|
시장보고서
상품코드
2082896
국소 분절성 사구체 경화증(FSGS) : 시장 인사이트, 역학 및 시장 예측(2036년)Focal Segmental Glomerulosclerosis - Market Insight, Epidemiology, and Market Forecast - 2036 |
||||||
DelveInsight
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.
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.
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.
FSGS의 역학 분석 및 예측에 관한 주요 조사 결과
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.
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.
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) 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.
Key Findings from FSGS Epidemiological Analysis and Forecast
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
Focal Segmental Glomerulosclerosis (FSGS) Drug Updates
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.
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.
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.
Market Insights