Since 2013, the so-called 503B outsourcing facilities have been the only entities permitted to meet the demand for bulk compounded medications in the U.S. The continued growth of the 503B market is a challenge to pharmaceutical manufacturers, by eroding their hospital-channel revenue.
However, a new KPMG report, 503B outsourcing facilities: An opportunity for pharmaceutical manufacturers, argues that traditional pharma still has clear advantages over 503Bs. This means by entering the sector themselves, pharmaceutical manufacturers can exploit new growth opportunities.