| Study Period | 2019 - 2030 |
| Base Year For Estimation | 2024 |
| Forecast Data Period | 2025 - 2030 |
| CAGR | 4.10 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players*Disclaimer: Major Players sorted in no particular order |
Sirolimus Market Analysis
The Global Sirolimus Market is expected to register a CAGR of 4.1% during the forecast period.
The COVID-19 pandemic affected the healthcare industry significantly during the year 2020. However, data from the United Network for Organ Sharing (UNOS) published in 2021 states that there was not a huge decrease in organ transplant numbers during the pandemic which was majorly due to the dedication and collaboration of donor hospitals, organ procurement organizations, and transplant hospitals. As organ transplant is an essential procedure, it was performed at a regular pace during the pandemic. Hence, it is observed that the market for Sirolimus was not majorly hampered by the covid pandemic, however, few people have faced the troubles of acquiring hospital services due to the restriction on travel.
Sirolimus is unique from the other calcineurin inhibitors such as tacrolimus and cyclosporine, in its targeting of mTOR. The mammalian target of rapamycin (mTOR) coordinates cell growth and cell proliferation and its signaling pathway is implicated in the development of various conditions such as neurological diseases, cancer, genetic disorders, and obesity. As Sirolimus targets mTOR which involve in various critical biological functions, and it has many treatment applications beyond organ transplantation. Apart from organ transplantation application, this drug can be used in coating coronary stents for preventing rejection of transplanted organs by the body system and used for treating lymphangioleiomyomatosis, which is a rare lung ailment.
According to the World Health Organization (WHO), 2021 data suggest that the number of organ transplants is on the rise across the major countries in the world. This increasing transplantation rates and occurrence of lifestyle-related diseases, the promising pipeline for different indications, and improving healthcare infrastructure are the key driving factors of the sirolimus market.
Sirolimus Market Trends
Organ Transplant Rejection Segment is Expected to Hold a Major Market Share in the Sirolimus Market
Organ transplantation is a medical procedure used to replace a damaged or missing organ by removing it from the donor and placing it in the body of the recipient. To lower the body's ability to reject a transplanted organ immunosuppressants or anti-rejection drugs such as sirolimus are used.
According to the United States Department of Health and Human Services and Health Resources and Services Administration, nationwide, 13,861 persons donated their organs after passing away in 2021, setting a record for deceased donation for the eleventh year in a row and up 10.1% over the previous year i.e. 2020. The weekly total of deceased donors went over 300 for the first time in May 2021; the 300 donor mark was also exceeded twice more in June 2021. As the United States is one of the major countries for organ transplants, the market for sirolimus is expected to witness strong growth in the country.
Additionally, as per the data published by the Council of Europe in September 2021, there were over 16,000 kidney transplants done in Europe in the year 2020 whereas as of the year 2021, around 1,150 people were waiting for heart transplantation in Europe. Hence, increasing transplantation rates, the occurrence of lifestyle-related diseases, and technological advancements in organ transplantation are the key driving factors in the organ transplant rejection segment.
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North America is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period
North America is expected to hold a major market share in the global sirolimus market due to the high volume of organ transplants, rising incidence of chronic diseases, and presence of favorable reimbursement policies in this region. According to the Disease Control and Prevention (CDC) 2021 data, the most commonly transplanted organs in the United States are kidney, liver, heart, lungs, pancreas, and intestine. On average every day, there are about 75,000 people on the active waiting list for organ transplantation. Furthermore, technological advancements in organ transplantation, increasing healthcare spending, and the presence of well-established healthcare infrastructure are also fueling the growth of the overall regional market to a large extent.
Preliminary figures from United Network for Organ Sharing (UNOS), which acts as the Organ Procurement and Transplantation Network under federal contract, show that 41,354 organ transplants were carried out in the United States in 2021, up 5.9 percent from 2020 and for the first time the annual total exceeded 40,000.
Hence, from the above-mentioned factors, it is observed that North America is expected to witness a strong share in the sirolimus market.
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Sirolimus Industry Overview
The Sirolimus Market is fragmented competitive and consists of several major players. In terms of market share, few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are Pfizer, Inc, Biocon, Dr. Reddy's Laboratories Ltd, Concept Medical, Inc, Stentys SA, Torrent Pharmaceuticals Ltd, Zydus Cadila, Intas Pharmaceuticals Ltd and Concord Biotech.
Sirolimus Market Leaders
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Pfizer, Inc
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Dr. Reddy's Laboratories Ltd
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Concept Medical, Inc
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Stentys SA
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Biocon
- *Disclaimer: Major Players sorted in no particular order
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Sirolimus Market News
- In April 2022, Nobelpharma America has become the first company to win FDA approval for a topical treatment for facial angiofibroma associated with tuberous sclerosis complex (TSC). The approval covers a topical gel formulation of sirolimus, an mTOR inhibitor also known as rapamycin (Sirolimus).
- In November 2021, the United States Food and Drug Administration approved sirolimus protein-bound particles for injectable suspension (albumin-bound) (Fyarro, Aadi Bioscience, Inc.) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Sirolimus Industry Segmentation
Sirolimus is a macrolide antibiotic produced by Streptomyces hygroscopicus with potent immunosuppressive activity. The Sirolimus Market is segmented By Application (Organ Transplant Rejection, Lymphangioleiomyomatosis, Sirolimus Coated Balloons, Catheter Devices) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.
| By Application | Organ Transplant Rejection | ||
| Lymphangioleiomyomatosis | |||
| Sirolimus Coated Balloons and Catheter Devices | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia-Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle-East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle-East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
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Sirolimus Market Research FAQs
What is the current Global Sirolimus Market size?
The Global Sirolimus Market is projected to register a CAGR of 4.1% during the forecast period (2025-2030)
Who are the key players in Global Sirolimus Market?
Pfizer, Inc, Dr. Reddy's Laboratories Ltd, Concept Medical, Inc, Stentys SA and Biocon are the major companies operating in the Global Sirolimus Market.
Which is the fastest growing region in Global Sirolimus Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Global Sirolimus Market?
In 2025, the North America accounts for the largest market share in Global Sirolimus Market.
What years does this Global Sirolimus Market cover?
The report covers the Global Sirolimus Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Global Sirolimus Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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Sirolimus Industry Report
Statistics for the 2025 Global Sirolimus market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Global Sirolimus analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
