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Molecular Diagnostics in Infectious Disease Testing

  • May 2015
  • -
  • TriMark Publications
  • -
  • 441 pages

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.

Table Of Contents

Molecular Diagnostics in Infectious Disease Testing
TABLE OF CONTENTS

1. Overview 15
1.1 Statement of Report 15
1.2 About This Report 16
1.3 Scope of the Report 16
1.4 Objectives 18
1.5 Methodology 18
1.6 Executive Summary 20

2. Introduction to Molecular Diagnostics for Infectious Disease Testing 30
2.1 Molecular Diagnostics Testing and Opportunities in the Infectious Disease Sector 30
2.2 The Infectious Disease Problem 33
2.3 Impact of the Human Genome Project on Molecular Diagnostics 37
2.4 Opportunities for Molecular and Clinical Diagnostics 37
2.4.1 Companion Diagnostics 38
2.5 Development of Molecular Diagnostics Testing Markets 39
2.6 Target-Based Gene Amplification 40
2.6.1 Polymerase Chain Reaction 40
2.6.2 Real-Time PCR 41
2.6.3 Nucleic Acid Sequence-Based Amplification 41
2.6.4 Next Generation Sequencing 42
2.6.4.1 Second-Generation Sequencing 43
2.6.4.2 Whole Genome Sequencing (WGS) 44
2.6.4.3 Epigenomics 44
2.6.4.4 Bioinformatics and Next Generation Sequencing 44
2.6.4.5 Third Next Generation Sequencing 44
2.6.5 Market Drivers and Restraints 48
2.6.5.1 Market Drivers 48
2.6.5.2 Market Restraints 48
2.6.6 Market and Technology Trends 48
2.6.6.1 Market Trends 48
2.6.6 2 Technology Trends 49
2.6.7 Strategic Recommendations 50
2.7 PCR Reagents for Clinical Diagnostics 50

