Towards Healthcare
Compounded Topical Drug Market Size, Trends and Shares by 2034

Compounded Topical Drug Market Size to Climb $6.78 Bn in 2034

The compounded topical drug market is growing due to increasing skin disorders affecting 1.8 billion people, personalized medicine demands, and drug shortages. Compounding allows for tailored medications without allergens. Key trends include Medisca's acquisition of liposomal bases in May 2022 and the FDA's addition of new APIs for compounding. Calgary Co-op reported $1.3 million in sales in 2023, up $0.1 million from 2022.

Compounded Topical Drug Market Companies and Developments Announcements

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.

Compounded Topical Drug Market Revenue 2023 - 2034

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Compounded Topical Drug Market: Customized Care

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 global supplier of pharmaceutical compounding products, announced the acquisition of DIFFUSIMAX and DIFFUSIMAX10 liposomal bases. These products are used for preparing compounded topical formulations and all intellectual property assets of Maxima Pharmaceuticals.
  • In April 2022, the US FDA added four substances to its 503B Bulks List comprising APIs for which the FDA had determined the clinical need for use in compounding by outsourcing facilities. The API includes diphenylcyclopropenone, glycolic acid, squaric acid dibutyl ester, and trichloroacetic acid, all in topical formulations.
  • The sales of Calgary Co-op in 2023 were reported to be approximately $1.3 million, an increase of $0.1 million from 2022. While the net earnings of the company in 2023 were $16,704.

Automation: Future of the Compounded Topical Drug Market

The latest technological advancements like artificial intelligence (AI) introduce automation in the compounding of products. These advancements lead to enhanced efficiency, improved accuracy, and increased safety. Conventional pharmacy compounding is a labor-intensive procedure involving careful human labor. Implementing AI in pharmacy compounding automates the entire process using state-of-the-art technology to streamline workflows and reduce the possibility of errors.

AI can incorporate precision and consistency by precisely measuring and dispensing drug components. It can also facilitate real-time monitoring, detecting, and correcting errors on a prior basis. Additionally, it unlocks valuable time for pharmacists to focus on delivering personalized patient care and medication counseling, ultimately leading to better health experiences for everyone. Hence, automation can significantly reduce the occurrence of human errors, leading to safer and more efficient compounding processes.

Potential Side Effects Hinderance for the Industry

Since compounded topical drugs are not approved by regulatory agencies, they can cause severe side effects in patients. Unnecessary use of compounded drugs may expose patients to potentially serious health risks. Compounding too small quantity of medications provides lesser treatment efficacy, while more quantity of medications can lead to potential side effects.

Regional Insights

Technological Innovation: North America to Dominate

North America held a dominant presence in the compounded topical drug market in 2023. The presence of key players, technological advancements, increasing demand for personalized medicines, and drug shortages drive the market. It is estimated that 1-3% of prescriptions in the US are for compounded medications. Compounding practices in the US are driven by the presence of key players like Apollo, Aurora, B Braun, Equashield, etc. These companies hold a major share of the US market. Companies like Equashield and Baxter use AI to incorporate automation in compounding drugs. The US Food and Drug Administration and Center for Drug Evaluation and Research do not regulate compounded drugs but release guidelines on safe and high-quality drug compounding.

Skin Disorders on Rise: Asia’s Projection to Grow

Asia-Pacific is anticipated to grow fastest in the compounded topical drug market during the forecast period. The rising population, increasing incidences of skin conditions, diverse patient needs, and growing research and development drive the market. In India, registered medical practitioners can legally dispense medications for their patients and can get drugs compounded through pharmacies for their patients. The regulations for compounding drugs in India are mentioned in the Drugs and Cosmetics Act. In Japan, it is estimated that around 30% of the population suffers from atopic dermatitis due to rapid urbanization. The prevalence of psoriasis in China and Japan is about 0.56% and 0.34%, respectively. While the prevalence of psoriasis in India among adults varies from 0.44% to 2.8%.

