World Point of Care Diagnostic Testing Market

Report Description

TriMarkPublications.com cites in its newly published “Point of Care Diagnostic Testing World Markets” report that the point of care diagnostic testing world market will jump to $15.9 billion by 2018.

Point of care diagnostic testing can be categorized into ten main modalities: blood glucose monitoring, blood gas and electrolytes, rapid coagulation, rapid cardiac markers, substance abuse, infectious diseases, urine strip tests, pregnancy tests, fecal occult testing and cholesterol. The U.S. is recognized as the largest single market for point of care testing products, valued at $3.45 billion in 2011. The U.S. point of care market sub-segment represents an estimated 18.6% of the total U.S. market for in vitro diagnostic (IVD) goods and services.

Point of Care Diagnostic Testing Market

The “Point of Care Diagnostic Testing World Markets” report covers:

  •     B-Type Natriuretic Peptide (BNP)
  •     Whole-Blood Lactate
  •     Creatinine
  •     D-Dimer Testing
  •     C-Reactive Protein (CRP)
  •     Glucose Urine Testing
  •     Fertility Testing
  •     HIV Testing
  •     Alcohol Testing
  •     Substance Abuse Testing

The “Point of Care Diagnostic Testing World Markets” report examines companies manufacturing point of care diagnostic testing equipment and supplies in the world. Companies covered include: Abaxis, Abbott, Accumetrics, AccuTech, ACON, Acrongenomics, AgaMatrix, Alere, Alfa, Ani, Ark, Arkray, Atonomics, Audit, Augurix, Axis-Shield, Axxin, Bayer Corp., Beckman Coulter, BioLytical, Biomerica, bioMerieux, BiOracle, Bio-Rad, BioScan, BioSite, Calmark, Calypte, Chembio, Chempaq, Cholestech, Claros, CompuCyte, Concateno, Diagnostics, Dexcom, Enigma, EY, Eurotrol, Exalenz, GenBio, Genzyme, Helena, Hema, HemoCue, HemoSense, Instrumentation Laboratory, International Technidyne, Johnson & Johnson (LifeScan), LifeAssays, LifeSign, Medica, Medical Automation, Mediwatch, Medix, MedMira, MELA, A. Menarini, Meretek, Meridian, Micronics, Minimed, Mitsubishi, New Horizons, Nexus DX/ITC, Nova Biomedical, OraSure, Polymedco, Polymer, Prima, QBC, Qualigen, Quest, Quidel, Radiometer, Response, Roche, Savyon, Selfcare, Shionogi, Siemens Healthcare Diagostnics, Guided, Spectral, StatSure, Strategic, Trinity and Vasamed.

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 21

2. Overview of Diagnostic Testing Point of Care 27
2.1 Key Issues in the Point of Care Diagnostic Testing Sector 27
2.1.1 Current Market Trends and Drivers 27
2.1.2 Effectiveness of POCT 29
2.1.3 New Growth Areas for POCT 29
2.1.4 Advantages of POCT in a Clinical Setting 29
2.1.5 Pricing and Reimbursement Issues 30
2.1.6 Key Customer Segments 30
2.2 Global Point of Care Marketplace 30
2.3 Shifts from Central Lab Testing to POCT 32
2.4 Geographical Distribution 32
2.5 Challenges of POCT 35
2.6 Key Issues for POCT 36
2.6.1 Locations of POCT 36
2.6.2 Milestones in Technology Development 38
2.6.3 Drive for Decentralization from Lab to Patient 39
2.6.4 Competitive Landscape for POCT 39
2.7 The Future of POCT 40

3. Summary Analysis of the Global POCT Market: Value, Growth Rates and Market Share 42
3.1 Global POCT Market 42

4. Analysis of the U.S. POCT Market: Value, Growth Rates and Market Share 54

5. Analysis of the European POCT Market: Value, Growth Rates and Market Shares 63

6. Analysis of the POCT Markets for Japan, China and India: Value, Growth Rates and Market Share 84
6.1 Summary Analysis of the Japanese POCT Market 90
6.2 Summary Analysis of the Indian POCT Market 92
6.3 Summary Analysis of the Chinese POCT Market 95

7. Analysis of the Rest of World (ROW) POCT Market: Value, Growth Rates and Market Share 105
7.1 Summary Analysis of the ROW POCT Market Revenues 105
7.1.1 Summary Analysis of the Argentinian POCT Market 111
7.1.2 Summary Analysis of the Australian POCT Market 112
7.1.3 Summary Analysis of the Brazilian POCT Market 112
7.1.4 Summary Analysis of the Canadian POCT Market 113
7.1.5 Summary Analysis of the Russian POCT Market 113
7.1.6 Summary Analysis of the Middle East POCT Market 114
7.1.7 Summary Analysis of the African POCT Market 115
7.1.8 Summary Analysis of the Asia (Other) POCT Market 116
7.1.9 Summary Analysis of the Latin America (Other) POCT Market 119

