A patient who cannot be treated with an Food and Drug Administration (FDA)-approved drug, such as one who has a dye allergy and needs a medication to be made without it, or a patient who is elderly or a child who is unable to swallow a tablet or capsule and needs a medication in a liquid dosage form, may require a drug to be compounded. When a Food and Drug Administration (FDA)-approved drug is not medically necessary to treat a patient, doctors at hospitals, clinics, and other healthcare facilities occasionally provide them compounded medications.
U.S. compounding pharmacies market is estimated to be valued at US$ 4,789.6 million in 2022 and is expected to exhibit a CAGR of 5.9 % during the forecast period (2022-2030).
Figure 1.U.S. Compounding Pharmacies Market Share (%), by Therapeutic Area, 2022
Increasing demand for hormone replacement therapy (HRT) is expected to boost growth of the U.S. compounding pharmacies market over the forecast period.
Increasing demand for hormone replacement therapy (HRT) is expected to boost growth of the U.S. compounding pharmacies market over the forecast period. For instance, according to data published on September 2021, on National Library of Medicine, in the U.S., in 2018, about 4 out of 10 women aged 70-79 years reported having had a hysterectomy.
|Base Year:||2021||Market Size in 2022:||US$ 4,789.6 Mn|
|Historical Data for:||2017 to 2020||Forecast Period:||2022 to 2030|
|Forecast Period 2022 to 2030 CAGR:||5.9 %||2030 Value Projection:||US$ 7,578.0 Mn|
Avella Specialty Pharmacy,Ltd PharMEDium Services, Institutional Pharmacy Solutions, Cantrell Drug Company,Triangle Compounding Pharmacies,Hoye’s Pharmacy,Vertisis Custom Pharmacy,Smith Caldwell Drug Store,Nephron Pharmaceuticals Corporation,Rx3 Compounding Pharmacy,B Braun Melsungen AG,Clinigen Group PLC,QuVa Pharma,ITC Compounding Pharmacy, and Lorraine’s Pharmacy
|Restraints & Challenges:||
Figure 2.U.S. Compounding Pharmacies Market Share (%), by Application, 2022
Increasing shortage of drugs in the U.S. is expected to boost growth of the U.S. compounding pharmacies market over the forecast period.
Increasing shortage of drugs in the U.S. is expected to boost growth of the U.S. compounding pharmacies market over the forecast period. For instance, according to a report of the U.S. Food and Drug Administration (FDA): Drug Shortages: Root Causes and Potential Solutions 2019, 56% of hospitals reported they had changed patient care or delayed therapy in light of drug shortages and 36.6% said they had rescheduled non-urgent or emergent procedures. Such scenario leads to use of readily available compounded medications, which is expected to boost growth of the U.S. 503B compounding pharmacies market
U.S. Compounding Pharmacies 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 had declared it a public health emergency on January 30, 2020.
COVID-19 has affected the economy in three main ways: by directly affecting production and demand of drugs and vaccines, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets.
The COVID-19 pandemic resulted in increased demand for drugs and decreased manufacturing capacity of commercially available medications, both of which had a favorable effect for the compounding pharmacy sector. For instance, due to a shortage of medications needed to treat patients, the Food and Drug Administration (FDA) issued guidance regarding the compounding of specific medications for hospitalized patients by Federal facilities and State-licensed pharmacies, including health system and hospital pharmacies, during the period of the public health emergency.
U.S. Compounding Pharmacies Market: Key Developments
In July 2019, PharMEDium Services, LLC which is a pharmaceutical manufacturing announced to recall 45 lots of 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe to the user level. The recall was due to presence of sulfite in PharMEDium’s electronic customer ordering system that claimed to be sulfite-free.
U.S. Compounding Pharmacies Market: Restraint
The major factors that hinder growth of the U.S. compounding pharmacies market include increasing product warnings in sterile compounding, which have led to decrease in sales of compounded injectable drugs, which is also expected to hinder growth of market. For instance, the U.S. FDA expanded an original warning on using Becton-Dickinson (BD) general use syringes of sizes 1mL, 3mL, 5mL, 10mL, 20mL, and 30mL. The agency noted that interaction with the rubber stopper in some lots of these syringes may adversely impact drug potency if filled in syringes and not used immediately.
Major players operating in the U.S. compounding pharmacies market include Avella Specialty Pharmacy,Ltd PharMEDium Services, Institutional Pharmacy Solutions, Cantrell Drug Company,Triangle Compounding Pharmacies,Hoye’s Pharmacy,Vertisis Custom Pharmacy,Smith Caldwell Drug Store,Nephron Pharmaceuticals Corporation,Rx3 Compounding Pharmacy,B Braun Melsungen AG,Clinigen Group PLC,QuVa Pharma,ITC Compounding Pharmacy, and Lorraine’s Pharmacy.
A pharmacy that is operated by a licensed pharmacist, licensed physician or a person under the guidance of a licensed pharmacist is called compounding pharmacy. The process of combining, blending, or modifying substances to make a treatment specific to the requirements of a certain patient is known as drug compounding. Compounding is the process of combining two or more medications. These medications are not FDA-approved. Compounding pharmacists can combine medications to create liquids with a specific flavor, topical creams, transdermal gels, suppositories, or other dosage forms that are suitable for the individual needs of their patients. Making copies of pharmaceuticals that are already in market is not considered compounding because it is against the law to do so.
When a medication is traditionally compounded, it is prepared to the prescriber's exact specifications and given directly to the patient in accordance with a valid prescription for that person. A pharmacist who has been granted licensure by a state board of pharmacy does or oversees the compounding of pharmaceuticals. State pharmacy boards oversee the practice of compounding. All pharmacists and pharmacies engaged in compounding are subject to regulation by both federal and state authorities, with the exception of community and hospital compounding pharmacists who are permitted exemptions from the Federal Food, Drug and Cosmetic Act of 1938 if they comply with the regulations set forth in Section 503A.
Increasing geriatric population is expected to drive market growth over the forecast period. For instance, according to data published in February 2022, on International Association for the Study of Pain, in the U.S., in 2021, about 50 million elder patients were suffering from chronic pain.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.