The Chronic Spontaneous Urticaria market growth is driven by factors like increase in the prevalence of Chronic Spontaneous Urticaria, investments in research and development, entry of emerging therapies during the study period 2019-2032.
The Chronic Spontaneous Urticaria market report also offers comprehensive insights into the Chronic Spontaneous Urticaria market size, share, Chronic Spontaneous Urticaria epidemiology, emerging therapies, market drivers and barriers, ongoing clinical trials, key collaboration in the space, market uptake by key therapies and companies actively pushing Chronic Spontaneous Urticaria market size growth forward.
Some of the key highlights from the Chronic Spontaneous Urticaria Market Insights Report:
- Several key pharmaceutical companies, including Sanofi, Regeneron, AstraZeneca, Kyowa Hakko Kirin, Allakos, BioWa, Amgen, Taiho Pharmaceutical, Celldex Therapeutics, and others, are developing novel products to improve the Chronic Spontaneous Urticaria treatment outlook.
- The total Chronic Spontaneous Urticaria market size will include the market size of the potential upcoming therapies and current treatment regimens in the seven major markets.
- As per DelveInsight analysis, the Chronic Spontaneous Urticaria market is anticipated to witness growth at a considerable CAGR
- 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.
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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.
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.
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Recent Breakthroughs in the Chronic Spontaneous Urticaria Market:
- On March 21, 2014, the FDA approved Xolair for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives for people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy.
Chronic Spontaneous Urticaria Epidemiology Segmentation
DelveInsight’s Chronic Spontaneous Urticaria market report is prepared on the basis of epidemiology model. It offers comprehensive insights to the Chronic Spontaneous Urticaria historical patient pools and forecasted Chronic Spontaneous Urticaria patients. The report provides in-depth data of various subtypes and for the same epidemiology is segmented further. The Chronic Spontaneous Urticaria Market report proffers epidemiological analysis for the study period 2019-32 in the 7MM segmented into:
- Chronic Spontaneous Urticaria Prevalence
- Age-Specific Chronic Spontaneous Urticaria Prevalence
- Gender-Specific Chronic Spontaneous Urticaria Prevalence
- Diagnosed and Treatable Cases of Chronic Spontaneous Urticaria
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Chronic Spontaneous Urticaria Treatment Market
The Chronic Spontaneous Urticaria market outlook of the report helps to build a detailed comprehension of the historic, current, and forecasted Chronic Spontaneous Urticaria market trends by analyzing the impact of current Chronic Spontaneous Urticaria therapies on the market, unmet needs, drivers and barriers, and demand for better technology.
This segment gives a thorough detail of 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.
Chronic Spontaneous Urticaria Therapy Assessment
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 naïve 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.
Chronic Spontaneous Urticaria Key Companies
- Sanofi, Regeneron
- AstraZeneca
- Kyowa Hakko Kirin
- Allakos
- BioWa
- Amgen
- Taiho Pharmaceutical
- Celldex Therapeutics
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Scope of the Chronic Spontaneous Urticaria Market Report:
- 11 Years Forecast
- 7MM Coverage
- Descriptive overview of Chronic Spontaneous Urticaria, causes, signs and symptoms, diagnosis, treatment
- Comprehensive insight into Chronic Spontaneous Urticaria epidemiology in the 7MM
- Chronic Spontaneous Urticaria marketed and emerging therapies
- Chronic Spontaneous Urticaria companies
- Chronic Spontaneous Urticaria market drivers and barriers
Key Questions Answered in the Chronic Spontaneous Urticaria Market Report 2032:
- What was the Chronic Spontaneous Urticaria market share distribution in 2019, and how would it appear in 2032?
- What is the total Chronic Spontaneous Urticaria market size and the market size by therapy across the 7MM for the study period (2019-32)?
- What are the important findings from 7MM, and which country will have the greatest Chronic Spontaneous Urticaria market size from 2019-32?
- During the study period (2019-2032), at what CAGR is the Chronic Spontaneous Urticaria market projected to expand at 7MM?
Table of Contents:
1 Chronic Spontaneous Urticaria Market Key Comprehensive Insights
2 Chronic Spontaneous Urticaria Market Report Introduction
3 Competitive Intelligence Analysis for Chronic Spontaneous Urticaria
4 Chronic Spontaneous Urticaria Market Analysis Overview at a Glance
5 Executive Summary of Chronic Spontaneous Urticaria
6 Chronic Spontaneous Urticaria Epidemiology and Market Methodology
7 Chronic Spontaneous Urticaria Epidemiology and Patient Population
8 Chronic Spontaneous Urticaria Patient Journey
9 Chronic Spontaneous Urticaria Treatment Algorithm, Chronic Spontaneous Urticaria Current Treatment, and Medical Practices
10 Key Endpoints in Chronic Spontaneous Urticaria Clinical Trials
11 Chronic Spontaneous Urticaria Marketed Therapies
12 Chronic Spontaneous Urticaria Emerging Therapies
13 Chronic Spontaneous Urticaria: 7 Major Market Analysis
14 Attribute analysis
15 Access and Reimbursement Overview of Chronic Spontaneous Urticaria
16 Chronic Spontaneous Urticaria Market Key Opinion Leaders Reviews
18 Chronic Spontaneous Urticaria Market Drivers
19 Chronic Spontaneous Urticaria Market Barriers
20 SWOT Analysis
21 Disclaimer
22 DelveInsight Capabilities
23 About DelveInsight
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