Table of Contents

Chapter One: Executive Summary

• Scope
• Categories
• Methodology
• The Market
• Major Marketers
• Major Brands
• Market Structure
• Market Projections
• Marketers
  • Cold Allergy Sinus
  • Cough Medication
  • Combination CCSA Medication
  • Others CCSA Medication
  • Nasal Products
  • Chest Rubs
  • Consumers
  • Cold/Allergy/Sinus
  • Sore Throat
  • Cough Syrup
  • Children
• Key Issues and Trends
  • Curbs on Methamphetamine
  • Seasonal Market
  • Consumer Trends
  • Flavor Trends
  • Trends in Dosing forms
• Growth Factors
  • Rx to OTC Switch
  • Generics/Private Labels
  • Global Branding
  • Product Extensions
  • Alternative Remedies
  • Advertising Expenditure
  • Retail

Chapter Two: The Market

• Introduction
• Epidemiology of Conditions
• Product Segmentation

The Market

• Overview
• Market Size
• Smaller Players Maintain Growth

Key Market Players

• Top Marketers
• No Dominant Brand
• Market Structure
• Combinations Take the Lead
• Market Projections
• Overall Market to Reach $4.93 Billion by 2009
• Regulatory Environment
• FDA
• Brand and Generic Names
• The Cost Factor
• Approval Process
• OTC and Prescription Drugs
• Rx-to-OTC Switch
• Dual Regulatory Status

OTC Switching and the Marketplace

• Pharmaceutical Company Perspecitve
• Managed Care Perspective
• The Consumer’s Perspective

Labeling Issues

Advertising and Promotional Guidelines

• The FDA- Promotional Guidelines
• Basic Regulatory Standards
• Substantiation of Claims
• Comparative Advertising
• Contests and Sweepstakes
• Prescription Drug Advertising

Chapter Three: The Marketers

• Cold Allergy Sinus Category
  • Overview
  • Sales Trends
  • Market Share
  • Claritin Leads the Way
  • Antihistamine
  • Non-Sedating Antihistamine
  • Pre Claritin Era
  • Claritin Drives Growth
  • Future Trends
  • Decongestants
  • Future Trends
• Cough Medication
  • Overview
  • Sales Trend
  • Expectorants
  • Antitussives
  • Sales Trends
• Combinations
  • Sales Trends
  • The Pseudoephedrine Effect
  • Cough Combinations
  • Cold Allergy Sinus Combinations
• Others
  • Others—Cough
  • Other—Cold/Allergy/Sinus
• Nasal Products
  • Overview
  • Nasal Sprays/Inhalers/Drops
  • Nasal Aspirators
  • Mast Cell Stabilizers
  • Nasal Strips
• Chest Rubs

Chapter Four: The Consumer

• Note on Simmons Survey Data and Figures
• OTC Usage Overview
• Demographics Favoring OTC over Prescription
• Cold Allergy Sinus
  • Cold Medication More Popular
  • Allergy Sinus Sufferers Heavy Users
  • Younger Generation Leans toward Daytime Medicines
  • Tylenol Allergy/Sinus More Popular with Older Generation
  • Sudafed Nasal Decongestant Preferred by Middle-Aged Population
• Sore Throat
  • Lozenges are Most Popular Type of Dosage
  • Regular Sore Drops Ride High
  • Vicks More Popular in Younger Generation; Cepacol Preferred by Older Generation
• Cough Syrup
  • Younger Generation Skewed Toward Cough Suppressants
  • Older Generation More Frequent Users
• Children/Pediatric Products
  • Largest Market Group—Children
  • Liquids Highly Popular
  • Children Vicks Nyquil—A Young Parent’s Choice
  • Pediacare Popular with Young Mothers

