만성 특발성 두드러기 시장 - 시장 인사이트, 역학, 시장 예측(2034년)

Key Highlights:

• According to DelveInsight's analysis, the Chronic Spontaneous Urticaria Market Size in the 7MM was valued at approximately USD 2,173.3 million in 2023. Over the forecast period from 2024 to 2034, this market is projected to grow at a CAGR of more than 10%, driven by the introduction of innovative therapies such as remibrutinib (LOU064), TEZSPIRE (Tezepelumab), and Rilzabrutinib (SAR444671), as well as increased awareness and better diagnostic capabilities. Additionally, changes in immune system function, potentially influenced by factors such as the increased use of antibiotics.
• According to DelveInsight's estimates, in 2023, there were approximately 2.8 million Chronic Spontaneous Urticaria Diagnosed Prevalent Cases in the 7MM. Of these, the US accounted for nearly 19% of the cases, while the EU4 and the UK accounted for 44% and Japan represented 38% of the cases, respectively.
• The recent approvals of OMLYCLO (CT-P39) by the European Commission and DUPIXENT (Dupilumab) by Japan's MHLW mark a major shift in the treatment landscape, introducing cost-effective alternatives that could increase market competition and influence adoption and pricing strategies.
• Although treatments like XOLAIR (omalizumab) and DUPIXENT (dupilumab) are available, many patients still face relapses or insufficient symptom control. Higher doses of H1-antihistamines come with serious side effects, such as sedation and anticholinergic effects, and XOLAIR has a risk of anaphylaxis. This highlights the need for safer and more effective alternatives.
• The rise of biosimilars, variable disease presentations, and incomplete patient histories, along with the growing use of generics and OTC products, might pose significant challenges to both existing and new therapies, potentially hindering their effectiveness and market adoption.

DelveInsight's "Chronic Spontaneous Urticaria Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Chronic Spontaneous Urticaria, historical and forecasted epidemiology, as well as the Chronic Spontaneous Urticaria market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Chronic Spontaneous Urticaria Treatment Market Report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM chronic spontaneous urticaria market size from 2020 to 2034. The report also covers Chronic Spontaneous Urticaria Treatment Market practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Chronic Spontaneous Urticaria Treatment Market: Understanding and Algorithm

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.

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.

Chronic Spontaneous Urticaria Epidemiology

As the market is derived using a patient-based model, the Chronic Spontaneous Urticaria epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented total diagnosed prevalent cases of chronic urticaria, type-specific cases of chronic urticaria, total diagnosed prevalent cases of chronic spontaneous urticaria, age-specific cases of chronic spontaneous urticaria, gender-specific cases of chronic spontaneous urticaria, and severity-specific cases of chronic spontaneous urticaria in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• According to DelveInsight's epidemiology model, the total Chronic Spontaneous Urticaria Diagnosed Prevalent Cases were approximately 2.8 million among the 7MM in 2023 which is expected to change during the forecast period (2024-2034).
• In the US, there were approximately 521 thousand Chronic Spontaneous Urticaria Diagnosed Prevalent Cases in 2023 which was nearly 19% of the total 7MM.
• Among the EU4 and the UK, Germany had the highest Chronic Spontaneous Urticaria Diagnosed Prevalent Cases in 2023 with approximately 327 thousand cases followed by France with nearly 255 thousand cases. On the other hand, Spain accounted for the least with approximately 163 thousand cases.
• In 2023, Japan accounted for the highest Chronic Spontaneous Urticaria Diagnosed Prevalent Cases with approximately 1 million cases.
• Among the age-specific diagnosed prevalent cases of chronic spontaneous urticaria in the US, there were approximately 47 thousand, 80 thousand, 72 thousand, 81 thousand, 86 thousand, and 156 thousand cases in the age groups <18, 18-29, 30-39, 40-49, 50-59, and >=60, respectively, in 2023.
• There were approximately 391 thousand male and 839 thousand female cases of chronic spontaneous urticarial among EU4 and the UK in 2023.
• In Japan, there were approximately 46 thousand mild cases, 690 thousand moderate cases, and 326 thousand severe cases of chronic spontaneous urticaria in 2023.

