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Reportlinker Adds Molecular Diagnostics Markets
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 Markets

http://www.reportlinker.com/p096374/Molecular-Diagnostics-Markets.html

The technologies that constitute molecular diagnostics--like first-generation amplification, DNA probes, fluorescent in situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors, and molecular labels--are influencing the discovery of therapeutic molecules, the screening and diagnosis of patients, and the optimization of drug therapy. In the past few years, this rapidly evolving field has seen several fascinating developments. This TriMark Publications report describes the specific market segment of the in vitro diagnostics market known as molecular diagnostics and includes all of the generally accepted clinical analytical activities in use today. It examines the prevalent clinical-measurement devices, as well as their reagents and supplies as utilized in hospitals, clinics, large reference laboratories and doctor's offices. Diagnostic tests marketed primarily as over-the-counter are generally not included in this report, although there is inevitably some overlap. The main objectives of this analysis are: 1) identifying viable technology drivers through a comprehensive look at platform technologies for molecular diagnostics, including probe-based nucleic acid assays, microarrays and sequencing; 2) obtaining a complete understanding of the chief molecular diagnostics tests--i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic--from their basic principles to their applications; 3) discovering feasible market opportunities by identifying high-growth applications in different clinical diagnostic areas and by focusing on expanding markets, such as communicable diseases, cardiology and oncology; and 4) focusing on global industry development through an in-depth analysis of the major world markets for molecular diagnostics, including growth forecasts.

