U.S. INJECTABLE COMPOUNDING PHARMACY MARKET ANALYSIS

Market Challenges And Opportunities

• Product recalls

U.S. Injectable Compounding Pharmacy Market - Drivers

• Growing prevalence of chronic diseases: The increasing burden of chronic diseases in the U.S. is expected to drive the injectable compounding pharmacy market growth over the forecast period. For instance, in May 2023, according to the data published by the Centers for Disease Control and Prevention, in 2023 at least six in ten Americans live with one chronic disease and four in ten adults with two or more. This escalating prevalence of chronic diseases, such as diabetes, cardiovascular disorders, and cancer, serves as a major driver for the U.S. injectable compounding pharmacy market growth. These conditions often demand individualized medication regimens, dosage adjustments, or alternative formulations due to patient-specific factors. Injectable compounding pharmacies play a vital role in meeting these specialized requirements, as they can prepare tailored injectable medications to address diverse patient needs. Thus, with a rise in the incidence of chronic diseases, the demand for these pharmacies is expected to rise, making them indispensable in providing precise and effective treatments for individuals living with chronic health conditions.
• Advancements in drug delivery methods: Advancements in drug delivery methods are a significant driver of the U.S. injectable compounding pharmacy market growth. These innovations have enabled the development of complex and specialized injectable medications that cater to patient-specific needs. For instance, on October 02, 2023, Enable Injections, Inc., a U.S.-based medical equipment manufacturing company, announced that the U.S. Food and Drug Administration (FDA) had approved EMPAVELI Injector (enFuse), a wearable injector for the subcutaneous delivery of EMPAVELI. Such innovative delivery technologies enhance the precision and safety of drug administration. Compounding pharmacies leverage these advancements to create customized injectables, meeting the rising demand for tailored therapies. As a result, they play a pivotal role in translating cutting-edge drug delivery techniques into practical solutions, and thus attracting healthcare providers and patients seeking optimized treatment options.

U.S. Injectable Compounding Pharmacy Market: Key Developments

• In June 2023, the U.S. FDA registered 503B outsourcing company Leiters Health, which offers pharmacy services and compounded sterile preparations, announced the rebranding of its business to better reflect the company’s expanding market dominance in the healthcare industry and planned strategic growth. A new corporate logo, Quality Compounding for Life, and a name change to Leiters Health are the three main components of this rebranding.
• In July 2020, Piramal Critical Care (PCC), a manufacturer of inhalation anesthesia products, entered into a strategic partnership with Medivant Healthcare, a U.S.-based pharmaceutical outsourcing facility, for addressing severe shortage of injectable drugs in hospitals across the U.S. The companies focused on the distribution of single-dose injectable drugs in all approved states of the U.S. that had fallen dangerously in shortage of the supply of drugs, for the treatment of COVID-19 patients.

U.S. Injectable Compounding Pharmacy Market: Restraints

• Product recalls: Product recalls can significantly constrain the U.S. injectable compounding pharmacy market, leading to reputational damage, financial losses, and regulatory scrutiny. Such events erode trust and compromise patient safety, as they often result from quality control issues, non-compliance with regulations, or contamination incidents, necessitating stringent preventive measures and corrective actions. For instance, in April 2020, QuVa Pharma Inc., a U.S.-based compounding pharmacy, recalled the entire batch of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac which was obtained from Fresenius Kabi due to the presence of particulate matter in the reserve sample vials.
• Counterbalance: Manufacturers must focus on the quality of production and adhere to current good manufacturing practices (CGMP) to avoid contamination in drugs.