Drug companies are investing heavily in biomarker-driven treatments, yet face a labyrinth of varying validation requirements and siloed datasets across borders.

This fragmentation forces unnecessary duplication of effort, increases regulatory rejection risk, and impedes the implementation of life-saving precision medicines.

As a result, innovative therapies are caught between scientific promise and commercial reality—leaving patients and providers waiting for solutions that could be available today.

No unified cross-border framework exists for biomarker validation, and regulatory bodies have yet to converge on common evidence requirements.

Trusted, interoperable infrastructure for secure biomarker data exchange is missing, and competitive dynamics disincentivize open collaboration.

Isolated, country-specific validation protocols and ad hoc consortia efforts exist, but none are systematized or widely adopted.

Data is rarely standardized, secure, or interoperable at scale.