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Molecular Diagnostics in Infectious Disease Testing

  • May 2016
  • -
  • TriMark Publications
  • -
  • 265 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 11

1.1 Statement of Report 11

1.2 About This Report 12

1.3 Scope of the Report 12

1.4 Objectives 14

1.5 Methodology 14

1.6 Executive Summary 16



2. Introduction to Molecular Diagnostics for Infectious Disease Testing 26

2.1 Molecular Diagnostics Testing and Opportunities in the Infectious Disease
Sector 26

2.2 The Infectious Disease Problem 29

2.3 Impact of the Human Genome Project on Molecular Diagnostics 32

2.4 Opportunities for Molecular and Clinical Diagnostics 32

2.4.1 Companion Diagnostics 34

2.5 Development of Molecular Diagnostics Testing Markets 34

2.6 Molecular Diagnostics Testing Technologies and Platforms 35

2.6.1 Amplification Technologies 35

2.6.1.1 PCR and PCR Derivative Platforms 36

2.6.1.2 Multiple Displacement Amplification 41

2.6.1.3 Multiple Annealing and Looping-Based Amplification Cycles 42

2.6.1.4 Whole Genome Amplification 42

2.6.1.5 Nucleic Acid Sequence-Based Amplification 42

2.6.2 Detection of Amplified Gene Products 43

2.6.2.1 High Resolution Melting Analysis 44

2.6.2.2 Microparticle-Based Flow Cytometry 44

2.6.3 DNA and Oligonucleotide Microarrays and Chips 44

2.6.3.1 Array Comparative Genomic Hybridization 47

2.6.4 Gene Sequencing 47

2.6.4.1 Sanger Sequencing 47

2.6.4.2 Next Generation Sequencing 48

2.6.5 Fluorescence In situ Hybridization 53

2.6.6 PCR Reagents for Clinical Diagnostics 54

2.7 Molecular Diagnostics Technologies for Infectious Disease Testing 54

2.8 Market Drivers and Restraints for Molecular Diagnostics of Infectious
Diseases 59

2.8.1 Market Drivers 59

2.8.2 Market Restraints 59

2.9 Market and Technology Trends 60

2.9.1 Market Trends 60

2.9.2 Technology Trends 60

2.10 Strategic Recommendations 61



3. Infectious Disease Diagnostics Molecular Testing Market 62

3.1 Molecular Diagnostics Market Overview 62

3.1.2 Overall Infectious Disease Market Analysis 67

3.2 Molecular Testing for Infectious Disease Diagnostics Market 67

3.3 Infectious Disease Molecular Diagnostic Testing Market Segments 79

3.3.1 HIV 79

3.3.1.1 Disease Background and Statistics 79

3.3.1.2 Overview of HIV Testing Methods 82

3.3.1.2.1 Clinical Diagnostic Screening Tests for HIV 84

3.3.1.2.2 HIV Monitoring Tests 84

3.3.1.2.3 Measuring Viral Loads 84

3.3.1.2.4 Genotyping Assays 85

3.3.1.2.5 Phenotyping Assays 85

3.3.1.3 Instruments and MDx Reagents 87

3.3.1.3.1 Abbott Molecular 87

3.3.1.3.2 Alere (becoming part of Abbott) 89

3.3.1.3.3 Beckman Coulter 89

3.3.1.3.4 bioMerieux 90

3.3.1.3.5 Cepheid 90

3.3.1.3.6 Grifols 91

3.3.1.3.7 Hologic 91

3.3.1.3.8 Qiagen 92

3.3.1.3.9 Roche Diagnostics 92

3.3.1.3.10 Siemens Healthcare Diagnostics 95

3.3.1.3.11 LabCorp 96

3.3.1.4 Market Size 96

3.3.1.4.1 HIV Diagnostic Testing 97

3.3.1.5 HIV Market Challenges and Strategic Recommendations 99

3.3.1.5.1 HIV Molecular Diagnostic Market History 99

3.3.1.6 Market Drivers and Restraints 101

3.3.1.6.1 Market Drivers 101

3.3.1.6.2 Market Restraints 101

3.3.1.7 Market and Technology Trends 101

3.3.1.7.1 Market Trends 101

3.3.1.7.2 Technology Trends 102

3.3.1.8 Strategic Recommendations 102

3.3.2 Hepatitis 103

3.3.2.1 Hepatitis B Virus 104

3.3.2.1.1 Hepatitis B Disease Background and Statistics 104

3.3.2.1.2 Clinical Applications of HBV MDx Testing 105

3.3.2.1.3 MDx Instruments and Reagents for Hepatitis B Detection 106

3.3.2.1.3.1 Abbott 107

3.3.2.1.3.2 Beckman Coulter 108

3.3.2.1.3.3 Grifols 108

3.3.2.1.3.4 Hologic 109

3.3.2.1.3.5 Roche 109

3.3.2.1.3.6 Siemens 109

3.3.2.1.4 Hepatitis B Market Size 110

3.3.2.1.5 HBV Market Challenges and Strategic Recommendations 111

3.3.2.1.5.1 Market Drivers and Restraints 111

3.3.2.1.5.1.1 Market Drivers 111

3.3.2.1.5.1.2 Market Restraints 111

3.3.2.1.6 Market and Technology Trends 111

3.3.2.1.6.1 Market Trends 111

3.3.2.1.6.2 Technology Trends 112

3.3.2.1.7 Strategic Recommendations 112

3.3.2.2 Hepatitis C Virus Testing 112

3.3.2.2.1 Disease Background and Statistics 112

3.3.2.2.2 Instruments and Reagents for Hepatitis C Detection 118

3.3.2.2.2.1 Roche 119

3.3.2.2.2.2 Grifols 120

3.3.2.2.2.3 Siemens 121

3.3.2.2.2.4 Hologic 121

3.3.2.2.2.5 Abbott 122

3.3.2.2.2.6 Beckman Coulter 122

3.3.2.2.2.7 Cepheid 122

3.3.2.2.3 Hepatitis C Market Size 123

3.3.2.2.3.1 HCV Market Share 123

3.3.2.2.4 HCV Market Challenges and Strategic Recommendations 124

3.3.2.2.4.1 Market Drivers and Restraints 124

3.3.2.2.4.1.1 Market Drivers 124

3.3.2.2.4.1.2 Market Restraints 125

3.3.2.2.4.2 Market and Technology Trends 125

3.3.2.2.4.2.1 Market Trends 125

3.3.2.2.4.2.2 Technology Trends 126

3.3.2.2.5 Strategic Recommendations 127

3.3.3 Human Papillomavirus 127

3.3.3.1 Disease Background and Statistics 127

3.3.3.2 Instruments and Reagents for HPV Detection 130

3.3.3.2.1 Hologic 131

3.3.3.2.2 Qiagen 132

3.3.3.2.3 Roche 134

3.3.3.2.4 Cepheid 135

3.3.3.2.5 AutoGenomics 135

3.3.3.2.6 incellDx 135

3.3.3.2.7 Fujirebio 136

3.3.3.2.8 Greiner Bio-one 136

3.3.3.2.9 Becton Dickinson 136

3.3.3.3 HPV Market Size 136

3.3.3.4 Market Challenges and Strategic Recommendations 138

3.3.3.4.1 Market Drivers and Restraints 138

3.3.3.4.1.1 Market Drivers 138

3.3.3.4.1.2 Market Restraints 138

3.3.3.4.2 Market and Technology Trends 138

3.3.3.4.2.1 Market Trends 138

3.3.3.4.2.2 Technology Trends 140

3.3.3.4.3 Strategic Recommendations 140

3.3.4 Influenza Viruses 140

3.3.4.1 Disease Background and Statistics 140

3.3.4.2 Instruments and Reagents for Influenza Detection 143

3.3.4.2.1 Quest Diagnostics 143

3.3.4.2.2 bioMerieux 144

3.3.4.2.3 Cepheid 144

3.3.4.2.4 Hologic 144

3.3.4.2.5 Quidel 145

3.3.4.2.6 Veredus Laboratories 145

3.3.4.2.7 Alere (bought by Abbott) 145

3.3.4.2.8 Luminex 145

3.3.4.2.9 GenMark Diagnostic 146

3.3.4.2.10 Nanosphere 146

3.3.4.2.11 Roche 146

3.3.4.3 Influenza Market Size 146

3.3.4.4 Influenza Market Challenges and Strategic Recommendations 147

3.3.4.4.1 Market Drivers and Restraints 147

3.3.4.4.1.1 Market Drivers 147

3.3.4.4.1.2 Market Restraints 147

3.3.4.4.2 Market and Technology Trends 148

3.3.4.4.2.1 Market Trends 148

3.3.4.4.2.2 Technology Trends 148

3.3.4.4.3 Strategic Recommendations 150

3.3.5 STD Testing (including Chlamydia/Gonorrhea Molecular Diagnostic Testing)
150

3.3.5.1 Disease Backgrounds and STD Statistics 150

