Strengthening the supply chain for chemical-based IMPs
Gillian Wilson, project services liaison at Almac Clinical Services, looks at practical strategies to safeguard clinical trial success
The global clinical development landscape is evolving and with it the complexity of the supply chain for investigational medicinal products( IMPs). Among these, chemical-based IMPs occupy a unique and rapidly growing segment of the market.
Indeed, the pharmaceutical chemicals market, which includes APIs and advanced intermediates, is expected to grow from $ 111 billion in 2021 to $ 201 billion by 2030.1 This also highlights a growing challenge relating to maintaining streamlined, compliant and cost-effective packaging, labelling and distribution operations.
APIs demand precision synthesis, rigorous quality standards, specialised handling and rapid turnaround times for early-phase clinical trials. From a clinical supply chain perspective, this introduces levels of complexity that require careful management and strategic planning to ensure the right drugs reach the right patients at the right time and in the correct condition.
As sponsors navigate this high-risk environment while simultaneously responding to universal supply chain challenges, including geopolitical tensions, unpredictable clinical demand, the need for temperaturecontrolled logistics and compliance with global regulatory frameworks, the challenges for IMPs are as distinctive as the molecules themselves. Exploring supply chain challenges at the earliest opportunity will place sponsors in the best position to design and implement effective supply chain solutions.
Forecasting & packaging implications
Engineered for specific therapeutic targets, typically within oncology, rare diseases or precision medicine, IMPs are inherently high-value and low-volume. They require custom synthesis involving complex multi-step reactions, specialised containment for high-potency or hazardous substances and compliance with stringent GMP standards. The development cost per kilogram can be extremely high due to specialised reagents, highly skilled labour and expensive analytical validation, while clinical trials demand only small batch quantities for early-phase studies.
All this creates major challenges for supply forecasting and planning, as clinical trial demand is inherently uncertain— protocol changes, enrolment delays, or early trial termination can result in either overproduction( leading to costly waste) or stock outs( risking negative patient impact and trial delays).
Dynamic forecasting is therefore essential for sponsors to adjust quickly to changing study needs. A best practice approach hinges on proactive, data-driven planning that ensures the right drug is in the right place at the right time. By integrating real-time demand forecasting with advanced technologies, like MRP and
58 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981