全球OTC诊断设备市场

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.

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 Chinese 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
• 3.2 Pregnancy and Fertility 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 Tuberculosis Testing
  • 3.5.2 Infectious Disease Testing in Non-Medical Settings
  • 3.5.3 West Nile Virus
  • 3.5.4 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

5. Patient Management Trends

• 5.1 Trends in OTC Testing and Reimbursement
  • 5.1.1 American OTC Testing and Home Self-testing 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 Collection

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 Satellite Facilities
• 7.8 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 Adjacent Markets
  • 8.1.5 Market Drivers and Restraints
  • 8.1.6 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
• 8.5 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 Corporate Screening
• 9.3 Generational Drivers of Home Testing
• 9.4 Move Away from Central Laboratories
• 9.5 Healthcare Cost Controls
• 9.6 Mergers of Diagnostic Companies
• 9.7 Home Healthcare Trends
• 9.8 Home Healthcare Providers versus Mass Market Retailers
• 9.9 Demographic Merchandising
• 9.10 Marketing Strategies
• 9.11 Third-Party Pharmacy Networks
• 9.12 Which Customer Segments Purchase Home Healthcare? Which Products Fit Their Needs?
• 9.13 Future of Patient Self-Testing

10. Corporate Profiles

• 10.1 Abbott Diagnostics
• 10.2 AmeriSourceBergen
• 10.3 Bindley Western Industries, Inc.
• 10.4 Biosite, Inc.
• 10.5 Cardinal Health, Inc.
• 10.6 Cholestech
• 10.7 HemoCue
• 10.8 Home Access Health Corp.
• 10.9 Inverness Medical Innovations, Inc.
• 10.10 Johnson & Johnson
• 10.11 LifeScan
• 10.12 Princeton BioMeditech
• 10.13 Quidel Corp.
• 10.14 Roche Diagnostics
• 10.15 Saliva Diagnostics

11. Corporate Directory

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

Appendix 2: FDA Approved and Unapproved Tests for HIV Home Testing

Appendix 3: Home Medical Equipment Reimbursement Contacts for Medicare

Appendix 4: 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, 2008
• Figure 3.3: The Glucose Market U.S. Sales, 2000-2012

INDEX OF TABLES

• Table 2.1: Market Share of Top Three In Vitro Diagnostic Companies
• Table 2.2: Worldwide Clinical Laboratory Market Size, 2003-2012
• Table 2.3: U.S. Clinical Laboratory Testing Market, 2003-2012
• Table 2.4: Worldwide Near-Patient Diagnostic Testing, 2003-2013
• Table 2.5: Worldwide OTC Diagnostic Products Market, 2003-2013
• Table 2.6: Worldwide OTC Diagnostic Products Market by Region, 2008
• Table 2.7: Major European OTC Diagnostics Markets, 2008
• Table 2.8: German OTC Diagnostic Products Market Sales, 2003-2013
• Table 2.9: U.K. OTC Diagnostic Products Market Sales, 2003-2013
• 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, 2003-2013
• Table 2.14: Italian OTC Diagnostic Products Market Sales, 2003-2013
• Table 2.15: Spanish OTC Diagnostic Products Market Sales, 2003-2013
• Table 2.16: Japanese OTC Diagnostic Products Market Sales, 2003-2013
• Table 2.17: Chinese OTC Diagnostic Products Market Sales, 2003-2013
• Table 2.18: U.S. OTC Diagnostic Products Market Sales 2003-2013
• 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: Market for OTC Glucose Self-Testing in the U.S., 2004-2012
• Table 3.2: Glucose Market for OTC Testing Worldwide, 2003-2013
• Table 3.3: Top Ten Countries in Number of Person with Diabetes (Aged 20 Years to 79 Years), in 2007 and 2025
• Table 3.4: Share of the U.S. Self-Testing Diagnostic Market, 2008
• 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), 2000-2013
• Table 3.15: The Glucose Market for Self-Testing and POC Devices in the U.S., 2003-2013
• Table 3.16: U.S. Blood Glucose Reagent Strip Market, 2004-2013
• 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, 2008
• Table 3.20: Leading Blood Glucose Meters and Strips Brands in the U.S., 2008
• Table 3.21: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2004-2013
• Table 3.22: European Glucose Self-Testing Market by Country Market
• Table 3.23: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2004-2012
• Table 3.24: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2002-2012
• Table 3.25: Chinese Glucose Self-Testing Market (Meters, Strips, Lancets), 2003-2012
• Table 3.26: Chinese 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), 2003-2013
• Table 3.30: Unit Sales of Homecare Lancets in the U.S., 2003-2013
• Table 3.31: Unit Sales of Lancets in the E.U., 2003-2013
• Table 3.32: Dollar Sales of Lancets in the U.S., 2003-2013
• Table 3.33: Dollar Sales of Lancets in the E.U., 2003-2013
• Table 3.34: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2003-2013
• Table 3.35: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2003-2013
• 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: Pregnancy Test Market for OTC Testing in the U.S., 2000-2012
• Table 3.41: Pregnancy Test Market for OTC Testing in Europe, 2003-2013
• Table 3.42: European Market Share for OTC Pregnancy Tests
• Table 3.43: Home Pregnancy Tests Available in the U.S. Market
• Table 3.44: Hepatitis C Statistics
• Table 3.45: Hepatitis Market for OTC Testing in the U.S., 2003-2013
• Table 3.46: U.S. POC Drugs of Abuse Testing Market in the U.S., 2006-2012
• Table 3.47: Illicit Drugs that are Important for Detection
• Table 3.48: Analytical Detection Levels for Drugs of Abuse
• Table 3.49: Princeton BioMeditech' s Drugs of Abuse Tests
• Table 3.50: Abbott Drugs of Abuse Tests on the ARCHITECT System
• Table 3.51: Infectious Disease Market for OTC Testing in the U.S., 2003-2013
• Table 3.52: HIV Testing Market for OTC Testing in the U.S., 2003-2013
• Table 3.53: Home Testing for Urinary Tract Infections
• Table 3.54: Cholesterol Market for OTC and Home Self-Testing in the U.S., 2003-2013
• Table 3.55: Coagulation Market for OTC Testing in the U.S., 2003-2013
• Table 3.56: Glucose Market for OTC Testing in the U.S., 2003-2013
• Table 3.57: Fertility Testing Market for OTC Testing in the U.S., 2003-2013
• Table 3.58: Fertility Testing Market for OTC Testing in Europe, 2003-2013
• Table 3.59: Rite Aid and Other OEM Ovulation Predictors
• Table 3.60: At-Home DNA Tests
• Table 3.61: At-Home DNA Market for OTC Testing Worldwide, 2003-2013
• Table 3.62: Home Genetic Testing Market in the U.S., 2003-2013
• Table 3.63: Genovations Profiles
• Table 3.64: Featured Tests by DNA Direct
• Table 3.65: 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, 2003-2013
• Table 6.1: Normal Glucose Values, Fasting State
• Table 6.2: Leading Home Patient Monitoring Products in the U.S. Market
• Table 7.1: POC Testing: Cost Analysis
• Table 7.2: POC Testing: Cost Analysis with Labor Included
• Table 8.1: Total World Cholesterol Testing Market, 2006-2012
• Table A.1: Over-the-Counter In Vitro Diagnostic Devices