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성인 성장호르몬 결핍증 : 시장 인사이트, 역학 및 시장 예측(2036년)

Adult-onset Growth Hormone Deficiency - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 200 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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영문목차

성인 성장호르몬 결핍증(AGHD)에 대한 인사이트와 동향

  • 성장호르몬 결핍증(GHD)은 성인 성장호르몬 결핍증(AGHD) 및 소아 GHD를 포함하여, 뇌하수체에서 성장호르몬 분비가 부족하여 발생하는 희귀 내분비 질환으로, 소아에게는 성장 지연을, 성인에게는 대사 이상, 심혈관계 장애 및 삶의 질 저하를 초래합니다.
  • 영국에서는 성인기에 발병한 AGHD의 경우, 특정 시점에서 성인 1만 명당 약 1명의 비율로 유병되는 것으로 추정되지만, 소아기 및 성인기에 발병한 GHD를 합친 유병률은 1만 명당 약 3명으로 더 높은 수준입니다.
  • 일본에서 진단이 확정된 모든 AGHD 사례 중 여성이 간신히 과반수를 차지하여 전체 사례의 약 54%를 차지하고 있으며, 남성은 전체 환자 수의 46%를 차지하고 있습니다.
  • AGHD 시장은 치료 순응도, 편의성 및 장기적인 지속성 향상이 요구됨에 따라, 매일 시행하는 재조합 인간 성장 호르몬(hGH) 주사에서 주 1회 투여하는 지속형 치료로 빠르게 전환되고 있습니다.
  • 2020년까지 AGHD 치료는 주로 매일 소마트로핀 주사를 투여하는 기존의 표준 치료에 의존해 왔으나, 소마파시탄(SOGROYA)의 승인으로 AGHD를 위한 최초의 주 1회 투여 요법이 등장하면서, 장시간 작용형 성장 호르몬 보충 요법으로의 큰 전환이 이루어졌습니다.
  • 최근 성인 AGHD 치료제로 로나페그소마트로핀(SKYTROFA)이 승인됨에 따라 AGHD 시장 내 경쟁이 격화되고 있으며, 이는 지속 시간이 긴 성장호르몬(GH) 보충 요법에 대한 의료진의 수용도가 높아지고 있음을 뒷받침하고 있습니다.
  • GX-H9 등 새로운 파이프라인 후보들은 Fc 융합 및 알부민 결합 플랫폼과 같은 첨단 반감기 연장 기술을 활용하고 있어, 주 1회 또는월2회 투여가 가능해질 전망입니다.
  • 매일 투여하는 성장 호르몬 주사에 대한 복약 순응도가 낮은 것은 AGHD 관리에 있어 여전히 주요한 미충족 요구 사항으로 남아 있으며, 특히 평생에 걸쳐 호르몬 대체 요법이 필요한 성인 환자에서 두드러지게 나타납니다. 그 때문에 주 1회 투여하거나 투여 간격을 연장한 제품에 대한 수요가 증가하고 있습니다.
  • Versartis사의 소마바라탄(VRS-317) 프로그램 중단 등 과거의 임상적 실패 사례들은 여전히 규제 당국의 심사에 영향을 미치고 있으며, 장시간 작용형 성장호르몬(GH) 개발에서 유효성, 안전성 및 IGF-1의 안정성 간의 균형이 중요하다는 점을 여실히 보여주고 있습니다.

'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.

성인 성장호르몬 결핍증(AGHD) 시장의 성장을 주도하는 주요 요인

  • AGHD에 대한 인식 제고와 진단 건수 증가

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.

  • 장시간 작용형 성장호르몬 요법의 적용 확대

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.

  • 장기적인 치료 의존성

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 이해와 치료 알고리즘

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.

