Over-the-Counter Diagnostic Products World Markets

Published by: Trimark Publications

Published: Aug. 1, 2009 - 277 Pages

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

Abstract

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 250,000 market research reports, company profiles and country profiles from over 650 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.