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
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