Innovative Breakthroughs and Translational Applications in Organoid Research: a Multidimensional Perspective on Technology, Applications, and Policy
BAI Hui1#, CHEN Ziye2#, WANG Mingshuo1, LUO Tianzi1, WANG Yunfang1,2*
Organoid technology, by faithfully recapitulating the structure and function of native organs, provides a revolutionary platform for developmental biology research, disease mechanism elucidation, and drug screening. Recent breakthroughs, driven by the convergence of stem cell biology, biomedical engineering, and artificial intelligence, have significantly advanced this field. In drug discovery, patient-derived tumor organoids serve as individualized predictive tools for precision oncology, while liver and heart organoids substantially enhance the accuracy of drug safety assessment. Multi-organ chip systems further offer novel integrated platforms for evaluating drug metabolism and toxicity. Global policy support has injected strong momentum into this technology, with regulatory agencies like the US FDA (Food and Drug Administration) and EMA (European Medicines Agency) actively promoting the adoption of organoids in drug evaluation. China’s 14th Five-Year Plan also prioritizes organoids as a key biotechnology. This review systematically outlines cutting-edge advances, translational applications, and evolving regulatory landscapes of organoid technology. It highlights its pivotal role in reshaping drug development paradigms and provides a forward-looking analysis of critical challenges—particularly standardization and scalable cultivation—along with future prospects, aiming to deliver a comprehensive roadmap for academia and industry.
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