The U.S. injectable compounding pharmacy market provides customized medication for patients who cannot use commercially available pharmaceutical drugs owing to allergies or lack of suitable dosage forms. Compounded sterile preparations play a vital role in healthcare by providing patients access to therapies tailored to their needs. The increasing availability of specialized compounding services for complex injectable formulations is also driving the demand for compounding pharmacies.
The U.S. injectable compounding pharmacy market is estimated to be valued at US$ 1747.98 Mn in 2024 and is expected to exhibit a CAGR of 4.8% over the forecast period 2024 to 2031.
The need for sterile compounded drugs is increasing rapidly due to growing elderly population suffering from chronic diseases in the country. Moreover, compounding pharmacies are able to cater to patients’ unmet medical needs by providing them access to alternative dosage forms and routes of administration not commercially available for branded drugs.
Key Takeaways
Key players operating in the U.S. Injectable Compounding Pharmacy Market Demand are PerkinElmer, LabLogic Systems Ltd., Hidex Oy, Intertechnique, LabLogic Systems Limited, AMETEK Inc, Beckman Coulter Inc, Berthold Technologies GmbH & Co. KG, Bio-Rad Laboratories Inc., Hach. These players are focusing on expanding their product portfolios and service offerings through collaborations with large chain pharmacies and hospitals.
Major opportunities in the market include increasing demand for antibiotic suspensions, pain management medications, and hormone therapy formulations. In addition, growing geriatric population suffering from arthritis, cancer and other chronic conditions requiring customized injectable drugs presents an opportunity for compounding pharmacists.
Key players are also exploring opportunities in global markets by establishing compounding facilities in various regions. For instance, Fresenius Kabi opened new injectable compounding pharmacies in Canada and UK to cater to international demand. Other players are expanding in Asia Pacific and Latin America through strategic partnerships with local pharmaceutical suppliers.
Market Drivers:
Rise in specialized services: Compounding pharmacy services for complex injectable preparations such as chemotherapy drugs, total parenteral nutrition, and epidural injections are witnessing high demand. This is a major market driver.
Market Restraints:
Stringent regulations: Regulatory environment for compounding pharmacies is stringent in the U.S. due to FDA guidelines. Complying with these regulations increases operating costs, thus restraining market growth.
Segment Analysis
The U.S. injectable compounding pharmacy market is dominated by the 503B outsourcing facilities segment owing to the fact that these facilities provide sterile compounded drugs directly to hospitals, clinics and patient care facilities. 503B outsourcing facilities undergo strict cGMP regulations and quality testing set by the FDA to ensure the safety of compounded drugs dispensed. Their ability to mass produce large volumes of sterile drugs in a controlled environment and deliver to healthcare centers makes them an attractive option compared to in-house compounding by individual healthcare facilities.
Global Analysis
The North America region holds the largest share in the global injectable compounding pharmacy market due to stringent regulatory norms governing sterile compounding and a zero-tolerance policy towards contamination. The presence of leading 503B outsourcing facilities like Advanced Pharma, Fagron and Institutional Compounding Pharmacy catering to the demands of hospitals and infusion centers predominantly drives the North America market.Asia Pacific is anticipated to exhibit the fastest growth over the forecast period owing to rising healthcare infrastructure, increased acceptance of customized medicines and growing geriatric population susceptible to chronic diseases.
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