SIROLIMUS MARKET ANALYSIS

Sirolimus MarketSize and Trends

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.