Chronic Spontaneous Urticaria Market Heats Up as Pharma Companies Race to Address Unmet Needs | DelveInsight

The chronic spontaneous urticaria market is witnessing significant growth, driven by increasing disease awareness, improved diagnosis rates, and the rising prevalence of treatment-refractory patients. The introduction of emerging therapies such as Barzolvolimab (CDX-0159) (Celldex Therapeutics), Rilzabrutinib (Sanofi), Briquilimab (Jasper Therapeutics), EVO756 (Evommune), and others will further propel the market growth.

LAS VEGAS, June 24, 2026 /PRNewswire/ -- Recently published Chronic Spontaneous Urticaria Market Insights report includes a comprehensive understanding of current treatment practices, chronic spontaneous urticaria emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Chronic Spontaneous Urticaria Market Summary

• The total market size of chronic spontaneous urticaria in the 7MM in 2025 was approximately USD 2 billion.
• The United States accounted for the largest chronic spontaneous urticaria treatment market size in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• The total diagnosed prevalent cases of chronic urticaria in the 7MM were approximately 4.8 million in 2025, with these numbers anticipated to increase by 2036.
• Leading chronic spontaneous urticaria companies, such as Celldex Therapeutics, Sanofi, Jasper Therapeutics, Evommune, Blueprint Medicines, ARS Pharmaceuticals, Nurix Therapeutics, InflaRx, Otsuka Holdings (Taiho Pharmaceutical), and others, are developing new chronic spontaneous urticaria treatment drugs that can be available in the chronic spontaneous urticaria market in the coming years. 
• The promising chronic spontaneous urticaria therapies in clinical trials include Barzolvolimab (CDX-0159), Rilzabrutinib, Briquilimab, EVO756, BLU-808, ARS -1, bexobrutideg (NX-5948), INF904, TAS5315, and others.

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Key Factors Driving the Growth of the Chronic Spontaneous Urticaria Market 

• Growing Chronic Spontaneous Urticaria Prevalence: According to DelveInsight's estimates, the total diagnosed prevalent cases of chronic urticaria in the 7MM were approximately 4.8 million in 2025, with these numbers anticipated to increase by 2036.
• DUPIXENT's Monopoly in the CSU Market: The recent approval of DUPIXENT (dupilumab) by the US FDA, along with its earlier approval in Japan by the MHLW, marks a notable shift in the treatment landscape, introducing targeted therapies that are likely to drive market competition and influence the adoption. 
• Advancements in Patient-Friendly Treatment Delivery: Improved delivery formats, such as oral small molecules like BTK inhibitors and potential JAK inhibitors, offer alternatives to injections, enhancing patient convenience and treatment adherence.
• Growing CSU Clinical Trial Activity: The CSU treatment pipeline is increasingly competitive, featuring several promising candidates at different stages of development, including Barzolvolimab (CDX-0159) (Celldex Therapeutics), Rilzabrutinib (Sanofi), Briquilimab (Jasper Therapeutics), EVO756 (Evommune), BLU-808 (Blueprint Medicines), ARS -1 (ARS Pharmaceuticals), bexobrutideg (NX-5948), bexobrutideg (NX-5948) (Nurix Therapeutics), INF904 (InflaRx), TAS5315 [Otsuka Holdings (Taiho Pharmaceutical)], and others.

Ramandeep Singh, senior consultant of forecasting at DelveInsight, said that advancements in biologic therapies, such as omalizumab, have shown strong efficacy in antihistamine-refractory CSU, providing targeted and effective options for difficult-to-treat patients.

Chronic Spontaneous Urticaria Market Analysis

• Managing chronic spontaneous urticaria remains complex, with treatment goals centered on reducing disease activity, achieving complete symptom relief, and enhancing patients' quality of life (QoL). 
• Current management follows a stepwise strategy, beginning with first-line therapies and escalating to more advanced interventions when adequate disease control is not achieved. 
• While existing treatments such as high-dose H1-antihistamines and anti-IgE therapy with omalizumab have improved outcomes, a substantial proportion of patients continue to experience persistent symptoms, underscoring the need for additional therapeutic options. 
• The recent approvals of DUPIXENT (dupilumab) and RHAPSIDO (remibrutinib), a highly selective Bruton's tyrosine kinase (BTK) inhibitor, have broadened the treatment landscape beyond traditional anti-IgE biologics. 
• Furthermore, the CSU pipeline remains robust and competitive, with several promising investigational therapies, including barzolvolimab (CDX-0159), rilzabrutinib, briquilimab, and others advancing through clinical development and offering potential new avenues for disease management.

Chronic Spontaneous Urticaria Competitive Landscape

Some of the CSU drugs under development include Barzolvolimab (CDX-0159) (Celldex Therapeutics), Rilzabrutinib (Sanofi), Briquilimab (Jasper Therapeutics), EVO756 (Evommune), BLU-808 (Blueprint Medicines), ARS -1 (ARS Pharmaceuticals), bexobrutideg (NX-5948), bexobrutideg (NX-5948) (Nurix Therapeutics), INF904 (InflaRx), TAS5315 [Otsuka Holdings (Taiho Pharmaceutical)], and others.

