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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 13
1.1 Statement of Report 13
1.2 About This Report 13
1.3 Scope of the Report 14
1.4 Objectives 14
1.5 Methodology 15
1.6 Executive Summary 16

2. Introduction to Molecular Diagnostics and PCR Technology 20
2.1 Introduction to Genomics and Its Opportunity 20
2.2 Impact of the Human Genome Project on Molecular Diagnostics 22
2.3 Key Considerations for Molecular Diagnostics 22
2.4 Molecular Diagnostics in the Post-Genomic Era 23
2.5 Advances in Molecular Diagnostics Technologies 25
2.6 Genetic Variability and Disease 25
2.7 Major Technology Platforms 26
2.7.1 Gene-based Amplification Technologies 28
2.7.2 Detection of Amplified Gene Products 29
2.7.3 Target-based Gene Amplification 29
2.7.3.1 Polymerase Chain Reaction (PCR) 29
2.7.3.2 Real-Time PCR 30
2.7.3.3 Nucleic Acid Sequence-based Amplification (NASBA) 30
2.7.4 Probe-based Amplification 31
2.7.4.1 Ligase Chain Reaction (LCR) 31
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 32
2.7.5.1 Branched DNA (bDNA) 32
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) 33
2.7.6.3 Hybrid Capture 33
2.7.7 Next Generation Sequencing 33
2.8 PCR Reagents for Clinical Diagnostics 35

3. Nucleic Acid Test Applications 36
3.1 Molecular Diagnostic Testing and Infectious Diseases 37
3.1.1 Genomics Molecular Diagnostics Market 38
3.1.1.1 Methods for DNA Detection and Gene Sequencing 49
3.1.1.2 Products and Applications 51
3.1.1.3 Oncology 52
3.1.2 SNPs and Genes: Medical Utility (Clinical Applications) 52
3.1.2.1 Clinical Application Initiatives 54
3.1.2.2 Sampling of Affymetrix's Clinical Application Collaborations 55
3.2 Infectious Disease Testing Using Molecular Diagnostics 57
3.2.1 HIV 63
3.2.2 Hepatitis Serologic Markers and Nucleic Acid Testing 68
3.2.2.1 Hepatitis A Virus (HAV) 68
3.2.2.2 Hepatitis B Virus (HBV) 69
3.2.2.2.1 Hepatitis B Market Size 74
3.2.2.3 Hepatitis C Virus (HCV) 75
3.2.2.4 Hepatitis D Virus (HDV) 81
3.2.2.5 Hepatitis E Virus (HEV) 81
3.2.3 Human Papillomavirus (HPV) 83
3.2.4 Influenza Viruses 88
3.2.4.1 H5N1 Influenza Virus 88
3.2.4.2 H1N1 Influenza Virus 90
3.2.5 Cancer Detection Using Molecular Diagnostics 92
3.2.5.1 Lung Cancer 93
3.2.5.2 Oral Cancer 93
3.2.5.3 Prostate Cancer 93
3.2.5.3.1 PCA3 93
3.2.5.3.2 Companies Active in Molecular Diagnostics and Prostate Cancer Analysis 94
3.2.5.4 Chronic Myelogenous Leukemia 96
3.2.5.5 Malignant Gliomas 96
3.2.5.6 Colorectal Cancer 97
3.2.5.6.1 Background on KRAS Mutation 97
3.2.5.7 Breast Cancer 101
3.2.5.8 Bladder Cancer 104
3.2.5.9 Ovarian Cancer 104
3.2.5.10 Molecular Diagnostic Screening Test for Cancer 105
3.2.5.11 Cervical Cancer 105
3.2.6 Microbiology Testing Using Molecular Diagnostics 105
3.2.6.1 Chlamydia 107
3.2.6.1.1 Revenue Forecasts 109
3.2.6.2 Gonorrhea 110
3.2.6.3 Tuberculosis (TB) 112
3.2.6.4 Group B Streptococcus (GBS) 114
3.2.6.5 Bordetella pertussis 117
3.2.6.6 Legionella pneumophila 118
3.2.6.7 Periodontal Bacteria 118
3.2.6.8 Pneumocystis carinii 118
3.2.6.9 Methicillin-resistant Staphylococcus Aureus (MRSA) 118
3.2.6.10 Clostridium difficile 119
3.2.6.11 Vancomycin-resistant Enterococci (VRE) 120
3.2.6.12 Fungal Infections 122
3.2.6.13 Herpes 122
3.2.6.14 Other Infectious Diseases 123
3.2.7 Blood Screening Using Molecular Diagnostics 123
