The Shift Away from Animal Testing in Pharmaceuticals: FDA Announces a Phase out Plan

Written By Kyle Skelton

This Month, the NIH announced an initiative to adopt “innovative, human-based science” to limit the use of animals in medical testing.

For decades, animal testing has been a vital step in drug development. Rodents, primates, and other animals were used to evaluate the safety and efficacy of new biologics before human trials. The conversation of finding worthy alternatives to animal testing has been decades long, but we are now developing the technology to do so.

Several innovative technologies are replacing the need for animal testing, including:

  • Organ-on-a-chip: These devices simulate the structure and function of human organs. Allowing the researchers to study drugs in a highly controlled environment.

  • 3D bioprinting: Scientist can now create human tissue models to test how drugs interact with different body systems.

  • Computer Modeling and AI: Advanced AI tools predict how drugs will behave in the human body, reducing the need for live animal data.

  • In Vitro Testing: Although this technology is not new, In Vitro testing involves testing human cells in a lab setting.

Pharmaceutical giants and biotechs are investing heavily in non-animal testing technology. The global non-animal testing market is valued at approximately 1.8 billion dollars and set to grow by 11.3 percent by 2032.

What does this mean for patients? Moving away from animal testing doesn’t mean cutting corners, in fact it could be the opposite. Non-animal testing methods can streamline drug discovery timelines and improve accuracy by using models that better reflect human biology.

While animal testing hasn’t disappeared entirely, with continued investment, and collaboration we can have an animal free drug discovery process in the not so distant future.

References:

1. FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs. U.S. Food and Drug Administration. 10 Apr. 2025.

3. Block, Kitty and Sara Amundson. “We’re calling on the FDA to save animals by modernizing drug testing.” Humane World for Animals. 15 May 2024.

5. Good Laboratory Practice and Compliance Monitoring. OECD. Accessed 11 Apr. 2025.

6. “Animal Rule Information.” U.S. Food and Drug Administration. 15 Dec. 2024.

7. Smith, Daniel. “The End of an Era: What the FDA's Move Away from Animal Testing Means for Biopharma.” Pharma Almac. 14 April 2025

Kyle Skelton