Reportlinker Adds Molecular Diagnostics in Infectious Disease Testing
NEW YORK, March 29, 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
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 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 26
2.1 Molecular Diagnostics Testing and Opportunities in the Infectious Disease
Sector 26
2.2 The Infectious Disease Problem 30
2.3 Impact of the Human Genome Project on Molecular Diagnostics 34
2.4 Opportunities for Molecular and Clinical Diagnostics 34
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 (PCR) 38
2.6.2 Real-time PCR (RT-PCR) 38
2.6.3 Nucleic Acid Sequence-based Amplification (NASBA) 39
2.6.4 Market Drivers and Restraints 45
2.6.4.1 Market Drivers 45
2.6.4.2 Market Restraints 45
2.6.5 Market and Technology Trends 45
2.6.5.1 Market Trends 45
2.6.5 2 Technology Trends 46
2.6.6 Strategic Recommendations 46
3. Infectious Disease Diagnostics Molecular Testing Market 48
3.1 Market Overview 48
3.1.1 Overall Infectious Disease Market Analysis 51
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 MD Reagents 73
3.3.1.4 Method Comparisons 79
3.3.1.5 Market Size 81
3.3.1.5.1 HIV Diagnostic Testing 81
3.3.1.6 HIV Market Challenges and Strategic Recommendations 86
3.3.1.6.1 HIV Molecular Diagnostic Market History 86
3.3.1.7 Market Drivers and Restraints 87
3.3.1.7.1 Market Drivers 87
3.3.1.7.2 Market Restraints 87
3.3.1.8 Market and Technology Trends 87
3.3.1.8.1 Market Trends 87
3.3.1.8.2 Technology Trends 88
3.3.1.8.3 Strategic Recommendations 89
3.3.2 Hepatitis 89
3.3.2.1 Hepatitis B Virus 89
3.3.2.1.1 Hepatitis B Disease Background and Statistics 89
3.3.2.1.2 Instruments and Reagents for Hepatitis B Detection 91
3.3.2.1.3 Method Comparisons 93
3.3.2.1.4 Hepatitis B Market Size 95
3.3.2.1.5 HBV Market Challenges and Strategic Recommendations 96
3.3.2.1.5.1 Market Drivers and Restraints 96
3.3.2.1.5.1.1 Market Drivers 96
3.3.2.1.5.1.2 Market Restraints 97
3.3.2.1.6 Market and Technology Trends 97
3.3.2.1.6.1 Market Trends 97
3.3.2.1.6.2 Technology Trends 97
3.3.2.1.7 Strategic Recommendations 98
3.3.2.2 Hepatitis C Virus (HCV) Testing 99
3.3.2.2.1 Disease Background and Statistics 99
3.3.2.2.2 Instruments and Reagents for Hepatitis C Detection 105
3.3.2.2.3 Method Comparisons for HCV Tests 110
3.3.2.2.4 Hepatitis C Market Size 112
3.3.2.2.4.1 HCV Market Share 113
3.3.2.2.5 HCV Market Challenges and Strategic Recommendations 114
3.3.2.2.5.1 Market Drivers and Restraints 114
3.3.2.2.5.1.1 Market Drivers 114
3.3.2.2.5.2 Market Restraints 115
3.3.2.2.6 Market and Technology Trends 115
3.3.2.2.6.1 Market Trends 115
3.3.2.2.6.2 Technology Trends 116
3.3.2.2.7 Strategic Recommendations 117
3.3.3 Human Papillomavirus (HPV) 117
3.3.3.1 Disease Background and Statistics 117
3.3.3.2 Instruments and Reagents for HPV Detection 121
3.3.3.3 Method Comparison 128
3.3.3.4 HPV Market Size 129
3.3.3.4.1 North American Market 130
3.3.3.4.2 European Market 132
3.3.3.5 Market Challenges and Strategic Recommendations 134
3.3.3.5.1 Market Drivers and Restraints 134
3.3.3.5.1.1 Market Drivers 134
3.3.3.5.1.2 Market Restraints 134
3.3.3.6 Market and Technology Trends 134
3.3.3.6.1 Market Trends 134
3.3.3.6.2 Technology Trends 135
3.3.3.6.3 Strategic Recommendations 136
3.3.4 Influenza Viruses 136
3.3.4.1 Disease Background and Statistics 136
3.3.4.2 Instruments and Reagents for Influenza Detection 142
3.3.4.3 Method Comparisons 144
3.3.4.4 Influenza Market Size 144
3.3.4.5 Influenza Market Challenges and Strategic Recommendations 146
3.3.4.5.1 Market Drivers and Restraints 146
3.3.4.5.1.1 Market Drivers 146
3.3.4.5.1.2 Market Restraints 146
3.3.4.6 Market and Technology Trends 146
3.3.4.6.1 Market Trends 146
3.3.4.6.2 Technology Trends 147
3.3.4.7 Strategic Recommendations 148
3.3.5 STD Testing 148
3.3.5.1 Chlamydia 149
3.3.5.1.1 Disease Background and Description 149
3.3.5.1.2 Product Analysis: Instruments and Reagents for Testing Chlamydia 152
3.3.5.1.3 Method Comparison 154
3.3.5.1.4 Chlamydia/Gonorrhea Molecular Diagnostic Testing Market Size 156
3.3.5.1.5 Competitive Structure and Market Share Analysis 157
3.3.5.1.6 Market Forecasts 158
3.3.5.1.6.1 Revenue Forecasts 158
3.3.5.1.7 Market Forecasts 159
3.3.5.1.7.1 Revenue Forecasts 159
3.3.5.1.8 Market Challenges 159
3.3.5.1.8.1 Market Drivers 159
3.3.5.1.8.2 Market Restraints 160
3.3.5.1.9 Market and Technology Trends 160
3.3.5.1.9.1 Market Trends 160
3.3.5.1.9.2 Technology Trends 160
3.3.5.1.9.3 Strategic Recommendations 161
3.3.6 Gonorrhea 161
3.3.6.1 Disease Background and Description 161
3.3.6.2 Product Analysis: Instruments and Reagents 163
3.3.6.3 Method Comparison 165
3.3.6.4 Competitive Structure and Market Share Analysis 166
3.3.6.5 Market Forecasts 167
3.3.6.5.1 Revenue Forecasts 167
3.3.6.6 Market Challenges 167
3.3.6.6.1 Market Drivers 167
3.3.6.6.2 Market Restraints 167
3.3.6.7 Market and Technology Trends 168
3.3.6.7.1 Market Trends 168
3.3.6.7.2 Technology Trends 168
3.3.6.8 Strategic Recommendations 168
3.3.7 Tuberculosis (TB) 168
3.3.7.1 Disease Background and Description 168
3.3.7.2 Product Analysis: Instruments and Reagents 175
3.3.7.3 Method Comparison 176
3.3.7.4 Tuberculosis Market Size 177
3.3.7.5 Competitive Structure and Market Share Analysis 178
3.3.7.6 Market Forecasts 181
3.3.7.6.1 Revenue Forecasts 181
3.3.7.7 Market Challenges 181
3.3.7.7.1 Market Drivers 181
3.3.7.7.2 Market Restraints 182
3.3.7.8 Market and Technology Trends 182
3.3.7.8.1 Market Trends 182
3.3.7.8.2 Technology Trends 183
3.3.7.9 Strategic Recommendations 183
3.3.8 Methicillin-resistant Staphylococcus Aureus (MRSA) 184
3.3.8.1 Disease Background and Description 184
3.3.8.2 Product Analysis: Instruments and Reagents 187
3.3.8.3 Method Comparison 188
3.3.8.4 MRSA Market Size 188
3.3.8.5 Competitive Structure and Market Share Analysis 189
3.3.8.6 Market Forecasts 191
3.3.8.6.1 Revenue Forecasts 191
3.3.8.7 Market Challenges 191
3.3.8.7.1 Market Drivers 191
3.3.8.7.2 Market Restraints 192
3.3.8.8 Market and Technology Trends 192
3.3.8.8.1 Market Trends 192
3.3.8.8.2 Technology Trends 193
3.3.8.9 Strategic Recommendations 193
3.3.9 Vancomycin-resistant Enterococci (VRE) 194
3.3.9.1 Disease Background and Description 194
3.3.9.2 Product Analysis: Instruments and Reagents 196
3.3.9.3 Method Comparison 197
3.3.9.4 Competitive Structure and Market Share Analysis 199
3.3.9.5 Market Forecasts 200
3.3.9.5.1 Revenue Forecasts 200
3.3.9.6 Market Challenges 200
3.3.9.6.1 Market Drivers 200
3.3.9.6.2 Market Restraints 201
3.3.9.7 Market and Technology Trends 201
3.3.9.7.1 Market Trends 201
3.3.9.7.2 Technology Trends 202
3.3.9.8 Strategic Recommendations 202
3.4 Blood Screening 202
3.4.1 Product Analysis: Instruments and Reagents 204
3.4.2 Method Comparison 206
3.4.3 Blood Screening Market Size 207
3.4.4 Competitive Positions 208
3.4.5 Market Challenges and Strategic Recommendations 212
