The global sirolimus market size was estimated to be USD 315.8 million in 2023 and is expected to reach at USD 653.8 million by 2034 with a CAGR of 6.84% during the forecast period 2024-2034. The rising demand for organ transplants, increased requirement for immunosuppressive medications, rise in research efforts focused on immunosuppressant drugs, growing number of clinical studies, heightened research & development activities, high emphasis on developing innovative products, and increase in the approval of novel sirolimus drugs are some of the key factors boosting the market growth.
Increase in the approval of novel sirolimus drugs is predicted to boost the market growth during the forecast period. Sirolimus, also recognized as rapamycin, is a potent immunosuppressive macrolide compound with antifungal and anticancer properties. Its mechanism involves the suppression of the immune system to facilitate the acceptance of a transplanted organ, thereby diminishing the risk of organ rejection. Additionally, sirolimus finds applications in coating coronary stents, addressing lymphangioleiomyomatosis (a lung disease), and preventing the rejection of transplanted organs in individuals undergoing renal transplantation. For instance, in April 2022, The U.S. FDA has granted approval for Nobelpharma's Hyftor (sirolimus topical gel) to treat facial angiofibroma linked to tuberous sclerosis in individuals aged six and above.
By dosage, tablet was the highest revenue-grossing segment in the global sirolimus market in 2023 owing to the convenience of use and cost-effectiveness have led to an increase in the prescription of sirolimus for patients with autoimmune diseases. Additionally, injection is predicted to grow at the fastest CAGR during the forecast period owing to the rising incidence of cancer cases, an increasing population of organ transplant recipients, and the growing number of approvals from regulatory authorities. For instance, in February 2023, Concept Medical, a research and development company specializing in drug delivery devices, has obtained the second approval for Investigational Device Exemption (IDE) from the US FDA for its Sirolimus Coated Balloon, Magic Touch PTA, specifically for Below the Knee (BTK) applications.
By strength, 2mg was the highest revenue-grossing segment in the global sirolimus market in 2023 owing to the widespread accessibility, a notable increase in technological advancements within drug delivery systems, and the growing approvals from regulatory entities. For instance, in January 2023, MedAlliance has disclosed that its sirolimus-eluting balloon, the Selution SLR, has obtained conditional approval from the FDA for an investigational device exemption (IDE). This allows the initiation of a pivotal clinical trial for the device's use in treating coronary de novo lesions. Additionally, 1 mg/ml is predicted to grow at the fastest CAGR during the forecast period owing to the growing frequency of organ transplantations and an escalating demand for generic medications.
By application, organ transplantation was the highest revenue-grossing segment in the global sirolimus market in 2023 owing to the rising rates of organ transplantation, the prevalence of lifestyle-related diseases, and advancements in organ transplantation technology. Sirolimus medication is commonly prescribed for individuals who have undergone organ transplantation. This medication plays a crucial role in minimizing the risk of rejection by the immune system against foreign objects, such as transplanted organs, by modulating the immune response. Administering sirolimus helps mitigate the immune system's rejection response, ensuring that the transplanted organ integrates effectively with the recipient's body and functions properly. Additionally, autoimmune diseases is predicted to grow at the fastest CAGR during the forecast period owing to the increased emphasis on research and development, coupled with a heightened focus on creating innovative products, is evident. Sirolimus is predominantly employed for preventing various autoimmune diseases like myasthenia gravis, arthritis, lupus, rheumatoid arthritis, and Crohn’s disease. It serves as a medication to inhibit cell replication in conditions such as psoriasis and inflammatory bowel disease. Additionally, in cases of autoimmune hepatitis, it plays a crucial role in reducing liver inflammation and preventing further damage. For instance, in April 2023, Terumo Europe N.V., a prominent medical device company, declares the commencement of a new forward-looking clinical investigation: the examination of the Ultimaster Nagomi sirolimus-eluting coronary stent system in patients undergoing complex percutaneous coronary intervention (PCI).
By distribution channel, hospital pharmacy was the highest revenue-grossing segment in the global sirolimus market in 2023. Sirolimus is extensively employed in hospitals for organ transplantation, and increasing approvals from regulatory authorities. For instance, in April 2022, The first company to receive FDA approval for a topical treatment for facial angiofibroma linked to tuberous sclerosis complex (TSC) is Nobelpharma America. The topical gel formulation of the mTOR inhibitor Sirolimus, also known as rapamycin, has received approval. Additionally, online pharmacies is predicted to grow at the fastest CAGR during the forecast period owing to the availability of discounts and a wider selection offered by online pharmacies, the growing prevalence of eCommerce platforms, rising consumer inclination towards online channels, and the convenience for customers in procuring medication are contributing factors in the pharmaceutical industry.
