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Home Medical Test Products Market

Packaged Facts
March 1, 1995
170 Pages - SKU: LA328919

Abstract Table of Contents Search inside this report Related Reports

Countries covered: United States

Now 50% off the original sale price of $2,750.
This report from Packaged Facts analyzes the booming U.S. market for home medical tests. Improvements in technology are providing excitement in this market as new tests are developed and older tests are improved. Products covered include Blood Glucose Monitors, Pregnancy Tests, Blood Pressure Monitors, Fecal Occult Blood Tests, Cholestrol Tests, Urinary Tract Infection Tests, and HIV Tests. Find out what Johnson & Johnson, ChemTrak, Quidel, Boehringer Mannheim, and others are doing to create consumer interest as they compete for market share in this exciting market.

The Overall Market

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
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)
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

Home Blood Glucose Monitoring Products

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
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)
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
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
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

Home Pregnancy, Ovulation, And Other Fertility Test Kits

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
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)
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
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
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

Home Blood Pressure Monitors And Pulse Testing Devices

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
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
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"
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
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

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