Chronic Spontaneous Urticaria Market Set for Robust Growth Driven by Innovation and Pipeline Advances by 2036 - DelveInsight

DelveInsight's report, "Chronic Spontaneous Urticaria Market Insights, Epidemiology, and Market Forecast-2036" provides a comprehensive analysis of the Chronic Spontaneous Urticaria landscape. The report delivers detailed insights into the disease, including historical and projected epidemiology, helping stakeholders understand the prevalence, incidence, and patient demographics across key regions.
Additionally, it examines Chronic Spontaneous Urticaria market dynamics, offering a thorough assessment of current and emerging market trends, treatment patterns, and therapeutic developments. The analysis spans major markets, including the United States, EU4 (Germany, Spain, Italy, France, and the United Kingdom), and Japan, equipping decision-makers with actionable intelligence for strategic planning, investment, and research initiatives.

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Some of the key facts of the Chronic Spontaneous Urticaria Market Report:
• The Chronic Spontaneous Urticaria market size across the 7MM was valued at approximately USD 2,000 million in 2025 and is anticipated to experience substantial growth throughout the forecast period from 2026 to 2036.
• 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.
• In November 2025, the European Commission has approved DUPIXENT (dupilumab) for the treatment of moderate-to-severe CSU in adult and adolescent patients 12 years and above with inadequate response to histamine-1 antihistamines (H1AH) and who are naive to anti- immunoglobulin-E (IgE) therapy for CSU. Eligible patients can use DUPIXENT as a first-line targeted treatment option.
• In September 2025, Novartis announced that Rhapsido® (remibrutinib) has been approved by the U.S. Food and Drug Administration (FDA) as an oral therapy for adults with chronic spontaneous urticaria (CSU) who continue to experience symptoms despite treatment with H1 antihistamines. The medication is taken twice daily in pill form and eliminates the need for injections or routine lab monitoring. It is the first FDA-approved Bruton's tyrosine kinase inhibitor (BTKi) for CSU, working by targeting BTK to reduce the release of histamine and other proinflammatory mediators, thereby offering a novel treatment approach.
• In July 2025, Jasper Therapeutics, Inc. (Nasdaq: JSPR), a clinical-stage biotech developing briquilimab, a novel KIT (CD117)-targeting antibody therapy for mast cell-driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), has shared updated data from its BEACON Phase 1b/2a study of subcutaneous briquilimab in adults with CSU, along with a program update. Treatment with briquilimab in the 240mg and 360mg single-dose cohorts achieved rapid and deep disease control, with 8 of 9 participants (89%) attaining a complete response and 7 of 9 (78%) showing clinical response by week 2. Participants rolling over into the open-label extension at 180mg Q8W demonstrated strong efficacy, with 8 of 11 (73%) achieving a complete response by 12 weeks.
• In March 2025, Results from the Phase III REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) trials demonstrate that remibrutinib effectively alleviates symptoms of chronic spontaneous urticaria (CSU) in patients who do not respond to second-generation H1-antihistamines. The studies, published in The New England Journal of Medicine, showed that the drug has a rapid onset of action, with efficacy maintained for 24 weeks, and a favorable safety profile.
• In April 2025, Sanofi and Regeneron's Dupixent (dupilumab) has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of chronic spontaneous urticaria (CSU).
• In January 2025, Jasper Therapeutics, Inc. (Nasdaq: JSPR), a clinical-stage biotechnology company developing briquilimab, a novel c-Kit (CD117) targeting antibody for mast cell-driven diseases like chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), and asthma, has announced positive preliminary data from its ongoing BEACON Phase 1b/2a study of subcutaneous briquilimab in adults with CSU. The study reported significant reductions in UAS7 scores, with an average change of -26.6 at eight weeks in the 240mg single-dose cohort. Multiple dosing regimens at or above 120mg showed reductions of over -25 points. Clinical responses were observed within a week, and patients across all dose levels (80mg, 120mg, 180mg, and 240mg) achieved Complete Responses (UAS7 = 0), with all participants in the 240mg single-dose group maintaining their response through eight weeks. The treatment demonstrated dose-dependent durability, reductions in serum tryptase, and a favorable safety profile.
• The market size of CSU in the US was approximately USD 1 billion in 2025 and is expected to increase at a CAGR of 15% during the forecast period driven by the increasing awareness of the disease and the launch of the emerging therapy.
• The total market size of CSU in EU4 and the UK was calculated to be approximately USD 600 million in 2025, which was nearly 30% of the total market revenue for the 7MM.
• Among EU4 and the UK, Germany accounted for the highest market with approximately USD 160 million in 2025, while Spain accounted for the lowest market with nearly USD 80 million in 2025.
• In 2025, the market size of CSU in Japan was nearly USD 380 million which is expected to change by 2036.
• 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.
• 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. These cases are expected to change during the forecast period (2026-2036). EU4 and the UK accounted for approximately 39% of the total chronic urticaria cases, while Japan accounted for around 42% in 2025.
• According to DelveInsight's age-specific prevalence estimates, in EU4 and the UK, the age group ≥60 years represented the largest number of diagnosed CSU cases in 2025, with nearly 450,000 cases, followed by the 50-59 years age group, with around 250,000 cases.
• The US accounted for approximately 610,000 diagnosed prevalent cases of CSU in 2025, and these cases are projected to increase by 2036.
• In 2025, among EU4 and the UK, Germany reported the highest number of diagnosed prevalent cases of CSU with approximately 390,000 cases, while Spain reported the lowest with approximately 190,000 cases.
• Japan accounted for nearly 37% of the total diagnosed prevalent CSU cases across the 7MM in 2025
• Key Chronic Spontaneous Urticaria Companies: Allakos, AstraZeneca, Biosana, Celldex Therapeutics, Celltrion, Eli Lilly and Company, Genentech, GI Innovation/Yuhan, Regeneron, GlaxoSmithKline, Taiho Pharma, Glenmark Pharmaceuticals, Gossamer Bio, Kiniksa Pharmaceuticals, Mycenax Biotech, Novartis, Regeneron, Synermore Biologics, UCB Biopharma, United BioPharma, and others
• Key Chronic Spontaneous Urticaria Therapies: Ligelizumab, Remibrutinib (LOU064), Tezepelumab, CDX-0159, GI-301, Dupilumab (DUPIXENT), UB-221, MTPS9579A, Lirentelimab (AK002), TAS5315, rilzabrutinib, GDC-0853, AZD1981, Desloratadine, and others
• The Chronic Spontaneous Urticaria epidemiology based on gender analyzed that Chronic Spontaneous Urticaria is more prominent in females in comparison to males
• The Chronic Spontaneous Urticaria market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Chronic Spontaneous Urticaria pipeline products will significantly revolutionize the Chronic Spontaneous Urticaria market dynamics.

Chronic Spontaneous Urticaria Overview
Chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria, is a skin condition characterized by the recurrent appearance of hives (wheals or welts) and/or angioedema (swelling in deeper layers of the skin) for a duration of at least six weeks. It is termed "spontaneous" because the hives and swelling occur without an identifiable trigger or external stimulus. CSU can be associated with significant discomfort, itching, and distress, impacting the quality of life of affected individuals.

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Chronic Spontaneous Urticaria Epidemiology
The Chronic Spontaneous Urticaria epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2022 to 2036. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Chronic Spontaneous Urticaria Epidemiology Segmentation:
The Chronic Spontaneous Urticaria market report proffers epidemiological analysis for the study period 2022-2036 in the 7MM segmented into:
• Total Diagnosed Prevalent Cases of Chronic Urticaria
• Type-specific Cases of Chronic Urticaria
• Gender-specific Cases of Chronic Spontaneous Urticaria
• Age-specific Cases of Chronic Spontaneous Urticaria
• Severity-specific Cases of Chronic Spontaneous Urticaria

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Chronic Spontaneous Urticaria Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Chronic Spontaneous Urticaria market or expected to get launched during the study period. The analysis covers Chronic Spontaneous Urticaria market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Chronic Spontaneous Urticaria Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Chronic Spontaneous Urticaria Therapies and Key Companies
• Ligelizumab: Novartis
• Remibrutinib (LOU064): Novartis
• Tezepelumab: Amgen
• CDX-0159: Celldex Therapeutics
• GI-301: GI Innovation
• Dupilumab (DUPIXENT): Sanofi/ Regeneron
• UB-221: United BioPharma
• MTPS9579A: Genentech
• Lirentelimab (AK002): Allakos Inc.
• TAS5315: Taiho Pharma
• rilzabrutinib: Sanofi
• GDC-0853: Genentech, Inc.
• AZD1981: AstraZeneca
• Desloratadine: Organon and Co

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Chronic Spontaneous Urticaria Market Drivers
• Rising prevalence and increasing diagnosis rates: Growing awareness among patients and healthcare providers is expanding the diagnosed patient pool.
• Advancements in targeted therapies: Biologics such as omalizumab and emerging anti-IgE or anti-siglec-8 therapies are improving efficacy and quality of life for patients with refractory CSU.
• Focus on patient-centric treatment approaches: Emphasis on symptom relief, reduced flare-ups, and improved quality of life is driving adoption of advanced therapies.
• Strong clinical pipeline and innovation: Ongoing development of novel small molecules and biologics is broadening treatment options.
• Regulatory support and reimbursement for rare/complex cases: Orphan drug incentives and coverage for specialty therapies encourage market growth.

Chronic Spontaneous Urticaria Market Barriers
• Limited treatment options for refractory cases: A subset of patients remains unresponsive to current therapies, posing a challenge to clinical management.
• High cost of biologic treatments: Premium pricing and reimbursement restrictions may limit access in certain regions.
• Variability in disease severity and response: Heterogeneous patient presentations make treatment optimization challenging.
• Safety and long-term tolerability concerns: Potential side effects of biologics and immunomodulators may restrict widespread use.
• Slow patient recruitment for clinical trials: Rare and complex nature of refractory CSU can hinder enrollment, delaying therapy development.

Scope of the Chronic Spontaneous Urticaria Market Report
• Study Period: 2022-2036
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Chronic Spontaneous Urticaria Companies: Allakos, AstraZeneca, Biosana, Celldex Therapeutics, Celltrion, Eli Lilly and Company, Genentech, GI Innovation/Yuhan, Regeneron, GlaxoSmithKline, Taiho Pharma, Glenmark Pharmaceuticals, Gossamer Bio, Kiniksa Pharmaceuticals, Mycenax Biotech, Novartis, Regeneron, Synermore Biologics, UCB Biopharma, United BioPharma, and others
• Key Chronic Spontaneous Urticaria Therapies: Ligelizumab, Remibrutinib (LOU064), Tezepelumab, CDX-0159, GI-301, Dupilumab (DUPIXENT), UB-221, MTPS9579A, Lirentelimab (AK002), TAS5315, rilzabrutinib, GDC-0853, AZD1981, Desloratadine, and others
• Chronic Spontaneous Urticaria Therapeutic Assessment: Chronic Spontaneous Urticaria current marketed and Chronic Spontaneous Urticaria emerging therapies
• Chronic Spontaneous Urticaria Market Dynamics: Chronic Spontaneous Urticaria market drivers and Chronic Spontaneous Urticaria market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Chronic Spontaneous Urticaria Unmet Needs, KOL's views, Analyst's views, Chronic Spontaneous Urticaria Market Access and Reimbursement

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