|
시장보고서
상품코드
2082929
성인 성장호르몬 결핍증 : 시장 인사이트, 역학 및 시장 예측(2036년)Adult-onset Growth Hormone Deficiency - Market Insight, Epidemiology, and Market Forecast - 2036 |
||||||
DelveInsight
'성인 성장호르몬 결핍증(AGHD)' 시장 보고서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 본 보고서에서는 AGHD 환자의 부담 추이, 수익 및 시장 점유율 추이, 피크 시기의 환자 점유율 및 치료 도입률 분석을 평가함과 동시에, 세계 각 지역의 상세한 시장 규모 평가 및 성장률 예측(과거 데이터 및 2022년-2036년 예측)을 제시하고 있습니다. 본 보고서에서는 AGHD 분야의 주요 미충족 요구 사항을 부각시키고, 경쟁 구도 및 임상 현황을 정리함으로써 고부가가치의 성장 기회를 밝혀내는 한편, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
치료되지 않은 AGHD가 대사, 심혈관 건강 및 삶의 질(QOL)에 미치는 영향에 대한 인식이 높아짐에 따라, 선별 검사, 진단 및 내분비 전문의로의 의뢰가 증가하고 있습니다.
소마파시탄(SOGROYA)이나 로나페그소마트로핀(SKYTROFA)과 같은 주 1회 투여 요법의 도입으로 환자의 편의성, 복약 순응도 및 장기적인 치료 지속성이 향상되어, 매일 주사하는 방식에서 이러한 요법으로의 전환이 가속화되고 있습니다.
AGHD는 일반적으로 만성적이거나 평생에 걸친 호르몬 대체 요법이 필요하기 때문에 승인된 치료법과 개발 중인 치료법에 대해 지속적인 수요와 안정적이고 지속적인 수익 기회가 창출되고 있습니다.
성인 성장호르몬 결핍증(AGHD)의 개요와 진단
AGHD는 성인기 뇌하수체에서 성장호르몬(GH) 분비 부족을 특징으로 하는 만성 내분비 질환이며, 그 가장 흔한 원인으로는 뇌하수체 종양, 뇌하수체 수술, 방사선 치료, 외상성 뇌손상 또는 시상하부·뇌하수체 질환 등이 있습니다. AGHD는 체성분의 변화, 근육량 및 골밀도의 감소, 내장 지방 증가, 심혈관 기능 및 대사 기능의 장애, 피로, 운동 능력 저하, 그리고 삶의 질 저하와 관련이 있습니다. 소아 GHD와 달리, AGHD는 주로 직선적인 성장에 영향을 미치는 것이 아니라, 대사 건강 상태나 신체 기능에 영향을 미칩니다.
AGHD의 진단은 복잡하며, 내인성 GH 분비가 맥동성을 보이기 때문에 일반적으로 임상 평가, 병력, 혈청 인슐린 유사 성장 인자-1(IGF-1) 측정 및 확정 진단을 위한 동적 자극 검사를 종합적으로 실시해야 합니다. 다만, 혈청 IGF-1 수치가 정상 범위 내에 있더라도 AGHD를 배제할 수는 없습니다. 많은 환자의 경우, 여전히 표준 기준 범위 내의 수치를 보이고 있기 때문입니다. 일반적인 진단 검사로는 인슐린 내성 검사(ITT), 글루카곤 자극 검사, 마시모렐린 자극 검사가 있습니다. 이 중 ITT는 여전히 골드 스탠다드 진단법이지만, 번거로울 뿐만 아니라 심혈관 질환이 있거나 발작이 있는 특정 환자에게는 금기 사항입니다. 증상은 비특이적인 경우가 많으며, 진단 절차에는 내분비학에 대한 전문 지식이 필요하기 때문에 많은 의료 현장에서 AGHD는 여전히 상당 부분 진단 누락이 발생하고 있습니다.
