Molecular Diagnostics in Infectious Disease Testing

  • November 2013
  • -
  • TriMark Publications
  • -
  • 405 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

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 36
2.6 Target-Based Gene Amplification 38
2.6.1 Polymerase Chain Reaction 38
2.6.2 Real-Time PCR 38
2.6.3 Nucleic Acid Sequence-Based Amplification 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 45
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 63
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 MDx Reagents 73
3.3.1.4 Method Comparisons 79
3.3.1.5 Market Size 81
3.3.1.6 HIV Market Challenges and Strategic Recommendations 86
3.3.1.7 Market Drivers and Restraints 87
3.3.1.8 Market and Technology Trends 88
3.3.1.9 Strategic Recommendations 89
3.3.2 Hepatitis 89
3.3.2.1 Hepatitis B Virus 90
3.3.2.2 Hepatitis C Virus Testing 100
3.3.3 Human Papillomavirus 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 132
3.3.3.4 HPV Market Size 132
3.3.3.5 Market Challenges and Strategic Recommendations 138
3.3.4 Influenza Viruses 142
3.3.4.1 Disease Background and Statistics 142
3.3.4.2 Instruments and Reagents for Influenza Detection 148
3.3.4.3 Method Comparisons 150
3.3.4.4 Influenza Market Size 150
3.3.4.5 Influenza Market Challenges and Strategic Recommendations 152
3.3.5 STD Testing (Chlamydia/Gonorrhea Molecular Diagnostic Testing) 154
3.3.5.1 Chlamydia/Gonorrhea Molecular Diagnostic Testing Market Size 156
3.3.5.2 Competitive Structure and Market Share Analysis 156
3.3.5.3 Chlamydia Molecular Diagnostic Testing 158
3.3.5.4 Gonorrhea Molecular Diagnostic Testing 168
3.3.6 Tuberculosis 176
3.3.6.1 Disease Background and Description 176
3.3.6.2 Product Analysis: Instruments and Reagents 184
3.3.6.3 Method Comparison 185
3.3.6.4 Tuberculosis Market Size 186
3.3.6.5 Competitive Structure and Market Share Analysis 187
3.3.6.6 Market Forecasts 189
3.3.6.7 Market Challenges 190
3.3.6.8 Market and Technology Trends 191
3.3.6.9 Strategic Recommendations 192
3.3.7 Methicillin-Resistant Staphylococcus aureus (MRSA) 193
3.3.7.1 Disease Background and Description 193
3.3.7.2 Product Analysis: Instruments and Reagents 196
3.3.7.3 Method Comparison 197
3.3.7.4 MRSA Market Size 198
3.3.7.5 Competitive Structure and Market Share Analysis 199
3.3.7.6 Market Forecasts 201
3.3.7.7 Market Challenges 201
3.3.7.8 Market and Technology Trends 202
3.3.7.9 Strategic Recommendations 203
3.3.8 Vancomycin-resistant Enterococci 204
3.3.8.1 Disease Background and Description 204
3.3.8.2 Product Analysis: Instruments and Reagents 206
3.3.8.3 Method Comparison 207
3.3.8.4 Competitive Structure and Market Share Analysis 209
3.3.8.5 Market Forecasts 210
3.3.8.6 Market Challenges 210
3.3.8.7 Market and Technology Trends 211
3.3.8.8 Strategic Recommendations 212
3.3.9 Herpes Simplex Virus 212
3.3.10 C. difficile 212
3.3.11 Cytomegalovirus 213
3.4 Blood Screening 214
3.4.1 Product Analysis: Instruments and Reagents 215
3.4.2 Method Comparison 217
3.4.3 Blood Screening Market Size 218
3.4.4 Competitive Positions 219
3.4.5 Market Challenges and Strategic Recommendations 223
3.4.5.1 Market Drivers and Restraints 223
3.4.5.2 Market and Technology Trends 223
3.4.5.3 Strategic Recommendations 225

4. Molecular Diagnostic Testing Technology for Infectious Disease Testing 226
4.1 Infectious Disease Diagnostic Tests 226
4.1.1 Molecular Diagnostic Tools Solutions 228
4.1.2 Technology of Gene Expression Analysis 228
4.1.2.1 Amplification and Detection of RNA 228
4.1.2.2 Analysis of Multiple Genes 229
4.1.2.3 Advanced Information Technology 230
4.2 Use of Molecular Tests in Infectious Disease 230
4.2.1 Molecular Screening 230
4.2.2 Early Detection 231
4.2.3 Detection of Specific Resistance Genes and Viral Loading Tests 231
4.2.4 Pharmacogenomics and Personalized Medicine in Molecular Diagnostic
Infectious Disease Testing 231
4.2.5 Molecular Strain Typing 233
4.3 Cost of Molecular Diagnostic Testing 234
4.4 Use of Multiplex PCR Tests 235
4.4.1 Advantages of Multiplex PCR 235
4.4.2 Applications of Multiplex PCR 235
4.5 Next-Generation Sequencing 237
4.6 Patient Flow Software 238
4.7 Digital PCR 238
4.8 LAMP 239
4.9 Ion Proton System for Gene Sequencing 239

5. Business 242
5.1 Technology and Market Trends 242
5.1.1 Technology Trends 242
5.2 Mandamp;A Activity 245
5.3 Partnerships 248
5.4 Competitive Analysis 251
5.4.1 Primary Competitors 251
5.4.2 Industry Challenges and Strategic Recommendations 252
5.4.3 Commercialization of Molecular Diagnostic Products 252
5.5 Intellectual Property Rights 253
5.5.1 New Patents 254
5.5.2 Current Patent Disputes 255
5.6 Opportunities and Strategic Recommendations 256
5.6.1 The Key Technical Opportunities with Significant Market Appeal in the
Molecular Diagnostic Space in the Next Five Years 256
5.6.2 Developments for Molecular Diagnostic Instrumentation Products 256
5.6.3 Market Penetration Strategies for Infectious Disease Testing 256
5.7 Business Models and Requirements for a Successful Molecular Diagnostics
Infectious Disease Products Industry 257
5.7.1 Scope of This Section 257
5.7.2 The Success Achieved by the Molecular Diagnostics Infectious Disease
Products 257
5.7.3 Business Models in Molecular Diagnostics Infectious Disease Products 257
5.7.4 SWOT Comparison of Business Models for Molecular Diagnostic Infectious
Disease Testing 258
5.7.5 Commercial Manufacturing of Molecular Diagnostics Infectious Disease
Products: Requirements 272
5.7.5.1 Elements of Commercial Manufacturing 272
5.7.5.2 Contract Manufacturing: Commercial and Academic 273
5.7.6 Sales and Marketing Strategies for Infectious Disease Tests 274
5.8 Companion Diagnostics Development in Partnership with a Pharmaceutical
Company 277
5.8.1 Description of Business Model 277
5.8.2 Anti-Infective Pharmaceutical Market 281

6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for
Infectious Disease 288
6.1 Overview 288
6.1.1 Gap Filling 289
6.2 Trends in Reimbursement Practice 289
6.2.1 Medicare Reimbursement Threats 291
6.2.2 Analysis of ROI for Molecular Diagnostic Tests for Infectious Disease
Using Current Medicare Reimbursement Rules 293
6.3 Trends in Patient Care and Reimbursement 293
6.4 Revenue Threats 295
6.4.1 Medicare Payment Exceptions 296
6.4.2 Three Areas for Denial of Claims 297
6.5 Billing Rules 297
6.5.1 Medicare Billing Procedures 298
6.5.2 Medicare CPT Coding Rules for Molecular Diagnostic Infectious Disease
Testing 298
6.5.3 Infectious Disease Billing Strategies 299

7. Regulatory Requirements 301
7.1 Food and Drug Administration 301
7.2 CLIA Regulations 301
7.3 Clinical Laboratory Improvement Act 303
7.4 State Licensing for Service Laboratories 304
7.5 IVDMIAs 304
7.6 FDA Draft Guidance on In Vitro Companion Diagnostic Devices 305
7.7 510(k) Clearance 305
7.8 Pre-Market Approval 306
7.8.1 Pre-Market Approval Application 306
7.9 Analyte Specific Reagents 307
7.9.1 Laboratory Developed Tests 308
7.10 What Regulatory Guidance is Needed for Companion Biomarkers? 309
7.11 U.S. Patent and Trademark Office 310
7.12 IRB Approval in Clinical Trials 311
7.13 CE Marking and the European In Vitro Diagnostic Device Directive 311
7.14 De Novo Classification 311
7.15 Research Use Only Reagents 311
7.16 FDA Recommendations on MRSA and SA Testing 312

