1. Overview 15
1.1 About This Report 15
1.2 Scope of the Report 16
1.3 Objectives 17
1.4 Methodology 17
1.5 Executive Summary 18
2. Overview of Diagnostic Testing Point of Care 22
2.1 Point of Care Testing Sites 22
2.2 Point of Care Market Structure 23
2.3 New Directions in Clinical IVD Testing 23
3. POCT and Rapid Testing Market Analysis: Size, Background Analysis, Growth,
Share and
Competitors 26
3.1 Global POCT Market 33
3.2 U.S. POCT Market 36
3.3 European POCT Market 38
3.3.1 German POCT Diagnostic Market 45
3.3.2 U.K. POCT Diagnostic Market 47
3.3.2.1 U.K. POCT Market Statistics 47
3.3.2.2 U.K. Competitive Analysis 49
3.3.2.3 U.K. Market Access 50
3.3.3 French POCT Diagnostic Market 50
3.3.4 Italian POCT Diagnostic Market 51
3.3.5 Spanish POCT Diagnostic Market 53
3.3.6 Scandinavian POCT Diagnostic Market 54
3.3.7 Swedish POCT Diagnostic Market 55
3.3.8 Finnish POCT Diagnostic Market 56
3.3.9 Norwegian POCT Diagnostic Market 57
3.3.10 Swiss POCT Diagnostic Market 58
3.3.11 Dutch POCT Diagnostic Market 59
3.3.12 Belgian POCT Diagnostic Market 60
3.3.13 Portuguese POCT Diagnostic Market 61
3.3.14 Austrian POCT Diagnostic Market 62
3.3.15 Greek POCT Diagnostic Market 63
3.3.16 Polish POCT Diagnostic Market 64
3.3.17 Czech Republic POCT Diagnostic Market 65
3.3.18 Turkish POCT Diagnostic Market 66
3.4 Asian POCT Markets 66
3.4.1 Japanese POCT Diagnostic Market 66
3.4.2 Indian POCT Diagnostic Market 68
3.4.3 Chinese POCT Diagnostic Market 73
3.5 Rest of the World POCT Market 83
3.5.1 Canadian POCT Diagnostic Market 84
3.5.2 Brazilian POCT Diagnostic Market 84
3.5.3 Australian POCT Diagnostic Market 85
3.6 Overview of Asian Healthcare Market 85
3.6.1 Singapore 87
3.6.2 Malaysia 87
3.6.3 Thailand 88
3.6.4 Indonesia 88
3.6.5 Philippines 88
3.6.6 South Korea 89
3.6.7 Taiwan 89
4. POCT Individual Markets 90
4.1 Glucose Testing 90
4.2 POCT Individual Market Sectors, Size, Growth Rates and Competitors 91
4.2.1 World Market Revenue and Forecasts 91
4.2.2 Professional Glucose Testing Market for POCT U.S. Revenue and Forecasts
During 2001-2012 92
4.2.3 European Market 93
4.2.4 Market Share 93
4.2.5 Alternate Glucose Monitoring Products 94
4.2.6 HbA1c POCT 95
4.2.7 Market Challenges and Strategic Recommendations 96
4.2.7.1 Market Drivers and Restraints 96
4.2.7.1.1 Market Drivers 96
4.2.7.1.2 Market Restraints 96
4.2.7.2 Point of Care Glucose Testing Assay Market and Technology Trends 97
4.2.7.2.1 Point of Care Glucose Testing Assay Market Trends 97
4.2.7.2.2 Point of Care Glucose Testing Assay Technology Trends 97
4.2.7.2.3 Point of Care Glucose Testing Assay Strategic Recommendations 97
4.3 Blood Gas and Electrolytes 98
4.3.1 Whole Blood Lactate 101
4.3.2 Creatinine 101
4.4 Rapid Coagulation Tests 102
4.4.1 World POCT Coagulation Market 104
4.4.2 U.S. Coagulation Market 105
4.4.3 European Coagulation Market 108
4.4.4 Trends in POCT Coagulation Testing 109
4.4.4.1 Self-testing Coagulation Market 109
4.4.4.2 D-Dimer Testing 110
4.4.5 Point of Care Coagulation Testing Assay Market and Technology Trends 110
4.4.5.1 Point of Care Coagulation Testing Assay Market Trends 110
4.4.5.2 Point of Care Coagulation Testing Assay Technology Trends 110
4.4.5.3 Point of Care Coagulation Testing Assay Strategic Recommendations 110
4.5 Rapid Cardiac Markers 111
4.5.1 U.S. Market 111
4.5.2 European Market 114
4.5.3 Market Drivers and Restraints 115
4.5.3.1 Market Drivers 115
4.5.3.2 Market Restraints 116
4.5.4 Point of Care Cardiac Marker Testing Assay Market and Technology Trends
116
4.5.4.1 Point of Care Cardiac Marker Testing Assay Market Trends 116
4.5.4.2 Point of Care Cardiac Marker Testing Assay Technology Trends 116
4.5.4.3 Point of Care Cardiac Marker Testing Assay Strategic Recommendations 116
4.6 Drugs of Abuse Screening Testing 117
4.6.1 Acetaminophen 124
4.6.2 Tricyclic Antidepressants (TCAs) 125
4.6.3 Other Toxic Drugs 125
