Over The Counter Diagnostic Product World Markets

1 Overview 7
1.1 Statement of Report 7
1.2 About This Report 7
1.3 Scope of the Report 9
1.4 Objectives 10
1.5 Methodology 10
1.6 Executive Summary 11
2 Sector Overview 17
2.1 Global Diagnostic Products Industry 17
2.2 Global OTC Diagnostic Products Industry 19
2.2.1 General Global Market 19
2.2.2 German OTC and Home Self-Testing Diagnostic Markets 22
2.2.3 U.K. OTC and Home Self-Test Diagnostic Markets 22
2.2.3.1 U.K. Market Statistics 23
2.2.3.2 U.K. Competitive Analysis 24
2.2.3.3 U.K. Market Access 25
2.2.4 French OTC Diagnostic Market 25
2.2.5 Italian OTC Diagnostic Market 26
2.2.6 Spanish OTC Diagnostic Market 27
2.2.7 Japanese OTC Diagnostic Market 27
2.2.8 Chinese OTC Diagnostic Market 29
2.3 Description of the U.S. OTC Diagnostics Industry Segment 29
2.3.1 Market Overview 29
2.3.2 Diagnostic Test Categories 30
2.4 Market Drivers in the OTC Diagnostics Sector 31
2.4.1 Overview 31
2.4.2 Market Segments 31
2.5 Key Players in the OTC Diagnostics Segment 32
2.6 Sector Analysis 33
3 Market Analysis: Size, Growth, Share and Competitors 34
3.1 Glucose Monitoring 34
3.1.1 Glucose Control in Diabetic Patients 39
3.1.2 Tight Glucose Control in Treating Diabetes 40
3.1.3 Glucose-Monitoring Devices 41
3.1.4 Key Issues for Glucose Monitoring 41
3.1.5 Glucose Device Description 42
3.1.6 Precision in Glucose Meters 43
3.1.7 Limitations of Existing Glucose Monitoring Products 44
3.1.8 Over-the-Counter (OTC) Self-Testing Glucose Market 45
3.1.9 Worldwide Glucose Testing Market 47
3.1.9.1 U.S. Market 48
3.1.9.2 European Market 52
3.1.9.3 Asian Market 53
3.1.9.3.1 Japanese Market 54
3.1.9.3.2 Chinese Market 55
3.1.9.3.3 Indian Market 57
3.1.9.4 ROW Markets 58
3.1.10 Reagents and Equipment 58
3.1.10.1 Blood Glucose Monitoring 58
3.1.10.2 Lancets 59
3.1.10.3 Blood Glucose Monitor and Insulin Doser 65
3.1.10.4 Blood Glucose Reagent Test Strips 66
3.1.10.5 Control Solutions and Calibrators 66
3.1.10.6 Sharps Devices 67
3.1.10.7 Needle Destruction Devices 67
3.1.11 Glucose Meters 68
3.1.12 Voice-Operated Glucose Meters 85
3.2 Pregnancy and Fertility Testing 87
3.2.1 Major Players 88
3.2.1.1 U.S. Market 89
3.2.1.2 European Market 90
3.2.2 Diagnostic Kit Information 90
3.3 Hepatitis Testing 95
3.4 Drugs of Abuse Screening Testing 99
3.5 Infectious Disease Testing 109
3.5.1 HIV 110
3.5.2 Tuberculosis Testing 117
3.5.3 Infectious Disease Testing in Non-Medical Settings 118
3.5.4 West Nile Virus 120
3.5.5 Urinary Tract Infections 120
3.6 Cholesterol Testing 121
3.7 Coagulation Testing 123
3.8 Urine Dipstick Testing 129
3.9 Fertility Testing 130
3.9.1 Players 131
3.9.2 Diagnostic Test Kits 132
3.10 At-Home DNA Analysis 134
3.11 Biowarfare Detection 140
3.12 Home Patient Monitoring Devices 142
3.13 Home Patient Alert Systems 144
3.14 Home Genetic Testing Kits 144
3.15 Home Paternity Testing 148
3.16 Health Hazards Detection 149
3.16.1 Lead 149
3.16.2 Radon 149
3.16.3 Asbestos 149
3.16.4 Pesticides 150
3.16.5 Mold 150
3.16.6 Carbon Monoxide 150
3.16.7 Water Quality 150
3.16.8 Bacteria in Water 150
3.17 Thyroid Disease 151
3.18 Carpal Tunnel 151
3.19 Allergies 151
3.20 Nutrition and Wellness 151
3.20.1 Testosterone and Male Hormones 151
3.20.2 Female Hormones 151
3.20.3 Antioxidants 151
3.20.4 Sleep Apnea 152
3.20.5 Mineral Check 152
3.20.6 Stress Check 152
3.21 Colorectal Cancer (Occult Blood) Testing 153
3.22 Alzheimer's Disease Home Screening Test 154
3.23 Tobacco Testing 154
4. Business Trends in the Industry 155
4.1 Wholesale Distribution Overview 155
4.2 Factors Affecting OTC Medical Product Distribution 156
4.3 Government Regulation of Medical Devices 158
4.3.1 U.S. Regulations 158
4.3.2 U.K. Regulations 161
4.4 Clinical Laboratory Improvement Act (CLIA) 162
4.5 Legal, M&A and Corporate Partnerships 164
5. Patient Management Trends 165
5.1 Trends in OTC Testing and Reimbursement 165
5.1.1 American OTC Testing and Home Self-testing Reimbursement 165
5.1.2 European Reimbursement 166
5.2 Drivers of OTC and Home Self-Testing 166
5.3 Cost Elements of OTC Testing 166
5.4 Important Elements of OTC Testing 167
5.5 Growth of Home Care Testing 167
5.6 Non-Traditional Methods for Sample Collection 168
6. Technology Trends 169
6.1 Sensor Systems for Diagnostic Applications 169
6.2 Glucose Measurements 170
6.3 Cholesterol Testing 174
6.4 Immunoassay Technology 175
6.5 Biosensor Technology 175
6.6 Fructosamine Test 177
6.7 Home Telemedicine Devices 177
7. OTC Testing: Critical Issues 180
7.1 Moderators of Growth for OTC Testing 180
7.2 Attitudes of Critical Care Nurses and Physicians 180
7.3 Personnel Impact for OTC Testing 180
7.4 Data Management Issues 181
7.5 POC Decentralization Issues 181
7.6 POC Testing and Clinical Outcomes 181
7.7 Focused Testing 181
7.8 Satellite Facilities 181
7.9 POC Testing Comparison and Cost Analysis 182
8. Competitive Assessments of the High-Growth Markets 185
8.1 Glucose Monitoring 185
8.1.1 Overview of Market Segment 185
8.1.2 Competitive Strategies 186
8.1.3 Analyses of the Current Market Conditions, Competition and Product Mix 187
8.1.4 Adjacent Markets 192
8.1.5 Market Drivers and Restraints 193
8.1.6 Market and Product Trends 193
8.2 Coagulation Testing 193
8.2.1 Overview of Market Segment 193
8.2.2 Competitive Strategies 196
8.2.3 Analyses of Current Market Conditions 197
8.2.4 Product Mix in Coagulation Testing 197
8.2.5 Adjacent Markets 198
8.2.6 Market Drivers and Restraints 199
8.2.7 Market and Product Trends 200
8.3 Cholesterol Testing 200
8.3.1 Overview of Market Segment 200
8.3.2 Competitive Strategies 201
8.3.3 Adjacent Markets 203
8.4 Infectious Disease Testing 203
8.4.1 Overview of Market Segment 203
8.4.2 Competitive Strategies 206
8.5 Drugs of Abuse 207
8.5.1 Overview of Market Segment 207
8.5.2 Analyses of the Current Market Conditions, Competition and Product Mix 207
8.5.3 Adjacent Markets 209
8.6 Home Pregnancy Testing 209
8.6.1 Overview of Market Segment 209
8.6.2 Competitive Strategies 209
8.6.3 Analysis of Current Market Conditions 210
8.6.4 Product Mix 211
8.6.5 Adjacent Markets 211
8.6.6 Market Drivers and Restraints 211
8.6.7 Market and Product Trends 212
9. Current Issues for OTC and Home Diagnostic Testing 213
9.1 New Markets for OTC and Home Diagnostic Testing 213
9.2 Utility of OTC and Home Self-Testing 216
9.3 Corporate Screening 216
9.4 Generational Drivers of Home Testing 218
9.5 Move Away from Central Laboratories 220
9.6 Healthcare Cost Controls 220
9.7 Mergers of Diagnostic Companies 220
9.8 Home Healthcare Trends 220
9.9 Home Healthcare Providers versus Mass Market Retailers 220
9.10 Demographic Merchandising 221
9.11 Marketing Strategies 221
9.12 Third-Party Pharmacy Networks 222
9.13 Which Customer Segments Purchase Home Healthcare? Which Products Fit Their Needs? 222
9.14 Future of Patient Self-Testing 224
10. Corporate Profiles 225
10.1 Abbott Diagnostics 225
10.2 AmeriSourceBergen 226
10.3 Bayer Diagnostics 227
10.4 Becton Dickinson 228
10.5 Bindley Western Industries, Inc. 228
10.6 Biosite, Inc. 228
10.7 Cardinal Health, Inc. 229
10.8 Cholestech 229
10.9 HemoCue 232
10.10 Home Access Health Corp. 232
10.11 Inverness Medical Innovations, Inc. 233
10.12 Johnson & Johnson 237
10.13 LifeScan 238
10.14 Princeton BioMeditech 238
10.15 Quidel Corp. 239
10.16 Roche Diagnostics 241
10.17 Saliva Diagnostics 243
11. Corporate Directory 245
Appendix 1: Over-the-Counter In Vitro Diagnostic Devices 250
Appendix 2: OTC Waived Tests for Drugs of Abuse 268
Appendix 3: FDA Approved and Unapproved Tests for HIV Home Testing 271
Appendix 4: Home Medical Equipment Reimbursement Contacts for Medicare 274
Appendix 5: Frequently-Asked Questions About Drug Screening Kits 275
INDEX OF FIGURES
Figure 2.1: European OTC Diagnostic Products Market by Country 21
Figure 3.1: Single-Day Continuous Blood Glucose Data 45
Figure 3.2: Share of the U.S. Self-Testing Diagnostic Market, 2008 50
Figure 3.3: The Glucose Market U.S. Sales, 2000-2012 51
INDEX OF TABLES
Table 2.1: Market Share of Top Three In Vitro Diagnostic Companies 17
Table 2.2: Worldwide Clinical Laboratory Market Size, 2003-2012 18
Table 2.3: U.S. Clinical Laboratory Testing Market, 2003-2012 18
Table 2.4: Worldwide Near-Patient Diagnostic Testing, 2003-2013 18
Table 2.5: Worldwide OTC Diagnostic Products Market, 2003-2013 20
Table 2.6: Worldwide OTC Diagnostic Products Market by Region, 2008 20
Table 2.7: Major European OTC Diagnostics Markets, 2008 21
Table 2.8: German OTC Diagnostic Products Market Sales, 2003-2013 22
Table 2.9: U.K. OTC Diagnostic Products Market Sales, 2003-2013 23
Table 2.10: Major U.K. IVD Manufacturers 24
Table 2.11: U.S. IVD Manufacturers Doing Business in the U.K. 24
Table 2.12: Other European Companies that Manufacture IVD Products in the U.K. 25
Table 2.13: French OTC Diagnostic Products Market Sales, 2003-2013 26
Table 2.14: Italian OTC Diagnostic Products Market Sales, 2003-2013 26
Table 2.15: Spanish OTC Diagnostic Products Market Sales, 2003-2013 27
Table 2.16: Japanese OTC Diagnostic Products Market Sales, 2003-2013 28
Table 2.17: Chinese OTC Diagnostic Products Market Sales, 2003-2013 29
Table 2.18: U.S. OTC Diagnostic Products Market Sales 2003-2013 30
Table 2.19: U.S. Clinical Diagnostic Home Test Market Segments 30
Table 2.20: Top Drugstore Retailers in the U.S. 32
Table 2.21: Top Drugstore Wholesalers in the U.S. 32
Table 3.1: Market for OTC Glucose Self-Testing in the U.S., 2004-2012 35
Table 3.2: Glucose Market for OTC Testing Worldwide, 2003-2013 35
Table 3.3: Top Ten Countries in Number of Persons with Diabetes (Aged 20 to 79 Years), in 2007 and 2025 36
Table 3.4: Share of the U.S. Self-Testing Diagnostic Market, 2008 37
Table 3.5: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 39
Table 3.6: World Market Share of POC Glucose Monitoring Marketers 39
Table 3.7: Key Features Considered for Glucose Meter Devices 43
Table 3.8: Demographic Characteristics Home-Testing Kit Buyers 46
Table 3.9: Top Brand Preferences for Home Glucose Testing Kits 46
Table 3.10: Instances When Patients Prefer Professional's Glucose Testing 46
Table 3.11: Advantages of a Home-Testing Kit 46
Table 3.12: Disadvantages of Using a Home-Testing Kit 47
Table 3.13: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits 47
Table 3.14: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2000-2013 47
Table 3.15: The Glucose Market for Self-Testing and POC Devices in the U.S., 2003-2013 48
Table 3.16: U.S. Blood Glucose Reagent Strip Market, 2004-2013 49
Table 3.17: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements 50
Table 3.18: U.S. Diabetes Glucose Monitoring Market Repeat Retail Replacement Sales Percentages 51
Table 3.19: Top Four Players in the U.S. Blood Glucose Strips Market-Ranked by Percentage Sales, 2008 51
Table 3.20: Leading Blood Glucose Meters and Strips Brands in the U.S., 2008 51
