Focal Segmental Glomerulosclerosis market size and share 2020

1. Focal Segmental Glomerulosclerosis market research DelveInsight’s Focal Segmental Glomerulosclerosis Market Insights, Epidemiology, and Market Forecast—2030 report delivers an in-depth understanding of the Focal Segmental Glomerulosclerosis (FSGS), historical and forecasted epidemiology as well as the market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan. The Focal Segmental Glomerulosclerosis market report provides current treatment practices, emerging drugs and their market share of the individual therapies, current and forecasted FSGS symptoms Focal Segmental Glomerulosclerosis market Size from 2017 to 2030 segmented by seven major markets. The Report also covers current Focal Segmental Glomerulosclerosis (FSGS) symptoms treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market. Geographies Covered • The United States • EU5 (Germany, France, Italy, Spain, and the United Kingdom) • Japan Focal Segmental Glomerulosclerosis 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.The use of the word “focal” signifies that in FSGS, only some glomeruli are sclerosed, and

2. “segmental” means that only a portion of the affected glomerulus is affected. 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. 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. Commonly, it is divided into primary (idiopathic) and secondary FSGS. Primary FSGS sometimes has no identifiable cause or known etiology, and it is linked to genetic mutations in podocyte-specific proteins, whereas, secondary FSGS may occur in response to previous glomerular injury, glomerular hypertension, hypertrophy, drug toxicity, some malignancies or viral infections, obesity, and reduced renal mass. The clinical features of FSGS are the features of nephrotic syndrome and include peripheral edema, marked proteinuria, hypertension, hypoalbuminemia, hyperlipidemia, and progressive loss of renal function. FSGS is further classified as collapsing, tip, cellular, perihilar, and not otherwise specified variants according to the location and character of the sclerotic lesion. Also, primary or idiopathic FSGS is considered to be related to podocyte injury, and the pathogenesis of podocyte injury has been actively investigated. Disease presentation and associated medical conditions are beneficial to distinguish between primary and secondary FSGS. Conditions, such as infections, hypertension, and obesity, as well as proteinuria that is within nephrotic range but not accompanied by the full-blown nephrotic syndrome are suggestive of secondary FSGS. Focal segmental glomerulosclerosis Diagnosis and Treatment It covers the details of conventional and current medical therapies and diagnosis available in the Focal segmental glomerulosclerosis (FSGS) market for the treatment of 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 FSGS symptoms by including details such as disease definition, symptoms, causes, pathophysiology, and diagnosis. It also provides FSGS symptoms of treatment algorithms and treatment guidelines for FSGS symptoms in the US, Europe, and Japan. Focal segmental glomerulosclerosis (FSGS) Epidemiology The FSGS symptoms epidemiology division provides insights about the historical and current patient pool along with the forecasted trend for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

3. Key Findings The disease epidemiology covered in the report provides historical as well as forecasted FSGS epidemiology segmented as the Total prevalence of FSGS, Gender-Specific cases of FSGS, and Clinical Subtype specific cases of FSGS. The report includes the prevalent scenario of FSGS symptoms in 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2017 to 2030. 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 total prevalent population of FSGS in 7MM countries was estimated to be 202,687 in 2017. Focal segmental glomerulosclerosis (FSGS) Drug Chapters The drug chapter segment of the Focal segmental glomerulosclerosis (FSGS) report encloses the detailed analysis of FSGS marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to 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. The therapeutic market size of FSGS in the US is mainly accounted for the off-label treatment options, such as non- immune therapy in conjunction with immunotherapy. Focal segmental glomerulosclerosis (FSGS) Emerging Drugs Sparsentan: Retrophin Sparsentan is a novel investigational, dual mechanism of action that acts as potent angiotensin receptor blocker (ARB) and strongly selective endothelin receptor (ETA) antagonist, with in vitro selectivity toward endothelin receptor type A. It has also received orphan drug designation for FSGS from both FDA and EMA. Currently, it is in the phase III development for the FSGS. Focal segmental glomerulosclerosis (FSGS) Market Outlook The Focal segmental glomerulosclerosis (FSGS) market outlook of the report helps to build the detailed comprehension of the historic, current and forecasted Focal segmental glomerulosclerosis (FSGS) market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers and demand of better technology.