성인 성장호르몬 결핍증(AGHD)의 현재 치료 현황
AGHD의 치료는 주로 생리적인 GH 수치를 회복시키고, 대사 기능, 체성분, 골밀도, 심혈관 건강 및 삶의 질을 개선하는 것을 목적으로 하는 재조합 hGH 보충 요법을 중심으로 이루어집니다. 기존에는 AGHD의 관리가 매일 소마토트로핀 주사에 의존해 왔으나, 치료 추세는 주사 빈도를 줄이고 환자의 복약 순응도를 높이는 지속형 성장호르몬 요법으로 점차 전환되고 있습니다. 소마파시탄(SOGROYA)이나 로나페그소마트로핀(SKYTROFA) 등, FDA 승인을 받은 주 1회 투여 요법은 매일 투여하는 성장호르몬(GH) 제제와 동등한 유효성을 가지면서도, 인슐린 유사 성장 인자-1(IGF-1)을 지속적으로 조절함으로써 치료 선택지를 대폭 확대했습니다. 부종, 관절통, 인슐린 저항성, 체액 저류 등의 부작용을 완화하기 위해, 최신 임상 지침에서는 체중에 기반하지 않는 개별화된 ' '저용량으로 시작하여 서서히 증량한다'는 용량 조절 프로토콜이 의무화되어 있으며, 혈청 IGF-1 농도가 연령 보정 중앙값에서 상한 기준 범위 내로 정상화될 때까지 매월 투여량을 조정하도록 되어 있습니다. 치료 용량은 연령 및 생물학적 성별에 따라 크게 달라집니다. 고령자는 민감도가 높기 때문에 초기 용량을 낮게 설정해야 하지만, 반면 경구용 에스트로겐을 복용 중인 여성은 간에 의한 성장 호르몬 저항성을 극복하기 위해 상당히 높은 용량이 필요합니다.
AGHD의 역학적 분석 및 예측에 관한 주요 결과
AGHD 시장은 오랫동안 의존해 온 하루 1회 재조합 인간 성장 호르몬(hGH) 주사에서 환자의 복약 순응도, 편의성 및 장기적인 치료 지속성을 향상시키도록 설계된 지속형 성장 호르몬 제제로 전환되며, 완만하지만 의미 있는 변화를 이루고 있습니다. 아센디스 파마(Ascendis Pharma)의 로나페그소마토트로핀(SKYTROFA)과 노보노르디스크(Novo Nordisk)의 소마파시탄(SOGROYA)의 승인은 주 1회 성장호르몬 대체 요법의 임상적 및 상업적 잠재력을 입증함으로써 치료의 양상을 크게 변화시켰습니다. 이러한 약물은 지속적인 IGF-1 조절, 매일 시행하는 GH 요법과 동등한 효능, 그리고 주사 부담의 경감을 입증함으로써, 장시간 작용형 내분비 요법의 보다 광범위한 도입을 촉진하고 있습니다.
시장의 변천은 장기 작용형 GH 개발 초기 단계에서 겪은 좌절에 의해서도 형성되어 왔습니다. 내분비 분야에 특화된 바이오의약품 기업인 베르살티스는 이전에 AGHD(성인 성장호르몬 결핍증)를 대상으로 한 장기 작용형 재조합 인간 성장호르몬(hGH) 후보물질인 소마바라탄(VRS-317)을 개발하고 있었습니다. 그러나 2017년 제3상 임상시험에서 유효성 평가 지표를 달성하지 못함에 따라 이 프로그램은 중단되었고, 결국 2018년에 해당 회사는 알라바이브사와 합병하게 되었습니다. 이러한 좌절에도 불구하고, 반감기 연장 기술과 최적화된 약동학 플랫폼 분야의 지속적인 발전 덕분에, 지속형 GH 분야에 대한 신뢰가 다시 높아지고 있습니다.
