Focal Segmental Glomerulosclerosis Market Summary
The Focal Segmental Glomerulosclerosis (FSGS) market is expected to experience significant growth during the forecast period (2023–2034), driven primarily by the approval of potential new therapies. According to DelveInsight’s analysis, the United States accounts for the highest proportion of diagnosed FSGS cases in the 7MM, representing 46.96% of the total, followed by Japan at approximately 14.83% of cases in 2022. Epidemiological data indicate a higher prevalence of FSGS in males across the 7MM, which may be influenced by hormonal, genetic, or environmental factors. The FSGS treatment landscape is dominated by therapies such as statins, Ezetimibe/Bempedoic Acid and their combinations, as well as PCSK9 inhibitors, which collectively generated nearly USD 23 million in 2022. With ongoing research and emerging therapies, the market outlook suggests increasing patient access to innovative treatments, expanded therapeutic options, and improved disease management, highlighting the potential for sustained growth and development in the global FSGS market.
DelveInsight’s, Focal Segmental Glomerulosclerosis market report offers a comprehensive analysis of current treatment The Focal Segmental Glomerulosclerosis (FSGS) Drugs Market report offers a comprehensive analysis of current treatment paradigms, emerging therapeutic candidates, and the market share of individual therapies, alongside the historical and projected FSGS market size across the 7MM from 2020 to 2034. The report further examines established FSGS treatment algorithms, clinical management practices, and unmet medical needs, providing an in-depth assessment of market dynamics and identifying high-potential opportunities within the FSGS treatment landscape.
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Key Takeaways of the Focal Segmental Glomerulosclerosis Market Report
- 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 renal disorder characterized by segmental sclerosis within the glomeruli, the kidney’s primary filtration units. The glomeruli are responsible for removing metabolic waste and excess fluid from the bloodstream to form urine. Clinically, FSGS manifests as proteinuria, reflecting significant urinary protein excretion, and edema, typically presenting in the periorbital region, extremities, and abdomen, often accompanied by abrupt weight gain. Additional laboratory and clinical features may include hypoalbuminemia, hyperlipidemia in select cases, hypertension, and an elevated risk of thromboembolic events. These pathophysiological changes collectively contribute to progressive renal impairment and associated systemic complications.
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:
- Approval and commercialization of novel therapies, including RNA interference (siRNA) drugs like LEQVIO (Inclisiran) and emerging therapies such as Olpasiran, driving treatment adoption.
- Increasing prevalence of FSGS globally, particularly in the 7MM, including high diagnosed cases in the US and Japan.
- Growing awareness among clinicians and patients regarding early diagnosis and management of FSGS.
- Advances in diagnostic techniques facilitating timely detection and targeted treatment strategies.
- Unmet medical needs due to limited approved treatment options, creating demand for innovative therapies.
Focal Segmental Glomerulosclerosis Market Barriers:
- High cost of therapy limiting patient access and healthcare reimbursement.
- Complex disease pathology and heterogeneity leading to challenges in treatment efficacy across patient populations.
- Regulatory hurdles and lengthy clinical development timelines for emerging therapies.
- Limited patient pool due to the rare nature of the disease, impacting market growth potential.
Focal Segmental Glomerulosclerosis Epidemiology
According to DelveInsight’s analysis, the total diagnosed prevalent cases of Focal Segmental Glomerulosclerosis in Japan were estimated at nearly 3.92 million in 2023, with a gender distribution of approximately 1.39 million males and 2.53 million females. In the United States, Alzheimer’s accounted for around 44% of diagnosed cases across the 7MM, totaling 6.98 million, a figure projected to increase by 2034. Age-specific prevalence in the US shows the 75–84 age group as the most affected, with nearly 2.79 million cases, while the under-65 group had the lowest prevalence at 175 thousand. Focal Segmental Glomerulosclerosis severity across EU4 and the UK indicates that mild cognitive impairment (MCI) is the most prevalent stage (2.56 million cases), whereas severe dementia has the fewest cases (645 thousand). Behavioral and psychiatric complications are also significant, with the US reporting nearly 5.23 million cases of agitation and Japan documenting 2.03 million cases of psychosis in 2023, both anticipated to rise over 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-κB 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 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
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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