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Published: 14 January 2025

Pharmaceutical companies invest in animal-free technologies

One of the largest pharmaceutical companies in the world, Merck, has recently acquired a leading company in the field of human-based research models. This strategic move, along with similar initiatives by other major pharmaceutical companies, signals a growing industry-wide transition away from animal testing. As regulators in the US and EU increasingly recognize the limitations of animal testing and the benefits of non-animal methods, the pharmaceutical landscape is poised for a new era of efficient, ethical and human-relevant drug development practices.

Darmstadt-based pharmaceutical giant Merck has announced the acquisition of HUB Organoids Holding B.V., a pioneer in organoid technology (1,2). This is a significant step towards more human-relevant research methods. This strategic acquisition signals an increasing shift in the pharmaceutical industry towards animal-free research. HUB's organoid technology, which creates 3D cell culture models similar in function to human organs, has the potential to accelerate drug development and improve understanding of disease treatment in diverse populations. In a press release, the Group emphasizes that this acquisition strengthens its portfolio in the field of next-generation biology and enables researchers to gain important insights into biological systems without lengthy animal testing.

Merck's acquisition of HUB Organoids fits perfectly with the company's previously stated goal of eliminating animal testing altogether. In 2023, Merck CEO Belén Garijo spoke about her vision of a future without animal testing in drug development and stated: “I dare to make a personal speculation: it will no longer be a matter of decades, but only of years.” (3).

Trend towards increased use of non-animal methods in the pharmaceutical industry

The pharmaceutical industry is increasingly investing in human-relevant models for drug development and testing, signaling a move away from the animal testing system. In addition to Merck, several other major pharmaceutical companies are at the forefront of this transition:

• AstraZeneca is working with academic institutions to develop organ-on-a-chip technologies and advanced in vitro models (4,5).
• Sanofi is investing in AI and machine learning to predict drug toxicity and efficacy (6).
• GlaxoSmithKline (GSK) is working with organizations that support non-animal technologies, including EUROoCS, the Microphysiological Systems Initiative of NA3RsC and NC3Rs (7).
• Roche has established the Institute of Human Biology (IHB) to develop new approaches to drug discovery and development using human model systems, including organoids (8).

These human-relevant models offer better predictive power for human patients. Human organ models can predict several types of toxicity that occur in humans but cannot be predicted in animal studies. Non-animal methods are also more cost-effective as they can reduce overall development costs and prevent late-stage failures. This is because they provide reliable data earlier in the drug development process. In addition, human-based models can significantly shorten the time needed for drug development. The shift towards human-relevant methods is also in line with the public's growing ethical concerns about animal testing.

Regulatory authorities see the potential of non-animal methods

As the pharmaceutical industry increasingly uses human-relevant research methods, regulators are also recognizing the significant advantages of non-animal methods over conventional animal testing. In the US, the FDA Modernization Act 2.0, passed in December 2022, removed the mandatory requirement for animal testing in the approval of new drugs (9). This legislation allows pharmaceutical companies to use non-animal testing methods such as cell-based assays, organ-on-a-chip systems, computer modeling and testing on human tissues.

The subsequent FDA Modernization Act 3.0, passed in 2024, aims to accelerate the phase-out of animal testing by forcing the FDA to update its regulations (10). This reflects regulators’ growing recognition that animal testing is not a good predictor for drug response in humans.

Regulatory authorities in the EU are also working on the stepwise phase-out of animal testing. The European Commission has launched an initiative to develop a roadmap for the transition to non-animal safety assessments for chemicals (11).  This roadmap is intended to outline statutorily and not-statutorily regulated measures to reduce and ultimately eliminate animal testing while promoting the validation and international acceptance of non-animal test methods. A final version is expected at the end of 2025/beginning of 2026.

Conclusion

With the introduction of human-relevant methods such as organoids, AI-driven modeling and advanced in-vitro technologies, the pharmaceutical industry is moving towards more precise, cheaper, ethical and effective research strategies. This development not only promises to accelerate medical innovation, but also addresses long-standing ethical concerns about animal testing. It is hoped that other areas of research, particularly basic research, which still makes extensive use of outdated animal experiments, will follow the positive example set by the pharmaceutical industry.