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면역복합체 막증식성 사구체신염(IC-MPGN) : 시장 인사이트, 역학 및 시장 예측(2036년)

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) - Market Insights, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 79 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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면역복합체 막증식성 사구체신염(IC-MPGN)에 대한 인사이트와 동향

  • DelveInsight의 분석에 따르면, 2025년 시점에서 주요 시장(미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국 및 일본)의 IC-MPGN 시장 규모는 약 3,000만 달러인 것으로 나타났습니다.
  • 원발성 면역복합체 막증식성 사구체신염(IC-MPGN)은 환자와 그 보호자에게 막대한 부담을 주며, 그들의 삶을 완전히 바꿔놓을 정도입니다.
  • 영국 등록부에 따르면, 영국 전역의 MPGN 최소 유병률은 10만 명당 1.3명입니다.
  • 2025년, 미국 내 IC-MPGN의 발생률에는 소아와 성인 간에 현저한 차이가 나타났습니다. 소아는 IC-MPGN 전체 환자 수의 약 10%에 불과한 반면, 성인의 유병률은 훨씬 더 높아 약 3,400건의 사례가 보고되었습니다.
  • IC-MPGN은 철저한 평가를 실시해도 근본적인 원인을 규명할 수 없는 경우에만 ‘특발성’으로 분류되지만, 일부 사례에서는 보체 대체 경로의 조절 이상이나 과잉 활성화가 관여하고 있을 가능성을 시사하는 새로운 증거가 제시되고 있습니다.
  • IC-MPGN의 진단은 조직병리학, 면역형광법 및 임상 평가를 종합하여 이루어집니다. 신장 생검은 여전히 골드 스탠다드이며, 면역 복합체의 침착이나 보체의 관여를 바탕으로 감별 진단을 내릴 수 있습니다.
  • IC-MPGN에서 신장 손상의 진행을 늦추기 위해 사용되는 약물로는 ACE 억제제, ARB, 이뇨제, 코르티코스테로이드 및 기타 면역억제제, 그리고 지질강하 요법 등이 있습니다.
  • IC-MPGN의 치료는 여전히 주로 지지요법을 중심으로 이루어지고 있으며, 이 질환에 특화된 표준 치료법으로 보편적으로 확립된 것은 없습니다. 기존의 치료법에는 RAAS 차단 요법 및 적격 환자에 대한 면역억제제 투여가 포함됩니다. 표적 치료법으로는 Apellis Pharmaceuticals사(EMPAVELI)가 보체 의존성 신장질환과 관련된 보체 억제제로 주목받고 있으며, 이는 IC-MPGN의 기전에 기반한 치료로 나아가는 첫걸음이 되고 있습니다.
  • IC-MPGN의 연구 흐름은 보체 대체 경로의 조절에 점점 더 초점을 맞추고 있습니다. 주목할 만한 신생 기업으로는 노바티스(iptacopan)와 사네젠바이오(SGB-9768) 등이 있습니다. 이러한 약물은 보체 활성화의 업스트림 조절 인자를 표적으로 하여, 보다 정밀하고 지속적인 질환 관리를 실현하는 것을 목표로 하고 있습니다.

G7 국가별 면역복합체 막증식성 사구체신염(IC-MPGN)의 시장 규모 및 전망

  • 2025년 IC-MPGN 시장 규모 : 약 3,000만 달러
  • IC-MPGN의 성장률(2026-2036년) : 연평균 성장률(CAGR) 26%

면역복합체 막증식성 사구체신염(IC-MPGN) 시장 보고서는 표준 치료, 임상 실무 및 진화하는 치료 알고리즘을 포함하여 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. 본 보고서에서는 IC-MPGN 환자의 부담 동향, 수익 및 시장 점유율 동향, 피크 시기의 환자 점유율 및 치료법 보급 현황에 대한 분석을 평가하는 한편, 전 세계 각 지역의 시장 규모에 대한 상세한 평가와 성장률 전망(과거 데이터 및 2022-2036년 전망)을 제공합니다. 또한, IC-MPGN 분야의 주요 미충족 요구 사항을 부각시키고, 경쟁 구도 및 임상 환경을 분석하여 고부가가치 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

