DelveInsight’s “Chronic Spontaneous Urticaria Market Insight, Epidemiology And Market Forecast—2034” report provides an in-depth understanding of chronic spontaneous urticaria, its historical and forecasted epidemiology, and the chronic spontaneous urticaria market trends in the 7MM, which include the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
According to the report, the chronic spontaneous urticaria treatment landscape is poised for significant transformation as the market size, valued at approximately USD 2 billion in 2023, is projected to expand at a CAGR of over 10% through 2034. This growth trajectory is being fueled by the introduction of innovative therapies targeting new pathways, improved diagnostic capabilities, and rising disease awareness. The chronic spontaneous urticaria market continues to attract substantial investment from leading pharmaceutical companies seeking to address significant unmet needs in a condition that severely impacts patients’ quality of life.
The US dominates the chronic spontaneous urticaria market landscape, accounting for USD 1.2 billion in 2023, representing over half of the 7MM market. This robust growth is largely driven by favorable reimbursement policies and the rapid adoption of premium-priced therapies. Meanwhile, the EU4 and UK collectively contribute approximately USD 600 million, with Germany leading at USD 160 million, followed by France. Japan accounts for 18% of the 7MM market, valued at approximately USD 380 million.
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The chronic spontaneous urticaria patient pool is substantial, with DelveInsight’s epidemiology model estimating approximately 4.1 million diagnosed prevalent cases across the 7MM in 2023. Among these markets, Japan bears the highest burden with nearly 1 million cases, followed by the US with approximately 500K cases. Furthermore, gender distribution analysis reveals a significant female predominance, with EU4 and the UK reporting 840K female cases compared to 390K male cases in 2023, highlighting important demographic considerations for targeted therapeutic development.
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The chronic spontaneous urticaria treatment market report also provides insights into current chronic spontaneous urticaria treatment practices, emerging drugs, the market share of individual therapies, and forecasts for emerging drugs in the 7MM from 2020 to 2034.
The current chronic spontaneous urticaria treatment paradigm follows a stepwise approach, beginning with second-generation H1-antihistamines as first-line therapy, followed by up-dosing to fourfold in refractory cases. For patients unresponsive to antihistamines, Roche/Novartis’s XOLAIR, a recombinant DNA-derived humanized IgG1k monoclonal antibody that selectively binds to IgE, remains the cornerstone therapy, generating approximately USD 913 million in US revenue in 2023. The recent approval of Sanofi/Regeneron’s DUPIXENT by Japan’s MHLW in February 2024 for chronic spontaneous urticaria patients aged 12 years and older introduces a valuable alternative mechanism targeting IL-4 and IL-13 signaling pathways.
The chronic spontaneous urticaria competitive landscape is evolving rapidly, with several promising candidates advancing through clinical development. Novartis Pharmaceuticals’ remibrutinib, an oral Bruton’s tyrosine kinase inhibitor, has demonstrated significant long-term efficacy and safety in Phase III trials (REMIX-1 and REMIX-2), with regulatory submission planned for 2025. AstraZeneca and Amgen’s TEZSPIRE, a first-in-class monoclonal antibody inhibiting thymic stromal lymphopoietin, has completed Phase II trials, while Sanofi’s rilzabrutinib (SAR444671), another oral BTK inhibitor, showed positive results in the Phase II RILECSU study with a Phase III program on the horizon.
Recent regulatory milestones underscore the dynamic nature of the chronic spontaneous urticaria market. In March 2025, Celltrion secured FDA approval for OMLYCLO (omalizumab-igec) as the first interchangeable biosimilar to XOLAIR, potentially improving treatment access and affordability. Additionally, the FDA’s acceptance of the resubmitted supplemental biologics license application for DUPIXENT in November 2024 could further diversify treatment options for patients with inadequate response to H1-antihistamines.
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Despite therapeutic advances, significant challenges persist in chronic spontaneous urticaria management. Nearly one-third of patients remain symptomatic despite omalizumab treatment, and the subcutaneous administration route creates an additional burden for healthcare systems and patients. The high cost of biologics limits accessibility, particularly in restricted healthcare environments where more affordable options like H2-antagonists and dapsone maintain relevance despite not being included in formal treatment guidelines. These unmet needs highlight the importance of continued innovation in developing cost-effective, convenient, and efficacious treatments for this challenging dermatological condition.
Table of Contents
1.
Key Insights
2.
Report Introduction
3.
Chronic Spontaneous Urticaria Market Overview at a Glance
4.
Methodology of Chronic Spontaneous Urticaria Epidemiology and Market
5.
Executive Summary of Chronic Spontaneous Urticaria
6.
Key Events
7.
Chronic Spontaneous Urticaria Disease Background and Overview
8.
Chronic Spontaneous Urticaria Patient Journey
9.
Chronic Spontaneous Urticaria Epidemiology and Patient Population
10.
Chronic Spontaneous Urticaria Marketed Drugs
11.
Chronic Spontaneous Urticaria Emerging Drugs
12.
Chronic Spontaneous Urticaria: Market Analysis
13.
Key Opinion Leaders’ Views
14.
SWOT
15.
Chronic Spontaneous Urticaria Unmet Needs
16.
Market Access and Reimbursement
17.
Appendix
18.
DelveInsight Capabilities
19.
Disclaimer
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About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
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