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2022

Orphan Drugs Market

Orphan Drugs Market Size, Share, Competitive Landscape and Trend Analysis Report, by Disease Type : Global Opportunity Analysis and Industry Forecast, 2021-2030

LS : Pharmaceuticals

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Author's: Suraj Sajeev| Monika Darandale | Roshan Deshmukh
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Orphan Drugs Market Statistics 2030:

The global orphan drugs market size was valued at $1,40,000.0 million in 2020 and is projected to reach $4,35,686.3 million by 2030 registering a CAGR of 11.8% from 2021 to 2030. An orphan drug is a special pharmaceutical agent, designed and developed to treat rare medical conditions. The definition of an orphan drug varies throughout the world. According to the U.S., any drug developed under the Orphan Drug Act of January 1983 (ODA) is an orphan drug. The ODA is a federal law concerning rare diseases (orphan diseases) that are of low prevalence or affect less than 200,000 people in the U.S. (less than 5 per 10,000 in the community). Similarly, in Europe, an orphan drug is defined as a drug that treats a disease or disorder that affects less than 5 in 10,000 (Orphan Drug Regulation 141/2000). A drug used to treat a disease with less than 50,000 prevalent cases (0.4%) is known as an orphan drug in Japan (Ministry of Health, Labor, and Welfare, Japan).

Increase in prevalence of rare diseases and favorable government policies drive the growth of the orphan drugs market. In addition, availability of market exclusivity for orphan drug developers further fuels the growth of the market. However, limited patient pool for clinical trials and product marketing, and high treatment costs per patient are expected to hinder the growth of the market during the forecast period. On the other hand, high growth potential in untapped emerging economies, and growth in novel indications for known orphan drugs is expected to offer profitable opportunities for the growth of the market during the forecast period.

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Impact of COVID-19 Pandemic on Orphan Drugs Market (Pre & Post Analysis)

The outbreak of COVID-19 has disrupted workflows in the health care sector around the world. The disease has forced a number of industries to shut their doors temporarily, including several sub-domains of healthcare. The orphan drugs market is also facing a negative growth, which can be attributed to factors such as a decline in screening services, reduced access to specialists, treatment interruption, limited operations in most industries, inadequate funding to research & academic institutes, temporary closure of major academic institutes, and disrupted supply chain and challenges, in terms of providing essential/post-sales services. However, the market is anticipated to witness recovery in 2021, and show stable growth for orphan drugs in the future.

Orphan Drugs Market Segmentation  

The global orphan drugs market is segmented on the basis of disease type, and region to provide a detailed assessment of the market. By disease type, it is bifurcated into oncological diseases, metabolic diseases, hematologic & immunologic diseases, infectious diseases, neurologic diseases, and other rare diseases that include transplantation diseases, gastrointestinal diseases, dermatologic diseases, perinatal & congenital abnormalities, and others. Oncological diseases segment is again divided into acute myeloid leukemia (AML), pancreatic cancer, ovarian cancer, multiple myeloma, renal cell carcinoma, and others. In addition, metabolic diseases is further classified into hunter syndrome, Fabry disease, Gaucher disease, hypoparathyroidism, and other. Furthermore, hematologic & immunologic diseases segment is again segmented into hereditary angioedema (HAE), hemophilia, and others. Moreover, the neurologic diseases segment is further segmented into Duchenne muscular dystrophy (DMD), Alzheimer's disease, Huntington's disease, and others. Region wise, the market is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

Segment Review

By disease type, the orphan drugs market is segmented into oncological diseases, metabolic diseases, hematologic & immunologic diseases, infectious diseases, neurologic diseases, and other rare diseases that further include transplantation diseases, gastrointestinal diseases, dermatologic diseases, perinatal & congenital abnormalities, and others. Oncological diseases is again classified into acute myeloid leukemia (AML), pancreatic cancer, ovarian cancer, multiple myeloma, renal cell carcinoma, and others. In addition, metabolic diseases is again divided into hunter syndrome, Fabry disease, Gaucher disease, hypoparathyroidism, and other. Furthermore, hematologic & immunologic diseases is further segmented into hereditary angioedema (HAE), hemophilia, and others. Moreover, neurologic diseases further bifurcated into Duchenne muscular dystrophy (DMD), Alzheimer's disease, Huntington's disease, and others. The oncological diseases segment was the major shareholder in 2020, owing to increase in prevalence of oncological diseases, rise in cancer awareness among population, early screening of cancer and availability of oncological orphan drugs for treatment of cancer

Orphan Drugs Market
By Disease Type
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Oncologic Diseases segment holds a dominant position in 2020 and would continue to maintain the lead over the forecast period.

Snapshot of the Asia-Pacific Orphan Drugs Market 

Asia-Pacific offers profitable opportunities for key players operating in the orphan drugs market, thereby registering the fastest growth rate during the forecast period, owing to the growing infrastructure of industries, rising disposable incomes, and favorable government policies in the region. In addition, the growth of the clinical trial in Asia-Pacific is expected to increase faster than the U.S. and Europe, which further drives the growth of the market in the region. Moreover, rise in government initiatives to increase the number of community health and oncology centers is also expected to widen the scope of orphan drugs in developing regions.

