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The Market for Rx-to-OTC Switches, 8th Edition

$6,000.00 – $12,000.00

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SKU: 22-707 Categories: Over-the-Counter (OTC) Drugs, Pharmaceuticals Market Research, Prescription Drugs Market Reports Tags: drug market, medications, Non-Prescription, Non-Prescription Medicine, OTC, over-the-counter, pharmaceuticals, Rx Pages: 195
  • Description
  • Table of Contents
  • Latest reports

Description

More than 700 pharmaceutical products have made the switch from Rx to OTC over the past several decades. The U.S. Rx-to-OTC market has grown into a $13.8 billion market. This has mainly been due to factors such as patent expirations, increasing competitiveness with the pharmaceutical environment, the FDA willingness to work with industry, brand re-invention, consumer demand, and cost containment strategies. 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 available only by prescription.

Aging baby boomers, many of which are taking greater interest in their health, have created a growing Rx-to-OTC industry in America. This was reinforced by the pandemic, which presented patients with more selfcare due to lockdowns and mandates. It is anticipated that Rx-to-OTC switch products will continue to grow as interest from both consumers and developers continue to expand. Many of the new products that are on the market may be potential candidates after standing the test of time as a prescription product. Also, the demand for OTC products is not likely to diminish, giving rise to more possibilities in the switched categories. Over one third of American consumers use an OTC medication at least every other day and the numbers are increasing on a regular basis as more products appear on the OTC market.

The current climate of patient-consumer awareness of health issues is continuing to influence the Rx-to-OTC market. Consumers are more prepared to take responsibility for their own health and are willing to purchase medicines over the counter. An increased focus on cost-savings, coupled with the effects of advertising and promotion, result in a higher rate of OTC purchases.

This report, The Market for Rx-to-OTC Switches, 8th Edition, analyses recent switches, products that are near switching. It estimates markets for switched products. Kalorama has examined this market in the past but this report reflects the most up-to-date analysis from Kalorama’s last report in 2017.

As part of its coverage, this report contains:

  • Issues and Trends Affecting The Rx-To-OTC Switches Market
  • Leading Participants
  • Information on the OTC industry
  • Overview Of The Over-The-Counter Drug Market
  • International Trends In Rx-To-OTC Switches
  • Markets by Category
  • Allergy, Cough, Cold, and Sinus Products: Recent Switches, Market Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents), Conditions Information, Overview
  • Analgesics and Other Pain Relievers Recent Switches, Market Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents), Conditions Information, Overview
  • Anti-Infectives: Recent Switches, Market Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents), Conditions Information, Overview
  • Gastrointestinal Drugs: Recent Switches, Market Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents), Conditions Information, Overview
  • Smoking Cessation Products: Recent Switches, Market Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents), Conditions Information, Overview
  • Other Drugs: Recent Switches, Overview, Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents)
  • Total Market: Market Size, Forecast, Market Share

Company Coverage

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 intense in the OTC market.

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
  • Glaxosmithkline
  • Johnson & Johnson
  • Perrigo Company
  • Prestige Brands
  • Procter & Gamble
  • Reckitt Benckiser
  • Sanofi (Chattem)

Products Discussed In This Report:

  • Carafate
  • Protonix
  • Zofran
  • Nicorette
  • Commit
  • Habitrol
  • Dimetapp
  • Dristan
  • Sudafed
  • Actifed
  • Benadryl
  • Drixoral Plus
  • Nyquil
  • Naphcon A
  • Nasalcrom
  • Mucinex
  • Claritin
  • Zyrtec
  • Aleve
  • Allegra
  • Astepro
  • Lastacaft
  • Aciphex
  • Dexilant
  • Zovirax
  • Xofluza
  • Maxalt
  • Zomig
  • Climara
  • Estraderm
  • Detrol
  • Retin-A
  • Lodine
  • Relafen
  • Zetia
  • Vytorin
  • TriCor
  • Proscar
  • Zithromax
  • Bactroban
  • Chantix
  • Lunesta
  • Ambien
  • Flomax
  • and Scores of Other Brands

The Food and Drug Administration (FDA) is the regulatory authority supervising both the prescription and over-the-counter drug approvals and Rx-to-OTC switches. Through a process, the FDA decides if Rx medications meet the requirements to become OTC available drugs if and when a petition is filed. The FDA evaluates a drug for OTC use upon several factors within a benefit-to-risk comparison. The evaluation includes:

  • Safety—potential overdose or poisoning with possible misuse of the drug and side effects of the drug is determined.
  • Compliance—understanding of OTC label information for proper dosing and administration and correct use without the direction of a physician or pharmacist.
  • Effectiveness—effective treatment of symptoms at doses appropriate for OTC use.
  • Follow up Care—correct diagnosis among consumers for common conditions and follow-up for unresolved symptoms.

Prescription drugs can be introduced for a switch evaluation in one of two ways, either by the manufacturers’ submission of additional information to the original drug application for OTC or by a petition by another source for the FDA to evaluate a drug for OTC use.
Submissions to the FDA by a manufacturer are the most common process for an Rx-to-OTC switch. The manufacturer provides information and evidence to support that the drug is safe for self-administration. The submission usually includes data from clinical studies and a preliminary OTC product label, displaying clear instructions for use.

The OTC drug review is a continual assessment of a product by a panel of non-government experts who review a prescription drug’s ingredients to determine whether it meets the guidelines for use as a safe drug under OTC marketing regulations. This is a more unconventional process for OTC switches as the manufacturer has not provided data for a formal review of the drug.

Pharmacists Generally Favor Self-Medication

Pharmacists are generally in favor of self-medication and actively promote OTC products. Switches do provide a way for pharmacists to increase profit margins and expand their role as a professional healthcare advisor. In recent surveys pharmacists estimate consumers go on to purchase the pharmacists recommended product at least 85% of the time. It is becoming increasingly important for the health industry to promote the pharmacist-consumer relationship as new OTCs reach the market. However, several barriers to successful relationships have been noted, including:

  • Workload—busy workloads may prevent noticing consumers struggling with product selections.
  • Compensation—lack of compensation for counseling, advice, and recommendations to consumers.
  • Workspace—lack of room to provide adequate consumer counseling.
  • Embarrassment—consumers may not approach pharmacists due to feeling of embarrassment.

The pharmacist’s role is becoming enhanced as new products hit the market and the “behind the counter” approach emerges. Pharmacists should be available to assist consumers with several aspects of OTC selection and use. Changes in the industry could enhance the pharmacist’s position and increase the level of consumer interaction with pharmacists. A typical counseling session should follow similarly to the figure below.

This report describes these processes and trends in detail, and provides a comprehensive view of the market in 2022.

The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, government databases, and medical and business journals. Person-to-person, email and telephone interviews were the primary method of gathering information. Over the past decade of Kalorama’s research into this market segment, more than 50 direct interviews have been conducted with industry officials, consultants, health providers, company representatives and government personnel. These sources are 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 is 2021. Compound annual growth rates (CAGRs) are provided for the 2021-2026, for each industry segment covered.

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

    The Market for Rx-to-OTC Switches, 8th Edition
    May 5, 2022
    Global Over-the-Counter (OTC) Drug Markets
    January 23, 2018
    The US Market for Rx to OTC Switches, Forecasts to 2019, 7th Edition
    February 2, 2015
    The U.S. Market for Rx to OTC Switches, 6th Edition
    January 11, 2013

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