U.S. 503B Compounding Pharmacies Market, by Molecule (Acetaminophen, Phenylephrine, Midazolam, Esmolol, Vancomycin, Epinephrine, Adenocaine, Fentanyl/ Bupivacaine, Morphine, Amiodarone, Heparin, Ketamine, Dextrose, Hydromorphone, Bupivacaine, Lidocaine, BKK (Bupivacaine, ketorolac, Ketamine), RCK (Ropivacaine, Clonidine, Ketorolac), RKK (Ropivacaine, Ketorolac, Ketamine), Other Molecules), by Packaging Type (Vials, Pre-filled Syringes, Ampoule, Syringes, and Others)- Size, Share, Outlook, and Opportunity Analysis, 2022 - 2030

Published In : Aug 2022

Code : CMI4481

Pages :211

Formats :

Excel and PDF

Industry : Pharmaceutical

U.S. 503B Compounding Pharmacies MarketSize and Trends

The U.S 503B compounding pharmacies market is estimated to be valued at US$ 985.6 million in 2022 and is expected to exhibit a CAGR of 7.6 % over the forecast period (2022-2030)

Figure 1. U.S 503B Compounding Pharmacies Market Value (US$ Mn), By Packaging Type, 2022

Increasing availability of compounded preparation is expected to drive the market growth over the forecast period

For instance, in May 2020, Central Admixture Pharmacy Services, Inc. launched three new compounded sterile preparations, which are in short supply for ICU patients, the products are two vasodilators: Norepinephrine 8 mg added to 250 ml normal saline (NS), Vasopressin 50 units added to 50 ml NS and sedative: Midazolam 125 mg added to NS (1mg/ml)

Moreover, in November 2019, West Pharmaceuticals Services, Inc., a 503B outsourcing facility launched Ready Pack containment system, consisting of sterile, ready-to-use (RU) NovaPure stoppers, Daikyo Crystal Zenith cyclic olefin polymer vials and Flip-Off (clean, certified, sterilized) CCS seals.

Figure 2. U.S. 503B Compounding Pharmacies Market Share (%), By Molecule Type, 2022

Increasing facility expansion by the market players is expected to drive the market growth over the forecast period.

For instance, in September 2019, Quva Pharma, a FDA registered manufacturer of compounded medicines announced that it completed the facility expansion of the cGMP compliant 503B, the U.S. FDA registered manufacturing facility at Bloomsbury, New Jersey, U.S, and this has increased the facility by 160,000 square feet.

Moreover, in August 2021, Empower pharmacy, a compounding pharmacy which based in Texas, U.S. announced the grand opening of its new facility in Houston, U.S. This facility will allow Empower pharmacy to prepare thousands of custom prescription each day for millions of patients across the country.

U.S 503B Compounding Pharmacies Market – Impact of Coronavirus (COVID-19) Pandemic

The coronavirus (COVID-19) outbreak was first reported on December 31, 2019, in Wuhan, China. The World Health Organization declared COVID-19 a pandemic on March 11, 2020. According to the Coronavirus (COVID-19) Weekly Epidemiological Update by the World Health Organization, over 546,357,444 cases of coronavirus disease (COVID-19) were reported till 2 July, 2022, across the globe.

In the times of covid-19 pandemic pharmacies are struggling to fulfil the demand of the medicine. Consequently, 503B outsourcing facilities are proving to be crucial partners to health systems and hospital pharmacies in helping to fulfil drug scarcity and the impact on patients during the covid-19 pandemic. The Drug Quality and Security Act, passed in 2013, allowed 503B outsourcing facilities to compound certain nonsterile and sterile drugs products in anticipation of need by providers and based on meeting certain standards required by the U.S. FDA, with massive demand surged for critical care medicines because of the pandemic, 503B facilities can supplement hospitals when commercial manufacturers cannot supply.