3.4.5.1 Market Drivers and Restraints 212
3.4.5.1.1 Market Drivers 212
3.4.5.1.2 Market Restraints 213
3.4.6 Market and Technology Trends 213
3.4.6.1 Market Trends 213
3.4.6.2 Technology Trends 214
3.4.7 Strategic Recommendations 214
4. Molecular Diagnostic Testing Technology for Infectious Disease Testing 215
4.1 Infectious Disease Diagnostic Tests 215
4.1.2 Molecular Diagnostic Tools Solutions 217
4.1.3 Technology of Gene Expression Analysis 217
4.1.3.1 Amplification and Detection of RNA 217
4.1.3.2 Analysis of Multiple Genes 218
4.1.3.3 Advanced Information Technology 219
4.2 Use of Molecular Tests in Infectious Disease 219
4.2.1 Molecular Screening 219
4.2.2 Early Detection 219
4.2.3 Detection of Specific Resistance Genes and Viral Loading Tests 220
4.2.4 Pharmacogemomics and Personalized Medicine in MD Infectious Disease
Testing 220
4.2.5 Molecular Strain Typing 221
4.3 Cost of Molecular Diagnostic Testing 222
4.4 Use of Multiplex PCR Tests 223
4.5 Next Generation Sequencing 224
4.6 Patient Flow Software 226
4.7 Digital PCR 226
5. Business 227
5.1 Technology and Market Trends 227
5.1.1 Technology Trends 227
5.2 M&A Activity 230
5.3 Partnerships 231
5.4 Competitive Analysis 234
5.4.1 Primary Competitors 234
5.4.2 Industry Challenges and Strategic Recommendations 235
5.4.3 Commercialization of Molecular Diagnostic Products 235
5.5 Intellectual Property Rights 236
5.5.1 New Patents 237
5.5.2 Current Patent Disputes 238
5.6 Opportunities and Strategic Recommendations 238
5.6.1 The Key Technical Opportunities with Significant Market Appeal in the
Molecular Diagnostic Space in the Next Five Years 238
5.6.2 Developments for Molecular Diagnostic Instrumentation Products 239
5.6.3 Market Penetration Strategies for Infectious Disease Testing 239
5.7 Business Models and Requirements for a Successful Molecular Diagnostics
Infectious Disease Products Industry 239
5.7.1 Scope of this Section 239
5.7.2 The Success Achieved by the Molecular Diagnostics Infectious Disease
Products 240
5.7.3 Business Models in Molecular Diagnostics Infectious Disease Products 240
5.7.4 SWOT Comparison of Business Models for MD Infectious Disease Diagnostic
Testing 241
5.7.5 Commercial Manufacturing of Molecular Diagnostics Infectious Disease
Products: Requirements 252
5.7.5.1 Elements of Commercial Manufacturing 252
5.7.5.1.1 Regulatory Requirements 252
5.7.5.1.2 Manufacturing Process Scale 252
5.7.5.1.3 In-House Manufacturing 253
5.7.5.2 Contract Manufacturing: Commercial and Academic 253
5.7.6 Sales and Marketing Strategies for Infectious Disease Tests 254
5.8 Companion Diagnostics Development in Partnership with a Pharmaceutical
Company 258
5.8.1 Description of Business Model 258
5.8.2 Anti-infective Pharmaceutical Market 262
6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for
Infectious Disease 267
6.1 Overview 267
6.2 Trends in Reimbursement Practice 267
6.2.1 Medicare Reimbursement Threats 269
6.2.2 Analysis of ROI for Molecular Diagnostic Tests for Infectious Disease
Using Current Medicare Reimbursement Rules 271
6.3 Trends in Patient Care and Reimbursement 272
6.4 Revenue threats 273
6.4.1 Medicare Payment Exceptions 274
6.4.2 Three Areas for Denial of Claims 275
6.5 Billing Rules 275
6.5.1 Medicare Billing Procedures 276
6.5.2 Medicare CPT Coding Rules for MD Infectious Disease Testing 276
6.5.3 Infectious Disease Billing Strategies 277
7. Regulatory Requirements 279
7.1 U.S. Food and Drug Administration 279
