NAM Adoption Is Rising Fast, But a Real-World Impact Analysis shows: We Are Still at the Beginning

A recent analysis by Hao, Dao and Sadrieh at CDER of 574,963 nonclinical study reports submitted between 2011 and 2025 provides valuable insight into the real-world adoption of New Approach Methodologies (NAMs). The study identified 1,381 in vitro NAM reports across 981 applications. While adoption is steadily increasing, NAMs still account for just 0.24% of all nonclinical submissions, with the vast majority (87.6%) being used at the IND stage. (Applications of in vitro new approach methodologies (NAMs) in drug development: A scoping analysis of titles of nonclinical study reports submitted to the FDA - ScienceDirect) 

The key takeaway is clear: NAMs are already creating value, particularly where they improve early development decisions and help de-risk programs before entering the clinic. However, the analysis shows that most regulatory submissions still rely on established in vitro approaches such as co-cultures and sandwich cultures rather than more complex technologies.  

This highlights an important reality:  

Adoption is driven not by technological complexity, but by validation, reproducibility, and fit-for-purpose application. 

At abc biopply AG, we strongly support this perspective. We believe that drug development requires a combination of complementary models. The challenge is integrating these technologies effectively and selecting the right model for the right question. 

As Europe's first fully integrated Organoid CRO, abc biopply has built its services around this fit-for-purpose philosophy. Our validated 3D CoSeedis™ Humanized Multi-Organoid Technology addresses a key limitation of conventional organoid systems by generating highly standardized micro-tissues composed of hundreds of communicating organoids. This delivers more robust, scalable, and translationally relevant data for efficacy, safety, toxicity, resistance, relapse, and biomarker studies. 

Importantly, we do not position organoids as a replacement for existing approaches. Instead, our integrated CRO services embed them into an integrated workflow: 
✅ High throughput 2D assays 
✅ Humanized 3D CoSeedis™ Multi-Organoid Models 
✅ In vivo validation studies 

This enables fit-for-purpose study designs that generate decision-grade data at every stage of development, helping to improve predictability, reduce risk, and accelerate the path to the clinic. 

The FDA analysis reinforces what I continue to highlight since years: The future of drug development is not about replacing existing models. It is about intelligently combining them.