BioPlan Associates tracked these trends in its 9th Annual Report and Survey of Biopharmaceutical Manufacturers (1). As biologics companies contract out more sophisticated projects, global outsourcing has moved from a tactical to strategic decision for many companies. The decision calculus surrounding the choice of a global CMO reflects many of these changes. For example, perceptions of offshoring are changing, and drug innovators have become far less concerned about whether their CMO is based locally. Of 19 CMO attributes identified in the BioPlan study, "being local" came in last in terms of importance with only 6.3% of the 302 respondents identifying this attribute as "very important" (1). In 2005, 10.4% of respondents cited a CMO's location as "very important, but only 6.3% did in 2012. This change reflects greater acceptance of offshoring outsourcing activities due to industry globalization, more production projects being successfully offshored, and improved expertise of sponsors in managing offshored outsourcing.
FUTURE OF OFFSHORING
A large percentage of biomanufacturers in 2012—as much as 36%—expect some manufacturing offshored by their facility during next five years (see Figure 1) although the percentage expecting to offshore more than half of their operations rated only in the single digits. This finding suggests that it may be too soon to assert that offshoring will become a mainstream activity, although there are reasons to expect that offshoring will become more accepted, especially as regional operations outside the US and Europe begin to meet regulatory standards and as single-use bioprocessing devices enter commercial-scale manufacturing. These integrated, fully disposable facilities will enable manufacturing in more developing regions as many of the quality-management processes required for traditional facilities can be "built in" to the disposable devices.
In comparing survey results on offshoring in 2012 and 2011, the survey showed an across-the-board increase in the percentage of respondents who said they expect offshoring of at least some of their operations during the next five years (see Figure 1). Specifically the survey showed that: