U.S. Compounding Pharmacies Market Size on Track to Hit $10.93 Billion by 2034

The U.S. compounding pharmacies market size reached USD 6.10 billion in 2024 and is expected to grow from USD 6.45 billion in 2025 to USD 10.93 billion by 2034. The market is growing at a CAGR of 6.04% from 2025 to 2034, driven by rising personalized medicine demand and healthcare needs.

Ottawa, Aug. 18, 2025 (GLOBE NEWSWIRE) -- According to precedence research, the U.S. compounding pharmacies market size will hit around USD 10.93 billion by 2034, fueled by growing demand for customized medications and patient-centric care. The U.S. Market was valued at USD 6.10 billion in 2024 and is expected to reach around USD 6.45 billion in 2025. There is an increased need for compounding pharmacies in the U.S. due to drug shortages, discontinued medications, and the growing trend of personalized medicine.

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Key Takeaways

By pharmacy type, the 503A segment accounted for the biggest market share of 72.99% in 2024.
By pharmacy type, the 503B segment is expected to grow at the fastest CAGR from 2025 to 2034.
By product, the oral medications segment contributed the highest market share of 36.21% in 2024.
By product, the liquid preparations segment is growing at a solid CAGR between 2025 and 2034.
By sterility, the non-sterile segment held the major market share of 71.97% in 2024.
By sterility, the sterile segment is projected to grow at the fastest CAGR from 2025 to 2034.
By compounding type, the pharmaceutical dosage alteration (PDA) segment dominated the market in 2024.

By therapeutic area, the pain management segment dominated the market in 2024 and is expanding at the fastest CAGR from 2025 to 2034.
By end-user, the hospitals and clinics ssegment dominated the market in 2024.
By end-user, the specialty clinics segment is poised to grow at a strong CAGR between 2025 and 2034.

U.S. Compounding Pharmacies Market Revenue Analysis from 2022 to 2024

U.S. Compounding Pharmacies Market Revenue (USD Billion) By Pharmacy Type 2022-2024

By Pharmacy Type	2022	2023	2024
503A	3.99	4.21	4.45
503B	1.49	1.57	1.65

U.S. Compounding Pharmacies Market Revenue (USD Billion) By Sterility 2022-2024

By Sterility	2022	2023	2024
Sterile	1.53	1.62	1.71
Non-Sterile	3.95	4.16	4.39

U.S. Compounding Pharmacies Market Revenue (USD Billion) By Therapeutic Area 2022-2024

By Therapeutic Area	2022	2023	2024
Hormone Replacement	1.05	1.17	1.17
Pain Management	0.48	0.51	0.54
Dermatology	0.25	0.26	0.28
Pediatrics	0.19	0.20	0.21
Urology	0.15	0.16	0.17
Others	0.54	0.56	0.58

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U.S. Compounding Pharmacies Market Overview and Industry Potential:

What does Compounding mean in a Pharmacy?

The U.S. compounding pharmacies market revolves around any pharmacies that make on-site medications to meet specific patient needs. The American Pharmacists Association reports about 56,000 community-based or retail pharmacies in the U.S. out of which 7,500 are compounding pharmacies. The US Pharmacopeia provides resources to support supply chain resilience to resolve drug shortages.

In October 2024, Novo Nordisk petitioned the U.S. FDA to ban compounding pharmacies from manufacturing copied versions of its popular diabetes and weight-loss drugs. (Source: https://www.reuters.com)

Major Trends in the U.S. Compounding Pharmacies Market

How Strong is the Emphasis on Advanced Technology Integration?

Collaborative Healthcare Approach: There is a development of in-house compounding by larger hospitals and hospital systems. These establishments are committed to meeting specific clinical needs or supply concerns. There are increasing collaborations between compounding pharmacies and hospitals, clinics, physicians, and healthcare providers.
Expansion of Services: There is a greater diversification in compounding pharmacy services than traditional compounding. This offers novel healthcare solutions and services such as specialty medication compounding, medication therapy management, nutritional support, and hormone replacement therapy.

Growth Factors in the U.S. Compounding Pharmacies Market

What is the Rising Demand for Personalized Medicine?

Emergency Usage: The healthcare professionals and medical practitioners in clinics, hospitals, and other healthcare facilities rarely provide compounded drugs to patients. This preference is given when FDA-approved medications are not suitable for patients. This raises the need and importance of compounding pharmacies to meet patient needs.
Involvement of Pharmacy Benefit Manager in U.S. Healthcare: It involves pharmaceutical companies, insurance companies, patients, and pharmacies. The various major rationales behind this growth include market pricing, formulary availability and management, claims processing, prior authorization, and clinical medication programs. Moreover, reimbursement, in-network, or specialty pharmacies also drive the growth of U.S. healthcare.

