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:

Drivers

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.

Restraints:

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.

Opportunities:

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

Methodology

Research has its special purpose to undertake marketing efficiently. In this competitive scenario, businesses need information across all industry verticals; the information about customer wants, market demand, competition, industry trends, distribution channels etc. This information needs to be updated regularly because businesses operate in a dynamic environment. Our organization, The Brainy Insights incorporates scientific and systematic research procedures in order to get proper market insights and industry analysis for overall business success. The analysis consists of studying the market from a miniscule level wherein we implement statistical tools which helps us in examining the data with accuracy and precision. 

Our research reports feature both; quantitative and qualitative aspects for any market. Qualitative information for any market research process are fundamental because they reveal the customer needs and wants, usage and consumption for any product/service related to a specific industry. This in turn aids the marketers/investors in knowing certain perceptions of the customers. Qualitative research can enlighten about the different product concepts and designs along with unique service offering that in turn, helps define marketing problems and generate opportunities. On the other hand, quantitative research engages with the data collection process through interviews, e-mail interactions, surveys and pilot studies. Quantitative aspects for the market research are useful to validate the hypotheses generated during qualitative research method, explore empirical patterns in the data with the help of statistical tools, and finally make the market estimations.

The Brainy Insights offers comprehensive research and analysis, based on a wide assortment of factual insights gained through interviews with CXOs and global experts and secondary data from reliable sources. Our analysts and industry specialist assume vital roles in building up statistical tools and analysis models, which are used to analyse the data and arrive at accurate insights with exceedingly informative research discoveries. The data provided by our organization have proven precious to a diverse range of companies, facilitating them to address issues such as determining which products/services are the most appealing, whether or not customers use the product in the manner anticipated, the purchasing intentions of the market and many others.

Our research methodology encompasses an idyllic combination of primary and secondary initiatives. Key phases involved in this process are listed below:

MARKET RESEARCH PROCESS

Data Procurement:

The phase involves the gathering and collecting of market data and its related information with the help of different sources & research procedures.

The data procurement stage involves in data gathering and collecting through various data sources.

This stage involves in extensive research. These data sources includes:

Purchased Database: Purchased databases play a crucial role in estimating the market sizes irrespective of the domain. Our purchased database includes:

  • The organizational databases such as D&B Hoovers, and Bloomberg that helps us to identify the competitive scenario of the key market players/organizations along with the financial information.
  • Industry/Market databases such as Statista, and Factiva provides market/industry insights and deduce certain formulations. 
  • We also have contractual agreements with various reputed data providers and third party vendors who provide information which are not limited to:
    • Import & Export Data
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    • Usage rates of a particular product/service on certain demographics mainly focusing on the unmet prerequisites

Primary Research: The Brainy Insights interacts with leading companies and experts of the concerned domain to develop the analyst team’s market understanding and expertise. It improves and substantiates every single data presented in the market reports. Primary research mainly involves in telephonic interviews, E-mail interactions and face-to-face interviews with the raw material providers, manufacturers/producers, distributors, & independent consultants. The interviews that we conduct provides valuable data on market size and industry growth trends prevailing in the market. Our organization also conducts surveys with the various industry experts in order to gain overall insights of the industry/market. For instance, in healthcare industry we conduct surveys with the pharmacists, doctors, surgeons and nurses in order to gain insights and key information of a medical product/device/equipment which the customers are going to usage. Surveys are conducted in the form of questionnaire designed by our own analyst team. Surveys plays an important role in primary research because surveys helps us to identify the key target audiences of the market. Additionally, surveys helps to identify the key target audience engaged with the market. Our survey team conducts the survey by targeting the key audience, thus gaining insights from them. Based on the perspectives of the customers, this information is utilized to formulate market strategies. Moreover, market surveys helps us to understand the current competitive situation of the industry. To be precise, our survey process typically involve with the 360 analysis of the market. This analytical process begins by identifying the prospective customers for a product or service related to the market/industry to obtain data on how a product/service could fit into customers’ lives.

Secondary Research: The secondary data sources includes information published by the on-profit organizations such as World bank, WHO, company fillings, investor presentations, annual reports, national government documents, statistical databases, blogs, articles, white papers and others. From the annual report, we analyse a company’s revenue to understand the key segment and market share of that organization in a particular region. We analyse the company websites and adopt the product mapping technique which is important for deriving the segment revenue. In the product mapping method, we select and categorize the products offered by the companies catering to domain specific market, deduce the product revenue for each of the companies so as to get overall estimation of the market size. We also source data and analyses trends based on information received from supply side and demand side intermediaries in the value chain. The supply side denotes the data gathered from supplier, distributor, wholesaler and the demand side illustrates the data gathered from the end customers for respective market domain.

The supply side for a domain specific market is analysed by:

  • Estimating and projecting penetration rates through analysing product attributes, availability of internal and external substitutes, followed by pricing analysis of the product.
  • Experiential assessment of year-on-year sales of the product by conducting interviews.

The demand side for the market is estimated through:

  • Evaluating the penetration level and usage rates of the product.
  • Referring to the historical data to determine the growth rate and evaluate the industry trends

In-house Library: Apart from these third-party sources, we have our in-house library of qualitative and quantitative information. Our in-house database includes market data for various industry and domains. These data are updated on regular basis as per the changing market scenario. Our library includes, historic databases, internal audit reports and archives.

Sometimes there are instances where there is no metadata or raw data available for any domain specific market. For those cases, we use our expertise to forecast and estimate the market size in order to generate comprehensive data sets. Our analyst team adopt a robust research technique in order to produce the estimates:

  • Applying demographic along with psychographic segmentation for market evaluation
  • Determining the Micro and Macro-economic indicators for each region 
  • Examining the industry indicators prevailing in the market. 

Data Synthesis: This stage involves the analysis & mapping of all the information obtained from the previous step. It also involves in scrutinizing the data for any discrepancy observed while data gathering related to the market. The data is collected with consideration to the heterogeneity of sources. Robust scientific techniques are in place for synthesizing disparate data sets and provide the essential contextual information that can orient market strategies. The Brainy Insights has extensive experience in data synthesis where the data passes through various stages:

  • Data Screening: Data screening is the process of scrutinising data/information collected from primary research for errors and amending those collected data before data integration method. The screening involves in examining raw data, identifying errors and dealing with missing data. The purpose of the data screening is to ensure data is correctly entered or not. The Brainy Insights employs objective and systematic data screening grades involving repeated cycles of quality checks, screening and suspect analysis.
  • Data Integration: Integrating multiple data streams is necessary to produce research studies that provide in-depth picture to the clients. These data streams come from multiple research studies and our in house database. After screening of the data, our analysts conduct creative integration of data sets, optimizing connections between integrated surveys and syndicated data sources. There are mainly 2 research approaches that we follow in order to integrate our data; top down approach and bottom up approach.

Market Deduction & Formulation: The final stage comprises of assigning data points at appropriate market spaces so as to deduce feasible conclusions. Analyst perspective & subject matter expert based holistic form of market sizing coupled with industry analysis also plays a crucial role in this stage.

This stage involves in finalization of the market size and numbers that we have collected from data integration step. With data interpolation, it is made sure that there is no gap in the market data. Successful trend analysis is done by our analysts using extrapolation techniques, which provide the best possible forecasts for the market.

Data Validation & Market Feedback: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helps us finalize data-points to be used for final calculations.

The Brainy Insights interacts with leading companies and experts of the concerned domain to develop the analyst team’s market understanding and expertise. It improves and substantiates every single data presented in the market reports. The data validation interview and discussion panels are typically composed of the most experienced industry members. The participants include, however, are not limited to:

  • CXOs and VPs of leading companies’ specific to sector
  • Purchasing managers, technical personnel, end-users
  • Key opinion leaders such as investment bankers, and industry consultants

Moreover, we always validate our data and findings through primary respondents from all the major regions we are working on.

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