4.6.4 Drug Testing Selectivity 125
4.6.5 Methaqualone and Phencyclidine (PCP) 125
4.6.6 Tetrahydrocannabinol 125
4.6.7 Drug Panels by Toxidromes 126
4.6.8 Alcohol Testing 126
4.7 Urine Strips 127
4.8 Pregnancy Tests 129
4.9 Fecal Occult Blood 131
4.10 Hemoglobin Testing 131
4.11 Miscellaneous Rapid Tests 132
4.11.1 Estriol 132
4.11.2 Fetal Fibronectin (fFN) 133
4.11.3 H. pylori 133
4.11.4 Vaginal pH and Vaginitis 133
4.11.5 Bladder Cancer 134
4.11.6 Fetal Status 135
4.11.7 Heparin-induced Thrombocytopenia 136
4.12 Human Immunodeficiency Virus (HIV) 136
4.13 Cholesterol 142
4.14 Infectious Disease 143
4.14.1 Clostridium difficile 144
4.14.2 Giardia 144
4.14.3 Salmonella and Campylobacter 145
4.14.4 Malaria Testing 146
4.14.5 Influenza Testing 147
4.14.6 Strep Testing 150
4.14.7 Chlamydia 152
4.14.8 Mononucleosis 153
4.14.9 Rubella 153
4.14.10 Methicillin-resistant Staphylococcus aureus (MRSA) 153
4.14.11 Hepatitis 158
4.14.12 Gonorrhea 160
4.14.13 Tuberculosis (TB) 161
4.14.14 Herpes Simplex Virus Type-2 163
4.14.15 Legionella 163
4.14.16 RSV 163
4.14.16.1 Market Drivers and Restraints 166
4.14.16.1.1 Market Drivers 166
4.14.16.1.2 Market Restraints 166
4.14.16.2 Point of Care Infectious Disease Testing Assay Market and Technology
Trends 166
4.14.16.2.1 Point of Care Infectious Disease Testing Assay Market Trends 166
4.14.16.2.2 Point of Care Infectious Disease Testing Assay Technology Trends 167
4.14.16.2.3 Point of Care Infectious Disease Testing Assay Strategic
Recommendations 167
4.15 Infant Jaundice 167
4.16 Anthrax 167
4.17 Rupture of Fetal Membranes (ROM) 169
4.18 Food Pathogens 170
4.19 Typhoid 170
5. POCT: Reagents and Equipment 171
5.1 Blood Glucose Monitoring 171
5.1.1 LifeScan 172
5.1.2 Roche Accu-Chek 175
5.1.3 Abbott Diabetes Care 177
5.1.4 HemoCue 178
5.1.5 Stanbio/GDS Technology 178
5.1.6 Abaxis, Inc. 179
5.1.7 Arkray (Japan) 180
5.1.8 Accurex (India) 180
5.1.9 Home Diagnostics, Inc. 180
5.1.10 Nova Biomedical 180
5.1.11 Bayer 181
5.1.11.1 Hemoglobin A1c Measurements 182
5.1.12 Biosite (now part of Alere) 182
5.1.13 Siemens Healthcare Diagnostics 182
5.1.14 Infopia 183
5.1.15 Diasys 183
5.1.16 Quotient Dx 183
5.1.17 Cholestech (Acquired by Inverness Medical Innovations, now named Alere)
183
5.1.18 Bio-Rad 183
5.1.19 Axis-Shield 183
5.2 Blood Gas and Electrolytes 184
5.2.1 Roche Corporation 184
5.2.2 TechnoMedica 184
5.2.3 Siemens Healthcare Diagnostics 184
5.2.4 Instrumentation Laboratory 185
5.2.5 Nova Biomedical 185
5.2.6 Radiometer 185
5.2.7 Abbott Laboratories 186
5.2.8 Span Diagnostics 186
5.2.9 Nexus Dx Avoximeter Systems for Co-oximetry 186
5.2.10 ITC (Nexus Dx) 188
5.2.11 Alere 188
5.2.12 Abaxis, Inc. 188
5.3 Rapid Coagulation Tests 188
5.3.1 POC Coagulation Instrument Description 193
5.3.1.1 Roche Diagnostics Corp. 194
5.3.1.2 Abbott Laboratories 196
5.3.1.3 International Technidyne Corporation Nexus DX 196
5.3.1.4 Medtronic 198
5.3.1.5 HemoSense (Inverness) 198
5.3.1.6 Helena Laboratories Point of Care 199
5.3.1.7 Sienco, Inc. 201
5.3.1.8 Accumetrics 201
5.3.1.9 Alere 201
5.3.1.10 ITC 202
5.3.2 Connectivity Issues 202
5.3.3 Cost Benefits 202
5.3.4 Quality Control Issues 203
5.3.5 Certification for Point of Care Coagulation Devices 203
5.4 Rapid Cardiac Markers 204
5.4.1 Biosite Diagnostics (Inverness, now called Alere) 204
5.4.2 Roche Diagnostics 205
5.4.3 Ani Biotech 206
5.4.4 Response Biomedical Corporation 206
5.4.5 Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics,
Diagnostic Products Corporation, and Dade Behring) 207
5.4.6 Lab21 Ltd. 207
5.4.7 Abbott Laboratories 208
5.4.8 LifeSign (Princeton BioMediTech Corp.) 208
5.4.9 Mitsubishi Kagaku Iatron 208
5.4.10 Alpha Scientific 208
5.5 Rapid Drugs of Abuse 208
5.5.1 Biosite Diagnostics (Inverness, now called Alere) 210
5.5.2 Abbott Diagnostics 211
5.5.3 Roche Diagnostics 211
5.5.4 BioScan Screening Systems, Inc. 212
5.5.5 American Bio Medica Corp. 212
