PROJECTIONS

The survey evaluated 24 different areas associated with outsourced operations and asked respondents which activities will be outsourced "more often" during the next 24 months. More than one-third (35.4%) expect to increase outsourcing of analytical testing/bioassays. BioPlan believes much of this increase relates to product characterization, including for biosimilars.

Validation services was the area where respondents predicted the highest rate of increase (32.3% indicated high rates in outsourcing in 2012, compared with 22.1% in 2011 and 23.8% in 2010). Also, 26.2% of biomanufacturers predict they will outsource significantly more fill–finish operations during the next 24 months compared with 23% in 2011, and 25% in 2010. Other areas of outsourcing growth include: API biologics manufacturing, cell-line development, testing for lot release, and toxicity testing. Some recent decreases in predictions for outsourcing growth are in: downstream production operations, testing/product characterization, media optimization, upstream production operations, regulatory services, upstream process development, and testing cell-line stability.

The biopharmaceutical industry continues to focus on productivity, efficiency, getting more out of existing internal resources, and maximizing performance from their provider relationships. Although outsourcing can improve overall efficiency and reduce costs, the management of relationships continues to be challenging and necessitates CMO/CRO flexibility to meet clients' shifting needs. Data from this study shows that CMOs are expanding their manufacturing competence through the use of novel technologies, single-use/disposable bioreactors, and other differentiated bioprocessing services. Improved services are resulting in increased adaptability, lower costs, faster turnaround, and higher yields, thereby offering more choice for biopharmaceutical companies. At the same time, the costs for using CMOs for product manufacturing are becoming slightly more competitive.

Eric Langer is president and managing partner of BioPlan Associates and a member of BioPharm International's editorial advisory board, elanger@bioplanassociates.com
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REFERENCE

1. BioPlan Associates, 9th Annual Report and Survey of Biopharmaceutical Manufacturers (Rockville, MD, April 2012), http://www.bioplanassociates.com/.