TABLE OF CONTENTS CHAPTER ONE: EXECUTIVE SUMMARY Scope and Methodology Size and Growth of the Market Issues and Trends Affecting the Rx-to-OTC Switches Market Leading Competitors CHAPTER TWO: INTRODUCTION of the Over-the-Counter Market Development of the Rx-to-OTC Drug Market Rx-to-OTC Industry o Economic Indicators o The FDA and Rx-to-OTC Switches CHAPTER THREE: ALLERGY, COUGH, COLD, AND SINUS PRODUCTS o Antihistamines o Decongestants o Cough Preparations o Mast Cell Stabilizer o Ophthalmic Preparations o Allergic Rhinitis o Common Cold o Sinusitis o Hives o Ocular Allergies o Switched Products o Antihistamines o Decongestants o Cough Preparations o Mast Cell Stabilizers o Ophthalmic Preparations Prescription Products with Anticipated OTC Approvals o Allegra o Xyzal o Clarinex o Astelin Nasal Spray o Flonase o Nasacort AQ o Rhinocort o Nasonex
Market Analysis o Market Size and Forecast o Competitive Analysis CHAPTER FOUR: ANALGESICS AND OTHER PAIN RELIEVERS o Analgesics o Nonsteroidal Anti-inflammatory Drugs o Topical Pain Relievers and Other Similar Products o Pain o Inflammation o Switched Ingredients Antipruritic Internal analgesic/antipyretic Oral anesthetic o Prescription Products with Anticipated OTC Approvals Nonsteroidal anti-inflammatory drugs Voltaren (diclofenac) Diflunisal Etodolac Nabumetone Feldene (piroxicam) Migraine treatments Imitrex Maxalt Zomig Other Migraine Treatments o Market Analysis Market Size and Forecast Competitive Analysis CHAPTER FIVE: ANTI-INFECTIVES o Antibiotics o Antifungals o Antivirals o Antiparasitics o Vaginal Infections o Athlete s Foot o Jock Itch o Ringworm
o Dandruff o Scabies and Pediculosis o Pinworm o Fungal Nail Infections o Switched Ingredients Antifungals Anthelmintics Antimicrobials Pediculicides o Prescription Products with Anticipated OTC Approvals Antivirals Zovirax Valtrex Denavir Influenza Antivirals o Antibiotics o Antifungals Market Analysis o Market Size and Forecast o Competitive Analysis CHAPTER SIX: GASTROINTESTINAL DRUGS o Nausea o Diarrhea o Constipation o Heartburn o Acid reflux o Switched Ingredients Histamine H2 Inhibitors Proton Pump Inhibitors Antidiarrheals Laxatives Antiemetics o Prescription Products with Anticipated OTC Approvals Proton Pump Inhibitors Nexium Protonix Aciphex o Mucosal Protectants o Antiemetics o Market and Competitive Analysis
Market Size and Fore Competitive Analysis CHAPTER SEVEN: SMOKING CESSATION o Lung Cancer and Tobacco Use o Switched Ingredients o Prescription Products with Anticipated OTC Approvals Nicotrol Chantix Market Analysis o Market Size and Forecast o Competitive Analysis CHAPTER EIGHT: OTHER DRUG CLASSIFICATIONS o Contraceptives o Dental Rinses and Fluorides o Hair Growth Products o Rectal Ointments o Sleep Aids o Weight Management o Pregnancy o Global Birth Rates o Abortion Rates o Contraceptive Use o Dental carries o Hereditary Hair Loss o Hemorrhoids o Sleeplessness o Obesity Conditions with Possible Future OTC Treatments o Acne Vulgaris o Elevated Cholesterol o Osteoporosis o Menopause and Hormone Replacement o Erectile Dysfunction o Urinary Incontinence/Overactive Bladder o Benign Prostate Hypertrophy (BPH) o Switched Ingredients
o Contraceptives o Dental rinses and fluoride o Hair growth o Rectal ointments o Sleep aids o Weight Management o Prescription Products with Anticipated OTC Approvals o Acne Treatments o Cholesterol-reducing Drugs (antilipidemics) o Erectile Dysfunction o Hair Loss Treatment o Hormone-Replacement Therapies (HRT) o Osteoporosis Treatments o Overactive Bladder o Sleep Aids Market Analysis o Market Size and Forecast o New Product Segments; Post 2015 o Antilipidemics o Osteoporosis and Hormone Replacement o Overactive Bladder o Sexual Dysfunction o Competitive Analysis CHAPTER NINE: TOTAL MARKET SUMMARY Total market Size and Forecast Competitive Analysis Market Analysis CHAPTER TEN: ISSUES AND TRENDS AFFECTING THE RX-TO-OTC MARKET Introduction Regulatory Authorities A Third Class of Drug Insurance Issues and Reimbursement for OTC Drugs o Health Insurance Trends in the United States o Healthcare Flexible Spending Accounts and OTC Medicines Impact on the Consumer o Online Resources for Health Information o OTC Availability o Health Expenditures Pharmacists Role Impact on the Prescription Drug Manufacturer Strategies for Continued Product Growth
