U.S. Compounding Pharmacies Market, Opportunity, Growth Drivers, Industry Trend Analysis and Forecast, 2025-2034

U.S. Compounding Pharmacies Market was valued at USD 6 billion in 2024 and is estimated to grow at a CAGR of 6.2% to reach USD 10.8 billion by 2034, fueled by increasing demand for customized medications, a growing aging population, and rising instances of drug shortages. Compounding pharmacies play a critical role in preparing personalized medications that are not commercially available, addressing unique patient needs related to dosage form, strength, allergies, and discontinued drugs.

The growing prevalence of chronic conditions, such as cancer, hormonal imbalances, and autoimmune disorders, is also boosting the adoption of compounded medications. Healthcare providers are increasingly prescribing compounded therapies to improve patient adherence and therapeutic outcomes. Additionally, regulatory support from the U.S. Food and Drug Administration (FDA) and pharmacy boards is fostering innovation in compounding practices while simultaneously enhancing safety and quality standards.

By sterility, the sterile compounding segment dominated the U.S. market in 2024, generating USD 1.8 billion. Sterile compounding is vital for producing injectables, ophthalmic solutions, and intravenous (IV) medications, especially for patients requiring hospital-based or critical care treatments. The rise in hospital-acquired infections and the need for preservative-free formulations are further contributing to the demand for sterile compounded drugs. Compliance with United States Pharmacopeia (USP) standards, such as USP <797> and USP <800>, is reinforcing the safety and efficacy of sterile preparations, strengthening market confidence.

By product type, oral medications emerged as the leading segment, accounting for 33.1% market share in 2024. Oral compounded drugs, including capsules, tablets, lozenges, and suspensions, are widely used due to ease of administration and high patient acceptability. Pediatric and geriatric populations particularly benefit from custom-flavored, dosed, and form-altered medications. Pharmacies are also expanding services for hormone replacement therapy (HRT), pain management, and veterinary care—further broadening the market scope for oral compounding solutions.

Regionally, the U.S. market remains highly fragmented, with a mix of 503A traditional compounding pharmacies and 503B outsourcing facilities. The outsourcing model is gaining traction among hospitals and healthcare systems looking for large-scale, FDA-compliant sterile preparations. Investments in advanced cleanroom infrastructure, automated compounding technology, and digital prescription platforms are helping compounding pharmacies improve productivity and traceability.

Key players such as Fagron, PCCA, B. Braun Medical Inc., Nephron Pharmaceuticals Corporation, and PharMEDium (a part of AmerisourceBergen) are actively expanding their compounding capabilities through strategic acquisitions, R&D investments, and compliance with evolving regulatory frameworks. These companies are focusing on enhancing product quality, scalability, and service offerings to cater to the growing and diverse needs of patients, hospitals, and healthcare providers across the United States.

With continued advancements in pharmaceutical technology, rising healthcare personalization, and supportive regulatory oversight, the U.S. Compounding Pharmacies Market is poised for sustained growth throughout the forecast period.