Sirolimus Market

Sirolimus Market Size by Application (Organ Transplant Rejection, Sirolimus Catheter Device, Sirolimus Coated Balloons and Others), Dosage (Injections, Tablets and Others), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), Regions, Global Industry Analysis, Share, Growth, Trends, and Forecast 2024 to 2033

Base Year: 2023 Historical Data: 2020-22
  • Report ID: TBI-14321
  • Published Date: May, 2024
  • Pages: 237
  • Category: Healthcare
  • Format: PDF
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The global sirolimus market was valued at USD 250 million in 2023 and grew at a CAGR of 4% from 2024 to 2033. The market is expected to reach USD 370.06 million by 2033. The increasing rate of organ transplants will drive the growth of the global sirolimus market.

Market Introduction:

Sirolimus is also known as rapamycin. It is a potent medication derived from soil samples of Easter Island. Sirolimus belongs to the class of drugs known as mTOR inhibitors. It inhibits the action of mTOR protein, a key regulator of cell growth, proliferation, and survival. One of the primary uses of sirolimus is as an immunosuppressant in organ transplantation. By dampening the immune response, sirolimus helps prevent the rejection of transplanted organs such as kidneys, hearts, and livers. Additionally, its anti-proliferative effects make it useful in preventing the growth of certain cancers, notably kidney and certain skin cancers. Sirolimus also shows promise in treating rare diseases such as lymphangioleiomyomatosis (LAM), a lung condition characterized by abnormal cell growth. Ongoing research explores sirolimus's potential in autoimmune diseases like rheumatoid arthritis and systemic lupus erythematosus.

Sirolimus Market Size

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Recent Development
  • Patients with gynecologic or peritoneal perivascular epithelioid sarcoma (PEComa) responded quickly and durably to nab-sirolimus treatment, according to a subgroup analysis of the phase 2 AMPECT trial (NCT02494570) presented by Thomas Herzog, MD, at the 2024 SGO Annual Meeting on Women's Cancer.

Market Dynamics:


The increasing demand for organ transplants - the prevalence of chronic diseases like diabetes and hypertension is increasing, leading to a higher incidence of end-stage organ failure. Additionally, the ageing global population is more susceptible to organ failure, necessitating transplantation. Advanced surgical techniques, organ preservation, and immunosuppressive medications have improved transplant outcomes, expanding the pool of eligible candidates. Increased awareness and acceptance of transplantation as a viable treatment option, coupled with international collaboration and exchange programs, facilitate matching donors with recipients. Policy initiatives aimed at improving organ donation rates also augment the market. Therefore, the increasing demand for organ transplants will drive the global sirolimus market's growth as it is a key drug used in transplantations to ensure successful patient outcomes.


The side-effects of sirolimus Sirolimus can induce a range of side effects. Common side effects include mucositis, manifested as painful mouth ulcers, and gastrointestinal disturbances like nausea, vomiting, diarrhoea, and abdominal pain. Additionally, sirolimus often leads to elevated blood lipid levels, contributing to hyperlipidemia and increasing the risk of cardiovascular disease. Impaired wound healing and peripheral oedema are also notable side effects causing discomfort in affected individuals. Therefore, the potential side effects of sirolimus will limit the market's growth.


The increasing global healthcare infrastructure expenditure – As healthcare infrastructure improves worldwide, it will directly contribute to the increased demand and utilization of sirolimus. Enhanced healthcare infrastructure leads to improved access to organ transplantation services. With the establishment of specialized transplant centres and the expansion of surgical capabilities, more patients gain access to life-saving organ transplant procedures. This expanded pool of transplant recipients directly correlates with a greater demand for immunosuppressive medications like sirolimus to prevent organ rejection and ensure transplant success. Furthermore, advancements in medical technology as part of healthcare infrastructure development facilitate the broader adoption of sirolimus in various medical fields. Additionally, improved access to medical information and education among healthcare professionals and patients will contribute to the market's growth. Therefore, the increasing global healthcare expenditure will drive the market's growth during the forecast period.

Regional segmentation analysis:

The regions analyzed for the market include North America, Europe, South America, Asia Pacific, the Middle East, and Africa. North America emerged as the most significant global sirolimus market, with a 39% market revenue share in 2023.

The region has advanced healthcare infrastructure, including state-of-the-art medical facilities and a well-established network of transplant centres. This infrastructure facilitates the widespread adoption of sirolimus in organ transplantation. North America is a global leader in transplantation medicine, conducting many organ transplant procedures annually. Furthermore, many leading pharmaceutical companies, academic institutions, and research organizations in North America actively engage in sirolimus research. The regulatory environment in North America supports the timely approval and market access of new medications. Additionally, comprehensive healthcare coverage in North America ensures patient access to sirolimus therapy, enhancing affordability and equitable access to transplantation care.

