Global Sirolimus Market, By Strength (0.5mg, 1mg, 2mg, 1mg/mL), Application (Organ Transplant Rejection, Sirolimus Catheter Device, Sirolimus Coated Balloons, Others), Drug Class (MTOR Inhibitors, Selective Immunosuppressants), Dosage (Injection, Tablet, Others), Route of Administration (Oral, Intravenous, Others), End-Users (Hospitals, Specialty Clinics, Homecare, Others), Distribution Channel (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy, Others) – Industry Trends and Forecast to 2031.
Sirolimus Market Analysis and Size
The sirolimus market is anticipated to grow rapidly during the forecast period. As per the World Health Organization (WHO), around 100,800 solid organ transplants are conducted worldwide each year, with 69,400 kidney transplants, 20,200 liver transplants, 5,400 heart transplants, 3,400 lung transplants, and 2,400 pancreas transplants being the most common. The increasing transplantation rate and the emergence of lifestyle-related diseases are the major factors leading to the high demand for sirolimus in the market.
Data Bridge Market Research analyzes that the global sirolimus market which was USD 280.13 million in 2023, is expected to reach USD 424.23 million by 2031, and is expected to undergo a CAGR of 4.6% during the forecast period of 2024 to 2031. “0.5mg” dominates the strength segment of the market due to rising demand of sirolimus. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.
Sirolimus Market Scope and Segmentation
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Report Metric
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Details
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Forecast Period
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2024 to 2031
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Base Year
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2023
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Historic Years
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2022 (Customizable to 2016-2021)
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Quantitative Units
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Revenue in USD Million, Volumes in Units, Pricing in USD
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Segments Covered
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Strength (0.5mg, 1mg, 2mg, 1mg/mL), Application (Organ Transplant Rejection, Sirolimus Catheter Device, Sirolimus Coated Balloons, Others), Drug Class (MTOR Inhibitors, Selective Immunosuppressants), Dosage (Injection, Tablet, Others), Route of Administration (Oral, Intravenous, Others), End-Users (Hospitals, Specialty Clinics, Homecare, Others), Distribution Channel (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy, Others)
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Countries Covered
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U.S., Canada, Mexico, Germany, France, U.K., Belgium, Lithuania, Austria, Ireland, Norway, Poland, Italy, Spain, Russia, Turkey, Netherlands Switzerland, Rest of Europe, Japan, China, South Korea, India, Australia, Singapore, Thailand, Malaysia, Indonesia, Philippines, Rest of Asia-Pacific, Brazil, Argentina, Rest of South America, South Africa, Saudi Arabia, U.A.E., Egypt, Israel, Rest of Middle East and Africa.
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Market Players Covered
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Accord Healthcare (U.S.), Apotex Inc. (Canada), Amneal Pharmaceuticals LLC. (U.S.), Pfizer Inc. (U.S.), Zydus Cadila (India), Dr. Reddy's Laboratories Ltd. (India), Torrent Pharmaceuticals Ltd. (India), Biocon (India), Concept Medical (U.S.), Intas Pharmaceuticals Ltd (India), Concord Biotech (India), Livzon (China), Actiza Pharmaceutical Private Limited (India), Tiefenbacher API + Ingredients GmbH & Co. KG (Germany), Delphis Pharmaceutical (India)
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Market Opportunities
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Market Definition
Sirolimus, commonly known as rapamycin, is a macrolide molecule that is a strong immunosuppressant with antifungal and anticancer activities. It works by suppressing your immune system and assisting your body in accepting the new organ, so reducing organ rejection following transplant. Sirolimus is also used to coat coronary stents, as well as to treat lymphangioleiomyomatosis (lung disease) and to prevent organ transplant rejection in patients having renal transplants.
Global Sirolimus Market Dynamics
Drivers
- Increased Organ Transplantations
The rising number of organ transplant procedures globally has significantly Increased the demand for Sirolimus. It's widely employed as an immunosuppressant to prevent rejection in organ transplant recipients. The demand surge is attributed to advancements in surgical techniques, increased awareness about organ donation, and improved post-transplant care.
- Expanding Applications in Oncology
Sirolimus exhibits anti-tumor properties and is employed in treating various cancers, including renal cell carcinoma. This application in oncology has gained attention due to its ability to inhibit the mammalian target of rapamycin (mTOR), a protein associated with cancer cell proliferation. Clinical studies exploring Sirolimus's efficacy in different cancer types continue to fuel its use in oncological treatments.
