Point of Care Diagnostic Testing World Markets

NEW YORK, June 20, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Point of Care Diagnostic Testing World Markets
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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 26
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 32
2.1.5 Pricing and Reimbursement Issues 33
2.1.6 Key Customer Segments 33
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 43

3. Summary Analysis of the Global POCT Market: Value, Growth Rates and Market
Share 45
3.1 Global POCT Market 45

4. Analysis of the U.S. POCT Market: Value, Growth Rates and Market Share 55

5. Analysis of the European POCT Market: Value, Growth Rates and Market Shares
64

6. Analysis of the POCT Markets for Japan, China and India: Value, Growth Rates
and Market Share 85
6.1 Summary Analysis of the Japanese POCT Market 91
6.2 Summary Analysis of the Indian POCT Market 93
6.3 Summary Analysis of the Chinese POCT Market 96

7. Analysis of the Rest of World (ROW) POCT Market: Value, Growth Rates and
Market Share 106
7.1 Summary Analysis of the ROW POCT Market Revenues 106
7.1.1 Summary Analysis of the Argentinian POCT Market 112
7.1.2 Summary Analysis of the Australian POCT Market 113
7.1.3 Summary Analysis of the Brazilian POCT Market 113
7.1.4 Summary Analysis of the Canadian POCT Market 114
7.1.5 Summary Analysis of the Russian POCT Market 114
7.1.6 Summary Analysis of the Middle East POCT Market 115
7.1.7 Summary Analysis of the African POCT Market 116
7.1.8 Summary Analysis of the Asia (Other) POCT Market 117
7.1.9 Summary Analysis of the Latin America (Other) POCT Market 120