3. Infectious Disease Diagnostics Molecular Testing Market 52
3.1 Market Overview 52
3.1.1 Overall Infectious Disease Market Analysis 57
3.2 NAT Molecular Diagnostics Market 69
3.3 Infectious Disease Molecular Diagnostic Testing Markets 70
3.3.1 HIV 70
3.3.1.1 Disease Background and Statistics 70
3.3.1.2 Measuring Viral Loads 77
3.3.1.3 Instruments and MDx Reagents 78
3.3.1.4 Method Comparisons 85
3.3.1.5 Market Size 87
3.3.1.5.1 HIV Diagnostic Testing 88
3.3.1.6 HIV Market Challenges and Strategic Recommendations 93
3.3.1.6.1 HIV Molecular Diagnostic Market History 93
3.3.1.7 Market Drivers and Restraints 94
3.3.1.7.1 Market Drivers 94
3.3.1.7.2 Market Restraints 94
3.3.1.8 Market and Technology Trends 94
3.3.1.8.1 Market Trends 94
3.3.1.8.2 Technology Trends 95
3.3.1.9 Strategic Recommendations 96
3.3.2 Hepatitis 96
3.3.2.1 Hepatitis B Virus 97
3.3.2.1.1 Hepatitis B Disease Background and Statistics 97
3.3.2.1.2 Instruments and Reagents for Hepatitis B Detection 100
3.3.2.1.3 Method Comparisons 101
3.3.2.1.4 Hepatitis B Market Size 103
3.3.2.1.5 HBV Market Challenges and Strategic Recommendations 105
3.3.2.1.5.1 Market Drivers and Restraints 105
3.3.2.1.5.1.1 Market Drivers 105
3.3.2.1.5.1.2 Market Restraints 105
3.3.2.1.6 Market and Technology Trends 105
3.3.2.1.6.1 Market Trends 105
3.3.2.1.6.2 Technology Trends 106
3.3.2.1.7 Strategic Recommendations 106
3.3.2.2 Hepatitis C Virus Testing 107
3.3.2.2.1 Disease Background and Statistics 107
3.3.2.2.2 Instruments and Reagents for Hepatitis C Detection 113
3.3.2.2.3 Method Comparisons for HCV Tests 118
3.3.2.2.4 Hepatitis C Market Size 121
3.3.2.2.4.1 HCV Market Share 123
3.3.2.2.5 HCV Market Challenges and Strategic Recommendations 124
3.3.2.2.5.1 Market Drivers and Restraints 124
3.3.2.2.5.1.1 Market Drivers 124
3.3.2.2.5.1.2 Market Restraints 125
3.3.2.2.5.2 Market and Technology Trends 125
3.3.2.2.5.2.1 Market Trends 125
3.3.2.2.5.2.2 Technology Trends 126
3.3.2.2.6 Strategic Recommendations 127
3.3.3 Human Papillomavirus 128
3.3.3.1 Disease Background and Statistics 128
3.3.3.2 Instruments and Reagents for HPV Detection 133
3.3.3.3 Method Comparison 140
3.3.3.4 HPV Market Size 140
3.3.3.4.1 North American Market 142
3.3.3.4.2 European Market 144
3.3.3.5 Market Challenges and Strategic Recommendations 147
3.3.3.5.1 Market Drivers and Restraints 147
3.3.3.5.1.1 Market Drivers 147
3.3.3.5.1.2 Market Restraints 147
3.3.3.5.2 Market and Technology Trends 147
3.3.3.5.2.1 Market Trends 147
3.3.3.5.2.2 Technology Trends 148
3.3.3.5.3 Strategic Recommendations 150
3.3.4 Influenza Viruses 151
3.3.4.1 Disease Background and Statistics 151
3.3.4.2 Instruments and Reagents for Influenza Detection 157
3.3.4.3 Method Comparisons 159
3.3.4.4 Influenza Market Size 159
3.3.4.5 Influenza Market Challenges and Strategic Recommendations 161
3.3.4.5.1 Market Drivers and Restraints 161
3.3.4.5.1.1 Market Drivers 161
3.3.4.5.1.2 Market Restraints 161
3.3.4.5.2 Market and Technology Trends 161
3.3.4.5.2.1 Market Trends 161
3.3.4.5.2.2 Technology Trends 162
3.3.4.5.3 Strategic Recommendations 164
3.3.5 STD Testing (Chlamydia/Gonorrhea Molecular Diagnostic Testing) 164
3.3.5.1 Chlamydia/Gonorrhea Molecular Diagnostic Testing Market Size 165
3.3.5.2 Competitive Structure and Market Share Analysis 166
3.3.5.2.1 Market Forecasts 168
3.3.5.2.1.1 Revenue Forecasts 168
3.3.5.3 Chlamydia Molecular Diagnostic Testing 168
3.3.5.3.1 Disease Background and Description 168
3.3.5.3.2 Product Analysis: Instruments and Reagents for Testing Chlamydia 172
