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Point of Care Diagnostic Testing World Markets
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Features of this market research: | 375 pages | |||||||||
| About this market survey: |
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 e.....
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. [Fade out the market survey infos] |
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1. Overview 15 1.1 About this Report 15 1.2 Scope of the Report 16 1.3 Objectives 17 1.4 Methodology 17 1.5 Executive Summary 18 2. Overview of Diagnostic Testing Point of Care 22 2.1 Point of Care Testing Sites 22 2.2 Point of Care Market Structure 23 2.3 New Directions in Clinical IVD Testing 23 3. POCT and Rapid Testing Market Analysis: Size, Background Analysis, Growth, Share and Competitors 26 3.1 Global POCT Market 33 3.2 U.S. POCT Market 36 3.3 European POCT Market 38 3.3.1 German POCT Diagnostic Market 45 3.3.2 U.K. POCT Diagnostic Market 47 3.3.2.1 U.K. POCT Market Statistics 47 3.3.2.2 U.K. Competitive Analysis 49 3.3.2.3 U.K. Market Access 50 3.3.3 French POCT Diagnostic Market 50 3.3.4 Italian POCT Diagnostic Market 51 3.3.5 Spanish POCT Diagnostic Market 53 3.3.6 Scandinavian POCT Diagnostic Market 54 3.3.7 Swedish POCT Diagnostic Market 55 3.3.8 Finnish POCT Diagnostic Market 56 3.3.9 Norwegian POCT Diagnostic Market 57 3.3.10 Swiss POCT Diagnostic Market 58 3.3.11 Dutch POCT Diagnostic Market 59 3.3.12 Belgian POCT Diagnostic Market 60 3.3.13 Portuguese POCT Diagnostic Market 61 3.3.14 Austrian POCT Diagnostic Market 62 3.3.15 Greek POCT Diagnostic Market 63 3.3.16 Polish POCT Diagnostic Market 64 3.3.17 Czech Republic POCT Diagnostic Market 65 3.3.18 Turkish POCT Diagnostic Market 66 3.4 Asian POCT Markets 66 3.4.1 Japanese POCT Diagnostic Market 66 3.4.2 Indian POCT Diagnostic Market 68 3.4.3 Chinese POCT Diagnostic Market 73 3.5 Rest of the World POCT Market 83 3.5.1 Canadian POCT Diagnostic Market 84 3.5.2 Brazilian POCT Diagnostic Market 84 3.5.3 Australian POCT Diagnostic Market 85 3.6 Overview of Asian Healthcare Market 85 3.6.1 Singapore 87 3.6.2 Malaysia 87 3.6.3 Thailand 88 3.6.4 Indonesia 88 3.6.5 Philippines 88 3.6.6 South Korea 89 3.6.7 Taiwan 89 4. POCT Individual Markets 90 4.1 Glucose Testing 90 4.2 POCT Individual Market Sectors, Size, Growth Rates and Competitors 91 4.2.1 World Market Revenue and Forecasts 91 4.2.2 Professional Glucose Testing Market for POCT U.S. Revenue and Forecasts during 2001-2012 92 4.2.3 European Market 93 4.2.4 Market Share 93 4.2.5 Alternate Glucose Monitoring Products 94 4.2.6 HbA1c POCT 95 4.2.7 Market Challenges and Strategic Recommendations 96 4.2.7.1 Market Drivers and Restraints 96 4.2.7.1.1 Market Drivers 96 4.2.7.1.2 Market Restraints 96 4.2.7.2 Point of Care Glucose Testing Assay Market and Technology Trends 97 4.2.7.2.1 Point of Care Glucose Testing Assay Market Trends 97 4.2.7.2.2 Point of Care Glucose Testing Assay Technology Trends 97 4.2.7.2.3 Point of Care Glucose Testing Assay Strategic Recommendations 97 4.3 Blood Gas and Electrolytes 98 4.3.1 Whole Blood Lactate 101 4.3.2 Creatinine 101 4.4 Rapid Coagulation Tests 102 4.4.1 World POCT Coagulation Market 104 4.4.2 U.S. Coagulation Market 105 4.4.3 European Coagulation Market 108 4.4.4 Trends in POCT Coagulation Testing 109 4.4.4.1 Self-testing Coagulation Market 109 4.4.4.2 D-Dimer Testing 110 4.4.5 Point of Care Coagulation Testing Assay Market and Technology Trends 110 4.4.5.1 Point of Care Coagulation Testing Assay Market Trends 110 4.4.5.2 Point of Care Coagulation Testing Assay Technology Trends 110 4.4.5.3 Point of Care Coagulation Testing Assay Strategic Recommendations 110 4.5 Rapid Cardiac Markers 111 4.5.1 U.S. Market 111 4.5.2 European Market 114 4.5.3 Market Drivers and Restraints 115 4.5.3.1 Market Drivers 115 4.5.3.2 Market Restraints 116 4.5.4 Point of Care Cardiac Marker Testing