What is unmet need?
Unmet need describes a situation in which existing medical interventions do not sufficiently prevent, treat, or manage a disease or condition. This may be due to limited efficacy, safety concerns, lack of access, delayed diagnosis, or absence of approved therapies. Unmet needs can be clinical, functional, economic, or related to quality of life, and are often most pronounced in rare diseases, underserved populations, or complex chronic conditions.
Why is unmet need important in pharmaceutical strategy?
Identifying and addressing unmet need is central to drug development, regulatory prioritization, and Market Access. It supports indication selection, value proposition development, and engagement with regulators and payers, who often favor therapies that meaningfully advance patient care. Demonstrating a product’s ability to meet an unmet need can justify premium pricing, support accelerated pathways, and strengthen the clinical and economic rationale for adoption across healthcare systems.
