Focal Segmental Glomerulosclerosis (FSGS) - Market Insight, Epidemiology And Market Forecast - 2032

Focal Segmental Glomerulosclerosis (FSGS) - Market Insight, Epidemiology And Market Forecast - 2032

DelveInsight’s ‘focal segmental glomerulosclerosis (FSGS) – Market Insights, Epidemiology, and Market Forecast – 2032’ report delivers an in-depth understanding of the historical and forecasted epidemiology as well as the market trends of focal segmental glomerulosclerosis (FSGS) in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The focal segmental glomerulosclerosis (FSGS) market report provides current treatment practices, emerging drugs, market share of the individual therapies, current and forecasted focal segmental glomerulosclerosis (FSGS) market size from 2019 to 2032, segmented by seven major markets. The report also covers the current focal segmental glomerulosclerosis (FSGS) treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying market potential.

Geographies Covered

The United States

EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Japan

Study Period: 2019–2032

Focal segmental glomerulosclerosis (FSGS): Disease Understanding and Treatment Algorithm

Focal segmental glomerulosclerosis (FSGS) Overview

Focal segmental glomerulosclerosis (FSGS) is a well-defined histologic pattern of injury characterized by sclerosis, hyalinosis, foam-cell infiltration, vacuolization of podocytes, and podocyte precursor proliferation between glomeruli tuft and Bowman’s capsule. It is “focal” in that only some glomeruli are affected and “segmental” where only a portion of the affected glomerulus is sclerosed. It typically presents with nephrotic syndrome with characterized proteinuria and obliteration or failure of glomerular capillary loops by increased extracellular matrix in glomeruli capillary tufts. However, the capillary injury does not occupy the entire glomerulus.

The clinical features of FSGS are the features of nephrotic syndrome and include peripheral edema, marked proteinuria (with or without a nephrotic range), hypertension, hypoalbuminemia, hyperlipidemia, and progressive loss of renal function. It may be found either in primary or secondary forms.

Primary FSGS sometimes has no identifiable cause or known etiology (idiopathic) and is linked to genetic mutations in podocyte-specific proteins (e.g., membrane and podocyte slit diaphragm proteins), while secondary FSGS may occur in response to previous glomerular injury, glomerular hypertension, hypertrophy, drug toxicity (e.g., pamidronate, Adriamycin), some malignancies or viral infections (e.g., HIV infection), obesity, and reduced renal mass. FSGS is one of the most common causes of primary glomerular disease in children and adults, which may progress to end-stage renal disease (ESRD) with a relatively high risk.

FSGS is further classified as collapsing, tip, cellular, perihilar, and not otherwise specified variants according to the location and character of the sclerotic lesion. Primary or idiopathic FSGS is considered to be related to podocyte injury, and the pathogenesis of podocyte injury has been actively investigated. Several circulating factors affecting the podocyte permeability barrier have been proposed but not proven to cause FSGS. FSGS may also be caused by genetic alterations. These genes mainly regulate the slit diaphragm structure, actin cytoskeleton of podocytes, and foot process structure. The mode of inheritance and age of onset is different according to the gene involved.

Focal segmental glomerulosclerosis (FSGS) Diagnosis and Treatment

It covers the details of conventional and current medical therapies and diagnoses available in the focal segmental glomerulosclerosis (FSGS) market to treat the condition. It also provides the country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.

The DelveInsight focal segmental glomerulosclerosis (FSGS) Market Report gives a thorough understanding of focal segmental glomerulosclerosis (FSGS) by including details of disease definition, symptoms, causes, pathophysiology, and diagnosis. It also provides the treatment algorithms and treatment guidelines for focal segmental glomerulosclerosis (FSGS) in the US, Europe, and Japan.

Focal segmental glomerulosclerosis (FSGS) Epidemiology

The focal segmental glomerulosclerosis (FSGS) epidemiology division provides insights into the historical and current patient pool and the forecasted trend for every seven major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed incident patient pool, trends, and assumptions.

Key Findings

The disease epidemiology covered in the report provides historical and forecasted focal segmental glomerulosclerosis (FSGS) epidemiology segmented as the Diagnosed Prevalence of Focal Segmental Glomerulosclerosis, Gender-specific cases of Focal Segmental Glomerulosclerosis, and Type-specific cases of Focal Segmental Glomerulosclerosis. The report includes the diagnosed prevalent scenario of focal segmental glomerulosclerosis (FSGS) symptoms in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.

