시장보고서
상품코드
2082980

사구체 기저막 항체(Anti-GBM) : 시장 인사이트, 역학 및 예측(2036년)

Anti-Glomerular Basement Membrane (Anti-GBM) - Market Insights, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 92 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




■ 보고서에 따라 최신 정보로 업데이트하여 보내드립니다. 배송일정은 문의해 주시기 바랍니다.

가격
PDF (Single User License) help
PDF 보고서를 1명만 이용할 수 있는 라이선스입니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 7,990 금액 안내 화살표 ₩ 11,439,000
PDF & Excel (2-3 User License) help
PDF 및 Excel 보고서를 동일 사업장에서 3명까지 이용할 수 있는 라이선스입니다. PDF·Excel 내 텍스트 등의 복사 및 붙여넣기는 가능하나, 사내 이용으로만 제한됩니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 9,988 금액 안내 화살표 ₩ 14,299,000
PDF & Excel (Site License) help
PDF 및 Excel 보고서를 동일 사업장(소재지) 내 모든 분이 이용할 수 있는 라이선스입니다. PDF·Excel 내 텍스트 등의 복사 및 붙여넣기는 가능하나, 사내 이용으로만 제한됩니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 13,983 금액 안내 화살표 ₩ 20,019,000
PDF & Excel (Global License) help
PDF 및 Excel 보고서를 동일 기업의 모든 분이 이용할 수 있는 라이선스입니다. PDF·Excel 내 텍스트 등의 복사 및 붙여넣기는 가능하나, 사내 이용으로만 제한됩니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 17,978 금액 안내 화살표 ₩ 25,739,000
※ 부가세 별도
한글목차
영문목차

사구체 기저막 항체(항GBM) 질환에 대한 인사이트 및 동향

  • 사구체 기저막 항체병은 사구체 및 폐포의 기저막을 표적으로 하는 순환성 자가항체에 의해 유발되는 드물고 급속히 진행되는 자가면역 질환으로, 심각한 신장 및 폐 손상을 일으킵니다.
  • 사구체 기저막 항체 질환은 희귀질환으로, 연간 신규 환자 수는 약 100만 명당 1건 정도인 것으로 보고되고 있습니다.
  • 사구체 기저막 항체 질환은 신장(약 90%) 및 폐(약 60%)에 영향을 미치는 소혈관성 혈관염입니다.
  • 사구체 기저막 항체 검사, 선상 IgG 침착을 동반한 신장 생검, 그리고 첨단 신장 진단 기술의 활용이 증가함에 따라 진단의 정확도와 조기 발견률은 향상되었으나, 이 질환의 희귀성과 급속한 진행으로 인해 진단 지연은 여전히 흔히 발생하고 있습니다.
  • 사구체 기저막 항체병은 극히 드문 자가면역성 혈관염으로, 추정 연간 발생률은 인구 100만 명당 약 0.5-1.8건으로 알려져 있습니다. 유병률은 낮지만, 발병률, 사망률 및 의료비 부담에 크게 기여하고 있습니다.
  • GBM병 치료는 집중적인 면역억제요법 및 지지요법을 통해 순환하는 병원성 항체의 신속한 제거, 진행 중인 자가면역 활성의 억제, 그리고 신장 및 폐 기능의 유지에 중점을 두고 있습니다.
  • GBM병에 대한 현재의 표준 치료법으로는 혈장 교환술(플라즈마페레시스), 코르티코스테로이드, 시클로포스파미드가 포함되지만, 중증 환자의 경우 투석이나 인공호흡기 지원 등의 지지 요법이 필요할 수 있습니다.
  • 현재의 표준 치료는 신속한 항체 제거와 광범위한 면역억제요법의 병용을 중심으로 이루어지지만, 난치성 환자나 시클로포스파미드 사용이 금기인 경우에는 리툭시맙 등의 추가 약물이 사용되기도 합니다.
  • GBM 치료 파이프라인에는 이무리피다제(IDEFIRIX), 보체를 표적으로 하는 치료법, 그리고 신속한 항체 제거, 신기능 회복, 장기적인 질환 관리 개선을 목표로 하는 임상시험 단계의 IgG 절단 접근법 등 새로운 치료법이 포함되어 있습니다.
  • 치료법의 발전에도 불구하고, 사구체 기저막 항체 질환은 진단 지연, 급속한 질병 진행, 투석 의존 환자에서 신기능 회복의 한계, 질환 특이적인 승인된 치료법의 부재, 그리고 이 극히 드문 적응증에 대한 대규모 임상 증거의 부족으로 인해 여전히 심각한 미충족 의료 수요가 되고 있습니다.

