Building A Legacy In Sterile Injectables Through Strong CMO Synergy

The sterile injectables (SI) market is rapidly evolving, driven in large part by the growth of oncology therapeutics, which is projected to fuel a compound annual growth rate (CAGR) of 9.1% in the coming years. Within this space, biotechnology and pharmaceutical companies vary widely in size, infrastructure, and experience — from small, virtual startups to well-established global enterprises. These differences are particularly evident in oncology drug development, where companies' capabilities and operational maturity can vary significantly. The same diversity applies to contract manufacturing organizations (CMOs), whose ability to adapt to the unique needs of each client can be a determining factor in the success of a sterile injectable program.

CMOs play a critical role in enabling pharmaceutical innovation, partnering with organizations across the spectrum—from emerging biotechs launching their first product to seasoned pharma companies expanding their oncology portfolios. To serve such a broad client base, CMOs must demonstrate not only technical excellence but also a high degree of operational flexibility. Customizing manufacturing processes to align with each product's technical and regulatory requirements — while upholding the highest standards of quality and safety — is essential. Core principles such as "right first time" and "no cutting corners" guide these organizations in delivering reliable, compliant, and efficient outcomes.

This white paper examines how a highly experienced, adaptable CMO can deliver significant value to drug developers of all sizes by fostering successful outsourcing relationships, streamlining the path to market, and supporting the complex demands of the sterile injectable landscape — particularly in the fast-growing oncology sector.