Description
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, once only available by prescription. This report represents the six time that Kalorama Information has analyzed the market for drugs with switched ingredients in detail. 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.
The U.S. Market for Rx-to-OTC Switches focuses on several treatment segments in which Rx-to-OTC switches are available. These include:
- Allergy, Cough, Cold, and Sinus Products
- Analgesics, NSAIDs, and Pain Treatments
- Anti-Infectives
- Gastrointestinal Drugs
- Hair Loss Products
- Hormones
- Oral Care
- Rectal Ointments
- Sleep-aids
- Smoking Cessation
- Weight Loss
In addition to the areas with switches in place, Kalorama Information has identified other areas which may be open to Rx-to-OTC switches in the future. These include:
- Blood Products
- BPH Treatments
- Cholesterol-reducing Drugs
- Hormone Replacement Therapies
- Migraine Treatments
- Osteoporosis Treatments
- Overactive Bladder
- Sexual Dysfunction/ Erectile 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 detail 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.
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 allergy treatments, cholesterol-reducing drugs, urinary disorders treatments and hormones treatments are expected to make the most impact.
There are several companies that compete heavily in this market and use the Rx-to-OTC switch as a major part of their life-cycle management arsenal. Companies involved in the Rx-to-OTC switched market include brand, generic, and private label manufacturers. Competition will likely continue to be moderate in the OTC market, especially with the patent expiration of key products nearing. Consolidation remains a major factor in this market. Most major players have made a significant acquisition or formed a strategic alliance to increase revenues and drive growth. Product innovation, line extensions and strong promotional support are a few of the top strategies for growth in this industry.
Leading competitors offering key brand products are provided in this report. These companies include:
- Bayer Healthcare
- Boehringer Ingelheim
- GlaxoSmithKline
- Insight Pharmaceuticals
- Johnson & Johnson
- Merck
- Novartis
- Pfizer
- Prestige Brands
- Procter & Gamble
- Reckitt Benckiser
- Sanofi (Chattem)
- TEVA
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 providers, company representatives 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, business development managers, division managers, and product representatives.
All market data pertains to the U.S. market at the manufacturers’ level. The base year for data was 2012. Historical data are provided for 2007 through 2011, with forecast data provided for 2013 through 2017. Compound annual growth rates (CAGRs) are provided for the 2007-2012, 2012-2017 and 2007-2017 periods for each industry segment covered.”
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 Stabilizers
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
Xyzal
Clarinex
Astelin Nasal Spray
Atrovent Nasal Spray
Flonase
Nasacort AQ
Rhinocort
Nasonex
Beconase AQ
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
Pain
Inflammation
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
Axert
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
Famvir
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 Forecast
Competitive Analysis
CHAPTER SEVEN: SMOKING CESSATION PRODUCTS
Overview
Description of Conditions
Lung Cancer and Tobacco Use
Product Analysis
Switched Ingredients
Prescription Products with Anticipated OTC Approvals
Nicotrol
Chantix
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
Benign Prostate Hypertrophy (BPH)
Elevated Cholesterol
Erectile Dysfunction
Menopause and Hormone Replacement
Menorrhagia
Osteoporosis
Urinary Incontinence/Overactive Bladder
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)
Blood Products
BPH
Erectile Dysfunction
Hair Loss Treatment
Hormone-Replacement Therapies (HRT)
Osteoporosis Treatments
Overactive Bladder
Sleep Aids
Market Analysis
Current Market Segments
Short-Term New Product Segment Development; 2013-2017
Product segments with short-term potential include:
Antilipidemics
BPH Treatments
Hormone Replacement Therapy and Osteoporosis Treatments
Overactive Bladder Treatments
New Product Segments; Post 2017
Sexual Dysfunction
Competitive Analysis
CHAPTER NINE: TOTAL MARKET SUMMARY
Overview
Total market Size and Forecast
Competitive Analysis
CHAPTER TEN: ISSUES AND TRENDS AFFECTING THE RX-TO-OTC MARKET
Introduction
Regulatory Authorities
Additional Drug Access
Using Technology or Pharmacies for Nonprescription Drug Access
Physicians and Increasing Nonprescription Drug Access
Impact on the Consumer
Online Resources for Health Information
OTC Availability
Insurance Issues and Reimbursement for OTC Drugs
Health Insurance Trends in the United States
Healthcare Flexible Spending Accounts, Health Savings Accounts and OTC Medicines
Changing the Pharmacist’s Role
Impact on the Prescription Drug Manufacturer
Strategies for Continued Product Growth
Mergers and Acquisitions
Procter & Gamble and Teva Pharmaceutical Industries
Sanofi 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
Strategies in Switching
Dual Status Switching
Generic Competition
Direct-to-Consumer Advertising
Patent Expiration
International Trends in Rx-to-OTC Switches
Consumers around the World
Streamlined Access to OTC Drug Products in Canada
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
Insight Pharmaceuticals
Johnson & Johnson
Merck & Co
Novartis
Pfizer
Prestige Brands
Procter & Gamble
Reckitt Benckiser
Sanofi/Chattem
TEVA
APPENDIX: COMPANY DIRECTORY
