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Cystinuria Market Size, Trends, Outlook, Report, Forecast: By Disease Type: Type I Cystinuria, Type II Cystinuria, Type III Cystinuria; By Drug Type: Tiopronin, Penicillamine, Others; By Dosage Form: Solutions, Tablet, Injection, Others; By Route of Administration; By Distribution Channel; Regional Analysis; Supplier Landscape; 2024-2032
Cystinuria Market Outlook
The cystinuria market size was valued at USD 907.19 million in 2023, driven by increasing investment initiatives for research and development activities. The market size is anticipated to grow at a CAGR of 14.8% during the forecast period of 2024-2032 to achieve a value of USD 3141.8 million by 2032.
Cystinuria Market Overview
Cystinuria, a rare kidney stone disease results in the formation of cystine stones in the kidneys, bladder, and ureters. This condition is inherited from both parents through a gene defect. Symptoms of cystinuria may include blood in the urine, severe pain on one side of the back or side, nausea, vomiting, and pain in the pelvis, groin, or abdomen. Cystinuria is typically asymptomatic when no stones are present; however, symptoms will recur each time stones form in the kidneys, which is common.
The cystinuria market demand is driven by the rising incidence of the genetic condition. The market is further experiencing growth driven by increased regulatory attention and greater awareness of available treatments for this condition. This growth is further supported by expanded healthcare infrastructure investments by the government and private organizations coupled with the rise in inherited disorder prevalence. The collaborations among key players and the growing disposable income of individuals are also collectively contributing to the cystinuria market growth.
However, the lack of knowledge among healthcare professionals and people owing to the rarity of the disease and limited reimbursement in developing economies is a major factor expected to restrain the market growth. However, this lack of knowledge may help the government to develop new programs and launch initiatives to spread awareness about cystinuria. Additionally, the excessive costs associated with research and development, coupled with the scarcity of treatment options, are again expected to hinder the market growth. Stringent drug approval regulations further impede the pace of market growth. Overcoming these challenges will be crucial for sustained and robust development in the cystinuria market to relieve the patients suffering from the condition.
Promising Developments
The market is poised for significant growth driven by some interesting and promising developments in treatments and substantial investments in research for cystinuria. For instance, in January 2024, a new treatment, Advicenne's potassium bicarbonate + potassium citrate in prolonged release (PR) form is progressing through Phase III clinical development, showing potential as a treatment for cystinuria. This advancement exhibits a significant step toward addressing the therapeutic needs of those affected by this rare kidney stone disease, contributing to the rising cystinuria market share.
Increasing Research Grants
The market is driven by significant contributions through research grants. Determined researchers and their dedicated efforts backed by grants are highlighting the importance of exploring innovative solutions for this condition. For instance, the generous support from the Kiriwina Investment Company, amounting to USD 120,000 over five years, has enabled the establishment of a groundbreaking mouse model of cystinuria. Dr Malcolm Starkey received two grants to support his group’s research on cystinuria. This model, created through advanced CRISPR/Cas9 gene editing, exhibits the most common mutation causing the disease, providing a potentially strong platform for developing targeted therapies and propelling the cystinuria market demand.
These advancements reflect a growing interest and commitment within the medical community and among investors to dig deeper into understanding cystinuria and innovating treatments. The introduction of novel therapies in clinical development and substantial research funding is expected to drive the cystinuria market forward. As these initiatives progress, they promise to improve patient outcomes and potentially transform the standard of care for individuals battling cystinuria.
Clinical Trials
In December 2023, a clinical trial with Ethical Committee approval was conducted by Viola D’Ambrosio to characterize bone mineral density (BMD) in cystinuria. The study included thirty-nine patients and 40% were women, adult cystinuric patients followed at 3 specialized outpatient clinics in Italy (Rome, Naples, and Verona). The successful completion of the trial showcased a high prevalence of low BMD in cystinuric patients, despite having normal (or moderately impaired) kidney function and being relatively young.
The insights from this clinical trial highlighted the crucial gap of unmet needs in cystinuria. Such results are expected to gain traction among pharmaceutical companies to recognize the impacts of cystinuria on BMD in women along with kidney association. This may result in additional research and development of drugs and treatments to address this issue and boost the cystinuria market during the forecast period.
