Press release
Global Orphan Drug Pipeline & Regulatory Insight 2025
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
Report TOC
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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