Point of Care Diagnostic Testing - World Markets
The purpose of this report is to describe the point of care testing (POCT) market. It examines clinical measurement devices and their reagents and supplies as utilized in hospitals, clinics and doctor\'s offices. An analysis of analytes that are related to the common chemical constituents of blood, plasma or serum at the point of care of the patient is addressed. Moreover, the study defines the dollar volume of sales, both worldwide and in the U.S., and analyzes the factors that influence the size and the growth of the market segments.
Also examined are the subsections of each market segment, including the research labs, hospital labs and commercial laboratories. Additionally, rapid detection of food pathogens and infectious pathogens (MRSA, herpes simplex, avian flu, West Nile virus and typhoid) are discussed.
The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the point of care market in the U.S. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company\'s market position.
Table of Contents
- 1.Overview13
- 1.1About this Report 13
- 1.2Scope of the Report14
- 1.3Objectives15
- 1.4Methodology15
- 1.5Executive Summary16
- 2. Overview of Diagnostic Testing Point of Care20
- 2.1POCT Testing Sites20
- 2.2POCT Market Structure21
- 2.3New Directions in Clinical IVD Testing21
- 3.POC and Rapid Testing Market Analysis: Size, Background Analysis, Growth, Share and Competitors 23
- 3.1Global POCT Market28
- 3.2U.S. POCT Market30
- 3.3European POCT Market32
- 3.3.1German Point of Care Diagnostic Market38
- 3.3.2U.K. POCT Diagnostic Market41
- 3.3.2.1U.K. POC Market Statistics41
- 3.3.2.2U.K. Competitive Analysis43
- 3.3.2.3U.K. Market Access44
- 3.3.3French Point of Care Diagnostic Market44
- 3.3.4Italian POC Diagnostic Market45
- 3.3.5Spanish POC Diagnostic Market46
- 3.3.6Scandinavian Point of Care Market 48
- 3.3.7Swedish POCT Market48
- 3.3.8Finland POCT Market49
- 3.3.9Norway POCT Market50
- 3.3.10Swiss POCT Market51
- 3.3.11Dutch Clinical Laboratory Diagnostic Market51
- 3.3.12Belgian Clinical Laboratory Diagnostic Market52
- 3.3.13Portugal Clinical Laboratory Diagnostic Market53
- 3.3.14Austria Clinical Laboratory Diagnostic Market54
- 3.3.15Greek Clinical Laboratory Diagnostic Market54
- 3.3.16Poland Clinical Laboratory Diagnostic Market55
- 3.3.17Czech Republic Clinical Laboratory Diagnostic Market56
- 3.3.18Turkish Point of Care Market57
- 3.4Asian POCT Markets57
- 3.4.1Japanese POCT Market57
- 3.4.2 Indian POCT Market59
- 3.4.3Chinese Point of Care Market64
- 3.5Rest of the World POCT Market73
- 3.5.1Canada Point of Care Market73
- 3.5.2Brazil Point of Care Market74
- 3.5.3Australia Point of Care Market74
- 3.6Overview of Asian Healthcare Market75
- 3.6.1Singapore76
- 3.6.2Malaysia77
- 3.6.3Thailand 77
- 3.6.4Indonesia78
- 3.6.5Philippines78
- 3.6.6South Korea78
- 3.6.7Taiwan 79
- 4.POCT Individual Markets80
- 4.1Glucose Testing80
- 4.2POCT Individual Market Sectors, Size, Growth Rates and Competitors81
- 4.2.1World Market81
- 4.2.2 U.S. Market82
- 4.2.3European Market83
- 4.2.3Alternate Glucose Monitoring Products84
- 4.2.4 HbA1c POCT85
- 4.3Blood Gas and Electrolytes86
- 4.3.1Whole Blood Lactate88
- 4.4Rapid Coagulation Tests88
- 4.4.1World POCT Coagulation Market90
- 4.4.2 U.S. Coagulation Market90
- 4.4.2European Coagulation Market93
- 4.5Rapid Cardiac Markers94
- 4.5.1U.S. Market94
- 4.5.2European Market96
- 4.6Drugs of Abuse Screening Testing97
- 4.6.1Acetaminophen103
- 4.6.2Tricyclic Antidepressants (TCAs)104
- 4.6.3Other Toxic Drugs104
- 4.6.4Drug Testing Selectivity104
- 4.6.5Methaqualone and Phencyclidine (PCP)104
- 4.6.6Tetrahydrocannabinol104
- 4.6.7Drug Panels by Toxidromes105
- 4.6.8Alcohol Testing105
- 4.7Urine Strips106
- 4.8Pregnancy Tests108
- 4.9Fecal Occult Blood110
- 4.10Hemoglobin Testing110
- 4.11Miscellaneous Rapid Tests 111
- 4.11.1Estriol111
- 4.11.2Fetal Fibronectin (fFN)112
- 4.11.3H. pylori112
- 4.11.4Vaginal pH and Vaginitis112
- 4.11.5Bladder Cancer113
- 4.11.6Fetal Status114
- 4.12Human Immunodeficiency Virus (HIV)114
- 4.13Cholesterol119
- 4.14Infectious Disease120
- 4.14.1C. difficile120
- 4.14.2Giardia121
- 4.14.3Salmonella and Campylobacter122
- 4.14.4Malaria Testing123
- 4.14.5Influenza Testing 124
- 4.14.6Strep Testing125
- 4.14.7Chlamydia127
- 4.14.8Mononucleosis128
- 4.14.9Rubella128
- 4.14.10Staphylococcus Aureus128
- 4.14.11Hepatitis129
- 4.14.12Gonorrhea131
- 4.14.13Tuberculosis (TB)132
- 4.14.14Herpes Simplex Virus Type-2133
- 4.15Infant Jaundice134
- 4.16Anthrax 134
- 4.15Rupture of Fetal Membranes (ROM)136
- 4.16Food Pathogens 136
- 4.17Typhoid136
- 5. POCT: Reagents and Equipment137
- 5.1 Blood Glucose Monitoring137
- 5.1.1LifeScan138
- 5.1.2Roche Accu-Chek141
- 5.1.3Siemens141
- 5.1.4Cholestech143
- 5.1.5Medisense (Abbott)143
- 5.1.6International Technidyne Corporation144
- 5.1.7HemoCue145
- 5.1.8GDS Technology 145
- 5.1.9LXN Corporation 146
- 5.1.10Medtronic MiniMed146
- 5.1.11Cygnus146
- 5.1.12Abaxis148
- 5.1.13Inverness Medical Technology150
- 5.2Blood Gas and Electrolytes152
- 5.2.1Optical Sensors, Inc.152
- 5.2.2Roche Corporation152
- 5.2.3TechnoMedica152
- 5.2.4Siemens 153
- 5.2.5Instrumentation Laboratory153
- 5.2.6Nova Biomedical153
- 5.2.7Radiometer153
- 5.2.8Abbott (i-STAT Corporation)154
- 5.2.9Span Diagnostics 154
- 5.2.10Avox Systems154
- 5.2.11Disetronic Medical Systems156
- 5.2.12Nova156
- 5.2.13ITC156
- 5.2.14Osmetech157
- 5.3Rapid Coagulation Tests157
- 5.3.1POC Coagulation Instrument Description161
- 5.3.1.1Roche Diagnostics Corp.161
- 5.3.1.2Abbott (i-STAT Corp.)163
- 5.3.1.3International Technidyne Corp.163
- 5.3.1.4Medtronic Cardiac Surgery164
- 5.3.1.5HemoSense165
- 5.3.1.6Helena Point of Care165
- 5.3.1.7Siemens 165
- 5.3.1.8Beckman Coulter 166
- 5.3.1.9Pharmanetics (Cardiovascular Diagnostics)166
- 5.3.1.10Sienco168
- 5.3.1.11Accumetrics168
- 5.3.2Connectivity Issues168
- 5.3.3Cost Benefits168
- 5.3.4Quality Control Issues169
- 5.3.5Certification for POC Coagulation Devices169
- 5.3.1POC Coagulation Instrument Description161
- 5.4Rapid Cardiac Markers170
- 5.4.1Spectral Diagnostics170
- 5.4.2Biosite Diagnostics170
- 5.4.3Roche Diagnostics171
- 5.4.4First Medical171
- 5.4.5Ani Biotech171
- 5.4.6Response Biomedical171
- 5.4.7Dade Behring172
- 5.4.8SYN•X Pharma, Inc.172
- 5.4.9Ark Therapeutics, Ltd.173
- 5.4.10Abbott (i-STAT Corp.)173
- 5.4.11LifeSign 173
- 5.4.12Mitsubishi Kagaku Iatron173
- 5.5Rapid Drugs of Abuse173
- 5.5.1Biosite Diagnostics (Inverness)175
- 5.5.2Abbott Diagnostics176
- 5.5.3Roche Diagnostics176
- 5.5.4BioScan Screening Systems, Inc.177
- 5.5.5American Bio Medica Corp.178
- 5.5.6Pharmatech Corporation181
- 5.5.7Worldwide Medical181
- 5.5.8Syva Dade Behring182
- 5.5.9STC Technologies, Inc.182
- 5.5.10DynaGen, Inc.182
- 5.5.11OraSure 182
- 5.5.12LifePoint182
- 5.5.13Avitar, Inc.183
- 5.5.14Cozart Biosciences183
- 5.5.15Securetec184
- 5.6Urine Strips184
- 5.7Rapid Pregnancy and Fertility Tests 185
- 5.8Fecal Occult Blood188
- 5.8.1Helena Laboratories188
- 5.8.2Biomerica188
- 5.8.3Beckman Coulter188
- 5.8.4Wampole Laboratories188
- 5.8.5Worldwide Medical188
- 5.8.6Aerscher Diagnostics189
- 5.8.7Enterix189
- 5.8.8Medix Biochemica189
- 5.9Hemoglobin Testing190
- 5.9.1Wampole Laboratories190
- 5.9.2HemoCue, Inc.190
- 5.9.3Micro Diagnostics Corporation190
- 5.9.4GDS Technology 190
- 5.10Miscellaneous Rapid Tests 190
- 5.10.1Triage C. difficile Panel190
- 5.10.2Ketoacids191
- 5.10.3Acetaminophen191
- 5.10.4Estriol191
- 5.10.5H. pylori192
- 5.10.6Vaginal Fluid pH and Vaginitis194
- 5.10.7Prostate Specific Antigen (PSA)194
- 5.10.8Bladder Cancer195
- 5.10.9Other Rapid Cancer Tests198
- 5.10.10Fetal Status (PROM)198
- 5.10.11Osteoporosis199
- 5.11HIV199
- 5.12Cholesterol205
- 5.12.1Cholestech205
- 5.12.2Lifestream Technologies, Inc.206
- 5.12.3Actimed Laboratories207
- 5.12.4StatSite Meter207
- 5.12.5Polymer Technology Systems207
- 5.12.6International Medical Innovations Inc. (IMI)207
- 5.13Infectious Disease208
- 5.13.1C. difficile208
- 5.13.2Giardia208
- 5.13.3Dengue Fever209
- 5.13.4Malaria Testing209
- 5.13.5Rapid Influenza Testing211
- 5.13.6Streptococcus Testing212
- 5.13.7Chlamydia213
- 5.13.8Mononucleosis214
- 5.13.9Rubella215
- 5.13.10Staphylococcus Aureus215
- 5.13.11Hepatitis216
- 5.13.12E. coli O157218
- 5.13.13Gonorrhea Testing219
- 5.13.14Smallpox219
- 5.13.15SARS219
- 5.13.16Rabies219
- 5.13.17Tuberculosis219
- 5.13.18Avian Flu219
- 5.13.19West Nile Virus220
- 5.13.20Herpes Simplex Virus Type-2220
- 5.14Infant Jaundice220
- 5.15Anthrax221
- 5.16Homeland Defense222
- 5.17BSE (Mad Cow Disease)222
- 5.18Tuberculosis222
- 5.19 Typhoid223
- 5.20Avian flu223
- 5.21Food Pathogens (Salmonella, Listeria, Campylobacter)223
- 5.22Ruptured Fetal Membranes (ROM)224
- 5.1 Blood Glucose Monitoring137
- 6.POCT: Growth Regulators 225
- 6.1Moderators of Growth225
- 6.2Personnel Acceptance225
- 6.3Key People for POCT226
- 6.4Information Management Issues226
- 6.4.1Elements of Information Management for POCT: Information Processing Capabilities227
- 6.4.2Data Mining227
- 6.4.3Middleware228
- 6.4.4Web Portals229
- 6.4.5POCT-1A Standard229
- 6.5Key Elements for POCT229
- 6.6POCT and Reimbursement230
- 6.7Effectiveness of Clinical Outcomes232
- 6.8Rapid Near-Patient Testing in Hospitals232
- 6.9Satellite Facilities233
- 6.10Regionalization of Laboratory Care234
