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Healthcare and drugs / REPORT INFORMATION

Over-the-Counter Diagnostic Products World Markets

DateSep, 2006
Pages358
Price / format€2562 / Electronic (PDF)
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Abstract:
 The purpose of this 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. It is believed that this market segment has the potential for growth rates above 15% per year over the next five years in some of the less well-explored and well-developed areas.





OTC diagnostic products and home self-testing segments are poised for a major new phase of growth fueled by the availability of new technology coming out of the POC segment and the higher interest of individual patients and general healthcare consumers in taking charge of their own health status.

Global OTC Diagnostic Products Industry
Preventive healthcare is emerging as a primary focus of medical intervention, and consumer self-testing is becoming an important part of preventive healthcare as individuals become increasingly aware of and involved with their own health. Several self-tests—including those for blood glucose, pregnancy, ovulation, fecal occult blood and various urine components—are used as physicians and patients realize their potential for promoting improved healthcare.

The Structure and Size of the OTC Diagnostics Industry
The OTC market for home health tests in the U.S. has grown substantially in the last 15 years. It increased from $602 million in 1992 to over $1.4 billion in 1996, representing a 24.5% compounded annual growth rate (CAGR) in that earlier period. More recently, in 2005, the U.S. OTC market and home self-testing segment rose to $2,588 million. The growth rate for the U.S. market is estimated to be 14% per year through 2010, reaching almost $6 billion by that time.
Overall, the OTC market worldwide was estimated to be about $5.53 billion in 2005, with 46% of the market in the U.S., 34.5% in Europe and 9% in the rest of the world including Asia and Japan. The rapid non-instrument-based OTC market is estimated to have manufacturer-realized revenue of approximately $2.8 billion worldwide in 2004.




Table of contents:
 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 11
1.6 Executive Summary 11

2 Sector Overview 17
2.1 Global Diagnostic Products Industry 17
2.2 Global OTC Diagnostic Products Industry 18
2.2.1 General Global Market 18
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 26
2.2.7 Japanese OTC Diagnostic Market 27
2.2.8 Chinese OTC Diagnostic Market 28
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 34

3 Market Analysis: Size, Growth, Share and Competitors 35
3.1 Glucose Monitoring 35
3.1.1 Glucose Control in Diabetic Patients 41
3.1.2 Tight Glucose Control in Treating Diabetes 41
3.1.3 Glucose-Monitoring Devices 42
3.1.4 Key Issues for Glucose Monitoring 43
3.1.5 Glucose Device Description 43
3.1.6 Precision in Glucose Meters 44
3.1.7 Limitations of Existing Glucose Monitoring Products 45
3.1.8 Over-the-Counter (OTC) Self-Testing Glucose Market 46
3.1.9 Worldwide Glucose Testing Market 48
3.1.9.1 U.S. Market 49
3.1.9.2 European Market 53
3.1.9.3 Asian Market 54
3.1.9.3.1 Japanese Market 55
3.1.9.3.2 China Market 56
3.1.9.3.3 Indian Market 58
3.1.9.4 ROW Markets 59
3.1.10 Reagents and Equipment 59
3.1.10.1 Blood Glucose Monitoring 59
3.1.10.2 Lancets 60
3.1.10.3 Blood Glucose Monitor and Insulin Doser 67
3.1.10.4 Blood Glucose Reagent Test Strips 67
3.1.10.5 Control Solutions and Calibrators 68
3.1.10.6 Sharps Devices 68
3.1.10.7 Needle Destruction Devices 69
3.1.10.8 Voice-Operated Glucose Meters 70
3.1.11 Glucose Meters 73
3.2 Pregnancy Testing 98
3.2.1 Major Players 99
3.2.1.1 U.S. Market 100
3.2.1.2 European Market 101
3.2.2 Diagnostic Kit Information 101
3.3 Hepatitis Testing 108
3.4 Drugs of Abuse Screening Testing 111
3.5 Infectious Disease Testing 126
3.5.1 HIV 128
3.5.2 Tuberculosis Testing 139
3.5.3 Infectious Disease Testing in Non-medical Settings 140
3.5.4 West Nile Virus 142
3.5.5 Urinary Tract Infections 143
3.6 Cholesterol Testing 144
3.7 Coagulation Testing 146
3.8 Urine Dipstick Testing 153
3.9 Fertility Testing 153
3.9.1 Players 155
3.9.2 Diagnostic Test Kits 156
3.10 At-Home DNA Analysis 159
3.11 Biowarfare Detection 164
3.12 Home Patient Monitoring Devices 166
3.13 Home Patient Alert Systems 167
3.14 Home Genetic Testing Kits 167
3.15 Home Paternity Testing 171
3.16 Health Hazards Detection 172
3.16.1 Lead 172
3.16.2 Radon 172
3.16.3 Asbestos 172
3.16.4 Pesticides 173
3.16.5 Mold 173
3.16.6 Carbon Monoxide 173
3.16.7 Water Quality 173
3.16.8 Bacteria in Water 173
3.17 Thyroid Disease 174
3.18 Carpal Tunnel 174
3.19 Allergies 174
3.20 Nutrition and Wellness 174
3.20.1 Testosterone and Male Hormones 174
3.20.2 Female Hormones 174
3.20.3 Antioxidants 174
3.20.4 Sleep Apnea 175
3.20.5 Mineral Check 175
3.20.6 Stress Check 175
3.21 Colorectal Cancer (Occult Blood) Testing 176
3.22 Alzheimers Disease Home Screening Test 177
3.23 Tobacco Testing 177

