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In Vitro Diagnostic Testing World Markets

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Price:
$4,500.00
Publication Date:
January 2015; Pages: 339


Description


In Vitro Diagnostic Testing World Market Sample

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 microarrays—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

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 M&A 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 bioMérieux 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 bioMérieux now) 237
15.36 BioMedomics 237
15.37 bioMérieux 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 & Johnson 276
15.102 Kommanditgesellschaft Behnk Elektronik GmbH & 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 & 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 & 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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