8. Review of the Market Segments, Reagents and Equipment 122
8.1 Blood Glucose Monitoring 122
8.1.1 Introduction to Blood Glucose Monitoring 122
8.1.2 Types of Blood Glucose Testing 123
8.1.2.1 Fasting Blood Sugar (FBS) or Fasting Plasma Glucose (FPG) 123
8.1.2.2 Two-Hour Postprandial Blood Sugar or Two-Hour PC 123
8.1.2.3 Random Blood Sugar (RBS) 123
8.1.2.4 Glucose Urine Test 123
8.1.2.5 Blood Glucose Test Strip 123
8.1.2.6 Glycosylated Hemoglobin (HbA1C) 124
8.1.2.7 Intravenous Glucose Tolerance Test (IVGTT) 124
8.1.2.8 Oral Glucose Tolerance Test (OGTT) 124
8.1.3 Segmentation of POC Blood Glucose Testing 124
8.1.3.1 Continuous Blood Glucose Monitoring (CBGM) 124
8.1.3.2 Self-Monitoring Blood Glucose (SMBG) Testing 125
8.1.3.3 Minimally-Invasive and Non-Invasive Blood Glucose Testing 125
8.1.3.4 Emerging Glucose Monitoring Technologies 126
8.1.3.5 Optical Transducer Technologies 126
8.1.3.6 Transdermal Sensor Technologies 127
8.1.3.7 Invasive Glucose Sensor Technologies 129
8.1.4 Review of Selected POC Blood Glucose Monitoring Systems 129
8.1.5 Review of Company Products 133
8.1.5.1 LifeScan 133
8.1.5.2 Roche Accu-Chek 136
8.1.5.3 Abbott Diabetes Care 138
8.1.5.4 HemoCue 139
8.1.5.5 Stanbio/GDS® Technology 139
8.1.5.6 Abaxis, Inc. 140
8.1.5.7 Arkray (Japan) 141
8.1.5.8 Accurex (India) 141
8.1.5.9 Home Diagnostics, Inc. 141
8.1.5.10 Nova Biomedical 141
8.1.5.11 Bayer Diagnostics 142
8.1.5.11.1 Hemoglobin A1c Measurements 143
8.1.5.12 AgaMatrix 144
8.1.5.13 Akray 144
8.1.5.14 EKF Diagnostics 144
8.1.5.15 ACON 144
8.1.5.16 Biosite (Now Part of Alere) 145
8.1.5.17 Siemens Healthcare Diagnostics 145
8.1.5.18 Infopia 145
8.1.5.19 Diasys 145
8.1.5.20 Quotient Dx 145
8.1.5.21 Cholestech (Acquired by Inverness Medical Innovations, Now Named Alere)
145
8.1.5.22 Bio-Rad 146
8.1.5.23 Axis-Shield 146
8.1.5.24 Abaxis, Inc. 146
8.1.6 Market Share for Glucose Testing 146
8.1.7 Competitive Analysis for the Glucose POCT Sector 147
8.1.8 Market Analysis 148
8.1.8.1 Market Drivers 148
8.1.8.2 Market Restraints 148
8.1.9 POC Glucose Testing Assay Market and Technology Trends 148
8.1.9.1 POC Glucose Testing Assay Market Trends 148
8.1.9.2 POC Glucose Testing Assay Technology Trends 149
8.1.9.3 POC Glucose Testing Assay Strategic Recommendations 149
8.2 Blood Gas and Electrolytes 150
8.2.1 Background to POC Blood Gas and Electrolyte Testing 150
8.2.1.1 Acid-Base Balance and the Lungs 152
8.2.1.2 Respiratory Acidosis 152
8.2.1.3 Respiratory Alkalosis 152
8.2.1.4 Metabolic (or Non-Respiratory) Acidosis 152
8.2.1.5 Metabolic (or Non-Respiratory) Alkalosis 152
8.2.1.6 Increasing Popularity of POC Blood Gas and Electrolyte Testing 153
8.2.2 Market Segmentation (Segmentation by Type of Blood Gas Monitoring
Equipment) 153
8.2.2.1 Intermittent Blood Gas Monitoring Equipment 153
8.2.2.2 Continuous Blood Gas Monitoring Equipment 153
8.2.2.3 EABG Monitors 154
8.2.2.4 IABG Monitors 154
8.2.2.5 Portable Blood Gas Analyzers 154
8.2.2.6 Patient-Attached On-Demand Blood Gas Analyzers 154
8.2.3 Applications for POCT Blood Gas and Electrolyte Analyzers 155
8.2.4 Emerging Technologies 155
8.2.5 Whole-Blood Lactate 155
8.2.6 Creatinine 155
8.2.7 Electrolytes Point of Care Analysis: Comparison of POCT and Central Lab
Results 156
8.2.8 Review of Selected Blood Gas and Electrolyte Analyzers 157
8.2.9 Review of Company Products 159
8.2.9.1 Roche Corporation 159
8.2.9.2 TechnoMedica 159
8.2.9.3 Siemens Healthcare Diagnostics 159
8.2.9.4 Instrumentation Laboratory 160
8.2.9.5 Nova Biomedical 161
8.2.9.6 Radiometer 161
8.2.9.7 Abbott Point of Care 161
8.2.9.8 Span Diagnostics 162
8.2.9.9 Nexus Dx AVOXimeter Systems for CO-oximetry 162
8.2.9.10 ITC (Nexus Dx) 163
8.2.9.11 Alere 164
8.2.9.12 Abaxis, Inc. 164
8.2.9.13 Opti Medical 164
8.2.9.14 Arkray USA 164
8.2.10 Market Share for Blood Gas and Electrolyte Testing 165
8.2.11 Competitive Analysis for the Blood Gas and Electrolyte Point of Care
Testing Sector 165
8.2.12 Market Analysis 166
8.2.12.1 Market Drivers 166
8.2.12.2 Market Restraints 167
8.2.13 POC Blood Gas and Electrolyte Testing Assay Market and Technology Trends
168
8.2.13.1 POC Blood Gas and Electrolyte Testing Assay Market Trends 168
8.2.13.2 POC Blood Gas and Electrolyte Testing Assay Technology Trends 168
8.2.13.3 POC Blood Gas and Electrolyte Testing Assay Strategic Recommendations
168
8.3 Rapid Coagulation Tests 169
8.3.1 Background to Rapid Coagulation Tests 170
8.3.2 Review of Selected POC Rapid Coagulation Analyzers 176
8.3.3 Review of Company Products 178
8.3.3.1 Roche Diagnostics Corp. 178
8.3.3.2 Abbott Laboratories 180
8.3.3.3 International Technidyne Corporation Nexus DX 180
8.3.3.4 Medtronic 182
8.3.3.5 Alere HemoSense 183
8.3.3.6 Helena Laboratories Point of Care 183
8.3.3.7 Sienco, Inc. 185
8.3.3.8 Accumetrics 186
