Outsourcing Motivations Should Guide One's Outsourcing Approach

There are many ways to think about outsourcing. Most drug sponsors have more than one motivation for engaging a CDMO/CMO and use a combination of outsourcing approaches or types of outsourcing relationships to accomplish their manufacturing needs. Whether it’s cost- or time-savings, access to technologies, skills, scientific expertise, or capacity, there are many reasons for hiring a CMO. At ISR, we look at outsourcing motivations from a variety of different angles. At the top level, we ascertain whether a drug sponsor has internal manufacturing capabilities and uses CMOs to supplement their own manufacturing, or if the drug sponsor uses CMOs because it lacks manufacturing facilities.

Among those with internal manufacturing capabilities, we investigated how experience and capacity influence CMO use. In our Development and Commercial Manufacturing Outsourcing Models market research, we ask survey respondents to pick the best fit among four reasons that manufacturing may be split between in-house and external resources for the drug substance(s)/drug product(s) for which they are familiar. The options provided are: 1) adequate experience and adequate capacity, 2) adequate experience but lack capacity, 3) lack experience but adequate capacity, 4) lack experience and lack capacity.