Dublin, Dec. 15, 2016 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Global Orphan Drug Clinical Pipeline Insight 2022" drug pipelines to their offering.
Global Orphan Drug Clinical Pipeline Insight 2022 report gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe.
The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.
As of 2016, almost 30 million people in the U.S. and 350 million people worldwide suffer from rare ailments known as Orphan Diseases. The name comes from the treatment meted out for such diseases, wherein the pharma industry was reluctant to develop drugs for such illnesses due to their economic unviability.
Elaborating the concept, a rare disease or orphan diseases are the one's which affects only a small population. As per the official definition, rare diseases are classified as those that affect fewer than 200,000 in the United States and less than 5 in 10,000 in the EU. Consequently, in earlier times such truncated prevailed diseases were least attractive to the researchers and the investors. Previously, the market for orphan drugs was not as lucrative as it is today.
Nevertheless, the Scenario has changed after the Orphan Drug Act (ODA), 1983 was passed in United States and later various countries enacted similar laws. The number of requests for orphan drug designation received by FDA's Office of Orphan Products Development (OOPD) has grown dramatically in recent years and is prompting FDA to adjust its timeframes for reviewing orphan drug designations in order to meet the demand.
Key Topics Covered:
1. Global Orphan Drug Market Overview
1.1 Market Overview
1.2 Global Orphan Drug Clinical Pipeline Overview
2. Global Orphan Drug Designation Criteria
2.1 US Food and Drug Administration (US FDA)
2.2 European Medicines Agency (EMA)
2.3 Japan
2.4 Taiwan
2.5 Korean Food and Drug Administration (KFDA)
2.6 Australia
Global Orphan Drug Clinical Pipeline by Company, Indication & Phase
3. Orphan Drug Development Phase: Unknown
4. Orphan Drug Development Phase: Research
5. Orphan Drug Development Phase: Preclinical
6. Orphan Drug Development Phase: Clinical
7. Orphan Drug Development Phase: Phase-0
8. Orphan Drug Development Phase: Phase - I
9. Orphan Drug Development Phase: Phase - I/II
10. Orphan Drug Development Phase: Phase - II
11. Orphan Drug Development Phase: Phase - II/III
12. Orphan Drug Development Phase: Phase - III
13. Orphan Drug Development Phase: Preregistration
14. Orphan Drug Development Phase: Registered
15. Marketed Orphan Drug Clinical Insight by Company, Indication & Phase
16. Discontinued & Suspended Orphan Drugs in Clinical Pipeline by Company, Indication & Phase
16.1 No Development Reported
16.2 Discontinued
16.3 Preregistration Submission Withdrawal
16.4 Marketed Withdrawal
16.5 Suspended
17. Competitive Landscape
17.1 AOP Orphan
17.2 Agenus
17.3 Alexion
17.4 Bristol Myers Squibb
17.5 Biogen Idec
17.6 Celgene
17.7 Eli Lilly
17.8 Genethon
17.9 Genzyme Corporation
17.10 Glaxosmithkline
17.11 Merck
17.12 Novartis Pharmaceuticals
17.13 Orphan Europe
17.14 Pfizer
17.15 Prosensa
17.16 Rare Disease Therapeutics
17.17 Roche
17.18 Sanofi
17.19 Shire
17.20 Teva Pharmaceutical
For more information about this drug pipelines report visit http://www.researchandmarkets.com/research/tk94d7/global_orphan