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The Market for Rx-to-OTC Switches, 8th Edition
Publication Date: March 5, 2022
Tags: Out-of-Pocket Spending, Pharmaceuticals
Pages: 195
SKU: 22-707
The Market for Rx-to-OTC Switches, 8th Edition provides an in-depth analysis of the dynamic U.S. Rx-to-OTC switch market, which has grown into a double-digit multi-billion-dollar industry driven by patent expirations, increased competitiveness, FDA collaboration, brand reinvention, consumer demand, and cost containment strategies.
Report Highlights:
- Market Dynamics:
- Examination of the transition of over 700 pharmaceutical products from prescription (Rx) to over-the-counter (OTC) status.
- Analysis of how the aging baby boomer population and the pandemic have influenced self-care trends and expanded the Rx-to-OTC market.
- Discussion on the ongoing growth and interest in Rx-to-OTC switch products from both consumers and developers.
- Consumer Behavior:
- Insights into the rising patient-consumer awareness of health issues and the increasing willingness to purchase OTC medicines.
- The impact of cost-saving measures, advertising, and promotions on the rate of OTC purchases.
- Data showing that over one-third of American consumers use an OTC medication at least every other day, with numbers steadily increasing.
Scope and Methodology:
- Market Segmentation:
- Detailed analysis of recent Rx-to-OTC switches and products nearing switch status.
- Market size estimates and forecasts for switched products, reflecting the most up-to-date analysis since Kalorama’s 2017 report.
- Comprehensive Coverage:
- Issues and Trends: Key factors affecting the Rx-to-OTC switch market.
- Leading Participants: Profiles of major players in the OTC industry.
- OTC Market Overview: A look at the broader over-the-counter drug market.
- International Trends: Examination of global Rx-to-OTC switch trends.
- Market by Category:
- Allergy, Cough, Cold, and Sinus Products: Recent switches, market size, forecast, market share, and more.
- Analgesics and Pain Relievers: Detailed analysis of market dynamics.
- Anti-Infectives: Market insights and future outlook.
- Gastrointestinal Drugs: Comprehensive market overview.
- Smoking Cessation Products: Market trends and projections.
- Other Drugs: Market size, forecast, and share analysis.
- Total Market: Overall market size, forecast, and share.
Competitive Landscape:
- Company Coverage:
- Analysis of major companies competing in the Rx-to-OTC switched market, including brand, generic, and private label manufacturers.
- Overview of consolidation trends, strategic alliances, product innovation, line extensions, and promotional strategies driving growth in the industry.
- Profiles of leading competitors offering key brand products.
Table: The U.S. Market for Rx-to-OTC Switches, by Segment, 2021-2026 (in millions $)
| Segment | 2021 | % | 2026 | % | CAGR 2021-2026 |
| Allergy/Cold/Cough/Sinus | $XX Million | XX% | $XX Million | XX% | XX% |
| Analgesics | $XX Million | XX% | $XX Million | XX% | XX% |
| Infection/Fungal Treatments | $XX Million | XX% | $XX Million | XX% | XX% |
| Gastrointestinal/Digestive | $XX Million | XX% | $XX Million | XX% | XX% |
| Smoking Cessation | $XX Million | XX% | $XX Million | XX% | XX% |
| Others | $XX Million | XX% | $XX Million | XX% | XX% |
| Total | $XX Million | XX% | $XX Million | XX% | XX% |
Source: Kalorama Information
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Table of Contents
Chapter 1: Executive Summary
Overview
Scope and Methodology
Size and Growth of the Market
- Table 1-1: The U.S. Market for Rx-to-OTC Switches, 2021-2026
