Focal Segmental Glomerulosclerosis (FSGS): Market View

This report provides a data-driven overview of the current and future competitive landscape in Focal Segmental Glomerulosclerosis (FSGS) Therapeutics.

In 2025, there were 37,049 incident cases of FSGS in the 16 countries covered in GlobalData's epidemiology forecast.

In 2021, the most recent guideline for physicians for diagnosis and treatment of FSGS was established across seven major markets (US, France, Germany, Italy, Spain, the UK, and Japan) by the Kidney Disease Improving Global Outcomes (KDIGO).

Over roughly the past three years, the competitive landscape in FSGS has begun to shift from an area with no FDA-approved, disease-specific therapies, where care largely relied on supportive measures and off-label immunosuppression, to one with an on-label entrant.

In April 2026, Travere Therapeutics' Filspari (sparsentan) received FDA approval for FSGS, becoming the first FDA-approved therapy specifically indicated for the condition and marking a milestone for a treatment landscape historically dominated by ACE inhibitor/ARB-based proteinuria reduction, SGLT2 inhibitors and other CKD-risk mitigation strategies, and (in selected patients) glucocorticoids, calcineurin inhibitors, mycophenolate, or rituximab used off-label.

The FSGS pipeline holds 45 molecules, with no assets in the pre-registration stage, five assets in Phase III development, and 13 assets in Phase II development.

Over the past decade, 90 clinical trials have been conducted in FSGS. The years with the most studies initiated were 2022, with 12 trials, followed by 2025, with 11 trials.

Over the past decade, in deals involving companies developing FSGS products, acquisitions accounted for the largest share of deals in North America (45%). By comparison, licensing agreements were most prevalent in Europe (73%) and the Asia-Pacific region (56%). South America recorded only licensing agreements (100%), while the Middle East and Africa also leaned heavily toward licensing agreements (83%).

Scope

GlobalData's Focal Segmental Glomerulosclerosis (FSGS): Market View combines data from the Pharma Intelligence Center with in-house analyst expertise to provide a competitive assessment of the disease marketplace.

Components of the report include:

• Disease Landscape
• Disease Overview
• Epidemiology Overview
• Treatment Overview
• Marketed Products Assessment
• Breakdown by Mechanism of Action, Molecule type
• Product Profiles with Sales Forecast
• Pricing and Reimbursement Assessment
• Annual Therapy Cost
• Time to Pricing and Time to Reimbursement
• Pipeline Assessment
• Breakdown by Development Stage, Mechanism of Action, Molecule Type, Route of Administration
• Product Profiles with Sales Forecast
• Late-to-mid-stage Pipeline Drugs
• Phase Transition Success Rate and Likelihood of Approval
• Clinical Trials Assessment
• Breakdown of Trials by Phase, Status, Virtual Components, Sponsors, Geography, and Endpoint Status
• Enrolment Analytics, Site Analytics, Feasibility Analysis
• Deals Landscape
• Mergers, Acquisitions, and Strategic Alliances by Region
• Overview of Recent Deals
• Commercial Assessment
• Key Market Players
• Future Market Catalysts

Reasons to Buy

• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
• Develop business strategies by understanding the trends shaping and driving the Focal Segmental Glomerulosclerosis (FSGS) Therapeutics market.
• Drive revenues by understanding the key trends, innovative products and technologies, and companies likely to impact the global Focal Segmental Glomerulosclerosis (FSGS)Therapeutics market in the future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors.
• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
• Organize your sales and marketing efforts by identifying the market categories that present the maximum opportunities for consolidations, investments, and strategic partnerships.