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IVD (In Vitro Diagnostic) Testing World Markets

  • January 2015
  • -
  • TriMark Publications
  • -
  • 339 pages

In vitro diagnostic (IVD) testing is experiencing a revival fueled by a combination of technological improvements, cost pressures, reimbursement changes, rapid growth in molecular diagnostics and increasing interest in the genomics testing. Recent advances in molecular diagnostics technologies--including sequencing, PCR and microarray--are enabling greater sensitivity and precision in nucleic acid measurements, further expanding manufacturers’ offerings. This TriMark Publications report is an overview of each major in vitro diagnostic testing segment, including: point of care testing (POCT), molecular diagnostics, chemistry, diabetes and glucose, immunoassay, hematology, coagulation, pathology, microbiology, histology and cytology, and blood banking. For each segment, this study examines the generally accepted clinical analytical activities in use today. Moreover, the analysis here discusses the potential benefits of the diagnostics techniques, as well as provides market size and future growth potential. Additionally, this report assesses the various business models, including CLIA-licensed specialty labs, general reference labs and reagent kit marketing. This study also examines hundreds of companies that are actively developing and marketing IVD testing products around the world. This report analyzes the size and growth of the important sectors of the diagnostics market, including the drivers and restraints that influence the various market segments, as well as the dollar volume of sales and market growth rates, both in the U.S. and worldwide.

