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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. 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.

Table of Contents

• 1Overview7
  • 1.1Statement of Report7
  • 1.2About This Report7
  • 1.3Scope of the Report9
  • 1.4Objectives10
  • 1.5Methodology11
  • 1.6Executive Summary11
  
  
• 2Sector Overview17
  • 2.1Global Diagnostic Products Industry17
  • 2.2Global OTC Diagnostic Products Industry18
    • 2.2.1General Global Market18
    • 2.2.2German OTC and Home Self-Testing Diagnostic Markets22
    • 2.2.3U.K. OTC and Home Self-Test Diagnostic Markets22
      • 2.2.3.1U.K. Market Statistics23
      • 2.2.3.2U.K. Competitive Analysis24
      • 2.2.3.3U.K. Market Access25
    • 2.2.4French OTC Diagnostic Market25
    • 2.2.5Italian OTC Diagnostic Market26
    • 2.2.6Spanish OTC Diagnostic Market26
    • 2.2.7Japanese OTC Diagnostic Market27
    • 2.2.8Chinese OTC Diagnostic Market28
  • 2.3Description of the U.S. OTC Diagnostics Industry Segment29
    • 2.3.1Market Overview29
    • 2.3.2Diagnostic Test Categories30
  • 2.4Market Drivers in the OTC Diagnostics Sector31
    • 2.4.1Overview31
    • 2.4.2Market Segments31
  • 2.5Key Players in the OTC Diagnostics Segment32
  • 2.6Sector Analysis34
  
  
• 3Market Analysis: Size, Growth, Share and Competitors35
  • 3.1Glucose Monitoring35
    • 3.1.1Glucose Control in Diabetic Patients41
    • 3.1.2Tight Glucose Control in Treating Diabetes41
    • 3.1.3Glucose-Monitoring Devices42
    • 3.1.4Key Issues for Glucose Monitoring43
    • 3.1.5Glucose Device Description43
    • 3.1.6Precision in Glucose Meters44
    • 3.1.7Limitations of Existing Glucose Monitoring Products45
    • 3.1.8Over-the-Counter (OTC) Self-Testing Glucose Market46
    • 3.1.9Worldwide Glucose Testing Market48
      • 3.1.9.1U.S. Market49
      • 3.1.9.2European Market53
      • 3.1.9.3Asian Market54
        • 3.1.9.3.1Japanese Market55
        • 3.1.9.3.2 China Market56
        • 3.1.9.3.3 Indian Market58
      • 3.1.9.4ROW Markets59
    • 3.1.10Reagents and Equipment59
      • 3.1.10.1Blood Glucose Monitoring59
      • 3.1.10.2Lancets60
      • 3.1.10.3Blood Glucose Monitor and Insulin Doser67
      • 3.1.10.4Blood Glucose Reagent Test Strips67
      • 3.1.10.5Control Solutions and Calibrators68
      • 3.1.10.6Sharps Devices68
      • 3.1.10.7Needle Destruction Devices69
      • 3.1.10.8Voice-Operated Glucose Meters70
    • 3.1.11Glucose Meters73
  • 3.2Pregnancy Testing98
    • 3.2.1Major Players99
      • 3.2.1.1U.S. Market100
      • 3.2.1.2European Market101
    • 3.2.2Diagnostic Kit Information101
  • 3.3Hepatitis Testing108
  • 3.4Drugs of Abuse Screening Testing111
  • 3.5Infectious Disease Testing126
    • 3.5.1HIV128
    • 3.5.2Tuberculosis Testing139
    • 3.5.3Infectious Disease Testing in Non-medical Settings140
    • 3.5.4West Nile Virus142
    • 3.5.5Urinary Tract Infections143
  • 3.6Cholesterol Testing144
  • 3.7Coagulation Testing146
  • 3.8Urine Dipstick Testing153
  • 3.9Fertility Testing153
    • 3.9.1Players155
    • 3.9.2Diagnostic Test Kits156
  • 3.10At-Home DNA Analysis159
  • 3.11Biowarfare Detection164
  • 3.12Home Patient Monitoring Devices166
  • 3.13Home Patient Alert Systems167
  • 3.14Home Genetic Testing Kits167
  • 3.15Home Paternity Testing171
  • 3.16Health Hazards Detection172
    • 3.16.1Lead172
    • 3.16.2Radon172
    • 3.16.3Asbestos172
    • 3.16.4Pesticides173
    • 3.16.5Mold173
    • 3.16.6Carbon Monoxide173
    • 3.16.7Water Quality173
    • 3.16.8Bacteria in Water173
  • 3.17Thyroid Disease174
  • 3.18Carpal Tunnel174
  • 3.19Allergies174
  • 3.20Nutrition and Wellness174
    • 3.20.1Testosterone and Male Hormones174
    • 3.20.2Female Hormones174
    • 3.20.3Antioxidants174
    • 3.20.4Sleep Apnea175
    • 3.20.5Mineral Check175
    • 3.20.6Stress Check175
  • 3.21Colorectal Cancer (Occult Blood) Testing176
  • 3.22Alzheimer's Disease Home Screening Test177
  • 3.23Tobacco Testing177
  
