Global Orphan Drug Market Opportunity To Surpass US$ 300 Billion By 2026

"Global Orphan Drug Clinical Trials, Patent & Guidelines Insight 2026" Report Highlights:

o Global Orphan Drug Market Opportunity: US$ 300 Billion
o US Dominates Global Orphan Drug Market: 50% Market Share
o US Orphan Drug Opportunity To Surpass: US$ 150 Billion
o Global Orphan Drug Clinical Insight: More Than 900 Drugs
o Clinical Insight on Marketed Orphan Drugs: More Than 400 Drugs
o Oncology To Dominate Orphan Drug Development: 35% Share
o FDA & EMA Regulations For Orphan Drugs
o Orphan Drug Designation Criteria & Reimbursement Policy by Country

Download Report: https://www.pnspharma.com/buy-report.php?reporttitle=Global-Orphan-Drug-Clinical-Trials%2C-Patent-%26-Guidelines-Insight-2026

The research report "Global Orphan Drug Clinical Trials, Patent & Guidelines Insight 2026" discusses about the recent trends and opportunities that the orphan drug market has brought into the pharmaceutical sector. The information related to the current status of the evolving market strategies and ongoing clinical studies by the companies involved in development of the orphan drugs is elaborately discussed in the report. The research report shares the information related to drugs that have been successfully designated as orphan drugs by respective approval authorities, with an exclusive insight on clinical uniqueness and patent information. In addition to the commercial information, the report brings a deep insight about the efforts that have been put to establish the market as it is now.

" Global Orphan Drug Market Is Estimated To Witness 150% Market Growth By 2026 As Compare To 2018"

1. What Are Orphan Drugs?

2. Global Orphan Drug Designation Criteria

2.1 US
2.2 Europe
2.3 Asia & Australia
2.3.1 Japan
2.3.2 Taiwan
2.3.3 South Korea
2.3.4 Australia

3. Market Exclusivity & Patent Protection for Orphan Drugs

4. Global Orphan Drug Reimbursement Policy

4.1 US
4.2 Europe
4.3 Asia

5. Global Orphan Drug Market Opportunity Insight 2026

5.1 Global Orphan Drug Sales Opportunity
5.2 Market by Class Variation
5.3 Market by Therapeutic Application
5.4 Market by Regions

6. FDA Regulation for Clinical Trials Orphan Designated Drugs

6.1 Content & Format Of A Request For Written Recommendations
6.2 Provision For Granting & Refusing Written Recommendations
6.3 Content And Format Of A Request For Orphan Drug Designation
6.4 Verification Of Orphan Drug Status & Resident Agent For Foreign Sponsor
6.5 Timing Of Requests For Orphan Drug Designation & Designation Of Already Approved Drugs
6.6 Deficiency Letters And Granting Orphan Drug Designation
6.7 Refusal To Grant Orphan Drug Designation
6.8 Amendment & Change In Ownership To Orphan Drug Designation
6.9 Publication & Revocation Of Orphan Drug Designations
6.10 Annual Reports Of Holder Of Orphan Drug Designation
6.11 Scope & FDA Recognition Of Orphan Drug Exclusive Approval
6.12 Protocols for Investigations & Availability of Information

7. EMA Regulations for Clinical Trials of Orphan Designated Drugs

7.1 Committee for Orphan Medicinal Products
7.2 How to Apply for Orphan Designation in Europe
7.3 Marketing Authorization & Market Exclusivity
7.4 Transferring An Orphan Designation To Another Sponsor
7.5 Mandatory Submission Of Annual Report On Development
7.6 Incentives For Micro, Small And Medium-Sized Enterprises
7.7 Fee Reductions For Designated Orphan Medicinal Products
7.8 Procedure for Orphan Designation & Incentives for R&D ( Regulation (EC) No 141/2000 )

8. Asian Regulations for Clinical Trials of Orphan Designated Drugs

8.1 Taiwan Rare Disease and Orphan Drug Act
8.2 Japan Orphan Drug Regulation

9. Global Orphan Clinical Pipeline Overview

9.1 By Company
9.2 Drug Class
9.3 Formulation
9.4 Indication
9.5 Region
9.6 Priority Status
9.7 Patient Segment
9.8 By Phase

10. Unknown Phase - Orphan Drugs Clinical Pipeline By Company, Country & Indication

10.1 Overview
10.2 Clinical Pipeline Insight

11. Research Phase - Orphan Drugs Clinical Pipeline By Company, Country & Indication

11.1 Overview
11.2 Clinical Pipeline Insight

12. Preclinical Phase - Orphan Drugs Clinical Pipeline By Company, Country & Indication

12.1 Overview
12.2 Clinical Pipeline Insight

13. Clinical Phase - Orphan Drugs Clinical Pipeline By Company, Country & Indication

13.1 Overview
13.2 Clinical Pipeline Insight

14. Phase-I - Orphan Drugs Clinical Pipeline By Company, Country & Indication

14.1 Overview
14.2 Clinical Pipeline Insight

15. Phase-I/II - Orphan Drugs Clinical Pipeline By Company, Country & Indication

15.1 Overview
15.2 Clinical Pipeline Insight

16. Phase-II - Orphan Drugs Clinical Pipeline By Company, Country & Indication

16.1 Overview
16.2 Clinical Pipeline Insight

17. Phase-II/III - Orphan Drugs Clinical Pipeline By Company, Country & Indication

17.1 Overview
17.2 Clinical Pipeline Insight

18. Phase-III - Orphan Drugs Clinical Pipeline By Company, Country & Indication

18.1 Overview
18.2 Clinical Pipeline Insight

19. Preregistration - Orphan Drugs Clinical Pipeline By Company, Country & Indication

19.1 Overview
19.2 Clinical Pipeline Insight


20. Registered - Orphan Drugs Clinical Pipeline By Company, Country & Indication

20.1 Overview
20.2 Clinical Pipeline Insight

21. Marketed Orphan Drugs Clinical Insight By Company, Country & Indication

21.1 Overview
21.2 Clinical Pipeline Insight

22. Competitive Landscape

22.1 AOP Orphan
22.2 Agenus
22.3 Alexion
22.4 Bristol Myers Squibb
22.5 Biogen Idec
22.6 Celgene
22.7 Eli Lilly
22.8 Genethon
22.9 Genzyme Corporation
22.10 Glaxosmithkline
22.11 Merck
22.12 Novartis Pharmaceuticals
22.13 Orphan Europe
22.14 Pfizer
22.15 Prosensa
22.16 Rare Disease Therapeutics
22.17 Roche
22.18 Sanofi
22.19 Shire
22.20 Teva Pharmaceutical


List of Figures

Figure 5-1: Global - Orphan Drugs Market Value (US$ Billion), 2018-2026
Figure 5-2: US - Orphan Drugs Market Value (US$ Billion), 2018-2026
Figure 5-3: Europe - Orphan Drugs Market Value (US$ Billion), 2018-2026
Figure 5-4: Asia* - Orphan Drugs Market Value (US$ Billion), 2018-2026
Figure 5-5: Biological & Non Biological Orphan Drug Segment (%), 2018 & 2026
Figure 5-6: Biological & Non Biological Orphan Drug Market (US$ Billion), 2018-2026
Figure 5-7: Global Orphan Drugs Market by Therapeutic Area, 2018 & 2026
Figure 5-8: Regional Markets for Orphan Drugs, 2018 & 2026
Figure 8-1: Japan Orphan Drug/Medical Device Designation System
Figure 8-2: Japan Orphan Drug/Device Designation Process
Figure 9-1: Global - Orphan Drugs Clinical Pipeline by Company (Number), 2020 till 2026
Figure 9-2: Global - Orphan Drugs Clinical Pipeline by Drug Class (Number), 2020 till 2026
Figure 9-3: Global - Orphan Drugs Clinical Pipeline by Formulation (Number), 2020 till 2026
Figure 9-4: Global - Orphan Drugs Clinical Pipeline by Indication (Number), 2020 till 2026
Figure 9-5: Global - Orphan Drugs Clinical Pipeline by Region (Number), 2020 till 2026
Figure 9-6: Global - Orphan Drugs Clinical Pipeline by Priority Status (Number), 2020 till 2026
Figure 9-7: Global - Orphan Drugs Clinical Pipeline by Patient Segment (Number), 2020 till 2026
Figure 9-8: Global - Orphan Drugs Clinical Pipeline by Phase (Number), 2020 till 2026
Figure 9-9: Global - Orphan Drugs Clinical Pipeline by Phase (%), 2020 till 2026
Figure 10-1: Share of Initial Development Drug in Total Orphan Drug Pipeline, 2020
Figure 11-1: Share of in Research Phase Orphan Drugs in Total Pipeline, 2020
Figure 12-1: Share of in Preclinical Phase Orphan Drugs in Total Pipeline, 2020
Figure 13-1: Share of in Clinical Phase Orphan Drugs in Total Pipeline, 2020
Figure 14-1: Share of in Phase-I Orphan Drugs in Total Pipeline, 2020
Figure 15-1: Share of in Phase-I/II Orphan Drugs in Total Pipeline, 2020
Figure 16-1: Share of in Phase-II Orphan Drugs in Total Pipeline, 2020
Figure 17-1: Share of in Phase-II/III Orphan Drugs in Total Pipeline, 2020
Figure 18-1: Share of in Phase-III Orphan Drugs in Total Pipeline, 2020
Figure 19-1: Share of in Preregistration Orphan Drugs in Total Pipeline, 2020
Figure 20-1: Share of in Registered Orphan Drugs in Total Pipeline, 2020
Figure 21-1: Share of in Marketed Orphan Drugs in Total Pipeline, 2020

Contact:
Rajesh Arora
rajesh@pnspharma.com

Delhi
India

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.

This release was published on openPR.