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국소 분절성 사구체 경화증(FSGS) : 시장 인사이트, 역학 및 시장 예측(2036년)

Focal Segmental Glomerulosclerosis - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 184 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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국소 분절성 사구체 경화증(FSGS)에 대한 인사이트와 동향

  • FSGS는 사구체의 일부에 흉터(경화)가 생겨, 그 결과 소변으로 단백질이 현저하게 누출되는 것을 특징으로 하는 희귀 신장 질환입니다.
  • 치료 결과는 질환의 아형(원발성, 이차성, 유전성), 스테로이드에 대한 반응성, 그리고 근본적인 포도세포 손상의 기전에 따라 크게 달라지며, 이로 인해 치료법 선택과 장기적인 질환 관리가 어려워지고 있습니다.
  • 스테로이드 저항성 및 스테로이드 의존성 FSGS는 상업적·임상적으로 가장 큰 과제를 안고 있는 분야이며, 말기 신장 질환(ESKD)으로의 진행 및 의료비의 과반수를 차지하고 있습니다.
  • 검증된 비침습적 바이오마커가 부족하기 때문에 조기 발견 및 환자 분류에 제약이 따르고 있습니다. 따라서 진단은 신장 생검에 크게 의존하고 있습니다.
  • FSGS와 같은 신증후군의 경우, 일반적으로 면역억제 요법이 사용됩니다. 그러나 재발 관리와 글루코코르티코이드 의존성에 대한 대처는 여전히 과제로 남아 있습니다. B세포 제거 요법인 렙티맙은 잠재적인 해결책으로 여겨지고 있으나, 성인 환자에서의 유효성, 특히 초기 치료 성공 후의 관해 회복에 관한 근거는 여전히 제한적입니다. 환자에 대한 개별화된 재발 기반 접근법의 이점은 아직 완전히 밝혀지지 않았습니다.
  • 스파르센타(FILSPARI)는 FSGS 시장에서 스테로이드 및 면역억제제로부터의 패러다임 전환을 주도하고 있으며, DMX-200 등 주요 파이프라인 자산에서 단백뇨 감소가 주요 유효성 평가 지표로 부상하고 있습니다.
  • FSGS의 새로운 치료 환경에 관여하고 있는 주요 기업으로는 Dimerix, Boehringer Ingelheim, Akebia Therapeutics 등이 있습니다.
  • FSGS의 주요 미충족 의료 수요는 질환 진행 억제 요법의 선택지가 제한적이고 치료 저항성이 높다는 점에 기인하며, 많은 환자가 치료를 받더라도 만성 신장 질환으로 진행되고 있습니다. 이러한 점에서 단백뇨를 지속적으로 감소시키고 신장 기능을 유지할 수 있는 표적 치료제의 필요성이 부각되고 있습니다.

본 FSGS 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. 또한, FSGS 환자의 부담 추이, 매출액 및 시장 점유율 추이, 피크 시점의 환자 점유율 및 치료 도입률 분석을 평가하는 한편, 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022년-2036년 예측)을 제시하고 있습니다. 본 보고서에서는 FSGS와 관련된 주요 미충족 요구 사항을 부각시키고, 경쟁 구도 및 임상 현황을 분석하여 고부가가치의 성장 기회를 도출하는 한편, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

군집성 국소 분절 사구체 경화증(FSGS) 시장을 주도하는 주요 요인

질병 유병률 증가와 신장 질환의 부담 확대

가장 강력한 성장 요인 중 하나는 FSGS가 주요 아형 중 하나인 만성 신장 질환(CKD)의 전 세계 유병률 증가입니다. 당뇨병, 고혈압, 비만 증가 및 고령화의 진행이 FSGS 환자 수 증가에 직접적인 영향을 미치고 있습니다.

높은 미충족 수요가 혁신을 주도합니다.

FSGS는 여전히 희귀질환이며, 승인된 치료법도 제한적이기 때문에 큰 시장 기회가 생겨나는 한편, APOL1 억제제, 엔도세린 수용체 길항제, 생물학적 제제, TRPC 억제제, 이중 수용체 길항제 등 신규하고 표적화된 치료법의 개발이 가속화되고 있으며, 이러한 치료법들이 종합적으로 치료의 양상을 변화시키고 있습니다.

