Following the United States, Europe is also moving to reduce animal testing, marking a new turning point in research and development (R&D) strategies for the pharmaceutical and biotech sectors. As nonanimal testing technologies such as artificial intelligence (AI) and Organoid (miniature artificial organs) take root as core infrastructure for global new drug development, Korea's corporations are stepping up their response.
On the 13th, according to the pharmaceutical and biotech sectors, the European Union (EU) Executive Commission recently announced a roadmap to phase out the use of animals in safety assessments of chemicals, including medicines. The focus is on expanding the development of nonanimal test methods and building AI-based evaluation systems.
◇ U.S. and EU accelerate reduction of animal testing… New drug development paradigm shifts
Until now, a variety of animals, including mice, pigs, and monkeys, have been used in experiments during the new drug development process. It is estimated that about 200 million animals are used in experiments worldwide every year. Although animal testing has long been considered the basis for safety assessments, its limitations have been consistently raised, as physiological differences between animals and humans mean it does not sufficiently predict actual clinical outcomes.
Until recently, AI was used in the discovery stage of new drug candidates, but efficacy and toxicity evaluations still largely relied on animal testing. However, as the global regulatory stance shifts, the situation is changing.
Earlier, the U.S. Food and Drug Administration (FDA) created the basis to use various alternative test methods instead of animal testing in the new drug development process through the FDA Modernization Act 2.0. This year, it also set out plans to expand the use of Organoid and organ chips, and computer-based toxicity and safety assessments. An organ chip is an experimental platform that implements the structure and function of human organs on a small chip.
On top of that, a bill to ban the import of primates (monkeys) for research was introduced in the U.S. House last month, making the trend toward reducing animal testing even clearer.
The industry views this not simply as a step to strengthen animal welfare but as a paradigm shift in new drug development. As global regulators begin to define nonanimal test methods as essential capabilities rather than optional, whether one secures the related technologies is emerging as a key factor that will determine future competitiveness in new drug development.
◇ From Nvidia to Lilly to Samsung Bio… "The alternatives are AI and Organoid"
In particular, AI is rapidly expanding its scope of use across the entire new drug development process beyond the discovery of candidate substances. Global big tech corporations Nvidia and U.S. drugmaker Eli Lilly and Company announced plans to establish a joint AI-based new drug development research lab at the JP Morgan Healthcare Conference (JPM 2026) in January this year. Using Nvidia's bio-specialized platform BioNeMo, the plan is to push ahead from protein structure analysis and candidate discovery to building robot laboratories and research automation.
TuneLab, an AI new drug development platform built on research data accumulated by Lilly over decades, is also drawing attention. In Korea, Aribio and Pharos iBio are participating in efforts to advance TuneLab.
Interest in physical AI and Robotics technology, heightened after Nvidia CEO Jensen Huang's visit to Korea, is also spreading into the new drug development field. The establishment of next-generation research environments is gaining momentum, automating repetitive experiments performed by researchers and having AI handle experimental design and data analysis.
The Organoid and organ chip fields are also facing new growth opportunities. In Korea, corporations such as ORGANOIDSCIENCES, T&R Biofab, and NEXEL have developed related platforms, but the market size has been limited. However, as U.S. and European regulators move to expand nonanimal test methods, commercialization and market expansion are also expected to accelerate.
Korean biotech corporations are also moving quickly. Samsung Biologics in June last year unveiled an anticancer drug development strategy using the Samsung Organoid platform and the development suitability evaluation platform DEVELOPICK®. It is a contract development (CDO) service that verifies the efficacy of anticancer candidates using patient-derived tumor organoids.
HLB has also teamed up with Vastgenbio to begin developing a nonclinical service that combines AI with animal alternative test methods. The industry expects that as global regulatory changes take full effect, competition will intensify among new drug development platforms that combine AI with Organoid and organ chips.
HLB has also teamed up with Vastgenbio to begin developing a nonclinical service that combines AI with animal alternative test methods. The industry expects that as global regulatory changes take full effect, competition will intensify among new drug development platforms that combine AI with Organoid and organ chips.
The government is also expanding support. The Ministry of Health and Welfare and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) are promoting the 37.1 billion won K-AI new drug development preclinical and clinical model development project. The Ministry of Science and ICT also plans to invest 22.5 billion won over the next four years to develop AI technology that predicts differences in drug responses between Organoid and animal testing and to support the discovery of new drug candidates.
A representative at a Korean biotech developing an AI–Organoid new drug development platform said, "In the past, competitiveness depended on how efficiently you conducted animal testing, but going forward, the key will be how accurately you can predict human drug responses based on AI and Organoid," adding, "Global regulatory changes can be a new growth opportunity for Korea's corporations."