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.
1. Overview 9
1.1 Statement of Report 9
1.2 About This Report 9
1.3 Scope of the Report 9
1.4 Objectives 10
1.5 Methodology 11
1.6 Executive Summary 12
2. Introduction to Molecular Diagnostics and PCR Technology 16
2.1 Introduction to Genomics and Its Opportunity 16
2.2 Impact of the Human Genome Project on Molecular Diagnostics 18
2.3 Key Considerations for Molecular Diagnostics 18
2.4 Molecular Diagnostics in the Post-Genomic Era 19
2.5 Advances in Molecular Diagnostics Technologies 21
2.6 Genetic Variability and Disease 21
2.7 Major Technology Platforms 22
2.7.1 Gene-based Amplification Technologies 24
2.7.2 Detection of Amplified Gene Products 24
2.7.3 Target-based Gene Amplification 25
2.7.3.1 Polymerase Chain Reaction (PCR) 25
2.7.3.2 Real-Time PCR 25
2.7.3.3 Nucleic Acid Sequence-Based Amplification (NASBA) 26
2.7.4 Probe-Based Amplification 27
2.7.4.1 Ligase Chain Reaction (LCR) 27
2.7.4.2 Strand Displacement Amplification (SDA) 27
2.7.4.3 QB-Replicase Amplified Probe Assay 27
2.7.5 Signal-Based Amplification 27
2.7.5.1 Branched DNA (bDNA) 27
2.7.6 Other Gene Amplification Technologies 28
2.7.6.1 Immuno-PCR (IPCR) 28
2.7.6.2 Bio-Barcode Amplification Assay (BCA) 28
2.7.6.3 Hybrid Capture 29
3. Nucleic Acid Test Applications 30
3.1 Blood Testing and Infectious Diseases 31
3.1.1 Molecular Diagnostics Market 32
3.1.1.1 Methods for DNA Detection and Gene Sequencing 43
3.1.1.2 Products and Applications 44
3.1.1.3 Oncology 45
3.1.2 SNPs and Genes: Medical Utility (Clinical Applications) 45
3.1.2.1 Clinical Application Initiatives 47
3.1.2.2 Sampling of Affymetrix’s Clinical Application Collaborations 48
3.2 Diagnostic Testing Using DNA or RNA 50
3.2.1 HIV 51
3.2.2 Hepatitis Serologic Markers and Nucleic Acid Testing 55
3.2.2.1 Hepatitis A Virus (HAV) 55
3.2.2.2 Hepatitis B Virus (HBV) 56
3.2.2.3 Hepatitis C Virus (HCV) 61
3.2.2.4 Hepatitis D Virus (HDV) 65
3.2.2.5 Hepatitis E Virus (HEV) 65
3.2.3 Human Papillomavirus (HPV) 67
3.2.4 Influenza Viruses 71
3.2.4.1 H5N1 Influenza Virus 71
3.2.4.2 H1N1 Influenza Virus 73
3.2.5 Cancer Detection Using PCR 73
3.2.5.1 Lung Cancer 74
3.2.5.2 Oral Cancer 74
3.2.5.3 Prostate Cancer 74
3.2.5.4 Chronic Myelogenous Leukemia 77
3.2.5.5 Malignant Gliomas 77
3.2.5.6 Colorectal Cancer 77
3.2.5.7 Breast Cancer 79
3.2.5.8 Bladder Cancer 80
3.2.5.9 Ovarian Cancer 81
3.2.5.10 Molecular Diagnostic Screening Test for Cancer 81
3.2.5.11 Cervical Cancer 81
3.2.6 Microbiology Testing 81
3.2.6.1 Chlamydia 83
3.2.6.2 Gonorrhea 84
3.2.6.3 Tuberculosis (TB) 86
3.2.6.4 Group B Streptococcus (GBS) 90
3.2.6.5 Bordetella pertussis 92
3.2.6.6 Legionella pneumophila 92
3.2.6.7 Periodontal Bacteria 92
3.2.6.8 Pneumocystis carinii 92
3.2.6.9 Methicillin-resistant Staphylococcus Aureus (MRSA) 93
3.2.6.10 Clostridium difficile 94
3.2.6.11 Vancomycin-resistant Enterococci (VRE) 94
3.2.6.12 Fungal Infections 95
3.2.6.13 Herpes 95
3.2.6.14 Other Infectious Diseases 96
3.2.7 Blood Screening 96
3.2.7.1 Blood Screening Competitive Positions 97
3.3 SNPs in Clinical Diagnostics 102
3.3.1 Functional Genomics 111
3.3.2 Paternity Testing 111
3.4 Industrial Testing and Food Diagnostics 112
3.4.1 The Market 112
3.4.2 Detection of Helicobacter pylori by PCR 115
3.4.3 Detection of Escherichia coli 0157 116
3.4.4 Detection of Enteric Viruses 116
3.5 DNA Forensics Testing Market 116
3.5.1 Analysis by PCR-based DNA Typing 118
3.5.2 Rapid Isolation of DNA for Restriction Fragment Length Polymorphism (RFLP) and PCR 118
3.5.3 DNA for PCR-STR Typing 118
3.6 Bioterrorism and Molecular Diagnostics 118
3.6.1 Introduction 119
3.6.1.1 Current Biological Threat Detection Systems 121
3.6.1.2 Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWAs 122
3.6.1.3 Advantages and Disadvantages of Host Gene Expression Profiling as a Biothreat Detection 122
3.6.2 Biological Warfare Agents (BWAs) 123
3.6.2.1 Anthrax 123
3.6.2.2 Botulinum Toxin 124
3.6.2.3 Ricin 124
3.6.2.4 IVD Industry and Bioterrorism Preparedness 124
3.6.2.5 Rapid Lateral Flow Immunoassays 126
3.6.2.6 Biosensors 126
3.6.3 Anthrax in Clinical Samples 128
3.6.3.1 Overview of Anthrax and its Infectivity 128
3.6.3.2 Rapid Tests 130
3.7 Cystic Fibrosis Testing 131
3.8 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits 136
3.8.1 Transplantation of Tissues 137
3.9 Molecular Cytogenetic Testing 138
3.9.1 Hereditary Hemochromatosis 139
3.9.2 Apolipoprotein E (ApoE) Genotyping 140
3.9.3 Fragile X Syndrome (FXS) 141
3.9.4 Methylenetetrahydrofolate Reductase (MTHFR) Carrier Testing 142
3.9 5 Other Genetic Testing Procedures 142
3.10 Developments in DNA Biochips for Clinical Applications 144
3.10.1 Product Analysis 145
3.10.2 Breast Cancer DNA Arrays 147
3.10.3 eSensor DNA Detection System 147
3.11 Pharmacogenomics 148
3.11.1 Coumadin (Warfarin) 149
3.12 Thrombic Disorders 151
3.13 Respiratory Virus Panel 152
3.14 HFE (Hemochromatosis) 152
3.15 Lupus 152
3.16 Down’s Syndrome and Prenatal Screening 152
4. Trends in Molecular Diagnostics 154
4.1 Pharmacogenomics 154
4.1.1 The Market 154
4.1.1.1 Oncology 154
4.1.1.2 Toxicogenomics 154
4.1.2 Market Influences and Forecast 155
4.2 DNA Microarrays 155
4.2.1 Techniques 160
4.2.2 The Market 160
4.2.3 Identification of Sequence SNPs 161
4.2.4 Determining Gene Expression Levels 161
4.2.4.1 Hybridization Tests 161
4.2.4.2 Oligonucleotide Probes 162
4.2.5 Molecular Diagnostics Entry into Point-of-Care (POC) Testing 162
4.3 Emerging Markets of DNA Arrays 162
4.3.1 Pharmacogenomics 164
4.3.2 Adoption of Amplified Screening Technology 164
4.3.3 Advances in Automated Testing 165
4.3.4 Increased Focus on Safety of Blood Supply 165
4.3.5 Development of Emerging Markets for NAT Technology 166
4.3.6 Cancer 166
4.3.7 Human Leukocyte Antigen (HLA) Typing 166
4.3.8 Neonatal Screening 166
4.4 Drivers and Restraints 167
4.5 Market Forecast 168
4.6 Business Trends in the Industry 168
4.6.1 Molecular Diagnostics Industry Trends 168
4.6.1.1 Adoption of Amplified Screening Technology 169
4.6.1.2 Advances in Automated Testing 169
4.6.1.3 Responsiveness to Newly Emerging Threats 169
4.6.1.4 Increased Focus on Safety of Blood Supply 169
4.6.1.5 Growth in Viral Load Testing 169
4.6.1.6 Development of Emerging Markets for NAT Technology 170
4.6.1.7 Improvements in Detection Technologies 170
