If 2025 was the year bioanalytical labs embraced digital transformation and expanded automation, 2026 will be about operationalizing those systems. The next wave of evolution will orbit around efficiency gains, adapting to new drug modalities, and supporting innovative disease treatments. We’ll see deeper integration of systems biology and a stronger commitment to patient-centric trial design. And yes, the influence of AI will permeate nearly everything we do.
But beyond these broad strokes, what will materially change in our bioanalytical laboratories? That’s harder to forecast. Progress will continue as technology advances, but always under the umbrella of regulatory standards. What feels certain is a growing willingness to critically examine why we do what we do—and whether our practices are truly appropriate for the intended use of the data.
Context-of-Use (CoU): From Concept to Mainstream
Over the winter holidays, I revisited the European Bioanalysis Forum’s (EBF) recent paper on embracing CoU-driven scientific validation. This conversation is poised to become mainstream—not just for efficiency, but for scientific integrity. Modern bioanalytical tasks don’t always fit neatly into the scope of ICH M10 and forcing them to do so risks inefficiency and misalignment. My first prediction for 2026: CoU strategies will gain traction, shaping validation approaches and operational decisions across labs.
HRMS: The Sleeping Giant
Accurate mass capabilities of remain underutilized in regulated bioanalysis. For achieving selectivity, HRMS often outperforms MS/MS alone—and can even complement it. Critics argue HRMS sacrifices sensitivity compared to triple quadrupole systems, but when sensitivity is defined by signal-to-noise, HRMS is not always disadvantaged. With today’s astounding resolution and accuracy, HRMS deserves a more prominent role in regulated workflows.
Pushing Sensitivity Boundaries
Bioanalysts are always chasing sensitivity, and 2026 will bring incremental but meaningful gains:
-
Low-flow LC-MS continues to mature, making nano-flow (10× sensitivity) and microflow (4–5× sensitivity) more practical and user-friendly.
-
Ligand-binding platforms remain unmatched for sensitivity and throughput, though selectivity challenges persist. Expect modern tools to optimize critical reagent production, improving performance and reducing cost.
AI: From Buzzword to Backbone
AI’s impact on bioanalysis will deepen in 2026 and beyond. Where complexity and variability challenge us, AI will help optimize strategies, predict outcomes, and streamline operations. For labs tasked with developing and validating assays for novel chemistries and biologics, AI offers a powerful ally. For a deeper dive, see my colleague Jean Custodio’s excellent blog on AI in bioanalysis.
Cross-Validation Consensus
Another tactical hot topic: bioanalytical method cross-validation. The industry has wrestled with ICH M10’s language on this, particularly around defining acceptable bias between methods. While M10 outlines when cross-validation applies and how to measure bias, setting acceptance criteria remains contentious. I predict we’ll see clearer consensus on roles, responsibilities, and standardized processes—again tied to CoU principles.
NAMs, Multi-Omics, and Systems Biology
Global interest in New Approach Methodologies (NAMs) to improve clinical predictions and reduce animal use (3Rs) will continue to grow. While this is a long-term goal, expect stronger ties to multi-omics and systems biology. Bioanalytical scientists will play a key role in biomarker quantification and characterization, influencing proteomics, metabolomics, exposomics, and beyond. These disciplines will generate exponential data volumes, leveraging HRMS and demanding advanced analytics. AI will be essential for extracting insights and driving innovation in disease understanding, prevention, and treatment.
Final Thought
2026 won’t be about radical disruption, it will be about smart evolution. We’ll refine our practices, embrace CoU-driven validation, unlock HRMS potential, and integrate AI and efficiency gains into everyday workflows. These are all integral to IQVIA Laboratories Biosciences strategies for the year and I invite you to follow along with exciting developments we will be announcing throughout 2026. The challenge for bioanalysts? Stay agile, stay informed, and stay ready for a future where science and technology converge to redefine what’s possible.
