The North America Sterile Compounding Pharmacies Market 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 and the Growth of North America Sterile Compounding Pharmacies Market

Personalized medicine has gained significant traction in recent years due to its ability to tailor drug delivery and dosing to individual patient needs. According to the Personalized Medicine Coalition, over a quarter of new therapeutics approved since 2015 fall under this category. In 2020, the FDA’s Center for Drug Evaluation and Research (CDER) approved 53 new molecular entities (NMEs), 49 of which were therapeutics. Among these, 19 (39%) were personalized medicines—the highest proportion since 2018, when they accounted for 42% of new NME approvals.

North America Sterile Compounding Pharmacies Market play a crucial role in personalized medicine by providing customized formulations that FDA-approved drugs cannot offer. These pharmacies prepare tailored injectable medications, adjusting dosages, strengths, and administration routes to meet specific patient needs—such as eliminating allergens or accommodating unique treatment responses. As demand for precision therapies grows, sterile compounding has become a key revenue driver, with major market players increasingly focusing on innovation and strategic expansion to capitalize on this trend in North America.

Impact of COVID-19 on North America Sterile Compounding Pharmacies Market

The pandemic placed unprecedented strain on healthcare systems, with community and hospital compounding units facing significant operational challenges. Increased demand for PPE and supply chain disruptions forced many facilities to adapt their sterile compounding practices to maintain safety and compliance. The United States Pharmacopeia (USP) issued new guidelines to address these challenges, helping pharmacies navigate equipment shortages and shifting demands.

Additionally, supply chain disruptions—reported by entities like the Government of Canada—hindered critical services such as equipment calibration and maintenance, further complicating operations. These factors have profoundly influenced the sterile compounding market, accelerating the need for resilient and adaptive strategies.

Strategic Insights for North America Sterile Compounding Pharmacies Market

To thrive in this evolving landscape, stakeholders must leverage data-driven insights to identify emerging trends, untapped opportunities, and competitive differentiators. Key strategies include:

  • Market Adaptation: Anticipate shifts in demand, particularly in precision medicine and pandemic-responsive compounding.
  • Innovation & Expansion: Invest in advanced sterile compounding technologies and explore inorganic growth through partnerships or acquisitions.
  • Supply Chain Resilience: Develop robust logistics networks to mitigate disruptions and ensure consistent access to critical materials.
  • Regulatory Compliance: Stay ahead of evolving guidelines from organizations like USP to maintain operational integrity.

By adopting a forward-looking approach, industry players—whether investors, manufacturers, or pharmacies—can position themselves for long-term success in North America Sterile Compounding Pharmacies Market. Strategic decision-making, guided by actionable insights, will be essential to driving profitability and achieving sustainable growth.

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

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Business Market Insights is a market research platform that provides subscription service for industry and company reports. Our research team has extensive professional expertise in domains such as Electronics & Semiconductor; Aerospace & Defense; Automotive & Transportation; Energy & Power; Healthcare; Manufacturing & Construction; Food & Beverages; Chemicals & Materials; and Technology, Media, & Telecommunications.

Author’s Bio:

Suryakant Gadekar

Senior Market Research Expert at Business Market Insights