Celldex Therapeutics' Barzolvolimab is a humanized monoclonal antibody designed to specifically inhibit KIT, a receptor tyrosine kinase essential for mast cell growth, activation, and migration into tissues. Given the central role of mast cells in the inflammatory processes underlying chronic spontaneous urticaria (CSU), targeting KIT represents a promising strategy for disease management.

Sanofi's Rilzabrutinib is an orally administered, reversible covalent inhibitor of Bruton's tyrosine kinase (BTK) being developed as a potential first- or best-in-class treatment for a range of immune-mediated disorders. By selectively targeting BTK, a key signaling molecule found in both B cells and mast cells that regulates immune responses, rilzabrutinib utilizes Sanofi's proprietary TAILORED COVALENCY technology to enhance target specificity while reducing unintended effects on other pathways.

Jasper Therapeutics' Briquilimab is an investigational monoclonal antibody currently in Phase Ib/IIa development that targets the stem cell factor (SCF)/CD117 (c-Kit) signaling axis, which is critical for mast cell maintenance. By preventing the interaction between SCF and CD117, briquilimab aims to deplete mast cells in affected tissues, potentially providing therapeutic benefit to CSU patients who do not achieve adequate symptom control with antihistamine therapy.

The anticipated launch of these emerging therapies are poised to transform the chronic spontaneous urticaria market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the chronic spontaneous urticaria market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

Discover more about the most effective treatment options for chronic spontaneous urticaria @ Chronic Spontaneous Urticaria Treatment Guidelines 2026

Recent Developments in the Chronic Spontaneous Urticaria Market

• In May 2026, Nurix Therapeutics reported new preclinical and Phase 1 translational findings demonstrating the potential of bexobrutideg (NX-5948), its wholly owned Bruton's tyrosine kinase (BTK) degrader, as a treatment for chronic spontaneous urticaria (CSU). The results were presented at the 2026 Society for Investigative Dermatology Annual Meeting 2026 held in Chicago, Illinois.
• In April 2026, the FDA approved DUPIXENT (dupilumab) for treating children aged 2–11 years with chronic spontaneous urticaria who continue to experience symptoms despite treatment with histamine-1 antihistamines (H1AHs). The approval broadens Dupixent's existing indication, which previously covered adults and adolescents aged 12 years and older with CSU.
• In March 2026, Celldex unveiled further encouraging results from completed Phase 2 studies of barzolvolimab in CSU, ColdU, and SD, showing marked improvements in patient quality of life across all assessed areas, including symptom relief, emotional well-being, everyday activities, leisure pursuits, workplace and academic performance, interpersonal relationships, and treatment experience.
• In January 2026, Jasper Therapeutics reported updated results from the Phase Ib/IIa BEACON study and its open-label extension showing that briquilimab delivered sustained disease control in CSU. Additional patients achieved complete responses and marked reductions in UAS7 scores at 12 weeks.

What is Chronic Spontaneous Urticaria?

Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin disorder characterized by the recurrent appearance of itchy wheals (hives), angioedema, or both, occurring spontaneously without an identifiable external trigger for six weeks or longer. The condition is driven by the activation of mast cells and basophils, which release histamine and other inflammatory mediators, leading to redness, swelling, and intense itching. CSU can significantly impair patients' quality of life by disrupting sleep, daily activities, work productivity, and emotional well-being. Although the exact cause remains unclear, autoimmune mechanisms are believed to play a key role in many patients. The disease affects individuals of all ages and often requires long-term management with antihistamines, biologics, or other targeted therapies to control symptoms and prevent recurrence.

Chronic Spontaneous Urticaria Epidemiology Segmentation

The chronic spontaneous urticaria epidemiology section provides insights into the historical and current chronic spontaneous urticaria patient pool and forecasted trends for the leading markets. Among the 7MM, the US accounted for nearly 19% of the total diagnosed prevalent cases of chronic urticaria, with around 920,000 cases in 2025.

The chronic spontaneous urticaria treatment market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets, segmented into:

• Total Diagnosed Prevalent Cases of Chronic Urticaria
• Type-specific Cases of Chronic Urticaria
• Gender-specific Cases of CSU
• Age-specific Cases of CSU
• Severity-specific Cases of CSU 

Scope of the Chronic Spontaneous Urticaria Market Report

• Chronic Spontaneous Urticaria Patient Population Forecast
• Chronic Spontaneous Urticaria Therapeutics Market Size
• Chronic Spontaneous Urticaria Pipeline Analysis
• Chronic Spontaneous Urticaria Market Size and Trends
• Chronic Spontaneous Urticaria Market Opportunity
• Chronic Spontaneous Urticaria Market Unmet Needs
• KOL's Views on Chronic Spontaneous Urticaria
• Chronic Spontaneous Urticaria Market Access and Reimbursement

Download the report to understand the average treatment costs chronic spontaneous urticaria @ Chronic Spontaneous Urticaria Treatments Cost and Coverage

Table of Contents

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