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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