Human‑centric testing methods promise safer, cheaper drug development but repeatability remains a key obstacle

Regulators such as the FDA, EMA and ICH are urging drug developers to replace animal safety studies with New Approach Methodologies that use human‑relevant models. Early research shows these models can predict toxicology outcomes better for certain drug classes and may cut the high costs of traditional animal studies, which can involve dozens of primates at tens of thousands of dollars each.

Proponents argue that NAMs provide more directly relevant data and could streamline preclinical timelines. However, moving from animal tests to organoid‑based assays is not a simple swap. Scientists lack standardized processes for creating and validating organoids, leading to variability between laboratories.

Good Cell Culture Practice guidelines have been introduced to bring consistency to organoid production, but inter‑lab differences in culture conditions still hinder reproducibility. Demonstrating repeatable results is identified as the next major hurdle before NAMs can see widespread adoption in drug safety testing.

If these challenges are addressed, the industry could see a shift comparable to the impact of mass spectrometry in the 1990s, potentially reducing reliance on animal testing while improving human safety predictions.