Molecular Diagnostics Markets

  • November 2013
  • -
  • TriMark Publications
  • -
  • 403 pages

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

TABLE OF CONTENTS

1. Overview 15
1.1 Statement of Report 15
1.2 About This Report 15
1.3 Scope of the Report 15
1.4 Objectives 16
1.5 Methodology 17
1.6 Executive Summary 18

2. Introduction to Molecular Diagnostics and PCR Technology 22
2.1 Introduction to Genomics and Its Opportunity 22
2.2 Genetic Variability and Disease 24
2.3 Impact of the Human Genome Project on Molecular Diagnostics 24
2.4 Key Considerations for Molecular Diagnostics 26
2.5 Molecular Diagnostics in the Post-Genomic Era 27
2.6 Advances in Molecular Diagnostics Technologies 30
2.7 Molecular Diagnostics Testing Technologies and Platforms 33
2.7.1 Amplification Technologies 33
2.7.1.1 PCR and PCR Derivative Platforms 34
2.7.1.2 Multiple Displacement Amplification 39
2.7.1.3 Multiple Annealing and Looping-based Amplification Cycles 40
2.7.1.4 Whole Genome Amplification 40
2.7.1.5 Nucleic Acid Sequence-based Amplification 40
2.7.1.6 Ligase Chain Reaction 41
2.7.1.7 Branched DNA 41
2.7.1.8 Bio-Barcode Amplification Assay 42
2.7.2 Detection of Amplified Gene Products 42
2.7.2.1 High Resolution Melting Analysis 43
2.7.2.2 Microparticle-based Flow Cytometry 43
2.7.3 DNA and Oligonucleotide Microarrays and Chips 44
2.7.3.1 Array Comparative Genomic Hybridization 46
2.7.4 Gene Sequencing 47
2.7.4.1 Sanger Sequencing 47
2.7.4.2 Next Generation Sequencing 47
2.7.5 Fluorescence in situ Hybridization 52
2.8 PCR Reagents 53
2.9 Basic Molecular Testing Work Flow 53
2.10 Techniques 54
2.11 Advances in Automated Testing 54

3. Business Landscape for the Molecular Diagnostics Market Sectors 55
3.1 Market Overview 55
3.2 Molecular Diagnostics Market: Size, Growth, Share, and Competitors 59
3.2.1 Global Molecular Diagnostics Market 59
3.2.2 U.S. Molecular Diagnostics Market 61
3.2.3 Market Share 63
3.2.4 Competitive Environment 66
3.2.5 Marketing Strategies 68
3.3 Snapshot of Molecular Diagnostics Industry Structure 68
3.4 Commercialization and Market Penetration Strategies 69
3.4.1 Partnerships 70
3.5 Market Drivers and Restraints 71
3.6 Market and Technology Trends 73
3.6.1 Market Trends 73
3.6.2 Technology Trends 74
3.7 Strategic Recommendations 75
3.8 What are the Challenges for the Future? 77
3.9 What New Trends are in the Future? 78
3.10 Recent Industry Activity 78
3.10.1 Mandamp;A Activity 78
3.10.2 License Agreements and Partnerships 80
3.11 Key Areas Impacting Future of Molecular Diagnostics 82
3.11.1 Pharmacogenetics and Pharmacogenomics 82
3.11.1.1 Current Applications for Pharmacogenetics and Pharmacogenomics 84
3.11.1.2 Pharmacogenomics and Personalized Medicine in MDx Infectious Disease
Testing 85
3.11.1.3 Companion Diagnostics and Personalized Medicine in the Oncology Sector
86
3.11.2 Toxicogenomics 87
3.11.3 Multiplex Molecular Diagnostics 87
3.11.4 Point of Care Readers and Assays 87
3.11.5 Next Generation Sequencing 88
3.12 Intellectual Property Rights 90
3.12.1 New Patents 91
3.12.2 Current Patent Disputes 92

4. Overview of Clinical Molecular Diagnostic Platforms on the Market 93
4.1 Abbott 94
4.1.1 m2000 RealTime System 94
4.2 Affymetrix Gene Profiling Solutions 94
4.2.1 GeneChip System 3000Dx v.2 95
4.2.2 Gene Profiling Array cGMP U133 P2 95
4.2.3 Affymetrix Gene Profiling Reagents 95
4.3 AutoGenomics 96
4.3.1 INFINITI Plus Analyzer 96
4.4 Becton Dickinson 97
4.4.1 BD MAX System 97
4.4.2 BD Viper System 97
4.4.3 BD Affirm VPIII Microbial Identification System 97
4.4.4 BD ProbeTec ET System 98
4.5 Biomerieux 98
4.5.1 NucliSENS EasyQ 98
4.5.2 NucliSENS easyMAG 98
4.6 Cepheid 99
4.6.1 GeneXpert System 99
4.6.2 SmartCycler System 99
4.7 GenMark Dx 99
4.7.1 eSensor XT-8 System 99
4.8 Hologic Gen-Probe 99
4.8.1 PANTHER System 99
4.8.2 TIGRIS DTS System 100
4.9 Illumina 100
4.9.1 MiSeqDx Instrument 100
4.10 Life Technologies/Applied Biosystems 100
4.10.1 QuantStudio Dx Real-Time PCR 100
4.10.2 Veriti Dx PCR Thermal Cycler 100
4.10.3 3500 Dx Genetic Analyzers CS2 101
4.10.4 7500 Fast Dx Real-Time PCR System 101
4.11 Meridian Bioscience 101
4.11.1 Illumipro-10 101
4.12 Nanosphere 102
4.12.1 Verigene System 102
4.13 Qiagen 102
4.13.1 Rotor-Gene Q MDx 102
4.13.2 Rapid Capture System andamp; Hybrid Capture 2 Modular System 103
4.14 Roche 103
4.14.1 COBAS 4800 System 103
4.14.2 COBAS AmpliPrep / COBAS TaqMan System 104
4.14.3 COBAS AMPLICOR Analyzer 104
4.14.4 LightCycler 2.0 Instrument 105
4.15 Siemens 105
4.15.1 VERSANT 440 Molecular System 105

5. Molecular Diagnostic Testing and Infectious Diseases 106
5.1 Molecular Testing of Infectious Disease Market 106
5.2 HIV Molecular Testing 114
5.2.1 Summary of Assays and Platforms 114
5.2.2 HIV Molecular Diagnostics Market and Technology Trends 118
5.2.2.1 Market Trends 118
5.2.2.2 Technology Trends 119
5.2.2.3 Strategic Recommendations 119
5.3 Hepatitis Molecular Testing 120
5.3.1 Hepatitis B Virus 120
5.3.1.1 HBV Molecular Assays and Platforms 121
5.3.1.2 Hepatitis B Market 125
5.3.2 Hepatitis C Virus 126
5.3.2.1 HCV Molecular Assays 128
5.3.2.2 Hepatitis C Market 132
5.4 Influenza Virus Molecular Testing 135
5.4.1 Assays for Influenza Detection 136
5.4.2 Influenza Molecular Diagnostic Market 139
5.4.2.1 Market Trends 139
5.4.2.2 Technology Trends 140
5.4.2.3 Strategic Recommendations 141
5.5 STD Testing (Chlamydia/Gonorrhea Molecular Diagnostic Testing) 141
5.5.1 CT/NG Testing Competitive Structure and Market Share Analysis 142
5.5.1.1 CT/NG Testing Market Trends 142
5.5.1.2 Technology Trends 143
5.5.1.3 Strategic Recommendations 144
5.5.2 Chlamydia Molecular Diagnostic Testing 144
5.5.2.1 Product Analysis: Instruments and Reagents for Testing Chlamydia 145
5.5.3 Gonorrhea Molecular Diagnostic Testing 147
5.5.4 Product Analysis: Instruments and Reagents 148
5.6 Tuberculosis 151
5.6.1 Product Analysis: Instruments and Reagents 154
5.6.2 Tuberculosis Market 156
5.6.2.1 Market Trends 157
5.6.2.2 Technology Trends 159
5.6.2.3 Strategic Recommendations 159
5.7 Methicillin-Resistant Staphylococcus aureus 160
5.7.1 Product Analysis: Instruments and Reagents 161
5.7.2 MRSA Molecular Diagnostics Market 163
5.7.2.1 Market Trends 165
5.7.2.2 Technology Trends 166
5.7.2.3 Strategic Recommendations 166
5.8 Vancomycin-resistant Enterococci 168
5.8.1 Product Analysis: Instruments and Reagents 169
5.8.2 VRE Molecular Testing Market 170
5.8.2.1 Market Trends 171
5.8.2.2 Technology Trends 171
5.8.2.3 Strategic Recommendations 171
5.9 Herpes Simplex Virus 172
5.10 C. difficile 173
5.11 Cytomegalovirus 173
5.12 Blood Screening 175
5.12.1 Product Analysis: Instruments and Reagents 177
5.12.2 Blood Screening Market 180
5.12.2.1 Market Trends 181
5.12.2.2 Technology Trends 181
5.12.2.3 Strategic Recommendations 182
5.13 Human Papillomavirus 182
5.13.1 Molecular Instruments and Reagents for HPV Detection 184
5.13.2 HPV Market 191
5.13.2.1 North American Market 192
5.13.2.2 European Market 194
5.13.2.3 Market Trends 195
5.13.2.4 Technology Trends 196
5.13.2.5 Strategic Recommendations 198

6. Cancer Detection Using Molecular Diagnostics 199
6.1 Breast Cancer 200
6.1.2 Breast Cancer Prognostic Assays 202
6.1.2.1 Myriad Genetics (BRACA1 and BRACA2) 204
6.1.2.2 Genomic Health (Oncotype DX) 204
6.1.2.3 InterGenetics, Inc. 208
6.1.2.4 LabCorp (HER-2) 209
6.1.2.5 Clarient, Inc. (GE Healthcare) 211
6.1.2.6 BioTheronostics (AviaraDx) 212
6.1.2.7 Agendia B.V. (MammaPrint) 212
6.1.2.8 Oncogene Science (Wilex) 214
6.1.2.9 Ventana Medical Systems 216
6.1.3 Competition and Comparison of Methods 216
6.1.4 Competitive Structure and Market Share Analysis 217
6.1.4.1 Breast Cancer Molecular Diagnostic Testing Market Size 218
6.1.4.2 Market Forecasts 220
6.1.4.3 Market Drivers and Restraints 220
6.1.4.4 Breast Cancer Molecular Diagnostic Testing Assay Market and Technology
Trends 221
6.2 Colorectal Cancer Molecular Diagnostics Market 221
6.2.1 Colon Cancer Testing Platforms 223
6.2.1.1 Genomic Testing 223
6.2.1.2 Screening Test 228
6.2.2 Players in the Colorectal Cancer Space 228
6.2.3 Competitive Structure and Market Share Analysis 234
6.2.3.1 Colon Cancer Molecular Diagnostic Testing Market Size 235
6.2.3.2 Market Forecasts 236
6.2.3.4 Market Drivers and Restraints 237
6.2.3.5 Colon Cancer Molecular Diagnostic Testing Assay Market and Technology
Trends 237
6.3 Prostate Cancer Molecular Diagnostics Market 240
6.3.1 Screening for Prostate Cancer 241
6.3.1.1 PSA Screening Test for Prostate Cancer 241
6.3.1.2 PCA3 Screening Test for Prostate Cancer 242
6.3.1.3 Gen-Probe 244
6.3.1.4 Beckman Coulter (Danaher) Prostate Health Index 246
6.3.1.5 Opko Health 4KScore 246
6.3.1.6 Metabolon Prostarix DRE Urine Test 246
6.3.2 Tests after Positive Biopsy 247
6.3.2.1 Myriad Genetics (Prolaris) 247
6.3.2.2 Genomic Health (Genomic Prostate Score) 247
6.3.2.3 Bostwick Laboratories (ProstaVysion) 247
6.3.2.4 Metamark Genetics (Biopsy Test) 248
6.3.3 Tests After Negative Biopsy 248
6.3.3.1 Mitomics (Prostate Core Test) 248
6.3.3.2 MDxHealth (Confirm MDx) 249
6.3.4 Tests After Surgery 249
6.3.4.1 GenomeDx Sciences (Decipher) 249
6.3.4.2 Iris International (Nadia ProsVue) 250
6.3.5 Competition and Comparison of Methods 250
6.3.6 Competitive Structure and Market Share Analysis 251
6.3.7 Market Drivers and Restraints 252
6.3.7.1 Market Drivers 252
6.3.7.2 Market Restraints 252
6.3.8 Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology
Trends 252
6.3.8.1 Prostate Cancer Molecular Diagnostic Testing Assay Market Trends 252
6.3.8.2 Prostate Cancer Molecular Diagnostic Testing Assay Technology Trends 253
6.3.8.3 Prostate Cancer Testing Assay Strategic Recommendations 253
6.4 Other Cancer Molecular Diagnostic Markets 255
6.4.1 Bladder Cancer 255
6.4.2 Lung Cancer 256
6.4.3 Melanoma 263
6.5 Molecular Diagnostic Screening Test for Cancer 264
6.6 Companion Diagnostic Tests for Cancer Therapeutics 265