현재, 새로운 파이프라인은 투여의 유연성과 안전성 프로파일이 개선된 차세대 장기 작용형 생물학적 제제에 초점을 맞추었습니다. Genexine사의 GX-H9는 유력한 신약 후보 중 하나로, 주 1회, 혹은 향후에는월2회 투여가 가능하도록 설계되었습니다. 이 치료제는 임상시험에서 우수한 약동학 및 내약성 프로파일을 보여주었으며, 이는 장기적인 복약 순응도를 개선하고 전 세계 AGHD 시장에서 접근성을 확대할 수 있는 차별화된 지속형 제제에 대한 업계의 관심이 높아지고 있음을 반영합니다.
장시간 작용형 성장호르몬 요법: 로나페그소마트로핀(SKYTROFA)이나 소마파시탄(SOGROYA) 등 승인된 치료제는 주 1회 투여, 주사 부담 경감, 매일 GH 주사와 비교했을 때 치료 순응도 향상을 통해 성인 성장호르몬 결핍증(AGHD)의 치료 환경을 새롭게 바꾸어 가고 있습니다. 한편, GX-H9 등 새로운 후보 약물은 주 1회 또는월2회 투여가 가능한 차세대 장기 작용형 생물학적 제제로 개발이 진행되고 있으며, 투여의 유연성, 지속적인 IGF-1 조절, 그리고 환자 중심의 AGHD 관리에 초점을 맞춘 지속적인 혁신을 두드러지게 보여주고 있습니다.
DelveInsight's 'Adult-onset Growth Hormone Deficiency (AGHD) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the AGHD, historical and forecasted epidemiology, as well as the AGHD market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The Adult-onset Growth Hormone Deficiency (AGHD) market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, AGHD patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in AGHD and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.
Key Factors Driving the Adult-onset Growth Hormone Deficiency (AGHD) Market
Rising recognition of the metabolic, cardiovascular, and quality-of-life consequences associated with untreated AGHD is supporting greater screening, diagnosis, and referral to endocrine specialists.
The introduction of once-weekly therapies such as somapacitan (SOGROYA) and lonapegsomatropin (SKYTROFA) is accelerating the shift away from daily injections by improving patient convenience, adherence, and long-term treatment persistence.
AGHD generally requires chronic or lifelong hormone replacement therapy, creating sustained demand and stable recurring revenue opportunities for approved and emerging therapies.
Adult-onset Growth Hormone Deficiency (AGHD) Overview and Diagnosis
AGHD is a chronic endocrine disorder characterized by inadequate secretion of growth hormone (GH) from the pituitary gland during adulthood, most commonly resulting from pituitary tumors, pituitary surgery, radiation therapy, traumatic brain injury, or hypothalamic-pituitary disease. AGHD is associated with altered body composition, reduced muscle mass and bone density, increased visceral fat, impaired cardiovascular and metabolic function, fatigue, reduced exercise capacity, and diminished quality of life. Unlike pediatric GHD, AGHD primarily affects metabolic health and physical functioning rather than linear growth.
Diagnosis of AGHD is complex and typically requires a combination of clinical assessment, medical history, serum insulin-like growth factor-1 (IGF-1) evaluation, and confirmatory dynamic stimulation testing due to the pulsatile nature of endogenous GH secretion. However, a normal serum IGF-1 level does not rule out AGHD, as many affected patients still show values within the standard reference range. Common diagnostic tests include the insulin tolerance test (ITT), glucagon stimulation test, and macimorelin stimulation test. Among these, ITT remains the gold-standard diagnostic method but is labor-intensive and contraindicated in certain patients with cardiovascular disease or seizures. Because symptoms are often nonspecific and diagnostic procedures require specialized endocrine expertise, AGHD remains substantially underdiagnosed across many healthcare settings.
