Home Medical Test Products Market

Published by: Packaged Facts

Published: Mar. 1, 1995 - 170 Pages

Table of Contents

1. The Products
   
   The Products
   
   • Products Included in Home Medical Test Kits Market
     
   • Products Not Included in Home Medical Tests
     
   • Distinctions: Screening, Diagnosis, and Monitoring
     
   • Screening Includes Pregnancy
     
   • In Theory, No Home Test Performs Diagnosis
     
   • Monitoring Tests Measure an Indicator of Health
     or Illness
     
   • The Chief Requirements: Accuracy, Specificity, and
     Ease of Use
     
   • The Product of Digital and Monoclonal Antibody
     Technology
     
   • Products Need FDA Approval
     
   • 510(k) and PMA
     
   • PMA May Be the Better Route
     
   • What the FDA Wants in a Home Test
     
2. The Market
   
   Market Size and Growth
   
   • Total Market Reaches $909 Million in 1994
     
   • Note on Sales Estimates
     
   • [Table] Estimated Retail Sales and Growth of Home
     Medical Test Products: By Product Type (1990-1994)
     
   • Technological Advances Fuel Growth
     
   
   Factors in Future Market Growth
   
   • U.S. Health Care Trends Will Affect Home Testing's Future More than They've Affected Past Growth
     
   • The Reality of Rising Health Care Costs
     
   • The Changing Shape of the American Family
     
   • Baby Boomers and Aging of Population
     
   • Pharmacists' Endorsement of the Products
     
   • Medical Profession More Conservative, but Not
     Exclusionary
     
   • Physician Advocacy Can Be Crucial
     
   • FDA Approval Is the Chief Hurdle for New Tests
     
   • FDA Reluctant to Err
     
   • Marketers Advised to Work with FDA and Advocacy
     Groups
     
   
   Projected Growth
   
   • Market Will Reach $1.6 Billion by 1999
     
   • [Table] Projected Retail Sales and Growth of Home
     Medical Test Products: By Product Type (1994-1999)
     
   
   Market Composition
   
   • Blood Glucose Monitoring Responsible for Almost
     Half of Sales
     
   • [Graphic] Distribution of Home Medical Test Sales:
     By Product Type (1994)
     
   • Fertility's Share Will Decline
     
   • Drugstores Responsible for Nearly Two-Thirds of
     Retail Sales
     
   • [Graphic] Distribution of Home Medical Test Sales:
     By Outlet Type (1994)
     
3. The Marketers
   
   The Marketers
   
   • Over a Hundred Companies
     
   • Most Marketers also Sell to the Clinical and Point-of-
     Care Market
     
   • The Alliance of Big and Small
     
   • Johnson & Johnson Leader by a Large Margin
     
   • Most Other Market Leaders Limited to One Category
     
   • Minor Marketers Are More Eclectic
     
   
   Marketer Shares
   
   • Johnson & Johnson Is Market Leader by a Factor of Two
     
   • The Top Three Marketers Sell Blood Glucose Monitoring
     Products
     
   • A Good Year for Small Fry
     
   • [Table] Marketer Shares of Home Medical Test Kits
     
   
   Marketing and Product Trends
   
   • The FDA and the Home Diagnostic Gold Rush
     
   • Prospects for Oral Fluid-Based Testing
     
   • "Probe" Technology
     
   • Noninvasive Blood Analysis
     
   • Drug and Alcohol Testing
     
   • Heart Attack
     
   • Strep Throat
     
   • Home Breast Exams
     
   • Prostate Cancer
     
   • Sleep Disorders
     
   • Sports Tests
     

1. The Products
   
   Scope of Category
   
   • Products Included in the Home Blood Glucose
     Monitoring Category
     
   • Only the Retail Market, and Only Measurement,
     No Treatment
     
   • 3,500 Years of Diabetes
     
   • A Disease of Carbohydrate Metabolism
     
   • Type I and Type II Diabetes
     
   • The Function of Blood Glucose Monitoring in Diabetes
     
   • Blood Glucose Levels
     
   • [Chart] Blood Glucose Guidelines
     
   • Three Basic Components to Blood Glucose
     Measurement System
     
   • Wipe and No-Wipe
     
   • Each Strip Used with a Particular Monitor
     
   • Packaging and Display
     
   • Urine Sugar Test Strips
     
2. The Market
   
   Market Size and Growth
   
   • Blood Glucose Monitoring Market Reaches $425 Million
     in 1994
     
   • [Graphic] Retail Sales and Growth of Blood Glucose
     Monitoring Products: 1990-1994
     
