Cystinuria Market Size, Epidemiology, In-Market Drugs Sales, Pipeline Therapies, and Regional Outlook 2025-2035

Market Overview:

The cystinuria market reached a value of USD 84.9 Million across the top 7 markets (US, EU4, UK, and Japan) in 2024. Looking forward, IMARC Group expects the top 7 major markets to reach USD 145.5 Million by 2035, exhibiting a growth rate (CAGR) of 5.05% during 2025-2035.

The cystinuria market has been comprehensively analyzed in IMARC's new report titled "Cystinuria Market Size, Epidemiology, In-Market Drugs Sales, Pipeline Therapies, and Regional Outlook 2025-2035". Cystinuria is a genetic disorder that affects the way the body processes certain amino acids, particularly cystine. It is characterized by the abnormal buildup of cystine in the urine, which can lead to the formation of stones in the bladder, kidney, and urinary tract. The main symptom of this ailment includes sharp pain in the lower back or side of the stomach. Individuals suffering from cystinuria may also experience blood in the urine (hematuria), infections or blockages of the urinary tract, nausea, vomiting, abdominal discomfort, etc. Recurrences of these indications on a regular basis may eventually cause kidney damage in patients. The diagnosis of the illness is typically made based on a person's reported symptoms, medical history, and urinalysis. An X-ray examination of the urinary tract through an intravenous pyelogram, which involves the application of dye in the bloodstream to detect the stones, is further recommended to confirm a diagnosis. A healthcare provider may also perform a sodium cyanide-nitroprusside test for a simple, rapid, and qualitative evaluation of cystine concentrations in the body.

The rising cases of an inheritable autosomal recessive genetic abnormality that affects cystine reabsorption in the proximal renal tubule are primarily driving the cystinuria market. In addition to this, the inflating utilization of alkalinizing agents, such as acetazolamide and potassium citrate, which work by increasing the pH of urine, thereby making cystine more soluble, is also augmenting the market growth. Moreover, the widespread adoption of extracorporeal shock wave lithotripsy to treat this disease owing to its numerous benefits, including a lower risk of complications, a fast recovery time, improved outcomes in patients, etc., is further creating a positive outlook for the market. Additionally, various key players are making extensive investments in research activities to launch novel genetic counseling techniques that provide guidance on diagnosis and treatment options. This, in turn, is acting as another significant growth-inducing factor. Furthermore, the escalating usage of laser therapy, which involves the insertion of a flexible ureteroscope through the urethra to precisely allow the fragmentation of stones into tiny pieces that can be easily passed down the urinary tract, is expected to drive the cystinuria market in the coming years.

IMARC Group's new report provides an exhaustive analysis of the cystinuria market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for cystinuria and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the cystinuria market in any manner.

Recent Developments:

• In March 2024, Advicenne (Euronext Growth Paris ALDVI - FR0013296746) disclosed that it had received Orphan Drug Designation (ODD) for its unique medication ADV7103, which treats cystinuria. The US FDA issued this designation.

Key Highlights:

• The incidence of cystinuria is approximately one in every 7,000 people worldwide, including in the United States.
• The prevalence is 1 per 100,000 in Sweden, 1 per 18,000 in Japan, 1 per 4,000 in Australia, 1 per 2,500 in Israel, and 1 per 2,000 in the United Kingdom and Spain.
• In cystinuric stone formers, the average patient produces one stone every one to two years, has one surgical treatment every three years, and has undergone seven surgeries by the time they are middle-aged.
• Cystine stones have the highest 5-year recurrence rate of any stone type (83%).
• Men experience this illness approximately twice as often as women. The average age at which the first cystine stone is formed is 22 years old, while 22% of cystinuria patients develop calculi when still youngsters.
• Although the overall likelihood of any degree of renal injury or failure is considerable (up to 70%), cystinuria individuals have a modest risk of end-stage renal failure (less than 5%).

Drugs:

Thiola EC is a prescription drug that comes as a delayed-release tablet. It is used in conjunction with high fluid intake, alkali (low acid), and dietary adjustments to assist avoid the production of one type of kidney stone (cystine) in select adult and pediatric patients who weigh at least 44 pounds (20 kg) who do not react to these measures alone.

Time Period of the Study

• Base Year: 2024
• Historical Period: 2019-2024
• Market Forecast: 2025-2035

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan

Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the cystinuria market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the cystinuria market
• Reimbursement scenario in the market
• In-market and pipeline drugs

Competitive Landscape:

This report also provides a detailed analysis of the current cystinuria marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:

Market Insights

• How has the Cystinuria market performed so far and how will it perform in the coming years?
• What are the markets shares of various therapeutic segments in 2024 and how are they expected to perform till 2035?
• What was the country-wise size of the Cystinuria across the seven major markets in 2024 and what will it look like in 2035?
• What is the growth rate of the Cystinuria across the seven major markets and what will be the expected growth over the next ten years?
• What are the key unmet needs in the market?

Epidemiology Insights

• What is the number of prevalent cases (2019-2035) of Cystinuria across the seven major markets?
• What is the number of prevalent cases (2019-2035) of Cystinuria by age across the seven major markets?
• What is the number of prevalent cases (2019-2035) of Cystinuria by gender across the seven major markets?
• How many patients are diagnosed (2019-2035) with Cystinuria across the seven major markets?
• What is the size of the Cystinuria’ patient pool (2019-2024) across the seven major markets?
• What would be the forecasted patient pool (2025-2035) across the seven major markets?
• What are the key factors driving the epidemiological trend of Cystinuria?
• What will be the growth rate of patients across the seven major markets?

Cystinuria: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

• What are the current marketed drugs and what are their market performance?
• What are the key pipeline drugs and how are they expected to perform in the coming years?
• How safe are the current marketed drugs and what are their efficacies?
• How safe are the late-stage pipeline drugs and what are their efficacies?
• What are the current treatment guidelines for Cystinuria drugs across the seven major markets?
• Who are the key companies in the market and what are their market shares?
• What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the Cystinuria market?
• What are the key regulatory events related to the Cystinuria market?
• What is the structure of clinical trial landscape by status related to the Cystinuria market?
• What is the structure of clinical trial landscape by phase related to the Cystinuria market?
• What is the structure of clinical trial landscape by route of administration related to the Cystinuria market?