Biomarkers are important tools for understanding disease mechanism, developing more effective treatments, and improving the quality of patient care. The discovery of biomarkers for CNS disorders has gained considerable interest within the pharmaceutical industry due to the many unmet needs in current treatments and diagnostics. Here we discuss the role of CNS biomarkers in early discovery, in drug development, and for future diagnostics. We also discuss the different disease segments, describing gaps in treatment and limitations of current methods of diagnosis. This session also addresses the growth drivers and growth inhibitors that can affect CNS biomarker adoption.