Cystinuria Treatment Market Size, Share, Industry, Forecast and outlook (2024-2031)

Global Cystinuria Treatment Market is Segmented By Type(Cystinuria Type 1, Cystinuria Type 2, Cystinuria Type 3), By Drugs(Tiopronin (Thiola), Penicillamine, Captopril, Others), By Route of Administration(Oral, Injectables), By Distribution Channel(Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023 - 2030

Market Overview

The global cystinuria treatment market reached USD 110.7 million in 2022 and is expected to reach USD 153.8  million by 2030 growing with a CAGR of 4.3% during the forecast period 2023-2030.  The cystinuria treatment market trends show rising research owing to the rising technological advancements and research studies. ​

Furthermore, rising adoption of drugs for cystinuria treatment due to the rising availability of approved drugs, and increase in the number of cystinuria cases in the market, and an increase in the research and development is driving up the cystinuria treatment market size. 

The market is experiencing a growth in demand for treatment from North American areas as a result of the rising advancements in this field. With significant competitors like Travere Therapeutics, Inc., Dr. Reddy’s Laboratories Ltd., Advicenne, and Viatris Inc. actively operating in the market.

Market Scope

Market Dynamics

Growing Research and Development by Key Players Drive the Growth of the Cystinuria Treatment Market

Several clinical trials are taking place currently and resulting in positive outcomes. A recent study on 48 individuals with cystinuria found that patients lacking stone events had much higher cystine capacities than patients who had stone events, and that there was a clear inverse relationship between cystine capacities and stone activity. Preliminary data on 26 patients with cystinuria participating in the Consortium of Rare Kidney Stone have also been made public as part of an ongoing investigation. 

Patients with a positive cystine capacity had higher urine amounts, lower 24-hour cystine elimination levels, and increased urine pH, it was discovered. Furthermore, urologic stone removal, the development of a fresh stone, and stone passage with no intervention were all much less common in patients who had positive cystine capacity. A more dependable and precise technique to monitor people who have cystinuria and gauge how well they are responding to treatment appears to be cystine capacity. The market is predicted to take the lead throughout the forecast period owing to high research studies. 

Rising Collaboration by Key Players or Several Organizations Creates Opportunities for the Growth of the Market

As a result of years of study, a number of major manufacturers or organizations are now developing or studying several products for their therapeutic effects in cystinuria, which is promoting the expansion of the cystinuria treatment market. A clinical investigation that is sponsored by an FDA and NIH cooperation and run jointly by Drs. Chi and Stoller in which lipoid acid will be used to treat individuals with cystinuria and assess its impact on their blood, urine, and kidney stones. The experiment will be randomized, double-blind, and placebo-controlled. 

A naturally occurring substance called lipoic acid has shown outstanding results in a mouse model of cystinuria while being safe for people.  Almost all of the mice with cystinuria ceased generating new stones when the supplement was administered to them. In particular, the supplement may lessen the amount of medication needed, the frequency of stone occurrences resulting in hospitalizations and related operations, as well as aiding in the long-term maintenance of kidney function. Such research collaborations may help in providing treatment for cystinuria.

Side Effects Associated with Drugs for Cystinuria Treatment will hamper the growth of the market 

However, due to their, adverse effect profile, high cost, which includes drug sensitivity responses, nephrotic range proteinuria which is secondary to membranous nephropathy, and extremely rare abnormalities in the liver and hematologic disturbances, among which are thrombocytopenia and neutropenia, their use is restricted to cases that are resistant to conservative therapy. Tolvaptan, a vasopressin receptor antagonist, has been demonstrated to significantly increase urine volume in animal models to inhibit the development of cystine stones. 

While it seems safe and helpful for people who develop kidney stones due to cystinuria and other conditions, there are worries regarding potential hepatic toxicity because three incidences of potentially severe liver damage have been observed. It indicates that dosage, the existence of pre-existing liver conditions, or polycystic kidney disease with autosomal dominance are all associated with liver toxicity. According to FDA regulations, usage is currently restricted to 30 days. These factors are restricting the cystinuria market’s growth.

Segment Analysis

The global cystinuria treatment market is segmented based type, drugs, route of administration, distribution channel, and region.

Owing to High Demand, the Tiopronin from Drugs Segment Accounted for Approximately 53.2% of the Cystinuria Treatment Market Share

The tiopronin category from drugs held the largest market share in 2022 and is expected to maintain its dominance over the forecast period due to a growth in cystinuria treatment worldwide. A thiol medication on prescription, tiopronin is primarily used to treat severe homozygous cystinuria. Patients who have cystinuria have substantial quantities of cystine excreted through their urine and are susceptible to developing kidney stones. 