Assay Market and Technology Trends 116 4.5.4.1 Point of Care Cardiac Marker Testing Assay Market Trends 116 4.5.4.2 Point of Care Cardiac Marker Testing Assay Technology Trends 116 4.5.4.3 Point of Care Cardiac Marker Testing Assay Strategic Recommendations 116 4.6 Drugs of Abuse Screening Testing 117 4.6.1 Acetaminophen 124 4.6.2 Tricyclic Antidepressants (TCAs) 125 4.6.3 Other Toxic Drugs 125 4.6.4 Drug Testing Selectivity 125 4.6.5 Methaqualone and Phencyclidine (PCP) 125 4.6.6 Tetrahydrocannabinol 125 4.6.7 Drug Panels by Toxidromes 126 4.6.8 Alcohol Testing 126 4.7 Urine Strips 127 4.8 Pregnancy Tests 129 4.9 Fecal Occult Blood 131 4.10 Hemoglobin Testing 131 4.11 Miscellaneous Rapid Tests 132 4.11.1 Estriol 132 4.11.2 Fetal Fibronectin (fFN) 133 4.11.3 H. pylori 133 4.11.4 Vaginal pH and Vaginitis 133 4.11.5 Bladder Cancer 134 4.11.6 Fetal Status 135 4.11.7 Heparin-induced Thrombocytopenia 136 4.12 Human Immunodeficiency Virus (HIV) 136 4.13 Cholesterol 142 4.14 Infectious Disease 143 4.14.1 Clostridium difficile 144 4.14.2 Giardia 144 4.14.3 Salmonella and Campylobacter 145 4.14.4 Malaria Testing 146 4.14.5 Influenza Testing 147 4.14.6 Strep Testing 150 4.14.7 Chlamydia 152 4.14.8 Mononucleosis 153 4.14.9 Rubella 153 4.14.10 Methicillin-resistant Staphylococcus aureus (MRSA) 153 4.14.11 Hepatitis 158 4.14.12 Gonorrhea 160 4.14.13 Tuberculosis (TB) 161 4.14.14 Herpes Simplex Virus Type-2 163 4.14.15 Legionella 163 4.14.16 RSV 163 4.14.16.1 Market Drivers and Restraints 166 4.14.16.1.1 Market Drivers 166 4.14.16.1.2 Market Restraints 166 4.14.16.2 Point of Care Infectious Disease Testing Assay Market and Technology Trends 166 4.14.16.2.1 Point of Care Infectious Disease Testing Assay Market Trends 166 4.14.16.2.2 Point of Care Infectious Disease Testing Assay Technology Trends 167 4.14.16.2.3 Point of Care Infectious Disease Testing Assay Strategic Recommendations 167 4.15 Infant Jaundice 167 4.16 Anthrax 167 4.17 Rupture of Fetal Membranes (ROM) 169 4.18 Food Pathogens 170 4.19 Typhoid 170 5. POCT: Reagents and Equipment 171 5.1 Blood Glucose Monitoring 171 5.1.1 LifeScan 172 5.1.2 Roche Accu-Chek 175 5.1.3 Abbott Diabetes Care 177 5.1.4 HemoCue 178 5.1.5 Stanbio/GDS Technology 178 5.1.6 Abaxis, Inc. 179 5.1.7 Arkray (Japan) 180 5.1.8 Accurex (India) 180 5.1.9 Home Diagnostics, Inc. 180 5.1.10 Nova Biomedical 180 5.1.11 Bayer 181 5.1.11.1 Hemoglobin A1c Measurements 182 5.1.12 Biosite (now part of Alere) 182 5.1.13 Siemens Healthcare Diagnostics 182 5.1.14 Infopia 183 5.1.15 Diasys 183 5.1.16 Quotient Dx 183 5.1.17 Cholestech (Acquired by Inverness Medical Innovations, now named Alere) 183 5.1.18 Bio-Rad 183 5.1.19 Axis-Shield 183 5.2 Blood Gas and Electrolytes 184 5.2.1 Roche Corporation 184 5.2.2 TechnoMedica 184 5.2.3 Siemens Healthcare Diagnostics 184 5.2.4 Instrumentation Laboratory 185 5.2.5 Nova Biomedical 185 5.2.6 Radiometer 185 5.2.7 Abbott Laboratories 186 5.2.8 Span Diagnostics 186 5.2.9 Nexus Dx Avoximeter Systems for Co-oximetry 186 5.2.10 ITC (Nexus Dx) 188 5.2.11 Alere 188 5.2.12 Abaxis, Inc. 188 5.3 Rapid Coagulation Tests 188 5.3.1 POC Coagulation Instrument Description 193 5.3.1.1 Roche Diagnostics Corp. 194 5.3.1.2 Abbott Laboratories 196 5.3.1.3 International Technidyne Corporation Nexus DX 196 5.3.1.4 Medtronic 198 5.3.1.5 HemoSense (Inverness) 198 5.3.1.6 Helena Laboratories Point of Care 199 5.3.1.7 Sienco, Inc. 201 5.3.1.8 Accumetrics 201 5.3.1.9 Alere 201 5.3.1.10 ITC 202 5.3.2 Connectivity Issues 202 5.3.3 Cost Benefits 202 5.3.4 Quality Control Issues 203 5.3.5 Certification for Point of Care Coagulation Devices 203 5.4 Rapid Cardiac Markers 204 5.4.1 Biosite Diagnostics (Inverness, now called Alere) 204 5.4.2 Roche Diagnostics 205 5.4.3 Ani Biotech 206 5.4.4 Response Biomedical Corporation 206 5.4.5 Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics, Diagnostic Products Corporation, and Dade Behring) 207 5.4.6 Lab21 Ltd. 207 5.4.7 Abbott Laboratories 208 5.4.8 LifeSign (Princeton BioMediTech Corp.) 208 5.4.9 Mitsubishi Kagaku Iatron 208 5.4.10 Alpha Scientific 208 5.5 Rapid Drugs of Abuse 208 5.5.1 Biosite Diagnostics (Inverness, now called Alere) 210 5.5.2 Abbott Diagnostics 211 5.5.3 Roche Diagnostics 211 5.5.4 BioScan Screening Systems, Inc. 212 5.5.5 American Bio Medica Corp. 212 5.5.6 Phamatech, Inc. 215 5.5.7 First Check Medical 216 5.5.8 OraSure 216 5.5.9 Avitar, Inc. 217 5.5.10 Concateno 217 5.5.11 Pathtech 217 5.5.12 Alfa Scientific Designs, Inc. 218 5.5.13 TCPI, Inc. 218 5.5.14 Roche 219 5.5.15 Biophor Diagnostics 219 5.6 Rapid Pregnancy and Fertility Tests 219 5.7 Fecal Occult Blood 221 5.7.1 Helena Laboratories 222 5.7.2 Biomerica 222 5.7.3 Beckman Coulter 222 5.7.4 Worldwide Medical 222 5.7.5 Aerscher Diagnostics 222 5.7.6 Enterix 223 5.7.7 Medix Biochemica 223 5.7.8 Orion Diagnostica 223 5.8 Hemoglobin Testing 223 5.8.1 Wampole Laboratories 223 5.8.2 HemoCue, Inc. 224 5.8.3 Stanbio 224 5.9 Miscellaneous Rapid Tests 224 5.9.1 Triage C. difficile Panel 224 5.9.2 Ketoacids 224 5.9.3 Acetaminophen 224 5.9.4 Estriol 225 5.9.5 H. pylori 225 5.9.6 Vaginal Fluid pH and Vaginitis 227 5.9.7 Prostate-specific Antigen (PSA) 228 5.9.8 Bladder Cancer 228 5.9.9 Other Rapid Cancer Tests 232 5.9.10 Fetal Status (PROM) 232 5.9.11 Osteoporosis 233 5.9.12 Hemodynamic Monitoring 233 5.9.13 Heparin-induced Thrombocytopenia 233 5.10 HIV 233 5.10.1 Whole Blood, Serum or Plasma-based HIV Tests 236 5.10.1.1 Bio-Rad Laboratories 236 5.10.1.2 Orgenics (Inverness, now called Alere) 236 5.10.1.3 StatSure Diagnostic Systems 236 5.10.1.4 Trinity Biotech 236 5.10.1.5 Savyon Diagnostics 237 5.10.1.6 MedPharm 237 5.10.1.7 American Bio Medica Corp. 237 5.10.1.8 Chembio Diagnostics 237 5.10.1.9 OraSure Technologies 238 5.10.1.10 Inverness (Alere) 239 5.10.2 Saliva-based HIV Tests 239 5.10.2.1 OraSure Collection Device 240 5.10.2.2 SureStat 241 5.10.3 Urine-based HIV Tests 241 5.10.3.1 MedMira Laboratories, Inc. 241 5.10.3.2 Medical Services International, Inc. 242 5.10.3.3 Maxim Biomedical 242 5.10.3.4 Wampole Laboratories 242 5.11 Cholesterol 242 5.11.1 Cholestech (now a brand of Inverness Medical Innovations) 243 5.11.2 Actimed Laboratories 244 5.11.3 StatSite Meter 244 5.11.4 Polymer Technology Systems 244 5.11.5 PreMD, Inc. (f/k/a International Medical Innovations, Inc. [IMI]) 245 5.11.6 Abaxis, Inc. 245 5.12 Infectious Disease 245 5.12.1 C. difficile 245 5.12.2 Giardia 246 5.12.3 Dengue Fever 246 5.12.4 Malaria Testing 247 5.12.5 Rapid Influenza Testing 249 5.12.6 Streptococcus Testing 252 5.12.7 Chlamydia 254 5.12.8 Mononucleosis 254 5.12.9 Rubella 255 5.12.10 Staphylococcus aureus and MRSA 255 5.12.11 Hepatitis 256 5.12.12 E. Coli O157 259 5.12.13 Gonorrhea Testing 259 5.12.14 Smallpox 259 5.12.15 SARS 259 5.12.16 Rabies 259 5.12.17 Tuberculosis 259 5.12.18 Avian Flu 260 5.12.19 West Nile Virus 260 5.12.20 Herpes Simplex Virus Type-2 260 5.12.21 Legionella 260 5.12.22 RSV 261 5.13 Infant Jaundice 262 5.14 Anthrax 262 5.15 Homeland Defense (Plague and Tularemia) 264 5.16 BSE (Mad Cow Disease) 264 5.17 Tuberculosis 265 5.18 Typhoid 265 5.19 Avian Flu 265 5.20 Food Pathogens (Salmonella, Listeria, Campylobacter) 266 5.21 Ruptured Fetal Membranes (ROM) 267 6. POCT: Growth Regulators 268 6.1 Moderators of Growth 268 6.2 Personnel Acceptance 268 6.3 Key People for POCT 269 6.4 Information Management Issues 269 6.4.1 Elements of Information Management for POCT: Information Processing Capabilities 271 6.4.2 Data Mining 271 6.4.3 Middleware 271 6.4.4 Web Portals 272 6.4.5 POCT-1A Standard 272 6.5 Key Elements for POCT 273 6.6 POCT and Reimbursement 273 6.7 Effectiveness of Clinical Outcomes 275 6.8 Rapid Near-Patient Testing in Hospitals 276 6.9 Satellite Facilities 276 6.10 Regionalization of Laboratory Care 277 6.11 Requirements for POCT 278 6.12 Locations of Point of Care for Patient