The era of developing new drugs without animal testing is becoming a reality. As the U.S. Food and Drug Administration (FDA) moves to phase out mandatory animal testing, “organoids”—also known as mini organs—are gaining traction as an alternative. Korean pharmaceutical and biotech companies are increasingly adopting organoids for drug candidate evaluation, infrastructure development, and future business strategies.
Organoids are mini artificial organs created by 3D-culturing stem cells or tissue-derived cells. Because they mimic human physiology up to 85% better than animal models and come with lower costs and fewer ethical concerns, organoids are emerging as a viable alternative to animal testing. With the FDA’s recent announcement to gradually remove animal testing requirements, global pharma companies are actively considering organoid-based drug screening. According to Research and Markets, the global organoid market is expected to grow from $3.98 billion in 2024 to $4.83 billion in 2025, with a compound annual growth rate (CAGR) of 21.3%.
Riding this wave, Samsung Biologics announced on June 16 the launch of “Samsung Organoid,” a drug screening service based on organoid technology. Leveraging its Good Manufacturing Practice (GMP) experience, the company aims to deliver high-quality organoid services. This move is seen as an expansion from CDMO (Contract Development and Manufacturing Organization) to CRO (Contract Research Organization), allowing Samsung Biologics to engage with clients from the early stages of drug development and seamlessly transition to commercial production.
Initially, Samsung Biologics will focus on screening anti-cancer drug candidates using patient-derived organoids. These organoids, made from actual cancer cells of patients, can replicate the genetic characteristics and drug responses of the original tumor, making them valuable for predicting drug efficacy. This approach is expected to overcome the limitations of traditional cell and animal models, which suffer from low patient relevance, high costs, and ethical issues.
Meanwhile, GC Cell has recently initiated a joint research project with organoid specialist Next&Bio. The two companies plan to integrate patient-derived organoids with Microphysiological Systems (MPS) that simulate the tumor microenvironment, allowing for more precise preclinical evaluation of cell therapies compared to animal testing. Next&Bio will provide organoids made from patient tumor cells, while GC Cell will use them to assess the efficacy of its CAR-NK cell therapies.
While Samsung Biologics applies organoids in CRO services and GC Cell uses them as evaluation tools for its pipeline, Daewoong Pharmaceutical is working to lay the foundation for commercialization. Earlier this year, Daewoong was selected to lead a government-sponsored project by the Ministry of Trade, Industry and Energy aimed at developing large-scale production technology for regenerative organoid therapies. The company plans to localize key materials—such as specialized culture containers, extracellular matrix (ECM), and growth factors—and build an automated production system to accelerate global commercialization of organoid-based therapies.
Government policies in South Korea are also expected to positively influence the organoid ecosystem. President Lee Jae-myung had pledged during his presidential campaign to promote alternatives to animal testing and is reportedly pushing for legislation called the “Act on the Promotion of Alternatives to Animal Testing.”
The Ministry of Food and Drug Safety (MFDS) is currently pushing for international standardization of organoid-based toxicity tests. On June 16, it launched a joint industry-academia-government task force to discuss strategic directions for this effort. The MFDS is also collaborating with the OECD to develop the world’s first toxicity test guidelines using liver organoids.
An industry insider commented, “As the FDA increasingly shifts away from animal testing, organoids are emerging as a practical and realistic alternative. Pharmaceutical companies are moving beyond passive interest and actively looking to implement this technology.”
