The author highlights the top 10 outsourcing trends revealed during a survey of biopharmaceutical manufacturers.
The biopharmaceutical industry is changing the way it manufactures. According to BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1), outsourcing and off-shoring have migrated into much more high-value areas of opportunity over the past 10 years. BioPlan’s annual studies receive input from between 300-400 global respondents and facilities, on a broad range of issues. Outsourcing and offshoring are some of the many key areas analyzed. Over the past decade, BioPlan has found that developing regions, including China, India, and Brazil, as well as the substantial investments in technologies that improve productivity and efficiency are making outsourcing more strategic. Beyond typically outsourced activities like fill-finish, validation services, and assays, companies are increasingly relying on their suppliers to address more challenging processes. From expertly packing chromatography columns, to providing higher-quality liquid media and buffers at large-scale, suppliers with technical competence are taking on some of the industry’s most challenging operations.
Trend one: Outsourcing is growing across all production systems
Before looking at the finer details of the outsourcing landscape, it’s worth taking a broader view and data from BioPlan’s studies confirms that biomanufacturing outsourcing is a growing market. Part of BioPlan’s industry-wide census involves the percentage of facilities that are outsourcing at least some of their production. The results over the past 10 years tell show that outsourcing is not only increasing across traditional systems including mammalian cell culture and microbial fermentations, but also across newer systems such as plant and insect cells.
Specifically, this past year found:
>Only 46.2% of facilities involved in mammalian cell culture were keeping all manufacturing in-house, down from 57.6% in 2006
>An even smaller share (34.8%) of facilities involved with microbial fermentation were manufacturing 100% in-house, with that down from 58.1% in 2006
>For yeast systems, exactly half claimed to keep all their production in-house, down from 86.2% in 2006
>For plant cells, a strikingly small 28.6% of respondents kept all production in-house, down from a range of 68.6-88.9% not outsourcing any production from 2006 through 2012
A similar story emerged for insect cells: only 37.5% kept all production in-house, down from a range of 64.7-100% from 2006 through 2012.