OTC CONSUMER HEALTH MARKET ANALYSIS

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In several countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredients (API) rather than final products. By regulating APIs instead of specific drug formulations, governments of countries allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures. The term over-the-counter (OTC) refers to a medication that can be purchased without a medical prescription. In contrast, prescription drugs require a prescription from a doctor or other healthcare professional and should only be used by the prescribed individual. Some drugs may be legally classified as over-the-counter (i.e., no prescription is required), but may only be dispensed by a pharmacist after an assessment of the patient's needs or the provision of patient education. Regulations governing where drugs may be sold, who is authorized to dispense them and whether a prescription is required vary greatly between countries.

Global OTC consumer health market is estimated to be valued at USD 211.91 Bn in 2024 and is expected to exhibit a CAGR of 4.2% during the forecast period (2024-2031).

Figure 1: Global OTC Consumer Health Market Share (%) Analysis, By Product Type, 2024

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Increasing product launches by market players are expected to drive the global OTC consumer health market growth over the forecast period.

Increasing product launches by market players is expected to drive the global OTC consumer health market growth over the forecast period. For instance, on June 25, 2019, Hamdard Laboratories, a Unani pharmaceutical company had launched 12 Over the Counter (OTC) medicines that helps to boost immunity. The new range of products contain ingredients such as Aswagandhi, Kalonji, Gilo, and Jamun powder along with Zafran which are known for strengthening body immunity and overall health.

Increasing product approvals by regulatory authorities are expected to drive growth of the global OTC consumer health market over the forecast period.

Increasing product approvals by regulatory authorities are expected to drive growth of the global OTC consumer health market over the forecast period. For instance, on October 04, 2021, The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test, which adds to the growing list of tests that can be used at home without a prescription. This authorization aims to increasing the availability of appropriately accurate and reliable OTC tests to meet public health needs and increase access to testing for consumers.

Global OTC Consumer Health Market- Impact of the Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization declared it a public health emergency on January 30, 2020.

The COVID-19 can affect the economy in three main ways: by directly affecting the production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries such as China, India, Saudi Arabia, the U.A.E., Egypt, and others are facing problems with regard to the transportation of drugs from one place to another.

The COVID-19 pandemic also had a positive impact on the global OTC consumer health market owing to the increasing approvals for OTC healthcare products by regulatory authorities. For instance, on January 27, 2022, The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the InteliSwab COVID-19 Rapid Test developed by OraSure Technologies, Inc., a company in the medical device industry for developing diagnostic testing kits. InteliSwab COVID-19 Rapid Test is used for home use as Non-prescription product for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

Global OTC Consumer Health Market– Restraints

Withdrawal of over-the-counter (OTC) drugs by regulatory authorities is expected to restraint market growth over the forecast period. For instance, on April 01, 2020, The U.S. Food and Drug Administration (FDA) had announced that it was requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increased over time and when stored at higher than room temperatures and resulted in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products not available in new or existing prescriptions or OTC use in the U.S.

Global OTC Consumer Health Market– Regional Analysis

On the basis of region, the global OTC consumer health market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

Among regions, North America market is expected to witness significant growth, owing to key companies in market focusing on adopting inorganic strategies such as agreements with other market players. For instance, on July 29, 2022, Dr. Reddy’s Laboratories Ltd., a pharmaceutical company, announced that it had entered into a licensing agreement with Slayback Pharma LLC, a specialty pharmaceutical company to acquire rights in Slayback’s Brimonidine Tartrate Ophthalmic Solution 0.025%, the private label equivalent of Lumify in the U.S. Lumify is an over-the-counter (OTC) eye drop that can be used to relieve redness of the eye due to minor eye irritations. The agreement also provides Dr. Reddy’s exclusive rights to the product outside the U.S.

Figure 2: Global OTC Consumer Health Market Value (US$ Bn), by Regional Insights, 2024

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Global OTC Consumer Health Market– Competitive Landscape

Major players operating in the global OTC consumer health market include Johnson & Johnson, Abbott Laboratories, Sanofi, GlaxoSmithKline plc. Bayer AG, Nestle Company, Procter & Gamble Corp., Danone Food Company, Colgate Palmolive Mfg. Company, Unilever, and Henkel AG & Co. KGaA.

Recent Developments

In July 2023, Perrigo Company plc, a prominent producer of consumer self-care products, announced that the U.S. Food and Drug Administration (FDA) granted approval to Opill, a progestin-only daily oral contraceptive, for unrestricted over-the-counter (OTC) distribution across all age groups. Opill marks the pioneering instance of an over-the-counter birth control pill available in the United States.

In June 2023, McKesson, a multifaceted healthcare services entity, introduced Foster & Thrive, a carefully curated private brand featuring a range of over-the-counter (OTC) health and wellness products. This launch consolidates the company's private brand portfolio by integrating Health Mart and Sunmark branded OTC products, thereby, enhancing availability through increased production volumes and efficiencies to address evolving patient needs and escalating demand.

In April 2023, WellSpring Consumer Healthcare, a developer and promoter of premier over-the-counter (OTC) and personal care brands, announced the acquisition of a collection of reputable OTC skin care brands from Bayer AG, a global pharmaceutical and biotechnology enterprise. WellSpring Consumer Healthcare operates under the umbrella of Avista Capital Partners, a distinguished middle-market healthcare private equity firm with expertise in cultivating OTC platforms.

In April 2021, Ro, a healthcare technology company, announced that Roman's doctor-designed over-the-counter medications would be available in more than 4,600 Walmart stores nationwide. This is the company's first retail engagement, with the goal of providing Walmart customers with exclusive, science-backed health and wellness alternatives both in-store and online, as well as the ability to use Ro's telemedicine services for further healthcare needs.