AbbVie, Inc. emerged the undisputed leader in a highly consolidated global testosterone replacement therapy (TRT) market in 2015 thanks to its star performer TRT product, AndroGel, finds Transparency Market Research (TMR) in a new study. Endo Pharmaceuticals, Inc., Eli Lilly and Company, Allergan plc, and Bayer AG are the other strong contenders in this space. The top five players together held sway over 80% of the market in the same year, finds TMR.
Although in the short term, the advent of innovative testosterone replacement therapy technology such as spray-on and unmodified testosterone will give the testosterone market a shot in the arm, the market is nearing a patent cliff. As a result of these imminent patent expirations, the market will witness a decline in revenues. “Yet, it’s a not entirely a bleak picture. With several drivers acting upon the market, slow albeit steady growth will be possible. There is a rising demand for advanced TRT products as consumers become more aware about the options available to them,” says a TMR analyst.
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Testosterone deficiency, also referred to as hypogonadism, is a common problem among men aged between 40 and 79 years, with some studies stating that nearly 30% of all men worldwide are affected by hypogonadism. As the incidence of testosterone deficiency increases, it is expected that the demand for TRT will also show a simultaneous increase.
At the same time, the report states that the geriatric population, which is rising at a steady pace worldwide, represents a massive target demographic for companies in the TRT market. The number of men reporting a deficiency in testosterone levels is likely to rise as the number of aged individuals soars worldwide. Overall, the effect of these two drivers will be compounded by an overall increase in the awareness levels about testosterone replacement therapy (TRT).
The perceived risk of cardiovascular or metabolic disease associated with treating testosterone deficiency has hampered the consumption of TRT products. Moreover, with numerous studies evidencing the adverse effects, the FDA has issued adequate warnings pertaining to these risks, causing many patients to view TRT in a negative light. “Although these risks are associated only with certain TRT products, this is perhaps the greatest challenge that companies in the TRT market will have to overcome,” opines a TMR analyst.
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According to TMR, the other challenge that stands in the way of the market’s growth is the expiry of key TRT products, which will clear the path for the entry of generics. The three top performers in the testosterone replacement therapy market currently are AbbVie, Inc.’s AndroGel, Eli Lilly and Company’s Axiron, and Endo Pharmaceuticals, Inc.’s Nebido. While AndroGel’s patent expired in 2015, Axiron and Nebido are heading toward a patent expiry, which will deal a blow to the revenues of the top market players.
According to Transparency Market Research, testosterone replacement therapy revenues will reach US$1.3 bn globally in 2024, down noticeably from US$2.0 bn in 2015. This translates to a (-4.2)% CAGR for the market from 2016 to 2024.
By type, the global TRT products market was dominated by creams and gels in 2015, which accounted for nearly 66% of the market worldwide. The fastest growth will be observed in the injections product segment through the forecast period of TMR’s study.
Among all the major active ingredients available on the market, testosterone in its native form was observed to be the leading segment with over 68% of the global TRT market. Likewise, the North America TRT market stood as the largest worldwide in 2015 with an 84.7% share. It was trailed by Europe and Asia Pacific, in that order.
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