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市場調查報告書

歐洲的孤兒藥市場及臨床實驗趨勢

Europe Orphan Drug Market & Clinical Trial Insight 2015

出版商 PNS Pharma 商品編碼 322432
出版日期 內容資訊 英文 1100 Pages
商品交期: 最快1-2個工作天內
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歐洲的孤兒藥市場及臨床實驗趨勢 Europe Orphan Drug Market & Clinical Trial Insight 2015
出版日期: 2015年01月07日 內容資訊: 英文 1100 Pages
簡介

歐洲罕見疾病被視為優先領域,從1990年代早期開始該領域的研究受重視。2000年以後核準的罕見疾病治療藥超越100種,為了促進孤兒藥的開發,歐洲委員會進行著各種努力。

本報告提供歐洲的孤兒藥市場概要相關法規、臨床實驗平台趨勢、臨床實驗階段及已上市孤兒藥概要、進入各公司的競爭趨勢等彙整資料。

第1章 所謂孤兒藥

  • 簡介
  • 孤兒藥認證的偏好的評價標準

第2章 歐洲的孤兒藥指定標準

  • 指定標準
  • 臨床試驗贊助者申請次序

第3章 歐洲的孤兒藥償付政策

第4章 市場概要

  • 目前市場方案
  • 臨床實驗趨勢

第5章 孤兒藥相關歐洲的法律規章

  • 孤兒藥委員會
  • 歐洲的孤兒藥指定的申請方法
  • 銷售認證與市場的壟斷性
  • 轉讓給指定孤兒藥以外的臨床試驗贊助者
  • 開發相關年度報告書的繳交義務
  • 小、中小企業導向獎勵
  • 指定孤兒藥的降價
  • 孤兒藥指定次序與研究開發獎勵

第6章 歐洲的孤兒藥開發平台:各國家、企業、適應、Phase

  • 研究
  • 前臨床
  • 臨床
  • 第一階段
  • 第1/2階段
  • 第二階段
  • 第2/3階段
  • 第三階段
  • 登記前
  • 登記完畢

第7章 歐洲的已上市孤兒藥:各國家、企業、適應症

第8章 中止、中斷的孤兒藥臨床實驗平台

  • 沒有開發報告的項目
  • 中止的項目
  • 從市場撤退的項目
  • 中斷的項目

第9章 競爭環境

  • AOP Orphan
  • Genethon
  • Genzyme Corporation
  • Glaxosmithkline
  • Merck
  • Novartis Pharmaceuticals
  • Orphan Europe
  • Pfizer
  • Prosensa
  • Shire
  • Teva Pharmaceutical

圖表

目錄

The concept of rare diseases and the idea that a special attention needs to be given to this sector has been taking shape in Europe since the 1990s. Ever since then the political aspects and initiatives related to orphan medicinal products have been emerging at both the EU level and at the level of member states individually. Many member states in the EU have led the way during the 1990s in the space of orphan medicinal products, the result of which took the shape of the first European legislative text concerning rare diseases called the Orphan Medicinal Product Regulation. This Regulation was adopted in 1999 and came into effect in 2000.

In the European region, rare disease is considered to be a priority area and research in this field is given high importance by the EU Framework Programmes for Research and Technological Development (FP) ever since the early 1990s. Increasing the utilization of scarce resources and coordinating research efforts are the basic factors which have been responsible for success in the European rare diseases market. However, the absence of an exhaustive rare disease classification, standard terms of reference and a harmonized regulatory requirement, has always been a challenge in this region, which is currently impacting the global sharing of information, data and samples which would boost the research further.

It has been estimated that Europe has witnessed more than 100 therapies for rare diseases being approved since 2000, when the European Commission introduced incentives to encourage the development of these drugs. The share of R&D for orphan medicinal products development as a proportion of total biopharmaceutical industry's R&D has been increasing significantly over the years. This is strengthened by the fact that almost all companies which have been set up recently to develop orphan medicinal products have their extensive R&D plants and staff located in the European Union. This shows the significance of the region and its level of attractiveness.

Additionally, the investment in R&D by the European companies for developing orphan medicinal products has increased by more than 200%, while the total number of employees in these companies has recorded an increase of more than 150% since 2000. With the long durations of lead times in the biopharmaceuticals industry for R&D projects, it is most likely that the EU Regulation for Orphan medicinal products would have a significant impact in the coming years.

“Europe Orphan Drug Market & Clinical Trial Insight 2015” Report Highlights & Findings:

  • Europe Orphan Drug Market Overview
  • In-depth Insight on Regulatory Framework & for Orphan Drugs
  • Application Procedure for Seeking Orphan Drug Status
  • Comprehensive Insight on Orphan Drug Clinical Pipeline
  • Europe Orphan Drug Clinical Pipeline: 326 Drugs
  • Majority Orphan Designated Drugs in Phase-II : 111
  • Marketed Orphan Drugs in Europe: 130

Table of Contents

1. What Are Orphan Drugs?

  • 1.1. Introduction to Orphan Drug
  • 1.2. Favorable Parameters for Orphan Drugs Acceptance

2. Europe Orphan Drug Designation Criteria

  • 2.1. Designation Criteria
  • 2.2. Sponsors Application Procedure

3. Europe Orphan Drug Reimbursement Policy

4. Europe Orphan Drug Market Overview

  • 4.1. Current Market Scenario
  • 4.2. Europe Orphan Drug Clinical Trial Insight

5. Europe Regulatory Framework for Orphan Drugs

  • 5.1. Committee for Orphan Medicinal Products
  • 5.2. How to Apply for Orphan Designation in Europe
  • 5.3. Marketing Authorization & Market Exclusivity
  • 5.4. Transferring An Orphan Designation To Another Sponsor
  • 5.5. Mandatory Submission Of Annual Report On Development
  • 5.6. Incentives For Micro, Small And Medium-Sized Enterprises
  • 5.7. Fee Reductions For Designated Orphan Medicinal Products
  • 5.8. Procedure for Orphan Designation & Incentives for R&D (Regulation (EC) No 141/2000)

6. Europe Orphan Drug Pipeline by Country, Company, Indication & Phase

  • 6.1. Research
  • 6.2. Preclinical
  • 6.3. Clinical
  • 6.4. Phase-I
  • 6.5. Phase-I/II
  • 6.6. Phase-II
  • 6.7. Phase-II/III
  • 6.8. Phase-III
  • 6.9. Preregistration
  • 6.10. Registered

7. Marketed Orphan Drug in Europe by Country, Company & Indication

8. Discontinued & Suspended Orphan Drug Clinical Pipeline

  • 8.1. No Development Reported
  • 8.2. Discontinued
  • 8.3. Market Withdrawal
  • 8.4. Suspended

9. Competitive Landscape

  • 9.1. AOP Orphan
  • 9.2. Genethon
  • 9.3. Genzyme Corporation
  • 9.4. Glaxosmithkline
  • 9.5. Merck
  • 9.6. Novartis Pharmaceuticals
  • 9.7. Orphan Europe
  • 9.8. Pfizer
  • 9.9. Prosensa
  • 9.10. Shire
  • 9.11. Teva Pharmaceutical

List of Figures:

  • Figure 4-1: Europe Orphan Drug Market (US$ Billion), 2012-2018
  • Figure 4-2: Europe Share in Global Orphan Drug Market, 2012 & 2018
  • Figure 4-3: Biological & Non Biological Orphan Drug Segment (%), 2012 & 2018
  • Figure 4-4: Biological & Non Biological Orphan Drug Market (US$ Billion), 2012-2018
  • Figure 4-5: Europe Orphan Pipeline by Phase (%), 2014
  • Figure 4-6: Europe Orphan Pipeline by Phase (Number), 2014
  • Figure 4-7: No Development Reported Europe Orphan Pipeline by Phase (%), 2014
  • Figure 4-8: No Development Reported Europe Orphan Pipeline by Phase (Number), 2014
  • Figure 4-9: Discontinued Europe Orphan Pipeline by Phase (%), 2014
  • Figure 4-10: Discontinued Europe Orphan Pipeline by Phase (Number), 2014
  • Figure 4-11: Suspended Europe Orphan Pipeline by Phase (%), 2014
  • Figure 4-12: Suspended Europe Orphan Pipeline by Phase (Number), 2014
  • Figure 9-1: AOP Orphan
  • Figure 9-2: Genethon Drug Pipeline
  • Figure 9-3: Genzyme Drug Pipeline
  • Figure 9-4: Orphan Europe Pipeline
  • Figure 9-5: Prosensa Drug Pipeline
  • Figure 9-6: Shire Drug Pipeline
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