Biotech and Pharmaceuticals · global
Complex Molecules Reshape CDMO Competition as Biotech Companies Want More Than Capacity
As antibody-drug conjugates, bispecific antibodies, and novel biologics move into the clinic, the role of contract manufacturers is shifting from outsourced production plants to development partners that jointly unpack risk.
The challenge in biopharmaceuticals is moving from “can it be made” to “can it be made in a stable, scalable way that regulators will accept.” BioPharm International reported that Samsung Biologics’ Kasper Øland said the industry’s shift toward more complex molecular formats is redefining the criteria biotech companies use when choosing a CDMO; this is not just capacity procurement, but a reallocation of roles across early development, process design, and the path to commercialization.
Traditional monoclonal antibodies once gave large-scale biomanufacturing a relatively mature engineering language, but next-generation pipelines more often involve bispecific antibodies, antibody-drug conjugates, and other biologic molecules with more intricate structures. The challenges for these products are not only about bioreactor size, but also about the linked relationships among protein expression, purification, conjugation, consistency analysis, and impurity control. If any one part is handled unstably, it may expand into risk in clinical supply or regulatory submission materials.
For biotech companies with limited capital and staffing, a CDMO is therefore no longer merely an outsourced unit that takes orders and manufactures to specification. The earlier a manufacturing partner enters the collaboration, the more likely it is to influence whether a drug candidate can move smoothly from laboratory design into a reproducible production process, and it will also affect the pace of clinical batch supply, technology transfer, quality documentation, and future capacity expansion.
This change shifts CDMO competition from “who has more tanks” to “who can handle more uncertainty.” Complex molecules require stronger analytical capabilities, tighter cross-functional collaboration, and familiarity with global regulatory requirements. Especially between early clinical development and late-stage development, process changes, specification setting, and data integrity may all affect subsequent review.
However, the interview-style report itself provides limited public detail, and no independent external sources for the same event appear available for mutual corroboration. In other words, Øland is putting forward an industry assessment, not a single new contract, facility plan, or clinical milestone. Its significance lies in reflecting how large CDMOs understand customer needs, rather than proving that any company has established a clear advantage across all complex molecule fields.
Even so, the signal still speaks directly to the structural changes currently under way in biopharmaceuticals. As R&D pipelines become increasingly sophisticated, biotech companies will find it harder to make partnership decisions based only on price, capacity, and delivery timelines. The ability to handle molecular characteristics, process risks, and regulatory data on the same map is becoming the core language of the next round of CDMO competition.