Table Of Contents

IVD (In Vitro Diagnostic) Testing World Markets
1. IVD Market Overview 14

1.1 Statement of Report 14

1.2 About This Report 14

1.3 Scope of the Report 14

1.4 Objectives 15

1.5 Methodology 15

1.6 Executive Summary 16



2. IVD Global Market Overview 19

2.1 Total Global IVD Market 19

2.2 International Sector and Country IVD Markets 20

2.3 IVD Market Segments by Analyte 23

2.4 High Growth Markets 24

2.4.1 Summary Analysis of the Global IVD High-Growth Market by Geographic Region
24

2.4.1.1 U.S.: Summary of IVD High-Growth Market 25

2.4.1.2 Europe: Summary Analysis of the IVD High-Growth Market 26

2.4.1.3 South-East Asia and Japan: Summary Analysis of the IVD High-Growth
Market 28

2.4.1.4 BRIC: Summary Analysis of the IVD High-Growth Market 29

2.4.1.4.1 Brazil: Summary Analysis of the IVD High-Growth Market 29

2.4.1.4.2 Russia: Summary Analysis of the IVD High-Growth Market 30

2.4.1.4.3 Indian IVD High Growth Markets 31

2.4.1.4.4 Summary of IVD High-Growth Market India 33

2.4.1.4.5 China: Summary Analysis of the IVD High-Growth Market 34

2.4.1.4.6 Summary of IVD High-Growth Market China 36

2.5 Key Players 37

2.6 Key Trends in the IVD Industry 38

2.7 Acquisitions 38

2.8 Market Drivers and Barriers 42

2.8.1 Key Market Drivers 42

2.8.2 Barriers to Growth 43

2.9 Companion Diagnostics 43



3. POCT 46

3.1 POCT Market Overview 46

3.1.1 Total Global POCT Market 47

3.1.2 International Sector and Country POCT Markets 47

3.2 POCT Market Segments by Analyte 48

3.3 Key Players 50

3.3.1 Acquisition, License Agreements, Internal Development and Partnerships 51

3.4 Key Concepts for POCT Markets 52

3.5 The Future of POCT 54

3.6 The Biggest New Opportunities in POCT 55



4. Molecular Diagnostics 56

4.1 Market Overview 56

4.2 Market Size and Growth Rate 57

4.3 Key Players 58

4.4 Market Segments 59

4.4.1 Infectious Disease 60

4.4.1.1 Key Segments of Molecular Diagnostic Markets for Infectious Disease 61

4.4.2 Cancer 66

4.4.2.1 Technology and Market Trends in Cancer Testing 67

4.4.2.2 Cancer Testing 69

4.4.2.3 Cancer Prognostic Assays 72

4.4.2.4 Market Size 72

4.4.2.5 Key Players 74

4.4.2.6 Competitive Landscape 74

4.4.2.6.1 Myriad Genetics (BRCA1 and BRCA2) 75

4.4.2.6.2 Genomic Health (Oncotype DX) 76

4.4.2.6.3 InterGenetics, Inc. 77

4.4.2.6.4 Clarient, Inc. (GE Healthcare) 78

4.4.2.6.5 BioTheronostics 78

4.4.2.6.6 Agendia B.V. (MammaPrint) 79

4.4.2.6.7 LabCorp 80

4.4.2.6.8 Quest Diagnostics 81

4.4.2.7 Competitive Structure and Market Share Analysis 81

4.4.2.8 Drivers and Restraints 82

4.4.2.8.1 Molecular Diagnostics Cancer Market Drivers Ranked in Order of Impact
82

4.4.2.8.2 Molecular Diagnostics Cancer Market Restraints Ranked in Order of
Impact 82

4.4.2.9 Business Factors Influencing Advanced Oncology Testing Services 82

4.4.2.10 Market Trends in Cancer Testing 83

4.4.2.11 Strategic Recommendations on Molecular Diagnostic Sector Business
Functions 83

4.4.2.12 Emerging Cancer Personalized Medicine Market 83

4.4.3 Genetic Testing 84

4.4.3.1 Genetic Testing Market 84

4.4.3.2 Primary Competitors 86

4.4.3.3 Prominent Issues in Genetic Prenatal Diagnosis Using Molecular
Diagnostics Testing 86

4.5 Snapshot of Molecular Diagnostics Industry Structure 87

4.5.1 Technology and Market Trends 88

4.5.2 Emerging Technologies 89

4.5.3 Market Trends 89

4.6 Molecular Diagnostics Testing Going Forward 91

4.7 Key Sector Takeaways 93



5. Clinical Chemistry 94

5.1 Market Overview 94

5.2 International Markets 95

5.2.1 U.S. Market 95

5.2.2 European Market 95

5.2.3 Asian Market 96

5.3 Key Players 97

5.4 Market Segments 97

5.4.1 Ultra-Large Throughput Chemistry Analyzers 99

5.4.2 Large Throughput Analyzers 100

5.4.3 Mid-Size Clinical Chemistry Analyzers 101

5.4.4 Chemistry Analyzers for the Small-Volume Market 103

5.5 Long-Term Changes 104

5.6 Market Drivers 105

5.7 The Limits to Growth 106

5.8 Hot Sectors in the IVD Market 107

