Focal Segmental Glomerulosclerosis (FSGS) Market - Facts About Business Strategies and Financial Status over Forecast Period 2016-2025

Focal segmental glomerulosclerosis (FSGS) is a relatively common form of kidney disease in children and adults, associated with ammasing of cholesterol and lipids in the glomerulus of the kidney. Hardening or scarring of tiny blood vessels inside the kidney is referred to as glomerulosclerosis. The key function of glomeruli is filtration of wastes in the blood and its excretion outside the body in the form of urine. Damage caused to glomeruli leads to a condition known as proteinuria, which involves leakage of blood protein into urine rather than its retention in the blood stream. Due to increase in the protein level of urine, patients develop a specific set of symptoms known as nephrotic syndrome. These include hypoalbuminemia (lower than the normal level of protein in blood), hypertension, and edema (especially in legs). Hypertension is common in case of focal segmental glomerulosclerosis (FSGS), but it is often difficult to treat. Outcome of focal segmental glomerulosclerosis (FSGS) is greatly influenced by the level or severity of proteinuria, while the prognosis for patients with nephrotic syndrome is poor. As per a report published by the Medscape journal published on October 21, 2013, approximately 70% of patients with FSGS generally present with nephrotic disorder at the time of diagnosis, while more than 35% of patients manifest progression to end-stage renal disease within 10 years.

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Currently, diagnosis tests for FSGS include physical and clinical examination, routine laboratory tests, and kidney biopsy. Routine laboratory tests include creatinine tests and urinalysis employed to check creatinine and protein levels in blood and urine respectively. Creatinine is produced by healthy muscles, but it is generally filtered out by healthy kidneys. Thus, high level of creatinine in the blood indicates inefficiency of kidneys to filter creatinine in the blood. Traces of proteins are found in the normal urine, as the large size of protein hinders it to pass through tiny kidney filters (glomeruli). Thus, presence of a high amount of protein in the urine is presumptive of damage or scarring of glomeruli, which allows leakage of protein into the urine. Since several other indications apart from FSGS may be results of proteinuria and increase of creatinine level in the blood, kidney biopsy is also carried out as a standard test to diagnose FSGS. For kidney biopsy, a needle is inserted in the kidney to extract a small tissue sample, which is analyzed under microscope to check for scarring of glomeruli.

Causes of focal segmental glomerulosclerosis (FSGS) can be classified as primary and secondary causes. The term ‘primary causes’ refers to occurrence of FSGS without any obvious reasons or causes, while the term ‘secondary causes’ refers to its occurrence due to association with other medical conditions such as congenital kidney defect, reflux nephropathy, obesity, sickle cell anemia, obstructive sleep apnea, and infections such as HIV (Human Immunodeficiency Virus). The association of FSGS with HIV is a major factor driving the focal segmental glomerulosclerosis (FSGS) market for the last few years, as HIV is one of the major infectious diseases with high prevalence across the world. At present, no specific cure or treatment for FSGS is available. However, several drugs and therapies can be used to improve kidney function and prevent edema, hypertension, and proteinuria. Dialysis (hemodialysis and peritoneal dialysis) is carried out if the patient does not respond to the drug treatment, while kidney transplantation is carried out in case of kidney failure or end stage renal disease

Increasing cases of focal segmental glomerulosclerosis (FSGS) and research and development for the use of innovative and integrative therapies such as chelation therapy and regenerative therapy to improve the renal function are factors expected to boost the FSGS market. The inefficiency in diagnosis owing to lack of specificity of laboratory tests and the limited number of renal biopsies is a major restraint for the global focal segmental glomerulosclerosis (FSGS) market. For instance, as per the U.S. census data published in 2013, between 55,000 and 133,000 people are estimated to suffer from FSGS in the U.S. alone, with only 5,400 being diagnosed every year. This is considered to be an underestimate, owing to the limited number of renal biopsies performed annually, in spite of being required for the definitive diagnosis of FSGS. High cost of dialysis and kidney transplantation is another factor that is expected to restrain the market during the forecast period.

The focal segmental glomerulosclerosis (FSGS) market has been segmented by disease type, disease management, and region. Based on disease type, the market has been segmented into primary and secondary, depending upon the cause of the disease. Based on disease management, the FSGS market has been segmented into diagnosis and treatment. The diagnosis segment has been sub-divided into creatinine test, kidney biopsy, and others. The treatment segment has been sub-segmented into drug therapy (ACE inhibitors, corticosteroids, ARBs), dialysis, kidney transplant, and others, depending on the severity of the disease. Based on region, the FSGS market has been classified into Asia Pacific (APAC), Europe, Middle East & Africa (MEA), North America (NA), and Latin America (LA).

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Key players operating in the focal segmental glomerulosclerosis (FSGS) market include Medtronic plc., Variant Pharmaceuticals, AstraZeneca, Pfizer, Inc., ChemoCentryx, Inc., Novartis AG, Nipro Corporation, Biogen, and Retrophin Inc.

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