慢性特発性じんま疹市場 - 市場の洞察、疫学、市場予測：2032年

慢性特発性じんま疹は、健康関連QOLの低下、ヘルスケア資源利用の増加、生産性の低下、経済的負担の大幅な増大と関連しており、これらは疾患の重症度とともに増加します。

2022年、米国は主要7ヶ国諸国の中で慢性特発性じんま疹の市場規模が最も大きく、約11億440万米ドルを占め、2032年までにさらに増加すると予想されています。

承認されている唯一の薬剤は、ノバルティス社とジェネンテック社の抗IgEモノクローナル抗体であるXOLAIR（オマリズマブ）で、H1-抗ヒスタミン薬別治療にもかかわらず症状の残る12歳以上の患者を対象としています。慢性特発性じんま疹において、オマリズマブは膨疹および血管浮腫の発生を予防し、QOLを改善し、長期治療に適し、治療中止後の再発を効果的に治療します。しかし、オマリズマブを使用してもなお、3分の1近くの患者は症状を呈しています。

過去数十年にわたる治療法の進歩にもかかわらず、慢性特発性じんま疹は依然として蔓延している疾患であり、副作用なしに症状コントロールを改善し、難治性症例に有効な、費用対効果の高い長期的治療に対するアンメットニーズは明らかです。治療の視野を広げ、低コストで臨床で使用できる単剤療法や統合的アプローチの可能性を探ることが急務です。

2022年、主要7ヶ国における慢性蕁麻疹の総診断有病者数は約415万4,234例と推定されました。これらの症例は2032年までに減少すると予想されます。主要7ヶ国の中では、米国が2022年の慢性蕁麻疹の診断有病者総数の約18.7％を占めています。

当レポートでは、主要7ヶ国における慢性特発性じんま疹市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2032年までの市場規模予測、および医療のアンメットニーズなどを提供しています。

目次

第1章 重要な洞察

第2章 レポートのイントロダクション

第3章 慢性特発性じんま疹市場概要

• 2019年の慢性特発性じんま疹の市場シェア（%）分布
• 2032年の慢性特発性じんま疹の市場シェア（%）分布

第4章 慢性特発性じんま疹の疫学と市場の調査手法

第5章 慢性特発性じんま疹のエグゼクティブサマリー

第6章 主要な出来事

第7章 疾患の背景と概要

• イントロダクション
• 兆候と症状
• 分類
• 原因
• 病因
• 病態生理学
• 臨床症状
• 診断
• 治療と管理
• 慢性特発性じんま疹の治療
• 慢性特発性じんま疹の管理

第8章 患者動向

第9章 疫学と患者数

• 主な調査結果
• 仮定と根拠：主要7ヶ国
• 主要7ヶ国における慢性特発性じんま疹の有病診断症例の総数
• 米国
• 欧州4ヶ国と英国
• 日本

第10章 上市済み薬剤

第11章 新興薬剤

第12章 慢性特発性じんま疹：市場分析

• 主な調査結果
• 主要な市場予測の前提条件
• 市場の見通し
• 属性分析
• 主要7ヶ国における慢性特発性じんま疹の総市場規模
• 主要7ヶ国における慢性特発性じんま疹の総市場規模、治療法別
• 米国における慢性特発性じんま疹の総市場規模
• 欧州4ヶ国および英国における慢性特発性じんま疹の市場規模
• 日本における慢性特発性じんま疹の市場規模