Chapter Five: Issues and Trends

• The ‘Meth’ Effect
• Growing Healthcare Costs
• Payor Pressures
  • The Insurer Push
  • Revenue Protection
• Reimportation of Drugs
• Seasonal Variation
• Demographics
  • Children—The Largest Market
  • Birth Rate Trends
• Growing Share of Uninsured Population
• Technological Society
• Consumer Acceptance of Self-Medication
• Key Growth Factors
  • Rx to OTC Switch
  • The Growth of Generics/Private Labels
  • Third Class of Drugs
  • Importance of Establishing a Global Brand
  • Analgesic Combinations—The Entry Strategy
  • Brand Extensions
  • Extended-Release Single Ingredient Cough Products
  • Day-Night Products
• Unconventional Remedies
  • Vitamin C-Based Products
  • Prehistamine
• Anticipated Rx-to-OTC Switches
• New Channels
• Marketplace Trends
  • Direct-to-Consumer Advertising
  • Building Brands in Prescription Category for Future OTC Switch
  • The Online Healthcare Market
  • Lower Drug Costs Through Outsourcing
• Flavor Trends
  • Mint Flavor—The New Rage
  • Taste—Major Drawback for Liquids
  • Finally…It is a Medicine
• Trends in Dosing Forms
  • Convenience—Key for Selecting Kid’s Medicine
  • Tablets Still the Favorite
  • Rapid-Dissolve tablets
  • Oral Strips
  • Cough Sprays
  • Nasal Swabs
  • Spill-Resistant Formulations

Chapter Six: Marketing Dynamics

Advertising Expenditure

• Television
• The Leading Ad Spender
• Ad Spend as a Percentage of Revenues
• Ad Spend of Non-Sedating Products

Positioning

• Mom’s Brands
• Comparative Advertisements
• The Claritin Equivalents

Promotional Initiatives

Retail Structure and Distribution

• Wholesalers
• Drug Store Chains
• e-Pharmacies
• Retail Distribution
• Drugstores

The Role of the Pharmacist

The Most Recommended Brand

Retail Trends

• Impulse Purchase High for OTC Products
• Piggybacking on National Brands
• Supermarkets Stress ‘Whole Health’
• Dedicated Kids Ailment Center
• Entry of Dollar Stores
• FSAs
• Mail Order and Internet

New Product Introductions

• Selling Points by Package Tags
• Innovative Products
• Alternative Products

Chapter Seven: Company Profiles

• Procter & Gamble
  • Overview
  • Healthcare Segment
  • Performance
  • “Launch & Leverage”
• Cadbury Schweppes
  • Overview
  • “Halls” of Fame
  • Sustainable growth
  • “Voicevertising”- A Unique Marketing Strategy
• Johnson & Johnson
  • Overview
  • Makers of Tylenol
  • OTC CCSA Product Line
• Pfizer
  • Overview
  • OTC CCSA Product Line
  • Performance
  • Largest Pharmaceutical R&D Organization
  • Focus on Pharmaceuticals and Healthcare
• Wyeth Inc.
  • Overview
  • Product Line
  • Performance
  • Target: Two Novel Medicines Annually
• Bayer Group
  • Overview
  • U.S. Operations
  • OTC CCSA Product Line
  • Performance
  • Bayer: Expanding Its Reach
• Bristol-Myers Squibb Company
  • Overview
  • OTC Product Line
  • Renewed Strategy—Focus on Prescription Drugs
• Novartis
  • Overview
  • The Consumer Health Division
  • OTC Product Line
  • R&D: The Company’s Lifeblood
• Schering Plough Corporation
  • Overview
  • OTC Product Line
  • Performance
  • Recent News
• Matrixx Initiatives Inc.
  • Overview
  • OTC Product Line
  • Performance
  • Unique Innovations
• Leiner
  • Overview
  • Cost: The Driving Factor
  • Social Responsibility

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 Cough/Cold/Allergy/Sinus Medications Market 2000-2004

