Challenging the Status Quo: Standardisation, Regulation and the Rise of 3D In Vitro Models for a More Humane and Predictive Future in Healthcare

ABSTRACT

For decades, biomedical research has relied on two‐dimensional (2D) cell cultures and animal models to study human biology and develop new therapeutics. While these systems have been instrumental in advancing science, their limitations in capturing the complexity and variability of human physiology are increasingly evident. As therapeutic strategies become more sophisticated and personalised, the need for more predictive and human‐relevant models is becoming critical. In this Perspective, it is argued that three‐dimensional (3D) in vitro models such as organoids, bioprinted tissues, and microphysiological systems offer a necessary shift in how we approach disease modelling and drug development. These systems more accurately replicate tissue architecture, cellular interactions, and dynamic environments, yielding more meaningful insights into human biology. At the same time, they support a transition toward more ethical research practices by reducing reliance on animal testing. Discussing the scientific advances enabling these models, the growing regulatory and policy support for their adoption, and the key challenges that remain, is paramount. Addressing these barriers will require coordinated efforts across disciplines and sectors. The delayed adoption of these systems is also shaped by cultural inertia within the scientific and industrial ecosystems, where established methodologies still dominate due to familiarity, infrastructure and insufficient training.