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Over-the-Counter Diagnostic Products World Markets

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.

Table of Contents

• 1Overview7
  • 1.1Statement of Report7
  • 1.2About This Report7
  • 1.3Scope of the Report9
  • 1.4Objectives10
  • 1.5Methodology10
  • 1.6Executive Summary11
  
  
• 2Sector Overview17
  • 2.1Global Diagnostic Products Industry17
  • 2.2Global OTC Diagnostic Products Industry19
    • 2.2.1General Global Market19
    • 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 Market27
    • 2.2.7Japanese OTC Diagnostic Market27
    • 2.2.8Chinese OTC Diagnostic Market29
  • 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 Analysis33
  
  
• 3Market Analysis: Size, Growth, Share and Competitors34
  • 3.1Glucose Monitoring34
    • 3.1.1Glucose Control in Diabetic Patients39
    • 3.1.2Tight Glucose Control in Treating Diabetes40
    • 3.1.3Glucose-Monitoring Devices41
    • 3.1.4Key Issues for Glucose Monitoring41
    • 3.1.5Glucose Device Description42
    • 3.1.6Precision in Glucose Meters43
    • 3.1.7Limitations of Existing Glucose Monitoring Products44
    • 3.1.8Over-the-Counter (OTC) Self-Testing Glucose Market45
    • 3.1.9Worldwide Glucose Testing Market47
      • 3.1.9.1U.S. Market48
      • 3.1.9.2European Market52
      • 3.1.9.3Asian Market53
        • 3.1.9.3.1Japanese Market54
        • 3.1.9.3.2Chinese Market55
        • 3.1.9.3.3Indian Market57
      • 3.1.9.4ROW Markets58
    • 3.1.10Reagents and Equipment58
      • 3.1.10.1Blood Glucose Monitoring58
      • 3.1.10.2Lancets59
      • 3.1.10.3Blood Glucose Monitor and Insulin Doser65
      • 3.1.10.4Blood Glucose Reagent Test Strips66
      • 3.1.10.5Control Solutions and Calibrators66
      • 3.1.10.6Sharps Devices67
      • 3.1.10.7Needle Destruction Devices67
    • 3.1.11Glucose Meters68
    • 3.1.12Voice-Operated Glucose Meters85
  • 3.2Pregnancy and Fertility Testing87
    • 3.2.1Major Players88
      • 3.2.1.1U.S. Market89
      • 3.2.1.2European Market90
    • 3.2.2Diagnostic Kit Information90
  • 3.3Hepatitis Testing95
  • 3.4Drugs of Abuse Screening Testing99
  • 3.5Infectious Disease Testing109
    • 3.5.1HIV110
    • 3.5.2Tuberculosis Testing117
    • 3.5.3Infectious Disease Testing in Non-Medical Settings118
    • 3.5.4West Nile Virus120
    • 3.5.5Urinary Tract Infections120
  • 3.6Cholesterol Testing121
  • 3.7Coagulation Testing123
  • 3.8Urine Dipstick Testing129
  • 3.9Fertility Testing130
    • 3.9.1Players131
    • 3.9.2Diagnostic Test Kits132
  • 3.10At-Home DNA Analysis134
  • 3.11Biowarfare Detection140
  • 3.12Home Patient Monitoring Devices142
  • 3.13Home Patient Alert Systems144
  • 3.14Home Genetic Testing Kits144
  • 3.15Home Paternity Testing148
  • 3.16Health Hazards Detection149
    • 3.16.1Lead149
    • 3.16.2Radon149
    • 3.16.3Asbestos149
    • 3.16.4Pesticides150
    • 3.16.5Mold150
    • 3.16.6Carbon Monoxide150
    • 3.16.7Water Quality150
    • 3.16.8Bacteria in Water150
  • 3.17Thyroid Disease151
  • 3.18Carpal Tunnel151
  • 3.19Allergies151
  • 3.20Nutrition and Wellness151
    • 3.20.1Testosterone and Male Hormones151
    • 3.20.2Female Hormones151
    • 3.20.3Antioxidants151
    • 3.20.4Sleep Apnea152
    • 3.20.5Mineral Check152
    • 3.20.6Stress Check152
  • 3.21Colorectal Cancer (Occult Blood) Testing153
  • 3.22Alzheimer\'s Disease Home Screening Test154
  • 3.23Tobacco Testing154
  
