North America Focal Segmental Glomerulosclerosis Drugs Market - 2024 - 2031

Report Overview

The North America focal segmental glomerulosclerosis drugs market was valued at US$ 431.38 million in 2023 and is estimated to reach US$ 1400.15 million by 2031, growing at a CAGR of 17.3% during the forecast period from 2024-2031.

Focal segmental glomerulosclerosis drugs are the therapeutics used to treat Focal segmental glomerulosclerosis (FSGS), a disease in which scar tissue develops on the glomeruli, the small parts of the kidneys that filter waste from the blood. FSGS can be caused by a variety of conditions.

This serious condition can lead to kidney failure, which can only be treated with dialysis or kidney transplant. Treatment options for FSGS depend on the type.

Treatment for FSGS depends on the type and cause, age, and whether have other health conditions. The goal of treatment is to manage the symptoms to help maintain a good quality of life and slow scarring so that it doesn't lead to kidney failure. In some people with secondary FSGS, treating the underlying condition may stop kidney damage from progressing.

Market Dynamics: Drivers & Restraints

Rising Clinical Trials

The rising number of clinical trials for Focal Segmental Glomerulosclerosis (FSGS) plays a pivotal role in driving the market over the forecast period.

The initiation of new clinical trials allows companies to fast-track the development of novel therapies for FSGS. Successful trials reduce the time to market for new drugs, fueling rapid growth as new treatments emerge and meet previously unmet medical needs.

For instance, in November 2023, Travere Therapeutics released more data from the Phase III PROTECT and DUPLEX studies in IgA nephropathy and focal segmental glomerulosclerosis, respectively showing that treatment with Filspari (sparsentan) can preserve kidney function in these diseases. Travere Therapeutics' Phase 3 trial for sparsentan, a dual-acting endothelin and angiotensin receptor blocker, has shown promise in reducing proteinuria in FSGS patients. Positive trial results have boosted investor confidence and market anticipation for the drug's approval, accelerating its potential market entry.

Rising clinical trials attract more investment from pharmaceutical companies, biotech firms and venture capitalists. For instance, on April 1, 2024, Vertex Pharmaceuticals Incorporated released that inaxaplin (VX-147) has advanced into the Phase 3 portion of the global Phase 2/3 pivotal clinical trial in APOL1-mediated kidney disease (AMKD), where a 45 mg once daily oral dose will be compared to placebo, on top of standard of care. In addition, the trial has been expanded to include adolescents with AMKD ages 10 to 17 years. This drew significant attention from investors because Vertex demonstrated the ability to scale from trial to approval in rare diseases.

Market Opportunity

Demand for Combination Therapies

Combination therapies may create a market opportunity for the expansion of the focal segmental glomerulosclerosis drugs market.

Combination therapies for FSGS often involve a blend of corticosteroids, immunosuppressive drugs, angiotensin-converting enzyme inhibitors (ACEIs), and angiotensin receptor blockers (ARBs). These medications are frequently administered together to manage symptoms, decrease proteinuria, and slow the progression of the disease. Like, combining ACE inhibitors or ARBs with SGLT2 inhibitors can address both the proteinuria and inflammation associated with FSGS.

The reasoning for employing combination therapies stems from the necessity to target the various pathways implicated in the FSGS disease process. Corticosteroids can help control inflammation, while immunosuppressant can address specific immune system responses that contribute to kidney injury. Additionally, ACEIs and ARBs can assist in managing blood pressure and reducing the characteristic protein leakage in the urine observed in FSGS patients.

FSGS often involves immune dysregulation, fibrosis and inflammation. A combination of biologics such as rituximab (an anti-CD20 monoclonal antibody) with fibrosis-targeting agents like pamrevlumab could simultaneously target different disease mechanisms. By addressing multiple pathways involved in FSGS, combination therapies can offer more effective treatment options, driving growth in the market as they become more attractive to clinicians and patients.

Market Segment Analysis

The North America Focal Segmental Glomerulosclerosis Drugs Market is segmented based Disease Type, Drug Type, Route of Administration, and Distribution Channel.

Primary Focal Segmental Glomerulosclerosis

Primary focal segmental glomerulosclerosis in the global focal segmental glomerulosclerosis drugs market was valued at US$ 661.09 million in 2023 and is estimated to reach US$ 1950.80 million by 2031, growing at a CAGR of 15.8% during the forecast period from 2024-2031.

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 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.

Market Segmentation

By Disease Type

Primary Focal segmental glomerulosclerosis drugs*

Secondary Focal segmental glomerulosclerosis drugs

By Drugs

Corticosteroids *

Immunosuppressive Drugs

ACE inhibitors

Angiotensin Receptor Blockers

Diuretics

Others

By Route of Administration

Oral*

Parenteral

By Distribution Channel

Hospital Pharmacies *

Online Pharmacies

Retail Pharmacies

By End-User

Hospitals

Specialty Clinics

Others

Market Competitive Landscape

The major players in the market include AdvancedMD, Inc., NextGen Healthcare, MedInformatix, Inc., Oracle Health, Novarad Enterprise Healthcare Solutions, Kareo, Inc., Epic Systems Corporation, INFINITT North America Inc., and Carestream Health among others.

Why Purchase the Report?

To visualize the North America focal segmental glomerulosclerosis drugs market segmentation based on component, deployment mode, function, and usage, as well as understand key commercial assets and players.

Identify commercial opportunities by analyzing trends and co-development.

Excel data sheet with numerous data points of focal segmental glomerulosclerosis drugs market-level with all segments.

PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.

Product mapping available as Excel consisting of key products of all the major players.

The North America focal segmental glomerulosclerosis drugs market report would provide approximately 53 tables, 47 figures, and 176 pages.

Target Audience 2024

Manufacturers/ Buyers

Industry Investors/Investment Bankers

Research Professionals

Emerging Companies