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Point of Care Diagnostic Testing - World Markets

The purpose of this report is to describe the specific market segment of the in vitro diagnostics market called point of care testing (POCT).

The report examines POC clinical measurement devices and their reagents and supplies as utilized in near-patient enviroments like hospitals, clinics and doctors 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

TABLE OF CONTENTS

1. Overview 13

• 1.1 About this Report 13
• 1.2 Scope of the Report 14
• 1.3 Objectives 15
• 1.4 Methodology 15
• 1.5 Executive Summary 16

2. Overview of Diagnostic Testing Point of Care 20

• 2.1 Point of Care Testing Sites 20
• 2.2 Point of Care Market Structure 21

3. POCT and Rapid Testing Market Analysis: Size, Background Analysis, Growth, Share and Competitors 24

• 3.1 Global POCT Market 30
• 3.2 U.S. POCT Market 32
• 3.3 European POCT Market 34
  • 3.3.1 German POCT Diagnostic Market 40
  • 3.3.2 U.K. POCT Diagnostic Market 43
    • 3.3.2.1 U.K. POCT Market Statistics 43
    • 3.3.2.2 U.K. Competitive Analysis 45
    • 3.3.2.3 U.K. Market Access 46
  • 3.3.3 French POCT Diagnostic Market 46
  • 3.3.4 Italian POCT Diagnostic Market 47
  • 3.3.5 Spanish POCT Diagnostic Market 48
  • 3.3.6 Scandinavian POCT Diagnostic Market 50
  • 3.3.7 Swedish POCT Diagnostic Market 50
  • 3.3.8 Finland POCT Diagnostic Market 51
  • 3.3.9 Norway POCT Diagnostic Market 52
  • 3.3.10 Swiss POCT Diagnostic Market 53
  • 3.3.11 Dutch POCT Diagnostic Market 54
  • 3.3.12 Belgian POCT Diagnostic Market 55
  • 3.3.13 Portugal POCT Diagnostic Market 56
  • 3.3.14 Austria POCT Diagnostic Market 57
  • 3.3.15 Greek POCT Diagnostic Market 58
  • 3.3.16 Poland POCT Diagnostic Market 59
  • 3.3.17 Czech Republic POCT Diagnostic Market 60
  • 3.3.18 Turkish POCT Diagnostic Market 61
• 3.4 Asian POCT Markets 62
  • 3.4.1 Japanese POCT Diagnostic Market 62
  • 3.4.2 Indian POCT Diagnostic Market 63
  • 3.4.3 Chinese POCT Diagnostic Market 69
• 3.5 Rest of the World POCT Market 78
  • 3.5.1 Canada POCT Diagnostic Market 78
  • 3.5.2 Brazil POCT Diagnostic Market 79
  • 3.5.3 Australia POCT Diagnostic Market 79
• 3.6 Overview of Asian Healthcare Market 80
  • 3.6.1 Singapore 81
  • 3.6.2 Malaysia 82
  • 3.6.3 Thailand 82
  • 3.6.4 Indonesia 83
  • 3.6.5 Philippines 83
  • 3.6.6 South Korea 83
  • 3.6.7 Taiwan 84

4. POCT Individual Markets 85

• 4.1 Glucose Testing 85
• 4.2 POCT Individual Market Sectors, Size, Growth Rates and Competitors 87
  • 4.2.1 World Market 87
  • 4.2.2 U.S. Market 87
  • 4.2.3 European Market 89
  • 4.2.4 Alternate Glucose Monitoring Products 90
  • 4.2.5 HbA1c POCT 90
• 4.3 Blood Gas and Electrolytes 91
  • 4.3.1 Whole Blood Lactate 94
• 4.4 Rapid Coagulation Tests 94
  • 4.4.1 World POCT Coagulation Market 97
  • 4.4.2 U.S. Coagulation Market 97
  • 4.4.3 European Coagulation Market 100
  • 4.4.4 Trends in POCT Coagulation Testing 100
• 4.5 Rapid Cardiac Markers 101
  • 4.5.1 U.S. Market 101
  • 4.5.2 European Market 103
• 4.6 Drugs of Abuse Screening Testing 104
  • 4.6.1 Acetaminophen 111
  • 4.6.2 Tricyclic Antidepressants (TCAs) 111
  • 4.6.3 Other Toxic Drugs 112
  • 4.6.4 Drug Testing Selectivity 112
  • 4.6.5 Methaqualone and Phencyclidine (PCP) 112
  • 4.6.6 Tetrahydrocannabinol 112
  • 4.6.7 Drug Panels by Toxidromes 112
  • 4.6.8 Alcohol Testing 113
• 4.7 Urine Strips 113
• 4.8 Pregnancy Tests 116
• 4.9 Fecal Occult Blood 118
• 4.10 Hemoglobin Testing 119
• 4.11 Miscellaneous Rapid Tests 119
  • 4.11.1 Estriol 119
  • 4.11.2 Fetal Fibronectin (fFN) 120
  • 4.11.3 H. pylori 120
  • 4.11.4 Vaginal pH and Vaginitis 120
  • 4.11.5 Bladder Cancer 121
  • 4.11.6 Fetal Status 122
  • 4.11.7 Heparin-Induced Thrombocytopenia 123
• 4.12 Human Immunodeficiency Virus (HIV) 123
• 4.13 Cholesterol 129
• 4.14 Infectious Disease 130
  • 4.14.1 C. difficile 130
  • 4.14.2 Giardia 131
  • 4.14.3 Salmonella and Campylobacter 132
  • 4.14.4 Malaria Testing 132
  • 4.14.5 Influenza Testing 134
  • 4.14.6 Strep Testing 135
  • 4.14.7 Chlamydia 137
  • 4.14.8 Mononucleosis 138
  • 4.14.9 Rubella 138
  • 4.14.10 Methicillin-Resistant Staphylococcus Aureus (MRSA) 138
  • 4.14.11 Hepatitis 145
  • 4.14.12 Gonorrhea 147
  • 4.14.13 Tuberculosis (TB) 148
  • 4.14.14 Herpes Simplex Virus Type-2 150
• 4.15 Infant Jaundice 150
• 4.16 Anthrax 150
• 4.17 Rupture of Fetal Membranes (ROM) 152
• 4.18 Food Pathogens 152
• 4.19 Typhoid 152

