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Chronic Spontaneous Urticaria Market Assessment, By Treatment, By Diagnosis, By Route of Administration, By End-user, By Region, Opportunities and Forecast, 2017-2031F

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  • F. Hoffmann-La Roche Ltd.
  • Teva Pharmaceutical Industries Ltd.
  • Sanofi S.A.
  • Pfizer Inc.
  • GlaxoSmithKline plc
  • Novartis AG
  • Bayer AG
  • Eli Lilly and Company
  • Merck & Co., Inc.
  • AstraZeneca plc

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ksm 24.03.25

The chronic spontaneous urticaria market is projected to witness a CAGR of 11.93% during the forecast period 2024-2031, growing from USD 2.01 billion in 2023 to USD 4.95 billion in 2031. Various factors are shaping the global chronic spontaneous urticaria market such as the increasing prevalence of chronic spontaneous urticaria, significant investments in research and development, availability of suitable medications for treatment, clinical advantages of subcutaneous drugs, and increasing number of clinical trials. The global chronic spontaneous urticaria market, which is defined by recurring hives and angioedema without known triggers, is expanding significantly due to breakthrough discoveries and a better comprehension of the illness.

The creation of more potent treatments is being fueled by a more thorough investigation of the fundamental mechanisms of CSU. New therapeutic options are being discovered and introduced in the market through increased research and development funding from pharmaceutical companies and healthcare providers. Improved knowledge of the pathophysiology of CSU is leading to more effective tailored medicines that provide better symptom alleviation than conventional approaches. The global chronic spontaneous urticaria market is affected by the ability to administer medications subcutaneously. The method is highly effective as it allows complete absorption of the drug without affecting patient's peripheral system and no chances of injury to the vessels and nerves.

Novartis reported positive top-line data in August 2023 from the Phase III REMIX-1 and REMIX-2 studies assessing the BTK inhibitor remibrutinib 25 mg b.i.d. in patients with chronic spontaneous urticaria (CSU). Remibrutinib, if authorized, could be the first medication in a decade to treat chronic spontaneous urticaria (CSU), providing a straightforward and efficient alternative for 60% of patients for whom H1-antihistamines are ineffective.

Significant Investments for Expediting Research and Development

The growth of global chronic spontaneous urticaria market is being driven by a constant focus on research and development activities by pharmaceutical companies. Major companies in the market are spending huge amounts in conducting research activities to find innovative solutions for treating patients with CSU. Through research, companies can discover various insights into the factors revolving around the treatment of the disease. All these factors indicate that there is a strong association between the research efforts and the increasing growth trajectory of the global chronic spontaneous urticaria market. In January 2024, Enanta Pharmaceuticals, a clinical-stage biotechnology company, provided updates on its research and development programs and the outlook for the year 2024, at the 42nd Annual J.P. Morgan healthcare conference. The company announced its expansion into immunology and discovery programs to treat CSU.

Significant Investments for Improving Healthcare Infrastructure

Noticing the increasing need for efficient CSU therapies, major players in the global chronic spontaneous urticaria market are stepping up their efforts to improve healthcare infrastructure through investments. The calculated action is motivated by the rising incidence of CSU, a disorder marked by swelling and hives that develop suddenly and have no apparent reason. These businesses hope to create and offer novel, more potent treatment alternatives by investing more money in the healthcare infrastructure. In addition to demonstrating their dedication to meet the unmet needs of CSU patients, the investment shows the market has the potential to develop significantly due to better treatments resulting in favorable patient outcomes and a rise in demand for cutting-edge therapies.

Many companies in the global chronic spontaneous urticaria market are increasing their investments in the market. For instance, in April 2023, Evommune, Inc. announced the completion of USD 50 million Series B financing to develop new innovative technologies to treat inflammatory diseases such as CSU. Along with current investors EQT Life Sciences and SymBiosis, new investor Arix Bioscience led the funding.

Availability of Novel Medications for Treatment

The development and accessibility of therapeutic alternatives, such as immunosuppressants, biologic therapies, and antihistamines, are the main factors driving the global chronic spontaneous urticaria market. These medications are highly effective due to which their demand in the market is increasing drastically. Medical research advancements have led to the development of many such medications, with more under clinical trials. Second-line drugs like leukotriene receptor antagonists (like montelukast), oral corticosteroids (like prednisone), H2 blockers (like cimetidine), and biologics (like omalizumab; Xolair) may be prescribed to treat patients with refractory symptoms. In January 2024, Evommune, Inc., a clinical-stage biotechnology company, announced the beginning of its human study for Phase 1, to find out EVO756 in adults with CSU. If the trial turns out to be successful, then EVO756 can be the first oral treatment for several diseases such as CSU and inflammatory itch.

Clinical Advantages of Subcutaneous Drugs

Subcutaneous drugs absorb easily without any side effects. Subcutaneous drugs offer numerous clinical benefits such as patient convenience, reduced cost, fewer side effects, enhanced patient satisfaction, and improved drug absorption. With less frequent doses and consistent medication absorption, it can potentially minimize the need for hospital visits and increase patient compliance by enabling self-administration at home. Subcutaneous drugs are highly effective offering a reliable treatment for CSU. Home administration eliminates the need for expensive hospital visits and decreases the demand for medical personnel, resulting in lower healthcare expenses. Compared to intravenous administration, subcutaneous administration often leads to fewer adverse events, particularly those related to infusions, such as infections and hypersensitivity reactions.

On February 16, 2024, Genentech, a member of Roche Group, announced Xolair for the treatment of anaphylaxis and allergic reactions caused due to food allergies in children and adults. It received approval from the U.S. Food and Drug Administration (FDA) and has been cleared for use of treating CSU.

Asia-Pacific to Grow at the Fastest Rate During the Forecast Period

Several countries in Asia-Pacific are going to observe rapid growth in the global chronic spontaneous urticaria market. Economic growth in countries like China and India is going to play a major role in market expansion along with the countries such as China, Japan, India, Australia, and South Korea. The trend can be attributed to the region's increasing population growth, government initiatives, and improving healthcare infrastructure. People are becoming more aware of the illness and its implications, which increases the demand for effective therapies. Additionally, by giving patients more treatment options, the emergence of new pharmaceutical businesses in the market with a focus on cutting-edge CSU therapy promotes market expansion.

On 16 February 2024, Dupixent, a drug used for the treatment of CSU, jointly developed by Sanofi and Regeneron, was granted permission for manufacturing and marketing by the Ministry of Health, Labour and Welfare (MHLW) in Japan.

Future Market Scenario (2024 - 2031F)

To handle the complexity of CSU, businesses are actively seeking novel solutions. For example, Amalizumab, a monoclonal antibody that targets immunoglobulin E (IgE), was developed and is now authorized for use in CSU.

It is anticipated that the creation of novel diagnostic instruments and methodologies will enhance the precision and promptness of CSU diagnosis, resulting in improved patient outcomes. For instance, blood and skin prick tests can be used to determine the underlying cause of CSU, which enables doctors to adjust treatment regimens accordingly.

Advancement in treatment options like targeted therapies and biologics will lead to the expansion of the global spontaneous urticaria market.

Patients are more likely to receive access to cutting-edge CSU medicines and treatments as global healthcare spending rises.

Key Players Landscape and Outlook

The chronic spontaneous urticaria market is expected to experience significant growth in the coming years, driven by factors such as increasing prevalence of urticaria, rising healthcare spending, and technological advancements in medicine and digital health. The market is highly competitive, with key players including Roche, Novartis, Sanofi, AstraZeneca, and GlaxoSmithKline, and others. The global chronic spontaneous urticaria market is witnessing a significant shift towards strategic partnerships among leading companies in the industry. By working together, these organizations can overcome technical and clinical barriers that would otherwise prevent them from moving forward independently.

A Complete Response Letter (CRL) for the supplementary Biologics Licence Application for Dupixent was made available by the U.S. FDA in October 2023. A medication called Dupixent used to treat CSU, is being developed in collaboration with the American biotechnology company Regeneron and Sanofi.

Table of Contents

1.Research Methodology

2.Project Scope & Definitions

3.Executive Summary

4.Global Chronic Spontaneous Urticaria Market Outlook, 2017-2031F

  • 4.1.Market Size & Forecast
    • 4.1.1.By Value
    • 4.1.2.By Volume
  • 4.2.By Treatment
    • 4.2.1.Medication
    • 4.2.2.Plasmapheresis
    • 4.2.3.Phototherapy
    • 4.2.4.Others
  • 4.3.By Diagnosis
    • 4.3.1.Blood Test
    • 4.3.2.Allergy Test
    • 4.3.3.Physical Examination
    • 4.3.4.Others
  • 4.4.By Route of Administration
    • 4.4.1.Oral
    • 4.4.2.Topical
    • 4.4.3.Parenteral
    • 4.4.4.Others
  • 4.5.By End-user
    • 4.5.1.Hospitals
    • 4.5.2.Specialty Clinics
    • 4.5.3.Homecare
    • 4.5.4.Others
  • 4.6.By Region
    • 4.6.1.North America
    • 4.6.2.Europe
    • 4.6.3.Asia-Pacific
    • 4.6.4.South America
    • 4.6.5.Middle East and Africa
  • 4.7.By Company Market Share (%), 2023

