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Europe Orphan Drug Market Outlook 2018

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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.

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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 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

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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 Tables

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

List of Figures