The compounded topical drug market was estimated at US$ 4.27 billion in 2023 and is projected to grow to US$ 6.78 billion by 2034, rising at a compound annual growth rate (CAGR) of 4.29% from 2024 to 2034. The demand for personalized medicines and the increasing incidence of skin disorders drive the market.
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Compounded drugs are sterile or nonsterile drugs or nutrients formulated in a licensed pharmacy, outsourcing facility, or other healthcare-related facility. They are not FDA-approved for safety and effectiveness. Compounding involves combining, mixing, or altering ingredients tailored to the needs of the patients. According to the American Chronic Pain Association, the most common compounded medications are topical medications. Topical drugs are semisolid preparations or transdermal patches on the skin, mucous membranes, or cavities. Topical preparations treat pain for injured workers with a specific need. Topical agents are often prepared by mixing the powdered tablet in a petroleum base to form ointments.
The increasing incidences of skin disorders potentiate the demand for compounded topical drugs. According to the WHO, 1.8 billion people are estimated to be affected by skin conditions at any point in time. The demand for personalized medicines and the ease of preparation of topical drugs boost the market. If a person is allergic to any dye or ingredient, compounded preparations can be made without the dye or ingredient. The market is also driven by increasing drug shortages due to rising population and demand.
In May 2022, Medisca, a leading supplier of pharmaceutical compounding products, acquired DIFFUSIMAX and DIFFUSIMAX10 liposomal bases from Maxima Pharmaceuticals. These products are used in preparing compounded topical formulations and include all intellectual property assets from Maxima.
In April 2022, the U.S. FDA added four substances to its 503B Bulks List, which includes APIs determined to be necessary for compounding by outsourcing facilities. The new APIs added are diphenylcyclopropenone, glycolic acid, squaric acid dibutyl ester, and trichloroacetic acid, all for use in topical formulations.
Calgary Co-op’s 2023 sales were reported at approximately $1.3 million, marking a $0.1 million increase from 2022, with net earnings of $16,704.
Recent advancements in technology, such as artificial intelligence (AI), are transforming the compounding process by introducing automation. This shift improves efficiency, accuracy, and safety. Traditional pharmacy compounding is a labor-intensive process requiring careful human input, but AI-powered systems can automate the entire procedure, streamlining workflows and reducing the risk of errors.
AI can enhance precision by accurately measuring and dispensing ingredients, as well as enabling real-time monitoring to identify and correct mistakes early on. This automation not only helps minimize human errors but also frees up time for pharmacists to focus on patient care and medication counseling, leading to improved health outcomes.
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