The Testosterone Replacement Therapy Market is expected to register a CAGR of 3.1% during the forecast period.
The COVID-19 pandemic has had unprecedented health concerns and negatively affected communities, industries, businesses, and health worldwide and is still affected by the spread of new strains of the virus. As the COVID-19 epidemic has led to a decline in tourism due to job closures it has contributed to market growth. Research studies showing the relationship between testosterone and COVID-19 have also contributed to market growth. For example, an article in the Journal of the American Medical Association entitled 'Association for Circulating Sexual Hormones and Inflammation and Disease in Patients With COVID-19' published in May 2021 reported that patients with COVID-19 low testosterone concentration during hospitalization was associated with the ascent severity of disease and inflammation in men. Such studies show that COVID-19 increases the need for testosterone treatment and will stimulate market growth. On the other hand, some studies have suggested that during COVID-19, Testosterone Replacement Therapy (TRT) should be discontinued and thus hinder market growth. For example, an article on Therapeutic Ádvances in Endocrinology and Metabolism entitled 'Systemic effects of male hypogonadism hormone therapy with early indications for COVID-19 patient management' published in October 2020 reported that TRT may be temporarily discontinued in patients with COVID-19 and hypogonadism. Androgen-deprivation Therapy (ADT) may be considered in severe cases without hypogonadism to counteract the effect of androgens on SARS-CoV2 infection. Such studies suggesting discontinuation of treatment could impede market growth.
Testosterone replacement therapy involves the administration of testosterone through creams/gels, patches, injections, gums/buccal adhesives or implants.Testosterone is a major male hormone responsible for improving male sexual characteristics, spermatogenesis, and reproduction. Insufficient production of testosterone causes erectile dysfunction. Erectile dysfunction occurs due to a decrease in testosterone production to overcome this treatment instead of testosterone being used to improve the problem. Testosterone deficiency or hypogonadism is a common problem among men between 40 and 79 years of age. A number of research studies have shown the incidence and prevalence of testosterone deficiency in people of different regions and emphasized the fact that aging is strongly associated with increased incidence. For example, an article in the European Journal of Endocrinology titled 'Active hypogonadism in middle-aged men: testosterone treatment or not?' published in August 2021, reported that Functional hypogonadism, in older men, also called late hypogonadism is common to tested persons. It also reported that the prevalence of active hypogonadism was approximately 2.1% with a strong diagnostic procedure. In addition, the prevalence increases with age, occurring in 0.6% of men aged 50-59, increasing to 5.1% in men aged 70-79. Such an increase in load over time is expected to further market growth in the forecast period.
Additionally, an Indian Journal of the Endocrinology and Metabolism article entitled 'Prevalence of Testosterone Deficiency in Elderly Male and its Association with Frailty and Mobility at a Tertiary Care Centre' published in December 2021 reported an increase in testosterone deficiency by 21.67% in older men over 60 years of age. As men get older, their androgen levels gradually decrease. Such proliferation of testosterone creates a need for treatment instead of testosterone and thus furthers market growth.
Therefore, due to the increase in the elderly, unhealthy lifestyle and disease burden, incidence of testosterone deficiency is expected to increase which will enhance the growth of the testosterone replacement therapy market in the predictive period. However, the side effects of testosterone replacement therapy and strict product approval rules will hinder market growth.
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 has been shown to be 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 has been shown to be an alternative treatment for older men for conditions associated with a deficiency or lack of chronic testosterone. Such authorization accelerates market growth.
In addition, the strategic acquisition of testosterone replacement therapy by market players is also driving 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 who 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.
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 the 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 market growth in the forecast period. For example, in March 2019, the United States Food and Drug Administration approved a Clarus Therapeutics drug called Jatenzo (testosterone undecanoate). It is an oral testosterone capsule for the treatment of men with certain types of 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.
The Testosterone Replacement Therapy Market is Consolidated competitive and consists of few major players. In terms of market share, a few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are AbbVie Inc, Endo Pharmaceuticals Inc, Pfizer, Inc, Eli Lilly and Company, Bayer AG, Teva Pharmaceutical Industries Ltd, Ferring Pharmaceuticals, Acerus Pharmaceuticals Corporation and Mylan N.V.
