Current status of extracellular vesicle technology in industrialization and commercialization

Extracellular vesicles (EVs) are nanovesicles secreted by most cells types that play essential roles in intercellular communication and molecular exchange. Due to their diverse cellular origins, small molecule size, high stability, excellent biocompatibility, and cell targeting, EVs have emerged as promising tools for disease diagnosis and therapy, targeted drug delivery, and regenerative medicine. This review provides an overview of the biochemical characteristics, production methods, and industrial development of EVs based on patent filings and registered clinical trials related to EVs from 2015 to 2024. We further analyze major translational bottlenecks hindering the commercialization of EVs, emphasizing challenges related to batch-to-batch reproducibility, methodological standardization, manufacturing scalability, and regulatory pathway clarity. Finally, we highlight new engineering approaches including 3D hollow-fiber bioreactors, microfluidic isolation platforms, and genetic bioengineering that hold significant potential to address current limitations in EV manufacturing and clinical translation.