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Orphan Drug Rare Disease Drug Market Sales Clinical Trials Pipeline Exclusivity

December 7th, 2018 PNS Pharma Releases

” 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

Report TOC

 

  1. Orphan Drugs: Regimens For Rare Diseases

 

  1. 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

 

  1. Global Orphan Drug Market Perspectives: Current Market Evaluations

 

  1. Global Orphan Drug Market by Segmentation

4.1 Market by Class Variation

4.2 Market by Therapeutic Application

4.3 Market by Regions

 

  1. Global Orphan Drug Clinical Pipeline Overview

 

  1. 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

 

  1. Global Orphan Drug Reimbursement Policy

7.1 US

7.2 Europe

7.3 Asia

 

  1. 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

 

  1. 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

 

  1. Asian Regulations for Clinical Trials of Orphan Designated Drugs

10.1 Taiwan Rare Disease and Orphan Drug Act

10.2 Japan Orphan Drug Regulation

 

 

  1. 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

 

  1. Marketed Global Orphan Drug Clinical Insight by Company & Indication

 

  1. 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

 

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