5.9 Key Technologies 107

5.10 Key Sector Takeaways 108



6. Diabetes and Glucose Testing 109

6.1 Market Overview 109

6.2 Glucose Self-Testing Markets 111

6.3 Key Players 114

6.3.1 MandA Activity 115

6.3.2 Important Deals in BGM Market 115

6.4 Future of Patient Self-testing 116

6.5 Lancet Market 117

6.5.1 Market Size 117

6.5.2 Strategic Recommendations in the Lancet Business 119

6.5.3 Health and Safety Regulations 120

6.5.4 Key Players in the Blood Lancet Market 121

6.5.5 Lancet Distribution Networks 122

6.6 Drivers of OTC and Self-testing Markets 122

6.6.1 Factors Affecting OTC Medical Product Distribution 122

6.6.2 Drugstores Critical to the Diabetic Care Category 124

6.7 Important Elements of OTC Testing 124

6.8 Strategic Recommendations for Self-Monitoring Blood Glucose Markets 125

6.9 Future of Patient Self-Testing 125



7. Immunochemistry Markets 126

7.1 Market Overview 126

7.2 Markets for Immunoanalyzer Testing 126

7.3 Key Players 127

7.3.1 Abbott Diagnostics 127

7.3.2 Siemens 128

7.3.3 Roche 129

7.3.4 Beckman Coulter, Inc. 130

7.3.5 bioMerieux 131

7.3.6 Ortho-Clinical Diagnostics 132

7.4 Long Term Changes 133

7.4.1 Key Developments 133

7.5 Market Drivers and Restraints 134

7.6 Hot Sectors in the Immunoanalyzer Market 136

7.7 Key Technologies 137

7.7.1 Analyzer Integration Chemistry/Immunoassay 138

7.7.2 Consolidated Workstations 139

7.8 Key Sector Takeaways 140



8. Hematology 142

8.1 Market Overview 142

8.2 International Markets 142

8.2.1 U.S. Market 143

8.2.2 European Market 143

8.2.3 Asian Market 143

8.3 Key Players 143

8.4 Hematology Analyzers 144

8.4.1 Large Throughput Analyzers 145

8.4.2 Mid-Size Analyzers 145

8.4.3 Analyzers for the Small Volume Market 146

8.4.4 New Hematology Analyzers 147

8.5 Profitability 147

8.6 Market Drivers 147

8.7 Key Sector Takeaways 148



9. Coagulation 149

9.1 Market Overview 149

9.2 International Markets 150

9.2.1 U.S. Market 150

9.2.2 European Market 151

9.2.3 Asian Market 151

9.2.4 Rest of the World Markets 152

9.3 Key Players 153

9.4 Recent Coagulation Testing Sector Activity 155

9.4.1 Roche and Diagnostica Stago Parting Ways in Laboratory Coagulation 155

9.4.2 Roche Acquires Verum Diagnostica GmbH and Expands Coagulation Testing
Product Line 155

9.4.3 Universal Biosensors and Siemens Collaborate on Advanced POC Coagulation
Platform 155

9.4.4 Instrumentation Laboratory and Beckman Coulter concluded their
Cross-Distribution Agreement 156

9.4.5 CoaguChek® XS Personal Receives Reimbursement Approval for Self-Testing in
Japan 156

9.4.6 Diagnostica Stago Launches Products for Measurement of Rivaroxaban 156

9.4.7 Diagnostic Stago Offers Three Factor VII Detection Methods 156

9.4.8 Diagnostica Stago Offers Three Procoagulant Microparticle Detection
Methods 157

9.4.9 Diagnostica Stago S.A.S enters into Joint Research Agreement with
Bristol-Myers Squibb 157

9.4.10 Trinity Biotech Sold its Worldwide Coagulation Business to the Stago
Group 157

9.4.11 Alere aka Inverness Medical Innovations Acquired HemoSense, Inc. 158

9.4.12 Alere Announced Positive Results in Clinical Study Evaluating At-Home
Coagulation Testing 158

9.5 Anticoagulation Self-Testing and Self-Management 158

9.6 Market Drivers and Restraints 161

9.6.1 Market Drivers 161

9.6.2 Market Restraints 162

9.7 Impact of New Oral Anticoagulant Drugs on the Coagulation Testing Market 162

9.8 Key Technologies 164

9.9 Key Strategic Recommendations 164



10. Pathology 165

10.1 Overview 165

10.2 Pathology Markets 165

10.2.1 Market Size 165

10.2.2 Pathology Markets Served 165

10.2.3 Key Technologies 166

10.3 Key Sector Players 166

10.3.1 Ventana Medical Systems Inc. (part of Roche's Diagnostics Division) 166

10.3.2 Dako (An Agilent Technologies Company) 167

10.3.3 Aperio(Part of Leica Biosystems) 167

10.3.4 Abbott Laboratories 167

10.3.5 Omnyx, LLC (Part of GE Healthcare) 168

10.3.6 Visiopharm 168

10.4 Digital Pathology Markets 169

10.4.1 Market Drivers in the Digital Pathology Markets 171

10.4.2 Market Barriers in the Digital Pathology Markets 171

10.4.3 Digital Pathology Takeaways 171



11. Microbiology 172

11.1 Overview 172

11.1.1 Microbial Culture 172

11.1.2 Biochemical Tests 173

11.2 Microscopy 173

11.3 Microbiology Reagent Market Size and Revenue Analysis 174

11.4 Key Players 175

11.5 Diagnostic Platforms for Infectious Diseases 175

11.5.1 Culture Methods 175

11.5.2 Molecular Diagnostics 175

11.5.3 Mass Spectroscopy 177

11.6 Market Drivers and Restraints in Infectious Disease Testing Markets 178

11.6.1 Market Drivers 178

11.6.2 Market Restraints 178

11.7 Key Sector Takeaways 179



12. Blood Banking and Screening 180

12.1 Market Overview 180

12.2 International Markets 180

12.3 Key Players in Blood Screening 181



13. Histology and Cytology Tests 185

13.1 The Overall Market 185

13.1.1 Market Size 186

13.2 Market Drivers 186

13.3 Market Restraints 186

13.4 Cytology and Histology Technology Platforms 187

13.4.1 HLA Typing 187

13.5 Cytology Screening Procedures and Pap Smear Technology 187

13.5.1 Cytology 187

13.5.2 Pap Smears 188

13.5.2.1 Pap Smear Market Share 191

13.5.3 Detection of HPV 191

13.5.3.1 Detection of HPV DNA 191

13.5.3.2 Benefits of Pap Smear and HPV Co-Testing 192

13.5.3.3 Human Papillomavirus Testing Market Structure 193

13.5.3.3.1HPV Testing Market Overview 193

13.5.3.3.2U.S. Market 193

13.5.3.3.3European Market 194

13.5.3.3.4Latin American Market 195

13.5.3.3.5Asian Market 195

13.6 Histology 196

13.6.1 IHC Staining 197

13.6.2 ISH Staining 198

13.6.3 Special Stains Staining 198

13.6.4 Tissue Staining Market 198

13.6.7 Major Players 199



14. Data Management and Connectivity 200

14.1 Wireless LANs 200

14.2 Connectivity Platforms 202

14.2.1 DataLink Data Management System 203

14.2.1.1 DataLink Integrated with RALS®-Plus and Quick Multi-Linc 204

14.2.1.2 DataLink with RALS-Plus 204

14.2.1.3 DataLink with QML 205

14.2.2 RALS-Plus, RALS-Web3 and RALS-Freedom 205

14.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 206

14.2.2.2 Siemens Diagnostics Rapidpoint 500 206

14.2.2.3 Alere Connect Products 207

14.2.3 Medical Implant Communications Service (MICS) 207

14.2.4 Conworx Technology 207

14.2.5 Alere Informatics 208

14.2.6 Medasys 208

14.2.7 NoemaLife 208

14.3 Advantages of POCT Connectivity 208

14.3.1 Cost-Benefit Analysis of Testing Devices and IT Connectivity 209

14.3.2 Hospital Network Issues 209

14.4 POCT Analyzer Connectivity Software Solutions 210



15. Company Profiles 212

15.1 A. Menarini 212

15.2 Abaxis, Inc. 212

15.3 Abbott Laboratories 213

15.4 Accriva Diagnostics, Inc. 216

15.5 Adaltis 217

15.6 AdnaGen 217

15.7 AdvanDx 217

15.8 Affymetrix, Inc. 218

15.9 Agendia 220

15.10 Agilent Technologies 221

15.11 ALERE, INC. 222

15.12 Alfa Scientific Designs, Inc. 226

15.13 Alfa Wasserman, Inc. 226

15.14 ALPHELYS 227

15.15 AMS 227

15.16 Ambry Genetics 227

15.17 ArcticDx, Inc. 227

15.18 Ariosa Diagnostics, Inc. 228

15.19 ARKRAY USA, Inc. 228

15.20 Asuragen, Inc. 228

15.21 Atlas Genetics 229

15.22 Atonomics A/S 229

15.23 AutoGenomics, Inc. 230

15.24 Awareness Technology 231

15.25 Axxin 232

15.26 Bayer 232

15.27 BD 233

15.28 Beckman Coulter Genomics, Inc. 235

15.29 Biocartis SA 235

15.30 BioCytex 236

15.31 Biodata (Microlink Engineering Systems) 236

15.32 BioData Ltd. 236

15.33 Biodesix 236

15.34 BioGenex Laboratories, Inc. 237

15.35 BioFire Diagnostics, Inc. (Part of bioMerieux now) 237

15.36 BioMedomics 237

15.37 bioMerieux 238

15.38 Biophor Diagnostics 239

15.39 Bio-Rad 240

15.40 Biosensia Ltd. 240

15.41 Biosite Diagnostics (part of Alere) 241

15.42 Biotage AB 242

15.43 bioTheranostics 242

15.44 Cancer Genetics, Inc. 242

15.45 Caris Life Sciences 243

15.46 Cepheid 243

15.47 Celula, Inc. 244

15.48 Chembio Diagnostics, Inc. 244

15.49 Clarient 245

15.50 Coagusense, Inc. 245

15.51 CombiMatrix Corporation 245

15.52 Curetis AG 246

15.53 Cyber Medical Ltd. 246

15.54 Dako A/S (Agilent Technologies) 246

15.55 Debiotech 247

15.56 DexCom 247

15.57 Diagnostica Stago, Inc. 248

15.58 Diagnostica Stago S.A.S 248

15.59 Diagnostics for All 249

15.60 DiaSorin S.p.A. 249

15.61 DxNA, LLC. 249

15.62 Echo Therapeutics 250

15.63 Eiken Chemical Company Limited 251

15.64 Enigma Diagnostics Limited 251

15.65 Epigenomics 251

15.66 Exact Sciences Corporation 252

15.67 Exagen Diagnostics, Inc. 253

15.68 Exiqon 253

15.69 Exosome Diagnostics 253

15.70 FIFTY50 Medical, Inc. 254

15.71 Fluidigm Corporation 254

15.72 Fujirebio Inc. 256

15.73 GE Healthcare 257

15.74 Genera Biosystems 258

15.75 GenMark Diagnostics, Inc. 258

15.76 Genomica S.A.U. 259

15.77 Genomic Health, Inc. 260

15.78 Genomix Biotech 261

15.79 Genoptix, Inc. 261

15.80 Gentag, Inc. 262

15.81 Great Basin Corporation 262

15.82 Grifols 262

15.83 Haemonetics Corporation 262

15.84 Hologic Gen-Probe 263

15.85 Hutman Diagnostics, AG 269

15.86 Hy Laboratories Ltd. 269

15.87 HYPHEN BioMed 270

15.88 Ikonisys Inc. 270

15.89 Illumina, Inc. 270

15.90 Immunexpress Group 273

15.91 Infopia Co., Ltd. 273

15.92 Innovative Biosensors, Inc. 273

15.93 Integrity Applications 273

15.94 InterGenetics, Inc. 274

15.95 Integrated Diagnostics 274

15.96 International Technidyne Corp (THORATEC CORP 274

15.97 Instrumentation Laboratory 275

15.98 IQuum, Inc.(acquired by Roche) 275

15.99 iSense Corporation (subsidiary of BayerAG) 275

15.100 JEOL Ltd. 275

15.101 Johnson and Johnson 276

15.102 Kommanditgesellschaft Behnk Elektronik GmbH and Co. 277

15.103 Kyowa Medex 277

15.104 LabCorp 277

15.105 Labor BioMedical Technologies GmbH (LABiTec) 278

15.106 Leica Biosystems 278

15.107 Life Technologies Corporation 279

15.108 Luminex Corporation 281

15.109 Lumora Ltd. 285

15.110 M-Biotech 286

15.111 MBio Diagnostics, Inc. 286

15.112 MDxHealth 286

15.113 Medica Corporation, Inc. 286

15.114 Medtronic 287

15.115 Menssana Research, Inc. 288

15.116 Meridian Biosciences 288

15.117 Metaara Medical Technologies Inc. 289

15.118 Miraculins Inc. 289

15.119 Mobidiag 290

15.120 Myriad Genetics, Inc 290

15.121 Nanosphere 298

15.122 Nanostring 299

15.123 Natera Inc. 299

15.124 Neogenomics 300

15.125 Nipro Diagnostics 300

15.126 Nova Biomedical Corporation 300

15.127 Novartis 301

15.128 Novo Nordisk 301

15.129 Nuvera Biosciences 302

15.130 OraSure 303

15.131 Ortho Clinical Diagnostics (Formerly a Johnson and Johnson Company) 304

15.132 Pfizer, Inc. 306

15.133 Phamatech, Inc. 307

15.134 Pharma Supply, Inc. 307

15.135 Polymedco 308

15.136 Prodigy Diabetes Care, LLC (formerly Diagnostic Devices, Inc.) 309

15.137 Qiagen NV 309

15.138 Quidel Corporation 313

15.139 Radient Pharmaceuticals Corporation 317

15.140 Randox 317

15.141 Roche AG 319

15.142 Rosetta Genomics Ltd. 322

15.143 Sanofi 326

15.144 Seegene 326

15.145 Sekisui Diagnostics 326

15.146 Sensors for Medicine and Science 327

15.147 Sequenom, Inc. 327

15.148 Shimadzu Corporation 328

15.149 Siemens AG 328

15.150 Siemens Healthcare Diagnostics 329

15.151 Sienco Inc. 330

15.152 Simple Diagnostics 330

15.153 SIRS-Lab 330

15.154 Smiths Medical 331

15.155 Source MDx 331

15.156 Spartan Bioscience 332

15.157 Spectrum Laboratories, Inc. 332

15.158 Sysmex America, Inc. 333

15.159 Technoclone Gmbh 333

15.160 Telcare 333

15.161 Thermo Fisher Scientific, Inc. 334

15.162 TrimGen 336

15.163 TrovaGene 336

15.164 Trinity Biotech plc 337

15.165 U.S. Diagnostics 337

15.166 Universal Biosensors, Inc. 337

15.167 Ventana 338

15.168 VeraLight 338

15.169 Veredus Laboratories 339

15.170 Veridex (a Johnson and Johnson company) 339

15.171 Visiopharm 340

15.172 Wako 340

15.173 WILEX AG 340

15.174 ZS Genetics 341



INDEX OF FIGURES



Figure 2.1: Worldwide Geographic Distribution of Total IVD Testing Market, 2013
and 2018 19

