US FDA Moves to Replace Animal Testing... Samsung Biologics Targets $44 Billion Market

FDA Releases New Guidelines on New Approach Methodologies
Reducing Reliance on Animal Testing

As U.S. health authorities lower their reliance on animal testing in new drug development and fully expand the use of alternative testing methods—known as New Approach Methodologies (NAMs)—Korean contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) are expected to benefit significantly. In particular, companies such as Samsung Biologics and JW Pharmaceutical, which have proactively entered the organoid (organ-like tissue) business, are drawing attention.

According to the industry on March 26, the U.S. Food and Drug Administration (FDA) recently released a draft guideline related to the use of new approaches (NAMs) to replace animal testing. The draft, announced by the FDA’s Center for Drug Evaluation and Research (CDER), allows for the submission of data using NAMs such as organoids, organ-on-a-chip, human cell-based assays, and computational models. Even if these methods have not previously been approved as alternatives to animal testing or have not undergone non-clinical toxicity qualification, as long as there is a clear purpose of use, relevance to human biology, and reproducibility, new drug approval applications can be submitted. On the same day, the U.S. National Institutes of Health (NIH) also announced that, for the first time in history, it will provide $150 million (about 225.6 billion won) through the "Supplement to Animal Research Program" to support the development and validation of NAMs technologies, further strengthening policy support. Since the enactment of the FDA Modernization Act 2.0 in 2022, which eliminated the requirement for animal testing in new drug approvals, alternative testing methods have moved beyond the early research stage and into the core of regulatory decision-making.

According to global market research firm Market Research Future, the global market for animal alternative testing is expected to expand to approximately $29.4 billion (about 44 trillion won) by 2030. Especially within this, Fortune Business Insights forecasts that the human organoid market, considered a core technology, will see rapid growth from $1.44 billion (about 2.1664 trillion won) this year, with an average annual growth rate of 18.8%, reaching $5.71 billion (about 8.5906 trillion won) in 2034.

In line with the emergence of the animal alternative testing market, which can reduce the cost burden of drug development and increase patient similarity, global CDMO leader Samsung Biologics has proactively launched its own organoid screening platform, expanding into the CRO business. The core of this initiative is to provide advanced drug screening services that use three-dimensional models accurately replicating patient tumor tissues to identify candidate substances with efficacy against various cancers such as colon, lung, and liver cancer. By supporting rapid and precise drug efficacy evaluation and lead compound selection from the early stages of new drug development, the company has laid the foundation to dramatically improve clinical success rates for its multinational pharmaceutical clients. By forming CRO partnerships from the initial candidate screening phase—the very first step in drug development—Samsung Biologics can achieve a powerful 'lock-in' effect, binding the entire drug development cycle, from clinical contract development (CDO) to commercial contract manufacturing (CMO), to its own business.

JW Pharmaceutical has signed an agreement with Organoid Science to build a preclinical translational research platform and collaborate on joint research. The company is currently conducting research to reduce the discrepancy between results from traditional animal testing and actual clinical outcomes, using organoid models developed from patient tissue samples.

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