5.Global Chronic Spontaneous Urticaria Market Outlook, By Region, 2017-2031F

  • 5.1.North America*
    • 5.1.1.Market Size & Forecast
      • 5.1.1.1.By Value
      • 5.1.1.2.By Volume
    • 5.1.2.By Treatment
      • 5.1.2.1.Medication
      • 5.1.2.2.Plasmapheresis
      • 5.1.2.3.Phototherapy
      • 5.1.2.4.Others
    • 5.1.3.By Diagnosis
      • 5.1.3.1.Blood Test
      • 5.1.3.2.Allergy Test
      • 5.1.3.3.Physical Examination
      • 5.1.3.4.Others
    • 5.1.4.By Route of Administration
      • 5.1.4.1.Oral
      • 5.1.4.2.Topical
      • 5.1.4.3.Parenteral
      • 5.1.4.4.Others
    • 5.1.5.By End-user
      • 5.1.5.1.Hospitals
      • 5.1.5.2.Specialty Clinics
      • 5.1.5.3.Homecare
      • 5.1.5.4.Others
    • 5.1.6.United States*
      • 5.1.6.1.Market Size & Forecast
      • 5.1.6.1.1.By Value
      • 5.1.6.1.2.By Volume
      • 5.1.6.2.By Treatment
      • 5.1.6.2.1.Medication
      • 5.1.6.2.2.Plasmapheresis
      • 5.1.6.2.3.Phototherapy
      • 5.1.6.2.4.Others
      • 5.1.6.3.By Diagnosis
      • 5.1.6.3.1.Blood Test
      • 5.1.6.3.2.Allergy Test
      • 5.1.6.3.3.Physical Examination
      • 5.1.6.3.4.Others
      • 5.1.6.4.By Route of Administration
      • 5.1.6.4.1.Oral
      • 5.1.6.4.2.Topical
      • 5.1.6.4.3.Parenteral
      • 5.1.6.4.4.Others
      • 5.1.6.5.By End-user
      • 5.1.6.5.1.Hospitals
      • 5.1.6.5.2.Specialty Clinics
      • 5.1.6.5.3.Homecare
      • 5.1.6.5.4.Others
    • 5.1.7.Canada
    • 5.1.8.Mexico

All segments will be provided for all regions and countries covered

  • 5.2.Europe
    • 5.2.1.Germany
    • 5.2.2.France
    • 5.2.3.Italy
    • 5.2.4.United Kingdom
    • 5.2.5.Russia
    • 5.2.6.Netherlands
    • 5.2.7.Spain
    • 5.2.8.Turkey
    • 5.2.9.Poland
  • 5.3.Asia-Pacific
    • 5.3.1.India
    • 5.3.2.China
    • 5.3.3.Japan
    • 5.3.4.Australia
    • 5.3.5.Vietnam
    • 5.3.6.South Korea
    • 5.3.7.Indonesia
    • 5.3.8.Philippines
  • 5.4.South America
    • 5.4.1.Brazil
    • 5.4.2.Argentina
  • 5.5.Middle East & Africa
    • 5.5.1.Saudi Arabia
    • 5.5.2.UAE
    • 5.5.3.South Africa

6.Market Mapping, 2023

  • 6.1.By Treatment
  • 6.2.By Diagnosis
  • 6.3.By Route of Administration
  • 6.4.By End-user
  • 6.5.By Region

7.Macro Environment and Industry Structure

  • 7.1.Demand Supply Analysis
  • 7.2.Import Export Analysis
  • 7.3.Value Chain Analysis
  • 7.4.PESTEL Analysis
    • 7.4.1.Political Factors
    • 7.4.2.Economic System
    • 7.4.3.Social Implications
    • 7.4.4.Technological Advancements
    • 7.4.5.Environmental Impacts
    • 7.4.6.Legal Compliances and Regulatory Policies (Statutory Bodies Included)
  • 7.5.Porter's Five Forces Analysis
    • 7.5.1.Supplier Power
    • 7.5.2.Buyer Power
    • 7.5.3.Substitution Threat
    • 7.5.4.Threat from New Entrant
    • 7.5.5.Competitive Rivalry

8.Market Dynamics

  • 8.1.Growth Drivers
  • 8.2.Growth Inhibitors (Challenges and Restraints)

9.Regulatory Framework and Innovation

  • 9.1.Clinical Trials
  • 9.2.Patent Landscape
  • 9.3.Regulatory Approvals
  • 9.4.Innovations/Emerging Technologies

10.Key Players Landscape

  • 10.1.Competition Matrix of Top Five Market Leaders
  • 10.2.Market Revenue Analysis of Top Five Market Leaders (in %, 2023)
  • 10.3.Mergers and Acquisitions/Joint Ventures (If Applicable)
  • 10.4.SWOT Analysis (For Five Market Players)
  • 10.5.Patent Analysis (If Applicable)

11.Pricing Analysis

12.Case Studies

13.Key Players Outlook

  • 13.1.F. Hoffmann-La Roche Ltd.
    • 13.1.1.Company Details
    • 13.1.2.Key Management Personnel
    • 13.1.3.Products & Services
    • 13.1.4.Financials (As reported)
    • 13.1.5.Key Market Focus & Geographical Presence
    • 13.1.6.Recent Developments
  • 13.2.Teva Pharmaceutical Industries Ltd.
  • 13.3.Sanofi S.A.
  • 13.4.Pfizer Inc.
  • 13.5.GlaxoSmithKline plc
  • 13.6.Novartis AG
  • 13.7.Bayer AG
  • 13.8.Eli Lilly and Company
  • 13.9.Merck & Co., Inc.
  • 13.10.AstraZeneca plc

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

14.Strategic Recommendations

15.About Us & Disclaimer

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