Summary

Overview
Global chronic spontaneous urticaria treatment market reached US$ YY million in 2022 and is expected to reach US$ YY million by 2030, growing at a CAGR of YY% during the forecast period 2023-2030.
Chronic spontaneous urticaria also known as chronic idiopathic urticaria, is defined by the presence of hives on most days of the week, for a duration of six weeks or longer. Associated angioedema occurs in about 40 percent of patients. Standard management of CSU primarily involves second-generation H1 antihistamines, often at higher than usual doses and in combination with H2 antihistamines and leukotriene modifiers. Short courses of systemic glucocorticoids to control severe exacerbations may be needed.
Moreover, there is no cure for this condition, but antihistamines are known to relieve itching and reduce or prevent allergic reactions. A monthly injection of a drug called omalizumab (Xolair) blocks the body’s production of immunoglobin E (IgE). Corticosteroids like prednisone (Deltasone, Rayos) can ease symptoms that don’t respond to allergy medicines. Cyclosporine immunosuppressant is highly effective at clearing up severe chronic hives. Many other drugs is also used for symptomatic relief from chronic spontaneous urticaria.
Market Dynamics: Drivers
Increasing demand for novel drugs
The increasing demand for novel drugs for the treatment of chronic spontaneous urticaria is expected to hold the largest market share over the forecast period. The novel drugs aim to address the unmet needs providing alternative or complementary drugs for better disease management. The regulatory approvals increase the trust in patients about the development of novel drugs.
For instance, on March 7, 2023, Regeneron Pharmaceuticals, Inc. and Sanofi cleared that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the current standard of care, H1 antihistamine treatment.
Moreover, many clinical trials are going on for the development of novel drugs that show better results in chronic spontaneous urticaria treatment. For instance, on December 20, 2021, Novartis released the top-line results from PEARL 1 and PEARL 2 Phase III studies in chronic spontaneous urticaria (CSU), which showed that the studies met their primary endpoints of superiority for ligelizumab versus placebo at Week 12.
Additionally, on August 09, 2023, Novartis released the positive top-line results from the Phase III REMIX-1 and REMIX-2 studies evaluating remibrutinib 25 mg b.i.d., a Bruton’s tyrosine kinase (BTK) inhibitor, in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines.
Furthermore, ongoing research and development efforts may lead to the discovery of novel therapeutic targets and the development of innovative drugs. Pharmaceutical companies that invest in such research may benefit from a growing market demand for these novel treatments.
In addition, the increasing prevalence of chronic spontaneous urticaria, rising FDA approvals, increasing clinical trials, increasing development of novel drugs and therapies and technological advancements in the treatment options are the factors expected to drive the market over the forecast period.
Restraints
Factors such as complications associated with the high doses of corticosteroids and other drugs, the high cost of the treatment of inflammatory myositis and lack of better treatment for the treatment are expected to hamper the market.
Segment Analysis
The global chronic spontaneous urticaria treatment market is segmented based on treatment type, route of administration, distribution channel and region.
The antihistamines segment accounted for approximately 46.3% of the chronic spontaneous urticaria treatment market share
The antihistamines segment is expected to hold the largest market share over the forecast period. Usually, there is no cure for chronic spontaneous urticaria, but antihistamines are considered first-line therapeutics for the symptomatic management of this condition. Antihistamines such as cetirizine, loratadine, fexofenadine, desloratadine, levocetirizine, rupatadine, blexten and bilastine are most commonly used. Due to the rising prevalence, the demand for the use of antihistamines is continuously increasing.
For instance, on March 01, 2022, Aralez Pharmaceuticals Canada Inc. launched Blexten for pediatric use in patients 4 years of age and older. Blexten is a second-generation antihistamine drug for chronic spontaneous urticaria. Blexten (bilastine ) is indicated for the symptomatic relief of chronic spontaneous urticaria (e.g. pruritus and hives) in patients 4 years of age and older with a body weight of at least 16 kg.
Further, in cases where symptoms are not adequately controlled with antihistamines alone, physicians may consider combining antihistamines with other medications, such as leukotriene receptor antagonists, corticosteroids, or immunosuppressants for better management of the condition. Antihistamines are often used as long-term therapy. In addition, their wide adoption also increases the demand for antihistamines.
Geographical Analysis
North America accounted for approximately 40.3% of the market share
North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and increasing R&D activities. North America especially the United States is known for its strong presence of major players such as pharmaceutical companies and biotechnology companies. The presence of major players actively performing in clinical trials, leads to the launch of novel therapeutics and alternative treatment options.
For instance, on July 11, 2023, Celldex Therapeutics, Inc. released that patient enrollment had been completed in the Company’s Phase 2 clinical study of barzolvolimab for the treatment of chronic spontaneous urticaria (CSU). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of the mast cell.
Furthermore, increasing R&D activities also help to develop more advanced therapeutics for the better management of the symptoms in the early stages. As the research activities increase, the therapeutics are developed more precisely by reducing the adverse effects and complications associated with the therapeutics, which results in better patient outcomes.
Competitive Landscape
The major global players in the chronic spontaneous urticaria treatment market include F. Hoffmann-La Roche Ltd, Sanofi SA, Novartis AG, Bayer AG, Dr. Reddy’s Laboratories Ltd, STL Pharma Pvt. Ltd., Regeneron Pharmaceuticals Inc., Genentech, Inc., Jubilant Cadista Pharmaceuticals Inc. and Horizon Therapeutics plc among others.
Key Developments
• On October 18, 2022, Sanofi-aventis U.S. released the U.S. Food and Drug Administration approval of Allegra (fexofenadine hydrochloride) oral suspension for the twice-daily treatment of symptoms associated with seasonal allergies in pediatric patients, 2 to 11 years of age, and for the treatment of chronic idiopathic urticaria in children 6 months to 11 years of age. This approval makes available a safe and effective seasonal allergy and urticaria treatment option.
• On February 2, 2023, Amgen and AstraZeneca released that the U.S. Food and Drug Administration (FDA) approved TEZSPIRE (tezepelumab-ekko) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma and chronic urticaria. TEZSPIRE is also in development for other potential indications including chronic obstructive pulmonary disease and chronic spontaneous urticaria.
COVID-19 Impact Analysis
The COVID-19 pandemic significantly impacted the global chronic spontaneous urticaria treatment market. During the peak of the pandemic, healthcare resources were often redirected to manage COVID-19 cases. Non-urgent medical visits and elective procedures were postponed, which might have influenced the diagnosis and management of chronic conditions like chronic spontaneous urticaria.
The pandemic created unprecedented challenges by temporarily disrupting many clinical trials and research activities due to the redirected focus on the COVID-19 pandemic. The pandemic also disrupted the supply chain of these treatment drugs globally.
Market Segmentation
By Treatment Type
• Antihistamines
• Omalizumab (Xolair)
• Corticosteroids
• Hydroxychloroquine (Plaquenil)
• Cyclosporine
• Leukotriene Modifiers
• Others
By Route of Administration
• Oral
• Topical
• Intravenous
• Others
By Distribution Channel
• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies
By Region
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o U.K.
o France
o Spain
o Italy
o Rest of Europe
• South America
o Brazil
o Argentina
o Rest of South America
• Asia-Pacific
o China
o India
o Japan
o Australia
o Rest of Asia-Pacific
• Middle East and Africa
Why Purchase the Report?
• To visualize the global chronic spontaneous urticaria treatment market segmentation based on treatment type, route of administration, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of chronic spontaneous urticaria treatment market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.
The global chronic spontaneous urticaria treatment market report would provide approximately 61 tables, 61 figures, and 187 Pages.
Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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