Issue No approved therapy, unsettled dosing units and an unresolved manufacturing bottleneck

Summary

The strategic outlook is explicit that therapeutic use lags: no exosome-based therapy was FDA-approved as of late 2025, biological fluids contain many particles of similar size so pure reproducible exosomes are hard to obtain, manufacturing remains a bottleneck, and quality control standards for targeting precision, biodistribution, dosing and durability still have to be developed.