4. This segment gives a thorough detail of Focal segmental glomerulosclerosis (FSGS) market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of 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, Focal segmental glomerulosclerosis (FSGS) market in 7MM is expected to change in the study period 2017–2030. The current therapeutic landscape in the 7MM is divided into conventional therapies such as angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers, corticosteroids, calcineurin inhibitors (CNI) which are considered as first-line therapy for steroid-resistant nephrotic syndrome and in patients with relapsing disease, mycophenolate mofetil a third-line agent, is often used in combination with other immunosuppressants and has milder adverse reactions than CNIs, and Rituximab which are also considered as the first line of therapy followed by transplant. Key Findings This section includes a glimpse of the Focal segmental glomerulosclerosis (FSGS) market in 7MM. The market size of FSGS in the seven major markets was found to be USD 286.40 million in 2017. The United States Market Outlook This section provides the total Focal segmental glomerulosclerosis (FSGS) market size and market size by therapies in the United States. The United States accounts for the highest market size of FSGS in comparison to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan. FSGS in the US is mainly accounted for the off-label treatment options, such as non-immune therapy in conjunction with immunotherapy. The non-immune therapy includes the control of blood pressure, lipids, and weight by using angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARB) while the 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 transplant become the next treatment options. Despite these available treatments, the management of FSGS remains a challenge due to the complex causes of disease and dense pathogenesis. EU-5 Countries: Market Outlook

5. The total Focal segmental glomerulosclerosis (FSGS) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section. There is a lack of approved therapy for the treatment of Focal segmental glomerulosclerosis (FSGS), management of FSGS depends on the use of off label medications in Europe. Regardless of all available treatments, there is unsatisfied patients’ outcome under the current treatments, therefore, innovation are encouraged on the treatment strategy based on Kidney Disease, Improving Global Outcomes guideline, and international collaborations are required for the potential novel immunosuppressive or immunomodulatory therapies. Japan Market Outlook The total Focal segmental glomerulosclerosis (FSGS) market size and market size by therapies in Japan are also mentioned. Focal segmental glomerulosclerosis (FSGS) Drugs Uptake This section focusses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2017–2030. 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 allow the comparison of the drugs on the basis of Focal segmental glomerulosclerosis 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 II, and Phase III stage. It also analyses Focal segmental glomerulosclerosis (FSGS) key players involved in developing targeted therapeutics. Major players include Retrophin, Dimerix, Aurinia Pharmaceuticals, Complexa, Bristol- Myers Squibb, Reata Pharmaceuticals/ Kyowa Kirin, Astellas Pharma/Kyowa Kirin, Pfizer, Chemocentryx, ZyVersa Therapeutics and others. Currently, Sparsentan (Retrophin) designation will give an advantage in both the US and EU markets and is expected to get launch in 2022 Pipeline Development Activities The report covers the detailed information of collaborations, acquisition, and merger, licensing and patent details for Focal segmental glomerulosclerosis (FSGS) emerging therapies.

6. Reimbursement Scenario in FSGS Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we take reimbursement into consideration to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business & price strategy. According to USRDS statistics, costs of dialysis provided by Medical Centers have been estimated to exceed those in private settings, in part because patients had more comorbidities, outpatient and emergency visits, prescriptions, and longer hospital stays. KOL- Views To keep up with current market trends, we take KOLs and SME’s opinion working in Focal segmental glomerulosclerosis (FSGS) domain through primary research to fill the data gaps and validate our secondary Focal segmental glomerulosclerosis market research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Focal segmental glomerulosclerosis market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs. Competitive Intelligence Analysis We perform Competitive & Market Intelligence analysis of the Focal segmental glomerulosclerosis (FSGS) Market by using various Competitive Intelligence tools that includes –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.