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The U.S. Market for Over-the-Counter Diagnostics: Product Sales and Consumer Survey

 

This unprecedented study provides detailed market data on products and segments in the retail OTC diagnostic market in the United States.

In addition to market size, growth and competitive share information on each of six testing categories plus testing accessories, the report contains the results of a major consumer survey conducted jointly by Kalorama Information and The Telephone Centre, Inc., focusing on consumer attitudes and awareness of OTC testing products and their marketing channels. This valuable consumer information, never before published, is a must have for diagnostic manufacturers assessing the always promising OTC market.

Product segments examined include:

• Glucose Testing Kits
• Pregnancy Test Kits
• Blood Pressure Testing Kits
• Ovulation Prediction Kits
• Urine Tests/Kits
• Lancet/Device

Current competitive market share in these major categories is provided and market size and growth estimates are given through 2008. Promotional activities are reviewed and new products surveyed.

In addition, detailed information on consumer awareness of products and attitudes toward home testing are thoroughly documented in this first-ever survey dedicated to the home diagnostic segment. The report provides demographic information, product perception, promotional channel data, barriers to purchase and much more on smaller testing segments such as

 

• Drugs of Abuse Testing
• Home HIV testing
• Home Cancer Screening
• And more

The report methodology includes both primary and secondary research. Primary material was derived from three main sources:

 

• Information Resources Inc (IRI) tracks information about OTC diagnostic products that are sold through retail channels (F/D/M—food stores, drug stores and mass-merchandisers).
• Consumer attitudes, opinions, and product awareness information for all home diagnostic areas was derived from a telephone survey of U.S. consumers conducted specifically for this study by Kalorama Information in partnership with The Telephone Centre, Inc.
• The consumer data and analysis relating to home pregnancy testing kits are based on data provided by Simmons Marker Research Bureau derived from their NCS (National Consumer Survey), Spring 2004.

The secondary research data were obtained from trade associations, business journals, government agencies and other publicly available information. The secondary research methodology included defining sources for information; rating information based on relevance, timeliness, scope, and accuracy based on authenticity of the information provider (such information is meticulously sourced throughout the report); and exploring the position of the market after collating the information, including following key parameters were used to track market position:

 

• Market share
• Historic market growth rate
• Market size
• Market segmentation
• Pricing
• Competitive activities
• Number of competitors
• Customer base measurements
• Market maturity

Once the current position of the market was accurately identified, the next step was to forecast the future of the market. For this, we used the historic data provided by IRI, along with data from the consumer survey. However, many of the market trends and technical trends forecasted need to be surveyed over time to refine its accuracy. Other factors considered while forecasting were:

 

• Market trends
• Regulatory trends
• Market share movements

Kalorama Information's research partner for this survey was The Telephone Centre, Inc. (TCI) a New York-based market research company specializing in telephone survey research, both business to business and consumer. TCI employs a variety of methodologies including quantitative telephone, telephone/mail-web, telephone/mail-web/telephone, and qualitative telephone research and conducts over 400 studies each year. Some of the TCI’s clients include Harris Interactive, Yankelovich Partners, Inc., Marketing and Planning Systems, National Analysts, Data Development Corporation and Hall and Partners, conducting research on behalf of IBM, Pfizer Pharmaceuticals, Time Magazine and Prodigy among others.

Table of Contents

Chapter one: Executive Summary

• Scope
• Methodology
• Definition of OTC Diagnostic Products
• The Market
• Factors Promoting Growth


• Convenience
• An Aging Population
• Increased Health Consciousness
• Higher Incidence of Diseases
• Technological Advances: Prospects for Oral Fluid-Based Testing
  • Factors Hindering Growth
• FDA Approval
• Accuracy and Reliability
• Inadequate Information
• Too Complicated for Home Use
  • Market Players
  • Top Brands
  • Outlook

Chapter two: Industry Overview

• Product Introduction
• Market Size And Growth
• Key Market Trends


• Range of Conditions Tested Has Expanded
• Technologically Enhanced Blood-Glucose Testing Devices
• Digital Pregnancy Tests
• Value-Added Services
  • Market Projections
  • Factors Affecting Market Growth
• High Incidence of Diseases in the U.S.
• An Aging Population
• Switch from Rx to OTC products
  • Outlook