   • Promotional Efforts Create a Market for a Useful Product
     
   • Price of Monitors Falls
     
   • Diabetes Reports a Windfall
     
   
   Factors in Future Growth
   
   • Diabetic Population Will Increase as Baby Boomers Age
     
   • High-Risk Ethnic Groups Are a Fast Growing Part
     of Population
     
   • As Market Becomes Saturated, Marketers Can Reach
     Out to the Undiagnosed Diabetic
     
   • Consumer Advertising Remains to Be Exploited
     
   • Category Will Benefit from Passage of Health Care
     Package
     
   • The Prospect of Noninvasive Monitors
     
   • Value Brands and Private Labels Will Act as Brake
     on Price
     
   • Medicare Reimbursement Cuts Will also Slow Dollar
     Growth
     
   
   Projected Market Growth
   
   • Home Blood Glucose Monitoring Market to Reach $775
     by 1999
     
   • [Graphic] Projected Sales of Blood Glucose Monitoring
     Products: 1994-1999
     
   
   Market Composition
   
   • Test Strips Lead Market and Continue to Gain Share
     
   • Drugstores Sell 72% of Blood Glucose Monitoring
     Products
     
   • Blood Glucose Market Spikes around Holiday Season
     
   • Sales Are Highest Where Older People Are
     
   • [Table] Adults Reporting They Have Diabetes:
     By Census Region (1993)
     
3. The Marketers
   
   The Marketers
   
   • Three Companies Dominate the Market
     
   • Life Scan, a Johnson & Johnson Subsidiary
     
   • Boehringer Mannheim
     
   • Miles/Bayer AG
     
   • Two Marketers Represent a Second Tier
     
   • Minor Marketers of Blood Glucose Monitoring Systems
     
   • Value Brand Marketers
     
   • [Chart] Marketers of Blood Glucose Meters and
     Test Strips
     
   
   Marketer and Brand Shares
   
   • Johnson & Johnson Has Some 40% of the Market
     
   • Boehringer Mannheim and Miles Hold Distant Second
     and Third Spots
     
   • Medisense Hangs On at 7.5%
     
   • Polymer Surges Quickly Ahead
     
   • [Table] Estimated Marketer/Brand Shares of Blood
     Glucose Monitoring Products: 1994
     
   
   The Competitive Situation
   
   • Each Major Player Has a Different Competitive Strategy
     
   • Life Scan's Initial Focus on the Product
     
   • Life Scan's Modest Promotional Efforts
     
   • Johnson & Johnson's Advanced Care Division Buys
     Life Scan
     
   • Boehringer Mannheim: Focus on Patient Education
     
   • Boehringer Mannheim's Response to Life Scan
     
   • Boehringer Mannheim's False Start on a No-Wipe System
     
   • Miles/Ames: Focus on Distribution
     
   • Is Life Scan's Big Advantage Spent?
     
   • Medisense and Home Diagnostics Lag Despite
     Innovative Products
     
   • Cascade Picks Up Where Carter-Wallace Leaves Off
     
   
   Marketing and Product Trends
   
   • Several Companies Are Developing Noninvasive Monitors
     
   • Saliva-Based Noninvasive Testing also Possible
     
   • No-Wipe Claims Top Tier of Market
     
   • More Digital Features Give Opportunity for Product Differentiation
     
   • Rise of Generic/Value Brand Test Strips
     
   • [Chart] Selected New Blood Glucose Monitoring Products
     
   
   Measured Advertising Expenditures
   
   • Ad Expenditures Small but Growing Rapidly
     
   • Only Two Marketers Use Consumer Advertising
     
   • Johnson & Johnson Leads with $2 Million in Advertising
     
   • Johnson & Johnson Buys No TV or Radio
     
   • American Diagnostics Buys Approximately $1 Million
     on Television
     
   • [Table] Measured Advertising, Blood Glucose Meters
     and Test Strips: 1990-1993
     
   
   Advertising Positioning
   
   • Johnson & Johnson's Advertising Still Sells the Category
     
   • The Theme of the Normal Life and the Theme of Control
     
   • Reliability Is Also an Important Theme
     
   • Biotel Ads Compete on Price
     
   • The Educational Setting
     
   
   Consumer Promotion
   
   • Meters Often Discounted
     
   • Free Samples at Health Care Sites
     
   • Symposia; Patient and Doctor Education
     
   • Customer Support
     
   
   Trade Advertising
   
   • Trade Ads Appear Frequently in Drugstore Publications
     
   • Value Brands Advertise Heaviest
     
   • Ads Emphasize Sales
     
   • The Pharmacist as Health Professional
     
   • Some Ads Promise More to Trade
     
4. Distribution And Retail
   
   At the Retail Level
   
   • Drugstores are the Principle Retail Outlet
     
   • Blood Glucose Monitors and Strips Still Kept Behind
     Counter
     
   • Space Depends on Store Size
     
5. The Consumer
   
   The Consumer
   
   • 14 Million Diabetics in United States—7 Million
     Diagnosed
     
   • Gender Is Not Significant
     
   • Most Diabetics Are Over 40
     
   • Diabetes and the Post—World War II Baby Boom
     
   • Type II Diabetes Associated with Obesity
     
   • Race and Ethnicity
     
   • One in Four Hispanic Americans over 45 Has Diabetes
     
   • African Americans—Another Fast-Growing High-Risk
     Group
     
   • Upscale or Downscale—Evidence Mixed
     
   • Diabetes Associated with Other Health Problems and
     Handicaps
     

1. The Products
   
   The Products
   
   • Category Includes Products for Home Testing of Preg
     ancy and Ovulation and Other Fertility-Related Tests
     
   • Products Excluded
     
   • Technology Fills Long-Standing Need
     
   • Tests Measure Hormones During Pregnancy and the
     Menstrual Cycle
     
   • Home Pregnancy Tests Measure hCG
     
   • Accuracy of Home Pregnancy Tests
     
   • Forms and Delivery Systems Have Become Simpler
     and Easier
     
   • Three Basic Delivery Systems
     
   • Newest Home Tests Give Answers Quickly
     
   • Ovulation Home Test Kits Measure LH
     
   • Their Purpose is to Help Assist Conception
     
   • New Product Identifies Infertile Postovulatory Part
     of Cycle
     
   • The Potential for a Home Male Fertility Test Kit
     
   • Packaging and Labeling
     
2. The Market
   
   • [Graphic] Retail Sales and Projections of Home Pregnancy,
     Ovulation, and Other Fertility Kits: 1990-1994
     
   
   Category Size and Growth
   
   • Home Pregnancy and Ovulation Test Kits Reach
     $261 Million in 1994
     
   • Ovulation Kits Booming, Pregnancy Kits Slowing Down
     
   • [Table] Retail Sales and Growth of Home Pregnancy
     and Ovulation Test Kits: 1990-1994
     
   
   Factors in Future Market Growth
   
   • Rapid Improvement of Technology Expands Customer
     Base
     
   • Cost-Effectiveness of Tests a Major Plus
     
   • Effects of Baby Boomlet: Mildly Helpful
     
   • Around Half of Target Consumers for Home Pregnancy
     Test Kits Probably Use Them Already
     
   • Future Innovations Not Likely to Expand Category
     
   • Intensified Price Competition on the Horizon
     
   • Core User Group Set to Decline over Next Five Years
     
   
   Projected Growth
   
   • Category to Reach $347 by 1999
     
   • Prospects for Male Fertility Tests and Birth Control
     Products: Good, but Nothing Like Home Pregnancy
     
   • [Table] Projected Sales of Home Pregnancy, Ovulation,
     and Other Fertility Test Kits: 1994-1999
     
