Molecular Diagnostics in Infectious Disease Testing
NEW YORK, July 11, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Molecular Diagnostics in Infectious Disease Testing
http://www.reportlinker.com/p0368860/Molecular-Diagnostics-in-Infectious-Disease-Testing.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic
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
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 27
2.1 Molecular Diagnostics Testing and Opportunities in the Infectious Disease
Sector 27
2.2 The Infectious Disease Problem 31
2.3 Impact of the Human Genome Project on Molecular Diagnostics 35
2.4 Opportunities for Molecular and Clinical Diagnostics 35
2.4.1 Companion Diagnostics 36
2.5 Development of Molecular Diagnostics Testing Markets 37
2.6 Target-based Gene Amplification 38
2.6.1 Polymerase Chain Reaction (PCR) 38
2.6.2 Real-time PCR (RT-PCR) 39
2.6.3 Nucleic Acid Sequence-based Amplification (NASBA) 39
2.6.4 Market Drivers and Restraints 46
2.6.4.1 Market Drivers 46
2.6.4.2 Market Restraints 46
2.6.5 Market and Technology Trends 46
2.6.5.1 Market Trends 46
2.6.5 2 Technology Trends 47
2.6.6 Strategic Recommendations 47
2.7 PCR Reagents for Clinical Diagnostics 48
3. Infectious Disease Diagnostics Molecular Testing Market 50
3.1 Market Overview 50
3.1.1 Overall Infectious Disease Market Analysis 53
3.2 NAT Molecular Diagnostics Market 65
3.3 Infectious Disease Molecular Diagnostic Testing Markets 67
3.3.1 HIV 67
3.3.1.1 Disease Background and Statistics 67
3.3.1.2 Measuring Viral Loads 74
3.3.1.3 Instruments and MD Reagents 75
3.3.1.4 Method Comparisons 81
3.3.1.5 Market Size 83
3.3.1.5.1 HIV Diagnostic Testing 83
3.3.1.6 HIV Market Challenges and Strategic Recommendations 88
3.3.1.6.1 HIV Molecular Diagnostic Market History 88
3.3.1.7 Market Drivers and Restraints 89
3.3.1.7.1 Market Drivers 89
3.3.1.7.2 Market Restraints 89
3.3.1.8 Market and Technology Trends 89
3.3.1.8.1 Market Trends 89
3.3.1.8.2 Technology Trends 90
3.3.1.9 Strategic Recommendations 91
3.3.2 Hepatitis 91
3.3.2.1 Hepatitis B Virus 91
3.3.2.1.1 Hepatitis B Disease Background and Statistics 91
3.3.2.1.2 Instruments and Reagents for Hepatitis B Detection 93
3.3.2.1.3 Method Comparisons 95
3.3.2.1.4 Hepatitis B Market Size 97
3.3.2.1.5 HBV Market Challenges and Strategic Recommendations 98
3.3.2.1.5.1 Market Drivers and Restraints 98
3.3.2.1.5.1.1 Market Drivers 98
3.3.2.1.5.1.2 Market Restraints 99
3.3.2.1.6 Market and Technology Trends 99
3.3.2.1.6.1 Market Trends 99
3.3.2.1.6.2 Technology Trends 99
3.3.2.1.7 Strategic Recommendations 100
3.3.2.2 Hepatitis C Virus (HCV) Testing 101
3.3.2.2.1 Disease Background and Statistics 101
3.3.2.2.2 Instruments and Reagents for Hepatitis C Detection 107
3.3.2.2.3 Method Comparisons for HCV Tests 112
3.3.2.2.4 Hepatitis C Market Size 115
3.3.2.2.4.1 HCV Market Share 116
3.3.2.2.5 HCV Market Challenges and Strategic Recommendations 117
3.3.2.2.5.1 Market Drivers and Restraints 117
3.3.2.2.5.1.1 Market Drivers 117
3.3.2.2.5.1.2 Market Restraints 118
3.3.2.2.5.2 Market and Technology Trends 118
3.3.2.2.5.2.1 Market Trends 118
3.3.2.2.5.2.2 Technology Trends 119
3.3.2.2.6 Strategic Recommendations 119
3.3.3 Human Papillomavirus (HPV) 120
3.3.3.1 Disease Background and Statistics 120
3.3.3.2 Instruments and Reagents for HPV Detection 124
