Sirolimus Market, by Strength (0.5mg, 1mg, 2mg, and 1mg/mL), by Route of Administration (Oral and Intravenous), by Distribution Channel (Retail Pharmacies, Hospital Pharmacies, and Online Pharmacies), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2019-2026.

  • To Be Published : Aug 2019 |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Sirolimus is a macrolide compound also known as rapamycin, which is a potent immunosuppressant and shows both antifungal and antineoplastic properties. It works by weakening the immune system, and helps your body to accept the new organ, so in this manner it helps in preventing rejection of any organs after transplant. Sirolimus is also used to coat coronary stents, and prophylaxis of organ transplant rejection in patients receiving renal transplants, and for treating Lymphangioleiomyomatosis (lung disease).

Global Sirolimus Market Drivers

Approvals for generic versions of Rapamune (a branded sirolimus formulation) for preventing organ transplant rejection is expected to drive the global sirolimus market growth. For instance, in January 2019, Novitium Pharma LLC. received the final approval for its abbreviated new drug application (ANDA) from the U.S. FDA to market a generic version of an oral solution of Rapamune 1mg/ml manufactured by PF Prism CV. In October 2014, Dr. Reddys Laboratories Ltd., received the final approval for its abbreviated new drug application (ANDA) from the U.S, FDA to market a generic version of Rapamune tablet dosage (1mg). Thus, approvals of sirolimus products by regulatory authorities to manage (or prevent) organ transplant rejection is expected to drive growth of the global sirolimus market. Factors such as rising incidence of kidney diseases has led to an increase in the number of kidney transplants. Furthermore, increasing prevalence of lifestyle-related disorders, improvement of healthcare infrastructure due to increasing healthcare spending is expected to support global sirolimus market growth over the forecast period. According to the National Kidney Foundation, in 2014, around 17,107 kidney transplants took place in the U.S., among which, 5,537 kidneys were from living donors, and 11,570 kidneys were from deceased donors.

Moreover, rising incidence of Alagille syndrome, Cystinosis, Glomerulonephritis, Nephrotic syndrome, thrombotic thrombocytopenic purpura (TTP), hemolytic uremic syndrome (HUS), Interstitial nephritis, and others is expected to result in increasing demand for transplants. Major market players are engaged in research and development activities and product launches in order to introduce optimized dosage forms. For instance, in 2014, Rapamune, a formulation developed by Pfizer, lost its exclusivity as an immunosuppressant for kidney transplant rejection management in the U.S. However, in 2015, Rapamune became the first U.S. FDA approved drug for treating Lymphangioleiomyomatosis (LAM) which is a rare progressive lung disease. These factors are expected to support global sirolimus market growth over the forecast period.

Global Sirolimus Market Regional Insights

North America is expected to dominate the global sirolimus market due to an increasing number of product approvals for preventing organ transplant rejection. For instance, one of the major leading company Pfizer Inc. has carried out various clinical trial studies on sirolimus 1mg/2mg dose for different treatments such as graft rejection, kidney transplant, renal allograft recipients, and renal transplants which has successfully completed phase IV in 2013. Furthermore, growing demand for kidney transplants is expected to propel growth of the global sirolimus market growth over the forecast period. According to the National Kidney Foundation, 2014 in U.S. data, every month approximately 3,000 patients were added to the kidney transplant waiting list, and an estimated 13 people died each day while waiting for a life-saving kidney transplant.

Global Sirolimus Market Restraints

Some of the factors restraining the global sirolimus market growth are the side effects associated with sirolimus such as increased susceptibility to infection, malignancy, hypertriglyceridemia, hypercholesterolemia, angioedema, and proteinuria. Administering sirolimus to patients undergoing liver and lung transplants is generally avoided owing to side effects such as hyperlipidemia and hepatic artery thrombosis.

Global Sirolimus Market Key Players

Some of the major players operating in the global sirolimus market include Pfizer Inc., Actiza, Zydus Cadila Healthcare Ltd., Inc., Greenstone Llc., Biocon, Livzon NNR, and Intas Pharmaceuticals Ltd.

Global Sirolimus Market Taxonomy

By Strength

  • 0.5mg
  • 1mg
  • 2mg
  • 1mg/mL

By Route of Administration

  • Oral
  • Intravenous

 By Distribution Channel

  • Retail Pharmacies
  • Hospital Pharmacies
  • Online Pharmacies

By Region

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East
  • Africa

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


Smiley face

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.
Smiley face

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization:

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

Choose License Type

"How Can I Help You" ?

Finding it difficult to find the research that would cater to your business demands? Give us a chance to help you. One of our Research Consultants will connect to provide a customized solution.

[email protected]

Key Benefits

  • Custom Research Solution

    Talk to our research consultant to design an exclusive report as per your research needs.

  • Customer Fulfilment

    We aim to fulfil client's research demands with tailored research solutions.

  • Quick Turnaround Time Reports

    We aim to provide research studies in quickest turnaround time and in a much cost effective manner.

  • 360-degree Approach

    We cover each industry from supply and demand side with an aim to provide a most holistic research study.

  • Assured Quality

    We strive to provide most accurate and reliable research findings in our research reports.