第13章 主要なオピニオンリーダーの見解

第14章 SWOT

第15章 アンメットニーズ

第16章 市場アクセスと償還

• 米国
• 欧州4ヶ国と英国
• 日本

第17章 付録

第18章 DelveInsightのサービス内容

第19章 免責事項

List of Tables

• Table 1: Summary of Market and Epidemiology (2019-2032)
• Table 2: British Society for Allergy and Clinical Immunology (BSACI) Guidelines
• Table 3: Symptomatic pharmacological treatment Guidelines
• Table 4: Total Diagnosed Prevalent Cases of Chronic Spontaneous Urticaria in the 7MM (2019-2032)
• Table 5: Total Diagnosed Prevalent Cases of Chronic Urticaria in the US (2019-2032)
• Table 6: Type-specific Cases of Chronic Urticaria in the US (2019-2032)
• Table 7: Gender-specific Cases of Chronic Spontaneous Urticaria in the US (2019-2032)
• Table 8: Age-specific Cases of Chronic Spontaneous Urticaria in the US (2019-2032)
• Table 9: Severity-specific Cases of Chronic Spontaneous Urticaria in the US (2019-2032)
• Table 10: Total Diagnosed Prevalent Cases of Chronic Urticaria in EU4 and the UK (2019-2032)
• Table 11: Type-specific Cases of Chronic Urticaria in EU4 and the UK (2019-2032)
• Table 12: Gender-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK (2019-2032)
• Table 13: Age-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK (2019-2032)
• Table 14: Severity-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK (2019-2032)
• Table 15: Total Diagnosed Prevalent Cases of Chronic Urticaria in Japan (2019-2032)
• Table 16: Type-specific Cases of Chronic Urticaria in Japan (2019-2032)
• Table 17: Gender-specific Cases of Chronic Spontaneous Urticaria in Japan (2019-2032)
• Table 18: Age-specific Cases of Chronic Spontaneous Urticaria in Japan (2019-2032)
• Table 19: Severity-specific Cases of Chronic Spontaneous Urticaria in Japan (2019-2032)
• Table 20: XOLAIR (omalizumab), Clinical Trial Description, 2023
• Table 21: Remibrutinib (LOU064), Clinical Trial Description, 2023
• Table 22: DUPIXENT (dupilumab), Clinical Trial Description, 2023
• Table 23: FASENRA (benralizumab), Clinical Trial Description, 2023
• Table 24: Lirentelimab (AK002), Clinical Trial Description, 2023
• Table 25: TEZSPIRE (tezepelumab), Clinical Trial Description, 2023
• Table 26: Rilzabrutinib (SAR444671), Clinical Trial Description, 2023
• Table 27: TAS5315, Clinical Trial Description, 2023
• Table 28: Barzolvolimab (CDX-0159), Clinical Trial Description, 2023
• Table 29: Key Market Forecast Assumptions for Remibrutinib (LOU064)
• Table 30: Key Market Forecast Assumptions for DUPIXENT (dupilumab)
• Table 31: Key Market Forecast Assumptions for FASENRA (benralizumab)
• Table 32: Key Market Forecast Assumptions for Lirentelimab (AK002)
• Table 33: Key Market Forecast Assumptions for TEZSPIRE (tezepelumab)
• Table 34: Total Market Size of Chronic Spontaneous Urticaria in the 7MM, in USD million (2019-2032)
• Table 35: Total Market Size of Chronic Spontaneous Urticaria by Therapies in the 7MM, in USD million (2019-2032)
• Table 36: Market Size of Chronic Spontaneous Urticaria in the US, in USD million (2019-2032)
• Table 37: Market Size of Chronic Spontaneous Urticaria by Therapies in the US, in USD million (2019-2032)
• Table 38: Market Size of Chronic Spontaneous Urticaria in EU4 and the UK, in USD million (2019-2032)
• Table 39: Market Size of Chronic Spontaneous Urticaria by Therapies in EU4 and the UK, in USD million (2019-2032)
• Table 40: Market Size of Chronic Spontaneous Urticaria in Japan, in USD million (2019-2032)
• Table 41: Market Size of Chronic Spontaneous Urticaria by Therapies in Japan, in USD million (2019-2032)

List of Figures

• Figure 1: Classification
• Figure 2: Pathophysiology of Chronic Spontaneous Urticaria
• Figure 3: Model of the Mechanisms Underlying Chronic Urticaria
• Figure 4: Treatment Algorithm
• Figure 5: Step-care Approach to the Treatment for Chronic Urticaria
• Figure 6: Guidelines Supported by the Centre of Evidence of the French Society of Dermatology
• Figure 7: Comparison of Treatment Algorithm
• Figure 8: Treatment Algorithm
• Figure 9: Patient Journey
• Figure 10: Total Diagnosed Prevalent Cases of Chronic Spontaneous Urticaria in the 7MM (2019-2032)
• Figure 11: Total Diagnosed Prevalent Cases of Chronic Urticaria in the US (2019-2032)
• Figure 12: Type-specific Cases of Chronic Urticaria in the US (2019-2032)
• Figure 13: Gender-specific Cases of Chronic Spontaneous Urticaria in the US (2019-2032)
• Figure 14: Age-specific Cases of Chronic Spontaneous Urticaria in the US (2019-2032)
• Figure 15: Severity-specific Cases of Chronic Spontaneous Urticaria in the US (2019-2032)
• Figure 16: Total Diagnosed Prevalent Cases of Chronic Urticaria in EU4 and the UK (2019-2032)
• Figure 17: Type-specific Cases of Chronic Urticaria in EU4 and the UK (2019-2032)
• Figure 18: Gender-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK (2019-2032)
• Figure 19: Age-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK (2019-2032)
• Figure 20: Severity-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK (2019-2032)
• Figure 21: Total Diagnosed Prevalent Cases of Chronic Urticaria in Japan (2019-2032)
• Figure 22: Type-specific Cases of Chronic Urticaria in Japan (2019-2032)
• Figure 23: Gender-specific Cases of Chronic Spontaneous Urticaria in Japan (2019-2032)
• Figure 24: Age-specific Cases of Chronic Spontaneous Urticaria in Japan (2019-2032)
• Figure 25: Severity-specific Cases of Chronic Spontaneous Urticaria in Japan (2019-2032)
• Figure 26: Total Market Size of Chronic Spontaneous Urticaria in the 7MM, in USD million (2019-2032)
• Figure 27: Total Market Size of Chronic Spontaneous Urticaria by Therapies in the 7MM, in USD million (2019-2032)
• Figure 28: Market Size of Chronic Spontaneous Urticaria in the US, in USD million (2019-2032)
• Figure 29: Market Size of Chronic Spontaneous Urticaria by Therapies in the US, in USD million (2019-2032)
• Figure 30: Market Size of Chronic Spontaneous Urticaria in EU4 and the UK, in USD million (2019-2032)
• Figure 31: Market Size of Chronic Spontaneous Urticaria by Therapies in EU4 and the UK, in USD million (2019-2032)
• Figure 32: Market Size of Chronic Spontaneous Urticaria in Japan, in USD million (2019-2032)
• Figure 33: Market Size of Chronic Spontaneous Urticaria by Therapies in Japan, in USD million (2019-2032)
• Figure 34: SWOT Analysis of Chronic Spontaneous Urticaria
• Figure 35: Unmet Needs
• Figure 36: Health Technology Assessment
• Figure 37: Reimbursement Process in Germany
• Figure 38: Reimbursement Process in France
• Figure 39: Reimbursement Process in Italy
• Figure 40: Reimbursement Process in Spain
• Figure 41: Reimbursement Process in the United Kingdom
• Figure 42: Reimbursement Process in Japan

Key Highlights:

• The diagnosed prevalence of chronic spontaneous urticaria has been increasing due to improved understanding among healthcare professionals, changes in diagnostic criteria, besides an increasing population.
• Increased awareness and understanding of disease pathophysiology have led to better recognition, diagnosis, and treatment.
• The treatment pattern typically involves a stepwise approach. Various guidelines recommend using second-generation H1-antihistamines (cetirizine, loratadine, fexofenadine) as the first-line pharmacological treatment. The up-dosing of second-generation H1-antihistamine up to fourfold in patients with chronic spontaneous urticaria unresponsive to a standard dose is further recommended as the next step in treatment. As a second-line adjunct therapy for chronic spontaneous urticaria unresponsive to second-generation H1-antihistamines, guidelines recommend the only approved monoclonal antibody, omalizumab, for treating patients. Cyclosporine is recommended only for patients with severe disease, refractory to any combination dose of antihistamine and omalizumab. For acute flares of chronic spontaneous urticaria, short courses only of systemic corticosteroids may help alleviate symptom severity and reduce the flare duration. Other therapies like leukotriene antagonists, dapsone, mycophenolate mofetil, methotrexate, sulfasalazine, plasmapheresis, phototherapy, and IV immunoglobulin are recommended for individual cases.
• One of the major concerns in understanding the chronic spontaneous urticaria market is that the stepwise approach is not always followed, and the treatment regime in clinical practice usually depends upon the cost of therapy and other factors. The symptom control, besides adverse effects like somnolence, is also not as anticipated. Further, the rate of spontaneous remission is also high for chronic spontaneous urticaria, and the marketed drugs face the threat of generic erosion.
• Chronic spontaneous urticaria is associated with poor health-related quality of life, increased healthcare resource utilization, reduced productivity, and substantial economic burden, which increases with disease severity.
• In 2022, the US had the largest market size of chronic spontaneous urticaria among the 7MM countries, accounting for approximately USD 1,104.4 million, expected to increase further by 2032.
• The only approved drug is Novartis and Genentech's XOLAIR (omalizumab), an anti-IgE monoclonal antibody for patients age 12 years and older who remain symptomatic despite H1-antihistamine treatment. In chronic spontaneous urticaria, omalizumab prevents wheal and angioedema development, improves the quality of life, is suitable for long-term treatment, and effectively treats relapse after discontinuation. However, still, almost one-third of patients remain symptomatic despite the use of omalizumab.
• Despite all the advances made over the last few decades with treatment modalities, chronic spontaneous urticaria is still a prevalent disease, with a clear unmet need for cost-effective, long-term therapies that improve symptom control without side effects and are effective against refractory cases. There is an imperative need to extend the therapeutic horizon and explore the possibility of monotherapy or integrative approaches that are low-cost and are used in clinical practice.
• Advances in understanding chronic spontaneous urticaria pathomechanisms facilitate the development of therapeutic modalities targeting alternative pathways. Emerging therapies like Sanofi/Regeneron's DUPIXENT (dupilumab), Novartis Pharmaceuticals' remibrutinib (LOU064), AstraZeneca's FASENRA (benralizumab), Allakos/BioWa's lirentelimab (AK002), and AstraZeneca/Amgen's TEZSPIRE (tezepelumab), have the potential to quench the thirst for effective refractory therapies with long-term effects. The chronic spontaneous urticaria market will change during the forecast period due to the expected approval of these emerging therapies leading to the entry of new players in the treatment landscape.
• Sanofi/Regeneron's DUPIXENT (dupilumab), a human monoclonal IgG4 antibody, inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, blocking the cytokine-induced inflammatory responses, is being developed to treat individuals with chronic spontaneous urticaria refractory to H1 antihistamines. Being developed as an adjunct to first-line antihistamines, the drug has shown promising results in reducing the frequency and severity of hives in individuals with chronic spontaneous urticaria.
• Novartis Pharmaceuticals' remibrutinib (LOU064), a BTK inhibitor, is being developed for a target patient pool of chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines. It is another drug with the potential to enter the US market by 2025, as per DelveInsight's analysis. Novartis discontinued another drug, ligelizumab, developed for chronic spontaneous urticaria, as it failed to show superiority to omalizumab. Thus, remibrutinib keeps the hope alive for Novartis, and the drug will compete with Sanofi's DUPIXENT to maintain the dominance of Novartis, which currently enjoys the first mover advantage with XOLAIR, the lone biologic in the chronic spontaneous urticaria market space, that will lose its patent in 2025 in the US.
• Allakos/BioWa's lirentelimab (AK002), a monoclonal antibody that targets sialic acid-binding Ig-like lectin 8, is being developed to treat individuals with moderate to severe chronic spontaneous urticaria refractory to H1-antihistamine. With excellent safety and efficacy results, Allakos is a great speculative biotech play to look into, and the drug presents a good opportunity for the company to create a niche for itself in the crowded market space.