3.3.3.3 Method Comparison 131
3.3.3.4 HPV Market Size 132
3.3.3.4.1 North American Market 133
3.3.3.4.2 European Market 135
3.3.3.5 Market Challenges and Strategic Recommendations 137
3.3.3.5.1 Market Drivers and Restraints 137
3.3.3.5.1.1 Market Drivers 137
3.3.3.5.1.2 Market Restraints 137
3.3.3.5.2 Market and Technology Trends 138
3.3.3.5.2.1 Market Trends 138
3.3.3.5.2.2 Technology Trends 138
3.3.3.5.3 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 146
3.3.4.3 Method Comparisons 148
3.3.4.4 Influenza Market Size 148
3.3.4.5 Influenza Market Challenges and Strategic Recommendations 150
3.3.4.5.1 Market Drivers and Restraints 150
3.3.4.5.1.1 Market Drivers 150
3.3.4.5.1.2 Market Restraints 150
3.3.4.5.2 Market and Technology Trends 150
3.3.4.5.2.1 Market Trends 150
3.3.4.5.2.2 Technology Trends 151
3.3.4.5.3 Strategic Recommendations 152
3.3.5 STD Testing 152
3.3.5.1 Chlamydia 153
3.3.5.1.1 Disease Background and Description 153
3.3.5.1.2 Product Analysis: Instruments and Reagents for Testing Chlamydia 156
3.3.5.1.3 Method Comparison 158
3.3.5.1.4 Chlamydia/Gonorrhea Molecular Diagnostic Testing Market Size 159
3.3.5.1.5 Competitive Structure and Market Share Analysis 160
3.3.5.1.6 Market Forecasts 161
3.3.5.1.6.1 Revenue Forecasts 161
3.3.5.1.7 Market Forecasts 162
3.3.5.1.7.1 Revenue Forecasts 162
3.3.5.1.8 Market Challenges 162
3.3.5.1.8.1 Market Drivers 162
3.3.5.1.8.2 Market Restraints 163
3.3.5.1.9 Market and Technology Trends 163
3.3.5.1.9.1 Market Trends 163
3.3.5.1.9.2 Technology Trends 164
3.3.5.1.10 Strategic Recommendations 164
3.3.6 Gonorrhea 164
3.3.6.1 Disease Background and Description 164
3.3.6.2 Product Analysis: Instruments and Reagents 166
3.3.6.3 Method Comparison 168
3.3.6.4 Competitive Structure and Market Share Analysis 169
3.3.6.5 Market Forecasts 170
3.3.6.5.1 Revenue Forecasts 170
3.3.6.6 Market Challenges 170
3.3.6.6.1 Market Drivers 170
3.3.6.6.2 Market Restraints 170
3.3.6.7 Market and Technology Trends 171
3.3.6.7.1 Market Trends 171
3.3.6.7.2 Technology Trends 171
3.3.6.8 Strategic Recommendations 171
3.3.7 Tuberculosis (TB) 171
3.3.7.1 Disease Background and Description 171
3.3.7.2 Product Analysis: Instruments and Reagents 178
3.3.7.3 Method Comparison 179
3.3.7.4 Tuberculosis Market Size 180
3.3.7.5 Competitive Structure and Market Share Analysis 181
3.3.7.6 Market Forecasts 184
3.3.7.6.1 Revenue Forecasts 184
3.3.7.7 Market Challenges 184
3.3.7.7.1 Market Drivers 184
3.3.7.7.2 Market Restraints 185
3.3.7.8 Market and Technology Trends 185
3.3.7.8.1 Market Trends 185
3.3.7.8.2 Technology Trends 186
3.3.7.9 Strategic Recommendations 186
3.3.8 Methicillin-resistant Staphylococcus Aureus (MRSA) 187
3.3.8.1 Disease Background and Description 187
3.3.8.2 Product Analysis: Instruments and Reagents 190
3.3.8.3 Method Comparison 191
3.3.8.4 MRSA Market Size 192
3.3.8.5 Competitive Structure and Market Share Analysis 193
3.3.8.6 Market Forecasts 195
3.3.8.6.1 Revenue Forecasts 195
3.3.8.7 Market Challenges 195
3.3.8.7.1 Market Drivers 195
3.3.8.7.2 Market Restraints 196
3.3.8.8 Market and Technology Trends 196
3.3.8.8.1 Market Trends 196
3.3.8.8.2 Technology Trends 197
3.3.8.9 Strategic Recommendations 197
3.3.9 Vancomycin-resistant Enterococci (VRE) 198
3.3.9.1 Disease Background and Description 198
3.3.9.2 Product Analysis: Instruments and Reagents 200
