U.S. INJECTABLE COMPOUNDING PHARMACY MARKET ANALYSIS

The U.S. injectable compounding pharmacy market is estimated to be valued at US$ 1,516.3 Mn in 2023 and is expected to exhibit a CAGR of 7.3% during the forecast period (2023-2030). Advancements in drug delivery methods and the growing prevalence of chronic diseases are likely to increase the demand for injectable compounded medications in the U.S.

Analysts’ Views on U.S. Injectable Compounding Pharmacy Market:

The U.S. injectable compounding pharmacy market is poised for significant growth in the near future. Several key factors contribute to this positive outlook. Firstly, the increasing demand for personalized medicine and customized drug formulations is driving the market growth. Patients with unique medical needs, allergies or those requiring specific dosages benefit from tailored solutions provided by compounding pharmacies. Furthermore, the ongoing drug shortages in the pharmaceutical industry has underscored the importance of these facilities, as they can step in to address supply gaps and ensure patients have access to vital medications.

Figure 1. U.S. Injectable Compounding Pharmacy Market Share (%), By Packaging Type, 2023

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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 – Impact of Coronavirus (COVID-19) Pandemic

• Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe, and the World Health Organization (WHO), declared it a public health emergency on January 30, 2020.
• COVID-19 has affected the economy in three main ways: by directly affecting the production and demand for medical devices, by creating disruptions in modality, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries such as China, India, Saudi Arabia, UAE, Egypt, and others faced problems regarding the transportation of medical devices from one place to another.
• The COVID-19 pandemic significantly impacted the U.S. injectable compounding pharmacy market as well. These specialized pharmacies are essential in customizing medications for patients with unique needs, and their role became even more critical during the pandemic.
• Firstly, there was a rise in demand for certain medications, particularly those which were used in intensive care and respiratory support for COVID-19 patients such as hydroxychloroquine and others. Injectable compounding pharmacies played a pivotal role in ensuring a stable supply of these critical drugs. They responded by increasing the production and tailoring medications to meet the evolving needs of healthcare facilities.
• Secondly, the pandemic exposed vulnerabilities in the pharmaceutical supply chain like inability to meet sudden surge in drug demands, forcing healthcare providers to turn to compounding pharmacies for sourcing essential drugs. This shift in demand created pressure on these pharmacies to meet the supply gap, emphasizing their role as a reliable source of medications during crisis.
• To facilitate patient care, regulatory agencies, including the U.S. Food and Drug Administration (FDA), temporarily relaxed certain restrictions on compounding pharmacies. For instance, in July 2021, according to an article published by the University of Minnesota, the U.S. FDA issued temporary rules in April 2020 that allowed 503As to compound COVID-related medications without a specific prescription, by not only creating necessary copies of medications, but also required them to report about the adverse events to the U.S. FDA within 15 days and to have a shorter beyond-use date. These regulatory changes expedited the production and distribution of crucial medications, allowing compounding pharmacies to adapt quickly to the evolving healthcare landscape.
• Moreover, the pandemic accelerated the integration of telehealth services. Compounding pharmacies established remote consultation and prescription delivery services, ensuring that the patients' needs were met while adhering to social distancing measures.

Figure 2. U.S. Injectable Compounding Pharmacy Market Share (%), By Pharmacy Type, 2023

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U.S. Injectable Compounding Pharmacy Market Segmentation:

U.S. injectable compounding pharmacy market is segmented into molecule, packaging type, and pharmacy type.

• Based on molecule type, the U.S. injectable compounding pharmacy market is segmented into acetaminophen, phenylephrine, midazolam, esmolol, vancomycin, epinephrine, adenocaine, fentanyl/bupivacaine, morphine, amiodarone, fentanyl, heparin, ketamine, dextrose, hydromorphone, bupivacaine, lidocaine, BKK (bupivacaine, ketorolac, ketamine), RCK (ropivacaine, clonidine, ketorolac), RKK (ropivacaine, ketorolac, ketamine), norepinephrine, diltiazem, vasopressin, and others.
• Based on packaging type, the market is segmented into vials, ampoules, prefilled syringes, and others. Out of which, the prefilled syringes segment is expected to dominate the market over the forecast period due to low risk of cross-contamination with the use of sterile prefilled syringes.
• Based on pharmacy type, the market is segmented into 503A pharmacies and 503B pharmacies. Out of which, the 503B pharmacies segment is expected to dominate the market over the forecast period owing to a higher level of quality assurance and consistency in drug compounding.
• Among all the segmentation, 503B pharmacies segment has the highest potential due to increasing launches of 503B pharmacies by key pharmaceutical companies. For instance, in January 2022, Hikma Pharmaceuticals PLC, a U.K.-based multinational pharmaceutical company, launched the Hikma 503B pharmacy business. The new outsourced sterile compounding company aims at offering high-quality and ready-to-administer injectable pharmaceuticals that are adapted to patients' particular needs in the U.S.

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: Trends

• Acquisition by key market players: Key players in the market are focusing on inorganic growth strategies to increase their market penetration. For instance, in July 2023, Revelation Pharma, a national network of 503a and 503b compounding pharmacies, acquired Lee Silsby Compounding Pharmacy, a U.S.-based 503A compounding pharmacy.

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.

U.S. Injectable Compounding Pharmacy Market: Key Players

Major players operating in the U.S. injectable compounding pharmacy market include Central Admixture Pharmacy Services, Inc., Nephron Pharmaceuticals Corporation, QuVa Pharma, Olympia Pharmacy, ASP Cares, Fagron Compounding Pharmacies, Athenex, Inc., Avella Specialty Pharmacy, Atlas Pharmaceuticals, Empower Pharmacy, Carie Boyd’S Prescription Shop, Edge Pharma, Imprimis NJOF, LLC, IntegraDose Compounding Services, LLC, Wells Pharma of Houston, LLC, US Compounding Inc., SCA Pharma, Leiters Health, Medivant Healthcare and Vertisis Custom Pharmacy.

Definition: Injectable compounding pharmacy refers to specialized facilities that customize medications in injectable form to meet individual patient needs. These pharmacies prepare sterile and patient-specific drug formulations which are often used for unique medical conditions, allergies, or dosage requirements, following strict quality and safety standards.