The global orphan drugs market size reached US$ 129 Billion in 2019. Orphan drugs refer to medications that are intended for diagnosing, preventing and treating rare, life-threatening diseases or disorders. As they traditionally had a limited market, very few pharmaceutical companies pursued research into these products. Moreover, orphan drug research is dependent on government incentives. However, the growing number of rare diseases lacking treatment, along with improving access to healthcare and spending capacity of individuals, has led to a significant rise in the demand for orphan drugs.
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At present, incentives for drug development provided by government authorities in various countries are encouraging pharmaceutical companies to develop orphan drugs. For instance, the United States Food and Drug Administration (USFDA) offers benefits such as fast-track approval, protocol assistance, waiver of fees and marketing exclusivity to manufacturers, facilitating the development and commercialization of diagnostic tools and treatments devoted to rare diseases. Furthermore, there has been a rise in the development of orphan biological drugs that can prevent or treat various forms of cancer, tumors and blood disorders, which, in turn, is contributing to the market growth. In 2019, the Center for Drug Evaluation and Research (CDER), a division of the USFDA, approved various new orphan drug therapies for patients with numerous disorders, including tenosynovial giant cell tumor, sickle cell disease, diffuse large B-cell lymphoma, mantle cell lymphoma, acquired thrombotic thrombocytopenic purpura, beta-thalassemia, and acute hepatic porphyria. On account of these factors, the market is expected to exhibit moderate growth during 2020-2025.
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Market Segmentation:
Breakup by Drug Type:
Biological
Non-Biological
Breakup by Disease Type:
Oncology
Hematology
Neurology
Cardiovascular
Others
Breakup by Phase:
Phase I
Phase II
Phase III
Phase IV
Breakup by Top Selling Drugs:
Revlimid
Rituxan
Copaxone
Opdivo
Keytruda
Imbruvica
Avonex
Sensipar
Soliris
Others
Breakup by Distribution Channel:
Hospital Pharmacies
Retail Pharmacies
Online Stores
Others
Breakup by Region:
North America
Asia Pacific
Europe
Latin America
Middle East and Africa
Key highlights of the report:
Market Performance (2014-2019)
Market Outlook (2020- 2025)
Industry Trends
Market Drivers and Success Factors
The Impact of COVID-19 on the Market
Value Chain Analysis
Structure of the Global Market
Comprehensive mapping of the competitive landscape
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