Point of Care Diagnostic Testing World Markets

  • May 2014
  • -
  • TriMark Publications
  • -
  • 495 pages

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 18
1.1 About This Report 18
1.2 Scope of the Report 20
1.3 Objectives 20
1.4 Methodology 20
1.5 Executive Summary 22

2. Overview of Diagnostic Testing Point of Care Markets 27
2.1 Key Issues in the POC Diagnostic Testing Sector 31
2.1.1 Current Market Trends and Drivers 32
2.1.2 Effectiveness of POCT 33
2.1.3 New Growth Areas for POCT 33
2.1.4 Advantages of POCT in a Clinical Setting 33
2.1.5 Pricing and Reimbursement Issues 34
2.1.6 Key Customer Segments 34
2.2 Global Point of Care Marketplace 35
2.3 Shifts from Central Lab Testing to POCT 36
2.4 Geographical Distribution 36
2.5 Challenges of POCT 39
2.6 Key Issues for POCT 39
2.6.1 Locations of POCT 39
2.6.2 Milestones in Technology Development 42
2.6.3 Drive for Decentralization from Lab to Patient 42
2.6.4 Competitive Landscape for POCT 42
2.7 The Future of POCT 43

3. Summary Analysis of the Global POCT Market: Value, Growth Rates and Market Share 46
3.1 Global POCT Market 46

4. Analysis of the U.S. POCT Market: Value, Growth Rates and Market Share 56

5. Analysis of the European POCT Market: Value, Growth Rates and Market Shares 65

6. Analysis of the POCT Markets for Japan, China and India: Value, Growth Rates and
Market Share 86
6.1 Summary Analysis of the Japanese POCT Market 92
6.2 Summary Analysis of the Indian POCT Market 94
6.3 Summary Analysis of the Chinese POCT Market 97

7. Analysis of the Rest of World (ROW) POCT Market: Value, Growth Rates and Market Share 107
7.1 Summary Analysis of the ROW POCT Market Revenues 107
7.1.1 Summary Analysis of the Argentinian POCT Market 113
7.1.2 Summary Analysis of the Australian POCT Market 114
7.1.3 Summary Analysis of the Brazilian POCT Market 114
7.1.4 Summary Analysis of the Canadian POCT Market 115
7.1.5 Summary Analysis of the Russian POCT Market 115
7.1.6 Summary Analysis of the Middle East POCT Market 116
7.1.7 Summary Analysis of the African POCT Market 117
7.1.8 Summary Analysis of the Asia (Other) POCT Market 118
7.1.9 Summary Analysis of the Latin America (Other) POCT Market 121

