Focal Segmental Glomerulosclerosis Diagnosis and Treatment Market Size
| Study Period | 2021 - 2029 |
| Base Year For Estimation | 2023 |
| CAGR (2024 - 2029) | 7.50 % |
| Fastest Growing Market | Asia-Pacific |
| Largest Market | North America |
| Market Concentration | High |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Focal Segmental Glomerulosclerosis Diagnosis and Treatment Market Analysis
The Focal Segmental Glomerulosclerosis Treatment Market is expected to register a CAGR of 7.5% during 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 Diagnosis and 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 Diagnosis and 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 Diagnosis and Treatment Market Overview
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.
Focal Segmental Glomerulosclerosis Diagnosis and Treatment Market Leaders
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B. Braun Melsungen AG
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Beckman Coulter Inc. (Danaher Corporation)
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Medtronic Plc
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Retrophin Inc.
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Complexa Inc.
*Disclaimer: Major Players sorted in no particular order
Focal Segmental Glomerulosclerosis Diagnosis and Treatment Market News
- February 2022: Goldfinch Bio announced positive preliminary data from a phase 2 clinical trial evaluating gfb-887 as a precision medicine for patients with focal segmental glomerulosclerosis (FSGS).
- September 2021: Vifor Pharma and Travere Therapeutics inked a collaboration and licensing partnership to commercialize sparsentan in Europe, Australia, and New Zealand. The drug is being made to treat FSGS and IgAN, which are both rare, progressive kidney diseases that lead to end-stage kidney disease more often than other diseases.
Focal Segmental Glomerulosclerosis Treatment Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Burden of Focal Segmental Glomerulosclerosis (FSGS)
4.2.2 High Focus on Developing New Treatment Options
4.3 Market Restraints
4.3.1 High Cost of Dialysis and Kidney Transplant
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD)
5.1 By Disease Type
5.1.1 Primary FSGS
5.1.2 Secondary FSGS
5.2 By Disease Management
5.2.1 Diagnosis
5.2.1.1 Kidney Biopsy
5.2.1.2 Creatinine Test
5.2.1.3 Other Diagnoses
5.2.2 Treatment
5.2.2.1 Drug Therapy
5.2.2.2 Dialysis
5.2.2.3 Kidney Transplant
5.3 Geography
5.3.1 North America
5.3.1.1 United States
5.3.1.2 Canada
5.3.1.3 Mexico
5.3.2 Europe
5.3.2.1 Germany
5.3.2.2 United Kingdom
5.3.2.3 France
5.3.2.4 Italy
5.3.2.5 Spain
5.3.2.6 Rest of Europe
5.3.3 Asia-Pacific
5.3.3.1 China
5.3.3.2 Japan
5.3.3.3 India
5.3.3.4 Australia
5.3.3.5 South Korea
5.3.3.6 Rest of Asia-Pacific
5.3.4 Middle East and Africa
5.3.4.1 GCC
5.3.4.2 South Africa
5.3.4.3 Rest of Middle East and Africa
5.3.5 South America
5.3.5.1 Brazil
5.3.5.2 Argentina
5.3.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 LabcorpGenetics Inc.
6.1.2 Genentech, Inc.
6.1.3 F. Hoffmann La Roche Ltd.
6.1.4 Novartis
6.1.5 Merck KgaA
6.1.6 Teva Pharmaceuticals
6.1.7 Allina Health Laboratory
6.1.8 Arkana Laboratories
6.1.9 Travere Therapeutics, Inc.
6.1.10 Vertex Pharmaceuticals Incorporated
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Focal Segmental Glomerulosclerosis Diagnosis and Treatment Market Segmentation
As per the scope of the report, focal segmental glomerulosclerosis is the progressive scarring of the kidney, which is characterized by proteinuria. It is among the rare diseases that affect kidney function by attacking and damaging the glomeruli. The focal segmental glomerulosclerosis (FSGS) treatment market is segmented by disease type (primary FSGS and secondary FSGS), disease management (diagnosis and treatment), and geography (North America, Europe, Asia-Pacific, the Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD million) for the above segments.
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Focal Segmental Glomerulosclerosis Treatment Market Research FAQs
What is the current Focal Segmental Glomerulosclerosis Treatment Market size?
The Focal Segmental Glomerulosclerosis Treatment Market is projected to register a CAGR of 7.5% during the forecast period (2024-2029)
Who are the key players in Focal Segmental Glomerulosclerosis Treatment Market?
B. Braun Melsungen AG, Beckman Coulter Inc. (Danaher Corporation), Medtronic Plc, Retrophin Inc. and Complexa Inc. are the major companies operating in the Focal Segmental Glomerulosclerosis Treatment Market.
Which is the fastest growing region in Focal Segmental Glomerulosclerosis Treatment Market?
Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Focal Segmental Glomerulosclerosis Treatment Market?
In 2024, the North America accounts for the largest market share in Focal Segmental Glomerulosclerosis Treatment Market.
What years does this Focal Segmental Glomerulosclerosis Treatment Market cover?
The report covers the Focal Segmental Glomerulosclerosis Treatment Market historical market size for years: 2021, 2022 and 2023. The report also forecasts the Focal Segmental Glomerulosclerosis Treatment Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
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