Rx-to-OTC switches refer to the transition from proven prescription drugs to nonprescription, OTC status. According to a report by Future Market Insights (FMI), the global Rx-to-OTC switches market was valued at US$ 33 Bn in 2020 and is predicted to expand at a CAGR of over 5% during the forecast period (2021–2031).
Scientifically, it is a rigorous and highly regulated process that allows consumers to purchase OTC access to a growing range of medicines. For a medicine to be granted under OTC status, it must comply with the regulatory standards associated with its efficacy, have a wide safety margin, and bolster labelling to ensure proper usage of the product.
The increasing prevalence of diseases with common self-treatable symptoms, such as cold and flu, headaches, allergies, and others has fuelled the demand for OTC drugs. Thus, growing sales of nonprescription drugs have pushed pharmaceutical companies to focus on Rx to OTC switches to meet customer needs thereby gaining high revenue in the market.
It was observed in 2020, Rx-to-OTC activity was driven by growing regulatory approvals and increased OTC sales. The COVID-19 outbreak has restricted patients to visit hospitals and clinics suffering from common illnesses. Consequently, delays in prescribed medication have shifted the customer preference towards the OTC drug consumption. As a result, the COVID 19 outbreak bolstered the demand for OTC products, which in turn has supported the adoption of Rx-to-OTC switches.
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The Food and Drug Administration (FDA) introduced the non-prescription safe use regulatory expansion (NSURE) panel in 2013 that has supported a new wave of Rx-to-OTC switches, with a focus on creating conditions for switches in new therapeutic classes.
The introduction of the panel aimed to promote switches which had gained consumer attention, which in turn has aided the demand for the OTC drugs in the market.
Key Takeaways from Rx-to-OTC Switches Market Study
- Allergy and respiratory drugs are anticipated to gain a revenue share of more than 25% with a CAGR of 5.7% owing to the rising prevalence of lifestyle-based ailments.
- Retail pharmacies are anticipated to grow at a CAGR of 5.1% over the forecast period owing to the rise of e-commerce and the procurement of cost-effective medicines.
- The U.K. holds the lead in Europe, holding a share of over 33% owing to the implementation of favorable government policies.
- The U.S. will account for over 77% of the North America market by 2031, supported by a matured healthcare and pharmaceutical sector and favorable reimbursement policies.
- China is the largest and fastest growing market in East Asia estimated to account for close to 49% of the global market, owing to the country’s large-scale pharmaceutical requirements.
Who is Winning?
Rx to OTC switches have led the pharmaceutical companies to shift focus from patients to consumers in terms of end users. In addition to strategic collaborations, acquisitions, expansion, product launches, agreements and research sponsorships are the key strategies adopted by manufacturers to expand their research and development (R&D) capabilities increasing sales in wider geographical base to strengthen product portfolios in the Rx-to-OTC switches market.
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