8. Review of the Market Segments, Reagents and Equipment 123
8.1 Blood Glucose Monitoring 123
8.1.1 Introduction to Blood Glucose Monitoring 123
8.1.2 Types of Blood Glucose Testing 124
8.1.2.1 Fasting Blood Sugar (FBS) or Fasting Plasma Glucose (FPG) 124
8.1.2.2 Two-Hour Postprandial Blood Sugar or Two-Hour PC 124
8.1.2.3 Random Blood Sugar (RBS) 124
8.1.2.4 Glucose Urine Test 124
8.1.2.5 Blood Glucose Test Strip 124
8.1.2.6 Glycosylated Hemoglobin (HbA1c) 125
8.1.2.7 Intravenous Glucose Tolerance Test (IVGTT) 125
8.1.2.8 Oral Glucose Tolerance Test (OGTT) 125
8.1.3 Segmentation of POC Blood Glucose Testing 125
8.1.3.1 Continuous Blood Glucose Monitoring (CBGM) 125
8.1.3.2 Self-Monitoring Blood Glucose (SMBG) Testing 126
8.1.3.3 Minimally-Invasive and Non-Invasive Blood Glucose Testing 126
8.1.3.4 Emerging Glucose Monitoring Technologies 127
8.1.3.5 Optical Transducer Technologies 127
8.1.3.6 Transdermal Sensor Technologies 129
8.1.3.7 Invasive Glucose Sensor Technologies 130
8.1.4 Review of Selected POC Blood Glucose Monitoring Systems 130
8.1.5 Review of Company Products 134
8.1.5.1 LifeScan 134
8.1.5.2 Roche Accu-Chek 137
8.1.5.3 Abbott Diabetes Care 139
8.1.5.4 HemoCue 140
8.1.5.5 Stanbio/GDS Technology 141
8.1.5.6 Abaxis, Inc. 141
8.1.5.7 Arkray (Japan) 142
8.1.5.8 Accurex (India) 142
8.1.5.9 Home Diagnostics, Inc. 142
8.1.5.10 Nova Biomedical 143
8.1.5.11 Bayer Diagnostics 143
8.1.5.11.1 Hemoglobin A1c Measurements 144
8.1.5.12 AgaMatrix 144
8.1.5.13 Akray 144
8.1.5.14 EKF Diagnostics 145
8.1.5.15 ACON Laboratories, Inc. 145
8.1.5.16 Biosite (Now Part of Alere) 146
8.1.5.17 Siemens Healthcare Diagnostics 146
8.1.5.18 Infopia 146
8.1.5.19 Diasys 146
8.1.5.20 Quotient Dx 146
8.1.5.21 Cholestech (Acquired by Inverness Medical Innovations, now named Alere) 146
8.1.5.22 Bio-Rad 147
8.1.5.23 Axis-Shield 147
8.1.5.24 Abaxis, Inc. 147
8.1.6 Market Share for Glucose Testing 147
8.1.7 Competitive Analysis for the Glucose POCT Sector 148
8.1.8 Market Analysis 149
8.1.8.1 Market Drivers 149
8.1.8.2 Market Restraints 149
8.1.9 POC Glucose Testing Assay Market and Technology Trends 149
8.1.9.1 POC Glucose Testing Assay Market Trends 149
8.1.9.2 POC Glucose Testing Assay Technology Trends 150
8.1.9.3 POC Glucose Testing Assay Strategic Recommendations 150
8.2 Blood Gas and Electrolytes 151
8.2.1 Background to POC Blood Gas and Electrolyte Testing 151
8.2.1.1 Acid-Base Balance and the Lungs 153
8.2.1.2 Respiratory Acidosis 153
8.2.1.3 Respiratory Alkalosis 153
8.2.1.4 Metabolic (or Non-Respiratory) Acidosis 153
8.2.1.5 Metabolic (or Non-Respiratory) Alkalosis 153
8.2.1.6 Increasing Popularity of POC Blood Gas and Electrolyte Testing 154
8.2.2 Market Segmentation (Segmentation by Type of Blood Gas Monitoring Equipment) 154
8.2.2.1 Intermittent Blood Gas Monitoring Equipment 154
8.2.2.2 Continuous Blood Gas Monitoring Equipment 154
8.2.2.3 EABG Monitors 155
8.2.2.4 IABG Monitors 155
8.2.2.5 Portable Blood Gas Analyzers 155
8.2.2.6 Patient-Attached On-Demand Blood Gas Analyzers 156
8.2.3 Applications for POCT Blood Gas and Electrolyte Analyzers 156
8.2.4 Emerging Technologies 156
8.2.5 Whole-Blood Lactate 156
8.2.6 Creatinine 156
8.2.7 Electrolytes Point of Care Analysis: Comparison of POCT and Central Lab Results 157
8.2.8 Review of Selected Blood Gas and Electrolyte Analyzers 158
8.2.9 Review of Company Products 160
8.2.9.1 Roche Corporation 160
8.2.9.2 TechnoMedica 160
8.2.9.3 Siemens Healthcare Diagnostics 161
8.2.9.4 Instrumentation Laboratory 161
8.2.9.5 Nova Biomedical 162
8.2.9.6 Radiometer 162
8.2.9.7 Abbott Point of Care 163
8.2.9.8 Span Diagnostics 164
8.2.9.9 ITC AVOXimeter Systems for CO-oximetry 164
8.2.9.10 ITC (Nexus Dx) 165
8.2.9.11 Alere 165
8.2.9.12 Abaxis, Inc. 166
8.2.9.13 Opti Medical 166
8.2.9.14 Arkray USA 166
8.2.10 Market Share for Blood Gas and Electrolyte Testing 166
8.2.11 Competitive Analysis for the Blood Gas and Electrolyte Point of Care Testing Sector 167
8.2.12 Market Analysis 168
8.2.12.1 Market Drivers 168
8.2.12.2 Market Restraints 169
8.2.13 POC Blood Gas and Electrolyte Testing Assay Market and Technology Trends 170
8.2.13.1 POC Blood Gas and Electrolyte Testing Assay Market Trends 170
8.2.13.2 POC Blood Gas and Electrolyte Testing Assay Technology Trends 170
8.2.13.3 POC Blood Gas and Electrolyte Testing Assay Strategic Recommendations 170
8.3 Rapid Coagulation Tests 171
8.3.1 Background to Rapid Coagulation Tests 172
8.3.2 Review of Selected POC Rapid Coagulation Analyzers 178
8.3.3 Review of Company Products 181
8.3.3.1 Roche Diagnostics Corp. 181
8.3.3.2 Abbott Laboratories 182
8.3.3.3 International Technidyne Corporation Nexus DX 183
8.3.3.4 Medtronic 185
8.3.3.5 Alere 185
8.3.3.6 Helena Laboratories Point of Care 186
8.3.3.7 Sienco, Inc. 187