Current Adult-onset Growth Hormone Deficiency (AGHD) Treatment Landscape
The treatment of AGHD primarily involves recombinant hGH replacement therapy aimed at restoring physiological GH levels and improving metabolic function, body composition, bone density, cardiovascular health, and quality of life. Historically, AGHD management relied on daily somatropin injections; however, the treatment landscape is increasingly shifting toward long-acting growth hormone therapies that reduce injection frequency and improve patient adherence. The FDA-approved once-weekly therapies such as somapacitan (SOGROYA) and lonapegsomatropin (SKYTROFA) have significantly expanded treatment options by providing sustained insulin-like growth factor-1 (IGF-1) control with efficacy comparable to daily GH formulations. To mitigate adverse effects such as edema, arthralgia, insulin resistance, and fluid retention, modern clinical guidelines mandate an individualized, non-weight-based "start low, go slow" titration protocol, utilizing monthly dose adjustments until serum IGF-1 levels normalize to the age-adjusted median-to-upper reference range. Treatment dosing is highly dependent on age and biological sex; older adults exhibit heightened sensitivity and require lower introductory doses, whereas women taking oral estrogen require substantially higher doses to overcome hepatic growth hormone resistance.
Adult-onset Growth Hormone Deficiency (AGHD) Unmet Needs
The section "unmet needs of Adult-onset Growth Hormone Deficiency (AGHD)" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.
Key Findings from AGHD Epidemiological Analysis and Forecast
Adult-onset Growth Hormone Deficiency (AGHD) Drug Analysis & Competitive Landscape
The AGHD drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase III clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships upcoming key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the AGHD treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the AGHD therapeutics market.
Approved Therapies for Adult-onset Growth Hormone Deficiency (AGHD)
Lonapegsomatropin (SKYTROFA): Ascendis Pharma
Lonapegsomatropin is a long-acting prodrug of recombinant human growth hormone (hGH) designed for once-weekly SC administration in patients with AGHD. Utilizing the company's proprietary TransCon technology, lonapegsomatropin transiently binds unmodified somatropin to an inert carrier, enabling sustained release of active hGH over one week while maintaining physiologic IGF-1 levels. IN In July 2025, the therapy is approved for AGHD in the US and multiple global markets, while also approved in 2021 for pediatric growth hormone deficiency (PGHD) to reduce the burden of daily GH injections and improve long-term treatment adherence with sustained physiologic IGF-1 control.
Somapacitan (SOGROYA): Novo Nordisk
Novo Nordisk's somapacitan is a once-weekly long-acting recombinant hGH therapy designed for SC administration using prefilled, single-patient-use pens available in 5 mg, 10 mg, and 15 mg strengths. Approved for both AGHD and PGHD, Somapacitan became the first once-weekly hGH therapy approved for AGHD in 2020, offering a convenient alternative to daily GH injections while maintaining sustained efficacy and physiologic IGF-1 control.
Adult-onset Growth Hormone Deficiency (AGHD) Pipeline Analysis
GX-H9: Genexine/Handok
GX-H9 is a long-acting recombinant hGH being developed for AGHD and pediatric GHD using the company's proprietary hyFc fusion platform to extend half-life and enable once-weekly or twice-monthly SC administration. Designed as a biobetter alternative to conventional daily GH therapies, GX-H9 aims to improve patient convenience, adherence, and long-term treatment outcomes while maintaining comparable efficacy and safety. Clinical studies demonstrated favorable pharmacokinetic and pharmacodynamic profiles with sustained IGF-1 activity and good tolerability in AGHD patients. The drug has received orphan drug designation (ODD) from the US FDA for GHD.
Adult-onset Growth Hormone Deficiency (AGHD) Key Players, Market Leaders and Emerging Companies
Adult-onset Growth Hormone Deficiency (AGHD) Drug Updates
The AGHD market is undergoing a gradual but meaningful transformation, shifting from the long-standing reliance on daily recombinant hGH injections toward long-acting growth hormone formulations designed to improve patient adherence, convenience, and long-term treatment persistence. The approvals of Ascendis Pharma's lonapegsomatropin (SKYTROFA) and Novo Nordisk's somapacitan (SOGROYA) have significantly reshaped the treatment landscape by validating the clinical and commercial potential of once-weekly growth hormone replacement therapies. These agents have demonstrated sustained IGF-1 control, comparable efficacy to daily GH therapies, and reduced injection burden, supporting broader adoption of long-acting endocrine therapies.
The market's evolution has also been shaped by earlier setbacks in long-acting GH development. Versartis, an endocrine-focused biopharmaceutical company, previously developed somavaratan (VRS-317), a long-acting recombinant hGH candidate for AGHD. However, failure to meet efficacy endpoints in a Phase III trial in 2017 led to discontinuation of the program and ultimately the company's merger with Aravive in 2018. Despite this setback, continued advances in half-life extension technologies and optimized pharmacokinetic platforms have revitalized confidence in the long-acting GH segment.
The emerging pipeline is now focused on next-generation long-acting biologics with improved dosing flexibility and safety profiles. Genexine's GX-H9 is among the leading emerging candidates and is designed to support once-weekly or potentially twice-monthly dosing. The therapy has demonstrated favorable pharmacokinetic and tolerability profiles in clinical studies, reflecting the industry's growing emphasis on differentiated long-acting formulations capable of improving long-term adherence and expanding access across global AGHD markets.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Adult-onset Growth Hormone Deficiency (AGHD) (2022-2036 Forecast)
The AGHD market comprises daily and long-acting recombinant hGH therapies designed to restore physiological GH levels, improve metabolic function, enhance body composition, and reduce the long-term complications associated with hormone deficiency.
Long-acting growth hormone therapies: Approved therapies such as lonapegsomatropin (SKYTROFA) and somapacitan (SOGROYA) are reshaping the AGHD treatment landscape through once-weekly dosing, reduced injection burden, and improved treatment adherence compared with daily GH injections. Meanwhile, emerging candidates such as GX-H9 are advancing next-generation long-acting biologics with potential once-weekly or twice-monthly administration, highlighting continued innovation focused on dosing flexibility, sustained IGF-1 control, and patient-centric AGHD management.
Adult-onset Growth Hormone Deficiency (AGHD) Drug Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the AGHD drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.
Therapy uptake in the AGHD market is expected to be driven by clinical efficacy, long term safety, dosing convenience, treatment adherence, and sustained IGF-1 control. Approved long acting therapies such as lonapegsomatropin and somapacitan are anticipated to achieve rapid adoption due to their once weekly administration, lower injection burden, and efficacy comparable to daily recombinant hGH therapies. In contrast, emerging candidates such as GX-H9 may see more gradual uptake despite offering once weekly or twice monthly dosing, as broader adoption will likely depend on validation of long term efficacy, safety, real world adherence, and the clinical differentiation of its half life extension technology.
Detailed insights of emerging therapies' drug uptake is included in the report
Market Access and Reimbursement of Approved therapies in Adult-onset Growth Hormone Deficiency (AGHD)
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved 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.
Adult-onset Growth Hormone Deficiency (AGHD) Therapies Price Scenario & Trends
Pricing and analogue assessment of AGHD therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.
Industry Experts and Physician Views for AGHD
To keep up with AL amyloidosis market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions 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 AL amyloidosis emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in AGHD, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts connected with 15+ KOLs to gather insights at country level. Centers such as the Stanford University School of Medicine, Kobe University Hospital, University Medical Center Hamburg-Eppendorf, and University of Turin, etc. were contacted.Their opinion helps understand and validate current and emerging AL amyloidosis therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in AL amyloidosis.
Qualitative Analysis: SWOT and Conjoint Analysis
We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.
In the SWOT analysis of AGHD, 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.
Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
The team of analysts analyzes promising 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, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, 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 Insights