성인 성장호르몬 결핍증(AGHD)의 역학

AGHD의 역학적 분석 및 예측에 관한 주요 결과

  • 미국에서는 2025년 AGHD 진단 환자 수가 인구 10만 명당 약 0.2건으로 추정됩니다.
  • 2025년, 미국의 성별별 사례에서 여성은 AGHD 사례의 대부분을 차지하며, 환자의 평균 연령은 약 50세로 추정됩니다.
  • 유럽에서는 보고된 AGHD 환자 수가 프랑스에서 약 200건, 이탈리아에서 약 600건, 스페인에서 약 200건, 영국에서 약 100건으로 추정됩니다.
  • 영국에서 2025년 연령별 환자 수를 살펴보면, GHD 환자 수가 가장 많았던 연령대는 20-29세(24.5%)였으며, 그 다음으로 18-19세(17.2%), 40-49세(14.5%) 순이었습니다. 한편, 60-69세(9.9%) 및 70세 이상(5.5%)을 포함한 고령층에서는 유병률이 낮은 것으로 보고되었습니다.
  • 2025년, 일본 내 GHD 환자의 약 70%가 성인 발병형으로 진단되었습니다.

성인 성장호르몬 결핍증(AGHD) 시장 전망

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.

  • 치료되지 않은 AGHD로 인한 대사 및 심혈관계 합병증에 대한 인식이 높아지고, 내분비 검진의 보급이 확대되며, 환자 중심의 장기 작용형 치료법이 광범위하게 채택됨에 따라, 주요 7개국 전역에서 시장이 지속적인 성장을 이룰 것으로 예측됩니다.
  • 현재 AGHD 치료제 시장에서 가장 큰 점유율을 차지하고 있는 곳은 미국이며, 그 주된 요인은 높은 진단율, 확립된 보험 및 환급 제도, 그리고 선진적인 내분비학 네트워크에 있습니다.
  • 장시간 작용형 성장호르몬 요법은 투여 빈도를 줄여 환자의 편의성과 복약 순응도를 높임으로써, AGHD의 치료 환경을 새롭게 변화시키고 있습니다.
  • 소마파시탄(SOGROYA)은 GHD를 앓고 있는 성인을 대상으로 승인된 최초의 주 1회 투여형 성장호르몬 요법으로 등장하여, 지속형 GH 부문에서 상업적 및 임상적으로 중요한 이정표를 세웠습니다.
  • 개발 중인 AGHD 치료제 파이프라인은 여전히 적당한 수준의 경쟁 환경에 놓여 있으며, GX-H9를 비롯한 차세대 장시간 작용형 및 반감기 연장형 성장호르몬 후보물질들이 치료의 지속성을 높이고, 차별화된 약동학 및 반감기 연장 프로파일을 제공하기 위해 개발되고 있습니다.

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.

자주 묻는 질문

  • 성인 성장호르몬 결핍증(AGHD)의 유병률은 어떻게 되나요?
  • AGHD 치료 시장의 주요 변화는 무엇인가요?
  • AGHD 치료제 시장에서의 주요 기업은 어디인가요?
  • AGHD의 진단 과정은 어떻게 이루어지나요?
  • AGHD 치료에 대한 환자의 요구는 무엇인가요?
  • AGHD 시장의 성장 요인은 무엇인가요?
  • AGHD 치료제의 시장 규모는 어떻게 되나요?

목차

제1장 주요 인사이트

제2장 서론

제3장 성인 성장호르몬 결핍증 : 주요 요약

제4장 주요 이벤트

제5장 성인 성장호르몬 결핍증 : 역학 및 시장 조사 방법

제6장 성인 성장호르몬 결핍증 : 시장 개요

제7장 성인 성장호르몬 결핍증 : 질환 배경과 개요

제8장 성인 성장호르몬 결핍증 : 역학 및 환자 인구

제9장 성인 성장호르몬 결핍증 : 환자 경과

제10장 성인 성장호르몬 결핍증 : 시판 치료제

제11장 성인 성장호르몬 결핍증 : 신흥 치료법

제12장 성인 성장호르몬 결핍증 : 주요 7개국 분석

제13장 성인 성장호르몬 결핍증 : 미충족 요구

제14장 성인 성장호르몬 결핍증 : SWOT 분석

제15장 성인 성장호르몬 결핍증 : KOL(Key Opinion Leader)의 견해

제16장 성인 성장호르몬 결핍증 : 시장 참여 및 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight에 대해

