| | July 20198UTLOOK Healthcare Tech HEALTHCARE TECHNOLOGY KNOWLEDGE NETWORKIN MY OPINIONR&D LandscapeContract manufacturing of pharmaceuticals is growing rapidly and has recently seen an uptick in merger and acquisition activity, such as Thermo Fisher's bid to acquire Patheon. Despite the consolidation, outsourced pharmaceutical manufacturing remains a fragmented market, as outlined in a recent report and summary. Discovering and qualifying outsourced service providers is already challenging, and the persistent fragmentation compounds the challenges.Science Exchange has a unique vantage point for evaluating contract manufacturing services based on our diverse client base and the associated customer experience scorecard data we gather. In this article, we share our insights around navigating the complex contract manufacturing sector.Demand for contract manufacturing servicesThe high demand for external manufacturing capacity and expertise is one driving force behind the proliferation of CMOs and CDMOs. According to a 2016 survey, biopharma organizations cite the need to improve quality as the primary reason for using contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs). Additional goals for outsourcing include reducing time to market, controlling costs, achieving supply chain diversity, leveraging regulatory expertise, and accessing specialized technologies, including those required for complex biologics manufacturing processes.Competition between CMOs: Innovative manufacturing servicesCompetition in the marketplace is driving CMOs to develop innovative manufacturing technologies to capture new service categories--choosing a cutting-edge CMO partner can give a biopharma company advantages over its competitors.Many CMOs and CDMOs have adopted process improvements to provide their clients with faster cycle times and more informed decision-making. These improvements include cloud-based computing, real-time risk-monitoring tools, and integrated quality-by-design during process development. Such process improvements are especially important given the ability of multiple CMOs to manufacture the same API. Nearly 90 percent of the volume of drugs sold are generic small molecule therapeutics, requiring high production capacity that may be provided by any number of CMOs.Other CMOs differentiate themselves through specialized expertise--for example, they may be leaders in developing novel formulations, such as nanoparticles or lipid-based delivery systems. Some CMOs offer specialized regulatory certifications, such as CLIA/CAP, GLP, and GCP. Although cGMP compliance is not absolutely required for all CMOs, most reputable CMOs are cGMP certified.Navigating the Complex OutsourcedBy Leandro Grimaldi, Director & Digital Health Advisor - GIVE mHealth, Harvard University
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