The biopharmaceutical manufacturing community is heavily focused on productivity and efficiency. That focus continues in 2013 as a primary driver in the analysis of value in outsourcing of non-core activities. Over the past several years, studies conducted by BioPlan Associates have shown that an increasing number of biomanufacturers, up to 70%, are outsourcing at least some of their bioprocessing activities. While the recent rate of growth in outsourcing can't sustain its rapid pace indefinitely, there's no doubt that outsourcing has become a strategic element of manufacturing planning for most companies.
TODAY'S MOST COMMONLY OUTSOURCED ACTIVITIESBioPlan tested 24 key areas of bioprocess outsourcing in their 2013 global study of biomanufacturing. Preliminary results from the study indicate that the most commonly outsourced activity is analytical testing: other bioassays, by 89% of respondents. Other hot areas include toxicology testing (66%), fill/finish operations (64%), and validation services (63%).
At the other end of the spectrum, there is less interest in outsourcing for design of experiments (DoE) and certain process development tasks. These areas may still be considered by many to be too core to the corporation to be outsourced. Yet even these core capabilities not yet seeing widespread outsourcing activity aren't completely off the map, with as much as one-quarter of respondents or more outsourcing them to some degree.
To put in perspective the extent to which companies are leveraging outsourcing as part of their strategies, it's worth noting that of the 24 areas studied, 15 are being outsourced by at least 40% of study respondents.
The fore-runner in terms of outsourcing trends is clearly analytical methods, with nearly 89% reporting outsourcing, including all sorts of quality control-related (sometimes highly specialized) assays for product release. The reason for this situation is related to the need for highly specialized staff to run these assays and to have the expensive, high-maintenance equipment in constant operation. This percentage has increased from 83% last year and will likely increase in the future, with regulatory agencies wanting more and more characterization and other data about products.
A traditional field for outsourcing is fill-finish operations, and outsourcing of this activity appears to be holding steady so far this year. We might expect to see more outsourcing of this activity in the future, as more high-end fill-finish operations will be used, such as prefilled syringes, cartridge systems, and multi-use adjustable syringes. Indeed, demand for outsourcing of fill/finish operations is expected to rise: according to separate results from the study, 20% of respondents believe that their facility will outsource fill/finish operations to a much greater degree over the next two years. That makes it the second-biggest growth area among the 24 identified.
Meanwhile, some areas traditionally kept in-house, such as upstream and downstream process development and cell-line development have flattened out or decreased this year after having seen an upward shift last year. Study data also indicate that most companies so far are using their internal capacity for quality activities such as DoE and quality by design (QbD) rather than outsourcing, and that does not appear to be changing for the moment. With increasing importance, complexity, and new requirements coming from regulatory agencies, though, there may be more business need for these types of services in the future.
Overall, compared with 2012 data, the percentage of respondents outsourcing the activities identified remains for the most part relatively steady. Some of the biggest changes seen from last year (noting that this remains preliminary data) relate to the following activities: