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The purpose of this TriMark Publications 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 (MSRA, 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.
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Table of 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 SYNX 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
- INDEX 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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