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市場調查報告書

歐洲的孤兒藥市場預測

Europe Orphan Drug Market Outlook 2018

出版商 KuicK Research 商品編碼 302599
出版日期 內容資訊 英文 134 Pages
商品交期: 最快1-2個工作天內
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歐洲的孤兒藥市場預測 Europe Orphan Drug Market Outlook 2018
出版日期: 2014年02月01日 內容資訊: 英文 134 Pages
簡介

罕見疾病的概念與應關注這個領域的想法在1990年代之後在歐洲誕生。之後孤兒藥相關政治配合措施在EU層級及各國層級進行。歐洲成為孤兒藥的全球第二大市場。

本報告提供歐洲的孤兒藥市場概要和孤兒藥的指定標準、歐洲的給付政策與法律規章、開發平台趨勢、應該解決的連同課題、參與企業的競爭環境彙整,為您概述為以下內容。

第1章 孤兒藥的簡介

  • 孤兒藥定義
  • 孤兒藥日益流行

第2章 為何從非孤兒藥轉移到孤兒藥

  • 疲乏的產品平台
  • 孤兒藥的盈利
  • 研究開發投資的增加
  • 經濟獎勵所扮演的角色
  • 專利保護與市場壟斷性

第3章 歐洲的孤兒藥市場預測

  • 孤兒藥的指定標準
  • 市場概要
  • 孤兒藥的給付政策

第4章 歐洲的孤兒藥法律規章架構

  • 孤兒藥委員會
  • 歐洲的孤兒藥指定的申請方法
  • 行銷的認證與市場壟斷
  • 轉移到孤兒藥指定的另外贊助商
  • 強制性提交開發情形相關年度報告
  • 對小企業、中小企業的獎勵
  • 指定孤兒藥物的費用削減
  • 孤兒藥指定與研究開發獎勵相關手續

第5章 各相、適應症之孤兒藥開發平台

第6章 歐洲的已上市孤兒藥:品牌名與適應症

第7章 應解決的課題

  • 初期投資的高度
  • 臨床實驗的門檻
  • 法律規章的門檻
  • 各種給付政策

第8章 競爭環境

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

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.

Europe is the second largest market for orphan drugs. 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.

The orphan drugs enjoy significant competitive advantages in the market owing to the market exclusivity period after the drug has been authorized. Through this clause, the manufacturer of orphan drugs is given a monopoly status in the market because according to the law, no other company is allowed to market the orphan drugs during the exclusivity period. Additionally, this monopolistic power is further strengthened with the fact that no other alternative health technology exists for many orphan drugs.

"Europe Orphan Drug Market Outlook 2018" research report by KuicK Research comprehensive insight on following developments related to Europe orphan drug market:

  • Europe Orphan Drug Market Overview
  • Orphan Drug Designation Criteria
  • Market Specific Reimbursement Policy & Regulatory Framework
  • Europe Orphan Drug Pipeline by Phase, Indication & Originator
  • Marketed Orphan drug List by Indication & Brand Name
  • Key Issue to be Addressed
  • Competitive Landscape

Table of Contents

1. Introduction to Orphan Drugs

  • 1.1. Orphan Drug Defined
  • 1.2. Rising Popularity of Orphan Drugs

2. Why Shift from Non Orphan to Orphan Drugs?

  • 2.1. Exhausting Product Pipelines
  • 2.2. Profitability of Orphan Drugs
  • 2.3. Increasing R&D Investment
  • 2.4. Role of Economic Incentives
  • 2.5. Patent Protection & Market Exclusivity

3. Europe Orphan Drug Market Outlook

  • 3.1. Orphan Drug Designation Criteria
  • 3.2. Market Overview
  • 3.3. Europe Orphan Drug Reimbursement Policy

4. Europe Regulatory Framework for Orphan Drugs

  • 4.1. Committee for Orphan Medicinal Products
  • 4.2. How to Apply for Orphan Designation in Europe
  • 4.3. Marketing Authorization & Market Exclusivity
  • 4.4. Transferring An Orphan Designation To Another Sponsor
  • 4.5. Mandatory Submission Of Annual Report On Development
  • 4.6. Incentives For Micro, Small And Medium-Sized Enterprises
  • 4.7. Fee Reductions For Designated Orphan Medicinal Products
  • 4.8. Procedure for Orphan Designation & Incentives for R&D (Regulation (EC) No 141/2000)

5. Europe Orphan Drug Pipeline Insight by Phase & Indication

  • 5.1. Preclinical
  • 5.2. Phase I
  • 5.3. Phase I/II
  • 5.4. Phase II
  • 5.5. Phase II/III
  • 5.6. Phase III
  • 5.7. Preregistration
  • 5.8. Registration

6. Marketed Orphan Drugs in Europe: Brand Name & Indication

7. Key Issue to be Addressed

  • 7.1. High Initial Investment
  • 7.2. Clinical Study Hurdles
  • 7.3. Regulatory Hurdles
  • 7.4. Distribution Challenges

8. Competitive Landscape

  • 8.1. Genethon
  • 8.2. Prosensa
  • 8.3. Shire
  • 8.4. AOP Orphan
  • 8.5. Orphan Europe
  • 8.6. Pfizer
  • 8.7. Teva Pharmaceutical
  • 8.8. Genzyme Corporation
  • 8.9. Glaxosmithkline
  • 8.10. Merck
  • 8.11. Novartis Pharmaceuticals
  • List of Figures

    • Figure 2-1: Orphan v/s Non-Orphan Drugs -Phase II to Launch Clinical Development Time
    • Figure 2-2: Probability of Regulatory Success of Orphan v/s Non Orphan Drugs
    • Figure 3-1: Europe Orphan Drug Market (US$ Billion), 2012-2018
    • Figure 3-2: Europe Share in Global Orphan Drug Market, 2012 & 2018
    • Figure 3-3: Biological & Non Biological Orphan Drug Segment (%), 2012 & 2018
    • Figure 3-4: Biological & Non Biological Orphan Drug Market (US$ Billion), 2012-2018
    • Figure 5-1: Europe - Orphan Drug Development by Clinical Phase (%), 2014
    • Figure 5-2: Europe - Number of Orphan Drug by Clinical Phase, 2014
    • Figure 5-3: Europe - Number of Suspended & Discontinued Number of Orphan Drug, 2014
    • Figure 5-4: Europe - Number of Discontinued Orphan Drug by Clinical Phase, 2014
    • Figure 5-5: Europe - Number of Suspended Orphan Drug by Clinical Phase, 2014
    • Figure 7-1: Orphan Drug Regulatory Hurdles
    • Figure 8-1: Genethon Drug Pipeline Chart
    • Figure 8-2: Prosensa Drug Pipeline Chart
    • Figure 8-3: Shire Drug Pipeline Chart
    • Figure 8-4: Genzyme Drug Pipeline Chart
    • Table 2-1: Drugs Patent Expiry in 2014
    • Table 2-2: Drugs Patent Expiry in 2015
    • Table 2-3: Drugs Patent Expiry in 2016
    • Table 2-4: Orphan Drugs in the US and their Cost
    • Table 2-5: Orphan Drugs in the EU and their Cost
    • Table 2-6: Incentives for the Development of Orphan Drugs
    • Table 2-7: Orphan Drug Incentives by Country
    • Table 5-1: Europe - Orphan Drugs in Clinical Development Phase: Preclinical
    • Table 5-2: Europe - Orphan Drugs in Clinical Development Phase I
    • Table 5-3: Europe - Orphan Drugs in Clinical Development Phase I/II
    • Table 5-4: Europe - Orphan Drugs in Clinical Development Phase II
    • Table 5-5: Europe - Orphan Drugs in Clinical Development Phase II/III
    • Table 5-6: Europe - Orphan Drugs in Clinical Development Phase III
    • Table 5-7: Europe - Orphan Drugs in Clinical Development Phase: Preregistration
    • Table 5-8: Europe - Orphan Drugs in Clinical Development Phase: Registration
    • Table 6-1: Europe - Marketed Orphan Drug by Indication & Brand Name
    • Table 7-1: orphan Drug Clinical Study Hurdles
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