Country-wise focal segmental glomerulosclerosis (FSGS) Epidemiology

The epidemiology segment also provides the focal segmental glomerulosclerosis (FSGS) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

The diagnosed prevalence of focal segmental glomerulosclerosis (FSGS) population in the 7MM countries was estimated to be close to 220,000 cases in 2021.

Focal segmental glomerulosclerosis (FSGS) Drug Chapters

The drug chapter segment of the focal segmental glomerulosclerosis (FSGS) report encloses the detailed analysis of focal segmental glomerulosclerosis (FSGS) marketed drugs and late stage (Phase-III, Phase-II/III, Phase-II, and Phase-I/II) pipeline drugs. It also helps understand the focal segmental glomerulosclerosis (FSGS) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Currently, there are no FDA-approved therapies for FSGS at present. The therapeutic market size of FSGS in the US is mainly accounted for the off-label treatment options, such as nonimmune therapy in conjunction with immunotherapy. The nonimmune therapy includes the control of blood pressure, lipids, and weight by using angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARB). In contrast, immunotherapy includes corticosteroids (Prednisone), calcineurin inhibitors (Cyclosporine and Tacrolimus), Mycophenolate Mofetil, and biologics (Rituximab), as well as plasma exchange for those seriously ill patients. Moreover, in case of medication failure, dialysis and kidney transplants become the next treatment options

Products detail in the report…

Focal segmental glomerulosclerosis (FSGS) Emerging Drugs

To meet the current demands of the patient pool and to counter the unmet needs of the therapeutic market, drug developers are gradually shifting their attention toward FSGS as a possible indication for new targeted therapies.

Several companies are working robustly on many new therapies, such as Sparsentan (Travere Therapeutics), DMX-200 (Dimerix), GFB-887 (Goldfinch), VX-147 (Vertex Pharmaceuticals). The mid-stage pipeline is crowded, with several potential therapies with the imminent attention of big pharmaceutical companies for this market space.

Sparsentan (Travere Therapeutics), also known as RE-021, is a novel investigational, dual mechanism of action that acts as a potent angiotensin receptor blocker (ARB) and strongly selective endothelin receptor (ETA) antagonist, with in vitro selectivity toward endothelin receptor type. The molecule was originally discovered by Bristol-Myers Squibb and initially developed for hypertension with over 500 subjects in multiple clinical studies, revealing it as a well-tolerated drug. Later, Travere Therapeutics, formerly known as Retrophin, secured a license to Sparsentan (formerly known as DARA) as per the license agreement from Ligand Pharmaceuticals and Bristol-Myers Squibb. Sparsentan has received an Orphan Drug designation for FSGS from both FDA and EMA. In Phase II clinical studies, sparsentan effectively reduced proteinuria in patients with FSGS and achieved a continuous antiproteinuric effect in primary FSGS with early BP reduction and stable eGFR for 48 weeks. It is being evaluated in two pivotal Phase III clinical studies for rare kidney diseases such as FSGS and Immunoglobulin A nephropathy. In September 2021, Travere Therapeutics announced a successful outcome from the company’s type A meeting with the US FDA in which alignment was reached on the company’s plan to submit additional eGFR data from the ongoing pivotal Phase III DUPLEX Study of sparsentan in FSGS to support an application for accelerated approval in the first half of 2022.

DMX-200 (Dimerix) is a chemokine receptor (CCR2) blocker and is administered to patients taking irbesartan – angiotensin II type I (AT1) receptor blocker and the standard of care treatment for kidney disease as the adjunct therapy. Irbesartan stabilizes the blood pressure and decreases proteinuria. DMX-200 aims to combat the inflammation, preserving kidney function by blocking the CCR2 receptors. By adding the anti-inflammatory drug DMX-200 to irbesartan, it works in the synergetic form. The AT1R and CCR2, both G protein-coupled receptors, form functional heteromers. Simultaneous antagonism of these receptors had a beneficial effect on proteinuria, podocyte viability, and recruitment of inflammatory monocytes to the kidney. Both Irbesartan and DMX-200 have well-known safety profiles, as they have each been used safely for many years. DMX- 200 has been approved by PDMA to treat chronic hepatitis B. Currently, the company is conducting a Phase III study for FSGS. The drug had also received Orphan Designation by both EMA and FDA. The regulatory authorities claimed that if it is approved, it will significantly benefit FSGS patients and contribute to clinically relevant advantages. The company also believes it may increase kidney life by 3–5 years

Products detail in the report…

Focal segmental glomerulosclerosis (FSGS) Market Outlook

The focal segmental glomerulosclerosis (FSGS) market outlook of the report builds a detailed comprehension of the historical, current, and forecasted focal segmental glomerulosclerosis (FSGS) market trends by analyzing the impact of current therapies on the market, unmet needs, and demand for better technology.

