Testosterone Replacement Therapy Market Structure by Size, Valuable Shares, Industry Research, Top Manufacturers, Demand & Forecast Till 2021 – 2027

SEATTLE, April 09, 2021, (PHARMIWEB) — Testosterone Replacement Therapy (TRT), also known as low testosterone therapy or hormone therapy for men, is an approach to address the impact of reduced activity in the gonads or hypogonadism. In Hypogonadism, men lose the ability to produce physiological levels of testosterone. Hypogonadism can be classified as primary, due to a problem with the testes or secondary due to a problem with the hypothalamus or pituitary gland. The condition can also be a combination of primary and secondary conditions. Genetic abnormalities, testicular trauma, orchitis, and radiation treatment or chemotherapy are some of the major factors that cause primary hypogonadism. Genetic abnormalities of pituitary and hypothalamus can lead to secondary hypogonadism.

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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 are some of the functional causes of hypogonadism.

Testosterone replacement therapy can improve the symptoms of hypogonadism and increase the low testosterone level. Moreover, testosterone replacement therapy can also increase muscle tissue and decrease the symptoms of depression.

Testosterone Replacement Therapy Market – Drivers

Reduced concentration of serum testosterone, leasing to decreased libido, erectile dysfunction, loss of body and facial hair, decreased bone density, weakness, decreased lean body mass, increased body fat, fatigue and anemia are some of the symptoms of Hypogonadism in men. Hypogonadism in adult men is often neglected even in the presence of associated symptoms, assuming these symptoms as the result of ageing.

Increasing prevalence of hypogonadism in adult men is expected to increase demand for testosterone replacement therapy. For instance, 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 several experts, type II diabetes mellitus patients may also suffer from low testosterone levels. Visceral obesity may significantly lead to insulin resistance. An increased deposition of abdominal adipose tissue in the hypogonadal patients can reduce 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

Use of testosterone products may increase the risk of cardiovascular diseases. Therefore, several regulatory bodies have imposed stringent regulations for the use of testosterone products, which is expected to hinder the market growth. For instance, in February 2018, The U.S. FDA updated policies, stating that testosterone replacement product manufactures require to change the labelling to inform the patients about possible increased risk of heart attack and stroke.

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

Testosterone Replacement Therapy Market – Regional Analysis

On the basis of region, the global testosterone replacement therapy market is segmented into North America, Latin America, Europe, Middle East, Asia Pacific, and Africa. North America accounts for major market share. This is attributed to increasing prevalence of hypogonadism and high adoption of testosterone products in the U.S. 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.

The market in Asia Pacific is expected to witness high growth, owing to increasing prevalence of hypogonadism in men with type II diabetes mellitus and diabetes. 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 – Key Players

Key players in the market are focused on approval and launch of new products to enhance their market share. For instance, in March 2017, the 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). 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.

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. 

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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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