4.6.2 Pharmaceutical Industry Trends 172
4.6.3 Acquisitions, License Agreements and Partnerships 174
4.6.4 Ethical, Legal and Social Issues Related to the Use of Genetic Information 177
4.6.5 Regulatory Issues 177
4.6.6 Reimbursement Issues 179
4.6.6.1 Cystic Fibrosis 179
4.6.6.2 Viral Load Testing 179
4.6.6.3 NMP22 179
5. Molecular Diagnostics Automated Instrumentation Approved for Market by the FDA 180
5.1 Gene Expression Profiling 182
5.2 Proteomic Multiplex Assays 182
5.3 Solution-Phase Multiplexing 183
5.4 RNA Interference (RNAi) 183
5.4.1 Role of RNAi in Drug Target Validation 184
5.4.2 Other Companies Involved in the RNAi Market 184
5.5 DNA Tags 184
6. Market Trends and Forecasts 186
6.1 Market Dynamics 186
6.1.1 Molecular Diagnostics Market Opportunities 186
6.1.2 Market Forces 187
6.2 Future Considerations for Molecular Diagnosis 188
6.3 Role of Genomics in Transforming Pharmaceutical R&D 189
6.4 Cancer Markers 189
6.5 Cytology Markers 190
6.6 RNA Detection 190
6.7 Diagnosis of Inherited Disease 190
6.8 Ethical Considerations 191
6.9 NAT and Personalized Medicine 192
6.10 Five Molecular Diagnostics Growth Areas 192
6.11 Specific Commercial Nucleic Acid Probes 193
6.12 Novel Amplification Techniques in the Market 194
6.13 Ramification Amplification Method (RAM) 194
6.14 Invader Assays/Third Wave Technologies (Hologic) 195
6.15 Molecular Beacons 197
6.16 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits 198
6.17 Prenatal Diagnosis 198
6.18 Newborn Screening 199
6.19 NAT and Preventive Medicine: NAT-Based Assays 199
6.20 Prenatal and Pre-Implantation Diagnosis 199
6.21 FISH-Based Tests on Fetal Cells 200
6.22 Companion Therapeutic/Diagnostic Approach 200
6.23 Sample Preparation Market 200
6.24 Emerging Amplification Techniques 202
6.24.1 Gold Nanoparticle Molecular Probes 202
6.24.2 Real-Time Microfluidic PCR Using Magnetic Affinity Beads 203
6.25 ASRs (Analyte-Specific Reagents) 204
7. Company Profiles 205
7.1 Abbott Laboratories 205
7.2 Adnavance Technologies, Inc. 208
7.3 AdvanDx 208
7.4 Agendia 209
7.5 Agilent Technologies 209
7.6 Asuragen 211
7.7 Ambry Genetics 211
7.8 American Diagnostica 212
7.9 Applied Biosystems, Inc. (now Life Technologies) 212
7.10 ArcticDx, Inc. 212
7.11 Atlas Genetics 212
7.12 Aureon Laboratories 213
7.13 AutoGenomics, Inc. 213
7.14 Beckman Coulter, Inc. 213
7.15 Becton, Dickinson and Company 217
7.16 BG Medicine 218
7.17 BioGenex Laboratories, Inc. 218
7.18 Biohelix Corporation 219
7.19 bioMerieux 219
7.20 Bio-Rad Laboratories 220
7.21 Biotage AB 221
7.22 Biotest AG 222
7.23 Caliper Life Sciences, Inc. 222
7.24 Thermo Fisher Scientific 225
7.25 CombiMatrix Corporation 226
7.26 Cytocell Technologies Ltd. 227
7.27 CytoCore, Inc. 227
7.28 Dako A/S 228
7.29 diaDexus, Inc. 228
7.30 DiagnoCure, Inc. 229
7.31 DxS 229
7.32 Enzo Biochem 229
7.33 Epigenomics 230
7.34 EraGen Biosciences 230
7.35 Eurogentec 231
7.36 EXACT Sciences Corporation 231
7.37 Exiqon A/S 232
7.38 GeneOhm Sciences 232
7.39 Genzyme Corporation 232
7.40 Hologic 233
7.41 Illumina, Inc. 234
7.42 Invitrogen (Life Technologies) 236
7.43 Life Technologies 236
7.44 Luminex 238
7.45 Inverness Medical Innovations 240
