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Point of Care Diagnostic Testing World Markets


Description: The purpose of this report is to describe the specific market segment of the in vitro diagnostics market called point of care testing (POCT). It examines these clinical measurement devices and their reagents and supplies as utilized in hospitals, clinics and doctor’s offices. An analysis of analytes that are related to the common chemical constituents of blood, plasma or serum at the point of care of the patient is addressed. Moreover, the study defines the dollar volume of sales, both worldwide and in the U.S., and analyzes the factors that influence the size and the growth of the market segments. Also examined are the subsections of each market segment, including the research labs, hospital labs and commercial laboratories. Additionally, rapid detection of food pathogens and infectious pathogens (MRSA, herpes simplex, avian flu, West Nile virus and typhoid) are discussed.

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. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company’s market position.


Contents: 1. Overview 13
1.1 About this Report 13
1.2 Scope of the Report 14
1.3 Objectives 15
1.4 Methodology 15
1.5 Executive Summary 16

2. Overview of Diagnostic Testing Point of Care 20
2.1 POCT Testing Sites 20
2.2 POCT Market Structure 21
2.3 New Directions in Clinical IVD Testing 21

3. POC and Rapid Testing Market Analysis: Size, Background Analysis, Growth, Share and Competitors 23
3.1 Global POCT Market 28
3.2 U.S. POCT Market 30
3.3 European POCT Market 32
3.3.1 German Point of Care Diagnostic Market 38
3.3.2 U.K. POCT Diagnostic Market 41
3.3.2.1 U.K. POC Market Statistics 41
3.3.2.2 U.K. Competitive Analysis 43
3.3.2.3 U.K. Market Access 44
3.3.3 French Point of Care Diagnostic Market 44
3.3.4 Italian POC Diagnostic Market 45
3.3.5 Spanish POC Diagnostic Market 46
3.3.6 Scandinavian Point of Care Market 48
3.3.7 Swedish POCT Market 48
3.3.8 Finland POCT Market 49
3.3.9 Norway POCT Market 50
3.3.10 Swiss POCT Market 51
3.3.11 Dutch Clinical Laboratory Diagnostic Market 51
3.3.12 Belgian Clinical Laboratory Diagnostic Market 52
3.3.13 Portugal Clinical Laboratory Diagnostic Market 53
3.3.14 Austria Clinical Laboratory Diagnostic Market 54
3.3.15 Greek Clinical Laboratory Diagnostic Market 54
3.3.16 Poland Clinical Laboratory Diagnostic Market 55
3.3.17 Czech Republic Clinical Laboratory Diagnostic Market 56
3.3.18 Turkish Point of Care Market 57
3.4 Asian POCT Markets 57
3.4.1 Japanese POCT Market 57
3.4.2 Indian POCT Market 59
3.4.3 Chinese Point of Care Market 64
3.5 Rest of the World POCT Market 73
3.5.1 Canada Point of Care Market 73
3.5.2 Brazil Point of Care Market 74
3.5.3 Australia Point of Care Market 74
3.6 Overview of Asian Healthcare Market 75
3.6.1 Singapore 76
3.6.2 Malaysia 77
3.6.3 Thailand 77
3.6.4 Indonesia 78
3.6.5 Philippines 78
3.6.6 South Korea 78
3.6.7 Taiwan 79


