Abstract: With the passing of the FDA Modernization Act 2.0 by the U.S.Senate, there has been a renewed debate about alternatives to animal testing.Organoid technology is considered to be the most promising alternative to animal testing.The technology has a development history of over 15 years since Hans Clevers first cultivated organoids from small intestinal epithelial cells in 2007.In recent years, research on organoid technology has grown rapidly.Currently, organoid technology still faces unresolved technical challenges, and there are regulatory gaps that need to be supplemented.The industries related to organoid technology are still in the early stage, with ongoing exploration of its practical use and commercialization.This article reviews the research history, application status and challenges of organoids, then discusses their commercialization prospects, aiming to inform readers about the past, present and future of organoids technology, and to provide references for evaluating the application and commercial value of organoids technology in the development of new drugs.