GBM 치료제 시장 보고서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 본 보고서에서는 GBM 치료제의 환자 부담 동향, 매출액 및 시장 점유율 추이, 정점 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가함과 동시에, 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 전망(과거 데이터 및 2022-2036년 전망)을 제시하고 있습니다. 본 보고서는 사구체 기저막 항체 질환 분야의 주요 미충족 의료 수요를 부각하고, 경쟁 구도와 임상 현황을 정리하여 고부가가치 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

사구체 기저막 항체(Anti-GBM) 질환 시장을 주도하는 주요 요인

중증 병태의 진행으로 인해 여전히 높은 미충족 의료 수요

GBM 질환은 드물기는 하지만 급성형 자가면역 소혈관염으로, 급속히 진행되는 사구체신염을 일으키며, 종종 폐출혈을 유발합니다. 치료를 받지 않을 경우, 이 질환은 종종 치명적이거나 투석에 의존해야 하는 상태에 이르게 됩니다. 현재의 표준 치료를 시행하더라도 신기능 유지 기간은 여전히 제한적이며, 상당수의 환자에서 예후가 좋지 않습니다.

표적 치료를 가능하게 하는 병원성 항체 및 보체 생물학에 대한 관심이 높아지고 있습니다.

이 질환은 사구체 기저막의 IV형 콜라겐 a3 사슬에 대한 자가항체에 의해 유발되며, 보체 활성화와 심각한 조직 손상을 초래합니다.

새로운 기전에 기반한 치료법의 등장

GBM암 치료의 기전에 기반한 치료법, 즉 보체 억제제나 임상시험 중인 생물학적 제제의 등장으로 인해, 기존의 광범위한 면역억제 요법에서 표적을 좁힌 정밀한 면역 중재 치료로 전환이 진행되고 있습니다.

사구체 기저막 항체(항GBM) 질환의 이해와 치료 알고리즘

사구체 기저막 항체(항GBM) 질환의 개요 및 진단

사구체 기저막 항체 질환(굿패처 증후군으로도 알려져 있음)은 사구체 및 폐포 기저막에 대한 자가항체가 혈액 내에서 순환하는 것을 특징으로 하는 드물고 급속히 진행되는 자가면역 질환으로, 주로 신장과 폐에 영향을 미칩니다. 이 질환은 급속 진행성 사구체 신염(RPGN), 혈뇨, 단백뇨, 급성 신장 손상을 주요 증상으로 하며, 일부 환자에서는 객혈이나 호흡 곤란을 동반하는 폐출혈이 나타납니다. 병세가 급속히 진행되기 때문에 치료가 늦어지면 말기 신부전(ESRD)에 이르게 되며, 사망률도 높아집니다. 진단은 혈중 사구체 기저막 항체의 검출, 선상의 IgG 침착을 보여주는 신장 생검 소견, 그리고 신장과 폐의 병변 평가를 바탕으로 이루어집니다.

사구체 기저막 항체(항GBM) 질환의 진단

GBM 질환의 진단은 주로 임상 평가, 혈청학적 검사 및 신장 생검 소견에 근거합니다. 효소면역측정법(ELISA)을 이용한 순환 GBM 항체의 검출은 여전히 주요 진단 검사이며, 면역형광법을 통해 사구체 기저막을 따라 선형의 IgG 침착이 관찰되는 신생검 소견은 진단상의 특징으로 간주됩니다. 혈청 크레아티닌, 소변 검사, 단백뇨 평가, 염증 마커 등의 추가 검사는 신장 침범 여부나 질환의 중증도를 평가하는 데 도움이 됩니다. 폐출혈이나 폐 관련 문제가 의심되는 환자의 경우, 흉부 X선 검사나 CT 스캔 등의 영상 검사가 시행될 수 있습니다.

사구체 기저막 항체(항GBM) 질환의 치료

GBM 질환의 치료는 주로 순환하는 사구체 기저막 항체의 신속한 제거, 진행 중인 자가면역 활성의 억제, 그리고 신장 및 폐 기능의 유지에 중점을 둡니다. 표준 1차 치료법에는 염증을 완화하고 추가적인 항체 생성을 막기 위해 혈장 교환술(플라즈마페레시스)과 고용량 코르티코스테로이드, 그리고 면역억제제인 시클로포스파미드의 병용 요법이 포함됩니다. 폐출혈이 있는 환자의 경우, 집중적인 지지 요법이 필요할 수 있으며, 중증 환자의 경우 산소 요법이나 인공호흡기 사용이 필요할 수도 있습니다. 난치성 또는 재발성 사례에서는 리툭시맙 등의 추가적인 면역조절 요법이 고려될 수 있습니다. 말기 신부전(ESRD)으로 진행된 환자의 경우 투석이 필요할 수 있으며, 특정 사례에서는 항체 제거 후 신장 이식이 이루어지기도 합니다.