8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease
Testing 316
8.1 What are Key Opportunities in Infectious Disease Testing Development and
Commercialization? 316
8.2 What are the Current Obstacles for Molecular Diagnostic Infectious Disease
Testing
Implementation? 316
8.3 How do Business Strategies, Such as Those Relating to Acquisition, Drive
Molecular Diagnostic Strategies? 317
8.4 How Might Novel Infectious Disease Molecular Diagnostic Test Development
Lead to Acquisition Strategies and Their Implications for Deal Making? 317
8.5 How can Molecular Diagnostic Tests Increase Value in an Associated Drug
Marketing Plan? 318
8.6 Which Types of Infectious Disease Molecular Diagnostic Testing Should be
Developed by Diagnostic Companies at Various Stages in the Development Pipeline?
318
8.7 How can Regulatory Oversight Drive Approval and Adoption of New
Technologies? 319
8.8 What are the Noteworthy Deals? 319
8.9 Who are the Acquirers? 320
8.10 Who are the Target Companies? 320
8.11 How will Platform Technology Companies Enter the Space? 320
8.12 Will Pharma Integrate with Diagnostics? 322
8.13 How do Platform Technology Companies Position Themselves for Diagnostics
Development? 322
8.14 Evaluate How Partnering and Mandamp;As will Alter the Competitive Landscape 323
8.15 Predict How FDA Regulations will Impact New Diagnostic Tests 323
8.16 How can Big Pharma and Diagnostic Companies Co-Develop Biomarkers in a
Model for Regulatory Acceptance? 324
8.17 How to Maximize Business Development Through Biomarker Strategies? 324
8.18 What is the Best Type of Business Model for Developing Genetic Biomarkers
for Infectious
Disease? 325
8.19 How Best have Genetic Biomarkers Provided the Most Benefit in Infectious
Disease Testing? 325
8.20 What are the Most Innovative Methods in Development of Molecular Diagnostic
Biomarkers? 325
8.21 What are the Best Values for Genetic Biomarkers in Drug Development and in
Diagnostics? 326

9. Economics of Anti-Microbial Drug Resistance: The Persistent Need for
Antibacterials 329
9.1 Resistance and Antibiotic Usage 333
9.2 Infection Control Programs 335

10. Company Profiles 336
10.1 Abbott Laboratories 336
10.2 AdvanDx 339
10.3 Arcxis Biotechnologies 340
10.4 Atlas 340
10.5 AutoGenomics, Inc. 341
10.6 Becton, Dickinson and Company 342
10.7 bioMerieux 343
10.8 Biocartis 344
10.9 bioTheranostics 345
10.10 Cepheid 345
10.11 EraGen Biosciences 347
10.12 GenMark Diagnostics, Inc. 347
10.13 Genomix Biotech 348
10.14 Hologic Gen-Probe 349
10.15 Genomica S.A.U. 354
10.16 Great Basin Corporation 355
10.17 Illumina, Inc. 355
10.18 Innogenetics NV 356
10.19 Life Technologies 357
10.20 Mobidiag 360
10.21 Myconostica 360
10.22 Myriad Genetics, Inc. 360
10.23 Nanosphere 362
10.24 NorDiag ASA (The DiaSorin Group) 363
10.25 Qiagen NV 364
10.26 Roche Ltd. 366
10.27 Seegene 368
10.28 SIRS-Lab 368
10.29 TrimGen 369
10.30 TrovaGene 369
10.31 Veredus Laboratories 369
10.32 Veridex 369

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) 371
Appendix 2: Molecular Diagnostic Instruments with Combined Functions - Draft
Guidance for Industry and Food and Drug Administration Staff 394
Appendix 3: Applications for Molecular Testing 399


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 39
Figure 3.1: Global Market for Molecular Diagnostics, 2002-2018 47
Figure 3.2: Global Market for Molecular Diagnostics Testing, 2012 49
Figure 3.3: Share of Molecular Diagnostics Testing by Testing Type, 2012 50
Figure 3.4: Key Players Market Share in Global Molecular Diagnostics Testing
Markets, 2012 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, 2009-2018 54
Figure 3.7: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious
Disease, 2009-2018 55
Figure 3.8: Infectious Disease Testing Revenue Market Share of the Total U.S.
Molecular Diagnostics Market, 2012 and 2018 55
Figure 3.9: European Market Revenue for Molecular Diagnostics Testing for
Infectious Disease, 2009-
2018 56
Figure 3.10: Japanese Market Revenue for Molecular Diagnostics Testing for
Infectious Disease, 2009-
2018 57
Figure 3.11: Rest of World (ROW) Market Revenue for Molecular Diagnostics
Testing for Infectious Disease, 2009-2018 58
Figure 3.12: Infectious Disease Testing Revenue Market Share by Region, 2012 and
2018 58
Figure 3.13: Total Global Infectious Disease Molecular Diagnostics Markets, 2012
59
Figure 3.14: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2012
60
Figure 3.15: Total Global Infectious Disease Molecular Diagnostics Markets, 2018
61
Figure 3.16: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2018
61
Figure 3.17: Global Trend of HIV Infection, 1991-2011 65
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: Ethnic Distribution of AIDS Patients in the U.S., 2011 69
Figure 3.22: Global View of HIV Infection, 2009 70
Figure 3.23: Ten Best Selling AIDS Drugs in the U.S., 2011 70
Figure 3.24: U.S. Rates for New HIV Cases, 2011 71
Figure 3.25: U.S. Rates for New HIV Cases in Men, 2010 71
Figure 3.26: U.S. Rates for New HIV Cases in Women, 2010 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,
2011-2018 83
Figure 3.31: Market Share Viral Load HIV Molecular Diagnostic Testing 84
Figure 3.32: Geographic Distribution of Chronic HBV Infection 91
Figure 3.33: Reported Cases of Acute Hepatitis A, B and C Infections in the
U.S., 2005-2010 92
Figure 3.34: Global Prevalence of Hepatitis C 100
Figure 3.35: Primary Causes of Chronic Liver Disease 102
Figure 3.36: Incidence of Acute Hepatitis C by Age Group — United States,
1992-2009 103
Figure 3.37: Hepatitis C Infection by Source 104
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, 2012 116
Figure 3.40: Global Market Share (Excluding U.S.) of HCV Molecular Diagnostic
Market, 2012 116
Figure 3.41: Rate of New Cases and Deaths of Cervical Cancer by Age Group
Worldwide, 1980-2010 124
Figure 3.42: Hybrid Capture 2 (HC2) versus PCR - Analytical Sensitivity and
Clinical Sensitivity 127
Figure 3.43: Basic Steps in Hybrid Capture 2 Technology 128
Figure 3.44: U.S. Market Share of HPV Molecular Diagnostic Market, 2012 133
Figure 3.45: Global Market Share (Excluding U.S.) of HPV Molecular Diagnostic
Market, 2012 133
Figure 3.46: Market Share Estimates for Molecular Diagnostic HPV Testing, 2012
134