3.3.5.3.3 Method Comparison 174
3.3.5.3.4 Chlamydia Molecular Diagnostic Testing 175
3.3.5.3.4.1 Revenue Forecasts 175
3.3.5.3.4.2 Market Challenges 176
3.3.5.3.4.2.1 Market Restraints 177
3.3.5.3.5 Market and Technology Trends 177
3.3.5.3.5.1 Market Trends 177
3.3.5.3.5.2 Technology Trends 178
3.3.5.3.5.3 Strategic Recommendations 178
3.3.5.4 Gonorrhea Molecular Diagnostic Testing 179
3.3.5.4.1 Disease Background and Description 179
3.3.5.4.2 Product Analysis: Instruments and Reagents 182
3.3.5.4.3 Method Comparison 184
3.3.5.4.4 Competitive Structure and Market Share Analysis 185
3.3.5.4.5 Market Forecasts 185
3.3.5.4.6 Market Challenges 186
3.3.5.4.6.1 Market Drivers 186
3.3.5.4.6.2 Market Restraints 186
3.3.5.4.7 Market and Technology Trends 186
3.3.5.4.7.1 Market Trends 186
3.3.5.4.7.2 Technology Trends 187
3.3.5.4.8 Strategic Recommendations 187
3.3.6 Tuberculosis 187
3.3.6.1 Disease Background and Description 187
3.3.6.2 Product Analysis: Instruments and Reagents 196
3.3.6.3 Method Comparison 197
3.3.6.4 Tuberculosis Market Size 199
3.3.6.5 Competitive Structure and Market Share Analysis 200
3.3.6.6 Market Forecasts 203
3.3.6.6.1 Revenue Forecasts 203
3.3.6.7 Market Challenges 204
3.3.6.7.1 Market Drivers 204
3.3.6.7.2 Market Restraints 204
3.3.6.8 Market and Technology Trends 204
3.3.6.8.1 Market Trends 204
3.3.6.8.2 Technology Trends 206
3.3.6.9 Strategic Recommendations 206
3.3.7 Methicillin-Resistant Staphylococcus aureus (MRSA) 207
3.3.7.1 Disease Background and Description 207
3.3.7.2 Product Analysis: Instruments and Reagents 210
3.3.7.3 Method Comparison 211
3.3.7.4 MRSA Market Size 212
3.3.7.5 Competitive Structure and Market Share Analysis 213
3.3.7.6 Market Forecasts 215
3.3.7.6.1 Revenue Forecasts 215
3.3.7.7 Market Challenges 216
3.3.7.7.1 Market Drivers 216
3.3.7.7.2 Market Restraints 216
3.3.7.8 Market and Technology Trends 216
3.3.7.8.1 Market Trends 216
3.3.7.8.2 Technology Trends 217
3.3.7.9 Strategic Recommendations 217
3.3.8 Vancomycin-Resistant Enterococci 218
3.3.8.1 Disease Background and Description 218
3.3.8.2 Product Analysis: Instruments and Reagents 221
3.3.8.3 Method Comparison 221
3.3.8.4 Competitive Structure and Market Share Analysis 223
3.3.8.5 Market Forecasts 224
3.3.8.5.1 Revenue Forecasts 224
3.3.8.6 Market Challenges 225
3.3.8.6.1 Market Drivers 225
3.3.8.6.2 Market Restraints 226
3.3.8.7 Market and Technology Trends 226
3.3.8.7.1 Market Trends 226
3.3.8.7.2 Technology Trends 227
3.3.8.8 Strategic Recommendations 227
3.3.9 Herpes Simplex Virus 227
3.3.9.1 Disease Background and Description 227
3.3.9.2 Product Analysis: Instruments and Reagents 228
3.3.9.3 Method Comparison 229
3.3.9.4 Market Forecasts 230
3.3.9.4.1 Market Drivers 230
3.3.9.4.2 Market Restraints 231
3.3.9.5 Market and Technology Trends 231
3.3.9.5.1 Market Trends 231
3.3.9.5.2 Technology Trends 231
3.3.9.6 Strategic Recommendations 232
3.3.10 C. difficile 232
3.3.10.1 Disease Background and Description 232
3.3.10.2 Product Analysis: Instruments and Reagents 232
3.3.11 Cytomegalovirus 234
3.4 Blood Screening 234
3.4.1 Product Analysis: Instruments and Reagents 236
3.4.2 Method Comparison 238
3.4.3 Blood Screening Market Size 239
3.4.4 Competitive Positions 240
3.4.5 Market Challenges and Strategic Recommendations 244
3.4.5.1 Market Drivers and Restraints 244
3.4.5.1.1 Market Drivers 244
3.4.5.1.2 Market Restraints 244
3.4.5.2 Market and Technology Trends 244
3.4.5.2.1 Market Trends 244
3.4.5.2.2 Technology Trends 245
3.4.5.3 Strategic Recommendations 246