Case Study: AIS Healthcare & IU Health – Meeting the Demand for Category 3 Compounded Medications

Background:

Indiana University Health (IU Health) was experiencing growing demand for Category 3 compounded medications, particularly sterile patient-specific therapies, while facing challenges in compliance, workflow efficiency, and maintaining consistent quality standards.

Solution:

IU Health partnered with AIS Healthcare, a leading U.S. compounding pharmacy specializing in sterile preparations. AIS provided:

Robust quality controls including terminal sterilization, sterility assurance, and environmental monitoring.
Operational redundancy via multiple pharmacy sites to ensure continuity of supply.

Regulatory compliance support with documentation, staff training, and USP <797>/<800> adherence.
Simplified workflows through integrated ordering systems and patient support services.

Outcome:

The partnership allowed IU Health to outsource complex sterile compounding needs, reducing internal administrative burdens while ensuring safe, compliant, and patient-centered care. It also highlighted the strategic role that outsourcing facilities (503B compounding pharmacies) can play in strengthening U.S. healthcare delivery.

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How is Artificial Intelligence Changing the U.S. Compounding Pharmacies Industry?

AI technology greatly contributes to pharmacointelligence in streamlining processes for clinical pharmacists and making more accurate and evidence-based clinical decisions. Moreover, AI plays a major role in drug development by accelerating the rate of discovery, analyzing data sets, recognizing optimal compounds, and predicting their efficacy.

Opportunities in the U.S. Compounding Pharmacies Market

How is the Expansion of Services in the U.S. Healthcare?

In March 2024, the U.S. Food and Drug Administration (FDA) announced a request for $7.2 billion to enhance nutrition and food safety, encourage medical product safety, and boost public health. (Source: https://www.fda.gov)
In July 2025, AstraZeneca announced the investment of $50 billion in America for the manufacturing of medicines along with research and development. (Source: https://www.astrazeneca.com)

U.S. Compounding Pharmacies Market Challenges and Limitations:

How can FDA Approvals and Quality Control Measures Limit Compounding Pharmacies?

Lack of FDA Approvals: The FDA does not verify and approve the safety, quality, and effectiveness of compounded drugs before their marketing. There is a dependency of healthcare professionals and consumers on FDA’s drug approval process to verify safety, quality, and effectiveness of medicinal drugs.
Evolving Compounding Needs: These include specific dosage strength, formulation change, and combination of drugs. Compounding sometimes needs a lower dose for pediatric patients, oral solids, liquids, or removing allergens, and magic mouthwash.

Scope of the U.S. Compounding Pharmacies Market

Report Attributes	Key Statistics
Growth Rate 2025 to 2034	CAGR of 6.04%
Market Size in 2025	USD 6.45 Billion
Market Size in 2026	USD 6.82 Billion
Market Size in 2030	USD 8.62 Billion
Market Size in 2032	USD 9.75 Billion
Market Size by 2034	USD 10.93 Billion
Base Year	2024
Forecast Period	2025 to 2034
Segments Covered	Pharmacy Type, Product, Sterility, Compounding Type, Therapeutic Area, and End-User
Largest Segment (2024)	Oral Medications with 36.21% share
Dominant Sterility Segment	Non-Sterile Compounding, holding 71.97% share in 2024
Key Growth Driver	Rising demand for personalized medicines and patient-centric care
Major Players	Triangle compounding pharmacy, Fagron, B. Braun melsungen ag, Fresenius kabi ag, Pencol Compounding Pharmacy, US Compounding Inc., Avella specialty pharmacy, Institutional pharmacy solutions, llc, Pharmedium services llc, and Vertisis custom pharmacy.

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U.S. Compounding Pharmacies Market Global and Country-Level Analysis:

How Big is the Global Compounding Pharmacies Market?

According to Precedence Research, the global compounding pharmacy market size is evaluated at USD 18.02 billion in 2025 and is projected to rise from USD 19.19 billion in 2026 to approximately USD 31.77 billion by 2034, expanding at a CAGR of 6.50% from 2025 to 2034.

Global Compounding Pharmacy Market – Key Takeaways

Regional Insights: North America led the market in 2024, accounting for 44.13% of total revenue.
By Compounding Type: The PIA segment emerged as the top contributor, capturing 38% of the market share in 2024.
By Sterility: Sterile preparations dominated the segment, holding a 58.8% share in 2024.
By Age Group: The adult segment generated the highest revenue share at 44.5% in 2024.
By Therapeutic Area: Pain management remained the leading application, representing 33.6% of revenue in 2024.

Global Compounding Pharmacy Market Top Companies

Fresenius Kabi
Fagron NV
B. Braun Medical Inc.
Rx3 Compounding Pharmacy
Clinigen Group PLC
Dougherty's Pharmacy, Inc.
Lorraine's Pharmacy
Wedgewood Pharmacy
Institutional Pharmacy Solutions
Mcguff compounding pharmacy services

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Global Compounding Pharmacy Market Insights

The global compounding pharmacy market is witnessing steady growth, fueled by rising demand for personalized medicines, increasing prevalence of chronic diseases, and frequent shortages of commercially manufactured drugs. Valued at around USD 16.92 billion in 2024, the market is projected to reach USD 31.77 billion by 2034, expanding at a CAGR of approximately 6.50% during the forecast period.

North America continues to dominate the global market, accounting for more than 44%13 of total revenue in 2024. The region’s strong regulatory framework, growing geriatric population, and increasing adoption of customized formulations have significantly contributed to its leadership. Meanwhile, Asia-Pacific is emerging as the fastest-growing regional market, driven by expanding healthcare infrastructure, rising awareness of personalized therapies, and supportive government initiatives.

From a product perspective, oral medications represent the largest share of compounded drugs, given their widespread use and patient convenience. However, demand for injectable and topical formulations is also rising, especially in critical care and dermatology. By compounding type, the Pharmaceutical Ingredient Alteration (PIA) segment leads the market, meeting the growing need for adjusted dosages and formulations tailored to specific patients.

In terms of sterility, sterile compounding is gaining traction globally, capturing a major portion of market revenue in 2024 due to the increasing use of injectables in hospitals and specialty clinics. Adult patients remain the primary consumers of compounded medications, though the pediatric segment is gaining attention as compounding addresses challenges with dosing and formulation for children.

By therapeutic area, pain management continues to dominate the market, supported by the rising incidence of chronic pain, musculoskeletal disorders, and post-surgical recovery needs. Other key therapeutic applications include hormone replacement therapy, dermatology, and oncology support care, all of which are contributing to market expansion.

Looking ahead, the global compounding pharmacy market will be shaped by advancements in pharmaceutical compounding technologies, growing investment in 503A and 503B pharmacy services, and regulatory oversight that ensures safety and efficacy. The increasing shift toward patient-centric healthcare models and demand for alternative formulations will further accelerate growth across developed and emerging regions.

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Why Compounding Pharmacies Matter: Guidelines and Regulatory Support?

The Cooperative of American Physicians stated the importance of compounding pharmacies for safe and effective treatment. It has been reported that compounding medications are effective for patients having issues with commercially available drugs.

The United States Pharmacopeia (USP) Convention states compounding as the preparation, mixing, device, or any other form of a licensed medical order and prescription in professional medical practice. The U.S. government and the federal register announced various activities related to human drug compounding, repackaging, and related purposes. These activities are also related to sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

In May 2025, Novo Nordisk announced the accessibility of FDA-approved Wegovy to patients in order to protect them from illegal and illicit effects of compounded semaglutide. (Source: https://www.prnewswire.com)

U.S. Compounding Pharmacies Market Segmentation Analysis:

Pharmacy Type Analysis:

How 503A Segment Dominated the U.S. Compounding Pharmacies Market in 2024?

The 503A segment dominated the U.S. compounding pharmacies market in 2024, owing to several key benefits of these traditional compounding pharmacies in meeting the specific needs of patients better than commercially available drugs. These pharmacies are popular because they offer customized medications, alternative dosage forms, flavors, etc.

The 503B segment is expected to grow at the fastest CAGR in the U.S. compounding pharmacies market during the forecast period due to the potential role of these outsourcing facilities in addressing drug shortages, ensuring high-quality medications, and offering cost-effective medication solutions. They implement safety standards while ensuring cost-savings, efficiency, expertise, and specialized services.

Product Analysis:

What made Oral Medications the Dominant Segment in the U.S. Compounding Pharmacies Market in 2024?

The oral medications segment dominated the U.S. compounding pharmacies market in 2024 owing to the ease of administration, variety of forms, and reduced need for healthcare visits. They facilitate the reliable absorption of medications, effective medical treatment, and controlled release of medicinal drugs.