8.3.3.9 Alere 186
8.3.3.10 ITC 186
8.3.3.11 Instrumentation Laboratory's GEM PCL Plus 186
8.3.3.12 Others 187
8.3.3.13 Self-Monitoring Products 187
8.3.3.14 Platelet Function and Antiplatelet Drug Assessment 187
8.3.4 Connectivity Issues 188
8.3.5 Cost Benefits 188
8.3.6 Quality Control Issues 189
8.3.7 Certification for POC Coagulation Devices 189
8.3.8 D-Dimer Testing 190
8.3.9 Market Analysis 190
8.3.9.1 Market Share for POCT Coagulation Testing 190
8.3.9.2 Competitive Analysis of Sector Companies 190
8.3.9.3 Market Drivers 191
8.3.9.4 Market Restraints 192
8.3.9.5 POC Coagulation Testing Assay Market Trends 193
8.3.9.6 POC Coagulation Testing Assay Technology Trends 193
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 194
8.4 POC Rapid Cardiac Markers 194
8.4.1 Background to POC Rapid Cardiac Marker Testing 195
8.4.2 Cardiac Marker Tests 196
8.4.2.1 Creatine Kinase (CK) 196
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) 197
8.4.2.5 Homocysteine 197
8.4.3 Emerging Markers 198
8.4.3.1 B-Type Natriuretic Peptide (BNP) 198
8.4.3.2 Myeloperoxidase (MPO) 198
8.4.3.3 Ischemia-Modified Albumin (IMA) 198
8.4.3.4 Glycogen Phosphorylase Isoenzyme BB (GPBB) 199
8.4.3.5 Fatty Acid-Binding Proteins (FABPs) 199
8.4.4 Review of Selected POC Cardiac Biomarker Analyzers 199
8.4.5 Review of Company Products 201
8.4.5.1 Alere Triage Cardiac Panel 201
8.4.5.2 Roche Diagnostics 202
8.4.5.3 Ani Biotech 203
8.4.5.4 Response Biomedical Corporation 204
8.4.5.5 Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics,
Diagnostic Products Corporation and Dade Behring) 205
8.4.5.6 Lab21 Ltd. 205
8.4.5.7 Abbott Laboratories 205
8.4.5.8 LifeSign (Princeton BioMediTech Corp.) 205
8.4.5.9 Mitsubishi Kagaku Iatron 205
8.4.5.10 Alpha Scientific 206
8.4.5.11 bioMérieux 206
8.4.5.12 Nexus 206
8.4.5.13 Princeton BioMeditech 206
8.4.5.14 Randox Laboratories 206
8.4.5.15 Market Share for Cardiac Marker Testing 207
8.4.6 Market Analysis 207
8.4.6.1 Market Drivers 207
8.4.6.2 Market Restraints 209
8.4.7 POC Cardiac Marker Testing Assay Market and Technology Trends 210
8.4.7.1 POC Cardiac Marker Testing Assay Market Trends 210
8.4.7.2 POC Cardiac Marker Testing Assay Technology Trends 210
8.4.7.3 POC Cardiac Marker Testing Assay Strategic Recommendations 211
8.5 POC Substance Abuse Testing 212
8.5.1 Background to POC Substance Abuse Testing 212
8.5.2 Substance Abuse Test Types 219
8.5.2.1 Urine Substance/Drug Screening 219
8.5.2.2 Hair Tests for Substance Abuse and Screening 219
8.5.2.3 Blood Tests for Substance Abuse and Screening 220
8.5.2.4 Saliva Tests for Substance Abuse and Screening 220
8.5.2.5 Sweat Tests for Substance Abuse and Screening 220
8.5.3 Alcohol Abuse and Screening 220
8.5.4 Saliva Testing 221
8.5.5 Qualitative Analysis 221
8.5.5.1 Market Drivers 221
8.5.5.2 Market Restraints 222
8.5.6 Review of Selected POC Substance Abuse Analyzers 222
8.5.7 Review of Company Products 224
8.5.7.1 Alere 224
8.5.7.2 Abbott Diagnostics 225
8.5.7.3 Roche Diagnostics 225
8.5.7.4 BioScan Screening Systems, Inc. 226
8.5.7.5 American Bio Medica Corp. 226
8.5.7.6 Phamatech, Inc. 231
8.5.7.7 First Check Medical 232
8.5.7.8 OraSure 232
8.5.7.9 Avitar, Inc. 233
8.5.7.10 Concateno 233
8.5.7.11 Pathtech 233
8.5.7.12 Alfa Scientific Designs, Inc. 233
8.5.7.13 TCPI, Inc. 234
8.5.7.14 Roche 235
8.5.7.15 Biophor Diagnostics 235
8.5.7.16 Randox Laboratories 235
8.5.7.17 Branan Medical 235
8.5.7.18 Concateno 236
8.6 POC Pregnancy and Fertility Tests 237
8.6.1 Background to POC Pregnancy and Fertility Tests 237
8.6.2 Review of Selected POC Pregnancy Testing Devices 237
8.6.3 Review of Company Products 239
8.6.3.1 Quidel 239
8.6.3.2 Abbott Diagnostics 239
8.6.3.3 Alere 239
8.6.3.4 Worldwide Medical Corporation 240
8.6.3.5 Genzyme Diagnostics 240
8.6.3.6 Siemens Diagnostics 240
8.6.3.7 Orgenics 240
8.6.3.8 LifeSign 240
8.6.3.9 Stanbio 241
8.6.3.10 Market Analysis 241
8.6.3.10.1 Competitive Sector Analysis 241
8.7 Fecal Occult Blood 241
8.7.1 Background to POC Fecal Occult Blood Testing 242
8.7.2 Review of Selected POC Fecal Occult Testing Devices 244
8.7.3 Review of Company Products 246
8.7.3.1 Helena Laboratories 246
8.7.3.2 Biomerica 246
8.7.3.3 Beckman Coulter 246
8.7.3.4 Worldwide Medical 246
8.7.3.5 Aerscher Diagnostics 247
8.7.3.6 Enterix 247
8.7.3.7 Medix Biochemica 247
8.7.3.8 Orion Diagnostica 247
8.7.3.9 ACON Laboratories' Mission FOB Reagent Strips 247
8.7.3.10 Alere's Products 248
8.7.3.11 Immunostics' Hema-Screen 248
8.7.3.12 Princeton BioMeditech's BioSign iFOBTest 248
8.7.3.13 Quest Diagnostics' InSure FIT 248
8.7.3.14 Quidel's QuickVue iFOB 248
8.7.4 Market Share for Fecal Occult Blood Testing 248
8.7.4.1 Company Analysis for the Fecal Occult Blood POCT Sector 248
8.7.5 Market Analysis 249
8.7.5.1 Market Drivers 249
8.7.5.2 Market Restraints 249