3.3.5.1.1 Chlamydia Disease Background and Statistics 152

3.3.5.1.2 Gonorrhea Disease Background and Statistics 153

3.3.5.1.3 Other STD Background and Statistics 155

3.3.5.1.3.1 Herpes Simplex Virus 155

3.3.5.1.3.2 Trichomoniasis 155

3.3.5.2 Instruments and Reagents for STD Detection 156

3.3.5.2.1 Becton Dickinson 156

3.3.5.2.2 Roche Diagnostics 157

3.3.5.2.3 Quest 157

3.3.5.2.4 Hologic 158

3.3.5.2.5 Siemens Healthcare 158

3.3.5.2.6 Abbott 159

3.3.5.2.7 Cepheid 159

3.3.5.2.8 Quidel 159

3.3.5.2.9 Luminex 160

3.3.5.2.10 Qiagen 160

3.3.5.3 Global STD (including Chlamydia/Gonorrhea) Molecular Diagnostic Testing
Market 161

3.3.5.3.1 Competitive Structure and Market Share Analysis 161

3.3.5.3.1.1 Market Challenges 162

3.3.5.3.1.2 Market Restraints 162

3.3.5.3.2 Market and Technology Trends 162

3.3.5.3.2.1 Market Trends 162

3.3.5.3.2.2 Technology Trends 163

3.3.5.3.2.3 Strategic Recommendations 163

3.3.6 Tuberculosis 164

3.3.6.1 Disease Background and Description 164

3.3.6.2 Product Analysis: Instruments and Reagents 167

3.3.6.2.1 Veredus Laboratories 167

3.3.6.2.2 Abbott 167

3.3.6.2.3 Seegene 168

3.3.6.2.4 Cepheid 168

3.3.6.3 Method Comparison 168

3.3.6.4 Tuberculosis Market Size 169

3.3.6.5 Competitive Structure and Market Share Analysis 170

3.3.6.6 Market Challenges 171

3.3.6.6.1 Market Drivers 171

3.3.6.6.2 Market Restraints 171

3.3.6.7 Market and Technology Trends 171

3.3.6.7.1 Market Trends 171

3.3.6.7.2 Technology Trends 172

3.3.6.8 Strategic Recommendations 172

3.3.7 Methicillin-Resistant Staphylococcus aureus (MRSA) 173

3.3.7.1 Disease Background and Description 173

3.3.7.2 Product Analysis: Instruments and Reagents 174

3.3.7.2.1 Cepheid 174

3.3.7.2.2 Roche 175

3.3.7.2.3 Becton Dickinson 175

3.3.7.2.4 Molecular Detection, Inc. (MDI) 176

3.3.7.3 MRSA Market Size 176

3.3.7.4 Competitive Structure and Market Share Analysis 177

3.3.7.5 Market Challenges 178

3.3.7.5.1 Market Drivers 178

3.3.7.5.2 Market Restraints 178

3.3.7.6 Market and Technology Trends 178

3.3.7.6.1 Market Trends 178

3.3.7.7 Strategic Recommendations 179

3.3.8 Vancomycin-Resistant Enterococci 180

3.3.8.1 Disease Background and Description 180

3.3.8.2 Assay Kits 182

3.3.9 C. difficile 182

3.3.9.1 Product Analysis: Instruments and Reagents 182



4. Molecular Diagnostic Testing Technology for Infectious Disease Testing 185

4.1 Infectious Disease Diagnostic Tests 185

4.1.1 Molecular Diagnostic Tools Solutions 187

4.1.2 Technology of Gene Expression Analysis 187

4.1.2.1 Amplification and Detection of RNA 187

4.1.2.2 Analysis of Multiple Genes 188

4.1.2.3 Advanced Information Technology 188

4.2 Use of Molecular Tests in Infectious Disease 189

4.2.1 Molecular Screening 189

4.2.2 Early Detection 189

4.2.3 Detection of Specific Resistance Genes and Viral Loading Tests 189

4.2.4 Pharmacogenomics and Personalized Medicine in Molecular Diagnostic
Infectious Disease

Testing 190

4.2.5 Molecular Strain Typing 191

4.3 Cost of Molecular Diagnostic Testing 193

4.4 Use of Multiplex PCR Tests 194

4.4.1 Advantages of Multiplex PCR 194

4.4.2 Applications of Multiplex PCR 194

4.5 Next-Generation Sequencing 194

4.6 Patient Flow Software 196

4.7 LAMP 196

4.8 Ion Proton System for Gene Sequencing 196

