Journal of Pharmacy And Bioallied Sciences

INVITED REVIEW
Year
: 2010  |  Volume : 2  |  Issue : 4  |  Page : 290--299

Orphan drug: Development trends and strategies


Aarti Sharma, Abraham Jacob, Manas Tandon, Dushyant Kumar 
 Drug Regulatory Affairs, Getwell Pharmaceuticals, Udyog Vihar, Gurgaon, India

Correspondence Address:
Aarti Sharma
Drug Regulatory Affairs, Getwell Pharmaceuticals, Udyog Vihar, Gurgaon
India

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.


How to cite this article:
Sharma A, Jacob A, Tandon M, Kumar D. Orphan drug: Development trends and strategies.J Pharm Bioall Sci 2010;2:290-299


How to cite this URL:
Sharma A, Jacob A, Tandon M, Kumar D. Orphan drug: Development trends and strategies. J Pharm Bioall Sci [serial online] 2010 [cited 2020 Sep 23 ];2:290-299
Available from: http://www.jpbsonline.org/article.asp?issn=0975-7406;year=2010;volume=2;issue=4;spage=290;epage=299;aulast=Sharma;type=0