Orphan Drugs Market
By Region
2030
North America 
Europe
Asia-Pacific
LAMEA

North America is expected to experience growth at the highest rate, registering a CAGR of 11.0% during the forecast period.

Key Benefits For Stakeholders

  • The study provides an in-depth analysis of the global orphan drugs market along with the current trends and future estimations to explain the imminent investment pockets.
  • A comprehensive analysis of the factors that drive and restrict the orphan drugs market growth is provided in the report.
  • Comprehensive quantitative analysis of the industry from 2020 to 2030 is provided to enable the stakeholders to capitalize on the prevailing orphan drugs market opportunities.
  • Extensive analysis of the key segments of the industry helps to understand the application and products of orphan drugs used across the globe.
  • Key market players and their strategies have been analyzed to understand the competitive outlook of the orphan drugs market.

Orphan Drugs Market Report Highlights

Aspects Details
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By DISEASE TYPE
  • Oncological diseases
    • Pancreatic Cancer
    • .Ovarian cancer
    • Multiple Myeloma
    • Renal Cell Carcinoma
    • Others
  • Metabolic diseases
    • Hunter Syndrome
    • Fabry Disease
    • Gaucher Disease
    • Hypoparathyroidism
    • Others
  • Hematologic & Immunologic diseases
    • Hereditary Angioedema (HAE)
    • Hemophilia
    • Others
  • Infectious diseases
  • Neurological diseases
    • Duchenne Muscular Dystrophy
    • Alzheimer's Disease
    • Huntington's Disease
    • Others
  • Other rare diseases
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By Region
  • .North America  (U.S, Canada, Mexico)
  • Europe  (Germany, France, UK, Italy, Spain, Rest of Europe)
  • Asia-Pacific  (Japan, China, Australia, India, Rest of Asia-Pacific)
  • LAMEA  (brazil, Turkey, South Africa, Rest of LAMEA)
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Key Market Players

AMRYT PHARMA PLC., BRISTOL-MYERS SQUIBB COMPANY, JOHNSON & JOHNSON (JANSSEN GLOBAL SERVICES, LLC), GLAXOSMITHKLINE PLC (GSK), PFIZER INC., ABBVIE INC., SANOFI S.A, F. HOFFMANN-LA ROCHE LTD., NOVARTIS INTERNATIONAL AG (SANDOZ), AMGEN INC.

Analyst Review

The global orphan drugs market is expected to exhibit high growth potential during the forecast years. This is attributed to increase in prevalence of rare diseases, favorable government policies, and availability of market exclusivity for orphan drugs developers. In addition, high growth potential in untapped emerging economies, and growth in novel indications for known orphan drugs are expected to offer profitable opportunities for the growth of the market during the forecast period.

North America is expected to witness the highest growth, in terms of revenue. This is owing to rise in incidence of rare diseases along with increase in awareness about early diagnosis among people. In addition, increase in number of pipeline products in North America is expected to provide new opportunities for market players in the future.

However, Asia-Pacific is expected to emerge as a lucrative market with maximum growth potential, owing to increase in R&D for therapeutic areas such as cancer, technological advancements in biotechnology research, and increase in focus of pharmaceutical and biotechnological companies on expanding their pipeline. In addition, surge in focus of leading manufacturers on expanding their geographical presence in emerging Asia-Pacific countries to capture high growth opportunities boosts the market.

 

 

Author Name(s) : Suraj Sajeev| Monika Darandale | Roshan Deshmukh
Frequently Asked Questions?

The total market value of orphan drugs market is $1,40,000 million in 2020.

The forcast period for orphan drugs market is 2021 to 2030

The market value of orphan drugs market in 2021 is $1,59,250 million.

The base year is 2020 in orphan drugs market

Top companies such as Johnson & Johnson (Janssen Global Services, LLC), F. Hoffmann-La Roche AG, Novartis AG (Sandoz), GlaxoSmithkline PLC, Abbvie Inc, and Bristol-Myers Squibb Company held a high market position in 2020.

The oncological diseases segment is the most influencing segment owing to increase in prevalence of oncological diseases, rise in cancer awareness among population, early screening of the cancer and availability of oncological orphan drugs for treatment of cancer.

Increase in prevalence of rare diseases, favorable government policies, drives the growth of the orphan drugs market. In addition, availability of market exclusivity for orphan drugs developers further fuel growth of the market.

Asia-Pacific is expected to experience the growth rate of 12.6% during the forecast period, owing to growing infrastructure of industries, rising disposable incomes, and favorable government policies in the region.

An orphan drug is a special pharmaceutical agent, designed and developed to treat rare medical conditions

Orphan drugs used to treat rare disease.

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Orphan Drugs Market

Global Opportunity Analysis and Industry Forecast, 2021-2030