3.2.7.1 Blood Screening Competitive Positions 124
3.3 Genetics Testing in Molecular Diagnostics 129
3.3.1 Functional Genomics 138
3.3.2 Genetic and Paternity Testing 139
3.4 Molecular Diagnostics Uses in Industrial Testing and Food Diagnostics 140
3.4.1 The Market 140
3.4.2 Detection of Helicobacter pylori by PCR 143
3.4.3 Detection of Escherichia coli 0157 143
3.4.4 Detection of Enteric Viruses 144
3.4.5 Industrial Microorganisms 144
3.5 Molecular Diagnostics Forensics Testing Market 144
3.5.1 Analysis by PCR-based DNA Typing 145
3.5.2 Rapid Isolation of DNA for Restriction Fragment Length Polymorphism (RFLP) and PCR 146
3.5.3 DNA for PCR-STR Typing 146
3.6 Bioterrorism and Molecular Diagnostics 146
3.6.1 Introduction 146
3.6.1.1 Current Biological Threat Detection Systems 149
3.6.1.2 Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWAs 150
3.6.1.3 Advantages and Disadvantages of Host Gene Expression Profiling as a Biothreat Detection 150
3.6.2 Biological Warfare Agents (BWAs) 151
3.6.2.1 Anthrax 152
3.6.2.2 Botulinum Toxin 153
3.6.2.3 Ricin 153
3.6.2.4 IVD Industry and Bioterrorism Preparedness 153
3.6.2.4.1 Brucellosis 153
3.6.2.4.2 Cholera 154
3.6.2.5 Rapid Lateral Flow Immunoassays 155
3.6.2.6 Biosensors 155
3.6.3 Anthrax in Clinical Samples 157
3.6.3.1 Overview of Anthrax and its Infectivity 157
3.6.3.2 Rapid Tests 158
3.7 Cystic Fibrosis Testing 160
3.8 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits 165
3.8.1 Transplantation of Tissues 165
3.9 Molecular Cytogenetic Testing 166
3.9.1 Hereditary Hemochromatosis 168
3.9.2 Apolipoprotein E (ApoE) Genotyping 168
3.9.3 Fragile X Syndrome (FXS) 169
3.9.4 Methylenetetrahydrofolate Reductase (MTHFR) Carrier Testing 170
3.9 5 Other Genetic Testing Procedures 171
3.10 Developments in DNA Biochips for Clinical Applications 172
3.10.1 Product Analysis 173
3.10.2 Breast Cancer DNA Arrays 175
3.10.3 eSensor DNA Detection System 176
3.11 Personalized Medicine, Pharmacogenomics and Molecular Diagnostics Testing 176
3.11.1 Coumadin (Warfarin) 179
3.12 Thrombic Disorders 181
3.13 Respiratory Virus Panel 181
3.14 HFE (Hemochromatosis) 181
3.15 Lupus 182
3.16 Down's Syndrome and Prenatal Screening 182
3.17 Molecular Diagnostics Technology Platforms and their Impact on Personalized Medicine 183

4. Trends in Molecular Diagnostics 186
4.1 Pharmacogenomics 186
4.1.1 The Market 186
4.1.1.1 Oncology 186
4.1.1.2 Toxicogenomics 186
4.1.2 Market Influences and Forecast 187
4.2 DNA Microarrays 187
4.2.1 Techniques 192
4.2.2 The Market 192
4.2.3 Identification of Sequence SNPs 192
4.2.4 Determining Gene Expression Levels 193
4.2.4.1 Hybridization Tests 193
4.2.4.2 Oligonucleotide Probes 194
4.2.5 Molecular Diagnostics Entry into Point-of-Care (POC) Testing 194
4.3 Emerging Markets of DNA Arrays 194
4.3.1 Pharmacogenomics 196
4.3.2 Adoption of Amplified Screening Technology 196
4.3.3 Advances in Automated Testing 197
4.3.4 Increased Focus on Safety of Blood Supply 197
4.3.5 Development of Emerging Markets for NAT Technology 197
4.3.6 Cancer 198
4.3.7 Human Leukocyte Antigen (HLA) Typing 198
4.3.8 Neonatal Screening 198
4.4 Drivers and Restraints 199
4.5 Market Forecast 201
4.6 Business Trends in the Industry 201
4.6.1 Molecular Diagnostics Industry Trends 201
4.6.1.1 Adoption of Amplified Screening Technology 202
4.6.1.2 Advances in Automated Testing 202
4.6.1.3 Responsiveness to Newly Emerging Threats 202
4.6.1.4 Increased Focus on Safety of Blood Supply 202
4.6.1.5 Growth in Viral Load Testing 203
4.6.1.6 Development of Emerging Markets for NAT Technology 203
4.6.1.7 Improvements in Detection Technologies 204
4.6.1.8 Use of Multiplex PCR Tests 204
4.6.2 Pharmaceutical Industry Trends 206
4.6.3 Acquisitions, License Agreements and Partnerships 208
4.6.4 Ethical, Legal and Social Issues Related to the Use of Genetic Information 212
4.6.5 Regulatory Issues 212
4.6.5.1 U.S. Food and Drug Administration 213
4.6.5.2 CLIA Regulations 213
4.6.5.3 Clinical Laboratory Improvement Act (CLIA) 214
4.6.5.4 State Licensing for Service Laboratories 216
4.6.5.5 Multivariate Index Assays (IVDMIAs) 216
4.6.5.6 510(k) Clearance 217
4.6.5.6.1 Pre-Market Approval (PMA) 217
4.6.5.7 PMAs 218
4.6.5.8 ASRs 219
4.6.5.9 Laboratory Developed Tests 219
4.6.5.10 What Regulatory Guidance is needed for Companion Biomarkers? 220
4.6.5.11 U.S. Patent and Trademark Office (USPTO) 222
4.6.5.12 IRB Approval in Clinical Trials 222
4.6.5.13 CE marking and the IVDD (European In Vitro Diagnostic Device Directive) 222
4.6.5.14 De Novo Classification 222
4.6.5.15 Research Use Only Reagents 223
4.6.6 Reimbursement Issues and Billing Landscape for Molecular Diagnostics Testing 223
4.6.6.1 Cystic Fibrosis 224
4.6.6.2 Viral Load Testing 224
4.6.6.3 NMP22 224
4.6.6.4 Trends in Reimbursement Practice 224
4.6.6.5 Medicare Reimbursement Threats 226
4.7 Patent Protection and Intellectual Property Rights 228
4.7.1 New Patents 229
4.7.2 BRCA1 and BRCA2 Gene Patents 230
4.7.3 Current Patent Disputes 231
4.8 Micoarray Quality Control (MAQC) 231

5. Molecular Diagnostics Automated Instrumentation Approved for Market by the FDA 233
5.1 Gene Expression Profiling 234
5.2 Proteomic Multiplex Assays 235
5.3 Solution-Phase Multiplexing 235
5.4 RNA Interference (RNAi) 235
5.4.1 Role of RNAi in Drug Target Validation 236
5.4.2 Other Companies involved in the RNAi Market 236
5.5 DNA Tags 237
5.6 Follow-on Optical Technologies 238

6. Market Trends and Forecasts 239
6.1 Market Dynamics 239
6.1.1 Molecular Diagnostics Market Opportunities 239
6.1.2 Market Forces 241
6.2 Future Considerations for Molecular Diagnosis 242
6.3 Role of Genomics in Transforming Pharmaceutical R&D 243
6.4 Cancer Markers 243
6.5 Cytology Markers 244
6.6 RNA Detection 244
6.7 Diagnosis of Inherited Disease 244
6.8 Ethical Considerations 244
6.9 NAT and Personalized Medicine 245
6.10 Five Molecular Diagnostics Growth Areas 246
6.11 Specific Commercial Nucleic Acid Probes 246
6.12 Novel Amplification Techniques in the Market 247
6.13 Ramification Amplification Method (RAM) 248
6.14 Invader Assays/Third Wave Technologies (Hologic) 249
6.15 Molecular Beacons 250
6.16 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits 252
6.17 Prenatal Diagnosis 252
6.18 Newborn Screening 252
6.19 NAT and Preventive Medicine: NAT-based Assays 253
6.20 Prenatal and Pre-Implantation Diagnosis 253
6.21 FISH-based Tests on Fetal Cells 253
6.22 Companion Therapeutic/Diagnostic Approach 253
6.23 Sample Preparation Market 254
6.24 Emerging Amplification Techniques 255
6.24.1 Gold Nanoparticle Molecular Probes 255
6.24.2 Real-Time Microfluidic PCR Using Magnetic Affinity Beads 256
