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. This is the highest percentage since 2018, where personalized medicines accounted for 42% of the newly approved NMEs. Sterile compounding medications act as the best alternative for traditional pharmacy compounding practices, especially for meeting specific medical needs of patients that the FDA-approved drugs cannot meet. For example, sterile compounding pharmacies offer customized (personalized) formulations, such as injectable drugs, via different administration routes to create dosages as per patients' requirements related to strengths or forms that can eliminate components of FDA-approved drugs that patients are allergic to. Moreover, in some cases, where patients do not respond to traditional forms of treatment or need a different administration route with diverse strengths, sterile products fulfill these needs by offering customized patient solutions. With compounding being considered an essential part of customized medicine, the accelerating demand for precision therapies in recent years has opened new revenue streams for sterile compounding pharmacies. Several key players have begun to focus on inorganic growth strategies for innovating and developing efficient products, which is further anticipated to drive the market in North America.
Both community and hospital compounding units were heavily involved in managing the COVID-19 pandemic. The increased demand for personal protective equipment (PPE) and other supplies has left many hospitals struggling to maintain the integrity and safety of their sterile compounding operations. Also, during the pandemic situation, United States Pharmacopeia (USP) published a new guidance document addressing operational concerns regarding sterile compounding during the COVID-19 crisis. Hospitals are taking seriously the need to adjust their approaches to sterile compounding due to COVID-19 related equipment shortages. The degree of adjustment needed varies widely from day to day and institution to institution. Apart from that, as per the report released by the Government of Canada, the pandemic has created a number of challenges for businesses. For example, disruptions in supply chain and distribution chains and the limited availability of contract service providers affect the ability to perform tasks such as external calibration and specialized equipment maintenance. Thus, the aforementioned factors have highly impacted the sterile compounding pharmacies market.
North America Sterile Compounding Pharmacies Market Revenue and Forecast to 2028 (US$ Million)
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 Strategic Insights
North America Sterile Compounding Pharmacies Market Report Highlights
| Report Attribute | Details |
| Market size in 2021 | US$ 1,997.45 Million |
| Market Size by 2028 | US$ 3,218.93 Million |
| CAGR (2021 - 2028) | 7.1% |
| Historical Data | 2019-2020 |
| Forecast period | 2022-2028 |
| Segments Covered |
By Product
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Regions and Countries Covered
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| North America | US, Canada, Mexico |
| Market leaders and key company profiles |
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North America Sterile Compounding Pharmacies Market Country and Regional Insights