3.3.9.3 Method Comparison 201
3.3.9.4 Competitive Structure and Market Share Analysis 203
3.3.9.5 Market Forecasts 204
3.3.9.5.1 Revenue Forecasts 204
3.3.9.6 Market Challenges 204
3.3.9.6.1 Market Drivers 204
3.3.9.6.2 Market Restraints 205
3.3.9.7 Market and Technology Trends 205
3.3.9.7.1 Market Trends 205
3.3.9.7.2 Technology Trends 206
3.3.9.8 Strategic Recommendations 206
3.3.10 Herpes Simplex Virus (HSV) 206
3.3.11 C. difficile 206
3.3.12 Cytomegalovirus 207
3.4 Blood Screening 207
3.4.1 Product Analysis: Instruments and Reagents 208
3.4.2 Method Comparison 211
3.4.3 Blood Screening Market Size 211
3.4.4 Competitive Positions 213
3.4.5 Market Challenges and Strategic Recommendations 217
3.4.5.1 Market Drivers and Restraints 217
3.4.5.1.1 Market Drivers 217
3.4.5.1.2 Market Restraints 218
3.4.5.2 Market and Technology Trends 218
3.4.5.2.1 Market Trends 218
3.4.5.2.2 Technology Trends 219
3.4.5.3 Strategic Recommendations 219
4. Molecular Diagnostic Testing Technology for Infectious Disease Testing 220
4.1 Infectious Disease Diagnostic Tests 220
4.1.2 Molecular Diagnostic Tools Solutions 222
4.1.3 Technology of Gene Expression Analysis 222
4.1.3.1 Amplification and Detection of RNA 222
4.1.3.2 Analysis of Multiple Genes 223
4.1.3.3 Advanced Information Technology 224
4.2 Use of Molecular Tests in Infectious Disease 224
4.2.1 Molecular Screening 224
4.2.2 Early Detection 225
4.2.3 Detection of Specific Resistance Genes and Viral Loading Tests 225
4.2.4 Pharmacogemomics and Personalized Medicine in MD Infectious Disease
Testing 225
4.2.5 Molecular Strain Typing 226
4.3 Cost of Molecular Diagnostic Testing 227
4.4 Use of Multiplex PCR Tests 228
4.5 Next Generation Sequencing 229
4.6 Patient Flow Software 231
4.7 Digital PCR 231
5. Business 232
5.1 Technology and Market Trends 232
5.1.1 Technology Trends 232
5.2 M&A Activity 235
5.3 Partnerships 237
5.4 Competitive Analysis 240
5.4.1 Primary Competitors 240
5.4.2 Industry Challenges and Strategic Recommendations 241
5.4.3 Commercialization of Molecular Diagnostic Products 241
5.5 Intellectual Property Rights 242
5.5.1 New Patents 243
5.5.2 Current Patent Disputes 244
5.6 Opportunities and Strategic Recommendations 244
5.6.1 The Key Technical Opportunities with Significant Market Appeal in the
Molecular Diagnostic Space in the Next Five Years 244
5.6.2 Developments for Molecular Diagnostic Instrumentation Products 244
5.6.3 Market Penetration Strategies for Infectious Disease Testing 245
5.7 Business Models and Requirements for a Successful Molecular Diagnostics
Infectious Disease Products Industry 245
5.7.1 Scope of This Section 245
5.7.2 The Success Achieved by the Molecular Diagnostics Infectious Disease
Products 245
5.7.3 Business Models in Molecular Diagnostics Infectious Disease Products 246
5.7.4 SWOT Comparison of Business Models for MD Infectious Disease Diagnostic
Testing 247
5.7.5 Commercial Manufacturing of Molecular Diagnostics Infectious Disease
Products: Requirements 258
5.7.5.1 Elements of Commercial Manufacturing 258
5.7.5.1.1 Regulatory Requirements 258
5.7.5.1.2 Manufacturing Process Scale 258
5.7.5.1.3 In-House Manufacturing 259
5.7.5.2 Contract Manufacturing: Commercial and Academic 259
5.7.6 Sales and Marketing Strategies for Infectious Disease Tests 260