면역복합체 막증식성 사구체신염(IC-MPGN) 시장을 주도하는 주요 요인

유병률의 증가와 기저질환

유병률의 증가는 만성 질환인 특정 장기 감염증(C형 간염), 자가면역 질환(루푸스 신염), 그리고(주로 성인에게서 나타나는) 단클론성 감마글로불린혈증에 기인하며, 이로 인해 치료 수요가 증가하고 있습니다.

승인된 치료법의 부족

FDA(미국 식품의약국)가 승인한 특정 약물이 없기 때문에 시장에서는 면역억제제, 스테로이드, 레닌-안지오텐신-알도스테론계(RAAS) 억제제 등의 적응증 외 치료가 주류를 이루고 있습니다. 따라서 각 기관은 새로운 치료법 개발에 주력하고 있습니다.

진단 기술의 향상

진단 기술의 발전과 IC-MPGN 및 C3 사구체증(C3G)을 구별하기 위한 임상의들의 인식 제고로 인해, 더 조기적이고 빈번한 진단이 가능해지면서 치료를 받는 환자 수가 증가하고 있습니다.

면역복합체 막증식성 사구체신염(IC-MPGN)의 이해와 치료 알고리즘

면역복합체 막증식성 사구체신염(IC-MPGN)의 개요 및 진단

원발성 IC-MPGN은 드문 만성 신장질환입니다. 과도한 C3 침착은 질환 활동성의 중요한 지표이며, 신장의 염증, 손상 및 기능 부전을 유발할 수 있습니다. IC-MPGN에는 원발성(특발성)인 경우와 감염증, 자가면역질환, 악성 종양 등의 기저 질환에 이차적으로 발생하는 경우가 있습니다. 임상적으로 환자는 종종 단백뇨, 혈뇨, 고혈압, 신기능 저하를 보이며, 적절한 관리가 이루어지지 않을 경우 이 질환은 진행되어 만성 신장질환(CKD)이나 말기 신부전으로 이어질 수 있습니다.

IC-MPGN의 진단은 임상 평가, 검사 소견 및 조직병리학적 확인을 종합하여 이루어집니다. 초기 소견으로는 일반적으로 단백뇨(대부분 신증 범위), 현미경적 혈뇨, 신기능 저하와 더불어 보체 수치(특히 C3 및 C4)의 저하가 관찰될 수 있습니다. 그러나 진단의 황금기준은 신장 생검이며, 이를 통해 메산기움 증식, 모세혈관벽 비후, 면역 복합체 침착과 같은 특징적인 소견이 확인됩니다. 면역형광현미경 검사에서는 보체 성분과 함께 면역글로불린(예 : IgG)의 존재가 확인되며, 이는 주로 C3 침착이 나타나는 C3 사구체 병변과의 감별 진단에 도움이 됩니다. C3G 및 원발성 IC-MPGN 환자의 약 50%는 진단 후 5-10년 이내에 신부전을 일으키며, 부담이 큰 신장 이식이나 평생 지속되는 투석 치료가 필요합니다.

면역복합체 막증식성 사구체신염(IC-MPGN)의 현재 치료 현황

IC-MPGN의 치료는 약물 요법, 생활 습관 개선, 그리고 새로운 보체 표적 요법을 병행함으로써 혈압 조절, 단백뇨 감소, 콜레스테롤 관리에 중점을 두고 있습니다.

신장 손상의 진행을 늦추기 위해 일반적으로 사용되는 약물로는 혈압을 낮추고, 단백질 손실을 줄이기 위한 ACE 억제제나 ARB, 체액 과다나 부종을 관리하기 위한 이뇨제, 면역 매개성 사구체 손상을 억제하기 위한 코르티코스테로이드나 기타 면역억제제, 그리고 콜레스테롤을 관리하고 심혈관 보호를 촉진하기 위한 스타틴 등이 있습니다.

