Orphan Drugs - Sourcing API from Emerging Markets

The drugs which are developed for the treatment of rare diseases (diseases which affect a very small population) are called Orphan Drugs. The Government of various countries provides incentives and patent exclusivities in order to encourage orphan drug development. Orphan drug manufacturers face several challenges in spite of the relaxations provided. One such difficulty is managing the cost involved in manufacturing orphan drugs. There are two areas where cost savings can be achieved during manufacturing, using single-use systems and reducing the raw material cost. Orphan drug manufacturing involves expensive Active Pharmaceutical Ingredient (API) when compared to non-orphan drugs. The cost of raw material can be reduced by sourcing the API form Contract Manufacturing Organizations (CMOs) who offer these high potent API at competitive prices. A complete market analysis suggests that such types of CMOs are located in emerging markets. This particular breed of CMOs who cater to personalized medicine and orphan drugs are slowly evolving in the market and are located predominantly in emerging markets. The advantages of sourcing the API for orphan drugs from emerging markets are discussed in this article.   Author: Vaishnavi Loganathan