COVINA, Calif., May 2, 2023 /PRNewswire/ -- According to prophecy market insights "Orphan Drugs Market is estimated to be US$ 869.6 million by 2030 with a CAGR of 10.4% during the forecast period"
What is the Overview of Orphan Drugs Market?
Orphan drugs are pharmaceutical products developed to treat rare diseases or conditions that affect a small number of people. These diseases, also known as rare diseases, are often life-threatening or chronically debilitating, and have historically been underserved by the pharmaceutical industry due to the limited commercial potential of developing drugs for such small patient populations.
The market for orphan drugs is expected to continue to grow in the coming years due to several factors, including increasing prevalence of rare diseases, favorable regulatory environment, and increasing investment in research and development. However, there are also challenges in the orphan drugs market, such as high costs of development and limited patient populations, which can make it difficult for companies to recoup their investments.
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Browse in-depth TOC on "Orphan Drugs Market"
60 – Tables
35 – Figures
140 - Slides
What is Prophecy's Analyst View on Orphan Drugs Market?
Growing prevalence of rare disease has become major contribution in target market growth. Favorable government policies on the use of orphan drugs is further, expected to propel growth of Orphan Drugs market over the forecast period.
Scope of the Report:
Attribute |
Details |
Base year for estimation |
2020 |
Forecast period |
2020 – 2030 |
Market representation |
Revenue in USD Million & CAGR from 2020 – 2030 |
Market Segmentation |
By Drug Type- Biological And Non- Biological By Top Selling Drug- Revlimid, Rituxan, Copaxone, Opdivo, Keytruda, Imbruvica, Avonex, Sensipar, Soliris, And Other Top Selling Drugs By Disease Type- Oncology, Hematology, Neurology, Cardiovascular, And Other Disease Types By Phase Type- Phase I, Phase II, Phase III, And Phase IV |
Regional scope |
North America - U.S., Canada Europe - UK, Germany, Spain, France, Italy, Russia, Rest of Europe Asia Pacific - Japan, India, China, South Korea, Australia, Rest of Asia-Pacific Latin America - Brazil, Mexico, Argentina, Rest of Latin America Middle East & Africa - South Africa, Saudi Arabia, UAE, Rest of Middle East & Africa |
Report coverage |
Revenue forecast, company share, competitive landscape, growth factors, and trends Request Customization: https://www.prophecymarketinsights.com/market_insight/Insight/request-customization/3793 |
What are some challenges faced by the orphan drugs market?
- High costs of development: Developing drugs for rare diseases can be expensive due to the limited patient populations and the need for specialized research and development.
- Limited patient populations: The small patient populations for rare diseases can make it difficult for companies to recoup their investment in drug development and can limit the availability of treatments for patients.
- Difficulty in obtaining reimbursement: Due to the high costs of orphan drugs and the limited patient populations, it can be difficult for companies to obtain reimbursement from insurance providers and government agencies.
- Regulatory challenges: The regulatory pathway for approval of orphan drugs can be complex and time-consuming, which can delay the availability of treatments for patients.
- Competition from off-label drugs: Patients with rare diseases may turn to off-label use of existing drugs, which can compete with newly developed orphan drugs and reduce the market potential for these products.
What recent developments are there in the Orphan Drugs Market?
- In February 2022, Lupin entered into an agreement with Medis for Lupin's orphan drug "NaMuscla" (mexiletine). Medis will commercialize the Lupin's orphan drug for symptomatic treatment of myotonia in adult patients with NDM (non-dystrophic myotonic) disorders in Eastern and Central Europe.
- In December 2021, Zydus Cadila received an orphan drug designation from US FDA (Food and Drug Administration) for its novel malarial drug "ZY19489 (MMV253)" in development with MMV (Medicines for Malaria Venture).
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Who are the Key Manufacturers in Orphan Drugs Market?
- AbbVie Inc
- Celgene Corporation
- Biogen
- Teva Pharmaceutical Industries
- F. Hoffmann-La Roche AG
- Bristol-Myers Squibb Company
- Alexion Pharmaceuticals
- Amgen
- Merck & Co. Inc
- Jazz Pharmaceuticals
What are the Drivers and Restrains of orphan drugs market?
Drivers of the orphan drugs market include:
1. Favorable regulatory environment: The Orphan Drug Act in the United States and similar regulations in Europe have provided incentives and streamlined the regulatory process for orphan drugs, encouraging investment in this area.
2. Increasing prevalence of rare diseases: The prevalence of rare diseases is increasing, leading to a growing need for treatments for these conditions.
3. Advances in technology: Advances in technology, such as gene therapy and precision medicine, have made it possible to develop targeted treatments for rare diseases.
4. Increasing investment in research and development: Many pharmaceutical companies are investing in research and development of orphan drugs, driven by the potential for market exclusivity and high prices for these products.
5. Growing patient advocacy: Patient advocacy groups have become increasingly influential in advocating for research and development of treatments for rare diseases, leading to increased awareness and funding for this area.
Restrains of the orphan drugs market include:
1. High costs of development: Developing drugs for rare diseases can be expensive due to the limited patient populations and the need for specialized research and development.
2. Limited patient populations: The small patient populations for rare diseases can make it difficult for companies to recoup their investment in drug development and can limit the availability of treatments for patients.
3. Difficulty in obtaining reimbursement: Due to the high costs of orphan drugs and the limited patient populations, it can be difficult for companies to obtain reimbursement from insurance providers and government agencies.
4. Competition from off-label drugs: Patients with rare diseases may turn to off-label use of existing drugs, which can compete with newly developed orphan drugs and reduce the market potential for these products.
5. Stringent regulatory requirements: The regulatory pathway for approval of orphan drugs can be complex and time-consuming, which can delay the availability of treatments for patients.
Geographical insights on orphan drugs market
The orphan drugs market is a global market, with a significant presence in North America, Europe, and Asia-Pacific. North America is the largest market for orphan drugs, driven by factors such as favorable regulatory environment, high healthcare spending, and increasing prevalence of rare diseases. The United States is the largest market within North America, accounting for the majority of the revenue in the region.
Europe is also a significant market for orphan drugs, with factors such as the Orphan Medicinal Product Designation program, increasing prevalence of rare diseases, and government support driving growth in the region. The United Kingdom, Germany, France, Italy, and Spain are among the largest markets in Europe. The Asia-Pacific region is expected to be the fastest-growing market for orphan drugs, driven by factors such as increasing awareness of rare diseases, improving healthcare infrastructure, and growing investment in research and development. China, Japan, and India are among the largest markets in the region.
Regional scope:
- North America - U.S., Canada
- Europe - UK, Germany, Spain, France, Italy, Russia, Rest of Europe
- Asia Pacific - Japan, India, China, South Korea, Australia, Rest of Asia-Pacific
- Latin America - Brazil, Mexico, Argentina, Rest of Latin America
- Middle East & Africa - South Africa, Saudi Arabia, UAE, Rest of Middle East & Africa
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2. Over the Counter Drugs Market: Over the Counter Drugs Market accounted for US$ 166.7 billion in 2022 and is estimated to be US$ 187.1 billion by 2032 and is anticipated to register a CAGR of 7.5%.
3. Erythropoietin Drugs Market: The Erythropoietin Drugs Market accounted for US$ 11 billion in 2020 and is estimated to be US$ 25.9 billion by 2030 and is anticipated to register a CAGR of 8.9%.
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