5.5.6 Phamatech, Inc. 215
5.5.7 First Check Medical 216
5.5.8 OraSure 216
5.5.9 Avitar, Inc. 217
5.5.10 Concateno 217
5.5.11 Pathtech 217
5.5.12 Alfa Scientific Designs, Inc. 218
5.5.13 TCPI, Inc. 218
5.5.14 Roche 219
5.5.15 Biophor Diagnostics 219
5.6 Rapid Pregnancy and Fertility Tests 219
5.7 Fecal Occult Blood 221
5.7.1 Helena Laboratories 222
5.7.2 Biomerica 222
5.7.3 Beckman Coulter 222
5.7.4 Worldwide Medical 222
5.7.5 Aerscher Diagnostics 222
5.7.6 Enterix 223
5.7.7 Medix Biochemica 223
5.7.8 Orion Diagnostica 223
5.8 Hemoglobin Testing 223
5.8.1 Wampole Laboratories 223
5.8.2 HemoCue, Inc. 224
5.8.3 Stanbio 224
5.9 Miscellaneous Rapid Tests 224
5.9.1 Triage C. difficile Panel 224
5.9.2 Ketoacids 224
5.9.3 Acetaminophen 224
5.9.4 Estriol 225
5.9.5 H. pylori 225
5.9.6 Vaginal Fluid pH and Vaginitis 227
5.9.7 Prostate-Specific Antigen (PSA) 228
5.9.8 Bladder Cancer 228
5.9.9 Other Rapid Cancer Tests 232
5.9.10 Fetal Status (PROM) 232
5.9.11 Osteoporosis 233
5.9.12 Hemodynamic Monitoring 233
5.9.13 Heparin-induced Thrombocytopenia 233
5.10 HIV 233
5.10.1 Whole Blood, Serum or Plasma-based HIV Tests 236
5.10.1.1 Bio-Rad Laboratories 236
5.10.1.2 Orgenics (Inverness, now called Alere) 236
5.10.1.3 StatSure Diagnostic Systems 236
5.10.1.4 Trinity Biotech 236
5.10.1.5 Savyon Diagnostics 237
5.10.1.6 MedPharm 237
5.10.1.7 American Bio Medica Corp. 237
5.10.1.8 Chembio Diagnostics 237
5.10.1.9 OraSure Technologies 238
5.10.1.10 Inverness (Alere) 239
5.10.2 Saliva-based HIV Tests 239
5.10.2.1 OraSure Collection Device 240
5.10.2.2 SureStat 241
5.10.3 Urine-based HIV Tests 241
5.10.3.1 MedMira Laboratories, Inc. 241
5.10.3.2 Medical Services International, Inc. 242
5.10.3.3 Maxim Biomedical 242
5.10.3.4 Wampole Laboratories 242
5.11 Cholesterol 242
5.11.1 Cholestech (now a Brand of Inverness Medical Innovations) 243
5.11.2 Actimed Laboratories 244
5.11.3 StatSite Meter 244
5.11.4 Polymer Technology Systems 244
5.11.5 PreMD, Inc. (f/k/a International Medical Innovations, Inc. [IMI]) 245
5.11.6 Abaxis, Inc. 245
5.12 Infectious Disease 245
5.12.1 C. difficile 245
5.12.2 Giardia 246
5.12.3 Dengue Fever 246
5.12.4 Malaria Testing 247
5.12.5 Rapid Influenza Testing 249
5.12.6 Streptococcus Testing 252
5.12.7 Chlamydia 254
5.12.8 Mononucleosis 254
5.12.9 Rubella 255
5.12.10 Staphylococcus aureus and MRSA 255
5.12.11 Hepatitis 256
5.12.12 E. Coli O157 259
5.12.13 Gonorrhea Testing 259
5.12.14 Smallpox 259
5.12.15 SARS 259
5.12.16 Rabies 259
5.12.17 Tuberculosis 259
5.12.18 Avian Flu 260
5.12.19 West Nile Virus 260
5.12.20 Herpes Simplex Virus Type-2 260
5.12.21 Legionella 260
5.12.22 RSV 261
5.13 Infant Jaundice 262
5.14 Anthrax 262
5.15 Homeland Defense (Plague and Tularemia) 264
5.16 BSE (Mad Cow Disease) 264
5.17 Tuberculosis 265
5.18 Typhoid 265
5.19 Avian Flu 265
5.20 Food Pathogens (Salmonella, Listeria, Campylobacter) 266
5.21 Ruptured Fetal Membranes (ROM) 267
6. POCT: Growth Regulators 268
6.1 Moderators of Growth 268
6.2 Personnel Acceptance 268
6.3 Key People for POCT 269
6.4 Information Management Issues 269
6.4.1 Elements of Information Management for POCT: Information Processing
Capabilities 271
6.4.2 Data Mining 271
6.4.3 Middleware 271
6.4.4 Web Portals 272
6.4.5 POCT-1A Standard 272
6.5 Key Elements for POCT 273
6.6 POCT and Reimbursement 273
6.7 Effectiveness of Clinical Outcomes 275
6.8 Rapid Near-Patient Testing in Hospitals 276
6.9 Satellite Facilities 276
6.10 Regionalization of Laboratory Care 277
6.11 Requirements for POCT 278
6.12 Locations of Point of Care for Patient Care 279
6.13 Benefits of POCT 280
6.14 Cost Elements of POCT 281
6.15 Necessary Functions in POCT 281
6.16 TAT for POCT 281
6.17 Clinical Laboratory Improvement Amendments (CLIA) 282
6.18 Sexually-Transmitted Diseases in Underdeveloped Countries 284
6.19 Sources of Error in Point of Care Testing 284