North America region is anticipated for the highest revenue share during the forecast period owing to the escalating healthcare expenditures, a growing prevalence of transplant procedures, government & healthcare organizations' initiatives to promote organ donation, and surge in mergers & acquisitions. For instance, in October 2022, Cordis, a global leader in the creation and production of interventional cardiovascular and endovascular technologies, has disclosed its acquisition of MedAlliance, a Switzerland-based company specializing in groundbreaking drug-eluting balloons. The acquisition is contingent upon standard closing conditions, including regulatory approvals. Through this acquisition, Cordis aims to reach a potential of treating two million patients worldwide by 2027 using the SELUTION SLR (Sustained Limus Release) drug-eluting balloon. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the growing investment in research & development activities by pharmaceutical companies, surge in number of research initiatives, and growing approvals of innovative drug products by regulatory bodies. For instance, in February 2023, Zydus Lifesciences Ltd has obtained the final approval from the US Food and Drug Administration (USFDA) for Sirolimus tablets in both 1 mg and 2 mg strengths. These tablets are recognized as reference listed drugs for Rapamune tablets.
Increase in the approval of novel sirolimus drugs is predicted to boost the market growth during the forecast period. Sirolimus, also recognized as rapamycin, is a potent immunosuppressive macrolide compound with antifungal and anticancer properties. Its mechanism involves the suppression of the immune system to facilitate the acceptance of a transplanted organ, thereby diminishing the risk of organ rejection. Additionally, sirolimus finds applications in coating coronary stents, addressing lymphangioleiomyomatosis (a lung disease), and preventing the rejection of transplanted organs in individuals undergoing renal transplantation. For instance, in April 2022, The U.S. FDA has granted approval for Nobelpharma's Hyftor (sirolimus topical gel) to treat facial angiofibroma linked to tuberous sclerosis in individuals aged six and above.
By dosage, tablet was the highest revenue-grossing segment in the global sirolimus market in 2023 owing to the convenience of use and cost-effectiveness have led to an increase in the prescription of sirolimus for patients with autoimmune diseases. Additionally, injection is predicted to grow at the fastest CAGR during the forecast period owing to the rising incidence of cancer cases, an increasing population of organ transplant recipients, and the growing number of approvals from regulatory authorities. For instance, in February 2023, Concept Medical, a research and development company specializing in drug delivery devices, has obtained the second approval for Investigational Device Exemption (IDE) from the US FDA for its Sirolimus Coated Balloon, Magic Touch PTA, specifically for Below the Knee (BTK) applications.
By strength, 2mg was the highest revenue-grossing segment in the global sirolimus market in 2023 owing to the widespread accessibility, a notable increase in technological advancements within drug delivery systems, and the growing approvals from regulatory entities. For instance, in January 2023, MedAlliance has disclosed that its sirolimus-eluting balloon, the Selution SLR, has obtained conditional approval from the FDA for an investigational device exemption (IDE). This allows the initiation of a pivotal clinical trial for the device's use in treating coronary de novo lesions. Additionally, 1 mg/ml is predicted to grow at the fastest CAGR during the forecast period owing to the growing frequency of organ transplantations and an escalating demand for generic medications.
By application, organ transplantation was the highest revenue-grossing segment in the global sirolimus market in 2023 owing to the rising rates of organ transplantation, the prevalence of lifestyle-related diseases, and advancements in organ transplantation technology. Sirolimus medication is commonly prescribed for individuals who have undergone organ transplantation. This medication plays a crucial role in minimizing the risk of rejection by the immune system against foreign objects, such as transplanted organs, by modulating the immune response. Administering sirolimus helps mitigate the immune system's rejection response, ensuring that the transplanted organ integrates effectively with the recipient's body and functions properly. Additionally, autoimmune diseases is predicted to grow at the fastest CAGR during the forecast period owing to the increased emphasis on research and development, coupled with a heightened focus on creating innovative products, is evident. Sirolimus is predominantly employed for preventing various autoimmune diseases like myasthenia gravis, arthritis, lupus, rheumatoid arthritis, and Crohn’s disease. It serves as a medication to inhibit cell replication in conditions such as psoriasis and inflammatory bowel disease. Additionally, in cases of autoimmune hepatitis, it plays a crucial role in reducing liver inflammation and preventing further damage. For instance, in April 2023, Terumo Europe N.V., a prominent medical device company, declares the commencement of a new forward-looking clinical investigation: the examination of the Ultimaster Nagomi sirolimus-eluting coronary stent system in patients undergoing complex percutaneous coronary intervention (PCI).
