A Future Without Animal Testing: The Science Making It Possible
When 90% of drug candidates entering human trials don’t succeed, the need for more human-relevant systems becomes urgent. To address this gap, the life sciences field is accelerating the adoption of New Approach Methodologies (NAMs)—technologies and strategies that reduce or replace animal models with alternatives grounded in human biology.
The Rise of NAMs: Innovation, Ethics, and Necessity
In 2024, several high-profile drug candidates failed in human clinical trials.
Pfizer’s gene therapy Fordadistrogene Movaparvovec entered Phase III trials with high expectations after promising results in animal models. But the treatment failed to improve motor function in patients with Duchenne muscular dystrophy, and raised safety concerns that ultimately halted development. Other high-profile failures have followed a similar arc: Dalzanemdor from Sage Therapeutics, which missed efficacy endpoints across several neurodegenerative diseases despite preclinical success, and Emraclidine, once expected to reshape schizophrenia treatment, both failed in back-to-back Phase II trials.
These examples highlight a recurring problem in drug development: animal models often fail to predict human biology. Metabolism, gene regulation, immune function, and disease progression can differ significantly between species.
The Shift Toward Human-Relevant Models
NAMs include a broad range of tools: organoids, iPSC-derived tissues, microphysiological systems (also known as organ-on-a-chip), computational modeling, and high-throughput assays using well-defined human cells. These technologies aim to provide earlier, more predictive insights into safety, efficacy, and mechanism of action, critical for reducing risk in the clinic.
Momentum is also building on the regulatory side. The U.S. Food and Drug Administration has published a roadmap to reduce reliance on animal testing in preclinical safety studies. In Europe, the EMA has created pathways for the acceptance and qualification of NAMs. The NIH has launched offices to coordinate efforts around non-animal models, while longstanding institutions such as the NC3Rs continue to advocate for the replacement, reduction, and refinement of animal use.
Public attitudes, policy trends, and technological advances are aligning to push human-based testing methods to the forefront.
Challenges Ahead—and How to Overcome Them
Wider adoption of NAMs requires solving a few persistent problems: ensuring reproducibility, validating performance for specific applications, improving throughput and scalability, and harmonizing regulatory expectations across regions. Integrating NAM-generated data into regulatory frameworks is another critical step.
These challenges are real, but solvable.
Tools Supporting the Transition to NAMs
Recent advancements in 3D culture and tissue modeling are making it easier for researchers to implement NAMs. One example is the integration of validated microtissue models from MatTek Corp —now part of Sartorius—into broader workflows that include high-content imaging and data analysis. These in vitro models, developed for applications such as skin, airway, and liver toxicity studies, support more physiologically relevant testing and are increasingly being used as part of preclinical pipelines.
Synthetic matrices like NexaGel® provide a defined and tunable environment for growing complex 3D structures such as spheroids and organoids. Unlike traditional animal-derived matrices, NexaGel® offers batch consistency and customizable mechanical properties, which can help improve reproducibility across experiments.
As researchers look to move away from animal testing, access to consistent materials and integrated workflows will play a critical role in enabling broader adoption of NAMs.
Looking Ahead: A Model Pipeline for the Post-Animal Era
With regulators moving toward broader acceptance of NAM data, these methods are set to become an integral part of drug discovery and toxicology. As costs come down and automation improves, these platforms will become more accessible, even for smaller labs and emerging biotechs, helping to bring better therapies to patients, faster and more ethically.
