Compounding Pharmacies Market Size to Reach USD 23.13 Billion by 2034 – Key Trends, Growth Drivers, and Forecast
Compounding Pharmacies Market Size and Growth
The global compounding pharmacies market was worth USD 13.23 billion in 2024 and is expected to reach around USD 23.13 billion by 2034, with a noteworthy CAGR of 5.8% from 2025 to 2034. The market is greatly influenced by the regulatory framework and costs associated with mass-manufactured drugs.
Compounding Pharmacies Market: A New Paradigm
A compounding pharmacy can be defined as a pharmaceutical facility that specializes in creating medications customized to personalized prescriptions. These prescriptions are customized based on individual-specific preferences and requirements. Compounding medication involves combining, altering, or mixing existing pharmaceutical formulations or developing new ones using pharmaceutical-grade ingredients to cater to the patient's needs.
Within the healthcare sector, clinicians face challenges while treating patients with special needs with traditionally marketed medications. The patient may have concerns about certain components, such as dyes, adjuvants, flavors, or stabilizers, that may elicit an allergic response. Other times, the composition, dosage, or form may be a hindrance to medication adherence in individuals. Compounding offers an easy and cheaper solution to these problems.
A compounding pharmacy should be mindful of its ingredients in terms of quality, availability, and ethical and federal acceptance. They are required to follow certain sterility and purity standards. Sections 503A and 503B under the Federal Food, Drug, and Cosmetic Act provide information about the laws and policies associated with safe compounding practices.
- In October 2020, the FDA signed an MOU with the NABP to help enhance communication and maximize federal and state resources for oversight of compounded drugs produced by traditional pharmacies.
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Types of Compounding Pharmacies & Their Applications
Type of Compounding Pharmacy |
Key Application |
Market Focus |
Sterile Compounding |
Preparation of IV therapies, oral medication, injectables and gels. |
To cater patients with specialized sterile medication requirements. |
Non-sterile Compounding |
Preparation of hormone replacement therapy |
To emphasize over veterinary, dermatology and customized hormone therapies |
503A Compounding |
Small batch production of tailored dosing |
To focus on solutions with non-standard dosage or formulations |
503B Compounding |
Large-scale production of medications that are not commercially available |
To focus on specialty drugs markets for long-term care facilities |
Major Undertakings in the Compounding Pharmacies Market
The compounding pharmacies market is a niche and obscure sector of the pharmaceutical industry. It heavily relies on government initiatives promoting the services provided by the industry, which attract the interest of established market players. Business participation in the form of mergers, awards, and acquisitions not only results in the development of new products and services but also widespread exposure.
- In April 2024, a global clinical trial supplier, Myonex acquired Segway Compounding Pharmacy.
- In July 2024, a global pharmaceutical compounding company, Fagron bought a 503B outsourcing facility in Boston.
- In November 2023, the U.S. Food and Drug Administration (FDA) conducted the 12th intergovernmental working meeting on drug compounding. The virtual program was attended by state government officials, including state regulators, representatives from the National Association of Boards of Pharmacy (NABP), and other FDA representatives.
Compounding Pharmacies Market: Trends & Insights
Insight |
Trend |
Development |
Guidelines |
Organized guidelines enable practitioners to organize their resources. |
In March 2021, the National Association of Boards of Pharmacy (NABP), in partnership with the U.S. FDA, launched the Compounding Pharmacy Information Sharing Project. |
Infrastructure |
Major players are expanding their existing infrastructure by mergers and acquisitions. |
In February 2024, Empower Pharma announced its intentions to acquire Eugia U.S. Manufacturing’s facility in East Windsor. This acquisition will help the former develop its personalized compounded medication facility. |
Consumer Preference |
Demand for personalized medications due to their efficacy and affordability |
In May 2024, Hims & Hers introduced an injectable weight loss drug with the same active ingredient as Novo Nordisk’s semaglutide. The new drug is offered to the market at a lower rate combined with consultancy services. |
Top Investment Opportunities in the Compounding Pharmacy Industry
- Personalized Medicine
Compounding pharmacies are at the forefront of creating bioidentical therapies that are commercially available. As the healthcare sector across the globe shows shift towards precision or personalized medicine, the demand for customized hormone replacement therapies is observed to rise. Alongside, medication requirement for pain management will increase that requires combination of multiple active ingredients in a single topical formulation.
- Suitable Regulatory Environment
The industry for compounding pharmacy revolves around stringent regulatory environment, particularly in areas where the pharmaceutical sector is well-established. In the upcoming period, these regulatory compliances are observed to serve a potential for investors by offering security and quality assurance acts.
For a better perspective for investors, in the predicted timeframe the 503A and 503B are major market segments that are observed to capture a larger base in the industry which ca produce larger batches of compounds.