4. POCT Individual Markets 80
4.1 Glucose Testing 80
4.2 POCT Individual Market Sectors, Size, Growth Rates and Competitors 81
4.2.1 World Market 81
4.2.2 U.S. Market 82
4.2.3 European Market 83
4.2.3 Alternate Glucose Monitoring Products 84
4.2.4 HbA1c POCT 85
4.3 Blood Gas and Electrolytes 86
4.3.1 Whole Blood Lactate 88
4.4 Rapid Coagulation Tests 88
4.4.1 World POCT Coagulation Market 90
4.4.2 U.S. Coagulation Market 90
4.4.2 European Coagulation Market 93
4.5 Rapid Cardiac Markers 94
4.5.1 U.S. Market 94
4.5.2 European Market 96
4.6 Drugs of Abuse Screening Testing 97
4.6.1 Acetaminophen 103
4.6.2 Tricyclic Antidepressants (TCAs) 104
4.6.3 Other Toxic Drugs 104
4.6.4 Drug Testing Selectivity 104
4.6.5 Methaqualone and Phencyclidine (PCP) 104
4.6.6 Tetrahydrocannabinol 104
4.6.7 Drug Panels by Toxidromes 105
4.6.8 Alcohol Testing 105
4.7 Urine Strips 106
4.8 Pregnancy Tests 108
4.9 Fecal Occult Blood 110
4.10 Hemoglobin Testing 110
4.11 Miscellaneous Rapid Tests 111
4.11.1 Estriol 111
4.11.2 Fetal Fibronectin (fFN) 112
4.11.3 H. pylori 112
4.11.4 Vaginal pH and Vaginitis 112
4.11.5 Bladder Cancer 113
4.11.6 Fetal Status 114
4.12 Human Immunodeficiency Virus (HIV) 114
4.13 Cholesterol 119
4.14 Infectious Disease 120
4.14.1 C. difficile 120
4.14.2 Giardia 121
4.14.3 Salmonella and Campylobacter 122
4.14.4 Malaria Testing 123
4.14.5 Influenza Testing 124
4.14.6 Strep Testing 125
4.14.7 Chlamydia 127
4.14.8 Mononucleosis 128
4.14.9 Rubella 128
4.14.10 Staphylococcus Aureus 128
4.14.11 Hepatitis 129
4.14.12 Gonorrhea 131
4.14.13 Tuberculosis (TB) 132
4.14.14 Herpes Simplex Virus Type-2 133
4.15 Infant Jaundice 134
4.16 Anthrax 134
4.15 Rupture of Fetal Membranes (ROM) 136
4.16 Food Pathogens 136
4.17 Typhoid 136

