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Pharmaceutical Technology Europe BIO/PHARMA OUTSOURCING INNOVATION eBOOK 2022 23 Development I n pharmaceutical science several divergent paths typi- cally exhibit clear validity. Decisions often boil down to embracing instead of eschewing risk, to accelerate as the only priority, or to trust a partner rather than emphasize self-reliance. Each molecule, each company or research group possessing that molecule, has an assortment of strengths and weakness to guard against or to leverage. Multiple fac- tors weigh in the balance when deciding how best to move forward, and increasingly the route chosen is to outsource research, development, and manufacturing. The global contract development and manufacturing organization (CDMO) industry, averaging across several market research firm estimates, is currently valued around US$100 billion (€87.26 billion) (1). In part, this growth is shaped through direct regulatory inf luences suggesting, if not demanding, that a drug have multiple sites of manu- facture to spread the risk for supply chain planning. Above regulations, companies also seek to reduce the complexity of their operations internally, and to reallocate internal re- sources most effectively. Rising demands According to Hanns-Christian Mahler, CEO and board mem- ber of ten23 health—a new CDMO that offers development, manufacturing, and testing services for injectables—there are a variety of reasons as to why demand for outsourced services of technical R&D activities is increasing. "[Reasons] include a potential lack of internal asset(s) for a given technology and/or specific requirement," he says. "For example, the building and operating costs of a sterile fill/finish facility are significant. If a pharma company would not have sufficient molecules in a portfolio that would benefit from being manufactured in that facility, the costs could be quite prohibitive, and outsourcing is surely much more cost efficient." There could also be instances where a pharma or biotech company has an asset but does not necessarily have the re- quired technology or features, Mahler continues. For smaller companies, in particular, he adds, there may not be inter- nal knowledge or industry and scientific expertise available. M.MPHOTO - STOCK.ADOBE.COM Balancing Internal Focus Against External Capabilities Chris Spivey Demand for outsourced services of technical R&D activities is increasing.