OTC Topical Drugs Market Size, Share, Industry, Forecast and outlook (2024-2031)

OTC Topical Drugs Market is segmented By Product Type (Creams, Ointments, Gels, Lotions and Others), By Application Type (Skin Diseases, Pain Relief, Skincare and Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies and Online Pharmacies), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023 - 2030

OTC Topical Drugs Market Size

The Global OTC Topical Drugs Market reached USD 46.8 billion in 2022 and is projected to witness lucrative growth by reaching up to USD 79.0 billion by 2027. The global OTC topical drugs market is expected to exhibit a CAGR of 6.9% during the forecast period 2023-2027. The global OTC topical drugs market trends show a dynamic and evolving landscape for drugs owing to the rising prevalence of infectious diseases such as dermatophytosis and increasing research and development. 

Furthermore, the numerous clinical trials, together with the rising demand for treatment at the point of care, are driving up the global OTC topical drugs market.

The OTC topical drugs market covers a wide range of therapeutic categories and products, including creams, ointments, gels, lotions, Lotions, and patches. OTC topical drugs offer consumers the convenience of self-treatment and the ability to manage minor health conditions without visiting a healthcare professional. OTC drugs are widely available in pharmacies, supermarkets, retail stores, and online platforms, making them easily accessible to consumers.

OTC Topical Drugs Market Scope

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OTC Topical Drugs Market Dynamics

Increasing Number of Clinical Trials of OTC Drugs Drives the Growth of Global OTC Topical Drugs Market

According to the ClinicalTrials.gov, on June 10, 2022 GlycosBio, Inc. conducted an interventional study on assessment of the effects on the skin microbiome of amending an over-the-counter Eczema product with activated oil (AO). It is a single-center, randomized, blinded, and controlled trial assessing the effects on the skin microbiome in patients with eczema of amending a standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with modified plant oil.

Also, on October 4, 2022, the University of Alabama at Birmingham conducted clinical trials on Bodewell products for the treatment of atopic dermatitis. This study aims to examine the safety and efficacy of topical application of the Bodewell eczema products. All patients were treated with the active product, Bodewell. Bodewell is a non-prescription drug that contains 22 botanical ingredients in addition to colloidal oatmeal. Bodewell will be applied topically twice a day to all active lesions. Hence, the above information proves that the rise of clinical trials of OTC topical drugs drives the global market.

Rising Regulatory Approvals and Novel Product Launches Create Lucrative Opportunities for Manufacturers

OTC treatments have seen ongoing advancements, including the launch of new formulations and delivery systems. These products may include creams, gels, cleansers, or spot treatments containing ingredients like benzoyl peroxide, salicylic acid, or retinoids. The rising novel product launches by major key players are also a global OTC topical drugs market trend driving the market. 

For instance, on May 16, 2023, Codex Labs launched its new product Shaant over-the-counter topicals collection for acne management. The formulation of the items was done in collaboration with an integrative dermatologist and licensed ayurvedic practitioner M.D Raja Sivamani.

The patented Shaant Complex, a biotech-based combination of actives derived from terrestrial and marine plants, is used in the OTC collection to treat acne. It has been clinically proven to help control oiliness, shed pore-clogging dead skin cells, reduce the appearance of pores and minimize the appearance of redness.

Side Effects Associated with OTC Topical Drugs Will Hamper the Growth of the Market

The ingestion of inappropriate doses can lead to side effects and the occurrence of adverse reactions and drug–drug interactions. The specific side effects can vary depending on the active ingredient and the individual's sensitivity or allergic reactions. Certain topical drugs, especially those used for acne treatment or skin conditions, may cause dryness or excessive moisture in the treated area. This can lead to flaking, peeling, or increased oiliness, depending on the formulation and individual response. The side effects of OTC drug abuse which include slurred speech, impaired motor coordination, and impaired cognitive abilities.

For instance, during the treatment of dermatophytosis by using anti-fungal topical drugs, it can lead to many side effects which include allergic reactions, intensive facial pruritus, nausea and vomiting. Hence, owing to the above factors, the market is expected to hamper over the forecast period.

OTC Topical Drugs Market Segment Analysis

The global OTC topical drug market is segmented based on product type, application type,  distribution channels and region.