Care 279 6.13 Benefits of POCT 280 6.14 Cost Elements of POCT 281 6.15 Necessary Functions in POCT 281 6.16 TAT for POCT 281 6.17 Clinical Laboratory Improvement Amendments (CLIA) 282 6.18 Sexually-transmitted Diseases in Underdeveloped Countries 284 6.19 Sources of Error in Point of Care Testing 284 7. Business Trends in the Point of Care Sector 287 7.1 Sector Consolidation 287 7.2 Diagnostic Testing Growth Trends 288 7.2.1 Opportunities for Healthcare Stakeholders 289 7.3 Acquisition, License Agreements, Internal Development and Partnerships 289 7.4 Product Testing Depth in POCT 292 7.5 Government Regulation 292 7.5.1 U.S. Regulation 293 7.5.1.1 Importing Medical Devices into the U.S. 294 7.5.1.2 Exporting Medical Devices from the U.S. 295 7.5.2 U.K. Regulation 295 7.5.3 E.U. Regulation 296 7.5.3.1 French Regulation 298 7.5.4 Japanese Regulation 298 7.5.5 Korean Regulation 299 7.6 Increased Market Penetration 299 7.7 Costs of doing Business in Europe 300 7.8 Drivers of European Diagnostics Testing 300 7.9 European Reimbursement Practices 300 7.10 Cost Containment in Europe 301 8. Technology Platform Innovations in POCT 304 8.1 Sensor Systems for Diagnostic Applications 304 8.2 Glucose Measurements 307 8.2.1 Continuous Glucose Monitoring Systems 309 8.3 Glucose Test Methods 311 8.4 Cholesterol Testing 312 8.5 The New Paradigm 312 8.6 Consolidated Workstations and Modularity 313 8.7 Automation and Robotics in the Clinical Laboratory 313 8.8 Laboratory Information Systems (LIS) 314 8.8.1 NOVIUS Lab 314 8.9 Biosensor Technology 314 8.10 Nanogen Third Generation Point of Care Analyzer 316 8.11 Quidel MChip 317 9. Data Management and Connectivity 318 9.1 Wireless LANs 318 9.2 Connectivity Platforms 321 9.2.1 DataLink Data Management System 321 9.2.2 RALS-Plus 322 9.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 324 9.2.2.2 Siemens Diagnostics Rapidpoint Coag 324 9.2.2.3 Radiometer 324 9.2.2.4 HemoCue�s DM Hemoglobin 324 9.2.2.5 Roche Diagnostics 324 9.2.3 BD.id 325 9.2.4 Medical Implant Communications Service (MICS) 325 9.3 Advantages of POCT Connectivity 325 9.3.1 Cost Benefit of POCT and IT Connectivity 326 9.3.2 Hospital Network Issues 326 10. Corporate Profiles 327 10.1 Abaxis, Inc. 327 10.2 Abbott Laboratories 330 10.3 Accumetrics, Inc. 332 10.4 AccuTech, LLC 332 10.5 ACON Laboratories 332 10.6 Acrongenomics 332 10.7 Aerscher Diagnostics 333 10.8 Akers Biosciences, Inc. 333 10.9 Alere 333 10.10 Alfa Scientific Designs, Inc. 336 10.11 American Bio Medica Corporation 337 10.12 Amic AB 338 10.13 Ani Biotech Oy Ltd. 338 10.14 Arkray, Inc. 338 10.15 Atonomics A/S 338 10.16 Audit Diagnostics 339 10.17 Augurix Diagnostics Ltd. 339 10.18 Axis-Shield 339 10.19 Axxin 340 10.20 Bayer 340 10.21 Beckman Coulter 340 10.22 BioLytical Laboratories 342 10.23 Biomerica, Inc. 342 10.24 BiOracle 343 10.25 Bio-Rad Laboratories, Inc. 343 10.26 BioScan Screening Systems, Inc. 343 10.27 BioSite 343 10.28 Calmark Sweden AB 344 10.29 Calypte Biomedical Corporation 344 10.30 Chembio Diagnostic Systems 345 10.31 Chempaq A/S 345 10.32 Cholestech 345 10.33 Claros Diagnostics 345 10.34 Concateno Plc 345 10.35 Dexcom 345 10.36 Enigma Diagnostics Ltd. 346 10.37 Epinex Diagnostics 346 10.38 Eurotrol 346 10.39 Exalenz Bioscience 347 10.40 GenBio 347 10.41 Genzyme 347 10.42 Helena Laboratories 347 10.43 HemoCue AB 348 10.44 HemoSense 348 10.45 Home Diagnostics (Nipro Diagnostics) 348 10.46 IND Diagnostic 348 10.47 Instrumentation Laboratory Company 348 10.48 ITC (International Technidyne Corporation) 348 10.49 Jant Pharmacal Corporation 349 10.50 Johnson & Johnson 349 10.51 Lein Applied Diagnostics 350 10.52 LifeAssays AB 350 10.53 LifeSign 350 10.54 Medica 350 10.55 Medical Automation Systems 350 10.56 Mediwatch 350 10.57 Medix Biochemica 351 10.58 MedMira 351 10.59 MELA Sciences (formerly Electro-Optical Sciences) 351 10.60 Meretek Diagnostics Group 351 10.61 Meridian Bioscience 351 