5. POCT: Reagents and Equipment 137
5.1 Blood Glucose Monitoring 137
5.1.1 LifeScan 138
5.1.2 Roche Accu-Chek 141
5.1.3 Siemens 141
5.1.4 Cholestech 143
5.1.5 Medisense (Abbott) 143
5.1.6 International Technidyne Corporation 144
5.1.7 HemoCue 145
5.1.8 GDS Technology 145
5.1.9 LXN Corporation 146
5.1.10 Medtronic MiniMed 146
5.1.11 Cygnus 146
5.1.12 Abaxis 148
5.1.13 Inverness Medical Technology 150
5.2 Blood Gas and Electrolytes 152
5.2.1 Optical Sensors, Inc. 152
5.2.2 Roche Corporation 152
5.2.3 TechnoMedica 152
5.2.4 Siemens 153
5.2.5 Instrumentation Laboratory 153
5.2.6 Nova Biomedical 153
5.2.7 Radiometer 153
5.2.8 Abbott (i-STAT Corporation) 154
5.2.9 Span Diagnostics 154
5.2.10 Avox Systems 154
5.2.11 Disetronic Medical Systems 156
5.2.12 Nova 156
5.2.13 ITC 156
5.2.14 Osmetech 157
5.3 Rapid Coagulation Tests 157
5.3.1 POC Coagulation Instrument Description 161
5.3.1.1 Roche Diagnostics Corp. 161
5.3.1.2 Abbott (i-STAT Corp.) 163
5.3.1.3 International Technidyne Corp. 163
5.3.1.4 Medtronic Cardiac Surgery 164
5.3.1.5 HemoSense 165
5.3.1.6 Helena Point of Care 165
5.3.1.7 Siemens 165
5.3.1.8 Beckman Coulter 166
5.3.1.9 Pharmanetics (Cardiovascular Diagnostics) 166
5.3.1.10 Sienco 168
5.3.1.11 Accumetrics 168
5.3.2 Connectivity Issues 168
5.3.3 Cost Benefits 168
5.3.4 Quality Control Issues 169
5.3.5 Certification for POC Coagulation Devices 169
5.4 Rapid Cardiac Markers 170
5.4.1 Spectral Diagnostics 170
5.4.2 Biosite Diagnostics 170
5.4.3 Roche Diagnostics 171
5.4.4 First Medical 171
5.4.5 Ani Biotech 171
5.4.6 Response Biomedical 171
5.4.7 Dade Behring 172
5.4.8 SYN-X Pharma, Inc. 172
5.4.9 Ark Therapeutics, Ltd. 173
5.4.10 Abbott (i-STAT Corp.) 173
5.4.11 LifeSign 173
5.4.12 Mitsubishi Kagaku Iatron 173
5.5 Rapid Drugs of Abuse 173
5.5.1 Biosite Diagnostics (Inverness) 175
5.5.2 Abbott Diagnostics 176
5.5.3 Roche Diagnostics 176
5.5.4 BioScan Screening Systems, Inc. 177
5.5.5 American Bio Medica Corp. 178
5.5.6 Pharmatech Corporation 181
5.5.7 Worldwide Medical 181
5.5.8 Syva Dade Behring 182
5.5.9 STC Technologies, Inc. 182
5.5.10 DynaGen, Inc. 182
5.5.11 OraSure 182
5.5.12 LifePoint 182
5.5.13 Avitar, Inc. 183
5.5.14 Cozart Biosciences 183
5.5.15 Securetec 184
5.6 Urine Strips 184
5.7 Rapid Pregnancy and Fertility Tests 185
5.8 Fecal Occult Blood 188
5.8.1 Helena Laboratories 188
5.8.2 Biomerica 188
5.8.3 Beckman Coulter 188
5.8.4 Wampole Laboratories 188
5.8.5 Worldwide Medical 188
5.8.6 Aerscher Diagnostics 189
5.8.7 Enterix 189
5.8.8 Medix Biochemica 189
5.9 Hemoglobin Testing 190
5.9.1 Wampole Laboratories 190
5.9.2 HemoCue, Inc. 190
5.9.3 Micro Diagnostics Corporation 190
5.9.4 GDS Technology 190
5.10 Miscellaneous Rapid Tests 190
5.10.1 Triage C. difficile Panel 190
5.10.2 Ketoacids 191
5.10.3 Acetaminophen 191
5.10.4 Estriol 191
5.10.5 H. pylori 192
5.10.6 Vaginal Fluid pH and Vaginitis 194
5.10.7 Prostate Specific Antigen (PSA) 194
5.10.8 Bladder Cancer 195
5.10.9 Other Rapid Cancer Tests 198
5.10.10 Fetal Status (PROM) 198
5.10.11 Osteoporosis 199
5.11 HIV 199
5.12 Cholesterol 205
5.12.1 Cholestech 205
5.12.2 Lifestream Technologies, Inc. 206
5.12.3 Actimed Laboratories 207
5.12.4 StatSite Meter 207
5.12.5 Polymer Technology Systems 207
5.12.6 International Medical Innovations Inc. (IMI) 207
5.13 Infectious Disease 208
5.13.1 C. difficile 208
5.13.2 Giardia 208
5.13.3 Dengue Fever 209
5.13.4 Malaria Testing 209
5.13.5 Rapid Influenza Testing 211
5.13.6 Streptococcus Testing 212
5.13.7 Chlamydia 213
5.13.8 Mononucleosis 214
5.13.9 Rubella 215
5.13.10 Staphylococcus Aureus 215
5.13.11 Hepatitis 216
5.13.12 E. coli O157 218
5.13.13 Gonorrhea Testing 219
5.13.14 Smallpox 219
5.13.15 SARS 219
5.13.16 Rabies 219
5.13.17 Tuberculosis 219
5.13.18 Avian Flu 219
5.13.19 West Nile Virus 220
5.13.20 Herpes Simplex Virus Type-2 220
5.14 Infant Jaundice 220
5.15 Anthrax 221
5.16 Homeland Defense 222
5.17 BSE (Mad Cow Disease) 222
5.18 Tuberculosis 222
5.19 Typhoid 223
5.20 Avian flu 223
5.21 Food Pathogens (Salmonella, Listeria, Campylobacter) 223
5.22 Ruptured Fetal Membranes (ROM) 224

6. POCT: Growth Regulators 225
6.1 Moderators of Growth 225
6.2 Personnel Acceptance 225
6.3 Key People for POCT 226
6.4 Information Management Issues 226
6.4.1 Elements of Information Management for POCT: Information Processing Capabilities 227
6.4.2 Data Mining 227
6.4.3 Middleware 228
6.4.4 Web Portals 229
6.4.5 POCT-1A Standard 229
6.5 Key Elements for POCT 229
6.6 POCT and Reimbursement 230
6.7 Effectiveness of Clinical Outcomes 232
6.8 Rapid Near-Patient Testing in Hospitals 232
6.9 Satellite Facilities 233
6.10 Regionalization of Laboratory Care 234
6.11 Requirements for POCT 235
6.12 Locations of Point of Care for Patient Care 236
6.13 Benefits of POCT 236
6.14 TAT for POCT 237
6.15 Clinical Laboratory Improvement Amendments (CLIA) 237
6.16 Sexually-Transmitted Diseases in Underdeveloped Countries 239