7.46 Monogram Biosciences, Inc. 241
7.47 Nanogen 241
7.48 ARCA biopharma 241
7.49 PharMingen 241
7.50 Qiagen N.V. 241
7.51 Roche Diagnostics 244
7.52 SABiosciences Corporation 247
7.53 Siemens Healthcare Diagnostics (Siemens) 247
7.54 Targeted Molecular Diagnostics 248
7.55 Thorne Diagnostics 248
7.56 U.S. Genomics, Inc. 248
7.57 Shenzhen PG Biotech 249
8. Market Overview 250
8.1 Snapshot of Molecular Diagnostics Industry Structure 251
8.2 Global Molecular Diagnostics Testing Market 253
8.3 U.S. Molecular Diagnostics Testing Market 255
8.4 European Molecular Diagnostics Market 256
8.5 Japanese Molecular Diagnostics Testing Market 257
8.6 Overview of the European Molecular Diagnostics Country Markets 257
8.6.1 France 257
8.6.2 Germany 257
8.6.3 U.K. 258
8.6.4 Italy 258
8.6.5 Spain 259
8.7 Strategic Assessment and Business Development in the Molecular Diagnostics Sector 259
8.7.1 Industry Background 259
8.7.2 Competition 259
8.7.3 Business Strategy 260
8.7.4 Corporate Examples 261
8.7.4.1 Gen-Probe 261
8.7.4.2 Osmetech 264
8.7.4.3 Combimatrix 264
8.7.4.4 Sekisui Chemical Co. Ltd. 264
8.7.4.5 Myriad Genetics 265
8.7.4.6 Luminex 265
8.7.5 IVD Manufacturers’ Goals in Detection Technology Development 269
8.7.5.1 New Developments in Molecular Diagnostic Markers are Driven by Corporate Joint Ventures 269
8.7.5.2 Factors for Growth in Molecular Diagnostics 270
8.7.5.3 How Has the IVD Industry Changed? 270
8.7.5.4 What are the Challenges for the Future? 270
8.7.5.5 What New Trends are in the Future? 270
INDEX OF FIGURES
Figure 2.1: Segment of Double-stranded DNA Showing the Base-Pair Relationship 16
Figure 3.1: Overall Structure of Nucleic Acid Testing Market 33
Figure 3.2: Key Players Market Share in Global Molecular Diagnostics Testing Markets 37
Figure 3.3: Revenue Mix from BioChips 45
Figure 3.4: Markers of Acute HBV Infection as a Function of Time after Exposure to Infection 57
Figure 3.5: Primary Causes of Chronic Liver Disease 61
Figure 3.6: Markers of Acute HCV Infection as a Function of Time after Exposure to Infection 62
Figure 3.7: Market Share Estimates for Molecular Diagnostic HPV Testing, 2009 70
Figure 3.8: U.S. Total Infectious Disease Molecular Diagnostics Markets, 2009 82
Figure 3.9: Blood Screening Market Share, 2009 100
Figure 3.10: Bacillus anthracis 129
Figure 8.1: Molecular Diagnostics Market Segmentation 251
Figure 8.2: Molecular Diagnostics Market Segmentation by Technology 251
Figure 8.3: Global Distribution of Molecular Diagnostics Testing, 2009 254
INDEX OF TABLES
Table 2.1: Key Assay Technologies for Molecular Diagnostics 22
Table 3.1: Applications of Molecular Diagnostics Technology Platforms 31
Table 3.2: Global Market for Molecular Diagnostics Testing, 2000-2015 35
Table 3.3: U.S. Market for Molecular Diagnostics Testing, 2004-2015 35
Table 3.4: Summary of Molecular Diagnostics Testing Clinical Focus and Detection 36
Table 3.5: Share of Molecular Diagnostics Testing by Testing Type, 2009 36
Table 3.6: Key Players and Market Share in Global Molecular Diagnostics Testing Market 37
Table 3.7: Revenue Model for Molecular Diagnostics Testing 37
