The rare kidney disease treatment market is expected to expand at a CAGR of 6% during the forecast period of 2023 to 2030 The global market for rare kidney disease treatment market was valued at US$ 2.5 Bn in 2021. The fact that only a relatively small number of people are afflicted, the fact that the causes of the disease are unclear, the absence of diagnostic biomarkers, and the demand for sophisticated care are the primary hurdles encountered when diagnosing and treating these diseases. Diseases of the kidney and urinary tract that are extremely uncommon go by both of these names. Fabry disease, atypical hemolytic uremic syndrome, lupus nephritis, nephropathic cystinosis, renal nutcracker syndrome, and a number of other conditions are classified as rare kidney illnesses. Polycystic kidney disease, often known as PKD, is an extremely uncommon hereditary condition that affects the kidneys. This condition causes the kidneys to enlarge as a result of the development of clusters of cysts mostly within the kidneys. Enzyme replacement therapy, monoclonal antibodies, and other forms of treatment are some of the options for uncommon urinary disorders. A very uncommon venous compression condition is known as renal nutcracker syndrome. It has a predominant impact on the left renal (kidney) vein. Pain in the flank and blood in the urine are both signs that one might have this condition. The progression of the market is also being driven by an increase in the prevalence of kidney disorders and an accompanying growth in public awareness of these conditions. An increase in the world's elderly population is projected to have a positive impact on the market share of treatments for rare kidney disorders in the not-too-distant future.
Rare kidney disease, or RKD, encompasses 150 diseases. The prevalence of rare kidney disease in the U.S. and Europe is believed to be between 60 and 80 per 100,000 people. This set of symptoms is regarded to be one of the fundamental causes of renal illness, along with diabetes and other inherited kidney abnormalities, despite its low prevalence. Diabetes causes kidney damage. Due to low incidence and lack of awareness, diagnosis is sometimes delayed or inaccurate. This allows inadequate treatment management, which degrades long-term outcomes. The factors outlined above are believed to be responsible for high mortality rates and a dramatic decrease in survival rates for patients with rare renal illnesses. Because of this spike in mortality, pharmaceutical manufacturers have had to do important research to find new pharmaceuticals that can cure rare kidney illnesses.
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Untreated chronic kidney disease (CKD) affects 1 in 10 people worldwide. High blood pressure and diabetes caused 75% of kidney failure between 2015 and 2017. In 2020, the National Renal Foundation found that 35.0% of diabetics over 20 will acquire chronic kidney disease. CKD is anticipated to be the main cause of death in the U.S. in 2020, overtaking prostate cancer and breast cancer. People don't realize this health issue is an emergency. 1 in 3 adult Americans is at risk for CKD. In 2020, 1 in 3 diabetics and 1 in 5 hypertensives will develop chronic kidney disease, according to the CDC. In 2015, 30,3 million Americans have diabetes, according to the American Diabetes Association. CDC predicts 118,000 Americans initiated end-stage renal disease treatment in 2014. As more individuals learn about this ailment, more will seek therapy. 96% of people with chronic renal disease are unaware, according to the CDC. This shows renal disease's market potential. These factors should boost the market throughout the forecast period. Untreated renal abnormalities may cause serious health issues in the future. WHO estimates that 1 in 40,000 males and 1 in 20,000 females in the U.S. have Fabry disease (WHO). National Organization for Rare Disorders, Inc. reports that two persons per million have the atypical hemolytic uremic syndrome.
In the next few years, rare kidney diseases are expected to increase globally. Fabry disease, atypical hemolytic uremic syndrome, lupus nephritis, nephropathic cystinosis, renal nutcracker syndrome, polycystic kidney disease (PKD), distal renal tubular acidosis, IgA nephropathy illness are more common. Because of the challenges with typical treatments like dialysis, kidney transplantation, and biopsy, pharmaceutical companies in this field are focusing on creating drugs for rare kidney diseases. Since 2020, seven treatments for rare kidney illnesses have been approved. Galafold® (Fabry disease, EMA, 2021), LupkynisTM (Lupus Nephritis, USFDA, 2021), and SibnayalTM (distal Renal Tubular Acidosis). Over 90 possible treatments for rare kidney diseases are undergoing clinical testing, while more new leads are in the early phases of drug development. Private and public investors have shown interest in this industry due to its profit potential. Since 2020, around $4.5 billion has been invested in this area. We expect the market to grow rapidly in the near future as more candidates move to later development stages.
In 2021, enzyme replacement therapy dominated the market. Fabry disease is treated with enzyme replacement therapy. Fabry disease is predicted to be a large market segment throughout the forecast period. The disease's indication dictates this. Growth in Fabry disease diagnoses and the usage of novel therapies like chaperone therapy fuel this industry. Intensive R&D, a solid product pipeline, and increased use of substrate reduction therapies and enzyme replacement therapies will drive the segment. Galafold, Replagal, and Fabrazyme treat Fabry disease. More phase 3 items will be sold soon. A recent increase in Fabry disease diagnoses is projected to boost demand for innovative treatments.
In 2021, diagnostics contributed the most revenue. Increased blood, urine, and imaging tests are driving the market growth. Diagnosis held 55% of the renal disease market in 2021. In 2021, hospitals had a large portion of the market, and this category is expected to register the highest CAGR. In 2021, hospitals held 48% of the worldwide renal diseases market.
North America held 45% of the market for rare kidney disease medicines in 2021, according to forecasts. Fabry disease, atypical hemolytic uremic syndrome, lupus nephritis, nephropathic cystinosis, and other kidney illnesses, as well as the region's history, may explain this phenomenon. Favorable government and charitable trust funding for healthcare research, an increase in the acceptance of technologically advanced products, a surge in healthcare expenditures, and early access to advanced technologies are expected to accelerate the North American market during the forecast period. Due to big players and more U.S. product approvals. FDA dominated the region's market. Asia Pacific would have the highest CAGR for treating rare kidney illnesses, according to this estimate. The enormous patient population in India and China and the rise in awareness of rare urinary illnesses are likely to drive market growth between 2023 and 2030.
Only a few companies dominate the market for rare kidney disease treatment. Most companies invest much in R&D to create novel therapies for rare kidney diseases. Many successful organizations today have embraced expansion tactics like expanding their product offerings and merging. Firms often use product launches and approvals to expand their global footprints and product portfolios to meet consumer demand. Renal disease market participants collaborate to grow their global client base. Calliditas Therapeutics AB, GSK plc., Aurinia Pharmaceuticals, Inc., Amicus Therapeutics, Inc., Shire (Takeda Pharmaceutical Company Limited), Sanofi, Advicenne, Alexion Pharmaceuticals, Inc., Horizon Therapeutics plc, Otsuka Pharmaceutical Co., Ltd., and Reata Pharmaceuticals, Inc.
