Description
While many areas of the pharmaceutical industry will suffer from current economic conditions worldwide, sales of over-the-counter drugs are widely anticipated to grow as consumers seek cheaper alternatives. Manufacturers are expected to switch prescription drugs to over-the-counter status where possible. In the early part of the last decade there was a decline in Rx-to-OTC switches; since 2006, however, there has been a number of uses of this tactic to extend the revenue of pharmaceutical products. In Kalorama Information’s Market for Rx to OTC Switches, we take a look at recent switches, products that may switch in the future, and categories that can benefit most from an OTC product.
The U.S. market for Rx-to-OTC switches encompasses a wide variety of products that have been determined safe and effective as over-the-counter products.
The market is fueled by several factors including an aging population; steady to increased incidences of conditions and diseases; new drug classes switched to OTC; product demand; economic conditions and several other factors.
All product areas contribute to the growth and development of the OTC market; however, new product development and additional regulatory review and approval of new OTC drug classifications, specifically in areas such as gastrointestinal drugs, cholesterol-reducing drugs, and contraceptives are expected to make the most impact for continued growth.
As part of its coverage, this report includes:
- Current Market for Rx to OTC across major categories
- Past Results of OTC Switches
- Products Most Likely to Switch to OTC
- Assessment of the Economic Situation
The U.S. Market for Rx-to-OTC Switches focuses on several treatment segments in which Rx-to-OTC switches are available:
- Allergy, Cough, Cold, and Sinus Products
- Analgesics, NSAIDs, and Pain Treatments
- Anti-Infectives
- Gastrointestinal Drugs
- Oral Care
- Smoking Cessation
- Other Drugs, including:
- Dental Rinses and Fluorides
- Hair Growth Products
- Rectal Ointments
- Sleep Aids
- Weight Management
- Hormone Replacement
In addition to the areas with switches in place, Kalorama Information has identified other areas which may become open to Rx-to-OTC switches in the future, including: cholesterol-reducing drugs, osteoporosis treatments, overactive bladder and sexual dysfunction. The report covers OTC drugs that were once only available by prescription due to either the active ingredient or dosage of the drug.
Current and historical revenues for product segments include both the switched brands and OTC drugs containing switched ingredients. Forecasted data includes current products and forecasted switches which are outlined in the report.
The report includes statistical information for conditions and diseases affecting the U.S. population, including detailed discussions, tables and figures. Each segment provides an overview, descriptions of products on the market, market estimates and forecasts, and competitive analysis of leading providers. In addition to above-mentioned information, the report includes current issues and trends affecting the industry and identifies trends that may arise in the future.
Trends covered in the report include:
- Healthcare Flexible Spending Accounts and OTC Medicines
- A Third Class of Drug
- Insurance Issues and Reimbursement for OTC Drugs
- Health Insurance Trends in the United States
- Impact on the Consumer
- Online Resources for Health Information
- OTC Availability
- Health Expenditures
- Pharmacists Role
- Impact on the Prescription Drug Manufacturer
- Strategies for Continued Product Growth
- Mergers and Acquisitions
- Dual Status Switching
- Generic Competition
- Direct-to-Consumer Advertising
- Patent Expiration
- Labeling Changes
- International Trends in Rx-to-OTC Switches
- Consumers around the World
- Prescription vs Over-the-Counter Industry
- World Health, Demographics and Life Expectancy
- Life Expectancy
- Birth Rates
Companies profiled in this report include:
- Bayer Healthcare
- Boehringer Ingelheim
- GlaxoSmithKline
- Johnson & Johnson
- Merck/ Schering-Plough
- Novartis
- Pfizer/Wyeth
- Procter & Gamble
- Reckitt Benckiser
- Sanofi-Aventis/Chattem
The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals. Person-to-person, email and telephone interviews were the primary method of gathering information. For the purpose of this study Kalorama Information conducted interviews with approximately 50 industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Specific interviews with pharmaceutical company representatives included marketing directors, division managers, and product representatives.
All Kalorama reports advertise the single user price. Use is limited to one user. We also feature department and global pricing for reports that we be utilized by more than one user at your company. Please consult ask your sales representative or select the correct license on our website.
