Chronic urticaria (CU) is a dermatological condition characterized by the spontaneous or recurrent appearance of hives, angioedema, or both, lasting for more than six weeks. CU significantly impacts quality of life due to persistent itching, sleep disruption, and emotional distress.
The CSU market is evolving gradually, shaped by a well-defined treatment algorithm and a modest pipeline of emerging therapies. First-line treatment remains second-generation antihistamines, which are effective for the majority of patients. However, patients who are refractory to antihistamines require advanced therapies such as omalizumab (Xolair) and, more recently, dupilumab (Dupixent), which gained approval in April 2025 for CSU in the US. The CSU pipeline does have a few promising candidates offering novel mechanisms of action and formulations; however, market growth is expected to be marginal, constrained by the limited size of the drug-eligible population and the launch of biosimilar omalizumab, which is anticipated to retain significant market share due to physician familiarity and comparable efficacy.

This Datamonitor Healthcare report contains a Disease Analysis module.