” 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
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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
Contact:
Rajesh Arora
Sr. Analyst
PNS Pharma
rajesh@pnspharma.com
+91-11-47067990