This segment gives a thorough detail of the focal segmental glomerulosclerosis (FSGS) market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need for the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

According to DelveInsight, the focal segmental glomerulosclerosis (FSGS) market in the 7MM is expected to change in the study period 2019–2032.

Key Findings

This section includes a glimpse of the focal segmental glomerulosclerosis (FSGS) market in the 7MM. Focal segmental glomerulosclerosis (FSGS) market size in the seven major markets was approximately USD 300 million in 2021.

The United States: Market Outlook

This section provides the total segmental glomerulosclerosis (FSGS) market size and market size by focal segmental glomerulosclerosis (FSGS) therapies in the United States.

The reduction of proteinuria is essential in managing FSGS, as persistent proteinuria can lead to a higher risk of cardiovascular disease and long-term kidney damage. As FSGS often presents as nephrotic syndrome, Oral corticosteroids are the main treatment for FSGS, and this strategy is the first-line therapy for patients with proteinuria within the nephrotic range. The standard corticosteroid treatment is majorly done with oral prednisone. If proteinuria does not decrease by at least 20% from baseline after 2 months of therapy, this most likely denotes steroid resistance; then steroid therapy should be discontinued.

In the case of steroid-resistant nephrotic syndrome and patients with relapsing disease, Calcineurin inhibitors (CNIs) are recommended as the first-line therapy. Cyclosporine and Tacrolimus are CNIs that act on podocyte structure, intracellular signaling, and glomerular blood flow to decrease proteinuria. Tacrolimus is effective in patients who have a lower risk of kidney toxicity. While, Mycophenolate Mofetil, a second-line agent, is often used with other immunosuppressants and has milder adverse reactions than CNIs. However, Mycophenolate carries a risk of developing serious infections or malignancies, and there is a lack of data on the long-term efficacy of the drug. Additionally, there is a need for more long-term studies on its therapeutic effect on FSGS. Biological therapy is also used as an effective treatment option for FSGS, such as Rituximab.

The United States accounts for the highest market size of focal segmental glomerulosclerosis (FSGS) compared to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.

EU-5 Countries: Market Outlook

The total focal segmental glomerulosclerosis (FSGS) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are also mentioned.

Japan Market Outlook

The total focal segmental glomerulosclerosis (FSGS) market size and market size by therapies of focal segmental glomerulosclerosis (FSGS) in Japan are also mentioned.

Focal segmental glomerulosclerosis (FSGS) Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2019–2032. The analysis covers focal segmental glomerulosclerosis (FSGS) market uptake by drugs, patient uptake by therapies, and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size, which again will be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.

Focal segmental glomerulosclerosis (FSGS) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, and Phase I/II stage. It also analyses focal segmental glomerulosclerosis (FSGS)’s key players involved in developing targeted therapeutics.

Major players include Travere Therapeutics, Vertex Pharmaceuticals, Dimerix, and others whose key products are expected to get launched in the US market by 20XX.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for focal segmental glomerulosclerosis (FSGS) emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the focal segmental glomerulosclerosis (FSGS) domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps understand and validate current and emerging therapies treatment patterns or focal segmental glomerulosclerosis (FSGS) market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform a Competitive and Market Intelligence analysis of the focal segmental glomerulosclerosis (FSGS) market using various Competitive Intelligence tools: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

The report covers the descriptive overview of focal segmental glomerulosclerosis (FSGS), explaining its causes, signs and symptoms, pathophysiology, and currently available therapies

Comprehensive insight is provided into the focal segmental glomerulosclerosis (FSGS) epidemiology and treatment in the 7MM

Additionally, an all-inclusive account of both the current and emerging therapies for focal segmental glomerulosclerosis (FSGS) is provided, along with the assessment of new therapies, which will impact the current treatment landscape.

