Orphan Drugs Market: Opportunities and Forecasts by 2020

An orphan drug is meant to treat a rare medical condition which is commonly known as orphan disease. The definition of orphan disease varies by countries. According to US, the prevalence of any disease less than 200,000 is considered as an orphan disease complying with the Orphan Drug Act of January 1983 (ODA). While Japan considers a disease tagged orphan if the prevalence is below 50,000. Statistics indicates that currently there are more than 5,000 rare diseases listed globally with addition of at least 4-5 new rare diseases being identified by scientists and researchers. There are currently close to 70 million people suffering from orphan diseases across the world from over 5000 rare diseases. The growth of pharma has slowed considerably in recent times owing to significant challenges from the generic market. The research and development along with commercialization of a drug consumes enormous amount of company resources that need to be safeguarded and returned through revenues. The spiraling cost of drug development along with stringent regulations, and low return on investment in developing treatment for orphan diseases often discourages large and small pharmaceutical innovators. In recent time many pharmaceutical and biotechnology companies have invested hefty sum in R&D to resolve challenges related to the treatment of rare diseases. Focused approach towards developing new drug molecules is in line to treat several rare diseases and improve the lives of many sufferers. There are close to 300 drugs and devices that have been approved in the last 25 years, which slows the slow progress and initiation of this pharma segment.

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The most commonly known rare diseases are Type 1 Gaucher disease, Pulmonary arterial hypertension, Acute promyelocytic leukemia (APL), Acromegaly, Fabry’s disease (alpha-galactosidase A deficiency), High-grade dysplasia (HGD), Hairy cell leukemia, Hyperammonemia, etc. Many of the rare diseases symptoms may appear at birth or during childhood, for ex- patent ductus arteriosus (PDA), cystic fibrosis and infantile spinal muscular atrophy. While, around 50-60% of rare diseases appear during adulthood, such as renal cell carcinoma and acute myeloid leukemia. Around 70-80% of rare diseases have been identified to be of genetic origin. A small proportion of rare diseases are the results of bacterial or viral infection and allergies. United States is the major contributor with more than 50% market share of the total orphan drugs sales globally. Biological orphan drugs segment holds a bigger share compared to non-biological segment. Oncology is the top most revenue generating sector in orphan drugs segment, contributing around 40% of the market share. Around $35 billion is the total revenue generated in the year 2011- 2012 and expected to grow at a double digit CAGR to reach around $50 billion in the year 2015-2016. Companies developing orphan drugs have good advantage due to lucrative incentives attached with orphan drugs and commercial benefits such as less timeline for clinical trials, high chances of regulatory approvals, premium prices and reduced marketing cost, appreciable reimbursement support from governments.

Recently, many global pharmaceutical players received approval for orphan drugs for example- GSK’s Lexiva (Fosamprenavir) for HIV infection and Novartis’s Visudyen (Verteporfin) for age-related macular degeneration. Other key players catering in this segment are Actelion Pharmaceuticals, Cephalon, Pfizer, Sanofi (acquired Genzyme in 2011), Novartis, J&J, Roche, Bayer, etc. This report intends to provide qualitative analysis for market segmentation, treatment algorithms, drivers and inhibitors, opportunities (organic and non-organic), pipeline analysis and the competitive landscape of the market. Along with this quantitative analysis will be provided for treatment by disease segments and geography. In 2013, a record 260 molecules were given orphan designation in Europe.

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