DelveInsight's "Chronic Spontaneous Urticaria (CSU) - Market Insights, Epidemiology, and Market Forecast - 2032" report delivers an in-depth understanding of chronic spontaneous urticaria, historical and forecasted epidemiology, as well as the chronic spontaneous urticaria market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The chronic spontaneous urticaria market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM chronic spontaneous urticaria market size from 2019 to 2032. The report also covers chronic spontaneous urticaria treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2019-2032.

Chronic Spontaneous Urticaria Understanding and Treatment Algorithm

Chronic Spontaneous Urticaria overview

Urticaria is a common and heterogeneous inflammatory skin disorder with or without associated angioedema. It presents with wheals, angioedema, or both due to activation and degranulation of skin mast cells, followed by the release of histamine and other mediators leading to sensory nerve activation, vasodilatation, plasma extravasation, and cellular recruitment. It is classified as acute or chronic, depending on whether the onset of episodes lasts for less or >6 weeks, respectively.

Chronic urticaria is spontaneous or inducible, lasts >6 weeks, and persists for >1 year. It impacts the quality of life and is linked to psychiatric comorbidities and high healthcare costs, often causing huge socio-economic distress for the patients. In contrast to chronic spontaneous urticaria, where the cause is unknown, chronic inducible urticaria has definite and subtype-specific triggers that induce signs and symptoms.

A mast cell-driven disease is characterized by recurrent itchy wheals (hives) that may accompany angioedema, due to activation and degranulation of skin mast cells, followed by the release of histamine and other mediators. The typical lesion is a pale-to-red, well-demarcated papule or plaque. Lesions may be round, oval, annular, arcuate, serpiginous, or generalized. They resolve without post-inflammatory pigmentary changes or scaling. Women are twice as likely as men to be diagnosed with the disease, and most people first develop symptoms between 20 and 40 years.

The etiology of chronic spontaneous urticaria is yet to be fully established. The exact cause is often unknown, but it may be due to autoimmune reactions wherein the immune system mistakenly targets healthy cells in the skin. Other potential triggers include medications, infections, insect bites, stress, and temperature changes. The prognosis in chronic spontaneous urticaria depends on the comorbid disease causing the urticaria and the patient's response to therapy. The autoimmune pathogenesis of chronic urticaria, including recent data, suggests that chronic spontaneous urticaria may involve contributions from both immunoglobulin G (IgG)-specific and immunoglobulin E (IgE)-specific autoantibodies against a vast array of antigens that can span beyond those found on the surface of mast cells and basophils.

Chronic Spontaneous Urticaria diagnosis

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. Screening tests for thyroid function and antithyroid peroxidase and antithyroglobulin antibodies are recommended. Positive autologous serum skin test (ASST) and in vitro testing of the patient's serum for the anti-FCeRIa or the anti-IgE autoantibodies by basophil histamine release assay (BHRA) is also recommended.

Some tools have been developed to assess disease activity (e.g., urticaria activity score), disease control (e.g., urticaria control test), and impacts on quality of life (e.g., chronic urticaria quality of life index). Baseline assessments should be performed to help guide treatment decisions and monitor progress.

Further details related to country-based variations are provided in the report…

Chronic Spontaneous Urticaria treatment

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.

The guidelines recommend using second-generation H1-antihistamines (cetirizine, loratadine, fexofenadine) as the first-line pharmacological treatment. Due to anticholinergic properties and the adverse effect profile on the central nervous system, the routine use of first-generation H1-antihistamines is no longer recommended, though they are still used in clinical practice. The up-dosing of second-generation H1-antihistamine up to fourfold in patients with chronic spontaneous urticaria unresponsive to a standard dose is further recommended as the next step in treatment. H2 antihistamines are often combined with H1 to achieve better symptom control in chronic spontaneous urticaria.

As a second-line adjunct therapy for chronic spontaneous urticaria unresponsive to second-generation H1-antihistamines, guidelines recommend the only approved monoclonal antibody, omalizumab, for treating patients. It is a monoclonal antibody with a high affinity for free IgE. Novartis and Genentech's XOLAIR is the only approved biologic for chronic spontaneous urticaria patients age 12 years and older who remain symptomatic despite H1-antihistamine treatment. In chronic spontaneous urticaria, omalizumab prevents wheal and angioedema development, improves the quality of life, is suitable for long-term treatment, and effectively treats relapse after discontinuation. The drug is approved in the US, Europe, and Japan for treating chronic spontaneous urticaria who remain symptomatic despite H1-antihistamine treatment.

Cyclosporine is recommended only for patients with severe disease, refractory to any combination dose of antihistamine and omalizumab. Cyclosporine is immunosuppressive and has a moderate, direct effect on mast cell mediator release. In various trials, the efficacy of cyclosporine in combination with a modern second-generation H1-antihistamine has been established; however, due to a high incidence of adverse effects, the drug is not recommended as the standard treatment but as an add-on.

For acute flares of chronic spontaneous urticaria, short courses only of systemic corticosteroids may help alleviate symptom severity and reduce the flare duration. However, depending on the country, certain steroids are not licensed for chronic urticaria; for example, in Germany, prednisolone is only licensed for acute urticaria.

The use of leukotriene receptor antagonists like montelukast, zafirlukast, zileuton, etc., has also been assessed in various trials. In general, the evidence for the efficacy of leukotriene receptor antagonists in urticaria is low, but best for montelukast. The class is often given as an add-on therapy to histamines.