5.8 Companion Diagnostics Development in Partnership with a Pharmaceutical
Company 264
5.8.1 Description of Business Model 264
5.8.2 Anti-infective Pharmaceutical Market 268
6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for
Infectious Disease 273
6.1 Overview 273
6.2 Trends in Reimbursement Practice 273
6.2.1 Medicare Reimbursement Threats 275
6.2.2 Analysis of ROI for Molecular Diagnostic Tests for Infectious Disease
Using Current Medicare Reimbursement Rules 277
6.3 Trends in Patient Care and Reimbursement 278
6.4 Revenue threats 279
6.4.1 Medicare Payment Exceptions 280
6.4.2 Three Areas for Denial of Claims 281
6.5 Billing Rules 281
6.5.1 Medicare Billing Procedures 282
6.5.2 Medicare CPT Coding Rules for MD Infectious Disease Testing 282
6.5.3 Infectious Disease Billing Strategies 283
7. Regulatory Requirements 285
7.1 U.S. Food and Drug Administration 285
7.2 CLIA Regulations 285
7.3 Clinical Laboratory Improvement Act (CLIA) 287
7.4 State Licensing for Service Laboratories 288
7.5 IVDMIAs 288
7.6 510(k) Clearance 289
7.7 Pre-Market Approval (PMA) 290
7.7.1 Pre-Market Approval Application 290
7.8 Analyte Specific Reagents (ASRs) 291
7.8.1 Laboratory Developed Tests 292
7.9 What Regulatory Guidance is Needed for Companion Biomarkers? 293
7.10 U.S. Patent and Trademark Office (USPTO) 294
7.11 IRB Approval in Clinical Trials 294
7.12 CE Marking and the IVDD (European In Vitro Diagnostic Device Directive) 294
7.13 De Novo Classification 294
7.14 Research Use Only Reagents 295
7.15 FDA Recommendations on MRSA Testing 295
8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease
Testing 297
8.1 What are Key Opportunities in Infectious Disease Testing Development and
Commercialization? 297
8.2 What are the Current Obstacles for MD Infectious Disease Testing
Implementation? 297
8.3 How do Business Strategies, such as those relating to Acquisition, Drive MD
Strategies? 297
8.4 How Might Novel Infectious Disease MD Test Development Lead to Acquisition
Strategies and their Implications for Deal Making? 298
8.5 How can Molecular Diagnostic Tests Increase Value in an Associated Drug
Marketing Plan? 298
8.6 Which Types of Infectious Disease MD Testing should be Developed by
Diagnostic Companies at Various Stages in the Development Pipeline? 299
8.7 How can Regulatory Oversight Drive Approval and Adoption of New
Technologies? 299
8.8 What are the Noteworthy Deals? 299
8.9 Who are the Acquirers? 300
8.10 Who are the Target Companies? 300
8.11 How will Platform Technology Companies Enter the Space? 300
8.12 Will Pharma Integrate with Diagnostics? 301
8.13 How do Platform Technology Companies Position themselves for Diagnostics
Development? 301
8.14 Evaluate how Partnering and M&As will Alter the Competitive Landscape 301
8.15 Predict how FDA Regs will Impact New Diagnostic Tests 302
8.16 How can Big Pharma and Diagnostic Companies Co-develop Biomarkers in a
Model for Regulatory Acceptance? 303
8.17 How to Maximize Business Development through Biomarker Strategies? 303
8.18 What is the Best Type of Business Model for Developing Genetic Biomarkers
for
Infectious Disease? 303
8.19 How Best have Genetic Biomarkers Provided the Most Benefit in Infectious
Disease Testing? 303
8.20 What are the Most Innovative Methods in Development of Molecular Diagnostic
Biomarkers? 304
