Point of Care Diagnostic Testing World Markets

1. Overview 14
1.1 About this Report 14
1.2 Scope of the Report 15
1.3 Objectives 16
1.4 Methodology 16
1.5 Executive Summary 17

2. Overview of Diagnostic Testing Point of Care 21
2.1 Point of Care Testing Sites 21
2.2 Point of Care Market Structure 22
2.3 New Directions in Clinical IVD Testing 22

3. POCT and Rapid Testing Market Analysis: Size, Background Analysis, Growth,
Share and Competitors 25
3.1 Global POCT Market 31
3.2 U.S. POCT Market 34
3.3 European POCT Market 37
3.3.1 German POCT Diagnostic Market 43
3.3.2 U.K. POCT Diagnostic Market 45
3.3.2.1 U.K. POCT Market Statistics 45
3.3.2.2 U.K. Competitive Analysis 47
3.3.2.3 U.K. Market Access 48
3.3.3 French POCT Diagnostic Market 48
3.3.4 Italian POCT Diagnostic Market 50
3.3.5 Spanish POCT Diagnostic Market 51
3.3.6 Scandinavian POCT Diagnostic Market 53
3.3.7 Swedish POCT Diagnostic Market 54
3.3.8 Finnish POCT Diagnostic Market 55
3.3.9 Norwegian POCT Diagnostic Market 56
3.3.10 Swiss POCT Diagnostic Market 57
3.3.11 Dutch POCT Diagnostic Market 58
3.3.12 Belgian POCT Diagnostic Market 59
3.3.13 Portuguese POCT Diagnostic Market 60
3.3.14 Austrian POCT Diagnostic Market 61
3.3.15 Greek POCT Diagnostic Market 62
3.3.16 Polish POCT Diagnostic Market 63
3.3.17 Czech Republic POCT Diagnostic Market 64
3.3.18 Turkish POCT Diagnostic Market 65
3.4 Asian POCT Markets 65
3.4.1 Japanese POCT Diagnostic Market 65
3.4.2 Indian POCT Diagnostic Market 67
3.4.3 Chinese POCT Diagnostic Market 72
3.5 Rest of the World POCT Market 82
3.5.1 Canadian POCT Diagnostic Market 82
3.5.2 Brazilian POCT Diagnostic Market 83
3.5.3 Australian POCT Diagnostic Market 83
3.6 Overview of Asian Healthcare Market 84
3.6.1 Singapore 85
3.6.2 Malaysia 86
3.6.3 Thailand 86
3.6.4 Indonesia 86
3.6.5 Philippines 87
3.6.6 South Korea 87
3.6.7 Taiwan 87

4. POCT Individual Markets 88
4.1 Glucose Testing 88
4.2 POCT Individual Market Sectors, Size, Growth Rates and Competitors 89
4.2.1 World Market 89
4.2.2 U.S. Market 90
4.2.3 European Market 91
4.2.4 Alternate Glucose Monitoring Products 92
4.2.5 HbA1c POCT 93
4.3 Blood Gas and Electrolytes 94
4.3.1 Whole Blood Lactate 96
4.4 Rapid Coagulation Tests 96
4.4.1 World POCT Coagulation Market 99
4.4.2 U.S. Coagulation Market 99
4.4.3 European Coagulation Market 103
4.4.4 Trends in POCT Coagulation Testing 103
4.4.4.1 Self-testing Coagulation Market 103
4.5 Rapid Cardiac Markers 104
4.5.1 U.S. Market 104
4.5.2 European Market 106
4.6 Drugs of Abuse Screening Testing 107
4.6.1 Acetaminophen 115
4.6.2 Tricyclic Antidepressants (TCAs) 115
4.6.3 Other Toxic Drugs 115
4.6.4 Drug Testing Selectivity 115
4.6.5 Methaqualone and Phencyclidine (PCP) 116
4.6.6 Tetrahydrocannabinol 116
4.6.7 Drug Panels by Toxidromes 116
4.6.8 Alcohol Testing 116
4.7 Urine Strips 117
4.8 Pregnancy Tests 120
4.9 Fecal Occult Blood 122
4.10 Hemoglobin Testing 122
4.11 Miscellaneous Rapid Tests 123
4.11.1 Estriol 123
4.11.2 Fetal Fibronectin (fFN) 124
4.11.3 H. pylori 124
4.11.4 Vaginal pH and Vaginitis 124
4.11.5 Bladder Cancer 125
4.11.6 Fetal Status 126
4.11.7 Heparin-induced Thrombocytopenia 127
4.12 Human Immunodeficiency Virus (HIV) 127
4.13 Cholesterol 133
4.14 Infectious Disease 134
4.14.1 Clostridium difficile 135
4.14.2 Giardia 135
4.14.3 Salmonella and Campylobacter 136
4.14.4 Malaria Testing 137
4.14.5 Influenza Testing 138
4.14.6 Strep Testing 139
4.14.7 Chlamydia 141
4.14.8 Mononucleosis 142
4.14.9 Rubella 142
4.14.10 Methicillin-resistant Staphylococcus aureus (MRSA) 142
4.14.11 Hepatitis 149
4.14.12 Gonorrhea 151
4.14.13 Tuberculosis (TB) 151
4.14.14 Herpes Simplex Virus Type-2 153
4.14.15 Legionella 153
4.15 Infant Jaundice 153
4.16 Anthrax 153
4.17 Rupture of Fetal Membranes (ROM) 155
4.18 Food Pathogens 156
4.19 Typhoid 156

