The report found that in particular there’s an overall trend toward outsourcing more bioprocessing, which runs in parallel with the fact that more platform processes are becoming available from CMOs.
“Outsourced projects are being used not only to fill temporary gaps in capacity, but also to focus a company’s skill base on core competencies, in addition to controlling costs. As a result, activities that were previously considered essential to retain in-house may become options for outsourcing,” the report says.
In terms of the system by system breakdown, the report found that for mammalian cell culture, the percentage of facilities performing all production in-house shifted from 57.6% in 2006 to 35.3% this year, the lowest point in a decade. For microbial systems, there has been an overall shift downward, and for yeast systems, “there similarly appears to be an overall trend toward increased outsourcing, with this year’s 43.8% outsourcing ‘No Production’ also a decade-long low.”
“Microbial manufacturing is the area with the highest proportion now projecting some outsourcing in five years,” the report finds.
And although outsourcing is seeing an uptick generally across the board, specific services that are outsourced are “dominated by relatively lower value-added and more specific or restricted services,” such as fill-finish, plant maintenance operations and analytical testing.
Between 2010 and 2015, the report found the greatest percentage shift has occurred in “API biologics manufacturing,” going from 7.9% in 2010 to 18.5% this year. “Analytical testing” is another area with significant growth in outsourcing, from 18.9% in 2010 to 27.2% today, while “Use of upstream process development services” has also been steadily increasing.
At the other end of the spectrum, there appears to still be relatively low outsourcing activity for what companies believe to be core capabilities, including “Design of Experiments” (40.0%), “Downstream Production Operations“ (38.9%), and “QbD Services” (37.9%).
In looking ahead, budgets for outsourcing at individual facilities are anticipated to increase by 13% over the next 12 months, down slightly from last year’s estimate of 13.5%, but up from 2013’s 10.4% expected increase. And about 17% of biomanufacturers will be outsourcing significantly more validation servicesover the next 24 months than are currently done, according to the report.
Biosimilars are also expected to be a target for CMOs looking forward as they “are generally reporting up to a 15% increase in business due to biosimilars, with most developers targeting the as-yet undeveloped US market.”