군집성 국소 분절 사구체 경화증(FSGS)의 이해와 치료 알고리즘

포진성 사구체 경화증(FSGS) 개요

FSGS는 신장의 여과 단위인 사구체 중 일부(국소성) 사구체의 특정 부분(분절)에 흉터(경화)가 생기는 것을 특징으로 하는 드물지만 중증의 신장 질환입니다. 원발성(특발성) 또는 이차성으로 분류되며, 이차성의 경우 비만, 바이러스 감염, 유전적 변이 등의 병태와 관련이 있습니다. FSGS에서는 종종 단백뇨(소변 내 과도한 단백질)가 나타나며, 치료를 받지 않으면 신증후군으로 진행되어 결국 만성 신장 질환이나 말기 신부전으로 이어질 수 있습니다. 당뇨병이나 고혈압 등의 위험 요인의 유병률이 증가함에 따라 전 세계적으로 이 질환으로 인한 부담이 커지고 있으며, 신장학 분야에서 이에 대한 우려가 점점 더 커지고 있습니다.

포진성 사구체 경화증(FSGS)의 진단

FSGS의 진단은 일반적으로 임상 평가, 검사 소견 및 확정 진단을 위한 검사를 종합하여 이루어집니다. 초기 증상으로는 지속적인 단백뇨, 부종, 신기능 저하 등이 있으며, 이러한 증상들은 소변 검사나 크레아티닌 및 알부민 수치를 측정하는 혈액 검사를 통해 확인됩니다. 그러나 확정 진단을 위해서는 신장 생검이 필요하며, 조직학적 검사를 통해 사구체의 분절성 섬유화가 확인됩니다. 유전자 검사 및 바이오마커 확인을 포함한 진단 기법의 발전으로 인해, 원발성과 이차성 병형을 구별하는 능력이 향상되고 있으며, 이는 최적의 치료 전략을 선택하는 데 있어 매우 중요합니다.

현재의 둥지형 국소 분절 사구체 경화증(FSGS) 치료 현황

FSGS의 치료는 단백뇨 감소, 질환 진행 지연, 그리고 신기능 유지를 목적으로 합니다. 기존의 치료법에는 코르티코스테로이드, 면역억제제, 그리고 혈압과 단백뇨를 조절하기 위한 ACE 억제제 및 안지오텐신 수용체 차단제 등의 지지 요법이 포함됩니다. 최근에는 FSGS 치료제로서 최초로 FDA 승인을 받은 약물인 스파센탄의 승인으로 인해 치료 현황이 변화했습니다. 이 엔도세린 및 안지오텐신 II 수용체 길항제(DEARA)는 단백뇨를 완화하는 데 도움이 되며, 그동안 적응증 외 사용이 주를 이루던 분야에서 획기적인 진전을 이루고 있습니다. 스파센탄은 현재 이 질환에 대해 승인된 유일한 표적 치료제로, 질환 특이적이고 정밀 의학에 기반한 치료 접근 방식으로의 전환을 상징합니다.

군집성 국소 분절 사구체 경화증(FSGS)의 역학

FSGS의 역학 분석 및 예측에 관한 주요 조사 결과

  • 분석에 따르면, 2025년 기준 주요 7개국에서 FSGS로 진단받은 환자 수는 약 21만 3,000명이며, 2036년까지 증가할 것으로 예측됩니다.
  • FSGS로 진단받은 환자 수는 미국이 가장 많으며, 2025년 주요 7개국 전체 환자 수의 약 36%를 차지하고 있습니다.
  • EU4 국가 및 영국 중에서 2025년 기준 FSGS 진단을 받은 환자 수는 영국이 가장 많았고, 그 다음으로 독일이 뒤를 이었습니다.
  • FSGS의 유병률은 18-64세 연령대에서 가장 높게 나타났습니다.
  • 2025년, FSGS의 두 가지 형태 중 원발성 FSGS가 더 많이 관찰되었으며, 미국 내 진단받은 환자 수의 약 80%를 차지했습니다.
  • DelveInsight의 추산에 따르면, 일본에서 FSGS로 진단받은 환자 수를 기준으로 볼 때 남성(61%)이 여성(39%)보다 더 많은 것으로 나타났습니다.

