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ANCA 관련 혈관염 : 시장 인사이트, 역학 및 시장 예측(2036년)

ANCA associated Vasculitis - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 232 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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ANCA 관련 혈관염에 대한 인사이트와 동향

  • DelveInsight의 분석에 따르면, 주요 지역인 미국, EU4(독일, 프랑스, 이탈리아, 스페인), 영국 및 일본의 항호중구 세포질 항체(ANCA) 시장은 2025년에 약 18억 달러로 추산되었습니다. 최근 분석에 따르면, 표적 치료의 도입 확대에 힘입어 이 수준을 상회하는 성장이 예상됩니다.
  • ANCA 관련 혈관염은 혈관에 염증을 일으키며 다양한 증상을 보이는 희귀 자가면역 질환군입니다. 여기에는 다발성 혈관염을 동반한 육아종증(GPA, 구칭: 베게너 육아종증), 호산구성 육아종증을 동반한 다발성 혈관염(EGPA, 구칭: 차그-스트라우스 증후군), 그리고 현미경적 다발성 혈관염(MPA)의 3가지 주요 질환이 포함됩니다.
  • ANCA 관련 혈관염의 치료는 관해 유도기와 관해 유지기로 나뉘며, 면역억제요법을 통해 지속적인 질환 관리를 목표로 하고 있지만, 재발은 여전히 빈번하게 발생합니다.
  • 관해 유도 요법에는 일반적으로 시클로포스파미드 또는 리툭시맙과 고용량 스테로이드를 병용하며, 관해 유지 요법에는 메토트렉세이트 또는 아자티오프린이 사용됩니다. 새로 승인된 치료제로는 TAVNEOS(아바코판)와 NUCALA(메폴리주맙) 등이 있습니다.
  • ANCA 관련 혈관염의 새로운 개발 파이프라인에는 데페모키맙(글락소스미스클라인), NS-229(NS 파마), FABHALTA(노바티스), 룩소풀바트(노벨메드) 등 유망한 후보 약물이 포함되어 있습니다.
  • ANCA 관련 혈관염의 현재 표준 치료법은 광범위한 면역억제를 수반하기 때문에 특히 감염 위험 증가나 중대한 이상반응 등 뚜렷한 안전성 문제가 있습니다. 이러한 증상은 주로 고용량의 글루코코르티코이드 사용과 관련이 있습니다.
  • ANCA 관련 혈관염의 3가지 유형 중 GPA는 MPA나 EGPA에 비해 유병률이 높아졌습니다.
  • ANCA 관련 혈관염의 정확한 진단이 지연될 경우, 심각한 합병증이나 사망률 증가로 이어질 수 있습니다. 이러한 점에서 조기 발견과 적시 진단을 가능하게 하는 신뢰도 높은 바이오마커의 필요성이 강조되고 있습니다.

G7 국가별 ANCA 관련 혈관염 시장 규모 및 전망

  • 2025년 ANCA 관련 혈관염 시장 규모 : 약 18억 달러
  • 2036년 ANCA 관련 혈관염 시장 규모 전망: 약 38억 달러
  • ANCA 관련 혈관염의 성장률(2026년-2036년) : 연평균 성장률(CAGR) 약 6.5%

본 ANCA 관련 혈관염 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. ANCA 관련 혈관염 환자의 부담 동향, 수익 및 시장 점유율 동향, 피크 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가함과 동시에, 전 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022년-2036년 예측)을 제시하고 있습니다. 본 보고서에서는 ANCA 관련 혈관염 분야의 주요 미충족 의료 수요에 초점을 맞추어, 경쟁 구도와 임상 현황을 분석함으로써 고부가가치의 성장 기회를 도출하고, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

ANCA 관련 혈관염 시장을 주도하는 주요 요인

ANCA 관련 혈관염 환자 수와 증가하는 질병 부담

인식 제고, 조기 진단 및 아형 분류 정확도의 향상으로 인해 주요 7개국 전체에서 AAV의 진단 유병률이 증가하고 있으며, 이것이 시장 성장을 뒷받침하고 있습니다. 치료 보급률이 높고 생물학적 제제에 대한 접근성이 용이하기 때문에 미국이 시장 점유율에서 선두를 달리고 있으며, EU4, 영국, 일본이 그 뒤를 잇고 있습니다.

ANCA 관련 혈관염 시장의 성장과 치료 현황

ANCA 관련 혈관염 시장은 바이오의약품 및 표적 치료법의 도입 확대에 힘입어 2036년까지 꾸준히 성장할 것으로 전망됩니다. 치료는 코르티코스테로이드, 면역억제제, 바이오의약품을 이용한 관해 유도 및 재발 예방을 중심으로 이루어지고 있으며, 릿룩시맙은 여전히 주요 치료법으로 자리 잡고 있습니다. 스테로이드 절약제 사용 증가와 장기적인 질환 관리의 필요성이 계속해서 시장 확대를 주도하고 있습니다.

ANCA 관련 혈관염의 새로운 치료법

이 새로운 치료법은 코르티코스테로이드의 사용량을 줄이고, 관해의 지속성을 높이며, 재발을 관리하는 것을 목적으로 합니다. 난치성 및 재발성 환자에게 더 안전하고 효과적인 치료 옵션을 제공하기 위해, 보체 억제제, B세포 표적 치료, 차세대 면역 조절 요법 등을 포함한 새로운 접근법이 개발되고 있습니다.

ANCA 관련 혈관염의 이해와 치료 알고리즘

ANCA 관련 혈관염 개요

ANCA 관련 혈관염은 소혈관의 염증 및 파괴를 특징으로 하는 생명을 위협하는 희귀 자가면역 질환으로, 심각한 장기 손상을 유발할 수 있습니다. 이 질환은 주로 신장, 폐, 상기도, 피부, 신경 및 기타 장기에 영향을 미칩니다. ANCA 관련 혈관염은 GPA, MPA, EGPA의 3가지 주요 아형으로 크게 분류되며, 각각 임상 증상과 침범된 장기가 다릅니다. 이 질환은 면역계가 건강한 혈관을 잘못 공격함으로써 발생하며, 염증, 혈류 감소, 조직 손상을 유발합니다. 치료를 받지 않고 방치할 경우, ANCA 관련 혈관염은 신부전, 폐출혈, 영구적인 장기 기능 장애 등 심각한 합병증을 유발할 수 있습니다.

ANCA 관련 혈관염의 진단

ANCA 관련 혈관염의 진단에는 임상 평가, 임상 검사, 영상 검사 및 조직 생검을 종합적으로 실시하여 질환의 아형을 확인하고, 장기의 병변을 평가합니다. 혈액 검사에서는 주요 진단 지표인 프로테아제-3(PR3-ANCA) 및 골수 과산화효소(MPO-ANCA)를 포함한 ANCA의 검출이 일반적으로 이루어집니다. 또한, 질환의 중증도를 평가하기 위해 염증 지표, 신기능 검사, 소변 검사 등의 추가 임상 검사가 실시되기도 합니다. CT 스캔, 흉부 X선, MRI 등의 영상 검사는 폐나 부비동으로의 전이를 확인하는 데 도움이 됩니다. 대부분의 경우, 신장, 폐, 피부 또는 기타 침범된 장기의 조직 생검은 혈관염을 확인하고 혈관 염증의 정도를 판단하기 위한 표준 검사법으로 자리 잡고 있습니다. 조기 진단은 적시에 치료를 시작하고, 돌이킬 수 없는 장기 손상을 예방하는 데 매우 중요합니다.

ANCA 관련 혈관염의 치료

ANCA 관련 혈관염(AAV)의 치료는 관해 유도, 재발 예방, 장기 손상의 최소화, 그리고 장기적인 치료에 따른 독성 경감에 중점을 둡니다. 치료법 선택은 질환의 아형(GPA, MPA 또는 EGPA), 장기 병변의 중증도 및 재발 이력에 따라 결정됩니다. 중증 환자나 새로 진단된 환자의 경우, 염증을 신속하게 억제하기 위해 일반적으로 고용량의 코르티코스테로이드가 사용되지만, 감염증, 골다공증, 대사 이상 등의 합병증으로 인해 장기간 사용에는 제한이 있습니다. 시클로포스파미드, 아자티오프린, 메토트렉세이트, 미코페놀산 모페틸 등의 면역억제제는 특히 장기적인 질환 관리가 필요한 환자의 경우, 관해 유도 및 유지 요법으로서 여전히 중요합니다.

표적 치료의 도입에 따라 치료의 전망은 변화해 왔습니다. 리툭시맙은 GPA 및 MPA 치료에 있어 여전히 중요한 생물학적 제제이며, 아바코판은 C5a 수용체를 억제함으로써 코르티코스테로이드 사용량을 줄이는 데 도움이 됩니다. EGPA의 경우, 메폴리주맙이 IL-5를 표적으로 삼음으로써 치료 옵션을 확대되고 있습니다.

데페모키마브(GSK3511294), NS-229, 이프타코판 등의 새로운 치료법은 장기 관해를 더욱 향상시키고, 더 안전한 스테로이드 감량 요법의 선택지를 제공할 것으로 기대됩니다. 전반적으로 시장은 표적 치료 및 재발 예방 치료로 전환되고 있습니다.

ANCA 관련 혈관염의 역학

ANCA 관련 혈관염의 역학 분석 및 예측에 관한 주요 조사 결과

  • DelveInsight의 추산에 따르면, 2025년 주요 7개국(주요 7개 시장)에서 ANCA 관련 혈관염으로 진단된 유병 사례 수는 약 22만 6,000건이며, 그중 미국이 가장 큰 비중을 차지하고 있습니다.
  • EU4 국가 중 2025년 기준 ANCA 관련 혈관염으로 진단받은 환자 수가 가장 많았던 곳은 독일이었고, 그 다음은 이탈리아였으며, 스페인은 가장 적었습니다.
  • 2025년, MPA에서 AAV의 항체 특이적 아형으로 가장 많이 진단된 것은 pANCA/MPO-ANCA였으며, 미국에서는 약 28,000건을 차지했습니다.
  • 2025년, 영국에서 장기별 MPA로 진단된 유병 사례 수는 신장 기능 장애가 가장 많았고, 그 다음으로 하기도, 피부 증상, 소화기계, 신경계, 상기도, 심혈관계, 안구 병변 등의 순이었습니다.
  • 미국에서는 다발성 혈관염을 동반한 육아종증이 다른 어떤 유형의 ANCA 관련 혈관염보다 유병률이 더 높은 것으로 밝혀졌습니다(약 35,000건).