5. POCT: Reagents and Equipment 157
5.1 Blood Glucose Monitoring 157
5.1.1 LifeScan 158
5.1.2 Roche Accu-Chek 161
5.1.3 Siemens Healthcare Diagnostics 162
5.1.4 Cholestech (Acquired by Inverness Medical Innovations, now named Alere)
164
5.1.5 Abbott Diabetes Care 164
5.1.6 International Technidyne Corporation 165
5.1.7 HemoCue 166
5.1.8 Stanbio/GDS Technology 166
5.1.9 Disetronic Medical Systems 167
5.1.10 Medtronic MiniMed 167
5.1.11 Abaxis, Inc. 168
5.1.12 Arkray 170
5.1.13 Nova Bio 170
5.1.14 Accurex (India) 170
5.1.15 Axis-Shield 170
5.1.16 Home Diagnostics, Inc. 170
5.1.17 Medisys/Hypoguard 170
5.1.18 Diametrics Medical 171
5.1.19 Metrika 171
5.1.20 Nova Biomedical 171
5.1.21 DexCom, Inc. 171
5.1.22 Bayer 172
5.1.23 Biosite 172
5.2 Blood Gas and Electrolytes 172
5.2.1 Roche Corporation 172
5.2.2 TechnoMedica 173
5.2.3 Siemens Healthcare Diagnostics 173
5.2.4 Instrumentation Laboratory 173
5.2.5 Nova Biomedical 174
5.2.6 Radiometer 174
5.2.7 Abbott Laboratories 174
5.2.8 Span Diagnostics 175
5.2.9 Avox Systems 175
5.2.10 ITC 176
5.2.11 OPTImedical 177
5.3 Rapid Coagulation Tests 177
5.3.1 POC Coagulation Instrument Description 181
5.3.1.1 Roche Diagnostics Corp. 182
5.3.1.2 Abbott Laboratories 184
5.3.1.3 International Technidyne Corporation 184
5.3.1.4 Medtronic 186
5.3.1.5 HemoSense (Inverness) 186
5.3.1.6 Helena Laboratories Point of Care 186
5.3.1.7 Sienco, Inc. 187
5.3.1.8 Accumetrics 188
5.3.2 Connectivity Issues 188
5.3.3 Cost Benefits 189
5.3.4 Quality Control Issues 189
5.3.5 Certification for Point of Care Coagulation Devices 190
5.4 Rapid Cardiac Markers 190
5.4.1 Biosite Diagnostics (Inverness, now called Alere) 190
5.4.2 Roche Diagnostics 191
5.4.3 Ani Biotech 192
5.4.4 Response Biomedical Corporation 192
5.4.5 Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics,
Diagnostic Products Corporation, and Dade Behring) 193
5.4.6 Lab21 Ltd. 194
5.4.7 Abbott Laboratories 194
5.4.8 LifeSign (Princeton BioMediTech Corp.) 194
5.4.9 Mitsubishi Kagaku Iatron 194
5.4.10 Alpha Scientific 194
5.5 Rapid Drugs of Abuse 195
5.5.1 Biosite Diagnostics (Inverness, now called Alere) 196
5.5.2 Abbott Diagnostics 197
5.5.3 Roche Diagnostics 197
5.5.4 BioScan Screening Systems, Inc. 198
5.5.5 American Bio Medica Corp. 198
5.5.6 Phamatech, Inc. 202
5.5.7 First Check Medical 202
5.5.8 OraSure 202
5.5.9 Avitar, Inc. 203
5.5.10 Concateno 203
5.5.11 Pathtech 204
5.5.12 Alfa Scientific Designs, Inc. 204
5.5.13 TCPI, Inc. 205
5.5.14 Roche 205
5.5.15 Biophor Diagnostics 205
5.6 Rapid Pregnancy and Fertility Tests 205
5.7 Fecal Occult Blood 207
