PHARMACEUTICALS
This can lead to greater pressure on critical project execution timelines, meaning that CDMOs must continue to expand their analytical capabilities, including investment into their workforce, analytical instrumentation and infrastructure, to maintain speed to market and meet critical timelines.
Demand for full supply chain security
Given the critical nature of supply chain security, it is typical for customers to de-risk their projects through dual-supply strategies. This might involve manufacturing an API with a select number of different suppliers or alternatively across multiple geographic locations within one corporate network.
This approach means that customers benefit from partnering with a single company that can offer both primary and secondary manufacturing options, validated within the same quality and process umbrella. It also helps to mitigate against the risk of having to use multiple suppliers and works well in practice, particularly when the region of supply aligns with the final drug’ s distribution market.
This supply chain consideration also translates to CDMOs that must ensure their network of suppliers for raw materials, intermediates, solvents and reagents is also robust and can prevent potential delays in the manufacturing and delivery of products.
End customers are increasingly looking into CDMO supply chain strategies as part of their evaluation processes, assessing their resilience against global economic forces, and exercising caution in cases where companies are wholly reliant on single-source countries, particularly for strategically important intermediates. The volatility of global tariffs oil prices and energy prices has put greater pressure on procurement teams to find ways to lower the cost of goods and reduce the risk of stock shortages, while maintaining compliance and meeting programme timelines.
Sustainable, longterm success
As always, CDMOs must continue to adapt and evolve within the uncertain geopolitical environment to ensure continued success and a robust supply chain for biotech and big pharma customers alike.
Specialised technologies will undoubtedly play an ongoing role in many CDMO strategies and some of the more underutilised technologies, such as flow chemistry and biocatalysis, are becoming more commonplace within late-phase and commercial-scale manufacturing. Specialist skills capabilities and capacities will be key to differentiating CDMOs for the long term. Embracing opportunities offered by emerging technologies, such as artificial intelligence, will enable CDMOs to add
considerable value to their partners’ projects, not least in time and resource efficiency.
Environmental sustainability strategies also play a key role, as both innovators and outsourcing partners continue to work towards their own sustainability goals. CDMOs continue to adapt and optimise development and manufacturing processes by innovation in substituting hazardous solvents and reagents with greener alternatives and / or looking to use technologies like flow or biocatalysis where appropriate.
Importantly, sustainable success for both CDMOs and their customers lies in developing deep, strategic partnerships, where projects are considered a part of a wider strategy to secure long-term advantages for both parties. These relationships are no longer transactional, due to the complexities of the market.
So, whilst ensuring the correct capacity is available and maintaining the capabilities, knowledge and expertise to handle the evergrowing complexity of projects is paramount, successful CDMOs will understand the real value of mutually beneficial relationships that stand the test of time. ●
Sterling’ s facility at Cork, Ireland |
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David Molyneux |
References: 1: US FDA, Novel Drug Approvals 2025. https:// www. fda. gov / drugs / novel-drugapprovals-fda / novel-drug-approvals-2025 2: IQVIA Institute, Global R & D Trends 2026. https:// www. iqvia. com / insights / |
the-iqvia-institute / reports-andpublications / reports / global-r-and-dtrends-2026? utm _ campaign = 2026 _ GlobalTrendsinR % 26D2026 _ INSTITUTE _ SM & utm |
3: Janus Henderson, Playing the Long Game in Biotech’ s Recovery. https:// www. janushenderson. com / en-gb / investor / article / playing-the-long-game-in-biotechsrecovery / |
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VP, BUSINESS DEVELOPMENT
STERLING PHARMA SOLUTIONS enquiries @ sterlingpsl. com www. sterlingpharmasolutions. com
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