ANCA 관련 혈관염 시장 전망

ANCA 관련 혈관염은 주로 신장, 폐 및 기타 주요 장기에 영향을 미치는 소혈관의 염증을 특징으로 하는 희귀 자가면역 질환입니다. 진단 능력의 향상, 질환에 대한 인식 제고, 그리고 표적 치료법의 활용 확대에 힘입어 시장은 꾸준한 성장을 이루고 있습니다. 질환 부담은 주로 육아종성 다발성 혈관염(GPA) 및 현미경적 다발성 혈관염(MPA)에 집중되어 있으며, 이들이 치료 대상 증례의 대부분을 차지하고 있습니다.

그동안 ANCA 관련 혈관염의 치료는 시클로포스파미드, 글루코코르티코이드, 아자티오프린, 메토트렉세이트, 미코페놀산 모페틸 등 광범위한 면역억제 요법에 의존해 왔습니다. 이러한 치료법은 관해 유도에는 효과적이지만, 심각한 장기적 독성, 감염 위험 및 높은 재발률을 동반합니다. 리툭시맙(RITUXAN/MabThera)의 도입으로, 관해 유도 요법과 유지 요법 모두에서 표적화된 B세포 제거 접근법이 가능해졌으며, 치료 양상은 크게 바뀌었습니다.

시장의 큰 전환점이 된 것은 암젠(Amgen, 당초 ChemoCentryx가 개발)의 아바코판(TAVNEOS) 승인이었습니다. 이 약물은 만성적인 스테로이드 사용에 대한 의존도를 줄여주는 동종 최초의 경구용 C5a 수용체 억제제입니다. 기존의 대량 코르티코스테로이드 요법과 비교했을 때, 스테로이드 사용량을 줄일 수 있는 특성과 안전성이 향상된 것으로 확인됨에 따라, 이 요법의 채택이 증가하는 추세입니다. 실제 임상 현장에서의 도입이 확대되고, 의사들 사이에서 인지도가 더욱 높아짐에 따라, 이 약물 시장 내 입지는 더욱 공고해질 것으로 예측됩니다.

개발 중인 파이프라인은 보체 억제, 정밀 면역학, 그리고 보다 안전한 장기 질환 관리 전략에 점점 더 중점을 두고 있습니다. 주요 신흥 치료법으로는 iptacopan(노바티스), ruxoprubart(NovelMed Therapeutics), tarperprumig(알렉시온/아스트라제네카), 그리고 NKX019(Nkarta사) 등의 세포 기반 면역요법이 있으며, 이들은 관해 지속 기간의 연장 및 재발률 감소를 목적으로 평가가 진행되고 있습니다. 이러한 새로운 치료법은 난치성 및 재발 환자의 치료 선택지를 넓힐 가능성이 있습니다.

치료법의 발전에도 불구하고, 시장은 여전히 진단 지연, 환자 수 부족, 생물학적 제제의 높은 비용, 재발 위험, 장기적인 모니터링의 필요성 등의 과제에 직면해 있습니다. 그러나 의사의 인식 제고, ANCA 진단 검사의 정확도 향상, 희귀질환에 대한 유리한 보험 급여, 그리고 새로운 표적 치료제의 출시 전망에 힘입어, 예측 기간 동안 시장은 완만한 성장을 이룰 것으로 예측됩니다. 전반적으로, ANCA 관련 혈관염 시장은 기존의 면역억제 요법에서 벗어나, 보다 표적화된, 스테로이드 사용을 최소화하는 그리고 개인 맞춤형 치료 방식으로 전환될 것으로 예측됩니다.

생물학적 제제 중에서는 리툭시맙(RITUXAN/MabThera) 등의 항-CD20 단일클론 항체가 ANCA 자가항체 생성에 관여하는 B세포를 감소시키기 때문에 관해 유도 및 유지를 위한 주요 시판 치료제로 자리 잡고 있습니다. 시클로포스파미드, 아자티오프린, 메토트렉세이트, 미코페놀산 모페틸 등의 기존 면역억제제는 특히 중증 환자나 유지요법 상황에서 계속해서 사용되고 있습니다.

큰 진전을 가져온 것은 보체 억제제이며, 그 선구자가 바로 아바코판(TAVNEOS)입니다. 이는 스테로이드 의존성을 감소시키는 최초의 경구용 C5a 수용체 억제제로, 널리 채택될 것으로 기대되고 있습니다.

개발 중인 파이프라인에는 이프타코판(노바티스), 비로베리맙(InflaRx), 룩소풀바트(NovelMed Therapeutics) 등의 차세대 보체 억제제 외에도, 장기 관해 달성 및 재발률 감소를 목표로 하는 정밀 면역학적 접근법에 점점 더 초점이 맞추어지고 있습니다. 이러한 치료법 덕분에 시장은 점차 더 정밀하고 안전한 치료 옵션으로 전환될 것으로 기대됩니다.

자주 묻는 질문

  • 2025년 ANCA 관련 혈관염 시장 규모는 어떻게 되나요?
  • 2036년 ANCA 관련 혈관염 시장 규모는 어떻게 예측되나요?
  • ANCA 관련 혈관염의 연평균 성장률(CAGR)은 어떻게 되나요?
  • ANCA 관련 혈관염의 주요 치료법은 무엇인가요?
  • ANCA 관련 혈관염의 주요 아형은 무엇인가요?
  • ANCA 관련 혈관염의 진단 방법은 무엇인가요?
  • ANCA 관련 혈관염의 치료에서 최근 승인된 약물은 무엇인가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 주요 요약

제4장 주요 이벤트

제5장 ANCA 관련 혈관염 : 역학 및 시장 예측 조사 방법

제6장 ANCA 관련 혈관염 : 시장 개요

제7장 ANCA 관련 혈관염 : 질환 배경과 개요

제8장 ANCA 관련 혈관염 : 역학 및 환자 인구

제9장 ANCA 관련 혈관염 : 환자 경과

제10장 시판 치료제

제11장 신흥 치료제

제12장 ANCA 관련 혈관염 : 주요 7개국 분석

제13장 ANCA 관련 혈관염 : 미충족 요구

제14장 ANCA 관련 혈관염 : SWOT 분석

제15장 ANCA 관련 혈관염 : KOL(Key Opinion Leader)의 견해

제16장 ANCA 관련 혈관염 : 시장 참여 및 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight에 대해

LSH 26.07.27

ANCA Vasculitis Insights and Trends

  • According to DelveInsight's analysis, the Anti-neutrophilic cytoplasmic antibody (ANCA) market across the major regions, the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan was estimated at approximately USD 1,800 million in 2025. Recent analyses suggest potential growth beyond this level, driven by increasing adoption of targeted therapies.
  • ANCA associated vasculitis are a group of rare autoimmune conditions causing blood vessel inflammation with diverse symptoms. They include three main diseases: granulomatosis with polyangiitis (GPA, formerly Wegener granulomatosis), eosinophilic granulomatosis with polyangiitis (EGPA, previously Churg-Strauss syndrome), and microscopic polyangiitis (MPA).
  • ANCA vasculitis treatment is divided into remission-induction and remission-maintenance phases, aiming for sustained disease control with immunosuppressive therapy, though relapses remain common.
  • Induction typically involves cyclophosphamide or rituximab with high-dose steroids, while maintenance uses methotrexate or azathioprine; newer approved options include TAVNEOS (avacopan) and NUCALA (mepolizumab).
  • The emerging pipeline for ANCA Vasculitis includes promising candidates such as depemokimab (GlaxoSmithKline), NS-229 (NS Pharma), FABHALTA (Novartis), Ruxoprubart (NovelMed), among others.
  • The current standard of care for ANCA vasculitis carries notable safety concerns due to broad immunosuppression, including higher infection risk and significant adverse events, largely linked to high-dose glucocorticoid use.
  • Among the three types of ANCA Vasculitis, GPA was more prevalent compared to MPA and EGPA.
  • Delays in accurately diagnosing ANCA vasculitis can lead to significant morbidity and higher mortality. This underscores the need for early detection and reliable biomarkers to enable timely diagnosis.

ANCA Vasculitis Market Size and Forecast in the 7MM

  • 2025 ANCA Vasculitis Market Size: ~USD ~1,800 million
  • 2036 Projected ANCA Vasculitis Market Size: ~USD ~3,800 million
  • ANCA Vasculitis Growth Rate (2026-2036): ~6.5% CAGR

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

The ANCA Vasculitis market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates ANCA Vasculitis 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 ANCA Vasculitis 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 ANCA Vasculitis Market

ANCA Vasculitis Patient Pool and Rising Disease Burden

The rising diagnosed prevalence of AAV across the 7MM, driven by improved awareness, earlier diagnosis, and better subtype classification, supports market growth. The US leads market share, followed by EU4, the UK, and Japan, due to higher treatment uptake and access to biologics.

ANCA Vasculitis Market Growth and Treatment Landscape

The ANCA vasculitis market is projected to grow steadily through 2036, driven by increasing adoption of biologics and targeted therapies. Treatment centers on remission induction and relapse prevention using corticosteroids, immunosuppressants, and biologics, with rituximab remaining a key therapy. Rising use of steroid-sparing agents and the need for long-term disease control continue to shape and drive market expansion.

ANCA Vasculitis Emerging Therapies

Emerging therapies aim to reduce corticosteroid use, enhance remission durability, and address relapse. Novel approaches, including complement inhibitors, B-cell targeted therapies, and next-generation immunomodulations, are being developed to offer safer and more effective options for refractory and relapsing patients.

ANCA Vasculitis Understanding and Treatment Algorithm

ANCA Vasculitis Overview

ANCA vasculitis is a rare, life-threatening autoimmune disease characterized by inflammation and destruction of small blood vessels, which can lead to significant organ damage. The disease primarily affects the kidneys, lungs, upper respiratory tract, skin, nerves, and other organs. ANCA vasculitis is broadly classified into three major subtypes: GPA, MPA, and EGPA, each differing in clinical presentation and organ involvement. The disease occurs when the immune system mistakenly attacks healthy blood vessels, leading to inflammation, reduced blood flow, and tissue damage. If left untreated, ANCA vasculitis can result in severe complications such as kidney failure, pulmonary hemorrhage, and permanent organ dysfunction.

ANCA Vasculitis Diagnosis

The diagnosis of ANCA vasculitis involves a combination of clinical evaluation, laboratory testing, imaging studies, and tissue biopsy to confirm disease subtype and assess organ involvement. Blood tests are commonly used to detect ANCA, including proteinase-3 (PR3-ANCA) and myeloperoxidase (MPO-ANCA), which are key diagnostic markers. Additional laboratory tests may include inflammatory markers, kidney function tests, and urinalysis to evaluate disease severity. Imaging techniques such as CT scans, chest X-rays, and MRI may help identify lung or sinus involvement. In many cases, a tissue biopsy of the kidney, lung, skin, or other affected organs remains the gold standard for confirming vasculitis and determining the extent of vascular inflammation. Early diagnosis is critical to initiating timely treatment and preventing irreversible organ damage.

ANCA Vasculitis Treatment

The treatment of ANCA-associated vasculitis (AAV) focuses on inducing remission, preventing relapse, minimizing organ damage, and reducing long-term treatment-related toxicities. Treatment selection depends on disease subtype (GPA, MPA, or EGPA), severity of organ involvement, and relapse history. In severe or newly diagnosed cases, high-dose corticosteroids are commonly used for rapid inflammation control, although long-term use is limited by complications such as infections, osteoporosis, and metabolic disorders. Immunosuppressive agents such as cyclophosphamide, azathioprine, methotrexate, and mycophenolate mofetil remain important for remission induction and maintenance therapy, particularly in patients requiring long-term disease control.

The treatment landscape has evolved with the adoption of targeted therapies. Rituximab remains a key biologic for GPA and MPA, while Avacopan helps reduce corticosteroid use through C5a receptor inhibition. In EGPA, Mepolizumab has expanded treatment options by targeting IL-5.

Emerging therapies such as Depemokimab (GSK3511294), NS-229, and Iptacopan are expected to further improve long-term remission and provide safer steroid-sparing treatment options. Overall, the market is shifting toward targeted and relapse-preventive therapies.

ANCA Vasculitis Unmet Needs

The section "unmet needs of ANCA Vasculitis" 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.

  • Heavy reliance on long-term corticosteroids and associated toxicities
  • High relapse rates despite current remission-inducing therapies
  • Lack of curative treatment options for ANCA vasculitis
  • Limited treatment options for refractory or relapsing patients
  • Limited biomarkers for early diagnosis, relapse prediction, and personalized treatment selection, and others....

Comprehensive unmet needs insights in ANCA Vasculitis and their strategic implications are provided in the full report.

ANCA Vasculitis Epidemiology

Key Findings from ANCA Vasculitis Epidemiological Analysis and Forecast

  • According to DelveInsight's estimates, there were approximately 226,000 diagnosed prevalent cases of ANCA vasculitis across the 7MM in 2025, with the United States accounting for the highest share.
  • Among EU4, Germany accounted for the largest number of diagnosed prevalent cases of ANCA Vasculitis, followed by Italy, whereas Spain accounted for the lowest cases in 2025.
  • In 2025, pANCAs/MPO-ANCAs represented the most commonly diagnosed antibody-specific subtype of AAV in MPA, accounting for approximately 28,000 cases in the US.
  • In 2025, the diagnosed prevalent cases of MPA by organ involvement in the UK were highest in renal impairment, followed by other organs such as the lower respiratory tract, cutaneous manifestations, gastrointestinal involvement, nervous system, upper respiratory tract, cardiovascular involvement, and eye involvement.
  • Granulomatosis with polyangiitis was found to be more prevalent than any other type of ANCA Vasculitis in the United States (~35,000).

ANCA Vasculitis Drug Chapters & Competitive Analysis

The ANCA Vasculitis drug chapter provides a detailed, market-focused review of approved therapies and 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 ANCA Vasculitis treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the ANCA Vasculitis therapeutics market.

Approved Therapies for ANCA Vasculitis

Mepolizumab (NUCALA): GlaxoSmithKline

NUCALA is a first-in-class monoclonal antibody targeting IL-5, blocking its interaction with receptors on eosinophils. In November 2021, the European Commission approved additional indications for NUCALA in eosinophil-driven diseases, including HES, EGPA, and chronic rhinosinusitis with nasal polyps, as an add-on therapy.

