drug Development and in
Diagnostics? 312
9. Economics of Anti-microbial Drug Resistance: The Persistent need for
Anti-bacterials 315
9.1 Resistance and Antibiotic Usage 318
9.2 Infection Control Programs 320
10. Company Profiles 321
10.1 Abbott Laboratories 321
10.2 AdvanDx 324
10.3 Arcxis Biotechnologies 325
10.4 Atlas 325
10.5 AutoGenomics, Inc. 325
10.6 Becton, Dickinson and Company 327
10.7 bioMérieux 328
10.8 Biocartis 329
10.9 bioTheranostics 330
10.10 Cepheid 330
10.11 EraGen Biosciences 331
10.12 GenMark Diagnostics, Inc. 332
10.13 Genomix Biotech 332
10.14 Hologic Gen-Probe 333
10.15 Genomica S.A.U. 336
10.16 Great Basin Corporation 337
10.17 Illumina, Inc. 337
10.18 Innogenetics NV 338
10.19 Life Technologies 339
10.20 Mobidiag 341
10.21 Myconostica 341
10.22 Myriad Genetics, Inc. 341
10.23 Nanosphere 343
10.24 NorDiag ASA 344
10.25 Qiagen NV 344
10.26 Roche Ltd. 346
10.27 Seegene 348
10.28 SIRS-Lab 348
10.29 TrimGen 348
10.30 TrovaGene 348
10.31 Veredus Laboratories 349
10.32 Veridex 349
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) 350
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 40
Figure 3.1: Global Market for Molecular Diagnostics, 2002-2016 47
Figure 3.2: Global Market for Molecular Diagnostics Testing, 2011 49
Figure 3.3: Share of Molecular Diagnostics Testing by Testing Type, 2011 51
Figure 3.4: Key Players Market Share in Global Molecular Diagnostics Testing
Markets, 2011 51
Figure 3.5: Global Market for Infectious Disease Treatments, 2008-2014 52
Figure 3.6: Global Revenue for Molecular Diagnostics Testing for Infectious
Disease, 2009-2016 54
Figure 3.7: Global Market Revenue Share Forecasts for Molecular Diagnostics
Infectious Disease Testing Markets by Region, 2011 and 2015 55
Figure 3.8: Infectious Disease Testing Revenue Market Share of Total U.S. MD
Market, 2011 and 2015 56
Figure 3.9: European Market Revenue for Molecular Diagnostics Testing for
Infectious Disease,
2009-2016 57
Figure 3.10: Infectious Disease Testing Revenue Market Share of Total European
MD Market,
2011 and 2015 57
Figure 3.11: Japanese Market Revenue for Molecular Diagnostics Testing for
Infectious Disease,
2009-2016 58
Figure 3.12: Infectious Disease Testing Revenue Market Share of Total Japanese
MD Market,
2011 and 2015 59
Figure 3.13: Total Global Infectious Disease Molecular Diagnostics Markets, 2011
60
Figure 3.14: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2011
60
Figure 3.15: Total Global Infectious Disease Molecular Diagnostics Markets, 2016
61
Figure 3.16: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2016
62
Figure 3.17: Global Trend of HIV Infection, 1991-2011 66
Figure 3.18: Number of People Living with HIV, Newly Infected with HIV and
Number of AIDS Deaths in the World, 1990-2011 66
Figure 3.19: Worldwide Rate of New HIV Cases, 1990-2011 67
Figure 3.20: Percentage of Adult Population in African Countries with HIV, 2010
68
Figure 3.21: Global View of HIV Infection, 2008 70
Figure 3.22: Ethnic Distribution of AIDS Patients in the U.S., 2007 70
Figure 3.23: Ten Best Selling AIDS Drugs in the U.S., 2011 71
Figure 3.24: U.S. Rates for New HIV Cases, 2008 71
Figure 3.25: U.S. Rates for New HIV Cases in Men, 2008 72
Figure 3.26: U.S. Rates for New HIV Cases in Women, 2008 72
Figure 3.27: Proposed HIV Testing Algorithm 80
Figure 3.28: Distribution of HIV Molecular Diagnostic Testing by Purpose 82
Figure 3.29: Estimated Market for Global HIV Molecular Diagnostic Testing,
2011-2016 83
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 90
Figure 3.33: Rate of New Hepatitis A, B and C Infections in the U.S., 1982-2006
