Reportlinker Adds Point of Care Diagnostic Testing World Markets
NEW YORK, March 31, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Point of Care Diagnostic Testing World Markets
http://www.reportlinker.com/p089474/Point-of-Care-Diagnostic-Testing-World-Markets.html
Point of care testing (POCT) enables rapid diagnostic tests to be performed while the patient is at the point of care facility where results can be obtained immediately, rather than waiting hours or even days for outside lab results to arrive. Point of care testing covers: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing, rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening. This TriMark Publications report describes latest developments in the point of care testing market segment. It examines clinical instruments, devices and reagents and supplies as utilized in near-patient environments like hospital emergency rooms, critical care units, clinics and doctor's offices. The study defines the dollar volume of point of care sales and makes five year projections--both in the U.S. and worldwide--including Europe, Asia and Latin America. It also examines in detail the point of care sector for 25 individual country markets. A detailed summary of all important instruments in each clinical market is provided with emphasis on newly introduced products. Moreover, parallel areas where rapid detection is important using hand-held devices such as rapid detection of food pathogens and infectious diseases (MRSA, herpes simplex, avian flu, West Nile virus and typhoid) are discussed. Growth moderators and developing trends in point of care applications, as well as technology platform innovations and connectivity questions are examined in detail. The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the point of care market in the U.S. and worldwide. Each company is discussed in depth, with a section on its history, product lines, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market data are also included.
TABLE OF CONTENTS
1. Overview 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 49
3.3.5 Spanish POCT Diagnostic Market 51
3.3.6 Scandinavian POCT Diagnostic Market 52
3.3.7 Swedish POCT Diagnostic Market 53
3.3.8 Finnish POCT Diagnostic Market 54
3.3.9 Norwegian POCT Diagnostic Market 55
3.3.10 Swiss POCT Diagnostic Market 56
3.3.11 Dutch POCT Diagnostic Market 57
3.3.12 Belgian POCT Diagnostic Market 58
3.3.13 Portuguese POCT Diagnostic Market 59
3.3.14 Austrian POCT Diagnostic Market 60
3.3.15 Greek POCT Diagnostic Market 61
3.3.16 Polish POCT Diagnostic Market 62
3.3.17 Czech Republic POCT Diagnostic Market 63
3.3.18 Turkish POCT Diagnostic Market 64
3.4 Asian POCT Markets 64
3.4.1 Japanese POCT Diagnostic Market 64
3.4.2 Indian POCT Diagnostic Market 66
3.4.3 Chinese POCT Diagnostic Market 71
3.5 Rest of the World POCT Market 81
3.5.1 Canadian POCT Diagnostic Market 82
3.5.2 Brazilian POCT Diagnostic Market 82
3.5.3 Australian POCT Diagnostic Market 83
3.6 Overview of Asian Healthcare Market 83
3.6.1 Singapore 85
3.6.2 Malaysia 85
3.6.3 Thailand 86
3.6.4 Indonesia 86
3.6.5 Philippines 86
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 Revenue and Forecasts 89
4.2.2 Professional Glucose Testing Market for POCT U.S. Revenue and Forecasts
during
2001-2012 90
4.2.3 European Market 91
4.2.4 Market Share 91
