Global Male Hypogonadism Market - 2025 - 2032

Global Male Hypogonadism Market - 2025 - 2032

The global male hypogonadism market reached US$ 3.56 billion in 2024 and is expected to reach US$ 5.38 billion by 2032, growing at a CAGR of 5.4 % during the forecast period 2025-2032.

Male hypogonadism is a condition characterized by insufficient production of testosterone, the hormone essential for masculine growth and development during puberty, as well as inadequate sperm production. This condition can be present at birth or develop later in life due to factors such as injury or infection. The impact of hypogonadism and potential treatment options depend on the underlying cause and the timing of its onset.

Hypogonadism can manifest during different stages in utero, before puberty, or in adulthood. The signs and symptoms vary based on when the condition arises. Some forms of male hypogonadism may be effectively managed with testosterone replacement therapy.

There are two primary types of hypogonadism one is primary hypogonadism also known as primary testicular failure, this type arises from issues within the testicles themselves. Another one is secondary hypogonadism this type indicates a problem in the hypothalamus or pituitary gland, which are brain regions that regulate testosterone production. The hypothalamus releases gonadotropin-releasing hormone (GnRH), prompting the pituitary gland to produce follicle-stimulating hormone (FSH) and luteinizing hormone (LH). LH then stimulates the testes to produce testosterone.

Both forms of hypogonadism can be caused by congenital (inherited) factors or can develop later in life due to conditions such as injury or infection. In some cases, primary and secondary hypogonadism may occur simultaneously. These factors have driven the global male hypogonadism market expansion.

Market Dynamics: Drivers & Restraints

Increasing Cases of Testosterone Deficiency

The increasing incidence of testosterone deficiency is a significant driving factor for the global male hypogonadism market. This rise can be attributed to several demographic and health-related trends, leading to a growing demand for diagnosis and treatment options.

Hypogonadism Epidemiology

As per Endocrine Society data in October 2022, hypogonadism is a prevalent condition among men, particularly affecting older individuals, those with obesity, and men diagnosed with type 2 diabetes. Research suggests that around 35% of men over the age of 45 experience hypogonadism, while the prevalence is estimated to be between 30% and 50% among men who are obese or have type 2 diabetes. In men diagnosed with hypogonadotropic hypogonadism, Klinefelter syndrome is the most prevalent cause, occurring in approximately 1 in every 500 to 1,000 live births.

As per Frontiers in Endocrinology research data in June 2024, a study found that the overall prevalence of testosterone deficiency in men is approximately 21.2%, with higher rates observed in older populations.

According to the Archivio Italiano di Urologia e Andrologia research data in April 2022, testosterone deficiency is often linked with chronic conditions such as obesity and diabetes. Studies show that testosterone deficiency rates can reach 15-30% among diabetic or obese men. This correlation highlights the need for targeted treatments in these populations.

Studies have shown that testosterone-deficient non-obese type 2 diabetic men often exhibit elevated visceral adiposity index (VAI), waist circumference, and triglyceride levels. Elevated VAI has been identified as a significant risk factor for testosterone deficiency, indicating that even in non-obese individuals, metabolic health issues can lead to hormonal imbalances.

Research indicates that approximately 20.7% of patients with type 2 diabetes experience hypogonadism. Furthermore, some studies suggest that the prevalence of low testosterone levels in men with type 2 diabetes can be as high as 64%, highlighting a strong association between diabetes and testosterone deficiency.

The rising incidence of testosterone deficiency among non-obese type 2 diabetic males significantly influences the global male hypogonadism market. With a notable prevalence of hypogonadism in this demographic and the ongoing discussions about its underlying causes, there is a clear need for improved screening and treatment options. As healthcare systems adapt to these needs, the demand for therapies addressing male hypogonadism is expected to grow, shaping the future landscape of the market. All these factors demand the global male hypogonadism market.

Moreover, the rising demand for technological advancements in treatment options contributes to the global male hypogonadism market expansion.

Side Effects Associated with the Treatment

The side effects associated with the treatment of male hypogonadism represent a significant restraint in the global male hypogonadism market. While testosterone replacement therapy (TRT) can effectively alleviate symptoms of testosterone deficiency, it also carries risks that may deter patients from seeking treatment or adhering to prescribed regimens.

