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市場調査レポート
商品コード
1634146
男性性腺機能低下症の世界市場 - 2025~2032年Global Male Hypogonadism Market - 2025 - 2032 |
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カスタマイズ可能
適宜更新あり
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男性性腺機能低下症の世界市場 - 2025~2032年 |
出版日: 2025年01月13日
発行: DataM Intelligence
ページ情報: 英文 176 Pages
納期: 即日から翌営業日
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男性性腺機能低下症の世界市場は、2024年に35億6,000万米ドルに達し、2032年には53億8,000万米ドルに達すると予測され、予測期間2025年のCAGRは5.4%で成長すると予測されています。
男性性腺機能低下症は、思春期における男性的な成長と開発に不可欠なホルモンであるテストステロンの不十分な産生、および精子の不十分な産生を特徴とする疾患です。この疾患は、出生時に存在することもあれば、怪我や感染症などの要因により、後年発症することもあります。性腺機能低下症の影響や治療法は、根本的な原因や発症時期によって異なります。
性腺機能低下症は、子宮内、思春期前、成人期のさまざまな段階で発現します。徴候や症状は、発症時期によって異なります。男性性腺機能低下症の中には、テストステロン補充療法で効果的に管理できるものもあります。
性腺機能低下症には主に2つのタイプがあります。1つは原発性性腺機能低下症で、原発性精巣機能不全としても知られています。もう一つは、二次性性腺機能低下症で、このタイプはテストステロンの産生を調節する脳の部位である視床下部や下垂体に問題があることを示しています。視床下部はゴナドトロピン放出ホルモン(GnRH)を分泌し、下垂体に卵胞刺激ホルモン(FSH)と黄体形成ホルモン(LH)の分泌を促します。そしてLHは精巣を刺激してテストステロンを産生させます。
両型の性腺機能低下症は、先天性(遺伝性)因子によって引き起こされることもあれば、傷害や感染症などの条件によって後年発症することもあります。場合によっては、原発性性腺機能低下症と続発性性腺機能低下症が同時に起こることもあります。これらの要因が世界の男性性腺機能低下症市場拡大の原動力となっています。
促進要因と抑制要因
テストステロン欠乏症の増加
テストステロン欠乏症の罹患率の増加は、男性性腺機能低下症世界市場の重要な促進要因です。この増加は、いくつかの人口動態や健康関連の動向に起因しており、診断や治療オプションに対する需要の高まりにつながっています。
性腺機能低下症の疫学
2022年10月の内分泌学会のデータによると、性腺機能低下症は男性の間で蔓延している疾患であり、特に高齢者、肥満者、2型糖尿病と診断された男性に影響を及ぼしています。調査によると、45歳以上の男性の約35%が性腺機能低下症を経験しており、肥満や2型糖尿病を有する男性の有病率は30~50%と推定されています。低ゴナドトロピン性性腺機能低下症と診断された男性では、クラインフェルター症候群が最も一般的な原因であり、生後500~1,000人に1人の割合で発症します。
2024年6月のFrontiers in Endocrinologyの調査データによると、男性におけるテストステロン欠乏症の全体的な有病率は約21.2%で、高齢者集団でより高い割合が観察されました。
2022年4月のArchivio Italiano di Urologia e Andrologiaの調査データによると、テストステロン欠乏症はしばしば肥満や糖尿病などの慢性疾患と関連しています。研究によると、糖尿病や肥満の男性のテストステロン欠乏率は15~30%に達します。この相関関係は、これらの集団における標的治療の必要性を強調しています。
テストステロン欠乏症の非肥満型2型糖尿病男性は、しばしば内臓脂肪指数(VAI)、ウエスト周囲径、トリグリセリド値の上昇を示すことが研究で示されています。VAIの上昇は、テストステロン欠乏症の重大な危険因子として同定されており、非肥満者においても、代謝の健康問題がホルモンの不均衡につながる可能性があることを示しています。
調査によると、2型糖尿病患者の約20.7%が性腺機能低下症を経験しています。さらに、2型糖尿病の男性におけるテストステロン値低下の有病率は64%にも達することを示唆する研究もあり、糖尿病とテストステロン欠乏症との間に強い関連があることが浮き彫りになっています。
肥満でない2型糖尿病男性におけるテストステロン欠乏症の罹患率の上昇は、世界の男性性腺機能低下症市場に大きな影響を与えています。この層における性腺機能低下症の顕著な有病率と、その根本原因に関する継続的な議論により、スクリーニングと治療オプションの改善が明らかに必要とされています。ヘルスケアシステムがこのようなニーズに適応するにつれて、男性性腺機能低下症に対応する治療法に対する需要が高まり、市場の将来的な展望が形成されると予想されます。これらすべての要因が、世界の男性性腺機能低下症市場に需要をもたらしています。
さらに、治療オプションの技術的進歩に対する需要の高まりも、世界の男性性腺機能低下症市場の拡大に寄与しています。
治療に伴う副作用
男性性腺機能低下症の治療に伴う副作用は、男性性腺機能低下症の世界市場における大きな抑制要因となっています。テストステロン補充療法(TRT)は、テストステロン欠乏症の症状を効果的に緩和することができる一方で、患者が治療を求めたり、処方されたレジメンを遵守することを躊躇させるリスクも伴います。
2022年1月の内分泌学会のデータによると、テストステロン補充療法は、患者のコンプライアンスと全体的な治療成績に影響を与えうるいくつかの潜在的な副作用と関連しています。テストステロン療法の副作用は、心理的な影響を及ぼすこともあります。テストステロン療法は、赤血球産生増加、にきび、乳房肥大(女性化乳房)、睡眠障害、前立腺肥大、精子産生減少など、いくつかのリスクと関連しています。ほとんどの副作用は、テストステロンの過剰な高用量に関連しており、その多くは投与量を調整すれば解消する可能性があります。テストステロンレベルを監視し、副作用を管理するには、ヘルスケアプロバイダーとの定期的なフォローアップ診察が重要です。
性腺機能低下症の危険因子には、ヒト免疫不全ウイルス(HIV)/ 後天性免疫不全症候群(AIDS)、化学療法または放射線治療の既往、加齢、肥満、栄養不良などがあります。性腺機能低下症は遺伝性の場合もあります。家族歴にこれらの危険因子がある場合は、主治医に知らせることが重要です。
未治療の性腺機能低下症の合併症は、胎児期、思春期、成人期など発症時期によって異なります。起こりうる合併症には、生殖器の発育異常、女性化乳房、不妊症、勃起不全、骨粗しょう症、自尊心の低下などがあります。男児では早期発見が思春期の遅れに関連する問題の予防に役立ち、成人男性では適時の診断と治療が骨粗鬆症やその他の関連疾患に関連するリスクを軽減することができます。従って、上記の要因が世界の男性性腺機能低下症市場の潜在的成長を制限している可能性があります。
このレポートの詳細 - サンプル請求
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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The global male hypogonadism market is segmented based on type, therapy type, route of administration, and region.
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.
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.
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.
The global male hypogonadism market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.
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