4.9 xMap Technology (Luminex) 197

4.10 The Invader® Chemistry Platform (Hologic) 198



5. Business 200

5.1 Technology and Market Trends 200

5.1.1 Technology Trends 200

5.1.2 Market Trends and Financial Considerations 203

5.2 Mandamp;A Activity 204

5.3 Partnerships 205

5.4 Competitive Analysis 206

5.4.1 Primary Competitors 206

5.4.2 Industry Challenges and Strategic Recommendations 207

5.4.3 Commercialization of Molecular Diagnostic Products 208

5.5 Intellectual Property Rights 208

5.5.1 Patents 209

5.6 Opportunities and Strategic Recommendations 210

5.6.1 The Key Technical Opportunities with Significant Market Appeal in the
Molecular Diagnostic Space in the Next Five Years 210

5.6.2 Developments for Molecular Diagnostic Instrumentation Products 211

5.6.3 Market Penetration Strategies for Infectious Disease Testing 211

5.7 Commercial Manufacturing of Molecular Diagnostics Infectious Disease
Products: Requirements 211

5.7.1 Elements of Commercial Manufacturing 211

5.7.1.1 Regulatory Requirements 211

5.7.1.2 Manufacturing Process Scale 212

5.7.1.3 In-House Manufacturing 212

5.7.2 Contract Manufacturing: Commercial and Academic 213

5.7.3 Sales and Marketing Strategies for Infectious Disease Tests 214



6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for
Infectious Disease 217

6.1 Overview 217

6.1.1 Gap Filling 217

6.2 Trends in Reimbursement Practice 218

6.2.1 Medicare Reimbursement Threats 219

6.2.2 Analysis of ROI for Molecular Diagnostic Tests for Infectious Disease
Using Current Medicare Reimbursement Rules 220

6.3 Trends in Patient Care and Reimbursement 221

6.4 Revenue Threats 222

6.4.1 Medicare Payment Exceptions 223

6.4.2 Three Areas for Denial of Claims 224

6.5 Billing Rules 224

6.5.1 Medicare Billing Procedures 225



7. Regulatory Requirements 226

7.1 Food and Drug Administration 226

7.2 CLIA Regulations 226

7.3 Clinical Laboratory Improvement Act 227

7.4 State Licensing for Service Laboratories 228

7.5 IVDMIAs 228

7.6 FDA Draft Guidance on In Vitro Companion Diagnostic Devices 230

7.7 510(k) Clearance 230

7.8 Pre-Market Approval 231

7.8.1 Pre-Market Approval Application 231

7.9 Analyte Specific Reagents 232

7.9.1 Laboratory Developed Tests 233

7.10 What Regulatory Guidance is Needed for Companion Biomarkers? 234

7.11 U.S. Patent and Trademark Office 235

7.12 IRB Approval in Clinical Trials 235

7.13 CE Marking and the European In Vitro Diagnostic Device Directive 236

7.14 De Novo Classification 236

7.15 Research Use Only Reagents 236

7.16 FDA Recommendations on MRSA and SA Testing 236

7.17 FDA Guidance on Molecular Diagnostic Instruments with Combined Functions
237



8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease
Testing 240

8.1 What are Key Opportunities in Infectious Disease Testing Development and
Commercialization? 240

8.2 What are the Current Obstacles for Molecular Diagnostic Infectious Disease
Testing Implementation? 240

8.3 How do Business Strategies, Such as Those Relating to Acquisition, Drive
Molecular Diagnostic Strategies? 240

8.4 How might Novel Infectious Disease Molecular Diagnostic Test Development
Lead to Acquisition Strategies and their Implications for Deal Making? 241

8.5 How can Molecular Diagnostic Tests Increase Value in an Associated Drug
Marketing Plan? 241

8.6 Which Types of Infectious Disease Molecular Diagnostic Testing should be
Developed by Diagnostic Companies at Various Stages in the Development Pipeline?
242

8.7 How can Regulatory Oversight Drive Approval and Adoption of New
Technologies? 242

8.8 How will Platform Technology Companies Enter the Space? 242

8.9 Will Pharma Integrate with Diagnostics? 243

8.10 How do Platform Technology Companies Position Themselves for Diagnostics
Development? 244

8.11 Evaluate How Partnering and Mandamp;As will Alter the Competitive Landscape 244

8.12 How can Big Pharma and Diagnostic Companies Co-Develop Biomarkers in a
Model for Regulatory Acceptance? 245

8.13 How to Maximize Business Development Through Biomarker Strategies? 245

8.14 What is the Best Type of Business Model for Developing Genetic Biomarkers
for Infectious Disease? 246

8.15 How Best have Genetic Biomarkers Provided the Most Benefit in Infectious
Disease Testing? 246

8.16 What are the Most Innovative Methods in Development of Molecular Diagnostic
Biomarkers? 246

8.17 What are the Best Values for Genetic Biomarkers in Drug Development and in
Diagnostics? 246



9. Economics of Anti-Microbial Drug Resistance: The Persistent Need for
Antibacterials 248

9.1 Resistance and Antibiotic Usage 250

9.2 Infection Control Programs 252



10. Company Profiles 253

10.1 Abbott Laboratories 253

10.2 AdvanDx 254

10.3 Affymetrix 254

10.4 AutoGenomics, Inc. 255

10.5 Beckman Coulter 256

10.6 Becton, Dickinson and Company 256

10.7 bioMerieux 257

10.8 Cepheid 257

10.9 GenMark Diagnostics, Inc. 258

10.10 Genomica S.A.U. 258

10.11 Great Basin Corporation 259

10.12 Grifols 259

10.13 Hologic 259

10.14 Illumina, Inc. 260

10.15 Luminex Corp. 261

10.16 Nanosphere 262

10.17 Qiagen N.V. 263

10.18 Quidel 264

10.19 Roche Diagnostics (Roche Ltd.) 265

10.20 Siemens AG 265

10.21 Veredus Laboratories 266





INDEX OF FIGURES



Figure 2.1: Relationship of DNA Testing to Key Areas of Clinical Diagnosis 26

Figure 2.2: Finding Genes with Microassays 27

Figure 2.3: The Use of Microassays for Studying Gene Expression 28

Figure 2.4: Overall Structure of Nucleic Acid Testing Market 33

Figure 2.5: The PCR Cycle 36

Figure 2.6: Multiple Displacement Amplification 41

Figure 2.7: Using DNA Microassays to Measure Gene Expression 46

Figure 3.1: Global Market for Molecular Diagnostics, 2012-2020 62

Figure 3.2: Global Market for Molecular Diagnostics Testing, 2015 64

Figure 3.3: Share of Molecular Diagnostics Testing by Testing Type, 2015 65

Figure 3.4: Key Players Market Share in Global Molecular Diagnostics Testing
Markets, 2015 66

Figure 3.5: Global Revenue for Molecular Diagnostics Testing for Infectious
Disease, 2012-2020 68

Figure 3.6: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious
Disease, 2012-2020 69

Figure 3.7: Infectious Disease Testing Revenue Market Share of the Total U.S.
Molecular Diagnostics Market,

2010 and 2020 70

Figure 3.8: European Market Revenue for Molecular Diagnostics Testing for
Infectious Disease,

2012-2020 71

Figure 3.9: Japanese Market Revenue for Molecular Diagnostics Testing for
Infectious Disease,

2012-2020 72

Figure 3.10: Rest of World (ROW) Market Revenue for Molecular Diagnostics
Testing for Infectious Disease,

2012-2020 73

Figure 3.11: Infectious Disease Testing Revenue Market Share by Region, 2015 73

Figure 3.12: Total Global Infectious Disease Molecular Diagnostics Markets, 2015
74

Figure 3.13: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2015
75

Figure 3.14: Total Global Infectious Disease Molecular Diagnostics Markets, 2020
76