Chronic Spontaneous Urticaria Drug Chapters

The drug chapter segment of the Chronic Spontaneous Urticaria therapeutics market report encloses a detailed analysis of Chronic Spontaneous Urticaria-marketed drugs and mid to late-stage (Phase III and Phase II) Chronic Spontaneous Urticaria pipeline drugs analysis. It also helps understand the Chronic Spontaneous Urticaria clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest Chronic Spontaneous Urticaria news and press releases.

Chronic Spontaneous Urticaria Marketed Drugs

• XOLAIR (omalizumab): Roche/Novartis

XOLAIR (omalizumab) is a recombinant DNA-derived humanized IgG1κ 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 (FcεRI) 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, the European Commission (EC) 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. 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.

In May 2024, the EC approved OMLYCLO (CT-P39), an omalizumab biosimilar referencing XOLAIR.

Chronic Spontaneous Urticaria Emerging Drugs

• 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.

Recently, Novartis announced new data that confirm the long-term efficacy and safety of remibrutinib in chronic spontaneous urticaria. In the pivotal Phase III studies, REMIX-1 and REMIX-2, remibrutinib treatment showed significant symptom improvement early in patients with chronic spontaneous urticaria who remained symptomatic despite second-generation H1-antihistamine use. Moreover, the company plans to plans to submit remibrutinib for regulatory approval in 2025. Data presented at European Academy of Allergy and Clinical Immunology (EAACI) 2024.

• TEZSPIRE (Tezepelumab): AstraZeneca/Amgen

TEZSPIRE (tezepelumab [AMG 157]) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of blocks thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and airway inflammation diseases. TSLP, IL-25, and IL-33 are released following different triggers on epithelia and start the Th2 inflammatory response, mediating T-cell polarization in Th2 cells. Tezepelumab with its inhibitory action of TSLP appears to prevent and treat the lesional skin of patients with chronic spontaneous urticaria.

The drug has completed a Phase II (INCEPTION) trial and posted results for the treatment of chronic spontaneous urticarial with no further updates. Moreover, TEZSPIRE is approved for treating severe asthma in the US, EU, Japan, and other countries. TEZSPIRE is also approved in the US for the add-on maintenance treatment of adult and pediatric patients aged 12 and older with severe asthma. Moreover the drug candidate is being investigated for other potential indications, including COPD, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis.

Chronic Spontaneous Urticaria Drugs Market Insights

Chronic spontaneous urticaria is a chronic condition characterized by the recurrent appearance of hives or wheals on the skin. It is a disturbing allergic condition of the skin, where symptoms persist for more than 6 weeks. 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. 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 if necessary.

Chronic Spontaneous Urticaria Market Outlook

Treatment is generally initiated with nonsedating antihistamines in the daytime and sedating antihistamines at night. H2 antihistamines are often combined with H1 to achieve better symptom control in chronic spontaneous urticaria and are added if individuals complain of indigestion or acidity. The most commonly used H2 antihistamine for chronic spontaneous urticaria is ranitidine. However, it is important to note that ranitidine has been withdrawn from many markets due to safety concerns.

Many patients, however, do not achieve symptom control, with only less than half of patients responding to H1-antihistamines at standard doses. Adverse effects such as somnolence can occur in susceptible individuals, increasing the treatment burden, despite increasing the dose.

Novartis and Genentech's XOLAIR is an 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.

However, almost one-third of patients remain symptomatic despite omalizumab, and the SC administration route further burdens the healthcare infrastructure and patients.

The current Chronic Spontaneous Urticaria Drugs Market has been segmented into different commonly used therapeutic classes based on the prevailing treatment pattern across the 7MM, which presents minor variations in the overall prescription pattern. Oral corticosteroids, prescription antihistamines, leukotriene receptor antagonists, immunosuppressive agents, XOLAIR, and others are the major drugs covered in the forecast model.