7. Genetics Testing in Molecular Diagnostics 268
7.1 Key Functions of Molecular Genetic Testing 268
7.1.1 Diagnostic Testing of Genetic Disorders 269
7.1.1.1 Common Genetic Disorders 269
7.1.2 Carrier Testing for Genetic Disorders 269
7.1.3 Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening
271
7.1.4 Prenatal/In utero Genetic Testing 273
7.1.5 Newborn Genetic Screening Tests 273
7.1.6 Presymptomatic and Predictive Testing for Adult Onset Disorders 274
7.1.7 Pharmacogenomics 274
7.1.8 Tissue and Blood Typing 274
7.1.8.1 Human Leukocyte Antigen Determination 274
7.1.8.2 Rhesus D Factor Determination 277
7.1.9 Parentage/Relationship Testing (Paternity Testing) 278
7.1.10 Genealogical DNA Testing 278
7.1.11 Criminal and Forensics Testing 279
7.2 Market Structure and Competitive Situation 279
7.2.1 Primary Competitors 280
7.2.2 Commercialization Strategies for Molecular Diagnostic Products 280
7.2.3 Market Penetration Strategies for Genetic Testing 281
7.3 Growing Genetic Testing Market Segments 281
7.3.1 Personalized Medicine and Companion Diagnostics Market 281
7.3.2 Predictive Molecular Diagnostics Market 283
7.3.3 Parallel Genetic Tests for Drug Development 283
7.3.4 Direct-to-Consumer Genetic Testing Market 284
7.3.5 Detecting Genetic Disorders 285
7.3.6 Pre-natal Screening 285
7.3.7 Neonatal Screening 286
7.3.8 Forensic Testing 286
7.3.9 Parentage Testing 286
7.3.10 Blood and Tissue Typing 287
7.3.11 DNA Sequencing 287
7.4 Select Diagnostic and Carrier Tests for Genetic Disorders 288
7.4.1 CombiMatrix Diagnostics’ DNAarray™ Pediatric Microarray Oligo 105K 288
7.4.2 GeneDx’s Genetic Testing for Hereditary Disorders 289
7.4.3 Hologic’s Factor V Reagents 289
7.4.4 Progenika’s FH Test 289
7.4.5 Abbott Molecular’s Cystic Fibrosis Genotyping Assay 289
7.4.6 Counsyl’s Universal Genetic Test 290
7.4.7 Hologic’s InPlex® CF Molecular Test 290
7.4.8 Integrated Genetic’s Inheritest Carrier Screen 291
7.4.9 Luminex’s xTAG Cystic Fibrosis (CFTR) v2 Assays 291
7.4.10 Natera’s Natera One Multi-Disease Genetic Carrier Screening Panel 291
7.4.11 Sequenom’s Heredi-T Cystic Fibrosis Carrier Screen Test 292
7.4.12 Summary of Cystic Fibrosis Tests 293
7.5 Pre-implantation Genetic Tests 293
7.5.1 Natera’s Preimplantation Genetic Diagnosis Test 293
7.6 Prenatal/In Utero Molecular Genetic Screening Tests 294
7.6.1 Cell-Free Fetal DNA Testing 294
7.6.1.1 Ariosa Diagnostics’ Harmony Prenatal Test 294
7.6.1.2 Natera’s Panorama 294
7.6.1.3 Sequenom’s MaterniT21 PLUS Test 295
7.6.1.4 Verinata Health’s verifi Prenatal Test 295
7.6.2 Molecular Cytogenetic Tests 296
7.6.2.1 Abbott Molecular’s AneuVysion Multicolor DNA Probe Panel 296
7.6.2.2 CombiMatrix Diagnostics’ DNAarray Prenatal Microarrays 296
7.6.2.3 Signature Genomics’ Signature Precision Panel I Prenatal 297
7.6.2.4 Signature Genomics’ Signature PrenatalChip TE (Targeted Enhanced)
Microarray 298
7.6.2.5 Signature Genomics’ Signature PrenatalChip OS Microarray 298
7.7 Newborn Genetic Screening Tests 299
7.7.1 Screening for Cystic Fibrosis with Molecular Diagnostic Assays 299
7.7.2 Screening for SCID with the TREC Assay 299
7.7.2.1 PerkinElmer Genetics 300

8. Molecular Diagnostics Uses in Industrial Testing and Food Diagnostics 301
8.1 The Market 301
8.1.1 Detection of Helicobacter pylori by PCR 304
8.1.2 Detection of Escherichia coli 0157 304
8.1.3 Detection of Enteric Viruses 304
8.1.4 Industrial Microorganisms 304
8.2 Molecular Diagnostics Forensics Testing Market 304
8.2.1 Analysis by PCR-based DNA Typing 306
8.2.2 Rapid Isolation of DNA for Restriction Fragment Length Polymorphism (RFLP)
and PCR 306
8.2.3 DNA for PCR-STR Typing 306

9. Bioterrorism and Molecular Diagnostics 307
9.1 Introduction 307
9.2 Current Biological Threat Detection Systems 309
9.2.1 Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWAs
310
9.2.2 Advantages and Disadvantages of Host Gene Expression Profiling as a
Biothreat Detection 310
9.2.3 Biological Warfare Agents 311
9.2.4 Anthrax 312
9.2.5 Botulinum Toxin 313
9.2.6 Ricin 313
9.2.7 IVD Industry and Bioterrorism Preparedness 313
9.2.8 Brucellosis 314
9.2.9 Cholera 315
9.3 Rapid Lateral Flow Immunoassays 315
9.4 Biosensors 315
9.5 Anthrax in Clinical Samples 317
9.5.1 Rapid Tests 318

10. Regulatory Requirements 320
10.1 U.S. Food and Drug Administration 321
10.1.1 FDA Labeling Requirements 321
10.1.2 U.S. Government Regulation of Medical Devices 321
10.1.3 FDA’s Qualification of Biomarkers 322
10.1.4 FDA’s Voluntary Genomic Data Submission 323
10.2 Clinical Laboratory Improvement Act 324
10.3 CLIA Regulations 325
10.4 State Licensing for Service Laboratories 325
10.5 Multivariate Index Assays 326
10.6 FDA Draft Guidance on In Vitro Companion Diagnostic Devices 327
10.7 FDA Draft Guidance on Molecular Diagnostic Instruments with Combined
Functions 327
10.8 510(k) Clearance 327
10.9 Pre-Market Approval 328
10.10 Pre-market Approval Application 328
10.11 Laboratory Developed Tests 329
10.12 Analyte Specific Reagents 332
10.13 What Regulatory Guidance is needed for Companion Biomarkers? 333
10.14 IRB Approval in Clinical Trials 334
10.15 CE marking and the European In Vitro Diagnostic Device Directive 334
10.16 De Novo Classification 334
10.17 Research Use Only Reagents 335
10.18 Ethical, Legal and Social Issues Related to the Use of Genetic Information
335
10.19 Regulatory Issues for Direct to the Consumer Genetic Tests 335
10.20 The Genetic Information Nondiscrimination Act of 2008 337
10.21 Genetic Tests and Medical Records 337
10.22 Recommendations by the American College of Medical Genetics and Genomics
337