7. Business Trends in the Point of Care Sector 240
7.1 Sector Consolidation 240
7.2 Diagnostic Testing Growth Trends 241
7.3 Acquisition, License Agreements, Internal Development and Partnerships 241
7.4 Product Testing Depth in POCT 244
7.5 Government Regulation 245
7.5.1 U.S. Regulation 245
7.5.1.1 Importing Medical Devices into the U.S. 246
7.5.1.2 Exporting Medical Devices from the U.S. 247
7.5.2 U.K. Regulation 247
7.5.3 E.U. Regulation 248
7.5.3.1 French Regulation 250
7.5.4 Japanese Regulation 250
7.5.5 Korean Regulation 251
7.6 Increased Market Penetration 251
7.7 Costs of Doing Business in Europe 252
7.8 Drivers of European Diagnostics Testing 252
7.9 European Reimbursement Practices 252
7.10 Cost Containment in Europe 253

8. Technology Platform Innovations in POCT 254
8.1 Sensor Systems for Diagnostic Applications 254
8.2 Glucose Measurements 256
8.3 Glucose Test Methods 259
8.4 Cholesterol Testing 260
8.5 The New Paradigm 260
8.6 Consolidated Workstations and Modularity 261
8.7 Automation and Robotics in the Clinical Laboratory 261
8.8 Laboratory Information Systems (LIS) 261
8.8.1 NOVIUS Lab 262
8.9 Biosensor Technology 262

9. Data Management and Connectivity 265
9.1 Wireless LANs 265
9.2 Connectivity Platforms 268
9.2.1 DataLink Data Management System 268
9.2.2 RALS-Plus 269
9.2.3 LabPortal.com 271
9.2.4 BD.id 271
9.3 Advantages of POCT Connectivity 272
9.3.1 Cost Benefit of POCT and IT Connectivity 272

