Technology to replace animal testing is emerging as a core infrastructure for new drug development, moving beyond an ethical issue. The limitation that animal models fail to sufficiently predict actual human responses has been consistently raised, while the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are moving to recognize advanced alternative testing methods as tools for drug development. As a result, Korean companies are tightening their grip on the market with drug responsiveness and toxicity prediction technologies.
According to the industry Wednesday, an advanced alternative testing platform called "K-NAMs" was recently launched in Korea. Involving more than 22 industry, academic, and research institutions, K-NAMs is pursuing the creation of an alternative testing ecosystem that links organoids, organ-on-a-chip technology mimicking living organs, and artificial intelligence (AI)-based analysis technology. It aims to connect testing method standardization, regulatory compliance verification, and global commercialization. Organoids are three-dimensional cell models that reproduce structures and functions similar to human organs, while organ-on-a-chip is a technology that recreates the human environment on a chip through cell cultures. Until now, even when Korean companies possessed alternative testing technologies, they faced difficulties in industrial application because the standards for gaining recognition in the approval and review process were unclear. In response, the government also launched the National Bio Innovation Committee last month and began preparing an evaluation system for innovative technologies for new drug development, such as organoids.
Changes in the global regulatory environment are cited as the background for the full-scale discussion of alternative testing methods in Korea. In April last year, the FDA announced a roadmap to reduce animal testing at the preclinical stage, followed by the release of a one-year progress report this April. It presented the preparation of a draft guideline for using alternative testing methods in new drug reviews and the establishment of a global data-sharing foundation related to alternative testing methods as major achievements. The European Union (EU) is also pushing to announce a roadmap for abolishing animal testing during the first half of this year, while the EMA is accelerating the promotion of alternative testing methods based on the 3R (Replacement, Reduction, Refinement) principles.
Accordingly, Korean companies are also speeding up their market push with organoids and organ-on-a-chip technology. Organoidsciences, which led the launch of K-NAMs, is expanding its business around "Odyssey," an organoid-based drug evaluation platform. Beyond its existing pipelines such as tumor, intestine, and skin, it is now expanding into an integrated evaluation platform for the development of antibody-drug conjugates (ADC). The company recently unveiled a platform at the American Association for Cancer Research meeting (AACR 2026) that simultaneously evaluates target expression, drug responsiveness, and potential toxicity to normal tissue using tumor models derived from more than 10 cancer types. "With toxicity prediction technology using normal tissue organoids such as eyes and skin, we can identify the risks of drugs in advance," a company official said.
In the organ-on-a-chip field, Mepsgen is developing a preclinical multi-organ chip platform with support from the Ministry of Trade, Industry and Energy (MOTIE). Its plan is to build a model integrating intestine, brain, and vagus nerve organoids to enhance the predictability of new drug evaluation. It is also jointly developing a placenta bio-tissue chip with the Biofusion Systems Laboratory at Inha University. Kangstem Biotech, which possesses an organoid platform, was also recently selected as a company to carry out the "Public Research Achievement Demonstration Pilot Project" supervised by the Ministry of Science and ICT (MSIT), and plans to establish manufacturing processes and quality standards for skin and hair follicle organoids and begin full-scale commercialization.
Large contract development and manufacturing organization (CDMO) companies are also incorporating organoid technology into new drug development. Samsung Biologics, which launched an organoid-based contract research organization (CRO) service last year, recently participated in succession in "AACR 2026" and the "Protein & Antibody Engineering Summit (PEGS) Boston," emphasizing its achievements in developing anticancer drugs using organoids. Using "cancer patient-derived organoids" that reproduce patient tumors, the company compares and analyzes drug efficacy to select promising candidates, thereby lowering the possibility of failure in the early development stage.
Along with this rise of the alternative testing market, Woojung Bio, which has provided animal testing-based preclinical services for 37 years, is currently seeking a new path by jointly developing an organ-on-a-chip platform with U.S.-based Excella Biosystems.
The market outlook is also favorable. According to market research firm Global Market Insights (GMI), the animal alternative testing market is expected to grow at an average annual rate of 11.9% from $1.8 billion (about 2.7 trillion won) in 2023 to $4.8 billion (about 7.2 trillion won) in 2032. "Alternative testing methods should be seen not simply as a technology to reduce animal testing, but as an industrial infrastructure that enhances the predictive power of new drug development," an industry official said. "The more concrete the framework becomes, the faster Korean companies' commercialization will accelerate."
