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Exosomes have incredible properties that enable researchers to engineer exosomes as carriers for the delivery of drugs and target tissues of interest, while evading or modulating immune responses. Drug delivery and development of exosome-mediated therapies is a growing market segment, with over 50 companies forging ahead in this field. All the recent advances in exosome research are technology-based and this helps researchers to quantify exosome cargoes and subtypes, allowing for the tracking of exosomes with remarkable precision. This is helping companies to regulate exosome drug dosage and delivery, as well as deliver effective treatments for hard-to-treat diseases, such as cancer and neurodegenerative diseases.
In recent years, there have been increased interactions between pharmaceutical companies and academic scientists working within the fields of neuroscience, cell and gene therapy, molecular biology, and imaging. These interactions are expediting the effective translation of bench discoveries to clinical trials in humans. Because of their natural properties as intracellular messengers, many companies are commercializing naïve exosomes, which are the exosomes naturally released by cells. Additionally, both small and large companies are now developing engineered exosomes, an approach that has the potential to facilitate drug delivery to hard-to-reach tissues, such as the central nervous system (CNS).
In recent years, several universities and research hospitals have performed small-scale Phase I clinical trials using exosomes. So far, only a few companies, such as Direct Biologics, Aegle Therapeutics, Exopharm Ltd, United Therapeutics, Avalon Globocare, have reached the pivotal point of transitioning exosome therapeutics into human trials. In other exciting news, EXO Biologics is the first company in the world to be authorized for a Phase I/II clinical trial in the EU for MSCs-derived exosomes and ExoXpert is the only CDMO to offer an exosome manufacturing platform with clinical track record in EU.
Despite all of this exciting progress, as of today, no exosome therapeutic has gained FDA approval.
However, globally, several exosome-based skincare cosmeceuticals are distributed and sold through dermatologist’s offices and aesthetic clinics. These products are used when patients receive radio frequency, laser and microneedling treatments or at home to promote skin longevity. Laboratory-based exosome studies have shown enhanced outcomes in skin rejuvenation, scar revision, hair restoration and fat graft survival. Products are also being developed for wound healing and ocular treatments.
Exosome-based therapeutics are likely to reach the markets in U.K., Italy, and South Korea earlier than in the U.S., as companies in these countries have a larger number of products in their pipelines. With the expected arrival of some ocular therapeutics and wound healing products, the market for exosome therapeutics is anticipated to rise substantially by 2030.



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