Over-the-Counter Diagnostic Products World Markets
The purpose of this TriMark Publications analysis is to describe the specific market segments of the over-the-counter (OTC) diagnostic products and home healthcare markets. It examines the diagnostic measurement devices and their reagents and supplies that are utilized in clinics and by patients directly in their homes to diagnose and monitor disease. This study also includes a review of home healthcare kits and devices that measure health-related conditions. Focus is on market dynamics and current market drivers of the OTC and home self-testing diagnostics market. This report also looks at the industry challenges and potential threats, and it makes strategic recommendations for boosting market share. The analysis covers healthcare-related devices that are designed for the home market in order to allow consumers to assess their health status through self-testing. In addition, this review examines some biowarfare detection systems. The emphasis in this report is on those companies and products that are actively developing and marketing diagnostic reagents and supplies in market segments that are targeted for direct sale to the public.
Table of Contents
1. Overview 9
1.1 Statement of Report 9
1.2 About This Report 9
1.3 Scope of the Report 11
1.4 Objectives 12
1.5 Methodology 12
1.6 Executive Summary 13
2. Sector Overview 20
2.1 Global Diagnostic Products Industry 20
2.2 Global OTC Diagnostic Products Industry 22
2.3 European OTC and Home Self-Testing Diagnostic Markets 24
2.3.1 German OTC and Home Self-Testing Diagnostic Markets 26
2.3.2 U.K. OTC and Home Self-Test Diagnostic Markets 26
2.3.2.1 U.K. Market Statistics 27
2.3.2.2 U.K. Competitive Analysis 28
2.3.2.3 U.K. Market Access 29
2.3.3 French OTC Diagnostic Market 29
2.3.4 Italian OTC Diagnostic Market 30
2.3.5 Spanish OTC Diagnostic Market 31
2.3.6 Japanese OTC Diagnostic Market 31
2.3.7 Chinese OTC Diagnostic Market 33
2.4 Description of the U.S. OTC Diagnostics Industry Segment 33
2.4.1 Market Overview 33
2.4.2 Diagnostic Test Categories 34
2.5 Market Drivers in the OTC Diagnostics Sector 35
2.5.1 Overview 35
2.5.2 Market Segments 35
2.6 Key Players in the OTC Diagnostics Segment 36
2.7 Sector Analysis 37
3. Market Analysis: Size, Growth, Share and Competitors 39
3.1 Glucose Monitoring 39
3.1.1 Glucose Control in Diabetic Patients 45
3.1.2 Tight Glucose Control in Treating Diabetes 45
3.1.3 Glucose-Monitoring Devices 46
3.1.4 Key Issues for Glucose Monitoring 47
3.1.5 Glucose Device Description 47
3.1.6 Precision in Glucose Meters 49
3.1.7 Limitations of Existing Glucose Monitoring Products 49
3.1.8 Over-the-Counter (OTC) Self-Testing Glucose Market 50
3.1.9 Worldwide Glucose Testing Market 52
3.1.9.1 U.S. Market 53
3.1.9.2 European Market 56
3.1.9.3 Asia-Pacific (Excluding Japan) 58
3.1.9.3.1 Japanese Market 59
3.1.9.3.2 Chinese Market 61
3.1.9.3.3 Indian Market 63
3.1.9.4 ROW Markets 64
3.1.10 Reagents and Equipment 64
3.1.10.1 Blood Glucose Monitoring 64
3.1.10.2 Lancets 65
3.1.10.3 Blood Glucose Monitor and Insulin Doser 69
3.1.10.4 Blood Glucose Reagent Test Strips 70
3.1.10.5 Control Solutions and Calibrators 70
3.1.10.6 Sharps Devices 71
3.1.10.7 Needle Destruction Devices 71
3.1.11 Glucose Meters 72
3.1.12 Voice-Operated Glucose Meters 89
3.1.13 Continuous Blood Glucose Monitoring (CBGM) 91
3.1.14 Self-Monitoring Blood Glucose (SMBG) Testing 92
3.1.15 Minimally-Invasive and Non-Invasive Blood Glucose Testing 92
3.1.16 Emerging Glucose Monitoring Technologies 93
3.1.16.1 Optical Transducer Technologies 93
3.1.16.2 Transdermal Sensor Technologies 95
3.1.16.3 Invasive Glucose Sensor Technologies 96
3.2 Pregnancy and Fertility Testing 96
3.2.1 Major Players 98
3.2.1.1 U.S. Market 98
3.2.1.2 European Market 99
3.2.2 Diagnostic Kit Information 99
3.2.3 Competitive Sector Analysis 104
3.3 Hepatitis Testing 104
3.4 Drugs of Abuse Screening Testing 109
3.5 Infectious Disease Testing 119
3.5.1 HIV 121
3.5.2 Tuberculosis Testing 128
3.5.3 Infectious Disease Testing in Non-Medical Settings 129
3.5.4 West Nile Virus 132
3.5.5 Urinary Tract Infections 132
3.6 Cholesterol Testing 133
3.7 Coagulation Testing 135
3.8 Urine Dipstick Testing 141
3.9 Fertility Testing 142
3.9.1 Players 144
3.9.2 Diagnostic Test Kits 144
3.10 At-Home DNA Analysis 146
3.11 Biowarfare Detection 149
3.12 Home Patient Monitoring Devices 151
3.13 Home Patient Alert Systems 153
3.14 Home Genetic Testing Kits 154
3.15 Home Paternity Testing 157
3.16 Health Hazards Detection 158
3.16.1 Lead 158
3.16.2 Radon 158
3.16.3 Asbestos 159
3.16.4 Pesticides 159
3.16.5 Mold 159
3.16.6 Carbon Monoxide 159
3.16.7 Water Quality 159
3.16.8 Bacteria in Water 160
3.17 Thyroid Disease 160
3.18 Carpal Tunnel 160
3.19 Allergies 160
3.20 Nutrition and Wellness 160
3.20.1 Testosterone and Male Hormones 160
3.20.2 Female Hormones 160
3.20.3 Antioxidants 161
3.20.4 Sleep Apnea 161
3.20.5 Mineral Check 161
3.20.6 Stress Check 162
3.21 Colorectal Cancer (Occult Blood) Testing 162
3.22 Alzheimer's Disease Home Screening Test 163
3.23 Tobacco Testing 164
4. Business Trends in the Industry 165
4.1 Wholesale Distribution Overview 165
4.2 Factors Affecting OTC Medical Product Distribution 166
4.3 Government Regulation of Medical Devices 168
4.3.1 U.S. Regulations 168
4.3.2 U.K. Regulations 171
4.4 Clinical Laboratory Improvement Act (CLIA) 172
4.5 Legal, M&A and Corporate Partnerships 175
5. Patient Management Trends 177
5.1 Trends in OTC Testing and Reimbursement 177
5.1.1 American OTC Testing and Home Self-testing Reimbursement 177
5.1.2 European Reimbursement 179
5.2 Drivers of OTC and Home Self-Testing 182
5.3 Cost Elements of OTC Testing 183
5.4 Important Elements of OTC Testing 183
5.5 Growth of Home Care Testing 183
5.6 Non-Traditional Methods for Sample Collection 183
6. Technology Trends 185
6.1 Sensor Systems for Diagnostic Applications 185
6.2 Glucose Measurements 186
6.3 Cholesterol Testing 191
6.4 Immunoassay Technology 192
6.5 Biosensor Technology 193
6.5.1 Recent Biosensor Product Introductions and Latest Innovative Developments 194
6.5.1.1 Nanoscale Sensors for the Detection of Cancer Biomarkers 194
6.5.1.2 ForteBio Introduces Dip and Read Protein G Biosensor for Octet Instruments 195
6.5.1.3 ForteBio Launches New Octet RED96 System and Dip and Read Protein L Biosensor 195
6.5.1.4 AgaMatrix Europe Limited introduces the New Jazz Blood Glucose Meter in the U.K. 196
6.5.1.5 STMicroelectronics to Manufacture Worlds Smallest Biosensors 196
6.5.1.6 Universal Biosensors Advances Point of Care Molecular Diagnostic Opportunity 196
6.5.1.7 Clinitek AdvantusA Semi Automated Urine Analyzer for Point of Care Testing 196
6.5.1.8 The NOVA 16 STAT Chemistry Analyzer Offers the First All-Electrode-based Seven Test
Chemistry Profile 196
6.6 Fructosamine Test 197
6.7 Home Telemedicine Devices 198
6.8 Insulin Pumps 200
7. OTC Testing: Critical Issues 201
7.1 Moderators of Growth for OTC Testing 201
7.2 Attitudes of Critical Care Nurses and Physicians 211
7.3 Personnel Impact for OTC Testing 211
7.4 Data Management Issues 211
7.5 POC Decentralization Issues 212
7.6 POC Testing and Clinical Outcomes 212
7.7 Focused Testing 212
7.8 Satellite Facilities 212
7.9 POC Testing Comparison and Cost Analysis 212
8. Competitive Assessments of the High-Growth Markets 215
8.1 Glucose Monitoring 215
8.1.1 Overview of Market Segment 215
8.1.2 Competitive Strategies 229
8.1.3 Analyses of the Current Market Conditions, Competition and Product Mix 231
8.1.4 Adjacent Markets 236
8.1.5 Market Drivers and Restraints 237
8.1.6 Market and Product Trends 239
8.2 Coagulation Testing 240
8.2.1 Overview of Market Segment 240
8.2.2 Competitive Strategies 246
8.2.3 Analyses of Current Market Conditions 246
8.2.4 Product Mix in Coagulation Testing 247
8.2.4.1 Review of Selected POC Rapid Coagulation Analyzers 247
8.2.5 Adjacent Markets 253
8.2.6 Market Drivers and Restraints 253
8.2.7 Market and Product Trends 254
8.2.8 Quality Control Issues 255
8.3 Cholesterol Testing 255
8.3.1 Overview of Market Segment 255
8.3.2 Competitive Strategies 257
8.3.3 Adjacent Markets 260
8.4 Infectious Disease Testing 260
8.4.1 Overview of Market Segment 260
8.5 Drugs of Abuse 266
8.5.1 Overview of Market Segment 266
8.5.2 Analyses of the Current Market Conditions, Competition and Product Mix 273
8.5.2.1 Alere 273
8.5.2.2 Abbott Diagnostics 274
8.5.2.3 Roche Diagnostics 274
8.5.2.4 BioScan Screening Systems, Inc. 275
8.5.2.5 American Bio Medica Corp. 275
8.5.2.6 Phamatech, Inc. 278
8.5.2.7 First Check Medical (Inverness Medical Innovations, Inc.) 279
8.5.2.8 OraSure 279
8.5.2.9 Avitar, Inc. 280
8.5.2.10 Concateno 280
8.5.2.11 Pathtech 280
8.5.2.12 Alfa Scientific Designs, Inc. 281
8.5.2.13 TCPI, Inc. 282
8.5.2.14 Roche 282
8.5.2.15 Biophor Diagnostics 282
8.5.2.16 Randox Laboratories 282
8.5.2.17 Branan Medical 282
8.5.2.18 Concateno 283
8.5.3 Adjacent Markets 284
8.6 Home Pregnancy Testing 284
8.6.1 Overview of Market Segment 284
8.6.2 Competitive Strategies 284
8.6.3 Analysis of Current Market Conditions 284
8.6.4 Product Mix 285
8.6.5 Adjacent Markets 286
8.6.6 Market Drivers and Restraints 286
8.6.7 Market and Product Trends 286
9. Current Issues for OTC and Home Diagnostic Testing 287
9.1 New Markets for OTC and Home Diagnostic Testing 287
9.2 Utility of OTC and Home Self-Testing 291
9.3 Corporate Screening 292
9.4 Generational Drivers of Home Testing 293
9.5 Move Away from Central Laboratories 295
9.6 Healthcare Cost Controls 295
9.7 Mergers of Diagnostic Companies 296
9.8 Home Healthcare Trends 297
9.9 Home Healthcare Providers versus Mass Market Retailers 297
9.10 Demographic Merchandising 297
9.11 Marketing Strategies 298
9.12 Third-Party Pharmacy Networks 299
9.13 Which Customer Segments Purchase Home Healthcare? Which Products Fit Their Needs? 299
9.14 Future of Patient Self-Testing 300
10. Corporate Profiles 303
10.1 Abbott Diagnostics 303
10.2 ACON Laboratories, Inc. 304
10.3 AgaMatrix 305
10.4 Alere, Inc. 305
10.5 American Bio Medica Corporation (ABMC) 307
10.6 AmeriSourceBergen 309
10.7 Ani Biotech Oy 310
10.8 ARKRAY, Inc. 311
10.9 Bayer Corporation 312
10.10 Becton Dickinson (BD) 314
10.11 Biomerica, Inc. 314
10.12 Calypte Biomedical Corporation 315
10.13 Cardinal Health, Inc. 316
10.14 HemoCue 318
10.15 Home Access Health Corp. 318
10.16 Insulet Corporation 318
10.17 International Technidyne Corporation (ITC) Nexus Dx 318
10.18 Johnson & Johnson 319
10.19 LifeScan 321
10.20 A Menarini Diagnostics 322
10.21 NOVA Biomedical 322
10.22 Orasure 323
10.23 Princeton BioMeditech 323
10.24 Quidel Corp. 323
10.25 Roche Diagnostics (a Division of Roche Holdings) 328
10.26 Saliva Diagnostics 330
10.27 Trinity Biotech, Plc 330
11. Corporate Directory 334
Appendix 1: Over-the-Counter In Vitro Diagnostic Devices 342
Appendix 2: Recent OTC Waived Tests for Drugs of Abuse 388
Appendix 3: FDA Approved and Unapproved Tests for HIV Home Testing 391
Appendix 4: Home Medical Equipment Reimbursement Contacts for Medicare 395
Appendix 5: Frequently-Asked Questions About Drug Screening Kits 396
INDEX OF FIGURES
Figure 2.1: European OTC Diagnostic Products Market by Country 24
Figure 3.1: Single-Day Continuous Blood Glucose Data 51
Figure 3.2: Share of the U.S. Self-Testing Diagnostic Market, 2011 55
Figure 7.1: Conformity Assessment Route, Annexes and Quality System Standards by IVD
Device Category 206
Figure 8.1: Coagulation Testing 242
INDEX OF TABLES
Table 2.1: Worldwide Distribution of IVD Testing, 2011 20
Table 2.2: Top 13 Country IVD Testing Markets, 2011 21
Table 2.3: Total Global POCT Market, 2008-2018 21
Table 2.4: Global POC Market Share Analysis, 2011 22
Table 2.5: Worldwide OTC Diagnostic Products Market, 2008-2018 23
Table 2.6: Worldwide OTC Diagnostic Products Market by Region, 2011 23
Table 2.7: European OTC Diagnostic Products Market, 2008-2018 24
Table 2.8: Major European OTC Diagnostics Markets, 2011 25
Table 2.9: German OTC Diagnostic Products Market Sales, 2008-2018 26
Table 2.10: U.K. OTC Diagnostic Products Market Sales, 2008-2018 27
Table 2.11: Major U.K. Suppliers of IVD Products 28
Table 2.12: French OTC Diagnostic Products Market Sales, 2008-2018 30
Table 2.13: Italian OTC Diagnostic Products Market Sales, 2008-2018 30
Table 2.14: Spanish OTC Diagnostic Products Market Sales, 2008-2018 31
Table 2.15: Japanese OTC Diagnostic Products Market Sales, 2008-2018 32
Table 2.16: Chinese OTC Diagnostic Products Market Sales, 2008-2018 33
Table 2.17: U.S. OTC Diagnostic Products Market Sales, 2008-2018 34
Table 2.18: U.S. Clinical Diagnostic Home Test Market Segments, 2011 34
Table 2.19: Top Drugstore Retailers in the U.S. 36
Table 2.20: Top Drugstore Wholesalers in the U.S. 36
Table 3.1: Global Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 40
Table 3.2: U.S. Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 40
Table 3.3: Top Ten Countries in Number of Persons with Diabetes (Aged 20 to 79 Years), 2011 and 2030 42
Table 3.4: Share of the U.S. Self-Testing Diagnostic Market, 2011 43
Table 3.5: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 44
Table 3.6: World Market Share of POC Glucose Monitoring Marketers 45
Table 3.7: Key Features Considered for Glucose Meter Devices 48
Table 3.8: Demographic Characteristics Home-Testing Kit Buyers 51
Table 3.9: Top Brand Preferences for Home Glucose Testing Kits 51
Table 3.10: Instances When Patients Prefer Professional's Glucose Testing 52
Table 3.11: Advantages of a Home-Testing Kit 52
Table 3.12: Disadvantages of Using a Home-Testing Kit 52
Table 3.13: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits 52
Table 3.14: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2008-2018 53
Table 3.15: U.S. Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 54
Table 3.16: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements 55
Table 3.17: U.S. Diabetes Glucose Monitoring Market Repeat Retail Replacement Sales Percentages 55
Table 3.18: Top Four Players in the U.S. Blood Glucose Strips MarketRanked by Percentage
Sales, 2011 56
Table 3.19: Leading Blood Glucose Meters and Strips Brands in the U.S., 2011 56
Table 3.20: European Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 57
Table 3.21: European Glucose Self-Testing Market by Country, 2011 58
Table 3.22: Asia-Pacific (Excluding Japan) Glucose Self-Testing Market (Meters, Lancets and Test Strips),
2008-2018 59
Table 3.23: Japan Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 60
Table 3.24: Chinese Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 61
Table 3.25: Chinese Glucose Self-Testing Market (Test Strips), 2008-2018 62
Table 3.26: Indian Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 63
Table 3.27: Indian Glucose Self-Testing Market (Test Strips), 2008-2018 63
Table 3.28: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2008-2018 64
Table 3.29: Unit Sales of Homecare Lancets in the U.S., 2008-2018 67
Table 3.30: Unit Sales of Lancets in the E.U., 2008-2018 67
Table 3.31: Competition in the Lancet Market Segment 68
Table 3.32: Key Features of Reagent Test Strips 70
Table 3.33: Customer PrioritiesGlucose Meter Self-Testing Market, 2001, 2006 and 2012 72
Table 3.34: Accu-Chek Blood Glucose Monitoring Systems 77
Table 3.35: Summary of Emerging Glucose Sensor Technologies, 2011 94
Table 3.36: Pregnancy Test Market for OTC Testing in the U.S., 2008-2018 97
Table 3.37: Pregnancy Test Market for OTC Testing in Europe, 2008-2018 97
Table 3.38: U.S. Market Share for Home Pregnancy Tests 99
Table 3.39: European Market Share for OTC Pregnancy Tests 99
Table 3.40: Home Pregnancy Tests Available in the U.S. Market 102
Table 3.41: Hepatitis C Statistics 107
Table 3.42: Hepatitis Market for OTC Testing in the U.S., 2008-2018 108
Table 3.43: U.S. OTC Drugs of Abuse Testing Market in the U.S., 2008-2018 109
Table 3.44: Illicit Drugs that are Important for Detection 111
Table 3.45: Analytical Detection Levels for Drugs of Abuse 111
