The U.S. Market for Over-The-Counter Pain Medication

Table of Contents

Chapter one: Executive Summary

• Report Scope
• Definitions and Products
  • Acetaminophen
  • NSAIDs
  • Topical Medications
• Methodology
• Market Overview
• Market Players
  • Internal Analgesic Segment
  • Topical Analgesic Segment
• Top Brands
  • Internal Analgesic Segment
  • Topical Analgesic Segment
• Key Issues and Trends
  • Rise of Selective Cox Inhibitors
  • Prescription Brand Building for Future OTC Switches
  • OTC Push from Healthcare Providers
  • Growing Healthcare Costs
  • Decade of Pain Control and Research
  • Prevalence of Self Medication for Pain
  • New Channels
  • Outlook
  • Ageing Population
  • OTC Analgesics as Lifesavers

Chapter Two: Industry Overview and Trends

• Introduction
  • Definition of Pain
  • Pain—The Fifth Vital Sign
  • Types of Pain
  • Nervous System and Pain
  • Prostaglandin—The Pain Trigger
• Analgesic Products and Classifications
• Aspirin Products
  • Overview
  • The Origin of Aspirin
  • Description of Products
• Acetaminophen Products
  • Overview
  • Description of Products
• Ibuprofen Products
  • Overview
  • Description of Products
• Naproxen Products
  • Overview
  • Description of Products
• Ketoprofen Products
  • Overview
  • Description of Products
• Combination Formulation
  • Overview
  • Description of Products
• Topical Medications
  • Overview
  • Description of Products
  • Consumer Issues
  • Side Effects and Interactions
    • Aspirin
    • Acetaminophen
    • Other NSAIDs
    • Side Effects Across the Population
    • Drug Interactions
    • Product Innovations Reduce Side Effects
    • Some Positive Side Effects of OTC Analgesics
  • Regulatory Environment
    • The Cost Factor
    • Approval Process
    • Rx-to-OTC Switch
  • Labeling Issues
  • The Market
    • Market Structure
    • Top Five Marketers Hold Sway
    • Internal Analgesics Continue to Dominate
    • Acetaminophen’s Market Hold Slips External Analgesics Increase Presence
  • Market Size and Growth
  • Key Market Players
    • Overall Market
    • Internal Analgesics Segment
    • Topical Analgesics Segment
  • Market Projections
  • Key Growth Factors
    • Rx to OTC Switch
    • Withdrawal of Vioxx Opens Opportunity for OTC Drugs
    • Other Health Benefits of Pain Relievers
    • The Growth of Generics / Private Label
    • Improved Products and Brand Extensions
    • Dual Regulatory Status
    • Third Class of Drugs
  • Key Issues and Trends
    • Building Brands in Prescription Category for Future OTC Switch
    • Rise of Select Cox Inhibitors and Triptans
    • Growing Healthcare Costs
    • OTC-Push from Health Care Providers
    • Prevalence of Pain among US Populace
    • Ageing Population and Pain
    • Wide Prevalence of Self-Medication for Pain
    • New Channels
    • Lower Drug Costs Through Outsourcing

International OTC Trends

Chapter Three: Competitive Market Analysis

Overview

Aspirin

• Market Share

Acetaminophen

• Market Share
• The Rise of Condition-Specific Treatments
• Instant Pain Relievers Holds the Key

Other NSAIDs

• Market Share

External Analgesics

• Market Share
• Innovation Holds the Key

Combination Formulations

• Arrival of Triptans
• Acceptance of Internal Analgesic Powders

Other OTC Analgesics

• Spill-resistant Formulations

Private Labels

Chapter Four: The Consumer

Note on Simmons Survey Data and Figures

Pain Incidence

Frequency of Occurrence

Impact of Pain

Pain at Workplace

Major Pain Ailments

• Demographic Profiles of People Suffering from Pain
• Arthritis
• Backache
• Chronic Pain
• Migraine Headache

Other Major Pain-related Ailments

• Insomnia/sleep Disorder
• Chronic Bronchitis
• Flu
• Nasal allergies/hay fever

Internal Analgesics

• Forms of Pain Relievers Used
• Generation Y Seeks Easier Forms of Pain Medication
• Middle-Aged and Older People Stick to Traditional Tablets, Powders and Caplets

Frequency of Usage

Types of Headache / Pain Relievers Used

• More People Go for Higher Dosages
• Middle-Aged and Women Likely to Use Extra-Strength Versions
• Younger and Higher Strata Prefer Regular Pain Relievers
• Migraine Pain Relievers
• Nighttime Pain relievers

Purpose of Use

• Users of Pain Relievers for Heart Attack/Stroke Prevention
• Migraine Headache — Young adults and females
• Normal Pain conditions — Age group (35-54)
• Menstrual Pain — Younger females / students
• Arthritis and Sleeplessness — Older Population
• Minor Ailments — Hispanics

Brand Preference

• The Common Thread
• Overuse Among African Americans
• Aspirin’s Health Benefits Attract Elders
• Middle Age Groups Prefer Acetaminophen and Other NSAIDs
• Males Prefer Aspirin for Heart Attack Prevention
• Store Brands: No Cheap Image; It’s the Upper Class Who Prefer It
• External Analgesics
  • Forms of External Analgesics
• Brand Preference
  • Bengay, the most preferred brand
• Purpose of Use
  • Muscle Pain: Hispanics and African Americans High Users of External Analgesics
  • Menstrual Pain: Low Education and Income Groups Go for External Pain Relief Methods
• The Weekend Warriors
• Children’s Fever / Pain Relievers
  • Forms of Children’s Pain Relievers
  • Frequency of Use Lower in Children’s Pain Relievers
  • Brand Preference
• Attitudes
  • Fact Sheet
  • Preference for Store Brands
  • Older Consumer Influenced by Advertising
  • Careless OTC Analgesics Users
  • Older Population Careful of Medicine Intake
• Preference for OTC over Prescription
  • OTC Meds Preferred for Backache and Migraine
  • Demographics Favoring OTC over Prescription

Chapter Five: Marketing and New Product Trends

Advertising and Promotional Guidelines

• Basic Regulatory Standards
• Substantiation of Claims
• Claims Relating to Heart Benefits of Aspirin
• Comparative Advertising
• The Case of Doans
• Contests and Sweepstakes

Prescription Drug Advertising

• Prescription DTC Advertising Norms Relaxed

Consumer Advertising Expenditure

• McNeil — The Leading Ad Spender
• Aleve Tops Bayer’s Ad Spend
• Wyeth’s Advil Brand line — The Second Largest Ad Spend
• Higher Strength Products Lead Ad Spend

Advertising Positioning

• Pain as a Normal Incidence
• Positioning Beyond Just Pain Relief
• Ads Target the Young & the Active
• Aspirin Drugs Play the Heart Card
• The Fight for All Day Pain Relief -Tylenol and Aleve
• Catching in on Drug Interaction
• Liquid and Powders Cash In on the ‘Quick’ Factor
• Celebrity Advertising — ‘Icy Hot’
• Pain-Specific Positioning — Excedrin, The Headache Medicine
• Comparative Advertising
• Patches Positioned as Stylish
• Vioxx’s Absence Presents an Opportunity
• The “Stop. Think. Tylenol’’ Campaign

Marketer’s Promotional Initiatives

• Coupon Promotions Along with Ads and FSIs
• Other Offers

New Product Introductions

• Acetaminophen — McNeil Dominates With New Products
• Ibuprofen Goes External
• Mint Flavor: The New Rage
• External Analgesics See Dynamic New Product Introductions
• Alternate Medications Have Wider Appeal
• Patches: The Hottest Segment
• Selling Points by Package Tags

Retail Distribution

Retail Structure

Sales Trends

• Drugstores Beat Supermarkets as the Largest Sales Channel
• Drug Stores: The Star Performers
• Purchasing Patterns

Retail Trends

• Impulse Purchase High for OTC Products
• Supermarkets Stress on ‘Whole Health and Displays’
• Mail Order and Internet: The New Media

Chapter SIX: Company Profiles

Competitive Summary

Johnson & Johnson

• Overview
• Makers of Tylenol
• OTC Analgesic Product Line
• Performance
• Focus on Strong Branding and Younger Population

Bayer Group

• Overview
• OTC Analgesic Product Line
• Performance
• Bayer: Expanding Its Reach