7.2 CLIA Regulations 279
7.3 Clinical Laboratory Improvement Act (CLIA) 281
7.4 State Licensing for Service Laboratories 282
7.5 IVDMIAs 282
7.6 510(k) Clearance 283
7.7 Pre-Market Approval (PMA) 284
7.7.1 Premarket Approval Application 284
7.8 Analyte Specific Reagents (ASRs) 285
7.8.1 Laboratory Developed Tests 286
7.9 What Regulatory Guidance Is Needed for Companion Biomarkers? 287
7.10 U.S. Patent and Trademark Office (USPTO) 288
7.11 IRB Approval in Clinical Trials 288
7.12 CE Marking and the IVDD (European In Vitro Diagnostic Device Directive) 288
7.13 De Novo Classification 289
7.14 Research Use Only Reagents 289
8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease
Testing 291
8.1 What are Key Opportunities in Infectious Disease Testing Development and
Commercialization 291
8.2 What are the Current Obstacles for MD Infectious Disease Testing
Implementation? 291
8.3 How do Business Strategies, such as those relating to Acquisition, Drive MD
Strategies? 291
8.4 How Might Novel Infectious Disease MD Test Development Lead to Acquisition
Strategies and their Implications for Deal Making? 292
8.5 How can Molecular Diagnostic Tests Increase Value in an Associated Drug
Marketing Plan 292
8.6 Which Types of Infectious Disease MD Testing should be Developed by
Diagnostic Companies at Various Stages in the Development Pipeline? 293
8.7 How can Regulatory Oversight Drive Approval and Adoption of New
Technologies? 293
8.8 What are the Noteworthy Deals? 293
8.9 Who are the Acquirers? 294
8.10 Who are the Target Companies? 294
8.11 How will Platform Technology Companies Enter the Space? 294
8.12 Will Pharma Integrate with Diagnostics? 295
8.13 How do Platform Technology Companies Position themselves for Diagnostics
Development? 295
8.14 Evaluate how Partnering and M&As will Alter the Competitive Landscape? 295
8.15 Predict how FDA Regs will Impact New Diagnostic Tests 296
8.16 How can Big Pharma and Diagnostic Companies Co-develop Biomarkers in a
Model for Regulatory Acceptance? 297
8.17 How to Maximize Business Development through Biomarker Strategies? 297
8.18 What is the Best Type of Business Model for Developing Genetic Biomarkers
for Infectious Disease? 297
8.19 How Best have Genetic Biomarkers Provided the Most Benefit in Infectious
Disease Testing? 297
8.20 What are the Most Innovative Methods in Development of Molecular Diagnostic
Biomarkers? 298
8.21 What are the Best Values for Genetic Biomarkers in Drug Development and in
Diagnostics? 298
9. Economics of Anti-microbial Drug Resistance: The Persistent need for
Anti-bacterials 301
9.1 Resistance and Antibiotic Usage 304
9.2 Infection Control Programs 305
10. Company Profiles 306
10.1 Abbott Laboratories 306
10.2 AdvanDx 306
10.3 Arcxis Biotechnologies 307
10.4 Atlas Genetics 307
10.5 AutoGenomics, Inc. 307
10.6 Becton, Dickinson and Company 309
10.7 BioGenex Laboratories, Inc. 309
10.8 BioHelix Corporation 310
10.9 bioMerieux 310
10.10 Biocartis 310
10.11 bioTheranostics 311
10.12 Celera 311
10.13 Cepheid 313
10.14 EraGen Biosciences 314
10.15 Exiqon A/S 314
10.16 Genera Biosystems 314
10.17 GenMark Diagnostics, Inc. 315
10.18 Genomix Biotech 315
10.19 Gen-Probe 315
10.20 PANTHER System 316
10.21 Gene Express 318
10.22 Genomica 318
10.23 Great Basin Scientific 318
10.24 Hologic 318
10.25 Illumina, Inc. 319
10.26 Innogenetics NV 320
10.27 Life Technologies 320
10.28 Mobidiag 321
10.29 Myconostica 321
10.30 Nanosphere 321