4.2.5 Alternate Glucose Monitoring Products 92
4.2.6 HbA1c POCT 93
4.2.7 Market Challenges and Strategic Recommendations 94
4.2.7.1 Market Drivers and Restraints 94
4.2.7.1.1 Market Drivers 94
4.2.7.1.2 Market Restraints 94
4.2.7.2 Point of Care Glucose Testing Assay Market and Technology Trends 95
4.2.7.2.1 Point of Care Glucose Testing Assay Market Trends 95
4.2.7.2.2 Point of Care Glucose Testing Assay Technology Trends 95
4.2.7.2.3 Point of Care Glucose Testing Assay Strategic Recommendations 95
4.3 Blood Gas and Electrolytes 96
4.3.1 Whole Blood Lactate 99
4.4 Rapid Coagulation Tests 99
4.4.1 World POCT Coagulation Market 102
4.4.2 U.S. Coagulation Market 102
4.4.3 European Coagulation Market 106
4.4.4 Trends in POCT Coagulation Testing 106
4.4.4.1 Self-testing Coagulation Market 106
4.4.4.2 D-Dimer Testing 107
4.4.5 Point of Care Coagulation Testing Assay Market and Technology Trends 107
4.4.5.1 Point of Care Coagulation Testing Assay Market Trends 107
4.4.5.2 Point of Care Coagulation Testing Assay Technology Trends 108
4.4.5.3 Point of Care Coagulation Testing Assay Strategic Recommendations 108
4.5 Rapid Cardiac Markers 109
4.5.1 U.S. Market 109
4.5.2 European Market 111
4.5.3 Market Drivers and Restraints 113
4.5.3.1 Market Drivers 113
4.5.3.2 Market Restraints 113
4.5.4 Point of Care Cardiac Marker Testing Assay Market and Technology Trends
113
4.5.4.1 Point of Care Cardiac Marker Testing Assay Market Trends 113
4.5.4.2 Point of Care Cardiac Marker Testing Assay Technology Trends 114
4.5.4.3 Point of Care Cardiac Marker Testing Assay Strategic Recommendations 114
4.6 Drugs of Abuse Screening Testing 114
4.6.1 Acetaminophen 121
4.6.2 Tricyclic Antidepressants (TCAs) 122
4.6.3 Other Toxic Drugs 122
4.6.4 Drug Testing Selectivity 122
4.6.5 Methaqualone and Phencyclidine (PCP) 123
4.6.6 Tetrahydrocannabinol 123
4.6.7 Drug Panels by Toxidromes 123
4.6.8 Alcohol Testing 123
4.7 Urine Strips 124
4.8 Pregnancy Tests 127
4.9 Fecal Occult Blood 128
4.10 Hemoglobin Testing 129
4.11 Miscellaneous Rapid Tests 130
4.11.1 Estriol 130
4.11.2 Fetal Fibronectin (fFN) 131
4.11.3 H. pylori 131
4.11.4 Vaginal pH and Vaginitis 131
4.11.5 Bladder Cancer 132
4.11.6 Fetal Status 133
4.11.7 Heparin-induced Thrombocytopenia 133
4.12 Human Immunodeficiency Virus (HIV) 133
4.13 Cholesterol 140
4.14 Infectious Disease 141
4.14.1 Clostridium difficile 141
4.14.2 Giardia 142
4.14.3 Salmonella and Campylobacter 143
4.14.4 Malaria Testing 143
4.14.5 Influenza Testing 144
4.14.6 Strep Testing 148
4.14.7 Chlamydia 149
4.14.8 Mononucleosis 150
4.14.9 Rubella 150
4.14.10 Methicillin-resistant Staphylococcus aureus (MRSA) 151
4.14.11 Hepatitis 156
4.14.12 Gonorrhea 158
4.14.13 Tuberculosis (TB) 158
4.14.14 Herpes Simplex Virus Type-2 160
4.14.15 Legionella 160
4.14.16 RSV 161
4.14.16.1 Market Drivers and Restraints 163
4.14.16.1.1 Market Drivers 163
4.14.16.1.2 Market Restraints 163
4.14.16.2 Point of Care Infectious Disease Testing Assay Market and Technology
Trends 164
4.14.16.2.1 Point of Care Infectious Disease Testing Assay Market Trends 164
4.14.16.2.2 Point of Care Infectious Disease Testing Assay Technology Trends 164
4.14.16.2.3 Point of Care Infectious disease Testing Assay Strategic
Recommendations 164
4.15 Infant Jaundice 164
4.16 Anthrax 165
4.17 Rupture of Fetal Membranes (ROM) 167
4.18 Food Pathogens 167
4.19 Typhoid 167
5. POCT: Reagents and Equipment 168