면역복합체 막증식성 사구체신염(IC-MPGN)의 역학

IC-MPGN의 역학 분석 및 예측에 관한 주요 조사 결과

  • DelveInsight사의 추산에 따르면, 2025년 시점에서 주요 7개국에서 IC-MPGN으로 진단받은 환자 총 수는 약 7,000건이었습니다.
  • 2025년, IC-MPGN으로 진단받은 환자 수는 미국이 약 3,500건으로 가장 많았으며, 그 다음으로 일본이 뒤를 이었습니다.
  • DelveInsight사의 추산에 따르면, 2025년 미국의 IC-MPGN 총 환자 수 중 50% 이상을 남성이 차지하고 있습니다.
  • IC-MPGN의 증례는 소아보다 성인에서 더 많이 나타납니다.
  • 특발성 IC-MPGN의 발생률은 여전히 불분명하지만, C3G의 전 세계 연간 발생률은 인구 100만 명당 1-3건으로 추정됩니다. 신부전으로 진행될 위험이 매우 높으며, C3G 또는 특발성 IC-MPGN 환자의 최대 30-35%가 진단 후 10년 이내에 신부전을 발병하고 있습니다.

면역복합체 막증식성 사구체신염(IC-MPGN) 시장의 전망

IC-MPGN의 치료 양상은, 오랫동안 지지요법이나 광범위한 면역억제 요법에 의존해 온 상태에서, 작용 기전에 기반한 표적 치료로 크게 전환되고 있습니다. 그동안 환자 관리에는 레닌-안지오텐신계 억제제, 이뇨제, 코르티코스테로이드 및 기타 면역억제제가 사용되어 왔습니다.

이 분야의 큰 전환점이 된 것은 IC-MPGN에 대한 최초의 표적 치료제인 페그세타코플란(EMPAVELI)의 승인입니다. 이 약제는 C3를 억제하여 단백뇨의 임상적으로 유의미한 감소와 신기능의 안정화를 보였으며, 이를 통해 보체 억제가 질환 수정 요법으로서 유효하다는 것이 입증되었습니다.

이와 동시에, 유효성, 편의성, 안전성 향상을 목표로 하는 차세대 보체 표적 치료제 덕분에 개발 파이프라인이 급속히 확대되고 있습니다. 이프타코판 등의 보체 인자 B 억제제는 현재 진행 중인 임상시험을 통해 평가되고 있으며, 경구 투여를 통한 장기적인 보체 조절 전략으로의 전환을 시사하고 있습니다. 또 다른 파이프라인 후보인 SGB-9768은 임상시험 단계에 있는 RNA 간섭(siRNA) 치료법입니다. 이 약제는 혈중 C3 농도를 낮춤으로써 IC-MPGN에 의한 신장 손상을 예방하고, 질환의 진행을 늦추는 것을 목표로 하고 있습니다.

전반적으로, 승인된 치료법의 출시와 해당 질환에 대한 인식 제고에 힘입어 2022년부터 2036년까지 주요 7개국 규모의 IC-MPGN 시장은 꾸준한 성장을 이룰 것으로 예상되며, 이는 시판 제품과 신약 파이프라인 모두에 큰 상업적 영향을 미칠 것으로 전망됩니다.

  • 주요 7개국 중 미국은 IC-MPGN 시장에서 가장 큰 시장 규모를 차지하고 있으며, 2025년에는 약 2,000만 달러에 달할 것으로 전망됩니다.
  • 이프타코판(LNP023)이나 SGB-9768과 같은 후기-중기 단계의 후보 약물이 시장에 진입함에 따라, 예측 기간 후반에 IC-MPGN 치료 분야에서의 경쟁이 격화될 것으로 예상됩니다.
  • EMPAVELI는 3,000 환자년 이상에 걸친 전신 페그세타코플란 노출 실적을 바탕으로 한 강력하고 일관된 안전성 프로파일을 통해 표준 치료의 수준을 지속적으로 높이고 있습니다.
  • 보체 인자 C 억제제 : 이미 승인된 치료제인 페그세타코플란은 C3를 통한 중추성 보체 활성화를 억제하고, 다운스트림 염증 경로를 억제함으로써 IC-MPGN에서 신장 손상을 억제하기 위한 기전에 기반한 종합적인 접근 방식을 제공합니다.
  • 보체 인자 B 억제제 : 이프타코판과 같은 새로운 치료법은 인자 B를 억제함으로써 대체 보체 경로를 표적으로 삼아 C3 컨버터제의 형성을 차단하고, IC-MPGN에서 보체에 의한 사구체 손상을 완화합니다.

보체 인자 C와 B는 IC-MPGN 치료 파이프라인 확장을 주도하는, 승인된 치료법과 신흥 치료법에서 핵심적인 혁신 동향을 정의하고 있습니다.

자주 묻는 질문

  • 면역복합체 막증식성 사구체신염(IC-MPGN)의 시장 규모는 어떻게 되나요?
  • IC-MPGN의 유병률은 어떻게 되나요?
  • IC-MPGN의 치료 현황은 어떤가요?
  • IC-MPGN의 진단 방법은 무엇인가요?
  • IC-MPGN의 주요 연구 흐름은 무엇인가요?
  • IC-MPGN의 치료에 사용되는 약물은 어떤 것들이 있나요?

목차

제1장 주요 인사이트

제2장 소개

제3장 주요 요약

제4장 주요 사건

제5장 면역복합체 막증식성 사구체신염(IC-MPGN) : 역학 및 시장 조사 방법

제6장 면역복합체 막증식성 사구체신염(IC-MPGN) : 시장 개요

제7장 면역복합체 막증식성 사구체신염(IC-MPGN) : 질환 배경과 개요

제8장 면역복합체 막증식성 사구체신염(IC-MPGN) : 역학 및 환자 인구

제9장 면역복합체 막증식성 사구체신염(IC-MPGN) : 환자 경과

제10장 시판 치료제

제11장 새로운 치료법

제12장 면역복합체 막증식성 사구체신염(IC-MPGN) : 주요 7개국 분석

제13장 면역복합체 막증식성 사구체신염(IC-MPGN) : 미충족 수요

제14장 면역복합체 막증식성 사구체신염(IC-MPGN) : SWOT 분석

제15장 면역복합체 막증식성 사구체신염(IC-MPGN) : KOL의 견해

제16장 면역복합체 막증식성 사구체신염(IC-MPGN) : 시장 진입 및 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight 소개

KSM 26.07.20

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Insights and Trends

  • According to DelveInsight's analysis, the IC-MPGN market size was found to be ~USD 30 million in the leading markets (the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan) in 2025.
  • Primary immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN) impose a significant, disruptive burden on patients and their caregivers.
  • According to the registry in the UK, the minimal point prevalence is 1.3/100,000 for MPGN UK-wide.
  • In 2025, there was a significant disparity in the frequency of IC-MPGN cases between children and adults in the US. Children accounted for only about 10% of the total IC-MPGN cases, while adults had a much higher prevalence, with approximately 3,400 cases reported.
  • IC-MPGN is classified as idiopathic only after an exhaustive evaluation fails to identify an underlying cause, with emerging evidence suggesting that a subset of cases may be driven by dysregulation and overactivation of the alternative complement pathway.
  • Diagnosis of IC-MPGN relies on a combination of histopathology, immunofluorescence, and clinical evaluation. Kidney biopsy remains the gold standard, enabling differentiation based on immune complex deposition and complement involvement.
  • Medications used to slow kidney damage in IC-MPGN include ACE inhibitors and ARBs, diuretics, corticosteroids and other immunosuppressive agents, as well as lipid-lowering therapies.
  • Treatment of IC-MPGN remains largely supportive, with no universally established disease-specific standard of care. Conventional management includes RAAS blockade and immunosuppressive agents in selected patients. Among targeted approaches, Apellis Pharmaceuticals (EMPAVELI) has emerged as a complement inhibitor with relevance to complement-driven renal diseases, representing a step toward mechanism-based therapy in IC-MPGN.
  • The IC-MPGN pipeline is increasingly focused on modulation of the alternative complement pathway. Key emerging companies include Novartis (iptacopan) and SanegeneBio (SGB-9768). These agents target upstream regulators of complement activation, aiming to provide more precise and sustained disease control.

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Market Size and Forecast in the 7MM

  • 2025 IC-MPGN Market Size: ~USD 30 million
  • IC-MPGN Growth Rate (2026-2036): 26% CAGR

DelveInsight's 'Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the IC-MPGN, historical and forecasted epidemiology, as well as the IC-MPGN market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates IC-MPGN 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 IC-MPGN 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 Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Market

Rising Prevalence & Underlying Conditions

The increasing prevalence is driven by certain long-term infections as chronic conditions (hepatitis C), autoimmune diseases (lupus nephritis), and monoclonal gammopathy (often in adults), which drive the need for treatment.

Lack of Approved Therapies

The absence of specific, FDA-approved drugs means the market is dominated by off-label treatments, including immunosuppressants, steroids, and renin-angiotensin-aldosterone system (RAAS) inhibitors. Hence, drives the organizations to develop new therapies.

Improved Diagnostics

Better diagnostic technologies and increased awareness among clinicians for distinguishing IC-MPGN from C3 Glomerulopathy (C3G) lead to earlier, more frequent diagnoses, boosting treated patient numbers.

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Understanding and Treatment Algorithm

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Overview and Diagnosis

Primary IC-MPGN is a rare, chronic kidney disorder. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. IC-MPGN can be primary (idiopathic) or secondary to underlying conditions such as infections, autoimmune diseases, or malignancies. Clinically, patients often present with proteinuria, hematuria, hypertension, and declining kidney function, and the disease may progressively lead to chronic kidney disease (CKD) or end-stage kidney failure if not adequately managed.

The diagnosis of IC-MPGN involves a combination of clinical evaluation, laboratory testing, and histopathological confirmation. Initial findings typically include proteinuria (often nephrotic range), microscopic hematuria, and reduced kidney function, along with possible low complement levels (especially C3 and C4). However, the gold standard for diagnosis is a kidney biopsy, which reveals characteristic features such as mesangial proliferation, thickened capillary walls, and immune complex deposits. Immunofluorescence microscopy demonstrates the presence of immunoglobulins (e.g., IgG) along with complement components, helping differentiate IC-MPGN from C3 glomerulopathy, where C3 deposition predominates. Approximately 50% of people living with C3G and primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring a burdensome kidney transplant or lifelong dialysis therapy.

Current Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treatment Landscape

Treatment of IC-MPGN focuses on controlling blood pressure, reducing proteinuria, and managing cholesterol through a combination of pharmacologic interventions, lifestyle modifications, and emerging complement-targeted therapies.

Medications commonly used to slow kidney damage include ACE inhibitors and ARBs to lower blood pressure and reduce protein loss; diuretics to manage fluid overload and edema; corticosteroids and other immunosuppressive agents to modulate immune-mediated glomerular injury; and statins to manage cholesterol and support cardiovascular protection.

