Chronic Spontaneous Urticaria Treatment Market 2034: EMA, PDMA, FDA Approvals, Medication, Clinical Trials, NDA Approval, Therapies, ROA, MOA and Companies by DelveInsight

Chronic Spontaneous Urticaria Treatment Market

(Albany, USA) DelveInsight’s “Chronic Spontaneous Urticaria Market Insights, Epidemiology and Market Forecast 2034” report delivers an in-depth understanding of the Chronic Spontaneous Urticaria, historical and forecasted epidemiology as well as the Chronic Spontaneous Urticaria market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Chronic Spontaneous Urticaria market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Chronic Spontaneous Urticaria market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Chronic Spontaneous Urticaria treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Chronic Spontaneous Urticaria market.

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Key Takeaways from the Chronic Spontaneous Urticaria Market

• According to DelveInsight’s epidemiology model, the total diagnosed prevalent cases of chronic spontaneous urticaria were approximately 2.8 million among the 7MM in 2023 which is expected to change during the forecast period (2024-2034).
• In the US, there were approximately 521 thousand diagnosed prevalent cases of chronic spontaneous urticaria in 2023 which was nearly 19% of the total 7MM.
• Among the EU4 and the UK, Germany had the highest diagnosed prevalent cases of chronic spontaneous urticarial in 2023 with approximately 327 thousand cases followed by France with nearly 255 thousand cases. On the other hand, Spain accounted for the least with approximately 163 thousand cases.
• In 2023, Japan accounted for the highest diagnosed prevalent cases of chronic spontaneous urticaria with approximately 1 million cases.
• Among the age-specific diagnosed prevalent cases of chronic spontaneous urticaria in the US, there were approximately 47 thousand, 80 thousand, 72 thousand, 81 thousand, 86 thousand, and 156 thousand cases in the age groups <18, 18−29, 30−39, 40−49, 50−59, and ≥60, respectively, in 2023.
• There were approximately 391 thousand male and 839 thousand female cases of chronic spontaneous urticarial among EU4 and the UK in 2023.
• In Japan, there were approximately 46 thousand mild cases, 690 thousand moderate cases, and 326 thousand severe cases of chronic spontaneous urticaria in 2023.
• The leading Chronic Spontaneous Urticaria Companies such as Roche, Novartis, Sanofi Pharmaceutical, Genentech, AstraZeneca, Kiniksa Pharmaceuticals, Ltd, United BioPharma, GlaxoSmithKline, Allakos, Eli Lilly and Company and others.
• Promising Chronic Spontaneous Urticaria Therapies such as barzolvolimab, CMAB007, Xolair, Dupilumab, LOU064 (blinded), and others.
• In March 2025, Evommune, Inc announced results of a Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of EVO756 in Adults with Moderate to Severe Chronic Spontaneous Urticaria
• In March 2025, Jiangsu Hansoh Pharmaceutical Co., Ltd. announced results of a Randomized, Double-blind, Placebo-controlled Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HS-10561 Capsule in Healthy Chinese Adults and Patients With Chronic Spontaneous Urticaria.
• In February 2025, Celldex Therapeutics announced results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU2)
• In October 2024, Jasper Therapeutics announced the launch of an open-label extension study for CSU, enrolling patients from the BEACON and SPOTLIGHT trials after their initial follow-up. The company also received regulatory approval in the US and EU to add a 360mg single-dose cohort (n=4) to the BEACON study in CSU. Initial data from doses up to 240mg will be reported in January 2025, with 360mg cohort data expected in the first half of 2025.

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Chronic Spontaneous Urticaria Epidemiology Segmentation in the 7MM

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

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Chronic Spontaneous Urticaria Treatment Market

The treatment of CSU is challenging, and the therapeutic goal is a reduction in disease activity, complete symptom control, and improvement in QoL. The current treatment regime aims to alleviate symptoms and prevent their recurrence. The treatment pattern typically involves a step-wise approach, starting with first-line treatments and progressing to more advanced options if necessary. Treatment is generally initiated with nonsedating antihistamines in the daytime and sedating antihistamines at night. H2-antihistamines are often combined with H1 to achieve better symptom control in CSU and are added if individuals complain of indigestion or acidity. The most commonly used H2 antihistamine for CSU is ranitidine. However, it is important to note that ranitidine has been withdrawn from many markets due to safety concerns. Many patients, however, do not achieve symptom control, with only less than half of patients responding to H1-antihistamines at standard doses. Adverse effects such as somnolence can occur in susceptible individuals, increasing the treatment burden, despite increasing the dose.

