Following the FDA, the National Institutes of Health (NIH) has also joined in the movement to phase out animal testing, which is considered essential for verifying toxicity and efficacy, but faces criticism and ethical concerns leading towards a gradual abolition. Recently, global scientific and pharmaceutical sectors have been buzzing as U.S. regulatory bodies have announced plans to gradually reduce reliance on animal testing.
With animal testing historically being a cornerstone in drug development and life sciences research, there is vigorous research underway to find alternative technologies. NASA declared last month it will cease funding for research proposals solely dependent on animal testing, stating that as of July, funding for new animal-centric studies will officially end. They plan to use New Approach Methodologies (NAMs) as the criteria for research funding.
This step follows the FDA’s announcement in April to phase out animal testing as well. The NIH, which is one of the largest departments supporting research, constituting over 20% of government R&D funding in the U.S., is transitioning towards these changes.
Animal testing dates back over 2000 years, with historical records indicating that Aristotle performed animal dissection to understand anatomy. In the U.S., the Federal Food, Drug, and Cosmetic Act was passed in 1938 to ensure drug safety, establishing animal testing as a legal standard. However, the movement towards eliminating animal testing now arises from not only ethical considerations but also doubts about the utility of such tests. For instance, approximately 90% of drugs that pass animal tests failed to show safety or efficacy in humans, due to significant biological differences between humans and animals.
The massive number of animals sacrificed for testing is another issue, with nearly 5 million animals used in experiments domestically last year alone, the majority being mice at over 2.7 million. Consequently, environmental groups have consistently advocated for the abolition of animal testing.
Despite this, completely eliminating animal testing presents challenges. The U.S. had announced plans in 2019 to eliminate animal testing but retracted last year due to the lack of sufficient alternative methods.
Professor Sanggi Park from POSTECH’s Life Sciences Department notes that although there is a direction towards eventual abolition, a complete phase-out won’t be feasible anytime soon. In neuroscience research in particular, observing behavioral changes in animals is essential for measuring brain function changes, as current methods are limited outside of animal testing.
There have been efforts to prevent unnecessary animal sacrifices, with research institutions establishing ethics committees to monitor excessive animal use in studies. However, some argue these regulations hinder research autonomy.
Alternative research is progressing but deemed insufficient. New Approach Methodologies encompass organoids and modeling via big data and artificial intelligence. Professor Jinwoo Kim from KAIST notes that organoids are not fully standardized, making them unreliable currently as they don’t replicate the exact conditions of human organs, lacking key components like blood vessels.
Arguments against the total abandonment of animal testing also highlight that bypassing animal tests directly for human trials could be even riskier, equating to experimental use of humans. Additionally, the foundational premise of animal testing that all animals are evolutionary similar raises concerns about challenging the theory of evolution if dismissed outright.
One notable technology replicating the microstructure and environment of organs on a chip, called “organs-on-a-chip,” is gaining attention as a partial substitute for animal studies. Professor Juheon Kang from the UNIST Biomedical Engineering Department states that many organs and diseases are now being addressed via organs-on-a-chip, which in some stages are already replacing animal testing for drug efficacy evaluations.
However, technical limitations make it difficult to simulate human body conditions perfectly, thus industrial utilization will take time. Diverse cell culturing mediums are needed to mimic organs properly, a challenge as different media for different cells are currently utilized.
Domestically and internationally, companies are advancing into the organoid market, propelled by the FDA’s official move towards phasing out animal testing. Collaborative efforts to secure leadership in the organoid industry are intensifying, as evidenced by the “K-Organoid Consortium,” a public-private partnership launched with 27 domestic companies and 18 institutions to bolster research, development, commercialization, and global competitiveness in the organoid sector.
Worldwide, pharmaceutical giants like Roche, AstraZeneca, and GlaxoSmithKline (GSK) are utilizing organoids in drug development. In 2023, Roche established the largest organoid research institute among global pharmaceutical companies, the Institute of Human Biology (IHB), spearheaded by noted scholar Hans Clevers, to incorporate diverse organoids for developing new drug compounds.
AstraZeneca leverages organoids for blood cancer treatment development, utilizing bone marrow organoids and AI platforms to significantly enhance Phase 1 clinical trial success rates.
Organoids, meaning “mini organs” cultured in three dimensions from stem cells, began with intestinal organoids and have since expanded to include organs like the brain, lungs, liver, and intestines. Their high patient similarity allows for more accurate predictions in human drug responses compared to animal testing.
According to Research and Markets, the global patient-derived organoids market is expected to grow at an average annual rate of 22%, reaching $3.3 billion in 2030 from $1 billion in 2024.
In Korea, companies such as Organoid Science, Next & Bio, and Kangstem Biotech are developing organoid technologies. Recognized as a pioneer in the domestic organoid field, Organoid Science owns organoid-based regenerative therapies, including ATORM, and new drug evaluation platforms like ODYSSEY, which various pharmaceutical companies utilize to verify drug efficiency and safety.
Kangstem Biotech has been developing skin organoids capable of modeling atopic skin conditions through complex intercellular relationships. Meanwhile, Next & Bio is researching organoids using solid tumor tissues.
Pharmaceutical companies are collaborating with these organoid specialists to leverage new technologies in drug development, demonstrated by JW Pharmaceutical’s joint research with Organoid Science since 2022 to establish a new drug development platform, using it in preclinical tests for a hair loss treatment candidate.
GC Cell collaborates with Next & Bio to verify the efficacy of immune cell therapy CAR-NK using the organoid platform. Daewoong Pharmaceutical is developing automated and standardized processes for mass-producing regenerative therapies using organoids.
Samsung Biologics has recently entered the market by launching “Samsung Organoid,” a service for selecting new drug candidates using organoids to evaluate drug efficacy and provide data to clients within five weeks, helping identify likely candidates for actual development from various anticancer drugs.