Chronic Urticaria Market: Innovation Accelerates Amid High Unmet Need and Pipeline Momentum
The chronic urticaria (CU) treatment landscape is poised for disruption, with long-standing reliance on antihistamines and omalizumab giving way to a new wave of targeted therapies. Chronic spontaneous urticaria (CSU), the most common subtype, continues to present significant challenges in diagnosis and management, with up to 50% of antihistamine-refractory patients failing to respond to current biologics.
The recent FDA approval of Dupixent and the anticipated launch of oral BTK inhibitor remibrutinib mark a turning point in the CSU market. Meanwhile, Celldex’s barzolvolimab is showing strong promise in Xolair-refractory patients, addressing a critical unmet need. Biosimilar competition is also heating up, with Omlyclo and AVT23 expected to reshape pricing dynamics.
This report provides a comprehensive analysis of the CU market across the US, EU5, and Japan, including 20-year epidemiological forecasts, treatment trends, and a deep dive into the competitive pipeline.
In this report we cover:
- Key growth drivers: Rising diagnosed prevalence across major markets, FDA approval of Dupixent for CSU and expected launch of remibrutinib in Q4 2025, and increasing demand for oral therapies and longer dosing intervals
- Promising therapies: Dupixent (IL-4/IL-13 antagonist), Remibrutinib (oral BTK inhibitor) and Barzolvolimab (KIT inhibitor).
- Novel modalities: oral small molecules (remibrutinib, povorcitinib), Biosimilars (Omlyclo, AVT23) entering the market, Monoclonal antibodies with novel targets (e.g., barzolvolimab, JYB1904).