TABLE OF CONTENTS

1. Overview 12

1.1 Statement of Report 12

1.2 About This Report 12

1.3 Scope of the Report 13

1.4 Objectives 13

1.5 Methodology 14

1.6 Executive Summary 15

2. Introduction to Molecular Diagnostics and PCR Technology 19

2.1 Introduction to Genomics and Its Opportunity 19

2.2 Impact of the Human Genome Project on Molecular Diagnostics 21

2.3 Key Considerations for Molecular Diagnostics 21

2.4 Molecular Diagnostics in the Post-Genomic Era 23

2.5 Advances in Molecular Diagnostics Technologies 24

2.6 Genetic Variability and Disease 25

2.7 Major Technology Platforms 25

2.7.1 Gene-based Amplification Technologies 28

2.7.2 Detection of Amplified Gene Products 28

2.7.3 Target-based Gene Amplification 29

2.7.3.1 Polymerase Chain Reaction (PCR) 29

2.7.3.2 Real-Time PCR 29

2.7.3.3 Nucleic Acid Sequence-based Amplification (NASBA) 30

2.7.4 Probe-based Amplification 30

2.7.4.1 Ligase Chain Reaction (LCR) 30

2.7.4.2 Strand Displacement Amplification (SDA) 31

2.7.4.3 QB-Replicase Amplified Probe Assay 31

2.7.5 Signal-based Amplification 31

2.7.5.1 Branched DNA (bDNA) 31

2.7.6 Other Gene Amplification Technologies 32

2.7.6.1 Immuno-PCR (IPCR) 32

2.7.6.2 Bio-Barcode Amplification Assay (BCA) 32

2.7.6.3 Hybrid Capture 33

2.7.7 Next Generation Sequencing 33

3. Nucleic Acid Test Applications 35

3.1 Molecular Diagnostic Testing and Infectious Diseases 36

3.1.1 Genomics Molecular Diagnostics Market 37

3.1.1.1 Methods for DNA Detection and Gene Sequencing 48

3.1.1.2 Products and Applications 50

3.1.1.3 Oncology 51

3.1.2 SNPs and Genes: Medical Utility (Clinical Applications) 51

3.1.2.1 Clinical Application Initiatives 53

3.1.2.2 Sampling of Affymetrix's Clinical Application Collaborations 54

3.2 Infectious Disease Testing Using Molecular Diagnostics 56

3.2.1 HIV 62

3.2.2 Hepatitis Serologic Markers and Nucleic Acid Testing 67

3.2.2.1 Hepatitis A Virus (HAV) 67

3.2.2.2 Hepatitis B Virus (HBV) 68

3.2.2.2.1 Hepatitis B Market Size 73

3.2.2.3 Hepatitis C Virus (HCV) 74

3.2.2.4 Hepatitis D Virus (HDV) 80

3.2.2.5 Hepatitis E Virus (HEV) 80

3.2.3 Human Papillomavirus (HPV) 82

3.2.4 Influenza Viruses 87

3.2.4.1 H5N1 Influenza Virus 87

3.2.4.2 H1N1 Influenza Virus 89

3.2.5 Cancer Detection Using Molecular Diagnostics 91

3.2.5.1 Lung Cancer 92

3.2.5.2 Oral Cancer 92

3.2.5.3 Prostate Cancer 92

3.2.5.3.1 PCA3 92

3.2.5.3.2 Companies Active in Molecular Diagnostics and Prostate Cancer Analysis

93

3.2.5.4 Chronic Myelogenous Leukemia 95

3.2.5.5 Malignant Gliomas 96

3.2.5.6 Colorectal Cancer 96

3.2.5.6.1 Background on KRAS Mutation 96

3.2.5.7 Breast Cancer 100

3.2.5.8 Bladder Cancer 103

3.2.5.9 Ovarian Cancer 103

3.2.5.10 Molecular Diagnostic Screening Test for Cancer 104

3.2.5.11 Cervical Cancer 104

3.2.6 Microbiology Testing Using Molecular Diagnostics 104

3.2.6.1 Chlamydia 106

3.2.6.1.1 Revenue Forecasts 108

3.2.6.2 Gonorrhea 109

3.2.6.3 Tuberculosis (TB) 111

3.2.6.4 Group B Streptococcus (GBS) 113

3.2.6.5 Bordetella pertussis 116

3.2.6.6 Legionella pneumophila 117

3.2.6.7 Periodontal Bacteria 117

3.2.6.8 Pneumocystis carinii 117

3.2.6.9 Methicillin-resistant Staphylococcus Aureus (MRSA) 117

3.2.6.10 Clostridium difficile 118

3.2.6.11 Vancomycin-resistant Enterococci (VRE) 119

3.2.6.12 Fungal Infections 121

3.2.6.13 Herpes 121

3.2.6.14 Other Infectious Diseases 122

3.2.7 Blood Screening Using Molecular Diagnostics 122

3.2.7.1 Blood Screening Competitive Positions 123

3.3 Genetics Testing in Molecular Diagnostics 128

3.3.1 Functional Genomics 137

3.3.2 Genetic and Paternity Testing 138

3.4 Molecular Diagnostics Uses in Industrial Testing and Food Diagnostics 139

3.4.1 The Market 139

3.4.2 Detection of Helicobacter pylori by PCR 142

3.4.3 Detection of Escherichia coli 0157 142

3.4.4 Detection of Enteric Viruses 143

3.4.5 Industrial Microorganisms 143

3.5 Molecular Diagnostics Forensics Testing Market 143

3.5.1 Analysis by PCR-based DNA Typing 144

3.5.2 Rapid Isolation of DNA for Restriction Fragment Length Polymorphism (RFLP)

and PCR 145