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Unmet Needs

The section "unmet needs of Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)" 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. Limited approved therapies

2. Distinction from C3G and underlying causes

3. High risk of progression to kidney failure

4. Diagnostic delays, and others.....

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Epidemiology

Key Findings from IC-MPGN Epidemiological Analysis and Forecast

  • According to DelveInsight's estimates, in 2025, the total number of diagnosed prevalent cases of IC-MPGN in the 7MM were about 7,000.
  • In 2025, the US accounted for the highest number of diagnosed prevalent cases of IC-MPGN, with ~3,500 cases, followed by Japan.
  • According to DelveInsight's estimates, males represent more than 50% of the total IC-MPGN cases in the US in 2025.
  • The cases of IC-MPGN are more prevalent in adults than in pediatrics.
  • Although the incidence of idiopathic IC-MPGN remains unknown, the estimated global annual incidence of C3G ranges from 1 to 3 cases per million individuals. The risk of progression to kidney failure is substantial, with up to 30-35% of patients with C3G or idiopathic IC-MPGN developing kidney failure within 10 years of diagnosis.

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Drug Analysis & Competitive Landscape

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

Approved Therapies for Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

Pegcetacoplan (EMPAVELI): Biogen (Apellis pharmaceuticals)and Swedish Orphan Biovitrum AB

Pegcetacoplan (EMPAVELI), developed by Apellis Pharmaceuticals, is a targeted complement component 3 (C3) therapy designed to regulate excessive activation of the complement cascade, a part of the body's immune system. EMPAVELI is the first and only FDA-approved treatment for pediatric (12+ years) and adult patients. The VALIANT study was the largest single trial conducted in patients who were 12 years of age and older and the only study to include pediatric and adult patients, with native and post-transplant kidneys. In the study, EMPAVELI demonstrated a 68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits compared to placebo.

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Pipeline Analysis

Iptacopan (LNP023): Novartis

Iptacopan is an oral, first-in-class, small-molecule inhibitor of complement factor B. Iptacopan is currently in a Phase III (APPARENT) study for Idiopathic IC-MPGN. It is the most advanced asset in the Novartis nephrology pipeline and has the potential to become the first targeted therapy to delay progression to dialysis in C3G9. According to the company's February 2026 investor presentation, clinical trial data readout is anticipated in 2028..

SGB-9768: SanegeneBio

SGB-9768 is a GalNAc-conjugated experimental RNAi-based medicine designed to silence C3 mRNA in hepatocytes, thereby inhibiting complement activation, currently in Phase II clinical studies for the treatment of IC-MPGN. In a Phase I clinical trial, a single subcutaneous administration of SGB-9768 achieved dose-dependent, significant, and sustained reduction in serum C3 and inhibition of complement pathway activity, as well as a favorable safety and tolerability profile, demonstrating its best-in-class potential. Currently , the clinical trial is ongoing in China, and the company has global commercial rights.

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Key Players, Market Leaders and Emerging Companies

  • Biogen (Apellis pharmaceuticals)Swedish Orphan Biovitrum AB
  • SanegeneBio
  • Novartis

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Drug Updates

  • In March 2026, Biogen and Apellis Pharmaceuticals announced that the companies have entered into a definitive agreement under which Biogen has agreed to acquire Apellis.
  • In February 2026, SanegeneBio announced that SGB-9768 has received Orphan Drug Designation from the US FD for the treatment of IC-MPGN.
  • In July 2025, Apellis Pharmaceuticals announced that US FDA has approved EMPAVELI (pegcetacoplan) as the first treatment for primary IC-MPGN in patients 12 years of age and older, to reduce proteinuria. The approval of EMPAVELI is based on positive six-month results from Phase III (VALIANT) study.
  • In November 2025, SanegeneBio announced that the results from Phase I clinical studies of SGB-9768 were presented in a poster session at the American Society of Nephrology (ASN) Kidney Week 2025.
  • In December 2025, Apellis Pharmaceuticals announced that The New England Journal of Medicine (NEJM) published positive results from the Phase III (VALIANT) study investigating EMPAVELI.

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Market Outlook

The treatment landscape of IC-MPGN is undergoing a significant transition from long-standing reliance on supportive care and broad immunosuppression toward more mechanism-based and targeted therapeutic strategies. Historically, patients were managed with renin-angiotensin system blockers, diuretics, corticosteroids, and other immunosuppressive agents.

