Pharma Focus Asia
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Orphan Drugs – Sourcing API from Emerging Markets

Vaishnavi Loganathan, Research Analyst, Beroe Inc.

Abstract

The drugs which are developed for the treatment of rare diseases (diseases which affect a very small population) are called Orphan Drugs. The Governments of various countries provide 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.

Introduction

Orphan drugs are those drugs which are targeted to treat rare diseases. There are nearly 6000 to 7000 rare diseases and new diseases are being discovered every day. The increasing need for orphan drugs and the regulatory relaxations provided by the governing bodies drives the market for orphan drug manufacturing. The global orphan drugs market is expected to reach USD 112 billion in 2017 growing at a CAGR of 5.4% from USD 86 billion in 2012. The top five revenue generating orphan drugs are listed below.

Developing drugs for rare diseases is usually considered expensive since it affects a small population. In order to encourage orphan drug development the government provides various incentives, regulatory relaxations and financial benefits to the drug developers. In spite of the relaxations provided leading orphan drug manufacturers like Roche, Novartis, Celegene and so on face difficulties in cost reduction while manufacturing orphan drugs.

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