10.62 Micronics 352 10.63 3M 352 10.64 New Horizons Diagnostics 353 10.65 Nexus DX/ITC 353 10.66 Nova Biomedical 353 10.67 OraSure Technologies 354 10.68 Orion Diagnostica 355 10.69 Polymer Technology Systems 355 10.70 Prima Biomedical Company 355 10.71 QBC Diagnostics 355 10.72 Qualigen 355 10.73 Quidel 356 10.74 Radiometer Medical 358 10.75 Response Biomedical 359 10.76 Roche 359 10.77 Telcor 360 10.78 SA Scientific 360 10.79 Siemens AG 361 10.80 Stanbio Laboratory 361 11. POCT Sector Trends and Forecasts 363 11.1 Home Care Analysis as Part of Near-Patient Testing 363 11.2 Non-Traditional Collection for POCT 363 11.3 New Systems for Critical Care and Near-Patient Testing 363 11.4 Utility of Near-Patient Testing in Critical Care Settings 364 11.5 Physician�s Office Market 364 11.6 Information Management Advances 365 11.7 Test-Ordering Patterns and Demand for POCT 365 11.8 Demand for Emergency Department Services 365 11.9 Move Away from Central Laboratory 366 11.10 Healthcare Cost Controls 367 11.11 M&A in POCT 367 11.12 Competition for Services 368 11.13 Drivers of POCT 368 11.14 Confluence of New Technology 369 11.15 Difficulties of Design for Point of Care Products 369 11.16 European Hospital Structure 369 11.17 The Biggest New Opportunities in POCT 369 12. Corporate Directory 370 [Fade out table of contents] |
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Figure 3.1: Blood Tests Ordered in Emergency Department Visits 27 Figure 3.2: Worldwide Distribution of IVD Testing, 2010 31 Figure 3.3: Global Point of Care Revenues, 2005-2012 33 Figure 3.4: Global Growth of Point of Care Testing Volume, 2000-2012 34 Figure 3.5: Global POCT Share of Total IVD Testing Market, 2010 35 Figure 4.1: Number of HbA1c Tests Performed Globally as POCT, 1991-2006 95 Figure 4.2: Percentage of Visits for Influenza-like Illness (ILI) Reported by the U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet) and Weekly National Summary, September 30, 2007- February 12, 2011 148 Figure 4.3: Influenza Positive Tests Reported to CDC by U.S. WHO/NREVSS Collaborating Laboratories, National Summary, 2010-2011 149 Figure 5.1: Global POCT Share of HIV Testing Market, 2008 235 Figure 6.1: Annual Rate of Emergency Room Visits by Primary Expected Source of Payment 275 Figure 6.2: CLIA Laboratories by Certificate Types 282 Table 2.1: Percentage of POCT Performed in Selected Hospitals 22 Table 2.2: POCT Procedural Advantages for Hospital Testing 24 Table 2.3: POCT Trends 25 Table 2.4: Professional POCT Compared to Home Testing 25 Table 2.5: Drivers for Integrating POCT into Hospital Routines 25 Table 3.1: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2010 26 Table 3.2: Number of Point of Care Tests in the U.S., 2000-2012 27 Table 3.3: Global Clinical Laboratory Market Sales, 1998-2011 30 Table 3.4: Overall IVD Testing Market Worldwide, 2010 31 Table 3.5: Worldwide Distribution of IVD Testing, 2010 31 Table 3.6: Top 12 Country IVD Testing Markets, 2010 32 Table 3.7: Global Point of Care Revenues, 2005-2012 33 Table 3.8: Worldwide POCT Market Size by Geographic Location, 2005-2012 34 Table 3.9: Worldwide Distribution of POCT, 2010 34 Table 3.10: Worldwide Clinical Diagnostic POCT and Rapid Test Market Segments, 2010 35 Table 3.11: Worldwide POCT by Performance Location, 2010 35 Table 3.12: Largest POCT Diagnostic Companies Worldwide, 2010 36 Table 3.13: U.S. Clinical Laboratory Testing Market, 2003-2012 36 Table 3.14: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, 2010 37 Table 3.15: U.S. POCT Market, 2000-2012 37 Table 3.16: U.S. POCT by Performance Location, 2010 38 Table 3.17: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2010 38 Table 3.18: European Clinical Laboratory Testing IVD Reagents and Instruments Market in Dollars, 2000-2012 39 Table 3.19: European Clinical Laboratory Testing IVD Reagents and Instruments Market in Euros, 2000-2012 39 Table 