3.5.3 DNA for PCR-STR Typing 145

3.6 Bioterrorism and Molecular Diagnostics 145

3.6.1 Introduction 145

3.6.1.1 Current Biological Threat Detection Systems 148

3.6.1.2 Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWAs

149

3.6.1.3 Advantages and Disadvantages of Host Gene Expression Profiling as a

Biothreat Detection 149

3.6.2 Biological Warfare Agents (BWAs) 150

3.6.2.1 Anthrax 151

3.6.2.2 Botulinum Toxin 152

3.6.2.3 Ricin 152

3.6.2.4 IVD Industry and Bioterrorism Preparedness 152

3.6.2.4.1 Brucellosis 152

3.6.2.4.2 Cholera 153

3.6.2.5 Rapid Lateral Flow Immunoassays 154

3.6.2.6 Biosensors 154

3.6.3 Anthrax in Clinical Samples 156

3.6.3.1 Overview of Anthrax and its Infectivity 156

3.6.3.2 Rapid Tests 157

3.7 Cystic Fibrosis Testing 159

3.8 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits 164

3.8.1 Transplantation of Tissues 164

3.9 Molecular Cytogenetic Testing 165

3.9.1 Hereditary Hemochromatosis 167

3.9.2 Apolipoprotein E (ApoE) Genotyping 167

3.9.3 Fragile X Syndrome (FXS) 168

3.9.4 Methylenetetrahydrofolate Reductase (MTHFR) Carrier Testing 169

3.9 5 Other Genetic Testing Procedures 170

3.10 Developments in DNA Biochips for Clinical Applications 171

3.10.1 Product Analysis 172

3.10.2 Breast Cancer DNA Arrays 174

3.10.3 eSensor DNA Detection System 175

3.11 Personalized Medicine, Pharmacogenomics and Molecular Diagnostics Testing

175

3.11.1 Coumadin (Warfarin) 178

3.12 Thrombic Disorders 180

3.13 Respiratory Virus Panel 180

3.14 HFE (Hemochromatosis) 180

3.15 Lupus 181

3.16 Down's Syndrome and Prenatal Screening 181

3.17 Molecular Diagnostics Technology Platforms and their Impact on Personalized

Medicine 182

4. Trends in Molecular Diagnostics 185

4.1 Pharmacogenomics 185

4.1.1 The Market 185

4.1.1.1 Oncology 185

4.1.1.2 Toxicogenomics 185

4.1.2 Market Influences and Forecast 186

4.2 DNA Microarrays 186

4.2.1 Techniques 191

4.2.2 The Market 191

4.2.3 Identification of Sequence SNPs 191

4.2.4 Determining Gene Expression Levels 192

4.2.4.1 Hybridization Tests 192

4.2.4.2 Oligonucleotide Probes 193

4.2.5 Molecular Diagnostics Entry into Point-of-Care (POC) Testing 193

4.3 Emerging Markets of DNA Arrays 193

4.3.1 Pharmacogenomics 195

4.3.2 Adoption of Amplified Screening Technology 195

4.3.3 Advances in Automated Testing 196

4.3.4 Increased Focus on Safety of Blood Supply 196

4.3.5 Development of Emerging Markets for NAT Technology 196

4.3.6 Cancer 197

4.3.7 Human Leukocyte Antigen (HLA) Typing 197

4.3.8 Neonatal Screening 197

4.4 Drivers and Restraints 198

4.5 Market Forecast 200

4.6 Business Trends in the Industry 200

4.6.1 Molecular Diagnostics Industry Trends 200

4.6.1.1 Adoption of Amplified Screening Technology 201

4.6.1.2 Advances in Automated Testing 201

4.6.1.3 Responsiveness to Newly Emerging Threats 201

4.6.1.4 Increased Focus on Safety of Blood Supply 201

4.6.1.5 Growth in Viral Load Testing 202

4.6.1.6 Development of Emerging Markets for NAT Technology 202

4.6.1.7 Improvements in Detection Technologies 203

4.6.1.8 Use of Multiplex PCR Tests 203

4.6.2 Pharmaceutical Industry Trends 205

4.6.3 Acquisitions, License Agreements and Partnerships 207

4.6.4 Ethical, Legal and Social Issues Related to the Use of Genetic Information

211

4.6.5 Regulatory Issues 211

4.6.5.1 U.S. Food and Drug Administration 212

4.6.5.2 CLIA Regulations 212

4.6.5.3 Clinical Laboratory Improvement Act (CLIA) 213

4.6.5.4 State Licensing for Service Laboratories 215

4.6.5.5 Multivariate Index Assays (IVDMIAs) 215

4.6.5.6 510(k) Clearance 216

4.6.5.6.1 Pre-Market Approval (PMA) 216

4.6.5.7 PMAs 217

4.6.5.8 ASRs 218

4.6.5.9 Laboratory Developed Tests 218

4.6.5.10 What Regulatory Guidance is needed for Companion Biomarkers? 219

4.6.5.11 U.S. Patent and Trademark Office (USPTO) 221

4.6.5.12 IRB Approval in Clinical Trials 221

4.6.5.13 CE marking and the IVDD (European In Vitro Diagnostic Device Directive)

221

4.6.5.14 De Novo Classification 221

4.6.5.15 Research Use Only Reagents 222

4.6.6 Reimbursement Issues and Billing Landscape for Molecular Diagnostics