사구체 기저막 항체(항GBM) 질환의 역학

사구체 기저막 항체(항GBM) 질환의 역학 분석 및 예측에 관한 주요 연구 결과

  • 사구체 기저막 항체 질환은 극히 드물지만 중증의 소혈관성 혈관염으로, 발생률은 인구 100만 명당 연간 약 0.5-1.8건입니다.
  • 그 희귀성 때문에 사구체 기저막 항체 질환의 발병률에 관한 결정적인 연구 결과는 부족한 실정입니다. 유럽 인구 집단에서는 연간 인구 100만 명당 약 1건의 발생률을 보인다고 흔히 알려져 있으며, 이는 주로 단일 기관에서 실시된 생검 또는 혈청학적 검사를 바탕으로 한 사례 시리즈에 근거한 것입니다. 다만, 이러한 연구에서 위험군에 속하는 집단을 정확하게 정의하는 것은 어렵습니다.
  • GBM암의 연령 분포는 이중 정점을 보이며, 30대(남성이 약간 더 많음)와 60-70대(성별 차이 없음)에서 정점을 나타내며, 고령자의 경우 이 질환의 경과가 비교적 경미한 것으로 보입니다.
  • 연간 발생률은 인구 100만 명당 0.4-2.8건 범위였으며, 관찰 기간 동안의 평균 발생률은 인구 100만 명당 1.64건이었습니다.
  • 사구체 기저막 항체 질환은 20대 남성과 60대 여성에게서 가장 많이 나타나지만, 어떤 연령대에서도 발병할 가능성이 있습니다. 소아에게도 발병할 수 있지만, 이는 극히 드문 경우입니다.
  • GBM암 환자 중 가장 높은 비율을 차지하는 것은 30-49세 여성(50%)이며, 그 다음으로 49-65세 여성(40%)이 뒤를 잇고, 65세 이상 여성은 전체 환자의 10%를 차지합니다.
  • GBM 뇌종양의 발생률은 인구 100만 명당 연간 약 1-1.64건입니다.
  • GBM암의 연령별 발병률에는 두 가지 정점이 있는데, 하나는 20-30대, 다른 하나는 60-70대입니다. 소아의 경우, 만성 신장 질환(CKD)의 전체 원인 중 0.4%가 사구체 기저막 항체 질환에 기인하는 것으로 보고되고 있습니다.

사구체 기저막 항체(항GBM) 질환 시장 전망

사구체 기저막 항체 질환 시장은 여전히 치료 수요가 충분히 충족되지 않은 상황이며, 현재의 치료는 주로 병인성 자가항체의 활성을 억제하고 신장 기능을 유지하기 위해 신속한 혈장 교환, 코르티코스테로이드, 시클로포스파미드 투여에 의존하고 있습니다. 적극적인 치료에도 불구하고, 특히 중증 신장 기능 장애를 보이는 환자나 진단이 늦어진 환자 중 상당수가 말기 신부전(ESRD)으로 진행되거나 장기간 투석이 필요함에 따라, 보다 효과적이고 표적화된 치료법에 대한 막대한 미충족 수요가 부각되고 있습니다.

치료 방식은 기존의 광범위한 면역억제 요법에서 병원성 IgG 항체나 면역매개성 조직 손상을 표적으로 하는 작용기전에 기반한 치료 접근법으로 점차 전환되고 있습니다. Hansa Biopharma사가 개발한 임리피다제(IDEFIRIX) 등의 신흥 치료법은 IgG 항체의 신속한 절단 및 IgG를 매개로 하는 면역 반응의 억제를 통해 새로운 접근 방식을 제시했습니다. 그러나 사구체 기저막 항체 치료제인 이무리피다제의 개발은 주요 3상 임상시험인 GOOD IDES 02 임상시험(NCT05679401)이 주요 평가 지표를 달성하지 못함에 따라 중단되었으며, 그 결과 해당 임상시험의 장기 추적 조사 단계도 종료되게 되었습니다. 이와 병행하여, 중증 또는 난치성 환자의 신기능 회복과 질환 조절을 개선하기 위해, 릿룩시맙, 보체를 표적으로 하는 치료법, 베베리마 등 새로운 면역 조절 접근법을 포함한 기타 치료 전략들이 검토되고 있습니다. 조사가 계속되고 있음에도 불구하고, 현재 GBM 치료에 특별히 적응증이 승인된 FDA 승인 치료법은 존재하지 않으며, 치료는 여전히 표준 치료와 병용하는 면역억제제의 적응증 외 사용에 크게 의존하고 있습니다.

