mRNA: The State of Play in Oncology and Infectious Disease

Building on the landmark success of COVID-19 mRNA vaccines Comirnaty and Spikevax, the pharmaceutical industry is now advancing mRNA technology into a broad range of disease areas — with 1,035 drug candidates in the pipeline as of early 2024, spanning infectious disease, oncology, genetic disorders, metabolic conditions, and central nervous system indications.

This 2024 report by Datwyler draws on GlobalData's proprietary pipeline analytics to assess the state of mRNA innovation across both infectious disease (45% of active pipeline) and oncology (27%), analyzing clinical trial trends, late-stage candidates, and the competitive landscape of companies including Moderna, BioNTech, and CureVac. On the packaging side, the report addresses the significant primary packaging challenges posed by mRNA's ultra-cold storage requirements — including the impact of deep-freeze and freeze-thaw cycles on elastomeric component performance, container closure integrity (CCI), and glide force. It details Datwyler's validated testing of plunger performance at -50°C, the rationale for uncoated versus coated rubber components in vials and prefilled syringes at ultra-low temperatures. Datwyler's recognition by BioNTech as a pivotal partner in COVID-19 vaccine supply underscores its established role in supporting mRNA drug manufacturers at scale.