5.1 Blood Glucose Monitoring 168
5.1.1 LifeScan 169
5.1.2 Roche Accu-Chek 172
5.1.3 Abbott Diabetes Care 174
5.1.4 HemoCue 175
5.1.5 Stanbio/GDS Technology 175
5.1.6 Abaxis, Inc. 176
5.1.7 Arkray (Japan) 176
5.1.8 Accurex (India) 177
5.1.9 Home Diagnostics, Inc. 177
5.1.10 Nova Biomedical 177
5.1.11 Bayer 177
5.1.11.1 Hemoglobin A1c Measurements 179
5.1.12 Biosite (now part of Alere) 179
5.1.13 Siemens Healthcare Diagnostics 179
5.1.14 Infopia 179
5.1.15 Diasys 179
5.1.16 Quotient Dx 180
5.1.17 Cholestech (Acquired by Inverness Medical Innovations, now named Alere)
180
5.1.18 Bio-Rad 180
5.1.19 Axis-Shield 180
5.2 Blood Gas and Electrolytes 180
5.2.1 Roche Corporation 180
5.2.2 TechnoMedica 180
5.2.3 Siemens Healthcare Diagnostics 181
5.2.4 Instrumentation Laboratory 181
5.2.5 Nova Biomedical 182
5.2.6 Radiometer 182
5.2.7 Abbott Laboratories 182
5.2.8 Span Diagnostics 183
5.2.9 Nexus Dx Avoximeter Systems for Co-oximetry 183
5.2.10 ITC (Nexus Dx) 184
5.2.11 Alere 185
5.3 Rapid Coagulation Tests 185
5.3.1 POC Coagulation Instrument Description 189
5.3.1.1 Roche Diagnostics Corp. 190
5.3.1.2 Abbott Laboratories 191
5.3.1.3 International Technidyne Corporation 192
5.3.1.4 Medtronic 193
5.3.1.5 HemoSense (Inverness) 194
5.3.1.6 Helena Laboratories Point of Care 194
5.3.1.7 Sienco, Inc. 195
5.3.1.8 Accumetrics 196
5.3.1.9 Alere 196
5.3.2 Connectivity Issues 196
5.3.3 Cost Benefits 197
5.3.4 Quality Control Issues 197
5.3.5 Certification for Point of Care Coagulation Devices 198
5.4 Rapid Cardiac Markers 198
5.4.1 Biosite Diagnostics (Inverness, now called Alere) 198
5.4.2 Roche Diagnostics 199
5.4.3 Ani Biotech 200
5.4.4 Response Biomedical Corporation 201
5.4.5 Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics,
Diagnostic Products Corporation, and Dade Behring) 202
5.4.6 Lab21 Ltd. 202
5.4.7 Abbott Laboratories 202
5.4.8 LifeSign (Princeton BioMediTech Corp.) 202
5.4.9 Mitsubishi Kagaku Iatron 202
5.4.10 Alpha Scientific 202
5.5 Rapid Drugs of Abuse 203
5.5.1 Biosite Diagnostics (Inverness, now called Alere) 204
5.5.2 Abbott Diagnostics 205
5.5.3 Roche Diagnostics 205
5.5.4 BioScan Screening Systems, Inc. 206
5.5.5 American Bio Medica Corp. 206
5.5.6 Phamatech, Inc. 210
5.5.7 First Check Medical 210
5.5.8 OraSure 211
5.5.9 Avitar, Inc. 211
5.5.10 Concateno 212
5.5.11 Pathtech 212
5.5.12 Alfa Scientific Designs, Inc. 212
5.5.13 TCPI, Inc. 213
5.5.14 Roche 213
5.5.15 Biophor Diagnostics 213
5.6 Rapid Pregnancy and Fertility Tests 213
5.7 Fecal Occult Blood 215
5.7.1 Helena Laboratories 216
5.7.2 Biomerica 216
5.7.3 Beckman Coulter 216
5.7.4 Worldwide Medical 216
5.7.5 Aerscher Diagnostics 217
5.7.6 Enterix 217
5.7.7 Medix Biochemica 217
5.7.8 Orion Diagnostica 218
5.8 Hemoglobin Testing 218
5.8.1 Wampole Laboratories 218
5.8.2 HemoCue, Inc. 218
5.8.3 Stanbio 218
5.9 Miscellaneous Rapid Tests 218
5.9.1 Triage C. difficile Panel 218
5.9.2 Ketoacids 219
5.9.3 Acetaminophen 219
5.9.4 Estriol 219
5.9.5 H. pylori 220
5.9.6 Vaginal Fluid pH and Vaginitis 222
5.9.7 Prostate-specific Antigen (PSA) 222
5.9.8 Bladder Cancer 223
5.9.9 Other Rapid Cancer Tests 226
5.9.10 Fetal Status (PROM) 227
5.9.11 Osteoporosis 227
5.9.12 Hemodynamic Monitoring 227
5.9.13 Heparin-induced Thrombocytopenia 227
5.10 HIV 228
5.10.1 Whole Blood, Serum or Plasma-based HIV Tests 230
5.10.1.1 Bio-Rad Laboratories 230