Segmental Insights

By type, the cream segment held a significant share of the compounded topical drug market in 2023. Creams are the most common topical drug formulations used for diverse applications from pain management to eczema and psoriasis. The rising incidences of skin disorders and demand for personalized medicines drive the segment growth. Compounded topical creams frequently combine more than one API, and sometimes up to four to six APIs, depending on the patient's conditions.

The ointment segment is projected to expand rapidly in the market in the coming years. Ointments are widely used to soothe or heal wounds, burns, rashes, scrapes, or other skin problems. Ointments stay on the skin for longer periods, absorbing more medication and providing better treatment efficacy.

By application, the retail pharmacy segment is estimated to grow at a notable rate in the compounded topical drug market during the forecast period. Compounding is the most common application in retail pharmacies. Retail pharmacies have sufficient trained professionals to formulate compounded preparations. Patients can directly explain their conditions or difficulties in taking medications to the pharmacists present at retail stores, allowing them to prepare custom drugs.

Recent Developments in the Compounded Topical Drug Market

  • In July 2024, Hello Cake, a sexual health startup, introduced two new prescription medications: dissolvable tablet Libido Lift Rx and topical O-Cream. O-Cream contains topical sildenafil, meant to be applied directly to the vagina. Both medications are compounded by the digital pharmacy company Epiq Scripts.
  • In September 2023, Medisca launched the Medisca MAZ Mixer, a compounding technology that provides an efficient, uniform, high-quality solution for compounding hundreds of formulations.

Top Companies in the Compounded Topical Drug Market

  • Albertsons Companies, Inc.
  • Apollo Clinical Pharmacy
  • Aurora Health Care
  • B Braun Melsungen AG
  • Calgary Co-op
  • Epiq Scripts
  • Equashield Compounding Technologies
  • Eucalyptus
  • Medisca
  • Nephron Pharmaceuticals Corporation
  • PCCA (Professional Compounding Centers of America)
  • ReNue Rx
  • SaveWay Compounding Pharmacy
  • Triangle Compounding Pharmacy

Segments Covered in the Report

By Type

  • Cream
  • Ointment
  • Gel
  • Lotion

By Application

  • Retail Pharmacy
  • Hospitals
  • Others

By Region

  • North America
    • US
    • Canada
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Thailand
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Sweden
    • Denmark
    • Norway
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa (MEA)
    • South Africa
    • UAE
    • Saudi Arabia
    • Kuwait
  • Insight Code: 5317
  • No. of Pages: 150+
  • Format: PDF/PPT/Excel
  • Published: November 2024
  • Report Covered: [Revenue + Volume]
  • Historical Year: 2021-2022
  • Base Year: 2023
  • Estimated Years: 2024-2033

About The Author

Deepa has certified the degree of Master’s in Pharmacy in the Pharmaceutical Quality Assurance department from Dr D.Y. Patil College of Pharmacy. Her research is focused on the healthcare industry. She is the author or co-author of four Review Articles, which include Solid dispersion a strategic method for poorly soluble drugs and solubility improvement techniques for poorly soluble drugs, Herbal Drugs Used In Treatment Of Cataracts, Nano sponges And Their Application in Cancer Prevention and Ayurvedic Remedies of Peptic ulcer. She has also published a Research Article on the Formulation and Evaluation of Mucoadhesive Tablets of Miconazole cocrystal which was published in GIS Science Journal Volume 9 Issue 8. Her passion for secondary research and desire to take on the challenge of solving unresolved issues is making her flourish is the in the research sector.

FAQ's

Compounding drugs contain customized strength or dosage and additive flavors. The drug can be reformulated to exclude an unwanted, nonessential ingredient, to which a patient is allergic.

Some patients require a reduced strength of medication or a special dosage that is unavailable commercially. Compounded drugs can enable the preparation of custom medications for individual requirements.

National Institute of Health, Food and Drug Administration, World Health Organization