미국은 첨단 신장 의료 인프라, 진단 능력 향상, 그리고 고가의 생물학적 제제 및 혈장 교환 요법에 대한 접근성이 뒷받침되어, 사구체 기저막 항체 질환 치료제 시장의 최대 시장이 될 것으로 예측됩니다.

  • GBM 치료 방식은 비특이적인 면역 억제에서 표적을 정확히 겨냥한 항체 제거 및 정밀한 면역 조절 접근법으로 점차 전환되고 있습니다.
  • 중증 신장 기능 장애, 투석 의존, 또는 폐출혈이 있는 환자의 경우, 현재의 치료에도 불구하고 신장 기능의 회복이 제한적이기 때문에 여전히 큰 미충족 의료 수요가 존재합니다.
  • 항체 제거 요법 : 혈장 교환(플라즈마페레시스)은 혈류 내에서 순환하는 사구체 기저막 항체를 신속하게 제거하기 위한 표준적인 치료법이며, 일반적으로 진단 직후에 시작됩니다.
  • 면역억제 요법 : 코르티코스테로이드와 시클로포스파미드는 염증을 완화하고 추가적인 사구체 기저막 항체 생성을 억제함으로써 치료의 핵심을 이룹니다. 리툭시맙은 난치성 환자나 시클로포스파미드를 사용할 수 없는 경우에서 고려될 수 있습니다.

전반적으로, 혈장 교환 요법과 면역 억제 요법은 사구체 기저막 항체 질환 관리에 있어 여전히 현재의 표준 치료법으로 자리 잡고 있으며, 병인성 항체의 생성을 억제하고 면역 매개성 염증을 조절하기 위해서는 코르티코스테로이드와 시클로포스파미드가 여전히 필수적입니다.

자주 묻는 질문

  • 사구체 기저막 항체 질환의 연간 발생률은 어떻게 되나요?
  • 사구체 기저막 항체 질환의 주요 증상은 무엇인가요?
  • 사구체 기저막 항체 질환의 치료 방법은 무엇인가요?
  • 사구체 기저막 항체 질환의 진단 방법은 무엇인가요?
  • 사구체 기저막 항체 질환의 시장 전망은 어떻게 되나요?
  • 사구체 기저막 항체 질환의 치료에 사용되는 주요 약물은 무엇인가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 주요 요약

제4장 주요 이벤트

제5장 사구체 기저막 항체(항GBM) 병 역학 및 시장 조사 방법

제6장 사구체 기저막 항체(Anti-GBM) : 시장 개요

제7장 질환 배경과 항GBM 요법 개요

제8장 치료 및 가이드라인

제9장 사구체 기저막 항체(Anti-GBM) : 역학 및 환자 인구

제10장 사구체 기저막 항체(Anti-GBM) : 환자 경과

제11장 신흥 치료법

제12장 항GBM병 : 주요 7개국 분석

제13장 항GBM병 : 미충족 수요

제14장 항GBM병 : SWOT 분석

제15장 항GBM병 : KOL(Key Opinion Leader)의 견해

제16장 시장 참여 및 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight에 대해

KTH 26.07.24

Anti-Glomerular Basement Membrane (Anti-GBM) Disease Insights and Trends

  • Anti-GBM disease is a rare and rapidly progressive autoimmune disorder caused by circulating autoantibodies directed against the glomerular and alveolar basement membranes, leading to severe kidney and lung injury.
  • Anti-GBM disease is rare, with only about 1 in 1 million new cases being reported per year.
  • Anti-GBM disease is a small-vessel vasculitis involving the kidneys (~90%) and the lungs (~60%).
  • Increasing use of anti-GBM antibody testing, kidney biopsy with linear IgG deposition, and advanced renal diagnostic techniques has improved diagnostic accuracy and early disease detection, although delayed diagnosis remains common due to the rarity and rapid progression of the disease.
  • Anti-GBM disease is an ultra-rare autoimmune vasculitis disorder, with an estimated incidence of approximately 0.5-1.8 cases per million population annually, contributing to substantial morbidity, mortality, and healthcare burden despite its low prevalence.
  • Management of Anti-GBM disease focuses on rapid removal of circulating pathogenic antibodies, suppression of ongoing autoimmune activity, and preservation of renal and pulmonary function through intensive immunosuppressive and supportive therapies.
  • Current standard therapies for Anti-GBM disease include plasma exchange (plasmapheresis), corticosteroids, and cyclophosphamide, while supportive interventions such as dialysis and ventilator support may be required in severe disease.
  • The current standard of care is centered on rapid antibody removal combined with broad immunosuppression, while additional agents such as rituximab may be used in refractory patients or when cyclophosphamide is contraindicated.
  • The anti-GBM disease pipeline includes emerging therapies such as imlifidase (IDEFIRIX), complement-targeted therapies, and investigational IgG-cleaving approaches aimed at improving rapid antibody clearance, renal recovery, and long-term disease control.
  • Despite therapeutic advancements, anti-GBM disease continues to represent a significant unmet medical need due to delayed diagnosis, rapid disease progression, limited renal recovery in dialysis-dependent patients, lack of disease-specific approved therapies, and limited large-scale clinical evidence in this ultra-rare indication.

