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Point of Care Diagnostic Testing World Markets

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Price:
$5,500.00
Publication Date:
August 2016; Pages: 449
File Type:
Downloadable PDF


Description

 



Point of Care Report Sample


Point of care testing (POCT) enables rapid diagnostic tests to be performed while the patient is at the point of care facility where results can be obtained immediately, rather than waiting hours or even days for outside lab results to arrive. Point of care testing covers: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing, rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening. This TriMark Publications report describes latest developments in the point of care testing market segment. It examines clinical instruments, devices and reagents and supplies as utilized in near-patient environments like hospital emergency rooms, critical care units, clinics and doctor's offices. The study defines the dollar volume of point of care sales and makes five year projections--both in the U.S. and worldwide--including Europe, Asia and Latin America. It also examines in detail the point of care sector for 25 individual country markets. A detailed summary of all important instruments in each clinical market is provided with emphasis on newly introduced products. Moreover, parallel areas where rapid detection is important using hand-held devices such as rapid detection of food pathogens and infectious diseases (MRSA, herpes simplex, avian flu, West Nile virus and typhoid) are discussed. Growth moderators and developing trends in point of care applications, as well as technology platform innovations and connectivity questions are examined in detail. The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the point of care market in the U.S. and worldwide. Each company is discussed in depth, with a section on its history, product lines, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market data are also included.

 

TABLE OF CONTENTS

1. Overview 19
1.1 About This Report 19
1.2 Scope of the Report 21
1.3 Objectives 21
1.4 Methodology 21
1.5 Executive Summary 23

2. Overview of Diagnostic Testing Point of Care Markets 27
2.1 Key Issues in the POC Diagnostic Testing Sector 30
2.1.1 Current Market Trends and Drivers 31
2.1.2 Effectiveness of POCT 32
2.1.3 New Growth Areas for POCT 32
2.1.4 Advantages of POCT in a Clinical Setting 33
2.1.5 Pricing and Reimbursement Issues 33
2.1.6 Key Customer Segments 34
2.2 Global Point of Care Marketplace 34
2.3 Shifts from Central Lab Testing to POCT 35
2.4 Geographical Distribution 35
2.5 Challenges of POCT 38
2.6 Key Issues for POCT 39
2.6.1 Locations of POCT 39
2.6.2 Milestones in Technology Development 41
2.6.3 Drive for Decentralization from Lab to Patient 41
2.6.4 Competitive Landscape for POCT 42
2.7 The Future of POCT 42

3. Summary Analysis of the Global POCT Market: Value, Growth Rates and Market Share 45
3.1 Global POCT Market 45
3.2 Global Market Revenues Analysis by Market Segment 46
3.2.1 Global POC Blood Glucose Monitoring Systems Market 46
3.2.2 Global POC Blood Gas and Electrolyte Analyzers Market 47
3.2.3 Global POC Rapid Coagulation Analyzers Market 47
3.2.4 Global POC Cardiac Markers Devices Market 48
3.2.5 Global POC Substance Abuse Testing Device Market 49
3.2.6 Global POC Infectious Disease Testing Device Market 49
3.2.7 Global POC Urine Strip Testing Market 50
3.2.8 Global POC Pregnancy Testing Device Market 50
3.2.9 Global POC Fecal Occult Device Market 51
3.2.10 Global POC Cholesterol Testing Market 51
3.3 Global Market Share Analysis 52
3.4 Global Market Size by Geographic Location 52
3.5 Global Market Size by Analyte Market Segment 53
3.6 Global POCT Testing by Location 54

4. Analysis of the U.S. POCT Market: Value, Growth Rates and Market Share 55
4.1 U.S. Market Revenues Analysis by Market Segment 56
4.1.1 U.S. POC Blood Glucose Monitoring Systems Market 56
4.1.2 U.S. POC Blood Gas and Electrolyte Analyzers Market 56
4.1.3 U.S. POC Rapid Coagulation Analyzers Market 57
4.1.4 U.S. POC Cardiac Markers Devices Market 57
4.1.5 U.S. POC Substance Abuse Testing Device Market 59
4.1.6 U.S. POC Infectious Disease Testing Device Market 59
4.1.7 U.S. POC Urine Strip Testing Market 60
4.1.8 U.S. POC Pregnancy Testing Device Market 60
4.1.9 U.S. POC Fecal Occult Device Market 61
4.1.10 U.S. POC Cholesterol Testing Market 61
4.2 U.S. Market Share Analysis 62
4.3 U.S. Market Size by Analyte Market Segment 62

5. Analysis of the European POCT Market: Value, Growth Rates and Market Shares 64
5.1 European Market Revenues Analysis 70
5.2 European Market Revenues Analysis by Geographic Region 71
5.2.1 French Revenues for POCT Systems 71
5.2.2 German Revenues for POCT Systems 72
5.2.3 Italian Revenues for POCT Systems 72
5.2.4 Spanish Revenues for POCT Systems 73
5.2.5 U.K. Revenues for POCT Systems 73
5.2.6 Benelux Revenues for POCT Systems 74
5.2.7 Scandinavian Revenues for POCT Systems 74
5.2.8 Rest of Europe Revenues for POCT Systems 75
5.3 European Market Revenues Analysis by Market Segment 75
5.3.1 European POC Blood Glucose Monitoring Systems Market 75
5.3.2 European POC Blood Gas and Electrolyte Analyzers Market 76
5.3.3 European POC Rapid Coagulation Analyzers Market 77
5.3.4 European POC Cardiac Marker Market 77
5.3.5 European POC Substance Abuse Testing Device Market 79
5.3.6 European POC Infectious Disease Testing Market 80
5.3.7 European POC Urine Strip Testing Market 81
5.3.8 European POC Pregnancy Testing Device Market 81
5.3.9 European POC Fecal Occult Blood Testing Market 82
5.3.10 European POC Cholesterol Testing Market 83
5.4 European Market Share Analysis 84

6. Analysis of the POCT Markets for Japan, China and India: Value, Growth Rates and Market
Share 85
6.1 Summary Analysis of Japanese, Chinese and Indian POCT Market Revenues 85
6.2 Summary of Asian (Japanese, Chinese and Indian) Market Revenues by Market Segment 86
6.2.1 Asian (Japanese, Chinese and Indian) POC Blood Glucose Monitoring Systems Market 86
6.2.2 Asian (Japanese, Chinese and Indian) POC Blood Gas and Electrolyte Analyzers Market 86
6.2.3 Asian (Japanese, Chinese and Indian) POC Rapid Coagulation Analyzers Market 87
6.2.4 Asian (Japanese, Chinese and Indian) POC Cardiac Markers Devices Market 87
6.2.5 Asian (Japanese, Chinese and Indian) POC Substance Abuse Testing Device Market 88
6.2.6 Asian (Japanese, Chinese and Indian) POC Infectious Disease Testing Device Market 88
6.2.7 Asian (Japanese, Chinese and Indian) POC Urine Strip Testing Market 89
6.2.8 Asian (Japanese, Chinese and Indian) POC Pregnancy Testing Device Market 89
6.2.9 Asian (Japanese, Chinese and Indian) POC Fecal Occult Device Market 90
6.2.10 Asian (Japanese, Chinese and Indian) POC Cholesterol Testing Market 90
6.3 Asian (Japanese, Chinese and Indian) Market Share Analysis 91
6.4 Summary Analysis of the Japanese POCT Market 91
6.5 Summary Analysis of the Indian POCT Market 94
6.6 Summary Analysis of the Chinese POCT Market 97