Table 3.8: Annual U.S. Market for DNA Probe Diagnostics, 1998-2012 38
Table 3.9: Annual Global Market for DNA Probe Diagnostics, 1998-2009 38
Table 3.10: Roche PCR Licenses 39
Table 3.11: Companies Marketing Products Using DNA Probes 41
Table 3.12: Companies Marketing Multiple Products in Molecular Diagnostics Sector 42
Table 3.13: Global Sales of DNA Probe Kits, 1998-2009 42
Table 3.14: Companies Marketing DNA Detection Platforms 43
Table 3.15: Companies Marketing Genotyping Technologies 46
Table 3.16: Companies Marketing Clinical Genotyping Technologies 47
Table 3.17: Summary of Assays for HIV Viral Load Testing 52
Table 3.18: Global Market for HIV Diagnostic Testing, 2000-2012 55
Table 3.19: U.S. Market for HIV Diagnostic Testing, 2000-2012 55
Table 3.20: Markers for Diagnosis of HBV Infections 58
Table 3.21: Recommendations for HBV Diagnostic Testing 58
Table 3.22: Lower Detection Limits of HBV DNA Assays 59
Table 3.23: Recommendations for HCV Diagnostic Testing 63
Table 3.24: Important HCV Statistics 64
Table 3.25: Global Market for DNA HAV Diagnostic Testing, 2000-2008 65
Table 3.26: U.S. Market for DNA HAV Diagnostic Testing, 2000-2008 66
Table 3.27: Global Market for DNA HBV Diagnostic Testing, 2000-2008 66
Table 3.28: U.S. Market for DNA HBV Diagnostic Testing, 2000-2008 66
Table 3.29: Global Market for DNA HCV Diagnostic Testing, 2000-2008 67
Table 3.30: U.S. Market for DNA HCV Diagnostic Testing, 2000-2008 67
Table 3.31: Global Market for HPV Diagnostic Testing, 2003-2011 71
Table 3.32: Global Market for Molecular Diagnostics Cancer Testing, 2004-2008 73
Table 3.33: U.S. Molecular Diagnostic Markets for Infectious Disease Testing, 2009 82
Table 3.34: CPT Code1 Description National Limitation Amount 86
Table 3.35: Annual Volume of NAT Infectious Disease Testing, 2000-2008 87
Table 3.36: Global Market Dollar Volume of NAT STD Testing, 2000-2008 87
Table 3.37: U.S. Market Dollar Volume of NAT STD Testing, 2000-2009 88
Table 3.38: Global Market for Chlamydia Diagnostic Testing, 2000-2009 88
Table 3.39: U.S. Market for Chlamydia Diagnostic Testing, 2000-2009 88
Table 3.40: Global Market for Gonorrhea Diagnostic Testing, 2000-2008 89
Table 3.41: Global Market for TB Diagnostic Testing, 2000-2008 89
Table 3.42: Global Market for DNA Group B Streptococcus Diagnostic Testing, 2000-2009 89
Table 3.43: U.S. Market for DNA Group B Streptococcus Diagnostic Testing, 2000-2009 90
Table 3.44: Gen-Probe Clinical Diagnostic Products for the Detection of Non-Viral Micro-Organisms 91
Table 3.45: Global Revenue and Forecast for Blood-Screening Market, 2000-2015 99
Table 3.46: U.S. Market and Forecast for Blood-Screening Market, 2000-2015 99
Table 3.47: Drivers of the Genetic Analysis Market 103
Table 3.48: Leading Players in the SNP Genotyping Space 104
Table 3.49: Global Market for SNP and Genotyping, 2009-2015 104
Table 3.50: Instrumentation 105
Table 3.51 Consumables 106
Table 3.52: DNA Analysis Market Competitors 110
Table 3.53: Leading Companies in Medical Utility of SNPs 111
Table 3.54: Competitors in the Field of Identity, Family and Paternity Testing 112
Table 3.55: Competitors in the Field of Forensic Testing 112
