Where NAMs Fit in the Current Research Landscape

scientist working in a lab

The rate of NAM development varies among the different scientific purposes for which animals are used. According to a Scientific American article, we are much closer to being able to completely replace animals used for regulatory testing purposes than for research. Specifically, safety testing of cosmetics and personal and household products will likely be the first to fully transition away from using animals—due in large part to consumer demand for “cruelty-free” products. Multiple US states and dozens of countries have banned animal-tested cosmetics, which has forced the industry to move more quickly toward alternatives. Similarly, the United States is making moves to transition away from using animals for safety testing of certain drugs and pharmaceuticals. The 2022 FDA Modernization Act 2.0 did away with a 1938 requirement to test every drug on animals before it goes to market, allowing for the use of certain alternatives to animal testing. In 2025, the FDA announced it would begin phasing out animal testing for monoclonal antibody therapies and other drugs; the announcement was accompanied by a roadmap for achieving this goal

Toxicity testing (i.e., of drugs or chemicals that may disperse into the environment) will likely be next to phase out the use of animals, as NAMs have proven to be very effective (in many cases, more effective than animal testing) at predicting which substances would cause adverse reactions in humans. A 2016 amendment to the Toxic Substances Control Act directed the EPA to begin reducing the use of vertebrate animals in toxicity testing. In 2019, the EPA formally committed to phasing out animal testing on mammals by 2035; in 2021, the EPA reneged on this deadline but updated its workplan to expand the goal to reducing testing on all vertebrate animals. In 2024, the EPA published a framework for using NAMs to assess eye irritation; in 2025, the EPA indicated it may bring back the 2035 target date. 

Research—especially basic research—is further away from phasing out the use of animals. Research studies ask broader questions about how biological systems work rather than specific questions about the toxic properties of particular compounds, and they often investigate behavioral or neurological outcomes that are challenging to reproduce in non-living subjects. Because of the complexity and exploratory nature of this research, it will likely take much longer to replace animals with nonanimal methods in research than in testing (by its very nature, building an accurate model of the very thing you are seeking to explore is difficult). 

This reality notwithstanding, in many cases where nonanimal alternatives do exist or could be developed with relative ease, scientists continue to rely on animals not for their scientific merit but due to other factors, such as lack of access to alternative methods, lack of knowledge or qualifications to use alternative methods, resistance to change, lack of governmental or professional incentive, regulatory obstacles, and real or perceived financial costs associated with alternative methods. Indeed, one major barrier to developing and implementing nonanimal methods is neither regulatory hurdles nor lack of funding, but rather a cultural mindset within the scientific community to maintain the status quo: Recently, researchers have shed light on an “animal methods bias”—a preference by researchers and funding bodies to maintain the protocols to which they are accustomed (i.e., those involving animal use), even when other methods are equally effective. It is AWI’s position that if an equally effective and legally acceptable nonanimal alternative is available, it must be used in preference to an experiment or test conducted with an animal. 

Many of these barriers to change can and must be addressed through increased education and awareness, increased funding and resources toward alternative development and implementation, and policy and regulatory changes. A huge societal and scientific shift will be required to help dismantle these barriers—but the shift is already underway. Indeed, in 2024, the National Institutes of Health (the world's largest funder of basic, biomedical research) developed a Common Fund program (see Complement-ARIE below) specifically designed to increase funding and collaboration on NAM development. In 2025, the NIH announced that it would begin to “prioritize human-based research technologies … to reduce use of animals in NIH-funded research,” by expanding funding and training in NAMs, and increasing awareness of their value. AWI will monitor the NIH’s commitment to this objective and seek to hold the agency accountable for its fulfillment.