By distribution channel, hospital pharmacy was the highest revenue-grossing segment in the global sirolimus market in 2023. Sirolimus is extensively employed in hospitals for organ transplantation, and increasing approvals from regulatory authorities. For instance, in April 2022, The first company to receive FDA approval for a topical treatment for facial angiofibroma linked to tuberous sclerosis complex (TSC) is Nobelpharma America. The topical gel formulation of the mTOR inhibitor Sirolimus, also known as rapamycin, has received approval. Additionally, online pharmacies is predicted to grow at the fastest CAGR during the forecast period owing to the availability of discounts and a wider selection offered by online pharmacies, the growing prevalence of eCommerce platforms, rising consumer inclination towards online channels, and the convenience for customers in procuring medication are contributing factors in the pharmaceutical industry.
North America region is anticipated for the highest revenue share during the forecast period owing to the escalating healthcare expenditures, a growing prevalence of transplant procedures, government & healthcare organizations' initiatives to promote organ donation, and surge in mergers & acquisitions. For instance, in October 2022, Cordis, a global leader in the creation and production of interventional cardiovascular and endovascular technologies, has disclosed its acquisition of MedAlliance, a Switzerland-based company specializing in groundbreaking drug-eluting balloons. The acquisition is contingent upon standard closing conditions, including regulatory approvals. Through this acquisition, Cordis aims to reach a potential of treating two million patients worldwide by 2027 using the SELUTION SLR (Sustained Limus Release) drug-eluting balloon. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the growing investment in research & development activities by pharmaceutical companies, surge in number of research initiatives, and growing approvals of innovative drug products by regulatory bodies. For instance, in February 2023, Zydus Lifesciences Ltd has obtained the final approval from the US Food and Drug Administration (USFDA) for Sirolimus tablets in both 1 mg and 2 mg strengths. These tablets are recognized as reference listed drugs for Rapamune tablets.
Segmentation: Sirolimus Market Report 2023 - 2034
Sirolimus Market Analysis & Forecast by Dosage 2023 - 2034 (Revenue USD Mn)
- Tablets
- Injections
- Others
Sirolimus Market Analysis & Forecast by Strength 2023 - 2034 (Revenue USD Mn)
- 1mg/mL
- 2mg
- 1mg
- 0.5mg
Sirolimus Market Analysis & Forecast by Application 2023 - 2034 (Revenue USD Mn)
- Autoimmune Diseases
- Organ Transplantation
- Others
Sirolimus Market Analysis & Forecast by Distribution Channel 2023 - 2034 (Revenue USD Mn)
- Retail Pharmacies
- Hospital Pharmacies
- Online Pharmacies
Sirolimus Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Mn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Sirolimus Market: Dosage Estimates & Trend Analysis
8. Sirolimus Market: Strength Estimates & Trend Analysis
9. Sirolimus Market: Application Estimates & Trend Analysis
10. Sirolimus Market: Distribution Channel Estimates & Trend Analysis
11. Regional Market Analysis
12. North America Sirolimus Market
13. Europe Global Sirolimus Market
14. Asia Pacific Global Sirolimus Market
15. Latin America Global Sirolimus Market
16. MEA Global Sirolimus Market
17. Competitor Analysis
18. Company Profiles
Companies Mentioned
- Concord Biotech
- Accord Healthcare
- Actiza Pharmaceutical Private Limited
- Apotex Inc
- Biocon Concept Medical
- Intas Pharmaceuticals Ltd
- Livzon
- Pfizer Inc.
- Amneal Pharmaceuticals LLC.
- Delphis Pharmaceutical
- Dr. Reddy's Laboratories Ltd.
- Zydus
- Cadila
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | March 2024 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 315.8 Million |
| Forecasted Market Value ( USD | $ 653.8 Million |
| Compound Annual Growth Rate | 6.8% |
| Regions Covered | Global |
| No. of Companies Mentioned | 13 |
