The UK Government is investing £60m ($78.76m) to push pharma and biotech to use alternative preclinical models in a pull back from animal testing.
UK Science Minister Lord Vallance has given the industry a timeline in which to phase out previous animal models to position the UK as a global leader in the regulation of alternative methods.
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The government wants the industry to consider models including organ-on-a-chip, A), and 3D-bioprinted tissues to test the early toxicity of therapeutic candidates before they move to Phase I trials.
In the timeline, this would request an end to regulatory testing on animals to assess the potential for new treatments to cause skin and eye irritation and skin sensitisation by the end of 2026.
By 2027, researchers are expected to only use DNA-based lab methods to detect viruses or bacteria that might accidentally contaminate medicines. In addition, pharmacokinetic studies that involve dogs and non-human primates should be reduced by 2030 and only used in cases where no alternatives are possible.
The move is backed by £60m of funding to establish a hub that will bring together data, technology and expertise to promote collaboration between researchers, and a separate new centre to make the path to regulatory approval for new alternatives as straightforward as possible.
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By GlobalDataVallance said: “The government is also committed to supporting validation to ensure that scientific and technical advances lead to a faster transition away from animal use – with robust targets underscoring the need to bring these alternatives forward as soon as they are viable.”
A further £15.9m has been committed by the Medical Research Council (MRC), Innovate UK and the Wellcome Trust to advance promising ‘human in vitro models’ including organ-on-a-chip systems, with five teams across the UK set to focus on human in vitro disease models of the liver, brain, cancer, pain and blood vessels.
The Association of the British Pharmaceutical Industry’s (ABPI) CEO Richard Torbett said that the industry has been leading in the development of alternatives to animal research, and that the ABPI welcomes the government’s strategy to accelerate this.
Torbett said: “Patient safety relies on robust evidence to develop new medicines and vaccines. While the science does not yet exist to fully eliminate animal testing, industry has already made significant strides in reducing, replacing and refining their use and remains committed to driving further advances at pace. Wherever animals are still required, they are cared for to the highest welfare standards.”
The move builds on previous developments in the UK such as the establishment of the government-backed National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), which has already assisted in the development of non-animal alternatives in areas such as vaccines.
The UK Government will also provide foundational training in alternative methods for early career researchers from 2026. To keep on target, there will be published lists of research priorities for alternative methods at least every two years, which will also start next year.
Finally, the government will support research funders with alternative methods and increase the visibility of these, including through academic journals.
Other countries, regions and companies already implementing measures
The UK Government’s plans follow similar efforts by the US Food and Drug Administration (FDA) to phase out animal testing in April 2025, a move that FDA Commissioner Martin Makary called “a paradigm shift in drug evaluation” that could accelerate access to treatments while improving animal welfare.
The US shift stems from the 2022 FDA Modernization Act, which for the first time authorised the use of non-animal alternatives in preclinical testing. The 2025 framework will initially target monoclonal antibodies (mAbs), but this is set to be broadened as new techniques become more widely available.
The European Commission (EC) also announced it would be phasing out animal testing through Directive 2010/63/EU1 a few days before the FDA’s enforcement. While the EC does not currently require developers to remove animal testing from their roster, its goal is to “protect animals as sentient beings” by gradually reducing animal use for research and regulatory purposes.
While most regulatory bodies are now pushing for this, Steve Bulera, CVP and chief scientific officer for safety assessment and toxicology, at Charles River Laboratories, previously told Clinical Trials Arena that the sector has several hurdles to overcome before this becomes standard practice.
Even before regulators were pushing for change, the industry was already making moves. In March 2025, researchers from Heinrich Heine University Düsseldorf and biotech firm Dynamic42 created a pancreatic cancer chip model, which showed promising results in testing MSD’s FDA-approved therapy Zolinza (vorinostat). AstraZeneca, in partnership with biological simulation company Turbine, has also shown development here, using AI-driven models of cancer cells to predict drug resistance mechanisms and identify viable combination therapies in blood cancer.
Editor’s note: Steve Bulera’s title has been amended from executive director of GLBL Toxicology to CVP and chief scientific officer for safety assessment and toxicology.