Owing to the Increasing Prevalence of Skin Diseases and Rising Clinical Trials, the Skin Disease Type Segment Accounted for Approximately 45.2% of the Global OTC Topical Drug Market Share 

The increasing prevalence of skin diseases has a significant impact on the OTC topical drug market. Skin diseases encompass a wide range of conditions, including acne, eczema, psoriasis, dermatitis, fungal infections, and others. Patients with mild to moderate symptoms often prefer to try self-care options before seeking medical intervention. OTC topical drugs provide accessible and convenient solutions for managing common skin conditions, such as over-the-counter acne treatments or eczema creams.

Pharmaceutical companies and researchers are continuously exploring new formulations, delivery systems, and active ingredients for OTC topical drugs. This drive for innovation leads to an increased number of clinical trials to evaluate the effectiveness and safety of the new approaches.

For instance, on July 18,  2022, Incyte Announce the U.S. FDA approval Of Opzelura (Ruxolitinib) Cream for the treatment of Vitiligo. Opzelura is the first and only FDA-approved treatment for repigmentation in patients with vitiligo, and the only topical formulation of a Janus kinase (JAK) inhibitor approved in the United States. The FDA approval was based on data from the pivotal Phase 3 TRuE-V clinical trial program (TRuE-V1 and TRuE-V2), evaluating the safety and efficacy of Opzelura. Thus, owing to the above factors, the market segment is expected to hold the largest market share over the forecast period.

Source: DataM Intelligence Analysis (2023)

OTC Topical Drugs Market Geographical Share

North America Accounted for Approximately 39.4% of the Market Share in 2022, Owing to the Increasing Research and Development Activities and Well-Established Healthcare Infrastructure  

North America, particularly the United States and Canada, has a well-developed healthcare infrastructure, including a robust pharmaceutical industry, advanced research facilities, and a strong regulatory framework. This enables efficient product development, clinical trials, and regulatory approvals for OTC topical drugs. 

Skin conditions are prevalent in North America, with a significant portion of the population experiencing issues such as acne, eczema, dermatitis, and psoriasis. The increasing prevalence of these conditions drives the demand for OTC topical drugs as consumers seek convenient and cost-effective solutions.

North America has a strong retail infrastructure, with well-established pharmacy chains, drugstores, supermarkets, and convenience stores. These retail channels provide wide distribution networks for OTC topical drugs, making them easily accessible to consumers. Additionally, the growth of e-commerce platforms has further expanded the availability and convenience of purchasing OTC topical drugs online.

Source: DataM Intelligence Analysis (2023)

OTC Topical Drugs Market Players

The major global players in the market include Merck & Co., Inc., Johnson & Johnson, Bayer AG, Galderma, Sanofi, Taisho Pharmaceuticals, Takeda Pharmaceuticals, Novartis AG, Pfizer, and Teva Pharmaceuticals.

COVID-19 Impact on OTC Topical Drugs Market

Russia-Ukraine Conflict Analysis

The Russia-Ukraine conflict is estimated to have a moderate impact on the global topical OTC drugs market, owing to the low prevalence and absence of key market players in this region. Regulatory processes and approvals for OTC topical drugs face challenges in conflict-affected regions due to the disruption of government institutions and regulatory authorities. This can hinder the introduction of new products or the registration of existing ones, impacting the market dynamics. However, the impact of the import and export of raw materials is expected to have little influence over the global OTC topical drug market growth over the forecast period.

According to the national statistics, as of 18 August 2022, about 505 pharmacies were damaged in Eastern Ukraine and 47 were completely ruined. Moreover, the invaders have been blocking humanitarian aid provided to these territories by the Ukrainian government or other countries. The economic availability of drugs is also profoundly influenced by the significant increase in the cost of medications and the fall in average salaries.

Key Developments

• On June 27, 2022, the FDA announced the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use. The proposed rule is intended to increase options for the development and marketing of safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.
• On June 12, 2023, the US FDA granted Over-the-Counter Marketing Authorization to Futura for Fast-Acting Topical Gel, MED3000, to treat erectile dysfunction. The company also announced that it raised proceeds of £4,375,000 to fund the future commercialization of MED3000 via a warrant exercise by a large institutional shareholder. 

MED3000 has already been approved as the first pan-European clinically proven topical treatment for ED available OTC and is now available in Belgium and the UK. With multiple commercial agreements in key markets including the European Economic Area, the UK, Switzerland, South Korea, Latin America and the Middle East

Why Purchase the Report?

• To visualize the global OTC topical drug market segmentation based on the product type, application type, distribution channel, and region, as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development. 
• Excel data sheet with numerous data points of OTC topical market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as Excel consisting of key products of all the major players.

The global OTC topical market report would provide approximately 95 tables, 95 figures, and 180 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies