The global U.S. compounding pharmacy market size in 2024 was US$ 6.57 billion, expected to grow to US$ 6.98 billion in 2025 and further to US$ 12.02 billion by 2034, backed by a robust CAGR of 6.24% between 2025 and 2034.
Focus on developing novel formulations, delivery systems, and bioidentical therapies tailored to patient needs. Activities include stability studies, safety profiling, and compatibility testing of active pharmaceutical ingredients (APIs).
Organizations: Compounding pharmacies’ in-house R&D units, academic research centers, pharmaceutical ingredient suppliers, and technology partners working on automated compounding systems.
While compounded drugs are not FDA-approved like commercial drugs, they must comply with USP standards (USP <795>, <797>, <800>) and FDA oversight for 503A and 503B pharmacies. Quality assurance involves sterility testing, batch testing, and adherence to Current Good Manufacturing Practices (CGMP) in outsourcing facilities.
Organizations: U.S. Food and Drug Administration (FDA), United States Pharmacopeia (USP), state pharmacy boards, and 503B outsourcing facilities.
Services include customized dosage adjustments, allergen-free formulations, telehealth consultations, and direct-to-patient or hospital delivery. Pharmacies provide ongoing patient education, refill reminders, therapy monitoring, and adverse event reporting to ensure safety and adherence.
Organizations: Compounding pharmacies (503A and 503B), hospitals, specialty clinics, telehealth providers, and patient advocacy groups supporting awareness of personalized therapies.
In May 2025, the Chairman and CEO of LifeMD, stated that LifeMD, Inc., a leading virtual primary care provider has announced a special US$299 introductory bundle for new self-pay patients who are prescribed Wegovy (semaglutide). This bundle includes both the prescription drugs and the ability to use LifeMD's online weight-loss program. In light of April, LifeMD announced a partnership with Novo Nordisk to offer Wegovy at a discounted price of US$199. An extra US$100 will cover LifeMD's clinical care, onboarding, and maintenance.
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