   
   Market Composition
   
   • Pregnancy Kits Outsell Ovulation Prediction Kits Eight
     to One
     
   • [Graphic] Share of Fertility Test Kits: By Product Type
     -1994
     
   • Women 18-34
     
   • Drugstores Account for 56% of Sales
     
   • [Graphic] Share of Pregnancy and Ovulation Test Kits
     Sales: By Class of Trade (1994)
     
   • More Users of Ovulation Kits in Northeast
     
   • [Table] Home Pregnancy and Ovulation Test Kit Users:
     By Region (1993)
     
3. The Marketers
   
   The Marketers
   
   • Ten Companies Are Nationwide Marketers of Home
     Pregnancy Test Kits and Ovulation Prediction Kits
     
   • Warner-Wellcome, Johnson & Johnson, and Carter-
     Wallace in First Tier
     
   • American Home Products Is Mid-level Marketer
     
   • Becton Dickinson and Quidel
     
   • Schmid Labs, a Newcomer with Value In-Stream Brand
     
   • [Chart] Leading Marketers of Home Pregnancy Test Kits
     and Ovulation Prediction Kits
     
   
   Marketer/Brand Shares
   
   • Top Three Marketers in Pregnancy Tests Nearly Even
     
   • AHP's Gain, Warner-Wellcome's and J&J's Loss
     
   • Small Marketers Were Biggest Winner
     
   • [Table] Estimated Marketer Shares of Home Pregnancy
     Test Kits: 1994
     
   • Brand Shares in Ovulation Category Have Changed
     Sharply
     
   • [Table] Estimated Marketer Shares of Ovulation
     Prediction Test Kits: 1994
     
   
   The Competitive Situation
   
   • Competition Intensifies as Opportunities for Product
     Improvement Diminish
     
   • The Challenge of Change
     
   • E.p.t. Maintains Identity through Evolution
     
   • E.p.t. Dethronement Followed by Restoration
     
   • Advertising's Place in the Mix
     
   • Johnson & Johnson Confronts Market in Many Guises
     
   • Johnson & Johnson Maintains Share Without an In-Stream
     Product
     
   • AHP's Whitehall Challenges First Response's
     "One-Minute" Claim
     
   • The Changing Value Brand Segment
     
   
   Marketing and Product Trends
   
   • In-Stream Value Brand Is the Most Important Marketing/
     Product Trend
     
   • QuickVue: Predicts Pregnancy Before Missed Period
     
   • SafePlan: A Contraceptive Test
     
   • Male Fertility Test Marketed in Netherlands
     
   • [Chart] Selected New Product Introductions:
     Home Pregnancy and Ovulation Prediction
     
   
   Measured Advertising Expenditures
   
   • Ad Spending Jumps to $25.5 in 1993
     
   • Spending for e.p.t. $1.5 Million More than that of Nearest
     Competitor
     
   • Advertising for e.p.t. Only on Television
     
   • Johnson & Johnson also Increases Spending, to $7.5 Million
     
   • Carter-Wallace Is Third-Place Spender
     
   • American Home Products Category Spending Declines
     Steadily in 1990s
     
   • Quidel Is the Only Other Advertiser in Category
     
   • [Chart] Measured Advertising Expenditures: Home Preg
     nancy Test Kits and Ovulation Predictors (1990-1993)
     
   
   Advertising Positioning
   
   • Advertising Aimed Primarily at Women
     
   • Chief Selling Points Are Simplicity and Accuracy
     
   • Pregnancy Tests and Ovulation Prediction Kit Advertising
     Similar and Sometimes the Same
     
