Point Of Care Diagnostic Testing World Markets - eport deals with the analysis of analytes that are related to the common chemical constituents of blood, plasma or serum at the point of care of the patient

	Point Of Care Diagnostic Testing World Markets
	Table of Contents: 1. Overview 12 1.1 About this Report 12 1.2 Scope of the Report 13 1.3 Objectives 14 1.4 Methodology 14 1.5 Executive Summary 15 2. Overview of Diagnostic Testing Point of Care 18 2.1 POCT Testing Sites 18 2.2 POCT Market Structure 19 2.3 New Directions in Clinical IVD Testing 19 3. POC and Rapid Testing: Market Analysis: Size, Background Analysis, Growth, Share and Competitors 21 3.1 Global POCT Market 26 3.2 U.S. POCT Markets 26 3.3 European POCT Market 28 3.3.1 German Point of Care Diagnostic Markets 34 3.3.2 U.K. POCT Diagnostic Market 37 3.3.2.1 U.K. POC Market Statistics 38 3.3.2.2 U.K. Competitive Analysis 39 3.3.2.3 U.K. Market Access 40 3.3.3 French Point of Care Diagnostic Market 40 3.3.4 Italian POC Diagnostic Market 42 3.3.5 Spanish POC Diagnostic Market 43 3.3.6 Scandinavian Point of Care Market 45 3.3.7 Swedish POCT Market 46 3.3.8 Finland POCT Market 47 3.3. 9 Norway POCT Market 48 3.3.10 Swiss POCT Market 49 3.3.11 Dutch Clinical Laboratory Diagnostic Market 50 3.3.12 Belgian Clinical Laboratory Diagnostic Market 51 3.3.13 Portugal Clinical Laboratory Diagnostic Market 51 3.3.14 Austria Clinical Laboratory Diagnostic Market 52 3.3.15 Greece Clinical Laboratory Diagnostic Market 53 3.3.16 Poland Clinical Laboratory Diagnostic Market 54 3.3.17 Czech Republic Clinical Laboratory Diagnostic Market 55 3.3.18 Turkey Point of Care Market 56 3.4 Asian POCT Markets 56 3.4.1 Japanese POCT Market 56 3.4.2 Indian POCT Market 58 3.4.3 Chinese Point of Care Market 66 3.5 Rest of the World POCT Market 75 3.5.1 Canada Point of Care Market 76 3.5.2 Brazil Point of Care Market 76 3.5.3 Australia Point of Care Market 77 3.6 Overview of Asian Healthcare Market 77 3.6.1 Singapore 79 3.6.2 Malaysia 80 3.6.3 Thailand 80 3.6.4 Indonesia 80 3.6.5 Philippines 80 3.6.6 South Korea 81 3.6.7 Taiwan 81 4. POCT Individual Markets 82 4.1 Glucose Testing 82 4.2 POCT Individual Market Sectors, Size, Growth Rates and Competitors 83 4.2.1 U.S. Market 83 4.2.2 European Market 84 4.2.3 Alternate Glucose Monitoring Products 85 4.3 Blood Gas and Electrolytes 86 4.4 Rapid Coagulation Tests 88 4.4.1 U.S. Coagulation Market 90 4.4.2 European Coagulation Market 92 4.5 Rapid Cardiac Markers 93 4.5.1 American Market 93 4.5.2 European Market 94 4.6 Drugs of Abuse Screening Testing 96 4.6.1 Acetaminophen 101 4.6.2 TriCyclic Antidepressants 101 4.6.3 Other Toxic Drugs 101 4.6.4 Drug Testing Selectivity 101 4.6.5 Methaqualone and Phencyclidine (PCP) 102 4.6.6 