Over the Counter Diagnostic Product World Markets

Table of Contents

1 Overview

• 1.1 Statement of Report
• 1.2 About This Report
• 1.3 Scope of the Report
• 1.4 Objectives
• 1.5 Methodology
• 1.6 Executive Summary

2 Sector Overview

• 2.1 Global Diagnostic Products Industry
• 2.2 Global OTC Diagnostic Products Industry
  • 2.2.1 General Global Market
  • 2.2.2 German OTC and Home Self-Testing Diagnostic Markets
  • 2.2.3 U.K. OTC and Home Self-Test Diagnostic Markets
    • 2.2.3.1 U.K. Market Statistics
    • 2.2.3.2 U.K. Competitive Analysis
    • 2.2.3.3 U.K. Market Access
  • 2.2.4 French OTC Diagnostic Market
  • 2.2.5 Italian OTC Diagnostic Market
  • 2.2.6 Spanish OTC Diagnostic Market
  • 2.2.7 Japanese OTC Diagnostic Market
  • 2.2.8 Chinese OTC Diagnostic Market
• 2.3 Description of the U.S. OTC Diagnostics Industry Segment
  • 2.3.1 Market Overview
  • 2.3.2 Diagnostic Test Categories
• 2.4 Market Drivers in the OTC Diagnostics Sector
  • 2.4.1 Overview
  • 2.4.2 Market Segments
• 2.5 Key Players in the OTC Diagnostics Segment
• 2.6 Sector Analysis

3 Market Analysis: Size, Growth, Share and Competitors

• 3.1 Glucose Monitoring
  • 3.1.1 Glucose Control in Diabetic Patients
  • 3.1.2 Tight Glucose Control in Treating Diabetes
  • 3.1.3 Glucose-Monitoring Devices
  • 3.1.4 Key Issues for Glucose Monitoring
  • 3.1.5 Glucose Device Description
  • 3.1.6 Precision in Glucose Meters
  • 3.1.7 Limitations of Existing Glucose Monitoring Products
  • 3.1.8 Over-the-Counter (OTC) Self-Testing Glucose Market
  • 3.1.9 Worldwide Glucose Testing Market
    • 3.1.9.1 U.S. Market
    • 3.1.9.2 European Market
    • 3.1.9.3 Asian Market
      • 3.1.9.3.1 Japanese Market
      • 3.1.9.3.2 China Market
      • 3.1.9.3.3 Indian Market
    • 3.1.9.4 ROW Markets
  • 3.1.10 Reagents and Equipment
    • 3.1.10.1 Blood Glucose Monitoring
    • 3.1.10.2 Lancets
    • 3.1.10.3 Blood Glucose Monitor and Insulin Doser
    • 3.1.10.4 Blood Glucose Reagent Test Strips
    • 3.1.10.5 Control Solutions and Calibrators
    • 3.1.10.6 Sharps Devices
    • 3.1.10.7 Needle Destruction Devices
    • 3.1.10.8 Voice-Operated Glucose Meters
  • 3.1.11 Glucose Meters
• 3.2 Pregnancy Testing
  • 3.2.1 Major Players
    • 3.2.1.1 U.S. Market
    • 3.2.1.2 European Market
  • 3.2.2 Diagnostic Kit Information
• 3.3 Hepatitis Testing
• 3.4 Drugs of Abuse Screening Testing
• 3.5 Infectious Disease Testing
  • 3.5.1 HIV
  • 3.5.2 Tuberculosis Testing
  • 3.5.3 Infectious Disease Testing in Non-medical Settings
  • 3.5.4 West Nile Virus
  • 3.5.5 Urinary Tract Infections
• 3.6 Cholesterol Testing
• 3.7 Coagulation Testing
• 3.8 Urine Dipstick Testing
• 3.9 Fertility Testing
  • 3.9.1 Players
  • 3.9.2 Diagnostic Test Kits
• 3.10 At-Home DNA Analysis
• 3.11 Biowarfare Detection
• 3.12 Home Patient Monitoring Devices
• 3.13 Home Patient Alert Systems
• 3.14 Home Genetic Testing Kits
• 3.15 Home Paternity Testing
• 3.16 Health Hazards Detection
  • 3.16.1 Lead
  • 3.16.2 Radon
  • 3.16.3 Asbestos
  • 3.16.4 Pesticides
  • 3.16.5 Mold
  • 3.16.6 Carbon Monoxide
  • 3.16.7 Water Quality
  • 3.16.8 Bacteria in Water
• 3.17 Thyroid Disease
• 3.18 Carpal Tunnel
• 3.19 Allergies
• 3.20 Nutrition and Wellness
  • 3.20.1 Testosterone and Male Hormones
  • 3.20.2 Female Hormones
  • 3.20.3 Antioxidants
  • 3.20.4 Sleep Apnea
  • 3.20.5 Mineral Check
  • 3.20.6 Stress Check
• 3.21 Colorectal Cancer (Occult Blood) Testing
• 3.22 Alzheimer' s Disease Home Screening Test
• 3.23 Tobacco Testing