North America Region Sirolimus Market Share in 2023 - 39%

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  • Aadi Bioscience, Inc., a commercial-stage precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, has announced that it will present new non-clinical data highlighting nab-sirolimus' combinability and potential for synergy to enhance anti-cancer effects and overcome resistance. These findings were presented as poster presentations at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, California.
Application Segment Analysis

The application segment is divided into organ transplant rejection, sirolimus catheter devices, sirolimus-coated balloons and others. The organ transplant rejection segment dominated the market, with a market share of around 43% in 2023. Sirolimus is predominantly used in organ transplantation to prevent rejection. Sirolimus, an mTOR inhibitor, suppresses the immune response, which leads to organ rejection by inhibiting T cell activation and proliferation. This dual action, targeting both acute and chronic rejection, underscores its efficacy in transplantation. Sirolimus has a significantly lower nephrotoxicity profile than traditional calcineurin inhibitors, making it particularly valuable in kidney transplantation. Additionally, sirolimus carries a lower risk of metabolic side effects, making it preferable in patients prone to metabolic complications. Sirolimus's dominance in organ transplantation stems from its potent immunosuppressive effects, efficacy in preventing rejection, and favourable side effect profile.

Dosage Segment Analysis

The dosage segment is divided into injections, tablets and others. The tablets segment dominated the market, with a market share of around 59% in 2023. A tablet is a solid pharmaceutical dosage form that contains a precise unit dose of medication. Tablets are widely used for convenience, ease of administration, stability, and accurate dosing. Tablets ensure accurate sirolimus dosing, where precise dosing is essential for therapeutic efficacy. Additionally, tablets are easy to swallow and can be taken with or without food, enhancing patient convenience and adherence to treatment regimens. Furthermore, sirolimus tablets offer good stability, maintaining the potency and efficacy of the medication over time. Tablets can also be manufactured efficiently using automated processes, resulting in cost-effective production and patient accessibility. Tablets provide flexibility in dosage strengths, allowing healthcare providers to tailor the dose of sirolimus to individual patient needs and treatment regimens.

Distribution Channel Segment Analysis

The distribution channel segment is divided into hospital, retail, and online pharmacies. The hospital pharmacies segment dominated, with a market share of around 42% in 2023. Hospital pharmacies are specialized facilities within hospitals responsible for managing medications used in patient care. Hospital pharmacists possess specialized training and expertise in managing complex medications. They work closely with healthcare teams to ensure optimal medication therapy. Hospital pharmacies offer access to specialized services such as therapeutic drug monitoring (TDM). Additionally, hospital pharmacies can prepare customized compounded formulations of sirolimus to meet individual patient needs, ensuring accessibility and suitability for diverse patient populations. Hospital pharmacies adhere to stringent quality assurance and safety measures. This commitment to quality and safety ensures the integrity and safety of sirolimus therapy for patients. Hospital pharmacies serve inpatient and outpatient populations, providing continuity of care and consistent access to sirolimus therapy across care settings.

Some of the Key Market Players:
  • Accord Healthcare
  • Actiza Pharmaceutical Private Limited
  • Amneal Pharmaceuticals LLC
  • Apotex Inc
  • Biocon Concept Medical
  • Concord Biotech
  • Delphis Pharmaceutical
  • Dr Reddy's Laboratories Ltd.
  • Intas Pharmaceuticals Ltd
  • Livzon

Report Description:

Attribute Description
Market Size Revenue (USD Million)
Market size value in 2023 USD 250 Million
Market size value in 2033 USD 370.06 Million
CAGR (2024 to 2033) 4%
Historical data 2020-2022
Base Year 2023
Forecast 2024-2033
Region The regions analyzed for the market are Asia Pacific, Europe, South America, North America, and Middle East and Africa. Furthermore, the regions are further analyzed at the country level.
Segments Application, Dosage and Distribution Channel

Frequesntly Asked Questions

As per The Brainy Insights, the size of the global sirolimus market was valued at USD 250 million in 2023 to USD 370.06 million by 2033.

Global sirolimus market is growing at a CAGR of 4% during the forecast period 2024-2033.

The market's growth will be influenced by the increasing demand for organ transplants.

The side-effects of sirolimus could hamper the market growth.

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This study forecasts revenue at global, regional, and country levels from 2020 to 2033. The Brainy Insights has segmented the global sirolimus market based on below mentioned segments:

Global Sirolimus Market by Application:

  • Organ Transplant Rejection
  • Sirolimus Catheter Device
  • Sirolimus Coated Balloons
  • Others

Global Sirolimus Market by Dosage:

  • Injections
  • Tablets
  • Others

Global Sirolimus Market by Distribution Channel:

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

Global Sirolimus Market by Region:

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
  • Asia-Pacific
    • Japan
    • China
    • India
  • South America
    • Brazil
  • Middle East and Africa  
    • UAE
    • South Africa


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