o Mergers and Acquisitions Sanofi-Aventis and Chattem Consumer Schering-Plough and Merck & Co. Wyeth and Pfizer Reckitt Benckiser and Adams Respiratory Therapeutics Bristol-Myers Squibb and Novartis AG Johnson & Johnson and Pfizer Reckitt Benckiser and Boots Healthcare Bayer and Roche o Dual Status Switching o Generic Competition o Direct-to-Consumer Advertising Patent Expiration Labeling Changes International Trends in Rx-to-OTC Switches o Consumers around the World o Prescription vs Over-the-Counter Industry o World Health, Demographics and Life Expectancy o Life Expectancy o Birth Rates CHAPTER ELEVEN: COMPANY PROFILES Introduction Bayer Healthcare Boehringer Ingelheim GlaxoSmithKline Johnson & Johnson Merck/ Schering-Plough Novartis Pfizer/Wyeth Procter & Gamble Reckitt Benckiser Sanofi-Aventis/Chattem APPENDIX: COMPANY DIRECTORY LIST OF EXHIBITS EXECUTIVE SUMMARY Table 1-1 The U.S. Market for Rx-to-OTC Switches 2005-2015 Compound Annual Growth Rate Figure 1-1 The U.S. Market for Rx-to-OTC Switches, 2005-2015 INTRODUCTION Table 2-1 OTC Retail Sales, 1976-2009
Figure 2-1 OTC Retail Sales, 1976-2009 Table 2-2 Rx-to-OTC Switches Approved by the FDA 1976-2010 Figure 2-2 Number of New Rx-to-OTC Switches by the FDA per Year 1976-2010 Table 2-3 Statistics for Selected Rx-to-OTC Switches (United States) Table 2-4 Estimated OTC Sales by Product Type and Percent of Sales Attributed to Rxto-OTC Switched Ingredients Figure 2-3 Estimated OTC Sales by Product Type and Percent of Sales Attributed to Rxto-OTC Switched Ingredients Table 2-5 U.S. Population by Sex, 2005-2050 Figure 2-4 U.S. Population by Sex, 2005-2050 Table 2-6 United States Population Trend Age 65+ Figure 2-5 United States Population Trend Age 65+ Table 2-7 World Population by Sex, 2005-2050 Figure 2-6 World Population by Sex, 2005-2050 Table 2-8 World Population Trend Age 65+ Figure 2-7 World Population Trend Age 65+ Table 2-9 Healthcare Industry Inflation Rates Healthcare Industry Consumer Price Index Comparisons Based on 2009 Data Figure 2-8 Healthcare Industry Inflation Rates Healthcare Industry Consumer Price Index Comparisons Based on 2009 Data Table 2-10 FDA Human Drugs Outcomes Table, FY 2005 - FY 2009 ALLERGY, COUGH, COLD, AND SINUS PRODUCTS Table 3-1 Incidence of Allergy, Cough, Cold, Sinus Conditions 2010 Figure 3-1 World Incidence of Allergy, Cough, Cold, Sinus Conditions, Superimposed on Total Population, 2010 Table 3-2 Allergy, Cough, Cold, Sinus Product Ingredients Transferred from Rx-to-OTC Status Table 3-2 (continued) Allergy, Cough, Cold, Sinus Product Ingredients Transferred from Rx-to-OTC Status Figure 3-2 Allergy, Cough, Cold, Sinus Product Ingredients Transferred from Rx-to-OTC by Year Table 3-3 Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Table 3-4 The U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Product Revenues 2005-2015 Compound Annual Growth Rate Figure 3-3 The U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Product Revenues 2005-2015 Figure 3-4 The U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, by Percent and Product Type, 2010 Table 3-5 Leading Suppliers Shares of the U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, 2010 Figure 3-5 Leading Suppliers Shares of the U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, 2010