As per Endocrine Society data in January 2022, testosterone replacement therapy is linked to several potential side effects that can impact patient compliance and overall treatment outcomes. The side effects of testosterone therapy can also have psychological implications. Testosterone therapy is associated with several risks, including increased production of red blood cells, acne, breast enlargement (gynecomastia), sleep disturbances, prostate growth, and reduced sperm production. Most side effects are linked to excessively high doses of testosterone, and many may resolve if the dosage is adjusted. Regular follow-up appointments with a healthcare provider are crucial for monitoring testosterone levels and managing any adverse effects.

Risk factors for hypogonadism include human immunodeficiency virus (HIV) / acquired immunodeficiency syndrome (AIDS), previous chemotherapy or radiation treatment, aging, obesity, and malnutrition. Hypogonadism can also be hereditary. If any of these risk factors are present in your family history, it is important to inform your doctor.

The complications of untreated hypogonadism vary depending on the timing of its onset whether during fetal development, puberty, or adulthood. Potential complications include abnormal genital development, gynecomastia, infertility, erectile dysfunction, osteoporosis, and poor self-esteem. Early detection in boys can help prevent issues related to delayed puberty, while timely diagnosis and treatment in adult men can mitigate risks associated with osteoporosis and other related conditions. Thus, the above factors could be limiting the global male hypogonadism market's potential growth.

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Segment Analysis

The global male hypogonadism market is segmented based on type, therapy type, route of administration, and region.

Therapy Type:

The testosterone replacement therapy (TRT) segment is expected to dominate the global male hypogonadism market share

The testosterone replacement therapy (TRT) segment holds a major portion of the global male hypogonadism market share and is expected to continue to hold a significant portion of the global male hypogonadism market share during the forecast period.

Testosterone replacement therapy is a medical treatment aimed at restoring normal testosterone levels in men diagnosed with hypogonadism, a condition marked by insufficient testosterone production. Symptoms of hypogonadism can include fatigue, reduced libido, mood disturbances, and decreased muscle mass. TRT has been shown to significantly alleviate these symptoms and improve the overall quality of life for affected individuals.

Testosterone replacement therapy (TRT), also known as androgen replacement therapy (ART), is a treatment prescribed by doctors for men experiencing testosterone deficiency and exhibiting symptoms of hypogonadism. By administering prescription testosterone, TRT aims to restore hormone levels in the bloodstream, effectively alleviating the symptoms associated with low testosterone. Individuals undergoing this therapy may experience improvements in various areas, including increased alertness, enhanced sexual function, greater energy levels, improved mood, and an overall boost in well-being.

The development of various delivery methods for TRT including topical gels, injectables, and transdermal patches has made it easier for patients to adhere to treatment regimens. Topical gels, in particular, have gained popularity due to their convenience and effectiveness.

Furthermore, key players in the industry product launches and approvals would drive this segment's growth in the global male hypogonadism market. For instance, in March 2022, the FDA approved Tlando (testosterone undecanoate), an oral medication designed for testosterone replacement therapy (TRT) in adult males experiencing conditions associated with a deficiency or absence of endogenous testosterone, commonly known as hypogonadism. Developed by Antares Pharma, Tlando represents a significant advancement in TRT options, offering a convenient oral formulation that does not require dose titration. These factors have solidified the segment's position in the global male hypogonadism market.

Geographical Analysis

North America is expected to hold a significant position in the global male hypogonadism market share

North America holds a substantial position in the global male hypogonadism market and is expected to hold most of the market share.

The North America male hypogonadism market is witnessing significant growth, driven by several key factors that contribute to the increasing demand for testosterone replacement therapies (TRT) and related treatments.

The prevalence of male hypogonadism is increasing, particularly among older men and those with chronic health conditions such as obesity and diabetes. Research indicates that approximately 19% of men in their 60s, 28% in their 70s, and nearly 49% in their 80s experience some form of testosterone deficiency. This growing incidence serves as a major driver for the male hypogonadism market, as more individuals seek diagnosis and effective treatment options to manage their symptoms.