7. Analysis of the Rest of World (ROW) POCT Market: Value, Growth Rates and Market Share 104
7.1 Summary Analysis of the ROW POCT Market Revenues 104
7.2 Summary of the ROW Market Revenues by Market Segment 105
7.2.1 ROW POC Blood Glucose Monitoring Systems Market 105
7.2.2 ROW POC Blood Gas and Electrolyte Analyzers Market 105
7.2.3 ROW POC Rapid Coagulation Analyzers Market 106
7.2.4 ROW POC Cardiac Markers Devices Market 106
7.2.5 ROW POC Substance Abuse Testing Device Market 107
7.2.6 ROW POC Infectious Disease Testing Device Market 107
7.2.7 ROW POC Urine Strip Testing Market 108
7.2.8 ROW POC Pregnancy Testing Device Market 108
7.2.9 ROW POC Fecal Occult Device Market 109
7.2.10 ROW POC Cholesterol Testing Market 109
7.3 ROW Market Share Analysis 110
7.4 Summary Analysis of the ROW POCT Market Revenues 110
7.4.1 Summary Analysis of the Argentinian POCT Market 110
7.4.2 Summary Analysis of the Australian POCT Market 111
7.4.3 Summary Analysis of the Brazilian POCT Market 111
7.4.4 Summary Analysis of the Canadian POCT Market 112
7.4.5 Summary Analysis of the Russian POCT Market 113
7.4.6 Summary Analysis of the Middle East POCT Market 113
7.4.7 Summary Analysis of the African POCT Market 114
7.4.8 Summary Analysis of the Asia-Pacific POCT Market 116