11. Reimbursement Issues and Billing Landscape for Molecular Diagnostics Testing
338
11.1 Overview 338
11.1.1 Gap Filling 339
11.2 Trends in Healthcare Reimbursement Practices 340
11.2.1 Molecular Genetics Testing Reimbursement 341
11.3 Medicare Reimbursement Program 342
11.4 Medicare Billing Procedure 343
11.5 CPT Coding Rules for Molecular Diagnostics 345
11.5.1 Former Coding Rules for Molecular Diagnostics 345
11.5.2 Current Coding Rules for Molecular Diagnostics 346
11.5.2.1 Gapfilling 346
11.5.2.2 Reimbursement Delays for Molecular Diagnostics 347
11.6 Revenue Threats 348
11.6.1 Medicare Payment Exceptions 350
11.6.2 Three Areas for Denial of Claims 350
11.7 Bundled Payments for Care Improvement Initiative 350
11.8 Infectious Disease Billing Strategies 351
11.9 Analysis of ROI for MDx Tests for Cancer Using Medicare Reimbursement Rules
352
11.9.1 Reimbursement for Insight Dx, MammaPrint and Oncotype Dx 352
11.9.2 Reimbursement for JAK2 Mutation Testing for Myeloproliferative Neoplasms
353

12. Company Profiles 354
12.1 Abbott Laboratories 354
12.2 AdvanDx 357
12.3 Agendia 358
12.4 Arcxis Biotechnologies 358
12.5 Agilent Technologies 359
12.6 Ambry Genetics 360
12.7 Atlas Genetics 361
12.8 AutoGenomics, Inc. 361
12.9 Beckman Coulter 362
12.10 Becton, Dickinson and Company 365
12.11 Biodesix 367
12.12 Biohelix Corporation 367
12.13 bioMerieux 368
12.14 Bio-Rad Laboratories 368
12.15 Cancer Genetics, Inc. 370
12.16 Celera (acquired by Quest Diagnostics) 371
12.17 Cepheid 372
12.18 Clarient, Inc. (GE Healthcare) 374
12.19 CombiMatrix Corporation 375
12.20 Cytocell Technologies Ltd. 375
12.21 DiagnoCure, Inc. 376
12.22 Enzo Biochem 376
12.23 Epigenomics 377
12.24 Exact Sciences Corporation 377
12.25 Exagen Diagnostics, Inc. 378
12.26 Exiqon 378
12.27 Genera Biosystems 379
12.28 GenMark Diagnostics, Inc. 379
12.29 Genomic Health 380
12.30 Great Basin Corporation 380
12.31 Hologic 381
12.32 Illumina 385
12.33 IntegenX 386
12.34 InterGenetics, Inc. 386
12.35 LabCorp 386
12.36 Life Technologies Corporation 387
12.37 Luminex 389
12.38 Myriad Genetics, Inc. 391
12.39 Nanosphere 393
12.40 Nanostring 394
12.41 Natera 394
12.42 NetBio 394
12.43 Neogenomics 395
12.44 Nuvera Biosciences 395
12.45 Orion Genomics 395
12.46 PerkinElmer Genetics 396
12.47 Progenika 396
12.48 QIAGEN N.V. 396
12.49 Roche Diagnostics 399
12.50 Rosetta Genomics Ltd. 400
12.51 Seegene 400
12.52 Sequenom, Inc. 401
12.53 Siemens Healthcare Diagnostics (Siemens) 401
12.54 Spartan Bioscience 402
12.55 Thorne Diagnostics 402
12.56 Transgenomic 403
12.57 TrimGen 403
12.58 Trovagene, Inc. 403
12.59 Veredus Laboratories 403
12.60 Veridex 403