둥지형 국소 분절 사구체 경화증(FSGS) 시장 전망

FSGS의 치료는 지금까지 레닌-안지오텐신-알도스테론계(RAAS) 차단이나 코르티코스테로이드 등의 대증요법에 의존해 왔습니다. FILSPARI의 승인으로 큰 진전이 있었습니다. 이 약물은 DEARA 길항제로, 단백뇨를 줄이고 질환의 진행을 늦추도록 고안되었습니다. 이는 FSGS에 특화되어 승인된 최초의 표적 치료이자 비면역억제 요법으로, 기전에 기반한 치료 접근 방식으로의 전환을 상징합니다.

FSGS 치료 분야는 확대되고 있으며, 새로운 경로를 표적으로 하는 유망한 임상시험용 약물이 몇 가지 있습니다. DMX-200은 CCR2 길항제로, 신장 손상의 주요 원인인 단핵구의 동원을 억제함으로써 신장 염증 및 섬유화를 완화하는 것을 목적으로 합니다. BI-764198(아페코트렙)은 포도세포 기능 장애 및 단백뇨와 관련이 있는 것으로 알려진 TRPC5 이온 채널을 표적으로 하며, 신장 여과 장벽의 무결성을 유지하는 데 중점을 둔 새로운 작용기전을 제공합니다. 또 다른 후보인 프랄리시구아트는 sGC 자극제로 작용하여, 일산화질소 경로의 조절을 통해 신장 혈역학을 개선하고 섬유화를 완화할 가능성이 있습니다.

전반적으로, 새로운 치료법의 등장, 진단 기술의 발전, 그리고 FSGS에 대한 인식 제고에 힘입어 2022년부터 2036년에 걸쳐 주요 7개국 전체에서 꾸준한 시장 성장이 예상되며, 이는 기존 제품 및 파이프라인 후보들에게 큰 상업적 기회를 가져다줄 것으로 전망됩니다.

  • 추산에 따르면, 2025년 주요 7개국(G7)의 FSGS 시장 총 규모는 약 3억 달러이며, 미국이 가장 큰 점유율을 차지하고 있으며, 이 시장은 2036년까지 높은 연평균 성장률(CAGR)을 기록하며 성장할 것으로 전망됩니다.
  • 2025년, EU4 및 영국 중에서 영국이 가장 높은 시장 점유율을 차지했고, 그 다음으로 독일이 뒤를 이었으며, 이탈리아는 점유율이 가장 낮았습니다.
  • 저분자 화합물: 현재 FSGS 파이프라인에는 서로 다르지만 상호 보완적인 질환 경로에 작용하도록 설계된 여러 저분자 화합물 후보가 포함되어 있습니다. 스파르센타(FILSPARI)는 혈역학적 조절을 통해 단백뇨를 감소시키고 사구체 구조를 보호하는 DEARA입니다. DMX-200은 대식세포의 동원을 억제함으로써 염증 및 섬유화 경로를 표적으로 하는 CCR2 억제제입니다. BI 764198은 TRPC5 채널 억제제로, 포도세포의 구조와 기능을 안정화시켜 단백질 누출의 주요 원인을 해결합니다.

FSGS 분야의 혁신은 단일한 지배적 기전에 의해 주도되는 것이 아니라, 포도세포 손상, 염증, 섬유화 및 사구체의 혈역학을 표적으로 하는 저분자 치료제의 융합을 통해 추진되고 있으며, 이러한 요소들이 결합되어 파이프라인의 확장을 이끌고, 질병 수정 치료 전략을 발전시키고 있습니다.

