Sirolimus is a macrolide compound also known as rapamycin, which is a potent immunosuppressant and exhibits both antifungal and antineoplastic properties. It works by weakening the immune system and helps your body accept the new organ, in this way it helps prevent rejection of any organ after transplantation. Sirolimus is also used to coat coronary stents and for the prophylaxis of organ transplant rejection in patients having a kidney transplant, and for the treatment of lymphangioleiomyomatosis (lung disease).
Approvals for generic versions of Rapamune (a brand name formulation of sirolimus) to prevent organ transplant rejection are expected to drive the growth of the global sirolimus market. For example, in January 2019, Novitium Pharma LLC. received final approval for its Abbreviated New Drug Application (ANDA) from the US FDA to market a generic version of a 1 mg / ml Rapamune oral solution manufactured by PF Prism CV. In October 2014, Dr. Reddys Laboratories Ltd., received final approval for its Abbreviated New Drug Application (ANDA) from the United States, the FDA to market a generic version of Rapamune dosed tablet (1 mg). Thus, approvals of sirolimus products by regulatory authorities to manage (or prevent) organ transplant rejection are expected to drive the growth of the global sirolimus market.
Some of the companies competing in the Sirolimus market are: Pfizer Inc., Actiza, Zydus Cadila Healthcare Ltd., Inc., Greenstone Llc., Biocon, Livzon NNR and Intas Pharmaceuticals Ltd.
Factors such as the increased incidence of kidney disease have led to an increase in the number of kidney transplants. Additionally, increasing prevalence of lifestyle disorders, improving healthcare infrastructure owing to increasing healthcare spending are expected to support the growth of the global sirolimus market during the forecast period. . According to the National Kidney Foundation, in 2014, approximately 17,107 kidney transplants were performed in the United States, of which 5,537 kidneys were from living donors and 11,570 kidneys were from deceased donors.
In addition, the increased incidence of Alagille syndrome, cystinosis, glomerulonephritis, nephrotic syndrome, thrombotic thrombocytopenic purpura (TTP), hemolytic uremic syndrome (HUS), interstitial nephritis and others are expected to lead to a growing demand for transplants. The main market players are engaged in research and development activities and product launches in order to introduce optimized dosage forms. For example, in 2014, Rapamune, a formulation developed by Pfizer, lost its exclusivity as an immunosuppressant for the management of kidney transplant rejection in the U.S. However, in 2015, Rapamune became the first drug approved by the US FDA for the treatment of lymphangioleiomyomatosis (AML) which is a rare progressive lung disease. These factors are expected to support the growth of the global sirolimus market during the forecast period.
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