• Key Chronic Spontaneous Urticaria Companies such as Novartis Pharmaceuticals' remibrutinib (LOU064), AstraZeneca/Amgen's TEZSPIRE (tezepelumab), and Sanofi's Rilzabrutinib (SAR444671), among others, are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products to treat chronic spontaneous urticaria.
• The total Chronic Spontaneous Urticaria Treatment Market Size in the 7MM was approximately USD 2,173.3 million in 2023 and is projected to increase during the forecast period (2024-2034).
• The Chronic Spontaneous Urticaria Treatment Market Size in the US was approximately USD 1,194.7 million in 2023 and will increase at a CAGR of 9.5% during the study period driven by the increasing awareness of the disease and the launch of the emerging therapy.
• The total Chronic Spontaneous Urticaria Treatment Market Size in EU4 and the UK was calculated to be approximately USD 600 million in 2023, which was nearly 28% of the total market revenue for the 7MM.
• Among EU4 and the UK, Germany accounted for the highest Chronic Spontaneous Urticaria Treatment Market Size with approximately USD 159.3 million in 2023, followed by France with approximately USD 139.5 million in the respective year, while Spain accounted for the lowest market with nearly USD 78.1 million in 2023.
• In the US, Novartis' XOLAIR had the highest market share among all the therapies, in 2023, with a revenue of approximately USD 913 million, followed by prescription antihistamines and immunosuppressive agents, with USD 138 million and USD 123 million respectively.
• In 2023, the Chronic Spontaneous Urticaria Treatment Market Size in Japan was nearly 18.2% of the total market size in the 7MM, with a revenue of approximately USD 378.6 million.

Chronic Spontaneous Urticaria Drugs Uptake

This section focuses on the uptake rate of potential Chronic Spontaneous Urticaria drugs expected to be launched in the market during 2020-2034. For example, Novartis Pharmaceuticals' remibrutinib (LOU064), a BTK inhibitor, is expected to enter the US market by 2025 and is projected to have a slow uptake during the forecast period.

Chronic Spontaneous Urticaria Pipeline Development Activities

The Chronic Spontaneous Urticaria therapeutics market report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key Chronic Spontaneous Urticaria Companies involved in developing targeted therapeutics.

Pipeline Development Activities

The Chronic Spontaneous Urticaria therapeutics market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for Chronic Spontaneous Urticaria.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on chronic spontaneous urticaria evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University of Texas Health Science Center, Johns Hopkins University, Harvard Medical School, King's College in London, Fondation Fondamental in Creteil, and the University of Shizuoka were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or chronic spontaneous urticaria market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician's view

According to our primary research analysis, though the current treatment guideline recommends the use of second-generation H1-antihistamines (cetirizine, loratadine, fexofenadine) as the first-line pharmacological treatment, followed by up-dosing in patients with chronic spontaneous urticaria unresponsive to a standard dose and omalizumab as a second-line adjunct therapy for chronic spontaneous urticaria unresponsive to second-generation H1-antihistamines, patients are not always treated according to formal guideline recommendations. Usage of sedating first-generation H1-antihistamines, IV immunoglobulin, and long-term oral corticosteroids as primary treatments are common, and the high cost of the only approved biologic, XOLAIR, further dampens its use, despite all the benefits. Further, almost one-third of patients remain symptomatic despite using omalizumab, and the SC administration route further burdens the healthcare infrastructure and patients. H2-antagonists and dapsone though not recommended, still have relevance as they are affordable in some restricted healthcare systems.

The current Chronic Spontaneous Urticaria Pipeline, though, mostly has adjuncts to treat refractory cases, they are still novel molecules like BTK inhibitors, interleukins inhibitors, and siglec-8-directed agonists, targeting novel pathways in chronic spontaneous urticaria that have shown significant improvements in UAS7 scores with improved safety profiles in early-stage trials. There is hope that the entry of these biologics and drugs will provide options based on patient-specific needs. Further, the competition will end the monopoly and hopefully improve the accessibility of biologics, which ensures more patient compliance than OTC therapies. However, there is still a need for personalized curative monotherapies that cure the disease rather than relieve the symptoms.

Chronic Spontaneous Urticaria Drugs Market: Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.

Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Chronic Spontaneous Urticaria Therapeutics Market Access and Reimbursement

The guidelines recommend second-generation H1-antihistamine as a first-line treatment for all types of urticaria. X of second-generation H1- antihistamine up to fourfold in patients with CU unresponsive to a standard dose is recommended as a second-line treatment before other treatments are considered. The guidelines further recommend the only approved monoclonal antibody, omalizumab, for treating patients with CU unresponsive to high-dose antihistamines. Cyclosporine is used off-label and is recommended only for patients with severe disease, refractory to any dose of antihistamine and omalizumab in combination.

