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Orphan drug: Development trends and strategies
The growth of pharma industries has slowed in recent years because of various reasons such as patent expiries, generic competition, drying pipelines, and increasingly stringent regulatory guidelines. Many blockbuster drugs will loose their exclusivity in next 5 years. Therefore, the current economic...
Autores principales: | , , , |
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Formato: | Texto |
Lenguaje: | English |
Publicado: |
Medknow Publications
2010
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2996062/ https://www.ncbi.nlm.nih.gov/pubmed/21180460 http://dx.doi.org/10.4103/0975-7406.72128 |
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author | Sharma, Aarti Jacob, Abraham Tandon, Manas Kumar, Dushyant |
author_facet | Sharma, Aarti Jacob, Abraham Tandon, Manas Kumar, Dushyant |
author_sort | Sharma, Aarti |
collection | PubMed |
description | The growth of pharma industries has slowed in recent years because of various reasons such as patent expiries, generic competition, drying pipelines, and increasingly stringent regulatory guidelines. Many blockbuster drugs will loose their exclusivity in next 5 years. Therefore, the current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies from the essential medicines to the new business model — niche busters, also called orphan drugs. Orphan drugs may help pharma companies to reduce the impact of revenue loss caused by patent expiries of blockbuster drugs. The new business model of orphan drugs could offer an integrated healthcare solution that enables pharma companies to develop newer areas of therapeutics, diagnosis, treatment, monitoring, and patient support. Incentives for drug development provided by governments, as well as support from the FDA and EU Commission in special protocols, are a further boost for the companies developing orphan drugs. Although there may still be challenges ahead for the pharmaceutical industry, orphan drugs seem to offer the key to recovery and stability within the market. In our study, we have compared the policies and orphan drug incentives worldwide alongwith the challenges faced by the pharmaceutical companies. Recent developments are seen in orphan drug approval, the various drugs in orphan drug pipeline, and the future prospectives for orphan drugs and diseases. |
format | Text |
id | pubmed-2996062 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | Medknow Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-29960622010-12-21 Orphan drug: Development trends and strategies Sharma, Aarti Jacob, Abraham Tandon, Manas Kumar, Dushyant J Pharm Bioallied Sci Invited Review The growth of pharma industries has slowed in recent years because of various reasons such as patent expiries, generic competition, drying pipelines, and increasingly stringent regulatory guidelines. Many blockbuster drugs will loose their exclusivity in next 5 years. Therefore, the current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies from the essential medicines to the new business model — niche busters, also called orphan drugs. Orphan drugs may help pharma companies to reduce the impact of revenue loss caused by patent expiries of blockbuster drugs. The new business model of orphan drugs could offer an integrated healthcare solution that enables pharma companies to develop newer areas of therapeutics, diagnosis, treatment, monitoring, and patient support. Incentives for drug development provided by governments, as well as support from the FDA and EU Commission in special protocols, are a further boost for the companies developing orphan drugs. Although there may still be challenges ahead for the pharmaceutical industry, orphan drugs seem to offer the key to recovery and stability within the market. In our study, we have compared the policies and orphan drug incentives worldwide alongwith the challenges faced by the pharmaceutical companies. Recent developments are seen in orphan drug approval, the various drugs in orphan drug pipeline, and the future prospectives for orphan drugs and diseases. Medknow Publications 2010 /pmc/articles/PMC2996062/ /pubmed/21180460 http://dx.doi.org/10.4103/0975-7406.72128 Text en © Journal of Pharmacy and Bioallied Sciences http://creativecommons.org/licenses/by/2.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Invited Review Sharma, Aarti Jacob, Abraham Tandon, Manas Kumar, Dushyant Orphan drug: Development trends and strategies |
title | Orphan drug: Development trends and strategies |
title_full | Orphan drug: Development trends and strategies |
title_fullStr | Orphan drug: Development trends and strategies |
title_full_unstemmed | Orphan drug: Development trends and strategies |
title_short | Orphan drug: Development trends and strategies |
title_sort | orphan drug: development trends and strategies |
topic | Invited Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2996062/ https://www.ncbi.nlm.nih.gov/pubmed/21180460 http://dx.doi.org/10.4103/0975-7406.72128 |
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