4. Business Trends In The Industry

• 4.1 Wholesale Distribution Overview
• 4.2 Factors Affecting OTC Medical Product Distribution
• 4.3 Government Regulation of Medical Devices
  • 4.3.1 U.S. Regulations
  • 4.3.2 U.K. Regulations
• 4.4 Clinical Laboratory Improvement Act (CLIA)
• 4.5 Legal, M&A and Corporate Partnerships
• 4.6 New Product Launches

5. Patient Management Trends

• 5.1 Trends in OTC Testing and Reimbursement
  • 5.1.1 American OTC Testing and Home Self-testing Reimbursement
  • 5.1.2 European Reimbursement
• 5.2 Drivers of OTC and Home Self-Testing
• 5.3 Cost Elements of OTC Testing
• 5.4 Important Elements of OTC Testing
• 5.5 Growth of Home Care Testing
• 5.6 Non-Traditional Methods for Sample Collecting

6. Technology Trends

• 6.1 Sensor Systems for Diagnostic Applications
• 6.2 Glucose Measurements
• 6.3 Cholesterol Testing
• 6.4 Immunoassay Technology
• 6.5 Biosensor Technology
• 6.6 Fructosamine Test
• 6.7 Home Telemedicine Devices

7. OTC Testing: Critical Issues

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

8. Competitive Assessments of the High-Growth Markets

• 8.1 Glucose Monitoring
  • 8.1.1 Overview of Market Segment
  • 8.1.2 Competitive Strategies
  • 8.1.3 Analyses of the Current Market Conditions, Competition and Product Mix
  • 8.1.4 Product Mix
  • 8.1.5 Adjacent Markets
  • 8.1.6 Market Drivers and Restraints
  • 8.1.7 Market and Product Trends
• 8.2 Coagulation Testing
  • 8.2.1 Overview of Market Segment
  • 8.2.2 Competitive Strategies
  • 8.2.3 Analyses of Current Market Conditions
  • 8.2.4 Product Mix in Coagulation Testing
  • 8.2.5 Adjacent Markets
  • 8.2.6 Market Drivers and Restraints
  • 8.2.7 Market and Product Trends
• 8.3 Cholesterol Testing
  • 8.3.1 Overview of Market Segment
  • 8.3.2 Competitive Strategies
  • 8.3.3 Adjacent Markets
• 8.4 Infectious Disease Testing
  • 8.4.1 Overview of Market Segment
  • 8.4.2 Competitive Strategies
• 8.5 Drugs of Abuse
  • 8.5.1 Overview of Market Segment
  • 8.5.2 Analyses of the Current Market Conditions, Competition and Product Mix
  • 8.5.3 Adjacent Markets
• 8.6 Home Pregnancy Testing
  • 8.6.1 Overview of Market Segment
  • 8.6.2 Competitive Strategies
  • 8.6.3 Analysis of Current Market Conditions
  • 8.6.4 Product Mix
  • 8.6.5 Adjacent Markets
  • 8.6.6 Market Drivers and Restraints
  • 8.6.7 Market and Product Trends