Testing 222

4.6.6.1 Cystic Fibrosis 223

4.6.6.2 Viral Load Testing 223

4.6.6.3 NMP22 223

4.6.6.4 Trends in Reimbursement Practice 223

4.6.6.5 Medicare Reimbursement Threats 225

4.7 Patent Protection and Intellectual Property Rights 227

4.7.1 New Patents 228

4.7.2 BRCA1 and BRCA2 Gene Patents 229

4.7.3 Current Patent Disputes 230

4.8 Micoarray Quality Control (MAQC) 230

5. Molecular Diagnostics Automated Instrumentation Approved for Market by the

FDA 232

5.1 Gene Expression Profiling 233

5.2 Proteomic Multiplex Assays 234

5.3 Solution-Phase Multiplexing 234

5.4 RNA Interference (RNAi) 234

5.4.1 Role of RNAi in Drug Target Validation 235

5.4.2 Other Companies involved in the RNAi Market 235

5.5 DNA Tags 236

5.6 Follow-on Optical Technologies 237

6. Market Trends and Forecasts 238

6.1 Market Dynamics 238

6.1.1 Molecular Diagnostics Market Opportunities 238

6.1.2 Market Forces 240

6.2 Future Considerations for Molecular Diagnosis 241

6.3 Role of Genomics in Transforming Pharmaceutical R&D 242

6.4 Cancer Markers 242

6.5 Cytology Markers 243

6.6 RNA Detection 243

6.7 Diagnosis of Inherited Disease 243

6.8 Ethical Considerations 243

6.9 NAT and Personalized Medicine 244

6.10 Five Molecular Diagnostics Growth Areas 245

6.11 Specific Commercial Nucleic Acid Probes 245

6.12 Novel Amplification Techniques in the Market 246

6.13 Ramification Amplification Method (RAM) 247

6.14 Invader Assays/Third Wave Technologies (Hologic) 248

6.15 Molecular Beacons 249

6.16 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits 251

6.17 Prenatal Diagnosis 251

6.18 Newborn Screening 251

6.19 NAT and Preventive Medicine: NAT-based Assays 252

6.20 Prenatal and Pre-Implantation Diagnosis 252

6.21 FISH-based Tests on Fetal Cells 252

6.22 Companion Therapeutic/Diagnostic Approach 252

6.23 Sample Preparation Market 253

6.24 Emerging Amplification Techniques 254

6.24.1 Gold Nanoparticle Molecular Probes 254

6.24.2 Real-Time Microfluidic PCR Using Magnetic Affinity Beads 255

6.25 ASRs (Analyte-Specific Reagents) 256

7. Company Profiles 257

7.1 Abbott Laboratories 257

7.2 Adnavance Technologies, Inc. 260

7.3 AdvanDx 260

7.4 Agendia 261

7.5 Agilent Technologies 261

7.6 Asuragen 263

7.7 Ambry Genetics 263

7.8 American Diagnostica 264

7.9 Applied Biosystems, Inc. (now Life Technologies) 264

7.10 ARCA biopharma 264

7.11 ArcticDx, Inc. 264

7.12 Arcxis Biotechnologies 264

7.13 Atlas Genetics 265

7.14 Aureon Laboratories 265

7.15 AutoGenomics, Inc. 266

7.16 Beckman Coulter, Inc. 267

7.17 Becton, Dickinson and Company 271

7.18 BG Medicine 272

7.19 Biocartis 272

7.20 BioGenex Laboratories, Inc. 273

7.21 Biohelix Corporation 273

7.22 bioMerieux 273

7.23 Bio-Rad Laboratories 274

7.24 Biotage AB 276

7.25 Biotest AG 276

7.26 Caliper Life Sciences, Inc. 277

7.27 Celera 280

7.28 Cepheid 281

7.29 CombiMatrix Corporation 282

7.30 Cytocell Technologies Ltd. 283

7.31 CytoCore, Inc. 283

7.32 DiagnoCure, Inc. 283

7.33 DxS 284

7.34 Enzo Biochem 284

7.35 Epigenomics 285

7.36 EraGen Biosciences 285

7.37 Eurogentec 286

7.38 EXACT Sciences Corporation 286

7.39 Exiqon A/S 287

7.40 GeneOhm Sciences 287

7.41 Genera Biosystems 287

7.42 Genzyme Corporation 287

7.43 GenMark Diagnostics, Inc. 288

7.44 Genomix Biotech 288

7.45 Gen-Probe 289

7.46 Gene Express 291

7.47 Genomica 291

7.48 Hologic 291

7.49 Illumina, Inc. 292

7.50 Innogenetics NV 294

7.51 Invitrogen (Life Technologies) 294

7.52 Life Technologies 294

7.53 Luminex 297

7.54 Inverness Medical Innovations 299

7.55 Monogram Biosciences, Inc. 299

7.56 Myconostica 299

7.57 Nanogen 299

7.58 Nanosphere 299

7.59 NorDiag ASA 300

7.60 PharMingen 300

7.61 Qiagen N.V. 300

7.62 Roche Diagnostics 303

7.63 SABiosciences Corporation 306

7.64 Seegene 306

7.65 Siemens Healthcare Diagnostics (Siemens) 306

7.66 SIRS-Lab 307

7.67 Source MDx 307

7.68 Targeted Molecular Diagnostics 308

7.69 Thermo Fisher Scientific 308

7.70 Thorne Diagnostics 309

7.71 TrimGen 310

7.72 TrovaGene 310

7.73 U.S. Genomics, Inc. 310

7.74 Veredus Laboratories 311

