Molecular Diagnostics in Infectious Disease Testing

  • September 2014
  • -
  • TriMark Publications
  • -
  • 451 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 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 84
3.3.1.5 Market Size 86
3.3.1.5.1 HIV Diagnostic Testing 87
3.3.1.6 HIV Market Challenges and Strategic Recommendations 92
3.3.1.6.1 HIV Molecular Diagnostic Market History 92
3.3.1.7 Market Drivers and Restraints 93
3.3.1.7.1 Market Drivers 93
3.3.1.7.2 Market Restraints 93
3.3.1.8 Market and Technology Trends 93
3.3.1.8.1 Market Trends 93
3.3.1.8.2 Technology Trends 94
3.3.1.9 Strategic Recommendations 95
3.3.2 Hepatitis 95
3.3.2.1 Hepatitis B Virus 96
3.3.2.1.1 Hepatitis B Disease Background and Statistics 96
3.3.2.1.2 Instruments and Reagents for Hepatitis B Detection 99
3.3.2.1.3 Method Comparisons 100
3.3.2.1.4 Hepatitis B Market Size 102
3.3.2.1.5 HBV Market Challenges and Strategic Recommendations 104
3.3.2.1.5.1 Market Drivers and Restraints 104
3.3.2.1.5.1.1 Market Drivers 104
3.3.2.1.5.1.2 Market Restraints 104
3.3.2.1.6 Market and Technology Trends 104
3.3.2.1.6.1 Market Trends 104
3.3.2.1.6.2 Technology Trends 105
3.3.2.1.7 Strategic Recommendations 105
3.3.2.2 Hepatitis C Virus Testing 106
3.3.2.2.1 Disease Background and Statistics 106
3.3.2.2.2 Instruments and Reagents for Hepatitis C Detection 112
3.3.2.2.3 Method Comparisons for HCV Tests 117
3.3.2.2.4 Hepatitis C Market Size 120
3.3.2.2.4.1 HCV Market Share 122
3.3.2.2.5 HCV Market Challenges and Strategic Recommendations 123
3.3.2.2.5.1 Market Drivers and Restraints 123
3.3.2.2.5.1.1 Market Drivers 123
3.3.2.2.5.1.2 Market Restraints 124
3.3.2.2.5.2 Market and Technology Trends 124
3.3.2.2.5.2.1 Market Trends 124
3.3.2.2.5.2.2 Technology Trends 125
3.3.2.2.6 Strategic Recommendations 126
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 132
3.3.3.3 Method Comparison 139
3.3.3.4 HPV Market Size 139
3.3.3.4.1 North American Market 141
3.3.3.4.2 European Market 143
3.3.3.5 Market Challenges and Strategic Recommendations 146
3.3.3.5.1 Market Drivers and Restraints 146
3.3.3.5.1.1 Market Drivers 146
3.3.3.5.1.2 Market Restraints 146
3.3.3.5.2 Market and Technology Trends 146
3.3.3.5.2.1 Market Trends 146
3.3.3.5.2.2 Technology Trends 147
3.3.3.5.3 Strategic Recommendations 149
3.3.4 Influenza Viruses 150
3.3.4.1 Disease Background and Statistics 150
3.3.4.2 Instruments and Reagents for Influenza Detection 156
3.3.4.3 Method Comparisons 158
3.3.4.4 Influenza Market Size 158
3.3.4.5 Influenza Market Challenges and Strategic Recommendations 160
3.3.4.5.1 Market Drivers and Restraints 160
3.3.4.5.1.1 Market Drivers 160
3.3.4.5.1.2 Market Restraints 160
3.3.4.5.2 Market and Technology Trends 160
3.3.4.5.2.1 Market Trends 160
3.3.4.5.2.2 Technology Trends 161
3.3.4.5.3 Strategic Recommendations 163
3.3.5 STD Testing (Chlamydia/Gonorrhea Molecular Diagnostic Testing) 163
3.3.5.1 Chlamydia/Gonorrhea Molecular Diagnostic Testing Market Size 164
3.3.5.2 Competitive Structure and Market Share Analysis 165
3.3.5.2.1 Market Forecasts 167
3.3.5.2.1.1 Revenue Forecasts 167
3.3.5.3 Chlamydia Molecular Diagnostic Testing 167
3.3.5.3.1 Disease Background and Description 167
3.3.5.3.2 Product Analysis: Instruments and Reagents for Testing Chlamydia 171
3.3.5.3.3 Method Comparison 173
3.3.5.3.4 Chlamydia Molecular Diagnostic Testing 174
3.3.5.3.4.1 Revenue Forecasts 174
3.3.5.3.4.2 Market Challenges 175
3.3.5.3.4.2.1 Market Restraints 176
3.3.5.3.5 Market and Technology Trends 176
3.3.5.3.5.1 Market Trends 176
3.3.5.3.5.2 Technology Trends 177
3.3.5.3.5.3 Strategic Recommendations 177
3.3.5.4 Gonorrhea Molecular Diagnostic Testing 178
3.3.5.4.1 Disease Background and Description 178
3.3.5.4.2 Product Analysis: Instruments and Reagents 181
3.3.5.4.3 Method Comparison 183
3.3.5.4.4 Competitive Structure and Market Share Analysis 184
3.3.5.4.5 Market Forecasts 184
3.3.5.4.6 Market Challenges 185
3.3.5.4.6.1 Market Drivers 185
3.3.5.4.6.2 Market Restraints 185
3.3.5.4.7 Market and Technology Trends 185
3.3.5.4.7.1 Market Trends 185
3.3.5.4.7.2 Technology Trends 186
3.3.5.4.8 Strategic Recommendations 186
3.3.6 Tuberculosis 186
3.3.6.1 Disease Background and Description 186
3.3.6.2 Product Analysis: Instruments and Reagents 195
3.3.6.3 Method Comparison 196
3.3.6.4 Tuberculosis Market Size 198
3.3.6.5 Competitive Structure and Market Share Analysis 199
3.3.6.6 Market Forecasts 202
3.3.6.6.1 Revenue Forecasts 202
3.3.6.7 Market Challenges 203
3.3.6.7.1 Market Drivers 203
3.3.6.7.2 Market Restraints 203
3.3.6.8 Market and Technology Trends 203
3.3.6.8.1 Market Trends 203
3.3.6.8.2 Technology Trends 205
3.3.6.9 Strategic Recommendations 205
3.3.7 Methicillin-Resistant Staphylococcus aureus (MRSA) 206
3.3.7.1 Disease Background and Description 206
3.3.7.2 Product Analysis: Instruments and Reagents 209
3.3.7.3 Method Comparison 210
3.3.7.4 MRSA Market Size 211
3.3.7.5 Competitive Structure and Market Share Analysis 212
3.3.7.6 Market Forecasts 214
3.3.7.6.1 Revenue Forecasts 214
3.3.7.7 Market Challenges 215
3.3.7.7.1 Market Drivers 215
3.3.7.7.2 Market Restraints 215
3.3.7.8 Market and Technology Trends 215
3.3.7.8.1 Market Trends 215
3.3.7.8.2 Technology Trends 216
3.3.7.9 Strategic Recommendations 216
3.3.8 Vancomycin-Resistant Enterococci 217
3.3.8.1 Disease Background and Description 217
3.3.8.2 Product Analysis: Instruments and Reagents 220
3.3.8.3 Method Comparison 220
3.3.8.4 Competitive Structure and Market Share Analysis 222
3.3.8.5 Market Forecasts 223
3.3.8.5.1 Revenue Forecasts 223
3.3.8.6 Market Challenges 224
3.3.8.6.1 Market Drivers 224
3.3.8.6.2 Market Restraints 225
3.3.8.7 Market and Technology Trends 225
3.3.8.7.1 Market Trends 225
3.3.8.7.2 Technology Trends 226
3.3.8.8 Strategic Recommendations 226
3.3.9 Herpes Simplex Virus 226
3.3.9.1 Disease Background and Description 226
3.3.9.2 Product Analysis: Instruments and Reagents 227
3.3.9.3 Method Comparison 228
3.3.9.4 Market Forecasts 229
3.3.9.4.1 Market Drivers 229
3.3.9.4.2 Market Restraints 230
3.3.9.5 Market and Technology Trends 230
3.3.9.5.1 Market Trends 230
3.3.9.5.2 Technology Trends 230
3.3.9.6 Strategic Recommendations 231
3.3.10 C. difficile 231
3.3.10.1 Disease Background and Description 231
3.3.10.2 Product Analysis: Instruments and Reagents 231
3.3.11 Cytomegalovirus 232
3.4 Blood Screening 232
3.4.1 Product Analysis: Instruments and Reagents 234
3.4.2 Method Comparison 236
3.4.3 Blood Screening Market Size 237
3.4.4 Competitive Positions 238
3.4.5 Market Challenges and Strategic Recommendations 242
3.4.5.1 Market Drivers and Restraints 242
3.4.5.1.1 Market Drivers 242
3.4.5.1.2 Market Restraints 242
3.4.5.2 Market and Technology Trends 242
3.4.5.2.1 Market Trends 242
3.4.5.2.2 Technology Trends 243
3.4.5.3 Strategic Recommendations 244