For Kalorama’s take on the healthcare news of the week, based on our analysis of healthcare markets, follow Kalorama Information’s Key Point Blog at http://kaloramakeypoint.blogspot.com/
Table of Contents
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
- Overview of the Over-the-Counter Market
- Development of the Rx-to-OTC Drug Market
- Rx-to-OTC Industry
- Economic Indicators
- The FDA and Rx-to-OTC Switches
CHAPTER THREE: ALLERGY, COUGH, COLD, AND SINUS PRODUCTS
- Overview
- Antihistamines
- Decongestants
- Cough Preparations
- Mast Cell Stabilizer
- Ophthalmic Preparations
- Description of Conditions
- Allergic Rhinitis
- Common Cold
- Sinusitis
- Hives
- Ocular Allergies
- Product Analysis
- Switched Products
- Antihistamines
- Decongestants
- Cough Preparations
- Mast Cell Stabilizers
- Ophthalmic Preparations
- Prescription Products with Anticipated OTC Approvals
- Allegra
- Xyzal
- Clarinex
- Astelin Nasal Spray
- Flonase
- Nasacort AQ
- Rhinocort
- Nasonex
- Market Analysis
- Market Size and Forecast
- Competitive Analysis
CHAPTER FOUR: ANALGESICS AND OTHER PAIN RELIEVERS
- Overview
- Analgesics
- Nonsteroidal Anti-inflammatory Drugs
- Topical Pain Relievers and Other Similar Products
- Description of Conditions
- Product Analysis
- Switched Ingredients
- Antipruritic
- Internal analgesic/antipyretic
- Oral anesthetic
- 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
- Market Analysis
- Market Size and Forecast
- Competitive Analysis
CHAPTER FIVE: ANTI-INFECTIVES
- Overview
- Antibiotics
- Antifungals
- Antivirals
- Antiparasitics
- Description of Conditions
- Vaginal Infections
- Athlete’s Foot
- Jock Itch
- Ringworm
- Dandruff
- Scabies and Pediculosis
- Pinworm
- Fungal Nail Infections
- Product Analysis
- Switched Ingredients
- Antifungals
- Anthelmintics
- Antimicrobials
- Pediculicides
- Prescription Products with Anticipated OTC Approvals
- Antivirals
- Zovirax
- Valtrex
- Denavir
- Influenza Antivirals
- Antibiotics
- Antifungals
- Market Analysis
- Market Size and Forecast
- Competitive Analysis
CHAPTER SIX: GASTROINTESTINAL DRUGS
- Overview
- Description of Conditions
- Nausea
- Diarrhea
- Constipation
- Heartburn
- Acid reflux
- Product Analysis
- Switched Ingredients
- Histamine H2 Inhibitors
- Proton Pump Inhibitors
- Antidiarrheals
- Laxatives
- Antiemetics
- Prescription Products with Anticipated OTC Approvals
- Proton Pump Inhibitors
- Nexium
- Protonix
- Aciphex
- Mucosal Protectants
- Antiemetics
- Market and Competitive Analysis
- Market Size and Fore
- Competitive Analysis
CHAPTER SEVEN: SMOKING CESSATION
- Overview
- Description of Conditions
- Lung Cancer and Tobacco Use
- Product Analysis
- Switched Ingredients
- Prescription Products with Anticipated OTC Approvals
- Market Analysis
- Market Size and Forecast
- Competitive Analysis
CHAPTER EIGHT: OTHER DRUG CLASSIFICATIONS
- Overview
- Contraceptives
- Dental Rinses and Fluorides
- Hair Growth Products
- Rectal Ointments
- Sleep Aids
- Weight Management
- Description of Conditions
- Pregnancy
- Global Birth Rates
- Abortion Rates
- Contraceptive Use
- Dental carries
- Hereditary Hair Loss
- Hemorrhoids
- Sleeplessness
- Obesity
- Conditions with Possible Future OTC Treatments
- Acne Vulgaris
- Elevated Cholesterol
- Osteoporosis
- Menopause and Hormone Replacement
- Erectile Dysfunction
- Urinary Incontinence/Overactive Bladder
- Benign Prostate Hypertrophy (BPH)
- Product Analysis
- Switched Ingredients
- Contraceptives
- Dental rinses and fluoride
- Hair growth
- Rectal ointments
- Sleep aids
- Weight Management
- Prescription Products with Anticipated OTC Approvals
- Acne Treatments
- Cholesterol-reducing Drugs (antilipidemics)
- Erectile Dysfunction
- Hair Loss Treatment
- Hormone-Replacement Therapies (HRT)
- Osteoporosis Treatments
- Overactive Bladder
- Sleep Aids
- Market Analysis
- Market Size and Forecast
- New Product Segments; Post 2015
- Antilipidemics
- Osteoporosis and Hormone Replacement
- Overactive Bladder
- Sexual Dysfunction
- Competitive Analysis
CHAPTER NINE: TOTAL MARKET SUMMARY
- Overview
- 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
- Health Insurance Trends in the United States
- Healthcare Flexible Spending Accounts and OTC Medicines
- Impact on the Consumer
- Online Resources for Health Information
- OTC Availability
- Health Expenditures
- Pharmacists Role
- Impact on the Prescription Drug Manufacturer
- Strategies for Continued Product Growth
- 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
- Dual Status Switching
- Generic Competition
- Direct-to-Consumer Advertising
- Patent Expiration
- Labeling Changes
- International Trends in Rx-to-OTC Switches
- Consumers around the World
- Prescription vs Over-the-Counter Industry
- World Health, Demographics and Life Expectancy
- Life Expectancy
- 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 Rx-to-OTC Switched Ingredients
- Figure 2-3 Estimated OTC Sales by Product Type and Percent of Sales Attributed to Rx-to-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 Name, Distributor and Current Activity
- 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 Name, Distributor and Current Activity
- 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 Name, Distributor and Current Activity
- 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 Anti-infectives 2010
- Figure 5-5 Leading Suppliers’ Shares of The U.S. Market for Rx-to-OTC Switched Anti-infectives 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 Name, Distributor and Current Activity
- 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 Name, Distributor and Current Activity
- 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 Name, Distributor and Current Activity
- Table 8-8 (continued) Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity
- 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