Figure 3.15: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2020
77

Figure 3.16: Global Population Living with HIV, 2001-2014 79

Figure 3.17: Global View of HIV Infection, 2013 80

Figure 3.18: Top Selling AIDS Drugs, 2014 82

Figure 3.19: CDC Recommendations for HIV Testing in Laboratories, 2014 83

Figure 3.20: Distribution of HIV Molecular Diagnostic Testing by Purpose 97

Figure 3.21: Estimated Market for Global HIV Molecular Diagnostic Testing,
2014-2020 98

Figure 3.22: Estimated Market for U.S. HIV Molecular Diagnostic Testing,
2014-2020 98

Figure 3.23: Global Market Share Viral Load HIV Molecular Diagnostic Testing 99

Figure 3.24: Geographic Distribution of Chronic HBV Infection 105

Figure 3.25: Global Prevalence of Hepatitis C 113

Figure 3.26: Incidence of Acute Hepatitis C in the U.S., 1982-2013 114

Figure 3.27: Primary Causes of Chronic Liver Disease 116

Figure 3.28: Global Market Share of HCV Molecular Diagnostic Market, 2015 124

Figure 3.29: Hybrid Capture 2 (HC2) versus PCR—Analytical Sensitivity and
Clinical Sensitivity 133

Figure 3.30: Basic Steps in Hybrid Capture 2 Technology 134

Figure 3.31: Global Market Share Estimates for Molecular Diagnostic HPV Testing,
2015 137

Figure 3.32: Influenza Positive Tests Reported to the CDC, 2015-2016 Season 142

Figure 3.33: Number of Reported and Confirmed Cases of Influenza by Virus
Sub-Type Worldwide,

2013 142

Figure 3.34: U.S. Rates of Sexually Transmitted Diseases, 1940-2012 151

Figure 3.35: Reported Cases of Chlamydia in the U.S. by Sex, 1994-2014 153

Figure 3.36: Reported Cases of Gonorrhea in the U.S. by Sex, 1994-2014 154

Figure 3.37: Global Market Share of Chlamydia/Gonorrhea Molecular Diagnostic
Market, 2013 161

Figure 3.38: Global Estimated Tuberculosis Incidence Rates, 2014 165

Figure 3.39: Global Market Share of Tuberculosis Molecular Diagnostic Testing
170

Figure 3.40: Global Market Share of MRSA Molecular Diagnostic Market, 2015 177

Figure 3.41: Global Frequency of Vancomycin-Resistant Enterococci, 2006 182

Figure 4.1: Using DNA Microassays to Measure Gene Expression 185

Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in
Patients 186

Figure 4.3: Personalized Medicine in Treatment of Infectious Disease 191

Figure 5.1: FDA Co-Developed Products as a Model for Collaboration 206

Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision Making 218





INDEX OF TABLES



Table 1.1: Market Trends in Infectious Disease DNA Testing 19

Table 1.2: Molecular Diagnostics Infectious Disease Market: Market Drivers
Ranked in Order of Impact 20

Table 1.3: Molecular Diagnostics Infectious Disease Market: Market Restraints
Ranked in Order of

Impact 20

Table 1.4: Strategic Recommendations on Molecular Diagnostic Sector Business
Functions 20

Table 2.1: Top Ten Causes of Death Worldwide, 2012 30

Table 2.2: Prevalent Infectious Diseases Worldwide 31

Table 2.3: Emerging Molecular Diagnostic Technologies 35

Table 2.4: DNA Microarray Applications 45

Table 2.5: Companies Involved in Next Generation Sequencing Platforms 50

Table 2.6: Desired Characteristics for Clinical Versus Discovery Next Generation
Sequencing 51

Table 2.7: Automated Molecular Diagnostics Platforms for Infectious Disease
Testing 55

Table 2.8: Companies Marketing Products in Molecular Diagnostics Infectious
Disease Sector 56

Table 2.9: FDA-Approved Molecular Diagnostic Commercial Kits for the Detection
of Infectious Agents 56

Table 2.10: Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 59

Table 2.11: Molecular Diagnostics Market: Market Restraints Ranked in Order of
Impact 59

Table 2.12: Attractive Growth Areas for Molecular Diagnostic Testing 61

Table 3.1: Global Market for Molecular Diagnostics Testing, 2012-2020 62

Table 3.2: U.S. Market for Molecular Diagnostics Testing, 2012-2020 63

Table 3.3: European Market for Molecular Diagnostics Testing, 2012-2020 63

Table 3.4: Japanese Market for Molecular Diagnostics Testing, 2012-2020 63

Table 3.5: Summary of Molecular Diagnostics Testing Sectors 64

Table 3.6: Share of Global Molecular Diagnostics Testing by Testing Type, 2015
65

Table 3.7: Key Players and Market Share in Global Molecular Diagnostics Testing
Market, 2015 65

Table 3.8: Revenue Model for Molecular Diagnostics Testing 66

Table 3.9: Molecular Infectious Disease Diagnostics Market: Market Drivers
Ranked in Order of Impact 67

Table 3.10: Molecular Infectious Disease Diagnostics Market: Market Restraints
Ranked in Order of

Impact 68

Table 3.11: Global Revenue for Molecular Diagnostics Testing for Infectious
Disease, 2012-2020 68

Table 3.12: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious
Disease, 2012-2020 69

Table 3.13: European Market Revenue for Molecular Diagnostics Testing for
Infectious Disease,

2012-2020 70

Table 3.14: Japanese Market Revenue for Molecular Diagnostics Testing for
Infectious Disease,

2012-2020 71

Table 3.15: Rest of World (ROW) Market Revenue for Molecular Diagnostics Testing
for Infectious Disease,

2012-2020 72

Table 3.16: Molecular Diagnostic Markets for Infectious Disease Testing, 2015 74

Table 3.17: Molecular Diagnostic Markets for Infectious Disease Testing, 2020 76

Table 3.18: Business Factors Influencing Advanced Infectious Disease MDx Testing
Services 77

Table 3.19: Global Summary of the HIV/AIDS Epidemic, 2014 80

Table 3.20: Global HIV Statistics, 2014 80

Table 3.21: Estimated Number of New HIV Cases in the U.S. by Age, 2014 81

Table 3.22: Top Ten States with New HIV Cases in the U.S., 2014 81

Table 3.21: HIV Resistance Testing Recommendations 86

Table 3.22: Summary of HIV Viral Load, Genotyping, and Donor Screening Molecular
Assays 86

Table 3.23: Global Market for Molecular Diagnostic HIV Testing, 2014-2020 97

Table 3.24: U.S. Market for HIV Molecular Diagnostic Testing, 2014-2020 97

Table 3.25: HIV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 101

Table 3.26: HIV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 101

Table 3.27: Estimated Number of New Cases of HBV in the U.S., 2011-2013 105

Table 3.28: Lower Detection Limits of HBV DNA Assays 106

Table 3.29: Clinical Application of Quantitative HBV DNA Testing 106

Table 3.30: Summary of Molecular Diagnostic Assays for Testing HBV 110

Table 3.31: Global Market for HBV Diagnostic Testing, 2014-2020 110

Table 3.32: U.S. Market for HBV Diagnostic Testing, 2014-2020 110

Table 3.33: HBV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 111

Table 3.34: HBV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 111

Table 3.35: Worldwide Rate of HCV Cases 113

Table 3.36: Commercially Available Molecular Diagnostic Products for HCV Assay
118

Table 3.37: Global Market for NAT HCV Diagnostic Testing, 2014-2020 123

Table 3.38: U.S. Market for NAT HCV Diagnostic Testing, 2014-2020 123

Table 3.39: HCV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 124

Table 3.40: HCV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 125

Table 3.41: Recommendations for HCV Diagnostic Testing 127

Table 3.42: Commercially Available Molecular Diagnostic Products for HPV Assay
130

Table 3.43: Global Market for HPV Molecular Diagnostic Testing, 2014-2020 136

Table 3.44: U.S. Market for HPV Molecular Diagnostic Testing, 2014-2020 137

Table 3.45: HPV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 138

Table 3.46: HPV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 138

Table 3.47: Commercially Available Molecular Diagnostic Products for Influenza
Assay 143

Table 3.48 Global Market for Influenza Molecular Diagnostic Testing, 2014-2020
146

Table 3.49: U.S. Market for Influenza Molecular Diagnostic Testing, 2014-2020
147

Table 3.50: Influenza Molecular Diagnostics Market: Market Drivers Ranked in
Order of Impact 147

Table 3.51: Influenza Molecular Diagnostics Market: Market Restraints Ranked in
Order of Impact 147

