市場調査レポート

COPD治療薬市場の機会と臨床パイプライン分析

COPD Drug Market Opportunity & Clinical Pipeline Analysis

発行 KuicK Research 商品コード 302587
出版日 ページ情報 英文 590 Pages
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COPD治療薬市場の機会と臨床パイプライン分析 COPD Drug Market Opportunity & Clinical Pipeline Analysis
出版日: 2014年04月01日 ページ情報: 英文 590 Pages
概要

世界では10億人近くの人々が呼吸器または肺の疾患を患っています。中でも喘息とCOPDが多く、患者全体の75%近くを占めています。慢性閉塞性肺疾患(COPD)は肺で進行する疾患で一生を通じて治療が必要です。世界のCOPD市場は2013年に120億米ドル近くとなりました。市場にはより効率的かつ利便性の高い薬剤が参入しており、今後も同市場はCAGR8%で拡大しつづけ、2018年には175億米ドルに拡大すると予測されています。

当レポートでは、COPD治療薬市場概要と世界、米国および欧州のCOPD患者動向、治験に関するFDAおよびEMAのガイドライン、治験動向などとともに、参入する企業の競合環境をまとめ、概略下記の構成で取り上げております。

第1章 世界の慢性閉塞性肺疾患市場概要

  • 市場概要
  • 治験分析

第2章 COPD治療薬の治験に関するEMAガイドライン

  • イントロダクション
  • 法的基礎と関連するガイドライン
  • 患者の特性化と患者の選定
  • 有効性評価方法
  • 治験の戦略と設計
  • 安全性

第3章 COPD治療薬の治験に関するFDAガイドライン

  • 疾患標的と適応
  • COPD治療薬の種類
  • 薬剤開発人口
  • 投与量の選定
  • 有効性評価
  • 推奨される一次および二次有効性エンドポイント
  • 研究期間
  • 研究件数
  • 有効性決定に関する検討事項
  • 安全性決定に関する検討事項
  • 有効性調査に関する検討事項

第4章 相、国別治験動向

第5章 国別上市済みCOPD治療薬

第6章 相、国別開発なし、中止、中断された薬剤

  • 開発レポートなし
  • 中止
  • 市場からの撤退
  • 中断

第7章 競合環境

  • Almirall
  • AstraZeneca
  • Boehringer Ingelheim
  • Bayer
  • Chiesi Farmaceutici
  • Forest Laboratories
  • Lallemand Pharma
  • Merck & Co
  • Novartis
  • Sunovion Pharmaceuticals

図表

目次

Close to 1 Billion people worldwide suffer from respiratory or pulmonary diseases. In the respiratory therapeutic domain, Asthma and COPD are the major categories, accounting for close to 75% of the total patient for respiratory or pulmonary diseases. Chronic obstructive pulmonary disease (COPD) is a disease which progresses in the lungs and requires treatment all through the life. It is an inflammatory disorder which is characterized by obstruction in the variable airflow and airway hyper-responsiveness to many intrinsic, genetic and environmental stimuli. These disorders have become one of the major reasons for disability and death. The prevalence and incidence of this disease is increasing worldwide.

Bronchodilators and polypharmacy dominates the treatment for this disease. It is expected that by 2020, COPD would account for more than 6 Million deaths across the globe annually. Inspite of significant investments in the development of novel agents to treat the disease, the COPD therapy area is generally dominated by inhaled bronchodilator therapies which only relieve symptoms, but do not completely cure the disease. There exist many opportunities for a disease-modifying therapy. However, the development of new COPD therapies is increasingly focusing on therapies which combine two bronchodilators into one inhaler.

The global market for COPD has been estimated to be close to US$ 12 billion in 2013. With a high number of new and more efficient and convenient drugs crowding the market, it is expected that this market would grow at a CAGR of 8% to reach close to US$ 17.5 billion by 2018. Some of the drugs which are major contributors to this growth include once-daily LABA/LAMA fixed-dose combinations such as QVA-149, umeclidinium bromide/vilanterol and olodaterol/tiotropium. By 2018, it is expected that the combinations of LABA/LAMA would the leading drugs driving sales in the COPD therapy market and by 2021, these drugs would account for more than 25% of the market share. While in 2013, close to 50% of the global market was accounted by the US, with the other regions together accounting for 50%. However, it is expected that by 2018, the share of the USA would reduce marginally to 45%, while the lost share of this region would be taken over by the Asian region.