Figure 2.2: Worldwide Geographic Distribution of Total IVD Testing Markets by
Country, 2013 21

Figure 2.3: Global IVD Market Share by Specialty, 2013 23

Figure 2.4: Indian Diagnostics Market Segments, 2011 32

Figure 2.5: Company Market Share for IVD Testing Markets, 2013 37

Figure 3.1: Percentage Uptake by Analyte in Hospitals Performing POC Testing 46

Figure 3.2: Total Global POCT Market, 2008-2018 47

Figure 3.3: Worldwide Distribution of POCT, 2013 48

Figure 3.4: Summary of Global POCT Markets by Market Segment, 2013 49

Figure 4.1: Global Market for Molecular Diagnostics, 2002-2019 57

Figure 4.2: Market Share by Region for Molecular Diagnostics Testing, 2013 58

Figure 4.3: Key Players Market Share in Global Molecular Diagnostics Testing
Markets, 2013 59

Figure 4.4: Share of Molecular Diagnostics Testing by Application, 2013 60

Figure 4.5: Global Revenue for Molecular Diagnostics Testing for Infectious
Disease, 2009-2018 61

Figure 4.6: Total Global Infectious Disease Molecular Diagnostics Markets, 2013
64

Figure 4.7: Key Players Market Share in Global Molecular Diagnostics Cancer
Testing Markets 67

Figure 4.8: Molecular Diagnostic Markets for Cancer Testing Globally, 2013 73

Figure 4.9: Molecular Diagnostic Markets for Cancer Testing U.S., 2013 73

Figure 5.1: Global Clinical Chemistry Revenues, 2000-2018 94

Figure 5.2: Worldwide Geographical Distribution of Clinical Chemistry Testing,
2013 95

Figure 6.1: Geographic Segments of the Worldwide Glucose Self-Testing Market,
2012 and 2018 113

Figure 6.2: Worldwide Glucose Self-Testing Market by Region, 2018 113

Figure 6.3: Personal Lancet Unit Sales Market Share by Geographic Region, 2013
122

Figure 7.1: Market Share for Key Players in Immunoassay Testing Markets, 2013
127

Figure 9.1: Global Revenue Forecasts for Coagulation Testing, 2010-2018 150

Figure 9.2: U.S. Revenue Forecasts for Coagulation Testing, 2010-2018 150

Figure 9.3: European Revenue Forecasts for Coagulation Testing, 2010-2018 151

Figure 9.4: Japanese Revenue Forecasts for Coagulation Testing, 2010-2018 152

Figure 9.5: ROW Revenue Forecasts for Coagulation Testing, 2010-2018 152

Figure 10.1: Market Shares in Pathology Diagnostics, by Company 166

Figure 10.2: The Global Laboratory Digital Pathology Market, 2012-2018 170

Figure 13.1: Liquid-Based Pap Test Market Share 191

Figure 14.1: The RALS Data Management System Connects to Most of the Major
Instruments Used in

Point of Care 204

Figure 14.2: AegisPOC Point of Care and Critical Care Connectivity and
Information Management System 210





INDEX OF TABLES



Table 2.1: Global Distribution of IVD Testing by Key Geographic Regions, 2013
and 2018 19

Table 2.2: Global GDP Growth Rates, 2011 to 2015 20

Table 2.3: Top 15 Country Markets for IVD Testing, 2013 22

Table 2.4: Global Distribution of IVD Testing by Market Segments, 2013-2018 23

Table 2.5: Global Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing, 2008-2018 24

Table 2.6: Global IVD High-Growth Markets Percentage of Revenues by Geographic
Region, 2008-2018 25