Avacopan (TAVNEOS): CSL/Amgen

TAVNEOS, developed by Amgen and CSL (outside the US), is a first-in-class, orally administered small molecule approved by the FDA as an adjunctive treatment for adults with severe active AAV, offering a highly targeted mechanism in complement-driven inflammation.

In August 2022, NICE recommended TAVNEOS in combination with rituximab or cyclophosphamide for adult patients with severe GPA or MPA following MHRA approval in May 2022. In March 2023, it was also included in the updated EULAR AAV management recommendations.

ANCA Vasculitis Pipeline Analysis

Depemokimab (GSK3511294): GlaxoSmithKline

Depemokimab is a humanized anti-IL-5 monoclonal antibody (IgG1, kappa) designed with an extended half-life and higher IL-5 affinity than approved anti-IL-5 therapies. It binds the same epitope as mepolizumab, with modifications intended to prolong duration of action without altering efficacy or safety, and has shown ~29-fold greater IL-5 potency in vitro.

It is currently in Phase III development, including the OCEAN study for EGPA, with top-line results expected in H2 2026 and potential European regulatory submissions in 2026.

NS-229: NS Pharma

NS-229 is a potent, selective JAK1 inhibitor developed in-house, designed to suppress the overactivation of T cells, B cells, and other white blood cells, thereby potentially reducing tissue damage and symptoms in EGPA.

It is currently being evaluated in a Phase II randomized, double-blind, placebo-controlled global study by Nippon Shinyaku and NS Pharma to assess its efficacy and safety. NS-229 received Orphan Drug Designation from the EC in January 2024 and the US FDA in April 2025, followed by FDA Fast Track Designation in September 2025.

ANCA Vasculitis Key Players, Market Leaders and Emerging Companies

  • GSK
  • CSL/Amgen
  • NS Pharma
  • Novartis
  • NovelMed, and others

ANCA Vasculitis Key Players Drug Updates

  • In March 2026, Amgen announced continued commercial expansion of avacopan (TAVNEOS) for ANCA-associated vasculitis following increasing global uptake as a steroid-sparing complement 5a receptor inhibitor. The company continues to generate real-world evidence supporting its role in reducing glucocorticoid-related toxicity in granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
  • In December 2025, Roche/Genentech highlighted ongoing long-term follow-up data for rituximab (RITUXAN/MabThera) in ANCA-associated vasculitis, reinforcing its continued use as a key therapy for remission induction and maintenance in GPA and MPA patients.
  • In October 2025, Chemocentryx (Amgen) presented additional real-world and long-term outcomes data for avacopan (TAVNEOS), demonstrating sustained remission benefits and reduced steroid exposure in patients with severe ANCA-associated vasculitis.
  • In June 2025, InflaRx announced continued development progress for vilobelimab (IFX-1), a monoclonal antibody targeting complement C5a, with ongoing interest in complement pathway inhibition as a potential future treatment strategy for ANCA-associated vasculitis.

Drug Class Insights

ANCA Vasculitis Market Outlook

ANCA vasculitis is a rare autoimmune disorder characterized by inflammation of small blood vessels, primarily affecting the kidneys, lungs, and other vital organs. The market is experiencing steady growth, fueled by better diagnostic capabilities, growing awareness of the disease, and the increasing use of targeted therapies. The disease burden is primarily concentrated in granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), which account for the majority of treated cases.

Historically, ANCA vasculitis treatment has relied on broad immunosuppressive regimens such as cyclophosphamide, glucocorticoids, azathioprine, methotrexate, and mycophenolate mofetil, which are effective in inducing remission but are associated with significant long-term toxicities, infection risks, and high relapse rates. The introduction of rituximab (RITUXAN/MabThera) significantly transformed the treatment landscape by offering a targeted B-cell depletion approach for both remission induction and maintenance therapy.

A major shift in the market occurred with the approval of avacopan (TAVNEOS) by Amgen (originally developed by ChemoCentryx), a first-in-class oral C5a receptor inhibitor that reduces dependence on chronic steroid use. Its adoption has been increasing due to its steroid-sparing profile and improved safety outcomes compared with traditional high-dose corticosteroid regimens. Ongoing real-world adoption and broader physician familiarity are expected to further strengthen its market position.

The emerging pipeline is increasingly focused on complement inhibition, precision immunology, and safer long-term disease control strategies. Key emerging therapies include iptacopan (Novartis), ruxoprubart (NovelMed Therapeutics), tarperprumig (Alexion/AstraZeneca), and cell-based immunotherapies such as NKX019 (Nkarta), which are being evaluated to improve remission durability and reduce relapse rates. These novel therapies could expand treatment options for refractory and relapsing patients.

Despite therapeutic advancements, the market continues to face challenges, including delayed diagnosis, small patient populations, high biologic costs, relapse risk, and long-term monitoring requirements. However, increasing physician awareness, improved ANCA diagnostic testing, favorable reimbursement for rare diseases, and the expected launch of novel targeted therapies are anticipated to drive gradual market growth over the forecast period. Overall, the ANCA vasculitis market is expected to shift from traditional immunosuppressive therapies toward more targeted, steroid-sparing, and personalized treatment approaches.