5. POCT: Reagents and Equipment 153

• 5.1 Blood Glucose Monitoring 153
  • 5.1.1 LifeScan 154
  • 5.1.2 Roche Accu-Chek 157
  • 5.1.3 Siemens Healthcare Diagnostics 157
  • 5.1.4 Cholestech (Acquired by Inverness Medical Innovations) 159
  • 5.1.5 Abbott Diabetes Care 159
  • 5.1.6 International Technidyne Corporation 160
  • 5.1.7 HemoCue 161
  • 5.1.8 Stanbio/GDS Technology 161
  • 5.1.9 Disetronic Medical Systems 162
  • 5.1.10 Medtronic MiniMed 162
  • 5.1.11 Abaxis 163
• 5.2 Blood Gas and Electrolytes 166
  • 5.2.1 Roche Corporation 166
  • 5.2.2 TechnoMedica 167
  • 5.2.3 Siemens Healthcare Diagnostics 167
  • 5.2.4 Instrumentation Laboratory 167
  • 5.2.5 Nova Biomedical 167
  • 5.2.6 Radiometer 168
  • 5.2.7 Abbott Laboratories 168
  • 5.2.8 Span Diagnostics 168
  • 5.2.9 Avox Systems 168
  • 5.2.10 ITC 170
  • 5.2.11 OPTImedical 170
• 5.3 Rapid Coagulation Tests 170
  • 5.3.1 POC Coagulation Instrument Description 175
    • 5.3.1.1 Roche Diagnostics Corp. 175
    • 5.3.1.2 Abbott Laboratories 177
    • 5.3.1.3 International Technidyne Corp. 177
    • 5.3.1.4 Medtronic 178
    • 5.3.1.5 HemoSense (Inverness) 179
    • 5.3.1.6 Helena Laboratories Point of Care 179
    • 5.3.1.7 Sienco, Inc. 180
    • 5.3.1.8 Accumetrics 181
  • 5.3.2 Connectivity Issues 181
  • 5.3.3 Cost Benefits 181
  • 5.3.4 Quality Control Issues 182
  • 5.3.5 Certification for POC Coagulation Devices 182
• 5.4 Rapid Cardiac Markers 183
  • 5.4.1 Nanogen 183
  • 5.4.2 Biosite Diagnostics (Inverness) 183
  • 5.4.3 Roche Diagnostics 184
  • 5.4.4 Ani Biotech 185
  • 5.4.5 Response Biomedical Corporation 185
  • 5.4.6 Siemens Healthcare Diagnostics 186
  • 5.4.7 Lab21 Limited 187
  • 5.4.8 Abbott Laboratories 187
  • 5.4.9 LifeSign (Princeton BioMediTech Corp) 187
  • 5.4.10 Mitsubishi Kagaku Iatron 187
• 5.5 Rapid Drugs of Abuse 187
  • 5.5.1 Biosite Diagnostics (now a brand of Inverness Medical Innovations) 189
  • 5.5.2 Abbott Diagnostics 190
  • 5.5.3 Roche Diagnostics 190
  • 5.5.4 BioScan Screening Systems, Inc. 191
  • 5.5.5 American Bio Medica Corp. 192
  • 5.5.6 Phamatech, Inc. 195
  • 5.5.7 Worldwide Medical 196
  • 5.5.8 OraSure 196
  • 5.5.9 LifePoint 196
  • 5.5.10 Avitar, Inc. 197
  • 5.5.11 Cozart Biosciences 197
  • 5.5.12 Pathtech 198
  • 5.5.13 Alfa Scientific Designs, Inc. 198
  • 5.5.14 TCPI, Inc. 198
  • 5.5.15 Roche 199
  • 5.5.16 Siemens Corporation 199
  • 5.5.17 Diagnostic Chemical, Ltd. 200
  • 5.5.18 Quidel 200
  • 5.5.19 HemoCue (Quest) 200
• 5.6 Rapid Pregnancy and Fertility Tests 200
• 5.7 Fecal Occult Blood 202
  • 5.7.1 Helena Laboratories 203
  • 5.7.2 Biomerica 203
  • 5.7.3 Beckman Coulter 203
  • 5.7.4 Worldwide Medical 203
  • 5.7.5 Aerscher Diagnostics 203