5.7.1 Helena Laboratories 208
5.7.2 Biomerica 208
5.7.3 Beckman Coulter 208
5.7.4 Worldwide Medical 208
5.7.5 Aerscher Diagnostics 209
5.7.6 Enterix 209
5.7.7 Medix Biochemica 209
5.7.8 Orion Diagnostica 209
5.8 Hemoglobin Testing 210
5.8.1 Wampole Laboratories 210
5.8.2 HemoCue, Inc. 210
5.8.3 Stanbio/GDS Technology 210
5.9 Miscellaneous Rapid Tests 210
5.9.1 Triage C. difficile Panel 210
5.9.2 Ketoacids 210
5.9.3 Acetaminophen 211
5.9.4 Estriol 211
5.9.5 H. pylori 211
5.9.6 Vaginal Fluid pH and Vaginitis 213
5.9.7 Prostate-specific Antigen (PSA) 214
5.9.8 Bladder Cancer 214
5.9.9 Other Rapid Cancer Tests 218
5.9.10 Fetal Status (PROM) 218
5.9.11 Osteoporosis 219
5.9.12 Hemodynamic Monitoring 219
5.9.13 Heparin-induced Thrombocytopenia 219
5.10 HIV 219
5.10.1 Whole Blood, Serum or Plasma-based HIV Tests 221
5.10.1.1 Bio-Rad Laboratories 222
5.10.1.2 Orgenics (Inverness, now called Alere) 222
5.10.1.3 StatSure Diagnostic Systems 222
5.10.1.4 Trinity Biotech 222
5.10.1.5 Savyon Diagnostics 223
5.10.1.6 MedPharm 223
5.10.1.7 American Bio Medica Corp. 223
5.10.1.8 Chembio Diagnostics 223
5.10.1.9 OraSure Technologies 223
5.10.1.10 Inverness (Alere) 225
5.10.2 Saliva-based HIV Tests 225
5.10.2.1 OraSure Collection Device 226
5.10.2.2 SureStat 226
5.10.3 Urine-based HIV Tests 226
5.10.3.1 MedMira Laboratories, Inc. 227
5.10.3.2 Medical Services International, Inc. 227
5.10.3.3 Maxim Biomedical 228
5.10.3.4 Wampole Laboratories 228
5.11 Cholesterol 228
5.11.1 Cholestech (now a brand of Inverness Medical Innovations) 228
5.11.2 Actimed Laboratories 229
5.11.3 StatSite Meter 230
5.11.4 Polymer Technology Systems 230
5.11.5 PreMD, Inc. (f/k/a International Medical Innovations, Inc. [IMI]) 230
5.11.6 Abaxis, Inc. 230
5.12 Infectious Disease 231
5.12.1 C. difficile 231
5.12.2 Giardia 232
5.12.3 Dengue Fever 232
5.12.4 Malaria Testing 232
5.12.5 Rapid Influenza Testing 234
5.12.6 Streptococcus Testing 235
5.12.7 Chlamydia 237
5.12.8 Mononucleosis 237
5.12.9 Rubella 238
5.12.10 Staphylococcus aureus and MRSA 239
5.12.11 Hepatitis 239
5.12.12 E. Coli O157 241
5.12.13 Gonorrhea Testing 242
5.12.14 Smallpox 242
5.12.15 SARS 242
5.12.16 Rabies 242
5.12.17 Tuberculosis 242
5.12.18 Avian Flu 243
5.12.19 West Nile Virus 243
5.12.20 Herpes Simplex Virus Type-2 243
5.12.21 Legionella 243
5.13 Infant Jaundice 243
5.14 Anthrax 244
5.15 Homeland Defense (Plague and Tularemia) 246
5.16 BSE (Mad Cow Disease) 246
5.17 Tuberculosis 246
5.18 Typhoid 246
5.19 Avian Flu 247
5.20 Food Pathogens (Salmonella, Listeria, Campylobacter) 247
5.21 Ruptured Fetal Membranes (ROM) 248

