Ninety per cent of drug candidates that enter clinical trials never reach patients. Developing a single new medicine now costs more than a billion dollars. Too often, the culprit is a molecule whose absorption, clearance, drug–drug interactions or leap from animals to humans was never fully understood, treated as a late-stage surprise rather than a design problem. The reality is that these failures are largely predictable and preventable when researchers build drug metabolism and pharmacokinetics (DMPK) into discovery from the start.

The market reflects this urgency. Bioanalysis and DMPK studies continue to be one of the fastest growing segments of the preclinical contract research organisation (CRO) landscape, driven by the increasing complexity of modern therapeutic modalities and growth in biologics, antibody–drug conjugates (ADCs), oligonucleotides and gene therapies. Yet for many drug discovery researchers, especially those in smaller biotechnology companies without dedicated DMPK expertise, the practical questions of which studies to run for complex modalities, regulatory expectations, translational pharmacokinetics/ pharmacodynamics (PK/PD) requirements, biomarker development and access to sensitive bioanalytical platforms are essential integrated services to de-risk the oncology pipeline and strengthen the translational decision-making framework.

DMPK is no longer viewed as a downstream box to check, nor is it confined to supporting medicinal chemistry. The real challenge today is the sheer complexity of modern therapeutic modalities such as ADCs, biologics, protein degraders and oligonucleotides. Each comes with behaviors that defy the assumptions of classical small‑molecule pharmacokinetics. In this landscape, DMPK has become a strategic discipline. Effective teams integrate it from the outset of discovery, using mechanistic insights to guide design, de‑risk liabilities and ensure that promising concepts translate into viable therapeutic candidates.