Tetrahydrocannabinol 102 4.6.7 Drug Panels by Toxidromes 102 4.6.8 Alcohol Testing 102 4.7 Urine Strips 102 4.8 Pregnancy Tests 105 4.9 Fecal Occult Blood 106 4.10 Hemoglobin Testing 106 4.11 Miscellaneous Rapid Tests 106 4.11.1 Estriol 106 4.11.2 Fetal Fibrinectin (fFN) 107 4.11.3 H. pylori 107 4.11.4 Vaginal pH and Vaginitis 108 4.11.5 Bladder Cancer 109 4.11.6 Fetal Status 110 4.12 HIV 110 4.13 Cholesterol 114 4.14 Infectious Disease 114 4.14.1 C. difficile 114 4.14.2 Giardia 115 4.14.3 Salmonella and Campylobacter 116 4.14.4 Malaria Testing 117 4.14.5 Influenza Testing 118 4.14.6 Strep Testing 119 4.14.7 Chlamydia 121 4.14.8 Mononucleosis 122 4.14.9 Rubella 122 4.14.10 Staphylococcus Aurea 122 4.14.11 Hepatitis 124 4.14.12 Gonorrhea 126 4.14.13 Tuberculosis (TB) 126 4.14.14 Herpes Simplex Virus Type-2 127 4.15 Infant Jaundice 127 4.16 Anthrax 128 4.15 Ruptured of Fetal Membranes (ROM) 130 4.16 Food Pathogens 130 4.17 Typhoid 130 5. POCT: Reagents and Equipment 131 5.1 Blood Glucose Monitoring 131 5.2 Blood Gas and Electrolytes 145 5.2.1 Optical Sensors 145 5.2.2 Roche Corp. 146 5.2.3 TechnoMedica 146 5.2.4 Bayer 146 5.2.5 Instrumentation Laboratory 147 5.2.6 Nova Biomedical 147 5.2.7 Radiometer 147 5.2.8 Abbott (i-STAT Corporation) 147 5.2.9 Avox Systems 148 5.2.10 Disetronic Medical Systems 150 5.2.11 Nova 150 5.2.12 Abbott 150 5.2.13 ITC 150 5.2.14 Osmetech 150 5.2.15 Span Diagnostics 151 5.3 Rapid Coagulation Tests 151 5.3.1 POC Coagulation Instrument Description 155 5.3.1.1 Roche Diagnostics Corp. 155 5.3.1.2 Abbott i-STAT 157 5.3.1.3 International Technidyne Corp. 157 5.3.1.4 Medtronic Cardiac Surgery 159 5.3.1.5 LifeScan 159 5.3.1.6 Instrumentation Laboratory 159 5.3.1.7 Hemosense 159 5.3.1.8 Helena Point of Care 159 5.3.1.9 Bayer 160 5.3.1.10 Beckman Coulter 160 5.3.1.11 Pharmanetics (Cardiovascular Diagnostics) 160 5.3.1.12 Sienco 162 5.3.1.13 Accumetrics 162 5.3.2 Connectivity Issues 162 5.3.3 Cost Benefits 162 5.3.4 Quality Control Issues 163 5.3.5 Certification for POC Coagulation Devices 164 5.3.6 Systems for ACT 164 5.4 Rapid Cardiac Markers 164 5.4.1 Spectral Diagnostics 164 5.4.2 Biosite Diagnostics 165 5.4.3 Roche Diagnostics 165 5.4.4 First Medical 166 5.4.5 Ani Biotech 166 5.4.6 Response Biomedical 166 5.4.7 Dade Behring 166 5.4.8 SYN•X Pharma, Inc. 167 5.4.9 Ark Therapeutics Ltd. 167 5.4.10 Abbott (i-STAT Corp.) 168 5.4.11 LifeSign 168 5.4.12 Mitsubishi Kagaku Iatron 168 5.5 Rapid Drugs of Abuse 168 5.5.1 Biosite Diagnostics 169 5.5.2 Point of Care Technologies 169 5.5.3 Abbott Diagnostics 170 5.5.4 Roche Diagnostics 170 5.5.5 BioScan Screening Systems, Inc. 171 5.5.6 American Bio Medica Corp. 171 5.5.7 Pharmatech Corporation 174 5.5.8 Worldwide Medical 174 5.5.9 Syva Dade Behring 175 5.5.10 STC Technologies Inc. 175 5.5.11 Dynagen Inc. 175 5.5.12 Orasure 175 5.5.13 LifePoint 175 5.5.14 Avitar, Inc. 176 5.5.15 Cozart Biosciences 176 5.5.16 GDS 177 5.5.17 Securetec 177 5.6 Urine Strips 177 5.7 Rapid Pregnancy and Fertility Tests 178 5.8 Fecal Occult Blood 180 5.8.1 Helena Laboratories 181 5.8.2 Biomerica 181 5.8.3 Beckman Coulter 181 5.8.4 Wampole Laboratories 181 5.8.5 Worldwide Medical 181 5.8.6 Aerscher Diagnostics 182 5.8.7 Enterix 182 5.8.8 Medix Biochemica 182 5.9 Hemoglobin Testing 182 5.9.1 Wampole Laboratories 182 5.9.2 HemoCue, Inc. 183 5.9.3 Micro Diagnostics Corporation 183 5.9.4 GDS Technology 183 5.10 Miscellaneous Rapid Tests 183 5.10.1 Triage C. difficile Panel 183 5.10.2 Ketoacids 184 5.10.3 Acetaminophen 184 5.10.4 Estriol 184 5.10.5 H. pylori 185 5.10.6 Vaginal Fluid pH and Vaginitis 186 5.10.7 PSA 187 5.10.8 Bladder Cancer 187 5.10.9 Other Rapid Cancer Tests 191 5.10.10 Fetal Status 191 5.10.11 Osteoporosis 192 5.11 HIV 192 5.12 Cholesterol 196 5.12.1 Cholestech 197 5.12.2 Lifestream Diagnostics 198 5.12.3 Actimed Laboratories 199 5.12.4 Stat Site Meter 199 5.12.5 Polymer Technology Systems 199 5.12.6 International Medical Innovations Inc. (IMI) 199 5.13 Infectious Disease 200 5.13.1 C. difficile 200 5.13.2 Giardia 201 5.13.3 Dengue Fever 201 5.13.4 Malaria Testing 201 5.13.5 Rapid Influenza Testing 203 5.13.6 Streptococcus Testing 204 5.13.7 Chlamydia 206 5.13.8 Mononucleosis 206 5.13.9 Rubella 207 5.13.10 Staphylococcus 207 5.13.11 Hepatitis 208 5.13.12 E. coli 0157 210 5.13.13 Gonorrhea Testing 210 5.13.14 Small Pox 211 5.13.15 SARS 211 5.13.16 Rabies 211 5.13.17 Tuberculosis 211 5.13.18 Avian Flu 211 5.13.19 West Nile Virus 211 5.13.20 Herpes Simplex Virus Type-2 212 5.14 Infant Jaundice 212 5.15 Anthrax 212 5.16 Homeland Defense 214 5.17 BSE 214 5.18 Tuberculosis 214 5.19 Typhoid 215 5.20 Asian Flu 215 5.21 Food Pathogens (Salmonella, Listeria, Campylobacter) 215 5.22 Ruptured Fetal Membranes (ROM) 216 6. POCT: Growth Regulators 217 6.1 Moderators of Growth 217 6.2 Personnel Acceptance 219 6.3 Key People for POCT 219 6.4 Information Management Issues 219 6.4.1 Elements of Information Management for POCT: Information Processing Capabilities 220 6.4.2 Data Mining 221 6.4.3 Middleware 221 6.4.4 Web Portals 222 6.4.5 POCT-1A Standard 222 6.5 Key Elements for POCT 222 6.6 POCT and Reimbursement 223 6.7 Effectiveness of Clinical Outcomes 225 6.8 Rapid Near Patient Testing in Hospitals 226 6.9 Satellite Facilities 226 6.10 Regionalization of Laboratory Care 227 6.11 Requirements for POCT 228 6.12 Locations of Point of Care for Patient Care 229 6.13 Benefits of POCT 229 6.14 TAT for POCT 230 6.15 Clinical Laboratory Improvement Amendments (CLIA) 231 6.16 Sexually Transmitted Diseases in Underdeveloped Countries 232 7. Business Trends in the Point of Care Sector 233 7.1 Sector Consolidation 233 7.2 Diagnostic Testing Growth Trends 234 7.3 Acquisition, License Agreements, Internal Development, Partnerships 235 7.4 Product Testing Depth in POCT 237 7.5 Government Regulation 237 7.5.1 U.S. Regulation 237 7.5.1.1 Importing Medical Devices into the U.S. 239 7.5.1.2 Exporting Medical Devices from the U.S. 239 7.5.2 U.K. Regulation 240 7.5.3 E.U. Regulation 241 7.5.3.1 French Regulation 243 7.5.4 Japanese Regulation 243 7.5.5 Korean Regulation 244 7.6 Increased Market Penetration 244 7.7 Costs of Doing Business in Europe 245 7.8 Drivers of European Diagnostics Testing 245 7.9 European Reimbursement Practices 245 7.10 Cost Containment in Europe 246 8. Technology Platform Innovations in POCT 247 8.1 Sensor Systems for Diagnostic Applications 247 8.2 Glucose Measurements 249 8.3 Glucose Test Methods 252 8.4 Cholesterol Testing 252 8.5 The New Paradigm 253 8.6 Consolidated Workstations and Modularity 253 8.7 Automation and Robotics in the Clinical Laboratory 254 8.8 Laboratory Information Systems (LIS) 254 8.9 Biosensor Technology 255 9. Data Management and Connectivity 258 9.1 Wireless LANs 258 9.2 Connectivity Platforms 261 9.2.1 DataLink Data Management System 261 9.2.2 RALS-Plus 263 9.2.3 LabPortal.com 265 9.3 Advantages of POCT Connectivity 265 10. Corporate Profiles 267 10.1 Abaxis, Inc. 267 10.2 Abbott Diagnostics 268 10.3 Accumetrics, Inc. 271 10.4 Accurex Biomedical, Pvt., Ltd. 272 10.5 ActiMed Diagnostics 272 10.6 Adeza Biomedical Corporation 272 10.7 Akers Bioscience 273 10.8 Ambri Ltd. 273 10.9 American Biogenetic Sciences, Inc. 273 10.10 American Bio Medica Corp. 273 10.11 Ani Biotech 275 10.12 Apogent Technologies 275 10.13 Ark Therapeutics 276 10.14 Arkray 276 10.15 Array Medical 276 10.16 Atlas Genetics 277 10.17 Autonomics 277 10.18 Avitar, Inc. 277 10.19 Avox Systems 278 10.20 Axis-Shield 278 10.21 Bayer Corporation 279 10.22 Beacon Diagnostics 281 10.23 Beckman Coulter 281 10.24 Biex Inc. 285 10.25 Binax Corporation 285 10.26 Biomerica 285 10.27 BioMérieux Vitek, Inc. 286 10.28 BioScan Screening Systems, Inc. 286 10.29 Biosite Diagnostics 286 10.30 BioStar 290 10.31 Bio-Warm Corporation 290 10.32 British Biocell Holdings 291 10.33 Caliper Life Sciences 291 10.34 Calypte Biomedical 291 10.35 Cardiovascular Diagnostics 293 10.36 Chembio Diagnostics 293 10.37 ChemTrak 293 10.38 Cholestech 293 10.39 Chongqing Sungene Pharmaceutical Co., Ltd. 294 10.40 Compucyte Corporation 294 10.41 Cortech Diagnostics Ltd. 295 10.42 Cozart Biosciences 296 10.43 Cygnus Therapeutic Systems 296 10.44 Cytogen 298 10.45 Dade Behring 298 10.46 Daiichi Co., Ltd. 299 10.47 Denka Seiken Co., Ltd. 299 10.48 Diagnology, Inc. 299 10.49 Ely Labs 299 10.50 Enterix, Inc. 300 10.51 First Medical, Inc. 300 10.52 Focus Diagnostics, Inc. 300 10.53 GDS Technology 300 10.54 GenBio 301 10.55 Genzyme Diagnostics 301 10.56 Grant Life Sciences 303 10.57 Gryphus Diagnostics 303 10.58 Helena Laboratories 303 10.59 Hema Diagnostic Systems 304 10.60 Hemocue, Inc. 304 10.61 Home Access Health Corp. 304 10.62 i-STAT Corporation 305 10.63 Instrumentation Laboratory 306 10.64 International Medical Innovations 306 10.65 Inverness Medical Innovations 306 10.66 Immunoscience, Inc. 309 10.67 Jiangnan Biotech 309 10.68 Johnson & Johnson 310 10.69 Kuerkeji Biotech 310 10.70 Kyowa Medex Co., Ltd. 311 10.71 LifeAssays 311 10.72 LifePoint, Inc. 311 10.73 LifeScan Corporation 313 10.74 Lifestream Technologies 314 10.75 LXN Corp. (Inverness Medical Technologies) 314 10.76 Matritech 314 10.77 Medical Services International Inc. 314 10.78 MediSense 315 10.79 Medisys 315 10.80 Medix Biochemica 315 10.81 MedMira Laboratories 315 10.82 Meretek Corporation 317 10.83 Meridian Bioscience 317 10.84 MiniMed 319 10.85 Mitsubishi Chemical America, Inc. 320 10.86 Mitsubishi Kagaku Iatron 320 10.87 Nanogen 320 10.88 New Horizons Diagnostics 321 10.89 Nova Diagnostics 321 10.90 Optical Sensors Inc. 323 10.91 Orasure 324 10.92 Orgenics 325 10.93 Orion Diagnostica 326 10.94 PanBio Corp. 326 10.95 PharmaNetics, Inc. 326 10.96 Pharmatech Corporation 327 10.97 Phillips Medical Systems 327 10.98 Point of Care Technologies 327 10.99 Polymedco 328 10.100 Polymer Technology Systems 329 10.101 Princeton BioMeditech Corporation 329 10.102 Quidel 329 10.103 Radiometer 332 10.104 Response Biomedical Corp. 334 10.105 Roche Diagnostics 335 10.106 Royal Philips Electronics 337 10.107 Saliva Diagnostics 338 10.108 Savyon Diagnostics 338 10.109 Selfcare, Inc. 339 10.110 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech) 339 10.111 Shionogi & Co., Ltd. 339 10.112 SpectRx, Inc. 339 10.113 Spectral Diagnostics 340 10.114 STC Technologies 341 10.115 Strategic Diagnostics 341 10.116 Sun Biomedical Laboratories 341 10.117 Sybron International Corporation 341 10.118 Taiwan Diagnostic 341 10.119 TCPI 342 10.120 Therasense, Inc. 343 10.121 Thermo Biostar 343 10.122 Thoratec/International Technidyne Corp. 343 10.123 Transmedica 344 10.124 Trinity Biotech 345 10.125 Venkateshwara Hatcheries Pvt. Ltd. 345 10.126 Wampole Laboratories 345 10.127 Worldwide Medical Corporation 346 11. POCT Sector Trends and Forecasts 347 12. Corporate Directory 350 LIST OF FIGURES Figure 6.1: Percent Distribution of Emergency Room Visits in the U.S., 2004 218 Figure 6.2: Annual Rate of Emergency Room Visits By Primary Expected Source of Payment: U.S., 2004 225