4. Molecular Diagnostic Testing Technology for Infectious Disease Testing 245
4.1 Infectious Disease Diagnostic Tests 245
4.1.1 Molecular Diagnostic Tools Solutions 247
4.1.2 Technology of Gene Expression Analysis 247
4.1.2.1 Amplification and Detection of RNA 247
4.1.2.2 Analysis of Multiple Genes 248
4.1.2.3 Advanced Information Technology 249
4.2 Use of Molecular Tests in Infectious Disease 249
4.2.1 Molecular Screening 249
4.2.2 Early Detection 250
4.2.3 Detection of Specific Resistance Genes and Viral Loading Tests 250
4.2.4 Pharmacogenomics and Personalized Medicine in Molecular Diagnostic Infectious Disease
Testing 250
4.2.5 Molecular Strain Typing 252
4.3 Cost of Molecular Diagnostic Testing 253
4.4 Use of Multiplex PCR Tests 254
4.4.1 Advantages of Multiplex PCR 254
4.4.2 Applications of Multiplex PCR 255
4.5 Next-Generation Sequencing 256
4.6 Patient Flow Software 257
4.7 Digital PCR 258
4.8 LAMP 258
4.9 Ion Proton System for Gene Sequencing 259
4.10 xMap Technology (Luminex) 260

5. Business 263
5.1 Technology and Market Trends 263
5.1.1 Technology Trends 263
5.2 MandA Activity 266
5.3 Partnerships 269
5.4 Competitive Analysis 272
5.4.1 Primary Competitors 272
5.4.2 Industry Challenges and Strategic Recommendations 273
5.4.3 Commercialization of Molecular Diagnostic Products 274
5.5 Intellectual Property Rights 274
5.5.1 New Patents 276
5.5.2 Current Patent Disputes 276
5.6 Opportunities and Strategic Recommendations 277
5.6.1 The Key Technical Opportunities with Significant Market Appeal in the Molecular Diagnostic Space in the Next Five Years 277
5.6.2 Developments for Molecular Diagnostic Instrumentation Products 277
5.6.3 Market Penetration Strategies for Infectious Disease Testing 278
5.7 Business Models and Requirements for a Successful Molecular Diagnostics Infectious Disease Products Industry 278
5.7.1 Scope of This Section 278
5.7.2 The Success Achieved by the Molecular Diagnostics Infectious Disease Products 278
5.7.3 Business Models in Molecular Diagnostics Infectious Disease Products 279
5.7.4 SWOT Comparison of Business Models for Molecular Diagnostic Infectious Disease Testing 280
5.7.5 Commercial Manufacturing of Molecular Diagnostics Infectious Disease Products: Requirements 293
5.7.5.1 Elements of Commercial Manufacturing 293
5.7.5.1.1 Regulatory Requirements 293
5.7.5.1.2 Manufacturing Process Scale 293
5.7.5.1.3 In-House Manufacturing 294
5.7.5.2 Contract Manufacturing: Commercial and Academic 294
5.7.6 Sales and Marketing Strategies for Infectious Disease Tests 295
5.8 Companion Diagnostics Development in Partnership with a Pharmaceutical Company 299
5.8.1 Description of Business Model 299
5.8.2 Anti-Infective Pharmaceutical Market 302

6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for Infectious Disease 309
6.1 Overview 309
6.1.1 Gap Filling 310
6.2 Trends in Reimbursement Practice 310
6.2.1 Medicare Reimbursement Threats 312
6.2.2 Analysis of ROI for Molecular Diagnostic Tests for Infectious Disease Using Current Medicare Reimbursement Rules 315
6.3 Trends in Patient Care and Reimbursement 315
6.4 Revenue Threats 316
6.4.1 Medicare Payment Exceptions 318
6.4.2 Three Areas for Denial of Claims 318
6.5 Billing Rules 319
6.5.1 Medicare Billing Procedures 319
6.5.2 Medicare CPT Coding Rules for Molecular Diagnostic Infectious Disease Testing 320
6.5.3 Infectious Disease Billing Strategies 321