7. Business Trends in the Point of Care Sector 287
7.1 Sector Consolidation 287
7.2 Diagnostic Testing Growth Trends 288
7.2.1 Opportunities for Healthcare Stakeholders 289
7.3 Acquisition, License Agreements, Internal Development and Partnerships 289
7.4 Product Testing Depth in POCT 292
7.5 Government Regulation 292
7.5.1 U.S. Regulation 293
7.5.1.1 Importing Medical Devices into the U.S. 294
7.5.1.2 Exporting Medical Devices from the U.S. 295
7.5.2 U.K. Regulation 295
7.5.3 E.U. Regulation 296
7.5.3.1 French Regulation 298
7.5.4 Japanese Regulation 298
7.5.5 Korean Regulation 299
7.6 Increased Market Penetration 299
7.7 Costs of doing Business in Europe 300
7.8 Drivers of European Diagnostics Testing 300
7.9 European Reimbursement Practices 300
7.10 Cost Containment in Europe 301
8. Technology Platform Innovations in POCT 304
8.1 Sensor Systems for Diagnostic Applications 304
8.2 Glucose Measurements 307
8.2.1 Continuous Glucose Monitoring Systems 309
8.3 Glucose Test Methods 311
8.4 Cholesterol Testing 312
8.5 The New Paradigm 312
8.6 Consolidated Workstations and Modularity 313
8.7 Automation and Robotics in the Clinical Laboratory 313
8.8 Laboratory Information Systems (LIS) 314
8.8.1 NOVIUS Lab 314
8.9 Biosensor Technology 314
8.10 Nanogen Third Generation Point of Care Analyzer 316
8.11 Quidel MChip 317
9. Data Management and Connectivity 318
9.1 Wireless LANs 318
9.2 Connectivity Platforms 321
9.2.1 DataLink Data Management System 321
9.2.2 RALS-Plus 322
9.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 324
9.2.2.2 Siemens Diagnostics Rapidpoint Coag 324
9.2.2.3 Radiometer 324
9.2.2.4 HemoCue’s DM Hemoglobin 324
9.2.2.5 Roche Diagnostics 324
9.2.3 BD.id 325
9.2.4 Medical Implant Communications Service (MICS) 325
9.3 Advantages of POCT Connectivity 325
9.3.1 Cost Benefit of POCT and IT Connectivity 326
9.3.2 Hospital Network Issues 326
10. Corporate Profiles 327
10.1 Abaxis, Inc. 327
10.2 Abbott Laboratories 330
10.3 Accumetrics, Inc. 332
10.4 AccuTech, LLC 332
10.5 ACON Laboratories 332
10.6 Acrongenomics 332
10.7 Aerscher Diagnostics 333
10.8 Akers Biosciences, Inc. 333
10.9 Alere 333
10.10 Alfa Scientific Designs, Inc. 336
10.11 American Bio Medica Corporation 337
10.12 Amic AB 338
10.13 Ani Biotech Oy Ltd. 338
10.14 Arkray, Inc. 338
10.15 Atonomics A/S 338
10.16 Audit Diagnostics 339
10.17 Augurix Diagnostics Ltd. 339
10.18 Axis-Shield 339
10.19 Axxin 340
10.20 Bayer 340
10.21 Beckman Coulter 340
10.22 BioLytical Laboratories 342
10.23 Biomerica, Inc. 342
10.24 BiOracle 343
10.25 Bio-Rad Laboratories, Inc. 343
10.26 BioScan Screening Systems, Inc. 343
10.27 BioSite 343
10.28 Calmark Sweden AB 344
10.29 Calypte Biomedical Corporation 344
10.30 Chembio Diagnostic Systems 345
10.31 Chempaq A/S 345
10.32 Cholestech 345
10.33 Claros Diagnostics 345
10.34 Concateno Plc 345
10.35 Dexcom 345
10.36 Enigma Diagnostics Ltd. 346
10.37 Epinex Diagnostics 346
10.38 Eurotrol 346
10.39 Exalenz Bioscience 347
10.40 GenBio 347
10.41 Genzyme 347
10.42 Helena Laboratories 347
10.43 HemoCue AB 348
10.44 HemoSense 348
10.45 Home Diagnostics (Nipro Diagnostics) 348
10.46 IND Diagnostic 348
10.47 Instrumentation Laboratory Company 348
10.48 ITC (International Technidyne Corporation) 348
10.49 Jant Pharmacal Corporation 349
10.50 Johnson & Johnson 349
10.51 Lein Applied Diagnostics 350
10.52 LifeAssays AB 350
10.53 LifeSign 350
10.54 Medica 350
10.55 Medical Automation Systems 350
10.56 Mediwatch 350
10.57 Medix Biochemica 351
10.58 MedMira 351
10.59 MELA Sciences (Formerly Electro-Optical Sciences) 351
10.60 Meretek Diagnostics Group 351
10.61 Meridian Bioscience 351
10.62 Micronics 352
10.63 3M 352
10.64 New Horizons Diagnostics 353
10.65 Nexus DX/ITC 353
10.66 Nova Biomedical 353
10.67 OraSure Technologies 354
10.68 Orion Diagnostica 355
10.69 Polymer Technology Systems 355
10.70 Prima Biomedical Company 355
10.71 QBC Diagnostics 355
10.72 Qualigen 355