INDEX OF FIGURES

Figure 2.1: Segment of Double-Stranded DNA Showing the Base-Pair Relationship 22
Figure 2.2: Schematic of Molecular Diagnostics for Studying Gene Expression in
Patients 28
Figure 2.3: The PCR Cycle 34
Figure 2.4: Multiple Displacement Amplification 39
Figure 2.5: Using DNA Microassays to Measure Gene Expression 45
Figure 3.1: Overall Structure of Nucleic Acid Testing Market 56
Figure 3.2: Global Market for Molecular Diagnostics Testing, 2012 60
Figure 3.3: Molecular Diagnostics Market Segmentation by Technology 61
Figure 3.4: Share of Molecular Diagnostics Testing by Application, 2012 63
Figure 3.5: Key Players Market Share in Global Molecular Diagnostics Testing
Markets 64
Figure 3.6: FDA Co-developed Products as a Model for Collaboration 71
Figure 5.1: Global Market for Infectious Disease Treatments, 2008-2014 106
Figure 5.2: Global Revenue for Molecular Diagnostics Testing for Infectious
Disease, 2009-2018 107
Figure 5.3: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious
Disease, 2009-2018 109
Figure 5.4: Infectious Disease Testing Revenue Market Share of Total U.S. MDx
Market, 2012 and 2018 109
Figure 5.5: Infectious Disease Testing Revenue Market Share by Region, 2012 and
2018 110
Figure 5.6: Markers of Acute HCV Infection as a Function of Time after Exposure
to Infection 127
Figure 5.7: Pipeline for TB Diagnostics, 2005-2015 154
Figure 5.8: The Development Pipeline for New TB Drugs, July 2012 154
Figure 5.9: U.S. Market Share of MRSA Molecular Diagnostic Market, 2012 164
Figure 5.10: Global Market Share (Excluding U.S.) of MRSA Molecular Diagnostic
Market, 2012 165
Figure 5.11: U.S. Market Share of VRE Molecular Diagnostic Market, 2012 171
Figure 5.12: Hybrid Capture 2 (HC2) versus PCR - Analytical Sensitivity and
Clinical Sensitivity 187
Figure 5.13: Basic Steps in Hybrid Capture 2 Technology 188
Figure 5.14: U.S. Market Share of HPV Molecular Diagnostic Market, 2012 192
Figure 5.15: Global Market Share (Excluding U.S.) of HPV Molecular Diagnostic
Market, 2012 193
Figure 5.16: Market Share Estimates for Molecular Diagnostic HPV Testing, 2012
193
Figure 6.1: HER-2/NEU Protein as a Target in Cancer Therapy 210
Figure 6.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal
Results with IHC 211
Figure 6.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by
FISH 211
Figure 6.4: Action of Herceptin in Breast Cancer Patients 212
Figure 6.5: Analysis of Cancer Tissue by Microarray 215
Figure 6.6: Global Market Size and Share of Breast Cancer Molecular Diagnostic
Market, 2012 220
Figure 6.7: HNPCC Mutation Increases Risk of Cancer 231
Figure 6.8: APC Mutation Increases the Risk of Cancer 232
Figure 6.9: Prostate-Specific Membrane Antigen 240
Figure 6.10: PCA3 Score Nomogram 243
Figure 6.11: Estimates for PCA3 Test Volume in the U.S., 2005-2012 244
Figure 7.1: Segmentation of the Biomarker Development Market 282
Figure 10.1: Current Regulations for Laboratory Testing 320
Figure 10.2: Existing Regulatory Framework for LDTs 332
Figure 11.1: Reimbursement for Diagnostics in Healthcare Decision Making 341
Figure 11.2: MAC Jurisdiction Map, 2012 347


