Orphan Drugs Market Size Worth $460.76 Billion By 2030 | CAGR: 12.2%

Orphan Drugs Market Size Worth $460.76 Billion By 2030 | CAGR: 12.2%

The global Orphan Drugs Market size is expected to reach USD 460.76 billion by 2030, according to a new study by Polaris Market Research. The report “Orphan Drugs Market Share, Size, Trends, Industry Analysis Report, By Therapy Area (Oncology, Hematology,  Neurology, Endocrinology, Cardiovascular, Respiratory, Immunotherapy, and Others); By Drug Type; By Distribution Channel; By Region; Segment Forecast, 2022 - 2030” gives a detailed insight into current market dynamics and provides analysis on future market growth.


Orphan drugs are medications that are used to treat life-threatening or extremely severe illnesses or problems that are unsuitable for prevention or treatment. The increasing prevalence of rare diseases is a significant factor driving the market growth during the forecast period.


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The Genetic and Rare Diseases Information Center (GARD) defines a rare disease as one that affects fewer than 200,000 people in the United States. There are approximately 7,000 known rare diseases, and one in every ten Americans (or 30 million people) has a rare disease.

With enhanced knowledge and awareness of rare diseases, many important clinical-stage biopharmaceutical businesses and defined industry players have robust pipeline applicants for orphan drugs currently in clinical trials. This growing interest in rare disease therapeutics is due to the fact that global pharmaceutical advancements resulting in blockbuster drug discovery are more likely in rare disorders than in pharmaceutical and medical portfolios.

Growing R&D investments by leading companies for orphan drug creation of new product offerings is one of the important driving factors occurring in the global market. The Center for Drug Research and Evaluation (CDER) of the United States Food and Drug Management (FDA) announced the launch of the Speeding up Rare Disease Cures (ARC) Initiative in May 2022 to accelerate the development of new therapies for rare diseases.

A rare illness is defined by the Food and drug administration as one that affects fewer than 200,000 people in the United States, and it is estimated that more than 30 million Americans have a rare disease. Only about 10% of the approximately 7,000 known rare conditions have FDA-approved treatments.


Orphan Drugs Market Report Highlights

  • The biological drugs segment is dominating with a market share during the forecast period owing to increasing various types of rare diseases which can be preventable by biological drugs and increasing investments in the adoption of drugs for rare diseases by major players.
  • Cardiovascular segment is growing at a significant CAGR over the forecast period is growing due to the rising prevalence of cardiac disease, and significant others are some of the key factors driving the orphan drug industry's overall expansion in recent years. Furthermore, the use of technological solutions for development is thought to be a major driver of the orphan drug market growth.
  • Asia Pacific is expected to grow at the fastest rate in the market during the forecast period. Infrastructure development in the region, rising disposable incomes, and favorable government policies all contribute to the region's growth.
  • The global players include AstraZeneca, Alexion Pharmaceutical, Bayer AG, Celegne Corporation, DAIICHI SANKYO, GlaxoSmithKline, Johnson & Johnson, Takeda Pharmaceutical, and others.


Polaris Market Research has segmented the Orphan Drugs market report based on  Therapy area, Drug Type, Distribution Channel, and region:


Orphan Drugs, Therapy area (Revenue - USD Billion, 2018 - 2030)

  • Oncology
  • Hematology
  • Neurology
  • Endocrinology
  • Cardiovascular
  • Respiratory
  • Immunotherapy
  • Others


Orphan Drugs, Drug Type Outlook (Revenue - USD Billion, 2018 - 2030)

  • Biologics
  • Non-Biologics


Orphan Drugs, Distribution Channel (Revenue - USD Billion, 2018 - 2030)

  • Hospital pharmacy
  • Retail pharmacy
  • Online sales
  • Others


Orphan Drugs, Regional Outlook (Revenue - USD Billion, 2018 - 2030)

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Russia
    • Netherlands
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Indonesia
    • Malaysia
  • Latin America
    • Argentina
    • Brazil
    • Mexico
  • Middle East & Africa
    • UAE
    • Saudi Arabia
    • Israel
    • South Africa