5.10.1.2 Orgenics (Inverness, now called Alere) 230
5.10.1.3 StatSure Diagnostic Systems 231
5.10.1.4 Trinity Biotech 231
5.10.1.5 Savyon Diagnostics 231
5.10.1.6 MedPharm 231
5.10.1.7 American Bio Medica Corp. 232
5.10.1.8 Chembio Diagnostics 232
5.10.1.9 OraSure Technologies 232
5.10.1.10 Inverness (Alere) 233
5.10.2 Saliva-based HIV Tests 233
5.10.2.1 OraSure Collection Device 234
5.10.2.2 SureStat 235
5.10.3 Urine-based HIV Tests 235
5.10.3.1 MedMira Laboratories, Inc. 235
5.10.3.2 Medical Services International, Inc. 236
5.10.3.3 Maxim Biomedical 236
5.10.3.4 Wampole Laboratories 237
5.11 Cholesterol 237
5.11.1 Cholestech (now a brand of Inverness Medical Innovations) 237
5.11.2 Actimed Laboratories 238
5.11.3 StatSite Meter 239
5.11.4 Polymer Technology Systems 239
5.11.5 PreMD, Inc. (f/k/a International Medical Innovations, Inc. [IMI]) 239
5.11.6 Abaxis, Inc. 239
5.12 Infectious Disease 240
5.12.1 C. difficile 240
5.12.2 Giardia 240
5.12.3 Dengue Fever 241
5.12.4 Malaria Testing 241
5.12.5 Rapid Influenza Testing 243
5.12.6 Streptococcus Testing 246
5.12.7 Chlamydia 248
5.12.8 Mononucleosis 248
5.12.9 Rubella 250
5.12.10 Staphylococcus aureus and MRSA 250
5.12.11 Hepatitis 251
5.12.12 E. Coli O157 253
5.12.13 Gonorrhea Testing 253
5.12.14 Smallpox 253
5.12.15 SARS 253
5.12.16 Rabies 254
5.12.17 Tuberculosis 254
5.12.18 Avian Flu 254
5.12.19 West Nile Virus 254
5.12.20 Herpes Simplex Virus Type-2 255
5.12.21 Legionella 255
5.12.22 RSV 255
5.13 Infant Jaundice 256
5.14 Anthrax 257
5.15 Homeland Defense (Plague and Tularemia) 259
5.16 BSE (Mad Cow Disease) 259
5.17 Tuberculosis 259
5.18 Typhoid 260
5.19 Avian Flu 260
5.20 Food Pathogens (Salmonella, Listeria, Campylobacter) 260
5.21 Ruptured Fetal Membranes (ROM) 261
6. POCT: Growth Regulators 263
6.1 Moderators of Growth 263
6.2 Personnel Acceptance 263
6.3 Key People for POCT 264
6.4 Information Management Issues 264
6.4.1 Elements of Information Management for POCT: Information Processing
Capabilities 266
6.4.2 Data Mining 266
6.4.3 Middleware 266
6.4.4 Web Portals 267
6.4.5 POCT-1A Standard 267
6.5 Key Elements for POCT 268
6.6 POCT and Reimbursement 268
6.7 Effectiveness of Clinical Outcomes 270
6.8 Rapid Near-Patient Testing in Hospitals 271
6.9 Satellite Facilities 271
6.10 Regionalization of Laboratory Care 272
6.11 Requirements for POCT 273
6.12 Locations of Point of Care for Patient Care 274
6.13 Benefits of POCT 274
6.14 Cost Elements of POCT 275
6.15 Necessary Functions in POCT 275
6.16 TAT for POCT 275
6.17 Clinical Laboratory Improvement Amendments (CLIA) 276
6.18 Sexually-transmitted Diseases in Underdeveloped Countries 277
7. Business Trends in the Point of Care Sector 279
7.1 Sector Consolidation 279
7.2 Diagnostic Testing Growth Trends 280
7.3 Acquisition, License Agreements, Internal Development and Partnerships 281
7.4 Product Testing Depth in POCT 284
7.5 Government Regulation 284
7.5.1 U.S. Regulation 285
7.5.1.1 Importing Medical Devices into the U.S. 286
7.5.1.2 Exporting Medical Devices from the U.S. 287
7.5.2 U.K. Regulation 287
7.5.3 E.U. Regulation 288
7.5.3.1 French Regulation 290
7.5.4 Japanese Regulation 290
7.5.5 Korean Regulation 291
7.6 Increased Market Penetration 291
7.7 Costs of doing Business in Europe 292
7.8 Drivers of European Diagnostics Testing 292
7.9 European Reimbursement Practices 292
7.10 Cost Containment in Europe 293