Chapter Two: The Market

• Table 2-1: Common OTC Medications for Cough, Cold, Allergy and Sinus Conditions
• Table 2-2: Major Antihistamines Brands and Year of OTC Switch
• Table 2-3: Selected Combination Products
• Figure 2-1: Performances of OTC Categories, 2000-2004
• Table 2-4: U.S. Retail Sales of Cough/Cold/Allergy/Sinus Medications, 2000-2004
• Figure 2-2: Cough/Cold/Allergy/Sinus Medications Sales Trend
• Figure 2-3: Market Breakups: Share of Top 3 Marketers, Next 5 Marketers, Private Labels, and All Others 2000-2004
• Figure 2-4: Overall Mass-Market Share by Competitor 2004
• Table 2-5: Mass-Market Sales for Top 10 Marketers, Private Labels, and
• Others 2000-2004
• Figure 2-5: Brand’s Market-share Break-up, 2004
• Table 2-6: Mass-Market Sales for Top 10 Brands, Private Labels, and
• Others 2000-2004
• Figure 2-6: Cough/Cold/Allergy/Sinus Market Composition, 2000-2004
• Table 2-7: Mass-Market Sales for Cough/Cold/Allergy/Sinus Medications by
• Type (18 Categories) 2000-2004
• Figure 2-7: Projected Market for U.S. Cough/Cold/Allergy/Sinus
• Medication, 2005-2009
• Table 2-8: Stages in Clinical Trial
• Figure 2-8: OTC Review Process
• Table 2-9: Selected OTC Cold/Allergy/Cough Ingredient
• Approvals 1976-2002
• Table 2-10: Residential Population Share by Age Group 2000-2015

Chapter Three: The Marketers

• Figure 3-1: U.S. Cold Allergy Sinus Market Classification 2004
• Figure 3-2: U.S. Cold Allergy Sinus Mass-Market Sales 2000-2004
• Table 3-1: Mass-Market Sales of Top Cold Allergy Sinus Brands 2000-2004
• Table 3-2: Mass-Market Sales of Top Cold Allergy Sinus Marketers 2000-2004
• Table 3-3: Mass-Market Sales of Top Cold Allergy Sinus Marketers, Brands 2000-2004
• Figure 3-3: U.S. Non-Sedating Antihistamine Retail Sales 2000-2004
• Table 3-4: Mass-Market Sales of Top Non-Sedating Antihistamine Brands 2000-2004
• Table 3-5: Mass-Market Sales of Top Non-Sedating Antihistamine Marketers 2000-2004
• Figure 3-4: U.S. Decongestant Retail Sales 2000-2004
• Table 3-6: Mass-Market Sales of Top Decongestant Brands 2000-2004
• Table 3-7: Mass-Market Sales of Top Decongestant Marketers 2000-2004
• Figure 3-5: U.S. Cough Medication Mass Market Sales, 2000-2004
• Table 3-8: Mass-Market Sales of Top Cough Medication Brands 2000-2004
• Table 3-9: Mass-Market Sales of Top Cough Medication Marketers 2000-2004
• Table 3-10: Mass-Market Sales of Top Expectorant Cough Medication Marketers, Brands 2000-2004
• Figure 3-6: U.S. Antitussives Medication Mass-Market Sales 2000-2004
• Table 3-11: Mass-Market Sales of Top Antitussives Brands 2000-2004
• Table 3-12: Mass-Market Sales of Top Antitussives Marketers 2000-2004