DelveInsight's 'Anti-Glomerular Basement Membrane (Anti-GBM) Disease - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the Anti-GBM disease, historical and forecasted epidemiology, as well as the Anti-GBM disease market trends in the United States, EU4 (Germany, Spain, Italy, and France), and the United Kingdom, and Japan.

The Anti-GBM Disease market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates Anti-GBM disease 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 Anti-GBM disease 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 Anti-Glomerular Basement Membrane (Anti-GBM) Disease Market

Persistent high unmet medical need due to severe disease course

Anti-GBM disease is a rare but fulminant autoimmune small-vessel vasculitis that causes rapidly progressive glomerulonephritis and often pulmonary hemorrhage. Without treatment, the disease is frequently fatal or leads to dialysis dependence. Even with current standard therapy, renal survival remains limited and outcomes are poor in a substantial proportion of patients.

Rising focus on pathogenic antibody and complement biology enabling targeted therapies

The disease is driven by autoantibodies against the a3 chain of type IV collagen in the glomerular basement membrane, leading to complement activation and severe tissue injury.

Emergence of novel mechanism-based therapies

The emergence of mechanism-based therapies in anti-GBM disease, complement inhibitors, and investigational biologics, is driving a shift from conventional broad immunosuppression toward targeted, precision immune intervention.

Anti-Glomerular Basement Membrane (Anti-GBM) Disease Understanding and Treatment Algorithm

Anti-Glomerular Basement Membrane (Anti-GBM) Disease Overview and Diagnosis

Anti-GBM disease, also known as Goodpasture's syndrome, is a rare and rapidly progressive autoimmune disorder characterized by circulating autoantibodies against the glomerular and alveolar basement membranes, primarily affecting the kidneys and lungs. The disease commonly presents with rapidly progressive glomerulonephritis (RPGN), hematuria, proteinuria, acute kidney injury, and in some patients, pulmonary hemorrhage with hemoptysis and respiratory distress. Due to its aggressive nature, delayed treatment can lead to end-stage renal disease (ESRD) and significant mortality. Diagnosis is based on detection of circulating anti-GBM antibodies, kidney biopsy demonstrating linear IgG deposition, and assessment of renal and pulmonary involvement.

Anti-Glomerular Basement Membrane (Anti-GBM) Disease Diagnosis

Diagnosis of anti-GBM disease is primarily based on clinical evaluation, serologic testing, and kidney biopsy findings. Detection of circulating anti-GBM antibodies using enzyme-linked immunosorbent assay (ELISA) remains the key diagnostic test, while kidney biopsy demonstrating linear IgG deposition along the glomerular basement membrane by immunofluorescence is considered the diagnostic hallmark. Additional laboratory investigations, including serum creatinine, urinalysis, proteinuria assessment, and inflammatory markers, help evaluate renal involvement and disease severity. Imaging studies such as chest X-ray or CT scan may be performed in patients with suspected pulmonary hemorrhage or lung involvement.

Anti-Glomerular Basement Membrane (Anti-GBM) Disease Treatment

Treatment of Anti-GBM disease primarily focuses on rapid removal of circulating anti-GBM antibodies, suppression of ongoing autoimmune activity, and preservation of renal and pulmonary function. Standard first-line therapy includes plasma exchange (plasmapheresis) combined with high-dose corticosteroids and the immunosuppressive agent cyclophosphamide to reduce inflammation and prevent further antibody production. Patients with pulmonary hemorrhage may require intensive supportive care, including oxygen therapy and mechanical ventilation in severe cases. In refractory or relapsing disease, additional immunomodulatory therapies such as rituximab may be considered. Patients progressing to ESRD may require dialysis and, in selected cases, renal transplantation following antibody clearance

Anti-Glomerular Basement Membrane (Anti-GBM) Disease Unmet Needs

The section "unmet needs of Anti-GBM Disease" 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. Need for targeted and disease-specific therapies

