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

Summary

The Dubai Future Foundation outlook cautions that therapeutic use of exosomes will advance more slowly than diagnostics. As of late 2025, no exosome-based therapy had FDA approval. Biological fluids contain many particles of similar size, which makes pure and reproducible exosomes hard to isolate. Manufacturing is still a bottleneck, and quality control standards for targeting precision, distribution in the body, dosing and durability remain to be developed. Measurement is also unsettled, since dose may be defined by particle count, protein content or payload activity, making studies hard to compare. Regulators also expect evidence of how a therapy spreads through the body, yet exosomes are designed to reach narrow targets.