New report defines which biologic manufacturing capabilities are needed
Informing the pharmaceutical drug development, manufacturing and commercialization industry.
Cary, NC – October 12, 2016 – A new report from Industry Standard Research (ISR), Bioprocessing Services and Technologies Market Trends and Outsourcing Dynamics, offers an in-depth look into the mammalian and microbial expression system manufacturing capabilities currently required by sponsor organizations for biologics in development and on the market, as well as information on the capabilities sponsors will need for products in development five years from now.
Using a drill-down approach, ISR asked respondents about ten categories of outsourced services along with a series of follow-up questions about specific activities and services inside each category. Within the process development category, which included cell line development services, upstream process development and downstream/purification process development, ISR learned that respondents foresee an increase in outsourcing cell line development services such as media evaluation, cell line stability, growth titer assessments, etc. In fact, respondents outsourcing mammalian expression system projects reported a 16 percentage-point increase in outsourced cell line selection over the next five years.
“Previous ISR research informed the industry of the increased reliance on CMOs for bioprocessing activities; this study identifies exactly which activities that are currently conducted in-house will shift to contract manufacturers over the next five years” explained Kate Hammeke, Vice President, Market Research at ISR. “Sponsor organizations that rely on contract manufacturers for bioprocessing know competition for CMO capacity is steadily picking up. The data in this report will help drug innovators to understand service areas where there is high demand that may result in a lack of available capacity and the need to identify alternate solutions.”
In addition to findings regarding considerable growth in outsourced cell line development services, the report includes key statistics on bioreactor preferences, outsourcing rates for services in process development, cell line development, upstream and downstream activities, analytical method development and qualification, biochemical analysis, process validation, quality and regulatory, cGMP manufacturing, stability testing, cell banking and storage, fill finish capabilities required and outsourced project management as well as forecasting how the need for these services and use of contract manufacturers will shift over the next five years.
This report provides in-depth insight into the specific services drug innovators acquire from contract manufacturers and why these services are outsourced. These data will enable readers to make better decisions regarding outsourced bioprocessing and whether additional outsourcing advantages can be obtained for sponsor organizations. CMOs can use the report to prepare for changes in demand by gaining insight into the current and future marketplace for outsourced bioprocessing services as well as determining how well their company’s offering matches the services, capabilities and expertise sponsors seek from contract manufacturers.
For more information on ISR’s “Bioprocessing Services and Technologies Market Trends and Outsourcing Dynamics” report, please visit ISR’s report page.
About Industry Standard Research
Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR’s off-the-shelf intelligence and custom research offerings, please visit the company’s website at www.isrreports.com, email info@isrreports.com or follow ISR on Twitter @ISRreports.
