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.
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 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.
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. 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.
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). Moreover, from 2000 to 2011, there was a 4.3-fold increase in testosterone testing compared to a 3.7-fold increase in prescriptions.
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.
Testosterone Replacement Therapy Market – Competitor
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
By Route of Administration