2. Delayed diagnosis and rapid disease progression

3. Limited renal recovery in severe and dialysis-dependent patients

4. Lack of large-scale clinical trials and standardized treatment evidence

5. Need for advanced and rapid diagnostic tools

6. Development of novel mechanism-based therapies, and others.....

Anti-Glomerular Basement Membrane (Anti-GBM) Disease Membrane Epidemiology

Key Findings from Anti-Glomerular Basement Membrane (Anti-GBM) Disease Epidemiological Analysis and Forecast

  • Anti-GBM Disease is an extremely rare but serious small vessel vasculitis and its incidence is approximately 0.5-1.8 cases per million population per year.
  • Given its rarity, definitive observations regarding the incidence of Anti-GBM disease are lacking. It is often said to have an incidence of about 1 per million population per year in European populations, largely on the basis of single-center biopsy- or serology-based series, although accurately defining populations at risk in such studies is difficult.
  • Anti-GBM disease has a bimodal age distribution, with peaks in the third decade (slight male preponderance) and in the sixth to seventh decades (no gender difference) and the disease in the elderly appears to take a milder course.
  • Annual incidence ranged from 0.4 to 2.8 per million population per year and the average incidence over the observation period was 1.64 per million population per year.
  • Anti-GBM disease most often affects men in their 20s and women in their 60s, but it can occur at any age. The condition can occur in children, but this is extremely rare.
  • The highest proportion of anti-GBM disease cases occurs in females aged 30-49 years (50%), followed by those aged 49-65 years (40%), while females aged over 65 years account for 10% of cases.
  • The incidence of anti-GBM disease is about 1-1.64 per million population per year.
  • Anti-GBM disease has a double peak in age incidence, one in the second-third decade and one in the sixth-seventh decade. In children, 0.4% of all causes of CKD are reported to be due to anti-GBM disease.

Anti-Glomerular Basement Membrane (Anti-GBM) Disease Drug Analysis & Competitive Landscape

The Anti-GBM Disease drug chapter provides a detailed, market-focused review of the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the Anti-GBM Disease treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the anti-GBM disease therapeutics market.

Anti-Glomerular Basement Membrane (Anti-GBM) Disease Pipeline Analysis

Veverimer: Renibus Therapeutics

Veverimer, an oral, non-absorbed hydrochloric acid binder being developed by Renibus Therapeutics, is being investigated as a potential treatment for anti-GBM disease. Unlike conventional immunosuppressive approaches, veverimer targets a complementary disease pathway by reducing renal ammoniagenesis and subsequent complement activation, which are implicated in kidney injury associated with anti-GBM disease. This differentiated mechanism may help mitigate complement-mediated renal damage and preserve kidney function. The potential of veverimer in this indication was recognized by the FDA through the granting of Orphan Drug Designation in May 2025.

Anti-Glomerular Basement Membrane (Anti-GBM) Disease Key Players, Market Leaders, and Emerging Companies

  • Renibus Therapeutics

Anti-Glomerular Basement Membrane (Anti-GBM) Disease Drug Updates

  • In January 2026 corporate presentation, Hansa Biopharma discontinued the long-term follow-up phase of the Phase III GOOD-IDES-02 trial in anti-GBM disease after the core study failed to meet its primary endpoint. Detailed results from the study are expected to be presented at a medical congress in 2026, providing further insights into the clinical profile of imlifidase in this indication.
  • In May 2025, Renibus Therapeutics announce that they received FDA Orphan Drug Designation for veverimer anti-GBM disease, supporting the asset's development for treatment.

Anti-Glomerular Basement Membrane (Anti-GBM) Disease Market Outlook

The Anti-GBM disease market remains highly underserved, with current treatment primarily dependent on rapid initiation of plasma exchange, corticosteroids, and cyclophosphamide to suppress pathogenic autoantibody activity and preserve renal function. Despite aggressive treatment, a substantial proportion of patients progress to ESRD or require long-term dialysis, particularly those presenting with severe renal impairment or delayed diagnosis, highlighting a significant unmet medical need for more effective and targeted therapies.

The treatment landscape is gradually evolving from conventional broad immunosuppression toward mechanism-based therapeutic approaches targeting pathogenic IgG antibodies and immune-mediated tissue injury. Emerging therapies such as imlifidase (IDEFIRIX), developed by Hansa Biopharma, and represented a novel approach through rapid IgG antibody cleavage and inhibition of IgG-mediated immune responses. However, development of imlifidase in anti-GBM disease was discontinued following the failure of the pivotal Phase III GOOD IDES 02 trial (NCT05679401) to meet its primary endpoint, leading to termination of the study's long-term follow-up phase. In parallel, other investigational strategies, including rituximab, complement-targeted therapies, and novel immune-modulating approaches such as veverimer, are being explored to improve renal recovery and disease control in severe or refractory patients. Despite ongoing research efforts, there are currently no FDA-approved therapies specifically indicated for anti-GBM disease, and treatment continues to rely largely on off-label use of immunosuppressive agents in combination with standard care.

