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
Strategic Insights: North America Sterile Compounding Pharmacies Market
Market Drivers & Growth Opportunities
The sterile compounding pharmacies market in North America is expanding due to rising demand for personalized medicine. In 2018, 42% of newly approved New Molecular Entities (NMEs) were personalized therapies—a trend that continues to accelerate. Sterile compounding addresses unmet needs by creating customized formulations (e.g., injectables, allergy-adjusted dosages) when FDA-approved drugs fall short. This includes altering administration routes, strengths, or removing allergens, offering critical solutions for patients unresponsive to traditional therapies. As precision medicine gains traction, sterile compounding pharmacies are tapping into new revenue streams, with key players pursuing inorganic growth strategies (e.g., partnerships, acquisitions) to innovate and scale operations.
COVID-19 Impact & Operational Challenges
The pandemic underscored the vital role of sterile compounding. Hospitals and community pharmacies faced heightened demand for PPE and medications, straining sterile compounding workflows. Supply chain disruptions (e.g., delayed equipment maintenance, calibration) further complicated operations, particularly in Canada. The United States Pharmacopeia (USP) released guidelines to address compounding safety during resource shortages, prompting hospitals to adopt adaptive strategies. These challenges highlighted vulnerabilities in supply chains and operational agility, emphasizing the need for resilient infrastructure.
Strategic Recommendations for Stakeholders
- Leverage Data-Driven Insights: Analyze regional trends, competitor activities, and patient needs to identify underserved niches (e.g., pediatric or oncology-focused formulations).
- Invest in Innovation: Prioritize R&D for advanced sterile technologies (e.g., robotics, precision dosing) to enhance efficiency and compliance.
- Strengthen Supply Chains: Diversify suppliers and adopt digital tools for real-time inventory tracking to mitigate future disruptions.
- Collaborate for Growth: Pursue partnerships with healthcare providers or tech firms to expand service offerings and geographic reach.
Future Outlook
The market’s trajectory hinges on anticipating shifts in healthcare demand, regulatory changes, and technological advancements. Stakeholders must adopt a proactive, patient-centric approach to differentiate themselves—whether through hyper-customized therapies, sustainability initiatives, or rapid response capabilities. By aligning strategic investments with emerging trends, businesses can secure long-term growth in this dynamic sector.
Why This Matters:
These insights empower stakeholders to navigate complexity, capitalize on unmet needs, and build competitive advantage in a market poised for transformation.
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Author’s Bio:
Suryakant Gadekar
Senior Market Research Expert at Business Market Insights
