Sirolimus Market
                     Sirolimus Market- Size, Share, Outlook, and Opportunity Analysis, 2020- 2027
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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