U.S. 503B Compounding Pharmacies Market Growth Strategies, SWOT Analysis, key Insights: Central Admixture Pharmacy Services, Nephron Pharmaceuticals Corporation, QuVa Pharma

In the U.S. 503B compounding pharmacies market, conventional compounding pharmacies operate without the supervision of the U.S. Food and Drug Administration (FDA). The State Boards of Pharmacy regulate the conventional compounding, also known as ‘within border’ compounding. The U.S. Pharmacopeia (USP) has set the standard pharmacy compounding practices in most U.S. states. Compounding pharmacies operate in five formats: independent stores, compounding departments in hospital, part of a big retail drug manufacturer chain, store with an online order-delivery system, and multiple-location shops. In the U.S., compounding pharmacies are majorly found in independent store format.

The U.S. 503B Compounding Pharmacies Market has accounted for US$ 919.0 Mn in 2020, and is expected to reach US$ 1,508.1 Million by 2028, growing at a CAGR 7.3% during the forecast period 2021 to 2028.

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Rising drug shortages in the U.S lead to an increased demand of new drugs which is expected to drive growth of the U.S. 503B compounding pharmacies market during the forecast period. For instance, according to the American Society of Health-System Pharmacists (ASHP) during 2020, significant shortages of sedatives, paralytics, and analgesics were observed by hospitals, out of which half of new shortages were for injectable.

Major Market Competitors

Central Admixture Pharmacy Services, Inc., Nephron Pharmaceuticals Corporation, QuVa Pharma, Olympia Pharmacy, ASP Cares, Fagron Compounding Pharmacies, Athenex, Inc., Avella Specialty Pharmacy, Atlas Pharmaceuticals, Empower Pharmacy, Carie Boyd’S Prescription Shop, Edge Pharma, Imprimis NJOF, LLC, IntegraDose Compounding services, LLC, Wells Pharma of Houston, LLC, US Compounding Inc., and SCA Pharma

Increasing product launches and approvals are expected to propel the market growth of U.S. 503B compounding pharmacies market. For instance, in January 2020, Fagron Compounding Pharmacies launched the ready-to-use OR syringes for hydromorphone. All OR Syringes are clearly labeled while adhering to American Society for Testing and Materials (ASTM), Drug Quality and Security Act (DQSA) and Institute for Safe Medication Practices’ (ISMP) medication and anesthesia labeling standards.

Market players are engaged in marketing strategies such as collaborations, mergers, acquisitions and expansion of companies, which are expected to drive growth of the U.S. 503B compounding pharmacies market. For instance, in 2017, Edge Pharma expanded its manufacturing facility in New York, U.S. The company invested approximately US$ 1.5 million for the expansion of the production facility. Moreover, in 2016, Empower Pharmacy inaugurated a new 15,000 square foot facility. The new facility meets the Good Manufacturing Practices (cGMP) requirements and has a 24 square foot GMP lyophilizer, a 200 square foot ISO-5 suite, and a 300 square foot United States Pharmacopeia (USP) 800-compliant hazardous drug cleanroom.

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