자주 묻는 질문

  • 국소 분절성 사구체 경화증(FSGS)의 주요 특징은 무엇인가요?
  • FSGS의 치료 결과는 어떤 요인에 따라 달라지나요?
  • FSGS의 조기 발견에 어려움이 있는 이유는 무엇인가요?
  • FSGS 시장에서 스파르센타(FILSPARI)의 역할은 무엇인가요?
  • FSGS의 유병률은 어떤 요인에 의해 증가하고 있나요?
  • FSGS 시장의 규모는 어떻게 예측되나요?
  • FSGS 치료에 참여하고 있는 주요 기업은 어디인가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 주요 요약

제4장 주요 이벤트

제5장 국소 분절성 사구체 경화증(FSGS) : 역학 및 시장 조사 방법

제6장 국소 분절성 사구체 경화증(FSGS) : 시장 개요

제7장 국소 분절성 사구체 경화증(FSGS) : 질환 배경과 개요

제8장 국소 분절성 사구체 경화증(FSGS) : 역학 및 환자 인구

제9장 국소 분절성 사구체 경화증(FSGS) : 환자 경과

제10장 시판 치료제

제11장 신흥 치료법

제12장 국소 분절성 사구체 경화증(FSGS) : 주요 7개국 분석

제13장 국소 분절성 사구체 경화증(FSGS) : 미충족 요구

제14장 국소 분절성 사구체 경화증(FSGS) : SWOT 분석

제15장 국소 분절성 사구체 경화증(FSGS) : KOL(Key Opinion Leader)의 견해

제16장 FSGS 시장 동향 및 국소 국소 분절 사구체 경화증(FSGS) 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight에 대해

LSH 26.07.27

Focal Segmental Glomerulosclerosis (FSGS) Insights and Trends

  • FSGS is a rare kidney disorder characterized by scarring (sclerosis) of parts of the glomeruli, leading to significant protein loss in urine.
  • Treatment outcomes are highly heterogeneous, driven by disease subtype (primary, secondary, genetic), steroid responsiveness, and underlying podocyte injury mechanisms, complicating therapy selection and long-term disease control.
  • Steroid-resistant and steroid-dependent FSGS represent the most commercially and clinically challenging segments, accounting for a disproportionate share of progression to end-stage kidney disease (ESKD) and healthcare costs.
  • Lack of validated non-invasive biomarkers limits early detection and patient stratification. Hence, the diagnosis relies heavily on a kidney biopsy.
  • In nephrotic syndromes like FSGS, immunosuppressive therapies are commonly used. However, managing relapses or dependency on glucocorticoids poses ongoing challenges. Rituximab, a B-cell-depleting approach, is considered a potential solution, but evidence for its efficacy in adults remains limited, especially in restoring remission after initial treatment success. The benefits of personalized, relapse-based approaches for patients are yet to be fully understood.
  • Sparsentan (FILSPARI) is driving a paradigm shift away from steroids and immunosuppressant's in the FSGS market, with proteinuria reduction emerging as the primary efficacy endpoint across key pipeline assets such as DMX-200.
  • Key Companies involved in the emerging treatment landscape of FSGS are Dimerix, Boehringer Ingelheim, Akebia Therapeutics, and others.
  • Major unmet need in FSGS stems from limited disease-modifying options and high treatment resistance, with many patients progressing to chronic kidney disease despite therapy, highlighting the need for targeted agents that can sustainably reduce proteinuria and preserve renal function.

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

The FSGS market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates FSGS 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 FSGS 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 Focal Segmental Glomerulosclerosis (FSGS) Market

Rising Disease Prevalence and Kidney Disorder Burden

One of the strongest growth drivers is the increasing global incidence of chronic kidney diseases (CKD), with FSGS being a significant subtype. Growth in diabetes, hypertension, obesity, and aging populations is directly contributing to higher FSGS cases.

High Unmet Need Driving Innovation

FSGS remains a rare condition with limited approved therapies, creating strong market opportunity while accelerating the development of novel and targeted treatments-including APOL1 inhibitors, endothelin receptor antagonists, biologics, TRPC inhibitors, and dual receptor antagonists-which are collectively reshaping the treatment landscape.

Focal Segmental Glomerulosclerosis (FSGS) Understanding and Treatment Algorithm

Focal Segmental Glomerulosclerosis (FSGS) Overview

FSGS is a rare but serious kidney disorder characterized by scarring (sclerosis) in parts (segments) of some (focal) glomeruli-the filtering units of the kidney. It can be classified as primary (idiopathic) or secondary, with secondary forms linked to conditions such as obesity, viral infections, or genetic mutations. FSGS often presents with proteinuria (excess protein in urine), which can progress to nephrotic syndrome and eventually chronic kidney disease or end-stage renal disease if untreated. The disease burden is increasing globally due to rising rates of risk factors like diabetes and hypertension, making it a growing concern in nephrology.

Focal Segmental Glomerulosclerosis (FSGS) Diagnosis

Diagnosis of FSGS typically involves a combination of clinical evaluation, laboratory testing, and confirmatory procedures. Initial signs include persistent proteinuria, edema, and reduced kidney function, detected through urine analysis and blood tests measuring creatinine and albumin levels. However, a definitive diagnosis requires a kidney biopsy, where histological examination reveals segmental scarring of glomeruli. Advances in diagnostic approaches, including genetic testing and biomarker identification, are improving the ability to differentiate between primary and secondary forms of the disease, which is critical for selecting the most appropriate treatment strategy.

Current Focal Segmental Glomerulosclerosis (FSGS) Treatment Landscape

Treatment of FSGS aims to reduce proteinuria, slow disease progression, and preserve kidney function. Traditional management includes corticosteroids, immunosuppressive agents, and supportive therapies such as ACE inhibitors or angiotensin receptor blockers to control blood pressure and protein leakage. Recently, the therapeutic landscape has evolved with the approval of sparsentan, the first FDA-approved drug specifically indicated for FSGS. This dual endothelin and angiotensin II receptor antagonist (DEARA) helps reduce proteinuria and represents a breakthrough in a field previously dominated by off-label treatments. Sparsentan is currently the only approved targeted therapy for this condition, marking a shift toward disease-specific and precision-based treatment approaches.

Focal Segmental Glomerulosclerosis (FSGS) Unmet Needs

The section "unmet needs of FSGS" 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 Disease-Specific Therapies

2. Incomplete Understanding of Disease Pathophysiology

3. High Relapse and Progression Rates and Others..

Focal Segmental Glomerulosclerosis (FSGS) Epidemiology

Key Findings from FSGS Epidemiological Analysis and Forecast

  • According to analysis, in 2025, the total diagnosed prevalent cases of FSGS in the 7MM were approximately 213,000 and are expected to increase through 2036.
  • The United States accounted for the highest diagnosed prevalent cases of FSGS, representing approximately 36% of total cases in the 7MM in 2025.
  • Among the EU4 and the UK, the UK accounted for the highest diagnosed prevalent cases of FSGS in 2025, followed by Germany.
  • The prevalence of FSGS was the highest in individuals aged 18-64.
  • In 2025, primary FSGS was found to be the more prevalent type among the two forms of FSGS, accounting for approximately 80% of the diagnosed population in the United States.
  • DelveInsight estimates that Japan has more diagnosed prevalent cases of FSGS in males (61%) than females (39%).

Focal Segmental Glomerulosclerosis (FSGS) Drug Analysis & Competitive Landscape

The FSGS drug chapter provides a detailed, market-focused review of the emerging pipeline across Phase I-III clinical trials and preclinical 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 FSGS treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the FSGS therapeutics market.

Approved Therapies for Focal Segmental Glomerulosclerosis (FSGS)

Sparsentan (FILSPARI): Travere Therapeutics and Ligand Pharmaceuticals

FILSPARI is the first and only medicine approved by the FDA for the treatment of FSGS. FILSPARI is a (Dual Endothelin Angiotensin Receptor Antagonist) DEARA. It has been granted Orphan Drug Designation (ODD) for the treatment of FSGS in the US and Europe. The US FDA approval was based on the Phase III (DUPLEX) study, which had a significant 46% reduction in proteinuria. In February 2012, Ligand Pharmaceuticals granted Travere Therapeutics a worldwide sublicense to develop, manufacture, and commercialize FILSPARI. Under the agreement, Ligand retained the right to receive approximately 9% royalty on worldwide net sales of the product. In September 2021, Travere Therapeutics and Vifor Pharma announced that they had entered into a collaboration and licensing agreement for the commercialization of FILSPARI in Europe, Australia, and New Zealand.

Focal Segmental Glomerulosclerosis (FSGS) Pipeline Analysis

DMX-200: Dimerix and Amicus Therapeutics

DMX-200 (QYTOVRA in some territories) is a chemokine receptor (CCR2) blocker and is administered to patients taking an angiotensin II type I (AT1) receptor blocker (ARB), which is the standard of care treatment for kidney disease. DMX-200 has been granted patents in various territories until 2032, with patent applications in that may extend this to 2042 if granted. DMX-200 for FSGS is currently in a Phase III clinical trial and has been granted ODD by the FDA and EMA. It has also received ODD in Japan.

BI-764198 (apecotrep): Boehringer Ingelheim

BI-764198 is a potential first-in-class, oral drug being investigated as a novel, targeted, non-immunosuppressive therapy in people with primary FSGS. The drug works by selectively inhibiting TRPC6, a calcium channel found in kidney podocytes that plays a key role in maintaining the filtration barrier. In clinical studies, the drug has shown promising results, including a notable reduction in proteinuria in Phase II trials, while generally demonstrating good tolerability with mild side effects such as headache or diarrhea. It is currently being evaluated in larger Phase III trials to confirm its long-term safety and effectiveness. BI-764198 was granted ODD by the EMA and the Japanese Ministry for Health, Labour and Welfare (MHLW). The Phase II results were published in The Lancet and presented at the 2025 American Society of Nephrology (ASN)'s Kidney Week.

Focal Segmental Glomerulosclerosis (FSGS) Key Players, Market Leaders, and Emerging Companies

  • Travere Therapeutics
  • Ligand Pharmaceuticals
  • Dimerix
  • Amicus Therapeutics
  • Boehringer Ingelheim
  • Akebia Therapeutics
  • Apellis Pharmaceuticals
  • Novartis Pharmaceuticals, and others

Focal Segmental Glomerulosclerosis (FSGS) Drug Updates

  • In April 2026, Travere Therapeutics announced that the US FDA had approved FILSPARI to reduce proteinuria in adult and pediatric patients aged 8 years and older with FSGS without nephrotic syndrome.
  • In April 2026, Dimerix and Amicus Therapeutics announced that the two companies had entered into an exclusive license agreement for the commercialization of drug candidate DMX-200 for all indications, including FSGS, in the United States.
  • In January 2026, Akebia Therapeutics announced that the first patient had been dosed in a Phase II clinical trial of praliciguat for the treatment of biopsy-confirmed FSGS.
  • In January 2026, Boehringer Ingelheim announced results from a 12-week Phase II clinical trial evaluating apecotrep (BI-764198). Apecotrep reduced proteinuria by 40% in the 20 mg dose group compared to placebo.
  • In December 2025, Dimerix announced that it had received feedback from the US FDA on the clinical appropriateness of proteinuria reduction as an endpoint for full approval of DMX-200 in the Phase III (ACTION 3) trial in patients with FSGS.

Focal Segmental Glomerulosclerosis (FSGS) Market Outlook

The treatment landscape for FSGS has historically depended on supportive care measures, including renin-angiotensin-aldosterone system (RAAS) blockade and corticosteroid. A significant advancement came with the approval of FILSPARI. It is a DEARA antagonist, designed to reduce proteinuria and slow disease progression. It represents the first targeted, non-immunosuppressive therapy approved specifically for FSGS, marking a shift toward mechanism-based treatment approaches.

The pipeline for FSGS is expanding, with several promising investigational agents targeting novel pathways. DMX-200 is a CCR2 antagonist that aims to reduce renal inflammation and fibrosis by inhibiting monocyte recruitment, a key driver in kidney injury. BI-764198 (apecotrep) targets the TRPC5 ion channel, which is implicated in podocyte dysfunction and proteinuria, offering a novel mechanism focused on preserving kidney filtration barrier integrity. Another candidate, Praliciguat, works as a sGC stimulator, potentially improving renal hemodynamics and reducing fibrosis through nitric oxide pathway modulation.

Overall, the launch of novel therapies, improved diagnostic techniques, and rising awareness of FSGS are projected to propel steady market growth across the 7MM from 2022 to 2036, yielding significant commercial opportunities for existing products and pipeline candidates.