  
• 4.Business Trends in the Industry155
  • 4.1Wholesale Distribution Overview155
  • 4.2Factors Affecting OTC Medical Product Distribution156
  • 4.3Government Regulation of Medical Devices158
    • 4.3.1U.S. Regulations158
    • 4.3.2U.K. Regulations161
  • 4.4Clinical Laboratory Improvement Act (CLIA)162
  • 4.5Legal, M&A and Corporate Partnerships164
  
  
• 5.Patient Management Trends165
  • 5.1Trends in OTC Testing and Reimbursement165
    • 5.1.1American OTC Testing and Home Self-testing Reimbursement165
    • 5.1.2European Reimbursement166
  • 5.2Drivers of OTC and Home Self-Testing166
  • 5.3Cost Elements of OTC Testing166
  • 5.4Important Elements of OTC Testing167
  • 5.5Growth of Home Care Testing167
  • 5.6Non-Traditional Methods for Sample Collection168
  
  
• 6.Technology Trends169
  • 6.1Sensor Systems for Diagnostic Applications169
  • 6.2Glucose Measurements170
  • 6.3Cholesterol Testing174
  • 6.4Immunoassay Technology175
  • 6.5Biosensor Technology175
  • 6.6Fructosamine Test177
  • 6.7Home Telemedicine Devices177
  
  
• 7.OTC Testing: Critical Issues180
  • 7.1Moderators of Growth for OTC Testing180
  • 7.2Attitudes of Critical Care Nurses and Physicians180
  • 7.3Personnel Impact for OTC Testing180
  • 7.4Data Management Issues181
  • 7.5POC Decentralization Issues181
  • 7.6POC Testing and Clinical Outcomes181
  • 7.7Focused Testing181
  • 7.8Satellite Facilities181
  • 7.9POC Testing Comparison and Cost Analysis182
  
  
• 8.Competitive Assessments of the High-Growth Markets185
  • 8.1Glucose Monitoring185
    • 8.1.1Overview of Market Segment185
    • 8.1.2Competitive Strategies186
    • 8.1.3Analyses of the Current Market Conditions, Competition and Product Mix187
    • 8.1.4Adjacent Markets192
    • 8.1.5Market Drivers and Restraints193
    • 8.1.6Market and Product Trends193
  • 8.2Coagulation Testing193
    • 8.2.1Overview of Market Segment193
    • 8.2.2Competitive Strategies196
    • 8.2.3Analyses of Current Market Conditions197
    • 8.2.4Product Mix in Coagulation Testing197
    • 8.2.5Adjacent Markets198
    • 8.2.6Market Drivers and Restraints199
    • 8.2.7Market and Product Trends200
  • 8.3Cholesterol Testing200
    • 8.3.1Overview of Market Segment200
    • 8.3.2Competitive Strategies201
    • 8.3.3Adjacent Markets203
  • 8.4Infectious Disease Testing203
    • 8.4.1Overview of Market Segment203
    • 8.4.2Competitive Strategies206
  • 8.5Drugs of Abuse207
    • 8.5.1Overview of Market Segment207
    • 8.5.2Analyses of the Current Market Conditions, Competition and Product Mix207
    • 8.5.3Adjacent Markets209
  • 8.6Home Pregnancy Testing209
    • 8.6.1Overview of Market Segment209
    • 8.6.2Competitive Strategies209
    • 8.6.3Analysis of Current Market Conditions210
    • 8.6.4Product Mix211
    • 8.6.5Adjacent Markets211
    • 8.6.6Market Drivers and Restraints211
    • 8.6.7Market and Product Trends212
    
    
• 9.Current Issues for OTC and Home Diagnostic Testing213
  • 9.1New Markets for OTC and Home Diagnostic Testing213
  • 9.2Utility of OTC and Home Self-Testing216
  • 9.3Corporate Screening216
  • 9.4Generational Drivers of Home Testing218
  • 9.5Move Away from Central Laboratories220
  • 9.6Healthcare Cost Controls220
  • 9.7Mergers of Diagnostic Companies220
  • 9.8Home Healthcare Trends220
  • 9.9Home Healthcare Providers versus Mass Market Retailers220
  • 9.10Demographic Merchandising221
  • 9.11Marketing Strategies221
  • 9.12Third-Party Pharmacy Networks222
  • 9.13Which Customer Segments Purchase Home Healthcare? Which Products Fit Their Needs?222
  • 9.14Future of Patient Self-Testing224
  
  
• 10.Corporate Profiles225
  • 10.1Abbott Diagnostics225
  • 10.2AmeriSourceBergen226
  • 10.3 Bayer Diagnostics227
  • 10.4Becton Dickinson228
  • 10.5Bindley Western Industries, Inc.228
  • 10.6Biosite, Inc.228
  • 10.7Cardinal Health, Inc.229
  • 10.8Cholestech229
  • 10.9HemoCue232
  • 10.10Home Access Health Corp.232
  • 10.11Inverness Medical Innovations, Inc.233
  • 10.12Johnson & Johnson237
  • 10.13LifeScan238
  • 10.14Princeton BioMeditech238
  • 10.15Quidel Corp.239
  • 10.16Roche Diagnostics241
  • 10.17Saliva Diagnostics243
  
  
• 11.Corporate Directory245

Appendix 1: Over-the-Counter In Vitro Diagnostic Devices250

Appendix 2: OTC Waived Tests for Drugs of Abuse268

Appendix 3: FDA Approved and Unapproved Tests for HIV Home Testing271

Appendix 4: Home Medical Equipment Reimbursement Contacts for Medicare274

Appendix 5: Frequently-Asked Questions About Drug Screening Kits275

INDEX OF FIGURES

Figure 2.1: European OTC Diagnostic Products Market by Country21

Figure 3.1: Single-Day Continuous Blood Glucose Data45

Figure 3.2: Share of the U.S. Self-Testing Diagnostic Market, 200850

Figure 3.3: The Glucose Market U.S. Sales, 2000-201251

INDEX OF TABLES

Table 2.1: Market Share of Top Three In Vitro Diagnostic Companies17

Table 2.2: Worldwide Clinical Laboratory Market Size, 2003-201218

Table 2.3: U.S. Clinical Laboratory Testing Market, 2003-201218

Table 2.4: Worldwide Near-Patient Diagnostic Testing, 2003-201318

Table 2.5: Worldwide OTC Diagnostic Products Market, 2003-201320

Table 2.6: Worldwide OTC Diagnostic Products Market by Region, 200820

Table 2.7: Major European OTC Diagnostics Markets, 200821

Table 2.8: German OTC Diagnostic Products Market Sales, 2003-201322

Table 2.9: U.K. OTC Diagnostic Products Market Sales, 2003-201323

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, 2003-201326

Table 2.14: Italian OTC Diagnostic Products Market Sales, 2003-201326

Table 2.15: Spanish OTC Diagnostic Products Market Sales, 2003-201327

Table 2.16: Japanese OTC Diagnostic Products Market Sales, 2003-201328

Table 2.17: Chinese OTC Diagnostic Products Market Sales, 2003-201329

Table 2.18: U.S. OTC Diagnostic Products Market Sales 2003-201330

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: Market for OTC Glucose Self-Testing in the U.S., 2004-201235

Table 3.2: Glucose Market for OTC Testing Worldwide, 2003-201335

Table 3.3: Top Ten Countries in Number of Persons with Diabetes (Aged 20 to 79 Years), in 2007 and 202536

Table 3.4: Share of the U.S. Self-Testing Diagnostic Market, 200837

Table 3.5: OTC Blood Glucose Instrument Reagents by Manufacturer Retail39

Table 3.6: World Market Share of POC Glucose Monitoring Marketers39

Table 3.7: Key Features Considered for Glucose Meter Devices43

Table 3.8: Demographic Characteristics Home-Testing Kit Buyers46

Table 3.9: Top Brand Preferences for Home Glucose Testing Kits46

Table 3.10: Instances When Patients Prefer Professional\'s Glucose Testing46

Table 3.11: Advantages of a Home-Testing Kit46

Table 3.12: Disadvantages of Using a Home-Testing Kit47

Table 3.13: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits47

Table 3.14: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2000-201347

Table 3.15: The Glucose Market for Self-Testing and POC Devices in the U.S., 2003-201348

Table 3.16: U.S. Blood Glucose Reagent Strip Market, 2004-201349

Table 3.17: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements50

Table 3.18: U.S. Diabetes Glucose Monitoring Market Repeat Retail Replacement Sales Percentages51

Table 3.19: Top Four Players in the U.S. Blood Glucose Strips Market-Ranked by Percentage Sales, 200851

Table 3.20: Leading Blood Glucose Meters and Strips Brands in the U.S., 200851

Table 3.21: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2004-201352

Table 3.22: European Glucose Self-Testing Market by Country Market53

Table 3.23: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2004-201254

Table 3.24: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2002-201255

Table 3.25: Chinese Glucose Self-Testing Market (Meters, Strips, Lancets), 2003-201256

Table 3.26: Chinese Blood Glucose Reagent Strip Market, 2000-201256

Table 3.27: Indian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-201257

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

Table 3.29: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2003-201358

Table 3.30: Unit Sales of Homecare Lancets in the U.S., 2003-201362

Table 3.31: Unit Sales of Lancets in the E.U., 2003-201362

Table 3.32: Dollar Sales of Lancets in the U.S., 2003-201362

Table 3.33: Dollar Sales of Lancets in the E.U., 2003-201363

Table 3.34: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2003-201363

Table 3.35: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2003-201363

Table 3.36: Competition in the Lancet Market Segment64

Table 3.37: Key Features of Reagent Test Strips66

Table 3.38: Customer Priorities-Glucose Meter Self-Testing Market, 2001, 2006 and 201268

Table 3.39: Accu-Chek Blood Glucose Monitoring Systems73

Table 3.40: Pregnancy Test Market for OTC Testing in the U.S., 2000-201288

Table 3.41: Pregnancy Test Market for OTC Testing in Europe, 2003-201388

Table 3.42: U.S. Market Share for Home Pregnancy Tests89

Table 3.43: European Market Share for OTC Pregnancy Tests90

Table 3.44: Home Pregnancy Tests Available in the U.S. Market93

Table 3.45: Hepatitis C Statistics97

Table 3.46: Hepatitis Market for OTC Testing in the U.S., 2003-201398

Table 3.47: U.S. POC Drugs of Abuse Testing Market in the U.S., 2006-201299

Table 3.48: Illicit Drugs that are Important for Detection101

Table 3.49: Analytical Detection Levels for Drugs of Abuse101

Table 3.50: Princeton BioMeditech\'s Drugs of Abuse Tests107

Table 3.51: Abbott Drugs of Abuse Tests on the ARCHITECT System107

Table 3.52: Infectious Disease Market for OTC Testing in the U.S., 2003-2013110

Table 3.53: HIV Testing Market for OTC Testing in the U.S., 2003-2013113

Table 3.54: Home Testing for Urinary Tract Infections121

Table 3.55: Cholesterol Market for OTC and Home Self-Testing in the U.S., 2003-2013122

Table 3.56: Coagulation Market for OTC Testing in the U.S., 2003-2013125

Table 3.57: Glucose Market for OTC Testing in the U.S., 2003-2013129

Table 3.58: Fertility Testing Market for OTC Testing in the U.S., 2003-2013131

Table 3.59: Fertility Testing Market for OTC Testing in Europe, 2003-2013131

Table 3.60: Rite Aid and Other OEM Ovulation Predictors133

Table 3.61: At-Home DNA Tests135

Table 3.62: At-Home DNA Market for OTC Testing Worldwide, 2003-2013136

Table 3.63: Home Genetic Testing Market in the U.S., 2003-2013145

Table 3.64: Genovations Profiles146

Table 3.65: Featured Tests by DNA Direct147

Table 3.66: Fee Schedule for Personal Home-Based Paternity Studies148

Table 4.1: Financial Comparison for Moderate and Waived CLIA Labs163

Table 5.1: U.S. Home Testing Market Size, 2003-2013168

Table 6.1: Normal Glucose Values, Fasting State172

Table 6.2: Leading Home Patient Monitoring Products in the U.S. Market179

Table 7.1: POC Testing: Cost Analysis183

Table 7.2: POC Testing: Cost Analysis with Labor Included183

Table 8.1: Total World Cholesterol Testing Market, 2006-2012201

Table A.1: Over-the-Counter In Vitro Diagnostic Devices250

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