Rx-to-OTC switching is the 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. For patients and healthcare providers, OTC products can reduce the cost of medical treatment and allow easier access of drugs to patients, and for pharmaceutical companies, they allow lifecycle extension of an off-patent drug by transferring it to the consumer environment, and facilitate renewed revenue growth.
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.
GBI Research conducted a targeted industry survey of experts and key opinion leaders (KOL) in the field of Rx-to-OTC switching to gather insight and opinions on the trends and commercial prospects of switching pharmaceuticals. The majority of these respondents believe that there will be an increase in Rx-to-OTC switching in the next five years, particularly in the weight control, dermatological and cough, cold and allergy segments.
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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.
-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.
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Table of Content:
1 Table of Contents 3
2 Rx-to-OTC Switching Overview 7
3 Leading Product Categories in the OTC Drugs Market 10
4 Rx-to-OTC Switch Case Studies 23
5 OTC Market Drivers and Barriers 28
5.1 Market Drivers 28
5.2 Market Barriers 28
6 Future Trends in the OTC Drugs Market and Rx-to-OTC Switches 30
7 Current Regulations and Recent Developments in Key Markets 44
7.1 US 44
7.1.1 OTC Drug Regulations in the US 44
7.1.2 FDA Principles and Requirements for Rx-to-OTC Switches 45
7.1.3 US Regulations for Rx-to-OTC Switches: Approval Process 45
7.1.4 FDA-Approved OTC Switches 1976-2016: Trends and Developments 46
7.1.5 Will Switching Improve Patient Care-47
7.1.6 List of Rx-to-OTC Switched Products from 2012 to August 2017 48
7.2 Europe 49
7.2.1 European Regulatory Guidelines for OTC Drugs 49
7.2.2 Need for Increased Harmonization of Regulatory Process in Europe 50
7.2.3 Further Regulatory Requirements for OTC Switches in Europe 50
7.2.4 Will Switching Improve Patient Care in the EU-51
7.2.5 Brexit, Boots and the UK 52
7.3 Asia-Pacific 53
7.3.1 Key Historical Developments in Japan 53
7.3.2 India 53
7.3.3 China 55
8 Other Geographic Trends and Insights 56
8.1 Australia 56
8.2 Canada 56
8.3 China 57
8.4 Germany 58
8.5 Poland 58
8.6 South Korea 59
8.7 Sweden 59
8.8 Russia 60
8.9 Greatest Revenue-Generating OTC Markets 60
8.10 In Which Countries is Reverse Switching a Possibility-61
9 Mergers and Acquisitions: Trends in the OTC Drugs Market 62
10 Appendix 66