Table 3.52: Commercially Available Molecular Diagnostic Assays for STDs 156

Table 3.53: Global Market for STD Molecular Diagnostic Testing, 2014-2020 161

Table 3.54: U.S. Market for STD Molecular Diagnostic Testing, 2014-2020 161

Table 3.55: STD Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 162

Table 3.56: STD Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 162

Table 3.57: Commercially Available Molecular Diagnostic Assays for Testing TB
167

Table 3.58 Global Market for Tuberculosis Molecular Diagnostic Testing,
2014-2020 169

Table 3.59: U.S. Market for Tuberculosis Molecular Diagnostic Testing, 2014-2020
170

Table 3.60: Tuberculosis Molecular Diagnostics Market: Market Drivers Ranked in
Order of Impact 171

Table 3.61: Tuberculosis Molecular Diagnostics Market: Market Restraints Ranked
in Order of Impact 171

Table 3.62: Global Market for MRSA Diagnostic Testing, 2014-2020 176

Table 3.63: U.S. Market for MRSA Diagnostic Testing, 2014-2020 177

Table 3.64: MRSA Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 178

Table 3.65: MRSA Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 178

Table 3.66: In Vitro Susceptibility of Staphylococci to New Agents in
Development 179

Table 4.1: Key Elements for Business Competition in Molecular Diagnostic Testing
for Infectious

Disease 189

Table 4.2: Key Elements for Future Success in Molecular Testing for Infectious
Disease 189

Table 4.3: Examples of Personalized Medicine in Treatment of Infectious Disease
191

Table 4.4: Molecular Methods for Epidemiologic Typing of Microorganisms 192

Table 4.5: Drivers of Molecular Diagnostic Methods for Infectious Disease
Testing in the Clinical Setting 193

Table 4.6: Barriers to Molecular Diagnostic Methods for Infectious Disease
Testing in the Clinical Setting 193

Table 5.1: Technology Trends in Molecular Diagnostic Infectious Disease Testing
200

Table 5.2: Clinical Testing Trends in Molecular Diagnostic Infectious Disease
Testing 200

Table 5.3: Business Market Trends in Molecular Diagnostics Infectious Disease
Testing 201

Table 5.4: Expected Changes in Healthcare 201

Table 5.5: Lab Customer Feedback for Automated Molecular Diagnostic Instruments
201

Table 5.6: Molecular Diagnostics Infectious Disease Market: Market Drivers
Ranked in Order of Impact 202

Table 5.7: Molecular Diagnostics Infectious Disease Market: Market Restraints
Ranked in Order of

Impact 202

Table 5.8: Advantages of European Markets for Molecular Diagnostic Testing 203

Table 5.9: Disadvantages of European Markets for Molecular Diagnostic Testing
203

Table 5.10: Summary of Recent Mandamp;A Activity in the Molecular Diagnostics Sector
204

Table 5.11: High Value Opportunities in Collaborative and Strategic Partnerships
205

Table 5.12: Principal Competitive Factors in the Molecular Diagnostics
Infectious Disease Testing

Market 207

Table 5.13: Molecular Diagnostics Infectious Disease Testing Market: Strategic
Recommendations on Molecular Diagnostic Sector Business Functions 207

Table 5.14: Molecular Diagnostics Infectious Disease Market: Impact of Top
Industry Challenges

in the U.S. 208

Table 5.15: Documents for Protecting Intellectual Property Rights 209

Table 5.16: Patents Related to PCR, Nucleic Acid Amplification and Sample Prep
210

Table 5.17: Specific Opportunities for Automated Instrumentation and Reagent
Systems in Molecular Diagnostics for Infectious Disease Testing 210

Table 5.18: The Required Elements of a Manufacturing Facility 212

Table 5.19: CMO Qualification Audit: Points to Investigate 213

Table 5.20: Strategies and POA for Marketing Infectious Disease Diagnostic
Products 214

Table 5.21: Key Elements of Molecular Diagnostic Companies Marketing Plan 215

Table 6.1: Factors Determining Third-Party Payment for Molecular Diagnostic
Tests for Infectious

Disease 222

Table 7.1: Regulatory Rules that Affect the Ability of a Diagnostic Testing
Reagent Company to Conduct

Business 226

Table 7.2: Strengths of the 510k Process 230

Table 7.3: Drawbacks of the 510k Process 231

Table 7.4: Focus Areas for the FDA Critical Path Initiative 235

Table 8.1: Impediments to Incorporating Promising Molecular Tests into Clinical
Practice 247






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