Testosterone Replacement Therapy Market Size
| Study Period | 2019 - 2029 |
| Base Year For Estimation | 2023 |
| Forecast Data Period | 2024 - 2029 |
| CAGR | 3.10 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Need a report that reflects how COVID-19 has impacted this market and its growth?
Testosterone Replacement Therapy Market Analysis
The Testosterone Replacement Therapy Market is expected to register a CAGR of 3.1% during the forecast period (2022-2027).
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 the 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 the 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. Several 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, the 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 the market growth.
Testosterone Replacement Therapy Market Trends
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.
Testosterone Replacement Therapy Industry Overview
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.
Testosterone Replacement Therapy Market Leaders
AbbVie Inc
Endo Pharmaceuticals Inc
Pfizer, Inc
Eli Lilly and Company
Bayer AG
*Disclaimer: Major Players sorted in no particular order
Testosterone Replacement Therapy Market News
- In August 2022, Marius Pharmaceuticals received United States Food and Drug Administration approval for KYZATREX (testosterone undecanoate). KYZATREX is an oral testosterone replacement therapy ("TRT") indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.
- In March 2022, the United States Food and Drug Administration (FDA) granted approval to testosterone undecanoate (TLANDO), an oral treatment for testosterone replacement therapy.
Testosterone Replacement Therapy Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rise in Incidence of Testosterone Deficiency
4.2.2 Increasing Novel Therapeutic Approaches
4.3 Market Restraints
4.3.1 Adverse Effects of the Testosterone Replacement Therapy
4.3.2 Stringent Regulations on Product Approval
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD million)
5.1 By Product Type
5.1.1 Injectables
5.1.2 Topicals
5.1.3 Others
5.2 Geography
5.2.1 North America
5.2.1.1 United States
5.2.1.2 Canada
5.2.1.3 Mexico
5.2.2 Europe
5.2.2.1 Germany
5.2.2.2 United Kingdom
5.2.2.3 France
5.2.2.4 Italy
5.2.2.5 Spain
5.2.2.6 Rest of Europe
5.2.3 Asia-Pacific
5.2.3.1 China
5.2.3.2 Japan
5.2.3.3 India
5.2.3.4 Australia
5.2.3.5 South Korea
5.2.3.6 Rest of Asia-Pacific
5.2.4 Middle East and Africa
5.2.4.1 GCC
5.2.4.2 South Africa
5.2.4.3 Rest of Middle East and Africa
5.2.5 South America
5.2.5.1 Brazil
5.2.5.2 Argentina
5.2.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 AbbVie Inc
6.1.2 Endo Pharmaceuticals Inc
6.1.3 Pfizer, Inc
6.1.4 Eli Lilly and Company
6.1.5 Bayer AG
6.1.6 Teva Pharmaceutical Industries Ltd
6.1.7 Ferring Pharmaceuticals
6.1.8 Acerus Pharmaceuticals Corporation
6.1.9 Mylan N.V.
6.1.10 Upsher-Smith Laboratories
6.1.11 Biote
6.1.12 Antares Pharma Inc.
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Testosterone Replacement Therapy Industry Segmentation
As per the scope of the report, testosterone replacement therapy (TRT) is a form of hormone therapy in which androgens testosterone, is replaced and this therapy is often prescribed to counter the effects of male hypogonadism. The Testosterone Replacement Therapy Market has segmented By Product Type (Injectables, Topicals, Others) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.
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Testosterone Replacement Therapy Market Research FAQs
What is the current Global Testosterone Replacement Therapy Market size?
The Global Testosterone Replacement Therapy Market is projected to register a CAGR of 3.10% during the forecast period (2024-2029)
Who are the key players in Global Testosterone Replacement Therapy Market?
AbbVie Inc, Endo Pharmaceuticals Inc, Pfizer, Inc, Eli Lilly and Company and Bayer AG are the major companies operating in the Global Testosterone Replacement Therapy Market.
Which is the fastest growing region in Global Testosterone Replacement Therapy Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Global Testosterone Replacement Therapy Market?
In 2024, the North America accounts for the largest market share in Global Testosterone Replacement Therapy Market.
What years does this Global Testosterone Replacement Therapy Market cover?
The report covers the Global Testosterone Replacement Therapy Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Global Testosterone Replacement Therapy Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
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