"COPD Drug Market Opportunity & Clinical Pipeline Analysis" Report Highlight:

  • COPD Drug Market Overview
  • COPD Patient Base: Global, US & Europe
  • FDA & EMA Guidelines on Clinical Investigation of COPD Drugs
  • COPD Drug Clinical Pipeline by Phase & Country
  • COPD Drug in Development Phase: 174
  • Majority of COPD Drugs in Preclinical Phase: 72
  • Marketed COPD Drugs: 36
  • Discontinued & Suspended COPD Drug Profiles

Table of Contents

1. Global Chronic Obstructive Pulmonary Disease Market Overview

  • 1.1. Market Overview
  • 1.2. Clinical Trial Analysis

2. EMA Guideline on Clinical Investigation of COPD Drugs

  • 2.1. Introduction
  • 2.2. Legal Basis & Relevant Guidelines
  • 2.3. Patient Characteristics & Selection Of Patients
  • 2.4. Methods to Assess Efficacy
  • 2.5. Strategy & Design Of Clinical Trials
  • 2.6. Safety

3. FDA Guideline on Clinical Investigation of COPD Drugs

  • 3.1. Disease Target and Indication
  • 3.2. Types of Drugs for COPD
  • 3.3. Drug Development Population
  • 3.4. Dose Selection
  • 3.5. Efficacy Assessment
  • 3.6. Recommended Primary and Secondary Efficacy Endpoints
  • 3.7. Study Duration
  • 3.8. Number of Studies
  • 3.9. Considerations Regarding Demonstration of Efficacy
  • 3.10. Considerations Regarding Demonstration of Safety
  • 3.11. Specific Efficacy Study Considerations

4. Chronic Obstructive Pulmonary Disease Drug Clinical Trial by Phase & Country

4.1. Phase Unknown

4.2. Research

4.3. Preclinical

4.4. Clinical

4.5. Phase I

4.6. Phase I/II

4.7. Phase II

4.8. Phase III

4.9. Preregistration

4.10. Registered

5. Marketed Drugs for Chronic Obstructive Pulmonary Disease by Country

6. No Development, Discontinued & Suspended Drug Clinical Trial by Phase & Country

  • 6.1. No Development Reported
  • 6.2. Discontinued
  • 6.3. Market Withdrawal
  • 6.4. Suspended

7. Competitive Landscape

  • 7.1. Almirall
  • 7.2. AstraZeneca
  • 7.3. Boehringer Ingelheim
  • 7.4. Bayer
  • 7.5. Chiesi Farmaceutici
  • 7.6. Forest Laboratories
  • 7.7. Lallemand Pharma
  • 7.8. Merck & Co
  • 7.9. Novartis
  • 7.10. Sunovion Pharmaceuticals

List of Figures

  • Figure 1-1: Global - People Suffering With COPD (Million), 2013-2018
  • Figure 1-2: US - People Suffering With COPD (Million), 2013-2018
  • Figure 1-3: US - People Suffering With COPD by Age Group (%)
  • Figure 1-4: Europe - People Suffering With COPD (Million), 2013-2018
  • Figure 1-5: Europe - Death from COPD ('000) , 2005 & 2030
  • Figure 1-6: Global COPD Drug Market (US$ Billion), 2012-2018
  • Figure 1-7: Number of COPD Drugs in Clinical Trial by Phase, 2014
  • Figure 1-8: COPD Drugs in Clinical Trial by Phase (%), 2014
  • Figure 1-9: Number of Discontinued COPD Drugs in Clinical Trial by Phase, 2014
  • Figure 1-10: Discontinued COPD Drugs in Clinical Trial by Phase (%), 2014
  • Figure 1-11: Number of Suspended COPD Drugs in Clinical Trial by Phase, 2014
  • Figure 1-12: Suspended COPD Drugs in Clinical Trial by Phase (%), 2014
  • Figure 1-13: Number of No Development in COPD Drugs in Clinical Trial by Phase, 2014
  • Figure 1-14: No Development in COPD Drugs in Clinical Trial by Phase (%), 2014
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