8.7.5.3 POC Fecal Occult Blood Testing Assay Market and Technology Trends 250
8.7.5.3.1 POC Fecal Occult Blood Testing Assay Market Trends 250
8.7.5.3.2 Fecal Occult Blood Testing Assay Technology Trends 250
8.7.5.3.3 POC Fecal Occult Blood Testing Assay Strategic Recommendations 250
8.8 POC Infectious Disease Testing 251
8.8.1 Background to POC Infectious Disease Testing 251
8.8.2 Types of Diagnosis for Infectious Diseases 252
8.8.2.1 Microbial Culture 252
8.8.2.2 Microscopy 252
8.8.2.3 Biochemical Tests 253
8.8.2.4 Molecular Diagnostics 253
8.8.3 Diagnostic Platforms for Infectious Diseases 254
8.8.3.1 Centralized Laboratory Testing for Infectious Diseases 254
8.8.3.2 POC Testing for Infectious Diseases 254
8.8.4 Emerging Technologies 254
8.8.5 Qualitative Analysis 255
8.8.5.1 Market Drivers 255
8.8.5.2 Market Restraints 255
8.8.6 Review of Selected POC Infectious Disease Testing Devices 255
8.9 POC Urine Strip Testing 258
8.9.1 Background to POC Urine Strip Testing 258
8.9.2 Emerging Technologies 260
8.9.3 Review of Selected POC Urine Strip Testing Devices 261
8.10 POC Cholesterol Testing 262
8.10.1 POC Cholesterol Testing Market Size and Development 262
8.10.2 Background to POC Cholesterol Testing 263
8.10.3 POC Cholesterol Testing Devices 265
8.10.3.1 Review of Selected POC Cholesterol Testing Devices 265
8.10.4 Review of Company Products 266
8.10.4.1 Cholestech (Now Alere) 266
8.10.4.2 Actimed Laboratories 267
8.10.4.3 StatSite Meter 267
8.10.4.4 Polymer Technology Systems 267
8.10.4.5 PreMD, Inc. (f/k/a International Medical Innovations, Inc. [IMI]) 267
8.10.4.6 Abaxis, Inc. 268
8.10.4.7 Miraculins' PREVU Point of Care Skin Sterol Test 268
8.10.5 Product Comparison of Leading Suppliers 268
8.10.6 Launch Dates of Leading Products in Europe 270
8.11 Miscellaneous POC Tests 271
8.11.1 Triage C. difficile Panel 271
8.11.2 Ketoacids 271
8.11.3 Acetaminophen 271
8.11.4 Estriol 272
8.11.5 POC H. pylori Testing 272
8.11.6 Bacterial Contamination of Platelet Units 276
8.12 POC Vaginal Fluid pH and Vaginitis Testing 276
8.13 POC Cancer Testing 277
8.13.1 Prostate-Specific Antigen (PSA) 277
8.13.2 Bladder Cancer 278
8.13.3 Other Rapid Cancer Tests 281
8.14 Fetal Status (PROM) 282
8.15 Osteoporosis 282
8.16 Hemodynamic Monitoring 282
8.17 Heparin-Induced Thrombocytopenia 283
8.18 HIV 283
8.18.1 Whole-Blood, Serum or Plasma-Based HIV Tests 286
8.18.1.1 Bio-Rad Laboratories 287
8.18.1.2 Orgenics (Inverness, Now Alere) 287
8.18.1.3 StatSure Diagnostic Systems 287
8.18.1.4 Trinity Biotech 287
8.18.1.5 Savyon Diagnostics 288
8.18.1.6 MedPharm 288
8.18.1.7 American Bio Medica Corp. 288
8.18.1.8 Chembio Diagnostics 288
8.18.1.9 OraSure Technologies 289
8.18.1.10 Alere 290
8.18.1.11 Hema Diagnostics Systems 290
8.18.1.12 bioLytical Laboratories' INSTI Kit 290
8.18.1.13 bioMérieux's VIKIA HIV-1/2 Test 291
8.18.1.14 Chembio Diagnostics' Dual-Path Platform Technology Products 291
8.18.1.15 Daktari Diagnostics' Daktari CD4 291
8.18.1.16 EY Laboratories' InstantCHEK 291
8.18.1.17 IND Diagnostic's One-Step Anti-HIV (1+2) Test 291
8.18.1.18 IQuum's Liat System 291
8.18.1.19 Lab21's Biotec Tests 291
8.18.1.20 MedMira's HIV Tests 292
8.18.1.21 YD Diagnostics' AIDScan 292
8.18.2 Saliva-Based HIV Tests 292
8.18.2.1 OraSure Collection Device 293
8.18.2.2 SureStat 294
8.18.2.3 Calypte 294
8.18.3 Urine-Based HIV Tests 294
8.18.3.1 MedMira Laboratories, Inc. 295
8.18.3.2 Medical Services International, Inc. 295
8.18.3.3 Maxim Biomedical 296
8.18.3.4 Wampole Laboratories 296
8.19 Infectious Diseases 296
8.19.1 C. difficile 296
8.19.2 Giardia 297
8.19.3 Dengue Fever 297
8.19.4 Malaria Testing 298
8.19.5 Rapid Influenza Testing 300
8.19.6 Streptococcus Testing 303
8.19.7 Chlamydia 305
8.19.8 Mononucleosis 305
8.19.9 Rubella 307
8.19.10 Staphylococcus aureus and MRSA 307
8.19.11 Hepatitis 308
8.19.12 E. coli O157 311
8.19.13 Gonorrhea Testing 311
8.19.14 Smallpox 311
8.19.15 SARS 312
8.19.16 Rabies 312
8.19.17 Tuberculosis 312
8.19.18 Avian Flu 314
8.19.19 West Nile Virus 314
8.19.20 Herpes Simplex Virus Type-2 314
8.19.21 Legionella 314
8.19.22 RSV 314
8.19.23 Leptospirosis 316
8.19.24 Sexually-Transmitted Diseases 316
8.19.25 Infant Jaundice 318
8.19.26 Anthrax 318
8.19.27 Tropical Diseases 320
8.20 Homeland Defense (Plague and Tularemia) 320
8.21 BSE (Mad Cow Disease) 320
8.22 Tuberculosis 321
8.23 Typhoid 322
8.24 Avian Flu 322
8.25 Food Pathogens (Salmonella, Listeria, Campylobacter) 322
8.26 Ruptured Fetal Membranes 323
8.27 Alcohol 324
8.28 Microalbumin Testing 324
8.29 Labor and Delivery Testing 324
8.29.1 Alere Triage PLGF 324
8.29.2 Amnisure 324
8.29.3 Medix Biochemica 325
8.30 Sperm Fertility 325
8.31 Surgical Coagulation and Hemostasis Management 326
8.32 Respiratory Tests 326
8.33 C-Reactive Protein 326

