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Over-the-Counter Diagnostic Products World Markets

TriMark Publications
August 1, 2009
277 Pages - SKU: TRI2385930

Abstract Table of Contents Related Reports

Countries covered: Global

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.

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; 2.3 Description of the U.S. OTC Diagnostics Industry Segment; 2.4 Market Drivers in the OTC Diagnostics Sector; 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; 3.2 Pregnancy Testing; 3.3 Hepatitis Testing; 3.4 Drugs of Abuse Screening Testing; 3.5 Infectious Disease Testing; 3.6 Cholesterol Testing; 3.7 Coagulation Testing; 3.8 Urine Dipstick Testing; 3.9 Fertility Testing; 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; 3.17 Thyroid Disease; 3.18 Carpal Tunnel; 3.19 Allergies; 3.20 Nutrition and Wellness; 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; 4.4 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; 5.3 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; 8.2 Coagulation Testing; 8.3 Cholesterol Testing; 8.4 Infectious Disease Testing; 8.5 Drugs of Abuse; 8.6 Home Pregnancy Testing
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

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