The liquid preparations segment is expected to grow at the fastest CAGR in the U.S. compounding pharmacies market during the forecast period due to the suitable nature of medications for patients with swallowing difficulties and options for flexible dosing. They introduce improved palatability, enhanced stability, and specific therapeutic benefits.

Sterility Analysis:

How did the Non-Sterile Segment Dominate the U.S. Compounding Pharmacies Market in 2024?

The non-sterile segment dominated the U.S. compounding pharmacies market in 2024 owing to the personalized treatment options, increased need to address medication shortages, and access to alternative dosage forms. These can meet specific needs of patients and children, especially patients with allergies and sensitivities.

The sterile segment is expected to grow at the fastest CAGR in the U.S. compounding pharmacies market during the forecast period due to the benefits of sterile pharmacies, including customized medications and unique formulations. They reduce the risk of contamination and infection and enhance patient safety.

Compounding Type Analysis:

How Pharmaceutical Dosage Alteration (PDA) Segment Dominated the U.S. Compounding Pharmacies Market in 2024?

The pharmaceutical dosage alteration (PDA) segment dominated the U.S. compounding pharmacies market in 2024 owing to the advantages of pharmaceutical dosage forms, which include improved patient adherence, convenience, enhanced safety, and efficacy. They reduce side effects, target precise drug delivery, protect drug substances, and prevent dose dumping.

Therapeutic Area Analysis:

What made Pain Management the Dominant Segment in the U.S. Compounding Pharmacies Market in 2024?

The pain management segment held a significant share in 2024 and is observed to grow at the fastest rate in the U.S. compounding pharmacies market during the forecast period. Effective pain management reduces pain intensity, improves physical function, and enhances mental and emotional health. It also improves the quality of life, independence, and self-management.

End-User Analysis:

How did the Hospitals and Clinics Segment Dominate the U.S. Compounding Pharmacies Market in 2024?

The hospitals and clinics segment dominated the U.S. compounding pharmacies market in 2024 because they deliver comprehensive care, advanced technology, and expertise. They are beneficial in terms of personalized care, relationships, cost-effectiveness, and preventive care.

The specialty clinics segment is expected to grow at the fastest CAGR in the U.S. compounding pharmacies market during the forecast period due to improved outcomes, integrated and coordinated care, and enhanced patient satisfaction. They provide access to expertise and allow targeted and personalized treatment.

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U.S. Compounding Pharmacies Market Top Companies

Fagron
ITC Compounding Pharmacy
Fresenius Kabi
Central Admixture Pharmacy Services
Dougherty's Pharmacy, Inc.
Nephron Pharmaceuticals Corporation
QuVa Pharma, Inc.
B. Braun
McGuff Compounding Pharmacy Services, Inc.
Pencol Compounding Pharmacy
Rx3 Compounding Pharmacy
Wedgewood Village Pharmacy, LLC
Clinigen Group Plc
Triangle Compounding Pharmacies
Athenex, Inc.
Avella Specialty Pharmacy
Fagron compounding pharmacies
Fusion Apothecary
Apollo Clinical Pharmacy
Aurora Compounding Pharmacy

What is Going Around the Globe?

In November 2024, Fagron announced a collaboration with the Pharmaceutical Supply Chain Initiative (PSCI) to encourage responsible value chain practices in the pharmaceutical industry. (Source: https://fagron.com)
In August 2024, Fresenius Kabi reported the innovations in aseptic compounding and their open access to qualified and trained pharmacists and technicians who are dedicated towards preparing injectable and other sterile products for individual patient use. (Source: https://hospitalprofessionalnews.ie)

U.S. Compounding Pharmacies Market Segments Covered in the Report

By Pharmacy Type

503A
503B

By Product

Oral Medications
- Capsules
- Granules
- Tablets
- Powder
- Others
Liquid Preparations
- Emulsion
- Syrup
- Solutions
- Suspension
- Others
Topical
- Gels
- Ointments
- Creams
- Pastes
- Others
Rectal
- Enema
- Suppositories
- Others
Ophthalmic
Nasal
Otic

By Sterility

Sterile
Non-Sterile

By Compounding Type

Pharmaceutical Ingredient Alteration (PIA)
Currently Unavailable Pharmaceutical Manufacturing (CUPM)
Pharmaceutical Dosage Alteration (PDA)
Others

By Therapeutic Area

Hormone Replacement
Pain Management
Dermatology
Pediatrics
Urology
Others

By End-User

Hospitals and Clinics
Specialty Clinics
Others

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