91
Figure 3.34: Global Prevalence of Hepatitis C 100
Figure 3.35: Primary Causes of Chronic Liver Disease 102
Figure 3.36: HCV Infection Prevalence, 1988-2008 102
Figure 3.37: Hepatitis C Infection by Source 103
Figure 3.38: Growth and Projections of HCV Therapies by Drug Class, 2008 and
2013 104
Figure 3.39: U.S. Market Share of HCV Molecular Diagnostic Market, 2011 115
Figure 3.40: Global Market Share (Excluding U.S.) of HCV Molecular Diagnostic
Market, 2011 115
Figure 3.41: Rate of New Cases and Deaths of Cervical Cancer by Age Group
Worldwide, 1980-2010 121
Figure 3.42: U.S. Market Share of HPV Molecular Diagnostic Market, 2011 131
Figure 3.43: Global Market Share (Excluding U.S.) of HPV Molecular Diagnostic
Market, 2011 131
Figure 3.44: Market Share Estimates for Molecular Diagnostic HPV Testing, 2011
131
Figure 3.45: Number of Reported and Confirmed Cases of Influenza H1N1 Strain
Worldwide, 2009 143
Figure 3.46: Distribution of H1N1 Flu in the U.S., 2009 144
Figure 3.47: H1N1 Confirmed and Probable Case Rate in the U.S., By Age Group 144
Figure 3.48: U.S. Rates of Sexually-transmitted Diseases, 1940-2010 152
Figure 3.49: U.S. Market Share of Chlamydia/Gonorrhea Molecular Diagnostic
Market, 2011 154
Figure 3.50: Global Market Share (Excluding U.S.) of Chlamydia/Gonorrhea
Molecular Diagnostic
Market, 2010 154
Figure 3.51: Chlamydia Infection Rates: Total and by Gender: U.S., 1989-2010 157
Figure 3.52: Chlamydia U.S. Prevalence by Age Group and Race/Ethnicity 158
Figure 3.53: U.S. and Outlying Areas Gonorrhea Infection Rates, 1941-2010 165
Figure 3.54: U.S. Gonorrhea Infection Rates by Race/Ethnicity, 1999-2010 165
Figure 3.55: Pipeline for TB Diagnostics, 2005-2015 174
Figure 3.56: Number of Tuberculosis (TB) Cases Among U.S.- and Foreign-born
Persons in the U.S.,
1993-2011 174
Figure 3.57: Rate of Tuberculosis (TB) Cases Among U.S.- and Foreign-born
Persons in the U.S.,
1993-2011 175
Figure 3.58: Rate of Tuberculosis (TB) Cases by State/Area in the U.S., 2011 176
Figure 3.59: U.S.-born Tuberculosis (TB) Cases by Ethnicity, 2011 177
Figure 3.60: Reported Tuberculosis (TB) Cases in the U.S., 1983-2011 180
Figure 3.61: Global Market Share of MD TB Testing 182
Figure 3.62: Global Market Share of MD TB Testing by Region, 2010 182
Figure 3.63: Incidence Rates of Invasive MRSA Infections by Age 188
Figure 3.64: MRSA Trends According to Patient Location, 1998-2005 189
Figure 3.65: Incidence of Healthcare-associated MRSA Infections, 2005-2008 190
Figure 3.66: U.S. Market Share of MRSA Molecular Diagnostic Market, 2010 194
Figure 3.67: Global Market Share (Excluding U.S.) of MRSA Molecular Diagnostic
Market, 2010 194
Figure 3.68: Global Frequency of Vancomycin-resistant Enterococci, 2006 199
Figure 3.69: U.S. Market Share of VRE Molecular Diagnostic Market, 2010 203
Figure 3.70: Estimated Market for Global Blood Screening Product Sales,
2007-2016 213
Figure 3.71: Hologic Gen-Probe Blood Screening Product Net Sales, 2005-2009 214
Figure 3.72: Blood Screening Product Market Share by Company, 2010 216
Figure 4.1: Using DNA Microassays to Measure Gene Expression 220
Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in
Patients 221
Figure 5.1: FDA Co-developed Products as a Model for Collaboration 240
Figure 5.2: Market Growth of MD Infectious Disease Tests 264
Figure 5.3: Segmentation of the Biomarker Development Market 268
Figure 5.4: Global Distribution of Anti-infective Agent Sales by Geography 271
Figure 5.5: Leading Companies in Anti-infectives Market Share, 2011 273
Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision Making 279
Figure 9.1: Global Multidrug Susceptibility in Pseudomonas aeruginosa 317
Figure 9.2: Global Frequency of Vancomycin-resistant Enterococci, 2006 318
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 21
Table 1.3: Molecular Diagnostics Infectious Disease Market: Market Restraints
Ranked in Order of Impact 21
Table 1.4: Strategic Recommendations on Molecular Diagnostic Sector Business
Functions 21
Table 2.1: Top Ten Causes of Death Worldwide 32
Table 2.2: The Most Prevalent Infectious Diseases Worldwide 32
Table 2.3: Annual Rates of Global Infectious Diseases 34
Table 2.4: Emerging Molecular Diagnostic Technologies 38
Table 2.5: Automated Molecular Diagnostics Platforms for Infectious Disease
Testing 40
Table 2.6: Companies Marketing Multiple Products in Molecular Diagnostics
Infectious Disease Sector 41
Table 2.7: FDA-approved Molecular Diagnostic Commercial Kits for the Detection
of Infectious Agents 42
Table 2.8: Global and U.S. Major Infectious Disease Market Size (Estimated
Infected Persons) 42
Table 2.9: Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 43
Table 2.10: Molecular Diagnostics Market: Market Restraints Ranked in Order of
Impact 43
Table 2.11: Attractive Growth Areas for Molecular Diagnostic Testing 45
Table 2.12: NAT Labs in U.S. and Five European Markets 45
Table 3.1: Global Market for Molecular Diagnostics Testing, 2000-2016 48
Table 3.2: U.S. Market for Molecular Diagnostics Testing, 2004-2016 48
Table 3.3: European Market for Molecular Diagnostics Testing, 2005-2016 49
Table 3.4: Japanese Market for Molecular Diagnostics Testing, 2009-2016 49
Table 3.5: Summary of Molecular Diagnostics Testing Sectors 50
Table 3.6: Share of Molecular Diagnostics Testing by Testing Type, 2011 50
Table 3.7: Key Players and Market Share in Global Molecular Diagnostics Testing
Market 2011 51
Table 3.8: Revenue Model for Molecular Diagnostics Testing 52
Table 3.9: Molecular Infectious Disease Diagnostics Market: Market Drivers
Ranked in Order of Impact 53
Table 3.10: Molecular Infectious Disease Diagnostics Market: Market Restraints
Ranked in Order of
Impact 53
Table 3.11: Global Revenue for Molecular Diagnostics Testing for Infectious
Disease, 2009-2016 54
Table 3.12: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious
Disease, 2009-2016 55
Table 3.13: European Market Revenue for Molecular Diagnostics Testing for
Infectious Disease,
2009-2015 56
Table 3.14: Japanese Market Revenue for Molecular Diagnostics Testing for
Infectious Disease,
2009-2016 58
Table 3.15: Molecular Diagnostic Markets for Infectious Disease Testing, 2011 60
Table 3.16: Molecular Diagnostic Markets for Infectious Disease Testing, 2016 61
Table 3.17: Business Factors Influencing Advanced Infectious Disease MD Testing
Services 63
Table 3.18: Global Summary of the HIV/AIDS Epidemic, 2011 67
Table 3.19: Global HIV Statistics, 2009 69
Table 3.20: HIV Resistance Testing Recommendations 73
Table 3.21: Summary of Assays for HIV Viral Load Testing 73
Table 3.22: Commercially Available Molecular Diagnostic Products for HIV Assay
79
Table 3.23: Global Market for Molecular Diagnostic HIV Testing, 2007-2011 82
Table 3.24: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2011 83
Table 3.25: Global Market for Molecular Diagnostic HIV Diagnostic Testing,
2012-2016 84
Table 3.26: U.S. Market for Molecular Diagnostic HIV Diagnostic Testing,
2012-2016 84
Table 3.27: Global Market for HIV Viral Load Diagnostic Testing, 2007-2011 85
Table 3.28: U.S. Market for HIV Viral Load Diagnostic Testing, 2007-2011 85
Table 3.29: Global Market for HIV Viral Load Diagnostic Testing, 2012-2016 86
Table 3.30: U.S. Market for HIV Viral Load Diagnostic Testing, 2012-2016 86
Table 3.31: HIV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 87
Table 3.32: HIV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 88
Table 3.33: Clinical Application of Quantitative HBV DNA Testing 92
Table 3.34: Lower Detection Limits of HBV DNA Assays 93
Table 3.35: Summary of Molecular Diagnostic Assays for Testing HBV 95
Table 3.36: Global Market for HBV Diagnostic Testing, 2000-2011 96
Table 3.37: U.S. Market for HBV Diagnostic Testing, 2000-2011 96
Table 3.38: Global Market for HBV Diagnostic Testing, 2012-2016 96
Table 3.39: U.S. Market for HBV Diagnostic Testing, 2012-2016 97
Table 3.40: HBV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 97
Table 3.41: HBV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 97
Table 3.42: Hepatitis B Facts 99
Table 3.43: U.S. HCV Statistics 104
Table 3.44: Worldwide Rate of HCV Cases 104
Table 3.45: Efficiency of Available HCV Screening Tests 106
Table 3.46: Commercially Available Molecular Diagnostic Products for HCV Assay
113
Table 3.47: Global Market for DNA HCV Diagnostic Testing, 2005-2011 113
Table 3.48: U.S. Market for DNA HCV Diagnostic Testing, 2005-2011 114
Table 3.49: Global Market for NAT HCV Diagnostic Testing, 2012-2016 114
Table 3.50: U.S. Market for NAT HCV Diagnostic Testing, 2012-2016 114
Table 3.51: Major Companies Marketing HCV Molecular Diagnostic Tests: Market
Size and Share, 2011 114
Table 3.52: HCV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 115
Table 3.53: HCV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 116
Table 3.54: Recommendations for HCV Diagnostic Testing 118
Table 3.55: Number of Pap Smears Performed by Country, 2009 119
Table 3.56: Deaths in Thousands from Cervical Cancer by Region and by Age Group
in 2010 121
Table 3.57: Qiagen’s Digene HC2 High-risk HPV DNA Test 124
Table 3.58: Commercially Available Molecular Diagnostic Products for HPV Assay
129
Table 3.59: Major Companies Marketing HPV Molecular Diagnostic Tests: Market
Size and Share, 2011 130
Table 3.60: Global Market for HPV Molecular Diagnostic Testing, 2007-2011 134
Table 3.61: U.S. Market for HPV Molecular Diagnostic Testing, 2007-2011 134
Table 3.62: Global Market for HPV Molecular Diagnostic Testing, 2012-2016 135
Table 3.63: U.S. Market for HPV Molecular Diagnostic Testing, 2012-2016 135
Table 3.64: HPV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 135
Table 3.65: HPV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 136
Table 3.66: Commercially Available Molecular Diagnostic Products for Influenza
Assay 147
Table 3.67: Global Market for Molecular Influenza Diagnostic Testing, 2007-2011
147
Table 3.68: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2011 148
Table 3.69: Global Market for Influenza Molecular Diagnostic Testing, 2012-2016
148
Table 3.70: U.S. Market for Influenza Molecular Diagnostic Testing, 2012-2016
148
Table 3.71: Influenza Molecular Diagnostics Market: Market Drivers Ranked in
Order of Impact 149
Table 3.72: Influenza Molecular Diagnostics Market: Market Restraints Ranked in
Order of Impact 149
Table 3.73: Global Market for Molecular Diagnostic Chlamydia/Gonorrhea
Diagnostic Testing, 2000-2011 152
Table 3.74: U.S. Market for Molecular Diagnostic Chlamydia/Gonorrhea Diagnostic
Testing, 2000-2011 153
Table 3.75: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic
Tests: Market Size and
Share, 2011 153
Table 3.76: Global Market for Chlamydia/Gonorrhea Diagnostic Testing, 2011-2016
