Europe Orphan Drug Market Sales Revenue Opportunity Report 2018

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.

Download Report:

https://www.kuickresearch.com/report-Europe-Orphan-Drug-Market-Outlook-2018.php

For Report Sample Contact: neeraj@kuickresearch.com or +91-11-47067990

"Europe Orphan Drug Market Outlook 2018" 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

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

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

Kuick Research is a market research and analytics company that provides targeted information for critical decisions at business, product and service levels. We are quick, predictive and known by the recommendations we have made in the past. Our result-oriented research methodology offers understanding of multiple issues in a short period of time and gives us the capability to keep you full with loads of practical ideas. By translating research answers into strategic insight and direction, we not only rate the success potential of your products and/or services, but also help you identify the opportunities for growth in new demographies and find ways to beat competition.

Neeraj Chawla
neeraj@kuickresearch.com
KuicK Research
Avanta Business Center 4th Floor,
Statesman House Barakhamba Road,
Connaught Place New Delhi – 110 001, India
+91-11-47067990

This release was published on openPR.