Testosterone Replacement Therapy Market Revenue Opportunists by Top Players AbbVie, Inc., Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International plc, Pfizer, Inc

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.

Hypogonadism in men is primarily characterized by reduced concentration of serum testosterone, causing decreased libido, erectile dysfunction, loss of body and facial hair, decreased bone density, weakness, decreased lean body mass, increased body fat, fatigue and anemia. Hypogonadism in adult men is often overlooked; even in the presence of associated symptoms, because the hypogonadism men often ignore the symptoms or they attribute them with alternate cause such as ageing.

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Increasing prevalence of hypogonadism in adult men worldwide is expected to drive growth of the testosterone replacement therapy market. According to the European Association of Urology: 2016 report, in middle-aged men, the incidence of hypogonadism varies from 2.1% to 12.8%. The incidence of low testosterone and symptoms of hypogonadism in men aged 40-79 varies form 2.1% to 5.7%, in Europe. Hypogonadism is more prevalent in older men, in men with obesity, those with co-morbidities, and in men with a poor health status. Furthermore, according to the Therapeutics Advances of Urology Journal: 2016, testosterone has become one of the most widely prescribed medications in the U.S. in 2011. These increase resulted in significant growth of testosterone replacement therapy, from US$ 18 million in the 1980 to US$ 1.6 billion in 2011, resulting in five-fold increase.

Many experts says people with type II diabetes mellitus tend to associated with low testosterone level in the blood. Visceral obesity is important cause of insulin resistance, and important feature in type II diabetes. An increased deposition of abdominal adipose tissue in the hypogonadal patients, leads to decrease testosterone concentrations. According to the Indian Journal of Endocrinology and Metabolism, 2017; a study conducted on 900 men with type II diabetes mellitus (T2DM) to evaluate the testosterone deficiency reported that prevalence of hypogonadism in T2DM patients was found to be 20.7%. Moreover, the percentage prevalence of hypogonadism in patients with T2DM was moderate with highest number of patients belonging to age group 50–59 year.

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.

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Some of the key players operating in the testosterone replacement therapy market include AbbVie, Inc., Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International plc, Pfizer, Inc., Acerus Pharmaceuticals Corporation, and Perrigo Company 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.

Testosterone Replacement Therapy Market – Taxonomy

By Active Ingredient Type

Testosterone
Methyl Testosterone
Testosterone Undecanoate
Testosterone Enanthate
Testosterone Cypionate
By Route of Administration

Injectables
Parenteral
By Region

North America
Latin America
Europe
Asia Pacific
Middle East
Africa

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