• Figure 3-7: U.S. Combination Medication Mass-Market Sales 2000-2004
• Table 3-13: Mass-Market Sales of Top Combination Brands, 2000-2004
• Table 3-14: Mass-Market Sales of Top Combination Marketers, 2000-2004
• Table 3-15: Mass-Market Sales of Combination Drugs Containing Pseudoephedrine vs Other Combinations 2003-2004
• Table 3-16: Mass Market Sales of Combination Brands Containing Pseudoephedrine 2003-2004
• Figure 3-8: U.S. Cough Combination Mass-Market Sales 2000 – 2004
• Table 3-17: Mass-Market Sales of Top Cough Combination Brands 2000-2004
• Table 3-18: Mass-Market Sales of Top Cough Combination Marketers 2000-2004
• Figure 3-9: U.S. Cold Sinus Allergy Combination Mass-Market Sales 2000-2004
• Table 3-19: Mass-Market Sales of Top Cold Sinus Allergy Combination Brands 2000-2004
• Table 3-20: Mass-Market Sales of Top Cold Sinus Allergy Combination Marketers 2000-2004
• Figure 3-10: U.S. Others Mass-Market Sales 2000 – 2004
• Table 3-21: Mass-Market Sales of Top Other Brands 2000-2004
• Table 3-22: Mass-Market Sales of Top Other Marketers 2000-2004
• Figure 3-11: U.S. Cough Other Mass-Market Sales 2000-2004
• Table 3-23: Mass-Market Sales of Top Cough Other Brands 2000-2004
• Table 3-24: Mass-Market Sales of Top Cough Other Marketers 2000-2004
• Figure 3-12: U.S. Cold Sinus Allergy Other Mass-Market Sales 2000- 2004
• Table 3-25: Mass-Market Sales of Top Cold Sinus Allergy Other Brands 2000-2004
• Table 3-26: Mass-Market Sales of Top Cold Sinus Allergy Other Marketers 2000-2004
• Figure 3-13: U.S. Nasal Products Mass-Market Sales 2000-2004
• Table 3-27: Mass Market Sales of Nasal Products by Type (Spary/Drops/Inhalers, Strips, Mast Cell Stabilizers, Aspirators) 2000-2004
• Table 3-28: Mass-Market Sales of Top Nasal Products Marketers 2000-2004
• Table 3-29: Mass-Market Sales of Top Nasal Products Brands 2000-2004
• Figure 3-14: U.S. Nasal Sprays/Inhalers/Drops Mass-Market Sales 2000-2004
• Table 3-30: Mass-Market Sales of Top Nasal Sprays/Inhalers/Drops Brands 2000-2004
• Table 3-31: Mass-Market Sales of Top Nasal Sprays/Inhalers/Drops Marketers 2000-2004
• Figure 3-15: U.S. Nasal Aspirators Mass-Market Sales 2000-2004
• Table 3-32: Mass-Market Sales of Top Nasal Aspirators Marketers/ Brands 2000-2004
• Table 3-33: Mass-Market Sales of Top Mast Cell Stabilizers Brands 2000-2004
• Table 3-34: Mass-Market Sales of Top Nasal Strip Marketers/Brands 2000-2004
• Figure 3-16: U.S. Chest Rubs Mass-Market Sales 2000-2004
• Table 3-35: Mass-Market Sales of Top Chest Rubs Brands 2000-2004
• Table 3-36: Mass-Market Sales of Top Chest Rubs Marketers 2000-2004