- Expansion of Niche Segments
The compounding pharmacies market is observed to receive unique requirements that are not generally met by commercial medications. The sector is seen to create specialized compound formulations for geriatric population, paediatrics and even for the dermatology sector.
For instance, PetMed Express, a prominent company in veterinary medicine is focused on offering tailored solutions to pave a path for potential profitability through compounding pharmacy via specialized compound formulations.
Affordability and Favourable Marketspace Paves the Path for the Compounding Pharmacies Market
A pharmaceutical composition has to undergo rigorous clinical trials before being mass-produced for market consumption. These trials are time-consuming, spanning multiple years. Furthermore, the costs associated with testing and the requirement for regulatory approval can affect the final product. In such conditions, the compounding pharmacies market offers faster and more affordable solutions.
A compound medication is basically an altered form of an existing drug or a combination of several components. However, these formulations do not require the approval of regulatory bodies such as the FDA or EMA. This substantially cuts down on the cost of the pharmaceuticals. Combined with a growing disposable income, these products are much more affordable to the general public.
Regulatory compliance is a double-edged sword. It allows a trustworthy product but at a slower pace and higher cost. The integrity of a compounded drug is reliant on the standard of its production facility and resources. A growing healthcare expenditure enables the development of better infrastructure in the compounding pharmacies market. State-monitored organizations and FDA-approved outsourcing facilities help the market to provide quality services.
North America to Dominate the Compounding Pharmacies Market
North America boasts an extensive healthcare sector due to rising disposable income, demand for personalized medical services, increasing healthcare expenditure, and shifting consumer trends. To cater to the geriatric and pediatric population, medications are often compounded, allowing ease of administration. The region hosts a growing population of senior citizens who utilize the services of the compounding pharmacies market.
- According to the 2020 United Nations report, approximately 727 million people were 65 and older. Additionally, the number of individuals aged 80 and above is expected to double by 2050, reaching over 1.5 billion.
Asia Pacific Boasts Immense Potential in the Compounding Pharmacies Market
The Asia Pacific compounding pharmacies market is driven by factors such as rising hormonal and dermal disorders, developing healthcare infrastructure, dedicated veterinary practices, and a rising vulnerable population. The old, infant and differently abled population of the region is heavily reliant on compounding pharmacies to alter their formulation. These include altering the form or dosage of an existing drug.
Another driver of the Asia Pacific compounding pharmacies market is the rising prevalence of hormonal imbalances and dermal disorders, especially in females. This is due to the changing environment and unhealthy lifestyles. The market caters to each individual based on their personal preferences and lifestyle choices.
Top Companies in the Compounding Pharmacies Market
- Fagron
- Patterson Companies, Inc.
- Wedgewood Pharmacy
- Capsule Pharmacy
- Medisca
- The Compounding Center
- PharMEDium Services
- Custom Rx Pharmacy
- Pharmacy Solutions
- NorthStar Rx
- Accella
- Harbor Compounding Pharmacy
- Vasanta Medical
- Revive Pharmacy
- RPh on the Go
Unregulated Facilities and Lack of Insurance Coverage Hampers the Compounding Pharmacies Market
Unregistered compounding pharmacies are often lax with their manufacturing processes. This may result in substandard medication that may even cause harm to the patient. Consumption of such medication can lead to even death. This results in a negative press and skepticism among the public.
Besides restrictions like supply chain disruption and fluctuation in the prices of raw materials, the market is also hampered due to a lack of insurance coverage. As these medications are not thoroughly tested and cannot guarantee the desired result, medical insurance does not reimburse the patients for their costs.
Compounding Pharmacies Market News
- In February 2023, a full-service testing facility for compounding pharmacies, Front Range Laboratories (FRL), was acquired by the Colorado-based Wedgewood Pharmacy.
Segments Covered in the Report
By Therapeutic Area
- Hormone Replacement Therapy
- Pain Management
- Specialty Drugs
- Dermatology
- Nutritional Supplements
- Others
By Age Cohort
- Pediatric
- Adult
- Geriatric
By Compounding Type
- Pharmaceutical Ingredient Alteration (PIA)
- Currently Unavailable Pharmaceutical Manufacturing (CUPM)
- Pharmaceutical Dosage Alteration (PDA)
- Others
By Sterility
- Sterile
- Non-sterile
By Product
- Oral
- Parenteral
- Topical
- Ophthalmic
- Nasal
- Rectal
- Otic
By region
- North America
- U.S.
- Canada
- Europe
- U.K.
- Germany
- France
- Asia Pacific
- China
- India
- Japan
- South Korea
- Latin America
- Middle East & Africa
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Editor Details
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Company:
- Cervicorn Consulting
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Name:
- Rutuja Borkar
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Telephone:
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Related Links
- Website: Compounding Pharmacies Market