  • 5.7.6 Enterix 204
  • 5.7.7 Medix Biochemica 204
• 5.8 Hemoglobin Testing 204
  • 5.8.1 Wampole Laboratories 204
  • 5.8.2 HemoCue, Inc. 204
  • 5.8.3 Stanbio/GDS Technology 205
• 5.9 Miscellaneous Rapid Tests 205
  • 5.9.1 Triage C. difficile Panel 205
  • 5.9.2 Ketoacids 205
  • 5.9.3 Acetaminophen 205
  • 5.9.4 Estriol 206
  • 5.9.5 H. pylori 206
  • 5.9.6 Vaginal Fluid pH and Vaginitis 208
  • 5.9.7 Prostate Specific Antigen (PSA) 209
  • 5.9.8 Bladder Cancer 209
  • 5.9.9 Other Rapid Cancer Tests 212
  • 5.9.10 Fetal Status (PROM) 213
  • 5.9.11 Osteoporosis 213
  • 5.9.12 Hemodynamic Monitoring 213
  • 5.9.13 Heparin-Induced Thrombocytopenia 214
• 5.10 HIV 214
  • 5.10.1 Whole Blood, Serum or Plasma-Based HIV Tests 216
    • 5.10.1.1 Bio-Rad Laboratories 216
    • 5.10.1.2 Orgenics (wholly-owned by Inverness Medical Innovations) 216
    • 5.10.1.3 StatSure Diagnostic Systems 217
    • 5.10.1.4 Trinity Biotech 217
    • 5.10.1.5 Savyon Diagnostics 217
    • 5.10.1.6 MedPharm 217
    • 5.10.1.7 American Bio Medica Corp. 217
    • 5.10.1.8 Chembio Diagnostics 218
    • 5.10.1.9 OraSure 218
    • 5.10.1.10 Inverness 219
  • 5.10.2 Saliva-Based HIV Tests 219
    • 5.10.2.1 OraSure Collection Device 220
    • 5.10.2.2 SureStat 221
  • 5.10.3 Urine-Based HIV Tests 221
    • 5.10.3.1 MedMira Laboratories, Inc. 221
    • 5.10.3.2 Medical Services International, Inc. 222
    • 5.10.3.3 Maxim Biomedical 222
    • 5.10.3.4 Wampole Laboratories 222
• 5.11 Cholesterol 222
  • 5.11.1 Cholestech (Now a Brand of Inverness Medical Innovations) 223
  • 5.11.2 Actimed Laboratories 224
  • 5.11.3 StatSite Meter 224
  • 5.11.4 Polymer Technology Systems 225
  • 5.11.5 PreMD Inc. (f/k/a International Medical Innovations, Inc. (IMI)) 225
  • 5.11.6 Abaxis, Inc. 225
• 5.12 Infectious Disease 225
  • 5.12.1 C. difficile 225
  • 5.12.2 Giardia 226
  • 5.12.3 Dengue Fever 227
  • 5.12.4 Malaria Testing 227
  • 5.12.5 Rapid Influenza Testing 229
  • 5.12.6 Streptococcus Testing 229
  • 5.12.7 Chlamydia 231
  • 5.12.8 Mononucleosis 231
  • 5.12.9 Rubella 233
  • 5.12.10 Staphylococcus Aureus and MRSA 233
  • 5.12.11 Hepatitis 234
  • 5.12.12 E. Coli O157 236
  • 5.12.13 Gonorrhea Testing 236
  • 5.12.14 Smallpox 236
  • 5.12.15 SARS 236
  • 5.12.16 Rabies 236
  • 5.12.17 Tuberculosis 237
  • 5.12.18 Avian Flu 237
  • 5.12.19 West Nile Virus 237
  • 5.12.20 Herpes Simplex Virus Type-2 237
• 5.13 Infant Jaundice 238
• 5.14 Anthrax 238
• 5.15 Homeland Defense (Plague and Tularemia) 239
• 5.16 BSE (Mad Cow Disease) 239
• 5.17 Tuberculosis 240
• 5.18 Typhoid 240
• 5.19 Avian Flu 240
• 5.20 Food Pathogens (Salmonella, Listeria, Campylobacter) 241
• 5.21 Ruptured Fetal Membranes (ROM) 242

