Bulk-Drug Compounding - Worldwide

Bulk-Drug Compounding Market Definition

According to the Food and Drug Administration (FDA), pharmaceutical compounding can be defined as the process of altering, combining, or mixing ingredients to cater to the specific medical requirements of an individual. These services are highly sought after by people unable to use marketed drugs due to medical, physical, or physiological issues. Compounded drugs are generally prepared in small batches based on a personalized prescription. However, in cases where the demand for a particular medication exceeds its market availability, bulk-drug compounding provides optimal solutions.

• According to the Homeland Security and Governmental Affairs Committee data,  The past ten years have experienced around 15 drug shortages lasting on an average for 1.5 years. The U.S. alone experienced a 30% increase in new drug shortage between 2021 and 2022.

The bulk drug compounding market not only assists with drug shortages but also helps with issues related to limitations in production capacity, economic conditions, complex manufacturing processes, and raw materials shortages.  This is commonly observed in highly sterile preparations that have a short shelf life combined with intricate production and often face a shortage in stock. Despite their immense potential, drug compounding is hindered due to a strict regulatory framework. A compounded version of a medication can only be produced if it is listed on the FDA's drug shortages list. Additionally, drug compounds require a specialized license and can only conduct their practices in an FDA-approved facility.

Another common application of the bulk drug compounding services market is seen in the veterinary sector. A compound from the antiviral drug GS-441524 received FDA approval for the treatment of treat feline infectious peritonitis in June 2024. Bulk compunding of such drugs can mutually benifict the industry players as well as the consumers.