   • E.p.t. Real-Life Advertising Gets Boost from Real-Life
     Pregnancy
     
   • Abortion Is Taboo
     
   • Price Is Not an Advertising Point
     
   • Simplicity Claim Supported in a Variety of Ways
     
   • Doctor Recommendation
     
   • Clearplan's Ovulation Prediction Ads Take Educational
     Approach
     
   
   Consumer Promotions
   
   • Consumer Coupons, Rebates, and Bonus Packs
     
   • Coupons Inside Kits
     
   • Booklets and Leaflets
     
   
   Trade Advertising
   
   • Frequent Trade Advertising
     
   • Ads Emphasize Display and Profit
     
   • Trade Ads Give Details of Promotional Support
     
   • Toll-Free Numbers
     
4. Distribution And Retail
   
   At the Retail Level
   
   • All Retail Outlets Well Developed, but Drugstores Still
     Predominate
     
   • Drugstore Location and Display
     
   • Marketers' Support to Drugstores
     
   • Supermarket Selection More Limited, and Not All Stock
     
   • Supermarket Location and Display
     
5. The Consumer
   
   The Consumer of Home Pregnancy Test Kits
   
   • Women between 18 and 34
     
   • Core User Group will Decrease in Size over Next
     Five Years
     
   • Number of Females 15-17 Will Increase
     
   • [Table] Projected Number of Females Aged 15-49 in U.S.:
     By Age Group (1994-1999)
     
   • Users Tend to be Mothers
     
   • Single Women More Likely to Use than Married
     
   • Likelihood to Use in Inverse Proportion to Income
     
   • Residence Rented
     
   • Education and Occupation
     
   • African Americans Less Likely to Use
     
   
   The Consumer of Ovulation Prediction Kits
   
   • Less Than 2% of Women Use Ovulation Prediction
     Kits Yearly
     
   • Fewer-than-Average Mothers
     
   • Age Corresponds to Fertile Years
     
   • Users are Slightly More Upscale than Average
     
   • A Single Woman Is More Likely to Use than a Married Woman—Nearly One User in Three Is a Single Woman
     
   • Users of Ovulation Prediction Kits Most Likely to Live
     in Northeast
     
   • [Table] Use of Ovulation Prediction Kits: By Region
     Race
     
   • [Chart] Demographic Characteristics Favoring
     the Use of Home Pregnancy Test Kits and
     
   • Ovulation Prediction Test Kits
     

1. The Products
   
   The Products
   
   • Products Included in the Home Blood Pressure and
     Pulse Testing Category
     
   • Benefits of Home Blood Pressure Monitoring
     
   • All Blood Pressure Monitors Work the Same Way
     
   • Manual Blood Pressure Monitors
     
   • Electronic Blood Pressure Monitors
     
   • Microphones Replaced by Oscillometric System
     
   • Finger Reading Monitors
     
   • Reading the Wrist
     
   • Electronic Units Are Less Accurate than Manual Units
     
   • Finger Blood Pressure Devices Found Least Reliable of All
     
   • Product Lines Are Extensive
     
   • Purpose and Function of Pulse-Rate Devices
     
   • Types of Pulse-Rate and Heart-Rate Monitors
     
   • Additional Features
     
   • Packaging and Labeling
     
2. The Market
   
   Market Size and Growth
   
   • Sales of Blood Pressure Monitors Reach $178 Million
     in 1994
     
   • Rate of Increase Doubles with End of Recession
     
   • Category Not Well Tracked
     
   • [Graphic] Estimated Retail Sales of Home Blood Pressure
     Devices and Pulse Meters: 1990-1994
     
   • Pulse Meters and Heart-Rate Monitors Sell around
     $1 Million
     
   
   Factors in Future Market Growth
   
   • Aging Baby Boomers Will Experience More Hypertension
     
   • Positive Effects of Public Education Programs
     
   • Hypertension Redefined to Include Greater Numbers
     of People
     
   • More Frequent Monitoring Recommended for Greater
     Accuracy
     
   • Aging of Baby Boomers Will Increase Public Health
     Initiatives
     
   • But Mature Population Explosion Will Not Come till
     After 2000
     
   • Some Slump Expected After Delayed Buying
     
   • Possibility of Saturation: Sales Depend on New Blood
     
   
   Projected Sales
   
   • Sales to Reach $273 Million by 1999
     
   • [Graphic] Projected Sales of Home Blood Pressure
     Devices and Pulse Meters: 1994-1999
     
   
   Market Composition
   
   • Blood Pressure Monitors Are Almost All of the Business
     
   • Electronic Models Dominate Home Market
     
   • Consumers Are Older Men and Women
     
   • Chain Drugstores, Home Health Care Dealers, and Mass
     Merchandisers Are Principal Outlets
     
