Tacrolimus Market Regional Analysis

North America Tacrolimus Market is expected to dominate over the forecast period. Presence of leading manufacturers as well as high number of organ transplant procedures is expected to support global tacrolimus market growth. Regional generic manufacturers are focusing on providing generic version of tacrolimus formulations in developed as well emerging economies. For instance, Strides Arcolab received the U.S. Food & Drug Administration (FDA) approval for tacrolimus capsules to be used as immuno-suppressant in 2014. Sandoz launched Tacrolimus, a generic version of Astellas’s PROGRAF (tacrolimus) in Japan, in 2015. Moreover, The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for tacrolimus’ generic, Tacforius in 2017. These factors have supported the global tacrolimus market growth.

Tacrolimus is used as an immunosuppressant mainly after organ transplant procedures to prevent organ rejection. Tacrolimus inhibits the activation of serine-threonine phosphatase, calcineurin, in T lymphocytes. This suppresses T lymphocyte activation and the subsequent generation of cytotoxic lymphocytes, thereby suppressing processes leading to organ rejection. Tacrolimus is primary immunosuppression drug used in kidney and liver transplant patients. Organ transplanted patients often require lifelong treatment with immunosuppressant. Major applications of this includes in cardiac transplant rejection, liver transplant rejection, kidney transplant rejection, and lung transplant immunosuppression treatment. Tacrolimus is available in various dosage forms such as tablets, capsules, and injections.

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Tacrolimus Market Drivers

Tacrolimus is majorly used as an immunosuppressant after organ transplant procedures. Advancement in organ transplant procedures is a major factor expected to increase the number of organ transplants, which in turn is expected to boost global tacrolimus market growth over the forecast period. For instance, new methods are being researched to match more donor organs with patients such as stem cell studies, trophic factor studies, and natural models. As the need for organ transplantation increases and the waiting list continues to grow, successful utilization and transplantation of as many available donor organs as possible has become important. According to Organ Procurement and Transplantation Network (OPTN) 117,000+ number of men, women, and children are on the national transplant waiting list as of July 2017 in the U.S. and 17,155 organ transplants are done so far in 2017.

Moreover, according to National Kidney Foundation as of 2016, 121,678 people are waiting for lifesaving organ transplants in the U.S., of which 100,791 people are waiting for kidney transplants. Moreover, organ transplantation procedures have evolved with increase in feasibility and better understanding of immunology, which has allowed for improved matching rates for organs and patients after transplants. This is expected to result in increasing number of organ transplants which is expected to support the global tacrolimus market growth over the forecast period.

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Certain side effects (malignancy, Psychosis, and others) of tacrolimus, although not significant, may hamper the global tacrolimus market growth. However, major growth limiting factor is expected to be significant gap between demand and supply of transplant organs, which indirectly could affect the global tacrolimus market growth.

Tacrolimus Market Key Players

Key players operating in the global tacrolimus market include GlaxoSmithKline Plc, Abbott Laboratories, Novartis International AG, Mylan N.V., Astellas Pharma, Inc., Takeda Pharmaceuticals Company Ltd, Senju Pharmaceutical Co. Ltd., Guike Pharmaceutical Co. Ltd., DR. Reddy’s Laboratories Ltd., and Glenmark Pharmaceuticals Ltd.

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