Replacing Animals in Research
While animal studies have been widely used in biomedical research, they usually fail to accurately predict human responses. Differences in physiology, genetics, and metabolism mean that animals do not accurately model human biology. As a result, results from animals rarely translate to people, with failure rates in drug development over 92% and access to effective treatments significantly delayed.
This has led many researchers to question whether animal models are the most reliable foundation for medical progress. AFSA supports replacing animals in research with modern, human-specific methods that better reflect our biology and improve health outcomes for all.
What Replaces Animals in Science?
Significant advances in science and technology have created a range of non-animal methods (NAMs) that can replace or reduce the need for animal testing. They are available now for widespread use, both in Australia and around the world.
Laboratory methods using human tissue
- Human cell and tissue cultures
- Organoids (miniaturised human organs grown in labs)
- Organ-on-a-chip systems that simulate organ function
- Microfluidic systems for studying drug behaviour
Data-driven and computational methods
- Computer modelling and simulations
- AI-assisted drug discovery
- Analysis of existing clinical and population data
Studies on humans
- Microdosing (very low-dose human testing with monitoring)
- Clinical and epidemiological research
Click on an image to see examples of some leading non-animal methods already proving successful:
Organ-on-a-chip
Computer Modelling
Microfluidics
Microdosing
Organoids
Human cells
AI
Human studies
Benefits of Replacing Animals
Replacing animals in research offers several key advantages:
✔️ Scientifically, human-specific methods provide a better prediction of human responses, leading to more reliable results. They also support faster development of treatments and offer more reproducible and scalable research systems that can be applied consistently across studies. People can now even access ‘personalised’ treatments, tailored specifically to their unique needs!
✔️ Ethically, replacing animals eliminates the harm, suffering, and death associated with animal experimentation. It also aligns research practices with modern expectations around animal welfare and the growing emphasis on minimising avoidable harm.
✔️ Economically, non-animal methods can reduce costly late-stage drug failures by improving early prediction of how treatments will perform in humans. This in turn increases the efficiency of research and development pipelines, saving time and resources throughout the drug discovery process.
References:
– Commonwealth Scientific and Industrial Research Organisation (CSIRO) (n.d.) Non-animal models.
– Animal Free Science Advocacy (2025) Business case for funding non-animal research methods.
– Animal Free Science Advocacy (n.d.) Australians support replacement of animals in science.
The Global Shift Toward Non-Animal Methods
Internationally, there is growing momentum toward reducing reliance on animal testing. Governments and research institutions in regions such as the United States, the European Union, and the United Kingdom are increasingly funding and supporting the development of non-animal methods.
The Netherlands is leading efforts to phase out animal testing, with the government committing to end toxicology tests for chemicals, food ingredients, pesticides, veterinary medicines and vaccines. Its Transition Programme for Innovation without the Use of Animals outlines a collaborative approach involving science, healthcare, government and industry to achieve this goal.
In 2022, the US Senate passed the FDA Modernization Act, allowing drug developers to use modern, human-relevant methods instead of animal testing. This followed the Environmental Protection Agency‘s (now-revised) pledge to end mammal testing by 2035. Inspired by the US, India amended its New Drugs and Clinical Trial Rules (2023) to reduce animal use in drug research.
The Consolidated Appropriations Act, 2023 provided funding to federal agencies for various initiatives aimed at increasing transparency, developing new approaches, encouraging rehoming and providing sanctuary for chimpanzees formally used in research.
In 2023, the Maryland legislature passed a bill to establish the Human-Relevant Research Fund, which will provide grants and loans for developing non-animal research methods. Starting January 15, 2024, facilities conducting animal testing must contribute to the fund based on the number of animals used.
In 2024, the National Institutes of Health (NIH) announced a common fund to speed the development, standardisation, validation and use of human-based New Approach Methodologies.
In 2024, the NIH’s National Center for Advancing Translational Sciences has established new centres to strengthen the use of organ-on-a-chip, or tissue chip, technology to develop drugs and potentially reduce the need for animals in research with a US $31M investment.
In 2025, the FDA published a Roadmap to Reducing Animal Testing in Preclinical Safety Studies with an initial focus on focus on monoclonal antibody testing.
In 2025, the NIH announced a major commitment to transitioning away from animal research in favour of innovative, human-based science.
In 2025, the NIH established the nation’s first dedicated organoid development center to reduce reliance on animal modeling.
In 2026, the Environmental Protection Agency reaffirmed its commitment to eliminate mammalian animal testing by 2035 by reinstating phase-out deadlines, prioritising New Approach Methods, and aligning chemical safety regulation with human-relevant, non-animal science.
In 2026, the NIH announced a US $150M investment in human-based research to reduce the use of animal models.
In 2026, the NIH honoured it’s 2025 commitment to establish the Office of Research Innovation, Validation, and Application (ORIVA) to coordinate and advance the use of human-based research technologies.
In 2021, the European Medicines Agency (EMA) put in place measures to encourage and accelerate the development and adoption of non-animal methods in the testing and approval of new human drugs.
In 2021, the European Parliament overwhelmingly passed a resolution urging the European Commission to create an EU-wide action plan to phase out animal experimentation, with clear targets and increased funding for non-animal research methods.
In 2025, the UK Government released a new roadmap to accelerate the phase-out of animal testing, backed by £75 million to support the development and validation of non-animal research methods.
In 2026, the Roadmap towards phasing out animal testing for chemical safety assessments was released.
On July 7, 2026, as part of China’s effort to modernise non-clinical drug evaluation, China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) announced the launch of PIONEER ( Propel Innovation and Operation of NAMs to Enhance Efficiency in R&D). This is a structured 5-year pilot initiative with a mission to advance research, validation, and the regulatory application of New Approach Technologies or Non-Animal Models. The initiative is recognised as an action of priority under China’s 15th Five-Year Plan for pharmaceutical industry development.
Be part of the change
Want to see animals in research replaced with ethical, human-relevant models? Help us make this happen by asking the government to fund animal-free research.
Learn More
- EU reports on alternatives to animals in breast cancer, neurodegenerative ,respiratory disease, autoimmune disorders and immuno-oncology.
- Global clearing house for information on alternatives to animal testing
- AltBib – Alternatives to the Use of Live Vertebrates in Biomedical Research and Testing
- Non-animal technologies database
- USDA Animal Welfare Information Center Alternatives Literature Searching Worksheet
- The RE-place project including a database of NAMs
- Biomedical Models Hub– a human biology based curated database
- NATworks – an interactive platform providing an overview of companies engaged in human-relevant research using Non-Animal Technologies (NAT), New Approach Methodologies (NAM), and alternative methods
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