10.73 Quidel 356
10.74 Radiometer Medical 358
10.75 Response Biomedical 359
10.76 Roche 359
10.77 Telcor 360
10.78 SA Scientific 360
10.79 Siemens AG 361
10.80 Stanbio Laboratory 361
11. POCT Sector Trends and Forecasts 363
11.1 Home Care Analysis as Part of Near-Patient Testing 363
11.2 Non-Traditional Collection for POCT 363
11.3 New Systems for Critical Care and Near-Patient Testing 363
11.4 Utility of Near-Patient Testing in Critical Care Settings 364
11.5 Physician’s Office Market 364
11.6 Information Management Advances 365
11.7 Test-Ordering Patterns and Demand for POCT 365
11.8 Demand for Emergency Department Services 365
11.9 Move Away from Central Laboratory 366
11.10 Healthcare Cost Controls 367
11.11 M&A in POCT 367
11.12 Competition for Services 368
11.13 Drivers of POCT 368
11.14 Confluence of New Technology 369
11.15 Difficulties of Design for Point of Care Products 369
11.16 European Hospital Structure 369
11.17 The Biggest New Opportunities in POCT 369
12. Corporate Directory 370
INDEX OF FIGURES
Figure 3.1: Blood Tests Ordered in Emergency Department Visits 27
Figure 3.2: Worldwide Distribution of IVD Testing, 2010 31
Figure 3.3: Global Point of Care Revenues, 2005-2012 33
Figure 3.4: Global Growth of Point of Care Testing Volume, 2000-2012 34
Figure 3.5: Global POCT Share of Total IVD Testing Market, 2010 35
Figure 4.1: Number of HbA1c Tests Performed Globally as POCT, 1991-2006 95
Figure 4.2: Percentage of Visits for Influenza-like Illness (ILI) Reported by
the U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet) and
Weekly National Summary, September 30, 2007-
February 12, 2011 148
Figure 4.3: Influenza Positive Tests Reported to CDC by U.S. WHO/NREVSS
Collaborating Laboratories, National Summary, 2010-2011 149
Figure 5.1: Global POCT Share of HIV Testing Market, 2008 235
Figure 6.1: Annual Rate of Emergency Room Visits by Primary Expected Source of
Payment 275
Figure 6.2: CLIA Laboratories by Certificate Types 282
INDEX OF TABLES
Table 2.1: Percentage of POCT Performed in Selected Hospitals 22
Table 2.2: POCT Procedural Advantages for Hospital Testing 24
Table 2.3: POCT Trends 25
Table 2.4: Professional POCT Compared to Home Testing 25
Table 2.5: Drivers for Integrating POCT into Hospital Routines 25
Table 3.1: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2010 26
Table 3.2: Number of Point of Care Tests in the U.S., 2000-2012 27
Table 3.3: Global Clinical Laboratory Market Sales, 1998-2011 30
Table 3.4: Overall IVD Testing Market Worldwide, 2010 31
Table 3.5: Worldwide Distribution of IVD Testing, 2010 31
Table 3.6: Top 12 Country IVD Testing Markets, 2010 32
Table 3.7: Global Point of Care Revenues, 2005-2012 33
Table 3.8: Worldwide POCT Market Size by Geographic Location, 2005-2012 34
Table 3.9: Worldwide Distribution of POCT, 2010 34
Table 3.10: Worldwide Clinical Diagnostic POCT and Rapid Test Market Segments,
2010 35
Table 3.11: Worldwide POCT by Performance Location, 2010 35
Table 3.12: Largest POCT Diagnostic Companies Worldwide, 2010 36
Table 3.13: U.S. Clinical Laboratory Testing Market, 2003-2012 36
Table 3.14: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location
of Analysis, 2010 37
Table 3.15: U.S. POCT Market, 2000-2012 37
Table 3.16: U.S. POCT by Performance Location, 2010 38
Table 3.17: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2010
38
Table 3.18: European Clinical Laboratory Testing IVD Reagents and Instruments
Market in Dollars,
2000-2012 39
Table 3.19: European Clinical Laboratory Testing IVD Reagents and Instruments
Market in Euros,
2000-2012 39
Table 3.20: European Clinical Laboratory Testing Diagnostics by Country Market
Estimates, 2010 40
Table 3.21: European Rapid POCT by Country Market Estimates, 2010 41
Table 3.22: Regional Comparison of Healthcare Spending for IVD for Eastern
Europe 44
Table 3.23: European POCT Market, 2005-2012 44
Table 3.24: Top 12 POCT Country Markets, 2010 44
Table 3.25: German Clinical Laboratory Testing Diagnostics Products Market
Sales, 2003-2012 45
Table 3.26: German POCT Diagnostics Products Market Sales, 2003-2012 45
Table 3.27: German Clinical Diagnostic Rapid Test Market Segments, 2010 46
Table 3.28: U.K. Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 47
Table 3.29: U.K. POCT Diagnostics Products Market Sales, 2006-2012 48
Table 3.30: U.K. Clinical Diagnostic Rapid Test Market Segments, 2010 48
Table 3.31: Major U.K. IVD Manufacturers 49
Table 3.32: U.S. IVD Manufacturers Doing Business in the U.K. 49
Table 3.33: Other European Companies that Manufacture IVD Products in the U.K.
49
Table 3.34: French Clinical IVD Testing Diagnostics Products Market Sales,
2003-2012 50
Table 3.35: French POCT Diagnostics Products Market Sales, 2005-2012 51
Table 3.36: French Clinical Diagnostic Rapid Test Market Segments, 2010 51
Table 3.37: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 52
Table 3.38: Italian POCT Diagnostics Products Market Sales, 2005-2012 52
Table 3.39: Italian Clinical Diagnostic Rapid Test Market Segments, 2010 52
Table 3.40: Spanish Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 53
Table 3.41: Spanish Clinical Diagnostic Rapid Test Market Segments, 2010 54
Table 3.42: Spanish POCT Diagnostics Products Market Sales, 2005-2012 54
Table 3.43: Scandinavian POCT Diagnostics Products Market Sales, 2000-2012 55
Table 3.44: Swedish Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 55
Table 3.45: Swedish POCT Diagnostics Products Market Sales, 2005-2012 56
Table 3.46: Finnish Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 56
Table 3.47: Finnish POCT Diagnostics Products Market Sales, 2005-2012 57
Table 3.48: Norwegian Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 57
Table 3.49: Norwegian POCT Diagnostics Products Market Sales, 2005-2012 58
Table 3.50: Swiss Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 58
Table 3.51: Swiss POCT Diagnostics Products Market Sales, 2005-2012 59
Table 3.52: Dutch Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 59
Table 3.53: Dutch POCT Diagnostics Products Market Sales, 2005-2012 60
Table 3.54: Belgian Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 60
Table 3.55: Belgian POCT Diagnostics Products Market Sales, 2005-2012 61
Table 3.56: Portuguese Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 61
Table 3.57: Portuguese POCT Diagnostics Products Market Sales, 2005-2012 62
Table 3.58: Austrian Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 62
Table 3.59: Austrian POCT Diagnostics Products Market Sales, 2005-2012 63
Table 3.60: Greek Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 63
Table 3.61: Greek POCT Diagnostics Products Market Sales, 2005-2012 64
Table 3.62: Polish Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 64
Table 3.63: Polish POCT Diagnostics Products Market Sales, 2005-2012 65
Table 3.64: Czech Clinical Laboratory Diagnostics Products Market Sales,
2004-2012 65
Table 3.65: Czech POCT Diagnostics Products Market Sales, 2005-2012 66
Table 3.66: Turkish POCT Market, 2000-2012 66
Table 3.67: Japanese POCT Market, 2000-2012 67
Table 3.68: Japanese Population and Aging Demographics Forecast, 2000-2050 67
Table 3.69: Indian IVD Market for Instruments and Reagents, 2004-2012 68
Table 3.70: Number of Automated Clinical Labs in India, 2004-2012 69
Table 3.71: Indian IVD Market, 2010 69
Table 3.72: Indian POCT Diagnostics Products Market Sales, 2000-2012 73
Table 3.73: Chinese IVD Market, 2006-2012 74
Table 3.74: Number of Automated Clinical Labs in China, 2004-2012 75
Table 3.75: Chinese IVD Market, 2010 75
Table 3.76: Chinese POCT Diagnostics Products Market Sales, 2000-2012 81
Table 3.77: Rest of the World POCT Market, 2000-2012 83
Table 3.78: Canadian POCT Market, 2000-2012 84
Table 3.79: Brazilian POCT Market, 2000-2012 84
Table 3.80: Australian POCT Market, 2000-2012 85
Table 4.1: World Market Share of Point of Care Glucose Monitoring Marketers 90
Table 4.2: Global Population of Persons with Diabetes, 1995 and 2025 91
Table 4.3: Professional Glucose Testing Market for POCT Worldwide Revenue and
Forecasts, 2001-2012 92
Table 4.4: U.S. Point of Care Glucose Testing Market, 1997-2012 92
Table 4.5: Rapid Testing U.S. Market Share for Blood Glucose Testing Segment 94
Table 4.6: HbA1c Testing Market for POCT Worldwide, 2006-2012 95
Table 4.7: Point of Care Glucose Testing Market: Market Drivers Ranked in Order
of Impact 96
Table 4.8: Point of Care Glucose Testing Market: Market Restraints Ranked in
Order of Impact 96
Table 4.9: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and
Threats of the Glucose Point of Care Market 98
Table 4.10: Critical Care Blood Gas Testing Market for POCT Worldwide, 2006-2012
99
Table 4.11: Blood Gas and Electrolyte Market for POCT in the U.S., 2001-2012 99
Table 4.12: Location Market Share of Critical Care Blood Gas Testing, 1990 and
2010 99
Table 4.13: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes
Market, 2010 101
Table 4.14: Hospital Locations of Point of Care Coagulation Testing 103
Table 4.15: Drivers for Point of Care Coagulation Testing 104
Table 4.16: Barriers for Point of Care Coagulation Testing 104
Table 4.17: Coagulation Testing Market for POCT Worldwide, 2006-2012 104
Table 4.18: Handheld Coagulation Testing Market for POCT Worldwide, 2006-2012
105
Table 4.19: Coagulation Market for POCT in the U.S., 2001-2015 106
Table 4.20: Point of Care Prothrombin Market for POCT in the U.S., 2000-2010 106
Table 4.21: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and
Threats of the Coagulation Point of Care Market 111
Table 4.22: Cardiac Marker Market for POCT in the U.S., 2001-2016 113
Table 4.23: Cardiac Marker Market for POCT Worldwide, 2001-2016 113
Table 4.24: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2010 114
Table 4.25: Cardiac Marker Market for POCT in Europe, 2008-2016 114
Table 4.26: Point of Care Cardiac Marker Testing Market: Market Drivers Ranked
in Order of Impact 115
Table 4.27: Point of Care Cardiac Marker Testing Market: Market Restraints
Ranked in Order of Impact 116
Table 4.28: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and
Threats of the Cardiac Marker Point of Care Market 117
Table 4.29: Drugs of Abuse Testing Market for POCT Worldwide, 2006-2015 122
Table 4.30: U.S. Point of Care Drugs of Abuse Testing Market, 2006-2015 122
Table 4.31: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency
Department 124
Table 4.32: Stat Urine Testing Drug Recommendations 124
Table 4.33: Device Specifications for POCT Breath Alcohol Analysis 126
Table 4.34: Global Point of Care Urine Test Strip Testing Market, 2001-2010 127
Table 4.35: Global Point of Care Urine Test Strip POCT Testing Market, 2006-2012
127
Table 4.36: U.S. Point of Care Urine Test Strip Testing Market, 2001-2011 127
Table 4.37: U.S. Point of Care Urine Test Strip Testing Market Share 128
Table 4.38: Medicare Fee Schedule for Urine Chemistry Testing, 129
Table 4.39: Pregnancy Testing Market for POCT Worldwide, 2006-2012 130
Table 4.40: U.S. Point of Care Pregnancy Testing Market, 2001-2012 130
Table 4.41: U.S. Market Share for Rapid Point of Care Pregnancy Tests 131
Table 4.42: Hemoglobin Testing Market for POCT Worldwide, 2006-2012 132
Table 4.43: Drivers of Demand for HIV Testing 136
Table 4.44: Worldwide POCT Market for HIV, 2001-2012 137
Table 4.45: U.S. POCT Market for HIV, 2001-2012 138
Table 4.46: Countries with the Highest Prevalence of HIV/AIDS 139
Table 4.47: FDA-approved Rapid HIV Antibody Screening Tests 141
Table 4.48: Cholesterol Testing Market for POCT Worldwide, 2006-2012 143
Table 4.49: Infectious Disease Testing Market for POCT Worldwide, 2006-2012 143
Table 4.50: Worldwide Point of Care Influenza Testing Market, 2002-2010 149
Table 4.51: U.S. Point of Care Influenza Testing Market, 2002-2010 150
Table 4.52: U.S. Market Share for Rapid Point of Care Influenza Tests, 2010 150
Table 4.53: Worldwide Point of Care Strep A Testing Market, 2002-2010 151
Table 4.54: U.S. Point of Care Strep A Testing Market, 2002-2010 151
Table 4.55: U.S. Market Share for Rapid Point of Care for Group A Strep Tests
151
Table 4.56: Global Market for Chlamydia Diagnostic Testing, 2000-2010 152
Table 4.57: U.S. Market for Chlamydia Diagnostic Testing, 2000-2010 152
Table 4.58: U.S. Market for MRSA Rapid Testing, 2006-2013 157
Table 4.59: Global Market for Gonorrhea Diagnostic Testing, 2000-2010 161
Table 4.60: Global Market for TB Diagnostic Testing, 2000-2010 163
Table 4.61: Point of Care Infectious Disease Testing Market: Market Drivers
Ranked in Order of Impact 166
Table 4.62: Point of Care Infectious Disease Testing Market: Market Restraints
Ranked in Order of Impact 166
Table 4.63: U.S. Anthrax Test Market 169
Table 5.1: Roche Diagnostics Glucose Testing Products 176
Table 5.2: Largest U.S. POCT Coagulation Diagnostic Testing Companies, 2010 193
Table 5.3: Actalyke XL 200
Table 5.4: Actalyke Mini 200
Table 5.5: Drug Test Sensitivity Cut-Off Levels Set by NIDA, WHO and SAMHSA for
Drugs of Abuse 209
Table 5.6: Major Competitors in the Drugs of Abuse Oral Testing Market Segment
209
Table 5.7: Major Competitors in the Drugs of Abuse Urine Testing Market Segment
209
Table 5.8: ColoCARE Fecal Occult Blood Test 222
Table 5.9: Competitive Factors Related to HIV Tests 234
Table 5.10: Largest POCT Diagnostic Companies Worldwide, 2008 235
Table 5.11: Influenza Diagnostic Rapid Tests 250
Table 5.12: Type of Hepatitis Test: Lateral Flow 257
Table 5.13: Flow-through 258
Table 5.14: Agglutination 258
Table 5.15: Immunoblot 258
Table 5.16: AmniSure 267
Table 6.1: Access Points 270
Table 6.2: Desktop Adapters—Four Computers 270
Table 6.3: Desktop Adapters—One Computer 270
Table 6.4: PCMCIA Adapters 270
Table 6.5: POCT1-Compliant Connectivity Point of Care Instruments 273
Table 6.6: POCT Clinical Outcomes in Diabetic Ketoacidosis 275
Table 6.7: POCT Clinical Outcomes in Arterial Blood Gas Measurements 276
Table 6.8: POCT in Three Hospitals—Cost Analysis with Labor Included 278
Table 6.9: POCT versus Central Lab—Cost Analysis for Glucose Testing 279
Table 6.10: CLIA Laboratories by Type of Facility 280
Table 6.11: Financial Comparison for Moderate and Waived CLIA Labs 283
Table 6.12: Top Ten CMS Survey Deficiencies for CLIA Laboratories 286
Table 7.1: Key Changes in IVD Business Structure 292
Table 7.2: Business Trends in POCT 301
Table 7.3: Key Players Bring Business Developments to Point of Care Diagnostic
Testing 301
Table 7.4: Emerging Trends in Point of Care Testing 301
Table 7.5: Future Developments in Point of Care Testing 302
Table 7.6: The Confluence of the New Technology 302
Table 7.7: Professional Continuous Glucose Monitoring (CGM) ICD-9 Codes 302
Table 7.8: Professional CGM 303
Table 8.1: Normal Glucose Values—Fasting State 308
Table 9.1: Applications for Wireless LAN Technology 318
Table 9.2: Customized Reports Must Support CAP and JCAHO Requirements 322
Table 9.3: RALS-Plus Point of Care Market Share 323
Table 9.4: Applications of RALS Connectivity with POCT Devices 323
Table 10.1: Abaxis Blood Analysis Diagnostic Tests 328
Table 10.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 329
Table 10.3: Products Marketed by Abbott in the Diagnostic Market 331
Table 11.1: Improvements in Achieving ED Operational Efficiency Using POCT 364
Table 11.2: Test Menu and TAT for ED 365
Table 11.3: Top Reasons Why Point of Care Cardiac Marker Testing is Implemented
in the ED 365
Table 11.4: Key Areas and Metrics that Hospitals Measure to Assess Efficiency of
ED 366
Table 11.5: Estimates of Patient Costs by DRG 367 |