8.3.3.8 Accumetrics (ITC Nexus Holding Company) 188
8.3.3.9 Alere 188
8.3.3.10 ITC 189
8.3.3.11 Instrumentation Laboratory’s GEM PCL Plus 189
8.3.3.12 Others 190
8.3.3.13 Self-Monitoring Products 190
8.3.3.14 Platelet Function and Antiplatelet Drug Assessment 190
8.3.4 Connectivity Issues 191
8.3.5 Cost Benefits 191
8.3.6 Quality Control Issues 192
8.3.7 Certification for POC Coagulation Devices 193
8.3.8 D-Dimer Testing 193
8.3.9 Market Analysis 193
8.3.9.1 Market Share for POCT Coagulation Testing 193
8.3.9.2 Competitive Analysis of Sector Companies 194
8.3.9.3 Market Drivers 194
8.3.9.4 Market Restraints 195
8.3.9.5 POC Coagulation Testing Assay Market Trends 196
8.3.9.6 POC Coagulation Testing Assay Technology Trends 196
8.3.9.7 POC Coagulation Testing Assay Strategic Recommendations 197
8.3.9.8 SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Coagulation POC Market 197
8.4 POC Rapid Cardiac Markers 198
8.4.1 Background to POC Rapid Cardiac Marker Testing 198
8.4.2 Cardiac Marker Tests 199
8.4.2.1 Creatine Kinase (CK) 199
8.4.2.2 Myoglobin 200
8.4.2.3 Cardiac Troponins T (TnT), I (TnI) and C (TnC) 200
8.4.2.4 C-Reactive Protein (CRP) 200
8.4.2.5 Homocysteine 201
8.4.3 Emerging Markers 201
8.4.3.1 B-Type Natriuretic Peptide (BNP) 201
8.4.3.2 Myeloperoxidase (MPO) 201
8.4.3.3 Ischemia-Modified Albumin (IMA) 202
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 203
8.4.5 Review of Company Products 204
8.4.5.1 Alere Triage Cardiac Panel 204
8.4.5.2 Roche Diagnostics 206
8.4.5.3 Any Biotech 207
8.4.5.4 Response Biomedical Corporation 207
8.4.5.5 Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics, Diagnostic Products Corporation and Dade Behring) 208
8.4.5.6 Abbott Point of Care 208
8.4.5.7 LifeSign (Princeton BioMediTech Corp.) 209
8.4.5.8 Mitsubishi Kagaku Iatron 209
8.4.5.9 Alpha Scientific 209
8.4.5.10 bioMerieux 209
8.4.5.11 Nexus 209
8.4.5.12 Princeton BioMeditech 210
8.4.5.13 Randox Laboratories 210
8.4.5.14 Market Share for Cardiac Marker Testing 210
8.4.6 Market Analysis 211
8.4.6.1 Market Drivers 211
8.4.6.2 Market Restraints 212
8.4.7 POC Cardiac Marker Testing Assay Market and Technology Trends 213
8.4.7.1 POC Cardiac Marker Testing Assay Market Trends 213
8.4.7.2 POC Cardiac Marker Testing Assay Technology Trends 214
8.4.7.3 POC Cardiac Marker Testing Assay Strategic Recommendations 214
8.5 POC Substance Abuse Testing 215
8.5.1 Background to POC Substance Abuse Testing 215
8.5.2 Substance Abuse Test Types 222
8.5.2.1 Urine Substance/Drug Screening 222
8.5.2.2 Hair Tests for Substance Abuse and Screening 222
8.5.2.3 Blood Tests for Substance Abuse and Screening 223
8.5.2.4 Saliva Tests for Substance Abuse and Screening 223
8.5.2.5 Sweat Tests for Substance Abuse and Screening 223
8.5.3 Alcohol Abuse and Screening 223
8.5.4 Saliva Testing 224
8.5.5 Qualitative Analysis 224
8.5.5.1 Market Drivers 224
8.5.5.2 Market Restraints 225
8.5.6 Review of Selected POC Substance Abuse Analyzers 225
8.5.7 Review of Company Products 227
8.5.7.1 Alere 227
8.5.7.2 Abbott Diagnostics 228
8.5.7.3 BTNX, Inc. 228
8.5.7.4 BioScan Screening Systems, Inc. 229
8.5.7.5 American Bio Medica Corp. 229
8.5.7.6 Phamatech, Inc. 234
8.5.7.7 First Check Diagnostics Corp. (Alere, Inc.) 235
8.5.7.8 OraSure 235
8.5.7.9 Noble Medical, Inc. 236
8.5.7.10 Guangzhou Wondfo Biotech Co., Ltd. 236
8.5.7.11 Pathtech 236
8.5.7.12 Alfa Scientific Designs, Inc. 236
8.5.7.13 TCPI, Inc. 237
8.5.7.14 Biophor Diagnostics 237
8.5.7.15 Randox Laboratories 238
8.5.7.16 Branan Medical 238
8.5.7.17 Concateno 238
8.5.7.18 LifeSign 239
8.6 POC Pregnancy and Fertility Tests 239
8.6.1 Background to POC Pregnancy and Fertility Tests 239
8.6.2 Review of Selected POC Pregnancy Testing Devices 240
8.6.3 Review of Company Products 241
8.6.3.1 Quidel 241
8.6.3.2 Abbott Diagnostics 242
8.6.3.3 Alere 242
8.6.3.4 Worldwide Medical Corporation 242
8.6.3.5 Sekisui Diagnostics, LLC 242
8.6.3.6 Siemens Diagnostics 243
8.6.3.7 Orgenics (A subsidiary of Alere) 243
8.6.3.8 LifeSign 243
8.6.3.9 Stanbio 243
8.6.3.10 Market Analysis 243
8.6.3.10.1 Competitive Sector Analysis 243
8.7 Fecal Occult Blood 244
8.7.1 Background to POC Fecal Occult Blood Testing 244
8.7.2 Review of Selected POC Fecal Occult Testing Devices 246
8.7.3 Review of Company Products 248
8.7.3.1 Helena Laboratories 248
8.7.3.2 Biomerica 249
8.7.3.3 Beckman Coulter 249
8.7.3.4 Worldwide Medical 249
8.7.3.5 Aerscher Diagnostics 249
8.7.3.6 Enterix 250
8.7.3.7 Medix Biochemica 250
8.7.3.8 Orion Diagnostica 250
8.7.3.9 ACON Laboratories’ Mission FOB Reagent Strips 250
8.7.3.10 Alere’s Products 250
8.7.3.11 Immunostics’ Hema-Screen 250
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
8.7.4 Market Share for Fecal Occult Blood Testing 251
8.7.4.1 Company Analysis for the Fecal Occult Blood POCT Sector 251