The United States is expected to represent the largest anti-GBM disease market, supported by advanced nephrology care infrastructure, improved diagnostic capabilities, and access to high-cost biologics and plasma exchange procedures.

  • The Anti-GBM disease treatment landscape is gradually shifting from non-specific immunosuppression toward targeted antibody-removal and precision immune-modulating approaches.
  • Patients with severe renal impairment, dialysis dependency, or pulmonary hemorrhage continue to represent a major unmet need due to limited renal recovery despite current therapy.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Anti-Glomerular Basement Membrane (Anti-GBM) Disease (2022-2036 Forecast)

The Anti-GBM disease treatment landscape consists of antibody removal therapies, immunosuppressive agents, and emerging targeted therapies aimed at controlling pathogenic autoantibody activity and preserving renal and pulmonary function.

  • Antibody removal therapies: Plasma exchange (plasmapheresis) remains the standard approach for rapidly removing circulating anti-GBM antibodies from the bloodstream and is typically initiated immediately after diagnosis.
  • Immunosuppressive therapies: Corticosteroids and cyclophosphamide form the backbone of treatment by reducing inflammation and suppressing further anti-GBM antibody production. Rituximab may be considered in refractory patients or in cases where cyclophosphamide cannot be used.

Overall, plasma exchange and immunosuppressive therapies continue to define the current standard of care in anti-GBM disease management, with corticosteroids and cyclophosphamide remaining essential for suppressing pathogenic antibody production and controlling immune-mediated inflammation.

Anti-Glomerular Basement Membrane (Anti-GBM) Disease 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 Anti-GBM Disease 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.

The uptake of therapies in anti-GBM disease is expected to vary across antibody removal therapies, immunosuppressive agents, and emerging targeted immune-modulating therapies. Established treatments such as plasma exchange (plasmapheresis), corticosteroids, and cyclophosphamide are anticipated to maintain strong and sustained use due to their central role in rapid antibody removal, suppression of autoimmune activity, and preservation of renal function in acute disease management. In parallel, supportive interventions including dialysis and respiratory support are expected to remain essential in patients with severe renal or pulmonary involvement.

In addition, investigational approaches including rituximab, complement-targeted therapies, and other IgG-directed therapies are being evaluated to improve disease control and renal outcomes. Their future uptake will depend on the generation of robust clinical evidence demonstrating improved efficacy, safety, renal recovery, and reduced progression to end-stage renal disease compared with conventional therapy alone.

Detailed insights of emerging therapies' drug uptake is included in the report.

Market Access and Reimbursement of Anti-Glomerular Basement Membrane (Anti-GBM) Disease

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

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.

NOTE: Further Details are provided in the final report....

Anti-Glomerular Basement Membrane (Anti-GBM) Disease Therapies Price Scenario & Trends

Pricing and analogue assessment of Anti-GBM disease therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, the closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

Further details are provided in the final report....

Industry Experts and Physician Views for Anti-Glomerular Basement Membrane (Anti-GBM) Disease

To keep up with Anti-GBM disease 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 emerging Anti-GBM disease 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 Anti-GBM disease, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights at the country level. Centers such as the Professor, Nephrologist, etc., were contacted. Their opinion helps understand and validate current and emerging Anti-GBM disease therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in Anti-GBM disease.

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 Anti-GBM Disease, 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 Anti-GBM disease, 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 elaborate profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the Anti-GBM Disease 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 Anti-GBM Disease market.

Report Insights

  • Anti-GBM Disease Patient Population Forecast
  • Anti-GBM Disease Therapeutics Market Size
  • Anti-GBM Disease Pipeline Analysis
  • Anti-GBM Disease Market Size and Trends
  • Anti-GBM Disease 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
  • Anti-GBM Disease Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (By Geography)
  • Anti-GBM Disease Treatment Addressable Market (TAM)
  • Anti-GBM Disease Competitive Landscape
  • Anti-GBM Disease Major Companies Insights
  • Anti-GBM Disease Price Trends and Analogue Assessment
  • Anti-GBM Disease Therapies Drug Adoption/Uptake
  • Anti-GBM Disease Therapies Peak Patient Share Analysis

