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Biopharma companies face: Massive competition and potential market saturation with over 500 GLP-1-related clinical trials across 100+ indications Downward price pressure Highly restricted reimbursement and resistance to new indications Mechanism-based stratification can: Enrich clinical trials for responders (response biomarkers) Identify strong responder subgroups (complementary diagnostic) Differentiate competing assets Support development in new indications (biomarker-led indication switching) De-risk late-stage programs (clinical trial design) Past efforts to expand GLP-1s into new indications - such as the semaglutide Alzheimers trial - largely targeted broad patient groups defined by their clinical symptoms or diagnostic labels

doi:10.1111/dom.14725 42

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