A detailed review of the focal segmental glomerulosclerosis (FSGS) market; historical and forecasted, is included in the report, covering drug outreach in the 7MM

The report provides an edge while developing business strategies by understanding trends shaping and driving the global focal segmental glomerulosclerosis (FSGS) market

Report Highlights

In the coming years, the focal segmental glomerulosclerosis (FSGS) market is set to change due to the rising awareness of the disease and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market

The companies and academics are working to assess challenges and seek opportunities that could influence focal segmental glomerulosclerosis (FSGS) R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.

Major players are involved in developing therapies for focal segmental glomerulosclerosis (FSGS). The launch of emerging therapies will significantly impact the focal segmental glomerulosclerosis (FSGS) market.

A better understanding of disease pathogenesis will also contribute to developing novel therapeutics for focal segmental glomerulosclerosis (FSGS).

Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competitor, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Focal segmental glomerulosclerosis (FSGS) Report Insights

Patient Population

Therapeutic Approaches

Focal segmental glomerulosclerosis (FSGS) Pipeline Analysis

Focal segmental glomerulosclerosis (FSGS) Market Size and Trends

Market Opportunities

Impact of upcoming Therapies

Focal segmental glomerulosclerosis (FSGS) Report Key Strengths

11-year Forecast

7MM Coverage

Focal segmental glomerulosclerosis (FSGS) Epidemiology Segmentation

Key Competitors

Highly Analyzed Market

Drugs Uptake

Focal segmental glomerulosclerosis (FSGS) Report Assessment

Current Treatment Practices

Unmet Needs

Pipeline Product Profiles

Market Attractiveness

Key Questions

Market Insights:

What was the market share (%) distribution, and how would it look in 2032?

What would be the focal segmental glomerulosclerosis (FSGS) total market size and market size by therapies across the 7MM during the forecast period (2019–2032)?

What are the key findings pertaining to the market across 7MM, and which country will have the largest focal segmental glomerulosclerosis (FSGS) market Size during the forecast period (2019–2032)?

At what CAGR is the focal segmental glomerulosclerosis (FSGS) market expected to grow in the 7MM during the forecast period (2019–2032)?

What would be the focal segmental glomerulosclerosis (FSGS) market outlook across the 7MM during the forecast period (2019–2032)?

What would be the focal segmental glomerulosclerosis (FSGS) market growth till 2032 and the resultant market Size in the year 2032?

How would the future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

What are the disease risk, burden, and unmet needs of focal segmental glomerulosclerosis (FSGS)?

What is the historical patient pool of focal segmental glomerulosclerosis (FSGS) in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?

What would be the forecasted patient pool of Focal segmental glomerulosclerosis (FSGS) in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?

What will be the growth opportunities in the 7MM concerning the patient population pertaining to Focal segmental glomerulosclerosis (FSGS)?

Out of all 7MM countries, which country would have the highest diagnosed prevalence of focal segmental glomerulosclerosis (FSGS) during the forecast period (2019–2032)?

At what CAGR is the population expected to grow in the 7MM during the forecast period (2019–2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

What are the current options for the treatment of focal segmental glomerulosclerosis (FSGS)?

What are the current treatment guidelines for treating focal segmental glomerulosclerosis (FSGS) in the US, Europe, and Japan?

What are the focal segmental glomerulosclerosis (FSGS) marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?

How many companies are developing therapies to treat focal segmental glomerulosclerosis (FSGS)?

How many therapies are developed by each company for the treatment of focal segmental glomerulosclerosis (FSGS)?

How many emerging therapies are in the mid-stage and late stages of development to treat focal segmental glomerulosclerosis (FSGS)?

What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to the focal segmental glomerulosclerosis (FSGS) therapies?

What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?

What are the clinical studies for focal segmental glomerulosclerosis (FSGS) and its status?

Which key designations have been granted for the emerging therapies for focal segmental glomerulosclerosis (FSGS)?

What are the global historical and forecasted markets for focal segmental glomerulosclerosis (FSGS)?

Reasons to buy

The report will help in developing business strategies by understanding trends shaping and driving the focal segmental glomerulosclerosis (FSGS) market

To understand the future market competition in the focal segmental glomerulosclerosis (FSGS) market and an Insightful review of the key market drivers and barriers.

Organize sales and marketing efforts by identifying the best opportunities for focal segmental glomerulosclerosis (FSGS) in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.

Organize sales and marketing efforts by identifying the best opportunities for the focal segmental glomerulosclerosis (FSGS) market.

To understand the future market competition in the focal segmental glomerulosclerosis (FSGS) market.