Recently, Konstantinos Apostolou, R&D senior manager at our Athens Development facility, was featured in European Pharmaceutical Manufacturer, where he explored the rapid rise of highly potent active pharmaceutical ingredients (HPAPIs). The market is valued at $185.5 billion in 2024 and projected to reach $520 billion by 2034, with oncology leading and growing use across asthma, diabetes, and CNS disorders. As potency increases and microdosing advances, developers face stringent containment needs down to nanogram levels.
He outlines key challenges, such as operator safety, lack of standardisation, and small-batch validation, and the strategies to address them: early hazard assessment, defining OELs and OEBs, QSAR-driven toxicology insights, advanced containment, robotics, and real-time exposure monitoring. Looking ahead, the sector is set to benefit from targeted delivery systems, ADCs, AI/ML-optimised manufacturing, and evolving regulation.
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