The Post-Animal Testing Era: Technologies, Applications, 
and Prospects of Organoids and Organ-on-a-Chip

Kaiting Zhang; Rui Zhou; Xiaoqin Wu; Man Zhao; Hui Liu

doi:10.70711/pmr.v3i2.8388

The Post-Animal Testing Era: Technologies, Applications, and Prospects of Organoids and Organ-on-a-Chip

Kaiting Zhang, Rui Zhou, Xiaoqin Wu, Man Zhao, Hui Liu

Abstract

The biomedical field is experiencing a major shift from relying on animal models to a "post-animal testing era" centered on humanrelevant research, driven by regulatory reforms like the U.S. FDA Modernization Act 2.0 and global funding agencies focus on human celland tissue-based New Approach Methodologies (NAMs). Against this backdrop, organoids and organs-on-a-chip (OOCs), as representative
NAMs, are moving from scientific exploration to industrial use. This review analyzes their technology, applications, industry ecosystem, and
future trends, outlining the regulatory framework, scientific pros and cons, and disruptive uses in areas like drug-induced liver injury prediction, oncology, and neurodegenerative disease modeling. It also explores the commercial scene, leading firms, and challenges like standardization, data integrity, compliance, and ethics. Ultimately, it envisions a future with "Human-on-a-Chip" systems and AI-driven predictive biology, offering a strategic reference for stakeholders.

Keywords

Organoids; Organs-on-a-Chip; Drug Development; Policy and Regulatory

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DOI: http://dx.doi.org/10.70711/pmr.v3i2.8388

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