Chapter Four: The Consumer

• Figure 4-1: Percentage of People Using Non-Prescription Medication Last 12
• Months, January 2004-September 2004
• Table 4-1: Adult U.S. Ailments Suffered and at Risk January 2004- Sep-04
• Table 4-2: Demographic Characteristics of U.S. Adults Favoring OTC over Prescription Products for Ailments January 2004-September 2004
• Table 4-3: Demographic Profile of U.S. Adult Attitudes Prescription vs. OTC Products January 2004-September 2004
• Table 4-4: Demographic Profile of U.S. Adult Cold Sinus Allergy Product User January 2004-September 2004
• Figure 4-2: OTC Usage of Product Based on Condition January 2004- Sep-04
• Table 4-5: Demographic Profile of U.S. Adult Cold Sinus Allergy Product User by Condition January 2004-September 2004
• Figure 4-3: Frequency of OTC Product Use by Condition
• Table 4-6: Demographic Profile of U.S. Adult Cold Sinus Allergy Product Heavy Users (13 or More in 12 Months) January 2004-September 2004
• Table 4-7: Top 10 Brands Cold Sinus Allergy January 2004-September 2004
• Table 4-8: Demographic Profile of U.S. Adult Cold Sinus Allergy Product Users by Brand, January 2004-September 2004
• Table 4-9: Demographic Profile of U.S. Adult Sinus & Allergy Product Users by Brand, January 2004-September 2004
• Table 4-10: Demographic Profile of U.S. Adult Cold Product Users by Brands, January 2004-September 2004
• Table 4-11: Demographic Profile of U.S. Adult Cold & Sinus Product Users by Brand, January 2004-September 2004
• Table 4-12: Demographic Profile of U.S. Adult Store Brand Cold Remedy Users, January 2004-September 2004
• Figure 4-4: Sore Throat Usage Frequency, January 2004-September 2004
• Figure 4-5: Sore Throat Types Used, January 2004-September 2004
• Table 4-13: Demographic Profile of U.S. Adult Sore Throat Product User by Type (Drops, Liquids, Lozenges, Sprays) January 2004-September 2004
• Figure 4-6: Sore Throat Kinds Used, January 2004-September 2004
• Table 4-14: Demographic Profile of U.S. Adult Sore Throat Product Users by Kinds (Extra-Strength, Regular, Sugar Free, Vitamin C-Based) January 2004-September 2004
• Table 4-15: Sore Throat—Top 10 Brands, January 2004-September 2004
• Table 4-16: Demographic Profile of U.S. Adult Sore Throat Product Users by Brands, January 2004-September 2004
• Table 4-17: Demographic Profile of U.S. Adult Cough Syrup Users January 2004-September 2004
• Figure 4-7: Users of Cough Syrups by Type (Suppressant vs Expectorant) January 2004-September 2004
• Table 4-18: Demographic Profile of U.S. Adult Cough Syrup User by Type (Suppressant vs Expectorant) January 2004-September 2004
• Table 4-19: Demographic Profile of U.S. Adult Cough Syrup Users by Frequency, January 2004-September 2004
• Table 4-20: Cough Syrups Top 10 Brands January 2004-September 2004
• Table 4-21: Demographic Profile of U.S. Adult Cough Syrups Users by Brand January 2004-September 2004
• Table 4-22: Demographic Profile of U.S. Adults Purchasing Children’s Cold/Cough Products, January 2004-September 2004
• Figure 4-8: Percentage Used for Children’s Cold/Cough Types, January 2004-September 2004
• Table 4-23: Demographic Profile U.S. Adult Purchasers of Children’s Cold/Cough Products by Types (Chewable, Drops, Liquids, Tablets), January 2004-September 2004
• Table 4-24: Children’s Cold/Cough Top 10 Brands, January 2004- Sep-04
• Table 4-25: Demographic Profile of U.S. Adult Purchasers of Children’s Cold/Cough Products by Brand, January 2004-September 2004
• Table 4-26: Demographic Profile of U.S. Adult Purchasers of Children’s Cold/Cough Products by Brand, January 2004-September 2004

Chapter Five: Issues and Trends

• Figure 5-1: National Health Expenditure, 1993-2003
• Table 5-1: Projected U.S. Health Expenditures and Per Capita
• Income 2005-2010
• Figure 5-2: Spending for Prescription Drugs by Source of Funds
• Figure 5-3: Seasonal Variation of the Cough/Cold/Allergy/Sinus Medication Market, 2003-2004
• Table 5-2: Quarterly Sales by Dosing forms (in $ million), 2003-2004
• Table 5-3: U.S. Population Under 15 Years of Age 2000-2030
• Table 5-4: Birth Rate by Women’s Age Group, 2002-2003
• Table 5-5: Uninsured Population by Age Group, 2003
• Table 5-6: Combination with Analgesic and OTC Approval
• Table 5-7: Anticipated Patent Expiry of Major Rx Allergy Drugs, 2003 Sales and DTC Promotional Spend
• Table 5-8: Number of New Product Introductions by Favor
• Table 5-9: Cough/Cold/Allergy/Sinus Market by Dosing Form, 2000-2004

