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From CMO to CDMO: Opportunities for Specializing and Innovation

By: A. Doig, S. Jones
Reprinted with the permission of BioProcess International , May 2016

The CMO landscape has evolved over the past three decades so that collectively the biologics CMO market offers large and small scale manufacturing capacity for customer products that are at all stages of clinical development. To respond to shifting biotechnology industry paradigms and the current trends in the industry, CMOs have continued to move away from the business model of solely “renting” manufacturing capacity to one of offering extensive and differentiated development and manufacturing support by adding “development” services. These emerging CDMOs generally now offer a variety of specialized, value-added services aimed at customers with early stage development needs and customers who require support to generate a BLA.

Full service CDMO’s offer a comprehensive set of services that connect all the aspects of the product development stage to drug production through to commercial manufacturing in an integrated process. The CDMO services sector is on a positive growth trajectory. Factors driving this growth include the increasing number and diversity of biotherapeutics in pipeline development, the demand generated by new healthcare markets, a goal to reduce costs through innovation and the unrelenting pressures to be first to market.