10.31 NorDiag ASA 321
10.32 Qiagen NV 322
10.33 Roche Ltd. 324
10.34 Seegene 326
10.35 SIRS-Lab 326
10.36 Source MDx 326
10.37 TrimGen 327
10.38 TrovaGene 327
10.39 Veredus Laboratories 327
10.40 Veridex 327
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) 328
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 41
Figure 2.5: Global Market for Molecular Diagnostics, 2002-2016 44
Figure 3.1: Global Market for Molecular Diagnostics Testing, 2010 49
Figure 3.2: Share of Molecular Diagnostics Testing by Testing Type, 2009 50
Figure 3.3: Key Players Market Share in Global Molecular Diagnostics Testing
Markets 51
Figure 3.4: Global Market for Infectious Disease Treatments, 2007-2014 52
Figure 3.5: Global Revenue Forecast for Molecular Diagnostics Testing for
Infectious Disease, 2009-2016 53
Figure 3.6: Global Market Revenue Share Forecasts for Molecular Diagnostics
Infectious Disease Testing Markets by Region, 2009 and 2015 54
Figure 3.7: Infectious Disease Testing Revenue Market Share of Total U.S. MD
Market, 2009 and 2015 55
Figure 3.8: European Market Revenue Forecast for Molecular Diagnostics Testing
for Infectious Disease, 2009-2015 56
Figure 3.9: Infectious Disease Testing Revenue Market Share of Total European MD
Market, 2009 and 2015 56
Figure 3.10: Japanese Market Revenue Forecast for Molecular Diagnostics Testing
for Infectious Disease, 2009-2016 57
Figure 3.11: Infectious Disease Testing Revenue Market Share of Total Japanese
MD Market, 2009 and 2015 58
Figure 3.12: Total Global Infectious Disease Molecular Diagnostics Markets, 2010
59
Figure 3.13: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2010
59
Figure 3.14: Total Global Infectious Disease Molecular Diagnostics Markets, 2016
60
Figure 3.15: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2016
61
Figure 3.16: Global Trend of HIV Infection, 1991-2007 65
Figure 3.17: Number of People Living with HIV, Newly Infected with HIV and
Number of AIDS Deaths in the World, 1990-2008 66
Figure 3.18: Worldwide Rate of New HIV Cases, 1990-2007 67
Figure 3.19: Percentage of Adult Population in African Countries with HIV, 2007
67
Figure 3.20: Global View of HIV Infection, 2008 69
Figure 3.21: Ethnic Distribution of AIDS Patients in the U.S., 2007 69
Figure 3.22: Ten Best Selling AIDS Drugs in the U.S., 2008 70
Figure 3.23: U.S. Rates for New HIV Cases, 2008 70
Figure 3.24: U.S. Rates for New HIV Cases in Men, 2008 71
Figure 3.25: U.S. Rates for New HIV Cases in Women, 2008 71
Figure 3.26: Global Trend of HIV Infections, 1991-2007 72
Figure 3.27: Proposed HIV Testing Algorithm* 79
Figure 3.28: Distribution of HIV Molecular Diagnostic Testing by Purpose 81
Figure 3.29: Estimated Market Forecast for Global HIV Molecular Diagnostic
Testing, 2011-2016 82
Figure 3.30: Estimated Market Forecast for U.S. HIV Molecular Diagnostic
Testing, 2011-2016 82
Figure 3.31: Market Share Viral Load HIV MD Diagnostic Testing 83
Figure 3.32: Geographic Distribution of Chronic HBV Infection 90
Figure 3.33: Rate of New Hepatitis A, B and C Infections in the U.S., 1982-2006
90
Figure 3.34: Global Prevalence of Hepatitis C 100
Figure 3.35: Primary Causes of Chronic Liver Disease 102
Figure 3.36: HCV Infection Prevalence 102
Figure 3.37: Hepatitis C Infection by Source 103
Figure 3.38: Growth and Projections of HCV Therapies by Drug Class, 2008 and
2013 104
Figure 3.39: U.S. Market Size and Share of HCV Molecular Diagnostic Market, 2010
114
Figure 3.40: Ex-U.S. Market Size and Share of HCV Molecular Diagnostic Market,
2010 114
Figure 3.41: Rate of New Cases and Deaths of Cervical Cancer by Age Group
Worldwide, 2008 119
Figure 3.42: U.S. Market Size and Share of HPV Molecular Diagnostic Market, 2010
129
Figure 3.43: Ex-U.S. Market Size and Share of HPV Molecular Diagnostic Market,
2010 129
Figure 3.44: Market Share Estimates for Molecular Diagnostic HPV Testing, 2009
130
Figure 3.45: Number of Reported and Confirmed Cases of Influenza H1N1 Strain
Worldwide, 2009 140
Figure 3.46: Distribution of H1N1 Flu in the U.S., 2009 141
Figure 3.47: H1N1 Confirmed and Probable Case Rate in the U.S., By Age Group 142
Figure 3:48: U.S. Rates of Sexually-transmitted Diseases, 1940-2007 149
Figure 3.49: Chlamydia Infection Rates: Total and by Gender: U.S., 1989-2008 151
Figure 3.50: Chlamydia U.S. Prevalence by Age Group and Race/Ethnicity 152
Figure 3.51: U.S. Market Size and Share of CT/NG Molecular Diagnostic Market,
2010 157
Figure 3.52: Ex-U.S. Market Size and Share of CT/NG Molecular Diagnostic Market,
2010 158
Figure 3.53: U.S. Gonorrhea Infection Rates, 1941-2006 162
Figure 3.54: U.S. Gonorrhea Infection Rates by Race/Ethnicity, 1999-2008 162
Figure 3.55: Pipeline for TB Diagnostics 170
Figure 3.56: Number of Tuberculosis Cases Among U.S. and Foreign-born Persons in
the U.S., 1993-2008 171
Figure 3.57: Rate of Tuberculosis Cases Among U.S. and Foreign-born Persons, in
the U.S., 1993-2008 171
Figure 3.58: Rate of Tuberculosis (TB) Cases by State/Area in the U.S., 2008 173
Figure 3.59: U.S.-born TB Cases by Ethnicity, 2008 174
Figure 3.60: Reported TB Cases in the U.S., 1983-2007 177
Figure 3.61: Global Market Share of MD TB Testing 178
Figure 3.62: Global Market Share of MD TB Testing by Region 179
Figure 3.63: Incidence Rates of Invasive MRSA Infections by Age 185
Figure 3.64: MRSA Trends According to Patient Location, 1998-2005 186
Figure 3.65: Incidence of Healthcare-associated MRSA Infections, 2005-2008 187
Figure 3.66: U.S. Market Size and Share of MRSA Molecular Diagnostic Market,
2010 190
Figure 3.67: Ex-U.S. Market Size and Share of MRSA Molecular Diagnostic Market,
2010 190
Figure 3.68 Global Frequency of Vancomycin-resistant Enterococci, 2006 195
Figure 3.69: U.S. Market Size and Share of VRE Molecular Diagnostic Market, 2010
199
Figure 3.70: Estimated Market for Global Blood Screening Product Sales,
2007-2016 207
Figure 3.71: Gen-Probe Blood Screening Product Market Share, 2005-2009 208
Figure 3.72: Blood Screening Product Market Share by Company, 2010 210
Figure 4.1: Using DNA Microassays to Measure Gene Expression 215
Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in
Patients 216
Figure 5.1: FDA Co-developed Products as a Model for Collaboration 232
Figure 5.2: Market Growth of MD Infectious Disease Tests 255
Figure 5.3: Segmentation of the Biomarker Development Market 259
Figure 5.4: Global Distribution of Anti-infective Agent Sales by Geography 262
Figure 5.5: Leading Companies in Anti-infectives Market Share, 2008 264
Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision Making 268
Figure 9.1: Global Multidrug Susceptibility in Pseudomonas aeruginosa 303
Figure 9.2: Global Frequency of Vancomycin-resistant Enterococci, 2006 304
Figure 10.1: Gen-Probe Key Acquisitions 317
Figure 10.2: Gen-Probe Projected R&D Expenditures 317
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: Nucleic Acid-based Tests for Clinically Important Viral and Bacterial
