Point Of Care Diagnostic Testing World Markets

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