8. Review of the Market Segments, Reagents and Equipment 120
8.1 Blood Glucose Monitoring 120
8.1.1 Introduction to Blood Glucose Monitoring 120
8.1.2 Types of Blood Glucose Testing 121
8.1.2.1 Fasting Blood Sugar (FBS) or Fasting Plasma Glucose (FPG) 121
8.1.2.2 Two-Hour Postprandial Blood Sugar or Two-Hour PC 121
8.1.2.3 Random Blood Sugar (RBS) 121
8.1.2.4 Glucose Urine Test 121
8.1.2.5 Blood Glucose Test Strip 121
8.1.2.6 Glycosylated Hemoglobin (HbA1c) 122
8.1.2.7 Intravenous Glucose Tolerance Test (IVGTT) 122
8.1.2.8 Oral Glucose Tolerance Test (OGTT) 122
8.1.3 Segmentation of POC Blood Glucose Testing 122
8.1.3.1 Continuous Blood Glucose Monitoring (CBGM) 122
8.1.3.2 Self-Monitoring Blood Glucose (SMBG) Testing 124
8.1.3.3 Minimally-Invasive and Non-Invasive Blood Glucose Testing 124
8.1.3.4 Emerging Glucose Monitoring Technologies 124
8.1.3.5 Optical Transducer Technologies 125
8.1.3.6 Transdermal Sensor Technologies 126
8.1.3.7 Invasive Glucose Sensor Technologies 126
8.1.4 Review of Professional POC Blood Glucose Monitoring Systems 127
8.1.4.1 New Guidance: Use of Blood Glucose Monitoring Systems for Professional and Home POC 127
8.1.5 Review of POC Blood Glucose Monitoring Products 128
8.1.5.1 Abaxis, Inc. 130
8.1.5.2 Abbott 130
8.1.5.3 Alere 132
8.1.5.4 Apex Biotechnology 132
8.1.5.5 ARKRAY, Inc. 132
8.1.5.6 DiaSys 133
8.1.5.7 EKF Diagnostics 133
8.1.5.8 Fora Care 134
8.1.5.9 HemoCue (part of Radiometer) 134
8.1.5.10 HMD BioMedical 134
8.1.5.11 Infopia 135
8.1.5.12 Instrumentation Laboratory 135
8.1.5.13 Jant Pharmacal 135
8.1.5.14 LifeHealth (formerly International Technidyne Corp.) 136
8.1.5.15 Medtronic 136
8.1.5.16 Nova Biomedical 137
8.1.5.17 Polymer Technology Systems 138
8.1.5.18 Radiometer 138
8.1.5.19 Randox Laboratories 139
8.1.5.20 Roche 140
8.1.5.21 Siemens 141
8.1.5.22 Stanbio Laboratory 142
8.1.5.23 Techno Medica Co., Ltd. 142
8.1.5.24 LifeScan 142
8.1.6 Professional POC Hemoglobin A1c (HbA1c) Testing 142
8.1.6.1 A. Menarini Diagnostics 143
8.1.6.2 Alere 143
8.1.6.3 Apex Biotechnology 144
8.1.6.4 Convergent Technologies GmbH & Co. 144
8.1.6.5 DiaSys Diagnostic Systems 144
8.1.6.6 Diazyme Laboratories 144
8.1.6.7 EKF Diagnostics 145
8.1.6.8 Eurolyser 145
8.1.6.9 Green Cross Medis (formerly Ceragem Medisys) 145
8.1.6.10 HemoCue (a division of Radiometer) 146
8.1.6.11 Infopia 146
8.1.6.12 Roche 146
8.1.6.13 SD Biosensor 146
8.1.6.14 Siemens Healthcare Diagnostics 147
8.1.6.15 Erba Diagnostics 147
8.1.7 Market Analysis 147
8.1.7.1 Worldwide Professional Glucose Testing Market 149
8.1.7.2 U.S. Professional Glucose Testing Market 149
8.1.8 Competitive Analysis for the Glucose POCT Sector 150
8.1.9 Market Share for Glucose Testing 152
8.1.10 Competitive Analysis for the Glucose POCT Sector 152
8.1.11 Market Analysis 153
8.1.11.1 Market Drivers 153
8.1.11.2 Market Restraints 153
8.1.12 POC Glucose Testing Assay Market and Technology Trends 154
8.1.12.1 POC Glucose Testing Assay Market Trends 154
8.1.12.2 POC Glucose Testing Assay Technology Trends 154
8.1.12.3 POC Glucose Testing Assay Strategic Recommendations 154
8.2 Blood Gas and Electrolytes 155
8.2.1 Background to POC Blood Gas and Electrolyte Testing 155
8.2.1.1 Acid-Base Balance and the Lungs 156
8.2.1.2 Respiratory Acidosis 156
8.2.1.3 Respiratory Alkalosis 156
8.2.1.4 Metabolic (or Non-Respiratory) Acidosis 156
8.2.1.5 Metabolic (or Non-Respiratory) Alkalosis 156
8.2.1.6 Increasing Popularity of POC Blood Gas and Electrolyte Testing 157
8.2.2 Market Segmentation (Segmentation by Type of Blood Gas Monitoring Equipment) 157
8.2.2.1 Intermittent Blood Gas Monitoring Equipment 157
8.2.2.2 Continuous Blood Gas Monitoring Equipment 157
8.2.2.3 EABG Monitors 158
8.2.2.4 IABG Monitors 158
8.2.2.5 Portable Blood Gas Analyzers 158
8.2.2.6 Patient-Attached On-Demand Blood Gas Analyzers 159
8.2.3 Applications for POCT Blood Gas and Electrolyte Analyzers 159
8.2.4 Emerging Technologies 159
8.2.5 Whole-Blood Lactate 159
8.2.6 Creatinine 159
8.2.7 Electrolytes Point of Care Analysis: Comparison of POCT and Central Lab Results 160
8.2.8 Review of Selected Blood Gas and Electrolyte Analyzers 161
8.2.9 Review of Company Products 163
8.2.9.1 Roche Corporation 163
8.2.9.2 Siemens Healthcare Diagnostics 163
8.2.9.3 Instrumentation Laboratory 164
8.2.9.4 Nova Biomedical 165
8.2.9.5 Radiometer 165
8.2.9.6 Abbott Point of Care 165
8.2.9.7 Accriva Diagnostics 166
8.2.9.8 Alere 167
8.2.9.9 Opti Medical 167
8.2.10 Market Share for Blood Gas and Electrolyte Testing 167
8.2.11 Market Analysis 168
8.2.11.1 Market Drivers 168
8.2.11.2 Market Restraints 169
8.2.12 POC Blood Gas and Electrolyte Testing Assay Market and Technology Trends 169
8.2.12.1 POC Blood Gas and Electrolyte Testing Assay Market Trends 169
8.2.12.2 POC Blood Gas and Electrolyte Testing Assay Technology Trends 169
8.2.12.3 POC Blood Gas and Electrolyte Testing Assay Strategic Recommendations 170
8.3 Rapid Coagulation Tests 170
8.3.1 Background to Rapid Coagulation Tests 171
8.3.2 Review of Selected POC Rapid Coagulation Analyzers 177
8.3.3 Review of Company Products 179
8.3.3.1 Roche Diagnostics Corp. 179
8.3.3.2 Abbott Laboratories 181
8.3.3.3 Accriva 181
8.3.3.4 Medtronic 183
8.3.3.5 Alere 183
8.3.3.6 Helena Laboratories Point of Care 184
8.3.3.7 Sienco, Inc. 185
8.3.3.8 Instrumentation Laboratory’s GEM PCL Plus 186
8.3.4 Connectivity Issues 187
8.3.5 Cost Benefits 187
8.3.6 Quality Control Issues 188
8.3.7 Certification for POC Coagulation Devices 189
8.3.8 D-Dimer Testing 189
8.3.9 Market Analysis 189
8.3.9.1 Market Share for POCT Coagulation Testing 189
8.3.9.2 Competitive Analysis of Sector Companies 190
8.3.9.3 Market Drivers 190
8.3.9.4 Market Restraints 191
8.3.9.5 POC Coagulation Testing Assay Market Trends 192
8.3.9.6 POC Coagulation Testing Assay Technology Trends 192
8.3.9.7 POC Coagulation Testing Assay Strategic Recommendations 193
8.3.9.8 SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Coagulation POC Market 193
8.4 POC Rapid Cardiac Markers 194
8.4.1 Background to POC Rapid Cardiac Marker Testing 194
8.4.2 Cardiac Marker Tests 195
8.4.2.1 Creatine Kinase (CK) 195
8.4.2.2 Myoglobin 196
8.4.2.3 Cardiac Troponins T (TnT), I (TnI) and C (TnC) 197
8.4.2.4 C-Reactive Protein (CRP) 198
8.4.2.5 Homocysteine 199
8.4.3 Emerging Markers 200
8.4.3.1 B-Type Natriuretic Peptide (BNP) 200
8.4.3.2 Myeloperoxidase (MPO) 201
8.4.3.3 Ischemia-Modified Albumin (IMA) 201
8.4.3.4 Glycogen Phosphorylase Isoenzyme BB (GPBB) 202
8.4.3.5 Fatty Acid-Binding Proteins (FABPs) 202
8.4.4 Review of Selected POC Cardiac Biomarker Analyzers 202
8.4.5 Review of Company Products 204
8.4.5.1 Abbott’s i-STAT System 204
8.4.5.2 Alere’s Triage System 204
8.4.5.3 Alpha Scientific 205
8.4.5.4 Boditech Med’s i-CHROMA System 206
8.4.5.5 BTNX 206
8.4.5.6 Homemed 206
8.4.5.7 LSI Medience (formerly Mitsubishi Chemical Medience Corp.) 207
8.4.5.8 Nano-Ditech 207
8.4.5.9 Princeton BioMeditech 207
8.4.5.10 Radiometer (part of Danaher) 207
8.4.5.11 Response Biomedical Corporation 208
8.4.5.12 Roche Diagnostics’ cobas h 232 POC System 209
8.4.5.13 Roche’s CARDIAC TROP T Sensitive Test (Visual) 210
8.4.5.14 Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics, Diagnostic Products Corporation and Dade Behring) 210
8.4.5.15 Trinity Biotech 211
8.4.5.16 Trivitron Healthcare (formerly Ani Biotech) 211
8.4.5.17 bioMérieux 211
8.4.6 Market Share and Sales for Cardiac Marker Testing 211
8.4.6.1 Market Drivers 213
8.4.6.2 Market Restraints 214
8.4.7 POC Cardiac Marker Testing Assay Market and Technology Trends 215
8.4.7.1 POC Cardiac Marker Testing Assay Market Trends 215
8.4.7.2 POC Cardiac Marker Testing Assay Technology Trends 216
8.4.7.3 POC Cardiac Marker Testing Assay Strategic Recommendations 216