8.7.5 Market Analysis 251
8.7.5.1 Market Drivers 251
8.7.5.2 Market Restraints 252
8.7.5.3 POC Fecal Occult Blood Testing Assay Market and Technology Trends 252
8.7.5.3.1 POC Fecal Occult Blood Testing Assay Market Trends 252
8.7.5.3.2 Fecal Occult Blood Testing Assay Technology Trends 252
8.7.5.3.3 POC Fecal Occult Blood Testing Assay Strategic Recommendations 253
8.8 POC Infectious Disease Testing 254
8.8.1 Background to POC Infectious Disease Testing 254
8.8.2 Types of Diagnosis for Infectious Diseases 255
8.8.2.1 Microbial Culture 255
8.8.2.2 Microscopy 255
8.8.2.3 Biochemical Tests 255
8.8.2.4 Molecular Diagnostics 255
8.8.3 Diagnostic Platforms for Infectious Diseases 256
8.8.3.1 Centralized Laboratory Testing for Infectious Diseases 256
8.8.3.2 POC Testing for Infectious Diseases 256
8.8.4 Emerging Technologies 257
8.8.5 Qualitative Analysis 257
8.8.5.1 Market Drivers 257
8.8.5.2 Market Restraints 258
8.8.6 Review of Selected POC Infectious Disease Testing Devices 258
8.9 POC Urine Strip Testing 260
8.9.1 Background to POC Urine Strip Testing 260
8.9.2 Emerging Technologies 263
8.9.3 Review of Selected POC Urine Strip Testing Devices 263
8.10 POC Cholesterol Testing 265
8.10.1 POC Cholesterol Testing Market Size and Development 265
8.10.2 Background to POC Cholesterol Testing 265
8.10.3 POC Cholesterol Testing Devices 267
8.10.3.1 Review of Selected POC Cholesterol Testing Devices 267
8.10.4 Review of Company Products 268
8.10.4.1 Cholestech (Now Alere) 268
8.10.4.2 Actimed Laboratories 269
8.10.4.3 StatSite Meter 269
8.10.4.4 Polymer Technology Systems 270
8.10.4.5 Miraculins 270
8.10.4.6 Abaxis, Inc. 270
8.10.5 Product Comparison of Leading Suppliers 271
8.10.6 Launch Dates of Leading Products in Europe 273
8.11 Miscellaneous POC Tests 273
8.11.1 Triage C. difficile Panel 273
8.11.2 Ketoacids 273
8.11.3 Acetaminophen 274
8.11.4 Estriol 274
8.11.5 POC H. pylori Testing 275
8.11.6 Bacterial Contamination of Platelet Units 278
8.12 POC Vaginal Fluid pH and Vaginitis Testing 279
8.13 POC Cancer Testing 279
8.13.1 Prostate-Specific Antigen (PSA) 279
8.13.2 Bladder Cancer 280
8.13.3 Other Rapid Cancer Tests 284
8.14 Fetal Status (PROM) 284
8.15 Osteoporosis 285
8.16 Hemodynamic Monitoring 285
8.17 Heparin-Induced Thrombocytopenia 286
8.18 HIV 286
8.18.1 Whole-Blood, Serum or Plasma-Based HIV Tests 289
8.18.1.1 Bio-Rad Laboratories 289
8.18.1.2 Orgenics (Inverness, Now Alere) 290
8.18.1.3 StatSure Diagnostic Systems 290
8.18.1.4 Trinity Biotech 290
8.18.1.5 Savyon Diagnostics 290
8.18.1.6 MedPharm 291
8.18.1.7 American Bio Medica Corp. 291
8.18.1.8 Chembio Diagnostics 291
8.18.1.9 OraSure Technologies 292
8.18.1.10 Alere 293
8.18.1.11 Hema Diagnostics Systems 293
8.18.1.12 bioLytical Laboratories’ INSTI Kit 293
8.18.1.13 bioMerieux’s VIKIA HIV-1/2 Test 293
8.18.1.14 Chembio Diagnostics’ Dual-Path Platform Technology Products 294
8.18.1.15 Daktari Diagnostics’ Daktari CD4 294
8.18.1.16 EY Laboratories’ InstantCHEK 294
8.18.1.17 IND Diagnostic’s One-Step Anti-HIV (1+2) Test 294
8.18.1.18 IQuum’s Liat System 294
8.18.1.19 Lab21’s Biotec Tests 294
8.18.1.20 MedMira’s HIV Tests 294
8.18.1.21 YD Diagnostics’ AIDScan 295
8.18.2 Saliva-Based HIV Tests 295
8.18.2.1 OraSure Collection Device 296
8.18.2.2 SureStat 297
8.18.2.3 Calypte 297
8.18.3 Urine-Based HIV Tests 297
8.18.3.1 MedMira Laboratories, Inc. 297
8.18.3.2 Medical Services International, Inc. 298
8.18.3.3 Maxim Biomedical 298
8.18.3.4 Wampole Laboratories 299
8.19 Infectious Diseases 299
8.19.1 C. difficile 299
8.19.2 Giardia 300
8.19.3 Dengue Fever 300
8.19.4 Malaria Testing 300
8.19.5 Rapid Influenza Testing 302
8.19.6 Streptococcus Testing 306
8.19.7 Chlamydia 308
8.19.8 Mononucleosis 308
8.19.9 Rubella 309
8.19.10 Staphylococcus aureus and MRSA 309
8.19.11 Hepatitis 310
8.19.12 E. coli O157 314
8.19.13 Gonorrhea Testing 314
8.19.14 Smallpox 314
8.19.15 SARS 314
8.19.16 Rabies 314
8.19.17 Tuberculosis 314
8.19.18 Avian Flu 316
8.19.19 West Nile Virus 316
8.19.20 Herpes Simplex Virus Type-2 316
8.19.21 Legionella 317
8.19.22 RSV 317
8.19.23 Leptospirosis 319
8.19.24 Sexually-Transmitted Diseases 319
8.19.25 Infant Jaundice 320
8.19.26 Anthrax 321
8.19.27 Tropical Diseases 322
8.20 Homeland Defense (Plague and Tularemia) 323
8.21 BSE (Mad Cow Disease) 323
8.22 Tuberculosis 323
8.23 Typhoid 324
8.24 Avian Flu 324
8.25 Food Pathogens (Salmonella, Listeria, Campylobacter) 325
8.26 Ruptured Fetal Membranes 326
8.27 Alcohol 326
8.28 Microalbumin Testing 326
8.29 Labor and Delivery Testing 327
8.29.1 Alere Triage PLGF 327
8.29.2 Amnisure 327
8.29.3 Medix Biochemica 327
8.30 Sperm Fertility 328
8.31 Surgical Coagulation and Hemostasis Management 328
8.32 Respiratory Tests 328
8.33 C-Reactive Protein 328

9. POCT: Growth Regulators 329
9.1 Moderators of Growth 329
9.2 Personnel Acceptance 329
9.3 Key People for POCT 330
9.4 Information Management Issues 330
9.4.1 Elements of Information Management for POCT: Information-Processing Capabilities 332
9.4.2 Data Mining 332
9.4.3 Middleware 333
9.4.4 Web Portals 333
9.4.5 POCT-1A Standard 333
9.5 Key Elements for POCT 334
9.6 POCT and Reimbursement 334
9.7 Effectiveness of Clinical Outcomes 336
9.8 Rapid Near-Patient Testing in Hospitals 337
9.9 Satellite Facilities 337
9.10 Regionalization of Laboratory Care 338
9.11 Requirements for POCT 339
9.12 Locations of POC for Patient Care 340
9.13 Benefits of POCT 341
9.14 Cost Elements of POCT 342
9.15 Necessary Functions in POCT 342
9.16 Turnaround Time (TAT) for POCT 342
9.17 Clinical Laboratory Improvement Amendments (CLIA) 343
9.18 Sexually-Transmitted Diseases in Underdeveloped Countries 345
9.19 Sources of Error in POC Testing 345

10. Business Trends in the POC Sector 348
10.1 Sector Consolidation 348
10.2 Diagnostic Testing Growth Trends 349
10.2.1 Opportunities for Healthcare Stakeholders 350
10.3 Acquisition, License Agreements, Internal Development and Partnerships 350
10.4 Product Testing Depth in POCT 354
10.5 Government Regulation 354
10.5.1 U.S. Regulation 354
10.5.1.1 Importing Medical Devices into the U.S. 356
10.5.1.2 Exporting Medical Devices from the U.S. 356
10.5.2 E.U. Regulation 357
10.5.3 Japanese Regulation 360
10.5.4 Korean Regulation 361
10.6 Post-Filing Regulations for POC Devices 361
10.7 Exporting Unapproved POCTs 362
10.8 Analyte-Specific Reagents (“Home-Brew” Tests) 362
10.9 Medical Device Registration 363
10.10 Product Labeling 363
10.11 Punitive FDA Actions 363
10.12 CLIA ‘88 and State Laboratory Laws 364
10.13 Impact of Regulations on the Industry 364
10.14 Minimizing Regulatory Barriers 365
10.15 Waived Testing 367

