As one of the most promising platforms for transdermal drug delivery and minimally invasive therapy in the 21st century, microneedle technology centers on micron‑scale needle‑like structures that penetrate the stratum corneum-the outermost skin barrier-in an almost pain‑free manner, creating temporary microchannels in the epidermis or superficial dermis. This sophisticated design perfectly combines the convenience of conventional transdermal patches with the high efficiency of subcutaneous injections, driving profound transformations in the medical, aesthetic and pharmaceutical sectors. The versatility of its technical principles and precision of its manufacturing processes directly determine product performance and application scope.

Classified by working principles, microneedles fall into four main categories: solid microneedles, dissolvable microneedles, coated microneedles and hollow microneedles. Solid microneedles (made of metals or silicon, for instance) are primarily used to pre‑form channels in the skin prior to topical drug application. Dissolvable microneedles are fabricated from biodegradable materials such as hyaluronic acid and polylactic acid, with drugs loaded inside the needle bodies. Upon skin penetration, they dissolve in interstitial fluid to release payloads, enabling non‑invasive drug administration. Coated microneedles feature drug layers wrapped around solid needle tips, while hollow microneedles function like miniature syringes for active liquid delivery. Among these types, dissolvable microneedles have become the mainstream for research, development and industrialization, owing to advantages including no residual medical sharps after use and controllable drug release.

Manufacturing processes represent a critical bottleneck and core competitiveness for translating microneedle technology from laboratory to market. Traditional photolithography and etching techniques are commonly used to produce molds for silicon or metallic microneedles, yet they incur high costs and involve complex procedures. In recent years, innovative enterprises represented by Zhongke Microneedle (Beijing) Technology Co., Ltd. have achieved breakthrough progress. Drawing on technical expertise from the Institute of Physics and Chemistry, Chinese Academy of Sciences, the company independently developed the RT‑SMP® Room‑Temperature Printing Method, certified as internationally advanced. This process enables precision molding of polymer microneedles at ambient temperature, avoiding damage to active pharmaceutical ingredients from high heat. It has also pioneered China's GMP‑compliant production line with an annual capacity of 150 million patches, addressing global challenges in large‑scale, low‑cost and high‑quality manufacturing of dissolvable microneedles.

In the field of materials science, a research team from Beijing University of Chemical Technology stands out for its pioneering use of green biodegradable polylactic acid (PLA) as the matrix material for microneedles. Boasting excellent biocompatibility and biodegradability, PLA has been adopted in full‑chain innovations by the team spanning mold design, fabrication processes and production line construction. The world's first production line for solid PLA microneedles has been established, with an annual output of 50 million pieces. Successfully commercialized and granted a medical device registration certificate, this technology has been proven to boost drug absorption efficiency by over 10‑fold with exceptional safety in clinical treatments for skin disorders such as psoriasis and melasma.

Another major industrialization pathway has been realized by Guangzhou Xinji Pharmaceutical Co., Ltd. Its dexmedetomidine hydrochloride microneedle patch, approved for clinical trials as China's first pharmaceutical microneedle patch, marks a new era for microneedle‑mediated drug delivery in China. The product's success stems from profound expertise in polymer material formulation, drug loading processes and large‑scale manufacturing. Microneedle production involves multiple precision‑driven steps including precision mold machining, homogeneous mixing of drugs and base materials, and drying molding. Minor deviations in any parameter can affect needle mechanical strength (for successful skin penetration) and drug release kinetics.

Looking ahead, microneedle manufacturing technologies are advancing toward intelligence and personalization. 3D printing enables customized microneedle arrays tailored to individual skin characteristics. Meanwhile, integrating smart materials such as thermosensitive and pH‑responsive materials into microneedles facilitates the development of intelligent systems capable of on‑demand drug release triggered by physiological signals-for example, smart insulin patches that automatically release insulin when blood glucose rises. These cutting‑edge innovations are evolving microneedles from simple physical penetration enhancers into intelligent biointerfaces for next‑generation precision medicine.