Testosterone Replacement Therapy Market: Top Global Players Competition with Production, Consumption, Revenue and Gross Margin by 2026 - AbbVie, Inc., Eli Lilly and Company, Kyowa Kirin International plc

Key players in these market are engaged in product regulatory approval and new product launch strategies to maintain competitive position in the market. For instance, in March 2017, U.S. FDA approved Abbreviated New Drug Application (ANDA) of Perrigo Company plc, for making the generic version of Eli Lilly and Company's Axiron topical solution, 30 mg/1.5 mL (testosterone topical solution, 30 mg/1.5 mL). Endo International Inc. is being an innovative player in the testosterone replacement therapy market, which engaged in launching novel and innovative product in these market. For instance, in March 2015, Endo Pharmaceuticals Inc., a subsidiary of Endo International plc, launched NATESTO (testosterone nasal gel), the first and only nasal gel for testosterone replacement therapy in adult males diagnosed with hypogonadism.

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Testosterone replacement therapy is promising technology for improving symptoms of hypogonadism and to raise the low testosterone level. Furthermore, benefits related to application of testosterone replacement therapy include, increase in muscle tissue, overall surge in body energy, and significant decrease in depression symptoms.

Stringent regulations proposed by the U.S. Food and Drug Administration (FDA), regarding the application of testosterone products, owing to increased risk of adverse cardiovascular events is expected to hamper the growth of the testosterone replacement therapy market, in near future. The U.S. FDA in February 2018 updated policies, stated that testosterone replacement product manufactures requires to change the labelling to inform the patients about possible increased risk of heart attack and stroke.

Furthermore, in January 2018 committee meeting, FDA proposed the regulation, demanding testosterone manufactures to conduct a post-marketing randomized, double-blind, placebo-controlled trial to definitively determine whether these therapies increase major adverse cardiovascular events, such as myocardial infarction and stroke or not before marketing the product.

Testosterone Replacement Therapy (TRT) or low testosterone therapy is commonly called hormone therapy for men, designed to counteract the effects of reduced activity in the gonads or hypogonadism. Hypogonadism in men is clinical syndrome, which results in the failure of the testes to produce physiological levels of testosterone. Hypogonadism may be primary, due to a problem with the testes or secondary due to a problem with the hypothalamus or pituitary gland or combined: primary and secondary. Primary hypogonadism is caused due to genetic abnormalities, testicular trauma, orchitis, radiation treatment or chemotherapy, while secondary hypogonadism is caused due to genetic abnormalities of pituitary and hypothalamus.

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