Focal Segmental Glomerulosclerosis (FSGS) Treatment Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023-2028)

The focal segmental glomerulosclerosis (FSGS) treatment market is expected to register a CAGR of 7.5% over the forecast period.

Although COVID-19 infection primarily affected the lungs, the cause of the nephropathy that developed as a result of COVID-19 infection was unknown because the damage could have been caused by another virus or kidney damage.Glomerular lesions were reported in a minority of patients with COVID-19, with collapsing focal segmental glomerulosclerosis (FSGS), also called COVID-associated nephropathy (COVAN). For instance, according to an article published by UpToDate, in November 2022, COVAN patients will be presented with nephrotic-range proteinuria and acute kidney injury. Similar to HIV-associated nephropathy, COVAN occurred exclusively in Africans, and a high proportion of those tested possessed high-risk APOL1 genotypes. Furthermore, according to an article published by Elsevier in December 2021, patients with focal segmental glomerulosclerosis associated with COVID-19 were treated with corticosteroids and cyclosporine. Hence, only a minority of patients associated with glomerular lesions were affected by COVID-19, and thereby the demand for FSGS treatment was unaffected during the pandemic.

Factors such as the increasing burden of focal segmental glomerulosclerosis (FSGS) and a high focus on developing new treatment options are major factors that are expected to drive growth in the market over the forecast period. For instance, according to an article published by MedSpace in October 2022, FSGS is one of the most common causes of primary glomerular disease in adults. FSGS accounts for 35% of all cases in adults undergoing kidney biopsy for proteinuria evaluation, and up to 80% of subjects in African-American patients.Furthermore, according to an article published by the National Library of Medicine in July 2022, FSGS is a frequently encountered cause of nephrotic syndrome, accounting for 40% of cases in adults and 20% in children. Such an increasing burden of FSGS is expected to drive the growth of the studied market.

In addition, a high focus on developing new treatment options is expected to drive the growth of this market over the forecast period. For instance, in February 2021, Travere Therapeutics, Inc. provided a regulatory update for its sparsentan program in focal segmental glomerulosclerosis (FSGS). The company conducted pre-new drug application interactions with the U.S. FDA in pursuit of an accelerated approval submission in the U.S. following the achievement of the interim proteinuria endpoint in the ongoing Phase 3 DUPLEX Study of sparsentan in FSGS, as well as pre-marketing authorization application interactions with the European Medicines Agency for conditional marketing authorization and accelerated assessment consideration in Europe. Over the next few years, the growth of the market is likely to be driven by efforts to find a new way to treat FSGS.

However, the high cost of dialysis and kidney transplants is expected to hinder market growth.

Focal Segmental Glomerulosclerosis Treatment Market Trends

Primary FSGS Segment is Expected to Witness High Growth Over the Forecast Period

Primary FSGS has become one of the most common causes of idiopathic glomerular disease in adults. The primary FSGS is usually 'idiopathic,' referring to the rise of disease without any known, definite, or apparent reason. It has several prototypical characteristics and is the most common form in adolescents and young adults. For instance, according to an article published by Springer Nature Limited in January 2021, the Research Group on Progressive Renal Disease from the Ministry of Health, Labor, and Welfare of Japan reported that approximately 800 patients per year were inferred to be diagnosed with FSGS by biopsy in Japan. An international survey revealed that FSGS accounted for 19.1% of primary glomerular disease in North America, 14.9% in Europe, 6.9% in Asia, and 15.8% in Latin America. The current therapy for primary FSGS includes immunosuppressive agents such as glucocorticoids and calcineurin inhibitors. Steroid therapy is one of the most basic and common treatments for oral prednisone.Some of the significant emerging companies with potential drug candidates in the pipeline are Chemocentryx, Reata Pharmaceuticals, Retrophin Inc., and Vertex Pharmaceuticals.

Since it is a rare disease, specialty clinical-stage companies will likely get more funds and are leveraging the strategic partnership opportunities. Moreover, the companies are directing their R&D efforts toward more targeted therapies as a solution to traditional drug and surgical treatments. So, based on what has been said above, it has been seen that the segment will grow quickly over the next few years.

North America is Expected to Dominate the FSGS Treatment Market Over the Forecast Period

North America accounts for a leading market share because of the presence of a properly structured healthcare industry and the availability of reimbursement policies with wider coverage. There is an increasing prevalence of FSGS; the presence of state-of-the-art healthcare infrastructure; the high adoption rate of new healthcare technology; and the presence of reimbursements are facilitating market growth. For instance, according to an article published by Evaluate Ltd., in December 2021, around 40,000 people in the United States will have FSGS. Furthermore, according to an article published in the November 2021 issue of Clinical Kidney Journal, the high prevalence of renal biopsy registry diagnoses of FSGS potentially points to secondary or genetic causes of FSGS in Mexico. Such an increase in the prevalence of FSGS is expected to drive the market.

Moreover, the United States is among the first choices for several manufacturers to conduct clinical trials. The majority of FSGS clinical trials have occurred or are currently underway in the United States, with universities and research centers heavily involved in funding the trials, which are dominated by drugs under trial. For instance, in December 2021, Vertex Pharmaceuticals Incorporated announced that, in a Phase 2 proof-of-concept (POC) study in patients with APOL1-mediated focal segmental glomerulosclerosis (FSGS), VX-147 on top of standard of care achieved a statistically significant, substantial, and clinically meaningful mean reduction of 47.6% in the urine protein to creatinine ratio (UPCR) at Week 13 compared to baseline. VX-147 was well tolerated. Based on these results, Vertex plans to advance VX-147 into pivotal development in APOL1-mediated kidney disease, including FSGS, in quarter 1 of FY2022. Several clinical trials and drug approvals for clinical trials are currently underway for FSGS, indicating a high growth rate over the forecast period.

Focal Segmental Glomerulosclerosis Treatment Market Competitor Analysis

The focal segmental glomerulosclerosis (FSGS) treatment market is consolidated due to the presence of several companies operating globally and regionally. The competitive landscape includes an analysis of a few international and local companies that hold market shares and are well known, including B. Braun Melsungen AG, Beckman Coulter Inc., Baxter International Inc., ChemoCentryx Inc., Complexa Inc., and Pfizer Inc., among others.

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