6.25 ASRs (Analyte-Specific Reagents) 257

7. Company Profiles 258
7.1 Abbott Laboratories 258
7.2 Adnavance Technologies, Inc. 261
7.3 AdvanDx 261
7.4 Agendia 262
7.5 Agilent Technologies 262
7.6 Asuragen 263
7.7 Ambry Genetics 264
7.8 American Diagnostica 264
7.9 Applied Biosystems, Inc. (now Life Technologies) 265
7.10 ARCA biopharma 265
7.11 ArcticDx, Inc. 265
7.12 Arcxis Biotechnologies 265
7.13 Atlas Genetics 266
7.14 Aureon Laboratories 266
7.15 AutoGenomics, Inc. 267
7.16 Beckman Coulter, Inc. 268
7.17 Becton, Dickinson and Company 271
7.18 BG Medicine 272
7.19 Biocartis 273
7.20 BioGenex Laboratories, Inc. 274
7.21 Biohelix Corporation 274
7.22 bioMerieux 274
7.23 Bio-Rad Laboratories 275
7.24 Biotage AB 276
7.25 Biotest AG 277
7.26 Caliper Life Sciences, Inc. 278
7.27 Celera 280
7.28 Cepheid 282
7.29 CombiMatrix Corporation 283
7.30 Cytocell Technologies Ltd. 284
7.31 CytoCore, Inc. 284
7.32 DiagnoCure, Inc. 284
7.33 DxS (Acquired by QIAGEN) 285
7.34 Enzo Biochem 285
7.35 Epigenomics 286
7.36 EraGen Biosciences 286
7.37 Eurogentec 286
7.38 EXACT Sciences Corporation 287
7.39 Exiqon A/S 288
7.40 GeneOhm Sciences 288
7.41 Genera Biosystems 288
7.42 Genzyme Corporation 288
7.43 GenMark Diagnostics, Inc. 289
7.44 Genomix Biotech 289
7.45 Gen-Probe 290
7.46 Gene Express 292
7.47 Genomica 292
7.48 Hologic 292
7.49 Illumina, Inc. 293
7.50 Innogenetics NV 295
7.51 Invitrogen (Life Technologies) 295
7.52 Life Technologies 295
7.53 Luminex 298
7.54 Inverness Medical Innovations 300
7.55 Monogram Biosciences, Inc. 300
7.56 Myconostica 300
7.57 Nanogen 300
7.58 Nanosphere 300
7.59 NorDiag ASA 301
7.60 PharMingen 301
7.61 QIAGEN N.V. 301
7.62 Roche Diagnostics 304
7.63 SABiosciences Corporation 307
7.64 Seegene 307
7.65 Siemens Healthcare Diagnostics (Siemens) 307
7.66 SIRS-Lab 308
7.67 Source MDx 308
7.68 Targeted Molecular Diagnostics 309
7.69 Thermo Fisher Scientific 309
7.70 Thorne Diagnostics 310
7.71 TrimGen 311
7.72 TrovaGene 311
7.73 U.S. Genomics, Inc. 311
7.74 Veredus Laboratories 312
7.75 Veridex 312

8. Market Overview 313
8.1 Snapshot of Molecular Diagnostics Industry Structure 315
8.2 Global Molecular Diagnostics Testing Market 316
8.3 U.S. Molecular Diagnostics Testing Market 319
8.4 European Molecular Diagnostics Market 320
8.5 Japanese Molecular Diagnostics Testing Market 321
8.6 Overview of the European Molecular Diagnostics Country Markets 321
8.6.1 France 321
8.6.2 Germany 321
8.6.3 U.K. 322
8.6.4 Italy 322
8.6.5 Spain 323
8.7 Strategic Assessment and Business Development in the Molecular Diagnostics Sector 323
8.7.1 Industry Background 323
8.7.2 Competition 323
8.7.3 Business Strategy 324
8.7.4 Corporate Examples 325
8.7.4.1 Gen-Probe 325
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 20
Figure 3.1: Overall Structure of Nucleic Acid Testing Market 39
Figure 3.2: Global Market for Molecular Diagnostics Testing, 2010 41
Figure 3.3: Share of Molecular Diagnostics Testing by Testing Type, 2009 43
Figure 3.4: Key Players Market Share in Global Molecular Diagnostics Testing Markets 44
Figure 3.5: Revenue Mix from BioChips 52
Figure 3.6: Global Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2016 59
Figure 3.7: Global Market Revenue Share Forecasts for Molecular Diagnostics Infectious Disease Testing Markets by Region, 2009 and 2016 60
Figure 3.8: Forecast for Total Global Infectious Disease Molecular Diagnostics Markets, 2016 61
Figure 3.9: Forecast for Total U.S. Infectious Disease Molecular Diagnostics Markets, 2016 62
Figure 3.10: Key Players Market Share in Global Molecular Diagnostics Infectious Disease Testing Markets 63
Figure 3.11: Estimated Market Forecast for Global HIV Molecular Diagnostic Testing, 2011-2016 68
Figure 3.12: Markers of Acute HBV Infection as a Function of Time after Exposure to Infection 70
Figure 3.13: Primary Causes of Chronic Liver Disease 75
Figure 3.14: Markers of Acute HCV Infection as a Function of Time after Exposure to Infection 76
Figure 3.15: U.S. Market Share for Molecular Diagnostic HPV Testing, 2010 87
Figure 3.16: Analysis of Cancer Tissue by Microarray 102
Figure 3.17: Number of Genomic Health Oncotype DX Tests Performed, 1991-2006 102
Figure 3.18: U.S. Total Infectious Disease Molecular Diagnostics Markets, 2009 106
Figure 3.19: Estimated Market for Global Blood Screening Product Sales, 2007-2016 126
Figure 3.20: Blood Screening Market Share, 2010 127
Figure 3.21: Bacillus anthracis 157
Figure 4.1: Reimbursement for Diagnostics in Healthcare Decision Making 225
Figure 7.1: Gen-Probe Projected R&D Expenditures 291
Figure 8.1: Molecular Diagnostics Market Segmentation by Testing Type 314
Figure 8.2: Molecular Diagnostics Market Segmentation by Technology 315
Figure 8.3: Global Market for Molecular Diagnostics, 2002-2016 318
Figure 8.4: Global Distribution of Molecular Diagnostics Testing by Geographic Region, 2010 318


INDEX OF TABLES

Table 2.1: Key Assay Technologies for Molecular Diagnostics 26
Table 2.2: Emerging Molecular Diagnostic Technologies 27
Table 2.3: Companies involved in Next Generation Sequencing Technology 34
Table 3.1: Applications of Molecular Diagnostics Technology Platforms 37
Table 3.2: Global Market for Molecular Diagnostics Testing, 2000-2016 41
Table 3.3: U.S. Market for Molecular Diagnostics Testing, 2004-2016 42
Table 3.4: Summary of Molecular Diagnostics Testing Clinical Focus and Detection 42
Table 3.5: Share of Molecular Diagnostics Testing by Testing Type, 2009 43
Table 3.6: Key Players and Market Share in Global Molecular Diagnostics Testing Market 43
Table 3.7: Revenue Model for Molecular Diagnostics Testing 44
Table 3.8: Annual U.S. Market for DNA Probe Diagnostics, 1998-2012 44
Table 3.9: Annual Global Market for DNA Probe Diagnostics, 1998-2010 45
Table 3.10: Roche PCR Licenses 46
Table 3.11: Companies Marketing Products Using DNA Probes 48
Table 3.12: Companies Marketing Multiple Products in Molecular Diagnostics Sector 48
Table 3.13: Global Sales of DNA Probe Kits, 1998-2009 49
Table 3.14: Companies Marketing DNA Detection Platforms 50
Table 3.15: Companies Marketing Genotyping Technologies 53
Table 3.16: Companies Marketing Clinical Genotyping Technologies 54
Table 3.17: Global Revenues and Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2016 59
Table 3.18: Molecular Diagnostic Markets for Infectious Disease Testing, 2010 61
Table 3.19: Molecular Diagnostic Markets for Infectious Disease Testing, 2016 61
Table 3.20: Key Players and Market Share in Global Molecular Diagnostics Infectious Disease Testing Market 62
Table 3.21: Commercially Available Molecular Diagnostic Products for HIV Assay 63
Table 3.22: Summary of Assays for HIV Viral Load Testing 64
Table 3.23: Global Market for Molecular Diagnostic HIV Testing, 2007-2010 67
Table 3.24: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2010 67
Table 3.25: Global Market Forecast for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016 67
Table 3.26: U.S. Market Forecast for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016 68
Table 3.27: Markers for Diagnosis of HBV Infections 71
Table 3.28: Recommendations for HBV Diagnostic Testing 71
Table 3.29: Lower Detection Limits of HBV DNA Assays 71
Table 3.30: Summary of Molecular Diagnostic Assays for Testing HBV 73
Table 3.31: Global Market for HBV Diagnostic Testing, 2000-2010 74
Table 3.32: U.S. Market for HBV Diagnostic Testing, 2000-2010 74
Table 3.33: Global Market Forecast for HBV Diagnostic Testing, 2011-2016 74
Table 3.34: U.S. Market Forecast for HBV Diagnostic Testing, 2011-2016 75
Table 3.35: Recommendations for HCV Diagnostic Testing 78
Table 3.36: Important HCV Statistics 78
Table 3.37: Commercially Available Molecular Diagnostic Products for HCV Assay 79
Table 3.38: Global Market for DNA HCV Diagnostic Testing, 2005-2010 80
Table 3.39: U.S. Market for DNA HCV Diagnostic Testing, 2005-2010 80
Table 3.40: Global Market Forecast for NAT HCV Diagnostic Testing, 2011-2016 80
Table 3.41: U.S. Market Forecast for NAT HCV Diagnostic Testing, 2011-2016 81
Table 3.42: Global Market for DNA HAV Diagnostic Testing, 2000-2008 81
Table 3.43: U.S. Market for DNA HAV Diagnostic Testing, 2000-2008 82
Table 3.44: Global Market for DNA HBV Diagnostic Testing, 2000-2008 82
Table 3.45: U.S. Market for DNA HBV Diagnostic Testing, 2000-2008 82
Table 3.46: Global Market for DNA HCV Diagnostic Testing, 2000-2008 83
Table 3.47: U.S. Market for DNA HCV Diagnostic Testing, 2000-2008 83
Table 3.48: Commercially Available Molecular Diagnostic Products for HPV Assay 86
Table 3.49: Major Companies Marketing HPV Molecular Diagnostic Tests: Market Size and Share, 2010 87
Table 3.50: Global Market for HPV Molecular Diagnostic Testing, 2007-2010 87
Table 3.51: U.S. Market for HPV Diagnostic Testing, 2007-2010 87
Table 3.52: Global Market Forecast for HPV Molecular Diagnostic Testing, 2011-2016 88
Table 3.53: U.S. Market Forecast for HPV Diagnostic Testing, 2011-2016 88
Table 3.54: Commercially Available Molecular Diagnostic Products for Influenza Assay 90
Table 3.55: Global Market for Molecular Influenza Diagnostic Testing, 2007-2010 91
Table 3.56: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2010 91
Table 3.57: Global Market Forecast for Influenza Molecular Diagnostic Testing, 2010-2016 91
Table 3.58: U.S. Market Forecast for Influenza Molecular Diagnostic Testing, 2010-2016 91
Table 3.59: Global Market for Molecular Diagnostics Cancer Testing, 2008-2016 92
Table 3.60: Leading Segments of the Molecular Diagnostic Testing Market 92
Table 3.61: KRAS Assays by Analytical Type 99
Table 3.62: KRAS Mutation Assay from Exiqon Diagnostics 99
Table 3.63: Players in the Breast Cancer Molecular Diagnostic Space 101
Table 3.64: U.S. Molecular Diagnostic Markets for Infectious Disease Testing, 2009 106
Table 3.65: Commercially Available Molecular Diagnostic Products for Chlamydia Assay 108
Table 3.66: Global Market for Molecular Diagnostic Chlamydia/Gonorrhea Diagnostic Testing, 2000-2010 108
Table 3.67: U.S. Market for Chlamydia/Gonorrhea Diagnostic Testing, 2000-2010 109
Table 3.68: Global Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing, 2011-2016 109
Table 3.69: U.S. Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing, 2010-2016 109
Table 3.70: CPT Code1 Description National Limitation Amount 112
Table 3.71: Global Market for MD TB Diagnostic Testing, 2005-2010 113
Table 3.72: U.S. Market for MD TB Diagnostic Testing, 2005-2010 113
Table 3.73: Global Market for DNA Group B Streptococcus Diagnostic Testing, 2000-2009 114
Table 3.74: U.S. Market for DNA Group B Streptococcus Diagnostic Testing, 2000-2009 114
Table 3.75: Gen-Probe Clinical Diagnostic Products for the Detection of Non-Viral Micro-Organisms 115
Table 3.76: Commercially Available Molecular Diagnostic Products for MRSA Assay 116
Table 3.77: Global Market for MRSA Diagnostic Testing, 2005-2010 116
Table 3.78: U.S. Market for MRSA Diagnostic Testing, 2005-2010 117
Table 3.79: Global Market Forecast for MD MRSA Diagnostic Testing, 2011-2016 117
Table 3.80: U.S. Market Forecast for MD MRSA Diagnostic Testing, 2011-2016 117
Table 3.81: Commercially Available Molecular Diagnostic Products for VRE Assay 121
Table 3.82: Global Market for VRE Diagnostic Testing, 2005-2010 121
Table 3.83: U.S. Market for VRE Diagnostic Testing, 2005-2010 121
Table 3.84: Global Market Forecast for MD VRE Diagnostic Testing, 2011-2016 122
Table 3.85: U.S. Market for MD VRE Diagnostic Testing, 2011-2016 122
Table 3.86: Global Market for Blood Screening Product Sales, 2007-2016 126
Table 3.87: Blood Screening Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 129
Table 3.88: Blood Screening Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 129
Table 3.89: Drivers of the Genetic Analysis Market 131
Table 3.90: Leading Players in the SNP Genotyping Space 131
Table 3.91: Global Market for SNP and Genotyping, 2009-2015 132
Table 3.92: Instrumentation 133
Table 3.93: Consumables 133
Table 3.94: DNA Analysis Market Competitors 138
Table 3.95: Leading Companies in Medical Utility of SNPs 138
Table 3.96: Competitors in the Field of Identity, Family and Paternity Testing 139
Table 3.97: Competitors in the Field of Forensic Testing 140
Table 3.98: U.S. Market for Food-Screening Diagnostic Testing Using MD Techniques, 2000-2016 142
Table 3.99: Molecular Diagnostics Methods for Detection of Salmonella in Food 143
Table 3.100: U.S. Market for Forensic Diagnostics Testing, 2000-2016 144
Table 3.101: Barriers for Biologics Warfare Monitoring Systems 147
Table 3.102: U.S. Market for Biological Threat Detection Testing, 2000-2010 149
Table 3.103: Technical Problems for PCR Assays for Pathogen Genotyping and Detection 149
Table 3.104: Biological Warfare Agents Identified by PCR Methods 152
Table 3.105: Companies Developing Detection Devices for Biological Warfare Agents 152
Table 3.106: Variation of CF Carrier Risks by Ethnic Group 161
Table 3.107: Reasons for CF Testing 161
Table 3.108: Variation of CF Detection Rates by Ethnic Background 161
Table 3.109: Global Market for CF Diagnostic Testing, 2000-2008 162
Table 3.110: U.S. Market for CF Diagnostic Testing, 2000-2008 162
Table 3.111: Projected Global Market for CF Diagnostic Testing, 2009-2013 162
Table 3.112: Projected U.S. Market for CF Diagnostic Testing, 2009-2013 162
Table 3.113: Commercial CF-Screening Products 163
Table 3.114: CF Screening Technology Summary 163
Table 3.115: U.S. Market for HLA Type Testing, 2000-2009 166
Table 3.116: Competitors in HLA Testing 166
Table 3.117: Carrier Rates of Common HFE Mutations in Caucasians 168
Table 3.118: Results and Diagnosis for Fragile X Syndrome 170
Table 3.119: Other Genetic Testing Procedures by Molecular Diagnostics 171
Table 3.120: DNA Chip Market Drivers and Restraints 172
Table 3.121: DNA Chip Major Players 173
Table 3.122: Applications of DNA Biochips 173
Table 3.123: Technology Trends in the DNA Microarray Market 175
Table 3.124: Molecular Diagnostic Personalized Medicine Tests 178
Table 3.125: Global Revenue Forecasts for Prenatal and Newborn Testing Segment, 2007-2015 182
Table 3.126: Various Molecular Diagnostics Technologies: Timeline for Impact 183
Table 3.127: Various Molecular Diagnostics Technologies: Impact on Different Therapeutic Areas in Personalized Medicine 184
Table 3.128: Various Molecular Diagnostics Technologies: Technical Challenges in the Deployment for Personalized Medicine 184
Table 4.1: DNA-Sequencing Molecular Diagnostics Market Players 189
Table 4.2: U.S. Market for DNA Chips, 2000-2015 190
Table 4.3: Affymetrix DNA Analysis Products 191
Table 4.4: PCR Segmentation by Sector 199
Table 4.5: Impediments to Incorporating Promising Molecular Tests into Clinical Practice 200
Table 4.6: Largest Market Opportunities in PCR Testing 201
Table 4.7: PCR Real-Time Applications 206
Table 4.8: Advantages of Using Real-Time PCR 206
Table 4.9: Pharmaceutical Company Challenges 206
Table 4.10: Molecular Diagnostic Sector Acquisitions, Agreements and Partnerships 208
Table 4.11: Regulatory Rules that Affect the Ability of a Diagnostic Testing Reagent Company to Conduct Business 212
Table 4.12: Strengths of the 510k Process 217
Table 4.13.: Focus Areas for the FDA Critical Path Initiative 222
Table 4.14: Medicare Pricing Methods 226
Table 4.15: Factors Affecting Third-Party Reimbursement for Molecular Diagnostic Tests 227
Table 4.16: Documents for Protecting Intellectual Property Rights 229
Table 4.17: Recent Patents Related to PCR, Nucleic Acid Amplification, and Sample Prep 230
Table 5.1: Molecular Diagnostic High-throughput Automated Testing Systems 233
Table 6.1: Five Molecular Diagnostics Growth Areas 246
Table 6.2: Limitations of Nucleic Acid Chip Probes 246
Table 6.3: Companies Licensed to Sell Custom Molecular Beacon Probes 251
Table 6.4: U.S. Sample Preparation Market, 2005-2012 254
Table 7.1: Products Marketed by Abbott in the Diagnostics Market 260
Table 7.2: Gen-Probe Key Acquisitions 291
Table 7.3: Roche Diagnostics Key Products 306
Table 7.4: Sales by Region 306
Table 7.5: Sales by Business Area 306
Table 7.6: Product Line Sales 307
Table 7.7: Growth Drivers 307
Table 8.1: Number of Molecular Diagnostics Tests in the U.S., 2008-2015 313
Table 8.2: Global Molecular Diagnostics Testing Revenues, 2000-2016 317
Table 8.3: Global Distribution of Molecular Diagnostics Testing by Geographic Region, 2010 318
Table 8.4: U.S. Molecular Diagnostics Testing Market, 2004-2016 320
Table 8.5: European Molecular Diagnostics Testing Market, 2005-2016 320
Table 8.6: Japanese Molecular Diagnostics Testing Market, 2005-2016 321
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