8.21 What are the Best Values for Genetic Biomarkers in Drug Development and in
Diagnostics? 304
9. Economics of Anti-microbial Drug Resistance: The Persistent need for Anti-bacterials
307
9.1 Resistance and Antibiotic Usage 310
9.2 Infection Control Programs 311
10. Company Profiles 312
10.1 Abbott Laboratories 312
10.2 AdvanDx 312
10.3 Arcxis Biotechnologies 313
10.4 Atlas Genetics 313
10.5 AutoGenomics, Inc. 313
10.6 Becton, Dickinson and Company 315
10.7 BioGenex Laboratories, Inc. 315
10.8 BioHelix Corporation 316
10.9 bioM eux 316
10.10 Biocartis 316
10.11 bioTheranostics 317
10.12 Celera 317
10.13 Cepheid 319
10.14 EraGen Biosciences 320
10.15 Exiqon A/S 321
10.16 Genera Biosystems 321
10.17 GenMark Diagnostics, Inc. 321
10.18 Genomix Biotech 321
10.19 Gen-Probe 322
10.20 Gene Express 324
10.21 Genomica 324
10.22 Great Basin Scientific 325
10.23 Hologic 325
10.24 Illumina, Inc. 325
10.25 Innogenetics NV 326
10.26 Life Technologies 326
10.27 Mobidiag 327
10.28 Myconostica 327
10.29 Nanosphere 327
10.30 NorDiag ASA 328
10.31 Qiagen NV 328
10.32 Roche Ltd. 331
10.33 Seegene 332
10.34 SIRS-Lab 333
10.35 Source MDx 333
10.36 TrimGen 333
10.37 TrovaGene 333
10.38 Veredus Laboratories 334
10.39 Veridex 334
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) 335
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 41
Figure 2.5: Global Market for Molecular Diagnostics, 2002-2016 45
Figure 3.1: Global Market for Molecular Diagnostics Testing, 2010 51
Figure 3.2: Share of Molecular Diagnostics Testing by Testing Type, 2009 52
Figure 3.3: Key Players Market Share in Global Molecular Diagnostics Testing
Markets 53
Figure 3.4: Global Market for Infectious Disease Treatments, 2008-2014 54
Figure 3.5: Global Revenue Forecast for Molecular Diagnostics Testing for
Infectious Disease,
2009-2016 55
Figure 3.6: Global Market Revenue Share Forecasts for Molecular Diagnostics
Infectious Disease Testing Markets by Region, 2009 and 2015 56
Figure 3.7: Infectious Disease Testing Revenue Market Share of Total U.S. MD
Market, 2009 and 2015 57
Figure 3.8: European Market Revenue Forecast for Molecular Diagnostics Testing
for Infectious Disease,
2009-2015 58
Figure 3.9: Infectious Disease Testing Revenue Market Share of Total European MD
Market,
2009 and 2015 58
Figure 3.10: Japanese Market Revenue Forecast for Molecular Diagnostics Testing
for Infectious Disease,
2009-2016 59
Figure 3.11: Infectious Disease Testing Revenue Market Share of Total Japanese
MD Market,
2009 and 2015 60
Figure 3.12: Total Global Infectious Disease Molecular Diagnostics Markets, 2010
61
Figure 3.13: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2010
61
Figure 3.14: Total Global Infectious Disease Molecular Diagnostics Markets, 2016
62
Figure 3.15: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2016
63
Figure 3.16: Global Trend of HIV Infection, 1991-2007 67
Figure 3.17: Number of People Living with HIV, Newly Infected with HIV and
Number of AIDS Deaths in the World, 1990-2008 68
Figure 3.18: Worldwide Rate of New HIV Cases, 1990-2007 69
Figure 3.19: Percentage of Adult Population in African Countries with HIV, 2007
69
Figure 3.20: Global View of HIV Infection, 2008 71
Figure 3.21: Ethnic Distribution of AIDS Patients in the U.S., 2007 71
Figure 3.22: Ten Best Selling AIDS Drugs in the U.S., 2008 72
