BACKGROUND: Transdermal delivery has the advantage of bypassing the first-pass effect and allowing sustained release of the drug. However, the drug delivery is limited owing to the barrier created by the stratum corneum. Microneedles are a transdermal drug delivery system that is painless, less invasive, and easy to self-administer, with a high drug bioavailability. AREA COVERED: The dose, delivery rate, and efficacy of the drugs can be controlled by the microneedle design and drug formulations. This review introduces the types of microneedles and their design, materials used for fabrication, and manufacturing methods. Additionally, recent biological applications and clinical trials are introduced. EXPERT OPINION: With advancements made in formulation technologies, the drug-loading capability of microneedles can be improved. 3D printing and digital technology contribute to the improvement of microneedle fabrication technology. However, regulations regarding the manufacture of microneedle products should be established as soon as possible to promote commercialization.