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Global Orphan Drug Pipeline & Regulatory Insight 2025

12-20-2018 01:09 PM CET | Health & Medicine

Press release from: PNS Pharma

” Global Orphan Drug Pipeline & Regulatory Insight 2025″ Report Highlights:

Global Orphan Drug Market Overview: US$ 260 Billion Opportunity
Global Orphan Drug market by Segment
Regulatory Landscape: USA, Europe & Asia
Orphan Drug Designation & Reimbursement Policy: USA, Europe & Asia
Global Orphan Drug Clinical Pipeline Insight: 973 Drugs
Marketed Orphan Drug Clinical Insight: 366 Drugs


Download Report: http://www.pnspharma.com/buy-report.php?reporttitle=Global-Orphan-Drug-Pipeline-%26-Regulatory-Insight-2025



Orphan Drugs: Regimens For Rare Diseases


Drivers of Orphan Drug Commercialization
2.1 Cost Aspects

2.2 Expiration of Patented Drugs

2.3 Economic & Non-Economic Incentives

2.4 Advantage of Patent & Market Exclusivity

2.5 High Investment in Research & Development



Global Orphan Drug Market Perspectives: Current Market Evaluations


Global Orphan Drug Market by Segmentation
4.1 Market by Class Variation

4.2 Market by Therapeutic Application

4.3 Market by Regions



Global Orphan Drug Clinical Pipeline Overview


Global Orphan Drug Designation Criteria
6.1 US

6.2 Europe

6.3 Asia & Australia

6.3.1 Japan

6.3.2 Taiwan

6.3.3 South Korea

6.3.4 Australia



Global Orphan Drug Reimbursement Policy
7.1 US

7.2 Europe

7.3 Asia



FDA Regulation for Clinical Trials Orphan Designated Drugs
8.1 Content & Format Of A Request For Written Recommendations

8.2 Provision For Granting & Refusing Written Recommendations

8.3 Content And Format Of A Request For Orphan Drug Designation

8.4 Verification Of Orphan Drug Status & Resident Agent For Foreign Sponsor

8.5 Timing Of Requests For Orphan Drug Designation & Designation Of Already Approved Drugs

8.6 Deficiency Letters And Granting Orphan Drug Designation

8.7 Refusal To Grant Orphan Drug Designation

8.8 Amendment & Change In Ownership To Orphan Drug Designation

8.9 Publication & Revocation Of Orphan Drug Designations

8.10 Annual Reports Of Holder Of Orphan Drug Designation

8.11 Scope & FDA Recognition Of Orphan Drug Exclusive Approval

8.12 Protocols for Investigations & Availability of Information



EMA Regulations for Clinical Trials of Orphan Designated Drugs
9.1 Committee for Orphan Medicinal Products

9.2 How to Apply for Orphan Designation in Europe

9.3 Marketing Authorization & Market Exclusivity

9.4 Transferring An Orphan Designation To Another Sponsor

9.5 Mandatory Submission Of Annual Report On Development

9.6 Incentives For Micro, Small And Medium-Sized Enterprises

9.7 Fee Reductions For Designated Orphan Medicinal Products

9.8 Procedure for Orphan Designation & Incentives for R&D



Asian Regulations for Clinical Trials of Orphan Designated Drugs
10.1 Taiwan Rare Disease and Orphan Drug Act

10.2 Japan Orphan Drug Regulation





Global Orphan Drug Clinical Pipeline by Company, Indication & Phase
11.1 Unknown

11.2 Research

11.3 Preclinical

11.4 Clinical

11.5 Phase-I

11.6 Phase-I/II

11.7 Phase-II

11.8 Phase-II/III

11.9 Phase-III

11.10 Preregistration

11.11 Registered



Marketed Global Orphan Drug Clinical Insight by Company & Indication


Competitive Landscape
13.1 AOP Orphan

13.2 Agenus

13.3 Alexion

13.4 Bristol Myers Squibb

13.5 Biogen Idec

13.6 Celgene

13.7 Eli Lilly

13.8 Genethon

13.9 Genzyme Corporation

13.10 Glaxosmithkline

13.11 Merck

13.12 Novartis Pharmaceuticals

13.13 Orphan Europe

13.14 Pfizer

13.15 Prosensa

13.16 Rare Disease Therapeutics

13.17 Roche

13.18 Sanofi

13.19 Shire

13.20 Teva Pharmaceutical

PNS Pharma is a pioneer in offering exclusive research reports for the pharmaceuticals industry. PNS Pharma offers Syndicated Research Reports on Drug Pipeline and Company Pipeline Analysis. These reports include comprehensive information related to the development of various drugs across clinical pipeline. Further, the reports include details on the originator, Owner, License, Chemical Formula, Patent Information, Phase of development, and Phase of development by country for each specific drug. The reports on company pipeline include all the drugs developed by particular companies across different therapeutic segments and phases and in different countries.

Rajesh Sharma
rajesh@pnspharma.com
PNS Pharma
New Delhi – 110 001, India
+91-11-47067990

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