Pathogens 29
Table 2.2: Top Ten Causes of Death Worldwide 31
Table 2.3: The Most Prevalent Infectious Diseases Worldwide 31
Table 2.4: Annual Rates of Global Infectious Diseases 33
Table 2.5: Emerging Molecular Diagnostic Technologies 37
Table 2.6: Global Market for Molecular Diagnostics Testing, 2000-2016 40
Table 2.7: U.S. Market for Molecular Diagnostics Testing, 2004-2016 40
Table 2.8: Automated Molecular Diagnostics Platforms for Infectious Disease
Testing 41
Table 2.9: Companies Marketing Products Using DNA Probes 42
Table 2.10: Companies Marketing Multiple Products in Molecular Diagnostics
Sector 42
Table 2.11: FDA-approved Molecular Diagnostic Commercial Kits for the Detection
of Infectious Agents 43
Table 2.12: Global and U.S. Major Infectious Disease Market Size 44
Table 2.13: Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 45
Table 2.14: Molecular Diagnostics Market: Market Restraints Ranked in Order of
Impact 45
Table 2.15: Attractive Growth Areas for Molecular Diagnostic Testing 47
Table 2.16: NAT Labs in U.S. and Five European Markets 47
Table 3.1: European Market for Molecular Diagnostics Testing, 2005-2015 48
Table 3.2: Japanese Market for Molecular Diagnostics Testing, 2009-2016 49
Table 3.3: Summary of Molecular Diagnostics Testing Sectors 49
Table 3.4: Share of Molecular Diagnostics Testing by Testing Type, 2009 50
Table 3.5: Key Players and Market Share in Global Molecular Diagnostics Testing
Market 50
Table 3.6: Revenue Model for Molecular Diagnostics Testing 51
Table 3.7: Molecular Infectious Disease Diagnostics Market: Market Drivers
Ranked in Order of Impact 52
Table 3.8: Molecular Infectious Disease Diagnostics Market: Market Restraints
Ranked in Order of Impact 52
Table 3.9: Global Revenue Forecast for Molecular Diagnostics Testing for
Infectious Disease, 2009-2016 53
Table 3.10: U.S. Market Revenue Forecast for Molecular Diagnostics Testing for
Infectious Disease, 2009-2016 54
Table 3.11: European Market Revenue Forecast for Molecular Diagnostics Testing
for Infectious Disease, 2009-2015 55
Table 3.12: Japanese Market Revenue Forecast for Molecular Diagnostics Testing
for Infectious Disease, 2009-2016 57
Table 3.13: Molecular Diagnostic Markets for Infectious Disease Testing, 2010 59
Table 3.14: Molecular Diagnostic Markets for Infectious Disease Testing, 2016 60
Table 3.15: Business Factors Influencing Advanced Infectious Disease MD Testing
Services 62
Table 3.16: Global Summary of the HIV/AIDS Epidemic, 2008 66
Table 3.17: Global HIV Statistics, 2008 68
Table 3.18: HIV Resistance Testing Recommendations 72
Table 3.19: Summary of Assays for HIV Viral Load Testing 73
Table 3.20: Commercially Available Molecular Diagnostic Products for HIV Assay
78
Table 3.21: Global Market for Molecular Diagnostic HIV Testing, 2007-2010 81
Table 3.22: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2010 82
Table 3.23: Global Market Forecast for Molecular Diagnostic HIV Diagnostic
Testing, 2011-2016 83
Table 3.24: U.S. Market Forecast for Molecular Diagnostic HIV Diagnostic
Testing, 2011-2016 83
Table 3.25: Global Market for HIV Viral Load Diagnostic Testing, 2007-2010 84
Table 3.26: U.S. Market for HIV Viral Load Diagnostic Testing, 2007-2010 84
Table 3.27: Global Market Forecast for HIV Viral Load Diagnostic Testing,
2011-2016 84
Table 3.28: U.S. Market Forecast for HIV Viral Load Diagnostic Testing,
2011-2016 84