154
Table 3.77: U.S. Market for Chlamydia/Gonorrhea a Diagnostic Testing, 2011-2016
155
Table 3.78: U.S. Chlamydia Infection Rates, 1985-2010 157
Table 3.79: U.S. Chlamydia Statistics 158
Table 3.80: Commercially Available Molecular Diagnostic Products for Chlamydia
Assay 161
Table 3.81: Global Market for Chlamydia Molecular Diagnostic Testing, 2011-2016
161
Table 3.82: U.S. Market for Chlamydia Molecular Diagnostic Testing, 2011-2016
161
Table 3.83: Chlamydia Molecular Diagnostics Market: Market Drivers Ranked in
Order of Impact 162
Table 3.84: Chlamydia Molecular Diagnostics Market: Market Restraints Ranked in
Order of Impact 162
Table 3.85: U.S. Gonorrhea Statistics 166
Table 3.86: Commercially Available Molecular Diagnostic Products for Gonorrhea
Assay 169
Table 3.87: Major Companies Marketing /Gonorrhea Molecular Diagnostic Tests:
Market Size and
Share, 2011 170
Table 3.88: Gonorrhea Molecular Diagnostics Market: Market Drivers Ranked in
Order of Impact 170
Table 3.89: Gonorrhea Molecular Diagnostics Market: Market Restraints Ranked in
Order of Impact 171
Table 3.90: Commercially Available Molecular Diagnostic Assays for Testing TB
179
Table 3.91: Global Market for MD TB Diagnostic Testing, 2005-2011 181
Table 3.92: U.S. Market for MD TB Diagnostic Testing, 2005-2011 181
Table 3.93: Global Market Share of MD TB Testing by Region, 2011 182
Table 3.94: Global Unit Sales of MD TB Testing by Region, 2010 183
Table 3.95: Comparative U.S. Claim Charges for TB Testing by Type, 2011 183
Table 3.96: Global Testing for TB by Testing Type, 2011 184
Table 3.97: Global Testing for TB by Testing Reason, 2011 184
Table 3.98: Global Market for MD TB Diagnostic Testing, 2012-2016 184
Table 3.99: U.S. Market for MD TB Diagnostic Testing, 2012-2016 184
Table 3.100: Tuberculosis Molecular Diagnostics Market: Market Drivers Ranked in
Order of Impact 185
Table 3.101: Tuberculosis Molecular Diagnostics Market: Market Restraints Ranked
in Order of Impact 185
Table 3.102: Leading Tuberculosis Therapeutic R&D Candidates 187
Table 3.103: Commercially Available Molecular Diagnostic Products for MRSA Assay
192
Table 3.104: Global Market for MRSA Diagnostic Testing, 2005-2011 192
Table 3.105: U.S. Market for MRSA Diagnostic Testing, 2005-2011 193
Table 3.106: Major Companies Marketing MRSA Molecular Diagnostic Tests: Market
Size and
Share, 2011 193
Table 3.107: Global Market for MD MRSA Diagnostic Testing, 2011-2016 195
Table 3.108: U.S. Market for MD MRSA Diagnostic Testing, 2011-2016 195
Table 3.109: MRSA Molecular Diagnostics Market: Market Drivers Ranked in Order
of Impact 195
Table 3.110: MRSA Molecular Diagnostics Market: Market Restraints Ranked in
Order of Impact 196
Table 3.111: In Vitro Susceptibility of Staphylococci to New Agents in
Development 198
Table 3.112: Commercially Available Molecular Diagnostic Products for VRE Assay
202
Table 3.113: Global Market for VRE Diagnostic Testing, 2005-2011 202
Table 3.114: U.S. Market for VRE Diagnostic Testing, 2005-2011 203
Table 3.115: Major Companies Marketing VRE Molecular Diagnostic Tests: Market
Size and Share, 2011 203
Table 3.116: Global Market for MD VRE Diagnostic Testing, 2012-2016 204
Table 3.117: U.S. Market for MD VRE Diagnostic Testing, 2012-2016 204
Table 3.118: VRE Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 204
Table 3.119: VRE Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 205
Table 3.120: Transmission-related Disease Screening from Blood Donor Pools 208
Table 3.121: Principal Blood Screening Products of Hologic Gen-Probe for HIV
Assay 210
Table 3.1