- 6.11Requirements for POCT235
- 6.12Locations of Point of Care for Patient Care236
- 6.13Benefits of POCT236
- 6.14TAT for POCT237
- 6.15Clinical Laboratory Improvement Amendments (CLIA)237
- 6.16 Sexually-Transmitted Diseases in Underdeveloped Countries239
- 7.Business Trends in the Point of Care Sector240
- 7.1Sector Consolidation240
- 7.2Diagnostic Testing Growth Trends241
- 7.3Acquisition, License Agreements, Internal Development and Partnerships241
- 7.4Product Testing Depth in POCT244
- 7.5Government Regulation245
- 7.5.1U.S. Regulation245
- 7.5.1.1Importing Medical Devices into the U.S.246
- 7.5.1.2Exporting Medical Devices from the U.S.247
- 7.5.2U.K. Regulation247
- 7.5.3E.U. Regulation248
- 7.5.3.1French Regulation250
- 7.5.4Japanese Regulation250
- 7.5.5Korean Regulation251
- 7.5.1U.S. Regulation245
- 7.6Increased Market Penetration251
- 7.7Costs of Doing Business in Europe252
- 7.8Drivers of European Diagnostics Testing252
- 7.9European Reimbursement Practices 252
- 7.10Cost Containment in Europe253
- 8.Technology Platform Innovations in POCT254
- 8.1Sensor Systems for Diagnostic Applications 254
- 8.2Glucose Measurements256
- 8.3Glucose Test Methods259
- 8.4Cholesterol Testing260
- 8.5The New Paradigm260
- 8.6Consolidated Workstations and Modularity261
- 8.7Automation and Robotics in the Clinical Laboratory261
- 8.8Laboratory Information Systems (LIS)261
- 8.8.1 NOVIUS Lab262
- 8.9Biosensor Technology262
- 9.Data Management and Connectivity265
- 9.1Wireless LANs265
- 9.2Connectivity Platforms268
- 9.2.1DataLink Data Management System268
- 9.2.2RALS-Plus269
- 9.2.3LabPortal.com271
- 9.2.4 BD.id271
- 9.3Advantages of POCT Connectivity 272
- 9.3.1 Cost Benefit of POCT and IT Connectivity272
- 10.Corporate Profiles274
- 10.1Abaxis, Inc.274
- 10.2Abbott Diagnostics276
- 10.3Accumetrics, Inc.279
- 10.4Accurex Biomedical, Pvt., Ltd.280
- 10.5Adeza Biomedical Corporation280
- 10.6Akers Biosciences280
- 10.7Ambri, Ltd.280
- 10.8American Biogenetic Sciences, Inc.281
- 10.9American Bio Medica Corp.281
- 10.10Ani Biotech282
- 10.11Apogent Technologies283
- 10.12Ark Therapeutics 283
- 10.13ARKRAY283
- 10.14Atlas Genetics284
- 10.15Atonomics284
- 10.16Avitar, Inc.284
- 10.17Avox Systems284
- 10.18Axis-Shield285
- 10.19Siemens Corporation285
- 10.20Beckman Coulter 286
- 10.21Binax Corporation290
- 10.22Biomerica290
- 10.23BioMérieux Vitek, Inc.291
- 10.24BioScan Screening Systems, Inc.291
- 10.25Biosite Diagnostics291
- 10.26BioStar291
- 10.27British Biocell Holdings291
- 10.28Caliper Life Sciences292
- 10.29Calypte Biomedical293
- 10.30Cardiovascular Diagnostics294
- 10.31Chembio Diagnostics294
- 10.32ChemTrak294
- 10.33Cholestech294
- 10.34Chongqing Sungene Pharmaceutical Co., Ltd.294
- 10.35CompuCyte Corporation294
- 10.36Cortech Diagnostics Ltd. (now called Kent International Holdings)295
- 10.37Cozart Biosciences295
- 10.38Cygnus Therapeutic Systems295
- 10.39Cytogen 295
- 10.40Dade Behring296
- 10.41Daiichi Co., Ltd.296
- 10.42Denka Seiken Co., Ltd.296
- 10.43Diagnostic Chemicals, Ltd.296
- 10.44Enterix, Inc.297
- 10.45First Medical, Inc.297
- 10.46Focus Diagnostics, Inc.297
- 10.47GDS Technology 297
- 10.48GenBio297
- 10.49Genzyme Diagnostics297
- 10.50Grant Life Sciences299
- 10.51Gryphus Diagnostics300
- 10.52Helena Laboratories300
- 10.53Hema Diagnostic Systems300
- 10.54Hemocue, Inc.301
- 10.55Home Access Health Corp.301
- 10.56i-STAT Corporation301
- 10.57Instrumentation Laboratory301
- 10.58International Medical Innovations302
- 10.59Inverness Medical Innovations302
- 10.60Immunoscience, Inc.306
- 10.61Johnson & Johnson307
- 10.62Kyowa Medex Co., Ltd.309
- 10.63LifeAssays309
- 10.64LifePoint, Inc.309
- 10.65LifeScan Corporation309
- 10.66Lifestream Technologies309
- 10.67LXN Corp. (Inverness Medical Technologies)309
- 10.68Matritech309
- 10.69Medical Services International, Inc. 310
- 10.70MediSense311
- 10.71Medisys 311
- 10.72Medix Biochemica311
- 10.73MedMira Laboratories311
- 10.74Meretek Corporation312
- 10.75Meridian Bioscience312
- 10.76MiniMed314
- 10.77Mitsubishi Chemical USA, Inc.315
- 10.78Mitsubishi Kagaku Iatron 315
- 10.79Nanogen316
- 10.80New Horizons Diagnostics 318
- 10.81Nova Biomedical318
- 10.82Väsamed, Inc.320
- 10.83OraSure321
- 10.84Orgenics324
- 10.85Orion Diagnostica324
- 10.86PanBio, Ltd.324
- 10.87PharmaNetics, Inc.325
- 10.88Phamatech, Inc.325
- 10.89Royal Philips Electronics325
- 10.90Polymedco326
- 10.91Polymer Technology Systems327
- 10.92Princeton BioMeditech Corporation 327
- 10.93Quest Diagnostics327
- 10.94Quidel328
- 10.95Radiometer332
- 10.96Response Biomedical Corp.334
- 10.97Roche Diagnostics335
- 10.98StatSure Diagnostic Systems337
- 10.99Savyon Diagnostics338
- 10.100Selfcare, Inc.339
- 10.101Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech)339
- 10.102Shionogi & Co., Ltd.339
- 10.103SpectRx, Inc.339
- 10.104Spectral Diagnostics340
- 10.105STC Technologies340
- 10.106Strategic Diagnostics340
- 10.107Sun Biomedical Laboratories340
- 10.108Sybron International Corporation341
- 10.109TCPI341
- 10.110Therasense, Inc.341
- 10.111Thermo Biostar341
- 10.112Thoratec/International Technidyne Corp.341
- 10.113Transmedica342
- 10.114Trinity Biotech343
- 10.115Venkateshwara Hatcheries Pvt., Ltd.345
- 10.116Wampole Laboratories345
- 10.117Worldwide Medical Corporation345
- 11.POCT Sector Trends and Forecasts 346
- 11.1 Home Care Analysis as Part of Near-Patient Testing346
- 11.2 Non-Traditional Collection for POCT346
- 11.3 New Systems for Critical Care and Near-Patient Testing346
- 11.4 Utility of Near-Patient Testing in Critical Care Settings346
- 11.5 Physician\'s Office Market 347
- 11.6 Information Management Advances347
- 11.7 Test-Ordering Patterns and Demand for POCT347
- 11.8 Demand for Emergency Department Services348
- 11.9 Move Away From Central Laboratory349
- 11.10 Healthcare Cost Controls350
- 11.11 M&A in POCT350
- 11.12 Competition for Services350
- 11.13 Drivers of POCT351
- 11.14 Confluence of New Technology351
- 11.15 Difficulties of Design for POC Products351
- 11.16 European Hospital Structure352
- 11.17 The Biggest New Opportunities in Point of Care Testing352
- 12.Corporate Directory353
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