Planning and decision-making for the manufacture of biopharmaceuticals are becoming more complex as companies continue to
implement cost-saving efforts, including outsourcing many support and even critical tasks. Companies must make difficult strategic
decisions about commercial manufacture earlier in product development. A recent BioPlan Associates analysis found that essentially
all biopharmaceutical developers use outsourcing services of some kind for the manufacture of clinical or commercial supplies,
process development, R&D, assay services, fill–finish, or other activities (1).
COST-CUTTING NOT A FACTOR
The BioPlan survey, which included responses from 302 representatives from biopharmaceutical companies and CMOs in 29 countries,
evaluated 23 key outsourcing areas in biomanufacturing (1). The study showed that companies are incorporating outsourcing
as a manufacturing strategy rather than as an ad-hoc method of adding flexible capacity or to simply eliminate overhead costs
associated with lower value production activities. Data also show a spike in the percentage of biopharmaceutical companies
projecting outsourcing of analytical testing, validation services, and fill–finish activities.
The BioPlan study further evaluated how companies are addressing cost issues in biopharmaceutical manufacturing. The survey
identified activities biomanufacturers undertake to reduce costs. The study showed that outsourcing activities ranked in the
bottom quarter of measured factors to reduce costs although outsourcing increased slightly for certain functions as a strategy
for cost-containment during the past 12 months (see Figure 1). There was an increase in respondents using outsourcing of jobs
in manufacturing to cut costs: 14.5% in 2012, up from 11.8% in 2011. Approximately 13% of respondents outsourced jobs in process
development and 8.8% did in R&D. An equal number of respondents (9.4%) reported outsourcing manufacturing activities to domestic
and nondomestic service providers. (see Figure 1)
Figure 1: Outsourcing actions taken by biomanufacturers to reduce costs at facilities during the past 12 months.
OUTSOURCING BUDGETS FLAT
The survey showed clear evidence that budgets are bouncing back in all areas in 2012, except outsourced manufacturing. The
uptick in areas other than outsourcing represents a change from two years ago when budgets decreased in areas ranging from
production, hiring new scientific staff, and new facility construction.
The survey also separately asked respondents to indicate how their outsourcing in R&D and manufacturing will change during
the next 12 months. On average, future outsourcing at individual facilities will see moderate overall increases for all types
of outsourcing not just manufacturing (9.3% during the next 12 months). These increases are more heavily distributed on key
outsourcing areas (see Figure 2) rather than broadly seen as increases across all operations.
Figure 2: Select outsourcing activities projected to be done at significantly higher levels.