6. POCT: Growth Regulators 249
6.1 Moderators of Growth 249
6.2 Personnel Acceptance 249
6.3 Key People for POCT 250
6.4 Information Management Issues 250
6.4.1 Elements of Information Management for POCT: Information Processing
Capabilities 251
6.4.2 Data Mining 251
6.4.3 Middleware 252
6.4.4 Web Portals 253
6.4.5 POCT-1A Standard 253
6.5 Key Elements for POCT 254
6.6 POCT and Reimbursement 254
6.7 Effectiveness of Clinical Outcomes 256
6.8 Rapid Near-Patient Testing in Hospitals 257
6.9 Satellite Facilities 257
6.10 Regionalization of Laboratory Care 258
6.11 Requirements for POCT 259
6.12 Locations of Point of Care for Patient Care 260
6.13 Benefits of POCT 260
6.14 Cost Elements of POCT 260
6.15 Necessary Functions in POCT 261
6.16 TAT for POCT 261
6.17 Clinical Laboratory Improvement Amendments (CLIA) 261
6.18 Sexually-Transmitted Diseases in Underdeveloped Countries 263

7. Business Trends in the Point of Care Sector 264
7.1 Sector Consolidation 264
7.2 Diagnostic Testing Growth Trends 265
7.3 Acquisition, License Agreements, Internal Development and Partnerships 266
7.4 Product Testing Depth in POCT 269
7.5 Government Regulation 269
7.5.1 U.S. Regulation 269
7.5.1.1 Importing Medical Devices into the U.S. 271
7.5.1.2 Exporting Medical Devices from the U.S. 272
7.5.2 U.K. Regulation 272
7.5.3 E.U. Regulation 273
7.5.3.1 French Regulation 275
7.5.4 Japanese Regulation 275
7.5.5 Korean Regulation 276
7.6 Increased Market Penetration 276
7.7 Costs of Doing Business in Europe 277
7.8 Drivers of European Diagnostics Testing 277
7.9 European Reimbursement Practices 277
7.10 Cost Containment in Europe 278

8. Technology Platform Innovations in POCT 280
8.1 Sensor Systems for Diagnostic Applications 280
8.2 Glucose Measurements 283
8.3 Glucose Test Methods 285
8.4 Cholesterol Testing 286
8.5 The New Paradigm 286
8.6 Consolidated Workstations and Modularity 287
8.7 Automation and Robotics in the Clinical Laboratory 287
8.8 Laboratory Information Systems (LIS) 288
8.8.1 NOVIUS Lab 288
8.9 Biosensor Technology 288
8.10 Nanogen Third Generation Point of Care Analyzer 290
8.11 Quidel MChip 291

9. Data Management and Connectivity 292
9.1 Wireless LANs 292
9.2 Connectivity Platforms 294
9.2.1 DataLink Data Management System 295
9.2.2 RALS-Plus 296
9.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 297
9.2.2.2 Siemens Diagnostics Rapidpoint Coag 298
9.2.2.3 Radiometer 298
9.2.2.4 HemoCue's DM Hemoglobin 298
9.2.2.5 Roche Diagnostics 298
9.2.3 BD.id 299
9.2.4 Medical Implant Communications Service (MICS) 299
9.3 Advantages of POCT Connectivity 299
9.3.1 Cost Benefit of POCT and IT Connectivity 299
9.3.2 Hospital Network Issues 300

10. Corporate Profiles 301
10.1 Abaxis, Inc. 301
10.2 Abbott Diagnostics 304
10.3 Accumetrics, Inc. 308
10.4 Accurex Biomedical, Pvt. Ltd. 308
10.5 Akers Biosciences, Inc. 308
10.6 Alfa Scientific Design, Inc. 309
10.7 Ambri Ltd. 309
10.8 American Bio Medica Corporation 309
10.9 Ani Biotech Oy Ltd. 311
10.10 Apogent Technologies 311
10.11 Ark Therapeutics 311
10.12 Arkray, Inc. 312
10.13 Atlas Genetics 312
10.14 Atonomics 312
10.15 Avitar, Inc. 312
10.16 Augurix Diagnostics Ltd. 313
10.17 Axis-Shield 313
10.18 Beckman Coulter, Inc. 313
10.19 Binax Corporation 318
10.20 Biomerica, Inc. 318
10.21 bioMerieux Vitek, Inc. 319
10.22 BioScan Screening Systems, Inc. 319
10.23 Biosite Diagnostics 319
10.24 BioStar, Inc. 319
10.25 British Biocell Holdings 319
10.26 Caliper Life Sciences 319
10.27 Calypte Biomedical Corporation 320
10.28 Chembio Diagnostics, Inc. 321
10.29 Cholestech 322
10.30 Chongqing Sungene Pharmaceutical Co., Ltd. 322
10.31 CompuCyte Corporation 322
10.32 Cortech Diagnostics Ltd. (now Kent International Holdings) 323
10.33 Concateno 323
10.34 Cygnus Therapeutic Systems 323
10.35 Cytogen Corporation 323
10.36 DexCom, Inc. 324
10.37 Daiichi Sankyo Group 324
10.38 Denka Seiken Co., Ltd. 325
10.39 Diagnostic Chemicals Ltd. 325
10.40 Enigma Diagnostics Ltd. 325
10.41 Focus Diagnostics, Inc. 325
10.42 GDS Technology 325
10.43 GenBio 326
10.44 Genzyme Diagnostics 326
10.45 Grant Life Sciences, Inc. 328
10.46 Gryphus Diagnostics, LLC 329
10.47 Helena Laboratories 329
10.48 Hema Diagnostic Systems, LLC 329
10.49 Hemocue, Inc. 330
10.50 Home Access Health Corp. 330
10.51 ImmunoScience, Inc. 330
10.52 Instrumentation Laboratory 331
10.53 International Medical Innovations 331
10.54 Inverness Medical Innovations, Inc. (Alere) 331
10.55 Johnson & Johnson 337
10.56 Kyowa Medex Co., Ltd. 339
10.57 LifeAssays 339
10.58 LifeScan Corporation 339
10.59 Lifestream Technologies 339
10.60 LXN Corp. (Inverness Medical Technologies) 339
10.61 Matritech 339
10.62 Medical Services International, Inc. 340
10.63 MediSense, Inc. 340
10.64 Medisys 341
10.65 Medix Biochemica 341
10.66 MedMira Laboratories 341
10.67 Meretek Corporation 342
10.68 Meridian Bioscience 342
10.69 MiniMed, Inc. 344
10.70 Mitsubishi Chemical USA, Inc. 345
10.71 Mitsubishi Kagaku Iatron 345
10.72 Nanogen 346
10.73 New Horizons Diagnostics 346
10.74 Nova Biomedical 346
10.75 OraSure Technologies, Inc. 348
10.76 Orgenics 351
10.77 Orion Diagnostica 352
10.78 PanBio Ltd. 352
10.79 Phamatech, Inc. 352
10.80 Polymedco, Inc. 352
10.81 Polymer Technology Systems, Inc. 353
10.82 Princeton BioMeditech Corporation 354
10.83 Quest Diagnostics, Inc. 354
10.84 Quidel Corporation 354
10.85 Radiometer 358
10.86 Response Biomedical Corp. 360
10.87 Roche Diagnostics 361
10.88 Royal Philips Electronics 362
10.89 Savyon Diagnostics 364
10.90 Selfcare, Inc. 365
10.91 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech) 365
10.92 Shionogi & Co., Ltd. 365
10.93 Siemens Corporation 365
10.94 SpectRx, Inc. 366
10.95 Spectral Diagnostics 367
10.96 StatSure Diagnostic Systems 367
10.97 Strategic Diagnostics, Inc. 367
10.98 Sun Biomedical Laboratories, Inc. 368
10.99 Thoratec/International Technidyne Corporation 368
10.100 Transmedica International, Inc. 369
10.101 Trinity Biotech 369
10.102 Vasamed, Inc. 372
10.103 Venkateshwara Hatcheries Pvt. Ltd. 372

11. POCT Sector Trends and Forecasts 373
11.1 Home Care Analysis as Part of Near-Patient Testing 373
11.2 Non-Traditional Collection for POCT 373
11.3 New Systems for Critical Care and Near-Patient Testing 373
11.4 Utility of Near-Patient Testing in Critical Care Settings 374
11.5 Physician's Office Market 374
11.6 Information Management Advances 375
11.7 Test-Ordering Patterns and Demand for POCT 375
11.8 Demand for Emergency Department Services 375
11.9 Move Away from Central Laboratory 376
11.10 Healthcare Cost Controls 377
11.11 M&A in POCT 377
11.12 Competition for Services 378
11.13 Drivers of POCT 378
11.14 Confluence of New Technology 378
11.15 Difficulties of Design for Point of Care Products 379
11.16 European Hospital Structure 379
11.17 The Biggest New Opportunities in POCT 379

12. Corporate Directory 380


INDEX OF FIGURES

Figure 3.1: Blood Tests Ordered in Emergency Department Visits 26
Figure 3.2: Worldwide Distribution of IVD Testing, 2008 29
Figure 3.3: Global Point of Care Revenues, 2005-2012 32
Figure 3.4: Global Growth of Point of Care Testing Volume, 2000-2008 32
Figure 3.5: Global POCT Share of Total IVD Testing Market, 2007 34
Figure 4.1: Number of HbA1c Tests Performed Globally as POCT, 1991-2006 93
Figure 4.2: Total Spending on Healthcare in the U.S., 1960-2007 143
Figure 4.3: International Per Capita Healthcare Spending Per Country, 2006 144
Figure 5.1: Global POCT Share of HIV Testing Market, 2008 221
Figure 6.1: Annual Rate of Emergency Room Visits by Primary Expected Source of
Payment 256


