Hypogonadism - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• Hypogonadism is often underreported, improperly diagnosed, and overtreated. The condition can be hypergonadotropic (primary, resulting when the gonads fail) or hypogonadotropic.
• The Endocrine Society Clinical Practice Guideline defines male hypogonadism as "a clinical syndrome that results from failure of the testes to produce physiological levels of testosterone due to disruption of one or more levels of the hypothalamic-pituitary-testicular axis.
• Patients with hypogonadism are typically treated with sex steroid replacement. The goals of treatment are: to promote the development of and maintain secondary sexual characteristics and normal sexual function, to build and sustain normal bone and muscle mass, and to assist in the proper psychosocial adjustment of adolescents with hypogonadism.
• Testosterone replacement therapy is a well-tolerated and established treatment for hypogonadism, providing excellent clinical and biochemical relief from the effects of sex steroid deficiency.
• Estrogen and progesterone are commonly used in girls and women for various medical reasons, including managing menopausal symptoms and in some cases, hormone injections or pills may also be used to stimulate ovulation.
• Asymptomatic hypogonadal patients do not require treatment. Only patients with symptoms possibly associated with low testosterone levels should be considered candidates for therapy.
• Oral testosterone supplements, such as methyltestosterone, are not recommended due to their associated liver toxicity, including jaundice, cholestasis, and abnormal hepatic function tests.
• Clomiphene citrate is an effective therapy for both biochemical and clinical male hypogonadism through a unique mechanism of action.
• Human chorionic gonadotropin (hCG) works similarly to clomiphene in that it will stimulate testosterone production by the Leydig cells of the testes without affecting sperm counts or spermatogenesis. hCG is similar to luteinizing hormone but has a much longer half-life (36 hours compared to 30 minutes), which is why it is often the preferred agent used in symptomatic testosterone-deficient men with hypogonadotropic hypogonadism.
• Very few biopharmaceutical companies are actively developing novel therapies for hypogonadism, with a notable example being RPN-001 (leflutrozole)-an oral aromatase inhibitor currently under development by REPRONOVO in collaboration with Mereo BioPharma.

DelveInsight's "Hypogonadism - Market Insight, Epidemiology and Market Forecast - 2034" report delivers an in-depth analysis of hypogonadism epidemiology, market, and clinical development in hypogonadism. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the hypogonadism market trends in the United States, EU4 (Germany, France, Italy, and Spain ), the United Kingdom, and Japan.

Hypogonadism market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted hypogonadism market size from 2020 to 2034 in 7MM. The report also covers current hypogonadism treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Hypogonadism Understanding and Treatment Algorithm

Hypogonadism Overview

Hypogonadism refers to a condition in which little or no hormone is produced by the testes or ovaries. The condition can be hypergonadotropic (primary, resulting when the gonads fail) or hypogonadotropic. The latter can result from failure of the hypothalamic Luteinizing-hormone Releasing Hormone (LHRH) pulse generator or from the inability of the pituitary to respond with secretion of Luteinizing Hormone (LH) and Follicle-stimulating Hormone (FSH). Morbidity for men and women with hypogonadism includes infertility and an increased risk of osteoporosis; there is no increase in mortality.

Hypogonadism Diagnosis

To diagnose hypogonadism, doctors typically begin with hormone testing-measuring estrogen levels in females and testosterone levels in males. Levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), both produced by the pituitary gland and essential for regulating gonadal function, are also assessed. In men, the Androgen Deficiency in Aging Males (ADAM) questionnaire can serve as a useful initial screening tool.

Diagnosis involves not only laboratory testing but also a thorough evaluation of symptoms, which may vary depending on the patient's age. Additional tests may include measurements of thyroid hormones, prolactin (a pituitary hormone involved in breast development and milk production), sperm count, screening for anemia, and genetic testing when appropriate. In women, a pelvic ultrasound may be performed to assess the ovaries. If a pituitary disorder is suspected, imaging studies such as MRI or CT scans may be used to examine the pituitary gland.

Hypogonadism Treatment

Patients with hypogonadism are typically treated with sex steroid replacement. Several testosterone-replacement therapies are approved for treatment and should be selected according to the patient's preference, cost, availability, and formulation-specific properties.

Asymptomatic hypogonadal patients do not require treatment; only those with symptoms and confirmed low testosterone levels should be considered for therapy. Lifestyle changes such as weight loss and exercise are preferred for symptomatic patients with normal testosterone levels. Oral testosterone formulations like methyltestosterone are discouraged due to liver toxicity. Testosterone therapy in men with proven hypogonadism can improve libido, anemia, bone density, lean body mass, and erectile function, though benefits for mood and metabolic conditions remain inconclusive. While testosterone may aid depression in hypogonadal men, evidence is mixed, and excessive use poses risks. Therapy should be avoided after recent cardiovascular events and in men trying to conceive, as it significantly suppresses sperm production, which may take months to recover after stopping treatment.

For women with an intact uterus, a combination of estrogen and progesterone is often recommended to reduce the risk of endometrial cancer; in cases of hypogonadism with low sex drive, low-dose testosterone may also be considered.

Currently, TLANDO (testosterone undecanoate), JATENZO (testosterone undecanoate), and others are approved for the treatment of hypogonadism.

Hypogonadism Epidemiology

The hypogonadism epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total prevalent cases of hypogonadism, total diagnosed prevalent cases of hypogonadism, type-specific diagnosed prevalent cases of hypogonadism, age-specific diagnosed prevalent cases of hypogonadism, gender-specific diagnosed prevalent cases of hypogonadism, and total treatable cases of hypogonadism in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• According to studies conducted by Galdiero and Longhi (2024), approximately 40% of men older than 45 and 50% of men in their 80s are hypogonadal.
• A recent study in nonobese diabetic males found that 29% were testosterone deficient. The visceral adiposity index was the only reliable indicator of testosterone deficiency in this group of patients.
• According to secondary research, hypogonadism is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes. It is estimated that approximately 35% of men older than 45 years of age and 30-50% of men with obesity or type 2 diabetes have hypogonadism.
• As per secondary research, Klinefelter's syndrome is the most common cause of primary hypogonadism and is reported in 1:660 male births according to data from newborn screening.

Hypogonadism Drug Chapters

The drug chapter segment of the hypogonadism report encloses a detailed analysis of hypogonadism-marketed drugs and emerging pipeline drugs. It also deep dives into hypogonadism's pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

TLANDO (testosterone undecanoate): Lipocine and Verity Pharmaceuticals

TLANDO is approved by the FDA as a Testosterone Replacement Therapy (TRT) in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). It was developed using Lipocine's proprietary Lip'ral drug delivery technology platform.

In March 2022, the US Food and Drug Administration (FDA) approved TLANDO in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

Earlier, Lipocine licensed the exclusive US commercialization rights for TLANDO to Antares Pharma.

In January 2024, Lipocine, Gordon Silver Limited, and Verity Pharmaceuticals entered into an exclusive licensing agreement granting Verity Pharmaceuticals the rights to market TLANDO in the United States and Canada, following the termination of the prior license agreement with Antares, which became effective on January 31, 2024, thereby transferring all rights in TLANDO from Antares to Verity Pharmaceuticals.

JATENZO (testosterone undecanoate): Tolmar Pharmaceuticals

JATENZO capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, like primary hypogonadism and hypogonadotropic hypogonadism (congenital or acquired). Safety and efficacy of JATENZO in males less than 18 years old have not been established.

In March 2019, the US FDA approved JATENZO to treat men with certain forms of hypogonadism.

In October 2022, Tolmar Pharmaceuticals acquired all rights to JATENZO from Clarus Therapeutics and its wholly-owned subsidiary.

Emerging Drugs

RPN-001 (leflutrozole): REPRONOVO and Mereo BioPharma

RPN-001 is a novel orally administered compound being developed for the treatment of infertility in men with low serum testosterone. ReproNovo has an exclusive global license agreement with Mereo BioPharma for the development and commercialization of leflutrozole.

In July 2025, ReproNovo announced the inclusion of the first participant in the company's Phase II clinical trial of its lead candidate RPN-001 in development for the treatment of male infertility.

Drug Class Insights

Aromatase inhibitors help treat hypogonadism by blocking the enzyme aromatase, which is responsible for converting testosterone into estrogen (estradiol). By inhibiting this conversion, aromatase inhibitors reduce estrogen levels and thereby increase the amount of circulating testosterone in the body. This leads to an improved testosterone-to-estrogen ratio, which can help alleviate symptoms of hypogonadism, particularly in men where low testosterone and relatively high estrogen levels are problematic.