Chapter Six: Marketing Dynamics

• Table 6-1: Preferred Media for Top 20 Brands, 2004
• Table 6-2: Ad Spend of the Top Five Marketers 2004
• Table 6-3: Ad Spends as Percentage of Sales by Brand Line 2004
• Table 6-4: Top Advertisement Spending and Media Channel by Brand 2004
• Table 6-5: Advertisement Spend and Media Channel of Leading Brands 2004
• Table 6-6: Tag Line/Positioning Statement of Selected New Product Introductions
• Table 6-6a: Consumer Promotions of Selected New Product Introductions
• Figure 6-1: Retail Channel Share of OTC Drug Sales
• Table 6-7: Distribution of Dollar Volume by Product Type and Channel (Drug Stores, Supermarkets, Other) 2004*
• Table 6-8: Distribution of Unit Sales by Product Type and Channel (Drug Stores, Supermarkets, Other) 2004*
• Table 6-9: Customer Reasons for Choosing OTC Medication Brands in 2004
• Table 6-10: Top Brand Recommended by Pharmacists in Each Category and Percentage of Pharmacists Making Recommendation, 2004
• Table 6-11: Top Three Pharmacist-Recommended Cough/Cold/Allergy/Sinus Brands by Product Category and Percentage of Pharmacists Making Recommendation, 2004
• Table 6-12: Top Three Pharmacist-Recommended Nasal Brands by Product Category and Percentage of Pharmacists Making Recommendation, 2004
• Table 6-13: Top Three Pharmacist-Recommended Children’s Brands by Product Category and Percentage of Pharmacists Making Recommendation, 2004
• Table 6-14: Top Three Pharmacist-Recommended Sore Throat and Zinc-Based Brand by Product Category and Percentage of Pharmacists Making Recommendation, 2004
• Table 6-15: Number of New Products Using Selected Selling Points/ Package Tags 2004
• Table 6-16: Selected Innovative New Product Introductions 2004
• Table 6-17: Number of New Product Introductions by Major Ingredients 2004
• Table 6-18: Selected New Product Introductions by Top 10 Marketers 2004
• Table 6-19: Selected Homeopathic New Product Introductions 2004
• Table 6-20: Other Selected New Product Introductions 2004
• Table 6-21: Number of New Product Introductions by Package Type

Chapter Seven: Company Profiles

• Figure 7-1: P&G OTC CCSA Segmentation
• Figure 7-2: P&G U.S. Mass-Market OTC CCSA Sales Revenue, 2000-2004
• Figure 7-3: Mass-Market OTC Sore Throat Drop Sales Comparison: U.S. Vs Cadbury Schweppes, 2000-2004
• Table 7-1: Johnson & Johnson Product Lines
• Figure 7-4: Johnson and Johnson OTC CCSA Segmentation
• Figure 7-5: Johnson & Johnson U.S. Mass-Market OTC CCSA Sales Revenue 2000-2004
• Table 7-2: Pfizer’s Product Lines
• Figure 7-6: Pfizer OTC CCSA Segmentation
• Figure 7-7: Pfizer U.S. Mass-Market OTC CCSA Sales Revenue 2000-2004
• Figure 7-8: Wyeth OTC CCSA Segmentation
• Figure 7-9: Wyeth U.S. Mass-Market OTC CCSA Sales Revenue 2000-2004
• Figure 7-10: Bayer OTC CCSA Segmentation
• Figure 7-11: Bayer U.S. Mass-Market OTC CCSA Sales Revenue 2000-2004
• Figure 7-12: Bristol Myers Squibb OTC CCSA Segmentation
• Figure 7-13: Bristol Myers Squibb U.S. Mass-Market OTC CCSA Sales Revenue 2000-2004
• Figure 7-14: Novartis OTC CCSA Segmentation
• Figure 7-15: Novartis U.S. Mass-Market OTC CCSA Sales Revenue 2000-2004
• Figure 7-16: Schering-Plough Corporation OTC CCSA Segmentation
• Figure 7-17: Schering—Plough Corporation U.S. Mass-Market OTC CCSA Sales Revenue 2000-2004
• Figure 7-18: Matrixx Initiatives Inc. OTC CCSA Segmentation
• Figure 7-19: Matrixx Initiatives Inc. U.S. Mass-Market OTC CCSA Sales Revenue 2000-2004