8.5 POCT Substance Abuse Testing 217
8.5.1 Background to POC Substance Abuse Testing 217
8.5.2 Substance Abuse Test Types 224
8.5.2.1 Urine Substance/Drug Screening 224
8.5.2.2 Hair Tests for Substance Abuse and Screening 224
8.5.2.3 Blood Tests for Substance Abuse and Screening 225
8.5.2.4 Saliva Tests for Substance Abuse and Screening 225
8.5.2.5 Sweat Tests for Substance Abuse and Screening 225
8.5.3 Alcohol Abuse and Screening 225
8.5.4 Saliva Testing 226
8.5.5 Qualitative Analysis 226
8.5.5.1 Market Drivers 226
8.5.5.2 Market Restraints 227
8.5.6 Review of Selected POC Substance Abuse Analyzers 227
8.5.7 Review of Company Products 228
8.5.7.1 Alere 228
8.5.7.2 Abbott Diagnostics 229
8.5.7.3 BTNX, Inc. 229
8.5.7.4 BioScan Screening Systems, Inc. 230
8.5.7.5 American Bio Medica Corp. 231
8.5.7.6 Phamatech, Inc. 236
8.5.7.7 First Check Diagnostics Corp. (Alere, Inc.) 236
8.5.7.8 OraSure 237
8.5.7.9 Noble Medical, Inc. 237
8.5.7.10 Guangzhou Wondfo Biotech Co., Ltd. 237
8.5.7.11 Pathtech 237
8.5.7.12 Alfa Scientific Designs, Inc. 238
8.5.7.13 American Bio Medica 238
8.5.7.14 Biophor Diagnostics 238
8.5.7.15 Randox Laboratories 239
8.5.7.16 Branan Medical 239
8.5.7.17 Concateno 239
8.5.7.18 LifeSign 240
8.6 POC Pregnancy and Fertility Tests 240
8.6.1 Background to POC Pregnancy and Fertility Tests 240
8.6.2 Review of Selected POC Pregnancy Testing Devices 241
8.6.3 Review of Company Products 242
8.6.3.1 Quidel 242
8.6.3.2 Abbott Diagnostics 243
8.6.3.3 Alere 243
8.6.3.4 Sutherland Health Group Ltd. 243
8.6.3.5 Sekisui Diagnostics, LLC 243
8.6.3.6 Siemens Diagnostics 244
8.6.3.7 Orgenics (A subsidiary of Alere) 244
8.6.3.8 LifeSign 244
8.6.3.9 Other Companies in this Sector 244
8.6.3.10 Market Analysis 245
8.6.3.10.1 Competitive Sector Analysis 245
8.7 Fecal Occult Blood 245
8.7.1 Background to POC Fecal Occult Blood Testing 245
8.7.2 Review of Selected POC Fecal Occult Testing Devices 247
8.7.3 Review of Company Products 249
8.7.3.1 Helena Laboratories 249
8.7.3.2 Biomerica 249
8.7.3.3 Beckman Coulter 249
8.7.3.4 Worldwide Medical 250
8.7.3.5 Aerscher Diagnostics 250
8.7.3.6 Enterix 250
8.7.3.7 Medix Biochemica 250
8.7.3.8 Orion Diagnostica 251
8.7.3.9 ACON Laboratories’ Mission FOB Reagent Strips 251
8.7.3.10 Alere’s Products 251
8.7.3.11 Immunostics Hema-Screen 251
8.7.3.12 Princeton BioMeditech’s BioSign iFOBTest 251
8.7.3.13 Quest Diagnostics’ InSure FIT 251
8.7.3.14 Quidel’s QuickVue iFOB 251
8.7.3.15 Exact Sciences’ Cologuard 251
8.7.3.16 Epigenomics 252
8.7.3.17 CTK Biotech 252
8.7.4 Market Share for Fecal Occult Blood Testing 252
8.7.4.1 Company Analysis for the Fecal Occult Blood POCT Sector 252
8.7.5 Market Analysis 252
8.7.5.1 Market Drivers 252
8.7.5.2 Market Restraints 253
8.7.5.3 POC Fecal Occult Blood Testing Assay Market and Technology Trends 253
8.7.5.3.1 POC Fecal Occult Blood Testing Assay Market Trends 253
8.7.5.3.2 Fecal Occult Blood Testing Assay Technology Trends 254
8.7.5.3.3 POC Fecal Occult Blood Testing Assay Strategic Recommendations 254
8.8 POC Infectious Disease Testing 255
8.8.1 Background to POC Infectious Disease Testing 255
8.8.2 Types of Diagnosis for Infectious Diseases 256
8.8.2.1 Microbial Culture 256
8.8.2.2 Microscopy 256
8.8.2.3 Biochemical Tests 256
8.8.2.4 Immunologic Tests 256
8.8.2.5 Molecular Diagnostics Testing 257
8.8.3 Diagnostic Platforms for Infectious Diseases 257
8.8.3.1 Centralized Laboratory Testing for Infectious Diseases 257
8.8.3.2 POC Testing for Infectious Diseases 257
8.8.4 Emerging Technologies 258
8.8.5 Market Analysis 258
8.8.5.1 Market Drivers 259
8.8.5.2 Market Restraints 259
8.8.6 Review of Selected POC Infectious Disease Testing Devices 259
8.8.6.1 POC Infectious Disease Testing Devices and Assays in Development 262
8.8.6.1.1 Cepheid’s GeneXpert Omni 262
8.8.6.1.2 Alere q 262
8.8.6.1.3 Quidel 262
8.8.6.1.4 Roche’s cobas Liat System 263
8.8.6.1.5 QuantuMDx’s Q-POC 263
8.8.6.1.6 SRI International 263
8.8.6.1.7 Atlas Genetics’ io System 263
8.8.7 Overview of POC Assays for Detection of Infectious Disease 264
8.8.7.1 Anthrax and Other Bio-threats 264
8.8.7.2 Campylobacter 266
8.8.7.3 Clostridium difficile 266
8.8.7.4 E. coli 268
8.8.7.5 Gastrointestinal Infectious Agents 269
8.8.7.5.1 Giardia and Cryptosporidium 269
8.8.7.5.2 Entamoeba histolytica 270
8.8.7.5.3 Rotavirus & Adenovirus 270
8.8.7.5.4 Norovirus 270
8.8.7.6 Hepatitis 271
8.8.7.7 Herpes Simplex Virus Type-2 273
8.8.7.8 Influenza 273
8.8.7.9 Legionella 278
8.8.7.10 Malaria Testing 279
8.8.7.11 Meningitis 281
8.8.7.12 Mononucleosis 281
8.8.7.13 Procalcitonin (Detects Sepsis) 282
8.8.7.14 Respiratory Tract Infections 283
8.8.7.14.1 C-Reactive Proteins 283
8.8.7.14.2 Pneumonia 284
8.8.7.14.3 Respiratory Tract Panels 284
8.8.7.15 RSV 284
8.8.7.16 Streptococcus 286
8.8.7.17 Rubella 286
8.8.7.18 Sexually-Transmitted Diseases 287
8.8.7.18.1 Chlamydia 287
8.8.7.18.2 Gonorrhea Testing 287
8.8.7.18.3 Syphilis 288
8.8.7.19 Staphylococcus aureus and MRSA 289
8.8.7.20 Streptococcus A Testing 290
8.8.7.21 Tropical Diseases 292
8.8.7.21.1 Chagas Disease 293
8.8.7.21.2 Dengue Fever 293
8.8.7.21.3 Ebola 294
8.8.7.21.4 Filariasis 294
8.8.7.21.5 Onchocerciasis 294
8.8.7.21.6 Zika Virus 294
8.8.7.22 Tuberculosis 294
8.8.7.23 Typhoid 296
8.9 POC Urine Strip Testing 296
8.9.1 Background to POC Urine Strip Testing 296
8.9.2 Emerging Technologies 298
8.9.3 Review of Selected POC Urine Strip Testing Devices 299
8.10 POC Cholesterol Testing 300
8.10.1 POC Cholesterol Testing Market Size and Development 300
8.10.2 Background to POC Cholesterol Testing 301
8.10.3 POC Cholesterol Testing Devices 303
8.10.3.1 Review of Selected POC Cholesterol Testing Devices 303
8.10.4 Review of Company Products 304
8.10.4.1 Cholestech (Now Alere) 304
8.10.4.2 Polymer Technology Systems 305
8.10.4.3 Miraculins 305
8.10.4.4 Abaxis, Inc. 305
8.10.5 Product Comparison of Leading Suppliers 306
8.10.6 Launch Dates of Leading Products Worldwide 308
8.11 Miscellaneous POC Tests 308
8.11.1 Estriol 308
8.11.2 POC H. pylori Testing 309
8.11.3 Bacterial Contamination of Platelet Units 311
8.11.4 POC Vaginal Fluid pH and Vaginitis Testing 312
8.11.5 POC Cancer Testing 312
8.11.5.1 Prostate-Specific Antigen (PSA) 312
8.11.5.2 Bladder Cancer 313
8.11.5.3 Other Rapid Cancer Tests 315
8.11.6 Fetal Status (PROM) 316
8.11.7 Hemodynamic Monitoring 316
8.11.8 Heparin-Induced Thrombocytopenia 317
8.11.9 Ruptured Fetal Membranes 317
8.11.10 Alcohol 318
8.11.12 Microalbumin Testing 318
8.11.13 Prenatal, Labor and Delivery Testing 318
8.11.13.1 Alere Triage PLGF 318
8.11.13.2 Medix Biochemica 319
8.11.14 Sperm Fertility 319
8.11.15 Surgical Coagulation and Hemostasis Management 319
8.11.16 Respiratory Tests 319
8.11.17 C-Reactive Protein 320
8.12 HIV 320
8.12.1 FDA-Approved Rapid HIV Assays 324
8.12.1.1 Alere 325
8.12.1.2 bioLytical Laboratories, Inc. 326
8.12.1.3 Bio-Rad Laboratories 327
8.12.1.4 Chembio Diagnostics 327
8.12.1.5 MedMira Laboratories, Inc. 327
8.12.1.6 OraSure Technologies 328
8.12.1.7 Trinity Biotech 329
8.12.2 Rapid HIV Assays Not Approved by the FDA (not commercially available in the U.S.) 329
8.12.2.1 Alere 329
8.12.2.2 bioMérieux 330
8.12.2.3 Bio-Rad 330
8.12.2.4 Core Diagnostics 331
8.12.2.5 CTK Biotech 331
8.12.2.6 EY Laboratories 331
8.12.2.7 Hema Diagnostics Systems 332
8.12.2.8 ImmunoScience 332
8.12.2.9 InTec Products 332
8.12.2.10 JAL Innovation 332
8.12.2.11 J Mitra & Co. 333
8.12.2.12 Premier Medical Corporation 333
8.12.2.13 Princeton BioMeditech 333
8.12.2.14 Savyon Diagnostics 334
8.12.2.15 Shanghai Kehua 334
8.12.2.16 Span Diagnostics 334
8.12.2.17 Tulip Group 334
8.12.2.18 YD Diagnostics’ AIDScan 335
8.12.3 POC Viral Load Technologies of the Future 335
8.12.3.1 Cepheid 335
8.12.3.2 Roche 335
8.12.3.3 Wave 80 Biosciences 335

9. POCT: Growth Regulators 336
9.1 Moderators of Growth 336
9.2 Personnel Acceptance 336
9.3 Key People for POCT 337
9.4 Information Management Issues 337
9.4.1 Elements of Information Management for POCT: Information-Processing Capabilities 337
9.4.2 Data Mining 338
9.4.3 Middleware 338
9.4.4 Web Portals 339
9.4.5 POCT-1A Standard 339
9.5 Key Elements for POCT 340
9.6 POCT and Reimbursement 340
9.7 Effectiveness of Clinical Outcomes 342
9.8 Rapid Near-Patient Testing in Hospitals 343
9.9 Satellite Facilities 343
9.10 Regionalization of Laboratory Care 344
9.11 Requirements for POCT 345
9.12 Locations of POC for Patient Care 346
9.13 Benefits of POCT 346
9.14 Cost Elements of POCT 346
9.15 Necessary Functions in POCT 347
9.16 Turnaround Time (TAT) for POCT 347
9.17 Clinical Laboratory Improvement Amendments (CLIA) 347
9.18 Sexually-Transmitted Diseases in Underdeveloped Countries 349
9.19 Sources of Error in POC Testing 349

10. Business Trends in the POC Sector 351
10.1 Sector Consolidation 351
10.2 Diagnostic Testing Growth Trends 352
10.2.1 Opportunities for Healthcare Stakeholders 353
10.3 Acquisition, License Agreements, Internal Development and Partnerships 353
10.4 Product Testing Depth in POCT 356
10.5 Government Regulation 356
10.5.1 U.S. Regulation 356
10.5.1.1 Importing Medical Devices into the U.S. 358
10.5.1.2 Exporting Medical Devices from the U.S. 359
10.5.2 E.U. Regulation 359
10.5.3 Japanese Regulation 362
10.6 Post-Filing Regulations for POC Devices 364
10.7 Exporting Unapproved POCTs 365
10.8 Analyte-Specific Reagents (“Home-Brew” Tests) 365
10.9 Medical Device Registration 365
10.10 Product Labeling 366
10.11 Punitive FDA Actions 366
10.12 CLIA ‘88 and State Laboratory Laws 366
10.13 Impact of Regulations on the Industry 367
10.14 Minimizing Regulatory Barriers 368
10.15 Waived Testing 370

11. Technology Platform Innovations in POCT 372
11.1 Latest POCT Technological Platforms 372
11.1.1 Device Miniaturization and Microfluidic Technologies 372
11.1.2 Minimally-Invasive and Non-Invasive POCT Technologies 373
11.1.2.1 Libre Flash Glucose Monitor and OneTouch Verio Sync Meter 373
11.1.2.2 Echo Therapeutics 373
11.1.3 Advances in Wireless Technologies 373
11.1.4 Automation of POCT 373
11.1.5 Developments in New Genomic Technologies (Genotyping, Haplotyping and Sequencing
Technologies) 374
11.1.6 Advances in Informatics Technologies 376
11.1.7 Pharmacogenetic Testing 377
11.1.8 Multi-Assay Technologies in POCT 377
11.1.9 Molecular Diagnostic Technology in POCT for Infectious Disease 377
11.2 Smart Phone Technology 378
11.2.1 Aquila Diagnostic Systems, Inc. 378
11.2.2 AgaMatrix 379
11.2.3 Quick HIV and Syphilis Screening 379
11.2.4 Accu-Check Connect System 379
11.3 QuantuMDx Handheld, Portable Low Cost Rapid Devices 379

12. Data Management and Connectivity 381
12.1 Wireless LANs 381
12.2 Connectivity Platforms 383
12.2.1 Data Management Systems 384
12.2.1.1 Alere RALS System 385
12.2.1.2 International Technidyne Corporation HEMOCHRON Signature Elite 386
12.2.1.3 Siemens Diagnostics Rapidpoint 386
12.2.1.4 Radiometer 386
12.2.1.5 HemoCue’s DM Hemoglobin 386
12.2.1.6 Roche Diagnostics Cobas IT 386
12.2.1.7 Accriva 387
12.2.3 BD.id 387
12.2.4 Medical Implant Communications Service (MICS) 387
12.2.5 Conworx Technology 387
12.2.6 Telcor QML 388
12.2.7 Medasys 388
12.2.8 NoemaLife 388
12.2.9 Telcare 388
12.3 Advantages of POCT Connectivity 388
12.3.1 Cost-Benefit Analysis of POCT and IT Connectivity 389
12.3.2 Hospital Network Issues 389

13. Corporate Profiles 391
13.1 Abaxis, Inc. 391
13.2 Abbott Laboratories 392
13.3 AccuBioTech Co., Ltd. 393
13.4 Accriva Diagnostics 393
13.5 ACON Laboratories, Inc. 394
13.6 Acrongenomics 394
13.7 AgaMatrix 395
13.8 Aerscher Diagnostics, LLC 395
13.9 Akers Biosciences, Inc. 395
13.10 Alere 397
13.11 Alfa Scientific Designs, Inc. 399
13.12 American Bio Medica Corporation 400
13.13 Arkray, Inc. 401
13.14 Atlas Genetics Ltd. 401
13.15 Atonomics A/S 401
13.16 Audit Diagnostics 401
13.17 Augurix Diagnostics Ltd. 402
13.18 Axxin 402
13.19 Beckman Coulter (Danaher Corporation) 402
13.20 bioLytical Laboratories 405
13.21 Biomerica, Inc. 405
13.22 bioMérieux 406
13.23 BiOracle 406
13.24 Bio-Rad Laboratories, Inc. 406
13.25 BioScan Screening Systems, Inc. 406
13.26 Calypte Biomedical Corporation 407
13.27 Chembio Diagnostic, Inc. 407
13.28 Cholestech 408
13.29 Claros Diagnostics (OPKO Healthcare) 408
13.30 ERBA Diagnostics, Inc. 408
13.31 Daktari Diagnostics 409
13.32 Dexcom 409
13.33 Diagnostics for All 411
13.34 Enigma Diagnostics Ltd. 411
13.35 EY Laboratoires, Inc. 412
13.36 Eurotrol 412
13.37 Exalenz Bioscience 412
13.38 GenBio 413
13.39 Guided Therapeutics, Inc. 413
13.40 Helena Laboratories 413
13.41 Hema Diagnostic Systems, LLC 413
13.42 Instrumentation Laboratory (IL)/Werfen Group 414
13.43 Jant Pharmacal Corporation 415
13.44 Lein Applied Diagnostics 415
13.45 LifeSign, LLC 415
13.46 Medica Corporation 415
13.47 Medix Biochemica 415
13.48 MedMira Laboratories 416
13.49 A. Menarini Diagnostics 416
13.50 Micronics 416
13.51 New Horizons Diagnostics 416
13.52 Nova Biomedical 416
13.53 OraSure Technologies, Inc. 418
13.54 Orion Diagnostica 419
13.55 Polymedco, Inc. 420
13.56 Polymer Technology Systems, Inc. 420
13.57 Prima Biomedical Company 421
13.58 Qualigen 421
13.59 Quest Diagnostics, Inc. 421
13.60 Quidel Corporation 421
13.61 Radiometer Medical 421
13.62 Response Biomedical Corp. 422
13.63 Roche Diagnostics 422
13.64 Savyon Diagnostics 422
13.65 Seegene 423
13.66 Sekisui Diagnostics, LLC 423
13.67 Shanghai Ruicare Medical Co., Ltd. 424
13.68 Shenzhen Fitconn Technology Co., Ltd. 424
13.69 Shionogi & Co., Ltd. 424
13.70 Siemens AG 425
13.71 Siloam Biosciences, Inc. 426
13.72 Spectral Diagnostics, Inc. 426
13.73 StatSure Diagnostic Systems, Inc. 426
13.74 One Step Detect Associates, LLC 427
13.75 Senseonics 427
13.76 Telcare 427
13.77 Trinity Biotech Plc 428
13.78 Väsamed, Inc. 430

14. POCT Sector Trends and Forecasts 431
14.1 Home Care Analysis as Part of Near-Patient Testing 431
14.2 Non-Traditional Collection for POCT 431
14.3 New Systems for Critical Care and Near-Patient Testing 432
14.4 Utility of Near-Patient Testing in Critical-Care Settings 432
14.5 Physician’s Office Market 433
14.6 Information Management Advances 433
14.7 Test-Ordering Patterns and Demand for POCT 434
14.8 Demand for Emergency Department Services 434
14.9 Move Away from the Central Laboratory 435
14.10 Healthcare Cost Controls 436
14.11 Mergers & Acquisitions 437
14.12 Competition for Services 437
14.13 Drivers of POCT 438
14.14 Confluence of New Technology 438
14.15 Difficulties of Design for POC Products 438
14.16 Point of Care Compliance 438
14.17 The Biggest New Opportunities in POCT 441

15. New Entrants to the Point of Care Market 442
15.1 Alliance International Co., Ltd. 442
15.2 Analyticon Biotechnologies AG 442
15.3 Ativa Medical Corporation 442
15.4 Aquila Diagnostic Systems, Inc. 443
15.5 ArcDia International Oyo Ltd. 443
15.6 Artron Laboratories, Inc. 444
15.7 Atlas Link Biotech Co., Ltd. 444
15.8 Audit Diagnostics 444
15.9 Autobio Diagnostics Co., Ltd. 444
15.10 Biocartis SA 444
15.11 BioFire Diagnostics, Inc. 445
15.12 BioMedomics 445
15.13 Biosensia Ltd. 445
15.14 Curetis AG 446
15.15 DxNA, LLC 446
15.16 Echo Therapeutics, Inc. 446
15.17 Gentag, Inc. 447
15.18 Great Basin Corporation 447
15.19 Immunexpress Group 447
15.20 Integrated Diagnostics 447
15.21 Integrity Applications 448
15.22 MBio Diagnostics, Inc. 448
15.23 Menssana Research, Inc. 448
15.24 Metaara Medical Technologies, Inc. 448
15.25 QuantuMDx Group 449
15.26 Venaxis, Inc. 449
15.27 Philips Business Group EBA 449
15.28 Wave 80 Biosciences 449
15.29 Veredus Laboratories Pte Ltd. 449


INDEX OF FIGURES

Figure 2.1: Worldwide Distribution of IVD Testing, 2015 36
Figure 2.2: Top 13 Country IVD Testing Markets, 2015 37
Figure 2.3: Market Share for IVD Testing by Company, 2015 38
Figure 3.1: Total Global POCT Market, 2008-2018 46
Figure 3.2: Worldwide Distribution of POCT, 2015 53
Figure 3.3: Summary of Global POCT Markets by Market Segment, 2015 54
Figure 4.1: U.S. Revenues for POCT Market, 2008-2018 55
Figure 4.2: Summary of U.S. POCT Markets by Market Segment, 2015 63
Figure 5.1: European Revenues for POCT Market, 2008-2018 71
Figure 6.1: Summary Analysis of Japanese, Chinese and Indian POCT Market, 2008-2018 85
Figure 6.2: Japanese Revenues for POCT Market, 2008-2018 93
Figure 6.3: Indian Revenues for POCT Market, 2008-2018 97
Figure 6.4: Chinese Revenues for POCT Market, 2008-2018 99
Figure 7.1: Summary Analysis of ROW POCT Market, 2008-2018 104
Figure 7.2: Summary Analysis of Russian Revenues for POCT Products Market, 2008-2018 113
Figure 7.3: Summary Analysis of Middle East Revenues for POCT Products Market, 2008-2018 114
Figure 7.4: Summary Analysis of African Revenues for POCT Products Market, 2008-2018 115
Figure 7.5: Summary Analysis of Latin America Revenues for POCT Products Market, 2008-2018 119
Figure 8.1: Global Share of Glucose Testing Market by Company, 2015 152
Figure 8.2: Global POCT Share of Blood Gas and Electrolyte Testing Market, 2015 167
Figure 8.3: Global POCT Share of Coagulation Testing Market, 2015 189
Figure 8.4: Global POCT Share of Cardiac Marker Testing Market, 2015 212
Figure 8.5: Distribution of Infectious Diseases Tested at the Point of Care 259
Figure 8.6: Global POCT Share of HIV Testing Market, 2015 323
Figure 9.1: Annual Rate of Emergency Room Visits by Primary Expected Source of Payment 342
Figure 10.1: Conformity Assessment Route, Annexes and Quality System Standards by IVD Device
Category 360
Figure 12.1: The Alere RALS Data Management System Connects to Most of the Major Instruments Used in Point of Care 385


