USD 182.4 billion
Report ID: SQMIG30A2005 | Region: Global | Published Date: August, 2022 | Pages: 157 | Tables: 65 | Figures: 65
Orphan Drug Market was valued at USD 182.4 billion in 2021, and it is expected to reach a value of USD 362.4 billion by 2028, at a CAGR of more than 10.3% over the forecast period (2022- 2028).
Orphan drugs are designed to treat illnesses that are so uncommon that their sponsors are reluctant to develop them under standard marketing guidelines.
According to the World Health Organization (WHO), this condition occurs less frequently than 6.5 to 10 times per 10,000 people.
The journey from a new molecule's discovery to its commercialization often takes ten years, costs several tens of millions of euros, and is fraught with uncertainty (among ten molecules tested, only one may have a therapeutic effect). The money spent on its research cannot be recouped when a medicine is developed to treat a rare condition.
Since the introduction of the Orphan Drug Act in 1983, intended to promote development of treatments for rare diseases, at least 378 orphan drugs have been approved. Kalydeco may be the orphan drug of all orphan drugs.
The U.S. dominated development of orphan drugs, with more than 300 in clinical trials, followed by Europe. Cancer treatment was the indication in more than 30% of orphan drug trials.
There are currently approximately 7000 rare diseases listed on the National Institute of Health’s (NIH) Office of Rare Diseases website, affecting an estimated 25–30 million people within the United States3, most of these rare diseases are genetic and many are neurological. Approximately 250 new rare diseases are described each year4, and with advances in genetics, many more common disorders will be subdivided into genetically distinct “rare” diseases.
US Orphan Drug Market is poised to grow at a sustainable CAGR for the next forecast year.
Global Market Size
USD 182.4 billion
more than 10.3% CAGR
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The Global Orphan Drug Market is segmented based on the Disease Type, Drug Type, and region. Based on the Disease Type, the Global Orphan Drug Market is segmented as Oncological diseases, metabolic diseases, hematologic & immunologic diseases, infectious diseases, neurologic diseases, and other rare diseases and Others.
Based On Drug Type, the Global Orphan Drug Market is segmented as biologics and non-biologics.
Based on Region Orphan Drug Market is categorized into North America, Europe, Asia-Pacific, Latin America, and MEA.
Orphan Drug Market Analysis by Disease Type
Oncological diseases, metabolic diseases, hematologic & immunologic diseases, infectious diseases, neurologic diseases, and other rare diseases, which also include transplantation diseases, gastrointestinal diseases, dermatologic diseases, perinatal & congenital abnormalities, and others, are the disease types that the orphan drugs market is divided into by category. Acute myeloid leukaemia (AML), pancreatic cancer, ovarian cancer, multiple myeloma, renal cell carcinoma, and other cancers are included in the classification of oncological illnesses. Huntington syndrome, Fabry disease, Gaucher disease, hypoparathyroidism, and other are further subtypes of metabolic illnesses. Hematologic and immunologic illnesses are further divided into haemophilia, hereditary angioedema, and other conditions. Duchenne muscular dystrophy (DMD), Alzheimer's disease, Huntington's disease, and other neurologic illnesses are further divided into subcategories.
Due to an increase in the prevalence of oncological illnesses, increased public awareness of cancer, the availability of oncological orphan medications for the treatment of cancer, and a surge in early cancer detection, the oncological disorders segment had the largest shareholder in 2021.
Orphan Drug Market Analysis by Drug Type
The Global Orphan Drug Market has been segmented on the basis of Drug Type as biologics and non-biologics. One of the main causes of the segment's domination in 2019 is the preponderance of product offerings that are categorized as biologics. The U.S. Food and Drug Administration (U.S. FDA) estimates that over 600 medicines and biologic products for rare conditions have been developed and marketed thanks to the organization's Orphan Products Development (OOPD) since 1983. The non-biologics market sector had a smaller market share overall and a lower CAGR than other segments.
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In terms of CAGR, North America is expected to grow quickly in the years to come. This is attributed to the increase in patients in this area who are susceptible to rare diseases. The unhealthy lifestyle and stressful lifestyle are the key factors that cause this disease to spread in this area. In order to reduce the number of patients brought on by this disease, government organisations like NGO are investing a significant amount of money in this region.
Also, the European Orphan Drug Market would grow in the coming years, due to the large patient population in the area and the widespread use of complex medicines for uncommon diseases. Due to rising healthcare costs and greater awareness of rare diseases, the market in Asia Pacific is expected to expand at the fastest rate. Latin America, the Middle East, and Africa made up the Rest of the World, which accounted for a smaller share of the worldwide market due to the under-penetration of the market.
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The Global Orphan Drug Market is relatively fragmented, with a high level of competition. The prominent players operating in the orphan drug market are constantly
Orphan Drug Market Top Player's Company Profiles
Orphan Drug Market Recent Developments
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Co-relates, and Analyses the Data collected utilizing Primary Exploratory Research backed by the robust Secondary Desk research.
According to our Global Orphan Drug Market Analysis, in terms of drug type, the availability of oncological orphan medications for the treatment of cancer, and a surge in early cancer detection, the oncological disorders segment had the largest shareholder in 2021. Combined, technological advancements have made it easier to both diagnose and cure uncommon genetic disorders, which has made them more manageable for pharmaceutical companies.
|Market size value in 2021||USD 182.4 billion|
|Market size value in 2028||USD 362.4 billion|
|Growth Rate||more than 10.3%|
|Forecast period||2022- 2028|
|Forecast Unit (Value)||USD Billion|
|Regions covered||North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA)|
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For the Global Orphan Drug Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Global Orphan Drug Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
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