4. Business Trends In The Industry 178
4.1 Wholesale Distribution Overview 178
4.2 Factors Affecting OTC Medical Product Distribution 180
4.3 Government Regulation of Medical Devices 181
4.3.1 U.S. Regulations 181
4.3.2 U.K. Regulations 184
4.4 Clinical Laboratory Improvement Act (CLIA) 185
4.5 Legal, M&A and Corporate Partnerships 189
4.6 New Product Launches 189

5. Patient Management Trends 190
5.1 Trends in OTC Testing and Reimbursement 190
5.1.1 American OTC Testing and Home Self-testing Reimbursement 190
5.1.2 European Reimbursement 191
5.2 Drivers of OTC and Home Self-Testing 191
5.3 Cost Elements of OTC Testing 192
5.4 Important Elements of OTC Testing 192
5.5 Growth of Home Care Testing 192
5.6 Non-Traditional Methods for Sample Collecting 193

6. Technology Trends 194
6.1 Sensor Systems for Diagnostic Applications 194
6.2 Glucose Measurements 195
6.3 Cholesterol Testing 200
6.4 Immunoassay Technology 201
6.5 Biosensor Technology 201
6.6 Fructosamine Test 203
6.7 Home Telemedicine Devices 203

7. OTC Testing: Critical Issues 206
7.1 Moderators of Growth for OTC Testing 206
7.2 Attitudes of Critical Care Nurses and Physicians 206
7.3 Personnel Impact for OTC Testing 207
7.4 Data Management Issues 207
7.5 POC Decentralization Issues 207
7.6 POC Testing and Clinical Outcomes 207
7.7 Focused Testing 208
7.8 Satellite Facilities 208
7.9 POC Testing Comparison and Cost Analysis 208

8. Competitive Assessments of the High-Growth Markets 211
8.1 Glucose Monitoring 211
8.1.1 Overview of Market Segment 211
8.1.2 Competitive Strategies 214
8.1.3 Analyses of the Current Market Conditions, Competition and Product Mix 215
8.1.4 Product Mix 222
8.1.5 Adjacent Markets 229
8.1.6 Market Drivers and Restraints 230
8.1.7 Market and Product Trends 230
8.2 Coagulation Testing 230
8.2.1 Overview of Market Segment 230
8.2.2 Competitive Strategies 234
8.2.3 Analyses of Current Market Conditions 235
8.2.4 Product Mix in Coagulation Testing 235
8.2.5 Adjacent Markets 237
8.2.6 Market Drivers and Restraints 237
8.2.7 Market and Product Trends 239
8.3 Cholesterol Testing 239
8.3.1 Overview of Market Segment 239
8.3.2 Competitive Strategies 240
8.3.3 Adjacent Markets 242
8.4 Infectious Disease Testing 242
8.4.1 Overview of Market Segment 242
8.4.2 Competitive Strategies 247
8.5 Drugs of Abuse 247
8.5.1 Overview of Market Segment 247
8.5.2 Analyses of the Current Market Conditions, Competition and Product Mix 248
8.5.3 Adjacent Markets 252
8.6 Home Pregnancy Testing 252
8.6.1 Overview of Market Segment 252
8.6.2 Competitive Strategies 252
8.6.3 Analysis of Current Market Conditions 253
8.6.4 Product Mix 254
8.6.5 Adjacent Markets 255
8.6.6 Market Drivers and Restraints 255
8.6.7 Market and Product Trends 255

9. Current Issues for OTC and Home Diagnostic Testing 256
9.1 New Markets for OTC and Home Diagnostic Testing 256
9.2 Utility of OTC and Home Self-Testing 258
9.3 Corporate Screening 259
9.4 Generational Drivers of Home Testing 260
9.5 Move Away from Central Laboratories 262
9.6 Healthcare Cost Controls 262
9.7 Mergers of Diagnostic Companies 262
9.8 Home Healthcare Trends 262
9.9 Home Healthcare Providers versus Mass Market Retailers 263
9.10 Demographic Merchandising 263
9.11 Marketing Strategies 264
9.12 Third-Party Pharmacy Networks 264
9.13 Which Customer Segments Are Purchasing Home Healthcare, and What Products Fit Their Needs? 265
9.14 Future of Patient Self-Testing 266

10. Corporate Profiles 268
10.1 Abbott Diagnostics (MediSense) 268
10.2 AmeriSourceBergen 269
10.3 Avitar Technologies, Inc. 271
10.4 Bayer Diagnostics 271
10.5 Beacon Diagnostics 273
10.6 Becton Dickinson 274
10.7 Bindley Western Industries, Inc. 275
10.8 Biosite, Inc. 275
10.9 Cardinal Health, Inc. 277
10.10 Cholestech 277
10.11 HemoCue 281
10.12 Home Access Health Corp. 281
10.13 Inverness Medical Innovations, Inc. 281
10.14 Johnson & Johnson 282
10.15 LifeScan 282
10.16 Princeton BioMeditech 283
10.17 Quidel Corp. 283
10.18 Roche Diagnostics 283
10.19 Saliva Diagnostics 285
10.20 Technical Chemicals & Products, Inc. 286
10.21 Worldwide Medical Corporation 287

11. Corporate Directory 288

Appendix 1: Over-the-Counter In Vitro Diagnostic Devices 294
Appendix 2: OTC Waived Tests for Drugs of Abuse 315
Appendix 3: FDA Approved and Unapproved Tests for HIV Home Testing 317
Appendix 4: Home Medical Equipment Reimbursement Contacts for Medicare 321
Appendix 5: Tests Waived by the FDA from January 2000 to June 30, 2005 322
Appendix 6: Frequently-Asked Questions About Drug Screening Kits 356


INDEX OF FIGURES

Figure 2.1: European OTC Diagnostic Products Market by Country 20
Figure 3.1: Single-Day Continuous Blood Glucose Data 46
Figure 3.2: Share of the U.S. Self-Testing Diagnostic Market, 2006 52
Figure 3.3: The Glucose Market U.S. Sales, 2000-2012 52


INDEX OF TABLES

Table 2.1: Worldwide Market Share of In Vitro Diagnostic Companies 17
Table 2.2: Worldwide Clinical In Vitro Diagnostics Market Size, 2001-2007 18
Table 2.3: Worldwide Clinical In Vitro Central Lab Diagnostic Testing, 2001-2007 18
Table 2.4: Worldwide Near-Patient Diagnostic Testing, 2001-2007 18
Table 2.5: Worldwide OTC Diagnostic Products Market, 2001-2010 20
Table 2.6: Worldwide OTC Diagnostic Products Market by Region, 2005 20
Table 2.7: Major European OTC Diagnostics Markets, 2004 21
Table 2.8: German OTC Diagnostic Products Market Sales, 1999-2007 22
Table 2.9: U.K. OTC Diagnostic Products Market Sales, 1998-2009 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, 1998-2007 25
Table 2.14: Italian OTC Diagnostic Products Market Sales, 1998-2009 26
Table 2.15: Spanish OTC Diagnostic Products Market Sales, 1998-2009 27
Table 2.16: Japanese OTC Diagnostic Products Market Sales, 1998-2007 28
Table 2.17: Chinese OTC Diagnostic Products Market Sales, 2000-2007 28
Table 2.18: U.S. OTC Diagnostic Products Market Sales 1992-2010 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: The Glucose Market for OTC Testing in the U.S., 1996-2010 36
Table 3.2: The Glucose Market for OTC Testing Worldwide, 2000-2010 36
Table 3.3: The Global Population of Persons with Diabetes, 1995 and 2025 37
Table 3.4: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements 38
Table 3.5: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 40
Table 3.6: World Market Share of POC Glucose Monitoring Marketers 40
Table 3.7: Key Features Considered for Glucose Meter Devices 44
Table 3.8: Demographic Characteristics Home-Testing Kit Buyers 47
Table 3.9: Top Brand Preferences for Home Glucose Testing Kits 47
Table 3.10: Instances when Patients Prefer Professionals Glucose Testing 47
Table 3.11: Advantages of a Home-Testing Kit 48
Table 3.12: Disadvantages of Using a Home-Testing Kit 48
Table 3.13: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits 48
Table 3.14: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2000-2012 49
Table 3.15: The Glucose Market for Self-Testing and POC Devices in the U.S., 2000-2012 50
Table 3.16: U.S. Blood Glucose Reagent Strip Market, 2000-2012 50
Table 3.17: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements 51
Table 3.18: U.S. Diabetes Glucose Monitoring Market Repeat Retail Replacement Sales Percentages 52
Table 3.19: Top Four Players in the U.S. Blood Glucose Strips Market-Ranked by Percentage Sales, 2006 52
Table 3.20: Leading Blood Glucose Meters and Strips Brands in the U.S., 2006 53
Table 3.21: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2004-2012 53
Table 3.22: European Glucose Self-Testing Market by Country Market 54
Table 3.23: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 55
Table 3.24: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 56
Table 3.25: Chinese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 57
Table 3.26: China Blood Glucose Reagent Strip Market, 2000-2012 57
Table 3.27: Indian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 58
Table 3.28: Indian Blood Glucose Reagent Strip Market, 2000-2012 58
Table 3.29: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 59
Table 3.30: Unit Sales of Homecare Lancets in the U.S., 2000-2012 62
Table 3.31: Unit Sales of Lancets in the E.U., 2000-2012 63
Table 3.32: Dollar Sales of Lancets in the U.S., 2000-2012 63
Table 3.33: Dollar Sales of Lancets in the E.U., 2000-2012 64
Table 3.34: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2000-2012 64
Table 3.35: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2000-2012 65
Table 3.36: Competition in the Lancet Market Segment 65
Table 3.37: Key Features of Reagent Test Strips 68
Table 3.38: Customer Priorities-Glucose Meter Self-Testing Market, 2001, 2006 and 2012 70
Table 3.39: Accu-Chek Blood Glucose Monitoring Systems 80
Table 3.40: The Pregnancy Test Market for OTC Testing in the U.S., 2000-2010 99
Table 3.41: The Pregnancy Test Market for OTC Testing in Europe, 2000-2010 99
Table 3.42: U.S. Market Share for Home Pregnancy Tests 100
Table 3.43: European Market Share for OTC Pregnancy Tests 101
Table 3.44: Home Pregnancy Tests Available in the U.S. Market 104
Table 3.45: Hepatitis C Statistics 109
Table 3.46: The Hepatitis Market for OTC Testing in the U.S., 2000-2007 110
Table 3.47: The Drugs of Abuse Market for OTC Testing in the U.S., 2000-2006 111
Table 3.48: Illicit Drugs that are Important for Detection 113
Table 3.49: Analytical Detection Levels for Drugs of Abuse 114
Table 3.50: Princeton BioMeditechs Drugs of Abuse Tests 125
Table 3.51: Abbott Tests on the ADx System 125
Table 3.52: The Infectious Disease Market for OTC Testing in the U.S., 2000-2010 128
Table 3.53: The HIV Testing Market for OTC Testing in the U.S., 2000-2008 133
Table 3.54: Home Testing for Urinary Tract Infections 143
Table 3.55: The Cholesterol Market for OTC and Home Self-Testing in the U.S., 2000-2010 144
Table 3.56: The Coagulation Market for OTC Testing in the U.S., 2000-2010 148
Table 3.57: The Glucose Market for OTC Testing in the U.S., 2000-2010 153
Table 3.58: The Fertility Testing Market for OTC Testing in the U.S., 2000-2010 155
Table 3.59: The Fertility Testing Market for OTC Testing in Europe, 2000-2008 155
Table 3.60: Rite Aid and Other OEM Ovulation Predictors 158
Table 3.61: At-Home DNA Tests 159
Table 3.62: The At-Home DNA Market for OTC Testing Worldwide, 2001-2007 160
Table 3.63: The Home Genetic Testing Market in the U.S., 2003-2010 168
Table 3.64: Genovations Profiles 169
Table 3.65: Featured Tests by DNA Direct 170
Table 3.66: Fee Schedule for Personal Home-Based Paternity Studies 171
Table 4.1: Financial Comparison for Moderate and Waived CLIA Labs 188
Table 5.1: U.S. Home Testing Market Size, 2004-2010 193
Table 6.1: Normal Glucose Values, Fasting State 197
Table 6.2: Leading Home Patient Monitoring Products in the U.S. Market 204
Table 6.3: Home Telemonitoring and Patient Assessment Products 205
Table 7.1: POCT Clinical Outcomes in Diabetic Ketoacidosis 207
Table 7.2: POC Testing: Cost Analysis with Labor Included 209
Table 7.3: POC Testing: Cost Analysis with Labor Included 210
Table 8.1: U.S. Diabetes Glucose Monitoring Market, 2002 212
Table 8.2: Total U.S. Market Size and CAGRs of Emerging At-Home Diagnostic Tests, 1997-2007 240
Table A.1: Over-the-Counter In Vitro Diagnostic Devices 294
Table A.2: Over-the-Counter In Vitro Diagnostic Devices Approved by the FDA 304




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