The increasing number of biologics entering the drug development pipeline has spurred the growth of the sterile injectables market but players with the required specialized capabilities remain few and limited.
The rise of biologics, with the increasing number of antibody-drug conjugates and monoclonal antibodies entering the drug development and clinical pipeline, has spurred the growth of the sterile injectables market. As a result, the industry is seeing a growing demand for injectable capabilities.
The development and manufacturing of sterile injectable, however, is both complex and capital intensive, notes Vivek Sharma, CEO, Pharma Solutions, Piramal, in this year’s CPhI annual report. According to him, operational costs are high because most injectables in today’s market are toxic and infectious in their natural state and, therefore, require a higher degree of quality and care in their manufacturing, packaging, storage, and distribution. Moreover, stringent FDA regulations on manufacturing sites bring additional challenges to existing players and potential new entrants.
Sharma points out that consolidation of in-house manufacturing capacities have resulted in the closure of many sterile manufacturing sites in the US and elsewhere, which in turn has led to product shortages. Mergers and acquisitions have resulted with single supply sources and capacity constraints, on one hand, while on the other, FDA violations leading to import alerts and bans at the affected manufacturing sites add to the drug shortage problem.
Technology transfer between sterile manufacturing facilities can pose a number of process-related challenges, says Sharma. There are several key considerations that manufactures must take into account, for example, sterility (bacterial and fungal contamination), stability issues (crystallization), extractables and leachables from packaging materials, particulates in vials, transportation and logistics to name a few.
The complex manufacturing process of sterile injectables, the high capital and operational costs involved, not to mention the compliance requirements for success has led to a smaller number of players, observes Sharma. These firms are being further reduced due to M&A activities within the sector that is rapidly consolidating. Sharma cited key deals such as the acquisition of Hospira by Pfizer and Piramal’s acquisition of Coldstream Laboratories.
CMOs with injectable capabilities will thrive. According to Sharma, outsourcing in the sterile injectable segment is still skewed towards the US, followed by the EU. He anticipates this market to grow during the next five years, with US remaining the preferred outsourcing destination.
Source: CPhI 2015 Annual Report