제1장 주요 인사이트

제2장 서론

제3장 성인 성장호르몬 결핍증 : 주요 요약

제4장 주요 이벤트

제5장 성인 성장호르몬 결핍증 : 역학 및 시장 조사 방법

제6장 성인 성장호르몬 결핍증 : 시장 개요

제7장 성인 성장호르몬 결핍증 : 질환 배경과 개요

제8장 성인 성장호르몬 결핍증 : 역학 및 환자 인구

제9장 성인 성장호르몬 결핍증 : 환자 경과

제10장 성인 성장호르몬 결핍증 : 시판 치료제

제11장 성인 성장호르몬 결핍증 : 신흥 치료법

제12장 성인 성장호르몬 결핍증 : 주요 7개국 분석

제13장 성인 성장호르몬 결핍증 : 미충족 요구

제14장 성인 성장호르몬 결핍증 : SWOT 분석

제15장 성인 성장호르몬 결핍증 : KOL(Key Opinion Leader)의 견해

제16장 성인 성장호르몬 결핍증 : 시장 참여 및 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight에 대해

LSH 26.07.27

Adult-onset Growth Hormone Deficiency (AGHD) Insights and Trends

  • Growth Hormone Deficiency (GHD), including Adult Growth Hormone Deficiency (AGHD) and pediatric GHD, is a rare endocrine disorder caused by inadequate secretion of growth hormone from the pituitary gland, leading to impaired growth in children and metabolic, cardiovascular, and quality-of-life impairments in adults.
  • In the United Kingdom, AGHD is estimated to affect approximately 1 in every 10,000 adults at any given time in adult-onset cases, while the combined prevalence of childhood-onset and adult-onset GHD is higher at approximately 3 in every 10,000 people.
  • Among all AGHD diagnosed prevalent cases, females represented a slight majority, accounting for about 54% of cases, while males comprised 46% of the total patient population, in Japan.
  • The AGHD market is rapidly transitioning from daily recombinant human growth hormone (hGH) injections toward long-acting weekly therapies, driven by the need to improve treatment adherence, convenience, and long-term persistence.
  • Until 2020, AGHD management primarily relied on daily somatropin injections as the traditional standard of care; however, the approval of somapacitan (SOGROYA) marked the first once-weekly therapy for AGHD, representing a major shift toward long-acting growth hormone replacement therapies.
  • The recent adult AGHD approval of lonapegsomatropin (SKYTROFA) has intensified competition within the AGHD market, validating broader physician acceptance of extended-duration GH replacement therapies.
  • Emerging pipeline candidates such as GX-H9 are leveraging advanced half-life extension technologies, including Fc-fusion and albumin-binding platforms, to potentially enable once-weekly or twice-monthly dosing.
  • Poor adherence to daily growth hormone injections remains a major unmet need in AGHD management, particularly among adult patients requiring lifelong hormone replacement therapy, thereby strengthening demand for once-weekly or extended-interval products.
  • Historical clinical setbacks, including the discontinuation of Versartis' somavaratan (VRS-317) program, continue to influence regulatory scrutiny and emphasize the importance of balanced efficacy, safety, and IGF-1 stability in long-acting GH development.

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

  • Increasing awareness and diagnosis of AGHD

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.

  • Growing adoption of long-acting growth hormone therapies

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.

  • Long-term treatment dependency

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) Understanding and Treatment Algorithm

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.

1. Delayed and complex diagnosis

2. Need for more convenient long-acting therapies with sustained IGF-1 control

3. Poor long-term adherence associated with daily GH injections

4. High chronic disease burden with persistent impairment in quality of life and long-term monitoring needs, and others.....