INDEX OF TABLES

Table 2.1: Key Assay Technologies for Molecular Diagnostics 32
Table 2.2: Emerging Molecular Diagnostic Technologies 32
Table 2.3: DNA Microarray Applications 45
Table 2.4: Companies Involved in Next Generation Sequencing Platforms 48
Table 2.5: Desired Characteristics for Clinical Versus Discovery Next Generation
Sequencing 51
Table 3.1: Applications of Molecular Diagnostics Technology Platforms 55
Table 3.2: Global Market for Molecular Diagnostics Testing, 2010-2018 59
Table 3.3: U.S. Market for Molecular Diagnostics Testing, 2010-2018 62
Table 3.4: Share of Molecular Diagnostics Testing by Application, 2012 63
Table 3.5: Key Players and Market Share in the Global Molecular Diagnostics
Testing Market 64
Table 3.6: Revenue Model for Molecular Diagnostics Testing 64
Table 3.7: Companies Marketing Multiple Products in Molecular Diagnostics Sector
67
Table 3.8: Companies Marketing Clinical Genotyping Technologies 67
Table 3.9: Molecular Diagnostics Market: Market Drivers Ranked in Order of
Impact 72
Table 3.10: Molecular Diagnostics Market: Market Restraints Ranked in Order of
Impact 72
Table 3.11: Molecular Diagnostic Testing Market Trends 73
Table 3.12: Molecular Diagnostic Testing Technology Trends 75
Table 3.13: Attractive Growth Areas for Molecular Diagnostic Testing 77
Table 3.14: Molecular Diagnostics Market: Strategic Recommendations on MDx
Sector Business Functions 77
Table 3.15: Potential Benefits of Pharmacogenetics 83
Table 3.16: Select Drugs with Commercially Available Pharmacogenetic Tests 85
Table 3.17: Examples of Personalized Medicine in Treatment of Infectious Disease
86
Table 3.18: Documents for Protecting Intellectual Property Rights 90
Table 3.19: Recent Patents Related to PCR, Nucleic Acid Amplification and Sample
Prep 92
Table 4.1: Molecular Diagnostic High-Throughput Automated Testing Systems 93
Table 5.1: Global Revenue for Molecular Diagnostics Testing for Infectious
Disease, 2009-2018 107
Table 5.2: Molecular Infectious Disease Diagnostics Market: Market Restraints
Ranked in Order of Impact 108
Table 5.3: Molecular Infectious Disease Diagnostics Market: Market Drivers
Ranked in Order of Impact 108
Table 5.4: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious
Disease, 2009-2018 108
Table 5.5: Molecular Diagnostic Markets for Infectious Disease Testing, 2012 110
Table 5.6: Molecular Diagnostic Markets for Infectious Disease Testing, 2018 111
Table 5.7: Business Factors Influencing Advanced Infectious Disease MDx Testing
Services 112
Table 5.8: Key Players in Global Molecular Diagnostics Infectious Disease
Testing Market 112
Table 5.9: Summary of Assays for HIV Viral Load Testing 114
Table 5.10: HIV Resistance Testing Recommendations 115
Table 5.11: Commercially Available Molecular Diagnostic Products for HIV Assay
115
Table 5.12: Lower Detection Limits of HBV DNA Assays 122
Table 5.13: Summary of Molecular Diagnostic Assays for Testing HBV 124
Table 5.14: Recommendations for HCV Diagnostic Testing 128
Table 5.15: Commercially Available Molecular Diagnostic Products for HCV Assay
132
Table 5.16: Major Companies Marketing HCV Molecular Diagnostic Tests: Market
Size and Share, 2012 133
Table 5.17: Commercially Available Molecular Diagnostic Products for Influenza
Assay 139
Table 5.18: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic
Tests: Market Size and
Share, 2012 142
Table 5.19: Commercially Available Molecular Diagnostic Products for Chlamydia
Assay 146
Table 5.20: Commercially Available Molecular Diagnostic Products for Gonorrhea
Assay 151
Table 5.21: Commercially Available Molecular Diagnostic Assays for Testing TB
155
Table 5.22: Comparative U.S. Claim Charges for TB Testing by Type, 2012 157
Table 5.23: Global Testing for TB by Testing Type, 2012 157
Table 5.24: Global Testing for TB by Testing Reason, 2012 157
Table 5.25: Commercially Available Molecular Diagnostic Products for MRSA Assay
163
Table 5.26: Major Companies Marketing MRSA Molecular Diagnostic Tests: Market
Size and Share, 2012 163
Table 5.27: Commercially Available Molecular Diagnostic Products for VRE Assay
170
Table 5.28 Major Companies Marketing VRE Molecular Diagnostic Tests: Market Size
and Share, 2012 170
Table 5.29: Transmission-related Disease Screening from Blood Donor Pools 174
Table 5.30: Principal Blood Screening Products of Hologic Gen-Probe for HIV
Assay 177
Table 5.31: Major Companies Marketing Blood Screening Molecular Diagnostic
Tests: Market Size and
Share, 2012 179
Table 5.32: Qiagen’s Digene HC2 High-risk HPV DNA Test 186
Table 5.33: Commercially Available Molecular Diagnostic Products for HPV Assay
191
Table 5.34: Major Companies Marketing HPV Molecular Diagnostic Tests: Market
Size and Share, 2012 192
Table 6.1: Companies Marketing Products in the Cancer Molecular Diagnostics
Sector 200
Table 6.2: Key Elements for Business Competition in Gene Expression Profiling
for Cancer 200
Table 6.3: Key Elements for Future Success in the Gene Profiling for Cancer
Segment 201
Table 6.4: Breast Cancer Overview 201
Table 6.5: Overview of ER/PR Testing and Response to Therapy 202
Table 6.6: Key Players in the Breast Cancer Molecular Diagnostic Space 203
Table 6.7: Commercially Available Molecular Diagnostic Products for Breast
Cancer Assay 204
Table 6.8: Summary of Strengths, Weaknesses, Opportunities and Threats of the
Breast Cancer Molecular Diagnostic Market 204
Table 6.9: Clinical Utility and Health Economic Benefits of Oncotype DX 206
Table 6.10: Oncotype DX Overview 206
Table 6.11: Comparison of Agendia vs. Genomic Health Breast Cancer Tests 207
Table 6.12: Overview of HER2/neu and Herceptin 210
Table 6.13: MammaPrint: Key Features 214
Table 6.14: Oncogene Science Biomarker Group Reagents 215
Table 6.15: Major Laboratory Testing Companies Marketing Breast Cancer Molecular
Diagnostic Tests, 2012 218
Table 6.16: Global Market for Breast Cancer Molecular Diagnostic Testing,
2005-2012 219
Table 6.17: U.S. Market for Breast Cancer Molecular Diagnostic Testing,
2005-2012 219
Table 6.18: Global Market Forecast for Breast Cancer Molecular Diagnostic
Testing, 2013-2018 221
Table 6.19: U.S. Market Forecast for Breast Cancer Molecular Diagnostic Testing,
2013-2018 221
Table 6.20: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers
Ranked in Order of Impact 221
Table 6.21: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints
Ranked in Order of Impact 222
Table 6.22: Colorectal Cancer Overview 223
Table 6.23: KRAS Mutation Assay 224
Table 6.24: KRAS Assays by Analytical Type 226
Table 6.25: KRAS Mutation Analysis Summary 226
Table 6.26: DxS KRAS Mutation Test Summary 227
Table 6.27: KRAS and BRAF in Clinical Use 228
Table 6.28: Product Development Opportunities in Cancer Tumor Types, 2008 228
Table 6.29: Key Players in the Colorectal Cancer Molecular Diagnostic Space 229
Table 6.30: ArcticDx Genetic Test, Colo Risk 233
Table 6.31: NexCourse CRC Test Offering and Treatment Direction 235
Table 6.32: Global Market for Molecular Diagnostic Colon Cancer Testing,
2005-2012 236
Table 6.33: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2005-2012
236
Table 6.34: Global Market Forecast for Colon Cancer Molecular Diagnostic
Testing, 2013-2018 237
Table 6.35: U.S. Market Forecast for Colon Cancer Molecular Diagnostic Testing,
2010-2018 237
Table 6.36: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers
Ranked in Order of Impact 238
Table 6.37: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints
Ranked in Order of Impact 238
Table 6.38: Summary of Strengths, Weaknesses, Opportunities and Threats of the
Colon Cancer Market 240
Table 6.39: Stages in Prostate Cancer Discovery and Diagnosis 241
Table 6.40: Corporate Players Entering the Prostate Cancer Molecular Diagnostic
Space 243
Table 6.41: Gen-Probe Genetic Testing Product Line 247
Table 6.42: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers
Ranked in Order of
Impact 253
Table 6.43: Prostate Cancer Molecular Diagnostic Testing Market: Market
Restraints Ranked in Order of
Impact 253
Table 6.44: Summary of Strengths, Weaknesses, Opportunities and Threats of the
Prostate Cancer Molecular Diagnostic Market 254
Table 6.45: Players in the Bladder Cancer Molecular Diagnostic Space 254
Table 6.46: Lung Cancer Survival Rates 256
Table 6.47: Lung Cancer Facts 256
Table 6.48: Lung Cancer Predictive and Prognostic Markers 260
Table 6.49: Potential of Cancer Biomarkers in Drug Delivery and Development 265
Table 6.50: Barriers to Adoption of Biomarkers in Clinical Use 265
Table 7.1: Common Genetic Disorders 269
Table 7.2: HLA Allele Nomenclature 276
Table 7.3: Comparison of HLA Typing Methods 277
Table 7.4: Diagnostic Companies with Existing Pharma Relationships (market caps
under $5 Billion) 282
Table 7.5: Use of Cancer Biomarkers in Drug Development 283
Table 7.6: Utility of Biomarkers as Companion Diagnostics to Drug Development
284
Table 7.7: Competitors in the Field of Forensic Testing 286
Table 7.8: Competitors in the Field of Identity, Family and Paternity Testing
286
Table 7.9: Comparison of Current Genetic Testing Protocols and Potential Use of
Whole Genome Sequencing 288
Table 7.10: Commercial CF-Screening Products 293
Table 7.11: CF Screening Technology Summary 293
Table 8.1: Molecular Diagnostics Met