Table 3.21: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2004-2013 52
Table 3.22: European Glucose Self-Testing Market by Country Market 53
Table 3.23: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2004-2012 54
Table 3.24: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2002-2012 55
Table 3.25: Chinese Glucose Self-Testing Market (Meters, Strips, Lancets), 2003-2012 56
Table 3.26: Chinese Blood Glucose Reagent Strip Market, 2000-2012 56
Table 3.27: Indian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 57
Table 3.28: Indian Blood Glucose Reagent Strip Market, 2000-2012 58
Table 3.29: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2003-2013 58
Table 3.30: Unit Sales of Homecare Lancets in the U.S., 2003-2013 62
Table 3.31: Unit Sales of Lancets in the E.U., 2003-2013 62
Table 3.32: Dollar Sales of Lancets in the U.S., 2003-2013 62
Table 3.33: Dollar Sales of Lancets in the E.U., 2003-2013 63
Table 3.34: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2003-2013 63
Table 3.35: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2003-2013 63
Table 3.36: Competition in the Lancet Market Segment 64
Table 3.37: Key Features of Reagent Test Strips 66
Table 3.38: Customer Priorities-Glucose Meter Self-Testing Market, 2001, 2006 and 2012 68
Table 3.39: Accu-Chek Blood Glucose Monitoring Systems 73
Table 3.40: Pregnancy Test Market for OTC Testing in the U.S., 2000-2012 88
Table 3.41: Pregnancy Test Market for OTC Testing in Europe, 2003-2013 88
Table 3.42: U.S. Market Share for Home Pregnancy Tests 89
Table 3.43: European Market Share for OTC Pregnancy Tests 90
Table 3.44: Home Pregnancy Tests Available in the U.S. Market 93
Table 3.45: Hepatitis C Statistics 97
Table 3.46: Hepatitis Market for OTC Testing in the U.S., 2003-2013 98
Table 3.47: U.S. POC Drugs of Abuse Testing Market in the U.S., 2006-2012 99
Table 3.48: Illicit Drugs that are Important for Detection 101
Table 3.49: Analytical Detection Levels for Drugs of Abuse 101
Table 3.50: Princeton BioMeditech's Drugs of Abuse Tests 107
Table 3.51: Abbott Drugs of Abuse Tests on the ARCHITECT System 107
Table 3.52: Infectious Disease Market for OTC Testing in the U.S., 2003-2013 110
Table 3.53: HIV Testing Market for OTC Testing in the U.S., 2003-2013 113
Table 3.54: Home Testing for Urinary Tract Infections 121
Table 3.55: Cholesterol Market for OTC and Home Self-Testing in the U.S., 2003-2013 122
Table 3.56: Coagulation Market for OTC Testing in the U.S., 2003-2013 125
Table 3.57: Glucose Market for OTC Testing in the U.S., 2003-2013 129
Table 3.58: Fertility Testing Market for OTC Testing in the U.S., 2003-2013 131
Table 3.59: Fertility Testing Market for OTC Testing in Europe, 2003-2013 131
Table 3.60: Rite Aid and Other OEM Ovulation Predictors 133
Table 3.61: At-Home DNA Tests 135
Table 3.62: At-Home DNA Market for OTC Testing Worldwide, 2003-2013 136
Table 3.63: Home Genetic Testing Market in the U.S., 2003-2013 145
Table 3.64: Genovations Profiles 146
Table 3.65: Featured Tests by DNA Direct 147
Table 3.66: Fee Schedule for Personal Home-Based Paternity Studies 148
Table 4.1: Financial Comparison for Moderate and Waived CLIA Labs 163
Table 5.1: U.S. Home Testing Market Size, 2003-2013 168
Table 6.1: Normal Glucose Values, Fasting State 172
Table 6.2: Leading Home Patient Monitoring Products in the U.S. Market 179
Table 7.1: POC Testing: Cost Analysis 183
Table 7.2: POC Testing: Cost Analysis with Labor Included 183
Table 8.1: Total World Cholesterol Testing Market, 2006-2012 201
Table A.1: Over-the-Counter In Vitro Diagnostic Devices 250