8. Review of the Market Segments, Reagents and Equipment 121
8.1 Blood Glucose Monitoring 121
8.1.1 Introduction to Blood Glucose Monitoring 121
8.1.2 Types of Blood Glucose Testing 122
8.1.2.1 Fasting Blood Sugar (FBS) or Fasting Plasma Glucose (FPG) 122
8.1.2.2 Two-Hour Postprandial Blood Sugar or Two-Hour PC 122
8.1.2.3 Random Blood Sugar (RBS) 122
8.1.2.4 Glucose Urine Test 122
8.1.2.5 Blood Glucose Test Strip 122
8.1.2.6 Glycosylated Hemoglobin (HbA1C) 123
8.1.2.7 Intravenous Glucose Tolerance Test (IVGTT) 123
8.1.2.8 Oral Glucose Tolerance Test (OGTT) 123
8.1.3 Segmentation of POC Blood Glucose Testing 123
8.1.3.1 Continuous Blood Glucose Monitoring (CBGM) 123
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 125
8.1.3.5 Optical Transducer Technologies 125
8.1.3.6 Transdermal Sensor Technologies 126
8.1.3.7 Invasive Glucose Sensor Technologies 128
8.1.4 Review of Selected POC Blood Glucose Monitoring Systems 128
8.1.5 Review of Company Products 132
8.1.5.1 LifeScan 132
8.1.5.2 Roche Accu-Chek 135
8.1.5.3 Abbott Diabetes Care 137
8.1.5.4 HemoCue 138
8.1.5.5 Stanbio/GDS Technology 138
8.1.5.6 Abaxis, Inc. 139
8.1.5.7 Arkray (Japan) 140
8.1.5.8 Accurex (India) 140
8.1.5.9 Home Diagnostics, Inc. 140
8.1.5.10 Nova Biomedical 140
8.1.5.11 Bayer 141
8.1.5.11.1 Hemoglobin A1c Measurements 142
8.1.5.12 AgaMatrix 143
8.1.5.13 Akray 143
8.1.5.14 EKF Diagnostics 143
8.1.5.15 ACON 143
8.1.5.16 Biosite (Now Part of Alere) 144
8.1.5.17 Siemens Healthcare Diagnostics 144
8.1.5.18 Infopia 144
8.1.5.19 Diasys 144
8.1.5.20 Quotient Dx 144
8.1.5.21 Cholestech (Acquired by Inverness Medical Innovations, Now Named Alere) 144
8.1.5.22 Bio-Rad 145
8.1.5.23 Axis-Shield 145
8.1.5.24 Abaxis, Inc. 145
8.1.6 Market Share for Glucose Testing 145
8.1.7 Competitive Analysis for the Glucose Point of Care Testing Sector 146
8.1.8 Market Analysis 147
8.1.8.1 Market Drivers 147
8.1.8.2 Market Restraints 147
8.1.9 POC Glucose Testing Assay Market and Technology Trends 147
8.1.9.1 POC Glucose Testing Assay Market Trends 147
8.1.9.2 POC Glucose Testing Assay Technology Trends 148
8.1.9.3 POC Glucose Testing Assay Strategic Recommendations 148
8.2 Blood Gas and Electrolytes 149
8.2.1 Background to POC Blood Gas and Electrolyte Testing 149
8.2.1.1 Acid-Base Balance and the Lungs 151
8.2.1.2 Respiratory Acidosis 151
8.2.1.3 Respiratory Alkalosis 151
8.2.1.4 Metabolic (or Non-Respiratory) Acidosis 151
8.2.1.5 Metabolic (or Non-Respiratory) Alkalosis 151
8.2.1.6 Increasing Popularity of POC Blood Gas and Electrolyte Testing 152
8.2.2 Market Segmentation (Segmentation by Type of Blood Gas Monitoring Equipment) 152
8.2.2.1 Intermittent Blood Gas Monitoring Equipment 152
8.2.2.2 Continuous Blood Gas Monitoring Equipment 152
8.2.2.3 Extra-Arterial Blood Gas (EABG) Monitors 153
8.2.2.4 Intra-Arterial Blood Gas (IABG) Monitors 153
8.2.2.5 Portable Blood Gas Analyzers 153
8.2.2.6 Patient-Attached On-Demand Blood Gas Analyzers 153
8.2.3 Applications for POCT Blood Gas and Electrolyte Analyzers 154
8.2.4 Emerging Technologies 154
8.2.5 Whole-Blood Lactate 154
8.2.6 Creatinine 154
8.2.7 Review of Selected Blood Gas and Electrolyte Analyzers 155
8.2.8 Review of Company Products 157
8.2.8.1 Roche Corporation 157
8.2.8.2 TechnoMedica 157
8.2.8.3 Siemens Healthcare Diagnostics 157
8.2.8.4 Instrumentation Laboratory 158
8.2.8.5 Nova Biomedical 158
8.2.8.6 Radiometer 159
8.2.8.7 Abbott Point of Care 159
8.2.8.8 Span Diagnostics 160
8.2.8.9 Nexus Dx AVOXimeter Systems for CO-oximetry 160
8.2.8.10 ITC (Nexus Dx) 161
8.2.8.11 Alere 161
8.2.8.12 Abaxis, Inc. 162
8.2.8.13 Opti Medical 162
8.2.8.14 Arkray USA 162
8.2.9 Market Share for Blood Gas and Electrolyte Testing 163
8.2.10 Competitive Analysis for the Blood Gas and Electrolyte Point of Care Testing Sector 163
8.2.11 Market Analysis 164
8.2.11.1 Market Drivers 164
8.2.11.2 Market Restraints 165
8.2.12 POC Blood Gas and Electrolyte Testing Assay Market and Technology Trends 166
8.2.12.1 POC Blood Gas and Electrolyte Testing Assay Market Trends 166
8.2.12.2 POC Blood Gas and Electrolyte Testing Assay Technology Trends 166
8.2.12.3 POC Blood Gas and Electrolyte Testing Assay Strategic Recommendations 166
8.3 Rapid Coagulation Tests 167
8.3.1 Background to Rapid Coagulation Tests 167
8.3.2 Review of Selected POC Rapid Coagulation Analyzers 173
8.3.3 Review of Company Products 175
8.3.3.1 Roche Diagnostics Corp. 175
8.3.3.2 Abbott Laboratories 177
8.3.3.3 International Technidyne Corporation Nexus DX 177
8.3.3.4 Medtronic 179
8.3.3.5 Alere HemoSense 179
8.3.3.6 Helena Laboratories Point of Care 180
8.3.3.7 Sienco, Inc. 182
8.3.3.8 Accumetrics 182
8.3.3.9 Alere 182
8.3.3.10 ITC 183
8.3.3.11 Instrumentation Laboratory’s GEM PCL Plus 183
8.3.3.12 Others 183
8.3.3.13 Self-Monitoring Products 183
8.3.3.14 Platelet Function and Antiplatelet Drug Assessment 183
8.3.4 Connectivity Issues 184
8.3.5 Cost Benefits 185
8.3.6 Quality Control Issues 185
8.3.7 Certification for POC Coagulation Devices 186
8.3.8 D-Dimer Testing 186
8.3.9 Market Analysis 187
8.3.9.1 Market Share for POCT Coagulation Testing 187
8.3.9.2 Competitive Analysis of Sector Companies 187
8.3.9.3 Market Drivers 188
8.3.9.4 Market Restraints 188
8.3.9.5 POC Coagulation Testing Assay Market Trends 189
8.3.9.6 POC Coagulation Testing Assay Technology Trends 189
8.3.9.7 POC Coagulation Testing Assay Strategic Recommendations 189
8.3.9.8 SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Coagulation POC Market 190
8.4 POC Rapid Cardiac Markers 190
8.4.1 Background to POC Rapid Cardiac Marker Testing 191
8.4.2 Cardiac Marker Tests 192
8.4.2.1 Creatine Kinase (CK) 192
8.4.2.2 Myoglobin 192
8.4.2.3 Cardiac Troponins T (TnT), I (TnI) and C (TnC) 193
8.4.2.4 C-Reactive Protein (CRP) 193
8.4.2.5 Homocysteine 193
8.4.3 Emerging Markers 194
8.4.3.1 B-type Natriuretic Peptide (BNP) 194
8.4.3.2 Myeloperoxidase (MPO) 194
8.4.3.3 Ischemia-Modified Albumin (IMA) 194
8.4.3.4 Glycogen Phosphorylase Isoenzyme BB (GPBB) 195
8.4.3.5 Fatty Acid-Binding Proteins (FABPs) 195
8.4.4 Review of Selected POC Cardiac Biomarkers Analyzers 195
8.4.5 Review of Company Products 197
8.4.5.1 Alere Triage Cardiac Panel 197
8.4.5.2 Roche Diagnostics 198
8.4.5.3 Ani Biotech 199
8.4.5.4 Response Biomedical Corporation 199
8.4.5.5 Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics, Diagnostic Products Corporation and Dade Behring) 200
8.4.5.6 Lab21 Ltd. 201
8.4.5.7 Abbott Laboratories 201
8.4.5.8 LifeSign (Princeton BioMediTech Corp.) 201
8.4.5.9 Mitsubishi Kagaku Iatron 201
8.4.5.10 Alpha Scientific 201
8.4.5.11 bioMérieux 202
8.4.5.12 Nexus 202
8.4.5.13 Princeton BioMeditech 202
8.4.5.14 Randox Laboratories 202
8.4.5.15 Market Share for Cardiac Marker Testing 203
8.4.6 Market Analysis 203
8.4.6.1 Market Drivers 203
8.4.6.2 Market Restraints 205
8.4.7 POC Cardiac Marker Testing Assay Market and Technology Trends 206
8.4.7.1 POC Cardiac Marker Testing Assay Market Trends 206
8.4.7.2 POC Cardiac Marker Testing Assay Technology Trends 206
8.4.7.3 POC Cardiac Marker Testing Assay Strategic Recommendations 207
8.5 POC Substance Abuse Testing 208
8.5.1 Background to POC Substance Abuse Testing 208
8.5.2 Substance Abuse Test Types 214
8.5.2.1 Urine Substance/Drug Screening 215
8.5.2.2 Hair Tests for Substance Abuse and Screening 215
8.5.2.3 Blood Tests for Substance Abuse and Screening 215
8.5.2.4 Saliva Tests for Substance Abuse and Screening 215
8.5.2.5 Sweat Tests for Substance Abuse and Screening 216
8.5.3 Alcohol Abuse and Screening 216
8.5.4 Saliva Testing 216
8.5.5 Qualitative Analysis 217
8.5.5.1 Market Drivers 217
8.5.5.2 Market Restraints 217
8.5.6 Review of Selected POC Substance Abuse Analyzers 218
8.5.7 Review of Company Products 219
8.5.7.1 Alere 219
8.5.7.2 Abbott Diagnostics 220
8.5.7.3 Roche Diagnostics 220
8.5.7.4 BioScan Screening Systems, Inc. 221
8.5.7.5 American Bio Medica Corp. 222
8.5.7.6 Phamatech, Inc. 225
8.5.7.7 First Check Medical 225
8.5.7.8 OraSure 226
8.5.7.9 Avitar, Inc. 226
8.5.7.10 Concateno 226
8.5.7.11 Pathtech 226
8.5.7.12 Alfa Scientific Designs, Inc. 227
8.5.7.13 TCPI, Inc. 228
8.5.7.14 Roche 228
8.5.7.15 Biophor Diagnostics 228
8.5.7.16 Randox Laboratories 228
8.5.7.17 Branan Medical 229
8.5.7.18 Concateno 229
8.6 POC Pregnancy and Fertility Tests 230
8.6.1 Background to POC Pregnancy and Fertility Tests 230
8.6.2 Review of Selected POC Pregnancy Testing Devices 230
8.6.3 Review of Company Products 232
8.6.3.1 Quidel 232
8.6.3.2 Abbott Diagnostics 232
8.6.3.3 Alere 232
8.6.3.4 Worldwide Medical Corporation 233
8.6.3.5 Genzyme Diagnostics 233
8.6.3.6 Siemens Diagnostics 233
8.6.3.7 Orgenics 233
8.6.3.8 LifeSign 233
8.6.3.9 Stanbio 234
8.6.3.10 Market Analysis 234
8.6.3.10.1 Competitive Sector Analysis 234
8.7 Fecal Occult Blood 234
8.7.1 Background to POC Fecal Occult Blood Testing 235
8.7.2 Review of Selected POC Fecal Occult Testing Devices 237
8.7.3 Review of Company Products 239
8.7.3.1 Helena Laboratories 239
8.7.3.2 Biomerica 239
8.7.3.3 Beckman Coulter 239
8.7.3.4 Worldwide Medical 239
8.7.3.5 Aerscher Diagnostics 240
8.7.3.6 Enterix 240
8.7.3.7 Medix Biochemica 240
8.7.3.8 Orion Diagnostica 240
8.7.3.9 ACON Laboratories’s Mission FOB Reagent Strips 240
8.7.3.10 Alere’s Products 241
8.7.3.11 Immunostics’s Hema-Screen 241
8.7.3.12 Princeton BioMeditech’s BioSign iFOBTest 241
8.7.3.13 Quest Diagnostics’s InSure FIT 241
8.7.3.14 Quidel’s QuickVue iFOB 241
8.7.4 Market Share for Fecal Occult Blood Testing 241
8.7.4.1 Company Analysis for the Fecal Occult Blood Point of Care Testing Sector 241
8.7.5 Market Analysis 242
8.7.5.1 Market Drivers 242
8.7.5.2 Market Restraints 242
8.7.5.3 POC Fecal Occult Blood Testing Assay Market and Technology Trends 242
8.7.5.3.1 POC Fecal Occult Blood Testing Assay Market Trends 242
8.7.5.3.2 Fecal Occult Blood Testing Assay Technology Trends 243
8.7.5.3.3 Point of Care Fecal Occult Blood Testing Assay Strategic Recommendations 243
8.8 POC Infectious Disease Testing 244
8.8.1 Background to POC Infectious Disease Testing 244
8.8.2 Types of Diagnosis for Infectious Diseases 245
8.8.2.1 Microbial Culture 245
8.8.2.2 Microscopy 245
8.8.2.3 Biochemical Tests 246
8.8.2.4 Molecular Diagnostics 246
8.8.3 Diagnostic Platforms for Infectious Diseases 247
8.8.3.1 Centralized Laboratory Testing for Infectious Diseases 247
8.8.3.2 POC Testing for Infectious Diseases 247
8.8.4 Emerging Technologies 247
8.8.5 Qualitative Analysis 248
8.8.5.1 Market Drivers 248
8.8.5.2 Market Restraints 248
8.8.6 Review of Selected POC Infectious Disease Testing Devices 248
8.9 POC Urine Strip Testing 251
8.9.1 Background to POC Urine Strip Testing 251
8.9.2 Emerging Technologies 253
8.9.3 Review of Selected POC Urine Strip Testing 254
8.10 POC Cholesterol Testing 255
8.10.1 Background to POC Cholesterol Testing 255
8.10.2 POC Cholesterol Testing Devices 258
8.10.2.1 Review of Selected POC Cholesterol Testing Devices 258
8.10.3 Review of Company Products 259
8.10.3.1 Cholestech (now Alere) 259
8.10.3.2 Actimed Laboratories 260
8.10.3.3 StatSite Meter 260
8.10.3.4 Polymer Technology Systems 260
8.10.3.5 PreMD, Inc. (f/k/a International Medical Innovations, Inc. [IMI]) 260
8.10.3.6 Abaxis, Inc. 261
8.10.3.7 Miraculins’s PREVU Point of Care Skin Sterol Test 261
8.10.4 Product Comparison of Leading Suppliers 261
8.10.5 Launch Dates of Leading Products in Europe 263
8.11 Miscellaneous POC Tests 263
8.11.1 Triage C. difficile Panel 263
8.11.2 Ketoacids 264
8.11.3 Acetaminophen 264
8.11.4 Estriol 264
8.11.5 POC H. pylori Testing 265
8.12 POC Vaginal Fluid pH and Vaginitis Testing 269
8.13 POC Cancer Testing 269
8.13.1 Prostate-Specific Antigen (PSA) 269
8.13.2 Bladder Cancer 270
8.13.3 Other Rapid Cancer Tests 274
8.14 Fetal Status (PROM) 274
8.15 Osteoporosis 275
8.16 Hemodynamic Monitoring 275
8.17 Heparin-Induced Thrombocytopenia 276
8.18 HIV 276
8.18.1 Whole-Blood, Serum or Plasma-Based HIV Tests 279
8.18.1.1 Bio-Rad Laboratories 279
8.18.1.2 Orgenics (Inverness, Now Called Alere) 279
8.18.1.3 StatSure Diagnostic Systems 279
8.18.1.4 Trinity Biotech 279
8.18.1.5 Savyon Diagnostics 280
8.18.1.6 MedPharm 280
8.18.1.7 American Bio Medica Corp. 280
8.18.1.8 Chembio Diagnostics 280
8.18.1.9 OraSure Technologies 281
8.18.1.10 Alere 282
8.18.1.11 Hema Diagnostics Systems 282
8.18.1.12 bioLytical Laboratories’s INSTI Kit 282
8.18.1.13 bioMérieux’s VIKIA HIV-1/2 Test 282
8.18.1.14 Chembio Diagnostics’s Dual-Path Platform Technology Products 282
8.18.1.15 Daktari Diagnostics’s Daktari CD4 283
8.18.1.16 EY Laboratories’s InstantCHEK 283
8.18.1.17 IND Diagnostic’s One-Step Anti-HIV (1+2) Test 283
8.18.1.18 IQuum’s Liat System 283
8.18.1.19 Lab21’s Biotec Tests 283
8.18.1.20 MedMira’s HIV Tests 283
8.18.1.21 YD Diagnostics’s AIDScan 283
8.18.2 Saliva-Based HIV Tests 283
8.18.2.1 OraSure Collection Device 284
8.18.2.2 SureStat 285
8.18.2.3 Calypte 285
8.18.3 Urine-Based HIV Tests 285
8.18.3.1 MedMira Laboratories, Inc. 285
8.18.3.2 Medical Services International, Inc. 286
8.18.3.3 Maxim Biomedical 286
8.18.3.4 Wampole Laboratories 287
8.19 Infectious Disease 287
8.19.1 C. difficile 287
8.19.2 Giardia 288
8.19.3 Dengue Fever 288
8.19.4 Malaria Testing 288
8.19.5 Rapid Influenza Testing 290
8.19.6 Streptococcus Testing 293
8.19.7 Chlamydia 295
8.19.8 Mononucleosis 296
8.19.9 Rubella 297
8.19.10 Staphylococcus aureus and MRSA 297
8.19.11 Hepatitis 298
8.19.12 E. coli O157 301
8.19.13 Gonorrhea Testing 301
8.19.14 Smallpox 302
8.19.15 SARS 302
8.19.16 Rabies 302
8.19.17 Tuberculosis 302
8.19.18 Avian Flu 303
8.19.19 West Nile Virus 304
8.19.20 Herpes Simplex Virus Type-2 304
8.19.21 Legionella 304
8.19.22 RSV 304
8.19.23 Leptospirosis 306
8.19.24 Sexually-Transmitted Diseases 306
8.19.25 Infant Jaundice 308
8.19.26 Anthrax 308
8.20 Homeland Defense (Plague and Tularemia) 310
8.21 BSE (Mad Cow Disease) 310
8.22 Tuberculosis 310
8.23 Typhoid 311
8.24 Avian Flu 311
8.25 Food Pathogens (Salmonella, Listeria, Campylobacter) 311
8.26 Ruptured Fetal Membranes 312
8.27 Alcohol 313
8.28 Microalbumin Testing 313
8.29 Labor and Delivery Testing 313
8.29.1 Alere Triage PLGF 313
8.29.2 Amnisure® 313
8.29.3 Medix Biochemica 314
8.30 Sperm Fertility 315
8.31 Surgical Coagulation and Hemostasis Management 315
8.32 Respiratory Tests 315
8.33 C-Reactive Protein 315

9. POCT: Growth Regulators 316
9.1 Moderators of Growth 316
9.2 Personnel Acceptance 316
9.3 Key People for POCT 317
9.4 Information Management Issues 317
9.4.1 Elements of Information Management for POCT: Information Processing Capabilities 319
9.4.2 Data Mining 319
9.4.3 Middleware 319
9.4.4 Web Portals 320
9.4.5 POCT-1A Standard 320
9.5 Key Elements for POCT 321
9.6 POCT and Reimbursement 321
9.7 Effectiveness of Clinical Outcomes 323
9.8 Rapid Near-Patient Testing in Hospitals 324
9.9 Satellite Facilities 324
9.10 Regionalization of Laboratory Care 325
9.11 Requirements for POCT 326
9.12 Locations of Point of Care for Patient Care 327
9.13 Benefits of POCT 328
9.14 Cost Elements of POCT 329
9.15 Necessary Functions in POCT 329
9.16 Turnaround Time (TAT) for POCT 329
9.17 Clinical Laboratory Improvement Amendments (CLIA) 330
9.18 Sexually-Transmitted Diseases in Underdeveloped Countries 332
9.19 Sources of Error in POC Testing 332

10. Business Trends in the POC Sector 335
10.1 Sector Consolidation 335
10.2 Diagnostic Testing Growth Trends 336
10.2.1 Opportunities for Healthcare Stakeholders 337
10.3 Acquisition, License Agreements, Internal Development and Partnerships 337
10.4 Product Testing Depth in POCT 341
10.5 Government Regulation 341
10.5.1 U.S. Regulation 341
10.5.1.1 Importing Medical Devices into the U.S. 342
10.5.1.2 Exporting Medical Devices from the U.S. 343
10.5.2 E.U. Regulation 344
10.5.3 Japanese Regulation 347
10.5.4 Korean Regulation 348
10.6 Post-Filing Regulations for POC Devices 348
10.7 Exporting Unapproved POCTs 349
10.8 Analyte-Specific Reagents (Home Brew Tests) 349
10.9 Medical Device Registration 350
10.10 Product Labeling 350
10.11 Punitive FDA Actions 350
10.12 CLIA ’88 and State Laboratory Laws 351
10.13 Impact of Regulations on the Industry 351
10.14 Minimizing Regulatory Barriers 352
10.15 Waived Testing 354

11. Technology Platform Innovations in POCT 356
11.1 Latest POCT Technological Platforms 356
11.1.1 Device Miniaturization and Microfluidic Technologies 356
11.1.2 Minimally-Invasive and Non-Invasive POCT Technologies 356
11.1.3 Advances in Wireless Technologies 356
11.1.4 Automation of POCT 357
11.1.5 Developments in New Genomic Technologies (Genotyping, Haplotyping and Sequencing Technologies) 357
11.1.6 Advances in Informatics Technologies 359
11.1.7 Pharmacogenetic Testing 360
11.1.8 Multi-Assay Technologies in POCT 360
11.2 Developments in Key Technologies 360
11.2.1 Medical and Biological Sensors and Sensor Systems 360
11.2.2 Recent Biosensor Product Introductions and Latest Innovative Developments 361
11.2.2.1 Nanoscale Sensors for the Detection of Cancer Biomarkers 361
11.2.2.2 ForteBio Introduces Dip and Read Protein G Biosensor for Octet Instruments 362
11.2.2.3 ForteBio Launches New Octet RED96 System and Dip and Read Protein L Biosensor 362
11.2.2.4 AgaMatrix Europe Limited Introduces the New Jazz™ Blood Glucose Meter in the U.K. 362
11.2.2.5 STMicroelectronics to Manufacture the World’s Smallest Biosensors 363
11.2.2.6 Universal Biosensors Advances POC Molecular Diagnostic Opportunity 363
11.2.2.7 Clinitek Advantus—A Semi-Automated Urine Analyzer for POC Testing 363
11.2.2.8 NOVA 16 STAT Chemistry Analyzer Offers the First All-Electrode-Based Seven-Test Chemistry Profile 363
11.3 Sensor Systems for Diagnostic Applications 364
11.4 Nanogen (The ELITech Group) Third-Generation POC Analyzer 367
11.5 Philips Development of Magnotech Technology 367
11.6 Quidel Corporation MChip, AVR Chip and F Chip 367
11.7 Sanofi-Aventis 368

12. Data Management and Connectivity 370
12.1 Wireless LANs 370
12.2 Connectivity Platforms 372
12.2.1 DataLink Data Management System 373
12.2.2 RALS-Plus 374
12.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 375
12.2.2.2 Siemens Diagnostics Rapidpoint Coag 376
12.2.2.3 Radiometer 376
12.2.2.4 HemoCue’s DM Hemoglobin 376
12.2.2.5 Roche Diagnostics 376
12.2.3 BD.id 377
12.2.4 Medical Implant Communications Service (MICS) 377
12.2.5 Conworx Technology 377
12.2.6 Lab Data Systems 377
12.2.7 Medasys 378
12.2.8 NoemaLife 378
12.3 Advantages of POCT Connectivity 378
12.3.1 Cost-Benefit Analysis of POCT and IT Connectivity 379
12.3.2 Hospital Network Issues 379
12.4 POCT Analyzer Connectivity Software Solutions 379
12.5 POCT2-P 381

