The Rx-to-OTC Switches Market is estimated to capture a valuation of USD 38.7 billion in 2023 and is projected to reach USD 66.5 billion by 2033. The market is estimated to secure a CAGR of 5.6% during the forecast period.
What are the Leading Opportunities for Market Growth?
Patient compatibility and safety for self-medication are key concerns among pharmaceutical companies. Manufacturers focus on patient-centricity to ensure long-term success by offering safe and high-potential products that attract consumers. They are exploring opportunities for manufacturers in the market.
The past decade has witnessed a decline in Rx-to-OTC switches with only one switch, including 2010, 2011, and 2015 and zero switches in 2018 and 2019. While in 2020, there was an increase in the switches owing to the growing demand for OTC products, which is expected to continue in 2021.
How the Regulations on Healthcare Sector Impact Rx-to-OTC Switches?
The regulatory burden associated with multiple clearance procedures under FDA’s scientific decisions to an elegant ‘administrative order’ process within agencies, speeding up decisions considerably, is key to requisite infrastructure.
OTC products should demonstrate an adequate safety and efficacy profile to meet the FDA’s approval standards. Evidence of safety, correct diagnosis, and treatment of medical conditions with minimal professional supervision complicate the approval process.
It creates hesitance among pharmaceutical companies to invest in the switch market, impeding the growth of the Rx-to-OTC switches market.
For instance, Mevacor (a cholesterol-lowering statin drug) and Pravachol (a statin medication) both failed to obtain approval for an Rx-to-OTC switch. Due to the FDA’s conclusion that patients’ perceptions of their disease and the monitoring necessary for successful disease management were not adequately understood and demonstrated. Additionally, the COVID-19 pandemic caused a shift in behaviors relating to prescription and OTC medicines due to the ease of drug use habits and availability.
OTC drugs, although, are less potent than other substances, they still pose a risk of addiction. Lack of awareness can cause incorrect self-diagnosis, complications, and associated adverse effects.
| Attribute | Details |
|---|---|
| Market CAGR (2023 to 2033) | 5.6% |
| Market Valuation (2023) | USD 38.7 billion |
| Market Valuation (2033) | USD 66.5 billion |
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As per Future Market Insights (FMI), the global market recorded a steady CAGR of 4.3% between 2018 and 2022. The market captured a valuation of USD 29.8 billion in 2018 and USD 36.8 billion in 2022.
Rx-to-OTC switch products are the transition of proven prescription drugs to nonprescription, over-the-counter (OTC) status. It is a strict and highly regulated process that allows consumers to gain OTC access to a growing range of medicines for treating common diseases like headaches, colds and flu, and coughs, among others.
Rx to OTC switch is gaining popularity as one of the best ways to provide cost-effective, first-line treatment for common illnesses. Many patients do not have time to visit the doctors or the physicians. They mainly prefer quick access to OTC medicines.
As OTC products are widely available in pharmacies, the delayed physician supervision has lowered the demand for prescription drugs to treat common diseases. Considerably, the rising demand for OTC over prescription products has led many pharmaceutical companies to assume that the switches may contribute significantly to OTC revenue growth shortly.
Key markets like the United States, India, and China have significant untapped potential for expanding the Rx-to-OTC switches market. Growth in research and development capabilities to meet the global demand for OTC medicines over prescription is estimated to aid the expansion of the market. Small and large pharmaceutical companies are focusing on the Rx to OTC switch owing to the rising OTC demand over prescription drugs.
Allergy and respiratory drugs have a higher potential for growth in the coming years. The segment is likely to thrive at a high CAGR of 5.7% in the coming decade.
Antihistamines are the first approved Rx-to-OTC switched drugs that can potentially treat lifestyle-based ailments and have gained popularity in the market. For example, OTC antihistamine eye drops relieve red itchy eyes, while nasal sprays can be used to treat the symptoms of seasonal or year-round allergies.
Retail pharmacies are currently leading the market, with significant growth in the Rx-to-OTC Switches market with a 5.1% CAGR in the forecast period. Retail pharmacies have made possible the availability of OTC drugs to treat numerous ailments without healthcare professionals in high stocks and cost-effective prices.
Pharmacists played a vital role in controlling numerous medications that are being dispensed as OTC drugs.
| Countries | Current Market Share |
|---|---|
| United States | 86.7% |
| Germany | 17.2% |
| Japan | 52.4% |
| Countries | Current Market CAGR |
|---|---|
| Australia | 7.8% |
| China | 6.2% |
| India | 6.8% |
| United Kingdom | 5.2% |
The United States holds over 86.7% share of the Rx-to-OTC switches market in North America. Research collaboration and approvals for prescription switched drugs are crucial to market developments in the United States.
Based on recent switches, the FDA seems to follow a more conservative path in approving traditional OTC products for self-limiting, acute, non-life-threatening conditions with readily recognizable symptoms that consumers can identify. However, the FDA tends to approve products for preventing chronic conditions like asthma or heart disease.