INDEX OF TABLES

Table 2.1: Summary of Global POCT Markets by Major Market Sub-Segment, 2015 and 2018 27
Table 2.2: Summary of U.S. POCT Markets by Major Market Sub-Segment, 2015 and 2018 27
Table 2.3: Summary of European POCT Markets by Major Market Sub-Segment, 2015 and 2018 28
Table 2.4: Summary of Asian POCT Markets by Major Market Sub-Segment, 2015 and 2018 28
Table 2.5: Summary of ROW POCT Markets by Major Market Sub-Segment, 2015 and 2018 29
Table 2.6: Worldwide Distribution of IVD Testing, 2015 36
Table 2.7: Top 13 Country IVD Testing Markets, 2015 37
Table 2.8: Company Market Share for IVD Testing Markets, 2015 38
Table 2.9: Competitive Landscape for POC Diagnostic Testing 42
Table 3.1: Total Global POCT Market, 2008-2018 45
Table 3.2: Global Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 46
Table 3.3: Global Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018 47
Table 3.4: Global Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018 48
Table 3.5: Global Revenues for POC Cardiac Marker Devices, 2008-2018 48
Table 3.6: Global Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018 49
Table 3.7: Global Revenues for POC Infectious Disease Testing Devices Market, 2008-2018 49
Table 3.8: Global Revenues for POC Urine Strip Testing Products Market, 2008-2018 50
Table 3.9: Global Revenues for POC Pregnancy Testing Devices Market, 2008-2018 50
Table 3.10: Global Revenues for POC Fecal Occult Testing Devices Market, 2008-2018 51
Table 3.11: Global Revenues for POC Cholesterol Testing Products Market, 2008-2018 51
Table 3.12: Global POCT Market Share Analysis, 2015 52
Table 3.13: Worldwide POCT Market Size by Geographic Location, 2008-2018 52
Table 3.14: Worldwide Distribution of POCT, 2015 53
Table 3.15: Summary of Global POCT Markets by Market Segment, 2015 53
Table 3.16: Worldwide POCT by Performance Location, 2015 54
Table 4.1: U.S. Revenues for POCT Market, 2008-2018 55
Table 4.2: U.S Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 56
Table 4.3: U.S. Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018 57
Table 4.4: U.S. Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018 57
Table 4.5: U.S. Revenues for POC Cardiac Marker Devices, 2008-2018 58
Table 4.6: Market Share of U.S. POCT Cardiac Marker Market, 2015 58
Table 4.7: U.S. Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018 59
Table 4.8: U.S. Revenues for POC Infectious Disease Testing Devices Market, 2008-2018 59
Table 4.9: U.S. Revenues for POC Urine Strip Testing Products Market, 2008-2018 60
Table 4.10: U.S. Revenues for POC Pregnancy Testing Devices Market, 2008-2018 60
Table 4.11: U.S. Revenues for POC Fecal Occult Testing Devices Market, 2008-2018 61
Table 4.12: U.S. Revenues for POC Cholesterol Testing Products Market, 2008-2018 61
Table 4.13: U.S. POCT Market Share Analysis, 2015 62
Table 4.14: Summary of U.S. POCT Markets by Market Segment, 2015 62
Table 5.1: Models of Public-Private Partnership in Hospital Provision 67
Table 5.2: European Revenues for POCT Market, 2008-2018 70
Table 5.3: French Revenues for POCT Systems, 2008-2018 71
Table 5.4: German Revenues for POCT Systems, 2008-2018 72
Table 5.5: Italian Revenues for POCT Systems, 2008-2018 72
Table 5.6: Spanish Revenues for POCT Systems, 2008-2018 73
Table 5.7: U.K. Revenues for POCT Systems, 2008-2018 73
Table 5.8: Benelux Revenues for POCT Systems, 2008-2018 74
Table 5.9: Scandinavian Revenues for POCT Systems, 2008-2018 74
Table 5.10: Rest-of-Europe Revenues for POCT Systems, 2008-2018 75
Table 5.11: European Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 76
Table 5.12: European Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018 76
Table 5.13: European Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018 77
Table 5.14: European Revenues for POC Cardiac Markers, 2008-2018 79
Table 5.15: European Revenues for POC Substance/Drug Abuse Testing Market, 2008-2018 80
Table 5.16: European Revenues for POC Infectious Disease Testing Market, 2008-2018 80
Table 5.17: European Revenues for POC Urine Strip Testing Products Market, 2008-2018 81
Table 5.18: European Revenues for POC Pregnancy Testing Market, 2008-2018 82
Table 5.19: European Revenues for POC Fecal Occult Blood Testing Market, 2008-2018 82
Table 5.20: European Revenues for POC Cholesterol Testing Products Market, 2008-2018 83
Table 5.21: European Market Share Analysis, 2015 84
Table 6.1: Summary Analysis of Japanese, Chinese and Indian POCT Market, 2008-2018 85
Table 6.2: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 86
Table 6.3: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018 86
Table 6.4: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018 87
Table 6.5: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Cardiac Marker Devices, 2008-2018 87
Table 6.6: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018 88
Table 6.7: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Infectious Disease Testing Devices Market, 2008-2018 88
Table 6.8: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Urine Strip Testing Products Market, 2008-2018 89
Table 6.9: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Pregnancy Testing Devices Market, 2008-2018 89
Table 6.10: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Fecal Occult Testing Devices Market, 2008-2018 90
Table 6.11: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Cholesterol Testing Products Market, 2008-2018 90
Table 6.12: Summary Analysis of Japanese, Chinese and Indian Market Shares, 2015 91
Table 6.13: Japanese Population and Aging Demographics Forecast, 2000-2050 92
Table 6.14: Japanese Revenues for POCT Market, 2008-2018 93
Table 6.15: Indian Revenues for POCT Market, 2008-2018 96
Table 6.16: Chinese Revenues for POCT Market, 2008-2018 98
Table 7.1: Summary Analysis of ROW POCT Market, 2008-2018 104
Table 7.2: Summary Analysis of ROW Revenues for POC Blood Glucose Monitoring Systems,
2008-2018 105
Table 7.3: Summary Analysis of ROW Revenues for POC Blood Gas and Electrolyte Analyzers,
2008-2018 106
Table 7.4: Summary Analysis of ROW Revenues for POC Rapid Coagulation Analyzer Systems,
2008-2018 106
Table 7.5: Summary Analysis of ROW Revenues for POC Cardiac Marker Devices, 2008-2018 107
Table 7.6: Summary Analysis of ROW Revenues for POC Substance/Drug Abuse Testing Device Market,
2008-2018 107
Table 7.7: Summary Analysis of ROW Revenues for POC Infectious Disease Testing Devices Market,
2008-2018 108
Table 7.8: Summary Analysis of ROW Revenues for POC Urine Strip Testing Products Market,
2008-2018 108
Table 7.9: Summary Analysis of ROW Revenues for POC Pregnancy Testing Devices Market,
2008-2018 109
Table 7.10: Summary Analysis of ROW Revenues for POC Fecal Occult Testing Devices Market,
2008-2018 109
Table 7.11: Summary Analysis of ROW Revenues for POC Cholesterol Testing Products Market,
2008-2018 110
Table 7.12: Summary Analysis of ROW Market Shares, 2015 110
Table 7.13: Summary Analysis of Argentinian Revenues for POCT Products Market, 2008-2018 111
Table 7.14: Summary Analysis of Australian Revenues for POCT Products Market, 2008-2018 111
Table 7.15: Summary Analysis of Brazilian Revenues for POCT Products Market, 2008-2018 112
Table 7.16: Summary Analysis of Canadian Revenues for POCT Products Market, 2008-2018 112
Table 7.17: Summary Analysis of Russian Revenues for POCT Products Market, 2008-2018 113
Table 7.18: Summary Analysis of Middle East Revenues for POCT Products Market, 2008-2018 114
Table 7.19: Summary Analysis of African Revenues for POCT Products Market, 2008-2018 115
Table 7.20: Summary Analysis of Asia (Other) Revenues for POCT Products Market, 2008-2018 116
Table 7.21: Summary Analysis of Latin America (Other) Revenues for POCT Products Market,
2008-2018 119
Table 8.1: Selected POC Blood Glucose and Blood Gas Meters Marketed for Professional Use, 2015 128
Table 8.2: POC HbA1c Testing Devices and Assays on the Market 143
Table 8.3: Global Revenues for Total Professional Blood Glucose Monitoring (Central Laboratory Testing and Hospital POC and POL), 2013-2019 149
Table 8.4: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market 150
Table 8.5: Global Share of Glucose Testing Market by Company, 2015 152
Table 8.6: Selected POC Blood Gas and Electrolyte Analyzers, 2015 162
Table 8.7: Market Share of Blood Gas and Electrolyte POCT Diagnostic Testing Companies Worldwide,
2015 168
Table 8.8: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Blood Gas and Electrolyte POC Market 170
Table 8.9: Hospital Locations of Point of Care Coagulation Testing 172
Table 8.10: Selected POC Rapid Coagulation Analyzers, 2015 178
Table 8.11: Actalyke XL 185
Table 8.12: Actalyke Mini 185
Table 8.13: Connectivity Modes for Leading Coagulation POCT Analyzers 187
Table 8.14: Market Share for Coagulation POCT Diagnostic Testing Companies, 2015 190
Table 8.15: Drivers for Point of Care Coagulation Testing 192
Table 8.16: Barriers for Point of Care Coagulation Testing 192
Table 8.17: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Coagulation POC Market 193
Table 8.18: Selected POC Cardiac Biomarkers, 2016 203
Table 8.19: Market Share of Cardiac Marker POCT Diagnostic Testing Companies Worldwide, 2015 212
Table 8.20: POC Cardiac Marker Testing Market: Market Drivers Ranked in Order of Impact 214
Table 8.21: POC Cardiac Marker Testing Market: Market Restraints Ranked in Order of Impact 215
Table 8.22: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Cardiac Marker POC Market 216
Table 8.23: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency Department 223
Table 8.24: Stat Urine Testing Drug Recommendations 223
Table 8.25: Selected POC Substance/Drug Abuse Testing Devices, 2016 227
Table 8.26: Selected POC Pregnancy Testing Devices, 2016 241
Table 8.27: Selected POC Fecal Occult Testing Devices, 2016 248
Table 8.28: ColoCARE Fecal Occult Blood Test 249
Table 8.29: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Fecal Occult Blood POC Market 254
Table 8.30: Selected POC Infectious Disease Testing Devices and Assays, 2016 260
Table 8.31: Influenza Diagnostic Rapid Tests 274
Table 8.32: Selected POC Urine Strip Testing, 2016 299
Table 8.33: Selected POC Cholesterol Testing Devices, 2016 303
Table 8.34: AmniSure 318
Table 8.35: Competitive Factors Related to HIV Tests 321
Table 8.36: Global POCT Market for Rapid HIV Testing, 2011-2020 323
Table 8.37: Global POCT Share of HIV Testing Market, 2015 323
Table 8.38: Rapid HIV Immunoassay Tests 324
Table 9.1: POCT1-Compliant Connectivity POC Instruments 340
Table 9.2: POCT Clinical Outcomes in Diabetic Ketoacidosis 342
Table 9.3: POCT Clinical Outcomes in Arterial Blood-Gas Measurements 342
Table 9.4: POCT in Three Hospitals—Cost Analysis with Labor Included 345
Table 9.5: POCT versus Central Lab—Cost Analysis for Glucose Testing 345
Table 11.1: Common Genotype Techniques 375
Table 12.1: Applications for Wireless LAN Technology 381
Table 12.2: Customized Reports Must Support CAP and JCAHO Requirements 384
Table 14.1: Improvements in Achieving ED Operational Efficiency Using POCT 433
Table 14.2: Test Menu and TAT for ED 434
Table 14.3: Top Reasons Why POC Cardiac Marker Testing is Implemented in the ED 434
Table 14.4: Key Areas and Metrics that Hospitals Measure to Assess Efficiency of ED 435
Table 14.5: Estimates of Patient Costs by DRG 436

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