   • [Graphic] Share of Home Blood Pressure Monitor
     Category Sales: By Outlet Type (1994)
     
   • Higher Sales in Retirement States Probable
     
3. The Marketers
   
   The Marketers
   
   • Four Marketers Rule the Category
     
   • Blood Pressure and Pulse Meter Marketers Are Usually
     Not Involved in Other Home Diagnostics
     
   • Three Major Companies in Category are Japanese Owned
     
   • Omron and Lumiscope Are Market Leaders
     
   • Sunbeam and A&D Are the Second-Tier Companies
     
   • Mark of Fitness, New Japanese Owned Competitor
     
   • Private Label
     
   • [Chart] Selected Marketers and Models of Home Blood
     Pressure Testing Devices
     
   
   Marketer Shares
   
   • Omron and Lumiscope in Front Rank
     
   • Sunbeam, A&D, and Private Label in Second Rank
     
   • [Graphic] Marketer Shares of Home Blood Pressure
     Monitor Sales: 1994
     
   
   The Competitive Situation
   
   • Assault by New Competition Leads to Consolidation
     and Shakeout
     
   • Casualties of a Maturing Market
     
   • Nissei Enters U.S. Market, Following Trend of Suppliers
     Turning Direct Marketers
     
   
   Marketing and Product Trends
   
   • Portability through Miniaturization
     
   • Large-Size Digital Readouts
     
   • "Bells and Whistles"
     
   • From Stethoscopes to Oscillometric Sensors
     
   • Fuzzy Logic Introduced
     
   • Heart-Rate Monitors Aimed at Fitness Enthusiasts
     
   • Heart-Rate Monitors Becoming the Sports Car of Home
     Diagnostics
     
   • Heart-Rate Monitor Makers Segmenting Market with Line
     Extensions
     
   • All Sales Channels Explored
     
   
   Estimated Advertising Expenditures
   
   • Ad Budgets Are Low
     
   • Only Two Advertisers in 1993
     
   • [Table] Measured Advertising Expenditures: Blood
     Pressure Monitors and Heart-Rate Monitors (1991-1993)
     
   
   Advertising Positionings
   
   • Ads Alert Consumers to Dangers of Hypertension
     
   • Accuracy through Latest Technology Is Primary
     Positioning
     
   • Ease of Use Is Main Secondary Positioning
     
   
   Consumer Promotions
   
   • Coupons, Discounts, Giveaways
     
   • Polar's Heart Rate Book
     
   
   Trade Advertising
   
   • Trade Ads More Common than Consumer Ads—
     Mostly Omron
     
   • Ad Message: Accuracy, Convenience, Dependability,
     Many Products
     
   • Ad Style: Catalog, Image, and "Advertorial"
     
4. Distribution And Retail
   
   Distribution
   
   • Medical and Surgical Supply Houses Act as Middlemen
     
   • Blood Pressure Monitors Distributed through Diverse
     Outlets
     
   
   At the Retail Level
   
   • Chain Drugstores Rank First
     
   • [Table] Sales of Home Blood Pressure Monitors:
     By Outlet Type (1994)
     
   • Blood Pressure Monitors' Location and Display
     
   • Pulse-Rate and Heart Monitors' Location and Display
     
   • NordicTrack Has Blood Pressure and Pulse Meter
     Department
     
5. The Consumer
   
   The Consumer
   
   • 17.2 Million Americans Know They Have High Blood
     Pressure
     
   • Risk for Hypertension Increases Exponentially with Age
     
   • [Table] Adults with High Blood Pressure: By Age
     
   • Use of Blood Pressure Monitors Increases with Age
     
   • [Table] Blood Pressure Testing Device Purchasers: By Age
     
   • Birth Dearthers and Baby Boomers
     
   • 54 Million People Over 55
     
   • [Table] Size and Growth of 55+ Age Groups: 1980-2030
     
   • Skew toward Older Americans Is Reflected in Other
     Demographic Factors
     
   • Geographical Distribution: Migration to the Sunbelt
     
   • Many Own More than One Blood Pressure Monitor
     
   • [Chart] Demographic Characteristics Favoring
     Occurrence of Hypertension Among U.S. Adults
     

Abstract

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