6. POCT: Growth Regulators 243

• 6.1 Moderators of Growth 243
• 6.2 Personnel Acceptance 243
• 6.3 Key People for POCT 244
• 6.4 Information Management Issues 244
  • 6.4.1 Elements of Information Management for POCT: Information Processing Capabilities 245
  • 6.4.2 Data Mining 246
  • 6.4.3 Middleware 246
  • 6.4.4 Web Portals 247
  • 6.4.5 POCT-1A Standard 247
• 6.5 Key Elements for POCT 248
• 6.6 POCT and Reimbursement 248
• 6.7 Effectiveness of Clinical Outcomes 250
• 6.8 Rapid Near-Patient Testing in Hospitals 250
• 6.9 Satellite Facilities 251
• 6.10 Regionalization of Laboratory Care 252
• 6.11 Requirements for POCT 253
• 6.12 Locations of Point of Care for Patient Care 254
• 6.13 Benefits of POCT 254
• 6.14 Cost Elements of POCT 254
• 6.15 Necessary Functions in POCT 255
• 6.16 TAT for POCT 255
• 6.17 Clinical Laboratory Improvement Amendments (CLIA) 255
• 6.18 Sexually-Transmitted Diseases in Underdeveloped Countries 257

7. Business Trends in the Point of Care Sector 258

• 7.1 Sector Consolidation 258
• 7.2 Diagnostic Testing Growth Trends 258
• 7.3 Acquisition, License Agreements, Internal Development and Partnerships 259
• 7.4 Product Testing Depth in POCT 263
• 7.5 Government Regulation 263
  • 7.5.1 U.S. Regulation 263
    • 7.5.1.1 Importing Medical Devices into the U.S. 264
    • 7.5.1.2 Exporting Medical Devices from the U.S. 265
  • 7.5.2 U.K. Regulation 265
  • 7.5.3 E.U. Regulation 267
    • 7.5.3.1 French Regulation 268
  • 7.5.4 Japanese Regulation 269
  • 7.5.5 Korean Regulation 269
• 7.6 Increased Market Penetration 269
• 7.7 Costs of Doing Business in Europe 270
• 7.8 Drivers of European Diagnostics Testing 271
• 7.9 European Reimbursement Practices 271
• 7.10 Cost Containment in Europe 271

8. Technology Platform Innovations in POCT 272

• 8.1 Sensor Systems for Diagnostic Applications 272
• 8.2 Glucose Measurements 275
• 8.3 Glucose Test Methods 277
• 8.4 Cholesterol Testing 278
• 8.5 The New Paradigm 279
• 8.6 Consolidated Workstations and Modularity 279
• 8.7 Automation and Robotics in the Clinical Laboratory 279
• 8.8 Laboratory Information Systems (LIS) 280
  • 8.8.1 NOVIUS Lab 280
• 8.9 Biosensor Technology 280
• 8.10 Nanogen Third Generation POC Analyzer 282
• 8.11 Quidel MChip 283

9. Data Management and Connectivity 284

• 9.1 Wireless LANs 284
• 9.2 Connectivity Platforms 286
  • 9.2.1 DataLink Data Management System 287
  • 9.2.2 RALS-Plus 288
    • 9.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 289
    • 9.2.2.2 Siemens Diagnostics Rapidpoint® Coag 290
    • 9.2.2.3 Radiometer 290
    • 9.2.2.4 HemoCue’s DM Hemoglobin 290
    • 9.2.2.5 Roche Diagnostics 290
  • 9.2.3 BD.id 291
  • 9.2.4 Medical Implant Communications Service (MICS) 291
• 9.3 Advantages of POCT Connectivity 291
  • 9.3.1 Cost Benefit of POCT and IT Connectivity 291
  • 9.3.2 Hospital Network Issues 292

10. Corporate Profiles 293

• 10.1 Abaxis, Inc. 293
• 10.2 Abbott Diagnostics 297
• 10.3 Accumetrics, Inc. 300
• 10.4 Accurex Biomedical, Pvt., Ltd. 301
• 10.5 Akers Biosciences 301
• 10.6 Alfa Scientific Design, Inc. 301
• 10.7 Ambri, Ltd. 301
• 10.8 American Bio Medica Corp. 302
• 10.9 Ani Biotech 303
• 10.10 Apogent Technologies 303
• 10.11 Ark Therapeutics 303
• 10.12 ARKRAY 304
• 10.13 Atlas Genetics 304
• 10.14 Atonomics 304
• 10.15 Avitar, Inc. 304
• 10.16 Avox Systems 305
• 10.17 Axis-Shield 305
• 10.18 Beckman Coulter 306
• 10.19 Binax Corporation 310
• 10.20 Biomerica 310
• 10.21 BioMérieux Vitek, Inc. 311
• 10.22 BioScan Screening Systems, Inc. 311
• 10.23 Biosite Diagnostics 311
• 10.24 BioStar 311
• 10.25 British Biocell Holdings 311
• 10.26 Caliper Life Sciences 312
• 10.27 Calypte Biomedical 313
• 10.28 Chembio Diagnostics 313
• 10.29 Cholestech 314
• 10.30 Chongqing Sungene Pharmaceutical Co., Ltd. 314
• 10.31 CompuCyte Corporation 315
• 10.32 Cortech Diagnostics Ltd. (Now Called Kent International Holdings) 315
• 10.33 Cozart Biosciences 315
• 10.34 Cygnus Therapeutic Systems 315
• 10.35 Cytogen 316
• 10.36 DexCom 316
• 10.37 Daiichi Sankyo Group 317
• 10.38 Denka Seiken Co., Ltd. 317
• 10.39 Diagnostic Chemicals, Ltd. 317
• 10.40 Enterix, Inc. 317
• 10.41 Focus Diagnostics, Inc. 317
• 10.42 GDS Technology 317
• 10.43 GenBio 318
• 10.44 Genzyme Diagnostics 318
• 10.45 Grant Life Sciences 320
• 10.46 Gryphus Diagnostics 320
• 10.47 Helena Laboratories 321
• 10.48 Hema Diagnostic Systems 321
• 10.49 Hemocue, Inc. 322
• 10.50 Home Access Health Corp. 322
• 10.51 Immunoscience, Inc. 322
• 10.52 Instrumentation Laboratory 322
• 10.53 International Medical Innovations 323
• 10.54 Inverness Medical Innovations 323
• 10.55 Johnson & Johnson 328
• 10.56 Kyowa Medex Co., Ltd. 330
• 10.57 LifeAssays 330
• 10.58 LifePoint, Inc. 330
• 10.59 LifeScan Corporation 330
• 10.60 Lifestream Technologies 331
• 10.61 LXN Corp. (Inverness Medical Technologies) 331
• 10.62 Matritech 331
• 10.63 Medical Services International, Inc. 331
• 10.64 MediSense 332
• 10.65 Medisys 332
• 10.66 Medix Biochemica 332
• 10.67 MedMira Laboratories 332
• 10.68 Meretek Corporation 334
• 10.69 Meridian Bioscience 334
• 10.70 MiniMed 336
• 10.71 Mitsubishi Chemical U.S.A, Inc. 336
• 10.72 Mitsubishi Kagaku Iatron 337
• 10.73 Nanogen 337
• 10.74 New Horizons Diagnostics 338
• 10.75 Nova Biomedical 338
• 10.76 OraSure 340
• 10.77 Orgenics 344
• 10.78 Orion Diagnostica 344
• 10.79 PanBio, Ltd. 344
• 10.80 Phamatech, Inc. 344
• 10.81 PharmaNetics, Inc. 345
• 10.82 Polymedco 345
• 10.83 Polymer Technology Systems 346
• 10.84 Princeton BioMeditech Corporation 346
• 10.85 Quest Diagnostics 346
• 10.86 Quidel 347
• 10.87 Radiometer 351
• 10.88 Response Biomedical Corp. 353
• 10.89 Roche Diagnostics 354
• 10.90 Royal Philips Electronics 355
• 10.91 Savyon Diagnostics 356
• 10.92 Selfcare, Inc. 357
• 10.93 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech) 357
• 10.94 Shionogi & Co., Ltd. 357
• 10.95 Siemens Corporation 357
• 10.96 SpectRx, Inc. 358
• 10.97 Spectral Diagnostics 359
• 10.98 StatSure Diagnostic Systems 359
• 10.99 Strategic Diagnostics 360
• 10.100 Sun Biomedical Laboratories 360
• 10.101 Thoratec/International Technidyne Corp. 360
• 10.102 Transmedica 362
• 10.103 Trinity Biotech 362
• 10.104 Vasamed, Inc. 364
• 10.105 Venkateshwara Hatcheries Pvt., Ltd. 365

11. POCT Sector Trends and Forecasts 366

• 11.1 Home Care Analysis as Part of Near-Patient Testing 366
• 11.2 Non-Traditional Collection for POCT 366
• 11.3 New Systems for Critical Care and Near-Patient Testing 366
• 11.4 Utility of Near-Patient Testing in Critical Care Settings 366
• 11.5 Physician’s Office Market 367
• 11.6 Information Management Advances 367
• 11.7 Test-Ordering Patterns and Demand for POCT 368
• 11.8 Demand for Emergency Department Services 368
• 11.9 Move Away From Central Laboratory 369
• 11.10 Healthcare Cost Controls 370
• 11.11 M&A in POCT 370
• 11.12 Competition for Services 370
• 11.13 Drivers of POCT 371
• 11.14 Confluence of New Technology 371
• 11.15 Difficulties of Design for POC Products 371
• 11.16 European Hospital Structure 372
• 11.17 The Biggest New Opportunities in Point of Care Testing 372

12. Corporate Directory 373


LIST OF TABLES

• Table 2.1: Percentage of Point of Care Testing Performed in Selected Hospitals 21
• Table 2.2: Point of Care Testing Procedural Advantages for Hospital Testing 23
• Table 2.3: Point of Care Testing Trends 23
• Table 2.4: Professional Point of Care Testing Compared to Home Testing 23
• Table 2.5: Drivers for Integrating Point of Care Testing into Hospital Routines 23
• Table 3.1: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2008 24
• Table 3.2: Number of Point of Care Tests in U.S., 2000-2012 25
• Table 3.3: Global Clinical Laboratory Market Sales, 1998-2010 27
• Table 3.4: Overall In Vitro Diagnostic Testing Market Worldwide, 2007 28
• Table 3.5: Worldwide Distribution of IVD Testing, 2008 28
• Table 3.6: Top Twelve Country IVD Testing Markets, 2007 29
• Table 3.7: Thirteen Largest Diagnostic Companies Worldwide, 2007 29
• Table 3.8: Global Point of Care Revenues, 2005-2012 30
• Table 3.9: Worldwide POCT Market Size by Geographic Location, 2005-2012 31
• Table 3.10: Worldwide Distribution of POCT, 2008 31
• Table 3.11: Worldwide POCT by Performance Location, 2008 31
• Table 3.12: Worldwide Clinical Diagnostic POCT and Rapid Test Market Segments, 2007 31
• Table 3.13: Largest POCT Diagnostic Companies Worldwide, 2007 32
• Table 3.14: U.S. Clinical Laboratory Testing Market, 2003-2012 33
• Table 3.15: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, 2008 33
• Table 3.16: U.S. POCT Market, 2000-2012 34
• Table 3.17: U.S. POCT by Performance Location, 2008 34
• Table 3.18: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007 34
• Table 3.19: European Clinical Laboratory Testing IVD Reagents and Instruments Market ($), 2000-2012 35
• Table 3.20: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 35
• Table 3.21: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007 36
• Table 3.22: European Rapid Point of Care Testing by Country Market Estimates, 2008 37
• Table 3.23: Regional Comparison of Healthcare Spending for IVD for Eastern Europe 40
• Table 3.24: European POCT Market, 2005-2012 40
• Table 3.25: Top Twelve Country IVD and POC Testing Markets, 2007 40
• Table 3.26: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012 41
• Table 3.27: German POCT Diagnostics Products Market Sales, 2003-2012 41
• Table 3.28: German Clinical Diagnostic Rapid Test Market Segments, 2007 42
• Table 3.29: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 43
• Table 3.30: U.K. POCT Diagnostics Products Market Sales, 2006-2012 44
• Table 3.31: U.K. Clinical Diagnostic Rapid Test Market Segments, 2007 44
• Table 3.32: Major U.K. IVD Manufacturers 45
• Table 3.33: U.S. IVD Manufacturers Doing Business in the U.K. 45
• Table 3.34: Other European Companies that Manufacture IVD Products in the U.K. 45
• Table 3.35: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2012 46
• Table 3.36: French POCT Diagnostics Products Market Sales, 2005-2012 47
• Table 3.37: French Clinical Diagnostic Rapid Test Market Segments, 2007 47
• Table 3.38: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 48
• Table 3.39: Italian POCT Diagnostics Products Market Sales, 2005-2012 48
• Table 3.40: Italian Clinical Diagnostic Rapid Test Market Segments, 2007 48
• Table 3.41: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 49
• Table 3.42: Spanish Clinical Diagnostic Rapid Test Market Segments, 2007 49
• Table 3.43: Spanish POCT Diagnostics Products Market Sales, 2005-2012 50
• Table 3.44: Scandinavian POCT Diagnostics Products Market Sales, 2000-2012 50
• Table 3.45: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 51
• Table 3.46: Swedish POCT Diagnostics Products Market Sales, 2005-2012 51
• Table 3.47: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 52
• Table 3.48: Finnish POCT Diagnostics Products Market Sales, 2005-2012 52
• Table 3.49: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 53
• Table 3.50: Norwegian POCT Diagnostics Products Market Sales, 2005-2012 53
• Table 3.51: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 54
• Table 3.52: Swiss POCT Diagnostics Products Market Sales, 2005-2012 54
• Table 3.53: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 55
• Table 3.54: Dutch POCT Diagnostics Products Market Sales, 2005-2012 55
• Table 3.55: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 56
• Table 3.56: Belgium POCT Diagnostics Products Market Sales, 2005-2012 56
• Table 3.57: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 57
• Table 3.58: Portuguese POCT Diagnostics Products Market Sales, 2005-2012 57
• Table 3.59: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 58
• Table 3.60: Austrian POCT Diagnostics Products Market Sales, 2005-2012 58
• Table 3.61: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 59
• Table 3.62: Greek POCT Diagnostics Products Market Sales, 2005-2012 59
• Table 3.63: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 60
• Table 3.64: Polish POCT Diagnostics Products Market Sales, 2005-2012 60
• Table 3.65: Czech Clinical Laboratory Diagnostics Products Market Sales, 2004-2012 61
• Table 3.66: Czech POCT Diagnostics Products Market Sales, 2005-2012 61
• Table 3.67: Turkish POCT Market, 2000-2012 62
• Table 3.68: Japan POCT Market, 2000-2012 62
• Table 3.69: Japanese Population and Aging Demographics Forecast, 2000-2050 63
• Table 3.70: Indian IVD Market for Instruments and Reagents, 2004-2012 64
• Table 3.71: Number of Automated Clinical Labs in India, 2004-2012 64
• Table 3.72: Indian IVD Market, 2007 64
• Table 3.73: Indian POCT Diagnostics Products Market Sales, 2000-2008 69
• Table 3.74: Chinese IVD Market, 2006-2012 69
• Table 3.75: Number of Automated Clinical Labs in China, 2004-2012 70
• Table 3.76: Chinese IVD Market, 2007 71
• Table 3.77: Chinese POCT Diagnostics Products Market Sales, 2000-2012 76
• Table 3.78: Rest of the World POCT Market, 2000-2012 78
• Table 3.79: Canadian POCT Market, 2000-2012 79
• Table 3.80: Brazilian POCT Market, 2000-2012 79
• Table 3.81: Australian POCT Market, 2000-2012 80
• Table 4.1: World Market Share of Point of Care Glucose Monitoring Marketers 85
• Table 4.2: Global Population of Persons with Diabetes, 1995 and 2025 87
• Table 4.3: Professional Glucose Testing Market for POCT Worldwide, 2001-2012 87
• Table 4.4: U.S. Point of Care Glucose Testing Market, 1997-2012 88
• Table 4.5: Manufacturer Market Share U.S. POCT Market, 2008 88
• Table 4.6: Rapid Testing U.S. Market Share for Blood Glucose Testing Segment 89
• Table 4.7: HbA1c Testing Market for POCT Worldwide, 2006-2012 91
• Table 4.8: Critical Care Blood Gas Testing Market for POCT Worldwide, 2006-2012 92
• Table 4.9: Blood Gas and Electrolyte Market for POCT in the U.S., 2001-2012 92
• Table 4.10: Location Market Share of Critical Care Blood Gas Testing 92
• Table 4.11: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2007 94
• Table 4.12: Hospital Locations of Point of Care Coagulation Testing 95
• Table 4.13: Drivers for Point of Care Coagulation Testing 96
• Table 4.14: Barriers for Point of Care Coagulation Testing 96
• Table 4.15: Coagulation Testing Market for POCT Worldwide, 2006-2012 97
• Table 4.16: Hand-held Coagulation Testing Market for POCT Worldwide, 2006-2012 97
• Table 4.17: Coagulation Market for POCT in the U.S., 2001-2012 98
• Table 4.18: POC Prothrombin Market for POCT in the U.S., 2000-2007 98
• Table 4.19: Cardiac Marker Market for POCT in the U.S., 2001-2012 102
• Table 4.20: Cardiac Marker Market for POCT Worldwide, 2001-2012 102
• Table 4.21: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2007 102
• Table 4.22: Cardiac Marker Market for POCT in Europe, 2001-2011 103
• Table 4.23: Drugs of Abuse Testing Market for POCT Worldwide, 2006-2012 109
• Table 4.24: U.S. Point of Care Drugs of Abuse Testing Market, 2006-2012 109
• Table 4.25: Drug Testing Needs Tier I for Rapid Serum Point of Care Testing in the Emergency Department 111
• Table 4.26: Stat Urine Testing Drug Recommendations 111
• Table 4.27: Device Specifications for POCT Breath Alcohol Analysis 113
• Table 4.28: Global Point of Care Urine Test Strip Testing Market, 2001-2007 114
• Table 4.29: Global Point of Care Urine Test Strip POCT Testing Market, 2006-2012 114
• Table 4.30: U.S. Point of Care Urine Test Strip Testing Market, 2001-2011 114
• Table 4.31: U.S. Point of Care Urine Test Strip Testing Market Share 115
• Table 4.32: Medicare Fee Schedule for Urine Chemistry Testing 116
• Table 4.33: Pregnancy Testing Market for POCT Worldwide, 2006-2012 117
• Table 4.34: U.S. Point of Care Pregnancy Testing Market, 2001-2012 117
• Table 4.35: International Point of Care Pregnancy Testing Markets, 2001-2007 118
• Table 4.36: U.S. Market Share for Rapid Point of Care Pregnancy Tests 118
• Table 4.37: Hemoglobin Testing Market for POCT Worldwide, 2006-2012 119
• Table 4.38: Drivers of Demand for HIV Testing 123
• Table 4.39: Worldwide POCT Market for HIV, 2001-2012 124
• Table 4.40: U.S. POCT Market for HIV, 2001-2012 125
• Table 4.41: Countries with the Highest Prevalence of HIV/AIDS 126
• Table 4.42: FDA-Approved Rapid HIV Antibody Screening Tests 128
• Table 4.43: OraSure OraQuick Rapid HIV Test Revenues, 2008 129
• Table 4.44: Cholesterol Testing Market for POCT Worldwide, 2006-2012 130
• Table 4.45: Infectious Disease Testing Market for POCT Worldwide, 2006-2012 130
• Table 4.46: Salmonella Testing Market, 2002-2007 132
• Table 4.47: Worldwide Point of Care Influenza Testing Market, 2002-2007 134
• Table 4.48: U.S. Point of Care Influenza Testing Market, 2002-2007 135
• Table 4.49: International Point of Care Influenza Testing Markets, 2002-2007 135
• Table 4.50: U.S. Market for Rapid Point of Care Influenza Tests, 2007 135
• Table 4.51: Worldwide Point of Care Strep A Testing Market, 2002-2007 136
• Table 4.52: U.S. Point of Care Strep A Testing Market, 2002-2007 136
• Table 4.53: International Point of Care Strep A Testing Markets, 2002-2007 136
• Table 4.54: U.S. Market for Rapid Point of Care for Group A Strep Tests 137
• Table 4.55: Global Market for Chlamydia Diagnostic Testing, 2000-2009 137
• Table 4.56: U.S. Market for Chlamydia Diagnostic Testing, 2000-2009 138
• Table 4.57: U.S. Market for MRSA Rapid Testing, 2006-2013 144
• Table 4.58: Global Market for Gonorrhea Diagnostic Testing, 2000-2009 148
• Table 4.59: Global Market for TB Diagnostic Testing, 2000-2008 150
• Table 4.60: U.S. Anthrax Test Market 151
• Table 5.1: Largest U.S. POCT Coagulation Diagnostic Testing Companies, 2008 175
• Table 5.2: Actalyke XL 180
• Table 5.3: Actalyke Mini 180
• Table 5.4: Drug Test Sensitivity Cut-Off Levels Set by NIDA, WHO and SAMHSA for Drugs of Abuse 188
• Table 5.5: Major Competitors in the Drugs of Abuse Testing Market Segment 188
• Table 5.6: Major Competitors in the Drugs of Abuse Oral Testing Market Segment 188
• Table 5.7: Major Competitors in the Drugs of Abuse Urine Testing Market Segment 189
• Table 5.8: Major Competitors in the Drugs of Abuse Saliva Testing Market Segment 189
• Table 5.9 : Siemens Urinalysis Near-Patient Devices 199
• Table 5.10: ColoCARE Fecal Occult Blood Test 203
• Table 5.11: Competitive Factors Related to HIV Tests 215
• Table 5.12: Largest POCT Diagnostic Companies Worldwide, 2008 216
• Table 5.13: Type of Hepatitis Test: Lateral Flow 234
• Table 5.14: Flow-Through 235
• Table 5.15: Agglutination 235
• Table 5.16: Immunoblot 235
• Table 5.17: AmniSure 242
• Table 6.1: Access Points 244
• Table 6.2: Desktop Adapters—One Computer 245
• Table 6.3: Desktop Adapters—Four Computers 245
• Table 6.4: PCMCIA Adapters 245
• Table 6.5: POCT1-Compliant Connectivity Point of Care Instruments 247
• Table 6.6: POCT Clinical Outcomes in Diabetic Ketoacidosis 250
• Table 6.7: POCT Clinical Outcomes in Arterial Blood Gas Measurements 250
• Table 6.8: POCT in Three Hospitals. Cost Analysis with Labor Included 253
• Table 6.9: Cost Analysis for Glucose Testing: POCT vs. Central Lab 253
• Table 6.10: Financial Comparison for Moderate and Waived CLIA Labs 256
• Table 9.1: Applications for Wireless LAN Technology 284
• Table 9.2: Customized Reports Must Support CAP and JCAHO Requirements 287
• Table 9.3: RALS-Plus Point of Care Market Share 288
• Table 9.4: Applications of RALS Connectivity with POCT Devices 289
• Table 10.1: Abaxis Blood Analysis Diagnostic Tests 294
• Table 10.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 295
• Table 10.3: Products Marketed by Abbott in the Diagnostic Market 299
• Table 10.4: Inverness Brands 328
• Table 10.5: Orasure’s Products 343
• Table 10.6: Quidel Product Sales Distribution and Sales, 2008 348
• Table 11.1: Improvements in Achieving ED Operational Efficiency Using POCT 367
• Table 11.2: Test Menu and TAT for ED 368
• Table 11.3: Top Reasons Why POC Cardiac Marker Testing is Implemented in the ED 368
• Table 11.4: Key Areas and Metrics That Hospitals Measure To Assess Efficiency of ED 369
• Table 11.5: Estimates of Patient Costs by DRG 370

LIST OF FIGURES

• Figure 3.1: Blood Tests Ordered in Emergency Department Visits 25
• Figure 3.2: Worldwide Distribution of IVD Testing, 2008 28
• Figure 3.3: Global Point of Care Testing Share of Total In Vitro Diagnostic Testing Market, 2007 32
• Figure 4.1: U.S. Point of Care Testing Share of Glucose Testing Market, 2008 86
• Figure 4.2: Number of HbA1c Tests Performed Globally as POCT, 1991-2006 91
• Figure 4.3: Total Spending on Healthcare in the U.S., 1960-2007 140
• Figure 4.4: International Per Capita Healthcare Spending Per Country, 2006 141
• Figure 5.1: Global Point of Care Testing Share of HIV Testing Market, 2008 216
• Figure 6.1: Annual Rate of Emergency Room Visits by Primary Expected Source of Payment 250

 

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