Orphan Disease Industry, and Challenges Till 2027

Global Orphan Drugs Market – Overview

The global orphan drugs market is growing exponentially owing to unmet needs for rare diseases and the growing investment in research and development are the major factor driving the orphan drugs Market.

The global Orphan Drug Market Industry was estimated to be $93 billion in 2015 and is projected to reach $200 billion by 2022. Orphan drugs, represented 35% of the industry’s new drug approvals. The orphan drugs are disorders that affects a small percentage of the population. The major driving factor for the growth are low marketing cost, extensive exclusivity, government support leading to economic, legislative and tax benefits, new technology development such as hybridoma, gene mapping, and DNA recombinant.

A pharmaceutical product aimed at rare diseases or disorders is known as an orphan drug. The Orphan Drug Act of 1983 has been financially incentivised through US law for the development of orphan drugs. According to the National Organization for Rare Disorders (NORD) established an act which estimates that approximately 30 million Americans suffer from 7,000 different types of rare diseases. Prior to the incorporation of Orphan Drug Act, 38 drugs from orphan category were already approved. The success of this act in the US led to its adoption in other key markets, most notably by the European Union in the early 2000 and in 1993 for Japan.

There are an estimated 30 million in Europe and 350 million people worldwide suffering from rare diseases. Almost half of the rare diseases are genetic in nature, with 50% of children being affected. Approved drug treatment for about 5% of rare diseases are available that accounts to only 326 new drugs being approved by the FDA and are supplied in the market.

The competition from generics and biosimilars, safety concern, extensive post market surveillance, and costly clinical trials are some factors that threats the growth of this market. The hindrance of commercialization and distribution channels can also be due to the differential availability of the product in the developed and developing countries due to social and economic factors.

The global market for vacuum blood collection tube is expected grow at a CAGR of 11.6% over the forecasted period.

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Industry Updates

Jan, 2017 Acucela Inc. received orphan drug FDA approval for emixustat for treating Stargardt disease. This approval was expected to be crucial for the treatment of this rare genetic disease.

Nov, 2015 Astellas Pharma acquired Ocata Therapeutics to increase its product portfolio for treatment of retinal disorders including Stargardt disease and age-related macular degeneration

June, 2015 Bayer Healthcare and Johns Hopkins University entered into a five year collaboration to develop for the treatment of Stargardt’s disease, retinal vein occlusion, diabetic macular edema, age-related macular degeneration, and geographic atrophy.

March, 2014 Santen Pharmaceuticals signed a pact with TRACON pharmaceuticals to develop and commercialize Tracon’s anti-VEGF product TRC105, an orphan drug category for the treatment of various eye related disorder

April, 2012 Baush and Lomb acquired Ista Pharmaceuticals for increasing its customer base and acquiring pipline drugs for the treatment of Stargardt disease.

Global Orphan Drugs Market – Regional Analysis

Depending on geographic region, Globally North America is the largest market for orphan drugs. Factors such as high product demand and the increasing government incentives are expected to promote market growth in the US region, which is considered to be the highest revenue-generating region in the Americas.

Europe is the second-largest market for Global orphan drugs. The future market for orphan drugs is anticipated to be dominated by the developed regions with developing regions act as a supporting pillar to its growth.

Asia Pacific will be the fastest growing regional market and is likely to be the key to the future. Middle East & Africa is expected to have limited but steady growth in the market.

Global Orphan Drugs Market – Company Analysis

This market is highly fragmented and is dominated by five major vendors including Bristol-Mayer Squibb Company, Celgene Corporation, F. Hoffmann La Roche, Novartis AG, and Pfizer Inc. as they have extensive product portfolios. Factors such as the high regulatory barriers, patent expiry of branded drugs, stringent rules and regulations, and decreased R&D productivity, pose significant challenges to the vendors during the forecast period.

Other prominent players in the value chain include AstraZeneca plc, AbbVie Inc., Aegerion Pharmaceuticals, Inc., GlaxoSmithKline plc, Vertex Pharmaceuticals, Merck & Co., Inc., Boehringer Ingelheim GmbH, Amgen Inc., and Actelion Pharmaceuticals Ltd.

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