The field of ADME toxicology—Absorption, Distribution, Metabolism, and Excretion—continues to evolve with new technologies that enhance drug safety profiling and streamline pharmaceutical development. Here’s a look at the latest advancements that are driving innovation and improving accuracy in toxicological assessments.
1. Organ-on-a-Chip Technology Enhances Predictive Power
One of the most promising developments in ADME toxicology is the use of organ-on-a-chip (OOC) systems. These microfluidic cell culture devices simulate the physiological responses of human organs, providing more accurate data than traditional models. CN Bio’s recent launch of the PhysioMimix® DILI Assay Kit: Human 24 offers researchers a tool for more predictive drug-induced liver injury (DILI) studies in vitro.
Source: News Medical Life Sciences. “CN Bio Launches PhysioMimix® DILI Assay Kit.”
2. Growth in High-Throughput ADME Screening
High-throughput screening is now a cornerstone of early drug discovery. By allowing rapid, automated testing of thousands of compounds, this technology accelerates decision-making during candidate selection. Recent literature highlights how improved microscale assays are supporting faster and more reliable ADME profiling.
Source: Paine et al. (2020). “ADME and Bioavailability Studies in Drug Development: Current Methods and Future Directions.” Drug Metabolism and Disposition. Link
3. Machine Learning Boosts Predictive Accuracy
AI and machine learning (ML) models are increasingly used to predict ADME properties such as solubility, permeability, and metabolic pathways. One such model, FP-GNN (Fingerprint-based Graph Neural Network), has shown improved accuracy in predicting molecular properties related to ADME/tox profiles.
Source: Li et al. (2022). “FP-GNN: Molecular Property Prediction Using Fingerprint-based Graph Neural Networks.” arXiv preprint arXiv:2205.03834. Link
4. Expanding Market for ADME Toxicology Testing
The global ADME toxicology testing market is poised for strong growth, projected to reach USD 16.3 billion by 2030 with a CAGR of over 10%. This expansion reflects increased demand for high-quality safety and efficacy evaluations in drug development pipelines.
Source: Grand View Research. “ADME Toxicology Testing Market Size, Share & Trends Analysis Report, 2023–2030.”
5. Regulatory Advancements: ICH M12 Guideline
Regulatory harmonization is critical in the evaluation of drug interactions. The International Council for Harmonisation (ICH) has released the M12 guideline to unify approaches to drug-drug interaction studies, enhancing data consistency across regions.
Source: Admescope. “The ICH M12 Guideline on Drug-Drug Interactions.”
Conclusion
The integration of organ-on-a-chip systems, AI-driven models, and regulatory updates is shaping a new era in ADME toxicology. These innovations not only reduce drug development timelines but also improve the predictability of human responses to new compounds. For researchers and developers, staying informed about these advancements is essential for building safer, more effective therapeutics.