In comparison to other glomerular diseases, the prevalence of FSGS is growing fast worldwide. It is becoming as one of the primary contributors to end-stage renal disease (ESRD), as reported in a 2017 publication, in Clinical Journal of American Society of Nephrology. It accounts for approximately 20% of cases of the nephrotic syndrome in children and about 40% of cases in adults, with nearly seven being diagnosed in 1 million population. Males have 1.5 to 2 folds higher risk of developing this disease over the whole life period.
As per the NephCure, each year, about more than 5,400 patients are diagnosed with FSGS and about 20,000 patients with ESRD were earlier affected due to FSGS. In addition, people of African ancestry have five times higher diagnosis rate, and those who do not respond to the steroids move for kidney transplant or dialysis, wherein 30%-40% of patients, the FSGS disease recurs. Further, as per the University of California, the ESRD is increasing by 5% each year. With that, the need for donor's kidneys is rising by 8% each year.
Both developed and emerging markets are going through increasing demand for the kidney transplants and a higher rate of hospitalizations, due to kidney malfunction. This increases the demand to diagnose the initial stage of FSGS diseases during the treatment of kidney diseases. The recurrence of FSGS is quite frequent after the kidney transplant, and nearly half of the patients with recurrent FSGS lose their transplanted kidney within five years, as per the UNC Kidney Center, 2018. Thus, the burden of glomerulus-related disorders drives the demand for the FSGS market over the forecast period.
Key Market Trends
Primary FSGS is Expected to Register Highest CAGR in the Disease Type Segment
The primary FSGS is usually “idiopathic,” referring to 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. The current therapy for the primary FSGS includes immunosuppressive agents, such as glucocorticoids and calcineurin inhibitors. Steroid therapy is among the most basic and standard treatment with oral prednisone.
As per a 2016 publication in Biomed Research International, about 80% of cases of FSGS primary or idiopathic. Furthermore, a significant number of FSGS cases are resistant to steroid treatment, which is leading to high demand for better-targeted therapies. Some of the major emerging companies having their 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 are likely to 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. Hence, owing to the above-mentioned statements, it has been observed that the segment will have rapid growth over the forecast period.
United States to Have the Largest Share of the Market in the North America Region
The increasing prevalence of FSGS, the presence of state-of-the-art healthcare infrastructure, the high adoption rate of new healthcare technology, and presence of reimbursements are facilitating the market growth. As per the NephroCure Kidney International, about 8,000 individuals are newly diagnosed each year with FSGS and nephrotic syndrome.
It is the leading cause of kidney failure among children, and in the African-American community, this disease is five times more common. Moreover, the country is among the first choice for several manufacturers to conduct clinical trials. Majority of FSGS clinical trials have happened or are in progress in the United States, with high involvement of universities and research centers involved in the funding of the trials, dominated by drugs under trials. For FSGS, several clinical trials and approvals for clinical trials of drugs are under process, which makes this market a highly lucrative over the forecast period.
The market for FSGS Treatment is moderately consolidated and consists of the global players that are into the medical devices business that provide products related to dialysis or other diagnostics. The major pharmaceutical companies involved in this market are having their products in the pipeline and are expected to release their products in the coming years.
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