Moreover, after a long period of decline in approvals, in 2020, FDA approved the Rx-to-OTC switch of three prescription drugs. However, expansion strategies implemented by pharmaceutical companies seeking approval are progressing towards providing consumers access to effective treatment.
For instance, in February 2020, GSK received FDA approval for Voltaren Arthritis Pain as an OTC product to temporarily relieve arthritis pain commercially available in the United States.
The United Kingdom is estimated to account for over 33%, with a CAGR of 5.2% in the global market through the assessment period ending in 2033. The United Kingdom Pharmacy Minister Earl Howe has continually stressed that considering the patient's demand for access and ease of availability, medicines without a prescription are a priority for the British government.
Outside the EU's regulatory systems, the MHRA focuses on exploring different pathways to Rx-to-OTC switches. Currently, the United Kingdom government is focusing on reviewing plans for all opioid-containing medicines sold in the country to carry on-pack addiction warnings, which is manipulating the demand for OTC products.
The German market is estimated to secure a share of 17.2% throughout the forecast period. Regulatory guidelines are relatively strict in Germany. As a result, achieving drug approvals for Rx-OTC switch assistance is a complex procedure in the country. Germany is the second leading market in Europe due to the presence of leading manufacturers enhancing the research & development capabilities.
For instance, Merck Co. Ltd., A German-based pharmaceutical company, invested around €18 million at its Tempe, Arizona, site in the United States. This investment would provide flexibility to invest in its production facilities and strengthen its research & development capabilities in its global network.
The Indian market accounted for more than 33% of the sales registered, with a CAGR of 6.8% in the global market by 2033. India ranks as the 11th leading OTC drug market globally and is counted as one of the most highly lucrative markets globally. Indian pharma companies have a significant edge over their counterparts, influenced by the consumer's needs.
The Indian pharma companies are shifting their focus to a less-explored market, i.e., OTC drugs, to reduce dependency on other countries for APIs and raw materials. Recent developments have given rise to new buying trends. Consumer preference towards ‘Made in India’ tagged drugs is expected to flourish post-pandemic.
Thus increasing disposable income and a shift in consumer attitude toward the cost-effectiveness- of self-medication have significantly propelled the demand for Rx-to-OTC switches in the country.
The market for Rx-to-OTC switches in China is exhibiting a 6.2% CAGR and is expected to account for more than 45% of the East Asia market throughout the projection period. Large emerging markets, especially in China, have a great opportunity to expand towards Rx-to-OTC switches.
As China has no market exclusivity for the research and development capacity of Rx-to-OTC switches, any leading pharmaceutical company can manufacture and commercialize in the region; once the switch sponsor has received approval from the Saudi Food and Drug Authority.
Participants in the Rx-to-OTC switch market aims for strategic collaborations and research & development investments to consolidate growth in a competitive and fragmented market. With this, pharmaceutical companies are also expanding their global and regional presence through acquisitions, expansions, product launches, and improvement of distribution channels to penetrate the new regional markets.
Recent Developments in the Global Market are:
Acquisition:
In April 2021, Pfizer Inc. acquired Amplyx Pharmaceuticals, Inc., a privately-held pharmaceutical company. Through this acquisition, Pfizer aims to advance its expertise in infectious diseases with the addition of Fosmanogepix, a Novel antifungal Phase 2 candidate.
Product Approval
In June 2021, United States FDA approved the Rx-to-OTC switch for Astepro allergy nasal spray. This is estimated to be liable at mass retail locations across the United States.
Product Launch
In January 2021, Viagra was estimated to be available to consumers in Ireland via OTC channels following a successful switch procedure with a simple pharmacist consultation.
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| Attribute | Details |
|---|---|
| Forecast Period | 2023 to 2033 |
| Historical Data Available for | 2018 to 2022 |
| Market Analysis | USD billion for Value |
| Key Countries Covered | United States, United Kingdom, Japan, India, China, Australia, Germany |
| Key Segments Covered | Drug Category, Distribution Channel, Region |
| Key Companies Profiled | GlaxoSmithKline plc.; Astrazeneca, Merck KGaA; Johnson & Johnson; Bayer AG; Sanofi; Boehringer Ingelheim Consumer Healthcare; Bausch and Lomb (A Subsidiary of Bausch Health); Galderma SA; Alcon; Arbor Pharmaceuticals |
| Report Coverage | Market Forecast, Company Share Analysis, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, and Strategic Growth Initiatives |
| Customization & Pricing | Available upon Request |
The global market size to reach USD 66.5 billion by 2033.
Alcon, Johnson & Johnson are the top key players.
The growth potential of the global market is 5.6% through 2033
The high cost of adoption is likely to limit market growth.
The retail pharmacy segment is highly preferred in the global market.
| Market Value for 2024 | USD 165.4 million |
|---|---|
| Market Value for 2034 | USD 287.9 million |
| Market CAGR (2024 to 2034) | 5.7% |
| Market Value for 2024 | USD 23,705.60 million |
|---|---|
| Market Value for 2034 | USD 35,090.10 million |
| Market CAGR (2024 to 2034) | 4.0% |
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Rx-to-OTC Switches Market
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