Table 3.29: Global Market for HIV Genotyping Testing, 2007-2010 85
Table 3.30: U.S. Market for HIV Genotype Testing, 2007-2010 85
Table 3.31: Global Market Forecast for HIV Genotyping Testing 2011-2015 85
Table 3.32: U.S. Market Forecast for HIV Genotyping Testing, 2011-2016 85
Table 3.33: HIV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 87
Table 3.34: HIV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 87
Table 3.35: Clinical Application of Quantitative HBV DNA Testing 91
Table 3.36: Lower Detection Limits of HBV DNA Assays 93
Table 3.37: Summary of Molecular Diagnostic Assays for Testing HBV 95
Table 3.38: Global Market for HBV Diagnostic Testing, 2000-2010 95
Table 3.39: U.S. Market for HBV Diagnostic Testing, 2000-2010 95
Table 3.40: Global Market Forecast for HBV Diagnostic Testing, 2011-2016 96
Table 3.41: U.S. Market Forecast for HBV Diagnostic Testing, 2011-2016 96
Table 3.42: HBV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 96
Table 3.43: HBV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 97
Table 3.44: Hepatitis B Facts 98
Table 3.45: U.S. HCV Statistics 104
Table 3.46: Worldwide Rate of HCV Cases 104
Table 3.47: Efficiency of Available HCV Screening Tests 106
Table 3.48: Commercially Available Molecular Diagnostic Products for HCV Assay
112
Table 3.49: Global Market for DNA HCV Diagnostic Testing, 2005-2010 112
Table 3.50: U.S. Market for DNA HCV Diagnostic Testing, 2005-2010 112
Table 3.51: Global Market Forecast for NAT HCV Diagnostic Testing, 2011-2016 113
Table 3.52: U.S. Market Forecast for NAT HCV Diagnostic Testing, 2011-2016 113
Table 3.53: Major Companies Marketing HCV Molecular Diagnostic Tests: Market
Size and Share, 2010 113
Table 3.54: HCV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 114
Table 3.55: HCV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 115
Table 3.56: Recommendations for HCV Diagnostic Testing 117
Table 3.57: Number of Pap Smears Performed by Country, 2009 118
Table 3.58: Qiagen's Digene HC2 High-risk HPV DNA Test 122
Table 3.59: Commercially Available Molecular Diagnostic Products for HPV Assay
128
Table 3.60: Major Companies Marketing HPV Molecular Diagnostic Tests: Market
Size and Share, 2010 129
Table 3.61: Global Market for HPV Molecular Diagnostic Testing, 2007-2010 133
Table 3.62: U.S. Market for HPV Molecular Diagnostic Testing, 2007-2010 133
Table 3.63: Global Market Forecast for HPV Molecular Diagnostic Testing,
2011-2016 133
Table 3.64: U.S. Market Forecast for HPV Molecular Diagnostic Testing, 2011-2016
133
Table 3.65: HPV Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 134
Table 3.66: HPV Molecular Diagnostics Market: Market Restraints Ranked in Order
of Impact 134
Table 3.67: Commercially Available Molecular Diagnostic Products for Influenza
Assay 144
Table 3.68: Global Market for Molecular Influenza Diagnostic Testing, 2007-2010
145
Table 3.69: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2010 145
Table 3.70: Global Market Forecast for Influenza Molecular Diagnostic Testing,
2010-2016 145
Table 3.71: U.S. Market Forecast for Influenza Molecular Diagnostic Testing,
2010-2016 145
Table 3.72: INFLUENZA Molecu
To order this report:
: Molecular Diagnostics in Infectious Disease Testing
Check our Company Profile, SWOT and Revenue Analysis!
Nicolas Bombourg
Reportlinker
Email: [email protected]
US: (805)652-2626
Intl: +1 805-652-2626
SOURCE Reportlinker
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