The non-viral delivery era has begun, with challenges ahead

Cell and Gene Therapy Insights 2026; 12(5), 519–522

10.18609/cgti.2026.061

Published: 17 June
Viewpoint
Yu Cao, Pete Smith



“Ultimately, the long‑term success of in vivo LNP delivery will depend on the ability to transform these platforms into robust, manufacturable, and globally accessible therapeutic modalities.”

In recent years, the development of lipid nanoparticles (LNPs) including targeted LNPs (tLNPs) has positioned non‑viral delivery as one of the most important aspects of the evolving genetic medicines space for the delivery of nucleic acid‑based moieties.

The success of COVID‑19 mRNA vaccines marked the first time the industry recognized the clinical relevance of non‑viral platforms and that these could be scaled for global industrial manufacturing. At the same time, the emergence of in vivo CAR‑T and in vivo gene editing has further strengthened market enthusiasm around LNP‑based technologies.

Despite continued progress and beneath the current excitement, there are still several major challenges to overcome with this technology.