表紙
市場調査レポート

欧州のオーファンドラッグ市場および治験動向

Europe Orphan Drug Market & Clinical Trial Insight 2015

発行 PNS Pharma 商品コード 322432
出版日 ページ情報 英文 1100 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=105.42円で換算しております。

ご注意: DRM (デジタル著作権管理システム) 付PDFになります。制限内容はお問合せください。
Multi-User License: 会社全体での使用権

Back to Top
欧州のオーファンドラッグ市場および治験動向 Europe Orphan Drug Market & Clinical Trial Insight 2015
出版日: 2015年01月07日 ページ情報: 英文 1100 Pages
概要

欧州では奇病は優先分野とみなされ、1990年代早期から同分野の研究は重要視されてきました。2000年以降に認可された奇病治療薬は100を超え、オーファンドラッグの開発を促進するために欧州委員会は様々な取組をおこなっています。

当レポートでは、欧州のオーファンドラッグ市場の概要と法規制の枠組み、臨床パイプライン動向、治験段階および上市済みオーファンドラッグの概要、参入各社の競合動向などをまとめています。

第1章 オーファンドラッグとは

  • イントロダクション
  • オーファンドラッグ認定のための好ましい評価基準

第2章 欧州のオーファンドラッグ指定基準

  • 指定基準
  • 治験依頼者申請手順

第3章 欧州のオーファンドラッグ償還政策

第4章 市場概要

  • 現在の市場シナリオ
  • 治験動向

第5章 オーファンドラッグに関する欧州の法規制

  • オーファンドラッグ委員会
  • 欧州でのオーファンドラッグ指定の申請方法
  • 販売認可と市場の独占性
  • オーファンドラッグ指定の他の治験依頼者への譲渡
  • 開発に関する年次報告書の提出義務
  • 零細、中小企業向けインセンティブ
  • 指定されたオーファンドラッグのための値下げ
  • オーファンドラッグ指定手順と研究開発インセンティブ

第6章 欧州のオーファンドラッグパイプライン:国、企業、適応、相別

  • 研究
  • 前臨床
  • 臨床
  • 第1相
  • 第1/2相
  • 第2相
  • 第2/3相
  • 第3相
  • 登録前
  • 登録済み

第7章 欧州の上市済みオーファンドラッグ:国、企業、適応別

第8章 中止・中断されたオーファンドラッグ臨床パイプライン

  • 開発報告されていないもの
  • 中止されたもの
  • 市場から撤退したもの
  • 中断しているもの

第9章 競合環境

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

図表

目次

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
Back to Top