Chapter Three: The Market Segments

• Glucose Testing Kits


• Market Size & Growth
• Market Players & Top Brands
• Top Brands
• Projections
• Factors Affecting Growth
  • Technology Innovations: Non-invasive Glucose Testing Meters
  • Increasing Number of Diabetics
  • Scope of the Undiagnosed Diabetes Market
  • Frequent Monitoring Advised
    • Pregnancy Test Kits
• Market Size & Growth
• Market Players & Brands
• Top Brands
• Projections
• Factors Affecting Growth
  • Convenience
  • Economy
  • Accuracy
    • Blood Pressure Testing Kits
  
  
  • Market Size & Growth
  • Market Players & Brands
  • Top Brands
  • Projections
  • Factors Affecting Growth
    • Need for Regularly Monitoring Blood Pressure
    • Undiagnosed Hypertension
    • Recent Medical Reports Recommend Home Monitoring
    • Hypertension Hits the Young
    • Monitoring White-Coat Hypertension
      • Ovulation Prediction Kits
  • Market Size & Growth
  • Market Players & Top Brands
  • Top Brands
  • Projections
  • Factors Affecting Growth
    • Increasing Number of Pregnancies in the U.S.
    • New Players and Products
    • Infertility
    • Use of Ovulation Predictors as a Contraceptive
      • Lancet Devices
  • Market Size & Growth
  • Market Players & Brands
  • Top Brands
  • Projections
  • Factor Affecting Growth
    • Other Home-Use Test Kits
  • Market Size & Growth
  • Market Players & Brands
  • Top Brands
  • Projections
    • Urine Tests/Kits
  • Market Size & Growth
  • Market Player & Brands
  • Top Brands
  • Projections
    • Outlook

Chapter Four: Marketing Dynamics

• Ad Spends
• Key Marketing Trends


• Marketers Tap Healthcare Network
• Promotional Tie-Ins with Retail Partners
• Direct-to-Consumer Advertising Helps to Create a Niche Position
• Product Line Extensions
• Online Advertising
  • Innovation
  • Retail Dynamics
• Pregnancy Test Kits Are More Popular in Drug Stores
• Retailers Seek to Educate Consumers About Diabetes
• Rising Health Costs Are a Boon to Retailers
• Monitors and Strips Still Kept Behind Counter
  • New Product Introductions

Chapter Five: The Consumer

• Methodology
• The Home Testing Kit Buyer
• Best Known Tests
• Older Buyers
• Pregnancy Test Kits
• Testing Kits for Fatal Diseases
• Consumer Evaluation of Key Advantages & Disadvantages
• Accuracy and Interpretation of Results a Major Concern
• Consumer Preference of Retail Channel
• Consumer Awareness
• Home Drug Testing
• Issues and Concerns


• Home Testing Cannot Replace a Doctor
• False Alarms can be Dangerous
• Fraudulent test kits

Chapter Six: Company Profiles

• LifeScan Inc


• Overview
• Selected OTC Diagnostic Product Brand Portfolio
  • Glucose monitoring
  • Lancet/devices
• Performance
• Future Strategy
  • Roche Diagnostics
• Overview
• Selected OTC Diagnostic Product Brand Portfolio
  • Glucose monitoring
  • Lancet/devices
• Performance
• Future Strategy
  • Pfizer Inc
• Overview
• Selected OTC Diagnostic Product Brand Portfolio
• Performance
• Future Strategy
  • Inverness Medical Innovations, Inc
• Overview
• Selected OTC Diagnostic Product Brand Portfolio
  • Ovulation Prediction Kits
• Performance
  • Church & Dwight Co., Inc.
• Overview
• Selected OTC Diagnostic Product Brand Portfolio
  • Ovulation Prediction Kits
  • Pregnancy Testing Kits
  • Urine Testing Kits
  • Performance
  • Future Strategy
    • Omron Health Care Inc
  • Overview
  • Selected OTC Diagnostic Product Brand Portfolio
    • Blood Pressure Monitoring
    • Other Home Testing Kits
    • Performance
    • Future Strategy
      • Becton, Dickinson and Company
    • Overview
    • Selected OTC Diagnostic Product Brand Portfolio
      • Glucose Monitoring
      • Lancet/devices
      • Testing Accessories
      • Performance
      • Future Strategy
        • Therasense Inc.
      • Overview
      • Selected OTC Diagnostic Product Brand Portfolio
        • Glucose Monitoring
        • Lancet/ Devices
      • Performance
      • Future Strategy
        • Bayer Corporation
      • Overview
      • Selected OTC Diagnostic Product Brand Portfolio
        • Glucose Monitoring
        • Lancet/devices
        • Urine Testing Kits
      • Performance
      • Future Strategy

Appendix: Addresses of Selected Marketers

 

 

List of Exhibits

Chapter one: Executive Summary

• Table 1-1: Retail Sales of OTC- Diagnostic Products in the U.S.
• Figure 1-1: Category Wise Break-up of OTC Diagnostic ProductMarket 2003
• Table 1-2: U.S. Retail Market Sales and Growth of OTC- Diagnostic Products 1999, 2003, 2008
• Table 1-3: U.S. Mass-Market Sales and Market Share of Top 10
• Marketers (2003)
• Table 1-4: U.S. Mass-Market Sales and Market Share of Top 10 Brands 2003

Chapter two: Industry Overview

• Figure 2-1: U.S. Retail Sales for OTC Diagnostic Products (1999-2003)
• Figure 2-2: Mass-Market Sales 2003 & Percentage Change Over 2002 by Category
• Table 2-1: U.S. Retail Sales and Growth of OTC DiagnosticProducts 1999-2003
• Figure 2-3: Projected Retail Sales for OTC Diagnostic Products 2004-2008
• Table 2-2: U.S. Prevalence of Type II Diabetes Cases (Diagnosed and Undiagnosed) by Total Population and Those 45 Years ofAge and Older 2003-2013

Chapter Three: The Market Segments

• Figure 3-1: U.S. Mass-Market Sales of Glucose Testing Kits
• Table 3-1: Glucose Testing Kits Share of the U.S. Mass Market OTCDiagnostic Market 2003
• Table 3-2: U.S. Mass-Market Sales of Top Glucose Testing KitMarketers 2002- 2003
• Table 3-3: U.S. Mass-Market Share of Top Glucose Testing KitMarketers 2002-2003
• Table 3-4: U.S. Mass-Market Sales of Top Glucose Testing KitBrands 2002-2003
• Table 3-5: Estimated Mass-Market Sales of Glucose TestingKits 2004-2008
• Figure 3-2: U.S. Mass-Market Sales of Pregnancy Test Kits
• Table 3-6: U.S. Market Share of Pregnancy Test Kits 1999-2003
• Table 3-7: U.S. Mass-Market Sales of Top Pregnancy Test KitMarketers 2002-2003
• Table 3-8: U.S. Mass-Market Shares of Top Pregnancy Test KitMarketers 2002-2003
• Table 3-9: U.S. Mass-Market Sales of Top Pregnancy Test KitBrands 2002-2003
• Table 3-10: Estimated Mass-Market Sales of Pregnancy TestKits 2004-2008
• Figure 3-3: U.S. Mass-Market Sales of Blood Pressure Testing Kits
• Table 3-11: U.S. Blood Pressure Testing Kit Share of OTC DiagnosticsMarket 1999-2003
• Table 3-12: U.S. Mass-Market Sales of Top Blood Pressure Testing KitMarketers 2002-2003
• Table 3-13: U.S. Mass-Market Share of Top Blood Pressure Testing Kit Marketers 2002-2003
• Table 3-14: U.S. Mass-Market Sales of Top Blood Pressure Testing KitBrands 2002-2003
• Table 3-15: Estimated Mass-market Sales of Blood Pressure MonitoringDevices
• Figure 3-5: U.S. Mass-Market Sales of Ovulation Prediction Kits
• Table 3-21: Share of Ovulation Prediction Kits in Total U.S. OTCDiagnostic Market, 1999-2003
• Table 3-22: U.S. Mass-Market Sales of Top Ovulation Prediction KitMarketers 2002-2003
• Table 3-23: U.S. Mass-Market Share of Top Ovulation Prediction KitMarketers 2002-2003
• Table 3-24: U.S. Mass-Market Sales of Top Ovulation Prediction KitBrands 2002-2003
• Table 3-25: Estimated Mass-Market Sales of Ovulation PredictionKits 2004-2008
• Figure 3-6: U.S. Mass-Market Sales of Lancet Devices 1999-2003
• Table 3-26: Share of Lancet/Device in Total U.S. OTC DiagnosticMarket 1999-2003
• Table 3-27: U.S. Mass-Market Sales of Top Lancet DeviceMarketers 2002-2003
• Table 3-28: U.S. Mass-Market Share of Top Lancet DeviceMarketers 2002-2003
• Table 3-29: U.S. Mass-Market Sales of Top Lancet Device Brands 2002-2003
• Table 3-30: Estimated Mass-Market Sales of Lancet Devices 2004-2008
• Figure 3-7: U.S. Mass-Market Sales of Other Home Use Test Kits 1999-2003U.S. Market for Other Home Use Test Kits 1999-2003
• Table 3-32: U.S. Mass-Market Sales of Top Other Home Use Test KitMarketers 2002-2003
• Table 3-33: U.S. Mass-Market Share of Top Other Home Use Test KitMarketers 2002-2003
• Table 3-34: U.S. Mass-Market Sales of Top Other Home Use Test KitBrands 2002-2003
• Table 3-35: Estimated Mass-Market Sales of Other Home Use TestKits 2004-2008
• Figure 3-8: U.S. Mass-Market Sales of Urine Tests/Kits 1999-2003
• Table 3-36: Share of Urine Tests/Kits in Total U.S. OTC DiagnosticMarket 1999-2003
• Table 3-37: U.S. Mass-Market Sales of Top Urine Tests/KitsMarketers 2002-2003
• Table 3-38: U.S. Mass-Market Share of Top Urine Tests/KitsMarketers 2002-2003
• Table 3-39: U.S. Mass-Market Sales of Top Urine Tests/KitsBrands 2002-2003
• Table 3-40: Estimated Mass-Market Sales of Urine Tests/Kits 2004-2008

Chapter Four: Marketing Dynamics

• Table 4-1: Ad Spends for Selected Brands in the U.S. Market for OTCDiagnostic Test Kits
• Table 4-2: The OTC Diagnostic Market: Selected New ProductInnovations, 2002-2003
• Table 4-3: U.S. Health Expenditures Total and Per Capita 1990-2013
• Table 4-4: The U.S. OTC Diagnostic Product Market: Selected NewProduct Introductions

Chapter Five: The Consumer

• Figure 5-1: Percentage of Respondents Who Purchased a Home TestingKit in the Past Six Months
• Figure 5-2: Percentage of Home Testing Kit Buyers by Type of Disease
• Table 5-1: Demographic Characteristics Home Testing Kit Buyers
• Figure 5-3: Incidence of Diagnosed Diabetes per 1,000 PopulationAged 18-79 Years, by Age, United States, 1997-2002
• Table 5-2: Demographic Characteristics of People Favoring HomePregnancy Kits
• Figure 5-4: Brand Preferences for Home Pregnancy Testing Kits
• Table 5-3: Preferred Tests for Thyroid, Alzheimer’s, & Cancer
• Table 5-4: Instances When Patients Prefer Professional’s Test
• Table 5-5: Advantages of a Home Testing Kit
• Table 5-6: Disadvantages of Using a Home Testing Kit
• Table 5-7: Popular Shopping Destinations for Buying or SeekingInformation on Home Testing Kits
• Table 5-8: Awareness Regarding Medical Testing Kits’ OTC Availability
• Figure 5-5: Awareness Regarding Home Drug Testing Kits’ OTCAvailability
• Figure 5-6: Percentage Willing to use Home Kits for Testing Cocaine, Heroin, Ecstasy or Marijuana on a Family or Household Member
• Table 5-9: Reasons for Not Purchasing Home Drug Test Kit

Chapter Six: Company Profiles

• Figure 6-1: U.S. Mass-Market OTC Diagnostic Product Sales ofLifeScan Inc 1999-2003
• Figure 6-2: U.S. Mass-Market OTC Diagnostic Product Sales of Boehringer Mannheim 1999-2003
• Figure 6-3: U.S. Mass-Market OTC Diagnostic Product Sales ofPfizer 1999-2003
• Figure 6-4: U.S. Mass-Market OTC Diagnostic Product Sales of Inverness Medical Innovations, Inc 1999-2003
• Figure 6-5: U.S. Mass-Market OTC Diagnostic Product Sales ofChurch & Dwight Co, Inc 1999-2003
• Figure 6-6: U.S. Mass-Market OTC Diagnostic Product Sales ofOmron Health Care Inc 1999-2003
• Figure 6-7: U.S. Mass-Market OTC Diagnostic Product Sales of Becton,Dickinson and Company 1999-2003
• Figure 6-8: U.S. Mass-Market OTC Diagnostic Product Sales ofTherasense Inc 1999-2003
• Figure 6-9: U.S. Mass-Market OTC Diagnostic Product Sales ofBayer AG and Company 1999-2003

 

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