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Bosatria(メポリズマブ)(ぜんそく治療薬):市場の予測と分析

Bosatria (Mepolizumab) (Asthma) - Forecast and Market Analysis to 2023

発行 GlobalData 商品コード 316084
出版日 ページ情報 英文 66 Pages
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Bosatria(メポリズマブ)(ぜんそく治療薬):市場の予測と分析 Bosatria (Mepolizumab) (Asthma) - Forecast and Market Analysis to 2023
出版日: 2014年08月31日 ページ情報: 英文 66 Pages
概要

BosatriaはGSKが開発した、IL-5(好酸球の活性化を制御するサイトカインの一種)を標的とするヒト化モノクローナル抗体です。当初は過好酸性症候群の治療薬として開発されましたが、「Bosatriaにはぜんそくに関するプラスのベネフィット・リスク評価を下せる、という結論を出すにはデータが不十分である」という欧州医薬品委員会(CHMP)の決定(2009年)を受けて、GSKはその認証過程から撤退しました。GSKでは「自社のブロックバスター製品Advair/Seretideは全世界で数十億米ドルもの売上がある」としていますが、Bosatriaの場合は、一部の難治性患者に限定して使用されているため、そこまでの地位に達するとは期待されていません。

当レポートでは、ぜんそくの治療薬の一つ、Bosatria(メポリズマブ)の世界市場について分析し、ぜんそくの概要や治療法、競合する企業・薬品の概要、市場競争の概況、Bosatriaの商品情報(特色・効能・安全性など)、世界の主要国における市場販売額の見通し(今後10年間分)などを調査して、その結果を概略以下の構成でお届けします。

第1章 目次

第2章 イントロダクション

第3章 疾患の概要

  • 病因と病態
    • 病因
    • 病態生理
    • 予後
    • 生活の質(QoL)
  • 症状

第4章 疾患管理

  • 診断・治療の概要
    • 診断
    • 治療のガイドライン、臨床診療、代表的な処方薬
    • 臨床診療

第5章 競合評価

  • 概要
  • 競合企業の戦略的評価

第6章 アンメットニーズと市場機会

  • 概要
  • 重症ぜんそくを管理するための個別化治療
    • アンメットニーズ
    • ギャップ分析
    • 市場機会
  • 患者コンプライアンスの改善
  • ぜんそく薬物治療の費用引き下げ
  • 小児ぜんそくの適切な診断

第7章 パイプライン評価

  • 概要
  • 治験中の有望な医薬品

第8章 Bosatria(メポリズマブ)

  • 概要
  • 効能
  • 安全性
  • 投与・剤形
  • 臨床面での潜在的な位置づけ
  • 商業面での潜在的な位置づけ
  • 価格設定と医療費償還
  • SWOT分析
  • 予測

第9章 付録

図表一覧

目次

GlobalData has released its new PharmaPoint Drug Evaluation report, "Bosatria (Mepolizumab) (Asthma) - Forecast and Market Analysis to 2023". The asthma market saw very slow growth over the past decade, as it has become saturated with relatively efficacious standard therapies, such as short-acting beta-agonists (SABAs), inhaled corticosteroids (ICSs), inhaled corticosteroids and long-acting beta-agonists (ICS/LABAs), and leukotriene modifiers, and has also been facing increasing generic competition. However, the launch of seven novel targeted biologic agents and once-daily ICS and ICS/LABA therapies delivered by the next-generation inhalers will strongly drive the market growth over the next 10 years. The biologic agents will not only reshape the market growth, but will also mark the beginning of a new era of a personalized approach to asthma treatment. The realization that asthma is a very heterogeneous disease is highly reflected in the rich assortment of these targeted therapies in the late-stage pipeline.

GSK's Bosatria (mepolizumab) is a humanized mAb targeting IL-5, a cytokine that regulates the activation of eosinophils. It was originally developed for the treatment of hypereosinophilic syndrome, but GSK withdrew its authorization application after the CHMP determined that the data were insufficient to conclude whether there is a positive benefit-risk balance for Bosatria in asthma (GSK, press release, July 29, 2009). GSK boasts multibillion dollar sales for its blockbuster, Advair/Seretide, but Bosatria is not expected to reach this status, since it will only be used in a limited number of refractory patients.

Scope

  • Overview of Asthma, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on Bosatria including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for Bosatria for the top eight countries from 2013 to 2023.
  • Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan and Australia.

Reasons to buy

  • Understand and capitalize by identifying products that are most likely to ensure a robust return
  • Stay ahead of the competition by understanding the changing competitive landscape for Asthma
  • Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
  • Make more informed business decisions from insightful and in-depth analysis of Bosatria performance
  • Obtain sales forecast for Bosatria from 2013-2023 in top eight countries (the US, France, Germany, Italy, Spain, the UK, Japan and Australia)

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports
  • 2.3. Upcoming Related Reports

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
    • 3.1.3. Prognosis
    • 3.1.4. Quality of Life
  • 3.2. Symptoms

4. Disease Management

  • 4.1. Diagnosis and Treatment Overview
    • 4.1.1. Diagnosis
    • 4.1.2. Treatment Guidelines, Clinical Practice, and Leading Prescribed Drugs
    • 4.1.3. Clinical Practice

5. Competitive Assessment

  • 5.1. Overview
  • 5.2. Strategic Competitor Assessment

6. Unmet Need and Opportunity

  • 6.1. Overview
  • 6.2. Personalized Therapies to Control Severe Asthma
    • 6.2.1. Unmet Need
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunity
  • 6.3. Better Patient Compliance
    • 6.3.1. Unmet Need
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunity
  • 6.4. Lower Cost of Asthma Medications
    • 6.4.1. Unmet Need
    • 6.4.2. Gap Analysis
    • 6.4.3. Opportunity
  • 6.5. Proper Diagnosis of Asthma in Children
    • 6.5.1. Unmet Need
    • 6.5.2. Gap Analysis
    • 6.5.3. Opportunity

7. Pipeline Assessment

  • 7.1. Overview
  • 7.2. Promising Drugs in Clinical Development

8. Bosatria (Mepolizumab)

  • 8.1. Overview
  • 8.2. Efficacy
  • 8.3. Safety
  • 8.4. Dosing and Formulation
  • 8.5. Potential Clinical Positioning
  • 8.6. Potential Commercial Positioning
  • 8.7. Pricing and Reimbursement
  • 8.8. SWOT Analysis
  • 8.9. Forecast

9. Appendix

  • 9.1. Bibliography
  • 9.2. Abbreviations
  • 9.3. Methodology
  • 9.4. Forecasting Methodology
    • 9.4.1. Diagnosed Asthma Patients
    • 9.4.2. Percent Drug-Treated Patients
    • 9.4.3. General Pricing Assumptions
    • 9.4.4. Generic Erosion
    • 9.4.5. Pricing of Pipeline Agents
  • 9.5. Physicians and Specialists Included in This Study
  • 9.6. About the Authors
    • 9.6.1. Author
    • 9.6.2. Author/Reviewer
    • 9.6.3. Reviewer
    • 9.6.4. Global Head of Healthcare
  • 9.7. About GlobalData
  • 9.8. Disclaimer

List of Tables

  • Table 1: Symptoms of Asthma
  • Table 2: Treatment Guidelines for Asthma by Country
  • Table 3: Most Prescribed Drugs for Asthma by Class and Disease Severity in the Global Markets, 2013
  • Table 4: Dosing of Common ICSs for Adult Asthma Therapy to Achieve Equivalent Therapeutic Potency
  • Table 5: Recommended Low Daily Dose of ICSs in Children with Asthma Under Five Years of Age
  • Table 6: Leading Treatments for Asthma, 2014
  • Table 7: Unmet Need and Opportunity in Asthma
  • Table 8: Asthma - Late Stage Pipeline, 2014
  • Table 9: Product Profile - Bosatria
  • Table 10: Efficacy of Bosatria Versus Placebo
  • Table 11: Bosatria's Safety Profile
  • Table 12: Bosatria SWOT Analysis, 2012
  • Table 13: Global Sales Forecast ($) for Bosatria, 2013-2023
  • Table 14: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1:Stepwise Disease Management Approach for Asthma in Adults
  • Figure 2: Stepwise Disease Management Approach for Asthma in Children Age Five and Younger
  • Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in Asthma, 2013-2023
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