Table 2.7: Summary of IVD High-Growth Market U.S., 2013 25

Table 2.8: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing U.S.,

2008-2018 26

Table 2.9: U.S. Individual IVD High-Growth Markets Revenue Forecast 2008-2018 26

Table 2.10: Europe: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 28

Table 2.11: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing Asia,

2008-2018 28

Table 2.12: Asia: Individual IVD High-Growth Markets Revenue Forecast, 2008-2018
29

Table 2.13: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing Brazil,

2008-2018 29

Table 2.14: Brazil: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 30

Table 2.15: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing Russia,

2008-2018 30

Table 2.16: Russia: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 31

Table 2.17: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing India,

2008-2018 33

Table 2.18: India: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 34

Table 2.19: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing China,

2008-2018 36

Table 2.20: China: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 36

Table 2.21: Company Market Share for IVD Testing Markets, 2013 37

Table 2.22: Market Trends in the Diagnostics Space 38

Table 3.1: Summary of Global POCT Markets by Major Market Sub-Segment, 2013 and
2018 50

Table 3.2: Global Company Market Share POCT Analysis, 2013 50

Table 3.3: Main Drivers for the Point of Care Market 53

Table 4.1: Applications of Molecular Diagnostics Technology Platforms 56

Table 4.2: Global Distribution of Molecular Diagnostics Testing by Geographic
Region, 2013 57

Table 4.3: Key Players and Market Share in the Global Molecular Diagnostics
Testing Market, 2013 59

Table 4.4: Share of Molecular Diagnostics Testing by Application, 2013 60

Table 4.5: Future Areas of Growth in Molecular Diagnostics 60

Table 4.6: Molecular Diagnostics Infectious Disease Market Drivers Ranked in
Order of Impact 63

Table 4.7: Molecular Diagnostics Infectious Disease Market Restraints Ranked in
Order of Impact 63

Table 4.8: Molecular Diagnostics Infectious Disease Sector: Strategic
Recommendations on Business

Functions 63

Table 4.9: Nucleic Acid Testing Reagents for HIV Testing 65

Table 4.10: Nucleic Acid Testing Reagents for HBV Testing 65

Table 4.11: Nucleic Acid Testing Reagents for HCV Testing 65

Table 4.12: Molecular Diagnostic Markets for Cancer Testing, 2012 66

Table 4.13: Specific Diagnostic Products Categories Comprising the General
Cancer Diagnostic Market 71

Table 4.14: Highlights of the Cancer Molecular Diagnostic Testing Segment 71

Table 4.15: Highlights of Certified Clinical Labs Specializing in Cancer
Genetics and Molecular Diagnostic Services 71

Table 4.16: U.S. Market for Molecular Diagnostics Cancer Testing, 2008-2018 72

Table 4.17: Key Diagnostic Company Players and Market Share in Global Molecular
Diagnostics Cancer Testing Market 74

Table 4.18: Key Players in the Breast Cancer Molecular Diagnostic Space 74

Table 4.19: Commercially Available Molecular Diagnostic Products for Breast
Cancer Assay 75

Table 4.20: Oncotype DX Overview 77

Table 4.21: Comparison of Agendia vs. Genomic Health Breast Cancer Tests 77

Table 4.22: Clarient's Offerings in Breast Cancer Testing 78

Table 4.23: Trends in Cancer Personalized Medicine 84

Table 4.24: Commercial Labs Performing Genetic Testing 86

Table 4.25: Technology Trends in Cancer Testing 89

Table 4.26: Trends in Theranostics 90

Table 4.27: Market Trends in Cancer Testing 90

Table 4.28: Molecular Diagnostics Cancer Market Drivers Ranked in Order of
Impact 91

Table 4.29: Molecular Diagnostics Cancer Market Restraints Ranked in Order of
Impact 91

Table 5.1: Global Distribution of General Chemistry Testing by Geographic
Region, 2013-2018 95

Table 5.2: Leading Marketers of Automated Clinical Chemistry Instruments 97

Table 5.3: Ultra-Large Clinical Chemistry Analyzers 99

Table 5.4: Large Clinical Chemistry Analyzers 101

Table 5.5: Mid-Size Clinical Chemistry Analyzers 102

Table 5.6: Small Clinical Laboratory Analyzers 103

Table 5.7: Clinical Chemistry Analyzer Market Drivers Ranked in Order of Impact
105

Table 5.8: Clinical Chemistry Analyzer Market Restraints Ranked in Order of
Impact 106