10. Corporate Profiles 274
10.1 Abaxis, Inc. 274
10.2 Abbott Diagnostics 276
10.3 Accumetrics, Inc. 279
10.4 Accurex Biomedical, Pvt., Ltd. 280
10.5 Adeza Biomedical Corporation 280
10.6 Akers Biosciences 280
10.7 Ambri, Ltd. 280
10.8 American Biogenetic Sciences, Inc. 281
10.9 American Bio Medica Corp. 281
10.10 Ani Biotech 282
10.11 Apogent Technologies 283
10.12 Ark Therapeutics 283
10.13 ARKRAY 283
10.14 Atlas Genetics 284
10.15 Atonomics 284
10.16 Avitar, Inc. 284
10.17 Avox Systems 284
10.18 Axis-Shield 285
10.19 Siemens Corporation 285
10.20 Beckman Coulter 286
10.21 Binax Corporation 290
10.22 Biomerica 290
10.23 BioMérieux Vitek, Inc. 291
10.24 BioScan Screening Systems, Inc. 291
10.25 Biosite Diagnostics 291
10.26 BioStar 291
10.27 British Biocell Holdings 291
10.28 Caliper Life Sciences 292
10.29 Calypte Biomedical 293
10.30 Cardiovascular Diagnostics 294
10.31 Chembio Diagnostics 294
10.32 ChemTrak 294
10.33 Cholestech 294
10.34 Chongqing Sungene Pharmaceutical Co., Ltd. 294
10.35 CompuCyte Corporation 294
10.36 Cortech Diagnostics Ltd. (now called Kent International Holdings) 295
10.37 Cozart Biosciences 295
10.38 Cygnus Therapeutic Systems 295
10.39 Cytogen 295
10.40 Dade Behring 296
10.41 Daiichi Co., Ltd. 296
10.42 Denka Seiken Co., Ltd. 296
10.43 Diagnostic Chemicals, Ltd. 296
10.44 Enterix, Inc. 297
10.45 First Medical, Inc. 297
10.46 Focus Diagnostics, Inc. 297
10.47 GDS Technology 297
10.48 GenBio 297
10.49 Genzyme Diagnostics 297
10.50 Grant Life Sciences 299
10.51 Gryphus Diagnostics 300
10.52 Helena Laboratories 300
10.53 Hema Diagnostic Systems 300
10.54 Hemocue, Inc. 301
10.55 Home Access Health Corp. 301
10.56 i-STAT Corporation 301
10.57 Instrumentation Laboratory 301
10.58 International Medical Innovations 302
10.59 Inverness Medical Innovations 302
10.60 Immunoscience, Inc. 306
10.61 Johnson & Johnson 307
10.62 Kyowa Medex Co., Ltd. 309
10.63 LifeAssays 309
10.64 LifePoint, Inc. 309
10.65 LifeScan Corporation 309
10.66 Lifestream Technologies 309
10.67 LXN Corp. (Inverness Medical Technologies) 309
10.68 Matritech 309
10.69 Medical Services International, Inc. 310
10.70 MediSense 311
10.71 Medisys 311
10.72 Medix Biochemica 311
10.73 MedMira Laboratories 311
10.74 Meretek Corporation 312
10.75 Meridian Bioscience 312
10.76 MiniMed 314
10.77 Mitsubishi Chemical USA, Inc. 315
10.78 Mitsubishi Kagaku Iatron 315
10.79 Nanogen 316
10.80 New Horizons Diagnostics 318
10.81 Nova Biomedical 318
10.82 Väsamed, Inc. 320
10.83 OraSure 321
10.84 Orgenics 324
10.85 Orion Diagnostica 324
10.86 PanBio, Ltd. 324
10.87 PharmaNetics, Inc. 325
10.88 Phamatech, Inc. 325
10.89 Royal Philips Electronics 325
10.90 Polymedco 326
10.91 Polymer Technology Systems 327
10.92 Princeton BioMeditech Corporation 327
10.93 Quest Diagnostics 327
10.94 Quidel 328
10.95 Radiometer 332
10.96 Response Biomedical Corp. 334
10.97 Roche Diagnostics 335
10.98 StatSure Diagnostic Systems 337
10.99 Savyon Diagnostics 338
10.100 Selfcare, Inc. 339
10.101 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech) 339
10.102 Shionogi & Co., Ltd. 339
10.103 SpectRx, Inc. 339
10.104 Spectral Diagnostics 340
10.105 STC Technologies 340
10.106 Strategic Diagnostics 340
10.107 Sun Biomedical Laboratories 340
10.108 Sybron International Corporation 341
10.109 TCPI 341
10.110 Therasense, Inc. 341
10.111 Thermo Biostar 341
10.112 Thoratec/International Technidyne Corp. 341
10.113 Transmedica 342
10.114 Trinity Biotech 343
10.115 Venkateshwara Hatcheries Pvt., Ltd. 345
10.116 Wampole Laboratories 345
10.117 Worldwide Medical Corporation 345

11. POCT Sector Trends and Forecasts 346
11.1 Home Care Analysis as Part of Near-Patient Testing 346
11.2 Non-Traditional Collection for POCT 346
11.3 New Systems for Critical Care and Near-Patient Testing 346
11.4 Utility of Near-Patient Testing in Critical Care Settings 346
11.5 Physician's Office Market 347
11.6 Information Management Advances 347
11.7 Test-Ordering Patterns and Demand for POCT 347
11.8 Demand for Emergency Department Services 348
11.9 Move Away From Central Laboratory 349
11.10 Healthcare Cost Controls 350
11.11 M&A in POCT 350
11.12 Competition for Services 350
11.13 Drivers of POCT 351
11.14 Confluence of New Technology 351
11.15 Difficulties of Design for POC Products 351
11.16 European Hospital Structure 352
11.17 The Biggest New Opportunities in Point of Care Testing 352

12. Corporate Directory 353

List of Figures

Figure 3.1: Worldwide Distribution of IVD Testing in 2006 26
Figure 3.2: Global Point of Care Revenues, 1998 - 2008 29
Figure 3.3: Global Point of Care Testing Share of Total In Vitro Diagnostic Testing Market 30
Figure 4.1 Number of HbA1c Tests Performed Globally as POCT (in Millions) 85
Figure 6.1: Annual Rate of Emergency Room Visits By Primary Expected Source of Payment: U.S., 2004 232

List of Tables

Table 2.1: POC Testing 21
Table 3.1: Number of ER Visits in U.S. Hospitals, 1997-2004 23
Table 3.2: Number of Point of Care Tests in U.S., 2000-2012 24
Table 3.3: Global Clinical Laboratory Market Sales, 1998-2010 25
Table 3.4: The Overall In Vitro Diagnostic Testing Market Worldwide in 2006 26
Table 3.5: Worldwide Distribution of IVD Testing in 2006 26
Table 3.6: Top Twelve Country IVD Testing Markets, 2005 27
Table 3.7: Fifteen Largest Diagnostic Companies Worldwide, 2005 27
Table 3.8: Global Point of Care Revenues, 2000-2012 28
Table 3.9: Worldwide POCT Market Size by Geographic Location, 2000 - 2012 29
Table 3.10: Worldwide Distribution of POCT, 2007 29
Table 3.11: Worldwide POCT by Performance Location, 2007 30
Table 3.12: Worldwide Clinical Diagnostic POCT and Rapid Test Market Segments, 2007 30
Table 3.13: U.S. Clinical Laboratory Testing Market, 2003-2012 31
Table 3.14: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, 2006 31
Table 3.15: U.S. POCT Market, 2000-2012 31
Table 3.16: U.S. POCT by Performance Location, 2007 32
Table 3.17: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2005 32
Table 3.18: European Clinical Laboratory Testing IVD Reagents and Instruments Market ($), 2000-2012 33
Table 3.19: European Clinical Laboratory Testing IVD Reagents and Instruments Market (€), 2000-2012 33
Table 3.20: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2006 34
Table 3.21: European Rapid Point of Care Testing by Country Market Estimates, 2006 34
Table 3.22: Regional Comparison of Healthcare Spending for IVD for Eastern Europe 37
Table 3.23: European POCT Market, 2000-2012 38
Table 3.24: Top Twelve Country IVD and POC Testing Markets, 2005 38
Table 3.25: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012 39
Table 3.26: German POCT Diagnostics Products Market Sales, 2003-2012 39
Table 3.27: German Clinical Diagnostic Rapid Test Market Segments, 2006 40
Table 3.28: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 41
Table 3.29: U.K. POCT Diagnostics Products Market Sales, 2006-2012 42
Table 3.30: U.K. Clinical Diagnostic Rapid Test Market Segments, 2006 42
Table 3.31: Major U.K. IVD Manufacturers 43
Table 3.32: U.S. IVD Manufacturers Doing Business in the U.K. 43
Table 3.33: Other European Companies that Manufacture IVD Products in the U.K. 43
Table 3.34: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2012 44
Table 3.35: French POC Diagnostics Products Market Sales, 2005-2012 45
Table 3.36: French Clinical Diagnostic Rapid Test Market Segments, 2006 45
Table 3.37: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 46
Table 3.38: Italian POC Diagnostics Products Market Sales, 2005-2012 46
Table 3.39: Italian Clinical Diagnostic Rapid Test Market Segments, 2006 46
Table 3.40: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 47
Table 3.41: Spanish Clinical Diagnostic Rapid Test Market Segments, 2006 47
Table 3.42: Spanish POC Diagnostics Products Market Sales, 2005-2012 48
Table 3.43: Scandinavian POCT Diagnostics Products Market Sales, 2000-2012 48
Table 3.44: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 49
Table 3.45: Swedish POC Diagnostics Products Market Sales, 2005-2012 49
Table 3.46: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 49
Table 3.47: Finnish POC Diagnostics Products Market Sales, 2005-2012 50
Table 3.48: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 50
Table 3.49: Norwegian POC Diagnostics Products Market Sales, 2005-2012 50
Table 3.50: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 51
Table 3.51: Swiss POCT Diagnostics Products Market Sales, 2005-2012 51
Table 3.52: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 52
Table 3.53: Dutch POC Diagnostics Products Market Sales, 2005-2012 52
Table 3.54: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 52
Table 3.55: Belgium POCT Diagnostics Products Market Sales, 2005-2012 53
Table 3.56: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 53
