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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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Table of Contents
Executive Summary
Scope of Study
Companies Mentioned
- Sanofi
- AstraZeneca
- Allakos
- Celldex
- Amgen
- Taiho Pharmaceutical
- Novartis Pharmaceuticals
- Evommune, Inc.
- Mabpharm Limited
- Jasper Therapeutics, Inc.
- Blueprint Medicines Corporation
- Longbio Pharma (Suzhou) Co., Ltd.
- United BioPharma
- Incyte Corporation
