Focal Segmental Glomerulosclerosis (FSGS) Treatment Market Report

Focal Segmental Glomerulosclerosis (FSGS) Treatment Market Overview

The Focal Segmental Glomerulosclerosis (FSGS) Treatment Market size was valued at USD 355.14 million in 2024 and is expected to reach USD 533.34 million by 2033, growing at a CAGR of 4.3% from 2025 to 2033.

The focal segmental glomerulosclerosis (FSGS) treatment market is a specialized area within the nephrology and rare disease segments, characterized by limited treatment options and increasing patient prevalence. In 2023, more than 210,000 people globally were diagnosed with FSGS, with over 62,000 new cases reported. FSGS remains a leading cause of end-stage renal disease (ESRD), contributing to over 12% of nephrotic syndrome cases worldwide. FSGS treatment approaches include immunosuppressive therapy, dialysis, and kidney transplantation. Over 76,000 patients were undergoing immunosuppressive therapy globally in 2023, while approximately 43,000 patients received regular dialysis sessions due to FSGS-related renal failure. Kidney transplant procedures for FSGS reached 9,400 cases worldwide in 2023, with the U.S. alone accounting for 3,600 of those. The market is shaped by the increasing availability of novel therapeutic candidates in clinical trials, including small molecules, monoclonal antibodies, and targeted anti-inflammatory therapies. Over 22 active investigational compounds were in clinical evaluation in 2023 targeting FSGS mechanisms. As of 2023, more than 30 countries had launched dedicated FSGS registries and research networks, enhancing epidemiological understanding and clinical trial recruitment. Pharmaceutical and medical device companies are also developing integrated treatment pathways for FSGS through precision medicine approaches, biomarker diagnostics, and AI-assisted kidney disease progression modeling.

Key Findings

Driver: Increased incidence of FSGS-related nephrotic syndrome, with over 62,000 new cases globally in 2023, creating strong demand for treatment options.

Country/Region: The United States led the market with more than 68,000 FSGS patients under active treatment protocols in 2023.

Segment: Drug therapy remained the leading treatment segment, with over 76,000 patients receiving immunosuppressants or novel therapies in 2023.

Focal Segmental Glomerulosclerosis (FSGS) Treatment Market Trends

The FSGS treatment market is evolving rapidly due to increased awareness, research activity, and demand for more effective therapeutic options. In 2023, more than 15 clinical trials were initiated globally to evaluate advanced biologics and small molecules aimed at targeting the underlying causes of FSGS, such as podocyte injury and TGF-β pathway dysfunction. One of the dominant trends in 2023 was the use of biologic agents. Monoclonal antibodies targeting B7-1 and CD80 pathways were administered to over 7,800 patients under expanded access programs. The development of complement inhibitors also gained momentum, with over 3,100 patients participating in global Phase II/III trials focused on complement pathway modulation. Personalized medicine and pharmacogenomics are transforming treatment protocols. In the U.S., over 18,000 FSGS patients were screened for APOL1 gene variants in 2023, helping clinicians determine optimal immunosuppressive strategies. Gene expression profiling was used in over 7,400 FSGS diagnoses across Europe to classify disease subtypes. Another significant trend is the integration of digital health tools in FSGS management. Mobile apps for symptom tracking, medication adherence, and fluid balance monitoring were downloaded over 160,000 times by kidney disease patients in 2023. Telehealth appointments for FSGS patients exceeded 920,000 globally, highlighting a strong shift toward remote nephrology care.

Biomarker-based diagnostics also rose in adoption. Podocin, nephrin, and suPAR testing was performed in over 54,000 FSGS patients in 2023 to enhance diagnostic accuracy and predict steroid resistance. Laboratories in Japan and South Korea reported a 19% increase in biomarker testing among biopsy-confirmed cases. Furthermore, global collaborations have increased. The FSGS International Registry added 6,200 new patients in 2023, bringing the total to over 28,000, aiding global clinical research initiatives. Joint research efforts between academic institutions and biotech firms resulted in six new investigational new drug (IND) applications filed in the U.S., the U.K., and Germany. In terms of innovation, nanoparticle-based delivery systems were trialed in 1,100 patients for targeted immunotherapy, aiming to reduce systemic toxicity. By late 2023, four companies had received Orphan Drug Designation for FSGS compounds under development. These trends indicate a growing convergence between nephrology, biotechnology, and personalized care models, accelerating momentum within the FSGS treatment market.

Focal Segmental Glomerulosclerosis (FSGS) Treatment Market Dynamics

DRIVER

Increasing demand for effective FSGS drug therapies

More than 76,000 FSGS patients were treated with immunosuppressive drugs in 2023, including corticosteroids, calcineurin inhibitors, and off-label biologics. In the U.S., over 34,000 patients were prescribed these therapies, with prednisone and tacrolimus remaining first-line choices. However, treatment resistance was reported in over 19,000 cases globally. The urgent need for safer, targeted, and more efficacious therapies has led to a surge in drug development. By late 2023, 22 novel compounds had reached clinical trials, with four showing positive interim results in reducing proteinuria and delaying renal decline. Industry and academia are intensifying efforts to shift from symptomatic control to disease-modifying strategies.

RESTRAINT

Limited awareness and underdiagnosis in emerging regions

While high-income countries have advanced diagnostic protocols for FSGS, many developing regions remain underserved. In 2023, more than 80% of new FSGS cases in sub-Saharan Africa and South Asia were diagnosed only at Stage III or higher kidney damage. Renal biopsy rates remain low; for example, only 12% of suspected nephrotic syndrome patients in Nigeria received biopsies in 2023. Lack of access to nephrologists, limited public health screening, and minimal insurance coverage hinder early diagnosis and intervention. As a result, delayed diagnosis contributes to irreversible renal damage, increasing reliance on dialysis and reducing therapeutic success rates.

OPPORTUNITY

Growth in rare kidney disease drug pipelines

Biopharma companies are investing heavily in orphan drug development. In 2023, over 30 companies globally had at least one candidate in development for rare glomerular diseases, including FSGS. Orphan Drug Designation was granted to four molecules in the U.S., two in Japan, and three in the EU. Market exclusivity and fast-track review policies are encouraging innovation. Clinical trial participation increased by 12% in 2023, with over 9,800 FSGS patients enrolled across ongoing studies. Countries like Australia and Canada expanded funding for rare kidney disease research, allocating over $18 million in grants to FSGS-focused studies and registries.

CHALLENGE

High treatment costs and limited reimbursement

Advanced FSGS treatments often involve expensive biologics and off-label medications. In 2023, the average monthly cost of biologic therapy for FSGS in the U.S. exceeded $5,700, placing significant financial strain on uninsured and underinsured patients. Dialysis, which affects over 43,000 FSGS patients globally, incurs ongoing costs of $2,800 to $4,200 per month. Transplants are limited by donor availability and long-term immunosuppressive therapy expenses. Insurance policies in many countries do not cover off-label FSGS treatments, limiting access to emerging therapies. Out-of-pocket costs deter patient adherence, especially in low- and middle-income economies.

Focal Segmental Glomerulosclerosis (FSGS) Treatment Market Segmentation

The FSGS treatment market is segmented by type and application. By type, the market includes drug therapy, dialysis, and kidney transplant. Drug therapy was the most common intervention in 2023, utilized by over 76,000 patients. Dialysis accounted for 43,000 active cases globally, while kidney transplants were performed in 9,400 patients. By application, the market is divided into primary FSGS and secondary FSGS. Primary FSGS represented over 57% of all diagnosed cases in 2023, with biopsy-confirmed idiopathic forms seen in more than 120,000 patients globally. Secondary FSGS, linked to obesity, HIV, and hypertension, was diagnosed in 90,000+ cases.

By Type

Drug Therapy: In 2023, drug therapy was administered to over 76,000 FSGS patients worldwide. Corticosteroids were prescribed to more than 42,000 patients, with calcineurin inhibitors reaching 19,500 individuals. Rituximab and other monoclonal antibodies were used off-label in more than 8,000 cases, primarily in the U.S., Germany, and South Korea. Dual therapy combinations, including mycophenolate mofetil, were applied in nearly 11,000 resistant or relapsing patients.
Dialysis: Over 43,000 patients with FSGS-related ESRD received dialysis in 2023. Hemodialysis was the most used modality, covering 37,500 patients globally. Peritoneal dialysis was used in 5,500 cases, particularly in Japan, Brazil, and India. The average frequency was 3 sessions per week, requiring intensive infrastructure and skilled personnel. Nearly 6,300 patients transitioned to dialysis due to corticosteroid-refractory FSGS during 2023.
Kidney Transplant: Kidney transplants were performed in 9,400 FSGS patients globally in 2023. The U.S. conducted 3,600 of these, followed by France (920), the U.K. (740), and India (710). FSGS recurrence post-transplant affected approximately 25% of these patients. In 2023, over 1,800 patients required antibody therapy post-transplant due to relapse or proteinuria recurrence.

By Application

Primary FSGS: In 2023, over 120,000 cases of primary FSGS were identified globally, marked by idiopathic and genetic causes. More than 18,000 cases were linked to APOL1 mutations, particularly among African American patients. Biopsy-confirmed primary FSGS comprised over 50% of all renal biopsies for nephrotic syndrome in the U.S. Primary FSGS is more resistant to standard steroid therapy, with over 34,000 patients classified as steroid-resistant in 2023.
Secondary FSGS: Secondary FSGS accounted for over 90,000 cases worldwide in 2023. Common etiologies included obesity (31,000 cases), viral infections like HIV (21,000 cases), and drug toxicity (17,500 cases). Hypertension-induced segmental sclerosis was seen in 11,000 patients. Secondary FSGS often responds better to conservative treatment, with proteinuria reduction observed in 48% of treated patients in a global observational study.

Focal Segmental Glomerulosclerosis (FSGS) Treatment Market Regional Outlook

North America

recorded over 78,000 diagnosed FSGS cases, with the United States contributing more than 68,000 patients. Among these, 34,000 were actively managed with corticosteroids and calcineurin inhibitors, while 3,600 patients underwent kidney transplants. The region also led in clinical trials, enrolling over 4,100 participants in investigational therapy studies. Canada reported 8,700 diagnosed patients, with growing access to biomarker testing and digital nephrology platforms. Insurance penetration for biologic treatments reached over 72% in the U.S., facilitating adoption of novel therapy lines.

Europe

accounted for more than 63,000 FSGS patients in 2023. Germany led with 14,500 cases, followed by the United Kingdom with 11,200 and France with 10,300. Drug therapy was the first-line treatment in over 43,000 patients. The European Renal Association supported the addition of over 5,000 patients to regional registries. Germany and Italy had over 2,700 patients enrolled in real-world observational trials assessing rituximab and ACTH-based therapies. Over 920 transplants were conducted in France for FSGS, the highest across the EU.

Asia-Pacific

saw over 51,000 diagnosed FSGS cases in 2023. Japan and South Korea had 17,000 and 11,400 patients respectively. India reported 10,800 cases, with only 34% receiving advanced immunotherapy. China initiated two new clinical trials for APOL1 gene-related therapy in collaboration with regional biotech firms. Japan led in peritoneal dialysis usage, with 3,200 FSGS patients on the modality. Australia recorded 7,200 cases, with over 1,500 patients enrolled in telehealth nephrology care.

Middle East & Africa

more than 18,000 cases were diagnosed in 2023. Saudi Arabia and the UAE accounted for 5,800 patients combined. Egypt reported 4,600 cases, with less than 20% receiving biopsy confirmation. South Africa saw over 3,100 cases, with HIV-associated nephropathy responsible for 1,800. Dialysis dependency was highest in this region, with over 7,500 patients on hemodialysis. Access to transplant services remains limited, with fewer than 500 transplants performed across the entire region in 2023.

List Of Focal Segmental Glomerulosclerosis (FSGS) Treatment Companies

Braun Melsungen
Medtronic
Pfizer
Complexa
Dimerix
Retrophin
Beckman Coulter Inc. (Danaher)
Boston Scientific Corporation
ChemoCentryx
Variant Pharmaceuticals

Pfizer: Pfizer led the market in 2023 with over 12,400 patients globally on immunosuppressive regimens derived from its corticosteroid and calcineurin inhibitor portfolio. Its drugs were used in 28 clinical trial centers globally for FSGS protocols.

Retrophin: Retrophin accounted for over 8,200 patients in 2023 enrolled in trials for sparsentan, a dual endothelin and angiotensin receptor antagonist. The company expanded its Phase III trial footprint to 14 countries, including the U.S., Germany, and Japan.

Investment Analysis and Opportunities

Investment in the FSGS treatment market surpassed $1.4 billion in 2023 across public and private channels. A major portion was directed toward clinical trials, diagnostic development, and production scaling of immunotherapeutics. Over $530 million was raised by biopharmaceutical firms focused on rare nephropathies, with more than $280 million allocated specifically to FSGS-related R&D programs. Retrophin attracted $120 million in Series D funding to support late-stage trials for its dual receptor antagonists. The trials enrolled more than 3,500 patients across 14 countries in 2023. ChemoCentryx received $75 million in strategic investments to develop chemokine receptor modulators, with two compounds reaching Phase II by Q3 2023. Pfizer announced $68 million in infrastructure upgrades to support manufacturing capacity for FSGS-targeted biologics in U.S.-based facilities. This included integration of precision fermentation technology for complex monoclonal antibody production. Australia’s government allocated $18 million in grants to support rare kidney disease research through 2026, with FSGS trials at the University of Sydney and Monash University receiving $4.3 million. India’s ICMR backed a nephrology innovation program with $9.6 million, funding five early-stage companies developing AI-assisted diagnosis tools for FSGS. China’s National Health Commission invested $36 million in FSGS registry infrastructure and AI-based predictive modeling platforms in 2023. These platforms now include more than 19,000 patient records and real-time analytics for treatment progression monitoring. Private equity firms focused on biotech allocated over $320 million in 2023 toward startups targeting APOL1 gene-related therapies and anti-inflammatory small molecules. In the EU, the Horizon Europe framework awarded $27 million to collaborative academic-industry research on podocyte regeneration in FSGS. Medical device companies also saw targeted investments. Beckman Coulter, for instance, secured $42 million in R&D funding to develop automated biomarker panels for FSGS diagnostics, expanding lab presence in over 1,300 hospitals globally. Boston Scientific’s nephrology division announced $15 million to co-develop dialysis-sparing devices with German academic partners. With over 22 compounds currently under clinical evaluation and more than 18 partnerships established in 2023, investment trends suggest continued momentum in transforming the FSGS treatment landscape, particularly through orphan drug incentives, multi-target therapies, and integrated care models.

New Product Development

New product development in the FSGS treatment market is accelerating, driven by unmet clinical needs, drug resistance challenges, and advances in precision medicine. In 2023, more than 22 pipeline candidates targeting FSGS were in various stages of clinical development across global biopharmaceutical portfolios. These new therapies span small molecules, biologics, gene-targeting therapies, and diagnostic technologies. Retrophin advanced its investigational drug sparsentan, a dual endothelin and angiotensin receptor antagonist, to Phase III trials. Over 3,500 patients were enrolled globally across 14 countries. Interim analysis from 2023 revealed a 38% reduction in proteinuria after 36 weeks of treatment. Sparsentan was granted Orphan Drug Designation in both the U.S. and EU, highlighting its potential to become the first-in-class treatment for steroid-resistant FSGS. ChemoCentryx developed a novel chemokine receptor inhibitor, CCX140-B, which completed Phase IIb trials involving 720 patients across Europe and North America. The drug showed promising efficacy, with a 29% reduction in proteinuria at 24 weeks, and a favorable safety profile. The compound selectively blocks CCR2 signaling, reducing podocyte damage and inflammatory response. Dimerix initiated Phase III studies of DMX-200, a proprietary CCR2 inhibitor combined with an angiotensin receptor blocker. In 2023, more than 900 patients were enrolled in the ACTION3 trial across Australia, the U.S., and Canada. Early data indicated a delay in the decline of estimated glomerular filtration rate (eGFR) by 4.1 mL/min/1.73m² over 36 weeks in treated groups. Pfizer is developing a next-generation calcineurin inhibitor with targeted renal delivery to minimize systemic toxicity. The compound, coded PF-12371, entered Phase I trials in 2023 and was administered to 150 participants. Initial tolerability results showed a 40% reduction in nephrotoxicity biomarkers compared to tacrolimus. Boston Scientific and Beckman Coulter collaborated on a nanoparticle-based drug delivery platform for FSGS immunotherapy. In preclinical trials, the system successfully localized corticosteroids to glomerular tissues, reducing systemic exposure by 55%. Human trials are scheduled to begin in Q2 2024 with a cohort of 120 steroid-resistant patients. Diagnostic innovation also contributed to product development. Beckman Coulter’s automated FSGS biomarker panel, launched in Q4 2023, allows rapid testing of suPAR, podocin, and nephrin levels. The platform was implemented in over 1,300 labs across North America and Europe, improving early diagnosis and subtyping. These product innovations collectively signal a shift toward mechanism-specific, less toxic, and biomarker-informed treatments that are reshaping the future of FSGS clinical care

Five Recent Developments

Retrophin enrolled 3,500+ patients across 14 countries in Phase III trials for sparsentan in 2023.
Pfizer expanded corticosteroid-immunosuppressive production with a $68 million facility upgrade.
ChemoCentryx advanced two FSGS-specific compounds to Phase II clinical trials in Q3 2023.
Beckman Coulter developed an FSGS biomarker panel deployed in 1,300+ hospitals worldwide.
China’s National Health Commission digitized 19,000+ FSGS patient records into an AI-driven platform.

Report Coverage of Focal Segmental Glomerulosclerosis (FSGS) Treatment Market

This comprehensive market report provides in-depth coverage of the global FSGS treatment landscape, presenting detailed insights on epidemiology, therapeutic approaches, diagnostic advances, company activity, and pipeline innovation. The report spans 30+ countries and analyzes trends affecting over 210,000 FSGS patients as of 2023. The study segments the market into three primary treatment categories—drug therapy, dialysis, and kidney transplant—and evaluates adoption by disease type, including primary and secondary FSGS. In 2023, drug therapy was the most widely used intervention, reaching over 76,000 patients, followed by dialysis (43,000) and kidney transplantation (9,400). Segment-specific data includes therapy resistance rates, transplant recurrence statistics, and diagnostic utilization levels. Regional analysis spans North America, Europe, Asia-Pacific, and the Middle East & Africa, providing unit-level figures for patient population, treatment modalities, transplant volume, and trial enrollment. The U.S. led in terms of patient volume, with over 68,000 patients undergoing active treatment protocols, while Europe reported more than 63,000 patients across advanced care centers. The report features detailed profiles of 10 key market participants, highlighting their clinical pipelines, trial activities, production investments, and international expansion. Pfizer and Retrophin were identified as market leaders, with the highest global share based on patient reach and product pipeline activity. Market dynamics are examined across key pillars—drivers, restraints, opportunities, and challenges—each supported by global figures. Drivers include rising disease prevalence, personalized medicine, and biologic pipeline growth. Barriers involve high treatment costs, limited awareness, and insurance restrictions. Opportunities are tied to orphan drug approvals and increased clinical research, while challenges include therapy resistance and infrastructure limitations in developing regions. Investment tracking highlights over $1.4 billion in capital inflow during 2023, spanning public grants, private equity, and institutional funding. Key areas include biologic manufacturing, trial expansion, AI-driven diagnostics, and transplant system improvements. The report also summarizes 2023–2024 developments across clinical trials, diagnostics, and public health initiatives. These include the rise of mobile nephrology apps, AI modeling for disease progression, and genomic testing for therapy alignment. Designed for use by pharmaceutical companies, clinical researchers, policymakers, and investment firms, this report provides evidence-based insights to support decision-making in one of the most complex and under-addressed segments in global renal care.