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:
For patients and healthcare providers, OTC products can reduce the cost of medical treatment and allow easier access of drugs to patients.
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.
A targeted industry survey of experts and key opinion leaders (KOL) was carried out 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, although only 41% of US respondents believe it has the potential to relieve pressures on their national healthcare system, compared with 82% of EU respondents.
Among survey respondents, over the next five years, weight control, dermatological and cough, cold and allergy drugs are anticipated to grow in volume, and to have a high likelihood of Rx-to-OTC switching compared to other areas.
Some 91% of survey respondents agreed that the OTC segment of cough, cold and allergy was likely to experience global Rx-to-OTC switching within the next five years, mirroring the 79% expecting faster than average market size growth in this segment during that time.
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?
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