11. Technology Platform Innovations in POCT 369
11.1 Latest POCT Technological Platforms 369
11.1.1 Device Miniaturization and Microfluidic Technologies 369
11.1.2 Minimally-Invasive and Non-Invasive POCT Technologies 369
11.1.2.1 Via Medical 369
11.1.2.2 Echo Therapeutics 371
11.1.3 Advances in Wireless Technologies 371
11.1.4 Automation of POCT 371
11.1.5 Developments in New Genomic Technologies (Genotyping, Haplotyping and Sequencing Technologies) 371
11.1.6 Advances in Informatics Technologies 374
11.1.7 Pharmacogenetic Testing 374
11.1.8 Multi-Assay Technologies in POCT 374
11.2 Developments in Key Technologies 375
11.2.1 Medical and Biological Sensors and Sensor Systems 375
11.2.2 Recent Biosensor Product Introductions and the Latest Innovative Developments 376
11.2.2.1 Nanoscale Sensors for the Detection of Cancer Biomarkers 376
11.2.2.2 ForteBio Introduces Dip and Read Protein G Biosensor for Octet Instruments 376
11.2.2.3 ForteBio Launches New Octet RED96 System and Dip and Read Protein L Biosensor 377
11.2.2.4 AgaMatrix Europe Limited Introduces New Jazz Blood Glucose Meter in the U.K. 377
11.2.2.5 STMicroelectronics to Manufacture the World’s Smallest Biosensors 377
11.2.2.6 Universal Biosensors Advances POC Molecular Diagnostic Opportunity 378
11.2.2.7 Clinitek Advantus—A Semi-Automated Urine Analyzer for POC Testing 378
11.2.2.8 NOVA 16 STAT Chemistry Analyzer Offers the First All-Electrode-Based Seven-Test Chemistry Profile 378
11.3 Sensor Systems for Diagnostic Applications 379
11.4 Nanogen (The ELITech Group) Third-Generation POC Analyzer 382
11.5 Philips Development of Magnotech Technology 382
11.6 Quidel Corporation MChip, AVR Chip and F Chip 382
11.7 Sanofi-Aventis 383
11.8 Siloam Biosciences Trova Open Source Point of Care System 384
11.9 Smart Phone Technology 384
11.9.1 Aquila Diagnostic Systems, Inc. 384
11.9.2 AgaMatrix 385
11.10 Sirigen HSF Technology 385

12. Data Management and Connectivity 386
12.1 Wireless LANs 386
12.2 Connectivity Platforms 388
12.2.1 DataLink Data Management System 389
12.2.2 RALS-Plus, RALS-Web3 and RALS-Freedom 391
12.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 392
12.2.2.2 Siemens Diagnostics Rapidpoint Coag 393
12.2.2.3 Radiometer 393
12.2.2.4 HemoCue’s DM Hemoglobin 393
12.2.2.5 Roche Diagnostics 393
12.2.2.6 ITC 394
12.2.3 BD.id 394
12.2.4 Medical Implant Communications Service (MICS) 394
12.2.5 Conworx Technology 394
12.2.6 Lab Data Systems 394
12.2.7 Medasys 395
12.2.8 NoemaLife 395
12.2.9 Telcare 395
12.3 Advantages of POCT Connectivity 395
12.3.1 Cost-Benefit Analysis of POCT and IT Connectivity 396
12.3.2 Hospital Network Issues 396
12.4 POCT Analyzer Connectivity Software Solutions 397
12.5 POCT2-P 398

13. Corporate Profiles 400
13.1 Abaxis, Inc. 400
13.2 Abbott Laboratories 403
13.3 AccuBioTech Co., Ltd. 405
13.4 Accumetrics, Inc. (Accriva Diagnostics) 406
13.5 AccuTech, LLC 406
13.6 ACON Laboratories, Inc. 406
13.7 Acrongenomics 407
13.8 AgaMatrix 408
13.9 Aerscher Diagnostics, LLC 408
13.10 Akers Biosciences, Inc. 408
13.11 Alere 410
13.12 Alfa Scientific Designs, Inc. 414
13.13 American Bio Medica Corporation 414
13.14 Any Biotech Oyo Ltd. 415
13.15 Ark Therapeutics Group Plc 416
13.16 Arkray, Inc. 417
13.17 Atlas Genetics Ltd. 417
13.18 Atonomics A/S 417
13.19 Audit Diagnostics 418
13.20 Augurix Diagnostics Ltd. 418
13.21 Axis-Shield Plc (Alere) 418
13.22 Axxin 419
13.23 Bayer Corp. 419
13.24 Beckman Coulter (Danaher Corporation) 421
13.25 BioLytical Laboratories 424
13.26 Biomerica, Inc. 425
13.27 bioMerieux 425
13.28 BiOracle 426
13.29 Bio-Rad Laboratories, Inc. 426
13.30 BioScan Screening Systems, Inc. 427
13.31 BioSite 428
13.32 Calmark Sweden AB 428
13.33 Calypte Biomedical Corporation 428
13.34 Chembio Diagnostic, Inc. 429
13.35 Chempaq A/S 429
13.36 Cholestech 429
13.37 Claros Diagnostics (OPKO Healthcare) 429
13.38 CompuCyte Corporation (Thorlabs) 430
13.39 Concateno Plc 430
13.40 Dexcom 430
13.41 Diagnostics for All 431
13.42 Enigma Diagnostics Ltd. 431
13.43 EY Laboratoires, Inc. 432
13.44 Eurotrol 433
13.45 Exalenz Bioscience 433
13.46 GenBio 433
13.47 Genzyme Diagnostics (Acquired by Sekisui Chemical Co., Ltd) 433
13.48 Guided Therapeutics, Inc. (SpectRx, Inc.) 434
13.49 Helena Laboratories 434
13.50 Hema Diagnostic Systems, LLC 435
13.51 HemoCue AB 435
13.52 HemoSense 436
13.53 Home Diagnostics (Nipro Diagnostics) 436
13.54 IND Diagnostic 436
13.55 Instrumentation Laboratory (IL)/Werfen Group 436
13.56 International Technidyne Corporation (ITC) 437
13.57 Jant Pharmacal Corporation 437
13.58 Johnson and Johnson 437
13.59 Lein Applied Diagnostics 438
13.60 LifeAssays AB 438
13.61 LifeSign, LLC 439
13.62 Medica Corporation 439
13.63 Medical Automation Systems 439
13.64 Mediwatch 439
13.65 Medix Biochemica 439
13.66 MedMira Laboratories 440
13.67 MELA Sciences (Formerly Electro-Optical Sciences) 441
13.68 A. Menarini Diagnostics 442
13.69 Meretek Diagnostics Group 442
13.70 Meridian Bioscience 443
13.71 Micronics 444
13.72 Minimed, Inc. 444
13.73 Mitsubishi Chemical Holdings USA, Inc. 445
13.74 Mitsubishi Kagaku Iatron 445
13.75 Nanogen (ELITech Group) 445
13.76 New Horizons Diagnostics 446
13.77 Nexus/ITC 446
13.78 Nova Biomedical 447
13.79 OraSure Technologies, Inc. 448
13.80 Orion Diagnostica 450
13.81 Polymedco, Inc. 450
13.82 Polymer Technology Systems, Inc. 451
13.83 Prima Biomedical Company 452
13.84 QBC Diagnostics 452
13.85 Qualigen 452
13.86 Quest Diagnostics, Inc. 452
13.87 Quidel Corporation 453
13.88 Radiometer Medical 457
13.89 Response Biomedical Corp. 461
13.90 Roche Diagnostics 462
13.91 Savyon Diagnostics 464
13.92 Seegene 465
13.93 Sekisui Diagnostics, LLC 465
13.94 Selfcare, Inc. 466
13.95 Shanghai Ruicare Medical Co., Ltd. 466
13.96 Shenzhen Fitconn Technology Co., Ltd. 466
13.97 Shionogi and Co., Ltd. 466
13.98 Siemens AG 466
13.99 Siloam Biosciences, Inc. 468
13.100 Spectral Diagnostics, Inc. 468
13.101 StatSure Diagnostic Systems, Inc. 469
13.102 Step Detect Associates, LLC 469
13.103 Strategic Diagnostics, Inc. 470
13.104 Techne Corporation 470
13.105 Telcare 471
13.106 Trinity Biotech Plc 472
13.107 Väsamed, Inc. 475

14. POCT Sector Trends and Forecasts 476
14.1 Home Care Analysis as Part of Near-Patient Testing 476
14.2 Non-Traditional Collection for POCT 476
14.3 New Systems for Critical Care and Near-Patient Testing 476
14.4 Utility of Near-Patient Testing in Critical-Care Settings 477
14.5 Physician’s Office Market 477
14.6 Information Management Advances 478
14.7 Test-Ordering Patterns and Demand for POCT 478
14.8 Demand for Emergency Department Services 478
14.9 Move Away from the Central Laboratory 479
14.10 Healthcare Cost Controls 480
14.11 Mergers and Acquisitions in POCT 481
14.12 Competition for Services 481
14.13 Drivers of POCT 482
14.14 Confluence of New Technology 482
14.15 Difficulties of Design for POC Products 482
14.16 European Hospital Structure 482
14.17 The Biggest New Opportunities in POCT 483

15. New Entrants to the Point of Care Market 484
15.1 Alliance International Co., Ltd. 484
15.2 Alverix, Inc. 484
15.3 Analyticon Biotechnologies AG 484
15.4 Aptiva Medical Corporation 484
15.5 Aquila Diagnostic Systems, Inc. 486
15.6 ArcDia International Oyo Ltd. 486
15.7 Artron Laboratories, Inc. 486
15.8 Atlas Genetics Ltd. 487
15.9 Atlas Link Biotech Co., Ltd. 487
15.10 Atonomics A/S 487
15.11 Audit Diagnostics 487
15.12 Augurix SA/Augurix Diagnostics 487
15.13 Autobio Diagnostics Co., Ltd. 488
15.14 Axxin 488
15.15 Biocartis SA 488
15.16 BioFire Diagnostics, Inc. 489
15.17 BioHelix Corporation 489
15.18 BioMedomics 490
15.19 Biosensia Ltd. 490
15.20 Curetis AG 490
15.21 DxNA, LLC 491
15.22 Echo Therapeutics, Inc. 491
15.23 Enigma Diagnostics Ltd. 491
15.24 Gentag, Inc. 491
15.25 Great Basin Corporation 492
15.26 Immunexpress Group 492
15.27 Innovative Biosensors, Inc. 492
15.28 Integrated Diagnostics 492
15.29 Integrity Applications 493
15.30 MBio Diagnostics, Inc. 493
15.31 Menssana Research, Inc. 493
15.32 Metaara Medical Technologies, Inc. 494
15.33 QuantuMDx Group 494
15.34 Venaxis, Inc. 494
15.35 Vivacta Limited 494
15.36 Wave 80 Biosciences 494
15.37 Veredus Laboratories Pte Ltd. 495
15.38 Via Medical Corporation 495
15.39 Vital Diagnostics, Inc. 496

INDEX OF FIGURES

Figure 2.1: Worldwide Distribution of IVD Testing, 2013 37
Figure 2.2: Top 13 Country IVD Testing Markets, 2013 38
Figure 2.3: Market Share for IVD Testing by Company, 2013 39
Figure 3.1: Total Global POCT Market, 2008-2018 47
Figure 3.2: Worldwide Distribution of POCT, 2013 54
Figure 3.3: Summary of Global POCT Markets by Market Segment, 2013 55
Figure 4.1: U.S. Revenues for POCT Market, 2008-2018 56
Figure 4.2: Summary of U.S. POCT Markets by Market Segment, 2013 64
Figure 5.1: European Revenues for POCT Market, 2008-2018 72
Figure 6.1: Summary Analysis of Japanese, Chinese and Indian POCT Market, 2008-2018 86
Figure 6.2: Japanese Revenues for POCT Market, 2008-2018 94
Figure 6.3: Indian Revenues for POCT Market, 2008-2018 97
Figure 6.4: Chinese Revenues for POCT Market, 2008-2018 100
Figure 7.1: Summary Analysis of ROW POCT Market, 2008-2018 107
Figure 7.2: Summary Analysis of Russian Revenues for POCT Products Market, 2008-2018 116
Figure 7.3: Summary Analysis of Middle East Revenues for POCT Products Market, 2008-2018 117
Figure 7.4: Summary Analysis of African Revenues for POCT Products Market, 2008-2018 118
Figure 7.5: Summary Analysis of Latin America (Other) Revenues for POCT Products Market, 2008-2018 122
Figure 8.1: Global Share of Glucose Testing Market by Company, 2013 147
Figure 8.2: Global POCT Share of Blood Gas and Electrolyte Testing Market, 2013 166
Figure 8.3: Global POCT Share of Coagulation Testing Market, 2013 193
Figure 8.4: Global POCT Share of Cardiac Marker Testing Market, 2013 210
Figure 8.5: Global POCT Share of HIV Testing Market, 2013 289
Figure 8.6: Performance Metrics of ROM Diagnostic Methods 327
Figure 9.1: Annual Rate of Emergency Room Visits by Primary Expected Source of Payment 336
Figure 9.2: CLIA Laboratories by Certificate Types 343
Figure 10.1: Conformity Assessment Route, Annexes and Quality System Standards by IVD Device
Category 358
Figure 12.1: The RALS Data Management System Connects to Most of the Major Instruments Used in
Point of Care 390
Figure 12.2: AegisPOC Point of Care and Critical Care Connectivity and Information Management System 397

INDEX OF TABLES

Table 2.1: Summary of Global POCT Markets by Major Market Sub-Segment, 2013 and 2018 27
Table 2.2: Summary of U.S. POCT Markets by Major Market Sub-Segment, 2013 and 2018 27
Table 2.3: Summary of European POCT Markets by Major Market Sub-Segment, 2013 and 2018 28
Table 2.4: Summary of Asian POCT Markets by Major Market Sub-Segment, 2013 and 2018 28
Table 2.5: Summary of ROW POCT Markets by Major Market Sub-Segment, 2013 and 2018 29
Table 2.6: Worldwide POCT Market Size by Geographic Location, 2008-2018 29
Table 2.7: Global Market Share POCT Analysis, 2013 30
Table 2.8: Worldwide Distribution of IVD Testing, 2013 37
Table 2.9: Top 13 Country IVD Testing Markets, 2013 37
Table 2.10: Company Market Share for IVD Testing Markets, 2013 38
Table 2.11: Competitive Landscape for POC Diagnostic Testing 43
Table 3.1: Total Global POCT Market, 2008-2018 46
Table 3.2: Global Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 47
Table 3.3: Global Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018 48
Table 3.4: Global Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018 49
Table 3.5: Global Revenues for POC Cardiac Marker Devices, 2008-2018 49
Table 3.6: Global Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018 50
Table 3.7: Global Revenues for POC Infectious Disease Testing Devices Market, 2008-2018 50
Table 3.8: Global Revenues for POC Urine Strip Testing Products Market, 2008-2018 51
Table 3.9: Global Revenues for POC Pregnancy Testing Devices Market, 2008-2018 51
Table 3.10: Global Revenues for POC Fecal Occult Testing Devices Market, 2008-2018

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