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Global Orphan Drug Market Outlook 2018

The global pharmaceutical industry has been experiencing a slow growth in recent years

owing to many factors such as expiration of patents, competition from generic drugs segment,
exhausting pipelines, and an increasingly stringent regulatory framework. It is most likely that
many blockbuster drugs would lose their exclusivity in the next 5 year horizon.

Thus, due to significant competition from generics and the current economic situation, the

focus area of the pharmaceutical companies is undergoing a paradigm shift from


manufacturing traditional essential medicines to investing in the new business model, which is

also called orphan drugs. The returns on investment from orphan drugs are expected to help
the pharma companies to overcome the impact of revenue loss due to expiry of patents of
blockbuster drugs.

The major drivers for companies to increasingly invest in orphan drugs include government
incentives for drug development and strong support from the FDA and EU Commission in

special protocols. Inspite of pharma companies facing many obstacles in this field, this
segment of orphan drugs is likely to have the potential to provide the key to recovery and
stability within the market.

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.

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

Global & Regional Orphan Drug Market Overview

Orphan Drug Designation Criteria Across Key Markets

Market Specific Reimbursement Policy & Regulatory Framework

Orphan Drug Pipeline by Phase, Orphan Designated Disease & Country


Competitive Landscape

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Global 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. Global Orphan Drug Market Outlook
3.1 Market Overview
3.2 Biological & Non-Biological Orphan Drugs
3.3 Therapeutic Segmentation
3.4 Regional Segmentation
4. US Orphan Drug Market Outlook
4.1 Orphan Drug Designation Criteria
4.2 Market Overview
4.3 Reimbursement Policy
4.4 Regulatory Framework
5. Europe Orphan Drug Market Outlook
5.1 Orphan Drug Designation Criteria
5.2 Market Overview
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Global Orphan Drug Market Outlook 2018


5.3 Reimbursement Policy
5.4 Regulatory Framework
6. Asia Orphan Drug Market Outlook
6.1 Orphan Drug Designation Criteria
6.2 Market Overview
6.3 Reimbursement Policy
6.4 Regulatory Framework
7. Global Orphan Drug Pipeline Insight by Phase, Orphan Designated Disease & Country
7.1 Clinical Phase: Research
7.2 Clinical Phase: Preclinical
7.3 Clinical Phase: Phase I
7.4 Clinical Phase: Phase I/II
7.5 Clinical Phase: Phase II
7.6 Clinical Phase: Phase II/III
7.7 Clinical Phase: Phase III
7.8 Clinical Phase: Preregistration
7.9 Clinical Phase: Registered
8. Key Issue to be Resolved
8.1 High Initial Investment
8.2 Clinical Study Hurdles
8.3 Regulatory Hurdles
8.4 Different Reimbursement Policy
8.5 Distribution Challenges

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Global Orphan Drug Market Outlook 2018


9. Competitive Landscape
9.1 Pfizer
9.2 Roche
9.3 Sanofi
9.4 Rare Disease Therapeutics
9.5 Glaxosmithkline
9.6 Merck
9.7 Novartis Pharmaceuticals
9.8 Alexion
9.9 Celgene
9.10 Biogen Idec
9.11 Eli Lilly
9.12 Bristol Myers Squibb

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: Global Orphan Drugs Market Value (US$ Billion), 2012-2018
Figure 3-2: Biological & Non Biological Orphan Drug Segment (%), 2012 & 2018
Figure 3-3: Biological & Non Biological Orphan Drug Market (US$ Billion), 2012-2018
Figure 3-4: Global Orphan Drugs Market by Therapeutic Area, 2012 & 2018
Figure 3-5: Regional Markets for Orphan Drugs, 2012 & 2018
Figure 4-1: US Market for Orphan Drugs (US$ Billion), 2012-2018
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Global Orphan Drug Market Outlook 2018


Figure 4-2: US - Orphan Drug Development by Clinical Phase (%)
Figure 4-3: US - Number of Orphan Drug by Clinical Phase
Figure 5-1: European Market for Orphan Drugs (US$ Billion), 2012-2018
Figure 5-2: Europe - Orphan Drug Development by Clinical Phase (%)
Figure 5-3: Europe - Number of Orphan Drug by Clinical Phase
Figure 6-1: Asia- Orphan Drug Development by Clinical Phase (%)
Figure 6-2: Asia - Number of Orphan Drug by Clinical Phase
Figure 6-3: Japan Orphan Drug/Medical Device Designation System
Figure 6-4: Japan Orphan Drug/Device Designation Process
Figure 7-1: Global - Orphan Drug Development by Clinical Phase (%)
Figure 7-2: Global - Number of Orphan Drug by Clinical Phase
Figure 7-3: Global - Number of Orphan Drug by Clinical Phase & Region
Figure 8-1: Orphan Drug Regulatory Hurdles

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 Costs
Table 2-5: Orphan Drugs in the EU and their Costs
Table 2-6: Incentives for the Development of Orphan Drugs
Table 2-7: Orphan Drug Incentives by Country
Table 7-1: Global - Orphan Drugs in Clinical Development Phase: Research
Table 7-2: Global -Orphan Drugs in Clinical Development Phase: Preclinical
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Global Orphan Drug Market Outlook 2018


Table 7-3: Global - Orphan Drugs in Clinical Development Phase I
Table 7-4: Global - Orphan Drugs in Clinical Development Phase I/II
Table 7-5: Global - Orphan Drugs in Clinical Development Phase II
Table 7-6: Global - Orphan Drugs in Clinical Development Phase II/III
Table 7-7: Global - Orphan Drugs in Clinical Development Phase III
Table 7-8: Global - Orphan Drugs in Clinical Development Phase: Preregistration
Table 7-9: Global - Orphan Drugs in Clinical Development Phase: Registered

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