4. Molecular Diagnostic Testing Technology for Infectious Disease Testing 247
4.1 Infectious Disease Diagnostic Tests 247
4.1.1 Molecular Diagnostic Tools Solutions 249
4.1.2 Technology of Gene Expression Analysis 249
4.1.2.1 Amplification and Detection of RNA 249
4.1.2.2 Analysis of Multiple Genes 250
4.1.2.3 Advanced Information Technology 251
4.2 Use of Molecular Tests in Infectious Disease 251
4.2.1 Molecular Screening 251
4.2.2 Early Detection 252
4.2.3 Detection of Specific Resistance Genes and Viral Loading Tests 252
4.2.4 Pharmacogenomics and Personalized Medicine in Molecular Diagnostic Infectious Disease
Testing 252
4.2.5 Molecular Strain Typing 254
4.3 Cost of Molecular Diagnostic Testing 255
4.4 Use of Multiplex PCR Tests 256
4.4.1 Advantages of Multiplex PCR 256
4.4.2 Applications of Multiplex PCR 257
4.5 Next-Generation Sequencing 258
4.6 Patient Flow Software 259
4.7 Digital PCR 260
4.8 LAMP 260
4.9 Ion Proton System for Gene Sequencing 261
4.10 xMap Technology (Luminex) 262

