Global Orphan Drug Market to Reach USD 120 Billion by 2018

Release Date: 11-Feb-2014

Global Orphan Drug Market Report Findings:

• Orphan Designated Drugs in Clinical Phase: 600
• Marketed Orphan Designated Drugs: 281
• Highest Number of Drugs in Phase-2 Trial: 231
• US Dominates Clinical Trial Process: 350 in Pipeline (Research till Registration)
• Indication for Clinical Trials for Orphan Drug: More than 30% for Cancer Treatment
• Share of Biological in Orphan Drug: More than 60%
• Key Market: US (Sales > US$ 40 Billion)

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.

Key Highlights of Report

• Why Shift to Orphan Drugs
• Global & Regional Orphan Drug Market Overview
• Orphan Drug Designation Criteria Across US, Europe & Asia
• Market Specific Reimbursement Policy for US, Europe & Asia
• Regulatory Framework for US, Europe & Asia
• Orphan Drug Pipeline by Phase, Orphan Designated Indication & Country
• Competitive Landscape

Global Orphan Drug Report Table of Contents

1. Introduction to Orphan Drugs

2. Why Shift from Non-Orphan to Orphan Drugs?

3. Global Orphan Drug Market Outlook

4. US Orphan Drug Market Outlook

5. Europe Orphan Drug Market Outlook

6. Asia Orphan Drug Market Outlook

7. Global Orphan Drug Pipeline Insight by Phase, Orphan Designated Disease & Country

8. Key Issue to be Resolved

9. Competitive Landscape

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