Home > Healthcare & Medical Devices > Orphan Drugs Market

Orphan Drugs Market Size, COVID-19 Impact Analysis, Regional Outlook, Application Potential, Price Trends, Competitive Market Share & Forecast, 2022 – 2028

  • Report ID: GMI4451

Orphan Drugs Market Size are slated to grow at significant rate from 2022 to 2028 propelled by the growing need for therapeutics subject to the rising incidences of rare diseases worldwide. According to reliable estimates, approximately 25 to 30 million people in the United States are currently living with a rare disease. Moreover, in India, nearly 72 to 96 million people are affected by rare diseases.

Orphan drugs are medicinal or therapeutic products intended for the detection, prevention, or treatment of life-threatening or critical diseases that are extremely rare.

One of the major factors contributing to the elevating growth of market worldwide is the introduction of various norms and regulations that promote the development and sales of these drugs to a small portion of population.

Besides, various countries have amended legislation like Orphan Drug Act to provide incentives to drug manufactures to urge them to develop drugs for rare diseases. For instance, recently, Inhibrx announced that the U.S FDA had offered orphan drug designation for its INBRX-109 for the treatment of chondrosarcoma.

However, high cost of research and development and orphan drug production and commercialization would impede the growth structure of market share over the forecast period. Nevertheless, surging awareness of the use of orphan drugs for treatment of such diseases would generate lucrative proceeds for the global market in the coming years.

Based on the component type, the biologics segment is projected to reap significant gains through 2028. This can be credited to the increasing presence of product offerings classified as biologics. It has been claimed that of the total number of drugs with active orphan status, nearly 39% are biologics. Many new biologics receive Orphan Drug designation for treating rare diseases.

Considering the therapeutic area, orphan drugs are likely to be extensively used to treat autoimmune diseases including ANCA Associated Vasculitis (AAV). AAV is a severe, rare and fatal autoimmune disease that is caused by autoantibodies and involves kidneys. The high prevalence of AAV would demand treatment through orphan drugs. As per industry experts, AAV impacts nearly 40,000 people in the US and more than 75,000 people in Europe. Various pharmaceutical companies are striving to develop therapeutic drugs for the treatment of AAV. In 2021, the US FDA granted Tavneos orphan-drug designation for autoimmune diseases including C3G, AAV, and atypical hemolytic uremic syndrome.

Online distribution of orphan drugs would complement the growing market dynamics over the coming years. This growth can be attributed to the ease offered by the platform to the consumer in terms of purchase of drugs. In addition, online pharmacy has registered strong growth during COVID-19 times due to the increasing number of consumers shifting to online pharmacies for purchase of these medications.

Asia Pacific orphan drugs market growth is poised to come from the rising incidences of rare diseases and growing cognizance of these across various developing economies. Moreover, increasing healthcare spendings and investments in the medical sector would further augment the APAC market share over the foreseeable time span.

Major participants operating in the overall market include Roche, Novartis International AG, Glenmark Pharmaceuticals, Pfizer Inc., Celgene Corporation (Bristol Myers Squibb), GlaxoSmithKline, and others. These industry leaders are involved in different marketing strategies like mergers and acquisitions, product launches, and partnerships, to consolidate their position in the global market.

COVID-19 crisis and its influence on the overall orphan drugs market progression

The novel COVID-19 outburst had enabled certain pharmaceutical markets to be affected moderately due to the postponement of treatment and diagnosis of non-life-threatening diseases. This holds significantly true for individuals suffering from rare diseases as more healthcare and financial resources by various central governments were focused on the fight against the pandemic. This apparently brought down the sales of orphan drugs, negatively impacting the market share.

The market research report of orphan drugs includes in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2017 to 2028 for the following segments:

Market, By Therapeutic Area

  • Autoimmune Diseases
  • Blood-related Diseases
  • Cancer
  • Cardiovascular Diseases
  • Ophthalmic Diseases
  • Genetic Disorders
  • Infectious Diseases
  • Neurological Disorders
  • Respiratory Disorders
  • Others

Market, By Drug Components

  • Biologics
  • Non-biologics

Market, By Route of Administration

  • Oral
  • Parenteral
    • Intravenous
    • Subcutaneous

Market, By Distribution Channel

  • Hospital pharmacy
  • Retail pharmacy
  • Specialty pharmacy

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Russia
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
  • Latin America
    • Argentina
    • Mexico
    • Brazil
  • Middle East and Africa
    • South Africa
    • Saudi Arabia
    • UAE


What Information does this report contain?

Historical data coverage: 2017 to 2021; Growth Projections: 2022 to 2028.
Expert analysis: industry, governing, innovation and technological trends; factors impacting development; drawbacks, SWOT.
6-7 year performance forecasts: major segments covering applications, top products and geographies.
Competitive landscape reporting: market leaders and important players, competencies and capacities of these companies in terms of production as well as sustainability and prospects.

Buy Now

Access to only 1 person; cannot be shared; cannot be printed
Access for 2 to 5 users only within same department of one company
Access to a company wide audience; includes subsidiary companies or other companies within a group of companies

Budget constraints? Get in touch with us for special pricing

Request Discount

Our Market Research Reports Include:

  • Market snapshot
  • Market Segmentation
  • Value Chain Analysis
  • Growth Dynamics
  • Potential Market Opportunities
  • Regulatory Overview
  • Technology Evolution
  • Innovation & Sustainability