Table 3.57: Portuguese POCT Diagnostics Products Market Sales, 2005-2012 53
Table 3.58: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 54
Table 3.59: Austrian POCT Diagnostics Products Market Sales, 2005-2012 54
Table 3.60: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 55
Table 3.61: Greek POCT Diagnostics Products Market Sales, 2005-2012 55
Table 3.62: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 55
Table 3.63: Polish POCT Diagnostics Products Market Sales, 2005-2012 56
Table 3.64: Czech Clinical Laboratory Diagnostics Products Market Sales, 2004-2012 56
Table 3.65: Czech POCT Diagnostics Products Market Sales, 2005-2012 56
Table 3.66: Turkish POCT Market, 2000-2012 57
Table 3.67: Japan Point of Care Testing Market, 2000-2012 58
Table 3.68: Japanese Population and Aging Demographics Forecast, 2000-2050 58
Table 3.69: Indian IVD Market for Instruments and Reagents, 2004-2012 59
Table 3.70: Number of Automated Clinical Labs in India, 2004-2012 59
Table 3.71: Indian IVD Market, 2006 60
Table 3.72: Indian Point of Care Diagnostics Products Market Sales, 2000-2008 64
Table 3.73: Chinese IVD Market, 2006-2012 64
Table 3.74: Number of Automated Clinical Labs in China, 2004-2012 65
Table 3.75: Chinese IVD Market, 2006 66
Table 3.76: Chinese Point of Care Diagnostics Products Market Sales, 2000-2012 71
Table 3.77: The Rest of the World POCT Market, 2000-2012 73
Table 3.78: Canadian POCT Market, 2000-2012 74
Table 3.79: Brazilian POCT Market, 2000-2012 74
Table 3.80: Australian POCT Market, 2000-2012 75
Table 4.1: World Market Share of Point of Care Glucose Monitoring Marketers 80
Table 4.2: The Global Population of Persons with Diabetes, 1995 and 2025 81
Table 4.3: The Glucose Testing Market for POCT Worldwide, 2001-2012 81
Table 4.4: U.S. Point of Care Glucose Testing Market, 1997-2012 82
Table 4.5: Manufacturer Market Share U.S. POCT Market, 2007 82
Table 4.6: Rapid Testing U.S. Market Share for Blood Glucose Testing Segment 83
Table 4.7: The HbA1c Testing Market for POCT Worldwide, 2006-2012 86
Table 4.8: The Critical Care Blood Gas Testing Market for POCT Worldwide, 2006-2012 86
Table 4.9: The Blood Gas and Electrolyte Market for POCT in the U.S., 2001-2012 87
Table 4.10: Location Market Share of Critical Care Blood Gas Testing 87
Table 4.11: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2005 88
Table 4.12: The Coagulation Testing Market for POCT Worldwide, 2006-2012 90
Table 4.13: The Hand-held Coagulation Testing Market for POCT Worldwide, 2006-2012 90
Table 4.14: The Coagulation Market for POCT in the U.S., 2001-2012 91
Table 4.15: The POC Prothrombin Market for POCT in the U.S., 2000-2007 91
Table 4.16: The Cardiac Marker Market for POCT in the U.S., 2001-2012 95
Table 4.17: The Cardiac Marker Market for POCT Worldwide, 2001-2012 95
Table 4.18: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2005 95
Table 4.19: The Cardiac Marker Market for POCT in Europe, 2001-2011 96
Table 4.20: Drugs of Abuse Testing Market for POCT Worldwide, 2006-2012 101
Table 4.21: U.S. Point of Care Drugs of Abuse Testing Market, 2006-2012 101
Table 4.22: Drug Testing Needs Tier 1 for Rapid Serum Point of Care Testing in the Emergency Department 103
Table 4.23: Stat Urine Testing Drug Recommendations 103
Table 4.24: Device Specifications for POC Breath Alcohol Analysis 105
Table 4.25: Global Point of Care Urine Test Strip Testing Market, 2001-2007 106
Table 4.26: Global Point of Care Urine Test Strip POCT Testing Market, 2006-2012 106
Table 4.27: U.S. Point of Care Urine Test Strip Testing Market, 2001-2011 106
Table 4.28: U.S. Point of Care Urine Test Strip Testing Market Share 107
Table 4.29: Medicare Fee Schedule for Urine Chemistry Testing 108
Table 4.30: Pregnancy Testing Market for POCT Worldwide, 2006-2012 108
Table 4.31: U.S. Point of Care Pregnancy Testing Market, 2001-2012 109
Table 4.32: International Point of Care Pregnancy Testing Markets, 2001-2007 109
Table 4.33: U.S. Market Share for Rapid Point of Care Pregnancy Tests 109
Table 4.34: Hemoglobin Testing Market for POCT Worldwide, 2006-2012 110
Table 4.35: Worldwide POCT Market for HIV, 2001-2012 115
Table 4.36: U.S. POCT Market for HIV, 2001-2012 115
Table 4.37: Countries with the Highest Prevalence of HIV/AIDS 117
Table 4.38: FDA-Approved Rapid HIV Antibody Screening Tests 118
Table 4.39: OraSure OraQuick Rapid HIV Test Revenues, 2005 119
Table 4.40: The Cholesterol Testing Market for POCT Worldwide, 2006-2012 120
Table 4.41: The Infectious Disease Testing Market for POCT Worldwide, 2006-2012 120
Table 4.42: Salmonella Testing Market, 2002-2007 122
Table 4.43: Worldwide Point of Care Influenza Testing Market, 2002-2007 124
Table 4.44: U.S. Point of Care Influenza Testing Market, 2002-2007 125
Table 4.45: International Point of Care Influenza Testing Markets, 2002-2007 125
Table 4.46: U.S. Market for Rapid Point of Care Influenza Tests, 2005 125
Table 4.47: Worldwide Point of Care Strep A Testing Market, 2002-2007 126
Table 4.48: U.S. Point of Care Strep A Testing Market, 2002-2007 126
Table 4.49: International Point of Care Strep A Testing Markets, 2002-2007 126
Table 4.50: U.S. Market for Rapid Point of Care for Group A Strep Tests 126
Table 4.51: Global Market for Chlamydia Diagnostic Testing, 2000-2009 127
Table 4.52: U.S. Market for Chlamydia Diagnostic Testing, 2000-2009 127
Table 4.53: Global Market for Gonorrhea Diagnostic Testing, 2000-2009 132
Table 4.54: Global Market for TB Diagnostic Testing, 2000-2008 133
Table 4.55: U.S. Anthrax Test Market 135
Table 5.1: Drug Test Sensitivity Cut-Off Levels Established as Standard by NIDA, WHO and SAMHSA for Drugs of Abuse 174
Table 5.2: Major Competitors in the Drugs of Abuse Testing Market Segment 174
Table 5.3: Major Competitors in the Drugs of Abuse Oral Testing Market Segment 174
Table 5.4: Major Competitors in the Drugs of Abuse Urine Testing Market Segment 175
Table 5.5: Major Competitors in the Drugs of Abuse Saliva Testing Market Segment 175
Table 5.6 Siemens Urinalysis Near-patient Devices 185
Table 5.7: ColoCARE Fecal Occult Blood Test 188
Table 5.8: Type of Hepatitis Test: Lateral Flow 217
Table 5.9: Flow-Through 218
Table 5.10: Agglutination 218
Table 5.11: Immunoblot 218
Table 5.12: AmniSure 224
Table 6.1: Access Points 226
Table 6.2: Desktop Adapters-One Computer 226
Table 6.3: Desktop Adapters-Four Computers 227
Table 6.4: PCMCIA Adapters 227
Table 6.5: POCT1-Compliant Connectivity Point of Care Instruments 229
Table 6.6: POCT Clinical Outcomes in Diabetic Ketoacidosis 232
Table 6.7: POCT Clinical Outcomes in Arterial Blood Gas Measurements 232
Table 6.8: POCT in Three Hospitals. Cost Analysis with Labor Included 235
Table 6.9: Cost Analysis for Glucose Testing: POCT vs. Central Lab 235
Table 6.10: Financial Comparison for Moderate and Waived CLIA Labs 238
Table 7.1 Key Changes in IVD Business Structure 244
Table 7.2 Business Trends in Point of Care Testing 253
Table 7.3 Key Players Bring Business Developments to Point of Care Diagnostic Testing 253
Table 8.1: Normal Glucose Values-Fasting State 258
Table 9.1: Applications for Wireless LAN Technology 265
Table 9.2: Wireless LAN Technology Companies 266
Table 9.3: Customized Reports Must Support CAP and JCAHO Requirements 269
Table 9.4 RALS-Plus Point of Care Market Share 270
Table 9.5: Applications of RALS Connectivity with POCT Devices 270
Table 10.1: Products Marketed by Abbott in the Diagnostic Market 278
Table 10.2: Quidel Product Sales Distribution and Sales, 2006 329
Table 11.1: Improvements in Achieving ED Operational Efficiency Using POCT 347
Table 11.2: Test Menu and TAT for ED 348
Table 11.3: Top Reasons Why POC Cardiac Marker Testing is Implemented in the ED 348
Table 11.4: Key Areas and Metrics That Hospitals Measure To Assess Efficiency of ED 349
Table 11.5: Estimates of Patient Costs by DRG 350




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