Report Assessment

  • Anti-GBM Disease Current Treatment Practices
  • Anti-GBM Disease Unmet Needs
  • Anti-GBM Disease Clinical Development Analysis
  • Anti-GBM Disease Emerging Drugs Product Profiles
  • Anti-GBM Disease Market Attractiveness
  • Anti-GBM Disease Qualitative Analysis (SWOT and conjoint analysis)

FAQs:

Market Insights

  • What was the Anti-GBM disease market size, the market size by therapies, the 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 Anti-GBM disease?
  • What are the disease risks, burdens, and unmet needs of Anti-GBM disease? What will be the growth opportunities across the 7MM concerning the patient population with Anti-GBM disease?
  • 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 Anti-GBM disease? What are the current guidelines for treating Anti-GBM disease 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 Anti-GBM Disease 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 into 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 summarizes and simplifies complex datasets within 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

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 . Anti-Glomerular Basement Membrane (Anti-GBM) Disease

6. Anti-GBM Disease Market Overview at a Glance

  • 6.1. Emerging Landscape Analysis (By Molecule Type, Phase, and Route of Administration [ROA])
  • 6.2. Market Share of Anti-GBM Disease By Therapies (%) in the 7MM in 2025
  • 6.3. Market Share of Anti-GBM Disease By Therapies (%) in the 7MM in 2036

7. Disease Background And Overview of Anti-GBM

  • 7.1. Introduction
  • 7.2. Risk Factors and Causes of Anti-GBM disease
  • 7.3. Signs and symptoms of Anti-GBM disease
  • 7.4. Pathophysiology of Anti-GBM disease
  • 7.5. Clinical manifestations of Anti-GBM disease
  • 7.6. Complications of Anti-GBM disease
  • 7.7. Diagnosis of Anti-GBM disease
  • 7.8. Diagnostic Algorithm
  • 7.9. Differential Diagnosis
    • 7.9.1. Diagnostic Guidelines
    • 7.9.2. Diagnostic guideline by KDIGO
    • 7.9.3. KDIGO diagnostic guideline for Kidney biopsy

8. Treatment and Guidelines

  • 8.1. KDIGO Treatment Algorithm of Anti-GBM disease
  • 8.2. Treatment Guidelines

9. Epidemiology and Patient Population of Anti-GBM Disease

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale: The 7MM
    • 9.2.1. Total Incident Cases of Anti-GBM Disease in the 7MM
  • 9.3. The US
    • 9.3.1. Total Incident Cases of Anti-GBM Disease in the US
    • 9.3.2. Total Diagnosed Cases of Anti-GBM Disease in the US
    • 9.3.3. Age-specific Incident Cases of Anti-GBM Disease in the US
    • 9.3.4. Total Treated Cases of Anti-GBM Disease in the US
  • 9.4. EU4 and the UK
    • 9.4.1. Total Incident Cases of Anti-GBM Disease in EU4 and the UK
    • 9.4.2. Total Diagnosed Cases of Anti-GBM Disease in EU4 and the UK
    • 9.4.3. Age-specific Incident Cases of Anti-GBM Disease in EU4 and the UK
    • 9.4.4. Total Treated Cases of Anti-GBM Disease in EU4 and the UK
  • 9.5. Japan
    • 9.5.1. Total Incident Cases of Anti-GBM Disease in the Japan
    • 9.5.2. Total Diagnosed Cases of Anti-GBM Disease in the Japan
    • 9.5.3. Age-specific Incident Cases of Anti-GBM Disease in the Japan
    • 9.5.4. Total Treated Cases of Anti-GBM Disease in the Japan

10. Patient Journey of Anti-GBM Disease

11. Emerging Therapies

  • 11.1. Competitive Landscape: Emerging Therapies
  • 11.2. Veverimer: Renibus Therapeutics
    • 11.2.1. Product Description
    • 11.2.2. Other Developmental Activities
    • 11.2.3. Clinical Development
    • 11.2.4. Safety and Efficacy
    • 11.2.5. Analyst's View

12. Anti-GBM Disease: Seven Major Market Analysis

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

13. Unmet Needs of Anti-GBM Disease

14. SWOT Analysis of Anti-GBM Disease

15. KOL Views of Anti-GBM Disease

  • 15.1. Expert/KOL Interview Highlights

16. Market Access and Reimbursement

  • 16.1. United States
    • 16.1.1. Centre for Medicare and Medicaid Services (CMS)
  • 16.2. 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 Anti-GBM Disease Therapies

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

샘플 요청 목록
0 건의 상품을 선택 중
목록 보기
전체삭제
문의
원하시는 정보를
찾아 드릴까요?
문의주시면 필요한 정보를
신속하게 찾아드릴게요.
02-2025-2992
email
문의하기