Further, since the severity of urticaria may fluctuate, and spontaneous remission may occur at any time, it is recommended to re-evaluate the necessity for continued or alternative drug treatment every 3-6 months. In addition, patients are not always treated according to formal guideline recommendations; for example, sedating first-generation H1-antihistamines, IV immunoglobulin, and long-term oral corticosteroid usage were not uncommon.

Chronic Spontaneous Urticaria Epidemiology

As the market is derived using a patient-based model, the chronic spontaneous urticaria epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by 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, and severity-specific cases of chronic spontaneous urticaria in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032.

• In 2022, the total diagnosed prevalent cases of chronic urticaria were estimated to be approximately 4,154,234 cases in the 7MM. These cases are expected to decrease by 2032.
• Among the 7MM, the United States accounted for nearly 18.7% of the total diagnosed prevalent cases of chronic urticaria in 2022. These cases are expected to increase during the study period (2019-2032).
• As per DelveInsight analysis, type-specific cases of chronic urticaria included chronic spontaneous urticaria and chronic inducible urticaria, which accounted for approximately 2,811,068 and 1,343,166 cases, respectively, in 2022, in the 7MM. These cases are expected to increase during the study period (2019-2032).
• According to estimates based on DelveInsight's epidemiology model of chronic spontaneous urticaria, in 2022, in the US, there were approximately 517,258 cases of chronic spontaneous urticaria and 258,629 cases of chronic inducible urticaria, which are expected to increase by 2032.
• In 2022, among the EU4 and the UK countries, Germany accounted for the highest diagnosed prevalent cases of chronic spontaneous urticaria, followed by France. While Spain accounted for the least diagnosed prevalent cases of chronic spontaneous urticaria. While Japan accounted for nearly 37.9% of the total diagnosed prevalent cases of chronic spontaneous urticaria in the 7MM.

According to estimates based on DelveInsight's epidemiology model, chronic spontaneous urticaria exhibits a significant female preponderance than males. In the US, gender-specific cases of chronic spontaneous urticaria accounted for nearly 26.7% of males and 73.3% of females in 2022.

• According to estimates based on DelveInsight's epidemiology model, the age-specific cases of chronic spontaneous urticaria in EU4 and the UK were approximately 113,956, 135,691, 185,670, 201,510, 205,685, and 385,461 cases in the age groups <18, 18-29, 30-39, 40-49, 50-59, and =60, respectively, in 2022.
• In 2022, in Japan, there were approximately 45,724, 693,114, and 326,999 cases of mild, moderate, and severe cases of chronic spontaneous urticaria. These severity-specific cases are expected to decrease in Japan by 2032.

Chronic Spontaneous Urticaria Drug Chapters

The drug chapter segment of the chronic spontaneous urticaria report encloses a detailed analysis of chronic spontaneous urticaria-marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the chronic spontaneous urticaria clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Drugs:

XOLAIR (omalizumab): Roche/Novartis

XOLAIR (omalizumab) is a recombinant DNA-derived humanized IgG1? 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 (FceRI) 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, Novartis announced that the EC had approved XOLAIR (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with chronic spontaneous urticaria to administer their treatment.

In September 2018, the US FDA approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes for XOLAIR as an additional formulation for chronic spontaneous urticaria. While in March 2017, the PMDA approved XOLAIR with a new additional indication and a new dosage (SC injection 150 mg and 75 mg) for treating chronic spontaneous urticaria. In March 2014, the US FDA and the EC approved XOLAIR (omalizumab) for treating chronic spontaneous urticaria for patients 12 years of age and older who remain symptomatic despite H1-antihistamine therapy.

Emerging Drugs:

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-4Ra 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.

In July 2021, the Phase III trial met its primary and key secondary endpoints at 24 weeks, showing DUPIXENT nearly doubled reduction in itch and urticaria activity scores. The drug is currently investigated in Phase III trials in patients naive to omalizumab or intolerant or incomplete responders to omalizumab. In March 2023, the US FDA accepted the supplemental biologics license application (sBLA) for DUPIXENT to treat adults and adolescents aged 12 and older with chronic spontaneous urticaria that is not adequately controlled with the current standard of care, H1-antihistamine treatment. The target action date for the FDA decision is October 2023. Additionally, the sBLA is supported by data from two Phase III trials.

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.

Lirentelimab (AK002): Allakos/BioWa

Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody that targets sialic acid-binding Ig-like lectin 8 (Siglec-8). Siglec-8 is an inhibitory receptor in eosinophils and mast cells, with low-level basophil expression. Thus, lirentelimab depletes eosinophils via antibody-dependent natural killer cell-mediated cytotoxicity and inhibition of FceRI-mediated histamine release.

AK002 has demonstrated activity in animal disease models of eosinophilic and mast cell-driven diseases. The company has completed a Phase IIa study to treat chronic urticaria, and another Phase IIb is ongoing in moderate-severe chronic spontaneous urticaria refractory to H1-antihistamine.

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insights:

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.

Standard-dose of second-generation H1- antihistamines are the primary class of medications used to treat chronic spontaneous urticaria. They work by blocking histamine H1 receptors in the body, alleviating the symptoms of itching, redness, and swelling associated with chronic spontaneous urticaria. 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 chronic spontaneous urticaria and are added if individuals complain of indigestion or acidity. Omalizumab, an anti-IgE monoclonal antibody, is the next-in-line therapy to be given as an add-on to improve treatment efficacy. Novartis and Genentech's XOLAIR is the only approved MAB for chronic spontaneous urticaria patients age 12 years and older who remain symptomatic despite H1-antihistamine treatment. In chronic spontaneous urticaria, omalizumab prevents wheal and angioedema development and improves the quality of life.

