Microneedle-Based Drug Delivery Systems: Advances, Challenges, And Future Prospects

Abstract

Microneedle-based drug delivery systems (MNDDS) represent one of the most innovative developments in transdermal therapeutics. Their ability to painlessly penetrate the stratum corneum and deliver or extract biomolecules has opened new possibilities in vaccination, chronic disease management, long-acting therapeutics, and wearable diagnostic platforms. Recent progress in materials science—including biodegradable polymers, hydrogels, smart composites, and stimuli-responsive systems—has significantly improved mechanical strength, drug-loading capacity, biocompatibility, and patient compliance. Parallel advances in fabrication technologies such as 3D printing, two-photon polymerization, micromolding, and micro-milling have enabled scalable, customizable, and highly precise microneedle manufacturing.
Beyond drug delivery, MNDDS have evolved into multifunctional systems capable of interstitial fluid sampling, real-time biosensing, closed-loop therapeutic feedback, and integration with Internet-of-Medical-Things (IoMT) platforms. These capabilities highlight their growing potential in personalized medicine and point-of-care healthcare.
This review provides a comprehensive evaluation of microneedle principles, classifications, materials, fabrication strategies, biomedical applications, safety considerations, and translational limitations. It also discusses regulatory challenges, cost-effectiveness, industrial commercialization pathways, and future opportunities, emphasizing the technological innovations needed for widespread clinical adoption of microneedle-based platforms.