慢性自然じんま疹治療の世界市場 - 2023-2030年

概要

慢性自然じんま疹は慢性特発性じんま疹としても知られ、1週間のほとんどの日にじんま疹が6週間以上持続することで定義されます。患者の約40％に血管浮腫がみられます。CSUの標準的な管理は、主に第2世代のH1抗ヒスタミン薬を通常より高用量で、H2抗ヒスタミン薬およびロイコトリエン調節薬と併用することです。重篤な増悪を抑制するために、グルココルチコイドの短期投与が必要となることもあります。

さらに、この疾患に対する治療法はないが、抗ヒスタミン薬がかゆみを和らげ、アレルギー反応を軽減または予防することが知られています。オマリズマブ（ゾレア）と呼ばれる薬剤を月1回注射することで、体内の免疫グロビンE（IgE）の産生をブロックします。プレドニゾン（デルタゾン、レイオス）のような副腎皮質ステロイドは、アレルギー薬に反応しない症状を緩和します。シクロスポリン免疫抑制剤は、重症の慢性じんましんに非常に有効です。慢性自然じんま疹の症状緩和には、他にも多くの薬剤が使用されています。

市場力学：促進要因

新規薬剤に対する需要の増加

慢性自然じんま疹の治療に対する新規薬剤の需要の増加は、予測期間において最大の市場シェアを占めると予想されます。新薬は、より良い疾患管理のための代替薬や補完薬を提供することで、アンメットニーズに対応することを目的としています。規制当局の承認は、新薬開発に対する患者の信頼を高める。

例えば、2023年3月7日、Regeneron Pharmaceuticals, Inc.とSanofiは、米国食品医薬品局（FDA）が、現在の標準治療であるH1抗ヒスタミン薬治療では十分にコントロールできない12歳以上の慢性自然じんま疹（CSU）の成人および青少年を治療するデュピクセント（デュピルマブ）の生物製剤追加承認申請（sBLA）を受理したことを明らかにしました。

さらに、慢性自然蕁麻疹治療においてより優れた効果を示す新規薬剤の開発に向けて、多くの臨床試験が進行中です。例えば、ノバルティスは2021年12月20日、慢性自然じんま疹（CSU）を対象としたPEARL 1およびPEARL 2フェーズIII試験のトップライン結果を発表し、12週目でリゲリズマブのプラセボに対する優越性が主要評価項目を達成したことを明らかにしました。

さらに、ノバルティスは2023年8月9日、H1-抗ヒスタミン薬で症状のコントロールが不十分な慢性自然じんま疹（CSU）患者を対象に、ブルトン型チロシンキナーゼ（BTK）阻害薬であるレミブルチニブ25mg b.i.d.を評価した第III相試験REMIX-1およびREMIX-2の良好なトップライン結果を発表しました。

さらに、現在進行中の研究開発努力により、新たな治療標的が発見され、革新的な医薬品が開発される可能性があります。このような研究に投資する製薬会社は、こうした新規治療薬に対する市場の需要拡大から利益を得る可能性があります。

さらに、慢性自然じんま疹の有病率の増加、FDA承認の増加、臨床試験の増加、新規薬剤や治療法の開発の増加、治療選択肢の技術的進歩などが、予測期間中に市場を牽引すると予想される要因です。

阻害要因

コルチコステロイドやその他の薬剤の大量投与に伴う合併症、炎症性筋炎の治療にかかる高額な費用、治療のためのより良い治療法の欠如などの要因が、市場の妨げになると予想されます。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • 新薬の需要増加
  • 抑制要因
    • 治療薬に伴う合併症
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析
• パイプライン分析
• アンメットニーズ
• 特許分析
• ボリューム分析
• DMIオピニオン

第6章 COVID-19分析

第7章 治療タイプ別

• 抗ヒスタミン薬
• オマリズマブ（ゾレア）
• 副腎皮質ステロイド
• ヒドロキシクロロキン（プラケニル）
• シクロスポリン
• ロイコトリエン調節薬
• その他

第8章 投与経路別

• 経口剤
• 局所
• 静脈内投与
• その他

第9章 流通チャネル別

• 病院薬局
• 小売薬局
• オンライン薬局

第10章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他の欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他の南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • オーストラリア
  • その他のアジア太平洋
• 中東・アフリカ

第11章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第12章 企業プロファイル

• F. Hoffmann-La Roche Ltd
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Sanofi SA
• Novartis AG
• Bayer AG
• Dr. Reddy's Laboratories Ltd
• STL Pharma Pvt. Ltd.
• Regeneron Pharmaceuticals Inc.
• Genentech, Inc.
• Jubilant Cadista Pharmaceuticals Inc.
• Horizon Therapeutics plc

第13章 付録

Overview

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
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • 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

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Treatment Type
• 3.2. Snippet by Route of Administration
• 3.3. Snippet by Distribution Channel
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing Demand for Novel Drugs
  • 4.1.2. Restraints
    • 4.1.2.1. Complications Associated with the Treatment Drugs
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Pipeline Analysis
• 5.6. Unmet Needs
• 5.7. Patent Analysis
• 5.8. Volume Analysis
• 5.9. DMI Opinion

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID
  • 6.1.2. Scenario During COVID
  • 6.1.3. Scenario Post COVID
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During the Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Treatment Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 7.1.2. Market Attractiveness Index, By Treatment Type
• 7.2. Antihistamines*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Omalizumab (Xolair)
• 7.4. Corticosteroids
• 7.5. Hydroxychloroquine (Plaquenil)
• 7.6. Cyclosporine
• 7.7. Leukotriene Modifiers
• 7.8. Others

8. By Route of Administration

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 8.1.2. Market Attractiveness Index, By Route of Administration
• 8.2. Oral*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Topical
• 8.4. Intravenous
• 8.5. Others

9. By Distribution Channel

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.1.2. Market Attractiveness Index, By Distribution Channel
• 9.2. Hospital Pharmacies*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Retail Pharmacies
• 9.4. Online Pharmacies

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.6.1. U.S.
    • 10.2.6.2. Canada
    • 10.2.6.3. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.6.1. Germany
    • 10.3.6.2. UK
    • 10.3.6.3. France
    • 10.3.6.4. Italy
    • 10.3.6.5. Spain
    • 10.3.6.6. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.6.1. Brazil
    • 10.4.6.2. Argentina
    • 10.4.6.3. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.6.1. China
    • 10.5.6.2. India
    • 10.5.6.3. Japan
    • 10.5.6.4. Australia
    • 10.5.6.5. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. F. Hoffmann-La Roche Ltd*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. Sanofi SA
• 12.3. Novartis AG
• 12.4. Bayer AG
• 12.5. Dr. Reddy's Laboratories Ltd
• 12.6. STL Pharma Pvt. Ltd.
• 12.7. Regeneron Pharmaceuticals Inc.
• 12.8. Genentech, Inc.
• 12.9. Jubilant Cadista Pharmaceuticals Inc.
• 12.10. Horizon Therapeutics plc

LIST NOT EXHAUSTIVE

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us