Patients with urticaria who do not show sufficient benefit from treatment with omalizumab are treated with cyclosporine 3.5-5 mg/kg per day. Cyclosporine is immunosuppressive and has a moderate, direct effect on mast cell mediator release. The use of leukotriene receptor antagonists like montelukast, zafirlukast, zileuton, etc., has also been assessed in various trials. In general, the evidence for the efficacy of leukotriene receptor antagonists in urticaria is low, but best for montelukast.

The guidelines also state that for acute urticaria and exacerbations of chronic spontaneous urticaria, a short course of oral corticosteroids helps reduce disease duration and activity.

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.

Treatment patterns vary depending on the individual and their response to different medications. Various factors, such as the severity of symptoms, treatment response, and any underlying conditions, are to be considered for the most appropriate treatment plan.

The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline recommends second-generation H1-antihistamine as first-line treatment for all types of urticaria. The up-dosing of second-generation H1- antihistamine up to fourfold in patients with CU unresponsive to a standard dose is recommended as a second-line treatment before other treatments are considered. The guidelines further recommend the only approved monoclonal antibody, omalizumab, for treating patients with CU unresponsive to high-dose antihistamines. Cyclosporine is used off-label and is recommended only for patients with severe disease, refractory to any dose of antihistamine and omalizumab in combination.

Other symptomatic therapies like corticosteroids, antidepressants, immunosuppressants, leukotriene receptor antagonists, sulfasalazine, methotrexate, interferon, plasmapheresis, phototherapy, IV immunoglobulins are other recommended options for individual cases.

Standard-dose of second-generation H1- antihistamines are the primary class of medications used to treat chronic spontaneous urticaria. They work by blocking histamine H1 receptors in the body, alleviating the symptoms of itching, redness, and swelling associated with chronic spontaneous urticaria.

Non-sedating antihistamines, such as the use of bilastine, cetirizine, desloratadine, ebastine, fexofenadine, levocetirizine, loratadine, and rupatadine, while sedating H1-antihistamines as brompheniramine, carbinoxamine, chlorpheniramine, clemastine, cyproheptadine, dexbrompheniramine, dexchlorpheniramine, diphenhydramine, doxylamine, pheniramine, promethazine, pyrilamine, tripelennamine, triprolidine are recommended.

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 chronic spontaneous urticaria and are added if individuals complain of indigestion or acidity. The most commonly used H2 antihistamine for chronic spontaneous urticaria 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.

Novartis and Genentech's XOLAIR is the only approved biologic for chronic spontaneous urticaria patients age 12 years and older who remain symptomatic despite H1-antihistamine treatment. In chronic spontaneous urticaria, omalizumab prevents wheal and angioedema development, improves the quality of life, is suitable for long-term treatment, and effectively treats relapse after discontinuation. The drug is approved in the US, Europe, and Japan for treating chronic spontaneous urticaria who remain symptomatic despite H1-antihistamine treatment.

However, almost one-third of patients remain symptomatic despite omalizumab, and the SC administration route further burdens the healthcare infrastructure and patients.

Patients with urticaria who do not show sufficient benefit from treatment with omalizumab are treated with cyclosporine 3.5-5 mg/kg per day. Cyclosporine is immunosuppressive and has a moderate, direct effect on mast cell mediator release. In various trials, the efficacy of cyclosporine in combination with a modern second-generation H1-antihistamine has been established; however, due to a high incidence of adverse effects, the drug is not recommended as the standard treatment but as an add-on. The use of leukotriene receptor antagonists like montelukast, zafirlukast, zileuton, etc., has also been assessed in various trials. The class is often given as an add-on therapy to histamines. The guidelines also state that for acute urticaria and exacerbations of chronic spontaneous urticaria, a short course of oral corticosteroids helps reduce disease duration and activity.

Generally, antihistamines at up to quadruple recommended dosages will control symptoms in large part of patients with urticaria in general practice; alternative treatments are needed for the remaining unresponsive patients. However, it is strongly recommended to stick to the algorithm, but it is acknowledged that omalizumab has restrictions due to its high cost and cyclosporine due to its safety profile. H2-antagonists and dapsone though not recommended, still have relevance as they are affordable in some restricted healthcare systems.

The current market has been segmented into different commonly used therapeutic classes based on the prevailing treatment pattern across the 7MM, which presents minor variations in the overall prescription pattern. Oral corticosteroids, prescription antihistamines, leukotriene receptor antagonists, immunosuppressive agents, XOLAIR, and others are the major drugs covered in the forecast model.

Key players Sanofi/Regeneron's DUPIXENT (dupilumab), Novartis Pharmaceuticals' remibrutinib (LOU064), AstraZeneca's FASENRA (benralizumab), Allakos/BioWa's lirentelimab (AK002), and AstraZeneca/Amgen's TEZSPIRE (tezepelumab) are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products to treat chronic spontaneous urticaria.

