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.

 

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Key Takeaways from the Chronic Spontaneous Urticaria Market

• In December 2024:- Celldex Therapeutics– The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
• In December 2024:- Novartis Pharmaceuticals– The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 studies. This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.
• According to DelveInsight’s epidemiology model, the total Chronic Spontaneous Urticaria Diagnosed Prevalent Cases 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 Chronic Spontaneous Urticaria Diagnosed Prevalent Cases in 2023 which was nearly 19% of the total 7MM.
• Among the EU4 and the UK, Germany had the highest Chronic Spontaneous Urticaria Diagnosed Prevalent Cases 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 Chronic Spontaneous Urticaria Diagnosed Prevalent Cases 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.

 

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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.

 

Chronic Spontaneous Urticaria Marketed Drugs

• XOLAIR (omalizumab): Roche/Novartis

XOLAIR (omalizumab) is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human IgE. It is produced by a Chinese hamster ovary (CHO) cell suspension culture in a nutrient medium that may contain the antibiotic gentamicin; gentamicin is not detectable in the final product. Omalizumab binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. Also, the mechanism by which these effects of omalizumab result in an improvement of CIU symptoms is unknown. In December 2018, the European Commission (EC) approved XOLAIR (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with chronic spontaneous urticaria to administer their treatment.

 

• DUPIXENT (Dupilumab): Sanofi/Regeneron

DUPIXENT (dupilumab) is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the ‘Type I’ receptor and both IL-4 and IL-13 signaling through the ‘Type II receptor.’ DUPIXENT is approved for multiple indications, including atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis.

 

Chronic Spontaneous Urticaria Emerging Drugs

• Remibrutinib (LOU064): Novartis Pharmaceuticals

Remibrutinib (LOU064) is an oral treatment that potently and selectively inhibits Bruton’s tyrosine kinase (BTK) enzyme, which plays a critical role in the inflammatory activity of certain immune cells such as B cells and microglia. Remibrutinib inhibits degranulation induced by IgE cross‐linking in mast cells and basophils and the activation triggered by factors present in the sera of spontaneous and inducible chronic urticaria patients. Remibrutinib is currently being tested in Phase III clinical studies for chronic spontaneous urticaria in patients inadequately controlled by H1-antihistamines. The drug is also being developed for other indications, including relapsing multiple sclerosis and peanut allergy.

 

• TEZSPIRE (Tezepelumab): AstraZeneca/Amgen

TEZSPIRE (tezepelumab [AMG 157]) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of blocks thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and airway inflammation diseases. TSLP, IL-25, and IL-33 are released following different triggers on epithelia and start the Th2 inflammatory response, mediating T-cell polarization in Th2 cells. Tezepelumab with its inhibitory action of TSLP appears to prevent and treat the lesional skin of patients with chronic spontaneous urticaria.

 

• Rilzabrutinib (SAR444671): Sanofi

Rilzabrutinib (SAR444671) is an oral Bruton’s tyrosine kinase (BTK) inhibitor incorporating Sanofi’s TAILORED COVALENCY technology being investigated for treating immune-mediated diseases. BTK is an intracellular signaling molecule involved in innate and adaptive immune responses in certain immune-mediated diseases. The BTK enzyme plays a key role in several immune processes, including B-cell expansion, production of immunoglobulins, and activation of innate cells such as mast cells, eosinophils, and basophils.

 

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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.

 

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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

 

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