5. Business 265
5.1 Technology and Market Trends 265
5.1.1 Technology Trends 265
5.1.2 Market Trends and Financial Considerations 268
5.2 Mandamp;A Activity 269
5.3 Partnerships 272
5.4 Competitive Analysis 275
5.4.1 Primary Competitors 275
5.4.2 Industry Challenges and Strategic Recommendations 276
5.4.3 Commercialization of Molecular Diagnostic Products 277
5.5 Intellectual Property Rights 277
5.5.1 New Patents 279
5.5.2 Current Patent Disputes 279
5.6 Opportunities and Strategic Recommendations 280
5.6.1 The Key Technical Opportunities with Significant Market Appeal in the Molecular Diagnostic Space in the Next Five Years 280
5.6.2 Developments for Molecular Diagnostic Instrumentation Products 280
5.6.3 Market Penetration Strategies for Infectious Disease Testing 281
5.7 Business Models and Requirements for a Successful Molecular Diagnostics Infectious Disease Products Industry 281
5.7.1 Scope of This Section 281
5.7.2 The Success Achieved by the Molecular Diagnostics Infectious Disease Products 281
5.7.3 Business Models in Molecular Diagnostics Infectious Disease Products 282
5.7.4 SWOT Comparison of Business Models for Molecular Diagnostic Infectious Disease Testing 283
5.7.5 Commercial Manufacturing of Molecular Diagnostics Infectious Disease Products: Requirements 296
5.7.5.1 Elements of Commercial Manufacturing 296
5.7.5.1.1 Regulatory Requirements 296
5.7.5.1.2 Manufacturing Process Scale 296
5.7.5.1.3 In-House Manufacturing 296
5.7.5.2 Contract Manufacturing: Commercial and Academic 297
5.7.6 Sales and Marketing Strategies for Infectious Disease Tests 298

6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for Infectious Disease 302
6.1 Overview 302
6.1.1 Gap Filling 303
6.2 Trends in Reimbursement Practice 303
6.2.1 Medicare Reimbursement Threats 305
6.2.2 Analysis of ROI for Molecular Diagnostic Tests for Infectious Disease Using Current Medicare Reimbursement Rules 308
6.3 Trends in Patient Care and Reimbursement 308
6.4 Revenue Threats 309
6.4.1 Medicare Payment Exceptions 311
6.4.2 Three Areas for Denial of Claims 311
6.5 Billing Rules 312
6.5.1 Medicare Billing Procedures 312
6.5.2 Medicare CPT Coding Rules for Molecular Diagnostic Infectious Disease Testing 313
6.5.3 Infectious Disease Billing Strategies 314

7. Regulatory Requirements 316
7.1 Food and Drug Administration 316
7.2 CLIA Regulations 316
7.3 Clinical Laboratory Improvement Act 318
7.4 State Licensing for Service Laboratories 319
7.5 IVDMIAs 319
7.6 FDA Draft Guidance on In Vitro Companion Diagnostic Devices 320
7.7 510(k) Clearance 321
7.8 Pre-Market Approval 321
7.8.1 Pre-Market Approval Application 322
7.9 Analyte Specific Reagents 323
7.9.1 Laboratory Developed Tests 323
7.10 What Regulatory Guidance is Needed for Companion Biomarkers? 325
7.11 U.S. Patent and Trademark Office 326
7.12 IRB Approval in Clinical Trials 326
7.13 CE Marking and the European In Vitro Diagnostic Device Directive 326
7.14 De Novo Classification 326
7.15 Research Use Only Reagents 327
7.16 FDA Recommendations on MRSA and SA Testing 327
7.17 FDA Guidance on Molecular Diagnostic Instruments with Combined Functions 328

8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease Testing 331
8.1 What are Key Opportunities in Infectious Disease Testing Development and Commercialization? 331
8.2 What are the Current Obstacles for Molecular Diagnostic Infectious Disease Testing
Implementation? 331
8.3 How do Business Strategies, Such as Those Relating to Acquisition, Drive Molecular Diagnostic Strategies? 332
8.4 How might Novel Infectious Disease Molecular Diagnostic Test Development Lead to Acquisition Strategies and their Implications for Deal Making? 332
8.5 How can Molecular Diagnostic Tests Increase Value in an Associated Drug Marketing Plan? 333
8.6 Which Types of Infectious Disease Molecular Diagnostic Testing should be Developed by Diagnostic Companies at Various Stages in the Development Pipeline? 333
8.7 How can Regulatory Oversight Drive Approval and Adoption of New Technologies? 334
8.8 What are the Noteworthy Deals? 334
8.9 Who are the Acquirers? 335
8.10 Who are the Target Companies? 335
8.11 How will Platform Technology Companies Enter the Space? 336
8.12 Will Pharma Integrate with Diagnostics? 337
8.13 How do Platform Technology Companies Position Themselves for Diagnostics Development? 337
8.14 Evaluate How Partnering and Mandamp;As will Alter the Competitive Landscape 338
8.15 Predict How FDA Regulations will Impact New Diagnostic Tests 338
8.16 How can Big Pharma and Diagnostic Companies Co-Develop Biomarkers in a Model for Regulatory Acceptance? 339
8.17 How to Maximize Business Development Through Biomarker Strategies? 339
8.18 What is the Best Type of Business Model for Developing Genetic Biomarkers for Infectious
Disease? 340
8.19 How Best have Genetic Biomarkers Provided the Most Benefit in Infectious Disease Testing? 340
8.20 What are the Most Innovative Methods in Development of Molecular Diagnostic Biomarkers? 340
8.21 What are the Best Values for Genetic Biomarkers in Drug Development and in Diagnostics? 341

9. Economics of Anti-Microbial Drug Resistance: The Persistent Need for Antibacterials 343
9.1 Resistance and Antibiotic Usage 347
9.2 Infection Control Programs 349

10. Company Profiles 350
10.1 Abbott Laboratories 350
10.2 AdvanDx 353
10.3 Affymetrix 354
10.4 Arcxis Biotechnologies 361
10.5 Asuragen, Inc. 362
10.6 AutoGenomics, Inc. 363
10.7 Becton, Dickinson and Company 365
10.8 bioMerieux 366
10.9 Biocartis 368
10.10 BioHelix Corporation (now part of Quidel) 369
10.11 bioTheranostics 370
10.12 Cepheid 370
10.13 EraGen Biosciences 372
10.14 GenMark Diagnostics, Inc. 372
10.15 Genomix Biotech 373
10.16 Gen-Probe, Inc. (now known as Hologic Gen-Probe) 374
10.17 Genomica S.A.U. 378
10.18 Great Basin Corporation 379
10.19 Illumina, Inc. 380
10.20 Life Technologies (Thermo Fisher Scientific) 383
10.21 Luminex Corp. 385
10.22 Mobidiag 387
10.23 Myconostica 388
10.24 Myriad Genetics, Inc. 388
10.25 Nanosphere 393
10.26 NorDiag ASA (The DiaSorin Group) 394
10.27 Qiagen N.V. 394
10.28 Quidel 398
10.29 Roche Diagnostics (Roche Ltd.) 403
10.30 SACACE 405
10.31 Seegene 405
10.32 Siemens AG 406
10.33 SIRS-Lab 408
10.34 TrimGen 408
10.35 TrovaGene 408
10.36 Veredus Laboratories 408
10.37 Veridex, LLC(Janssen Diagnostics, LLC) 409

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) 410
Appendix 2: Molecular Diagnostic Instruments with Combined Functions—Draft Guidance for Industry and Food and Drug Administration Staff 433
Appendix 3: Applications for Molecular Testing 437


INDEX OF FIGURES
Figure 2.1: Relationship of DNA Testing to Key Areas of Clinical Diagnosis 30
Figure 2.2: Finding Genes with Microassays 31
Figure 2.3: The Use of Microassays for Studying Gene Expression 32
Figure 2.4: Overall Structure of Nucleic Acid Testing Market 42
Figure 3.1: Global Market for Molecular Diagnostics, 2009-2020 52
Figure 3.2: Global Market for Molecular Diagnostics Testing, 2014 54
Figure 3.3: Share of Molecular Diagnostics Testing by Testing Type, 2014 55
Figure 3.4: Key Players Market Share in Global Molecular Diagnostics Testing Markets, 2014 56
Figure 3.5: Global Market for Infectious Disease Treatments, 2008-2014 57
Figure 3.6: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2020 59
Figure 3.7: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2020 60
Figure 3.8: Infectious Disease Testing Revenue Market Share of the Total U.S. Molecular Diagnostics Market,
2012 and 2018 60
Figure 3.9: European Market Revenue for Molecular Diagnostics Testing for Infectious Disease,
2009-2020 61
Figure 3.10: Japanese Market Revenue for Molecular Diagnostics Testing for Infectious Disease,
2009-2020 62
Figure 3.11: Rest of World (ROW) Market Revenue for Molecular Diagnostics Testing for Infectious Disease,
2009-2020 63
Figure 3.12: Infectious Disease Testing Revenue Market Share by Region, 2013 and 2020 64
Figure 3.13: Total Global Infectious Disease Molecular Diagnostics Markets, 2014 65
Figure 3.14: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2014 65
Figure 3.15: Total Global Infectious Disease Molecular Diagnostics Markets, 2020 66
Figure 3.16: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2020 67
Figure 3.17: Global Trend of HIV Infection, 1991-2012 71
Figure 3.18: Number of People Living with HIV, Newly Infected with HIV and Number of AIDS Deaths in the World, 1990-2012 71
Figure 3.19: Worldwide Rate of New HIV Cases, 1990-2012 72
Figure 3.20: Percentage of Adult Population in African Countries with HIV, 2011 73
Figure 3.21: Ethnic Distribution of AIDS Patients in the U.S., 2014 75
Figure 3.22: Global View of HIV Infection 75
Figure 3.23: Ten Best Selling AIDS Drugs in the U.S., 2014 76
Figure 3.24: U.S. Rates for New HIV Cases, 2014 76
Figure 3.25: U.S. Rates for New HIV Cases in Men, 2014 77
Figure 3.26: U.S. Rates for New HIV Cases in Women, 2014 77
Figure 3.27: Proposed HIV Testing Algorithm 86
Figure 3.28: Distribution of HIV Molecular Diagnostic Testing by Purpose 88
Figure 3.29: Estimated Market for Global HIV Molecular Diagnostic Testing, 2011-2020 89
Figure 3.30: Estimated Market for U.S. HIV Molecular Diagnostic Testing, 2011-2020 90
Figure 3.31: Market Share Viral Load HIV Molecular Diagnostic Testing 91
Figure 3.32: Geographic Distribution of Chronic HBV Infection 98
Figure 3.33: Incidence of Acute Hepatitis B by Age Group—U.S., 2000-2011 99
Figure 3.34: Global Prevalence of Hepatitis C 108
Figure 3.35: Primary Causes of Chronic Liver Disease 110
Figure 3.36: Incidence of Acute Hepatitis C by Age Group—U.S., 2000-2011 111
Figure 3.37: Hepatitis C Infection by Source 111
Figure 3.38: Growth and Projections of HCV Therapies by Drug Class, 2008 and 2013 112
Figure 3.39: U.S. Market Share of HCV Molecular Diagnostic Market, 2013 123
Figure 3.40: Global Market Share (Excluding U.S.) of HCV Molecular Diagnostic Market, 2013 124
Figure 3.41: Rate of New Cases and Deaths of Cervical Cancer by Age Group Worldwide, 1980-2010 132
Figure 3.42: Hybrid Capture 2 (HC2) versus PCR—Analytical Sensitivity and Clinical Sensitivity 135
Figure 3.43: Basic Steps in Hybrid Capture 2 Technology 136
Figure 3.44: U.S. Market Share of HPV Molecular Diagnostic Market, 2014 141
Figure 3.45: Global Market Share (Excluding U.S.) of HPV Molecular Diagnostic Market, 2014 141
Figure 3.46: Market Share Estimates for Molecular Diagnostic HPV Testing, 2014 142
Figure 3.47: Number of Reported and Confirmed Cases of Influenza by Virus Sub-Type Worldwide, 2013 155
Figure 3.48: Distribution of H1N1 Flu in the U.S., 2013 156
Figure 3.49: H1N1 Confirmed and Probable Case Rate in the U.S., By Age Group 156
Figure 3.50: U.S. Rates of Sexually Transmitted Diseases, 1940-2012 165
Figure 3.51: U.S. Market Share of Chlamydia/Gonorrhea Molecular Diagnostic Market, 2013 167
Figure 3.52: Global Market Share (Excluding U.S.) of Chlamydia/Gonorrhea Molecular Diagnostic Market,
2013 167
Figure 3.53: Chlamydia Infection Rates: Total and by Gender: U.S., 1989-2012 171
Figure 3.54: Chlamydia U.S. Prevalence by Age Group and Race/Ethnicity 172
Figure 3.55: U.S. and Outlying Areas Gonorrhea Infection Rates, 1941-2012 179
Figure 3.56: U.S. Gonorrhea Infection Rates by Race/Ethnicity, 2007-2012 181
Figure 3.57: Pipeline for TB Diagnostics, 2005-2015 190
Figure 3.58: The Development Pipeline for New TB Drugs, July 2012 191
Figure 3.59: Number of Tuberculosis Cases Among U.S. and Foreign-Born Persons in the U.S.,
1993-2012 191
Figure 3.60: Rate of Tuberculosis Cases Among U.S- and Foreign-Born Persons in the U.S., 1993-2012 192
Figure 3.61: Rate of Tuberculosis Cases by State/Area in the U.S., 2014 193
Figure 3.62: U.S.-Born Tuberculosis Cases by Ethnicity, 2014 194
Figure 3.63: Reported Tuberculosis Cases in the U.S., 1983-2012 199
Figure 3.64: Global Market Share of Tuberculosis Molecular Diagnostic Testing 201
Figure 3.65: Global Market Share of Tuberculosis Molecular Diagnostic Testing by Region, 2014 201
Figure 3.66: Incidence Rates of Invasive MRSA Infections by Age 209
Figure 3.67: MRSA Trends According to Patient Location, 1998-2005 209
Figure 3.68: Incidence of Healthcare-Associated MRSA Infections, 2005-2008 210
Figure 3.69: U.S. Market Share of MRSA Molecular Diagnostic Market, 2014 214
Figure 3.70: Global Market Share (Excluding U.S.) of MRSA Molecular Diagnostic Market, 2014 215
Figure 3.71: Global Frequency of Vancomycin-Resistant Enterococci, 2006 220
Figure 3.72: U.S. Market Share of VRE Molecular Diagnostic Market, 2014 224
Figure 3.73: Estimated Market for Global Blood Screening Product Sales, 2007-2020 240
Figure 3.74: Blood Screening Product Market Share by Company, 2014 242
Figure 4.1: Using DNA Microassays to Measure Gene Expression 247
Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients 248
Figure 4.3: Personalized Medicine in Treatment of Infectious Disease 253
Figure 5.1: FDA Co-Developed Products as a Model for Collaboration 273
Figure 5.2: Market Growth of Molecular Diagnostic Infectious Disease Tests 299
Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision Making 304
Figure 9.1: Global Multidrug Susceptibility in Pseudomonas aeruginosa 345
Figure 9.2: Global Frequency of Vancomycin-Resistant Enterococci, 2006 346


INDEX OF TABLES
Table 1.1: Market Trends in Infectious Disease DNA Testing 22
Table 1.2: Molecular Diagnostics Infectious Disease Market: Market Drivers Ranked in Order of Impact 23
Table 1.3: Molecular Diagnostics Infectious Disease Market: Market Restraints Ranked in Order of
Impact 23
Table 1.4: Strategic Recommendations on Molecular Diagnostic Sector Business Functions 23
Table 2.1: Top Ten Causes of Death Worldwide, 2014 34
Table 2.2: The Most Prevalent Infectious Diseases Worldwide 34
Table 2.3: Annual Rates of Global Infectious Diseases 36
Table 2.4: Emerging Molecular Diagnostic Technologies 40
Table 2.5: Automated Molecular Diagnostics Platforms for Infectious Disease Testing 45
Table 2.6: Companies Marketing Multiple Products in Molecular Diagnostics Infectious Disease Sector 45
Table 2.7: FDA-Approved Molecular Diagnostic Commercial Kits for the Detection of Infectious Agents 47
Table 2.8: Global and U.S. Major Infectious Disease Market Size (Estimated Infected Persons) 47
Table 2.9: Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 48
Table 2.10: Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 48
Table 2.11: Attractive Growth Areas for Molecular Diagnostic Testing 50
Table 2.12: NAT Labs in U.S. and Five European Markets 50
Table 3.1: Global Market for Molecular Diagnostics Testing, 2009-2020 52
Table 3.2: U.S. Market for Molecular Diagnostics Testing, 2009-2020 53
Table 3.3: European Market for Molecular Diagnostics Testing, 2009-2020 53
Table 3.4: Japanese Market for Molecular Diagnostics Testing, 2009-2020 54
Table 3.5: Summary of Molecular Diagnostics Testing Sectors 55
Table 3.6: Share of Molecular Diagnostics Testing by Testing Type, 2014 55
Table 3.7: Key Players and Market Share in Global Molecular Diagnostics Testing Market, 2014 56
Table 3.8: Revenue Model for Molecular Diagnostics Testing 56
Table 3.9: Molecular Infectious Disease Diagnostics Market: Market Drivers Ranked in Order of Impact 58
Table 3.10: Molecular Infectious Disease Diagnostics Market: Market Restraints Ranked in Order of
Impact 58
Table 3.11: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2020 58
Table 3.12: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2020 59
Table 3.13: European Market Revenue for Molecular Diagnostics Testing for Infectious Disease,
2009-2020 61
Table 3.14: Japanese Market Revenue for Molecular Diagnostics Testing for Infectious Disease,
2009-2020 62
Table 3.15: Rest of World (ROW) Market Revenue for Molecular Diagnostics Testing for Infectious Disease,
2009-2020 63
Table 3.16: Molecular Diagnostic Markets for Infectious Disease Testing, 2014 64
Table 3.17: Molecular Diagnostic Markets for Infectious Disease Testing, 2020 66
Table 3.18: Business Factors Influencing Advanced Infectious Disease MDx Testing Services 68
Table 3.19: Global Summary of the HIV/AIDS Epidemic, 2012 72
Table 3.20: Global HIV Statistics, 2012 74
Table 3.21: HIV Resistance Testing Recommendations 78
Table 3.22: Summary of Assays for HIV Viral Load Testing 78
Table 3.23: Commercially Available Molecular Diagnostic Products for HIV Assay 84
Table 3.24: Global Market for Molecular Diagnostic HIV Testing, 2007-2013 88
Table 3.25: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2013 89
Table 3.26: Global Market for Molecular Diagnostic HIV Diagnostic Testing, 2014-2020 90
Table 3.27: U.S. Market for Molecular Diagnostic HIV Diagnostic Testing, 2014-2020 91
Table 3.28: Global Market for HIV Viral Load Diagnostic Testing, 2007-2013 91
Table 3.29: U.S. Market for HIV Viral Load Diagnostic Testing, 2007-2013 92
Table 3.30: Global Market for HIV Viral Load Diagnostic Testing, 2014-2020 92
Table 3.31: U.S. Market for HIV Viral Load Diagnostic Testing, 2014-2020 92
Table 3.32: HIV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 94
Table 3.33: HIV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 94
Table 3.34: Clinical Application of Quantitative HBV DNA Testing 99
Table 3.35: Lower Detection Limits of HBV DNA Assays 101
Table 3.36: Summary of Molecular Diagnostic Assays for Testing HBV 103
Table 3.37: Global Market for HBV Diagnostic Testing, 2000-2013 103
Table 3.38: U.S. Market for HBV Diagnostic Testing, 2000-2013 104
Table 3.39: Global Market for HBV Diagnostic Testing, 2014-2020 104
Table 3.40: U.S. Market for HBV Diagnostic Testing, 2014-2020 104
Table 3.41: HBV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 105
Table 3.42: HBV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 105
Table 3.43: Hepatitis B Facts 107
Table 3.44: U.S. HCV Statistics 112
Table 3.45: Worldwide Rate of HCV Cases 113
Table 3.46: Efficiency of Available HCV Screening Tests 114
Table 3.47: Commercially Available Molecular Diagnostic Products for HCV Assay 121
Table 3.48: Global Market for DNA HCV Diagnostic Testing, 2005-2013 122
Table 3.49: U.S. Market for DNA HCV Diagnostic Testing, 2005-2013 122
Table 3.50: Global Market for NAT HCV Diagnostic Testing, 2014-2020 122
Table 3.51: U.S. Market for NAT HCV Diagnostic Testing, 2014-2020 123
Table 3.52: Major Companies Marketing HCV Molecular Diagnostic Tests: Market Size and Share, 2013 123
Table 3.53: HCV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 124
Table 3.54: HCV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 125
Table 3.55: Recommendations for HCV Diagnostic Testing 128
Table 3.56: Number of Pap Smears Performed by Country, 2014 129
Table 3.57: Number of Deaths from Cervical Cancer by Regionin 2012 131
Table 3.58: Qiagen's Digene HC2 High-Risk HPV DNA Test 134
Table 3.59: Commercially Available Molecular Diagnostic Products for HPV Assay 139
Table 3.60: Major Companies Marketing HPV Molecular Diagnostic Tests: Market Size and Share, 2014 141
Table 3.61: Global Market for HPV Molecular Diagnostic Testing, 2007-2013 145
Table 3.62: U.S. Market for HPV Molecular Diagnostic Testing, 2007-2013 146
Table 3.63: Global Market for HPV Molecular Diagnostic Testing, 2014-2020 146
Table 3.64: U.S. Market for HPV Molecular Diagnostic Testing, 2014-2020 146
Table 3.65: HPV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 147
Table 3.66: HPV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 147
Table 3.67: Commercially Available Molecular Diagnostic Products for Influenza Assay 159
Table 3.68: Global Market for Molecular Influenza Diagnostic Testing, 2007-2013 160
Table 3.69: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2013 160
Table 3.70 Global Market for Influenza Molecular Diagnostic Testing, 2014-2020 160
Table 3.71: U.S. Market for Influenza Molecular Diagnostic Testing, 2014-2020 160
Table 3.72: Influenza Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 161
Table 3.73: Influenza Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 161
Table 3.74: Global Market for Molecular Diagnostic Chlamydia/Gonorrhea Diagnostic Testing,
2000-2014 165
Table 3.75: U.S. Market for Molecular Diagnostic Chlamydia/Gonorrhea Diagnostic Testing, 2000-2014 166
Table 3.76: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic Tests: Market Size and Share, 2013 166
Table 3.77: Global Market for Chlamydia/Gonorrhea Diagnostic Testing, 2015-2020 168
Table 3.78: U.S. Market for Chlamydia/Gonorrhea a Diagnostic Testing, 2015-2020 168
Table 3.79: U.S. Chlamydia Infection Rates, 1985-2012 170
Table 3.80: U.S. Chlamydia Statistics 171
Table 3.81: Commercially Available Molecular Diagnostic Products for Chlamydia Assay 175
Table 3.82: Global Market for Chlamydia Molecular Diagnostic Testing, 2014-2020 175
Table 3.83: U.S. Market for Chlamydia Molecular Diagnostic Testing, 2014-2020 176
Table 3.84: Chlamydia Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 176
Table 3.85: Chlamydia Molecular Diagnostics Market: Market Rest

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