Informing the pharmaceutical drug development, manufacturing and commercialization industry. Cary, NC – February 8, 2017 – The 2nd edition of Industry Standard Research’s (ISR’s) Biologic API Contract Manufacturer Quality Benchmarking report indicates that buyers of outsourced biologic API services are less loyal to the CMOs they use compared to one year ago. The report includes information on respondents’ outsourcing philosophies and practices, CMO perceptions and interactions and CMO selection drivers before diving into a series of in-depth performance analyses specific to the large molecule offerings of 30 contract manufacturing organizations. 208 respondents provide rating assessments on 393 service encounters.
“This year, the data showed a decrease in the industry average for CMO loyalty of almost one-third of a point on a ten-point scale among biologic API contract manufacturers,” explained Kate Hammeke, Vice President, Market Research at Industry Standard Research. “ISR’s loyalty metric is an index of overall satisfaction, likelihood to use again and willingness to recommend. Changes in these scores may be indicative of a broader decline in customer loyalty, which retail has been experiencing for a few years, or a more direct response to changes in satisfaction with service provider performance. For CMOs featured in the report, it makes sense to investigate whether the change in loyalty traces back to a specific loyalty component or whether it can be attributed to broader changes in customer behavior.”
The report provides a Consumer Reports-style analysis where each of the 30 CMOs included in the research is evaluated across 27 service quality attributes, making this report the most comprehensive assessment of quality in the contract manufacturing space. These performance metrics are categorized into four ‘scorecards’: Delivery Factors, Organization Factors, Capabilities and Staff Characteristics. From these performance evaluations, respondents indicated how well the manufacturers performed with respect to expectations specific to their experience working with the manufacturer(s). For buyers of outsourced services, the report includes highly valuable information to help guide CMO selection for large molecule projects from early clinical stages to commercialization.
CMO performance attributes evaluated by respondents include Ability to manufacture biologic API, Reliable on-time delivery, Regulatory History, Quality performance metrics, Scale-up and tech transfer abilities, Scientific knowledge, Right-first-time measurements, and many others.
Data include an in-depth analysis of 16 of the 30 featured contract manufacturers, including AbbVie Contract Manufacturing, Boehringer Ingelheim, Catalent, Celltrion, CMC Biologics, FujiFilm Diosynth Biotechnologies, GSK Contract Manufacturing, KBI Biopharma, Lonza, Novasep, Patheon, Pfizer CentreOne, Samsung BioLogics, Sanofi CEPiA, Therapure Biopharma and Wuxi AppTec.
There are several stand-out CMOs this year. Two contract manufacturers—Pfizer CentreOne and Sanofi CEPiA—placed among the leaders across all of the four scorecards (Delivery, Organizational, Capabilities and Staff Characteristics). Among smaller CMOs, KBI Bio was a top performer in Delivery Factors and Staff Characteristics, while Therapure BioPharma scored well in Capabilities and Staff Characteristics.
For more information on ISR’s “Biologic API Contract Manufacturer Quality Benchmarking” report, please visit ISR’s report page.
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