9. Current Issues for OTC and Home Diagnostic Testing

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

10. Corporate Profiles

• 10.1 Abbott Diagnostics (MediSense)
• 10.2 AmeriSourceBergen
• 10.3 Avitar Technologies, Inc.
• 10.4 Bayer Diagnostics
• 10.5 Beacon Diagnostics
• 10.6 Becton Dickinson
• 10.7 Bindley Western Industries, Inc.
• 10.8 Biosite, Inc.
• 10.9 Cardinal Health, Inc.
• 10.10 Cholestech
• 10.11 HemoCue
• 10.12 Home Access Health Corp.
• 10.13 Inverness Medical Innovations, Inc.
• 10.14 Johnson & Johnson
• 10.15 LifeScan
• 10.16 Princeton BioMeditech
• 10.17 Quidel Corp.
• 10.18 Roche Diagnostics
• 10.19 Saliva Diagnostics
• 10.20 Technical Chemicals & Products, Inc.
• 10.21 Worldwide Medical Corporation

11. Corporate Directory

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

INDEX OF FIGURES

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

INDEX OF TABLES

• Table 2.1: Worldwide Market Share of In Vitro Diagnostic Companies
• Table 2.2: Worldwide Clinical In Vitro Diagnostics Market Size, 2001-2007
• Table 2.3: Worldwide Clinical In Vitro Central Lab Diagnostic Testing, 2001-2007
• Table 2.4: Worldwide Near-Patient Diagnostic Testing, 2001-2007
• Table 2.5: Worldwide OTC Diagnostic Products Market, 2001-2010
• Table 2.6: Worldwide OTC Diagnostic Products Market by Region, 2005
• Table 2.7: Major European OTC Diagnostics Markets, 2004
• Table 2.8: German OTC Diagnostic Products Market Sales, 1999-2007
• Table 2.9: U.K. OTC Diagnostic Products Market Sales, 1998-2009
• Table 2.10: Major U.K. IVD Manufacturers
• Table 2.11: U.S. IVD Manufacturers Doing Business in the U.K.
• Table 2.12: Other European Companies that Manufacture IVD Products in the U.K.
• Table 2.13: French OTC Diagnostic Products Market Sales, 1998-2007
• Table 2.14: Italian OTC Diagnostic Products Market Sales, 1998-2009
• Table 2.15: Spanish OTC Diagnostic Products Market Sales, 1998-2009
• Table 2.16: Japanese OTC Diagnostic Products Market Sales, 1998-2007
• Table 2.17: Chinese OTC Diagnostic Products Market Sales, 2000-2007
• Table 2.18: U.S. OTC Diagnostic Products Market Sales 1992-2010
• Table 2.19: U.S. Clinical Diagnostic Home Test Market Segments
• Table 2.20: Top Drugstore Retailers in the U.S.
• Table 2.21: Top Drugstore Wholesalers in the U.S.
• Table 3.1: The Glucose Market for OTC Testing in the U.S., 1996-2010
• Table 3.2: The Glucose Market for OTC Testing Worldwide, 2000-2010
• Table 3.3: The Global Population of Persons with Diabetes, 1995 and 2025
• Table 3.4: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements
• Table 3.5: OTC Blood Glucose Instrument Reagents by Manufacturer Retail
• Table 3.6: World Market Share of POC Glucose Monitoring Marketers
• Table 3.7: Key Features Considered for Glucose Meter Devices
• Table 3.8: Demographic Characteristics Home-Testing Kit Buyers
• Table 3.9: Top Brand Preferences for Home Glucose Testing Kits
• Table 3.10: Instances when Patients Prefer Professional' s Glucose Testing
• Table 3.11: Advantages of a Home-Testing Kit
• Table 3.12: Disadvantages of Using a Home-Testing Kit
• Table 3.13: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits
• Table 3.14: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2000-2012
• Table 3.15: The Glucose Market for Self-Testing and POC Devices in the U.S., 2000-2012
• Table 3.16: U.S. Blood Glucose Reagent Strip Market, 2000-2012
• Table 3.17: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements
• Table 3.18: U.S. Diabetes Glucose Monitoring Market Repeat Retail Replacement Sales Percentages
• Table 3.19: Top Four Players in the U.S. Blood Glucose Strips Market-Ranked by Percentage Sales, 2006
• Table 3.20: Leading Blood Glucose Meters and Strips Brands in the U.S., 2006
