Chronic Spontaneous Urticaria Market Outlook Report 2032 | Roche, Novartis, Sanofi Pharmaceutical, Genentech, AstraZeneca, Kiniksa Pharmaceuticals, Ltd, United BioPharma, GlaxoSmithKline, Allakos, Eli Lilly and Company

DelveInsight's "Chronic Spontaneous Urticaria 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, EU5 (Germany, Spain, Italy, France, and 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 2019 to 2032, 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.

Chronic Spontaneous Urticaria Market Report Highlights:

In 2022, the US had the largest chronic spontaneous urticaria market size among the 7MM countries, accounting for approximately USD 1,104.4 million, expected to increase further by 2032.
The diagnosed chronic spontaneous urticaria prevalence 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.
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.

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Chronic Spontaneous Urticaria Overview

Chronic spontaneous urticaria (CSU) is a condition characterized by recurrent episodes of hives (urticaria) that persist for more than six weeks without an identifiable external trigger. It is also known as chronic idiopathic urticaria. CSU is caused by an abnormal immune response, although the exact mechanisms are not fully understood.

Signs and symptoms of CSU include raised, itchy welts or hives on the skin that may appear suddenly and disappear within hours or days. These hives can vary in size and shape and may be accompanied by swelling (angioedema), typically affecting the face, lips, tongue, throat, hands, and feet.

Diagnosing CSU involves a thorough medical history and physical examination to rule out potential triggers or underlying conditions. Laboratory tests, such as complete blood count, thyroid function tests, and tests for autoimmune diseases, may be performed to identify any associated factors contributing to the condition. A skin prick test or allergy testing may also be conducted to rule out allergic triggers.

Treatment for CSU aims to alleviate symptoms and reduce the frequency and severity of flare-ups. Antihistamines are the first-line treatment and can effectively relieve itching and reduce the number of hives. If symptoms persist despite antihistamine therapy, additional medications such as oral corticosteroids, leukotriene receptor antagonists, or immunosuppressants may be prescribed. In severe cases, omalizumab, an injectable biologic medication that targets IgE antibodies, may be recommended.

Lifestyle modifications, such as avoiding known triggers, maintaining a healthy diet, managing stress, and wearing loose-fitting clothing, may also help manage symptoms and reduce the frequency of flare-ups. It is essential for individuals with CSU to work closely with their healthcare providers to develop a personalized treatment plan tailored to their specific needs and circumstances.

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Chronic Spontaneous Urticaria Market

The Chronic Spontaneous Urticaria market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted Chronic Spontaneous Urticaria market trends by analyzing the impact of current Chronic Spontaneous Urticaria therapies on the market and unmet needs, and drivers, barriers, and demand for better technology.

This segment gives a thorough detail of the Chronic Spontaneous Urticaria market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated Chronic Spontaneous Urticaria market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

According to DelveInsight, the Chronic Spontaneous Urticaria market in 7MM is expected to witness a major change in the study period 2019-2032.

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Chronic Spontaneous Urticaria Epidemiology

The Chronic Spontaneous Urticaria epidemiology section provides insights into the historical and current Chronic Spontaneous Urticaria patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Chronic Spontaneous Urticaria market report also provides the diagnosed patient pool, trends, and assumptions.

Chronic Spontaneous Urticaria Epidemiology Insights

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

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