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The COVID-19 pandemic has had unprecedented health concerns and negatively affected communities, industries, businesses, and health worldwide and is still affected by the spread of new strains of the virus. As the COVID-19 epidemic has led to a decline in tourism due to job closures it has contributed to market growth. Research studies showing the relationship between testosterone and COVID-19 have also contributed to market growth. For example, an article in the Journal of the American Medical Association entitled 'Association for Circulating Sexual Hormones and Inflammation and Disease in Patients With COVID-19' published in May 2021 reported that patients with COVID-19 low testosterone concentration during hospitalization was associated with the ascent severity of disease and inflammation in men. Such studies show that COVID-19 increases the need for testosterone treatment and will stimulate market growth. On the other hand, some studies have suggested that during COVID-19, Testosterone Replacement Therapy (TRT) should be discontinued and thus hinder market growth. For example, an article on Therapeutic Ádvances in Endocrinology and Metabolism entitled 'Systemic effects of male hypogonadism hormone therapy with early indications for COVID-19 patient management' published in October 2020 reported that TRT may be temporarily discontinued in patients with COVID-19 and hypogonadism. Androgen-deprivation Therapy (ADT) may be considered in severe cases without hypogonadism to counteract the effect of androgens on SARS-CoV2 infection. Such studies suggesting discontinuation of treatment could impede market growth.
Testosterone replacement therapy involves the administration of testosterone through creams/gels, patches, injections, gums/buccal adhesives or implants.Testosterone is a major male hormone responsible for improving male sexual characteristics, spermatogenesis, and reproduction. Insufficient production of testosterone causes erectile dysfunction. Erectile dysfunction occurs due to a decrease in testosterone production to overcome this treatment instead of testosterone being used to improve the problem. Testosterone deficiency or hypogonadism is a common problem among men between 40 and 79 years of age. A number of research studies have shown the incidence and prevalence of testosterone deficiency in people of different regions and emphasized the fact that aging is strongly associated with increased incidence. For example, an article in the European Journal of Endocrinology titled 'Active hypogonadism in middle-aged men: testosterone treatment or not?' published in August 2021, reported that Functional hypogonadism, in older men, also called late hypogonadism is common to tested persons. It also reported that the prevalence of active hypogonadism was approximately 2.1% with a strong diagnostic procedure. In addition, the prevalence increases with age, occurring in 0.6% of men aged 50-59, increasing to 5.1% in men aged 70-79. Such an increase in load over time is expected to further market growth in the forecast period.
Additionally, an Indian Journal of the Endocrinology and Metabolism article entitled 'Prevalence of Testosterone Deficiency in Elderly Male and its Association with Frailty and Mobility at a Tertiary Care Centre' published in December 2021 reported an increase in testosterone deficiency by 21.67% in older men over 60 years of age. As men get older, their androgen levels gradually decrease. Such proliferation of testosterone creates a need for treatment instead of testosterone and thus furthers market growth.
Therefore, due to the increase in the elderly, unhealthy lifestyle and disease burden, incidence of testosterone deficiency is expected to increase which will enhance the growth of the testosterone replacement therapy market in the predictive period. However, the side effects of testosterone replacement therapy and strict product approval rules will hinder market growth.
Key Market Trends
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 has been shown to be 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 has been shown to be an alternative treatment for older men for conditions associated with a deficiency or lack of chronic testosterone. Such authorization accelerates market growth.
In addition, the strategic acquisition of testosterone replacement therapy by market players is also driving 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 who 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 the 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 market growth in the forecast period. For example, in March 2019, the United States Food and Drug Administration approved a Clarus Therapeutics drug called Jatenzo (testosterone undecanoate). It is an oral testosterone capsule for the treatment of men with certain types of 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.
Competitive Landscape
The Testosterone Replacement Therapy Market is Consolidated competitive and consists of few major players. In terms of market share, a few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are AbbVie Inc, Endo Pharmaceuticals Inc, Pfizer, Inc, Eli Lilly and Company, Bayer AG, Teva Pharmaceutical Industries Ltd, Ferring Pharmaceuticals, Acerus Pharmaceuticals Corporation and Mylan N.V.
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Table of Contents
1 INTRODUCTION
4 MARKET DYNAMICS
5 MARKET SEGMENTATION (Market Size by Value - USD million)
6 COMPETITIVE LANDSCAPE
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- AbbVie Inc
- Endo Pharmaceuticals Inc
- Pfizer, Inc
- Eli Lilly and Company
- Bayer AG
- Teva Pharmaceutical Industries Ltd
- Ferring Pharmaceuticals
- Acerus Pharmaceuticals Corporation
- Mylan N.V.
- Upsher-Smith Laboratories
- Biote
- Antares Pharma Inc.
Methodology
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