• Table 3.21: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2004-2012
• Table 3.22: European Glucose Self-Testing Market by Country Market
• Table 3.23: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
• Table 3.24: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
• Table 3.25: Chinese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
• Table 3.26: China Blood Glucose Reagent Strip Market, 2000-2012
• Table 3.27: Indian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
• Table 3.28: Indian Blood Glucose Reagent Strip Market, 2000-2012
• Table 3.29: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
• Table 3.30: Unit Sales of Homecare Lancets in the U.S., 2000-2012
• Table 3.31: Unit Sales of Lancets in the E.U., 2000-2012
• Table 3.32: Dollar Sales of Lancets in the U.S., 2000-2012
• Table 3.33: Dollar Sales of Lancets in the E.U., 2000-2012
• Table 3.34: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2000-2012
• Table 3.35: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2000-2012
• Table 3.36: Competition in the Lancet Market Segment
• Table 3.37: Key Features of Reagent Test Strips
• Table 3.38: Customer Priorities-Glucose Meter Self-Testing Market, 2001, 2006 and 2012
• Table 3.39: Accu-Chek Blood Glucose Monitoring Systems
• Table 3.40: The Pregnancy Test Market for OTC Testing in the U.S., 2000-2010
• Table 3.41: The Pregnancy Test Market for OTC Testing in Europe, 2000-2010
• Table 3.42: U.S. Market Share for Home Pregnancy Tests
• Table 3.43: European Market Share for OTC Pregnancy Tests
• Table 3.44: Home Pregnancy Tests Available in the U.S. Market
• Table 3.45: Hepatitis C Statistics
• Table 3.46: The Hepatitis Market for OTC Testing in the U.S., 2000-2007
• Table 3.47: The Drugs of Abuse Market for OTC Testing in the U.S., 2000-2006
• Table 3.48: Illicit Drugs that are Important for Detection
• Table 3.49: Analytical Detection Levels for Drugs of Abuse
• Table 3.50: Princeton BioMeditech' s Drugs of Abuse Tests
• Table 3.51: Abbott Tests on the ADx System
• Table 3.52: The Infectious Disease Market for OTC Testing in the U.S., 2000-2010
• Table 3.53: The HIV Testing Market for OTC Testing in the U.S., 2000-2008
• Table 3.54: Home Testing for Urinary Tract Infections
• Table 3.55: The Cholesterol Market for OTC and Home Self-Testing in the U.S., 2000-2010
• Table 3.56: The Coagulation Market for OTC Testing in the U.S., 2000-2010
• Table 3.57: The Glucose Market for OTC Testing in the U.S., 2000-2010
• Table 3.58: The Fertility Testing Market for OTC Testing in the U.S., 2000-2010
• Table 3.59: The Fertility Testing Market for OTC Testing in Europe, 2000-2008
• Table 3.60: Rite Aid and Other OEM Ovulation Predictors
• Table 3.61: At-Home DNA Tests
• Table 3.62: The At-Home DNA Market for OTC Testing Worldwide, 2001-2007
• Table 3.63: The Home Genetic Testing Market in the U.S., 2003-2010
• Table 3.64: Genovations Profiles
• Table 3.65: Featured Tests by DNA Direct
• Table 3.66: Fee Schedule for Personal Home-Based Paternity Studies
• Table 4.1: Financial Comparison for Moderate and Waived CLIA Labs
• Table 5.1: U.S. Home Testing Market Size, 2004-2010
• Table 6.1: Normal Glucose Values, Fasting State
• Table 6.2: Leading Home Patient Monitoring Products in the U.S. Market
• Table 6.3: Home Telemonitoring and Patient Assessment Products
• Table 7.1: POCT Clinical Outcomes in Diabetic Ketoacidosis
• Table 7.2: POC Testing: Cost Analysis with Labor Included
• Table 7.3: POC Testing: Cost Analysis with Labor Included
• Table 8.1: U.S. Diabetes Glucose Monitoring Market, 2002
• Table 8.2: Total U.S. Market Size and CAGRs of Emerging At-Home Diagnostic Tests, 1997-2007
• Table A.1: Over-the-Counter In Vitro Diagnostic Devices
• Table A.2: Over-the-Counter In Vitro Diagnostic Devices Approved by the FDA