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Reportlinker Adds Molecular Diagnostics in Infectious Disease Testing
Date:3/31/2011

NEW YORK, March 31, 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

More  Market Research Report

Check our  Company Profile, SWOT and Revenue Analysis!

Nicolas Bombourg

Reportlinker

Email: nbo@reportlinker.com

US: (805)652-2626

Intl: +1 805-652-2626


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