• The total market size of chronic spontaneous urticaria in the 7MM was approximately USD 2,084.6 million in 2022 and is projected to increase during the forecast period (2023-2032).
• The market size of chronic spontaneous urticaria in the US will increase at a CAGR of 9.5% during the study period due to increasing awareness of the disease and the launch of the emerging therapy. The market size was approximately USD 1,104.4 million in 2022.
• The total market size of chronic spontaneous urticaria in EU4 and the UK was calculated to be approximately USD 600.8 million in 2022, which was nearly 28.8% of the total market revenue for the 7MM.
• According to DelveInsight's estimates, among EU4 and the UK, Germany accounted for the highest market with approximately USD 160.0 million in 2022, followed by France with approximately USD 139.3 million in the respective year, while Spain accounted for the lowest market in 2022.
• According to DelveInsight's analysis, in the US, Novartis' XOLAIR has the highest market share among all the therapies, in 2022, with a revenue of approximately USD 820.7 million, followed by prescription antihistamines and immunosuppressive agents, respectively.
• In 2022, the market size of chronic spontaneous urticaria in Japan was nearly 18.2% of the total market size in the 7MM, with a revenue of approximately USD 379.4 million.
• Among the emerging therapies, Sanofi/Regeneron's DUPIXENT (dupilumab), a human monoclonal IgG4 antibody that blocks the cytokine-induced inflammatory responses, is being developed to treat individuals with chronic spontaneous urticaria refractory to H1 antihistamines. It is expected to enter the US market by 2024 and is projected to generate a revenue of USD 2.7 million in its launch year with a niche patient pool; the drug is predicted to have a slow-medium uptake during the forecast period.

Chronic Spontaneous Urticaria Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019-2032. For example, Novartis Pharmaceuticals' remibrutinib (LOU064), a BTK inhibitor, is expected to enter the US market by 2025 and is projected to have a slow uptake during the forecast period.

Further detailed analysis of emerging therapies drug uptake in the report…

Chronic Spontaneous Urticaria Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therap

Table of Contents

1. Key Insights

2. Report Introduction

3. Chronic Spontaneous Urticaria Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Chronic Spontaneous Urticaria in 2019
• 3.2. Market Share (%) Distribution of Chronic Spontaneous Urticaria in 2032

4. Methodology of Chronic Spontaneous Urticaria Epidemiology and Market

5. Executive Summary of Chronic Spontaneous Urticaria

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Signs and Symptoms
• 7.3. Classification
  • 7.3.1. Classification of Urticaria Based on its Duration and the Relevance of Eliciting Factors
• 7.4. Causes
• 7.5. Etiology
• 7.6. Pathophysiology
  • 7.6.1. Role of Mast Cells
  • 7.6.2. Serum Factors
  • 7.6.3. Coagulation Cascade
  • 7.6.4. Basophils
  • 7.6.5. Eosinophils
  • 7.6.6. Lymphocytes
  • 7.6.7. Autoimmune Theory
• 7.7. Clinical Manifestation
• 7.8. Diagnosis
  • 7.8.1. Acute Urticaria Diagnosis
  • 7.8.2. Chronic Spontaneous Urticaria
  • 7.8.3. Auto-reactive Urticaria
  • 7.8.4. Wheals and Angioedema are not Always Urticaria
  • 7.8.5. Histologic Findings
• 7.9. Treatment and Management
  • 7.9.1. Nonsedating Antihistamines
  • 7.9.2. Leukotriene Receptor Antagonists
  • 7.9.3. Cyclosporine A
  • 7.9.4. Omalizumab
  • 7.9.5. Methotrexate
  • 7.9.6. Azathioprine and Mycophenolate Mofetil
  • 7.9.7. Dapsone
  • 7.9.8. Other Drugs
• 7.10. Treatment for Chronic Spontaneous Urticaria
  • 7.10.1. Treatment of Urticaria in Children
  • 7.10.2. Treatment of Urticaria During Pregnancy and Lactation
  • 7.10.3. Treatment of Angioedema
  • 7.10.4. EAACI/GA²LEN/EDF/WAO Guideline
  • 7.10.5. BSACI Guidelines for the Management of Chronic Urticaria and Angio-oedema
  • 7.10.6. Guidelines Supported by the Centre of Evidence of the French Society of Dermatology
  • 7.10.7. Treatment Algorithm
• 7.11. Management of Chronic Spontaneous Urticaria

8. Patient Journey

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale: The 7MM
  • 9.2.1. Diagnosed Prevalent Cases of Chronic Urticaria
  • 9.2.2. Type-specific Cases of Chronic Urticaria
  • 9.2.3. Age-specific Cases of Chronic Spontaneous Urticaria
  • 9.2.4. Gender-specific Cases of Chronic Spontaneous Urticaria
  • 9.2.5. Severity-specific Cases of Chronic Spontaneous Urticaria
• 9.3. Total Diagnosed Prevalent Cases of Chronic Spontaneous Urticaria in the 7MM
• 9.4. The US
  • 9.4.1. Total Diagnosed Prevalent Cases of Chronic Urticaria in the US
  • 9.4.2. Type-specific Cases of Chronic Urticaria in the US
  • 9.4.3. Gender-specific Cases of Chronic Spontaneous Urticaria in the US
  • 9.4.4. Age-specific Cases of Chronic Spontaneous Urticaria in the US
  • 9.4.5. Severity-specific Cases of Chronic Spontaneous Urticaria in the US
• 9.5. EU4 and the UK
  • 9.5.1. Total Diagnosed Prevalent Cases of Chronic Urticaria in EU4 and the UK
  • 9.5.2. Type-specific Cases of Chronic Urticaria in the EU4 and the UK
  • 9.5.3. Gender-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK
  • 9.5.4. Age-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK
  • 9.5.5. Severity-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK
• 9.6. Japan
  • 9.6.1. Total Diagnosed Prevalent Cases of Chronic Urticaria in Japan
  • 9.6.2. Type-specific Cases of Chronic Urticaria in Japan
  • 9.6.3. Gender-specific Cases of Chronic Spontaneous Urticaria in Japan
  • 9.6.4. Age-specific Cases of Chronic Spontaneous Urticaria in Japan
  • 9.6.5. Severity-specific Cases of Chronic Spontaneous Urticaria in Japan

10. Marketed Drugs

• 10.1. XOLAIR (omalizumab): Roche/Novartis
  • 10.1.1. Product Description
  • 10.1.2. Regulatory Milestones
  • 10.1.3. Other Development Activities
  • 10.1.4. Clinical Development
  • 10.1.5. Clinical Trials Information
  • 10.1.6. Safety and Efficacy
  • 10.1.7. Product Profile

11. Emerging Drugs

• 11.1. Key Cross Competition
• 11.2. Remibrutinib (LOU064): Novartis Pharmaceuticals
  • 11.2.1. Drug Description
  • 11.2.2. Clinical Development
  • 11.2.3. Clinical Trials Information
  • 11.2.4. Safety and Efficacy
  • 11.2.5. Product Profile
  • 11.2.6. Analysts' Views
• 11.3. DUPIXENT (dupilumab): Sanofi/Regeneron
  • 11.3.1. Product Description
  • 11.3.2. Other Developmental Activity
  • 11.3.3. Clinical Development
  • 11.3.4. Clinical Trials Information
  • 11.3.5. Safety and Efficacy
  • 11.3.6. Product Profile
  • 11.3.7. Analysts' Views
• 11.4. FASENRA (benralizumab): AstraZeneca/Kyowa Hakko Kirin
  • 11.4.1. Product Description
  • 11.4.2. Other Developmental Activity
  • 11.4.3. Clinical Development
  • 11.4.4. Clinical Trials Information
  • 11.4.5. Safety and Efficacy
  • 11.4.6. Product Profile
  • 11.4.7. Analysts' Views
• 11.5. Lirentelimab (AK002): Allakos/BioWa
  • 11.5.1. Drug Description
  • 11.5.2. Other Developmental Activity
  • 11.5.3. Clinical Development
  • 11.5.4. Clinical Trials Information
  • 11.5.5. Safety and Efficacy
  • 11.5.6. Product Profile
  • 11.5.7. Analysts' Views
• 11.6. TEZSPIRE (tezepelumab): AstraZeneca/Amgen
  • 11.6.1. Product Description
  • 11.6.2. Other Developmental Activity
  • 11.6.3. Clinical Development
  • 11.6.4. Clinical Trials Information
  • 11.6.5. Product Profile
  • 11.6.6. Analysts' Views
• 11.7. Rilzabrutinib (SAR444671): Sanofi
  • 11.7.1. Product Description
  • 11.7.2. Other Developmental Activity
  • 11.7.3. Clinical Development
  • 11.7.4. Clinical Trials Information
  • 11.7.5. Product Profile
• 11.8. TAS5315: Taiho Pharmaceutical
  • 11.8.1. Drug Description
  • 11.8.2. Clinical Development
  • 11.8.3. Clinical Trials Information
  • 11.8.4. Product Profile
• 11.9. Barzolvolimab (CDX-0159): Celldex Therapeutics
  • 11.9.1. Product Description
  • 11.9.2. Other Developmental Activity
  • 11.9.3. Clinical Development
  • 11.9.4. Clinical Trials Information
  • 11.9.5. Safety and Efficacy
  • 11.9.6. Product Profile

12. Chronic Spontaneous Urticaria: Market Analysis

• 12.1. Key Findings
• 12.2. Key Market Forecast Assumptions
• 12.3. Market Outlook
• 12.4. Attribute Analysis
• 12.5. Total Market Size of Chronic Spontaneous Urticaria in the 7MM
• 12.6. Total Market Size of Chronic Spontaneous Urticaria by Therapies in the 7MM
• 12.7. Total Market Size of Chronic Spontaneous Urticaria in the US
  • 12.7.1. Total Market Size of Chronic Spontaneous Urticaria
  • 12.7.2. The Market Size of Chronic Spontaneous Urticaria by Therapies
• 12.8. Market Size of Chronic Spontaneous Urticaria in EU4 and the UK
  • 12.8.1. Total Market Size of Chronic Spontaneous Urticaria
  • 12.8.2. The Market Size of Chronic Spontaneous Urticaria by Therapies
• 12.9. Market Size of Chronic Spontaneous Urticaria in Japan
  • 12.9.1. Total Market Size of Chronic Spontaneous Urticaria
  • 12.9.2. The Market Size of Chronic Spontaneous Urticaria by Therapies

13. Key Opinion Leaders' Views

14. SWOT

15. Unmet needs

16. Market Access and Reimbursement

• 16.1. The United States
  • 16.1.1. Centre for Medicare & Medicaid Services (CMS)
• 16.2. In EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. The United Kingdom
• 16.3. Japan
  • 16.3.1. MHLW

17. Appendix

• 17.1. Bibliography
• 17.2. Acronyms and Abbreviations
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer