Orphan drugs to create paradigm shift in Pharma industry, says F&S

The economic recovery process has proved difficult for the pharmaceutical industry. Factors like patent expiry, dry pipeline and strict approval guidelines, have slowed down the attractive drug discovery and industry growth. Coupled with an investment risk in new therapy or molecules, this creates a challenge for the industry to overcome. However, in the midst of the current status, there seems to be a bend in the road - marked by the evolution of a paradigm shift in the industry: Orphan drugs.

"While the pharmaceutical industries have been focusing on blockbuster small molecules (chemical drugs) for high revenue generation in the past, it is expected that in five years, around $90.0 billion worth of branded drugs will lose their exclusivity," finds Frost & Sullivan health care consultant Shabeer Hussain. "The current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies and they are moving to a new business model - 'Niche busters,' also called orphan drugs," he added.

Support from FDA and EU Commission

This new business model will provide an approach to an integrated health care solution, thereby enabling pharmaceutical companies to develop newer areas of therapeutics, diagnosis, treatment, monitoring and patient support. Orphan drugs provide attractive opportunities to reduce the impact of revenue loss due to the patent expiry for blockbuster drugs. Clinical trials for orphan drugs are run efficiently with smaller patient groups, thereby reducing costs significantly. Incentives for drug development provided by governments, the US Food and Drug Administration and the European Union Commission support in special protocols are a further boost for companies developing orphan drugs.