Issues and Trends Affecting the Rx-to-OTC Switches Market
Leading Participants
Chapter 2: The OTC Drug Industry
Overview of the Over-the-Counter Drug Market
Distribution Channels
- Table 2-1: Number of Retail Establishments in the United States and Non-Prescription Medicine Availability, 2017
Retail Market Value – OTC Drug Industry
- Figure 2-1: U.S. OTC Retail Sales, 2000-2021
Development of the Rx-to-OTC Drug Market
- Table 2-2: Rx-to-OTC Switches Approved by the FDA, 1976–2021
- Figure 2-2: Number of New Rx-to-OTC Switches in the United States, per Year 1976-2021
- Table 2-3: Estimated OTC Sales by Product Category 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 (% of total OTC Drug market)
U.S. Drug Regulation
Expanding Drug Access with Behind the Counter Status
Nonprescription Drug Safe Use Regulatory Expansion (NSURE)
Physician Uncertainty in Increasing Nonprescription Drug Access
Pharmacists Generally Favor Self-Medication
- Figure 2-4: Typical Pharmacist-Consumer OTC Drug Counseling Session
Online Resources for Health Information and Drug Selection
- Figure 2-5: Internet Uptake has Accelerated During the Pandemic According to the International Telecommunications Union, 2005-2021*
Social Media’s Influence on Consumer Health Products
U.S. Demographics and the Non-Prescription Drug Market
- Figure 2-6: U.S. Population 2020 and 2030 – > 65 years and < 65 years
U.S. Health Spending Indicators
- Table 2-4: U.S. Healthcare Industry Inflation Rates: Healthcare Industry Consumer Price Index Comparisons, 2015-2020 Data
International Trends in Rx-to-OTC Switches
- Table 2-5: Legal Classification Status of Selected Ingredients by Country (Country Code, Alpha-2) (updated through March 2022)
Chapter 3: Allergy, Cough, Cold, and Sinus Products
Overview
Antihistamines
Decongestants
Cough Preparations
Ophthalmic Preparations
Other Allergy Preparations
Mast Cell Stabilizers
Intranasal Steroids
Description of Conditions
Allergic Rhinitis
Common Cold
Sinusitis
Hives
Ocular Allergies
- Figure 3-1: Respiratory Symptoms Impacting Total U.S. Population, Average Annual
Product Analysis
Switched Products
- Table 3-1: 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
Recent Switch Activity
Astepro
Pataday Ophthalmic Spray and Solution
Lastacaft
Nasonex 24hr Allergy
Prescription Products with Anticipated OTC Approvals
- Table 3-2: Rx-to-OTC Product Candidates: Allergy, Cough, Cold, Sinus & Asthma
Beconase AQ
Clarinex
Atrovent Nasal Spray
Singulair
Ventolin (albuterol) and similar products
EpiPen (epinephrine) Autoject
Atarax, Vistaril (hydroxyzine)
Tessalon (benzonatate)
Market Analysis
- Table 3-3: The U.S. Market for Rx-to-OTC Switches: Allergy/Asthma, Cough, Cold, and Sinus Product Revenues, 2021 and Forecast 2026
- Figure 3-3: The U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, by Percent and Product Type, 2021 and 2026 Estimate
- Figure 3-4: U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, Sinus, Value Switched Brands vs. Switched Equivalents (Generics), 2010-2021
Competitive Analysis
- Figure 3-5: Leading Suppliers’ Shares for U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, 2021
Chapter 4: Analgesics and Other Pain Relievers
Overview
Analgesics
Nonsteroidal Anti-inflammatory Drugs
Topical Pain Relievers and Other Similar Products
Description of Conditions
Pain
Inflammation
- Figure 4-1: Pain Symptoms Impacting Total U.S. Population, Average Annual
Product Analysis
Switched Products
- Table 4-1: 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
Recent Switch Activity
Voltaren Arthritis Pain
Prescription Products with Anticipated OTC Approvals
- Table 4- 2: Rx-to-OTC Product Candidates: Analgesics and Other Pain Relievers
Nonsteroidal anti-inflammatory drugs
Diflunisal
Etodolac
Nabumetone
Feldene (piroxicam)
Migraine Treatments
Axert
Imitrex
Maxalt
Zomig
Other Migraine Treatments
Market Analysis
- Table 4-3: The U.S. Market for Rx-to-OTC Switches: Analgesic Revenues, 2021 and Forecast 2026
- Figure 4-3: The U.S. Market for Rx-to-OTC Switches: Analgesic Product by Percent and Product Type, 2021 and 2026 Estimate
- Figure 4-4: U.S. Market for Rx-to-OTC Switches: Analgesics, Value Switched Brands vs. Switched Equivalents (Generics), 2010-2021
Competitive Analysis
- Figure 4- 5: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches, Analgesics, 2021
Chapter 5: 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
- Figure 5-1: Infection and Fungal Symptoms Impacting Total U.S. Population, Average Annual
Product Analysis
Switched Products
- Table 5-1: Anti-infectives Ingredients Transferred from Rx-to-OTC Status
- Figure 5-2: Anti-infectives Ingredients Transferred from Rx-to-OTC by Year
Recent Switch Activity
Sklice
Prescription Products with Anticipated OTC Approvals
- Table 5-2: Rx-to-OTC Product Candidates: Anti-Infective Products
Antivirals
Zovirax
Valtrex
Denavir
Famvir
Influenza Antivirals
Antibiotics
Antifungals
Market Analysis
- Table 5-3: The U.S. Market for Rx-to-OTC Switches, Anti-infective Revenues, 2021 and Forecast 2026
- Figure 5-3: The U.S. Market for Rx-to-OTC Switches: Anti-infective Product by Percent and Product Type, 2021 and 2026 Estimate
- Figure 5-4: U.S. Market for Rx-to-OTC Switches: Anti-infective Products, Value Switched Brands vs. Switched Equivalents (Generics), 2010-2021
Competitive Analysis
- Figure 5-5: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switched Anti-infectives, 2021
Chapter 6: Gastrointestinal Drugs
Overview
Histamine H2 Inhibitors
Proton Pump Inhibitors
Antidiarrheals
Laxatives
Others
Description of Conditions
Nausea
Diarrhea
Constipation
Heartburn
Acid reflux
- Figure 6-1: Gastrointestinal/Digestive Symptoms Impacting Total U.S. Population, Average Annual
Product Analysis
Switched Products
- Table 6-1: Gastrointestinal Drug Ingredients Transferred from Rx-to-OTC Status
- Figure 6-2: Gastrointestinal Drug Ingredients Transferred from Rx-to-OTC by Year
Recent Switch Activity
Prescription Products with Anticipated OTC Approvals
- Table 6-2: Rx-to-OTC Product Candidates: Gastrointestinal Products
Proton Pump Inhibitors
Protonix
Aciphex
Dexilant
Mucosal Protectants
Antiemetics
Market Analysis
- Table 6-3: The U.S. Market for Rx-to-OTC Switches, Gastrointestinal Drug Revenues, 2021 and Forecast 2026
- Figure 6- 3: The U.S. Market for Rx-to-OTC Switches: Gastrointestinal Product by Percent and Product Type, 2021 and 2026 Estimate
- Figure 6-4: U.S. Market for Rx-to-OTC Switches: Gastrointestinal Products, Value Switched Brands vs. Switched Equivalents (Generics), 2010-2021
Competitive Analysis
- Figure 6-5: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches, Gastrointestinal Drugs, 2021
Chapter 7: Smoking Cessation Products
Overview
Description of Conditions
Lung Cancer and Tobacco Use
Product Analysis
Switched Products
- Table 7-1: Smoking Cessation Product Ingredients Transferred from Rx-to-OTC Status
Nicotine Chewing Gum
Nicotine Transdermal patch
Nicotine Oral lozenge
Prescription Products with Anticipated OTC Approvals
- Table 7-2: Rx-to-OTC Product Candidates: Smoking Cessation Products
Nicotrol
Chantix
Market Analysis
- Table 7-3: The U.S. Market for Rx-to-OTC Switches, Smoking Cessation Product Revenues, 2021 and Forecast 2026
- Figure 7-1: The U.S. Market for Rx-to-OTC Switches: Smoking Cessation by Percent and Product Type, 2021 and 2026 Estimate