There has been a notable rise in awareness regarding male hypogonadism and its treatment options. Public health campaigns and educational initiatives have played a crucial role in informing men about the symptoms and risks associated with low testosterone levels. Studies suggest that testosterone prescription trends in the United States have increased significantly, with estimates showing a rise of between 1.8 to 4-fold over the past two decades. This heightened awareness encourages more individuals to seek medical help, thereby expanding the market.

The development of various delivery methods for testosterone replacement therapy including topical gels, injectables, and transdermal patches has made it easier for patients to adhere to treatment regimens. Topical gels, in particular, have gained popularity due to their convenience and effectiveness. Innovations in formulation and delivery methods enhance patient compliance, leading to improved treatment outcomes.

Furthermore, Key player's strategies such as mergers and acquisitions would drive this male hypogonadism market growth. For instance, in October 2022, Olmar Pharmaceuticals, Inc., through its affiliate Tolmar, Inc., announced the acquisition of all rights to JATENZO, a testosterone replacement therapy, from Clarus Therapeutics Holdings, Inc. This acquisition follows a competitive auction process in which Tolmar was selected as the winning bidder for JATENZO and certain related assets in the U.S. Thus, the above factors are consolidating the region's position as a dominant force in the global male hypogonadism market.

Asia Pacific is growing at the fastest pace in the global male hypogonadism market share

Asia Pacific holds the fastest pace in the global male hypogonadism market and is expected to hold most of the market share.

The prevalence of male hypogonadism is increasing in the Asia-Pacific region, particularly among older men and those with chronic health conditions such as obesity and diabetes. Research indicates that the incidence of testosterone deficiency is on the rise, leading to more men seeking diagnosis and treatment options. This trend is especially pronounced in countries like China, India, and Malaysia, where lifestyle changes have contributed to higher rates of hypogonadism.

According to the National Center for Biotechnology Information (NCBI) data in February 2023, male hypogonadism (MH) is a clinical and biochemical syndrome characterized by insufficient synthesis of testosterone. If left untreated, MH can lead to long-term consequences, including metabolic, musculoskeletal, mood-related, and reproductive dysfunction. In India, the prevalence of MH among men over 40 years of age ranges from 20% to 29%. Additionally, studies indicate that 20.7% of men with type 2 diabetes mellitus are affected by hypogonadism.

Infertility is becoming a significant concern in many Asia-Pacific countries, often linked to low testosterone levels in men. As awareness of the connection between testosterone deficiency and infertility rises, more men are likely to seek medical advice and treatment for underlying hormonal issues. The increasing rates of infertility drive demand for effective treatments for hypogonadism.

There has been a notable increase in awareness regarding male hypogonadism and its treatment options across the Asia-Pacific region. Public health campaigns and educational initiatives organized by governments and healthcare organizations have played a crucial role in informing men about the symptoms and risks associated with low testosterone levels. This heightened awareness encourages more individuals to seek medical help, thereby expanding the global male hypogonadism market.

The modernization of healthcare infrastructure in emerging economies like India and China is facilitating better access to diagnosis and treatment for male hypogonadism. Improved healthcare facilities, availability of advanced medical technologies, and increased investment in healthcare services significantly contribute to market growth. As healthcare systems evolve, they are better equipped to manage conditions like hypogonadism effectively. Thus, the above factors are consolidating the region's position as the fastest-growing force in the global male hypogonadism market.

Competitive Landscape

The major global players in the male hypogonadism market include AbbVie Inc., Endo International plc, Bayer AG, Eli Lilly and Company, Pfizer Inc., Teva Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Limited, Lupin Limited, Upsher-Smith Laboratories, LLC., and Acerus Pharmaceuticals Corporation. among others.

Key Developments
• In October 2023, Aurobindo Pharma's subsidiary, Eugia Pharma Specialities, received final approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Testosterone Cypionate Injection USP in various formulations. This includes concentrations of 1,000 mg/10 mL (100 mg/mL) and 2,000 mg/10 mL (200 mg/mL) in multi-dose vials, as well as 200 mg/mL in single-dose vials.

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