한글목차

본 보고서는 주요 7개국(미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국, 일본)의 만성 특발성 두드러기(CSU) 치료제 XOLAIR의 시장 동향을 조사했으며, 치료제 개요, 작용기전, 임상개발 데이터, 관련 법규, 시판 및 개발 중인 약제와의 경쟁 분석, 국가별 시장 규모 추정 및 예측, SWOT 분석, 애널리스트의 견해 등을 정리하여 전해드립니다.

보고서 하이라이트:

• 만성 특발성 두드러기(CSU) 시장 시나리오는 광범위한 연구와 의료비 지출 증가로 인해 향후 몇 년 동안 변화할 것으로 예상됩니다.
• 각 회사는 질병을 치료 및 개선하고, 문제를 평가하고, XOLAIR의 우위에 영향을 미칠 수 있는 기회를 얻기 위해 새로운 접근 방식에 초점을 맞춘 치료제를 개발하고 있습니다.
• 다른 신흥 CSU 치료제가 XOLAIR와 치열한 시장 경쟁을 벌일 것으로 예상되며, 가까운 시일 내에 후발주자 신흥 치료제가 출시되면 시장에 큰 영향을 미칠 것으로 예상됩니다.
• 법과 규제 마일스톤 및 개발 활동에 대한 자세한 설명을 통해 CSU에서 XOLAIR의 현재 개발 시나리오를 제공합니다.
• 2027년부터 2032년까지 XOLAIR의 예측 판매 데이터에 대한 상세한 분석을 통해 CSU에서 XOLAIR의 전체 시나리오를 파악하고, 치료제 포트폴리오에 대한 의사결정 과정을 지원합니다.

목차

제1장 보고서 소개

제2장 만성 특발성 두드러기(CSU)의 XOLAIR : 개요

• 제품 상세
• 임상 개발
  • 임상 연구
  • 임상시험 정보
  • 안전성과 유효성
• 규제 마일스톤
• 기타 개발 활동
• 제품 프로파일

제3장 경쟁 구도(출시된 치료제)

제4장 경쟁 구도(후기 단계 신흥 치료제)

제5장 XOLAIR : 시장 평가

• CSU의 XOLAIR : 시장 전망
• 주요 7개국 분석
  • CSU 치료제 XOLAIR 시장 규모
• 국가별 시장 분석
  • 시장 규모 : 미국
  • 시장 규모 : 독일
  • 시장 규모 : 영국

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 보고서 구입 옵션

영문목차

"XOLAIR Market Size, Forecast, and Market Insight - 2032" report provides comprehensive insights about XOLAIR for Chronic Spontaneous Urticaria (CSU) in the seven major markets. A detailed picture of the XOLAIR for CSU in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2019 -2032 is provided in this report along with a detailed description of the XOLAIR for CSU. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the XOLAIR market forecast analysis for CSU in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in CSU.

Drug Summary:

XOLAIR (omalizumab) is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human IgE. The antibody has a molecular weight of approximately 149 kDa, and is approved for the treatment of CSU in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.

XOLAIR is approved for treating CSU in over 80 countries, including the EU, and CIU, as it is known in the US. Additionally, XOLAIR has been approved for allergic asthma, chronic urticaria, and nasal polyps. It is also being investigated in other indications including nasal polyps and food hypersensitivity.

Dosage: 150 mg or 300 mg of XOLAIR is administered by SC injection every 4 weeks to treat CIU. The dosing of XOLAIR in CIU patients is not dependent on serum IgE (free or total) level or body weight. XOLAIR injection is clear to a slightly opalescent and colorless-to-pale brownish-yellow solution available as 150 mg/mL in a single-dose prefilled syringe with a purple needle shield for CSU.

Administration: XOLAIR is available as a prefilled syringe and as a lyophilized powder in a vial for reconstitution. Both XOLAIR prefilled syringes and lyophilized powder should be administered by a healthcare professional. XOLAIR is administered by SC injection, which may take 5-10 s to administer. Also, more than one injection per site should not be administered.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the XOLAIR description, mechanism of action, dosage and administration, research and development activities in Chronic Spontaneous Urticaria (CSU).
• Elaborated details on XOLAIR regulatory milestones and other development activities have been provided in this report.
• The report also highlights the XOLAIR research and development activities in CSU across the United States, Europe, and Japan.
• The report also covers the patents information with expiry timeline around XOLAIR.
• The report contains forecasted sales of XOLAIR for CSU till 2032.
• Comprehensive coverage of the late-stage emerging therapies for CSU.
• The report also features the SWOT analysis with analyst views for XOLAIR in CSU.

Methodology:

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

XOLAIR Analytical Perspective by DelveInsight

• In-depth XOLAIR Market Assessment

This report provides a detailed market assessment of XOLAIR for Chronic Spontaneous Urticaria (CSU) in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2024 to 2032.

• XOLAIR Clinical Assessment

The report provides the clinical trials information of XOLAIR for Chronic Spontaneous Urticaria (CSU) covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for Chronic Spontaneous Urticaria (CSU) is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence XOLAIR dominance.
• Other emerging products for CSU are expected to give tough market competition to XOLAIR and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of XOLAIR in CSU.
• Our in-depth analysis of the forecasted sales data of XOLAIR from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the XOLAIR in CSU.

Key Questions:

• What is the product type, route of administration and mechanism of action of XOLAIR?
• What is the clinical trial status of the study related to XOLAIR in Chronic Spontaneous Urticaria (CSU) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the XOLAIR development?
• What are the key designations that have been granted to XOLAIR for CSU?
• What is the forecasted market scenario of XOLAIR for CSU?
• What are the forecasted sales of XOLAIR in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to XOLAIR for CSU?
• Which are the late-stage emerging therapies under development for the treatment of CSU?

Table of Contents

1. Report Introduction

2. XOLAIR Overview in Chronic Spontaneous Urticaria (CSU)

• 2.1. Product Detail
• 2.2. Clinical Development
  • 2.2.1. Clinical studies
  • 2.2.2. Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Regulatory Milestones
• 2.4. Other Developmental Activities
• 2.5. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. XOLAIR Market Assessment

• 5.1. Market Outlook of XOLAIR in Chronic Spontaneous Urticaria (CSU)
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of XOLAIR in the 7MM for Chronic Spontaneous Urticaria (CSU)
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of XOLAIR in the United States for Chronic Spontaneous Urticaria (CSU)
  • 5.3.2. Market Size of XOLAIR in Germany for Chronic Spontaneous Urticaria (CSU)
  • 5.3.3. Market Size of XOLAIR in France for Chronic Spontaneous Urticaria (CSU)
  • 5.3.4. Market Size of XOLAIR in Italy for Chronic Spontaneous Urticaria (CSU)
  • 5.3.5. Market Size of XOLAIR in Spain for Chronic Spontaneous Urticaria (CSU)
  • 5.3.6. Market Size of XOLAIR in the United Kingdom for Chronic Spontaneous Urticaria (CSU)
  • 5.3.7. Market Size of XOLAIR in Japan for Chronic Spontaneous Urticaria (CSU)

6. SWOT Analysis

7. Analysts' Views

8. Appendix

• 8.1. Bibliography
• 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options