9. POCT: Growth Regulators 327
9.1 Moderators of Growth 327
9.2 Personnel Acceptance 327
9.3 Key People for POCT 328
9.4 Information Management Issues 328
9.4.1 Elements of Information Management for POCT: Information-Processing
Capabilities 330
9.4.2 Data Mining 330
9.4.3 Middleware 330
9.4.4 Web Portals 331
9.4.5 POCT-1A Standard 331
9.5 Key Elements for POCT 332
9.6 POCT and Reimbursement 332
9.7 Effectiveness of Clinical Outcomes 334
9.8 Rapid Near-Patient Testing in Hospitals 335
9.9 Satellite Facilities 335
9.10 Regionalization of Laboratory Care 336
9.11 Requirements for POCT 337
9.12 Locations of POC for Patient Care 338
9.13 Benefits of POCT 339
9.14 Cost Elements of POCT 340
9.15 Necessary Functions in POCT 340
9.16 Turnaround Time (TAT) for POCT 340
9.17 Clinical Laboratory Improvement Amendments (CLIA) 341
9.18 Sexually-Transmitted Diseases in Underdeveloped Countries 343
9.19 Sources of Error in POC Testing 343

10. Business Trends in the POC Sector 346
10.1 Sector Consolidation 346
10.2 Diagnostic Testing Growth Trends 347
10.2.1 Opportunities for Healthcare Stakeholders 348
10.3 Acquisition, License Agreements, Internal Development and Partnerships 348
10.4 Product Testing Depth in POCT 351
10.5 Government Regulation 351
10.5.1 U.S. Regulation 351
10.5.1.1 Importing Medical Devices into the U.S. 353
10.5.1.2 Exporting Medical Devices from the U.S. 353
10.5.2 E.U. Regulation 354
10.5.3 Japanese Regulation 357
10.5.4 Korean Regulation 358
10.6 Post-Filing Regulations for POC Devices 358
10.7 Exporting Unapproved POCTs 359
10.8 Analyte-Specific Reagents ("Home-Brew" Tests) 359
10.9 Medical Device Registration 360
10.10 Product Labeling 360
10.11 Punitive FDA Actions 360
10.12 CLIA '88 and State Laboratory Laws 361
10.13 Impact of Regulations on the Industry 361
10.14 Minimizing Regulatory Barriers 362
10.15 Waived Testing 364