8. Technology Platform Innovations in POCT 296
8.1 Sensor Systems for Diagnostic Applications 296
8.2 Glucose Measurements 299
8.2.1 Continuous Glucose Monitoring Systems 301
8.3 Glucose Test Methods 303
8.4 Cholesterol Testing 304
8.5 The New Paradigm 304
8.6 Consolidated Workstations and Modularity 305
8.7 Automation and Robotics in the Clinical Laboratory 305
8.8 Laboratory Information Systems (LIS) 306
8.8.1 NOVIUS Lab 306
8.9 Biosensor Technology 306
8.10 Nanogen Third Generation Point of Care Analyzer 308
8.11 Quidel MChip 309
9. Data Management and Connectivity 310
9.1 Wireless LANs 310
9.2 Connectivity Platforms 313
9.2.1 DataLink Data Management System 313
9.2.2 RALS-Plus 314
9.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 316
9.2.2.2 Siemens Diagnostics Rapidpoint Coag 316
9.2.2.3 Radiometer 316
9.2.2.4 HemoCue's DM Hemoglobin 316
9.2.2.5 Roche Diagnostics 316
9.2.3 BD.id 317
9.2.4 Medical Implant Communications Service (MICS) 317
9.3 Advantages of POCT Connectivity 317
9.3.1 Cost Benefit of POCT and IT Connectivity 318
9.3.2 Hospital Network Issues 318
10. Corporate Profiles 319
10.1 Abaxis, Inc. 319
10.2 Abbott Laboratories 322
10.3 Accumetrics, Inc. 324
10.4 AccuTech, LLC 324
10.5 ACON Laboratories 324
10.6 Acrongenomics 324
10.7 Aerscher Diagnostics 325
10.8 Akers Biosciences, Inc. 325
10.9 Alere 325
10.10 Alfa Scientific Designs, Inc. 328
10.11 American Bio Medica Corporation 328
10.12 Amic AB 329
10.13 Ani Biotech Oy Ltd. 329
10.14 Arkray, Inc. 330
10.15 Atonomics A/S 330
10.16 Audit Diagnostics 330
10.17 Augurix Diagnostics Ltd. 330
10.18 Axis-Shield 330
10.19 Bayer 331
10.20 Beckman Coulter 331
10.21 BioLytical Laboratories 333
10.22 Biomerica, Inc. 333
10.23 BiOracle 334
10.24 Bio-Rad Laboratories, Inc. 334
10.25 BioScan Screening Systems, Inc. 335
10.26 BioSite 335
10.27 Calmark Sweden AB 335
10.28 Calypte Biomedical Corporation 335
10.29 Chembio Diagnostic Systems 336
10.30 Chempaq A/S 336
10.31 Cholestech 336
10.32 Claros Diagnostics 336
10.33 Concateno Plc 336
10.34 Dexcom 337
10.35 Enigma Diagnostics Ltd. 337
10.36 Epinex Diagnostics 337
10.37 Eurotrol 338
10.38 Exalenz Bioscience 338
10.39 GenBio 338
10.40 Genzyme 338
10.41 Helena Laboratories 339
10.42 HemoCue AB 339
10.43 HemoSense 339
10.44 Home Diagnostics (Nipro Diagnostics) 339
10.45 IND Diagnostic 339
10.46 Instrumentation Laboratory Company 339
10.47 Jant Pharmacal Corporation 340
10.48 Johnson & Johnson 340
10.49 Lein Applied Diagnostics 341
10.50 LifeAssays AB 341
10.51 LifeSign 341
10.52 Mediwatch 341
10.53 Medix Biochemica 341
10.54 MedMira 341
10.55 MELA Sciences (formerly Electro-Optical Sciences) 342
10.56 Meretek Diagnostics Group 342
10.57 Meridian Bioscience 342
10.58 Micronics 343
10.59 3M 343
10.60 New Horizons Diagnostics 343
10.61 OraSure Technologies 343
10.62 Orion Diagnostica 344
10.63 Polymer Technology Systems 344
10.64 Prima Biomedical Company 344
10.65 QBC Diagnostics 345
10.66 Qualigen 345
10.67 Quidel 345
10.68 Radiometer Medical 348
10.69 Response Biomedical 348
10.70 SA Scientific 348
10.71 Siemens AG 349
10.72 Stanbio Laboratory 349
11. POCT Sector Trends and Forecasts 351
11.1 Home Care Analysis as Part of Near-Patient Testing 351
11.2 Non-Traditional Collection for POCT 351
11.3 New Systems for Critical Care and Near-Patient Testing 351
11.4 Utility of Near-Patient Testing in Critical Care Settings 352
