Market Lifecycle Stage
The global spontaneous urticaria market is currently in the growth stage. This phase is driven by the increasing prevalence of chronic spontaneous urticaria, which affects a significant portion of the global population. The market is experiencing expansion due to the introduction of innovative biologic therapies, such as omalizumab, that target the underlying immune mechanisms of spontaneous urticaria, offering more effective treatment options than traditional antihistamines. Additionally, the growing awareness of spontaneous urticaria, coupled with advancements in early diagnosis and patient management, is further fueling market growth. While there are still challenges, such as high treatment costs and limited access in certain regions, the expanding pipeline of new therapies and the increasing demand for targeted treatments indicate that the market will continue to grow in the coming years, eventually moving towards the maturity phase as these therapies become more widely accessible and established.
Impact
Increasing demand for chronic spontaneous urticaria therapies is anticipated to support the growth of the global chronic spontaneous urticaria market during the forecast period 2025-2035.
The global chronic spontaneous urticaria market is expected to grow at a significant rate due to advancements in diagnostic technologies, the development of innovative therapies, and increasing awareness among patients and healthcare providers.
Market Segmentation:
Segmentation 1: by Region
North America
Europe
Asia-Pacific
Rest-of-the-World
North America is expected to dominate the global chronic spontaneous urticaria market during the forecast period due to its advanced healthcare infrastructure, high prevalence, and increased awareness of the disease. The region also benefits from regulatory advantages and a strong pharmaceutical presence, which accelerates the availability of effective treatments and drives the growth of the global chronic spontaneous urticaria market.
Recent Developments
Acquisition: In March 2025, Novartis acquired the rights to Kyorin’s chronic spontaneous urticaria (CSU) candidate, KRP-M223, in a deal valued at $830 million. The agreement granted Novartis an exclusive worldwide license to develop, manufacture, and commercialize KRP-M223, an MRGPRX2 antagonist targeting CSU and other allergic and inflammatory diseases involving mast cells.
Regulatory Activities: In April 2025, Sanofi and Regeneron Pharma received approval from the U.S. FDA for Dupixent (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remained symptomatic despite histamine-1 (H1) antihistamine treatment.
Demand – Drivers and Limitations
The following are the drivers for the global chronic spontaneous urticaria market:
Rising Prevalence of Chronic Spontaneous Urticaria
Continuous Advancements in Treatment Options
Growing Awareness and Screening Initiatives
The global chronic spontaneous urticaria market is expected to face some limitations, too, due to the following challenges:
High Treatment Costs
Limited Access to Treatments in Developing Regions
How Can This Report Add Value to an Organization?
Product/Innovation Strategy:Product launches and innovations in the global chronic spontaneous urticaria market are focused on advancing treatment options to improve patient care. These innovations aim to enhance the efficacy of therapies and streamline the detection and management of the disease. Key players in the market, such as Novartis, Sanofi, and Regeneron Pharma, have been involved in the development of therapies for chronic spontaneous urticaria.
Competitive Strategy:Enterprises led by market leaders in the global chronic spontaneous urticaria market are continuously working on updating their product portfolios with innovative treatments to maintain competitiveness. A detailed competitive benchmarking of the key players has been conducted, providing insights into how these companies compare in terms of product offerings, market share, and innovation. This benchmarking provides readers with a clear understanding of the market landscape and the positions of the leading players. Additionally, comprehensive competitive strategies, such as partnerships, agreements, and collaborations, will help readers identify untapped revenue opportunities in the market.
Key Market Players and Competition Synopsis
The companies that are profiled have been selected based on inputs gathered from primary experts and by analyzing company coverage, product portfolio, and market penetration.
Some of the prominent names established in this market are:
Allakos
Amgen
AstraZeneca
Celldex
Evommune, Inc.
Incyte Corporation
Jasper Therapeutics, Inc.
Longbio Pharma (Suzhou) Co., Ltd
Mabpharm Limited
Novartis Pharmaceuticals
Sanofi
Taiho Pharmaceutical
United BioPharma
Blueprint Medicines Corporation
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- Executive Summary
- Scope of Study
- 1. Global Chronic Spontaneous Urticaria Market: Market Outlook
- 1.1 Industry Outlook
- 1.1.1 Market Overview and Ecosystem
- 1.1.2 Epidemiological Analysis of Chronic Spontaneous Urticaria
- 1.1.3 Clinical Trials
- 1.1.4 Key Trends
- 1.1.5 Regulatory Landscape / Compliance
- 1.1.5.1 Legal Requirement and Framework in the U.S.
- 1.1.5.2 Legal Requirement and Framework in the E.U.
- 1.1.5.3 Legal Requirement and Framework in Asia-Pacific
- 1.1.5.4 Legal Requirement and Framework in Rest-of-the-World
- 1.2 Market Dynamics
- 1.2.1 Market Drivers
- 1.2.1.1 Impact Analysis
- 1.2.2 Market Restraints
- 1.2.2.1 Impact Analysis
- 1.2.3 Market Opportunities
- 2. Global Chronic Spontaneous Urticaria Market (By Region), $Million, 2023-2035
- 2.1 North America
- 2.1.1 Market Dynamics
- 2.1.2 Market Sizing and Forecast
- 2.1.2.1 North America Chronic Spontaneous Urticaria Market (by Country)
- 2.1.2.1.1 U.S.
- 2.1.2.1.2 Canada
- 2.2 Europe
- 2.2.1 Market Dynamics
- 2.2.2 Market Sizing and Forecast
- 2.2.2.1 Europe Chronic Spontaneous Urticaria Market (by Country)
- 2.2.2.1.1 U.K.