  
• 4.Business Trends In The Industry178
  • 4.1Wholesale Distribution Overview178
  • 4.2Factors Affecting OTC Medical Product Distribution180
  • 4.3Government Regulation of Medical Devices181
    • 4.3.1U.S. Regulations181
    • 4.3.2U.K. Regulations184
  • 4.4Clinical Laboratory Improvement Act (CLIA)185
  • 4.5Legal, M&A and Corporate Partnerships189
  • 4.6New Product Launches189
  
  
• 5.Patient Management Trends190
  • 5.1Trends in OTC Testing and Reimbursement190
    • 5.1.1American OTC Testing and Home Self-testing Reimbursement190
    • 5.1.2European Reimbursement191
  • 5.2Drivers of OTC and Home Self-Testing191
  • 5.3Cost Elements of OTC Testing192
  • 5.4Important Elements of OTC Testing192
  • 5.5Growth of Home Care Testing192
  • 5.6Non-Traditional Methods for Sample Collecting193
  
  
• 6.Technology Trends194
  • 6.1Sensor Systems for Diagnostic Applications194
  • 6.2Glucose Measurements195
  • 6.3Cholesterol Testing200
  • 6.4Immunoassay Technology201
  • 6.5Biosensor Technology201
  • 6.6Fructosamine Test203
  • 6.7Home Telemedicine Devices203
  
  
• 7.OTC Testing: Critical Issues206
  • 7.1Moderators of Growth for OTC Testing206
  • 7.2Attitudes of Critical Care Nurses and Physicians206
  • 7.3Personnel Impact for OTC Testing207
  • 7.4Data Management Issues207
  • 7.5POC Decentralization Issues207
  • 7.6POC Testing and Clinical Outcomes207
  • 7.7Focused Testing208
  • 7.8Satellite Facilities208
  • 7.9POC Testing Comparison and Cost Analysis208
  
  
• 8.Competitive Assessments of the High-Growth Markets211
  • 8.1Glucose Monitoring211
    • 8.1.1Overview of Market Segment211
    • 8.1.2Competitive Strategies214
    • 8.1.3Analyses of the Current Market Conditions, Competition and Product Mix215
    • 8.1.4Product Mix222
    • 8.1.5Adjacent Markets229
    • 8.1.6Market Drivers and Restraints230
    • 8.1.7Market and Product Trends230
  • 8.2Coagulation Testing230
    • 8.2.1Overview of Market Segment230
    • 8.2.2Competitive Strategies234
    • 8.2.3Analyses of Current Market Conditions235
    • 8.2.4Product Mix in Coagulation Testing235
    • 8.2.5Adjacent Markets237
    • 8.2.6Market Drivers and Restraints237
    • 8.2.7Market and Product Trends239
  • 8.3Cholesterol Testing239
    • 8.3.1Overview of Market Segment239
    • 8.3.2Competitive Strategies240
    • 8.3.3Adjacent Markets242
  • 8.4Infectious Disease Testing242
    • 8.4.1Overview of Market Segment242
    • 8.4.2Competitive Strategies247
  • 8.5Drugs of Abuse247
    • 8.5.1Overview of Market Segment247
    • 8.5.2Analyses of the Current Market Conditions, Competition and Product Mix248
    • 8.5.3Adjacent Markets252
  • 8.6Home Pregnancy Testing252
    • 8.6.1Overview of Market Segment252
    • 8.6.2Competitive Strategies252
    • 8.6.3Analysis of Current Market Conditions253
    • 8.6.4Product Mix254
    • 8.6.5Adjacent Markets255
    • 8.6.6Market Drivers and Restraints255
    • 8.6.7Market and Product Trends255
    
    
• 9.Current Issues for OTC and Home Diagnostic Testing256
  • 9.1New Markets for OTC and Home Diagnostic Testing256
  • 9.2Utility of OTC and Home Self-Testing258
  • 9.3Corporate Screening259
  • 9.4Generational Drivers of Home Testing260
  • 9.5Move Away from Central Laboratories262
  • 9.6Healthcare Cost Controls262
  • 9.7Mergers of Diagnostic Companies262
  • 9.8Home Healthcare Trends262
  • 9.9Home Healthcare Providers versus Mass Market Retailers263
  • 9.10Demographic Merchandising263
  • 9.11Marketing Strategies264
  • 9.12Third-Party Pharmacy Networks264
  • 9.13Which Customer Segments Are Purchasing Home Healthcare, and What Products Fit Their Needs?265
  • 9.14Future of Patient Self-Testing266
  
  
• 10.Corporate Profiles268
  • 10.1Abbott Diagnostics (MediSense)268
  • 10.2AmeriSourceBergen269
  • 10.3Avitar Technologies, Inc.271
  • 10.4Bayer Diagnostics271
  • 10.5Beacon Diagnostics273
  • 10.6Becton Dickinson274
  • 10.7Bindley Western Industries, Inc.275
  • 10.8Biosite, Inc.275
  • 10.9Cardinal Health, Inc.277
  • 10.10Cholestech277
  • 10.11HemoCue281
  • 10.12Home Access Health Corp.281
  • 10.13Inverness Medical Innovations, Inc.281
  • 10.14Johnson & Johnson282
  • 10.15LifeScan282
  • 10.16Princeton BioMeditech283
  • 10.17Quidel Corp.283
  • 10.18Roche Diagnostics283
  • 10.19Saliva Diagnostics285
  • 10.20Technical Chemicals & Products, Inc.286
  • 10.21Worldwide Medical Corporation287
  
  
• 11.Corporate Directory288

Appendix 1: Over-the-Counter In Vitro Diagnostic Devices294

Appendix 2: OTC Waived Tests for Drugs of Abuse315

Appendix 3: FDA Approved and Unapproved Tests for HIV Home Testing317

Appendix 4: Home Medical Equipment Reimbursement Contacts for Medicare321

Appendix 5: Tests Waived by the FDA from January 2000 to June 30, 2005322

Appendix 6: Frequently-Asked Questions About Drug Screening Kits356

INDEX OF FIGURES

Figure 2.1: European OTC Diagnostic Products Market by Country20

Figure 3.1: Single-Day Continuous Blood Glucose Data46

Figure 3.2: Share of the U.S. Self-Testing Diagnostic Market, 200652

Figure 3.3: The Glucose Market U.S. Sales, 2000-201252

INDEX OF TABLES

Table 2.1: Worldwide Market Share of In Vitro Diagnostic Companies17

Table 2.2: Worldwide Clinical In Vitro Diagnostics Market Size, 2001-200718

Table 2.3: Worldwide Clinical In Vitro Central Lab Diagnostic Testing, 2001-200718

Table 2.4: Worldwide Near-Patient Diagnostic Testing, 2001-200718

Table 2.5: Worldwide OTC Diagnostic Products Market, 2001-201020

Table 2.6: Worldwide OTC Diagnostic Products Market by Region, 200520

Table 2.7: Major European OTC Diagnostics Markets, 200421

Table 2.8: German OTC Diagnostic Products Market Sales, 1999-200722

Table 2.9: U.K. OTC Diagnostic Products Market Sales, 1998-200923

Table 2.10: Major U.K. IVD Manufacturers24

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, 1998-200725

Table 2.14: Italian OTC Diagnostic Products Market Sales, 1998-200926

Table 2.15: Spanish OTC Diagnostic Products Market Sales, 1998-200927

Table 2.16: Japanese OTC Diagnostic Products Market Sales, 1998-200728

Table 2.17: Chinese OTC Diagnostic Products Market Sales, 2000-200728

Table 2.18: U.S. OTC Diagnostic Products Market Sales 1992-201030

Table 2.19: U.S. Clinical Diagnostic Home Test Market Segments30

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., 1996-201036

Table 3.2: The Glucose Market for OTC Testing Worldwide, 2000-201036

Table 3.3: The Global Population of Persons with Diabetes, 1995 and 202537

Table 3.4: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements38

Table 3.5: OTC Blood Glucose Instrument Reagents by Manufacturer Retail40

Table 3.6: World Market Share of POC Glucose Monitoring Marketers40

Table 3.7: Key Features Considered for Glucose Meter Devices44

Table 3.8: Demographic Characteristics Home-Testing Kit Buyers47

Table 3.9: Top Brand Preferences for Home Glucose Testing Kits47

Table 3.10: Instances when Patients Prefer Professional's Glucose Testing47

Table 3.11: Advantages of a Home-Testing Kit48

Table 3.12: Disadvantages of Using a Home-Testing Kit48

Table 3.13: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits48

Table 3.14: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2000-201249

Table 3.15: The Glucose Market for Self-Testing and POC Devices in the U.S., 2000-201250

Table 3.16: U.S. Blood Glucose Reagent Strip Market, 2000-201250

Table 3.17: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements51

Table 3.18: U.S. Diabetes Glucose Monitoring Market Repeat Retail Replacement Sales Percentages52

Table 3.19: Top Four Players in the U.S. Blood Glucose Strips Market-Ranked by Percentage Sales, 200652

Table 3.20: Leading Blood Glucose Meters and Strips Brands in the U.S., 200653

Table 3.21: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2004-201253

Table 3.22: European Glucose Self-Testing Market by Country Market54

Table 3.23: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201255

Table 3.24: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201256

Table 3.25: Chinese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201257

Table 3.26: China Blood Glucose Reagent Strip Market, 2000-201257

Table 3.27: Indian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201258

Table 3.28: Indian Blood Glucose Reagent Strip Market, 2000-201258

Table 3.29: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201259

Table 3.30: Unit Sales of Homecare Lancets in the U.S., 2000-201262

Table 3.31: Unit Sales of Lancets in the E.U., 2000-201263

Table 3.32: Dollar Sales of Lancets in the U.S., 2000-201263

Table 3.33: Dollar Sales of Lancets in the E.U., 2000-201264

Table 3.34: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2000-201264

Table 3.35: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2000-201265

Table 3.36: Competition in the Lancet Market Segment65

Table 3.37: Key Features of Reagent Test Strips68

Table 3.38: Customer Priorities-Glucose Meter Self-Testing Market, 2001, 2006 and 201270

Table 3.39: Accu-Chek Blood Glucose Monitoring Systems80

Table 3.40: The Pregnancy Test Market for OTC Testing in the U.S., 2000-201099

Table 3.41: The Pregnancy Test Market for OTC Testing in Europe, 2000-201099

Table 3.42: U.S. Market Share for Home Pregnancy Tests100

Table 3.43: European Market Share for OTC Pregnancy Tests101

Table 3.44: Home Pregnancy Tests Available in the U.S. Market104

Table 3.45: Hepatitis C Statistics109

Table 3.46: The Hepatitis Market for OTC Testing in the U.S., 2000-2007110

Table 3.47: The Drugs of Abuse Market for OTC Testing in the U.S., 2000-2006111

Table 3.48: Illicit Drugs that are Important for Detection113

Table 3.49: Analytical Detection Levels for Drugs of Abuse114

Table 3.50: Princeton BioMeditech's Drugs of Abuse Tests125

Table 3.51: Abbott Tests on the ADx System125

Table 3.52: The Infectious Disease Market for OTC Testing in the U.S., 2000-2010128

Table 3.53: The HIV Testing Market for OTC Testing in the U.S., 2000-2008133

Table 3.54: Home Testing for Urinary Tract Infections143

Table 3.55: The Cholesterol Market for OTC and Home Self-Testing in the U.S., 2000-2010144

Table 3.56: The Coagulation Market for OTC Testing in the U.S., 2000-2010148

Table 3.57: The Glucose Market for OTC Testing in the U.S., 2000-2010153

Table 3.58: The Fertility Testing Market for OTC Testing in the U.S., 2000-2010155

Table 3.59: The Fertility Testing Market for OTC Testing in Europe, 2000-2008155

Table 3.60: Rite Aid and Other OEM Ovulation Predictors158

Table 3.61: At-Home DNA Tests159

Table 3.62: The At-Home DNA Market for OTC Testing Worldwide, 2001-2007160

Table 3.63: The Home Genetic Testing Market in the U.S., 2003-2010168

Table 3.64: Genovations Profiles169

Table 3.65: Featured Tests by DNA Direct170

Table 3.66: Fee Schedule for Personal Home-Based Paternity Studies171

Table 4.1: Financial Comparison for Moderate and Waived CLIA Labs188

Table 5.1: U.S. Home Testing Market Size, 2004-2010193

Table 6.1: Normal Glucose Values, Fasting State197

Table 6.2: Leading Home Patient Monitoring Products in the U.S. Market204

Table 6.3: Home Telemonitoring and Patient Assessment Products205

Table 7.1: POCT Clinical Outcomes in Diabetic Ketoacidosis207

Table 7.2: POC Testing: Cost Analysis with Labor Included209

Table 7.3: POC Testing: Cost Analysis with Labor Included210

Table 8.1: U.S. Diabetes Glucose Monitoring Market, 2002212

Table 8.2: Total U.S. Market Size and CAGRs of Emerging At-Home Diagnostic Tests, 1997-2007240

Table A.1: Over-the-Counter In Vitro Diagnostic Devices294

Table A.2: Over-the-Counter In Vitro Diagnostic Devices Approved by the FDA304

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