11.5 Physician's Office Market 352
11.6 Information Management Advances 353
11.7 Test-Ordering Patterns and Demand for POCT 353
11.8 Demand for Emergency Department Services 353
11.9 Move Away from Central Laboratory 354
11.10 Healthcare Cost Controls 355
11.11 M&A in POCT 355
11.12 Competition for Services 356
11.13 Drivers of POCT 356
11.14 Confluence of New Technology 357
11.15 Difficulties of Design for Point of Care Products 357
11.16 European Hospital Structure 357
11.17 The Biggest New Opportunities in POCT 357
12. Corporate Directory 358
INDEX OF FIGURES
Figure 3.1: Blood Tests Ordered in Emergency Department Visits 26
Figure 3.2: Worldwide Distribution of IVD Testing, 2010 30
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, 2010 34
Figure 4.1: Number of HbA1c Tests Performed Globally as POCT, 1991-2006 93
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 145
Figure 4.3: Influenza Positive Tests Reported to CDC by U.S. WHO/NREVSS
Collaborating Laboratories, National Summary, 2010-2011 146
Figure 5.1: Global POCT Share of HIV Testing Market, 2008 230
Figure 6.1: Annual Rate of Emergency Room Visits by Primary Expected Source of
Payment 270
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, 1997-2010 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, 2010 29
Table 3.5: Worldwide Distribution of IVD Testing, 2010 29
Table 3.6: Top 12 Country IVD Testing Markets, 2010 30
Table 3.7: Global Point of Care Revenues, 2005-2012 31
Table 3.8: Worldwide POCT Market Size by Geographic Location, 2005-2012 33
Table 3.9: Worldwide Distribution of POCT, 2010 33
Table 3.10: Worldwide Clinical Diagnostic POCT and Rapid Test Market Segments,
2010 33
Table 3.11: Worldwide POCT by Performance Location, 2010 34
Table 3.12: Largest POCT Diagnostic Companies Worldwide, 2010 34
Table 3.13: U.S. Clinical Laboratory Testing Market, 2003-2012 35
Table 3.14: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location
of Analysis, 2010 35
Table 3.15: U.S. POCT Market, 2000-2012 36
Table 3.16: U.S. POCT by Performance Location, 2010 36
Table 3.17: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2010
36
Table 3.18: European Clinical Laboratory Testing IVD Reagents and Instruments
Market in
Dollars, 2000-2012 37
Table 3.19: European Clinical Laboratory Testing IVD Reagents and Instruments
Market in
Euros, 2000-2012 37
Table 3.20: European Clinical Laboratory Testing Diagnostics by Country Market
Estimates, 2010 38
Table 3.21: European Rapid POCT by Country Market Estimates, 2010 39
Table 3.22: Regional Comparison of Healthcare Spending for IVD for Eastern
Europe 42
Table 3.23: European POCT Market, 2005-2012 42
Table 3.24: Top 12 POCT Country Markets, 2010 42
Table 3.25: German Clinical Laboratory Testing Diagnostics Products Market
Sales, 2003-2012 43
Table 3.26: German POCT Diagnostics Products Market Sales, 2003-2012 43
Table 3.27: German Clinical Diagnostic Rapid Test Market Segments, 2010 44
Table 3.28: U.K. Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 45
Table 3.29: U.K. POCT Diagnostics Products Market Sales, 2006-2012 46
Table 3.30: U.K. Clinical Diagnostic Rapid Test Market Segments, 2010 46
Table 3.31: Major U.K. IVD Manufacturers 47
Table 3.32: U.S. IVD Manufacturers Doing Business in the U.K. 47
Table 3.33: Other European Companies that Manufacture IVD Products in the U.K.
