Testosterone Replacement Therapy Market – Regional Analysis: Pfizer, Inc.,AbbVie, Inc., Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company

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.

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.

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). Moreover, from 2000 to 2011, there was a 4.3-fold increase in testosterone testing compared to a 3.7-fold increase in prescriptions.

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Asia Pacific is expected to witness high growth for testosterone replacement therapy, owing to the high prevalence of hypogonadism in men with type II diabetes mellitus, combined with growing prevalence of diabetes population, in these region. For instance, according to International Diabetes Federation (IDF) Diabetes Atlas: 2017, number of people with diabetes aged between 20 to 79 years in South East Asia region and Western Pacific region in 2017, was 82 million and 159 million, respectively.

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