11. Technology Platform Innovations in POCT 366
11.1 Latest POCT Technological Platforms 366
11.1.1 Device Miniaturization and Microfluidic Technologies 366
11.1.2 Minimally-Invasive and Non-Invasive POCT Technologies 366
11.1.2.1 Via Medical 366
11.1.2.2 Echo Therapeutics 368
11.1.3 Advances in Wireless Technologies 368
11.1.4 Automation of POCT 368
11.1.5 Developments in New Genomic Technologies (Genotyping, Haplotyping and
Sequencing Technologies) 368
11.1.6 Advances in Informatics Technologies 371
11.1.7 Pharmacogenetic Testing 371
11.1.8 Multi-Assay Technologies in POCT 371
11.2 Developments in Key Technologies 372
11.2.1 Medical and Biological Sensors and Sensor Systems 372
11.2.2 Recent Biosensor Product Introductions and the Latest Innovative
Developments 373
11.2.2.1 Nanoscale Sensors for the Detection of Cancer Biomarkers 373
11.2.2.2 ForteBio Introduces Dip and Read Protein G Biosensor for Octet
Instruments 373
11.2.2.3 ForteBio Launches New Octet RED96 System and Dip and Read Protein L
Biosensor 374
11.2.2.4 AgaMatrix Europe Limited Introduces New Jazz Blood Glucose Meter in the
U.K. 374
11.2.2.5 STMicroelectronics to Manufacture the World's Smallest Biosensors 374
11.2.2.6 Universal Biosensors Advances POC Molecular Diagnostic Opportunity 374
11.2.2.7 Clinitek Advantus—A Semi-Automated Urine Analyzer for POC Testing 375
11.2.2.8 NOVA 16 STAT Chemistry Analyzer Offers the First All-Electrode-Based
Seven-Test Chemistry Profile 375
11.3 Sensor Systems for Diagnostic Applications 376
11.4 Nanogen (The ELITech Group) Third-Generation POC Analyzer 379
11.5 Philips Development of Magnotech Technology 379
11.6 Quidel Corporation MChip, AVR Chip and F Chip 379
11.7 Sanofi-Aventis 380