  • According to estimates, the total FSGS market size in 7MM was approximately USD 300 million in 2025, with the United States accounting for the largest share, and the market is projected to grow at a significant CAGR through 2036.
  • In 2025, among the EU4 and the UK, the UK held the largest market share, followed by Germany, while Italy accounted for the smallest share.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Focal Segmental Glomerulosclerosis (FSGS) (2022-2036 Forecast)

The FSGS market (2022-2036 forecast) is evolving toward targeted, mechanism-based therapies that focus on reducing proteinuria, preserving podocyte function, and slowing disease progression rather than relying solely on broad immunosuppression after symptom onset.

  • Small molecule: The current FSGS pipeline features several small molecule candidates designed to act on distinct but complementary disease pathways. Sparsentan (FILSPARI) is a DEARA that reduces proteinuria and protects glomerular structure through hemodynamic modulation. DMX-200 is a CCR2 inhibitor targeting inflammatory and fibrotic pathways by limiting macrophage recruitment. BI 764198 is a TRPC5 channel inhibitor that stabilizes podocyte structure and function, addressing a key driver of protein leakage.

FSGS innovation is not driven by a single dominant mechanism, but rather by a convergence of small molecule therapies targeting podocyte injury, inflammation, fibrosis, and glomerular hemodynamics, collectively driving pipeline growth and advancing disease-modifying treatment strategies.

Focal Segmental Glomerulosclerosis (FSGS) 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 FSGS 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.

During the forecast period, drug uptake in FSGS is expected to remain gradual but more dynamic, driven by increasing recognition of the disease, improved diagnostic stratification (including genetic testing), and the emergence of targeted therapies. FILSPARI is expected to play a central role in the evolving FSGS treatment landscape. As a DEARA, FILSPARI targets both proteinuria and disease progression pathways. Its uptake is anticipated to expand steadily, particularly in patients with primary FSGS and significant proteinuria, supported by its differentiated mechanism and clinical efficacy in reducing proteinuria compared to standard therapies.

Emerging pipeline therapies for FSGS are expected to see gradual and selective uptake due to disease rarity and heterogeneity. DMX-200 (Dimerix) is likely to be used as an add-on therapy targeting inflammation and persistent proteinuria. BI 764198 (apecotrep) focuses on podocyte protection and may follow a biomarker-driven adoption pathway. Praliciguat is expected to provide anti-fibrotic and renal hemodynamic benefits. Overall uptake will depend on clinical efficacy, safety outcomes, and positioning alongside standard of care therapies.

Focal Segmental Glomerulosclerosis (FSGS) Therapies Price Scenario & Trends

Pricing and analogue assessment of FSGS 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.

Industry Experts and Physician Views for Focal Segmental Glomerulosclerosis (FSGS)

To keep up with FSGS 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 FSGS 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 FSGS, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 15+ KOLs to gather insights at the country level. Centers such as the Duke Molecular Physiology Institute, Department of Nephrology, Hospital Universitario Fundacion Alcorcon, and Nippon Medical School, etc. were contacted. Their opinion helps understand and validate current and emerging FSGS therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in FSGS.

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 FSGS, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical FSGS 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 FSGS, 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 elaborate profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the FSGS 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 FSGS market.

Report Insights

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

Report Assessment

  • Focal Segmental Glomerulosclerosis (FSGS) Current Treatment Practices
  • Focal Segmental Glomerulosclerosis (FSGS) Unmet Needs
  • Focal Segmental Glomerulosclerosis (FSGS) Clinical Development Analysis
  • Focal Segmental Glomerulosclerosis (FSGS) Emerging Drugs Product Profiles
  • Focal Segmental Glomerulosclerosis (FSGS) Market Attractiveness
  • Focal Segmental Glomerulosclerosis (FSGS) Qualitative Analysis (SWOT and conjoint analysis)

FAQs:

Market Insights

  • What was the FSGS 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 FSGS?
  • What are the disease risks, burdens, and unmet needs of FSGS? What will be the growth opportunities across the 7MM concerning the patient population with FSGS?
  • 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 FSGS? What are the current guidelines for treating FSGS 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 FSGS 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 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 Catalyst
  • 4.2. Key Conferences And Meetings
  • 4.3. Key Transactions And Collaborations
  • 4.4. News Flow

