90 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 DCAT ROUNDTABLE growth, even as routine generics and commoditised APIs stay under margin pressure. The overall mood seems to be “cautious optimism”: no broad boom, but a clear growth cycle in specialised, higher‑complexity segments. To what extent are geopolitical pressures reshaping sourcing decisions, particularly around regionalisation and dual sourcing? Geopolitics was once a footnote for outsourcing teams and now it’s become now a board‑level driver. With concerns around tariff uncertainty, US‑China tensions, export controls, and supply chain fragility, many pharma companies are seeking to reduce single‑country dependence, especially for patient critical medicines. At the commercial stage dual or multi‑sourcing is increasingly written into RFPs and tech‑transfer plans, especially for critical APIs and injectables. It’s becoming a design principle rather than a contingency plan. For clinical stage assets additional considerations such as trial location, regulatory pathways and licensing strategies can mean more regionally influenced decisions are made when outsourcing. Are customers prioritising cost control over resilience and innovation, or are you seeing a more balanced approach emerge? The approaches we see are definitely more balanced, though with a very ROI‑driven underpinning: resilience is non‑negotiable, cost is heavily negotiated, and innovation must prove its value quickly. Customers want cost efficiency, but not at the expense of reliability. The winners will be those who deliver both. Where do you see the most meaningful growth opportunities in the next 12–18 months - geographically or technologically? Geographically there will continue to be some reshoring/near‑shoring, especially for small‑molecule APIs, sterile injectables, and controlled substances where regulators and politicians care about local capacity. Technologically complex small molecules and HPAPIs: Oncology, CNS, and other high‑potency areas continue to drive demand for specialised containment and problem solving know-how with a proven track record. Biologics and advanced modalities: mAbs, ADCs, peptides, oligos, and viral vectors remain high‑growth, with strong demand for those having an established fill‑finish track record. What is the biggest misconception pharma companies currently have about the CDMO/API supply environment? The most damaging misconception is that capacity, capability, and geography are easily interchangeable and always available at the right price. With some proponents still touting “There’s plenty of high‑quality capacity everywhere.” However in reality specialised areas (HPAPIs, sterile fill‑finish, advanced modalities), genuinely top‑tier, inspection‑ready capacity are still constrained and often booked years ahead. Those with deep experience in the sector understand that outsourcing is no longer a simple lever you can pull late in the game—it’s a structural, strategic choice that needs to be designed into the asset and portfolio from the start. How would you describe the mood of the outsourcing market right now - stabilising, cautious, or entering a new growth cycle? The outsourcing market appears to be entering a broadly stabilising phase, although the mood varies across different segments. In mammalian cell-based biologics, the development of structurally more complex modalities - such as multispecific antibodies and bioconjugate products is increasing. As a result, biopharmaceutical developers are placing greater emphasis on working with CDMOs that possess strong analytical capabilities and deep manufacturing expertise. Accordingly, the criteria for CDMO selection have become more demanding than in the past. Rather than focusing primarily on scale or capacity, developers are also evaluating partners based on quality, execution capability, technical problemsolving, and a deep understanding of process development and manufacturing. This shift is encouraging more capability-driven, sustainable growth in this segment rather than indiscriminate KEVIN SHARP Executive Vice President and Head of Sales and Operations Samsung Biologics RYAN LEE Senior Director of Sales and Operations Samsung Biologics
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