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REVIEW

Microneedles in biomedicine: Innovations, challenges, and future prospects

Xinrui Li1 ,  Chi Zhang1 ,  Yuxin Zhang1 ,  Zhijing Liu1 ,  Jiaxin Li1 ,  Ying Meng1 ,  Peng Zhang1*
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1 Key Laboratory of Molecular Pharmacology and Drug Evaluation of the Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, School of Pharmacy, Yantai University, Yantai, Shandong, China
BMT, 122 https://doi.org/10.12336/bmt.25.00122
Submitted: 30 July 2025 | Revised: 18 September 2025 | Accepted: 23 October 2025 | Published: 5 November 2025
© 2025 by the Author(s). Licensee Biomaterials Translational, USA. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 (CC BY-NC-SA 4.0) (https://creativecommons.org/licenses/by-nc-sa/4.0/deed.en)
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Abstract

The effective delivery of therapeutic drugs is fundamental to modern medical practice. However, conventional administration methods, primarily oral and parenteral injection, exhibit numerous limitations, including the suboptimal bioavailability of macromolecules and challenges related to patient compliance. The advent of microneedle (MN) technology is reshaping strategies in the biomedical field, effectively overcoming the constraints of traditional drug delivery and diagnostic approaches. Research indicates that MNs can penetrate the stratum corneum to form transient microchannels, facilitating the transdermal delivery of therapeutic agents while bypassing gastrointestinal and hepatic barriers. This customizable and personalized drug delivery system holds significant potential for clinical application. Beyond drug delivery, MNs also have the capacity to transform healthcare models through real-time biomarker monitoring enabled by contact with interstitial fluid. This technology demonstrates considerable promise in managing chronic conditions such as diabetes, while also opening avenues for applications in vaccination, tissue regeneration, and cancer therapy. Recent innovations include the development of stimulus-responsive MNs for precision medicine and their integration with wearable devices to achieve closed-loop therapeutic diagnostics. Despite the substantial promise of this field, challenges remain regarding clinical translation, particularly in relation to biocompatibility, mechanical strength, and drug stability. This review outlines MN classifications, design principles, and applications, emphasizing their expanding role not only in healthcare but also in precision medicine, global health, and food safety. By overcoming current barriers and integrating emerging technologies, MNs have the potential to transform diagnostic and therapeutic paradigms, delivering scalable, patient-centered solutions to a broad range of biomedical challenges.

Keywords
Transdermal delivery system
Microneedle
Personalized medicines
Polymeric microneedles
Biomedical application
Funding
This study was supported by the Science and Technology Support Plan for Youth Innovation of Colleges and Universities of Shandong Province, China (Grant No. 2022KJ344), the Yantai Science and Technology Bureau (Grant No. 2024JCYJ063), and the National Science Foundation of China (Grant No. 82001961).
Conflict of interest
The authors affirm the absence of any financial or personal affiliations that could be construed as influencing the research presented in this study.
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