Biomarkers are defined as measurements or characteristics evaluated as indicators of normal biological or pathogenic processes, or responses to therapeutic interventions. Biomarkers have become increasingly important to a variety of healthcare stakeholders including physicians, drug and device manufacturers, regulatory agencies, and payers due to their potential for defining efficacy and safety and thus their ability to impact regulatory approvals, reimbursement, and treatment decisions. This article explores stakeholders’ views of the role biomarkers play in drug development and some evolving strategies to better align such views in the changing healthcare landscape.