- Advancements in Drug-Eluting Stents
Sirolimus-coated stents play a crucial role in interventional cardiology by reducing restenosis rates after angioplasty. These drug-eluting stents have shown superior efficacy compared to bare-metal stents. Continuous advancements in stent technology, including the development of newer-generation drug-eluting stents, contribute to the market's growth.
Opportunities
- Rising Demand for Personalized Medicine
The paradigm shift toward personalized medicine presents a significant opportunity for Sirolimus. Tailoring treatments based on patients' genetic makeup, disease characteristics, and individual responses to therapy offers avenues to optimize Sirolimus dosing and treatment regimens.
- Emerging Markets and Untapped Regions
Expanding into emerging markets and regions with unmet medical needs provides growth opportunities. Targeting regions witnessing a rise in organ transplantation rates or an increasing prevalence of cancers where Sirolimus can offer therapeutic benefits is a strategic opportunity.
Restraints/Challenges
- Adverse Effects and Safety Concerns
Sirolimus usage is associated with adverse effects such as immunosuppression-related complications, increased susceptibility to infections, metabolic disturbances, and delayed wound healing. Managing these adverse effects and ensuring patient safety pose significant challenges, particularly in long-term therapy.
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Regulatory Hurdles and Compliance
Regulatory approvals for pharmaceuticals, particularly for immunosuppressant like Sirolimus, involve stringent assessments of safety and efficacy. Meeting these stringent standards, especially in different regions with varying regulatory frameworks, can delay product launches and market entry.
This sirolimus market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the sirolimus market Contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.
Recent Development
- In November 2021, for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumors, the Food and Drug Administration licensed sirolimus protein-bound particles for injectable suspension (albumin-bound). Efficacy was assessed in 31 patients with locally advanced unresectable or metastatic malignant PEComa in the AMPECT (NCT02494570) multicenter, single-arm clinical study. Until disease progression or unacceptable toxicity, patients received 100 mg/m2 sirolimus protein-bound particles on days 1 and 8 of each 21-day cycle
Global Sirolimus Market Scope
The sirolimus market is segmented on the basis of strength, application, dosage, drug class, route of administration, end-users and distribution channel. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.
Strength
- 0.5mg
- 1mg
- 2mg
- 1mg/mL
Application
- Organ Transplant Rejection
- Sirolimus Catheter Device
- Sirolimus Coated Balloons
- Others
Drug Class
- MTOR Inhibitors
- Selective Immunosuppressants
Dosage
- Injection
- Tablet
- Others
Route of Administration
- Oral
- Intravenous
- Others
End-Users
- Hospitals
- Specialty Clinics
- Homecare
- Others
Distribution Channel
- Hospital Pharmacy
- Retail Pharmacy
- Online Pharmacy
- Others
Global Sirolimus Market Regional Analysis/Insights
The sirolimus market is analyzed and market size insights and trends are provided by country, strength, application, dosage, drug class, route of administration, end-users, and distribution channel as referenced above.
The countries covered in the market report are U.S., Canada, Mexico, Germany, U.K., France, Italy, Spain, Netherlands, Russia, Switzerland, Turkey, rest of Europe, Japan, China, Australia, India, South Korea, Singapore, Indonesia, Thailand, Malaysia, Philippines, rest of Asia-Pacific, Brazil, Argentina, rest of South America, Saudi Arabia, South Africa, U.A.E., Israel, Egypt, and rest of Middle East and Africa.
North America is expected to dominate the market due of the increase in the expenditure for research and development proficiencies, increasing government’s initiatives and improved health care infrastructure in various countries.
Asia-Pacific is expected to exhibit the highest growth rate in the market during the forecast period of 2024 to 2031 due to the increasing government expenditure on healthcare sector and rising technological advancements and initiatives by the government.
The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.
Competitive Landscape and Global Sirolimus Market Share Analysis
The sirolimus market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to sirolimus market.
Some of the major players operating in the sirolimus market are:
- Accord Healthcare (U.S.)
- Apotex Inc. (Canada)
- Amneal Pharmaceuticals LLC. (U.S.)
- Pfizer Inc. (U.S.)
- Zydus Cadila (India)
- Dr. Reddy's Laboratories Ltd. (India)
- Torrent Pharmaceuticals Ltd. (India)
- Biocon (India)
- Concept Medical (U.S.)
- Intas Pharmaceuticals Ltd (India)
- Concord Biotech (India)
- Livzon (China)
- Actiza Pharmaceutical Private Limited (India)
- Tiefenbacher API + Ingredients GmbH & Co. KG (Germany)
- Delphis Pharmaceutical (India)
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