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).
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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.
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.
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.
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.
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