Table 3.46: Princeton BioMeditech's Drugs of Abuse Tests 117
Table 3.47: Abbott Drugs of Abuse Tests on the ARCHITECT System 118
Table 3.48: Infectious Disease Market for OTC Testing in the U.S., 2008-2018 120
Table 3.49: HIV Testing Market for OTC Testing in the U.S., 2008-2018 123
Table 3.50: Home Testing for Urinary Tract Infections 133
Table 3.51: Cholesterol Market for OTC and Home Self-Testing in the U.S., 2008-2018 134
Table 3.52: Coagulation Market for OTC Testing in the U.S., 2008-2018 137
Table 3.53: Global Urine Dipstick Testing OTC Testing., 2008-2018 141
Table 3.54: Glucose Market for OTC Testing in the U.S., 2008-2018 142
Table 3.55: Fertility Testing Market for OTC Testing in the U.S., 2008-2018 143
Table 3.56: Fertility Testing Market for OTC Testing in Europe, 2008-2018 144
Table 3.57: Rite Aid and Other OEM Ovulation Predictors 146
Table 3.58: At-Home DNA Tests 147
Table 3.59: At-Home DNA Market for OTC Testing Worldwide, 2008-2018 148
Table 3.60: Home Genetic Testing Market in the U.S., 2008-2018 154
Table 3.61: Genovations Profiles 155
Table 3.62: Featured Tests by DNA Direct 157
Table 3.63: Fee Schedule for Personal Home-based Paternity Studies 158
Table 4.1: Financial Comparison for Moderate and Waived CLIA Labs 175
Table 6.1: Normal Glucose Values, Fasting State 188
Table 6.2: Cholesterol Levels and Desirability 192
Table 6.3: Leading Home Patient Monitoring Products in the U.S. Market 199
Table 7.1: POC Testing: Cost Analysis 214
Table 7.2: POC Testing: Cost Analysis with Labor Included 214
Table 8.1: Global Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 216
Table 8.2: Global Glucose Self-Testing Market (Meters), 2008-2018 217
Table 8.3: Global Glucose Self-Testing Market (Lancets), 2008-2018 217
Table 8.4: Global Glucose Self-Testing Market (Test Strips), 2008-2018 218
Table 8.5: U.S. Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 219
Table 8.6: U.S. Glucose Self-Testing Market (Meters), 2008-2018 219
Table 8.7: U.S. Glucose Self-Testing Market (Lancets), 2008-2018 220
Table 8.8: U.S. Glucose Self-Testing Market (Test Strips), 2008-2018 220
Table 8.9: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales Percentages, 2011 220
Table 8.10: Market Share of U.S. Blood Glucose Self-Testing, 2011 221
Table 8.11: European Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 222
Table 8.12: European Glucose Self-Testing Market (Meters), 2008-2018 222
Table 8.13: European Glucose Self-Testing Market (Lancets), 2008-2018 223
Table 8.14: European Glucose Self-Testing Market (Test Strips), 2008-2018 223
Table 8.15: European Glucose Self-Testing Market by Country, 2011 224
Table 8.16: Asia-Pacific (Excluding Japan) Glucose Self-Testing Market (Meters, Lancets and Test Strips),
2008-2018 226
Table 8.17: Asia-Pacific (Excluding Japan) Glucose Self-Testing Market (Meters), 2008-2018 226
Table 8.18: Asia-Pacific (Excluding Japan) Glucose Self-Testing Market (Lancets), 2008-2018 227
Table 8.19: Asia-Pacific (Excluding Japan) Glucose Self-Testing Market (Test Strips), 2008-2018 227
Table 8.20: Japanese Population and Aging Demographics Forecast, 2000-2050 228
Table 8.21: Japan Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 229
Table 8.22: Key Market Drivers for Glucose Self-Testing 237
Table 8.23: Market Drivers for Continuous Glucose Monitoring 238
Table 8.24: Key Market Restraints for Glucose Self-Testing 239
Table 8.25: Market Restraints for Continuous Glucose Monitoring 239
Table 8.26: U.S. Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2008-2018 245
Table 8.27: Selected POC Rapid Coagulation Analyzers, 2011 247
Table 8.28: Global Revenue Forecasts for POC Cholesterol Testing Products Market, 2008-2018 256
Table 8.29: U.S. Revenue Forecasts for POC Cholesterol Testing Products Market, 2008-2018 256
Table 8.30: European Revenue Forecasts for POC Cholesterol Testing Products Market, 2008-2018 257
Table 8.31: Selected POC Substance/Drug Abuse Testing Devices, 2011 271
Table 9.1: Instruments Available for INR Self-Testing 302
Table 9.2: INR PST Service Providers 302
Table 9.3: PST Reimbursement, 2011 302
Table 9.4: Future Strategies for INR Testing 302
Table 10.1: Alere, Inc. Financial FiguresNet Sales by Business Sector, 2008-2011 307
Table 10.2: Alere, Inc. Financial FiguresNet Sales by Geographic Region, 2008-2011 307
Table 10.3: AmerisourceBergen Financial FiguresStatement of Operations Data, 2008-2011 310
Table 10.4: Bayer AG Financial FiguresNet Sales by Business Sector, 2008-2011 313
Table 10.5: Bayer AG Financial FiguresNet Sales by Geographic Region, 2008-2011 313
Table 10.6: Cardinal Health Financial FiguresNet Sales by Business Sector, 2009-2011 317
Table 10.7: Cardinal Health Financial FiguresNet Sales by Geographic Region, 2009-2011 317
Table 10.8: Johnson & Johnson Financial FiguresNet Sales by Major Business Segment, 2009-2011 320
Table 10.9: Johnson & Johnson Financial FiguresNet Sales by Geographic Region, 2009-2011 320
Table 10.10: Roche Group Financial FiguresNet Sales by Business Sector, 2008-2011 329
Table 10.11: Roche Group Financial FiguresNet Sales by Geographic Region (Pharmaceuticals),
2009-2011 329
Table 10.12: Roche Group Financial FiguresNet Sales by Sub-Division (Diagnostics), 2008-2011 329
Table A1.1: Glucose (Whole Blood) UGLGlucose (Urine) Over-the-Counter In Vitro
Diagnostic Devices 342
Table A2.1: Cholesterol Over-the-Counter In Vitro Diagnostic Devices 375
Table A3.1: Fecal Occult Blood Over-the-Counter In Vitro Diagnostic Devices 376
Table A4.1: Cannabinoids (THC) Over-the-Counter In Vitro Diagnostic Devices 377
Table A5.1: hCG, Urine Over-the-Counter In Vitro Diagnostic Devices 381
Table A6.1: Alcohol, Breath Over-the-Counter In Vitro Diagnostic Devices 382
Table A7.1: Urine Qualitative Dipstick Blood Over-the-Counter In Vitro Diagnostic Devices 384
Table A8.1: Barbiturates Over-the-Counter In Vitro Diagnostic Devices 384
1. Overview 9
1.1 Statement of Report 9
1.2 About This Report 9
1.3 Scope of the Report 11
1.4 Objectives 12
1.5 Methodology 12
1.6 Executive Summary 13
2. Sector Overview 20
2.1 Global Diagnostic Products Industry 20
2.2 Global OTC Diagnostic Products Industry 22
2.3 European OTC and Home Self-Testing Diagnostic Markets 24
2.3.1 German OTC and Home Self-Testing Diagnostic Markets 26
2.3.2 U.K. OTC and Home Self-Test Diagnostic Markets 26
2.3.2.1 U.K. Market Statistics 27
2.3.2.2 U.K. Competitive Analysis 28
2.3.2.3 U.K. Market Access 29
2.3.3 French OTC Diagnostic Market 29
2.3.4 Italian OTC Diagnostic Market 30
2.3.5 Spanish OTC Diagnostic Market 31
2.3.6 Japanese OTC Diagnostic Market 31
2.3.7 Chinese OTC Diagnostic Market 33
2.4 Description of the U.S. OTC Diagnostics Industry Segment 33
2.4.1 Market Overview 33
2.4.2 Diagnostic Test Categories 34
2.5 Market Drivers in the OTC Diagnostics Sector 35
2.5.1 Overview 35
2.5.2 Market Segments 35
2.6 Key Players in the OTC Diagnostics Segment 36
2.7 Sector Analysis 37
3. Market Analysis: Size, Growth, Share and Competitors 39
3.1 Glucose Monitoring 39
3.1.1 Glucose Control in Diabetic Patients 45
3.1.2 Tight Glucose Control in Treating Diabetes 45
3.1.3 Glucose-Monitoring Devices 46
3.1.4 Key Issues for Glucose Monitoring 47
3.1.5 Glucose Device Description 47
3.1.6 Precision in Glucose Meters 49
3.1.7 Limitations of Existing Glucose Monitoring Products 49
3.1.8 Over-the-Counter (OTC) Self-Testing Glucose Market 50
3.1.9 Worldwide Glucose Testing Market 52
3.1.9.1 U.S. Market 53
3.1.9.2 European Market 56
3.1.9.3 Asia-Pacific (Excluding Japan) 58
3.1.9.3.1 Japanese Market 59
3.1.9.3.2 Chinese Market 61
3.1.9.3.3 Indian Market 63
3.1.9.4 ROW Markets 64
3.1.10 Reagents and Equipment 64
3.1.10.1 Blood Glucose Monitoring 64
3.1.10.2 Lancets 65
3.1.10.3 Blood Glucose Monitor and Insulin Doser 69
3.1.10.4 Blood Glucose Reagent Test Strips 70
3.1.10.5 Control Solutions and Calibrators 70
3.1.10.6 Sharps Devices 71
3.1.10.7 Needle Destruction Devices 71
3.1.11 Glucose Meters 72
3.1.12 Voice-Operated Glucose Meters 89
3.1.13 Continuous Blood Glucose Monitoring (CBGM) 91
3.1.14 Self-Monitoring Blood Glucose (SMBG) Testing 92
3.1.15 Minimally-Invasive and Non-Invasive Blood Glucose Testing 92
3.1.16 Emerging Glucose Monitoring Technologies 93
3.1.16.1 Optical Transducer Technologies 93
3.1.16.2 Transdermal Sensor Technologies 95
3.1.16.3 Invasive Glucose Sensor Technologies 96
3.2 Pregnancy and Fertility Testing 96
3.2.1 Major Players 98
3.2.1.1 U.S. Market 98
3.2.1.2 European Market 99
3.2.2 Diagnostic Kit Information 99
3.2.3 Competitive Sector Analysis 104
3.3 Hepatitis Testing 104
3.4 Drugs of Abuse Screening Testing 109
3.5 Infectious Disease Testing 119
3.5.1 HIV 121
3.5.2 Tuberculosis Testing 128
3.5.3 Infectious Disease Testing in Non-Medical Settings 129
3.5.4 West Nile Virus 132
3.5.5 Urinary Tract Infections 132
3.6 Cholesterol Testing 133
3.7 Coagulation Testing 135
3.8 Urine Dipstick Testing 141
3.9 Fertility Testing 142
3.9.1 Players 144
3.9.2 Diagnostic Test Kits 144
3.10 At-Home DNA Analysis 146
3.11 Biowarfare Detection 149
3.12 Home Patient Monitoring Devices 151
3.13 Home Patient Alert Systems 153
3.14 Home Genetic Testing Kits 154
3.15 Home Paternity Testing 157
3.16 Health Hazards Detection 158
3.16.1 Lead 158
3.16.2 Radon 158
3.16.3 Asbestos 159
3.16.4 Pesticides 159
3.16.5 Mold 159
3.16.6 Carbon Monoxide 159
3.16.7 Water Quality 159
3.16.8 Bacteria in Water 160
3.17 Thyroid Disease 160
3.18 Carpal Tunnel 160
3.19 Allergies 160
3.20 Nutrition and Wellness 160
3.20.1 Testosterone and Male Hormones 160
3.20.2 Female Hormones 160
3.20.3 Antioxidants 161
3.20.4 Sleep Apnea 161
3.20.5 Mineral Check 161
3.20.6 Stress Check 162
3.21 Colorectal Cancer (Occult Blood) Testing 162
3.22 Alzheimer's Disease Home Screening Test 163
3.23 Tobacco Testing 164
4. Business Trends in the Industry 165
4.1 Wholesale Distribution Overview 165
4.2 Factors Affecting OTC Medical Product Distribution 166
4.3 Government Regulation of Medical Devices 168
4.3.1 U.S. Regulations 168
4.3.2 U.K. Regulations 171
4.4 Clinical Laboratory Improvement Act (CLIA) 172
4.5 Legal, M&A and Corporate Partnerships 175
5. Patient Management Trends 177
5.1 Trends in OTC Testing and Reimbursement 177
5.1.1 American OTC Testing and Home Self-testing Reimbursement 177
5.1.2 European Reimbursement 179
5.2 Drivers of OTC and Home Self-Testing 182
5.3 Cost Elements of OTC Testing 183
5.4 Important Elements of OTC Testing 183
5.5 Growth of Home Care Testing 183
5.6 Non-Traditional Methods for Sample Collection 183
6. Technology Trends 185
6.1 Sensor Systems for Diagnostic Applications 185
6.2 Glucose Measurements 186
6.3 Cholesterol Testing 191
6.4 Immunoassay Technology 192
6.5 Biosensor Technology 193
6.5.1 Recent Biosensor Product Introductions and Latest Innovative Developments 194
6.5.1.1 Nanoscale Sensors for the Detection of Cancer Biomarkers 194
6.5.1.2 ForteBio Introduces Dip and Read Protein G Biosensor for Octet Instruments 195
6.5.1.3 ForteBio Launches New Octet RED96 System and Dip and Read Protein L Biosensor 195
6.5.1.4 AgaMatrix Europe Limited introduces the New Jazz Blood Glucose Meter in the U.K. 196
6.5.1.5 STMicroelectronics to Manufacture Worlds Smallest Biosensors 196
6.5.1.6 Universal Biosensors Advances Point of Care Molecular Diagnostic Opportunity 196
6.5.1.7 Clinitek AdvantusA Semi Automated Urine Analyzer for Point of Care Testing 196
6.5.1.8 The NOVA 16 STAT Chemistry Analyzer Offers the First All-Electrode-based Seven Test
Chemistry Profile 196
6.6 Fructosamine Test 197
6.7 Home Telemedicine Devices 198
6.8 Insulin Pumps 200
7. OTC Testing: Critical Issues 201
7.1 Moderators of Growth for OTC Testing 201
7.2 Attitudes of Critical Care Nurses and Physicians 211
7.3 Personnel Impact for OTC Testing 211
7.4 Data Management Issues 211
7.5 POC Decentralization Issues 212
7.6 POC Testing and Clinical Outcomes 212
7.7 Focused Testing 212
7.8 Satellite Facilities 212
7.9 POC Testing Comparison and Cost Analysis 212
8. Competitive Assessments of the High-Growth Markets 215
8.1 Glucose Monitoring 215
8.1.1 Overview of Market Segment 215
8.1.2 Competitive Strategies 229
8.1.3 Analyses of the Current Market Conditions, Competition and Product Mix 231
8.1.4 Adjacent Markets 236
8.1.5 Market Drivers and Restraints 237
8.1.6 Market and Product Trends 239
8.2 Coagulation Testing 240
8.2.1 Overview of Market Segment 240
8.2.2 Competitive Strategies 246
8.2.3 Analyses of Current Market Conditions 246
8.2.4 Product Mix in Coagulation Testing 247
8.2.4.1 Review of Selected POC Rapid Coagulation Analyzers 247
8.2.5 Adjacent Markets 253
8.2.6 Market Drivers and Restraints 253
8.2.7 Market and Product Trends 254
8.2.8 Quality Control Issues 255
8.3 Cholesterol Testing 255
8.3.1 Overview of Market Segment 255
8.3.2 Competitive Strategies 257
8.3.3 Adjacent Markets 260
8.4 Infectious Disease Testing 260
8.4.1 Overview of Market Segment 260
8.5 Drugs of Abuse 266
8.5.1 Overview of Market Segment 266
8.5.2 Analyses of the Current Market Conditions, Competition and Product Mix 273
8.5.2.1 Alere 273
8.5.2.2 Abbott Diagnostics 274
8.5.2.3 Roche Diagnostics 274
8.5.2.4 BioScan Screening Systems, Inc. 275
8.5.2.5 American Bio Medica Corp. 275
8.5.2.6 Phamatech, Inc. 278
8.5.2.7 First Check Medical (Inverness Medical Innovations, Inc.) 279
8.5.2.8 OraSure 279
8.5.2.9 Avitar, Inc. 280
8.5.2.10 Concateno 280
8.5.2.11 Pathtech 280
8.5.2.12 Alfa Scientific Designs, Inc. 281
8.5.2.13 TCPI, Inc. 282
8.5.2.14 Roche 282
8.5.2.15 Biophor Diagnostics 282
8.5.2.16 Randox Laboratories 282
8.5.2.17 Branan Medical 282
8.5.2.18 Concateno 283
8.5.3 Adjacent Markets 284
8.6 Home Pregnancy Testing 284
8.6.1 Overview of Market Segment 284
8.6.2 Competitive Strategies 284
8.6.3 Analysis of Current Market Conditions 284
8.6.4 Product Mix 285
8.6.5 Adjacent Markets 286
8.6.6 Market Drivers and Restraints 286
8.6.7 Market and Product Trends 286
9. Current Issues for OTC and Home Diagnostic Testing 287
9.1 New Markets for OTC and Home Diagnostic Testing 287
9.2 Utility of OTC and Home Self-Testing 291
9.3 Corporate Screening 292
9.4 Generational Drivers of Home Testing 293
9.5 Move Away from Central Laboratories 295
9.6 Healthcare Cost Controls 295
9.7 Mergers of Diagnostic Companies 296
9.8 Home Healthcare Trends 297
9.9 Home Healthcare Providers versus Mass Market Retailers 297
9.10 Demographic Merchandising 297
9.11 Marketing Strategies 298
9.12 Third-Party Pharmacy Networks 299
9.13 Which Customer Segments Purchase Home Healthcare? Which Products Fit Their Needs? 299
9.14 Future of Patient Self-Testing 300
10. Corporate Profiles 303
10.1 Abbott Diagnostics 303
10.2 ACON Laboratories, Inc. 304
10.3 AgaMatrix 305
10.4 Alere, Inc. 305
10.5 American Bio Medica Corporation (ABMC) 307
10.6 AmeriSourceBergen 309
10.7 Ani Biotech Oy 310
10.8 ARKRAY, Inc. 311
10.9 Bayer Corporation 312
10.10 Becton Dickinson (BD) 314
10.11 Biomerica, Inc. 314
10.12 Calypte Biomedical Corporation 315
10.13 Cardinal Health, Inc. 316
10.14 HemoCue 318
10.15 Home Access Health Corp. 318
10.16 Insulet Corporation 318
10.17 International Technidyne Corporation (ITC) Nexus Dx 318
10.18 Johnson & Johnson 319
10.19 LifeScan 321
10.20 A Menarini Diagnostics 322
10.21 NOVA Biomedical 322
10.22 Orasure 323
10.23 Princeton BioMeditech 323
10.24 Quidel Corp. 323
10.25 Roche Diagnostics (a Division of Roche Holdings) 328
10.26 Saliva Diagnostics 330
10.27 Trinity Biotech, Plc 330
11. Corporate Directory 334
Appendix 1: Over-the-Counter In Vitro Diagnostic Devices 342
Appendix 2: Recent OTC Waived Tests for Drugs of Abuse 388
Appendix 3: FDA Approved and Unapproved Tests for HIV Home Testing 391
Appendix 4: Home Medical Equipment Reimbursement Contacts for Medicare 395
Appendix 5: Frequently-Asked Questions About Drug Screening Kits 396
INDEX OF FIGURES
Figure 2.1: European OTC Diagnostic Products Market by Country 24
Figure 3.1: Single-Day Continuous Blood Glucose Data 51
Figure 3.2: Share of the U.S. Self-Testing Diagnostic Market, 2011 55
Figure 7.1: Conformity Assessment Route, Annexes and Quality System Standards by IVD
Device Category 206
Figure 8.1: Coagulation Testing 242
INDEX OF TABLES
Table 2.1: Worldwide Distribution of IVD Testing, 2011 20
Table 2.2: Top 13 Country IVD Testing Markets, 2011 21
Table 2.3: Total Global POCT Market, 2008-2018 21
Table 2.4: Global POC Market Share Analysis, 2011 22
Table 2.5: Worldwide OTC Diagnostic Products Market, 2008-2018 23
Table 2.6: Worldwide OTC Diagnostic Products Market by Region, 2011 23
Table 2.7: European OTC Diagnostic Products Market, 2008-2018 24
Table 2.8: Major European OTC Diagnostics Markets, 2011 25
Table 2.9: German OTC Diagnostic Products Market Sales, 2008-2018 26
Table 2.10: U.K. OTC Diagnostic Products Market Sales, 2008-2018 27
Table 2.11: Major U.K. Suppliers of IVD Products 28
Table 2.12: French OTC Diagnostic Products Market Sales, 2008-2018 30
Table 2.13: Italian OTC Diagnostic Products Market Sales, 2008-2018 30
Table 2.14: Spanish OTC Diagnostic Products Market Sales, 2008-2018 31
Table 2.15: Japanese OTC Diagnostic Products Market Sales, 2008-2018 32
Table 2.16: Chinese OTC Diagnostic Products Market Sales, 2008-2018 33
Table 2.17: U.S. OTC Diagnostic Products Market Sales, 2008-2018 34
Table 2.18: U.S. Clinical Diagnostic Home Test Market Segments, 2011 34
Table 2.19: Top Drugstore Retailers in the U.S. 36
Table 2.20: Top Drugstore Wholesalers in the U.S. 36
Table 3.1: Global Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 40
Table 3.2: U.S. Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 40
Table 3.3: Top Ten Countries in Number of Persons with Diabetes (Aged 20 to 79 Years), 2011 and 2030 42
Table 3.4: Share of the U.S. Self-Testing Diagnostic Market, 2011 43
Table 3.5: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 44
Table 3.6: World Market Share of POC Glucose Monitoring Marketers 45
Table 3.7: Key Features Considered for Glucose Meter Devices 48
Table 3.8: Demographic Characteristics Home-Testing Kit Buyers 51
Table 3.9: Top Brand Preferences for Home Glucose Testing Kits 51
Table 3.10: Instances When Patients Prefer Professional's Glucose Testing 52
Table 3.11: Advantages of a Home-Testing Kit 52
Table 3.12: Disadvantages of Using a Home-Testing Kit 52
Table 3.13: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits 52
Table 3.14: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2008-2018 53
Table 3.15: U.S. Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 54
Table 3.16: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements 55
Table 3.17: U.S. Diabetes Glucose Monitoring Market Repeat Retail Replacement Sales Percentages 55
Table 3.18: Top Four Players in the U.S. Blood Glucose Strips MarketRanked by Percentage
Sales, 2011 56
Table 3.19: Leading Blood Glucose Meters and Strips Brands in the U.S., 2011 56
Table 3.20: European Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 57
Table 3.21: European Glucose Self-Testing Market by Country, 2011 58
Table 3.22: Asia-Pacific (Excluding Japan) Glucose Self-Testing Market (Meters, Lancets and Test Strips),
2008-2018 59
Table 3.23: Japan Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 60
Table 3.24: Chinese Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 61
Table 3.25: Chinese Glucose Self-Testing Market (Test Strips), 2008-2018 62
Table 3.26: Indian Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 63
Table 3.27: Indian Glucose Self-Testing Market (Test Strips), 2008-2018 63
Table 3.28: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2008-2018 64
Table 3.29: Unit Sales of Homecare Lancets in the U.S., 2008-2018 67
Table 3.30: Unit Sales of Lancets in the E.U., 2008-2018 67
Table 3.31: Competition in the Lancet Market Segment 68
Table 3.32: Key Features of Reagent Test Strips 70
Table 3.33: Customer PrioritiesGlucose Meter Self-Testing Market, 2001, 2006 and 2012 72
Table 3.34: Accu-Chek Blood Glucose Monitoring Systems 77
Table 3.35: Summary of Emerging Glucose Sensor Technologies, 2011 94
Table 3.36: Pregnancy Test Market for OTC Testing in the U.S., 2008-2018 97
Table 3.37: Pregnancy Test Market for OTC Testing in Europe, 2008-2018 97
Table 3.38: U.S. Market Share for Home Pregnancy Tests 99
Table 3.39: European Market Share for OTC Pregnancy Tests 99
Table 3.40: Home Pregnancy Tests Available in the U.S. Market 102
Table 3.41: Hepatitis C Statistics 107
Table 3.42: Hepatitis Market for OTC Testing in the U.S., 2008-2018 108
Table 3.43: U.S. OTC Drugs of Abuse Testing Market in the U.S., 2008-2018 109
Table 3.44: Illicit Drugs that are Important for Detection 111
Table 3.45: Analytical Detection Levels for Drugs of Abuse 111
Table 3.46: Princeton BioMeditech's Drugs of Abuse Tests 117
Table 3.47: Abbott Drugs of Abuse Tests on the ARCHITECT System 118
Table 3.48: Infectious Disease Market for OTC Testing in the U.S., 2008-2018 120
Table 3.49: HIV Testing Market for OTC Testing in the U.S., 2008-2018 123
Table 3.50: Home Testing for Urinary Tract Infections 133
Table 3.51: Cholesterol Market for OTC and Home Self-Testing in the U.S., 2008-2018 134
Table 3.52: Coagulation Market for OTC Testing in the U.S., 2008-2018 137
Table 3.53: Global Urine Dipstick Testing OTC Testing., 2008-2018 141
Table 3.54: Glucose Market for OTC Testing in the U.S., 2008-2018 142