3.20: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2010 40 Table 3.21: European Rapid POCT by Country Market Estimates, 2010 41 Table 3.22: Regional Comparison of Healthcare Spending for IVD for Eastern Europe 44 Table 3.23: European POCT Market, 2005-2012 44 Table 3.24: Top 12 POCT Country Markets, 2010 44 Table 3.25: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012 45 Table 3.26: German POCT Diagnostics Products Market Sales, 2003-2012 45 Table 3.27: German Clinical Diagnostic Rapid Test Market Segments, 2010 46 Table 3.28: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 47 Table 3.29: U.K. POCT Diagnostics Products Market Sales, 2006-2012 48 Table 3.30: U.K. Clinical Diagnostic Rapid Test Market Segments, 2010 48 Table 3.31: Major U.K. IVD Manufacturers 49 Table 3.32: U.S. IVD Manufacturers Doing Business in the U.K. 49 Table 3.33: Other European Companies that Manufacture IVD Products in the U.K. 49 Table 3.34: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2012 50 Table 3.35: French POCT Diagnostics Products Market Sales, 2005-2012 51 Table 3.36: French Clinical Diagnostic Rapid Test Market Segments, 2010 51 Table 3.37: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 52 Table 3.38: Italian POCT Diagnostics Products Market Sales, 2005-2012 52 Table 3.39: Italian Clinical Diagnostic Rapid Test Market Segments, 2010 52 Table 3.40: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 53 Table 3.41: Spanish Clinical Diagnostic Rapid Test Market Segments, 2010 54 Table 3.42: Spanish POCT Diagnostics Products Market Sales, 2005-2012 54 Table 3.43: Scandinavian POCT Diagnostics Products Market Sales, 2000-2012 55 Table 3.44: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 55 Table 3.45: Swedish POCT Diagnostics Products Market Sales, 2005-2012 56 Table 3.46: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 56 Table 3.47: Finnish POCT Diagnostics Products Market Sales, 2005-2012 57 Table 3.48: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 57 Table 3.49: Norwegian POCT Diagnostics Products Market Sales, 2005-2012 58 Table 3.50: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 58 Table 3.51: Swiss POCT Diagnostics Products Market Sales, 2005-2012 59 Table 3.52: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 59 Table 3.53: Dutch POCT Diagnostics Products Market Sales, 2005-2012 60 Table 3.54: Belgian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 60 Table 3.55: Belgian POCT Diagnostics Products Market Sales, 2005-2012 61 Table 3.56: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 61 Table 3.57: Portuguese POCT Diagnostics Products Market Sales, 2005-2012 62 Table 3.58: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 62 Table 3.59: Austrian POCT Diagnostics Products Market Sales, 2005-2012 63 Table 3.60: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 63 Table 3.61: Greek POCT Diagnostics Products Market Sales, 2005-2012 64 Table 3.62: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 64 Table 3.63: Polish POCT Diagnostics Products Market Sales, 2005-2012 65 Table 3.64: Czech Clinical Laboratory Diagnostics Products Market Sales, 2004-2012 65 Table 3.65: Czech POCT Diagnostics Products Market Sales, 2005-2012 66 Table 3.66: Turkish POCT Market, 2000-2012 66 Table 3.67: Japanese POCT Market, 2000-2012 67 Table 3.68: Japanese Population and Aging Demographics Forecast, 2000-2050 67 Table 3.69: Indian IVD Market for Instruments and Reagents, 2004-2012 68 Table 3.70: Number of Automated Clinical Labs in India, 2004-2012 69 Table 3.71: Indian IVD Market, 2010 69 Table 3.72: Indian POCT Diagnostics Products Market Sales, 2000-2012 73 Table 3.73: Chinese IVD Market, 2006-2012 74 Table 3.74: Number of Automated Clinical Labs in China, 2004-2012 75 Table 3.75: Chinese IVD Market, 2010 75 Table 3.76: Chinese POCT Diagnostics Products Market Sales, 2000-2012 81 Table 3.77: Rest of the World POCT Market, 2000-2012 83 Table 3.78: Canadian POCT Market, 2000-2012 84 Table 3.79: Brazilian POCT Market, 2000-2012 84 Table 3.80: Australian POCT Market, 2000-2012 85 Table 4.1: World Market Share of Point of Care Glucose Monitoring Marketers 90 Table 4.2: Global Population of Persons with Diabetes, 1995 and 2025 91 Table 4.3: Professional Glucose Testing Market for POCT Worldwide Revenue and Forecasts, 2001-2012 92 Table 4.4: U.S. Point of Care Glucose Testing Market, 1997-2012 92 Table 4.5: Rapid Testing U.S. Market Share for Blood Glucose Testing Segment 94 Table 4.6: HbA1c Testing Market for POCT Worldwide, 2006-2012 95 Table 4.7: Point of Care Glucose Testing Market: Market Drivers Ranked in Order of Impact 96 Table 4.8: Point of Care Glucose Testing Market: Market Restraints Ranked in Order of Impact 96 Table 4.9: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market 98 Table 4.10: Critical Care Blood Gas Testing Market for POCT Worldwide, 2006-2012 99 Table 4.11: Blood Gas and Electrolyte Market for POCT in the U.S., 2001-2012 99 Table 4.12: Location Market Share of Critical Care Blood Gas Testing, 1990 and 2010 99 Table 4.13: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2010 101 Table 4.14: Hospital Locations of Point of Care Coagulation Testing 103 Table 4.15: Drivers for Point of Care Coagulation Testing 104 Table 4.16: Barriers for Point of Care Coagulation Testing 104 Table 4.17: Coagulation Testing Market for POCT Worldwide, 2006-2012 104 Table 4.18: Handheld Coagulation Testing Market for POCT Worldwide, 2006-2012 105 Table 4.19: Coagulation Market for POCT in the U.S., 2001-2015 106 Table 4.20: Point of Care Prothrombin Market for POCT in the U.S., 2000-2010 106 Table 4.21: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Coagulation Point of Care Market 111 Table 4.22: Cardiac Marker Market for POCT in the U.S., 2001-2016 113 Table 4.23: Cardiac Marker Market for POCT Worldwide, 2001-2016 113 Table 4.24: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2010 114 Table 4.25: Cardiac Marker Market for POCT in Europe, 2008-2016 114 Table 4.26: Point of Care Cardiac Marker Testing Market: Market Drivers Ranked in Order of Impact 115 Table 4.27: Point of Care Cardiac Marker Testing Market: Market Restraints Ranked in Order of Impact 116 Table 4.28: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Cardiac Marker Point of Care Market 117 Table 4.29: Drugs of Abuse Testing Market for POCT Worldwide, 2006-2015 122 Table 4.30: U.S. Point of Care Drugs of Abuse Testing Market, 2006-2015 122 Table 4.31: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency Department 124 Table 4.32: Stat Urine Testing Drug Recommendations 124 Table 4.33: Device Specifications for POCT Breath Alcohol Analysis 126 Table 4.34: Global Point of Care Urine Test Strip Testing Market, 2001-2010 127 Table 4.35: Global Point of Care Urine Test Strip POCT Testing Market, 2006-2012 127 Table 4.36: U.S. Point of Care Urine Test Strip Testing Market, 2001-2011 127 Table 4.37: U.S. Point of Care Urine Test Strip Testing Market Share 128 Table 4.38: Medicare Fee Schedule for Urine Chemistry Testing, 129 Table 4.39: Pregnancy Testing Market for POCT Worldwide, 2006-2012 130 Table 4.40: U.S. Point of Care Pregnancy Testing Market, 2001-2012 130 Table 4.41: U.S. Market Share for Rapid Point of Care Pregnancy Tests 131 Table 4.42: Hemoglobin Testing Market for POCT Worldwide, 2006-2012 132 Table 4.43: Drivers of Demand for HIV Testing 136 Table 4.44: Worldwide POCT Market for HIV, 2001-2012 137 Table 4.45: U.S. POCT Market for HIV, 2001-2012 138 Table 4.46: Countries with the Highest Prevalence of HIV/AIDS 139 Table 4.47: FDA-approved Rapid HIV Antibody Screening Tests 141 Table 4.48: Cholesterol Testing Market for POCT Worldwide, 2006-2012 143 Table 4.49: Infectious Disease Testing Market for POCT Worldwide, 2006-2012 143 Table 4.50: Worldwide Point of Care Influenza Testing Market, 2002-2010 149 Table 4.51: U.S. Point of Care Influenza Testing Market, 2002-2010 150 Table 4.52: U.S. Market Share for Rapid Point of Care Influenza Tests, 2010 150 Table 4.53: Worldwide Point of Care Strep A Testing Market, 2002-2010 151 Table 4.54: U.S. Point of Care Strep A Testing Market, 2002-2010 151 Table 4.55: U.S. Market Share for Rapid Point of Care for Group A Strep Tests 151 Table 4.56: Global Market for Chlamydia Diagnostic Testing, 2000-2010 152 Table 4.57: U.S. Market for Chlamydia Diagnostic Testing, 2000-2010 152 Table 4.58: U.S. Market for MRSA Rapid Testing, 2006-2013 157 Table 4.59: Global Market for Gonorrhea Diagnostic Testing, 2000-2010 161 Table 4.60: Global Market for TB Diagnostic Testing, 2000-2010 163 Table 4.61: Point of Care Infectious Disease Testing Market: Market Drivers Ranked in Order of Impact 166 Table 4.62: Point of Care Infectious Disease Testing Market: Market Restraints Ranked in Order of Impact 166 Table 4.63: U.S. Anthrax Test Market 169 Table 5.1: Roche Diagnostics Glucose Testing Products 176 Table 5.2: Largest U.S. POCT Coagulation Diagnostic Testing Companies, 2010 193 Table 5.3: Actalyke XL 200 Table 5.4: Actalyke Mini 200 Table 5.5: Drug Test Sensitivity Cut-Off Levels Set by NIDA, WHO and SAMHSA for Drugs of Abuse 209 Table 5.6: Major Competitors in the Drugs of Abuse Oral Testing Market Segment 209 Table 5.7: Major Competitors in the Drugs of Abuse Urine Testing Market Segment 209 Table 5.8: ColoCARE Fecal Occult Blood Test 222 Table 5.9: Competitive Factors Related to HIV Tests 234 Table 5.10: Largest POCT Diagnostic Companies Worldwide, 2008 235 Table 5.11: Influenza Diagnostic Rapid Tests 250 Table 5.12: Type of Hepatitis Test: Lateral Flow 257 Table 5.13: Flow-through 258 Table 5.14: Agglutination 258 Table 5.15: Immunoblot 258 Table 5.16: AmniSure 267 Table 6.1: Access Points 270 Table 6.2: Desktop Adapters�Four Computers 270 Table 6.3: Desktop Adapters�One Computer 270 Table 6.4: PCMCIA Adapters 270 Table 6.5: POCT1-Compliant Connectivity Point of Care Instruments 273 Table 6.6: POCT Clinical Outcomes in Diabetic Ketoacidosis 275 Table 6.7: POCT Clinical Outcomes in Arterial Blood Gas Measurements 276 Table 6.8: POCT in Three Hospitals�Cost Analysis with Labor Included 278 Table 6.9: POCT versus Central Lab�Cost Analysis for Glucose Testing 279 Table 6.10: CLIA Laboratories by Type of Facility 280 Table 6.11: Financial Comparison for Moderate and Waived CLIA Labs 283 Table 6.12: Top Ten CMS Survey Deficiencies for CLIA Laboratories 286 Table 7.1: Key Changes in IVD Business Structure 292 Table 7.2: Business Trends in POCT 301 Table 7.3: Key Players Bring Business Developments to Point of Care Diagnostic Testing 301 Table 7.4: Emerging Trends in Point of Care Testing 301 Table 7.5: Future Developments in Point of Care Testing 302 Table 7.6: The Confluence of the New Technology 302 Table 7.7: Professional Continuous Glucose Monitoring (CGM) ICD-9 Codes 302 Table 7.8: Professional CGM 303 Table 8.1: Normal Glucose Values�Fasting State 308 Table 9.1: Applications for Wireless LAN Technology 318 Table 9.2: Customized Reports Must Support CAP and JCAHO Requirements 322 Table 9.3: RALS-Plus Point of Care Market Share 323 Table 9.4: Applications of RALS Connectivity with POCT Devices 323 Table 10.1: Abaxis Blood Analysis Diagnostic Tests 328 Table 10.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 329 Table 10.3: Products Marketed by Abbott in the Diagnostic Market 331 Table 11.1: Improvements in Achieving ED Operational Efficiency Using POCT 364 Table 11.2: Test Menu and TAT for ED 365 Table 11.3: Top Reasons Why Point of Care Cardiac Marker Testing is Implemented in the ED 365 Table 11.4: Key Areas and Metrics that Hospitals Measure to Assess Efficiency of ED 366 Table 11.5: Estimates of Patient Costs by DRG 367 [Fade out list of tables / figures] |
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