The biopharmaceutical industry continues to increase its outsourcing of less common, more complex processes as companies seek
strategic advantage by leveraging external resources more efficiently. Until recently, outsourcing has focused primarily on
traditional expression systems (mammalian and microbial) versus less common systems (e.g., yeast, plant cell, and insect cell),
with those systems being more likely to be retained in-house.
Eric S. Langer
This year, there are signs that outsourcing of plant- and insect-cell culture-based processes are beginning to expand. Preliminary
data from BioPlan Associates' 10th Annual Report and Survey of Biopharmaceutical Manufacturers indicate that only 50% of plant-cell users are performing this operation fully in-house, with the other half outsourcing
some elements of bioprocessing to some degree. The data represent a shift from prior years, when up to 90% of the industry
kept their processes fully in-house.
The BioPlan data for insect-cell systems shows a similar trend. In past years, between 65% and 100% of respondents did all
their insect-based production in-house, but BioPlan's preliminary data from 2013 show a reduction to 60% of respondents doing
all insect-cell-based production in house; this is the lowest point in more than six years. For plant-cell and insect-cell
systems, the smaller number of facilities using these systems and the fact that the data still being preliminary make it too
soon to declare a definitive shift, but it is interesting to see that the trends projected by some industry analysts are reflected
in the preliminary findings. Meanwhile, the proportion of respondents outsourcing traditional expression systems, to at least
some degree, remains relatively steady as follows (2013 results are preliminary data):
Mammalian cell-culture systems: In 2013, 50% of respondents (47% in 2012 and 45% in 2011) indicated that they outsourced no production while 31.6% (47% in
2012, 44.6% in 2011, 30.3% in 2010, and 29% in 2009) outsourced up to half of production.
Microbial fermentation: In 2013, 45% (50% in 2012 and 43.8% in 2011) of respondents outsourced no production. Thirty-five percent (44.% in 2012 and
41.6% in 2011) outsourced up to half of production, and 20% outsourced more than half.
Yeast systems: In 2013, 66.7% of respondents (62.5% in 2012, and 59.1% in 2011) outsourced no production; in 2013, 22.2% of respondents
(31.3% in 2012, 27.2% in 2011, 32.1% in 2010, and 14% in 2009) outsourced up to half of production.
Plant-cell systems: 50% outsourced no production in 2013 (89% in 2012, 58% in 2011, and 75% in 2010).
Insect-cell systems: 60% outsourced no production in 2013 (83% in 2012, 65% in 2011, 100% in 2010, and 82% in 2009).
When the BioPlan survey separately asked respondents about the percentage of their production that they expect to outsource
in five years (i.e., by 2018), similar trends hold true. Future outsourcing of plant- and insect-cell systems appears to be
rising while outsourcing of traditional systems remains steady, suggesting a relatively stable production environment. The
preliminary data from 2013 show:
Mammalian cell-culture systems: 62.5% of respondents in 2013 (58.2% in 2012 and 63.5% in 2011) indicated they expect to outsource at least some of their
production in the next five years.
Microbial fermentation: In 2013, 68.2% of respondents (72.2% in 2012 and 59.6% in 2011) plan to outsource some production by 2018.
Yeast systems: 40% of respondents in 2013 (45% in 2012 and 52.2% in 2011) believe that at least some of their production will be outsourced
in the next five years.
Insect-cell systems: 42.9% of respondents plan to outsource some production by 2018.
Plant-cells systems: 40% of respondents in 2013 (25% in 2012) expect to outsource some production in the next five years.