Market Trends of Global Testosterone Replacement Therapy Industry
This section covers the major market trends shaping the Testosterone Replacement Therapy Market according to our research experts:
Topicals Segment is Expected to Hold a Major Market Share in the Testosterone Replacement Therapy Market
Topical testosterone is a drug used on the skin to treat hypogonadism, a condition that prevents the body from producing enough testosterone. Other forms of testosterone drugs are used topically in creams, gels, and patches. Increased incidence of testosterone deficiency, an increase in the number of adults and the introduction of new products and strategic plans taken by market players are the main factors in the growth of the segment of the market topics being studied.
The introduction of new products to the market encourages the growth of market share in the forecast period. For example, in August 2020, Xiromed LLC introduced the Testosterone Gel 1.62% Metered Dose Pump (20.25mg / 1.25g pump actuation), the AB generic version of AndroGel 1.62%. It is an alternative treatment for men with conditions associated with a deficiency or lack of chronic testosterone.
In addition, in March 2021, Alembic Pharmaceuticals Ltd and Aleor Dermaceuticals received final approval from the United States Food and Drug Administration (USFDA) for a summary of its new drug application (ANDA) Testosterone Gel, at 1.62%. It is an alternative treatment for older men for conditions associated with a deficiency or lack of chronic testosterone. Such authorization accelerates the market growth.
In addition, the strategic acquisition of testosterone replacement therapy by market players is also driving the market growth. For example, in February 2021, Simple Pharma acquired Testavan and Vitaros, two men's health products developed at Ferring Pharmaceuticals. Testavan (transdermal testosterone gel 2%) is a testosterone replacement for adult hypogonadism, where testosterone deficiency is confirmed by clinical and biochemical tests while Vitaros (alprostadil cream) is the only topical cream that treats Erectile Dysfunction (ED). Such developments in the market segment also increase market segment growth over the forecast period.
Therefore, due to the factors listed above, the market share is expected to grow in the forecast period.
North America is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period
The well-established healthcare infrastructure, rising burden of testosterone deficiency, development of new therapeutic approaches, and focus on research and development and launch of new products are driving the growth of the studied market in the United States.
Studies show that the burden of testosterone shortages in the country also increases market growth. For example, the International Journal of Impotence Research article titled "Evaluating incidence, prevalence, and treatment trends in adult men with hypogonadism in the United States'' published in November 2021 reported an estimated 16.1 annual cases of hypogonadism -100,000, with the highest incidence, observed among men aged 35-44 in 21.5 cases per 100,000 per year and among those living in the Southern United States with 22.6 cases per 100,000 per person. It also reported that the increase in hypogonadism during the study period increased from 0.78% to 5.4%. Such a heavy burden of testosterone deficiency creates a need for treatment instead of testosterone and thus enhances market growth.
In addition, the research studies conducted in this field, the positive results from them can lead to effective development and development of new products and thus are expected to further market growth. For example, according to clinicaltrials.gov.in as of March 23, 2022, there are about 69 ongoing studies in the United States for treatment in place of Testosterones.
In addition, the approval of new products from regulatory authorities also drives the market growth in the forecast period. For example, in March 2021, the United States Food and Drug Administration accepted a New Drug Application (NDA) for SOV2012-F1 (Kyzatrex), an oral testosterone undecanoate soft gelatin capsule, for the treatment of adult men with primary or secondary hypogonadism. Such approvals encourage market growth.
Therefore, because of the factors listed above, the market for testosterone replacement therapy in the United States is expected to continue to grow in the forecast period.
