Current and Future Trends in Rx-to-OTC Switching with Insight from Key Industry Opinion Leaders

Current and Future Trends in Rx-to-OTC Switching with Insight from Key Industry Opinion Leaders

Current and Future Trends in Rx-to-OTC Switching with Insight from Key Industry Opinion Leaders


Rx-to-OTC switching is the process of transferring Rx pharmaceuticals to non-prescription OTC status for the same dosage form, population, and route of administration. OTC drugs are defined as those that are safe and effective for use by the general public without requiring intervention from a healthcare professional to obtain the product. Therefore, OTC medicines are available through a far wider range of channels than Rx drugs, including pharmacies, department stores and E-commerce.

Drug switches can therefore make access to treatments much easier for patients. This offers the added benefit of freeing general practitioners from spending office time on minor issues or chronic conditions that patients can manage on their own.

For pharmaceutical companies, Rx-to-OTC switches allow lifecycle extension of an off-patent drug, moving it from an environment in which healthcare providers drive sales to one in which patients select their own medications and will often demonstrate brand loyalty towards the original drug. In general, the broadened availability of OTC products can often mean that sales of the drug will increase, in spite of the lower price point at which such drugs are sold.

Based on overall revenue, the OTC pharmaceutical market has been dominated by four main categories: cough, cold, and allergy; analgesics; dermatologicals; and gastrointestinals. These categories have led the OTC drugs market over the last two decades in revenue and volume.

Key barriers to switching include the potential for misuse and abuse of drugs, particularly for analgesics, and the resultant need to demonstrate safety and clear labelling to regulatory agencies. A lack of harmonization in OTC approval processes between different countries also increases the burden for companies that want to launch their products across multiple territories.

The report “Current and Future Trends in Rx-to-OTC Switching with Insight from Key Industry Opinion Leaders” analyzes contemporary trends in Rx-to-OTC switching, a process in which a drug which has formerly been marketed as a prescription-only Rx drug is authorized for sale to the general public, without the need for a prescription.

Companies mentioned in this report: Teva Pharmaceutical Industries, Novartis, Bayer, GlaxoSmithKline, Mylan, GlaxoSmithKline, Perrigo Company, Valeant, Pharmaceuticals International Inc, Grifols, Mallinckrodt.


  • What are the characteristics of an ideal Rx-to-OTC switching candidate?
  • How well have recent Rx-to-OTC switches performed, and into which therapeutic categories do they fall?
  • What are the key drivers and barriers of the global OTC market?
  • What are the key future trends that will influence the OTC market and Rx-to-OTC switches worldwide?
  • Which disease areas do industry professionals believe to hold the most opportunity for switches?
  • Which geographies hold the most potential for an OTC product, and which are the most amenable to Rx-to-OTC switching?
Key Reasons to Purchase
  • Gain a thorough understanding of Rx-to-OTC switching, including key concepts, the regulatory environment and geographic variations.
  • Understand the competitive environment of key disease areas in the OTC product space.
  • Identify the drug classes and indications which pharmaceutical professionals around the world believe hold the most opportunity for Rx-to-OTC switching.
  • Understand in depth the key trends driving and holding back the OTC market, both globally and within specific geographies.
  • Identify the geographies that are poised for growth, and those at the highest risk of experiencing reverse switching of products from OTC-to-Rx.
  • Understand which companies have been the most active in pursuing mergers and acquisitions in the OTC space."

1 Table of Contents
1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Rx-to-OTC Switching Overview
2.1 What is Rx-to-OTC switching?
3 Leading Product Categories in the OTC Drugs Market
3.1 Cough, Cold and Allergy OTC Drugs
3.1.1 Overview
3.1.2 Market Analysis
3.2 Analgesics
3.2.1 Overview
3.2.2 Internal Analgesics
3.2.3 External Analgesics
3.2.4 Market Analysis
3.3 Dermatology
3.3.1 Overview
3.3.2 Market Analysis
3.4 Gastrointestinal
3.4.1 Overview
3.4.2 Market Analysis
3.5 Erectile Dysfunction and Premature Ejaculation as Potential Future Segments
3.5.1 Erectile Dysfunction
3.5.2 Premature Ejaculation
3.6 Which are the Fastest Growing Segments According to Industry Professionals?
3.7 Which Treatment Segments are Most Likely to Experience Future Rx-to-OTC Switches?
3.8 Which Indications are Most Likely to Experience Future Rx-to-OTC Switches?
4 Rx-to-OTC Switch Case Studies
4.1 Xyzal Allergy 24HR
4.1.1 Overview
4.1.2 Switch Benefits
4.1.3 Financial Impact of Switch
4.2 Differin Gel, 0.1%
4.2.1 Overview
4.2.2 Switch Benefits
4.2.3 Financial Impact of Switch
4.3 Nexium 24HR
4.3.1 Overview
4.3.2 Switch Benefits
4.3.3 Financial and Economic Impact of Switch
4.4 Nasacort Allergy 24HR
4.4.1 Overview
4.4.2 Switch Benefits
4.4.3 Financial Impact of Switch
4.5 Oxytrol For Women
4.5.1 Overview
4.5.2 Switch Benefits
4.5.3 Financial Impact of Switch
5 OTC Market Drivers and Barriers
5.1 Market Drivers
5.2 Market Barriers
6 Future Trends in the OTC Drugs Market and Rx-to-OTC Switches
6.1 Growing Global Market for OTC Products
6.2 Growing Consumer Interest in OTC Products
6.3 Will there be an Increase in Rx-to-OTC Switching?
6.4 Opinions as to the Benefits of Rx-to-OTC Switching for Healthcare Systems are Mixed
6.5 Changes to the US Healthcare System will Increase Demand for OTC Products
6.6 The Importance of Marketing
6.7 Personalized Therapy an Attractive Concept
6.8 Industry Professionals Believe Motivation of Patients to Self-Treat Disease and Clear Label Instructions to be Strong Criteria for Successful Rx-to-OTC Switching
6.9 Impact of Smart Healthcare
6.9.1 Self-Diagnosis
6.9.2 Health Management
6.10 Impact of E-Commerce
6.10.1 Online Pharmacies
6.11 Other Trends to Consider
6.11.1 Increasing Elderly Population
6.11.2 Increasing Industrialization and Pollutants
6.11.3 Sedentary Working Environments
6.11.4 Fast-Paced and Stressful Lifestyles
7 Current Regulations and Recent Developments in Key Markets
7.1 US
7.1.1 OTC Drug Regulations in the US
7.1.2 FDA Principles and Requirements for Rx-to-OTC Switches
7.1.3 US Regulations for Rx-to-OTC Switches: Approval Process
7.1.4 FDA-Approved OTC Switches 1976-2016: Trends and Developments
7.1.5 Will Switching Improve Patient Care?
7.1.6 List of Rx-to-OTC Switched Products from 2012 to August 2017
7.2 Europe
7.2.1 European Regulatory Guidelines for OTC Drugs
7.2.2 Need for Increased Harmonization of Regulatory Process in Europe
7.2.3 Further Regulatory Requirements for OTC Switches in Europe
7.2.4 Will Switching Improve Patient Care in the EU?
7.2.5 Brexit, Boots and the UK
7.3 Asia-Pacific
7.3.1 Key Historical Developments in Japan
7.3.2 India
7.3.3 China
8 Other Geographic Trends and Insights
8.1 Australia
8.2 Canada
8.3 China
8.4 Germany
8.5 Poland
8.6 South Korea
8.7 Sweden
8.8 Russia
8.9 Greatest Revenue-Generating OTC Markets
8.10 In Which Countries is Reverse Switching a Possibility?
9 Mergers and Acquisitions: Trends in the OTC Drugs Market
9.1 OTC Mergers and Acquisition Trends
9.1.1 Almost Half of Deals Had an Undisclosed Value
9.1.2 Companies Focus on Acquisitions and Asset Transactions
9.1.3 Leading Companies Continue to Consolidate Market Position
9.2 Companies with Multiple M&A Deals in Recent Years
10 Appendix
10.1 Abbreviations
10.2 References
10.3 Report Methodology
10.4 About GBI Research
10.5 Disclaimer

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