DelveInsight, a leading market research firm, has released its latest report, “Focal Segmental Glomerulosclerosis (FSGS) Market Insight, Epidemiology, and Market Forecast–2034.” The report provides a comprehensive assessment of FSGS, including epidemiological trends, current treatment practices, emerging therapies, and market forecasts across the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan.
Key Takeaways from the FSGS Market Report
The FSGS market across the 7MM is expected to grow substantially during the forecast period 2025–2034.
The total FSGS market size in the 7MM was approximately USD 10 million in 2020 and is projected to reach nearly USD 16 million by 2034.
In 2024, the United States accounted for nearly 36% of the diagnosed prevalent FSGS cases across the 7MM.
The total diagnosed prevalent cases of FSGS in the US were approximately 76,000 in 2024 and are expected to increase during the forecast period.
Primary FSGS represented approximately 80% of diagnosed FSGS cases in the United States in 2024.
In Japan, diagnosed prevalent FSGS cases were higher in males (~16,500) than females (~11,000) in 2024.
There are currently no FDA-approved therapies specifically indicated for FSGS, resulting in a significant unmet medical need.
Key companies developing therapies for FSGS include Dimerix, Travere Therapeutics, Akebia Therapeutics, Walden Biosciences, and others.
Promising pipeline therapies include DMX-200, FILSPARI (sparsentan), Praliciguat, WAL0921, and others.
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Key Factors Driving the FSGS Market
High Unmet Need and Lack of Approved Therapies:- Currently, there are no FDA-approved pharmacological therapies specifically for FSGS. Existing treatment strategies rely largely on off-label therapies, including corticosteroids, calcineurin inhibitors, ACE inhibitors, ARBs, mycophenolate mofetil, rituximab, dialysis, and kidney transplantation. These approaches often demonstrate limited efficacy and high relapse rates.
Increasing Disease Awareness and Diagnostic Improvements:- Advances in genetic testing, APOL1 screening, biomarker research, and greater understanding of podocyte injury mechanisms are improving diagnosis and disease stratification, supporting earlier intervention and expanding the treatment-eligible population.
Emergence of Targeted Therapies: – Novel therapeutic candidates targeting endothelin signaling, CCR2 pathways, soluble guanylate cyclase stimulation, and other disease-specific pathways are expected to transform the treatment landscape and create new market opportunities.
FSGS Competitive Landscape:- The FSGS pipeline is rapidly evolving, with multiple companies developing therapies designed to reduce proteinuria, preserve kidney function, and delay progression to end-stage kidney disease.
Leading emerging therapies include:
FILSPARI (sparsentan) – Travere Therapeutics
DMX-200 – Dimerix
Praliciguat – Akebia Therapeutics
WAL0921 – Walden Biosciences
These therapies aim to address critical unmet needs and may significantly alter the future treatment paradigm for patients with FSGS.
Discover more about therapies set to grab major FSGS market share @ FSGS Treatment Landscape
Recent Developments in the FSGS Market
In January 2026, Akebia Therapeutics announced that the first patient had been dosed in a Phase II clinical trial evaluating Praliciguat in biopsy-confirmed FSGS patients.
In December 2025, Dimerix received FDA feedback supporting proteinuria reduction as a clinically appropriate endpoint for full approval of DMX-200 in the Phase III ACTION3 trial. The statistical powering analysis is expected in early 2026.
In November 2025, Travere Therapeutics presented new Phase III DUPLEX study data evaluating FILSPARI (sparsentan) in FSGS at ASN Kidney Week 2025.
In September 2025, Travere Therapeutics announced that the FDA no longer required an advisory committee review for the FILSPARI supplemental NDA in FSGS, with a PDUFA target action date of January 13, 2026.
What is Focal Segmental Glomerulosclerosis (FSGS)?
Focal Segmental Glomerulosclerosis (FSGS) is a rare kidney disorder characterized by scarring (sclerosis) of the glomeruli, leading to proteinuria, nephrotic syndrome, progressive loss of kidney function, and eventual kidney failure in many patients. FSGS can be classified into primary, secondary, and genetic forms, with disease progression and treatment response varying considerably among patients.
FSGS Epidemiology Segmentation
The FSGS epidemiology section provides insights into historical and forecasted patient populations across the 7MM and includes:
Total Diagnosed Prevalent Cases of FSGS
Gender-specific Diagnosed Prevalent Cases of FSGS
Age-specific Diagnosed Prevalent Cases of FSGS
Type-specific Diagnosed Prevalent Cases of FSGS
Country-wise Diagnosed Prevalent Cases of FSGS
Scope of the FSGS Market Report
Comprehensive Insight into FSGS Epidemiology and Market Trends
Historical and Forecasted Market Assessment (2020–2034)
Analysis of Current Treatment Practices and Emerging Therapies
Detailed Competitive Intelligence Assessment
Market Drivers, Barriers, Opportunities, and Unmet Needs
Key Companies: Dimerix, Travere Therapeutics, Akebia Therapeutics, Walden Biosciences, and others
Key Therapies: DMX-200, FILSPARI (sparsentan), Praliciguat, WAL0921, and others
Market Access and Reimbursement Analysis
SWOT Analysis and KOL Perspectives
To know more about FSGS companies working in the treatment market, visit @ FSGS Clinical Trials and Therapeutic Assessment
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.
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