Figure 3.47: Number of Reported and Confirmed Cases of Influenza by Virus
Sub-Type Worldwide, 2013 146
Figure 3.48: Distribution of H1N1 Flu in the U.S., 2013 147
Figure 3.49: H1N1 Confirmed and Probable Case Rate in the U.S., By Age Group 147
Figure 3.50: U.S. Rates of Sexually Transmitted Diseases, 1940-2010 155
Figure 3.51: U.S. Market Share of Chlamydia/Gonorrhea Molecular Diagnostic
Market, 2012 157
Figure 3.52: Global Market Share (Excluding U.S.) of Chlamydia/Gonorrhea
Molecular Diagnostic
Market, 2012 157
Figure 3.53: Chlamydia Infection Rates: Total and by Gender: U.S., 1989-2010 161
Figure 3.54: Chlamydia U.S. Prevalence by Age Group and Race/Ethnicity 162
Figure 3.55: U.S. and Outlying Areas Gonorrhea Infection Rates, 1941-2011 168
Figure 3.56: U.S. Gonorrhea Infection Rates by Race/Ethnicity, 1999-2011 169
Figure 3.57: Pipeline for TB Diagnostics, 2005-2015 178
Figure 3.58: The Development Pipeline for New TB Drugs, July 2012 179
Figure 3.59: Number of Tuberculosis Cases Among U.S.- and Foreign-Born Persons
in the U.S., z
1993-2011 179
Figure 3.60: Rate of Tuberculosis Cases Among U.S.- and Foreign-Born Persons in
the U.S., 1993-2011 180
Figure 3.61: Rate of Tuberculosis Cases by State/Area in the U.S., 2011 181
Figure 3.62: U.S.-Born Tuberculosis Cases by Ethnicity, 2011 182
Figure 3.63: Reported Tuberculosis Cases in the U.S., 1983-2011 186
Figure 3.64: Global Market Share of Tuberculosis Molecular Diagnostic Testing
187
Figure 3.65: Global Market Share of Tuberculosis Molecular Diagnostic Testing by
Region, 2012 188
Figure 3.66: Incidence Rates of Invasive MRSA Infections by Age 195
Figure 3.67: MRSA Trends According to Patient Location, 1998-2005 195
Figure 3.68: Incidence of Healthcare-Associated MRSA Infections, 2005-2008 196
Figure 3.69: U.S. Market Share of MRSA Molecular Diagnostic Market, 2012 200
Figure 3.70: Global Market Share (Excluding U.S.) of MRSA Molecular Diagnostic
Market, 2012 200
Figure 3.71: Global Frequency of Vancomycin-Resistant Enterococci, 2006 206
Figure 3.72: U.S. Market Share of VRE Molecular Diagnostic Market, 2012 209
Figure 3.73: Estimated Market for Global Blood Screening Product Sales,
2007-2019 219
Figure 3.74: Blood Screening Product Market Share by Company, 2012 221
Figure 4.1: Using DNA Microassays to Measure Gene Expression 226
Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in
Patients 227
Figure 4.3: Schematic of Molecular Diagnostics for Studying Gene Expression in
Patients 232
Figure 5.1: FDA Co-developed Products as a Model for Collaboration 249
Figure 5.2: Market Growth of Molecular Diagnostic Infectious Disease Tests 275
Figure 5.3: Segmentation of the Biomarker Development Market 279
Figure 5.4: Global Distribution of Anti-infective Agent Sales by Geography 282
Figure 5.5: Leading Companies in Anti-infectives Market Share, 2011 283
Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision Making 290
Figure 9.1: Global Multidrug Susceptibility in Pseudomonas aeruginosa 331
Figure 9.2: Global Frequency of Vancomycin-Resistant Enterococci, 2006 332


