51 CHEMICALS KNOWLEDGE HUB Issue 2 / October 2025 ROUNDTABLE ML. The pharmaceutical market has continued to evolve rapidly over the past year, with advanced modalities reshaping the innovation landscape. RNA therapeutics including mRNA-based medicines, siRNA, oligonucleotides and CRISPR gene-editing drugs are continuing their progression from early discovery into broader pipelines, driving unprecedented demand for high-quality raw materials and reliable CDMO partners. At the same time, global supply chains remain under scrutiny, as developers and regulators alike call for resilience, transparency and end-to-end traceability. At Hongene, we’ve positioned ourselves at the heart of this transformation by building a vertically integrated platform, from phosphoramidites, nucleotides, and enzymes through to CDMO services for oligonucleotide and mRNA manufacturing. This model allows us to mitigate the risks of fragmented supply chains and provide our partners with continuity from early research through commercial launch. We’re also closely monitoring the expansion of largepatient indications within the cardiometabolic disease space, where siRNA drugs may soon require multiton manufacturing capacity. To meet this demand, Hongene has scaled infrastructure and advanced chemoenzymatic ligation technology, enabling highpurity, cost-effective and sustainable siRNA production at volumes previously unattainable. Another trend capturing our attention is the advancement of targeted delivery. AbbVie’s acquisition of Capstan highlights growing interest in tLNP-based in vivo engineering, while Avidity’s partnership with Lonza secures capacity for antibody-oligonucleotide conjugates. These deals exemplify delivery as a critical frontier shaping both therapeutic potential and manufacturing strategy. BC. Over the past year, regulatory momentum has started to reshape biosimilar development. The FDA issued the first waiver of confirmatory clinical efficacy studies for a monoclonal-antibody biosimilar – elevating robust analytical and PK evidence – and the EMA’s reflection paper signals a similar, analyticsfirst direction. If sustained, this shift lowers barriers to entry, shortens timelines and broadens patient access. In parallel, trade policies (US tariffs and potential EU counter-measures) are adding cost and supply-chain uncertainty. To manage this, companies are diversifying manufacturing footprints, including contract manufacturing outside tariff zones to protect economics and continuity. Layered on top are tighter capital markets and cost discipline, pushing sponsors to prioritise assets with clear differentiation. Beyond classic mAbs, the pipeline mix is changing: ADCs and multi-specific antibodies are gaining share. I expect a growing portion of development programs to focus on these modalities, which will drive demand for specialised CMC capabilities. MM. Over the past year, two dynamics have stood out: the rapid rise of complex therapies such as GLP1s and ADCs and the continued dominance of small molecules. GLP-1 demand is already outpacing supply, while ADCs are becoming a cornerstone of oncology innovation. At the same time, small molecules remain the foundation of global pharma, accounting for the majority of prescriptions in areas such as cardiovascular, CNS and infectious diseases. Looking ahead, the challenge and the opportunity is twofold: scaling for the next wave of advanced therapies, while safeguarding the resilience of the small molecule supply chain that will continue to power most of the medicines of tomorrow. LS. Over the past year, the global pharma market has continued to shift towards more specialised, high-value therapies, particularly in biologics BARTŁOMIEJ CZUBEK Director of Business Development Mabion MARTIN MEESON CEO Axplora LISA STASI VP & GM Global Pharma Strategy & EU Region Ecolab Life Sciences MICHAEL LEUCK VP European Market Hongene Biotech
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