Table 3.56: U.S. Market for Food-Screening Diagnostic Testing Using MD Techniques, 2000-2015 114
Table 3.57: Molecular Diagnostics Methods for Detection of Salmonella in Food 115
Table 3.58: U.S. Market for Forensic Diagnostics Testing, 2000-2015 116
Table 3.59: Barriers for Biologics Warfare Monitoring Systems 119
Table 3.60: U.S. Market for Biological Threat Detection Testing, 2000-2010 121
Table 3.61: Technical Problems for PCR Assays for Pathogen Genotyping and Detection 121
Table 3.62: Variation of CF Carrier Risks by Ethnic Group 133
Table 3.63: Reasons for CF Testing 133
Table 3.64: Variation of CF Detection Rates by Ethnic Background 133
Table 3.65: Global Market for CF Diagnostic Testing, 2000-2008 133
Table 3.66: U.S. Market for CF Diagnostic Testing, 2000-2008 134
Table 3.67: Projected Global Market for CF Diagnostic Testing, 2009-2013 134
Table 3.68: Projected U.S. Market for CF Diagnostic Testing, 2009-2013 134
Table 3.69: Commercial CF-Screening Products 134
Table 3.70: CF Screening Technology Summary 135
Table 3.71: U.S. Market for HLA Type Testing, 2000-2009 137
Table 3.72: Competitors in HLA Testing 138
Table 3.73: Carrier Rates of Common HFE Mutations in Caucasians 139
Table 3.74: Results and Diagnosis for Fragile X Syndrome 141
Table 3.75: Other Genetic Testing Procedures by Molecular Diagnostics 143
Table 3.76: DNA Chip Market Drivers and Restraints 144
Table 3.77: DNA Chip Major Players 144
Table 3.78: Applications of DNA Biochips 145
Table 3.79: Technology Trends in the DNA Microarray Market 147
Table 3.80: Global Revenue Forecasts for Prenatal and Newborn Testing Segment, 2007-2015 153
Table 4.1: DNA-Sequencing Molecular Diagnostics Market Players 157
Table 4.2: U.S. Market for DNA Chips, 2000-2015 158
Table 6.1: Limitations of Nucleic Acid Chip Probes 193
Table 6.2: Companies Licensed to Sell Custom Molecular Beacon Probes 198
Table 6.3: U.S. Sample Preparation Market, 2005-2012 201
Table 7.1: Products Marketed by Abbott in the Diagnostics Market 207
Table 7.2: Roche Diagnostics Key Products 246
Table 7.3: Sales by Region 246
Table 7.4: Sales by Business Area 246
Table 7.5: Product Line Sales 247
Table 7.6: Growth Drivers 247
Table 8.1: Number of Molecular Diagnostics Tests in the U.S., 2008-2015 250
Table 8.2: Global Molecular Diagnostics Testing Revenues, 2000-2015 254
Table 8.3: Global Distribution of Molecular Diagnostics Testing, 2009 254
Table 8.4: U.S. Molecular Diagnostics Testing Market, 2004-2015 256
Table 8.5: European Molecular Diagnostics Testing Market, 2005-2015 256
Table 8.6: Japanese Molecular Diagnostics Testing Market, 2005-2015 257
Table 8.7: Molecular Diagnostics Market: Strategic Recommendations on MD Sector Business Functions 267
Table 8.8: Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 267
Table 8.9: Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 267
Table 8.10: Large General Diagnostic Lab Services 267
Table 8.11: Small Specialized Diagnostic Lab Services 268
Table 8.12: MDx Sector Leaders 268
Table 8.13: Point-of-Care MDx Leaders 268
Table 8.14: Pure Play MDx Companies 268
Table 8.15: Array Platforms 269
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