12. Data Management and Connectivity 381
12.1 Wireless LANs 381
12.2 Connectivity Platforms 383
12.2.1 DataLink Data Management System 384
12.2.2 RALS-Plus, RALS-Web3 and RALS-Freedom 386
12.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 387
12.2.2.2 Siemens Diagnostics Rapidpoint® Coag 388
12.2.2.3 Radiometer 388
12.2.2.4 HemoCue's DM Hemoglobin 388
12.2.2.5 Roche Diagnostics 388
12.2.2.6 ITC 389
12.2.3 BD.id 389
12.2.4 Medical Implant Communications Service (MICS) 389
12.2.5 Conworx Technology 389
12.2.6 Lab Data Systems 389
12.2.7 Medasys 390
12.2.8 NoemaLife 390
12.3 Advantages of POCT Connectivity 390
12.3.1 Cost-Benefit Analysis of POCT and IT Connectivity 391
12.3.2 Hospital Network Issues 391
12.4 POCT Analyzer Connectivity Software Solutions 391
12.5 POCT2-P 393

13. Corporate Profiles 395
13.1 Abaxis, Inc. 395
13.2 Abbott Laboratories 398
13.3 AccuBioTech 400
13.4 Accumetrics, Inc. 400
13.5 AccuTech, LLC 401
13.6 ACON Laboratories, Inc. 401
13.7 Acrongenomics 401
13.8 AgaMatrix 401
13.9 Aerscher Diagnostics 402
13.10 Akers Biosciences, Inc. 402
13.11 Alere 403
13.12 Alfa Scientific Designs, Inc. 406
13.13 American Bio Medica Corporation 407
13.14 Ani Biotech Oy Ltd. 408
13.15 Ark Therapeutics 408
13.16 Arkray, Inc. 409
13.17 Atlas 409
13.18 Atonomics A/S 409
13.19 Audit Diagnostics 410
13.20 Augurix Diagnostics Ltd. 410
13.21 Axis-Shield 410
13.22 Axxin 411
13.23 Bayer Corp. 411
13.24 Beckman Coulter 412
13.25 BioLytical Laboratories 415
13.26 Biomerica, Inc. 415
13.27 bioMérieux 415
13.28 BiOracle 416
13.29 Bio-Rad Laboratories, Inc. 416
13.30 BioScan Screening Systems, Inc. 417
13.31 BioSite 417
13.32 Calmark Sweden AB 417
13.33 Calypte Biomedical Corporation 417
13.34 Chembio Diagnostic, Inc 418
13.35 Chempaq A/S 419
13.36 Cholestech 419
13.37 Claros Diagnostics 419
13.38 CompuCyte Corporation 419
13.39 Concateno Plc 420
13.40 Diagnostics Chemicals Ltd. 420
13.41 Dexcom 420
13.42 Enigma Diagnostics Ltd. 421
13.43 EY Laboratoires, Inc. 421
13.44 Eurotrol 421
13.45 Exalenz Bioscience 422
13.46 GenBio 422
13.47 Genzyme Diagnostics 422
13.48 Guided Therapeutics, Inc. (SpectRx, Inc.) 423
13.49 Helena Laboratories 423
13.50 Hema Diagnostic Systems, LLC 423
13.51 HemoCue AB 425
13.52 HemoSense 425
13.53 Home Diagnostics (Nipro Diagnostics) 425
13.54 IND Diagnostic 425
13.55 Instrumentation Laboratory (IL)/Werfen Group 425
13.56 International Technidyne Corporation 426
13.57 Jant Pharmacal Corporation 426
13.58 Johnson & Johnson 426
13.59 Lein Applied Diagnostics 427
13.60 LifeAssays® AB 427
13.61 LifeSign, LLC 428
13.62 Medica 428
13.63 Medical Automation Systems 428
13.64 Mediwatch 428
13.65 Medix Biochemica 428
13.66 MedMira Laboratories 429
13.67 MELA Sciences (Formerly Electro-Optical Sciences) 430
13.68 A. Menarini Diagnostics 430
13.69 Meretek Diagnostics Group 431
13.70 Meridian Bioscience 431
13.71 Micronics 433
13.72 Minimed 433
13.73 Mitsubishi Chemical Holdings USA, Inc. 434
13.74 Mitsubishi Kagaku Iatron 434
13.75 Nanogen (ELITech Group) 435
13.76 New Horizons Diagnostics 435
13.77 Nexus DX/ITC 435
13.78 Nova Biomedical 436
13.79 OraSure Technologies, Inc. 437
13.80 Orion Diagnostica 439
13.81 Polymedco, Inc. 439
13.82 Polymer Technology Systems, Inc. 440
13.83 Prima Biomedical Company 441
13.84 QBC Diagnostics 441
13.85 Qualigen 441
13.86 Quest Diagnostics, Inc. 441
13.87 Quidel Corporation 442
13.88 Radiometer Medical 446
13.89 Response Biomedical 449
13.90 Roche Diagnostics 450
13.91 Savyon Diagnostics 452
13.92 Selfcare, Inc. 453
13.93 Shanghai Ruicare Medical 453
13.94 Shenzhen Fitconn Technology Co., Ltd. 453
13.95 Shionogi & Co., Ltd. 453
13.96 Siemens AG 453
13.97 Spectral Diagnostics 454
13.98 StatSure Diagnostic Systems, Inc. 454
13.99 Step Detect Associates 455
13.100 Strategic Diagnostics 455
13.101 Trinity Biotech, Plc 455
13.102 Väsamed, Inc. 458

14. POCT Sector Trends and Forecasts 460
14.1 Home Care Analysis as Part of Near-Patient Testing 460
14.2 Non-Traditional Collection for POCT 460
14.3 New Systems for Critical Care and Near-Patient Testing 460
14.4 Utility of Near-Patient Testing in Critical-Care Settings 461
14.5 Physician's Office Market 461
14.6 Information Management Advances 462
14.7 Test-Ordering Patterns and Demand for POCT 462
14.8 Demand for Emergency Department Services 462
14.9 Move Away from the Central Laboratory 463
14.10 Healthcare Cost Controls 464
14.11 Mergers and Acquisitions in POCT 465
14.12 Competition for Services 465
14.13 Drivers of POCT 466
14.14 Confluence of New Technology 466
14.15 Difficulties of Design for POC Products 466
14.16 European Hospital Structure 466
14.17 The Biggest New Opportunities in POCT 467

15. New Entrants to the Point of Care Market 468
15.1 Alliance International Co., Ltd. 468
15.2 Alverix, Inc. 468
15.3 Analyticon Biotechnologies AG 468
15.4 Aptiva Medical, Inc. 468
15.5 ArcDia International Oy Ltd. 470
15.6 Artron Laboratories, Inc. 470
15.7 Atlas Genetics Ltd. 470
15.8 Atlas Link Biotech Co., Ltd. 470
15.9 Atonomics A/S 471
15.10 Audit Diagnostics 471
15.11 Augurix SA/Augurix Diagnostics 471
15.12 Autobio Diagnostics Co., Ltd. 471
15.13 Axxin 471
15.14 BioFire Diagnostics, Inc. 471
15.15 BioMedomics 472
15.16 BioHelix Corporation 472
15.17 Biosensia Ltd. 472
15.18 DxNA, LLC 473
15.19 Echo Therapeutics, Inc. 473
15.20 Enigma Diagnostics Ltd. 473
15.21 Immunexpress Group 473
15.22 Integrity Applications 473
15.23 MBio Diagnostics, Inc. 474
15.24 Menssana Research, Inc. 475
15.25 Metaara Medical Technologies Inc. 475
15.26 Biocartis SA 475
15.27 Curetis AG 476
15.28 Gentag, Inc. 476
15.29 Great Basin Corporation 476
15.30 Innovative Biosensors, Inc. 477
15.31 Integrated Diagnostics 477
15.32 Venaxis, Inc. 477
15.33 Vivacta Limited 477
15.34 Wave 80 Biosciences 477
15.35 Veredus Laboratories Pte Ltd. 477
15.36 Via Medical Corporation 478
15.37 Vital Diagnostics, Inc. 479

