FSGS Market Analysis and Forecast 2024-2034: Clinical Trials, Epidemiology, Medications, and Leading Companies by DelveInsight

Focal Segmental Glomerulosclerosis Companies are Travere Therapeutics, Dimerix, Goldfinch Bio, Vertex Pharmaceuticals, GlaxoSmithKline, Dimerix Bioscience Pty Ltd, ChemoCentryx, AstraZeneca, Genentech, Inc., Sanofi, Mallinckrodt ARD LLC, ACELYRIN Inc., Kyowa Kirin Co., Ltd., Bristol-Myers Squibb, and others.
Focal Segmental Glomerulosclerosis (FSGS) market size across the 7MM was estimated at approximately USD 734 million in 2022, with forecasts indicating consistent expansion over the assessment period.

Focal Segmental Glomerulosclerosis Market Overview

The FSGS market is projected to demonstrate substantial growth from 2023 to 2034, primarily driven by the anticipated introduction and regulatory approval of novel therapeutic agents. DelveInsight's analysis shows that the United States accounts for the largest diagnosed patient population, representing 46.96% of total FSGS cases within the 7MM, followed by Japan at 14.83% in 2022. Epidemiological trends also reveal a higher prevalence among males, likely influenced by a combination of genetic, hormonal, and environmental determinants.

Current therapeutic management is largely centered around agents such as statins, ezetimibe/bempedoic acid combinations, and PCSK9 inhibitors, which collectively generated approximately USD 23 million in revenue in 2022. With continuous advancements in research and the emergence of innovative treatment modalities, the market is expected to benefit from broader access to new therapies, enhanced clinical outcomes, and improved disease management protocols. This evolution underscores the strong potential for sustained growth in the global FSGS therapeutic landscape.

DelveInsight's Focal Segmental Glomerulosclerosis Market Report delivers an in-depth evaluation of existing therapeutic paradigms, investigational drug candidates, and comparative market shares of approved treatments. It also provides historical and forecasted market estimates across the 7MM from 2020 to 2034, along with detailed analyses of current clinical management practices, treatment algorithms, unmet medical needs, and strategic opportunities expected to shape the future trajectory of the FSGS market.

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Key Takeaways of the Focal Segmental Glomerulosclerosis Market Report

* In November 2025, Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies and innovative treatments for rare diseases, announced that its abstract, "Adaptive Phase 2/3 Study for PCS499 (499) in Patients with Focal Segmental Glomerulosclerosis (FSGS)," had been accepted for presentation at the American Society of Nephrology (ASN) Kidney Week 2025, which took place from November 5-9, 2025, in Houston, Texas.
* In October 2025, Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; "Renalys") today announced that it has reached an agreement with the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan regarding development plans for two Phase III clinical trials of sparsentan in Japan (development code: RE-021) - one investigating the use of sparsentan in focal segmental glomerulosclerosis (FSGS) and the other in Alport syndrome (AS) in Japan.
* In June 2025, the DUPLEX trial (NCT03493685) determined that the dual endothelin angiotensin receptor antagonist sparsentan resulted in sustained proteinuria reduction among patients with focal segmental glomerulosclerosis (FSGS).
* In May 2025, Travere Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) had accepted its supplemental New Drug Application (sNDA) for traditional approval of FILSPARI (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS).
* Among the 7MM countries, Japan dominated the FSGS Drugs Market in 2022, capturing the The Focal Segmental Glomerulosclerosis market size was valued approximately USD 734 Million in 2022 and is anticipated to grow with a significant CAGR during the study period (2020-2034)
* In 2022, the US accounted for approximately 34% of the total FSGS market, with projections indicating a significant compound annual growth rate (CAGR) during the study period.
* In 2022, the EU4 countries and the UK generated an estimated USD 147 million, with this figure expected to grow at a significant CAGR. Among the European nations, France held the largest market share in 2022, followed by Germany.
* According to DelveInsight's assessments, there were roughly 55 million diagnosed prevalent cases of FSGS in the 7MM in 2022, with expectations of a rise during the forecast period.
* In 2022, around 26 million individuals in the United States were diagnosed with FSGS, and this number is projected to rise at an estimated CAGR throughout the study period from 2020 to 2034.
* In EU4 and the UK, Germany had the largest diagnosed prevalent population of FSGS in 2022, with approximately 5 million cases, followed by France and Italy. Conversely, Spain had the lowest diagnosed prevalent population in EU4 and the UK in 2022.
* Key Focal Segmental Glomerulosclerosis Companies: Travere Therapeutics, Dimerix, Goldfinch Bio, Vertex Pharmaceuticals, GlaxoSmithKline, Dimerix Bioscience Pty Ltd, ChemoCentryx, AstraZeneca, Genentech, Inc., Sanofi, Mallinckrodt ARD LLC, ACELYRIN Inc., Kyowa Kirin Co., Ltd., Bristol-Myers Squibb, and others
* Key Focal Segmental Glomerulosclerosis Therapies: DMX-200, GFB-887, VX-147, Losmapimod, Propagermanium, RE-021 (Sparsentan), CCX140-B, Dapagliflozin, rituximab, fresolimumab, Acthar Gel, VB119, Bleselumab, Abatacept, and others
* The Focal Segmental Glomerulosclerosis epidemiology based on gender analyzed that Focal Segmental Glomerulosclerosis is more prevalent in males than females in the United States
* The Focal Segmental Glomerulosclerosis market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Focal Segmental Glomerulosclerosis pipeline products will significantly revolutionize the Focal Segmental Glomerulosclerosis market dynamics.

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Focal Segmental Glomerulosclerosis Overview

Focal Segmental Glomerulosclerosis (FSGS) is a rare kidney disorder characterized by scarring in the glomeruli, the tiny filtering units of the kidneys. It can lead to proteinuria, reduced kidney function, and, in severe cases, progression to end-stage renal disease. FSGS may be primary (idiopathic) or secondary to conditions such as infections, obesity, or genetic mutations. Diagnosis typically involves clinical evaluation, lab tests, and kidney biopsy. Current treatment options include corticosteroids, immunosuppressants, ACE inhibitors, and supportive therapies, though many patients experience resistance or relapse. With limited effective therapies, FSGS remains an area of high unmet medical need and active research.

Focal Segmental Glomerulosclerosis Market Outlook

The Focal Segmental Glomerulosclerosis (FSGS) Treatment Market in the 7MM was valued at ~USD 734 million in 2022 and is projected to grow steadily, potentially reaching ~USD 837 million by 2034 with the anticipated launch of Olpasiran (Phase III). Japan led the market in 2022 with 46% share, followed by the US (34%), which is expected to grow at a substantial CAGR. The EU4 and UK collectively generated USD 147 million, with France holding the largest share, followed by Germany. Although the current FSGS pipeline remains limited, rising awareness and ongoing research are expected to drive gradual market expansion and improved treatment protocols.

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Focal Segmental Glomerulosclerosis Market Drivers and barriers

Focal Segmental Glomerulosclerosis Market Drivers:

* The introduction and commercialization of innovative therapies-such as RNA interference (siRNA) drugs like LEQVIO (Inclisiran) and pipeline agents like Olpasiran-are accelerating treatment uptake.
* Rising global prevalence of FSGS, especially across the 7MM, with substantial diagnosed populations in the US and Japan.
* Increasing awareness among healthcare providers and patients is improving early diagnosis and disease management.
* Advancements in diagnostic tools are enabling faster detection and more precise treatment approaches.
* Significant unmet needs due to the scarcity of approved therapies continue to fuel demand for novel treatment options.

Focal Segmental Glomerulosclerosis Market Barriers:

* High treatment costs pose challenges to patient access and reimbursement.
* The complex and heterogeneous nature of FSGS complicates therapeutic effectiveness across diverse patient groups.
* Stringent regulatory requirements and long clinical development timelines slow the availability of new therapies.
* The rarity of FSGS limits the overall patient pool, constraining market expansion.

Focal Segmental Glomerulosclerosis Epidemiology

DelveInsight's analysis indicates that Japan recorded approximately 3.92 million diagnosed prevalent cases of Focal Segmental Glomerulosclerosis (FSGS) in 2023, with around 1.39 million males and 2.53 million females affected. Within the 7MM, the United States represented about 44% of total diagnosed cases-6.98 million-a number expected to grow by 2034. In the US, prevalence was highest in the 75-84 age group at roughly 2.79 million cases, while individuals under 65 showed the lowest burden at 175,000 cases. Across the EU4 and the UK, mild cognitive impairment (MCI) emerged as the most common severity stage (2.56 million cases), whereas severe dementia accounted for only 645,000 cases. Neuropsychiatric complications also contributed significantly to the disease burden, with the US reporting 5.23 million agitation cases and Japan documenting 2.03 million psychosis cases in 2023-both expected to increase throughout the forecast period.

Focal Segmental Glomerulosclerosis Epidemiology Segmentation

The Focal Segmental Glomerulosclerosis market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

* Total Prevalence of Focal Segmental Glomerulosclerosis
* Prevalent Cases of Focal Segmental Glomerulosclerosis by severity
* Gender-specific Prevalence of Focal Segmental Glomerulosclerosis
* Diagnosed Cases of Episodic and Chronic Focal Segmental Glomerulosclerosis

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Focal Segmental Glomerulosclerosis Drugs Uptake and Pipeline Activities

* Masitinib (AB1010) - AB Science

Masitinib is an oral tyrosine kinase inhibitor targeting neuro-immune cells, including mast cells and microglia, which accumulate in the central nervous system (CNS) and are implicated in Focal Segmental Glomerulosclerosis pathology. Preclinical studies have shown that masitinib protects synapses by inhibiting mast cells, improving spatial learning and restoring synaptic markers. Clinically, Phase II trials demonstrated benefits in mild to moderate Focal Segmental Glomerulosclerosis, while Phase IIb/III studies indicated a significant slowing of cognitive decline. Masitinib is currently under confirmatory Phase III evaluation.

* Valiltramiprosate (ALZ-801) - Alzheon, Inc.

ALZ-801 is an oral small-molecule prodrug designed to block the formation of neurotoxic amyloid oligomers in the brain. It is a valine-conjugated form of tramiprosate, metabolizing into homotaurine for enhanced absorption and prolonged blood retention. Both ALZ-801 and tramiprosate metabolize to 3-sulfopropanoic acid (3-SPA), which inhibits ASs42 aggregation. Designed to improve gastrointestinal tolerance and pharmacokinetics, ALZ-801 has shown stable plasma levels in Phase I studies. It is currently in Phase III clinical trials for early-stage Focal Segmental Glomerulosclerosis as a potential disease-modifying therapy.

* Tricaprilin (CER-0001) - Cerecin

Tricaprilin (CER-0001), also known as AC-1204, is an oral formulation of caprylic triglyceride that induces mild chronic ketosis to enhance mitochondrial metabolism. Focal Segmental Glomerulosclerosis is associated with reduced cerebral glucose utilization, and CER-0001 provides ketone bodies as an alternative energy source, boosting cellular metabolism. Caprylic acid is converted to acetoacetic acid and Ss-hydroxybutyric acid, which form acetyl-CoA for energy production via the citric acid cycle. Clinical studies suggest cognitive improvements in mild to moderate Focal Segmental Glomerulosclerosis, particularly in APOE4-negative patients.

* Bezisterim (NE3107) - BioVie

NE3107 is an oral small molecule that crosses the blood-brain barrier and acts as both an anti-inflammatory agent and an insulin sensitizer. It selectively inhibits the ERK/NF-B pathway, reducing TNF production and modulating microglial activity without impairing essential functions. This dual action may reduce CNS inflammation and insulin resistance, potentially slowing Alzheimer's progression. Previously known as HE3286, NE3107 is also under investigation for Parkinson's disease, multiple myeloma, and prostate cancer. Phase III trials in mild to moderate Focal Segmental Glomerulosclerosis have been completed, with results presented at AD/PD 2024 in Lisbon, demonstrating potential to mitigate neurocognitive decline.

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Focal Segmental Glomerulosclerosis Therapeutic Assessment

Key Focal Segmental Glomerulosclerosis Companies are AstraZeneca, ACELYRIN Inc., Sanofi, Vertex Pharmaceuticals, Genentech Inc., Kyowa Kirin Co., Ltd., Travere Therapeutics, Mallinckrodt ARD LLC, Goldfinch Bio, Dimerix, GlaxoSmithKline, Bristol-Myers Squibb, ChemoCentryx, Dimerix Bioscience Pty Ltd, and others.

Scope of the Focal Segmental Glomerulosclerosis Market Report

* Study Period: 2020-2034
* Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
* Key Focal Segmental Glomerulosclerosis Companies: Travere Therapeutics, Dimerix, Goldfinch Bio, Vertex Pharmaceuticals, GlaxoSmithKline, Dimerix Bioscience Pty Ltd, ChemoCentryx, AstraZeneca, Genentech, Inc., Sanofi, Mallinckrodt ARD LLC, ACELYRIN Inc., Kyowa Kirin Co., Ltd., Bristol-Myers Squibb, and others
* Key Focal Segmental Glomerulosclerosis Therapies: DMX-200, GFB-887, VX-147, Losmapimod, Propagermanium, RE-021 (Sparsentan), CCX140-B, Dapagliflozin, rituximab, fresolimumab, Acthar Gel, VB119, Bleselumab, Abatacept, and others
* Focal Segmental Glomerulosclerosis Therapeutic Assessment: Focal Segmental Glomerulosclerosis current marketed and Focal Segmental Glomerulosclerosis emerging therapies
* Focal Segmental Glomerulosclerosis Market Dynamics: Focal Segmental Glomerulosclerosis market drivers and Focal Segmental Glomerulosclerosis market barriers
* Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
* Focal Segmental Glomerulosclerosis Unmet Needs, KOL's views, Analyst's views, Focal Segmental Glomerulosclerosis Market Access and Reimbursement

Table of Content:

* Key Insights
* Report Introduction
* Focal Segmental Glomerulosclerosis Market Overview at a Glance
* Methodology of Focal Segmental Glomerulosclerosis Epidemiology and Market
* Executive Summary of Focal Segmental Glomerulosclerosis
* Key Events
* Disease Background and Overview
* Focal Segmental Glomerulosclerosis Patient Journey
* Focal Segmental Glomerulosclerosis Epidemiology and Patient Population
* Marketed Focal Segmental Glomerulosclerosis Drugs
* Emerging Focal Segmental Glomerulosclerosis Drug Profiles
* Focal Segmental Glomerulosclerosis Market Analysis
* Key Opinion Leaders' Views
* Focal Segmental Glomerulosclerosis SWOT Analysis
* Unmet Needs in Focal Segmental Glomerulosclerosis
* Focal Segmental Glomerulosclerosis Market Access and Reimbursement
* Appendix
* DelveInsight Capabilities
* Disclaimer
* About DelveInsight

About DelveInsight

DelveInsight is a leading global business consulting and market research firm focused on the healthcare and pharmaceutical industries. The company provides in-depth insights, comprehensive analysis, and strategic solutions across therapeutic areas, helping stakeholders make informed decisions. With expertise in market intelligence, epidemiology, competitive landscapes, and product pipelines, DelveInsight supports clients in identifying growth opportunities, optimizing strategies, and staying ahead in a rapidly evolving healthcare market.

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