7.75 Veridex 311

8. Market Overview 312

8.1 Snapshot of Molecular Diagnostics Industry Structure 314

8.2 Global Molecular Diagnostics Testing Market 315

8.3 U.S. Molecular Diagnostics Testing Market 318

8.4 European Molecular Diagnostics Market 319

8.5 Japanese Molecular Diagnostics Testing Market 320

8.6 Overview of the European Molecular Diagnostics Country Markets 320

8.6.1 France 320

8.6.2 Germany 320

8.6.3 U.K. 321

8.6.4 Italy 321

8.6.5 Spain 322

8.7 Strategic Assessment and Business Development in the Molecular Diagnostics

Sector 322

8.7.1 Industry Background 322

8.7.2 Competition 322

8.7.3 Business Strategy 323

8.7.4 Corporate Examples 324

8.7.4.1 Gen-Probe 324

8.7.4.2 Osmetech 327

8.7.4.3 Combimatrix 327

8.7.4.4 Sekisui Chemical Co. Ltd. 327

8.7.4.5 Myriad Genetics 327

8.7.4.6 Luminex 328

8.7.5 IVD Manufacturers' Goals in Detection Technology Development 332

8.7.5.1 New Developments in Molecular Diagnostic Markers are driven by Corporate

Joint Ventures 332

8.7.5.2 Factors for Growth in Molecular Diagnostics 333

8.7.5.3 How has the IVD Industry Changed? 333

8.7.5.4 What are the Challenges for the Future? 333

8.7.5.5 What New Trends are in the Future? 333

8.7.5.5.1 Market and Technology Trends 334

8.7.5.5.1.1 Market Trends 334

8.7.5.5.1.2 Technology Trends 334

8.7.5.5.1.3 Strategic Recommendations 335

INDEX OF FIGURES

Figure 2.1: Segment of Double-stranded DNA Showing the Base-Pair Relationship 19

Figure 3.1: Overall Structure of Nucleic Acid Testing Market 38

Figure 3.2: Global Market for Molecular Diagnostics Testing, 2010 40

Figure 3.3: Share of Molecular Diagnostics Testing by Testing Type, 2009 42

Figure 3.4: Key Players Market Share in Global Molecular Diagnostics Testing

Markets 43

Figure 3.5: Revenue Mix from BioChips 51

Figure 3.6: Global Revenue Forecast for Molecular Diagnostics Testing for

Infectious Disease, 2009-2016 58

Figure 3.7: Global Market Revenue Share Forecasts for Molecular Diagnostics

Infectious Disease Testing Markets by Region, 2009 and 2016 59

Figure 3.8: Forecast for Total Global Infectious Disease Molecular Diagnostics

Markets, 2016 60

Figure 3.9: Forecast for Total U.S. Infectious Disease Molecular Diagnostics

Markets, 2016 61

Figure 3.10: Key Players Market Share in Global Molecular Diagnostics Infectious

Disease Testing Markets 62

Figure 3.11: Estimated Market Forecast for Global HIV Molecular Diagnostic

Testing, 2011-2016 67

Figure 3.12: Markers of Acute HBV Infection as a Function of Time after Exposure

to Infection 69

Figure 3.13: Primary Causes of Chronic Liver Disease 74

Figure 3.14: Markers of Acute HCV Infection as a Function of Time after Exposure

to Infection 75

Figure 3.15: U.S. Market Share for Molecular Diagnostic HPV Testing, 2010 86

Figure 3.16: Analysis of Cancer Tissue by Microarray 101

Figure 3.17: Number of Genomic Health Oncotype DX Tests Performed, 1991-2006 101

Figure 3.18: U.S. Total Infectious Disease Molecular Diagnostics Markets, 2009

105

Figure 3.19: Estimated Market for Global Blood Screening Product Sales,

2007-2016 125

Figure 3.20: Blood Screening Market Share, 2010 126

Figure 3.21: Bacillus anthracis 156

Figure 4.1: Reimbursement for Diagnostics in Healthcare Decision Making 224

Figure 7.1: Gen-Probe Projected R&D Expenditures 290

Figure 8.1: Molecular Diagnostics Market Segmentation by Testing Type 313

Figure 8.2: Molecular Diagnostics Market Segmentation by Technology 313

Figure 8.3: Global Market for Molecular Diagnostics, 2002-2016 316

Figure 8.4: Global Distribution of Molecular Diagnostics Testing by Geographic

Region, 2010 317

INDEX OF TABLES

Table 2.1: Key Assay Technologies for Molecular Diagnostics 26

Table 2.2: Emerging Molecular Diagnostic Technologies 26

Table 2.3: Companies involved in Next Generation Sequencing Technology 33

Table 3.1: Applications of Molecular Diagnostics Technology Platforms 36

Table 3.2: Global Market for Molecular Diagnostics Testing, 2000-2016 40

Table 3.3: U.S. Market for Molecular Diagnostics Testing, 2004-2016 41

