Orphan Drugs Market Size Worth USD 355 Billion by 2030 at 9.2% CAGR – Report by Market Research Future (MRFR)

Orphan Drugs Market Trends and Insights by Drug Type (Biologics & Non-Biologics), Sale (Generics & Prescribed), Drug (Revlimid, Rituxan, Opdivo, & Others), Therapy Class (Oncology, Blood, Endocrine, & Others), by Region (Americas, Europe, Asia-Pacific, and Middle East & Africa), Competitive Market Growth, Size, Share and Forecast to 2030


New York, USA, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Orphan Drugs Market Overview

According to a Comprehensive Research Report by Market Research Future (MRFR), “Orphan Drugs Market Information By Drug type, Drug Therapy Class, Sale, and Region - Forecast till 2030", the market is expected to reach USD 355 Billion by 2030 at 9.2% CAGR during the forecast period 2022-2030.

Orphan Drugs Market Synopsis

The critical medical problems for which orphan medications are produced are often uncommon in the history of medicine. Compared to more common medical disorders, these orphan diseases are less common, limiting the potential for orphan drug commercialization. Some major obstacles that orphan drugs had to overcome included lack of money, ethical concerns, scientific hiccups, and functional and operational problems. As a result, considerable support is needed for these suppliers to develop and commercialize these life-saving medications. Legislative measures and policies have recently supported the development of orphan pharmaceuticals. In the US, for instance, any medication created following the orphan drug act is regarded as an orphan medication and is granted regional approval.

The number of occurrences is used in some nations, like Japan, to classify a medicine as an orphan drug. Several developing and industrialized nations have passed laws to encourage the creation of orphan pharmaceuticals and guarantee that patients have unrestricted access to them. Additionally, more of these medicines are projected to be commercialized during the projection period due to the FDA's approval of several orphan drugs connected to cancer, notably in oncology therapy. Market growth will be fueled by increased demand for immunomodulators, which regulate or boost the immune system.

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Report Scope:

Report AttributeDetails
Market Size in 2030USD 355 Billion
CAGR9.2%
Base Year2021
Forecast Period2022-2030
Historical Data2020
Forecast UnitsValue (USD Billion)
Report CoverageRevenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments CoveredBy Drug Type, Sale, Drug, Therapy Class and End User
Geographies CoveredNorth America, Europe, Asia-Pacific, and Rest of the World (RoW)
Key Market DriversThe rapid increase of these orphan health conditions
The advent of new technologies like DNA recombinant, hybridoma and gene mapping

Orphan Drugs Market Competitive Landscape:

The core contenders in the orphan drugs market are:

  • Abbvie Inc.
  • Johnson & Johnson (Janssen Global Services, LLC)
  • Novartis International Ag (Sandoz)
  • Pfizer Inc.
  • Amgen Inc.
  • Amryt Pharma Plc.
  • Bristol-Myers Squibb Company
  • F. Hoffmann-La Roche Ltd.
  • Glaxosmithkline Plc (Gsk)
  • Sanofi S.A

Market U.S.P. Covered:

Market Drivers:

The market for orphan pharmaceuticals is expanding because of favorable government regulations and an increase in the occurrence of uncommon diseases. The possibility of commercial exclusivity for orphan medication producers also contributes to the industry's expansion. On the other hand, during the projection period, there are likely to be lucrative chances for market growth due to the high growth potential in unexplored emerging economies and the expansion of novel indications for well-known orphan medications. Additionally, it is anticipated that the commercialization of these treatments, particularly in the oncology therapy sector, will expand due to the FDA's clearance of several cancer-related orphan drugs throughout the forecast period. Increased demand for immunomodulators, which regulate or augment the immune system, will drive market expansion. The need for immunomodulators is anticipated to be fueled by rising rates of infectious diseases in developed and emerging nations and higher drug costs, which will support the expansion of the orphan drug market during the forecast period.

Market Restraints:

The discovery and marketing of medicines for rare diseases are receiving more attention globally, although there are still certain obstacles to the market's expansion. The high price tag attached to these treatments is one of the major impediments. Nevertheless, the market's expansion is anticipated to be hampered over the projected period by a small patient group for clinical studies, product marketing, and high treatment costs per patient.

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COVID 19 Analysis 

The COVID-19 epidemic has hampered workflows in the medical community in different parts of the world. Numerous companies, including parts of the healthcare industry, have been forced to close their doors due of the disease temporarily. The orphan drug market is also experiencing negative growth, which can be attributed to many factors, including a decline in screening services, restricted access to specialists, treatment interruptions, limited operations in the majority of industries, insufficient funding for research & academic institutes, temporary shutdown of major academic institutes, disrupted supply chains, and difficulties in providing necessary/post-sales services. The delay in the detection and treatment of non-life-threatening diseases is projected to have a greater impact on some pharmaceutical markets due to the COVID-19 pandemic. This seems particularly true for those with uncommon diseases because various countries allocated greater financial and medical resources to combat the pandemic.

Orphan Drugs Market Segmentation

By drug type, the market includes biologics & non-biologics.

By sale, the market includes generics & prescribed.

By drug, the market includes Rituxan, Opdivo, & Revlimid.

By therapy class, the market includes blood, endocrine, & oncology.

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Orphan Drugs Market Regional Insights

For the foreseeable future, North America is expected to continue to dominate the orphan drug market. In North America, the United States holds the largest market share. A drug designated as an orphan drug in the US receives tax incentives, a user fee waiver, and seven years of marketing exclusivity upon FDA certification for a specific purpose is one factor contributing to market expansion. Due to the region's vast patient population and widespread adoption of cutting-edge medicines for rare diseases, the European market is anticipated to expand quickly.

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Due to established market participants, the quick expansion of the medical infrastructure, and greater disposable incomes throughout the area, the Asia-Pacific region is experiencing significant growth in the orphan medication business. With rising healthcare expenses and increased awareness of rare diseases, the Asia Pacific region is expected to show the greatest growth in this market. The orphan medicine business has also recently benefited from the region's favorable government policies. As a result, the region is accelerating growth more than other regions, including the US and the EU. The use of orphan pharmaceuticals is expanding thanks to the region's expanding oncology clinics and health communities.

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