INDEX OF TABLES

Table 2.1: Percentage of POCT Performed in Selected Hospitals 21
Table 2.2: POCT Procedural Advantages for Hospital Testing 23
Table 2.3: POCT Trends 24
Table 2.4: Professional POCT Compared to Home Testing 24
Table 2.5: Drivers for Integrating POCT into Hospital Routines 24
Table 3.1: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2008 25
Table 3.2: Number of Point of Care Tests in the U.S., 2000-2012 26
Table 3.3: Global Clinical Laboratory Market Sales, 1998-2011 28
Table 3.4: Overall IVD Testing Market Worldwide, 2007 29
Table 3.5: Worldwide Distribution of IVD Testing, 2008 29
Table 3.6: Top 12 Country IVD Testing Markets, 2007 30
Table 3.7: Top 13 Diagnostic Companies Worldwide, 2007 30
Table 3.8: Global Point of Care Revenues, 2005-2012 31
Table 3.9: Worldwide POCT Market Size by Geographic Location, 2005-2012 33
Table 3.10: Worldwide Distribution of POCT, 2008 33
Table 3.11: Worldwide Clinical Diagnostic POCT and Rapid Test Market Segments,
2007 33
Table 3.12: Worldwide POCT by Performance Location, 2008 34
Table 3.13: Largest POCT Diagnostic Companies Worldwide, 2007 34
Table 3.14: U.S. Clinical Laboratory Testing Market, 2003-2012 35
Table 3.15: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location
of Analysis, 2008 35
Table 3.16: U.S. POCT Market, 2000-2012 36
Table 3.17: U.S. POCT by Performance Location, 2008 36
Table 3.18: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007
36
Table 3.19: European Clinical Laboratory Testing IVD Reagents and Instruments
Market in Dollars, 2000-2012 37
Table 3.20: European Clinical Laboratory Testing IVD Reagents and Instruments
Market in Euros, 2000-2012 37
Table 3.21: European Clinical Laboratory Testing Diagnostics by Country Market
Estimates, 2007 38
Table 3.22: European Rapid POCT by Country Market Estimates, 2008 39
Table 3.23: Regional Comparison of Healthcare Spending for IVD for Eastern
Europe 42
Table 3.24: European POCT Market, 2005-2012 42
Table 3.25: Top 12 Country IVD and POCT Markets, 2007 42
Table 3.26: German Clinical Laboratory Testing Diagnostics Products Market
Sales, 2003-2012 43
Table 3.27: German POCT Diagnostics Products Market Sales, 2003-2012 43
Table 3.28: German Clinical Diagnostic Rapid Test Market Segments, 2007 44
Table 3.29: U.K. Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 45
Table 3.30: U.K. POCT Diagnostics Products Market Sales, 2006-2012 46
Table 3.31: U.K. Clinical Diagnostic Rapid Test Market Segments, 2007 46
Table 3.32: Major U.K. IVD Manufacturers 47
Table 3.33: U.S. IVD Manufacturers Doing Business in the U.K. 47
Table 3.34: Other European Companies that Manufacture IVD Products in the U.K.
48
Table 3.35: French Clinical IVD Testing Diagnostics Products Market Sales,
2003-2012 48
Table 3.36: French POCT Diagnostics Products Market Sales, 2005-2012 49
Table 3.37: French Clinical Diagnostic Rapid Test Market Segments, 2007 50
Table 3.38: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 50
Table 3.39: Italian POCT Diagnostics Products Market Sales, 2005-2012 51
Table 3.40: Italian Clinical Diagnostic Rapid Test Market Segments, 2007 51
Table 3.41: Spanish Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 52
Table 3.42: Spanish Clinical Diagnostic Rapid Test Market Segments, 2007 52
Table 3.43: Spanish POCT Diagnostics Products Market Sales, 2005-2012 53
Table 3.44: Scandinavian POCT Diagnostics Products Market Sales, 2000-2012 53
Table 3.45: Swedish Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 54
Table 3.46: Swedish POCT Diagnostics Products Market Sales, 2005-2012 54
Table 3.47: Finnish Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 55
Table 3.48: Finnish POCT Diagnostics Products Market Sales, 2005-2012 55
Table 3.49: Norwegian Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 56
Table 3.50: Norwegian POCT Diagnostics Products Market Sales, 2005-2012 56
Table 3.51: Swiss Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 57
Table 3.52: Swiss POCT Diagnostics Products Market Sales, 2005-2012 57
Table 3.53: Dutch Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 58
Table 3.54: Dutch POCT Diagnostics Products Market Sales, 2005-2012 58
Table 3.55: Belgian Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 59
Table 3.56: Belgian POCT Diagnostics Products Market Sales, 2005-2012 59
Table 3.57: Portuguese Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 60
Table 3.58: Portuguese POCT Diagnostics Products Market Sales, 2005-2012 60
Table 3.59: Austrian Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 61
Table 3.60: Austrian POCT Diagnostics Products Market Sales, 2005-2012 61
Table 3.61: Greek Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 62
Table 3.62: Greek POCT Diagnostics Products Market Sales, 2005-2012 62
Table 3.63: Polish Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 63
Table 3.64: Polish POCT Diagnostics Products Market Sales, 2005-2012 63
Table 3.65: Czech Clinical Laboratory Diagnostics Products Market Sales,
2004-2012 64
Table 3.66: Czech POCT Diagnostics Products Market Sales, 2005-2012 64
Table 3.67: Turkish POCT Market, 2000-2012 65
Table 3.68: Japanese POCT Market, 2000-2012 66
Table 3.69: Japanese Population and Aging Demographics Forecast, 2000-2050 66
Table 3.70: Indian IVD Market for Instruments and Reagents, 2004-2012 67
Table 3.71: Number of Automated Clinical Labs in India, 2004-2012 68
Table 3.72: Indian IVD Market, 2007 68
Table 3.73: Indian POCT Diagnostics Products Market Sales, 2000-2012 72
Table 3.74: Chinese IVD Market, 2006-2012 72
Table 3.75: Number of Automated Clinical Labs in China, 2004-2012 74
Table 3.76: Chinese IVD Market, 2007 74
Table 3.77: Chinese POCT Diagnostics Products Market Sales, 2000-2012 79
Table 3.78: Rest of the World POCT Market, 2000-2012 82
Table 3.79: Canadian POCT Market, 2000-2012 82
Table 3.80: Brazilian POCT Market, 2000-2012 83
Table 3.81: Australian POCT Market, 2000-2012 83
Table 4.1: World Market Share of Point of Care Glucose Monitoring Marketers 88
Table 4.2: Global Population of Persons with Diabetes, 1995 and 2025 89
Table 4.3: Professional Glucose Testing Market for POCT Worldwide, 2001-2012 90
Table 4.4: U.S. Point of Care Glucose Testing Market, 1997-2012 90
Table 4.5: Manufacturer Market Share U.S. POCT Market, 2008 91
Table 4.6: Rapid Testing U.S. Market Share for Blood Glucose Testing Segment 91
Table 4.7: HbA1c Testing Market for POCT Worldwide, 2006-2012 93
Table 4.8: Critical Care Blood Gas Testing Market for POCT Worldwide, 2006-2012
94
Table 4.9: Blood Gas and Electrolyte Market for POCT in the U.S., 2001-2012 94
Table 4.10: Location Market Share of Critical Care Blood Gas Testing, 1990 and
2008 95
Table 4.11: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes
Market, 2007 96
Table 4.12: Hospital Locations of Point of Care Coagulation Testing 97
Table 4.13: Drivers for Point of Care Coagulation Testing 98
Table 4.14: Barriers for Point of Care Coagulation Testing 99
Table 4.15: Coagulation Testing Market for POCT Worldwide, 2006-2012 99
Table 4.16: Handheld Coagulation Testing Market for POCT Worldwide, 2006-2012 99
Table 4.17: Coagulation Market for POCT in the U.S., 2001-2015 100
Table 4.18: Point of Care Prothrombin Market for POCT in the U.S., 2000-2009 101
Table 4.19: Cardiac Marker Market for POCT in the U.S., 2001-2015 105
Table 4.20: Cardiac Marker Market for POCT Worldwide, 2001-2015 106
Table 4.21: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2007 106
Table 4.22: Cardiac Marker Market for POCT in Europe, 2001-2011 107
Table 4.23: Drugs of Abuse Testing Market for POCT Worldwide, 2006-2015 112
Table 4.24: U.S. Point of Care Drugs of Abuse Testing Market, 2006-2015 113
Table 4.25: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency
Department 114
Table 4.26: Stat Urine Testing Drug Recommendations 114
Table 4.27: Device Specifications for POCT Breath Alcohol Analysis 117
Table 4.28: Global Point of Care Urine Test Strip Testing Market, 2001-2008 117
Table 4.29: Global Point of Care Urine Test Strip POCT Testing Market, 2006-2012
118
Table 4.30: U.S. Point of Care Urine Test Strip Testing Market, 2001-2011 118
Table 4.31: U.S. Point of Care Urine Test Strip Testing Market Share 118
Table 4.32: Medicare Fee Schedule for Urine Chemistry Testing, 2003 120
Table 4.33: Pregnancy Testing Market for POCT Worldwide, 2006-2012 121
Table 4.34: U.S. Point of Care Pregnancy Testing Market, 2001-2012 121
Table 4.35: International Point of Care Pregnancy Testing Markets, 2001-2007 121
Table 4.36: U.S. Market Share for Rapid Point of Care Pregnancy Tests 122
Table 4.37: Hemoglobin Testing Market for POCT Worldwide, 2006-2012 123
Table 4.38: Drivers of Demand for HIV Testing 127
Table 4.39: Worldwide POCT Market for HIV, 2001-2012 128
Table 4.40: U.S. POCT Market for HIV, 2001-2012 129
Table 4.41: Countries with the Highest Prevalence of HIV/AIDS 130
Table 4.42: FDA-approved Rapid HIV Antibody Screening Tests 132
Table 4.43: OraSure OraQuick Rapid HIV Test Revenues, 2008 133
Table 4.44: Cholesterol Testing Market for POCT Worldwide, 2006-2012 134
Table 4.45: Infectious Disease Testing Market for POCT Worldwide, 2006-2012 134
Table 4.46: Salmonella Testing Market, 2002-2007 136
Table 4.47: Worldwide Point of Care Influenza Testing Market, 2002-2007 138
Table 4.48: U.S. Point of Care Influenza Testing Market, 2002-2007 139
Table 4.49: International Point of Care Influenza Testing Markets, 2002-2007 139
Table 4.50: U.S. Market for Rapid Point of Care Influenza Tests, 2007 139
Table 4.51: Worldwide Point of Care Strep A Testing Market, 2002-2007 140
Table 4.52: U.S. Point of Care Strep A Testing Market, 2002-2007 140
Table 4.53: International Point of Care Strep A Testing Markets, 2002-2007 140
Table 4.54: U.S. Market for Rapid Point of Care for Group A Strep Tests 141
Table 4.55: Global Market for Chlamydia Diagnostic Testing, 2000-2009 141
Table 4.56: U.S. Market for Chlamydia Diagnostic Testing, 2000-2009 142
Table 4.57: U.S. Market for MRSA Rapid Testing, 2006-2013 148
Table 4.58: Global Market for Gonorrhea Diagnostic Testing, 2000-2009 151
Table 4.59: Global Market for TB Diagnostic Testing, 2000-2008 153
Table 4.60: U.S. Anthrax Test Market 155
Table 5.1: Largest U.S. POCT Coagulation Diagnostic Testing Companies, 2009 182
Table 5.2: Actalyke XL 187
Table 5.3: Actalyke Mini 187
Table 5.4: Drug Test Sensitivity Cut-Off Levels Set by NIDA, WHO and SAMHSA for
Drugs of Abuse 195
Table 5.5: Major Competitors in the Drugs of Abuse Oral Testing Market Segment
195
Table 5.6: Major Competitors in the Drugs of Abuse Urine Testing Market Segment
196
Table 5.7: ColoCARE Fecal Occult Blood Test 208
Table 5.8: Competitive Factors Related to HIV Tests 220
Table 5.9: Largest POCT Diagnostic Companies Worldwide, 2008 221
Table 5.10: Type of Hepatitis Test: Lateral Flow 240
Table 5.11: Flow-through 241
Table 5.12: Agglutination 241
Table 5.13: Immunoblot 241
Table 5.14: AmniSure 248
Table 6.1: Access Points 250
Table 6.2: Desktop Adapters-Four Computers 250
Table 6.3: Desktop Adapters-One Computer 251
Table 6.4: PCMCIA Adapters 251
Table 6.5: POCT1-Compliant Connectivity Point of Care Instruments 253
Table 6.6: POCT Clinical Outcomes in Diabetic Ketoacidosis 256
Table 6.7: POCT Clinical Outcomes in Arterial Blood Gas Measurements 256
Table 6.8: POCT in Three Hospitals-Cost Analysis with Labor Included 259
Table 6.9: POCT versus Central Lab-Cost Analysis for Glucose Testing 259
Table 6.10: Financial Comparison for Moderate and Waived CLIA Labs 262
Table 7.1: Key Changes in IVD Business Structure 269
Table 7.2: Business Trends in POCT 278
Table 7.3: Key Players Bring Business Developments to Point of Care Diagnostic
Testing 278
Table 7.4: Emerging Trends in Point of Care Testing 278
Table 7.5: Future Developments in Point of Care Testing 279
Table 7.6: The Confluence of the New Technology 279
Table 8.1: Normal Glucose Values-Fasting State 284
Table 9.1: Applications for Wireless LAN Technology 292
Table 9.2: Customized Reports Must Support CAP and JCAHO Requirements 295
Table 9.3: RALS-Plus Point of Care Market Share 296
Table 9.4: Applications of RALS Connectivity with POCT Devices 297
Table 10.1: Abaxis Blood Analysis Diagnostic Tests 302
Table 10.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 302
Table 10.3: Products Marketed by Abbott in the Diagnostic Market 306
Table 10.4: Inverness Brands 336
Table 10.5: Orasure's Products 351
Table 10.6: Quidel Product Sales Distribution and Sales, 2008 356
Table 11.1: Improvements in Achieving ED Operational Efficiency Using POCT 374
Table 11.2: Test Menu and TAT for ED 375
Table 11.3: Top Reasons Why Point of Care Cardiac Marker Testing is Implemented
in the ED 375
Table 11.4: Key Areas and Metrics that Hospitals Measure to Assess Efficiency of
ED 376
Table 11.5: Estimates of Patient Costs by DRG 377