Wyeth Inc

• Overview
• OTC Analgesic Product Line
• Performance
• Target: Two Novel Medicines Annually

Bristol-Myers Squibb Company

• Overview
• OTC Analgesic Product Line
• Performance
• Focus on New Products

Chattem Inc

• Overview
• OTC Analgesic Product Line
• Performance
• New Product Introductions Drive Sales

GlaxoSmithKline

• Overview
• OTC Analgesic Product Line
• Performance
• Targeting Pharmacies and Doctors

Pfizer

• Overview
• OTC Analgesic Product Line
• Performance
• Largest Pharmaceutical R&D Organization
• Focus on Pharmaceuticals and Healthcare

Novartis

• Overview
• The Consumer Health Division
• OTC Analgesic Product Line
• Performance
• R&D: The Company’s Lifeblood

Rohto Pharmaceutical Co. Ltd.

• Overview
• OTC Analgesic Product Line
• Performance
• Creating Niche Markets

Perrigo Company

• Overview
• Major Divisions
• OTC Analgesic Product Line
• Cost: The Driving Factor

Appendix A: Company Directory

Appendix B: Advertising Tag Lines for Selected Brands

List of Exhibits

Chapter one: Executive Summary

• Table 1-1: U.S. Retail Sales of Analgesics

Chapter Two: Industry Overview and Trends

• Table 2-1: OTC Analgesic Dosages and Relief Time
• Table 2-2: Frequency of Aspirin Dosage
• Table 2-3: Frequency of Ibuprofen Dosage
• Table 2-4: Major Brands in Topical Analgesics
• Table 2-5: Preferred Daily Dosages for OTC Analgesics
• Table 2-6: Disease State and OTC Aanalgesic to Avoid
• Figure 2-1: OTC Review Process
• Figure 2-2: Share of Prescription and OTC drugs
• Figure 2-3: Performances of OTC Categories
• Figure 2-4: U.S. Market by Marketer Ranking
• Figure 2-5: Market Composition External and Internal Analgesics
• Figure 2-6: Analgesics Market Composition
• Table 2-7: U.S. Retail Sales of Analgesics 2000-2004
• Figure 2-7: Analgesics Sales Trends 2000-2004
• Figure 2-8: U.S. Mass-Market Sales of External Analgesics 1999 – 2004
• Figure 2-9: U.S. Mass-Market Sales of Internal Analgesics, 1999 – 2004
• Table 2-8: Top 10 Marketers’ Overall Analgesics Performance 2003-2004
• Figure 2-10: U.S. Sales Projections of Internal and External Analgesics 2005-2009
• Figure 2-11: Generic Drug Approvals, 1996-2003
• Figure 2-12: U.S. National Health Expenditure, 1993-2003
• Figure 2-13: U.S. Spending for Prescription Drugs by
• Source of Funds 1965, 1985, 2000
• Figure 2-14: U.S. Population above 65 Years of Age, 2000-2050
• Figure 2-15: U.S. Pain Prevalence by Age and Type (Osteoarthritis, Backache, Chronic Pain, Rheumatoid Arthritis)
• Table 2-9: Percent of World Population over 65 Years of Age by Region 2000 to 2030
• Table 2-10: Comparative Status of Active Ingredients in Key Pharmaceutical Markets

Chapter Three: Competitive Market Analysis

• Figure 3-1: U.S. Analgesics Market Share by Active Ingredients
• Figure 3-2: The U.S. Market for Aspirin 1999-2004
• Figure 3-3: U.S. Market Share of Aspirin by Leading Competitor 2004
• Figure 3-4: U.S. Sales and Market Share for Aspirin Products by Competitor 1999-2004
• Table 3-1: Marketers’ Brands Sales and Growth in the United States 2003-2004
• Figure 3-5: U.S Market for OTC Acetaminophen 1999-2004
• Figure 3-6: U.S. Market Share for OTC Acetaminophen by Competitor 2004
• Table 3-2: Marketers’ Brands Sales and Performance for OTC Acetaminophen 2003-2004
• Figure 3-7: U.S. Market Size for Other OTC NSAIDs 1999-2004
• Table 3-3: Marketers’ Brands Sales and Performance for OTC Ibubrofen, Ketoprofen, and Naproxen 2003-2004
• Figure 3-8: U.S. Market Size for OTC External Analgesics
• Figure 3-9: U.S. Market Share for External Analgesics by Leading Competitor 2004
• Table 3-4: Marketers’ Brands Sales and Performance for OTC Topical
• Analgesics Segment 2003-2004
• Figure 3-10: U.S. Market for OTC Combination Analgesic Formulations 1999-2004
• Table 3-5: Marketers’ Brands Sales and Performance for OTC Combination Analgesic Formulations 2003-2004
• Figure 3-11: Market Shares of Combination Analgesic Formulations 2003
• Figure 3-12: U.S. Market for Other OTC Analgesics 1999-2004
• Table 3-6: Marketers’ Brands Sales and Performance for Other OTC Analgesics 2003-2004
• Figure 3-13: Market Size of Private Labels 1999-2004
• Figure 3-14: Market Share Across Each Category for Private Labels 2002-2004

Chapter Four: The Consumer

• Table 4-1: Major Pain Ailments, Number of Sufferers, and Percentage of Total Pain Patient Population in the United States, 2004
• Figure 4-1: Frequency of Chronic Pain (Percentage of Pain Sufferers by Pain Duration) 2003
• Figure 4-2: Pain and Its Effect on Day-to-Day Life
• Figure 4-3: Major Pain Types at the Workplace
• Figure 4-4: Negative Impact of Pain at Workplace
• Table 4-2: Demographic Profiles of Arthritis Sufferers
• Table 4-3: Demographic Profiles of Backache Sufferers
• Table 4-4: Demographic Profiles of Chronic Pain Sufferers
• Table 4-5: Demographic Profiles of Migraine Headache Pain Sufferers
• Table 4-6: Demographic Profiles of Insomnia/Sleep Disorder Sufferers
• Table 4-7: Demographic Profiles of Chronic Bronchitis Sufferers
• Table 4-8: Demographic Profiles of Flu Sufferers
• Table 4-9: Demographic Profiles of Nasal Allergies/Hay Fever Sufferers
• Figure 4-5: Different Forms of Pain Relievers Used
• Table 4-10: Demographic Profile of Users of Different Forms of Pain Relievers
• Figure 4-6: Frequency of usage of headache / pain relievers
• Figure 4-7: Types of Headache / Pain Relievers Used
• Figure 4-8: Age-Wise Preference for Regular and Extra-Strength Pain Relievers
• Table 4-11: Types of Headache / Pain Relievers Used
• Figure 4-9: Purpose for Using Headache / Pain Relievers
• Table 4-12: Demographic Profile of People Using Pain Relievers for Heart Attack Prevention
• Table 4-13: Demographics of People Using Pain Relievers for Backache
• Table 4-14: Demographics of People Using Pain Relievers for Muscle or Body Aches
• Table 4-15: Demographics of people Using Pain Relievers for Arthritis/Sleeplessness
• Table 4-16: Demographics of People Using Pain Relievers for Regular/Migraine Headaches
• Table 4-17: Demographics of People Using Pain Relievers for Cold/Fever/Allergies
• Table 4-18: Demographics of people Using Pain Relievers for Menstrual Pain
• Figure 4-10: Age-Wise Preference for Major Brands of Internal analgesics
• Table 4-19: Age-wise Preference of Brands
• Table 4-20: Preference for Brands Based on Ethnic Origin
• Table 4-21: Preference for Brands Based on Education Level
• Table 4-22: Preference for Brands Based on Occupation
• Table 4-23: Preference for Brands Based on Household Income
• Table 4-24: Preference for Brands Based on Gender/Marital Status
• Table 4-25: Preference for Brands Based on Household Size
• Table 4-26: Preference for Brands Based on Age Group of Children in Household
• Figure 4-11: Forms of Pain Relieving Rubs/Liquids Used
• Table 4-27: Forms of Pain Relieving Rubs/Liquids Used by Demographic Characteristic
• Table 4-28: External Analgesic Brand Preference
• Table 4-29: Age-Wise Brand Preference for Pain Relieving Rubs/Liquids
• Table 4-30: Race / Ethnicity-Wise Brand Preference for Pain Relieving Rubs/Liquids
• Table 4-31: Household Income-Wise Brand Preference for Pain Relieving Rubs/Liquids
• Figure 4-12: Purpose for Using External Analgesics
• Table 4-32: Users of External and Internal Analgesics for Different Pain Conditions
• Table 4-33: Comparison of Users of External and Internal Analgesics by Type of Pain
• Table 4-34: Users of External Analgesics for Sports/Exercise-Related Injuries
• Figure 4-13: Forms of Children’s Pain relievers
• Table 4-35: Types of Children’s Fever / Pain Reliever Used
• Figure 4-14: Frequency of Use – Children’s Pain Relievers
• Table 4-36: Brand Preference for Children’s Pain Relievers
• Table 4-37: Brand Comparison for Children’s Pain Relief
• Figure 4-15: Attitude of a Frequent OTC User
• Figure 4-16: Attitude of Careful User of Drugs
• Table 4-38: Attitudinal Preference for Store Brands
• Table 4-39: Demographic Profile of Consumer Influenced by Advertising
• Table 4-40: Demographic Characteristics of Careless OTC Analgesics Users
• Table 4-41: Demographic Characteristics of Careful Drug Users
• Figure 4-17: Preference for OTC over Prescription
• Table 4-42: Demographic Characteristics Favoring OTC Over Prescription for Pain Ailments
• Table 4-43: Attitudes Prescription vs. OTC

Chapter Five: Marketing and New Product Trends

• Table 5-1: Ad Spend Among Marketers in the OTC Analgesic Market 2003
• Table 5-2: Ad Spends as Percentage of Sales along Brands Line 2003
• Table 5-3: Top Advertisement Spending Brands 2003
• Table 5-4: Leading Brands’ Advertisement Spends and Media Channels 2003
• Table 5-5: Positioning Statements in New Product Advertisements
• Table 5-6: Consumer Promotions of Selected New Product Introductions
• Table 5-7: OTC Analgesic New Product Selling Points by Selected Package Tags
• Table 5-8: Innovative Product Launches in the OTC Analgesic Market
• Table 5-9: Selected New Acetaminophen Introductions
• Table 5-10: Selected New Aspirin Introductions
• Table 5-11: Selected New Ibuprofen Introductions
• Table 5-12: Selected New External First Aid Product Introductions
• Table 5-13: Selected New External Dental Need Introductions
• Table 5-14: Selected New External Pain Relief Introductions
• Table 5-15: Selected New External Skin Care Introductions
• Table 5-16: Selected Other External Pain Reliever Introductions
• Table 5-17: Selected Internal Pain Relief Introductions
• Table 5-18: Selected Internal Stomach Relief Introductions
• Table 5-19: Selected Internal Vitamin Introductions
• Table 5-20: Selected Other Internal Pain Relief Introductions
• Figure 5-1: Retail Channel Share of OTC Drug Sales
• Figure 5-2: Sales Comparison: Supermarket and Drugstores for Internal Analgesics, 2002-2003
• Table 5-21: Internal Analgesic Tablets Purchasing Patterns by Outlet
• Table 5-22: Internal Analgesic Liquids’ Purchasing Patterns by Outlet
• Table 5-23: External Analgesics Purchasing Patterns by Outlet
• Figure 5-3: Why Rx Customers Buy OTC While Filling a Prescription
• Table 5-24: Customer Reasons for Choosing OTC Medication Brands in 2004
• Table 5-25: In-Store Behavior by Shopper Segment
• Table 5-26: Top Factors Influencing the Place of OTC drug Purchase

Chapter SIX: Company Profiles

• Figure 6-1: OTC Analgesic Sales for McNeil, 1999-2004
• Figure 6-2: OTC Analgesic Sales for Bayer, 1999-2004
• Figure 6-3: OTC Analgesic Sales for Wyeth, 1999-2004
• Figure 6-4: OTC Analgesic Sales for Bristol Myers-Squibb, 1999-2004
• Figure 6-5: OTC Analgesic Sales for Chattem, 1999-2004
• Figure 6-6: OTC Analgesic Sales for GSK, 1999-2004
• Figure 6-7: OTC Analgesic Sales for Pfizer, 1999-2004
• Figure 6-8: OTC Analgesic Sales for Novartis, 1999-2004
• Figure 6-9: OTC Analgesic Sales for Mentholatum, 1999-2004