- 2.2.2.1.2 Germany
- 2.2.2.1.3 France
- 2.2.2.1.4 Italy
- 2.2.2.1.5 Spain
- 2.2.2.1.6 Rest-of-Europe
- 2.3 Asia-Pacific
- 2.3.1 Market Dynamics
- 2.3.2 Market Sizing and Forecast
- 2.3.2.1 Asia-Pacific Chronic Spontaneous Urticaria Market (by Country)
- 2.3.2.1.1 Japan
- 2.3.2.1.2 China
- 2.3.2.1.3 India
- 2.3.2.1.4 Australia
- 2.3.2.1.5 South Korea
- 2.3.2.1.6 Rest-of-Asia-Pacific
- 2.4 Rest-of-the-World
- 2.4.1 Market Dynamics
- 2.4.2 Market Size and Forecast
- 3. Global Chronic Spontaneous Urticaria Market - Competitive Benchmarking and Company Profile
- 3.1 Competitive Benchmarking
- 3.2 Competitive Landscape
- 3.2.1 Key Strategies and Developments by Company
- 3.2.1.1 Funding Activities
- 3.2.1.2 Mergers and Acquisitions
- 3.2.1.3 Regulatory Approvals
- 3.2.1.4 Partnerships, Collaborations and Business Expansions
- 3.2.2 Key Developments Analysis
- 3.3 Company Profiles
- 3.3.1 Sanofi
- 3.3.1.1 Company Overview
- 3.3.1.2 Product Portfolio
- 3.3.1.3 Target Customers/End Users
- 3.3.1.4 Analyst View
- 3.3.2 AstraZeneca
- 3.3.2.1 Company Overview
- 3.3.2.2 Product Portfolio
- 3.3.2.3 Target Customers/End Users
- 3.3.2.4 Analyst View
- 3.3.3 Allakos
- 3.3.3.1 Company Overview
- 3.3.3.2 Product Portfolio
- 3.3.3.3 Target Customers/End Users
- 3.3.3.4 Analyst View
- 3.3.4 Celldex
- 3.3.4.1 Company Overview
- 3.3.4.2 Product Portfolio
- 3.3.4.3 Target Customers/End Users
- 3.3.4.4 Analyst View
- 3.3.5 Amgen
- 3.3.5.1 Company Overview
- 3.3.5.2 Product Portfolio
- 3.3.5.3 Target Customers/End Users
- 3.3.5.4 Analyst View
- 3.3.6 Taiho Pharmaceutical
- 3.3.6.1 Company Overview
- 3.3.6.2 Product Portfolio
- 3.3.6.3 Target Customers/End Users
- 3.3.6.4 Analyst View
- 3.3.7 Novartis Pharmaceuticals
- 3.3.7.1 Company Overview
- 3.3.7.2 Product Portfolio
- 3.3.7.3 Target Customers/End Users
- 3.3.7.4 Analyst View
- 3.3.8 Evommune, Inc.
- 3.3.8.1 Company Overview
- 3.3.8.2 Product Portfolio
- 3.3.8.3 Target Customers/End Users
- 3.3.8.4 Analyst View
- 3.3.9 Mabpharm Limited
- 3.3.9.1 Company Overview
- 3.3.9.2 Product Portfolio
- 3.3.9.3 Target Customers/End Users
- 3.3.9.4 Analyst View
- 3.3.10 Jasper Therapeutics, Inc.
- 3.3.10.1 Company Overview
- 3.3.10.2 Product Portfolio
- 3.3.10.3 Target Customers/End Users
- 3.3.10.4 Analyst View
- 3.3.11 Blueprint Medicines Corporation
- 3.3.11.1 Company Overview
- 3.3.11.2 Product Portfolio
- 3.3.11.3 Target Customers/End Users
- 3.3.11.4 Analyst View
- 3.3.12 Longbio Pharma (Suzhou) Co., Ltd.
- 3.3.12.1 Company Overview
- 3.3.12.2 Product Portfolio
- 3.3.12.3 Target Customers/End Users
- 3.3.12.4 Analyst View
- 3.3.13 United BioPharma
- 3.3.13.1 Company Overview
- 3.3.13.2 Product Portfolio
- 3.3.13.3 Target Customers/End Users
- 3.3.13.4 Analyst View
- 3.3.14 Incyte Corporation
- 3.3.14.1 Company Overview
- 3.3.14.2 Product Portfolio
- 3.3.14.3 Target Customers/End Users
- 3.3.14.4 Analyst View
- 4. Research Methodology
- List of Figures
- Figure: Global Chronic Spontaneous Urticaria Market, Market Overview
- Figure: Global Chronic Spontaneous Urticaria Market, Epidemiological Analysis, U.S.
- Figure: Global Chronic Spontaneous Urticaria Market, Epidemiological Analysis, EU5
- Figure: Global Chronic Spontaneous Urticaria Market, Epidemiological Analysis, Rest-of-the-World
- Figure: Global Chronic Spontaneous Urticaria Market, Epidemiological Analysis, by Age Group
- Figure: Global Chronic Spontaneous Urticaria Market Coverage
- Figure: Global Chronic Spontaneous Urticaria Market Key Trends, Impact Analysis, 2023-2035
- Figure: Global Chronic Spontaneous Urticaria Market, Competitive Landscape, January 2022-April 2025
- List of Tables
- Table: Global Chronic Spontaneous Urticaria Market, Regulatory Scenario
- Table: Global Chronic Spontaneous Urticaria Market Dynamics, Impact Analysis
- Table: Global Chronic Spontaneous Urticaria Market (by Region), $Million, 2023-2035
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