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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Furthermore, functional causes of hypogonadism are mainly attributed to the severe psychological or emotional stress, obesity (WHO grade III or IV- BMI > 30), nutritional deficiency or eating disorders, untreated obstructive sleep apnea, medication such as opioids, androgens, glucocorticoids, anabolic steroids; chronic systemic illness caused due to kidney, lung, heart failure, diabetes mellitus, HIV infection, Crohn’s disease, and aging.
Testosterone Replacement Therapy Market – Drivers
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.
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.
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Testosterone Replacement Therapy Market – Restraints
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 Market – Regional Analysis
Geographically, global testosterone replacement therapy market is segmented into North America, Latin America, Europe, Middle East, Asia Pacific, and Africa. North America holds major share in the testosterone replacement therapy market, owing to increasing number of people suffering from hypogonadism, combined with rising adoption of testosterone products in the U.S. market. According to the data published in European Association of Urology Journal: 2017, testosterone prescription trends in the U.S. demonstrated an increase between 1.8-and 4-fold over the last two decades (1997 - 2017).
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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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