Table 6.1: Worldwide Comprehensive Glucose Testing Market (Includes Reagents and
Supplies in both the Self-Testing and Professional Markets in $ Billions),
2012-2018 110

Table 6.2: Global Revenues for Total Professional Blood Glucose Monitoring
(Central Laboratory Testing and Hospital POC and POL), 2012-2018 111

Table 6.3: Global Revenues for Professional Point of Care Blood Glucose
Monitoring Systems (within Hospitals and Physician's Offices), 2012-2018 111

Table 6.4: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, and
Lancets), 2012-2018 112

Table 6.5: Revenues and Market Shares in the SMBG Market in 2013, by Company 114

Table 6.6: Unit Sales of Homecare Lancets in the U.S., 2012-2017 118

Table 6.7: Unit Sales of Homecare Lancets in the E.U., 2012-2017 118

Table 6.8: Dollar Sales of Homecare Lancets in the U.S., 2012-2017 119

Table 6.9: Dollar Sales of Homecare Lancets in the E.U., 2012-2017 119

Table 6.10: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S.,
2012-2017 119

Table 6.11: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U.,
2012-2017 119

Table 6.12: Competition in the Lancet Market Segment 121

Table 7.1: Global Revenue Forecasts for Immunoanalyzer Testing, 2012-2018 126

Table 7.2: Immunoanalyzer Market Drivers Ranked in Order of Impact 135

Table 7.3: Immunoanalyzer Market Restraints Ranked in Order of Impact 135

Table 8.1: Global Clinical Hematology Analyzer and Reagent Revenues, 2008-2018
142

Table 8.2: Worldwide Distribution of Clinical Hematology Testing Analyzer and
Reagent Revenues, 2013 143

Table 8.3 Key Players in Worldwide Hematology Analyzers and Reagent Market 144

Table 8.4: Hematology Analyzers Currently in Market, 2014 146

Table 9.1: Key Players in Anticoagulation Sector 153

Table 9.2: Benefits of Anticoagulation Self-Testing 158

Table 9.3: Barriers to Anticoagulation Self-Testing and Self-Management 160

Table 9.4: Key Market Drivers for Coagulation Testing 162

Table 9.5 Market Drivers for Point of Care Anticoagulation Testing Market 162

Table 9.6 Key Market Restraints for Coagulation Testing 162

Table 9.7: Market Restraints for Point of Care Anticoagulation Testing Market
162

Table 10.1: Global Distribution of Pathology Equipment and Reagents by
Geographic Region, 2013-2018 165

Table 10.2: Anatomical Laboratory Computer Systems Manufactures 169

Table 10.3: Digital Pathology Market Drivers Ranked in Order of Impact 171

Table 10.4: Digital Pathology Market Restraints Ranked in Order of Impact 171

Table 11.1: Global Microbiology Reagent Sales 2013-2018 175

Table 11.2: Clinical Microbiology Market Drivers Ranked in Order of Impact 178

Table 11.3: Clinical Microbiology Market Restraints Ranked in Order of Impact
178

Table 12.1: Global Distribution of Blood Banking Reagents Sales by Geographic
Region, 2013-2018 180

Table 12.2: Key Players in Blood Banking and Transfusion Markets 181

Table 12.3: Roche's cobas s 201 system: Competitive Advantages 183

Table 12.4: Blood Bank information Systems 184

Table 13.1: Global Histology and Cytology Sales by Segment, 2013-2018 185

Table 13.2: Cytology and Histology Market Drivers Ranked in Order of Impact 186

Table 13.3: Cytology and Histology Market Restraints Ranked in Order of Impact
187

Table 13.4: Estimated Number of Pap Smears Performed by Country, 2013 189

Table 13.5: Global Market for HPV Molecular Diagnostic Testing, 2009-2017 193

Table 13.6: U.S. Market for HPV Diagnostic Testing, 2009-2017 194

Table 13.7: Tissue Diagnostics Market Segments 199

Table 14.1: Applications for Wireless LAN Technology 200

Table 14.2: Customized Reports Must Support CAP and JCAHO Requirements 203

Table 14.3: Applications of RALS Connectivity with POCT Devices 205

Table 15.1: Drugs of Abuse Cut-off Levels for the TOX/See Test by Bio-Rad 240

Table 15.2: OraSure Portfolio of Drugs of Abuse Detection Methodologies 304

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