- Figure 7- 2: U.S. Market for Rx-to-OTC Switches: Smoking Cessation, Value Switched Brands vs. Switched Equivalents (Generics), 2010-2021
Competitive Analysis
- Figure 7-3 : Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches, Smoking Cessation Drugs, 2021
Chapter 8: Other Drug Classifications
Overview
Contraceptives
Dental Rinses and Fluorides
Hair Growth Products
Rectal Ointments
Sleep Aids
Weight Management
Urinary Incontinence Products
Description of Conditions
Pregnancy
- Table 8-1: U.S. Crude Birth Rate per 1,000 Persons 2000, 2005, 2010, 2015 and 2020
Abortion Rates
Contraceptive Use
Dental caries
Hereditary Hair Loss
Hemorrhoids
Sleeplessness
Obesity
Urinary Incontinence/Overactive Bladder
Conditions with Recent or Possible Future OTC Treatments
Benign Prostate Hypertrophy (BPH)
Elevated Cholesterol
Erectile Dysfunction
Menopause and Hormone Replacement
Menorrhagia
Osteoporosis
Product Analysis
Switched Ingredients
- Table 8-2: Miscellaneous Drug Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval
- Figure 8-1: Miscellaneous Drug Ingredients Transferred from Rx-to-OTC by Year
Contraceptives
Dental Rinses and Fluoride
Hair Growth
Overactive Bladder
Rectal Ointments
Sleep Aids
Weight Management
Prescription Products with Anticipated OTC Approvals
- Table 8-3: Rx-to-OTC Product Candidates: Various Classification of Products
Acne Treatments
Cholesterol-reducing Drugs (antilipidemics)
Blood Products
BPH
Erectile Dysfunction
Hair Loss Treatment
Hormone-Replacement Therapies (HRT)
Osteoporosis Treatments
Opioid Overdose Treatment
Overactive Bladder
Sleep Aids
Market Analysis
Current Market Segments
Potential Rx-to-OTC Switch Products/Categories
Antilipidemics
Opioid Overdose Treatment
Sexual Dysfunction
BPH Treatments
Hormone Replacement Therapy and Osteoporosis Treatments
Competitive Analysis
Chapter 9: Total Rx-to-OTC Drug Market Summary
Overview
Total Market Analysis
- Table 9-1: The U.S. Market for Rx-to-OTC Switches, 2021-2026
- Figure 9-1: The U.S. Market for Rx-to-OTC Switches, 2021 and 2026 Forecast
Switch Forecast in the United States
- Table 9-2: Potential Rx-to-OTC Switches for U.S. Markets
- Figure 9-2: The U.S. Market for Rx-to-OTC Switches, Distribution of Revenues by Product Category, 2021 and 2026 Forecast
Competitive Analysis
- Table 9-3: Top 5 Rx-to-OTC Switch Suppliers Significant Segments of Participation, 2021
- Figure 9-3: Leading Suppliers Market Share in the U.S. Market for Rx-to-OTC Switches, 2021
Chapter 10: Issues and Trends
Naloxone Switch Encouraged by Congress
Trends in Consumer Health Divisions
Retail Strategies
Mergers, Acquisitions and Partnerships
Simultaneous Marketing – Prescription vs. OTC
Impact on the Prescription Drug Manufacturer
Direct-to-Consumer Advertising
Patent Expiration
Insurance Coverage for OTC Products
Chapter 11: Profiles for Major Rx-to-OTC Participants
Introduction
Bayer AG
- Table 11-1: Bayer AG Corporate Summary
Company Overview
Switch Products
GlaxoSmithKline
- Table 11-2: GlaxoSmithKline Corporate Summary
Company Overview
Switched Products
Johnson & Johnson
- Table 11-3: Johnson & Johnson Corporate Summary
Company Overview
Switched Products
Perrigo Company plc
- Table 11-4: Perrigo Corporate Summary
Company Overview
Switched Products
Prestige Consumer Healthcare
- Table 11-5: Prestige Consumer Healthcare Corporate Summary
Company Overview
Proctor & Gamble
- Table 11-6: Proctor & Gamble Corporate Summary
Company Overview
Reckitt Benckiser
- Table 11-7: Reckitt Benckiser Corporate Summary
Company Overview
Sanofi/Chattem
- Table 11-8: Sanofi Corporate Summary
Company Overview
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