47
Table 3.34: French Clinical IVD Testing Diagnostics Products Market Sales,
2003-2012 48
Table 3.35: French POCT Diagnostics Products Market Sales, 2005-2012 49
Table 3.36: French Clinical Diagnostic Rapid Test Market Segments, 2010 49
Table 3.37: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 50
Table 3.38: Italian POCT Diagnostics Products Market Sales, 2005-2012 50
Table 3.39: Italian Clinical Diagnostic Rapid Test Market Segments, 2010 50
Table 3.40: Spanish Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 51
Table 3.41: Spanish Clinical Diagnostic Rapid Test Market Segments, 2010 52
Table 3.42: Spanish POCT Diagnostics Products Market Sales, 2005-2012 52
Table 3.43: Scandinavian POCT Diagnostics Products Market Sales, 2000-2012 53
Table 3.44: Swedish Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 53
Table 3.45: Swedish POCT Diagnostics Products Market Sales, 2005-2012 54
Table 3.46: Finnish Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 54
Table 3.47: Finnish POCT Diagnostics Products Market Sales, 2005-2012 55
Table 3.48: Norwegian Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 55
Table 3.49: Norwegian POCT Diagnostics Products Market Sales, 2005-2012 56
Table 3.50: Swiss Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 56
Table 3.51: Swiss POCT Diagnostics Products Market Sales, 2005-2012 57
Table 3.52: Dutch Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 57
Table 3.53: Dutch POCT Diagnostics Products Market Sales, 2005-2012 58
Table 3.54: Belgian Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 58
Table 3.55: Belgian POCT Diagnostics Products Market Sales, 2005-2012 59
Table 3.56: Portuguese Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 59
Table 3.57: Portuguese POCT Diagnostics Products Market Sales, 2005-2012 60
Table 3.58: Austrian Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 60
Table 3.59: Austrian POCT Diagnostics Products Market Sales, 2005-2012 61
Table 3.60: Greek Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 61
Table 3.61: Greek POCT Diagnostics Products Market Sales, 2005-2012 62
Table 3.62: Polish Clinical Laboratory Diagnostics Products Market Sales,
2003-2012 62
Table 3.63: Polish POCT Diagnostics Products Market Sales, 2005-2012 63
Table 3.64: Czech Clinical Laboratory Diagnostics Products Market Sales,
2004-2012 63
Table 3.65: Czech POCT Diagnostics Products Market Sales, 2005-2012 64
Table 3.66: Turkish POCT Market, 2000-2012 64
Table 3.67: Japanese POCT Market, 2000-2012 65
Table 3.68: Japanese Population and Aging Demographics Forecast, 2000-2050 65
Table 3.69: Indian IVD Market for Instruments and Reagents, 2004-2012 66
Table 3.70: Number of Automated Clinical Labs in India, 2004-2012 67
Table 3.71: Indian IVD Market, 2010 67
Table 3.72: Indian POCT Diagnostics Products Market Sales, 2000-2012 71
Table 3.73: Chinese IVD Market, 2006-2012 72
Table 3.74: Number of Automated Clinical Labs in China, 2004-2012 73
Table 3.75: Chinese IVD Market, 2010 73
Table 3.76: Chinese POCT Diagnostics Products Market Sales, 2000-2012 79
Table 3.77: Rest of the World POCT Market, 2000-2012 81
Table 3.78: Canadian POCT Market, 2000-2012 82
Table 3.79: Brazilian POCT Market, 2000-2012 82
Table 3.80: 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 Revenue and
Forecasts, 2001-2012 90
Table 4.4: U.S. Point of Care Glucose Testing Market, 1997-2012 90
Table 4.5: Rapid Testing U.S. Market Share for Blood Glucose Testing Segment 92
Table 4.6: HbA1c Testing Market for POCT Worldwide, 2006-2012 93
Table 4.7: Point of Care Glucose Testing Market: Market Drivers Ranked in Order
of Impact 94
Table 4.8: Point of Care Glucose Testing Market: Market Restraints Ranked in
Order of Impact 94
Table 4.9: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and
Threats of the Glucose Point of Care Market 96
Table 4.10: Critical Care Blood Gas Testing Market for POCT Worldwide, 2006-2012
97
Table 4.11: Blood Gas and Electrolyte Market for POCT in the U.S., 2001-2012 97