Table 3.4: Summary of Molecular Diagnostics Testing Clinical Focus and Detection

41

Table 3.5: Share of Molecular Diagnostics Testing by Testing Type, 2009 42

Table 3.6: Key Players and Market Share in Global Molecular Diagnostics Testing

Market 42

Table 3.7: Revenue Model for Molecular Diagnostics Testing 43

Table 3.8: Annual U.S. Market for DNA Probe Diagnostics, 1998-2012 43

Table 3.9: Annual Global Market for DNA Probe Diagnostics, 1998-2010 44

Table 3.10: Roche PCR Licenses 45

Table 3.11: Companies Marketing Products Using DNA Probes 47

Table 3.12: Companies Marketing Multiple Products in Molecular Diagnostics

Sector 47

Table 3.13: Global Sales of DNA Probe Kits, 1998-2009 48

Table 3.14: Companies Marketing DNA Detection Platforms 49

Table 3.15: Companies Marketing Genotyping Technologies 52

Table 3.16: Companies Marketing Clinical Genotyping Technologies 53

Table 3.17: Global Revenues and Forecast for Molecular Diagnostics Testing for

Infectious Disease, 2009-2016 58

Table 3.18: Molecular Diagnostic Markets for Infectious Disease Testing, 2010 60

Table 3.19: Molecular Diagnostic Markets for Infectious Disease Testing, 2016 60

Table 3.20: Key Players and Market Share in Global Molecular Diagnostics

Infectious Disease Testing Market 61

Table 3.21: Commercially Available Molecular Diagnostic Products for HIV Assay

62

Table 3.22: Summary of Assays for HIV Viral Load Testing 63

Table 3.23: Global Market for Molecular Diagnostic HIV Testing, 2007-2010 66

Table 3.24: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2010 66

Table 3.25: Global Market Forecast for Molecular Diagnostic HIV Diagnostic

Testing, 2011-2016 66

Table 3.26: U.S. Market Forecast for Molecular Diagnostic HIV Diagnostic

Testing, 2011-2016 67

Table 3.27: Markers for Diagnosis of HBV Infections 70

Table 3.28: Recommendations for HBV Diagnostic Testing 70

Table 3.29: Lower Detection Limits of HBV DNA Assays 70

Table 3.30: Summary of Molecular Diagnostic Assays for Testing HBV 72

Table 3.31: Global Market for HBV Diagnostic Testing, 2000-2010 73

Table 3.32: U.S. Market for HBV Diagnostic Testing, 2000-2010 73

Table 3.33: Global Market Forecast for HBV Diagnostic Testing, 2011-2016 73

Table 3.34: U.S. Market Forecast for HBV Diagnostic Testing, 2011-2016 74

Table 3.35: Recommendations for HCV Diagnostic Testing 77

Table 3.36: Important HCV Statistics 77

Table 3.37: Commercially Available Molecular Diagnostic Products for HCV Assay

78

Table 3.38: Global Market for DNA HCV Diagnostic Testing, 2005-2010 79

Table 3.39: U.S. Market for DNA HCV Diagnostic Testing, 2005-2010 79

Table 3.40: Global Market Forecast for NAT HCV Diagnostic Testing, 2011-2016 79

Table 3.41: U.S. Market Forecast for NAT HCV Diagnostic Testing, 2011-2016 80

Table 3.42: Global Market for DNA HAV Diagnostic Testing, 2000-2008 80

Table 3.43: U.S. Market for DNA HAV Diagnostic Testing, 2000-2008 81

Table 3.44: Global Market for DNA HBV Diagnostic Testing, 2000-2008 81

Table 3.45: U.S. Market for DNA HBV Diagnostic Testing, 2000-2008 81

Table 3.46: Global Market for DNA HCV Diagnostic Testing, 2000-2008 82

Table 3.47: U.S. Market for DNA HCV Diagnostic Testing, 2000-2008 82

Table 3.48: Commercially Available Molecular Diagnostic Products for HPV Assay

85

Table 3.49: Major Companies Marketing HPV Molecular Diagnostic Tests: Market

Size and Share, 2010 86

Table 3.50: Global Market for HPV Molecular Diagnostic Testing, 2007-2010 86

Table 3.51: U.S. Market for HPV Diagnostic Testing, 2007-2010 86

Table 3.52: Global Market Forecast for HPV Molecular Diagnostic Testing,

2011-2016 87

Table 3.53: U.S. Market Forecast for HPV Diagnostic Testing, 2011-2016 87

Table 3.54: Commercially Available Molecular Diagnostic Products for Influenza

Assay 89

Table 3.55: Global Market for Molecular Influenza Diagnostic Testing, 2007-2010

90

Table 3.56: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2010 90

Table 3.57: Global Market Forecast for Influenza Molecular Diagnostic Testing,

2010-2016 90

Table 3.58: U.S. Market Forecast for Influenza Molecular Diagnostic Testing,

2010-2016 90

Table 3.59: Global Market for Molecular Diagnostics Cancer Testing, 2008-2016 91

Table 3.60: Leading Segments of the Molecular Diagnostic Testing Market, 2008 91

Table 3.61: KRAS Assays by Analytical Type 98

Table 3.62: KRAS Mutation Assay from Exiqon Diagnostics 98

Table 3.63: Players in the Breast Cancer Molecular Diagnostic Space 100

Table 3.64: U.S. Molecular Diagnostic Markets for Infectious Disease Testing,

2009 105

Table 3.65: Commercially Available Molecular Diagnostic Products for Chlamydia

Assay 107

Table 3.66: Global Market for Molecular Diagnostic Chlamydia/Gonorrhea

Diagnostic Testing, 2000-2010 107

Table 3.67: U.S. Market for Chlamydia/Gonorrhea Diagnostic Testing, 2000-2010

108

Table 3.68: Global Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing,

2011-2016 108

Table 3.69: U.S. Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing,

2010-2016 108

Table 3.70: CPT Code1 Description National Limitation Amount 111

Table 3.71: Global Market for MD TB Diagnostic Testing, 2005-2010 112

Table 3.72: U.S. Market for MD TB Diagnostic Testing, 2005-2010 112

Table 3.73: Global Market for DNA Group B Streptococcus Diagnostic Testing,

2000-2009 113

Table 3.74: U.S. Market for DNA Group B Streptococcus Diagnostic Testing,

2000-2009 113

Table 3.75: Gen-Probe Clinical Diagnostic Products for the Detection of

Non-Viral Micro-Organisms 114

Table 3.76: Commercially Available Molecular Diagnostic Products for MRSA Assay

115

Table 3.77: Global Market for MRSA Diagnostic Testing, 2005-2010 115

Table 3.78: U.S. Market for MRSA Diagnostic Testing, 2005-2010 116

Table 3.79: Global Market Forecast for MD MRSA Diagnostic Testing, 2011-2016 116

Table 3.80: U.S. Market Forecast for MD MRSA Diagnostic Testing, 2011-2016 116

Table 3.81: Commercially Available Molecular Diagnostic Products for VRE Assay

120

Table 3.82: Global Market for VRE Diagnostic Testing, 2005-2010 120

Table 3.83: U.S. Market for VRE Diagnostic Testing, 2005-2010 120

Table 3.84: Global Market Forecast for MD VRE Diagnostic Testing, 2011-2016 121

Table 3.85: U.S. Market for MD VRE Diagnostic Testing, 2011-2016 121

Table 3.86: Global Market for Blood Screening Product Sales, 2007-2016 125

Table 3.87: Blood Screening Molecular Diagnostics Market: Market Drivers Ranked

in Order of Impact 128

Table 3.88: Blood Screening Molecular Diagnostics Market: Market Restraints

Ranked in Order of Impact 128

Table 3.89: Drivers of the Genetic Analysis Market 130

Table 3.90: Leading Players in the SNP Genotyping Space 130

Table 3.91: Global Market for SNP and Genotyping, 2009-2015 131

Table 3.92: Instrumentation 132

Table 3.93: Consumables 132

Table 3.94: DNA Analysis Market Competitors 137

Table 3.95: Leading Companies in Medical Utility of SNPs 137

Table 3.96: Competitors in the Field of Identity, Family and Paternity Testing

138

Table 3.97: Competitors in the Field of Forensic Testing 139

Table 3.98: U.S. Market for Food-Screening Diagnostic Testing Using MD

Techniques, 2000-2016 141

Table 3.99: Molecular Diagnostics Methods for Detection of Salmonella in Food

142

Table 3.100: U.S. Market for Forensic Diagnostics Testing, 2000-2016 143

Table 3.101: Barriers for Biologics Warfare Monitoring Systems 146

Table 3.102: U.S. Market for Biological Threat Detection Testing, 2000-2010 148

Table 3.103: Technical Problems for PCR Assays for Pathogen Genotyping and

Detection 148

Table 3.104: Biological Warfare Agents Identified by PCR Methods 151

Table 3.105: Companies Developing Detection Devices for Biological Warfare

Agents 151

Table 3.106: Variation of CF Carrier Risks by Ethnic Group 160

Table 3.107: Reasons for CF Testing 160

Table 3.108: Variation of CF Detection Rates by Ethnic Background 160

Table 3.109: Global Market for CF Diagnostic Testing, 2000-2008 161

Table 3.110: U.S. Market for CF Diagnostic Testing, 2000-2008 161

Table 3.111: Projected Global Market for CF Diagnostic Testing, 2009-2013 161

Table 3.112: Projected U.S. Market for CF Diagnostic Testing, 2009-2013 161

Table 3.113: Commercial CF-Screening Products 162

Table 3.114: CF Screening Technology Summary 162

Table 3.115: U.S. Market for HLA Type Testing, 2000-2009 165

Table 3.116: Competitors in HLA Testing 165

Table 3.117: Carrier Rates of Common HFE Mutations in Caucasians 167

Table 3.118: Results and Diagnosis for Fragile X Syndrome 169

Table 3.119: Other Genetic Testing Procedures by Molecular Diagnostics 170

Table 3.120: DNA Chip Market Drivers and Restraints 171

Table 3.121: DNA Chip Major Players 172

Table 3.122: Applications of DNA Biochips 172

Table 3.123: Technology Trends in the DNA Microarray Market 174

Table 3.124: Molecular Diagnostic Personalized Medicine Tests 177

Table 3.125: Global Revenue Forecasts for Prenatal and Newborn Testing Segment,

2007-2015 181

Table 3.126: Various Molecular Diagnostics Technologies: Timeline for Impact 182

Table 3.127: Various Molecular Diagnostics Technologies: Impact on Different

Therapeutic Areas in Personalized Medicine 183

Table 3.128: Various Molecular Diagnostics Technologies: Technical Challenges in

the Deployment for Personalized Medicine 183

Table 4.1: DNA-Sequencing Molecular Diagnostics Market Players 188

Table 4.2: U.S. Market for DNA Chips, 2000-2015 189

Table 4.3: Affymetrix DNA Analysis Products 190

Table 4.4: PCR Segmentation by Sector 198

Table 4.5: Impediments to Incorporating Promising Molecular Tests into Clinical

Practice 199

Table 4.6: Largest Market Opportunities in PCR Testing 200

Table 4.7: PCR Real-Time Applications 205

Table 4.8: Advantages of Using Real-Time PCR 205

Table 4.9: Pharmaceutical Company Challenges 205

Table 4.10: Molecular Diagnostic Sector Acquisitions, Agreements and

Partnerships 207

Table 4.11: Regulatory Rules that Affect the Ability of a Diagnostic Testing

Reagent Company to Conduct Business 211

Table 4.12: Strengths of the 510k Process 216

Table 4.13.: Focus Areas for the FDA Critical Path Initiative 221

Table 4.14: Medicare Pricing Methods 225

Table 4.15: Factors Affecting Third-Party Reimbursement for Molecular Diagnostic

Tests 226

Table 4.16: Documents for Protecting Intellectual Property Rights 228

Table 4.17: Recent Patents Related to PCR, Nucleic Acid Amplification, and

Sample Prep 229

Table 5.1: Molecular Diagnostic High-throughput Automated Testing Systems 232

Table 6.1: Five Molecular Diagnostics Growth Areas 245

Table 6.2: Limitations of Nucleic Acid Chip Probes 245

Table 6.3: Companies Licensed to Sell Custom Molecular Beacon Probes 250

Table 6.4: U.S. Sample Preparation Market, 2005-2012 253

Table 7.1: Products Marketed by Abbott in the Diagnostics Market 259

Table 7.2: Gen-Probe Key Acquisitions 290

Table 7.3: Roche Diagnostics Key Products 305

Table 7.4: Sales by Region 305

Table 7.5: Sales by Business Area 305

Table 7.6: Product Line Sales 306

Table 7.7: Growth Drivers 306

Table 8.1: Number of Molecular Diagnostics Tests in the U.S., 2008-2015 312

Table 8.2: Global Molecular Diagnostics Testing Revenues, 2000-2016 316

Table 8.3: Global Distribution of Molecular Diagnostics Testing by Geographic

Region, 2010 317

Table 8.4: U.S. Molecular Diagnostics Testing Market, 2004-2016 319

Table 8.5: European Molecular Diagnostics Testing Market, 2005-2016 319

Table 8.6: Japanese Molecular Diagnostics Testing Market, 2005-2016 320

Table 8.7: Molecular Diagnostics Market: Market Drivers Ranked in Order of

Impact 330

Table 8.8: Molecular Diagnostics Market: Market Restraints Ranked in Order of

Impact 330

Table 8.9: Large General Diagnostic Lab Services 330

Table 8.10: Small Specialized Diagnostic Lab Services 331

Table 8.11: MDx Sector Leaders 331

Table 8.12: Point-of-Care MDx Leaders 331

Table 8.13: Pure Play MDx Companies 331

Table 8.14: Array Platforms 331

Table 8.15: Molecular Diagnostic Testing Market Trends 334

Table 8.16: Molecular Diagnostic Testing Technology Trends 334

Table 8.17: Molecular Diagnostics Market: Strategic Recommendations on MD Sector

Business Functions 335

To order this report:

: Molecular Diagnostics Markets

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