To regulate the amount of cystine excretion and precipitation and stop the development of kidney stones, tiopronin is utilized as a second-line medication. After the non-pharmacological initial treatment involving higher fluid intake, protein and sodium restriction, and urinary alkalinization fail, it is utilized. Tiopronin is categorized as an orphan medicine and is not patentable in the United States because cystinuria is a condition that is relatively uncommon. In terms of use and effectiveness, it is comparable to d-penicillamine but has the benefit of having much less side effects.

Source: DataM Intelligence Analysis (2023)

Geographical Penetration

North America Accounted for Approximately 41.7% of the Market Share in 2022, Owing to the Strong Presence of Major Players and Increasing Healthcare Infrastructure Investment

Due to the rising need for cystinuria treatment in healthcare, manufacturers in North America have chances of increasing their operations. There are many producers and suppliers in North America and owing to the quick economic growth of the region, industrial production has expanded, driving the demand for drugs for cystinuria. 

Increasing expenditure on healthcare and rising adoption among patients, advancement of technologies for treatment, and increase in pharmaceutical business establishment across the region are also contributing to the growth of cystinuria treatment market share of this region. 

It is also anticipated that the main healthcare organizations' and enterprises' collaborative research projects as well as new product development, which constantly seeks to improve available alternatives, will contribute to the expanding demand. Individuals are becoming more aware of various types of drugs for cystinuria that are being utilized for management purposes, leading to the expansion of the market in this region. The above-mentioned factors further proves the dominance of North America on a global scale.

Source: DataM Intelligence Analysis (2023)

Major Key Players

The major global players in the cystinuria treatment market include Travere Therapeutics, Inc., Dr. Reddy’s Laboratories Ltd., Advicenne, Teva Pharmaceutical Industries Ltd., ANI Pharmaceuticals, Inc., Viatris Inc., AdvaCare Pharma, Camber Pharmaceuticals, Inc., Bausch Health Companies Inc., and Panacea Biotec among others. 

COVID-19 Impact Analysis

Russia-Ukraine Conflict Analysis

Due to the low prevalence as well as absence of major market participants in this region, it is predicted that the Russia-Ukraine conflict will not have a significant effect on the worldwide cystinuria treatment market. The growth of the global cystinuria treatment market, however, is anticipated to be relatively unaffected by the import and export of raw materials over the forecast period.

By Type

• Cystinuria Type 1 
• Cystinuria Type 2
• Cystinuria Type 3

By Drugs

• Tiopronin (Thiola)
• Penicillamine
• Captopril 
• Others

By Route of Administration

• Oral 
• Injectables

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region

• North America
  • The U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
• Middle East and Africa

Key Developments

• On November 28, 2022, an announcement was made by an established pharmaceutical company, Lupin Limited, stating that its fully owned Brazilian subsidiary, MedQumica Indstria Farmacêutica, has signed a binding contract to buy all of the rights to nine drugs from BL Indstria tica Ltda., a division of Bausch Health Companies Inc.
• On May 17, 2021, the first generic version of THIOLA (tiopronin) tablets to be made available in the United States has been released by Teva Pharmaceuticals, a subsidiary of Teva Pharmaceutical Industries Ltd. It is intended to be used in conjunction with elevated fluid intake, alkali, or diet modification to prevent the formation of cystine (kidney) stones in adults and pediatric patients with severe homozygous cystinuria who are older than 9 years old and are not responsive to these treatments alone.
• On March 2, 2021, Penicillamine Tablets USP, 250 mg were launched by pharmaceutical giant Lupin Limited after receiving FDA (United States Food and Drug Administration) approval. The generic version of Depen Tablets, 250 mg, made by Mylan Specialty, L.P., is Penicillamine Tablets USP, 250 mg. When patients with significant, active rheumatoid arthritis have not responded to enough trials of conventional medication, it is used to treat those conditions as well as Wilson's disease, cystinuria, and others.  

Why Purchase the Report?

• To visualize the global cystinuria treatment market segmentation based on type, drugs, route of administration, distribution channel, and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development. 
• Excel data sheet with numerous data points of cystinuria treatment market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global cystinuria treatment market report would provide approximately 53 tables, 54 figures, and 195 Pages.

DMI Opinion:

The global cystinuria market is going to see decent growth in upcoming years owing to rising incidence of cystinuria and novel product launches. Several researches are taking place worldwide for treatment of cystinuria. Numerous advances are taking place leading to the growth of market. According to DMI, the cystinuria market will see a decent growth with several novel treatments in the market.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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