ANALGESICS AND OTHER PAIN RELIEVERS Table 4-1 Incidence of Conditions with Pain and Inflammatory Symptoms 2010 Figure 4-1 World Incidence of Conditions with Pain and Inflammatory Symptoms Superimposed on Total Population, 2010 Table 4-2 Analgesics, NSAIDs and Other Ingredients Transferred from Rx-to-OTC Status Figure 4-2 Analgesics, NSAIDs and Other Ingredients Transferred from Rx-to-OTC by Year Table 4-3 Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Table 4-4 The U.S. Market for Rx-to-OTC Switches Analgesic Product Revenues 2005-2015 Compound Annual Growth Rate Figure 4-3 The U.S. Market for Rx-to-OTC Switches Analgesic Product Revenues 2005-2015 Figure 4-4 The U.S. Market for Rx-to-OTC Switches: Analgesic Product Type, 2010 Table 4-5 Leading Suppliers Shares of the U.S. Market for Rx-to-OTC Switches Analgesics 2010 Figure 4-5 Leading Suppliers Shares of the U.S. Market for Rx-to-OTC Switches Analgesics 2010 ANTI-INFECTIVES Table 5-1 Incidence of Infections by Type, 2010 Figure 5-1 Incidence of Infections by Type, 2010 Table 5-2 Anti-infectives Ingredients Transferred from Rx-to-OTC Status Figure 5-2 Anti-infectives Ingredients Transferred from Rx-to-OTC by Year Table 5-3 Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Table 5-4 The U.S. Market for Rx-to-OTC Switches Anti-infective Product Revenues 2005-2015 Compound Annual Growth Rate Figure 5-3 The U.S. Market for Rx-to-OTC Switches Anti-infective Product Revenues 2005-2015 Figure 5-4 The U.S. Market for Rx-to-OTC Switches: Anti-infective Product Type, 2010 Table 5-5 Leading Suppliers Shares of The U.S. Market for Rx-to-OTC Switched Antiinfectives 2010 Figure 5-5 Leading Suppliers Shares of The U.S. Market for Rx-to-OTC Switched Antiinfectives 2010 CHAPTER SIX: GASTROINTESTINAL DRUGS Table 6-1 Incidence of Gastrointestinal Conditions, 2010 Figure 6-1 Incidence of Gastrointestinal Conditions, 2010 Table 6-2 Gastrointestinal Drug Ingredients Transferred from Rx-to-OTC Status Figure 6-2 Gastrointestinal Drug Ingredients Transferred from Rx-to-OTC by Year
Table 6-3 Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Table 6-4 The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drug Revenues 2005-2015 Compound Annual Growth Rate Figure 6-3 The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drug Revenues 2005-2015 Figure 6-4 The U.S. Market for Rx-to-OTC Switches: Gastrointestinal Drug by Product Type, 2010 Table 6-5 Leading Suppliers Shares of the U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs 2010 Figure 6-5 Leading Suppliers Shares of the U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs 2010 SMOKING CESSATION Table 7-1 Percent of Smokers by Country Figure 7-1 Average Percent of Smokers Worldwide in Developed Regions Table 7-2 Estimated World Incidence of Lung Cancer by Country, 2010 Figure 7-2 Estimated World Incidence of Lung Cancer by Country, 2010 Table 7-3 Smoking Cessation Product Ingredients Transferred from Rx-to-OTC Status Figure 7-3 Smoking Cessation Product Ingredients Transferred from Rx-to-OTC Status Table 7-4 Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Table 7-5 The U.S. Market for Rx-to-OTC Switches Smoking Cessation Product Revenues 2005-2015 Compound Annual Growth Rate Figure 7-4 The U.S. Market for Rx-to-OTC Switches Smoking Cessation Product Revenues 2005-2015 Figure 7-5 The U.S. Market for Rx-to-OTC Switches: Smoking Cessation Product Type, 2010 Table 7-6 Leading Suppliers Shares of the U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs 2010 Figure 7-6 Leading Suppliers Shares of the U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs 2010 OTHER DRUG CLASSIFICATIONS Table 8-1 Crude Birth Rate per 1,000 Persons 2000, 2005 and Estimated 2010 Figure 8-1 Crude Birth Rate per 1,000 Persons 2000, 2005 and Projected 2010 Table 8-2 Number of Abortions in the United States by Year, 1990-2005 Figure 8-2 Number of Abortions in the United States by Year, 1990-2005 Table 8-3 Estimated U.S. Contraceptive Use by Method, 2006-2008 Table 8-4 Percentage of U.S. Incidence of Untreated Dental Carries by Age Group Table 8-5 Alopecia Trends by World Region Table 8-6 Percent of Obese* Population, 2006 Table 8-7 Miscellaneous Drug Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval
Figure 8-3 Miscellaneous Drug Ingredients Transferred from Rx-to-OTC by Year Table 8-8 Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Table 8-8 (continued) Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Table 8-9 The U.S. Market for Rx-to-OTC Switches Other Drug Classification Product Revenues 2005-2015 Compound Annual Growth Rate Figure 8-4 The U.S. Market for Rx-to-OTC Switches Other Drug Classification Product Revenues 2005-2015 Table 8-10 The U.S. Market for Rx-to-OTC Switches Other Drug Classifications Revenues by Product Type 2005-2015 Compound Annual Growth Rate Figure 8-5 The U.S. Market for Rx-to-OTC Switches Other Drug Classifications Revenues by Product Type 2005-2015 Figure 8-6 The U.S. Market for Rx-to-OTC Switches Other Drug Classifications Distribution of Revenues by Product Type 2010 Table 8-11 Leading Suppliers Shares of the U.S. Market for Rx-to-OTC Switches Other Drug Classifications 2010 Figure 8-7 Leading Suppliers Shares of the U.S. Market for Rx-o-OTC Switches Other Drug Classifications 2010 TOTAL MARKET SUMMARY Table 9-1 The U.S. Market for Rx-to-OTC Switches 2005-2015 Compound Annual Growth Rate Figure 9-1 The U.S. Market for Rx-to-OTC Switches, 2005-2015 Markets by Segments Figure 9-2 The U.S. Market for Rx-to-OTC Switches by Product Category, 2005-2015 Figure 9-3 The U.S. Market for Rx-to-OTC Switches, Distribution of Revenues by Product Category 2010 Table 9-2 Leading Suppliers Significant Segments of Participation within the U.S. Market for Rx-to-OTC Switches, 2010 Figure 9- Leading Suppliers Market Share in the U.S. Market for Rx-to-OTC Switches, 2010 ISSUES AND TRENDS AFFECTING THE RX-TO-OTC MARKET Table 10-1 Health Insurance Trends in the United States 2003-2007 Table 10-2 National Healthcare Expenditures in the United States 1960-2015 Figure 10-1 Healthcare Expenditures in the United States Figure 10-2 Healthcare Spending as a Percent of GDP in the United States Figure 10-3 Internet Users per 100 Inhabitants, 2010 Table 10-3 Number of Retail Establishments in the United States and Non-Prescription Medicine Sales, 2007 Table 10-4 Total Healthcare Expenditures as a Percent of GDP by Country 1990, 2000 and 2006 Figure 10-4 Total Healthcare Expenditures as a Percent of GDP by Country 1990, 2000, and 2006
Table 10-5 Average Annual Expenditures per Consumer Unit for Healthcare 2005-2007 Figure 10-5 Typical Pharmacist-Consumer OTC Drug Counseling Session Table 10-6 U.S. Patent Expirations for Select Prescription Pharmaceuticals Table 10-7 Legal Classification Status of Selected Ingredients Worldwide Table 10-7 Legal Classification Status of Selected Ingredients Worldwide (continued) Table 10-7 Legal Classification Status of Selected Ingredients Worldwide (continued) Table 10-8 Individual Ingredients Switched from Rx to OTC by Country, 2009/2010 Table 10-8 (continued) Individual Ingredients Switched from Rx to OTC by Country, 2009/2010 Table 10-9 Total Pharmaceutical Markets, Prescription vs. Non-Prescription by Country, 2009 Figure 10-7 Total Pharmaceutical Markets, Prescription vs. Non-Prescription by Country, 2009 Table 10-10 Average Life Expectancy in Years by Country 1980, 2004 and 2009 Table 10-11 Crude Birth Rate per 1,000 Persons 2000, 2005 and Projected 2010 Figure 10-8 Crude Birth Rate per 1,000 Persons 2000, 2005 and Projected 2010 COMPANY PROFILES