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

The ANCA vasculitis market is currently dominated by drug classes such as corticosteroids, anti-CD20 monoclonal antibodies, immunosuppressants, and complement inhibitors, with newer targeted therapies expected to reshape the market during the 2022-2036 forecast period.

Among biologics, anti-CD20 monoclonal antibodies such as rituximab (RITUXAN/MabThera) are key marketed therapies for remission induction and maintenance, as they deplete B cells responsible for ANCA autoantibody production. Traditional immunosuppressants, including cyclophosphamide, azathioprine, methotrexate, and mycophenolate mofetil, continue to be used, particularly in severe disease and maintenance settings.

A major advancement came with complement inhibitors, led by avacopan (TAVNEOS), a first-in-class oral C5a receptor inhibitor that reduces steroid dependence and is expected to witness strong uptake.

The emerging pipeline is increasingly focused on next-generation complement inhibitors, including iptacopan (Novartis), vilobelimab (InflaRx), and ruxoprubart (NovelMed Therapeutics), along with precision immunology approaches aimed at improving long-term remission and reducing relapse rates. These therapies are expected to gradually shift the market toward more targeted and safer treatment options.

ANCA Vasculitis 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 ANCA Vasculitis market's uptake by drugs, patient uptake by therapy, and sales of each drug.

The uptake of therapies in ANCA vasculitis is expected to vary across conventional immunosuppressants, biologics, complement inhibitors, and emerging targeted therapies over the forecast period. Traditional therapies such as cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, and corticosteroids are expected to maintain baseline uptake due to their long-standing use in remission induction and maintenance; however, their utilization may gradually decline due to long-term toxicity concerns and the growing preference for safer targeted therapies.

Among biologics, rituximab (RITUXAN/MabThera) is expected to continue witnessing strong uptake as it remains a cornerstone therapy for both remission induction and maintenance in granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Its strong physician familiarity, guideline support, and proven efficacy in reducing relapse rates will continue to support its market share.

A major shift in drug uptake is expected from avacopan (TAVNEOS), the first-in-class oral C5a receptor inhibitor, which is gaining increasing adoption due to its steroid-sparing benefits, improved renal outcomes, and favorable safety profile compared with prolonged glucocorticoid use. Its uptake is expected to expand steadily, particularly in patients with severe renal involvement and those at high risk of steroid-related adverse events.

Over the forecast period, next-generation complement inhibitors are expected to witness gradual uptake following potential approvals. Emerging therapies such as iptacopan (Novartis), vilobelimab (InflaRx), obinutuzumab, povetacicept, and other precision immunology approaches may gain traction in relapsed/refractory patients, although their adoption will depend on clinical trial success, regulatory approvals, pricing, and long-term safety outcomes.

Overall, the ANCA vasculitis market is expected to shift from broad immunosuppression toward targeted, steroid-sparing therapies, with complement inhibitors and next-generation B-cell-targeting therapies driving future market expansion.

ANCA Vasculitis Therapies Price Scenario & Trends

Pricing and analogue assessment of ANCA Vasculitis 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 the 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 ANCA Vasculitis

To keep up with the ANCA Vasculitis 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 ANCA Vasculitis 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 ANCA Vasculitis, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the University of Munich, Universite Centre Leon Berard, Aichi Medical University, etc., were contacted. Their opinion helps understand and validate current and emerging ANCA Vasculitis therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in ANCA Vasculitis.

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 ANCA Vasculitis, 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 mainly 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 ANCA Vasculitis, explaining its 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 ANCA Vasculitis 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 ANCA Vasculitis market.

Report Insights

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

Report Assessment

  • ANCA Vasculitis Current Treatment Practices
  • ANCA Vasculitis Unmet Needs
  • ANCA Vasculitis Clinical Development Analysis
  • ANCA Vasculitis Emerging Drugs Product Profiles
  • ANCA Vasculitis Market Attractiveness
  • ANCA Vasculitis Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the ANCA Vasculitis 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 ANCA Vasculitis?
  • What are the disease risks, burdens, and unmet needs of ANCA Vasculitis? What will be the growth opportunities across the 7MM concerning the patient population with ANCA Vasculitis?
  • 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 ANCA Vasculitis? What are the current guidelines for treating ANCA Vasculitis 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 ANCA Vasculitis 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 summarize and simplify 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 Transactions And Collaborations
  • 4.3. News Flow

5. Epidemiology and Market Forecast Methodology of ANCA Vasculitis

6. ANCA Vasculitis Market Overview at a Glance

  • 6.1. Clinical Landscape Analysis (By Phase, Molecule Type, and RoA)
  • 6.2. Market Share (%) Distribution of ANCA Vasculitis by Therapies in the 7MM, in 2025
  • 6.3. Market Share (%) Distribution of ANCA Vasculitis by Therapies in the 7MM, in 2036

7. Disease Background and Overview of ANCA Vasculitis

  • 7.1. Introduction
  • 7.2. Types
  • 7.3. Symptoms
  • 7.4. Causes
  • 7.5. Pathophysiology
  • 7.6. Diagnosis
  • 7.7. Treatment
    • 7.7.1. Treatment Guidelines