13. Corporate Profiles 382
13.1 Abaxis, Inc. 382
13.2 Abbott Laboratories 386
13.3 Accumetrics, Inc. 389
13.4 AccuTech, LLC 390
13.5 ACON Laboratories, Inc. 390
13.6 Acrongenomics 390
13.7 AgaMatrix 390
13.8 Aerscher Diagnostics 391
13.9 Akers Biosciences, Inc. 391
13.10 Alere 392
13.11 Alfa Scientific Designs, Inc. 396
13.12 American Bio Medica Corporation 397
13.13 Ani Biotech Oy Ltd. 398
13.14 Ark Therapeutics 398
13.15 Arkray, Inc. 399
13.16 Atonomics A/S 399
13.17 Audit Diagnostics 399
13.18 Augurix Diagnostics Ltd. 400
13.19 Axis-Shield 400
13.20 Axxin 400
13.21 Bayer Corp. 401
13.22 Beckman Coulter 402
13.23 BioLytical Laboratories 405
13.24 Biomerica, Inc. 405
13.25 bioMérieux 406
13.26 BiOracle 407
13.27 Bio-Rad Laboratories, Inc. 407
13.28 BioScan Screening Systems, Inc. 408
13.29 BioSite 408
13.30 Calmark Sweden AB 408
13.31 Calypte Biomedical Corporation 408
13.32 Chembio Diagnostic, Inc 409
13.33 Chempaq A/S 410
13.34 Cholestech 410
13.35 Claros Diagnostics 410
13.36 CompuCyte Corporation 410
13.37 Concateno Plc 411
13.38 Diagnostics Chemicals Ltd. 411
13.39 Dexcom 411
13.40 Enigma Diagnostics Ltd. 411
13.41 EY Laboratoires, Inc. 412
13.42 Eurotrol 412
13.43 Exalenz Bioscience 413
13.44 GenBio 413
13.45 Genzyme Diagnostics 413
13.46 Helena Laboratories 413
13.47 Hema Diagnostic Systems, LLC 414
13.48 HemoCue AB 414
13.49 HemoSense 415
13.50 Home Diagnostics (Nipro Diagnostics) 415
13.51 IND Diagnostic 415
13.52 Instrumentation Laboratory (IL)/Werfen Group 415
13.53 International Technidyne Corporation 415
13.54 Jant Pharmacal Corporation 416
13.55 Johnson & Johnson 416
13.56 Lein Applied Diagnostics 417
13.57 LifeAssays AB 418
13.58 LifeSign, LLC 418
13.59 Medica 418
13.60 Medical Automation Systems 418
13.61 Mediwatch 418
13.62 Medix Biochemica 418
13.63 MedMira Laboratories 419
13.64 MELA Sciences (Formerly Electro-Optical Sciences) 420
13.65 A. Menarini Diagnostics 421
13.66 Meretek Diagnostics Group 421
13.67 Meridian Bioscience 422
13.68 Micronics 424
13.69 Minimed 424
13.70 Mitsubishi Chemical Holdings USA, Inc. 424
13.71 Mitsubishi Kagaku Iatron 425
13.72 Nanogen (ELITech Group) 425
13.73 New Horizons Diagnostics 425
13.74 Nexus DX/ITC 426
13.75 Nova Biomedical 426
13.76 OraSure Technologies, Inc 428
13.77 Orion Diagnostica 429
13.78 Polymedco, Inc. 430
13.79 Polymer Technology Systems, Inc. 431
13.80 Prima Biomedical Company 431
13.81 QBC Diagnostics 431
13.82 Qualigen 431
13.83 Quest Diagnostics, Inc. 432
13.84 Quidel Corporation 433
13.85 Radiometer Medical 437
13.86 Response Biomedical 440
13.87 Roche Diagnostics 441
13.88 Savyon Diagnostics 443
13.89 Selfcare, Inc. 445
13.90 Shionogi & Co., Ltd. 445
13.91 Siemens AG 445
13.92 Guided Therapeutics, Inc. (SpectRx, Inc.) 446
13.93 Spectral Diagnostics 446
13.94 StatSure Diagnostic Systems, Inc. 446
13.95 Strategic Diagnostics 447
13.96 Trinity Biotech, Plc 447
13.97 Väsamed, Inc. 450

14. POCT Sector Trends and Forecasts 451
14.1 Home Care Analysis as Part of Near-Patient Testing 451
14.2 Non-Traditional Collection for POCT 451
14.3 New Systems for Critical Care and Near-Patient Testing 451
14.4 Utility of Near-Patient Testing in Critical-Care Settings 452
14.5 Physician’s Office Market 452
14.6 Information Management Advances 453
14.7 Test-Ordering Patterns and Demand for POCT 453
14.8 Demand for Emergency Department Services 453
14.9 Move Away from the Central Laboratory 454
14.10 Healthcare Cost Controls 455
14.11 Mergers and Acquisitions in POCT 455
14.12 Competition for Services 456
14.13 Drivers of POCT 456
14.14 Confluence of New Technology 456
14.15 Difficulties of Design for POC Products 457
14.16 European Hospital Structure 457
14.17 The Biggest New Opportunities in POCT 457

