Orphan Drugs Market to Reach USD 340.84 Billion with 10.5% CAGR by 2027; Increasing Number of Regulatory Approvals will Contribute to Market Growth, says Fortune Business Insights™

Key Prominent Players Covered in the Orphan Drugs Market Research Report Are Amgen Inc., Bayer AG, F. Hoffmann-La Roche Ltd, Alexion Pharmaceuticals Inc., Novo Nordisk A/S, Novartis AG, Bristol-Myers Squibb Company, AstraZeneca, DAIICHI SANKYO COMPANY, LIMITED, GlaxoSmithKline plc and other key market players.


Pune, Oct. 26, 2020 (GLOBE NEWSWIRE) -- The global orphan drugs market size is projected to reach USD 340.84 billion by the end of 2027. Increasing number of regulatory approvals will have a positive impact on the growth of the overall market in the coming years.

According to a report published by Fortune Business Insights, titled “Orphan Drugs Market Size, Share & COVID-19 Impact Analysis, By Therapy Area (Oncology, Hematology, Neurology, Endocrinology, Cardiovascular, Respiratory, Immunotherapy, and Others), By Drug Type (Biologics, and Non-Biologics), By Distribution Channel (Hospital Pharmacy, Retail Pharmacy, Online Sales, and Others), and Regional Forecast, 2020-2027,” the market was worth USD 151.00 billion in 2019 and will exhibit a CAGR of 10.5% during the forecast period, 2020-2027.

Industry Developments:

June 2020 – Chiasma, Inc. announced that the company had received the FDA approval for their product offering of Mycapssa for the treatment of acromegaly, a rare disorder.

June 2020 – Agios Pharmaceuticals, Inc. announced that the company had received the FDA Orphan Drug Designation for their pipeline candidate of Mitapivat for the treatment of Thalassemia.

May 2020 – AstraZeneca, and Daiichi Sankyo Company announced that the company had received the FDA Orphan Drug Designation for their product offering of Enhertu (trastuzumab deruxtecan) for the treatment of patients with gastric cancer, including gastroesophageal junction cancer.

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Non-essential Medical Treatments to be Postponed during the Covid-19 Pandemic, Leaving Manufacturers in a State of Turmoil

The recent coronavirus outbreak has instilled panic among people across the world. Accounting to the rapid spread of the disease in several countries, strict measures have been taken to curb the epidemic. Moreover, governments across the world are implementing strategies that will result in more attention towards the treatment of the coronavirus disease.

This has indirectly halted the non-essential and even a few long-term disease treatment procedures. This has certainly left manufacturers in a state of confusion. Given the current situation, the market is set to be negatively affected by the coronavirus outbreak.

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Increasing Number of Regulatory Approvals will Emerge in Favor of Orphan Drugs Market Growth

The report encompasses several factors that have contributed to the growth of the overall market in recent years. Accounting to the massive potential held by orphan drugs, there are numerous clinical trials associated with the drugs.

The increasing number of successful clinical trials has resulted in an increase in the number of regulatory approvals across the world. In May 2019, Pfizer announced that it has received approval from the US Food and Drug Administration for its latest products aimed at treatment of cardiomyopathy.

The company announced that it has received approval from the FDA for VYNDAQEL and VYNDAMAX, two products that have shown signs of promise in the clinical phases. Fortune Business Insights states that increasing number of such regulatory approvals for products of large scale companies will have a positive impact on the growth of the overall market in the coming years.

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List of companies profiled in the Orphan Drugs Market report:

•              Amgen Inc. (Thousand Oaks, U.S.)

•              Bayer AG (Leverkusen, Germany)

•              F. Hoffmann-La Roche Ltd (Basel, Switzerland)

•              Alexion Pharmaceuticals Inc. (Boston, U.S.)

•              Novo Nordisk A/S (Bagsværd, Denmark)

•              Novartis AG (Basel, Switzerland)

•              Bristol-Myers Squibb Company (New York, U.S.)

•              AstraZeneca (Cambridge, U.K.)

•              DAIICHI SANKYO COMPANY, LIMITED (Tokyo, Japan)

•              GlaxoSmithKline plc (Brentford, U.K.)

•              Other Players

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North America Currently Dominates the Market; Increasing Spending on R&D by Major Companies to Aid Growth

The report analyses the ongoing market trends across five major regions, including North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. Among all regions, the market in North America currently dominates the market.  The high spending on research and development of orphan drugs, coupled with the presence of several large-scale local manufacturers will bode well for market growth.

The rising demand for the product in the United States as well as Canada will also contribute to the growth of the market in the coming years. As of 2019, the market in North America was worth USD 81.22 billion and this value is projected to increase further in the coming years. The market in Europe will derive growth from the adoption of technologically advanced manufacturing equipment by major companies in the region.

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Orphan Drugs Market Segmentations:

By Therapy Area

•              Oncology

•              Hematology

•              Neurology

•              Endocrinology

•              Cardiovascular

•              Respiratory

•              Immunotherapy

•              Others

By Drug Type

•              Biologics

•              Non-Biologics

By Distribution Channel

•              Hospital Pharmacy

•              Retail Pharmacy

•              Online Sales

•              Others

By Geography

•              North America (U.S. and Canada)

•              Europe (U.K., Germany, France, Italy, Spain, Scandinavia, and Rest of Europe)

•              Asia-Pacific (Japan, China, India, Australia, Southeast Asia, and Rest of Asia- Pacific)

•              Rest of the World

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  • Annual reports, investor presentation, SEC filings, and press releases of companies operating in the market
  • Studies published by relevant associations MedTech Europe; American College of Radiology; Cancer Council Australia; Japan Hospital Association, etc.), government sources (Centers for Disease Control & Prevention, Ministry of Health, Labour & Welfare, Japan; National Health Service, England, etc.), international organizations (World Health Organization, The Organization for Economic Co-operation and Development, Eurostat, etc.), and articles published by Research Gate, NCBI, etc.
  • Website, reports, and press releases of end user facilities – Hospitals, Ambulatory Surgery Centres, Clinics
  • Industry journals and paid databases


  • Details such as revenues, market share, strategies, growth rate, product & their pricing by region/country for all major companies
  • Details in relation to prevalence, incidence, patient numbers, distribution of patients, average price of treatment, etc.
  • Number of end user facilities by region/country and average annual spending or procurement of devices by type of end user facility
  • Number of procedures and average price of procedures
  • Replacement rate and pricing of capital equipment
  • Market dynamics in relation to the market under focus – Drivers, restraints, trends, and opportunities
  • Market & technological trends, new product developments, product pipeline.

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