Chronic Spontaneous Urticaria Marketed Drugs

• XOLAIR (omalizumab): Roche/Novartis
• DUPIXENT (dupilumab): Sanofi/Regeneron

Chronic Spontaneous Urticaria Emerging Drugs Profile

• Remibrutinib (LOU064): Novartis Pharmaceuticals
• TEZSPIRE (tezepelumab): AstraZeneca/Amgen
• Rilzabrutinib (SAR444671): Sanofi

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Chronic Spontaneous Urticaria Therapeutics Market Landscape

Chronic spontaneous urticaria is a chronic condition characterized by the recurrent appearance of hives or wheals on the skin. It is a disturbing allergic condition of the skin, where symptoms persist for more than 6 weeks. The diagnosis is based on a physical examination and medical history. Additional tests are performed to rule out underlying causes or to identify triggers, such as blood tests, allergy tests, or skin biopsies. Treating chronic spontaneous urticaria is challenging, and the therapeutic goal is a reduction in disease activity, complete symptom control, and improvement in QoL. The current treatment regime aims to alleviate symptoms and prevent their recurrence. The treatment pattern typically involves a stepwise approach, starting with first-line treatments and progressing to more advanced options if necessary.

Chronic Spontaneous Urticaria Market Outlook

Chronic spontaneous urticaria is a disturbing allergic condition of the skin where symptoms persist for more than 6 weeks. A mast cell-driven disease is characterized by recurrent itchy wheals (hives) that may accompany angioedema. It often causes huge socio-economic distress for the patients, significantly impacting their quality of life. Treating chronic spontaneous urticaria is challenging, and the therapeutic goal is a reduction in disease activity, complete symptom control, and improvement in QoL. The current treatment regime aims to alleviate symptoms and prevent their recurrence. The treatment pattern typically involves a stepwise approach, starting with first-line treatments and progressing to more advanced options if necessary.

The Chronic Spontaneous Urticaria (CSU) market is driven by several key factors, including the rising prevalence of the condition, increasing awareness among patients and healthcare professionals, and advancements in biologic therapies. The growing demand for targeted treatment options, particularly monoclonal antibodies like omalizumab, has significantly improved disease management, driving market growth. Additionally, ongoing research and development (R&D) efforts, along with a strong pipeline of novel therapeutics, are expected to further expand treatment options. However, the market faces several barriers, such as high treatment costs, limited access to advanced biologics in certain regions, and potential side effects associated with long-term use of biologic therapies. Additionally, misdiagnosis and underreporting of cases, particularly in developing countries, pose challenges to market expansion. Despite these obstacles, continued advancements in precision medicine, the emergence of next-generation biologics, and increased regulatory approvals are expected to create new opportunities for growth in the CSU market.

Chronic Spontaneous Urticaria Companies

Roche, Novartis, Sanofi Pharmaceutical, Genentech, AstraZeneca, Kiniksa Pharmaceuticals, Ltd, United BioPharma, GlaxoSmithKline, Allakos, Eli Lilly and Company and others.

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Scope of the Chronic Spontaneous Urticaria Market Report

• Coverage- 7MM
• Study Period- 2020-2034
• Chronic Spontaneous Urticaria Companies- Roche, Novartis, Sanofi Pharmaceutical, Genentech, AstraZeneca, Kiniksa Pharmaceuticals, Ltd, United BioPharma, GlaxoSmithKline, Allakos, Eli Lilly and Company and others.
• Chronic Spontaneous Urticaria Therapies- Barzolvolimab, CMAB007, Xolair, Dupilumab, LOU064 (blinded), and others.
• Chronic Spontaneous Urticaria Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Chronic Spontaneous Urticaria Unmet Needs, KOL’s views, Analyst’s views, Chronic Spontaneous Urticaria Market Access and Reimbursement

Table of Content

1. Key Insights

2. Report Introduction

4. Methodology of Chronic Spontaneous Urticaria Epidemiology and Market

5. Executive Summary of Chronic Spontaneous Urticaria

6. Key Events

7. Disease Background and Overview

8. Patient Journey

9. Epidemiology and Patient Population

10. Marketed Drugs

11. Emerging Drugs

12. Chronic Spontaneous Urticaria: Market Analysis

13. Key Opinion Leaders’ Views

14. SWOT

15. Unmet needs

16. Market Access and Reimbursement

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

About DelveInsight

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