View This Report »

Find all the market research you need - instantly, in one place.

+1.2 Million Research Documents & Statistics +200,000 Trusted Public Sources 350 Industries With Global Coverage

24/7 Customer Support

Talk to Louis

+1 718 618 4302

Purchase Reports From Reputable Market Research Publishers

New Frontiers in Automated Microbiology: Global Challenges, Emerging Technologies, Competitive Landscape

New Frontiers in Automated Microbiology: Global Challenges, Emerging Technologies, Competitive Landscape

  • $ 21 100
  • Industry report
  • May 2014
  • by Venture Planning Group

“New Frontiers in Automated Microbiology: Global Challenges, Emerging Technologies, Competitive Landscape” is Venture Planning Group's new seven-country strategic analysis of the major business opportunities ...

Emerging Opportunities in the Global Virology and Bacteriology Testing Market

Emerging Opportunities in the Global Virology and Bacteriology Testing Market

  • $ 21 100
  • Industry report
  • June 2014
  • by Venture Planning Group

“Emerging Opportunities in the Global Virology and Bacteriology Testing Market” is a new seven-country strategic analysis of major business opportunities emerging in the infectious disease testing ...

New Frontiers in Coagulation Testing: Global Challenges, Emerging Technologies, Competitive Landscape

New Frontiers in Coagulation Testing: Global Challenges, Emerging Technologies, Competitive Landscape

  • $ 21 100
  • Industry report
  • May 2014
  • by Venture Planning Group

“New Frontiers in Coagulation Testing: Global Challenges, Emerging Technologies, Competitive Landscape” is Venture Planning Group's new seven-country report designed to help current suppliers and potential ...


ReportLinker is an award-winning market research solution that finds, filters and organizes the latest industry data so you get all the market research you need - quickly, in one place.