Figure 3.23: U.S. Rates for New HIV Cases, 2008 72
Figure 3.24: U.S. Rates for New HIV Cases in Men, 2008 73
Figure 3.25: U.S. Rates for New HIV Cases in Women, 2008 73
Figure 3.26: Global Trend of HIV Infections, 1991-2007 74
Figure 3.27: Proposed HIV Testing Algorithm 81
Figure 3.28: Distribution of HIV Molecular Diagnostic Testing by Purpose 83
Figure 3.29: Estimated Market Forecast for Global HIV Molecular Diagnostic
Testing, 2011-2016 84
Figure 3.30: Estimated Market Forecast for U.S. HIV Molecular Diagnostic
Testing, 2011-2016 84
Figure 3.31: Market Share Viral Load HIV MD Diagnostic Testing 85
Figure 3.32: Geographic Distribution of Chronic HBV Infection 92
Figure 3.33: Rate of New Hepatitis A, B and C Infections in the U.S., 1982-2006
92
Figure 3.34: Global Prevalence of Hepatitis C 102
Figure 3.35: Primary Causes of Chronic Liver Disease 104
Figure 3.36: HCV Infection Prevalence 104
Figure 3.37: Hepatitis C Infection by Source 105
Figure 3.38: Growth and Projections of HCV Therapies by Drug Class, 2008 and
2013 106
Figure 3.39: U.S. Market Share of HCV Molecular Diagnostic Market, 2010 116
Figure 3.40: Global Market Share (Excluding U.S.) of HCV Molecular Diagnostic
Market, 2010 117
Figure 3.41: Rate of New Cases and Deaths of Cervical Cancer by Age Group
Worldwide, 2008 122
Figure 3.42: U.S. Market Share of HPV Molecular Diagnostic Market, 2010 132
Figure 3.43: Global Market Share (Excluding U.S.) of HPV Molecular Diagnostic
Market, 2010 133
Figure 3.44: Market Share Estimates for Molecular Diagnostic HPV Testing, 2009
133
Figure 3.45: Number of Reported and Confirmed Cases of Influenza H1N1 Strain
Worldwide, 2009 144
Figure 3.46: Distribution of H1N1 Flu in the U.S., 2009 145
Figure 3.47: H1N1 Confirmed and Probable Case Rate in the U.S., By Age Group 145
Figure 3:48: U.S. Rates of Sexually-transmitted Diseases, 1940-2007 153
Figure 3.49: Chlamydia Infection Rates: Total and by Gender: U.S., 1989-2009 155
Figure 3.50: Chlamydia U.S. Prevalence by Age Group and Race/Ethnicity 156
Figure 3.51: U.S. Market Share of CT/NG Molecular Diagnostic Market, 2010 160
Figure 3.52: Global Market Share (Excluding U.S.) of CT/NG Molecular Diagnostic
Market, 2010 161
Figure 3.53: U.S. Gonorrhea Infection Rates, 1941-2006 165
Figure 3.54: U.S. Gonorrhea Infection Rates by Race/Ethnicity, 1999-2008 165
Figure 3.55: Pipeline for TB Diagnostics 173
Figure 3.56: Number of Tuberculosis (TB) Cases Among U.S.- and Foreign-born
Persons in the U.S.,
1993-2008 174
Figure 3.57: Rate of Tuberculosis (TB) Cases Among U.S.- and Foreign-born
Persons in the U.S.,
1993-2008 174
Figure 3.58: Rate of Tuberculosis (TB) Cases by State/Area in the U.S., 2008 176
Figure 3.59: U.S.-born Tuberculosis (TB) Cases by Ethnicity, 2008 177
Figure 3.60: Reported Tuberculosis (TB) Cases in the U.S., 1983-2007 180
Figure 3.61: Global Market Share of MD TB Testing 181
Figure 3.62: Global Market Share of MD TB Testing by Region, 2010 182
Figure 3.63: Incidence Rates of Invasive MRSA Infections by Age 188
Figure 3.64: MRSA Trends According to Patient Location, 1998-2005 189
Figure 3.65: Incidence of Healthcare-associated MRSA Infections, 2005-2008 190
Figure 3.66: U.S. Market Share of MRSA Molecular Diagnostic Market, 2010 194
Figure 3.67: Global Market Share (Excluding U.S.) of MRSA Molecular Diagnostic
Market, 2010 194
