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市場調查報告書

慢性阻塞性肺病治療藥市場機會與臨床實驗平台分析

COPD Drug Market Opportunity & Clinical Pipeline Analysis

出版商 KuicK Research 商品編碼 302587
出版日期 內容資訊 英文 590 Pages
商品交期: 最快1-2個工作天內
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慢性阻塞性肺病治療藥市場機會與臨床實驗平台分析 COPD Drug Market Opportunity & Clinical Pipeline Analysis
出版日期: 2014年04月01日 內容資訊: 英文 590 Pages
簡介

全球近10億人罹患呼吸系統或肺部疾病。尤其氣喘和慢性阻塞性肺病佔多數,患者近整體75%。慢性阻塞性肺病(COPD)由於是肺漸進性疾病需要終生治療。全球慢性阻塞性肺病市場2013年為近120億美元。市場有效率且便利性更高的藥物進入,今後該市場預計以年複合成長率8%持續擴大,2018年擴大到175億美元。

本報告提供慢性阻塞性肺病治療藥市場概要,與全球、美國及歐洲的慢性阻塞性肺病患者趨勢、臨床實驗相關FDA及EMA的指南、臨床實驗趨勢等,以及參與企業的競爭環境彙整,為您概述為以下內容。

第1章 全球慢性阻塞性肺部疾病市場概要

  • 市場概要
  • 臨床實驗分析

第2章 慢性阻塞性肺病治療藥臨床實驗相關EMA指南

  • 簡介
  • 法律上的基礎相關聯的指南
  • 患者的特性化和患者的選擇
  • 有效性評估方法
  • 臨床實驗的策略與設計
  • 安全性

第3章 慢性阻塞性肺病治療藥臨床實驗相關FDA指南

  • 疾病目標與適應
  • 慢性阻塞性肺病治療藥的種類
  • 藥物開發人口
  • 劑量的選擇
  • 有效性評估
  • 推薦的一次及二次有效性試驗指標
  • 研究期間
  • 研究數量
  • 有效性決策相關討論事項
  • 安全性決策相關討論事項
  • 有效性調查相關討論事項

第4章 各相、各國家臨床實驗趨勢

第5章 各國已上市慢性阻塞性肺病治療藥

第6章 各相、各國沒有開發、中止、中斷的藥物

  • 沒有開發報告
  • 中止
  • 撤出市場
  • 中斷

第7章 競爭環境

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

圖表

目錄

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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