Table 3.55: Fertility Testing Market for OTC Testing in the U.S., 2008-2018 143
Table 3.56: Fertility Testing Market for OTC Testing in Europe, 2008-2018 144
Table 3.57: Rite Aid and Other OEM Ovulation Predictors 146
Table 3.58: At-Home DNA Tests 147
Table 3.59: At-Home DNA Market for OTC Testing Worldwide, 2008-2018 148
Table 3.60: Home Genetic Testing Market in the U.S., 2008-2018 154
Table 3.61: Genovations Profiles 155
Table 3.62: Featured Tests by DNA Direct 157
Table 3.63: Fee Schedule for Personal Home-based Paternity Studies 158
Table 4.1: Financial Comparison for Moderate and Waived CLIA Labs 175
Table 6.1: Normal Glucose Values, Fasting State 188
Table 6.2: Cholesterol Levels and Desirability 192
Table 6.3: Leading Home Patient Monitoring Products in the U.S. Market 199
Table 7.1: POC Testing: Cost Analysis 214
Table 7.2: POC Testing: Cost Analysis with Labor Included 214
Table 8.1: Global Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 216
Table 8.2: Global Glucose Self-Testing Market (Meters), 2008-2018 217
Table 8.3: Global Glucose Self-Testing Market (Lancets), 2008-2018 217
Table 8.4: Global Glucose Self-Testing Market (Test Strips), 2008-2018 218
Table 8.5: U.S. Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 219
Table 8.6: U.S. Glucose Self-Testing Market (Meters), 2008-2018 219
Table 8.7: U.S. Glucose Self-Testing Market (Lancets), 2008-2018 220
Table 8.8: U.S. Glucose Self-Testing Market (Test Strips), 2008-2018 220
Table 8.9: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales Percentages, 2011 220
Table 8.10: Market Share of U.S. Blood Glucose Self-Testing, 2011 221
Table 8.11: European Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 222
Table 8.12: European Glucose Self-Testing Market (Meters), 2008-2018 222
Table 8.13: European Glucose Self-Testing Market (Lancets), 2008-2018 223
Table 8.14: European Glucose Self-Testing Market (Test Strips), 2008-2018 223
Table 8.15: European Glucose Self-Testing Market by Country, 2011 224
Table 8.16: Asia-Pacific (Excluding Japan) Glucose Self-Testing Market (Meters, Lancets and Test Strips),
2008-2018 226
Table 8.17: Asia-Pacific (Excluding Japan) Glucose Self-Testing Market (Meters), 2008-2018 226
Table 8.18: Asia-Pacific (Excluding Japan) Glucose Self-Testing Market (Lancets), 2008-2018 227
Table 8.19: Asia-Pacific (Excluding Japan) Glucose Self-Testing Market (Test Strips), 2008-2018 227
Table 8.20: Japanese Population and Aging Demographics Forecast, 2000-2050 228
Table 8.21: Japan Glucose Self-Testing Market (Meters, Lancets and Test Strips), 2008-2018 229
Table 8.22: Key Market Drivers for Glucose Self-Testing 237
Table 8.23: Market Drivers for Continuous Glucose Monitoring 238
Table 8.24: Key Market Restraints for Glucose Self-Testing 239
Table 8.25: Market Restraints for Continuous Glucose Monitoring 239
Table 8.26: U.S. Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2008-2018 245
Table 8.27: Selected POC Rapid Coagulation Analyzers, 2011 247
Table 8.28: Global Revenue Forecasts for POC Cholesterol Testing Products Market, 2008-2018 256
Table 8.29: U.S. Revenue Forecasts for POC Cholesterol Testing Products Market, 2008-2018 256
Table 8.30: European Revenue Forecasts for POC Cholesterol Testing Products Market, 2008-2018 257
Table 8.31: Selected POC Substance/Drug Abuse Testing Devices, 2011 271
Table 9.1: Instruments Available for INR Self-Testing 302
Table 9.2: INR PST Service Providers 302
Table 9.3: PST Reimbursement, 2011 302
Table 9.4: Future Strategies for INR Testing 302
Table 10.1: Alere, Inc. Financial FiguresNet Sales by Business Sector, 2008-2011 307
Table 10.2: Alere, Inc. Financial FiguresNet Sales by Geographic Region, 2008-2011 307
Table 10.3: AmerisourceBergen Financial FiguresStatement of Operations Data, 2008-2011 310
Table 10.4: Bayer AG Financial FiguresNet Sales by Business Sector, 2008-2011 313
Table 10.5: Bayer AG Financial FiguresNet Sales by Geographic Region, 2008-2011 313
Table 10.6: Cardinal Health Financial FiguresNet Sales by Business Sector, 2009-2011 317
Table 10.7: Cardinal Health Financial FiguresNet Sales by Geographic Region, 2009-2011 317
Table 10.8: Johnson & Johnson Financial FiguresNet Sales by Major Business Segment, 2009-2011 320
Table 10.9: Johnson & Johnson Financial FiguresNet Sales by Geographic Region, 2009-2011 320
Table 10.10: Roche Group Financial FiguresNet Sales by Business Sector, 2008-2011 329
Table 10.11: Roche Group Financial FiguresNet Sales by Geographic Region (Pharmaceuticals),
2009-2011 329
Table 10.12: Roche Group Financial FiguresNet Sales by Sub-Division (Diagnostics), 2008-2011 329
Table A1.1: Glucose (Whole Blood) UGLGlucose (Urine) Over-the-Counter In Vitro
Diagnostic Devices 342
Table A2.1: Cholesterol Over-the-Counter In Vitro Diagnostic Devices 375
Table A3.1: Fecal Occult Blood Over-the-Counter In Vitro Diagnostic Devices 376
Table A4.1: Cannabinoids (THC) Over-the-Counter In Vitro Diagnostic Devices 377
Table A5.1: hCG, Urine Over-the-Counter In Vitro Diagnostic Devices 381
Table A6.1: Alcohol, Breath Over-the-Counter In Vitro Diagnostic Devices 382
Table A7.1: Urine Qualitative Dipstick Blood Over-the-Counter In Vitro Diagnostic Devices 384
Table A8.1: Barbiturates Over-the-Counter In Vitro Diagnostic Devices 384
Related Reports
Stay In Touch