Figure 3.68: Global Frequency of Vancomycin-resistant Enterococci, 2006 199
Figure 3.69: U.S. Market Share of VRE Molecular Diagnostic Market, 2010 203
Figure 3.70: Estimated Market for Global Blood Screening Product Sales,
2007-2016 212
Figure 3.71: Gen-Probe Blood Screening Product Market Share, 2005-2009 213
Figure 3.72: Blood Screening Product Market Share by Company, 2010 215
Figure 4.1: Using DNA Microassays to Measure Gene Expression 220
Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in
Patients 221
Figure 5.1: FDA Co-developed Products as a Model for Collaboration 238
Figure 5.2: Market Growth of MD Infectious Disease Tests 261
Figure 5.3: Segmentation of the Biomarker Development Market 265
Figure 5.4: Global Distribution of Anti-infective Agent Sales by Geography 268
Figure 5.5: Leading Companies in Anti-infectives Market Share, 2008 270
Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision Making 274
Figure 9.1: Global Multidrug Susceptibility in Pseudomonas aeruginosa 309
Figure 9.2: Global Frequency of Vancomycin-resistant Enterococci, 2006 310
Figure 10.1: Gen-Probe Key Acquisitions 323
Figure 10.2: Gen-Probe Projected R&D Expenditures 324
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 22
Table 1.3: Molecular Diagnostics Infectious Disease Market: Market Restraints
Ranked in Order of Impact 22
Table 1.4: Strategic Recommendations on Molecular Diagnostic Sector Business
Functions 23
Table 2.1: Nucleic Acid-based Tests for Clinically Important Viral and Bacterial
Pathogens 30
Table 2.2: Top Ten Causes of Death Worldwide 32
Table 2.3: The Most Prevalent Infectious Diseases Worldwide 32
Table 2.4: Annual Rates of Global Infectious Diseases 34
Table 2.5: Emerging Molecular Diagnostic Technologies 38
Table 2.6: Global Market for Molecular Diagnostics Testing, 2000-2016 40
Table 2.7: U.S. Market for Molecular Diagnostics Testing, 2004-2016 41
Table 2.8: Automated Molecular Diagnostics Platforms for Infectious Disease
Testing 42
Table 2.9: Companies Marketing Products using DNA Probes 42
Table 2.10: Companies Marketing Multiple Products in Molecular Diagnostics
Sector 43
Table 2.11: FDA-approved Molecular Diagnostic Commercial Kits for the Detection
of Infectious Agents 44
Table 2.12: Global and U.S. Major Infectious Disease Market Size (Estimated
Infected Persons) 45
Table 2.13: Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 46
Table 2.14: Molecular Diagnostics Market: Market Restraints Ranked in Order of
Impact 46
Table 2.15: Attractive Growth Areas for Molecular Diagnostic Testing 48
Table 2.16: NAT Labs in U.S. and Five European Markets 48
Table 3.1: European Market for Molecular Diagnostics Testing, 2005-2015 50
Table 3.2: Japanese Market for Molecular Diagnostics Testing, 2009-2016 51
Table 3.3: Summary of Molecular Diagnostics Testing Sectors 51
Table 3.4: Share of Molecular Diagnostics Testing by Testing Type, 2009 52
Table 3.5: Key Players and Market Share in Global Molecular Diagnostics Testing
Market 52
Table 3.6: Revenue Model for Molecular Diagnostics Testing 53
Table 3.7: Molecular Infectious Disease Diagnostics Market: Market Drivers
Ranked in Order of Impact 54
Table 3.8: Molecular Infectious Disease Diagnostics Market: Market Restraints
Ranked in Order of Impact 54
Table 3.9: Global Revenue Forecast for Molecular Diagnostics Testing for