8. Epidemiology and Patient Population of ANCA Vasculitis

  • 8.1. Key Findings
  • 8.2. Assumptions and Rationale
  • 8.3. Total Diagnosed Prevalent Cases of ANCA Vasculitis in the 7MM
  • 8.4. The United States
    • 8.4.1. Total Diagnosed Prevalent Cases of ANCA Vasculitis in the United States
    • 8.4.2. Type-specific Diagnosed Prevalent Cases of ANCA Vasculitis in the United States
    • 8.4.3. Severity-specific Diagnosed Prevalence of ANCA Vasculitis in the United States
    • 8.4.4. Diagnosed Prevalent Cases of ANCA Vasculitis by Organ Involvement in the United States
    • 8.4.5. Diagnosed Prevalent Cases of ANCA Vasculitis by Antibody Type in the United States
    • 8.4.6. Total Treated Cases of ANCA Vasculitis by Type in the United States
  • 8.5. EU4 and the UK
    • 8.5.1. Total Diagnosed Prevalent Cases of ANCA Vasculitis in EU4 and the UK
    • 8.5.2. Type-specific Diagnosed Prevalent Cases of ANCA Vasculitis in EU4 and the UK
    • 8.5.3. Severity-specific Diagnosed Prevalence of ANCA Vasculitis in EU4 and the UK
    • 8.5.4. Diagnosed Prevalent Cases of ANCA Vasculitis by Organ Involvement in EU4 and the UK
    • 8.5.5. Diagnosed Prevalent Cases of ANCA Vasculitis by Antibody Type in EU4 and the UK
    • 8.5.6. Total Treated Cases of ANCA Vasculitis by Type in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Total Diagnosed Prevalent Cases of ANCA Vasculitis in Japan
    • 8.6.2. Type-specific Diagnosed Prevalent Cases of ANCA Vasculitis in Japan
    • 8.6.3. Severity-specific Diagnosed Prevalence of ANCA Vasculitis in Japan
    • 8.6.4. Diagnosed Prevalent Cases of ANCA Vasculitis by Organ Involvement in Japan
    • 8.6.5. Diagnosed Prevalent Cases of ANCA Vasculitis by Antibody Type in Japan
    • 8.6.6. Total Treated Cases of ANCA Vasculitis by Type in Japan

9. Patient Journey of ANCA Vasculitis

10. Marketed Therapies

  • 10.1. Marketed Competitive Landscape of ANCA Vasculitis
  • 10.2. Mepolizumab (NUCALA): GlaxoSmithKline
    • 10.2.1. Drug 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 Trial Information
    • 10.2.6. Analyst Views
  • 10.3. Avacopan (TAVNEOS): CSL/Amgen
    • 10.3.1. Drug 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 Trial Information
    • 10.3.6. Analyst Views

11. Emerging Drugs

  • 11.1. Emerging Competitive Landscape of ANCA Vasculitis
  • 11.2. Depemokimab (GSK3511294): GlaxoSmithKline
    • 11.2.1. Drug Description
    • 11.2.2. Other Developmental Activity
    • 11.2.3. Clinical Development
      • 11.2.3.1. Clinical Trials Information
    • 11.2.4. Analyst Views
  • 11.3. NS-229: NS Pharma
    • 11.3.1. Drug Description
    • 11.3.2. Other Developmental Activity
    • 11.3.3. Clinical Development
    • 11.3.4. Clinical Trials Information
    • 11.3.5. Analyst Views

12. ANCA Vasculitis: 7MM Analysis

  • 12.1. Key Findings
  • 12.2. Market Outlook of ANCA Vasculitis
  • 12.3. Key Market Forecast Assumptions
    • 12.3.1. Cost Assumptions
    • 12.3.2. Pricing Trends
    • 12.3.3. Analogue Assessment
    • 12.3.4. Launch Year and Therapy Uptakes
  • 12.4. Conjoint Analysis of ANCA Vasculitis
  • 12.5. Total Market Size of ANCA Vasculitis in the 7MM
  • 12.6. Total Market Size of ANCA Vasculitis by Therapies in the 7MM
  • 12.7. The United States
    • 12.7.1. Total Market Size of ANCA Vasculitis in the United States
    • 12.7.2. Total Market Size of ANCA Vasculitis by Therapies in the United States
  • 12.8. EU4 and the UK
    • 12.8.1. Total Market Size of ANCA Vasculitis in EU4 and the UK
    • 12.8.2. Total Market Size of ANCA Vasculitis by Therapies in EU4 and the UK
  • 12.9. Japan
    • 12.9.1. Total Market Size of ANCA Vasculitis in Japan
    • 12.9.2. Total Market Size of ANCA Vasculitis by Therapies in Japan

13. Unmet Needs of ANCA Vasculitis

14. SWOT Analysis of ANCA Vasculitis

15. KOL Views of ANCA Vasculitis

16. Market Access and Reimbursement of ANCA Vasculitis

  • 16.1. The United States
  • 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 ANCA Vasculitis Therapies

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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