5. Epidemiology and Market Methodology of Focal Segmental Glomerulosclerosis (FSGS)

6. Focal Segmental Glomerulosclerosis (FSGS) Market Overview at a Glance

  • 6.1. Emerging Landscape Analysis (By Molecule Type, Phase, and Route of Administration [ROA])
  • 6.2. Market Share of Focal Segmental Glomerulosclerosis (FSGS) by Therapies (%) in the 7MM in 2025
  • 6.3. Market Share of Focal Segmental Glomerulosclerosis (FSGS) by Therapies (%) in the 7MM in 2036

7. Disease Background And Overview of Focal Segmental Glomerulosclerosis (FSGS)

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

8. Epidemiology and Patient Population of Focal Segmental Glomerulosclerosis (FSGS)

  • 8.1. Key Findings
  • 8.2. Assumption and Rationale
  • 8.3. Total Diagnosed Prevalent Cases of Focal Segmental Glomerulosclerosis (FSGS) in the 7MM
  • 8.4. The United States
    • 8.4.1. Diagnosed Prevalent Cases of Focal Segmental Glomerulosclerosis (FSGS) in the United States
    • 8.4.2. Gender-specific Diagnosed Prevalent Cases of Focal Segmental Glomerulosclerosis (FSGS) in the United States
    • 8.4.3. Age-specific Diagnosed Prevalent Cases of Focal Segmental Glomerulosclerosis (FSGS) in the United States
    • 8.4.4. Type-specific Diagnosed Prevalent Cases of Focal Segmental Glomerulosclerosis (FSGS) in the United States
  • 8.5. EU4 and the UK
    • 8.5.1. Diagnosed Prevalent Cases of Focal Segmental Glomerulosclerosis (FSGS) in EU4 and the UK
    • 8.5.4. Gender-specific Diagnosed Prevalent Cases of Focal Segmental Glomerulosclerosis (FSGS) in EU4 and the UK
    • 8.5.5. Age-specific Diagnosed Prevalent Cases of Focal Segmental Glomerulosclerosis (FSGS) in EU4 and the UK
    • 8.5.6. Type-specific Diagnosed Prevalent Cases of Focal Segmental Glomerulosclerosis (FSGS) in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Diagnosed Prevalent Cases of Focal Segmental Glomerulosclerosis (FSGS) in Japan
    • 8.6.2. Gender-specific Diagnosed Prevalent Cases of Focal Segmental Glomerulosclerosis (FSGS) in Japan
    • 8.6.5. Age-specific Diagnosed Prevalent Cases of Focal Segmental Glomerulosclerosis (FSGS) in Japan
    • 8.6.6. Type-specific Diagnosed Prevalent Cases of Focal Segmental Glomerulosclerosis (FSGS) in Japan

9. Patient Journey of Focal Segmental Glomerulosclerosis (FSGS)

10. Marketed Therapies

  • 10.1. Marketed Competitive Landscape of Focal Segmental Glomerulosclerosis (FSGS)
  • 10.2. Sparsentan (FILSPARI): Travere Therapeutics and Ligand Pharmaceuticals
    • 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 Focal Segmental Glomerulosclerosis (FSGS)
  • 11.2. DMX-200: Dimerix
    • 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. BI 764198 (apecotrep): Boehringer Ingelheim
    • 11.3.1. Product Description
    • 11.3.2. Other Developmental Activities
    • 11.3.3. Clinical Development
      • 11.3.3.1. Clinical Trial Information
    • 11.3.4. Safety and Efficacy
    • 11.3.5. Analyst Views

12. Focal Segmental Glomerulosclerosis (FSGS): Seven Major Market Analysis

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

13. Unmet Needs of Focal Segmental Glomerulosclerosis (FSGS)

14. SWOT Analysis of Focal Segmental Glomerulosclerosis (FSGS)

15. KOL Views of Focal Segmental Glomerulosclerosis (FSGS)

  • 15.1. Expert/KOL Interview Highlights

16. Market FSGSess and Reimbursement of Focal Segmental Glomerulosclerosis (FSGS)

  • 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 FSGSess and Pricing Policy Developments in 2025
  • 16.5. Market FSGSess and Reimbursement of Focal Segmental Glomerulosclerosis (FSGS) Therapies

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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