Global Orphan Drugs Market Expected to Reach $338.51 bn by 2026

Orphan Drugs are implemented to heal rare and deadly diseases. Generally, these diseases appeal to a very small amount of population. “The overall global orphan drugs market is expected to grow at a significant compound CAGR rate of 11.14% from USD 145.44 billion in 2018 to USD 338.51 billion in 2026". Many government authorities encourage to develop and market these drugs. The Global Orphan Drugs Market is expected to grow rapidly in the future with some emerging trends. With the massive development in the field of drug development, many key players came into existence.

The Orphan Drugs Market consists of many experts with lots of experience in manufacturing drugs. Many vendors recruited skilled researchers, scientists, professionals who are trained in the domain of drug development. In the Global market, small players may face huge competition from the leading players. It is estimated that small and medium-sized markets would depend on incentives provided by the government to survive. The new comers are estimated to start from the basics by manufacturing drugs and then after upgrading to more complex drugs. 

Global Orphan Drugs Market: Competitive Landscape

The key players in the Global Market for orphan drugs include Celgene Corporation, Novartis AG, Pfizer Inc., GlaxoSmithKline plc, Alexion Pharmaceuticals Inc, and Johnson & Johnson. These players are key in manufacturing orphan drugs and estimated to elevate in the Future. The demand for orphan drugs is growing rapidly in recent times because of orphan

Global Orphan Drugs Market: Leading Segments

The Orphan Drug Market is segmented as disease type, product type, and distribution channels.

Disease Type: - Cardiovascular, Neurology, Oncology, Pulmonary, metabolic disorder, hematology, endocrinology, and infectious diseases.

Product Type: - Biological and Non-Biological

Distribution Channel: - Hospital Pharmacies, Specialty Pharmacies, Retail Pharmacies

Global Orphan Drugs Market: Region-Wise Outlook

Orphan Drug Market is segmented into seven key regions: North America, Latin America, and Western Europe, Eastern Europe and the Asia Pacific excluding Japan, Middle East, and Africa. North America is dominating in global drug market followed by Europe. It is estimated that the Asian Pacific region is growing rapidly in Healthcare Infrastructure and Research and Development. India, China, and Japan are set to be the most attractive countries for orphan drugs market due to the untapped market.

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Global Orphan Drugs Market: Market Trends

• Highest Market Share for Biological Orphan Drug

Biological Orphan Drug is expected to grow at a good pace and may reach the highest market share due to the higher cost of biological drugs in contrast to non-biological drugs. Approval of multiple indications for biological orphan drugs has resulted in growth and also encouraging new market entrants in the orphan drug market.

Global Orphan Drugs Market: Growth Drivers

• The escalation in demand for orphan drugs.

• Increase in recognition of the disease and drugs among patients and physicians.

• The rise in the growth of investment in research and development, economic, legislative, and tax benefits provided by governments

Global Orphan Drugs Market: Restraints

• One of the major factors is the high cost for development of drugs, which is estimated to be the growth of the overall orphan drugs market in the following years.

•  Factors hampering the market are a high treatment cost of diseases, availability of small patient pool for clinical trials & marketing.

• Threats like competition from generics and biosimilars, costlier clinical trials and extensive post-market surveillance, monopolized and unitary market that are to be managed.

•  Hindered commercialization and distribution

Global Orphan Drugs Market: Opportunities

• Specific Skills and Knowledge is required to market a rare disease drug which is different for a mass-market product.

• In Future, an increase in novel indications for known orphan drugs and increasing untapped economies account for new market opportunities for orphan drug manufacturers.

• Regulatory edges like longer market exclusively, reduced fees, and tax incentives.

Orphan Drugs Market Based on Disease Type (US$ Mn)


  • Neurologic diseases

  • Infectious diseases

  • Oncologic diseases

  • Hematologic & immunologic diseases

Orphan Drugs Market Based on Indication (Market Size and Forecast, and Y-o-Y Growth, (US$ Mn)


  • Non-Hodgkin Lymphoma

  • Cystic Fibrosis

  • Glioma

  • Duchenne Muscular Dystrophy

  • Graft vs. Host Disease

Orphan Drugs Market Based on Geographic Region (Market Size and Forecast, and Y-o-Y Growth, (US$ Mn)


  • APAC

  • Europe

  • North America

  • South America

Orphan Drugs Market Competitive Analysis (Financial, Product Overview, and Market Strategies)


  • Aptose Biosciences

  • Eiger BioPharmaceuticals, Inc.

  • Fibrocell Science, Inc.

  • Leadiant Biosciences, Inc.

  • Mereo BioPharma Group Plc

  • Sangamo Therapeutics

  • Soleno Therapeutics, Inc.

  • uniQure N.V.

  • Zynerba Pharmaceuticals, Inc.

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