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 31
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 37
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 40
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, 2002-2018 47
Table 3.2: U.S. Market for Molecular Diagnostics Testing, 2004-2018 48
Table 3.3: European Market for Molecular Diagnostics Testing, 2005-2018 48
Table 3.4: Japanese Market for Molecular Diagnostics Testing, 2009-2018 49
Table 3.5: Summary of Molecular Diagnostics Testing Sectors 50
Table 3.6: Share of Molecular Diagnostics Testing by Testing Type, 2012 50
Table 3.7: Key Players and Market Share in Global Molecular Diagnostics Testing
Market 2012 51
Table 3.8: Revenue Model for Molecular Diagnostics Testing 51
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, 2009-2018 53
Table 3.12: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious
Disease, 2009-2018 54
Table 3.13: European Market Revenue for Molecular Diagnostics Testing for
Infectious Disease, 2009-2018 56
Table 3.14: Japanese Market Revenue for Molecular Diagnostics Testing for
Infectious Disease, 2009-2018 56
Table 3.15: Rest of World (ROW) Market Revenue for Molecular Diagnostics Testing
for Infectious Disease, 2009-2018 57
Table 3.16: Molecular Diagnostic Markets for Infectious Disease Testing, 2012 59
Table 3.17: Molecular Diagnostic Markets for Infectious Disease Testing, 2018 60
Table 3.18: Business Factors Influencing Advanced Infectious Disease MDx Testing
Services 62
Table 3.19: Global Summary of the HIV/AIDS Epidemic, 2011 66
Table 3.20: Global HIV Statistics, 2011 69
Table 3.21: HIV Resistance Testing Recommendations 72
Table 3.22: Summary of Assays for HIV Viral Load Testing 73
Table 3.23: Commercially Available Molecular Diagnostic Products for HIV Assay
79
Table 3.24: Global Market for Molecular Diagnostic HIV Testing, 2007-2012 82
Table 3.25: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2012 83
Table 3.26: Global Market for Molecular Diagnostic HIV Diagnostic Testing,
2013-2018 84
Table 3.27: U.S. Market for Molecular Diagnostic HIV Diagnostic Testing,
2013-2018 84
Table 3.28: Global Market for HIV Viral Load Diagnostic Testing, 2007-2012 85
Table 3.29: U.S. Market for HIV Viral Load Diagnostic Testing, 2007-2012 85
Table 3.30: Global Market for HIV Viral Load Diagnostic Testing, 2013-2018 85
Table 3.31: U.S. Market for HIV Viral Load Diagnostic Testing, 2013-2018 86
Table 3.32: HIV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 87
Table 3.33: HIV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 87
Table 3.34: Clinical Application of Quantitative HBV DNA Testing 92
Table 3.35: Lower Detection Limits of HBV DNA Assays 94
Table 3.36: Summary of Molecular Diagnostic Assays for Testing HBV 96
Table 3.37: Global Market for HBV Diagnostic Testing, 2000-2012 96
Table 3.38: U.S. Market for HBV Diagnostic Testing, 2000-2012 96
Table 3.39: Global Market for HBV Diagnostic Testing, 2013-2018 97
Table 3.40: U.S. Market for HBV Diagnostic Testing, 2013-2018 97
Table 3.41: HBV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 97
Table 3.42: HBV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 98
Table 3.43: Hepatitis B Facts 99
Table 3.44: U.S. HCV Statistics 105
Table 3.45: Worldwide Rate of HCV Cases 105
Table 3.46: Efficiency of Available HCV Screening Tests 106
Table 3.47: Commercially Available Molecular Diagnostic Products for HCV Assay
113
Table 3.48: Global Market for DNA HCV Diagnostic Testing, 2005-2012 114
Table 3.49: U.S. Market for DNA HCV Diagnostic Testing, 2005-2012 114
Table 3.50: Global Market for NAT HCV Diagnostic Testing, 2013-2018 115
Table 3.51: U.S. Market for NAT HCV Diagnostic Testing, 2013-2018 115
Table 3.52: Major Companies Marketing HCV Molecular Diagnostic Tests: Market
Size and Share, 2012 115
Table 3.53: HCV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 117
Table 3.54: HCV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 117
Table 3.55: Recommendations for HCV Diagnostic Testing 120
Table 3.56: Number of Pap Smears Performed by Country, 2009 121
Table 3.57: Deaths in Thousands from Cervical Cancer by Region and by Age Group
in 2011 123
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, 2012 133
Table 3.61: Global Market for HPV Molecular Diagnostic Testing, 2007-2012 137
Table 3.62: U.S. Market for HPV Molecular Diagnostic Testing, 2007-2012 137
Table 3.63: Global Market for HPV Molecular Diagnostic Testing, 2013-2018 137
Table 3.64: U.S. Market for HPV Molecular Diagnostic Testing, 2013-2018 137
Table 3.65: HPV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 138
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 150
Table 3.68: Global Market for Molecular Influenza Diagnostic Testing, 2007-2012
150
Table 3.69: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2012 151
Table 3.70 Global Market for Influenza Molecular Diagnostic Testing, 2013-2018
151
Table 3.71: U.S. Market for Influenza Molecular Diagnostic Testing, 2013-2018
151
Table 3.72: Influenza Molecular Diagnostics Market: Market Drivers Ranked in
Order of Impact 152
Table 3.73: Influenza Molecular Diagnostics Market: Market Restraints Ranked in
Order of Impact 152
Table 3.74: Global Market for Molecular Diagnostic Chlamydia/Gonorrhea
Diagnostic Testing, 2000-2012 156
Table 3.75: U.S. Market for Molecular Diagnostic Chlamydia/Gonorrhea Diagnostic
Testing, 2000-2012 156
Table 3.76: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic
Tests: Market Size and Share, 2012 157
Table 3.77: Global Market for Chlamydia/Gonorrhea Diagnostic Testing, 2013-2018
158
Table 3.78: U.S. Market for Chlamydia/Gonorrhea a Diagnostic Testing, 2013-2018
158
Table 3.79: U.S. Chlamydia Infection Rates, 1985-2011 160
Table 3.80: U.S. Chlamydia Statistics 161
Table 3.81: Commercially Available Molecular Diagnostic Products for Chlamydia
Assay 164
Table 3.82: Global Market for Chlamydia Molecular Diagnostic Testing, 2012-2018
165
Table 3.83: U.S. Market for Chlamydia Molecular Diagnostic Testing, 2012-2018
165
Table 3.84: Chlamydia Molecular Diagnostics Market: Market Drivers Ranked in
Order of Impact 165
Table 3.85: Chlamydia Molecular Diagnostics Market: Market Restraints Ranked in
Order of Impact 166
Table 3.86: U.S. Gonorrhea Statistics 170
Table 3.87: Commercially Available Molecular Diagnostic Products for Gonorrhea
Assay 173
Table 3.88: Major Companies Marketing /Gonorrhea Molecular Diagnostic Tests:
Market Size and Share, 2012 174
Table 3.89: Gonorrhea Molecular Diagnostics Market: Market Drivers Ranked in
Order of Impact 174
Table 3.90: Gonorrhea Molecular Diagnostics Market: Market Restraints Ranked in
Order of Impact 175
Table 3.91: Commercially Available Molecular Diagnostic Assays for Testing TB
185
Table 3.92: Global Market for Tuberculosis Molecular Diagnostic Testing,
2005-2012 186
Table 3.93: U.S. Market for Tuberculosis Molecular Diagnostic Testing, 2005-2012
187
Table 3.94: Global Market Share of Tuberculosis Molecular Diagnostic Testing by
Region, 2012 187
Table 3.95: Global Unit Sales of Tuberculosis Molecular Diagnostic Testing by
Region, 2012 188
Table 3.96: Comparative U.S. Claim Charges for TB Testing by Type, 2012 189
Table 3.97: Global Testing for TB by Testing Type, 2012 189
Table 3.98: Global Testing for TB by Testing Reason, 2012 189
Table 3.99: Global Market for Tuberculosis Molecular Diagnostic Testing,
2013-2018 189
Table 3.100: U.S. Market for Tuberculosis Molecular Diagnostic Testing,
2013-2018 190
Table 3.101: Tuberculosis Molecular Diagnostics Market: Market Drivers Ranked in
Order of Impact 190
Table 3.102: Tuberculosis Molecular Diagnostics Market: Market Restraints Ranked
in Order of Impact 190
Table 3.103: Leading Tuberculosis Therapeutic Randamp;D Candidates 193
Table 3.104: Commercially Available Molecular Diagnostic Products for MRSA Assay
198
Table 3.105: Global Market for MRSA Diagnostic Testing, 2005-2012 198
Table 3.106: U.S. Market for MRSA Diagnostic Testing, 2005-2012 199
Table 3.107: Major Companies Marketing MRSA Molecular Diagnostic Tests: Market
Size and Share, 2012 199
Table 3.108: Global Market for MRSA Molecular Diagnostic Testing, 2013-2018 201
Table 3.109: U.S. Market for MRSA Molecular Diagnostic Testing, 2013-2018 201
Table 3.110: MRSA Molecular Diagnostics Market: Market Drivers Ranked in Order
of Impact 201
Table 3.111: MRSA Molecular Diagnostics Market: Market Restraints Ranked in
Order of Impact 202
Table 3.112: In Vitro Susceptibility of Staphylococci to New Agents in
Development 204
Table 3.113: Commercially Available Molecular Diagnostic Products for VRE Assay
208
Table 3.114: Global Market for VRE Diagnostic Testing, 2005-2012 208
Table 3.115: U.S. Market for VRE Diagnostic Testing, 2005-2012 209
Table 3.116: Major Companies Marketing VRE Molecular Diagnostic Tests: Market
Size and Share, 2012 209
Table 3.117: Global Market for VRE Molecular Diagnostic Testing, 2013-2018 210
Table 3.118: U.S. Market for VRE Molecular Diagnostic Testing, 2013-2018 210
Table 3.119: VRE Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 210
Table 3.120: VRE Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 211
Table 3.121: Transmission-related Disease Screening from Blood Donor Pools 214
Table 3.122: Principal Blood Screening Products of Hologic Gen-Probe for HIV
Assay 216
Table 3.123: Global Market for Molecular Diagnostics in Blood Screening,
2007-2019 218
Table 3.124: U.S. Market for Molecular Diagnostics in Blood Screening, 2007-2019
219
Table 3.125: Major Companies Marketing Blood Screening Molecular Diagnostic
Tests: Market Size and Share, 2012 220
Table 3.126: Blood Screening Molecular Diagnostics Market: Market Drivers Ranked
in Order of Impact 223
Table 3.127: Blood Screening Molecular Diagnostics Market: Market Restraints
Ranked in Order of Impact 223
Table 4.1: Key Elements for Business Competition in Molecular Diagnostic Testing
for Infectious Disease 230
Table 4.2: Key Elements for Future Success in Molecular Testing for Infectious
Disease 230
Table 4.3: Examples of Personal

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5 Companies

Company Profiles

Roche Holding AG

Switzerland

BD Biosciences

United States

Life Technologies Corp.

United States

Beckman Coulter Inc.

United States

Promega Corp.

United States

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