7. Regulatory Requirements 323
7.1 Food and Drug Administration 323
7.2 CLIA Regulations 323
7.3 Clinical Laboratory Improvement Act 325
7.4 State Licensing for Service Laboratories 326
7.5 IVDMIAs 326
7.6 FDA Draft Guidance on In Vitro Companion Diagnostic Devices 327
7.7 510(k) Clearance 328
7.8 Pre-Market Approval 328
7.8.1 Pre-Market Approval Application 329
7.9 Analyte Specific Reagents 330
7.9.1 Laboratory Developed Tests 330
7.10 What Regulatory Guidance is Needed for Companion Biomarkers? 332
7.11 U.S. Patent and Trademark Office 333
7.12 IRB Approval in Clinical Trials 333
7.13 CE Marking and the European In Vitro Diagnostic Device Directive 333
7.14 De Novo Classification 333
7.15 Research Use Only Reagents 334
7.16 FDA Recommendations on MRSA and SA Testing 334

8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease Testing 338
8.1 What are Key Opportunities in Infectious Disease Testing Development and Commercialization? 338
8.2 What are the Current Obstacles for Molecular Diagnostic Infectious Disease Testing
Implementation? 338
8.3 How do Business Strategies, Such as Those Relating to Acquisition, Drive Molecular Diagnostic Strategies? 339
8.4 How might Novel Infectious Disease Molecular Diagnostic Test Development Lead to Acquisition Strategies and their Implications for Deal Making? 339
8.5 How can Molecular Diagnostic Tests Increase Value in an Associated Drug Marketing Plan? 340
8.6 Which Types of Infectious Disease Molecular Diagnostic Testing should be Developed by Diagnostic Companies at Various Stages in the Development Pipeline? 340
8.7 How can Regulatory Oversight Drive Approval and Adoption of New Technologies? 341
8.8 What are the Noteworthy Deals? 341
8.9 Who are the Acquirers? 342
8.10 Who are the Target Companies? 342
8.11 How will Platform Technology Companies Enter the Space? 343
8.12 Will Pharma Integrate with Diagnostics? 344
8.13 How do Platform Technology Companies Position Themselves for Diagnostics Development? 344
8.14 Evaluate How Partnering and MandAs will Alter the Competitive Landscape 345
8.15 Predict How FDA Regulations will Impact New Diagnostic Tests 346
8.16 How can Big Pharma and Diagnostic Companies Co-Develop Biomarkers in a Model for Regulatory Acceptance? 346
8.17 How to Maximize Business Development Through Biomarker Strategies? 347
8.18 What is the Best Type of Business Model for Developing Genetic Biomarkers for Infectious
Disease? 347
8.19 How Best have Genetic Biomarkers Provided the Most Benefit in Infectious Disease Testing? 347
8.20 What are the Most Innovative Methods in Development of Molecular Diagnostic Biomarkers? 348
8.21 What are the Best Values for Genetic Biomarkers in Drug Development and in Diagnostics? 348

9. Economics of Anti-Microbial Drug Resistance: The Persistent Need for Antibacterials 351
9.1 Resistance and Antibiotic Usage 355
9.2 Infection Control Programs 357

10. Company Profiles 358
10.1 Abbott Laboratories 358
10.2 AdvanDx 361
10.3 Affymetrix 362
10.4 Arcxis Biotechnologies 369
10.5 Asuragen, Inc. 370
10.6 AutoGenomics, Inc. 371
10.7 Becton, Dickinson and Company 373
10.8 bioMerieux 375
10.9 Biocartis 377
10.10 BioHelix Corporation (now part of Quidel) 378
10.11 bioTheranostics 379
10.12 Cepheid 379
10.13 EraGen Biosciences 381
10.14 GenMark Diagnostics, Inc. 381
10.15 Genomix Biotech 382
10.16 Gen-Probe, Inc. (now known as Hologic Gen-Probe) 383
10.17 Genomica S.A.U. 387
10.18 Great Basin Corporation 388
10.19 Illumina, Inc. 388
10.20 Life Technologies (Thermo Fisher Scientific) 391
10.21 Luminex Corp. 394
10.22 Mobidiag 396
10.23 Myconostica 396
10.24 Myriad Genetics, Inc. 397
10.25 Nanosphere 402
10.26 NorDiag ASA (The DiaSorin Group) 403
10.27 Qiagen N.V. 403
10.28 Quidel 407
10.29 Roche Diagnostics (Roche Ltd.) 412
10.30 SACACE 414
10.31 Seegene 414
10.32 Siemens AG 415
10.33 SIRS-Lab 416
10.34 TrimGen 417
10.35 TrovaGene 417
10.36 Veredus Laboratories 417
10.37 Veridex, LLC (Janssen Diagnostics, LLC) 417

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) 419
Appendix 2: Molecular Diagnostic Instruments with Combined Functions—Draft Guidance for Industry and Food and Drug Administration Staff 442
Appendix 3: Applications for Molecular Testing 446

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