Hypogonadism Market Outlook

Asymptomatic hypogonadal patients do not require treatment. Only patients with symptoms possibly associated with low testosterone levels should be considered candidates for therapy. A subcutaneous TESTOPEL (testosterone pellet) is available for the treatment of hypogonadism. Nasal and buccal testosterone preparations are also available for the treatment of hypogonadism and may be useful in limited clinical settings where other testosterone preparations are not effective or appropriate. Use of nasal and buccal preparations is limited because of the potential for nasal/sinus and gingival irritation, limited published data on the use of the nasal preparation, and animal studies suggesting possible increases in central nervous system testosterone levels above that expected with other formulations. Oral ANDRIOL (testosterone undecanoate) is available in many countries outside the US; however, serum testosterone concentrations achieved with this formulation can be low, and administration must occur with a fat-containing meal. New self-emulsifying drug formulations of testosterone undecanoate are under development and may reach the market in the next 1-2 years.

Some newer testosterone formulations have recently come to the global market. These include both transdermal and injectable formulations. One of the transdermal formulations includes TESTOCUR (hydro-alcoholic 2.5% testosterone gel) that is approved for use in Germany. This drug was studied after application both transdermally and transscrotally, and compared with Androderm 2.5% patches applied transdermally in an open-label, parallel group, randomized controlled fashion in previously treated hypogonadal men for 24 weeks. While the scrotal gel and patches achieved equivalent serum androgen (testosterone and dihydrotestosterone [DHT]) concentrations, the transdermal gel achieved higher concentrations. The transdermal gel was also better tolerated than the patches, whilst proving equivalent in safety outcomes such as hematocrit, serum PSA, and prostate volumes. Another formulation that is currently approved for use in Australia is an alcohol-free testosterone cream (AndroForte 5, 50 mg/mL or 5%, Lawley Pharmaceuticals). This was studied in an open-label, randomized crossover study, comparing it with 1% testosterone gel in hypogonadal men with a treatment period of 30 days. The pharmacokinetic end points of both were comparable, and there were no differences in serum hormone concentrations.

Additionally, there are several non-testosterone alternative therapies too that can be considered, particularly in men desiring fertility or wishing to avoid specific side effects of testosterone therapy. Still newer therapies, currently in the stages of early clinical trials (selective androgen receptor modulators), may indeed be the future of androgen replacement therapy and hint at the promise of more benefits than harm, which would simplify these patient discussions and decisions.

Hypogonadism drug uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, which depends on the competitive landscape, safety, and efficacy data, along with the order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Hypogonadism Pipeline Development Activities

The report provides insights into different therapeutic candidates in the marketed and emerging stages. It also analyses key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for hypogonadism therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry Leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including MD, PhD, Researcher, Professor, and Others.

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centres such as University of Washington School of Medicine, Imperial College London, Creighton University School of Medicine, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or hypogonadism market trends.

Qualitative Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated.

Further, the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, a descriptive overview of hypogonadism, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the hypogonadism market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM hypogonadism market.

Hypogonadism Report Insights

• Patient Population
• Therapeutic Approaches
• Hypogonadism Pipeline Analysis
• Hypogonadism Market Size and Trends
• Existing and Future Market Opportunity

Hypogonadism Report Key Strengths

• Ten-Year Forecast
• 7MM Coverage
• Hypogonadism Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Hypogonadism Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint)

FAQs:

• What was the hypogonadism total market size, the market size by therapies, the market share (%) distribution in 2024, and what would it look like in 2034? What are the contributing factors for this growth?
• At what CAGR, the hypogonadism market is expected to grow at the 7MM level during the study period (2020-2034)?
• How is Japan's hypogonadism competitive landscape evolving?
• What are the disease risks, burdens, and unmet needs of hypogonadism?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to hypogonadism?
• What is the historical and forecasted hypogonadism patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• What factors are affecting the increase in the diagnosis of symptomatic cases?
• What are the current options for the treatment of hypogonadism? What are the current treatment guidelines for the treatment of hypogonadism in the US and Europe?
• How many companies are developing therapies for the treatment of hypogonadism?
• What key designations have been granted for the emerging therapies for hypogonadism?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the hypogonadism market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying upcoming players in the market will help devise strategies to help get ahead of competitors.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand KOLs' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.