A major turning point in the field has been the approval of pegcetacoplan (EMPAVELI), the first targeted therapy for IC-MPGN, which inhibits C3 and has demonstrated clinically meaningful reductions in proteinuria along with stabilization of kidney function, thereby validating complement inhibition as a disease-modifying approach.

In parallel, the pipeline is expanding rapidly with next-generation complement-targeted agents that aim to improve efficacy, convenience, and safety. Complement factor B inhibitors such as iptacopan are being evaluated in advanced clinical trials and represent a shift toward oral, long-term complement control strategies. Another pipeline candidate, SGB-9768 is an investigational RNA interference (siRNA) therapy. By lowering circulating C3 levels, the drug aims to prevent IC-MPGN mediated kidney damage and slow disease progression.

Overall, the launch of approved therapies and rising disease awareness are expected to drive steady growth in the 7MM IC-MPGN market from 2022-2036, with strong commercial implications for both marketed products and emerging pipelines.

  • Among the 7MM, the US accounted for the largest market size of IC-MPGN. i.e., USD ~20 million in 2025.
  • The entry of late to mid-stage candidates such as iptacopan (LNP023) and SGB-9768 is expected to intensify competition in the IC-MPGN treatment landscape during the latter half of the forecast period.
  • EMPAVELI continues to elevate the standard of care, supported by a strong and consistent safety profile, with over 3,000 patient-years of systemic pegcetacoplan exposure.

Drug Class/Insights into Leading Emerging and Marketed Therapies in IC-MPGN (2022-2036 Forecast)

The IC-MPGN market comprises Complement factor C and B inhibitors, each targeting different aspects of IC-MPGN.

  • Complement factor C inhibitor: Approved therapy, Pegcetacoplan blocks central complement activation at C3, inhibiting downstream inflammatory pathways and offering a broad, mechanism-based approach to limit kidney damage in IC-MPGN.
  • Complement factor B inhibitor: Emerging therapy like Iptacopan targets the alternative complement pathway by inhibiting factor B, preventing C3 convertase formation and reducing complement-driven glomerular injury in IC-MPGN.

Complement factors C and B defines the core innovation landscape in approved and emerging therapies driving pipeline growth of IC-MPGN.

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) 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 IC-MPGN 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 IC-MPGN is expected to based on clinical positioning, mechanism of action, and stage of development. Recently introduced complement-targeted therapy, such as pegcetacoplan, is projected to see moderate uptake, driven by its mechanism-based approach targeting central complement activation and the high unmet need in complement-mediated renal diseases.

In contrast, pipeline agent such as iptacopan is expected to follow a gradual to moderate uptake trajectory, reflecting its investigational status and the time required to establish robust clinical efficacy and safety data. The oral administration and targeted inhibition of the alternative pathway may support broader adoption over time, particularly if strong outcomes are demonstrated.

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

Market Access and Reimbursement of Approved therapies in Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

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.

The United States

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.

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

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Therapies Price Scenario & Trends

Pricing and analogue assessment of IC-MPGN 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 Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

To keep up with IC-MPGN 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 IC-MPGN 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 IC-MPGN, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights at country level. Centers such as the Stanford University, University of Wurzburg, and Cardiovascular Prevention Institute, etc. were contacted.Their opinion helps understand and validate current and emerging IC-MPGN therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in IC-MPGN.

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 IC-MPGN, 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 IC-MPGN, 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 IC-MPGN 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 IC-MPGN market.

