Analytical testing of bioassays, toxicity testing and fill/finish operations were the top three services outsourced by biopharma companies as more than 80% of those surveyed said they would outsource these operations, according to the 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.
“The results suggest that compared to last year, the most popular activities are being increasingly outsourced, while there has been a retrenchment in the proportion of the industry that is outsourcing less common activities,” Eric Langer, president of BioPlan Associates, which reviewed responses from nearly 250 biopharma manufacturers for the study, wrote in a recent article .
Langer told us: “We’re seeing the budgets for new up- and downstream technologies increasing faster than other areas, including outsourcing. This may be a rebound effect as companies try to identify ways to become more efficient and productive overall.”
Between 2013 and 2014, biopharma manufacturers seem to be devoting more of their outsourcing attention to upstream production operations and lot-release testing, while GMP training and regulatory services seem less likely to garner more outsourcing dollars.
“Preliminary study data also suggest that outsourcing activity remains strong and unlikely to abate, especially in more traditional areas. A pullback in the proportion of respondents indicating some degree of outsourcing—coupled with an increase in estimated levels of outsourcing—suggests that those facilities that are outsourcing activities are doing so at higher levels this year,” Langer wrote.
Project management services were one of the few areas in which significantly fewer respondents to the survey this year plan increases in outsourcing activity.
Design of experiments (34.1%), downstream process development (36.3%), and quality-by-design (QbD) services (37.4%) also topped the list of least likely to be outsourced, the survey found.
Langer told us: “Companies outsource what they feel are not core-competencies, and where external providers can do better work, or do it cheaper. In the case of Design of Experiments or QbD, it is possible that these quality measures are considered to internally important to outsource on a wholesale basis.
“In the case of downstream processes, there are few providers of these kinds of services, for one thing, and at this point, the drug product is taking on increasing value, so doing the purification could be considered more ‘core’ or important than other areas,” he said.
Moving forward, expectations for increases in outsourcing remain high, Langer noted.
“This year, if respondents follow through on their outsourcing plans, an even more influential dimension in the biopharmaceutical manufacturing industry can be expected,” he added. “And there are signs that this might already be the case.”