Global Focal Segmental Glomerulosclerosis Drugs Market - 2025-2033

Focal Segmental Glomerulosclerosis Drugs Market – Industry Trends & Outlook

Focal Segmental Glomerulosclerosis Drugs Market reached US$ 972.55 million in 2024 and is expected to reach US$ 3,550.15 million by 2033, growing at a CAGR of 15.7% during the forecast period of 2025-2033.

Focal segmental glomerulosclerosis (FSGS) is a kidney disorder marked by scarring in parts of the glomeruli, the filtering units of the kidney. The disease can arise from immunological, genetic, or secondary causes such as viral infections or drug toxicity. Its management is complex due to the heterogeneity of underlying causes, and treatment strategies must be tailored to the specific form and patient characteristics.

Recent advances in understanding FSGS pathophysiology have led to the development of novel therapies targeting specific disease mechanisms. The ongoing development of targeted therapies and the adoption of precision medicine approaches present significant opportunities to improve FSGS outcomes. The management of FSGS is increasingly moving toward personalized medicine, with genetic testing and biomarker identification playing a pivotal role.

Focal Segmental Glomerulosclerosis Drugs Market Dynamics: Drivers

Increasing awareness of the FSGS

The rising awareness of rare diseases is expected to drive the market over the forecast period. Awareness campaigns by patient advocacy groups, healthcare providers, and pharmaceutical companies have led to earlier diagnosis of FSGS. Like, efforts by organizations can result in an improved understanding of rare kidney diseases, resulting in earlier interventions and better outcomes, which, in turn, increases demand for effective therapies.

For instance, the American Kidney Fund recognizes AMKD Awareness Day to better understand AMKD and discover how it may impact kidney health which is going to be held on April 29, 2025, during National Minority Health Month, AMKD Awareness Day aims to raise awareness of APOL1-mediated kidney disease (AMKD). It is associated with mutations in the apolipoprotein L1 (APOL1) gene. People with two mutations are at higher risk of developing genetic forms of kidney disease, such as focal segmental glomerulosclerosis (FSGS).

Additionally, in June 2024, NBA All-Star and Olympic Gold Medalist Alonzo Mourning stopped by the 84th Omega Psi Phi grand conclave at the Tampa Convention Center to spread kidney disease awareness as he was diagnosed with AMKD, focal segmental glomerulosclerosis in 2000.

With the rising focus on this rare disease, the companies are focusing on this core segment by raising investments and funds, which may help to increase awareness and better treatment for the patients. For instance, in March 2024, Biotech Dimerix emerged from a trading halt to announce it had received binding commitments from new and existing institutional and sophisticated investors to raise $20 million after releasing a positive long-awaited interim analysis of its ACTION3 Phase 3 trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS).

As rare diseases like FSGS gain more visibility, driven by advocacy, policy support, and targeted research, the market for rare disease drugs continues to expand, attracting more investment and accelerating drug development.

Focal Segmental Glomerulosclerosis Drugs Market Dynamics: Restraints

Premium treatment costs

The premium cost associated with focal segmental glomerulosclerosis drugs is expected to hamper the market over the forecast period. The FSGS drug market includes corticosteroids, immunosuppressants, and emerging treatments like losmapimod and sparsentan. Patients with FSGS typically need a wide range of medical services, which may include hospitalization, dialysis, and possibly kidney transplantation. This holistic approach to treatment greatly contributes to the overall costs.

For instance, according to the study conducted by NIH, the comorbidity burden was higher in FSGS. Of 308 patients with available urine protein/creatinine ratio/albumin/creatinine ratio results, 36.4% were in the nephrotic range. Mean total medical costs were higher in FSGS ($59,753 vs. $8431 PPPY; P < 0.0001), driven by outpatient costs. Nephrotic range proteinuria was associated with higher all-cause inpatient, outpatient, and prescription costs versus non-nephrotic patients (all P < 0.0001), resulting in higher costs ($70,481 vs. $36,099 PPPY; P < 0.0001).

Additionally, according to the National Kidney Foundation, the total annual health care costs were >$68,000 per patient with FSGS-attributed kidney failure, underscoring the high economic burden of this disorder and the treatments required to sustain life. Novel therapies for FSGS are needed to delay or ideally prevent the need for dialysis and transplantation after kidney failure.

Premium treatment costs for focal segmental glomerulosclerosis (FSGS) present a significant barrier to market growth by limiting patient access and creating financial challenges for healthcare systems.

Focal Segmental Glomerulosclerosis Drugs Market Segment Analysis

The global focal segmental glomerulosclerosis drugs market is segmented based on disease type, drug type, route of administration, distribution channel, and region.

Disease Type:

The primary focal segmental glomerulosclerosis disease type segment is expected to hold 71.9% of the global focal segmental glomerulosclerosis drugs market in 2024

Primary focal segmental glomerulosclerosis (FSGS) refers to a form of FSGS where the exact cause is unknown (idiopathic), and it is not secondary to any other systemic disease or condition. It is considered to be a direct disease of the kidneys, characterized by scarring (sclerosis) in parts of the glomeruli.

Primary FSGS remains a complex condition that poses challenges to diagnosis, classification, and treatment. Current treatment options in primary FSGS are often unsatisfactory. Although the underlying pathophysiology remains debated, there is a suggestion of potential autoantibody-mediated disease, which may benefit from targeted B-cell therapy with rituximab.

There is an increasing number of clinical trials for the primary FSGS, which further boosts the market. For instance, Travere Therapeutics, Inc. is in a phase 3 trial to determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis.

Additionally, Complexa, Inc. is in a phase 2 trial with a study of oral CXA-10 in primary focal segmental glomerulosclerosis. The study will be performed at approximately 25 study centers across the United States of America (USA). The recruitment period is anticipated to be up to approximately 16 months. Approximately 30 subjects will be randomized to ensure 26 subjects complete the study.

Focal Segmental Glomerulosclerosis Drugs Market Geographical Analysis

North America  46.9% of the global focal segmental glomerulosclerosis drugs market share in 2024

The incidence of the condition, developments in research and treatment choices, the operations of the healthcare system, and socioeconomic dynamics within the region all influence the demand for medications for focal segmental glomerulosclerosis (FSGS) in North America. Chronic kidney disease (CKD) and possibly end-stage renal disease (ESRD) are among the grave health effects of FSGS, a dangerous kidney illness that causes glomeruli to scar.

The need for efficient treatments for FSGS is great in North America and will only increase as knowledge of the condition expands and new treatment options become accessible, considering the disease's progressive and chronic nature. As of 2024, in the US, the reported annual incidence of nephrotic syndrome is 2-7 cases per 100,000 children younger than 16 years. The cumulative prevalence is approximately 16 cases per 100,000 individuals.

Particularly in specific North American demographic groups, FSGS is one of the main causes of nephrotic syndrome in both adults and children. In part because of improved diagnostic methods and increased provider awareness, the incidence of FSGS has been rising over the past few decades. With African Americans being disproportionately impacted, the estimated yearly prevalence of FSGS in the United States alone is 7 per million persons. The increased frequency observed in African Americans has been associated with genetic variables, including mutations in the APOL1 gene, which are more prevalent in this demographic.

Both the US and Canada possess an effective healthcare system, which has been a major factor that determines the demand for FSGS medications in North America. With highly trained medical personnel, cutting-edge medical facilities, and extensive access to diagnostic services, both nations have well-established healthcare systems. To delay the progression of the disease and enhance patient outcomes, this infrastructure makes it easier to identify and manage FSGS early.

Another driver fueling the rising demand for FSGS drugs in the US is the healthcare system's focus on development, along with offering access to the latest treatments. Patients in the region have assured the availability of cutting-edge care and clinical studies owing to the region's abundance of research centers, university hospitals, and specialty kidney care centers.

Asia Pacific is expected to hold 21.1% of the global focal segmental glomerulosclerosis drugs market in 2024

The prevalence of FSGS varies significantly throughout the nations in the Asia-Pacific region, which is home to about 4.6 billion people. The anticipated frequency of FSGS in the Asia-Pacific area in 2023 is between 1 and 5 cases per 100,000 people. This means that there are between 46,000 and 230,000 cases of FSGS in the region due to the large population. The higher end of this range is especially important in nations with high population densities like China and India, where even modest prevalence rates lead to a sizable affected population.

APAC has a higher prevalence of FSGS due to a combination of lifestyle, environmental, and genetic factors. For example, research has demonstrated that populations from South and Southeast Asia are more likely to carry specific genetic variants linked to FSGS. The increased incidence of diabetes and hypertension, which are recognized risk factors for FSGS, together with rising urbanization and lifestyle modifications, all add to the growing prevalence of this ailment in the area.

The demand for FSGS therapies is anticipated to increase as the APAC region's healthcare systems continue to advance economically. This will present new chances for pharmaceutical companies and healthcare providers to enhance patient outcomes and attend to the unmet needs of FSGS patients in this vibrant and diverse region.

Focal Segmental Glomerulosclerosis Drugs Market Major Players

The major global players in the focal segmental glomerulosclerosis drugs market include GlaxoSmithKline plc, Pfizer Inc., Travere Therapeutics, Inc., Variant Pharmaceuticals, Inc., Dimerix, Complexa Inc., ChemoCentryx Inc., AstraZeneca, Novartis AG, and Vertex Pharmaceuticals Incorporated, among others.

Focal Segmental Glomerulosclerosis Drugs Market Key Developments

In May 2025, Travere Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) had accepted its supplemental New Drug Application (sNDA) seeking traditional approval of FILSPARI (sparsentan) for treating focal segmental glomerulosclerosis (FSGS).

In April 2025, ZyVersa Therapeutics announced important updates regarding its drug candidate VAR 200 for the treatment of Focal Segmental Glomerulosclerosis (FSGS). The recent recommendations from the PARASOL initiative are anticipated to accelerate FSGS drug development by allowing a reduction in proteinuria over 24 months to serve as a surrogate endpoint for regulatory approval, eliminating the previous requirement to demonstrate long-term kidney failure outcomes.

In July 2024, Dimerix Ltd shares rose after the Independent Data Monitoring Committee (IDMC) confirmed the dose of DMX-200 to be used in adolescent patients aged 12-17 years participating in the ACTION3 clinical trial. This allows the recruitment of adolescent patients into the ACTION3 Phase 3 global clinical trial in patients with focal segmental glomerulosclerosis (FSGS).

In May 2024, Taiba acquires exclusive rights to register and commercialize DMX-200 for the treatment of Focal Segmental Glomerulosclerosis (FSGS) in the United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain, and Iraq. Taiba’s core therapeutic focus is on rare diseases and has extensive experience commercializing medicines, being the first company to provide medicines for rare diseases in the Middle East.

The global focal segmental glomerulosclerosis drugs market report delivers a detailed analysis with 70 key tables, more than 64 visually impactful figures, and 173 pages of expert insights, providing a complete view of the market landscape.