The Sterile Compounding Pharmacies Market in North America is expected to grow from US$ 1,997.45 million in 2021 to US$ 3,218.93 million by 2028; it is estimated to grow at a CAGR of 7.1% from 2021 to 2028.
Personalized medicine has gained significant attention due to its specific drug delivery and dosing capabilities. According to the report published by Personalized Medicine Coalition, personalized medicines accounted for more than a quarter of all new therapeutics approved since 2015. For instance, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) approved 53 new molecular entities (NMEs) in 2020. Among the 49 therapeutics NMES, 19 (almost 39%) are personalized medicines.
North America Sterile Compounding Pharmacies Market Segmentation
North America Sterile Compounding Pharmacies Market – By Product
- Injectable Drugs
- Infusions
North America Sterile Compounding Pharmacies Market – By Route of Administration
- Intravenous
- Intramuscular
- Subcutaneous
North America Sterile Compounding Pharmacies Market– By Country
- US
- Canada
- Mexico
North America Sterile Compounding Pharmacies Market-Companies Mentioned
- Avella Specialty Pharmacy
- B. Braun Melsungen AG
- Fagron, Inc.
- Fresenius Kabi AG
- Pace Pharmacy
- Pavilion Compounding Pharmacy, LLC.
- Pencol Compounding Pharmacy
- PharMEDium Healthcare Holdings, Inc.
- SandsRx
- Triangle Compounding Pharmacy
North America Sterile Compounding Pharmacies Market Overview
The demand for personalized medicine continues to rise, with 42% of newly approved New Molecular Entities (NMEs) in 2018 classified as personalized treatments. Sterile compounding medications have emerged as a crucial alternative to traditional pharmacy compounding, particularly for addressing patient-specific medical needs that FDA-approved drugs cannot fulfill. These pharmacies provide customized formulations, including injectable drugs, through various administration routes, tailoring dosages to patient requirements. This customization allows for the removal of allergens present in FDA-approved drugs and offers solutions for patients who do not respond to standard treatments or require alternative strengths and administration methods. As compounding plays a vital role in personalized medicine, the increasing demand for precision therapies has created new revenue opportunities for sterile compounding pharmacies. Key industry players are actively pursuing inorganic growth strategies to drive innovation and enhance product efficiency, further propelling market expansion in North America.
Impact of COVID-19 on Sterile Compounding Pharmacies Market in North America
During the COVID-19 pandemic, both community and hospital-based compounding units played a significant role in managing healthcare demands. However, the increased need for personal protective equipment (PPE) and other essential supplies strained hospitals’ ability to maintain sterile compounding operations. In response, the United States Pharmacopeia (USP) issued new guidance to address operational challenges in sterile compounding during the crisis. The level of adjustment required varied across institutions, with hospitals struggling to navigate equipment shortages. Additionally, the Government of Canada reported that pandemic-related disruptions in supply chains and limited access to contract service providers hindered essential tasks such as external calibration and specialized equipment maintenance. These challenges significantly impacted the sterile compounding pharmacy market.
Strategic Insights for the North America Market
Strategic insights into the North American sterile compounding pharmacy market provide a data-driven analysis of industry trends, key players, and regional factors. These insights help stakeholders—ranging from investors to manufacturers—identify untapped market segments and develop unique value propositions. By leveraging data analytics, industry participants can anticipate market shifts and position themselves for long-term success. A forward-thinking approach is crucial in this dynamic sector, enabling stakeholders to make informed decisions that enhance profitability and drive growth.
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Author’s Bio:
Suryakant Gadekar
Senior Market Research Expert at Business Market Insights