Testosterone Replacement Therapy Market Size, Share, Industry, Forecast and outlook (2024-2031)

Global Testosterone Replacement Therapy Market is segmented By Product Type (Oral Implants, Injections, Patches, Creams/Gels, Gums/Buccal Adhesives), By Active Ingredient Type (Testosterone, Methyl Testosterone, Testosterone Undecanoate, Testosterone Enanthate, Testosterone Cypionate), By Indication (Hypogonadism, Autoimmune Conditions, Genetic Disorders, Sex Organ Surgeries, Others), By Region (North America, Europe, South America, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Report Overview

Global Testosterone Replacement Therapy Market size was valued at USD 1,838.90 million in 2021 and is estimated to reach at a compound annual growth rate (CAGR) of 4.00% over the forecast period 2024-2031.

Testosterone Replacement Therapy (TRT) or androgen replacement therapy is a type of hormone replacement therapy in which androgens, often testosterone, are replaced. TRT is an FDA-approved medical treatment for men of any age who have low testosterone, the primary male sex hormone.

Market Summary

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Market Dynamics

The major factors driving the growth of this market are the rise in the incidence of testosterone deficiency, an increase in the geriatric population with increasing awareness about testosterone substitute therapy.

Rise in geriatric population with a high risk of testosterone deficiency boost market growth

The world population is growing rapidly, especially in developed economies such as the U.S., most Western Europe, and Japan. As a result, developed economies present high rates of aging. This factor is attributed to improved health care infrastructure, policies, and advancement in health care infrastructure in these nations. Moreover, access to various diagnostic and treatment services has improved in the recent past, especially in developed economies.

According to World Health Organization (WHO) estimates, the global geriatric population is likely to reach around 2 billion (22% of the global population) by 2050 compared to 524 million in 2010. The geriatric population would rise at the fastest rates in developed countries such as the U.K, Germany, the U.S., and Japan. However, Brazil, China, Thailand, and South Korea are also expected to have a large geriatric population base in the shortest period soon.

Testosterone levels decrease as age increases beyond 30 years. However, in some cases, the significant decrease can lead to health problems. In addition, the world population is rapidly aging. Therefore, with the increasing population of age individuals, the testosterone deficient men population would also grow, increasing the demand for testosterone replacement therapy in the global market. Hence, an increase in the geriatric population is expected to fuel the growth of the testosterone replacement therapy market globally.  

Growing awareness about testosterone replacement therapy to drive market

Testosterone replacement therapy (TRT) is comparatively new as compared to other pharmaceutical therapy. However, increasing awareness regarding the benefits and efficacy of testosterone replacement therapy products is increasing acceptance among patients and physicians. As a result, market players focus on improving their products directly to customers, journals, physician detailing, and meetings and events. These companies are also spending large sums on marketing campaigns.

Marketing campaigns by leading players in the business for their branded commodities would help raise awareness about testosterone treatment among the world's general population. This increased awareness is anticipated to boost demand for testosterone replacement therapy products, which is likely to drive the market.

For instance, in April 2019, the U.S. FDA approved a generic version of testosterone gel 1.62% as replacement therapy for men with hypogonadism.

The high risks of diseases like prostate disease related to testosterone and cardiovascular sickness are expected to hinder the market growth  

The high risks of diseases like prostate disease related to testosterone and cardiovascular sickness hinder the market growth. In addition, the injectables, oral capsules, and topicals used in the treatment process might raise the risk of contracting various disorders such as prostate cancer, cardiovascular diseases, and obstructive sleep apnea. Such unfavorable effects associated with testosterone replacement therapy could reduce patient compliance.

COVID-19 Impact Analysis on Testosterone Replacement Therapy Market

The coronavirus disease 2019 (COVID-19) pandemic has substantially affected surgeons and patients who require surgical care. As such, the surgical workforce has faced distinct challenges compared with nonsurgical specialties during the COVID-19 pandemic. Specific issues include the best approach to protect health care personnel and the patient the ability to regulate delivery of surgical care efficiently, the detrimental effects on patients with the testosterone replacement therapy. These factors hinder the growth of the market in the forecast period.

Market Segmentation Analysis

Creams/Gels segment is expected to grow at the fastest CAGR during the forecast period (2024-2031)   

Testosterone Creams are formulated with plant-derived bio-identical testosterone. Creams come in different concentrations, depending on the amount required to optimize a patient’s testosterone level. Testosterone creams are used to treat low testosterone levels in both men and women. In most cases, they are prepared for a patient individually and are ordered through a specialized compounding pharmacy. The pharmacy prepares the cream or gel to the specific requirements ordered by the prescribing physician. As with all bio-identical hormone replacement therapy, it is not a one-size-fits-all approach. Instead, everything is carefully formulated to the individual needs of the patient. In addition to the generic testosterone creams and gels prepared by compounding pharmacies, two name brands of testosterone creams/gels in the U.S. are Androgel and Testim.

These products and all other synthetic versions of bio-identical testosterone in cream or gel form are bio-identical to your testosterone. They are called synthetic since they are made in the lab. However, synthetic does not mean they are not bio-identical to your hormones.

Testosterone creams and gels are incredibly convenient. The main advantage of creams is their ease of use. In addition, they don’t require patients to inject testosterone or receive a subdermal pellet implant. These factors are driving the segment growth in the forecast period.

Market Geographical Share

North America region holds the largest market share in the global testosterone replacement therapy market

North America region dominates the global testosterone replacement therapy market due to the increasing number of individuals suffering from hypogonadism and the rising geriatric population. According to the study published in the European Association of Urology Journal in 2017, testosterone prescription trends in the United States registered an increase between 1.8 and 4-fold over the last two decades. In addition, the American Thyroid Association recommended that around 12.0% of the U.S. population is expected to suffer from thyroid disease during their lifetime. It also stated that about 20.0 million U.S. citizens have any form of thyroid disease. In addition, a high number of congenital disorders in newborns is anticipated to drive the market. As per CDC, 1 in every 2,000 to 4,000 neonates suffers from congenital hypothyroidism, which, if left unattended, leads to mental retardation.

In April 2019, the U.S. FDA approved a generic version of testosterone gel 1.62% as replacement therapy for men with hypogonadism.

Testosterone Replacement Therapy Companies and Competitive Landscape

The testosterone replacement therapy market is moderately competitive with the presence of local as well as global companies.  Some of the key players which are contributing to the growth of the market include Clarus Therapeutics, Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly Company, Kyowa Kirin International plc, Mylan N.V., Novartis AG, and Pfizer, Inc., J & K SCIENTIFIC LTD., Beijing Coupling Technology Co., Ltd., Longyan Tianhua Biological Technology Co., Ltd, among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the testosterone replacement therapy market globally.    

Key Companies to Watch

Clarus Therapeutics

Overview: Clarus Therapeutics, Inc. develops and distributes androgen-based medicines. The Company provides products for erectile dysfunction, reduced sex drive, fatigue, mild depression, and increased body fat. Clarus Therapeutics serves patients in the United States.

Product Portfolio: The Company offers first and only FDA-approved oral treatment specifically developed for hypogonadism, JATENZO (testosterone undecanoate) capsules, CIII, and others.

Key Development: In March 2019, the U.S. FDA approved Jatenzo, an oral testosterone capsule, manufactured by Clarus Therapeutics for the treatment of certain forms of hypogonadism.