Adult-onset Growth Hormone Deficiency (AGHD) Epidemiology

Key Findings from AGHD Epidemiological Analysis and Forecast

  • In the United States, the total diagnosed prevalent cases of AGHD were estimated at approximately 0.2 cases per 100,000 population, in 2025.
  • In 2025, among gender-specific cases in the United States, females accounted for the majority of the AGHD cases, with the mean patient age estimated at approximately 50 years.
  • In Europe, the number of reported AGHD patients was estimated at ~200 cases in France, ~600 cases in Italy, ~200 cases in Spain, and ~100 cases in the United Kingdom.
  • In the United Kingdom, among age-specific cases in 2025, the highest GHD cases was observed in the 20-29 years (24.5%) age group, followed by 18-19 years (17.2%) and 40-49 years (14.5%), while lower prevalence was reported in older populations, including 60-69 years (9.9%) and >=70 years (5.5%).
  • In 2025, ~70% of patients with GHD were diagnosed with adult-onset disease, in Japan.

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.

  • GX-H9 is being co-developed with Handok, while I-Mab holds development and commercialization rights in Greater China, where the candidate achieved positive Phase III results and is advancing toward regulatory filing.
  • The drug is currenltly being evaluted in a Phase III clinical trial for AGHD.

Adult-onset Growth Hormone Deficiency (AGHD) Key Players, Market Leaders and Emerging Companies

  • Ascendis Pharma
  • Novo Nordisk
  • Genexine
  • Handok, among others

Adult-onset Growth Hormone Deficiency (AGHD) Drug Updates

  • In May 2026, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending an amendment to the marketing authorisation for somapacitan (SOGROYA) in Europe.
  • In February 2026, Teijin Pharma announced that it has submitted an application in Japan for the manufacturing and marketing approval of lonapegsomatropin, a once-weekly prodrug of somatropin developed as TransCon hGH by Ascendis Pharma.
  • In June 2025, Ascendis Pharma announced that the US FDA approved lonapegsomatropin for the replacement of endogenous growth hormone in adults with GHD.

Adult-onset Growth Hormone Deficiency (AGHD) Market Outlook

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.

  • The market is expected to witness sustained growth across the 7MM due to increasing awareness of the metabolic and cardiovascular consequences of untreated AGHD, expanding endocrine screening practices, and broader adoption of patient-centric long-acting therapies.
  • The United States currently holds the largest market share for AGHD therapies, largely due to strong diagnostic rates, well-established insurance and reimbursement infrastructures, and advanced endocrinology networks
  • Long-acting growth hormone therapies are reshaping the AGHD treatment landscape by reducing dosing frequency and improving patient convenience and adherence.
  • Somapacitan (SOGROYA) has emerged as the first once-weekly growth hormone therapy approved for adults with GHD, establishing a major commercial and clinical milestone in the long-acting GH segment.
  • The emerging AGHD pipeline remains moderately competitive, with several next-generation long-acting and extended half-life growth hormone candidates, including GX-H9, being developed to improve treatment persistence, and offer differentiated pharmacokinetic and half-life extension profiles.

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.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of Adult-onset Growth Hormone Deficiency (AGHD), explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, 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 AGHD 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 Adult-onset Growth Hormone Deficiency (AGHD) market.

Report Insights

  • Adult-onset Growth Hormone Deficiency (AGHD) Patient Population Forecast
  • Adult-onset Growth Hormone Deficiency (AGHD) Therapeutics Market Size
  • Adult-onset Growth Hormone Deficiency (AGHD) Pipeline Analysis
  • Adult-onset Growth Hormone Deficiency (AGHD) Market Size and Trends
  • Adult-onset Growth Hormone Deficiency (AGHD) Market Opportunity (Current and Forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-Enabled Market Research Report
  • 11-Year Forecast
  • Adult-onset Growth Hormone Deficiency (AGHD) Market Outlook (North America, Europe, Asia-pacific)
  • Patient Burden Trends (By Geography)
  • Adult-onset Growth Hormone Deficiency (AGHD) Treatment Addressable Market (TAM)
  • Adult-onset Growth Hormone Deficiency (AGHD) Competitive Landscape
  • Adult-onset Growth Hormone Deficiency (AGHD) Major Companies Insights
  • Adult-onset Growth Hormone Deficiency (AGHD) Price Trends and Analogue Assessment
  • Adult-onset Growth Hormone Deficiency (AGHD) Therapies Drug Adoption/Uptake
  • Adult-onset Growth Hormone Deficiency (AGHD) Therapies Peak Patient Share Analysis

Report Assessment

  • Adult-onset Growth Hormone Deficiency (AGHD) Current Treatment Practices
  • Adult-onset Growth Hormone Deficiency (AGHD) Unmet Needs
  • Adult-onset Growth Hormone Deficiency (AGHD) Clinical Development Analysis
  • Adult-onset Growth Hormone Deficiency (AGHD) Emerging Drugs Product Profiles
  • Adult-onset Growth Hormone Deficiency (AGHD) Market attractiveness
  • Adult-onset Growth Hormone Deficiency (AGHD) Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the AGHD market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of AGHD?
  • What are the disease risks, burdens, and unmet needs of AGHD? What will be the growth opportunities across the 7MM concerning the patient population with AGHD?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of AGHD? What are the current guidelines for treating AGHD in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the AGHD market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, 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.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • To understand KOLs' perspectives on 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.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets with in the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Adult-onset Growth Hormone Deficiency (AGHD)

4. Key Events

  • 4.1. Upcoming Key Catalysts
  • 4.2. Key Conferences And Meetings
  • 4.3. Key Transactions And Collaborations
  • 4.4. News Flow

5. Epidemiology and Market Methodology of Adult-onset Growth Hormone Deficiency (AGHD)

6. Adult-onset Growth Hormone Deficiency (AGHD) Market Overview at a Glance

  • 6.1. Clinical Landscape Analysis (By Molecule Type, Phase, and Route of Administration [ROA])
  • 6.2. Market Share of Adult-onset Growth Hormone Deficiency (AGHD) By Therapies (%) in the 7MM in 2025
  • 6.3. Market Share of Adult-onset Growth Hormone Deficiency (AGHD) By Therapies (%) in the 7MM in 2036

7. Disease Background And Overview of Adult-onset Growth Hormone Deficiency (AGHD)

  • 7.1. Introduction
  • 7.2. Causes and Risk Factors
  • 7.3. Pathophysiology
  • 7.4. Symptoms and Clinical Presentations
  • 7.5. Diagnosis
    • 7.5.1. Diagnostic Algorithm
    • 7.5.2. Diagnostic Guidelines
    • 7.5.3. Differential Diagnosis
  • 7.6. Treatment and Management
    • 7.6.1. Treatment Algorithm
    • 7.6.2. Treatment Guidelines

8. Epidemiology and Patient Population of Adult-onset Growth Hormone Deficiency (AGHD)

  • 8.1. Key Findings
  • 8.2. Assumption and Rationale
  • 8.3. Total Diagnosed Prevalent Cases of GHD in the 7MM
  • 8.4. Diagnosed Prevalent Cases of AGHD in the 7MM
  • 8.5. The United States
    • 8.5.1. Total Diagnosed Prevalent Cases of GHD in the United States
    • 8.5.2. GHD Diagnosed Prevalent Cases by Age in the United States
    • 8.5.3. AGHD Diagnosed Prevalent Cases in the United States
    • 8.5.4. AGHD Diagnosed Prevalent Cases by Gender in the United States
    • 8.6.5. AGHD Treated Cases in the United States
  • 8.7. EU4 and the UK
    • 8.7.1. Total Diagnosed Prevalent Cases of GHD in EU4 and the UK
    • 8.7.2. GHD Diagnosed Prevalent Cases by Age in EU4 and the UK
    • 8.7.3. AGHD Diagnosed Prevalent Cases in EU4 and the UK
    • 8.7.4. AGHD Diagnosed Prevalent Cases by Gender in EU4 and the UK
    • 8.7.5. AGHD Treated Cases in EU4 and the UK
  • 8.8. Japan
    • 8.8.1. Total Diagnosed Prevalent Cases of GHD in Japan
    • 8.8.2. GHD Diagnosed Prevalent Cases by Age in Japan
    • 8.8.3. AGHD Diagnosed Prevalent Cases in Japan
    • 8.8.4. AGHD Diagnosed Prevalent Cases by Gender in Japan
    • 8.8.5. AGHD Treated Cases in Japan

9. Patient Journey of Adult-onset Growth Hormone Deficiency (AGHD)

10. Marketed Therapies of Adult-onset Growth Hormone Deficiency (AGHD)

  • 10.1. Marketed Competitive Landscape of AGHD
  • 10.2. Lonapegsomatropin (SKYTROFA): Ascendis Pharma
    • 10.2.1. Product Description
    • 10.2.2. Regulatory Milestones
    • 10.2.3. Other Developmental Activities
    • 10.2.4. Summary of Pivotal Trials
    • 10.2.5. Clinical Development
      • 10.2.5.1. Clinical Trials Information
    • 10.2.6. Analyst Views
  • 10.3. Somapacitan (SOGROYA): Novo Nordisk
    • 10.3.1. Product Description
    • 10.3.2. Regulatory Milestones
    • 10.3.3. Other Developmental Activities
    • 10.3.4. Summary of Pivotal Trials
    • 10.3.5. Clinical Development
      • 10.3.5.1. Clinical Trials Information
    • 10.3.6. Analyst Views

11. Emerging Therapies of Adult-onset Growth Hormone Deficiency (AGHD)

  • 11.1. Emerging Competitive Landscape of AGHD
  • 11.2. GX-H9: Genexine/Handok
    • 11.2.1. Product Description
    • 11.2.2. Other Developmental Activities
    • 11.2.3. Clinical Development
      • 11.2.3.1. Clinical Trial Information
    • 11.2.4. Safety and Efficacy
    • 11.2.5. Analyst Views

12. Adult-onset Growth Hormone Deficiency (AGHD): 7MM Analysis

  • 12.1. Key Findings
  • 12.2. Market Outlook
  • 12.3. Conjoint Analysis
  • 12.4. Key Market Forecast Assumptions
    • 12.4.1. Cost Assumptions
    • 12.4.2. Pricing Trends
    • 12.4.3. Analogue Assessment
    • 12.4.4. Launch Year and Therapy Uptakes
  • 12.5. Total Market Size of AGHD in the 7MM
  • 12.6. The United States
    • 12.6.1. Total Market Size of AGHD in the United States
    • 12.6.2. Market Size of AGHD by Therapies in the United States
  • 12.7. EU4 and the UK
    • 12.7.1. Total Market Size of AGHD in EU4 and the UK
    • 12.7.2. Market Size of AGHD by Therapies in EU4 and the UK
  • 12.8. Japan
    • 12.8.1. Total Market Size of AGHD in Japan
    • 12.8.2. Market Size of AGHD by Therapies in Japan

13. Unmet Needs of Adult-onset Growth Hormone Deficiency (AGHD)

14. SWOT Analysis of Adult-onset Growth Hormone Deficiency (AGHD)

15. KOL Views of Adult-onset Growth Hormone Deficiency (AGHD)

  • 15.1. Expert/KOL Interview Highlights

16. Market Access and Reimbursement of Adult-onset Growth Hormone Deficiency (AGHD)

  • 16.1. The United States
  • 16.2. In EU4 and the UK
    • 16.2.1. Germany
    • 16.2.2. France
    • 16.2.3. Italy
    • 16.2.4. Spain
    • 16.2.5. United Kingdom
  • 16.3. Japan
  • 16.4. Summary and Comparison of Market Access and Pricing Policy Developments in 2025
  • 16.5. Market Access and Reimbursement of AGHD Therapies

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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