Table 4.12: Location Market Share of Critical Care Blood Gas Testing, 1990 and
2010 97
Table 4.13: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes
Market, 2010 99
Table 4.14: Hospital Locations of Point of Care Coagulation Testing 100
Table 4.15: Drivers for Point of Care Coagulation Testing 101
Table 4.16: Barriers for Point of Care Coagulation Testing 101
Table 4.17: Coagulation Testing Market for POCT Worldwide, 2006-2012 102
Table 4.18: Handheld Coagulation Testing Market for POCT Worldwide, 2006-2012
102
Table 4.19: Coagulation Market for POCT in the U.S., 2001-2015 103
Table 4.20: Point of Care Prothrombin Market for POCT in the U.S., 2000-2010 104
Table 4.21: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and
Threats of the Coagulation Point of Care Market 108
Table 4.22: Cardiac Marker Market for POCT in the U.S., 2001-2016 110
Table 4.23: Cardiac Marker Market for POCT Worldwide, 2001-2016 111
Table 4.24: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2010 111
Table 4.25: Cardiac Marker Market for POCT in Europe, 2008-2016 112
Table 4.26: Point of Care Cardiac Marker Testing Market: Market Drivers Ranked
in Order of Impact 113
Table 4.27: Point of Care Cardiac Marker Testing Market: Market Restraints
Ranked in Order of Impact 113
Table 4.28: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and
Threats of the Cardiac Marker Point of Care Market 114
Table 4.29: Drugs of Abuse Testing Market for POCT Worldwide, 2006-2015 119
Table 4.30: U.S. Point of Care Drugs of Abuse Testing Market, 2006-2015 120
Table 4.31: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency
Department 121
Table 4.32: Stat Urine Testing Drug Recommendations 121
Table 4.33: Device Specifications for POCT Breath Alcohol Analysis 124
Table 4.34: Global Point of Care Urine Test Strip Testing Market, 2001-2010 124
Table 4.35: Global Point of Care Urine Test Strip POCT Testing Market, 2006-2012
125
Table 4.36: U.S. Point of Care Urine Test Strip Testing Market, 2001-2011 125
Table 4.37: U.S. Point of Care Urine Test Strip Testing Market Share 125
Table 4.38: Medicare Fee Schedule for Urine Chemistry Testing, 127
Table 4.39: Pregnancy Testing Market for POCT Worldwide, 2006-2012 128
Table 4.40: U.S. Point of Care Pregnancy Testing Market, 2001-2012 128
Table 4.41: U.S. Market Share for Rapid Point of Care Pregnancy Tests 128
Table 4.42: Hemoglobin Testing Market for POCT Worldwide, 2006-2012 129
Table 4.43: Drivers of Demand for HIV Testing 134
Table 4.44: Worldwide POCT Market for HIV, 2001-2012 135
Table 4.45: U.S. POCT Market for HIV, 2001-2012 135
Table 4.46: Countries with the Highest Prevalence of HIV/AIDS 137
Table 4.47: FDA-approved Rapid HIV Antibody Screening Tests 138
Table 4.48: Cholesterol Testing Market for POCT Worldwide, 2006-2012 140
Table 4.49: Infectious Disease Testing Market for POCT Worldwide, 2006-2012 141
Table 4.50: Worldwide Point of Care Influenza Testing Market, 2002-2010 147
Table 4.51: U.S. Point of Care Influenza Testing Market, 2002-2010 147
Table 4.52: U.S. Market Share for Rapid Point of Care Influenza Tests, 2010 148
Table 4.53: Worldwide Point of Care Strep A Testing Market, 2002-2010 148
Table 4.54: U.S. Point of Care Strep A Testing Market, 2002-2010 149
Table 4.55: U.S. Market Share for Rapid Point of Care for Group A Strep Tests
149
Table 4.56: Global Market for Chlamydia Diagnostic Testing, 2000-2010 150
Table 4.57: U.S. Market for Chlamydia Diagnostic Testing, 2000-2010 150
Table 4.58: U.S. Market for MRSA Rapid Testing, 2006-2013 155
Table 4.59: Global Market for Gonorrhea Diagnostic Testing, 2000-2010 158
Table 4.60: Global Market for TB Diagnostic Testing, 2000-2010 160
Table 4.61: Point of Care Infectious Disease Testing Market: Market Drivers
Ranked in Order of Impact 163
Table 4.6
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Nicolas Bombourg
Reportlinker
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