The Global Market for Orphan Drugs is Projected to Reach US$225 Billion by 2024

Increased Government Support, Product Launches, and Huge Unmet Needs Drive the Global Orphan Drugs Market, According to a New Report by Global Industry Analysts, Inc.

GIA launches comprehensive analysis of industry segments, trends, growth drivers, market share, size, and demand forecasts on the global Orphan Drugs market. The global market for Orphan Drugs is projected to reach US$225 billion by 2024, driven by various regulatory and government initiatives to increase R&D, new product launches, and huge unmet needs.

The global Orphan drugs market is exhibiting healthy growth prospects, driven by favourable acts, regulations, financial incentives, and marketing exclusivities.  Backed by increased government support, pharma companies are beginning to consider orphan drugs as potential contributors to company revenues, and are plunging into the development of drugs for rare diseases. The low number of orphan drugs approved (just around 500-600) compared to the 7000 diseases deemed as rare, offers huge untapped market potential. Low competition, quick and cost-effective development vis-à-vis non-orphan drug development, longer life cycle owing to market exclusivity, and favourable payer reimbursement policies, are driving players to develop new orphan drugs. However, despite the optimistic outlook, major restraints include poorer understanding of the diseases, heterogeneous patient population with variable phenotypes, lack of clinical data, and high pricing, among others. Furthermore, with about 75% of rare disease patients being children, the recruitment and management of children for clinical trials is a significant challenge.

Over the past few years, the number of designations for orphan drugs increased. In addition, driven by the increasing number of rare disease drugs launched in the market, orphan drugs are witnessing higher and faster sales. In terms of therapeutic indications, there is a significant rise witnessed in the number of individuals affected from rare cancer conditions, such as renal cell carcinoma, GBM, lysosomal storage disorders, and acute myeloid leukaemia. Oncological diseases are therefore expected to drive the orphan drugs market. 

As stated by the new market research report on Orphan Drugs, the U.S. represents the largest and the fastest growing market worldwide. The market is being propelled by the financial incentives and seven year market exclusivity period offered to manufacturers by the US FDA. Additionally, the premium prices and full reimbursements commanded by orphan drugs drive growth in the market. Europe closely follows the US due to the adoption of regulation similar to the US market, as a measure to encourage the development of drugs targeting orphan diseases. In Japan, introduction of the Orphan Drug Development Program enabled the entry of a number of orphan drug developers, spurring the number of orphan drug approvals. In Asia-Pacific, population growth and the increasing prevalence of rare genetic diseases is driving manufacturers of orphan drugs to invest in the region. The governments in this region are also taking initiatives to increase investment in the development of orphan drugs, thus driving market growth.

Key players in the market include AbbVie Inc., Actelion Pharmaceuticals Ltd., Alexion Pharmaceuticals Inc., Amgen Inc., AstraZeneca Plc., Bayer AG, Biogen Inc., BioMarin Pharmaceutical Inc., Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company, Celgene Corp., CEL-SCI Corporation, Concordia International Corp., Eli Lilly and Company, F. Hoffmann-La Roche Ltd., Johnson & Johnson, Merck & Co. Inc., Merck Serono International S.A., Novartis AG, Pfizer Inc., Recordati S.p.A., Shire Plc., Sanofi SA, Genzyme Corp., and Vertex Pharmaceuticals, among others.

The research report titled “Orphan Drugs: A Global Strategic Business Report” announced by Global Industry Analysts Inc., provides a comprehensive review of market trends, issues, drivers, mergers, acquisitions and other strategic industry activities of major companies worldwide. The report provides market estimates and projections in terms of Value (US$) for all major geographic markets, such as the United States, Japan, Europe, and Rest of World. Key product segments covered include Biologic and Non-biologics.


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