INDEX OF FIGURES

Figure 2.1: Worldwide Distribution of IVD Testing, 2012 36
Figure 2.2: Top 13 Country IVD Testing Markets, 2012 37
Figure 3.1: Total Global POCT Market, 2008-2018 46
Figure 3.2: Worldwide Distribution of POCT, 2012 53
Figure 3.3: Summary of Global POCT Markets by Market Segment, 2012 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, 2012 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 96
Figure 6.4: Chinese Revenues for POCT Market, 2008-2018 99
Figure 7.1: Summary Analysis of ROW POCT Market, 2008-2018 106
Figure 7.2: Summary Analysis of Russian Revenues for POCT Products Market,
2008-2018 115
Figure 7.3: Summary Analysis of Middle East Revenues for POCT Products Market,
2008-2018 116
Figure 7.4: Summary Analysis of African Revenues for POCT Products Market,
2008-2018 117
Figure 7.5: Summary Analysis of Latin America (Other) Revenues for POCT Products
Market, 2008- 2018 121
Figure 8.1: Global Share of Glucose Testing Market by Company, 2012 146
Figure 8.2: Global POCT Share of Blood Gas and Electrolyte Testing Market, 2012
165
Figure 8.3: Global POCT Share of Coagulation Testing Market, 2012 190
Figure 8.4: Global POCT Share of Cardiac Marker Testing Market, 2012 207
Figure 8.5: Global POCT Share of HIV Testing Market, 2012 286
Figure 8.6: Performance Metrics of ROM Diagnostic Methods 325
Figure 9.1: Annual Rate of Emergency Room Visits by Primary Expected Source of
Payment 334
Figure 9.2: CLIA Laboratories by Certificate Types 341
Figure 10.1: Conformity Assessment Route, Annexes and Quality System Standards
by IVD Device Category 355
Figure 12.1: The RALS Data Management System Connects to Most of the Major
Instruments Used in Point of Care 385
Figure 12.2: AegisPOC Point of Care and Critical Care Connectivity and
Information Management System 392

INDEX OF TABLES

Table 2.1: Summary of Global POCT Markets by Major Market Sub-Segment, 2012 and
2018 26
Table 2.2: Summary of U.S. POCT Markets by Major Market Sub-Segment, 2012 and
2018 26
Table 2.3: Summary of European POCT Markets by Major Market Sub-Segment, 2012
and 2018 27
Table 2.4: Summary of Asian POCT Markets by Major Market Sub-Segment, 2012 and
2018 27
Table 2.5: Summary of ROW POCT Markets by Major Market Sub-Segment, 2012 and
2018 28
Table 2.6: Worldwide POCT Market Size by Geographic Location, 2008-2018 28
Table 2.7: Global Market Share POCT Analysis, 2012 29
Table 2.8: Worldwide Distribution of IVD Testing, 2012 36
Table 2.9: Top 13 Country IVD Testing Markets, 2012 36
Table 2.10: Top Ten Diagnostic Companies 2011 and 2012 37
Table 2.11: Company Market Share for IVD Testing Markets, 2012 38
Table 2.12: 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, 2011 52
Table 3.13: Worldwide POCT Market Size by Geographic Location, 2008-2018 52
Table 3.14: Worldwide Distribution of POCT, 2012 53
Table 3.15: Summary of Global POCT Markets by Market Segment, 2012 53
Table 3.16: Worldwide POCT by Performance Location, 2012 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, 2012 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, 2012 62
Table 4.14: U.S. POCT by Performance Location, 2012 62
Table 4.15: Summary of U.S. POCT Markets by Market Segment, 2012 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 Marker Devices, 2008-2018 79
Table 5.15: European Revenues for POC Substance/Drug Abuse Testing Device
Market, 2008-2018 80
Table 5.16: European Revenues for POC Infectious Disease Testing Devices Market,
2008-2018 81
Table 5.17: European Revenues for POC Urine Strip Testing Products Market,
2008-2018 81
Table 5.18: European Revenues for POC

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In_Vitro_Diagnostic Industry: Point of Care Diagnostic Testing World Markets

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