15. Corporate Directory 458

List of Tables

Table 1.1: Summary of Global POCT Markets by Major Market Sub-Segment, 2011 and 2018 22
Table 1.2: Summary of U.S. POCT Markets by Major Market Sub-Segment, 2011 and 2018 22
Table 1.3: Summary of European POCT Markets by Major Market Sub-Segment, 2011 and 2018 23
Table 1.4: Summary of Asian POCT Markets by Major Market Sub-Segment, 2011 and 2018 23
Table 1.5: Summary of ROW POCT Markets by Major Market Sub-Segment, 2011 and 2018 24
Table 1.6: Worldwide POCT Market Size by Geographic Location, 2008-2018 24
Table 1.7: Global Market Share Analysis, 2011 25
Table 2.1: POCT Frequency in Hospitals 31
Table 2.2: Worldwide Distribution of IVD Testing, 2011 33
Table 2.3: Top 13 Country IVD Testing Markets, 2011 34
Table 2.4: Company Market Share for IVD Testing Markets, 2011 35
Table 2.5: Competitive Landscape for Point of Care Diagnostic Testing 39
Table 3.1: Total Global POCT Market, 2008-2018 42
Table 3.2: Global Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 43
Table 3.3: Global Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018 44
Table 3.4: Global Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018 45
Table 3.5: Global Revenues for POC Cardiac Marker Devices, 2008-2018 46
Table 3.6: Global Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018 47
Table 3.7: Global Revenues for POC Infectious Disease Testing Devices Market, 2008-2018 47
Table 3.8: Global Revenues for POC Urine Strip Testing Products Market, 2008-2018 48
Table 3.9: Global Revenues for POC Pregnancy Testing Devices Market, 2008-2018 48
Table 3.10: Global Revenues for POC Fecal Occult Testing Devices Market, 2008-2018 49
Table 3.11: Global Revenues for POC Cholesterol Testing Products Market, 2008-2018 50
Table 3.12: Global POCT Market Share Analysis, 2011 51
Table 3.13: Worldwide POCT Market Size by Geographic Location, 2008-2018 51
Table 3.14: Worldwide Distribution of POCT, 2011 52
Table 3.15: Summary of Global POCT Markets by Market Segment, 2011 52
Table 3.16: Worldwide POCT by Performance Location, 2011 53
Table 4.1: U.S. Revenues for POCT Market, 2008-2018 54
Table 4.2: U.S Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 55
Table 4.3: U.S Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018 56
Table 4.4: U.S. Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018 56
Table 4.5: U.S. Revenues for POC Cardiac Marker Devices, 2008-2018 57
Table 4.6: U.S Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2011 57
Table 4.7: U.S. Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018 58
Table 4.8: U.S. Revenues for POC Infectious Disease Testing Devices Market, 2008-2018 58
Table 4.9: U.S. Revenues for POC Urine Strip Testing Products Market, 2008-2018 59
Table 4.10: U.S. Revenues for POC Pregnancy Testing Devices Market, 2008-2018 59
Table 4.11: U.S. Revenues for POC Fecal Occult Testing Devices Market, 2008-2018 60
Table 4.12: U.S. Revenues for POC Cholesterol Testing Products Market, 2008-2018 60
Table 4.13: U.S. POCT Market Share Analysis, 2011 61
Table 4.14: U.S. POCT by Performance Location, 2010 61
Table 4.15: Summary of U.S. POCT Markets by Market Segment, 2011 61
Table 5.1: Models of Public-Private Partnership in Hospital Provision 66
Table 5.2: European Revenues for POCT Market, 2008-2018 69
Table 5.3: French Revenues for POCT Systems, 2008-2018 70
Table 5.4: German Revenues for POCT Systems, 2008-2018 71
Table 5.5: Italian Revenues for POCT Systems, 2008-2018 71
Table 5.6: Spanish Revenues for POCT Systems, 2008-2018 72
Table 5.7: U.K. Revenues for POCT Systems, 2008-2018 72
Table 5.8: Benelux Revenues for POCT Systems, 2008-2018 73
Table 5.9: Scandinavian Revenues for POCT Systems, 2008-2018 73
Table 5.10: Rest-of-Europe Revenues for POCT Systems, 2008-2018 74
Table 5.11: European Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 75
Table 5.12: European Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018 75
Table 5.13: European Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018 76
Table 5.14: European Revenues for POC Cardiac Marker Devices, 2008-2018 78
Table 5.15: European Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018 79
Table 5.16: European Revenues for POC Infectious Disease Testing Devices Market, 2008-2018 80
Table 5.17: European Revenues for POC Urine Strip Testing Products Market, 2008-2018 80
Table 5.18: European Revenues for POC Pregnancy Testing Devices Market, 2008-2018 81
Table 5.19: European Revenues for POC Fecal Occult Testing Devices Market, 2008-2018 82
Table 5.20: European Revenues for POC Cholesterol Testing Products Market, 2008-2018 82
Table 5.21: European Market Share Analysis, 2011 83
Table 6.1: Summary Analysis of Japanese, Chinese and Indian POCT Market, 2008-2018 84
Table 6.2: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 85
Table 6.3: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018 85
Table 6.4: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018 86
Table 6.5: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Cardiac Marker Devices, 2008-2018 86
Table 6.6: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018 87
Table 6.7: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Infectious Disease Testing Devices Market, 2008-2018 87
Table 6.8: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Urine Strip Testing Products Market, 2008-2018 88
Table 6.9: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Pregnancy Testing Devices Market, 2008-2018 88
Table 6.10: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Fecal Occult Testing Devices Market, 2008-2018 89
Table 6.11: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Cholesterol Testing Products Market, 2008-2018 89
Table 6.12: Summary Analysis of Japanese, Chinese and Indian Market Shares, 2011 90
Table 6.13: Japanese Population and Aging Demographics Forecast, 2000-2050 91
Table 6.14: Japanese Revenues for POCT Market, 2008-2018 91
Table 6.15: Indian Revenues for POCT Market, 2008-2018 95
Table 6.16: Chinese Revenues for POCT Market, 2008-2018 98
Table 7.1: Summary Analysis of the ROW POCT Market, 2008-2018 105
Table 7.2: Summary Analysis of ROW Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 106
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 107
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 108
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 109
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 110
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, 2011 111
Table 7.13: Summary Analysis of Argentinian Revenues for POC Testing Products Market, 2008-2018 111
Table 7.14: Summary Analysis of Australian Revenues for POC Testing Products Market, 2008-2018 112
Table 7.15: Summary Analysis of Brazilian Revenues for POC Testing Products Market, 2008-2018 112
Table 7.16: Summary Analysis of Canadian Revenues for POC Testing Products Market, 2008-2018 113
Table 7.17: Summary Analysis of Russian Revenues for POC Testing Products Market, 2008-2018 113
Table 7.18: Summary Analysis of Middle East Revenues for POC Testing Products Market, 2008-2018 114
Table 7.19: Summary Analysis of African Revenues for POC Testing Products Market, 2008-2018 115
Table 7.20: Summary Analysis of Asia (Other) Revenues for POC Testing Products Market, 2008-2018 116
Table 7.21: Summary Analysis of Latin America (Other) Revenues for POC Testing Products Market, 2008-2018 119
Table 8.1: Summary of Emerging Glucose Sensor Technologies, 2011 126
Table 8.2: Selected POC Blood Glucose Monitoring Systems, 2011 129
Table 8.3: Roche Diagnostics Glucose Testing Products 137
Table 8.4: Market Share of Glucose POCT Diagnostic Testing Companies Worldwide, 2011 146
Table 8.5: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Glucose POC Market 149
Table 8.6: Selected POC Blood Gas and Electrolyte Analyzers, 2011 155
Table 8.7: Market Share Blood Gas and Electrolyte POCT Diagnostic Testing Companies Worldwide, 2011 163
Table 8.8: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Blood Gas and Electrolyte POC Market 167
Table 8.9: Selected POC Rapid Coagulation Analyzers, 2011 173
Table 8.10: Actalyke XL 181
Table 8.11: Actalyke Mini 181
Table 8.12: Market Share for Coagulation POCT Diagnostic Testing Companies Worldwide, 2011 187
Table 8.13: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Coagulation POC Market 190
Table 8.14: Selected POC Cardiac Biomarkers, 2011 195
Table 8.15: Market Share of Cardiac Marker POCT Diagnostic Testing Companies Worldwide, 2011 203
Table 8.16: POC Cardiac Marker Testing Market: Market Drivers Ranked in Order of Impact 205
Table 8.17: POC Cardiac Marker Testing Market: Market Restraints Ranked in Order of Impact 206
Table 8.18: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Cardiac Marker POC Market 207
Table 8.19: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency Department 213
Table 8.20: Stat Urine Testing Drug Recommendations 213
Table 8.21: Selected POC Substance/Drug Abuse Testing Devices, 2011 218
Table 8.22: Selected POC Pregnancy Testing Devices, 2011 231
Table 8.23: Selected POC Fecal Occult Testing Devices, 2011 237
Table 8.24: ColoCARE Fecal Occult Blood Test 239
Table 8.25: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Fecal Occult Blood Point of Care Market 244
Table 8.26: Selected POC Infectious Disease Testing Devices, 2011 249
Table 8.27: Selected POC Urine Strip Testing, 2011 254
Table 8.28: Selected POC Cholesterol Testing Devices, 2011 258
Table 8.29: Competitive Factors Related to HIV Tests 277
Table 8.30: Largest POCT Diagnostic Companies Worldwide, 2008 278
Table 8.31: Influenza Diagnostic Rapid Tests 291
Table 8.32: Type of Hepatitis Test: Lateral Flow 300
Table 8.33: Flow-Through 301
Table 8.34: Agglutination 301
Table 8.35: Immunoblot 301
Table 8.36: AmniSure 313
Table 9.1: Access Points 318
Table 9.2: Desktop Adapters—Four Computers 318
Table 9.3: Desktop Adapters—One Computer 318
Table 9.4: PCMCIA Adapters 318
Table 9.5: POCT1-Compliant Connectivity Point of Care Instruments 321
Table 9.6: POCT Clinical Outcomes in Diabetic Ketoacidosis 324
Table 9.7: POCT Clinical Outcomes in Arterial Blood Gas Measurements 324
Table 9.8: POCT in Three Hospitals—Cost Analysis with Labor Included 327
Table 9.9: POCT versus Central Lab—Cost Analysis for Glucose Testing 327
Table 9.10: CLIA Laboratories by Type of Facility 328
Table 9.11: Financial Comparison for Moderate and Waived CLIA Labs 331
Table 9.12: Top Ten CMS Survey Deficiencies for CLIA Laboratories 334
Table 10.1: Key Changes in IVD Business Structure 340
Table 11.1: Common Genotype Techniques 358
Table 12.1: Applications for Wireless LAN Technology 370
Table 12.2: Customized Reports Must Support CAP and JCAHO Requirements 373
Table 12.3: RALS-Plus POC Market Share 374
Table 12.4: Applications of RALS Connectivity with POCT Devices 375
Table 13.1: Abaxis Blood Analysis Diagnostic Tests 383
Table 13.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 384
Table 13.3: Abaxis, Inc. Financial Figures—Net Sales by Business Sector, 2008-2010 385
Table 13.4: Abaxis, Inc. Financial Figures—Net Sales by Geographic Region, 2008-2010 386
Table 13.5: Products Marketed by Abbott in the Diagnostic Market 387
Table 13.6: Abbott Laboratories Financial Figures—Net Sales by Business Sector, 2008-2010 388
Table 13.7: Abbott Laboratories Financial Figures—Net Sales by Geographic Region, 2008-2010 389
Table 13.8: Alere, Inc. Financial Figures—Net Sales by Business Sector, 2008-2010 396
Table 13.9: Alere, Inc. Financial Figures—Net Sales by Geographic Region, 2008-2010 396
Table 13.10: Bayer AG Financial Figures—Net Sales by Business Sector, 2008-2010 402
Table 13.11: Bayer AG Financial Figures—Net Sales by Geographic Region, 2008-2010 402
Table 13.12: Bio-Rad Laboratories, Inc. Financial Figures—Net Sales by Business Sector, 2008-2010 408
Table 13.13: Bio-Rad Laboratories, Inc. Financial Figures—Net Sales by Geographic Region, 2008-2010 408
Table 13.14: Johnson & Johnson Financial Figures—Net Sales by Major Medical and Diagnostics Businesses, 2008-2010 417
Table 13.15: Quidel Product Distribution and Sales, 2009 and 2010 434
Table 13.16: Danaher Corporation Financial Figures—Net Sales by Business Sector, 2008-2010 437
Table 13.17: Danaher Corporation Financial Figures—Net Sales by Geographic Region, 2008-2010 438
Table 13.18: Roche Group Financial Figures—Net Sales by Business Sector, 2008-2010 442
Table 13.19: Roche Group Financial Figures—Net Sales by Geographic Region, 2009 and 2010 443
Table 13.20: Roche Group Financial Figures—Net Sales by Sub-Division, 2008-2010 443
Table 14.1: Improvements in Achieving ED Operational Efficiency Using POCT 452
Table 14.2: Test Menu and TAT for ED 453
Table 14.3: Top Reasons Why POC Cardiac Marker Testing is Implemented in the ED 453
Table 14.4: Key Areas and Metrics that Hospitals Measure to Assess Efficiency of ED 454
Table 14.5: Estimates of Patient Costs by DRG 455

List of Figures

Figure 2.1: Worldwide Distribution of IVD Testing, 2011 33
Figure 2.2: Top 13 Country IVD Testing Markets, 2011 34
Figure 2.3: Company Market Share for IVD Testing Markets, 2011 35
Figure 3.1: Total Global POCT Market, 2008-2018 43
Figure 3.2: Worldwide Distribution of POCT, 2011 52
Figure 3.3: Summary of Global POCT Markets by Market Segment, 2011 53
Figure 4.1: U.S. Revenues for POCT Market, 2008-2018 54
Figure 4.2: Summary of U.S. POCT Markets by Market Segment, 2011 62
Figure 5.1: European Revenues for POCT Market, 2008-2018 70
Figure 6.1: Summary Analysis of Japanese, Chinese and Indian POCT Market, 2008-2018 84
Figure 6.2: Japanese Revenues for POCT Market, 2008-2018 92
Figure 6.3: Indian Revenues for POCT Market, 2008-2018 95
Figure 6.4: Chinese Revenues for POCT Market, 2008-2018 98
Figure 7.1: Summary Analysis of the ROW POCT Market, 2008-2018 105
Figure 7.2: Summary Analysis of the Russian Revenues for POC Testing Products Market, 2008-2018 114
Figure 7.3: Summary Analysis of the Middle East Revenues for POC Testing Products Market, 2008-2018 115
Figure 7.4: Summary Analysis of the African Revenues for POC Testing Products Market, 2008-2018 116
Figure 7.5: Summary Analysis of the Latin America (Other) Revenues for POC Testing Products Market, 2008- 2018 120
Figure 8.1: Global POCT Share of Glucose Testing Market, 2011 145
Figure 8.2: Global POCT Share of Blood Gas and Electrolyte Testing Market, 2011 163
Figure 8.3: Global POCT Share of Coagulation Testing Market, 2011 187
Figure 8.4: Global POCT Share of Cardiac Marker Testing Market, 2011 203
Figure 8.5: Global POCT Share of HIV Testing Market, 2008 278
Figure 8.6: Performance Metrics of ROM Diagnostic Methods 314
Figure 9.1: Annual Rate of Emergency Room Visits by Primary Expected Source of Payment 323
Figure 9.2: CLIA Laboratories by Certificate Types 330
Figure 10.1: Conformity Assessment Route, Annexes and Quality System Standards by IVD Device Category 345

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