Infectious Disease, 2009-2016 55
Table 3.10: U.S. Market Revenue Forecast for Molecular Diagnostics Testing for
Infectious Disease,
2009-2016 56
Table 3.11: European Market Revenue Forecast for Molecular Diagnostics Testing
for Infectious Disease,
2009-2015 57
Table 3.12: Japanese Market Revenue Forecast for Molecular Diagnostics Testing
for Infectious Disease,
2009-2016 59
Table 3.13: Molecular Diagnostic Markets for Infectious Disease Testing, 2010 61
Table 3.14: Molecular Diagnostic Markets for Infectious Disease Testing, 2016 62
Table 3.15: Business Factors Influencing Advanced Infectious Disease MD Testing
Services 64
Table 3.16: Global Summary of the HIV/AIDS Epidemic, 2008 68
Table 3.17: Global HIV Statistics, 2008 70
Table 3.18: HIV Resistance Testing Recommendations 74
Table 3.19: Summary of Assays for HIV Viral Load Testing 75
Table 3.20: Commercially Available Molecular Diagnostic Products for HIV Assay
80
Table 3.21: Global Market for Molecular Diagnostic HIV Testing, 2007-2010 83
Table 3.22: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2010 84
Table 3.23: Global Market Forecast for Molecular Diagnostic HIV Diagnostic
Testing, 2011-2016 85
Table 3.24: U.S. Market Forecast for Molecular Diagnostic HIV Diagnostic
Testing, 2011-2016 85
Table 3.25: Global Market for HIV Viral Load Diagnostic Testing, 2007-2010 86
Table 3.26: U.S. Market for HIV Viral Load Diagnostic Testing, 2007-2010 86
Table 3.27: Global Market Forecast for HIV Viral Load Diagnostic Testing,
2011-2016 86
Table 3.28: U.S. Market Forecast for HIV Viral Load Diagnostic Testing,
2011-2016 86
Table 3.29: Global Market for HIV Genotyping Testing, 2007-2010 87
Table 3.30: U.S. Market for HIV Genotype Testing, 2007-2010 87
Table 3.31: Global Market Forecast for HIV Genotyping Testing 2011-2015 87
Table 3.32: U.S. Market Forecast for HIV Genotyping Testing, 2011-2016 87
Table 3.33: HIV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 89
Table 3.34: HIV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 89
Table 3.35: Clinical Application of Quantitative HBV DNA Testing 93
Table 3.36: Lower Detection Limits of HBV DNA Assays 95
Table 3.37: Summary of Molecular Diagnostic Assays for Testing HBV 97
Table 3.38: Global Market for HBV Diagnostic Testing, 2000-2010 97
Table 3.39: U.S. Market for HBV Diagnostic Testing, 2000-2010 97
Table 3.40: Global Market Forecast for HBV Diagnostic Testing, 2011-2016 98
Table 3.41: U.S. Market Forecast for HBV Diagnostic Testing, 2011-2016 98
Table 3.42: HBV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 98
Table 3.43: HBV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 99
Table 3.44: Hepatitis B Facts 100
Table 3.45: U.S. HCV Statistics 106
Table 3.46: Worldwide Rate of HCV Cases 106
Table 3.47: Efficiency of Available HCV Screening Tests 108
Table 3.48: Commercially Available Molecular Diagnostic Products for HCV Assay
114
Table 3.49: Global Market for DNA HCV Diagnostic Testing, 2005-2010 115
Table 3.50: U.S. Market for DNA HCV Diagnostic Testing, 2005-2010 115
Table 3.51: Global Market Forecast for NAT HCV Diagnostic Testing, 2011-2016 115
Table 3.52: U.S. Market Forecast for NAT HCV Diagnostic Testing, 2011-2016 116
Table 3.53: Major Companies Marketing HCV Molecular Diagnostic Testing
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