Report Insights

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

Report Assessment

  • Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Current Treatment Practices
  • Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Unmet Needs
  • Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Clinical Development Analysis
  • Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Emerging Drugs Product Profiles
  • Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Market attractiveness
  • Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Qualitative Analysis (SWOT and conjoint analysis)

FAQs:

Market Insights

  • What was the IC-MPGN 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 IC-MPGN?
  • What are the disease risks, burdens, and unmet needs of IC-MPGN? What will be the growth opportunities across the 7MM concerning the patient population with IC-MPGN?
  • 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 IC-MPGN? What are the current guidelines for treating IC-MPGN 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 IC-MPGN 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

4. Key Events

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

5. Epidemiology and Market Methodology of IC-MPGN

6. IC-MPGN Market Overview at a Glance

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

7. Disease Background And Overview of IC-MPGN

  • 7.1. Introduction
  • 7.2. Causes
  • 7.3. Signs And Symptoms
  • 7.4. Diagnosis
    • 7.4.1. Differential Diagnosis
    • 7.4.2. Diagnostic Algorithm
  • 7.5. Treatment and Management
    • 7.5.1. Treatment Algorithm

8. Epidemiology and Patient Population of IC-MPGN

  • 8.1. Key Findings
  • 8.2. Assumption and Rationale
  • 8.3. Total Incident Cases of IC-MPGN in the 7MM
  • 8.4. The United States
    • 8.4.1. Total Prevalent Cases of IC-MPGN in the United States
    • 8.4.2. Total Diagnosed Prevalent Cases of IC-MPGN in the United States
    • 8.4.3. Gender-specific Incident Cases of IC-MPGN in the United States
    • 8.4.4. Age-specific Incident Cases of IC-MPGN in the United States
  • 8.5. EU4 and the UK
    • 8.5.1. Total Prevalent Cases of IC-MPGN in EU4 and the UK
    • 8.5.2. Total Diagnosed Prevalent Cases of IC-MPGN in EU4 and the UK
    • 8.5.3. Gender-specific Incident Cases of IC-MPGN in EU4 and the UK
    • 8.5.4. Age-specific Incident Cases of IC-MPGN in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Total Prevalent Cases of IC-MPGN in Japan
    • 8.6.2. Total Diagnosed Prevalent Cases of IC-MPGN in Japan
    • 8.6.3. Gender-specific Incident Cases of IC-MPGN in Japan
    • 8.6.4. Age-specific Incident Cases of IC-MPGN in Japan

9. Patient Journey of IC-MPGN

10. Marketed Therapies

  • 10.1. Marketed Competitive Landscape of IC-MPGN
  • 10.2. Pegcetacoplan (EMPAVELI): Apellis pharmaceuticals and Swedish Orphan Biovitrum AB
    • 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. Analyst Views

11. Emerging Therapies

  • 11.1. Emerging Competitive Landscape of IC-MPGN
  • 11.2. Iptacopan (LNP023): Novartis
    • 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
  • 11.3. SGB-9768: SaneheneBio
    • 11.3.1. Product Description
    • 11.3.2. Clinical Development
      • 1.1.1.1. Clinical Trial Information
    • 11.3.3. Analyst Views

12. IC-MPGN: Seven Major Market Analysis

  • 12.1. Key Findings
  • 12.2. Market Outlook of IC-MPGN
  • 12.3. Conjoint Analysis of IC-MPGN
  • 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 IC-MPGN in the 7MM
  • 12.6. The United States
    • 12.6.1. Total Market Size of IC-MPGN in the United States
    • 12.6.2. Market Size of IC-MPGN by Therapies in the United States
  • 12.7. EU4 and the UK
    • 12.7.1. Total Market Size of IC-MPGN in EU4 and the UK
    • 12.7.2. Market Size of IC-MPGN by Therapies in EU4 and the UK
  • 12.8. Japan
    • 12.8.1. Total Market Size of IC-MPGN in Japan
    • 12.8.2. Market Size of IC-MPGN by Therapies in Japan

13. Unmet Needs of IC-MPGN

14. SWOT Analysis of IC-MPGN

15. KOL Views of IC-MPGN

  • 15.1. Expert/KOL Interview Highlights

16. Market Access and Reimbursement of IC-MPGN

  • 16.1. The US
  • 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 IC-MPGN Therapies

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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