Chronic Spontaneous Urticaria Market to Register Incremental Growth During the Study Period (2020–2034) Owing to the Launch of Emerging Therapies | DelveInsight

According to DelveInsight’s analysis, the chronic spontaneous urticaria market is expected to increase due to an increase in disease prevalence, complemented by a rise in awareness and improvements in diagnosis and the expected launch of emerging therapies during the forecast period.

New York, USA, Feb. 20, 2025 (GLOBE NEWSWIRE) — Chronic Spontaneous Urticaria Market to Register Incremental Growth During the Study Period (2020–2034) Owing to the Launch of Emerging Therapies | DelveInsight 

According to DelveInsight’s analysis, the chronic spontaneous urticaria market is expected to increase due to an increase in disease prevalence, complemented by a rise in awareness and improvements in diagnosis and the expected launch of emerging therapies during the forecast period. 

DelveInsight’s proffers epidemiological analysis for the study period 2020–2034 in the 7MM 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 

Download the report to understand which factors are driving chronic spontaneous urticaria epidemiology trends @ Chronic Spontaneous Urticaria Epidemiological Insights

Chronic Spontaneous Urticaria Treatment Market 

Managing chronic spontaneous urticaria is difficult, with the main therapeutic objectives being reduced disease activity, complete symptom control, and enhanced quality of life (QoL). The current treatment approach focuses on symptom relief and preventing recurrence. Typically, treatment follows a step-by-step strategy, starting with first-line options and advancing to more specialized therapies if needed. 

In March 2023, the US FDA accepted the supplemental Biologics License Application (sBLA) for DUPIXENT (dupilumab) to treat adults and adolescents aged 12 and older with chronic spontaneous urticaria (CSU) who do not respond well to the current standard treatment, H1 antihistamines. However, in October 2023, Sanofi and Regeneron announced they had received a Complete Response Letter (CRL) from the US FDA. The CRL indicated that additional efficacy data are needed for approval but did not raise any concerns about safety or manufacturing. An ongoing clinical trial (Study C) is still recruiting patients, with results expected in late 2024 to provide the required efficacy data.

In February 2024, Japan’s Ministry of Health, Labor, and Welfare (MHLW) approved DUPIXENT for CSU treatment in individuals aged 12 and older whose condition is inadequately controlled with existing therapies. Japan became the first country to approve Dupixent for CSU, underscoring its importance as a novel treatment for patients with unmet medical needs. 

Novartis and Genentech’s (Roche) XOLAIR is an approved monoclonal antibody (MAB) for CSU patients aged 12 and older who continue to experience symptoms despite H1-antihistamine treatment. It helps prevent wheal and angioedema formation, enhances QoL, is suitable for long-term use, and effectively manages relapses after stopping treatment.

Learn more about the market of chronic spontaneous urticaria @ Chronic Spontaneous Urticaria Treatment 

Chronic Spontaneous Urticaria Emerging Drugs and Companies

Expected launch of emerging therapies, such as remibrutinib (LOU064) (Novartis Pharmaceuticals), DUPIXENT (dupilumab) (Sanofi/Regeneron), Barzolvolimab (Celldex Therapeutics), etc shall create a positive impact on the market. Other therapies by Sanofi, Jasper Therapeutics, Allakos, etc. in the early stages, are also being developed. 

Remibrutinib is an oral medication that effectively and selectively targets Bruton’s tyrosine kinase (BTK), an enzyme crucial to the inflammatory functions of immune cells like B cells and microglia. It inhibits IgE-mediated degranulation in mast cells and basophils, as well as the activation induced by factors in the sera of patients with spontaneous and inducible chronic urticaria. In the Phase III REMIX-1 and REMIX-2 trials, remibrutinib demonstrated a significant and clinically relevant reduction in weekly urticaria activity (UAS7), itch (ISS7), and hives (HSS7) at Week 12 compared to a placebo. 

The drug was well-tolerated, with an overall safety profile similar to that of the placebo, and showed balanced liver function tests across both trials. In May 2024, Novartis released additional data confirming remibrutinib’s long-term efficacy and safety in chronic spontaneous urticaria. These findings were presented at the 2024 European Academy of Allergy and Clinical Immunology (EAACI) Congress in Valencia, Spain, and Novartis plans to submit remibrutinib for approval in CSU to global health authorities in the second half of 2024 while continuing to explore its use in other immune-related conditions.

DUPIXENT is a human monoclonal IgG4 antibody that blocks interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by binding to the IL-4Rα subunit, which is common to both IL-4 and IL-13 receptor complexes. It inhibits IL-4 signaling through the ‘Type I’ receptor and both IL-4 and IL-13 signaling through the ‘Type II’ receptor. Various cell types express IL-4Rα. DUPIXENT is approved for several indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis, and prurigo nodularis. 

In July 2021, the Phase III trial successfully met its primary and key secondary endpoints at 24 weeks, showing that DUPIXENT nearly doubled the reduction in itch and urticaria activity scores. Sanofi and Regeneron submitted a supplemental New Drug Application (sNDA) for DUPIXENT for chronic spontaneous urticaria, but the US FDA issued a Complete Response Letter (CRL) requiring additional efficacy data for approval. The drug is currently undergoing Phase III trials in patients who are either naïve to omalizumab or intolerant to/incomplete responders of omalizumab, with results expected in late 2024 for DUPIXENT in biologic-naïve chronic spontaneous urticaria patients.

Barzolvolimab is a humanized monoclonal antibody that specifically targets the KIT receptor tyrosine kinase, effectively inhibiting its function. KIT is found in various cell types, including mast cells, which are key players in inflammatory processes like hypersensitivity and allergic reactions. KIT signaling is essential for the differentiation, recruitment, survival, and activity of mast cells. Inflammatory conditions such as chronic urticaria are driven by mast cell activation, which is critical to the disease’s onset and progression.

In June 2024, Celldex Therapeutics reported that Barzolvolimab significantly improved angioedema-free days compared to a placebo over 12 weeks. Patients in the 300 mg group were free of angioedema for 77% of the time during this period. Following these positive outcomes, Celldex launched its global Phase III program in July 2024, consisting of two trials, EMBARQ-CSU1 and EMBARQ-CSU2, to assess the safety and effectiveness of Barzolvolimab in adults with CSU who continue to experience symptoms despite H1 antihistamine treatment.

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.

To know more about chronic spontaneous urticaria clinical trials, visit @ Chronic Spontaneous Urticaria Treatment Drugs 

Chronic Spontaneous Urticaria Market Dynamics

The chronic spontaneous urticaria market dynamics are anticipated to change in the coming years. The advancement in clinical guidelines with GRADE methodologies provides evidence-based diagnostic and therapeutic approaches for different subtypes of urticaria, while substantial progress in CSU management over the past two decades has introduced multiple treatment options, including antihistamines, corticosteroids, and biologic therapies, offering relief to many patients. 

Moreover, advancements in medicine enable tailored treatment approaches for CSU, incorporating step-up or step-down strategies based on individual patient characteristics, triggers, and response patterns. This evolving landscape presents a lucrative opportunity to develop safe and effective therapies for patients who remain uncontrolled with existing treatment options.

Furthermore, many potential therapies are being investigated for the treatment of chronic spontaneous urticaria, and it is safe to predict that the treatment space will significantly impact the chronic spontaneous urticaria market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate is expected to drive the growth of the chronic spontaneous urticaria market in the 7MM.

However, several factors may impede the growth of the chronic spontaneous urticaria market. The disease’s variable presentations, along with patients often providing an incomplete history, contribute to delayed diagnosis and poor treatment outcomes. Additionally, not all patients respond well to the current treatment regime, leading to relapses or inadequate symptom control. 

Higher doses of H1-antihistamines are associated with significant side effects, such as sedation and anticholinergic effects, while XOLAIR carries a risk of anaphylaxis. Furthermore, variability in epidemiological data limits research and clinical health interventions. Meanwhile, the expected entry of biosimilars is anticipated to create downward pressure in the market.

Moreover, chronic spontaneous urticaria treatment poses a significant economic burden and disrupts patients’ overall well-being and QOL. Furthermore, the chronic spontaneous urticaria market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the chronic spontaneous urticaria market growth.

Scope of the Chronic Spontaneous Urticaria Market Report

• Chronic Spontaneous Urticaria Therapeutic Assessment: Chronic Spontaneous Urticaria current marketed and emerging therapies
• Chronic Spontaneous Urticaria Market Dynamics: Conjoint Analysis of Emerging Chronic Spontaneous Urticaria Drugs
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL’s views, Analyst’s views, Chronic Spontaneous Urticaria Market Access and Reimbursement

Discover more about chronic spontaneous urticaria drugs in development @ Chronic Spontaneous Urticaria Clinical Trials

Table of Contents

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