XOLAIR Copay Program is specific for patients who have commercial health insurance. Patients under Medicare, Medicaid, or any federal or state-level program are not eligible. The patient is enrolled in the copay program, which means that after reaching the maximum program benefit, the patient would bear all out-of-pocket costs. The patient must pay USD 5/XOLAIR out-of-pocket expenses, and the company will cover the remaining USD 10,000/12-month period. There is no income limit to avail of this program.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Chronic Spontaneous Urticaria Therapeutics Market Report Scope

• The Chronic Spontaneous Urticaria therapeutics market report covers a segment of key events, an executive summary, and a descriptive overview of chronic spontaneous urticaria, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current Chronic Spontaneous Urticaria Treatment Market Landscape.
• A detailed review of the Chronic Spontaneous Urticaria Treatment Market, historical and forecasted Chronic Spontaneous Urticaria Market Size, Chronic Spontaneous Urticaria Drugs Market Share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM chronic spontaneous urticaria market.

Chronic Spontaneous Urticaria Therapeutics Market Report Insights

• Patient-based Chronic Spontaneous Urticaria Market Forecasting
• Therapeutic Approaches
• Chronic Spontaneous Urticaria Pipeline Drugs Analysis
• Chronic spontaneous urticaria Market Size and Trends
• Existing and Future Chronic Spontaneous Urticaria Drugs Market Opportunity

Chronic Spontaneous Urticaria Therapeutics Market Report Key Strengths

• 11 years Chronic Spontaneous Urticaria Market Forecast
• The 7MM Coverage
• Chronic spontaneous urticaria Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Chronic Spontaneous Urticaria Drugs Uptake
• Key Chronic Spontaneous Urticaria Market Forecast Assumptions

Chronic Spontaneous Urticaria Therapeutics Market Report Assessment

• Current Chronic Spontaneous Urticaria Treatment Market Practices
• Chronic Spontaneous Urticaria Unmet Needs
• Chronic Spontaneous Urticaria Pipeline Drugs Profiles
• Chronic Spontaneous Urticaria Drugs Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions:

Chronic Spontaneous Urticaria Treatment Market Insights

• What was the total Chronic Spontaneous Urticaria Treatment Market Size, the Chronic Spontaneous Urticaria Market Size by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will remibrutinib (LOU064) affect the treatment paradigm of chronic spontaneous urticaria?
• How will XOLAIR (omalizumab) compete with similar-class products and off-label therapies?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Chronic Spontaneous Urticaria Epidemiology Insights

• What are the disease risks, burdens, and Chronic Spontaneous Urticaria Unmet Needs? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to chronic spontaneous urticaria?
• What is the historical and forecasted chronic spontaneous urticaria patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest diagnosed prevalent chronic spontaneous urticaria population during the forecast period (2024-2034)?
• What factors are contributing to the growth of chronic spontaneous urticaria cases?

Current Chronic Spontaneous Urticaria Treatment Market Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of chronic spontaneous urticaria? What are the current clinical and treatment guidelines for treating chronic spontaneous urticaria?
• How many companies are developing therapies for the treatment of chronic spontaneous urticaria?
• How many emerging therapies are in the mid-stage and late stage of development for treating chronic spontaneous urticaria?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted Chronic Spontaneous Urticaria Drugs Market?

Reasons to Buy:

• The Chronic Spontaneous Urticaria therapeutics market report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the chronic spontaneous urticaria drugs market.
• Insights on patient burden/disease Chronic Spontaneous Urticaria Prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing Chronic Spontaneous Urticaria Drugs Market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying upcoming solid players in the Chronic Spontaneous Urticaria Drugs Market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for chronic spontaneous urticaria, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing Chronic Spontaneous Urticaria Drugs Market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Chronic Spontaneous Urticaria Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Chronic Spontaneous Urticaria in 2020
• 3.2. Market Share (%) Distribution of Chronic Spontaneous Urticaria in 2034

4. Methodology of Chronic Spontaneous Urticaria Epidemiology and Market

5. Executive Summary of Chronic Spontaneous Urticaria

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Signs and Symptoms
• 7.3. Classification
  • 7.3.1. Classification of Urticaria Based on its Duration and the Relevance of Eliciting Factors
• 7.4. Causes
• 7.5. Etiology
• 7.6. Pathophysiology
  • 7.6.1. Role of Mast Cells
  • 7.6.2. Serum Factors
  • 7.6.3. Coagulation Cascade
  • 7.6.4. Basophils
  • 7.6.5. Eosinophils
  • 7.6.6. Lymphocytes
  • 7.6.7. Autoimmune Theory
• 7.7. Clinical Manifestation
• 7.8. Diagnosis
  • 7.8.1. Acute Urticaria Diagnosis
  • 7.8.2. Chronic Spontaneous Urticaria
  • 7.8.3. Auto-reactive Urticaria
  • 7.8.4. Wheals and Angioedema are not Always Urticaria
  • 7.8.5. Histologic Findings
• 7.9. Treatment and Management
  • 7.9.1. Nonsedating Antihistamines
  • 7.9.2. Leukotriene Receptor Antagonists
  • 7.9.3. Cyclosporine A
  • 7.9.4. Omalizumab
  • 7.9.5. Methotrexate
  • 7.9.6. Azathioprine and Mycophenolate Mofetil
  • 7.9.7. Dapsone
  • 7.9.8. Other Drugs
• 7.10. Treatment for Chronic Spontaneous Urticaria
  • 7.10.1. Treatment of Urticaria in Children
  • 7.10.2. Treatment of Urticaria During Pregnancy and Lactation
  • 7.10.3. Treatment of Angioedema
  • 7.10.4. EAACI/GA2LEN/EDF/WAO Guideline
  • 7.10.5. BSACI Guidelines for the Management of Chronic Urticaria and Angio-oedema
  • 7.10.6. Guidelines Supported by the Centre of Evidence of the French Society of Dermatology
  • 7.10.7. Treatment Algorithm
• 7.11. Management of Chronic Spontaneous Urticaria

8. Patient Journey

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale: The 7MM
  • 9.2.1. Diagnosed Prevalent Cases of Chronic Urticaria
  • 9.2.2. Type-specific Cases of Chronic Urticaria
  • 9.2.3. Age-specific Cases of Chronic Spontaneous Urticaria
  • 9.2.4. Gender-specific Cases of Chronic Spontaneous Urticaria
  • 9.2.5. Severity-specific Cases of Chronic Spontaneous Urticaria
• 9.3. Total Diagnosed Prevalent Cases of Chronic Spontaneous Urticaria in the 7MM
• 9.4. The US
  • 9.4.1. Total Diagnosed Prevalent Cases of Chronic Urticaria in the US
  • 9.4.2. Type-specific Cases of Chronic Urticaria in the US
  • 9.4.3. Gender-specific Cases of Chronic Spontaneous Urticaria in the US
  • 9.4.4. Age-specific Cases of Chronic Spontaneous Urticaria in the US
  • 9.4.5. Severity-specific Cases of Chronic Spontaneous Urticaria in the US
• 9.5. EU4 and the UK
  • 9.5.1. Total Diagnosed Prevalent Cases of Chronic Urticaria in EU4 and the UK
  • 9.5.2. Type-specific Cases of Chronic Urticaria in the EU4 and the UK
  • 9.5.3. Gender-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK
  • 9.5.4. Age-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK
  • 9.5.5. Severity-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK
• 9.6. Japan
  • 9.6.1. Total Diagnosed Prevalent Cases of Chronic Urticaria in Japan
  • 9.6.2. Type-specific Cases of Chronic Urticaria in Japan
  • 9.6.3. Gender-specific Cases of Chronic Spontaneous Urticaria in Japan
  • 9.6.4. Age-specific Cases of Chronic Spontaneous Urticaria in Japan
  • 9.6.5. Severity-specific Cases of Chronic Spontaneous Urticaria in Japan

10. Marketed Drugs

• 10.1. XOLAIR (omalizumab): Roche/Novartis
  • 10.1.1. Product Description
  • 10.1.2. Regulatory Milestones
  • 10.1.3. Other Development Activities
  • 10.1.4. Clinical Development
  • 10.1.5. Clinical Trials Information
  • 10.1.6. Safety and Efficacy
  • 10.1.7. Product Profile

11. Emerging Drugs

• 11.1. Key Cross Competition
• 11.2. Remibrutinib (LOU064): Novartis Pharmaceuticals
  • 11.2.1. Drug Description
  • 11.2.2. Clinical Development
  • 11.2.3. Clinical Trials Information
  • 11.2.4. Safety and Efficacy
  • 11.2.5. Product Profile
  • 11.2.6. Analysts' Views
• 11.3. DUPIXENT (dupilumab): Sanofi/Regeneron
  • 11.3.1. Product Description
  • 11.3.2. Other Developmental Activity
  • 11.3.3. Clinical Development
  • 11.3.4. Clinical Trials Information
  • 11.3.5. Safety and Efficacy
  • 11.3.6. Product Profile
  • 11.3.7. Analysts' Views
• 11.4. FASENRA (benralizumab): AstraZeneca/Kyowa Hakko Kirin
  • 11.4.1. Product Description
  • 11.4.2. Other Developmental Activity
  • 11.4.3. Clinical Development
  • 11.4.4. Clinical Trials Information
  • 11.4.5. Safety and Efficacy
  • 11.4.6. Product Profile
  • 11.4.7. Analysts' Views
• 11.5. Lirentelimab (AK002): Allakos/BioWa
  • 11.5.1. Drug Description
  • 11.5.2. Other Developmental Activity
  • 11.5.3. Clinical Development
  • 11.5.4. Clinical Trials Information
  • 11.5.5. Safety and Efficacy
  • 11.5.6. Product Profile
  • 11.5.7. Analysts' Views
• 11.6. TEZSPIRE (tezepelumab): AstraZeneca/Amgen
  • 11.6.1. Product Description
  • 11.6.2. Other Developmental Activity
  • 11.6.3. Clinical Development
  • 11.6.4. Clinical Trials Information
  • 11.6.5. Product Profile
  • 11.6.6. Analysts' Views
• 11.7. Rilzabrutinib (SAR444671): Sanofi
  • 11.7.1. Product Description
  • 11.7.2. Other Developmental Activity
  • 11.7.3. Clinical Development
  • 11.7.4. Clinical Trials Information
  • 11.7.5. Product Profile
• 11.8. TAS5315: Taiho Pharmaceutical
  • 11.8.1. Drug Description
  • 11.8.2. Clinical Development
  • 11.8.3. Clinical Trials Information
  • 11.8.4. Product Profile
• 11.9. Barzolvolimab (CDX-0159): Celldex Therapeutics
  • 11.9.1. Product Description
  • 11.9.2. Other Developmental Activity
  • 11.9.3. Clinical Development
  • 11.9.4. Clinical Trials Information
  • 11.9.5. Safety and Efficacy
  • 11.9.6. Product Profile

12. Chronic Spontaneous Urticaria: Market Analysis

• 12.1. Key Findings
• 12.2. Key Market Forecast Assumptions
• 12.3. Market Outlook
• 12.4. Attribute Analysis
• 12.5. Total Market Size of Chronic Spontaneous Urticaria in the 7MM
• 12.6. Total Market Size of Chronic Spontaneous Urticaria by Therapies in the 7MM
• 12.7. Total Market Size of Chronic Spontaneous Urticaria in the US
  • 12.7.1. Total Market Size of Chronic Spontaneous Urticaria
  • 12.7.2. The Market Size of Chronic Spontaneous Urticaria by Therapies
• 12.8. Market Size of Chronic Spontaneous Urticaria in EU4 and the UK
  • 12.8.1. Total Market Size of Chronic Spontaneous Urticaria
  • 12.8.2. The Market Size of Chronic Spontaneous Urticaria by Therapies
• 12.9. Market Size of Chronic Spontaneous Urticaria in Japan
  • 12.9.1. Total Market Size of Chronic Spontaneous Urticaria
  • 12.9.2. The Market Size of Chronic Spontaneous Urticaria by Therapies

13. Key Opinion Leaders' Views

14. SWOT

15. Unmet needs

16. Market Access and Reimbursement

• 16.1. The United States
  • 16.1.1. Centre for Medicare & Medicaid Services (CMS)
• 16.2. In EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. The United Kingdom
• 16.3. Japan
  • 16.3.1. MHLW

17. Appendix

• 17.1. Bibliography
• 17.2. Acronyms and Abbreviations
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer