市場調査報告書：OTC診断用品

Abstract

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
- 2.2.1 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

OTC診断用品の世界市場

Over the Counter Diagnostic Product World Markets

Abstract

Table of Contents

1 Overview

2 Sector Overview

3 Market Analysis: Size, Growth, Share and Competitors

4. Business Trends In The Industry

5. Patient Management Trends

6. Technology Trends

7. OTC Testing: Critical Issues

8. Competitive Assessments of the High-Growth Markets

9. Current Issues for OTC and Home Diagnostic Testing

10. Corporate Profiles

11. Corporate Directory

INDEX OF FIGURES

INDEX OF TABLES