Cystinuria Market Segmentations
Market Breakup by Disease Type
- Type I cystinuria
- Type II cystinuria
- Type III cystinuria
Market Breakup by Drug Type
- Tiopronin
- Penicillamine
- Others
Market Breakup by Dosage Form
- Solutions
- Tablet
- Injection
- Others
Market Breakup by Route of Administration
- Oral
- Intravenous
- Topical
- Others
Market Breakup by Distribution Channel
- Hospital Pharmacy
- Online Pharmacy
- Retail Pharmacy
Market Breakup by -8MM
- United States
- EU-4 and the United Kingdom
- Germany
- France
- Italy
- Spain
- United Kingdom
- Japan
- China
Cystinuria Market Regional Analysis
The United States is dominating the region market for cystinuria and is likely to lead the global market during the forecast period of 2024-2032. The region is dominating due to the increased prevalence of cystinuria and continued research and development activities to fill a critical gap of unmet medical needs in the market. The combined efforts of researchers and companies to create and establish an appropriate yet effective treatment for patients suffering from this rare disease are poised to foster cystinuria market growth in the forecast period. For instance, In February 2023, Ethicon, a Johnson & Johnson MedTech company, announced the first patient successfully receiving robotic-assisted removal of kidney stones using the MONARCH™ Platform for Urology.
As part of a clinical study, UCI Health, the clinical enterprise of the University of California, Irvine (UCI), used the MONARCH Platform for Urology to complete the first robotically assisted electromagnetic (EM)-guided percutaneous access and mini-percutaneous nephrolithotomy (PCNL) procedure. The clinical study involves a collaboration with co-investigator, Dr. Mihir Desai from the University of Southern California (USC).
Cystinuria Market: Competitor Landscape
The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
- Retrophin
- Recordati Rare Diseases
- Mission Therapeutics
- Enterome Bioscience
- Horizon Therapeutics
- Arcturus Therapeutics
- Codexis
- Mito pharmaceuticals
- Abbott
- Bausch Health Companies
- Allena Pharmaceuticals
- Mylan N.V. (now part of Viatris)
- Chiesi Farmaceutici S.p.A.
Please note that this only represents a partial list of companies, and the complete list has been provided in the report.
Key Highlights of the Report
| REPORT FEATURES | DETAILS |
| Base Year | 2023 |
| Historical Period | 2017-2023 |
| Forecast Period | 2024-2032 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Disease Type |
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| Breakup by Drug Type |
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| Breakup by Dosage Form |
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| Breakup by Route of Administration |
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| Breakup by Distribution Channel |
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| Breakup by Region |
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| Market Dynamics |
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| Competitive Landscape |
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| Companies Covered |
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*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Cystinuria Overview
3.1 Guidelines and Stages
3.2 Pathophysiology
3.3 Screening and Diagnosis
3.4 Pathway
4 Patient Profile
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Success Rate
5 Cystinuria Epidemiology Analysis- 8 Major Markets
5.1 8MM Epidemiology Scenario Overview (2017-2032)
5.2 United States Cystinuria Epidemiology Forecast (2017-2032)
5.3 EU-4 and United Kingdom Cystinuria Epidemiology Forecast (2017-2032)
5.3.1 Germany Cystinuria Epidemiology Forecast (2017-2032)
5.3.2 France Cystinuria Epidemiology Forecast (2017-2032)
5.3.3 Italy Cystinuria Epidemiology Forecast (2017-2032)
5.3.4 Spain Cystinuria Epidemiology Forecast (2017-2032)
5.3.5 United Kingdom Cystinuria Epidemiology Forecast (2017-2032)
5.4 Japan Cystinuria Epidemiology Forecast (2017-2032)
5.5 China Cystinuria Epidemiology Forecast (2017-2032)
6 Cystinuria Market Overview – 8 Major Markets
6.1 Cystinuria Market Historical Value (2017-2023)
6.2 Cystinuria Market Forecast Value (2024-2032)
7 Cystinuria Market Landscape – 8 Major Markets
7.1 Cystinuria Market: Developers Landscape
7.1.1 Analysis by Year of Establishment
7.1.2 Analysis by Company Size
7.1.3 Analysis by Region
7.2 Cystinuria Market: Product Landscape
7.2.1 Analysis by Drug Class
7.2.2 Analysis by Route of Administration
8 Cystinuria Challenges and Unmet Needs
8.1 Pathway Challenges
8.2 Compliance and Drop-Out Analysis
8.3 Awareness and Prevention Gaps
9 Cost of Treatment
10 Cystinuria Market Dynamics
10.1 Market Drivers and Constraints
10.2 SWOT Analysis
10.3 Porter’s Five Forces Model
10.4 Key Demand Indicators
10.5 Key Price Indicators
10.6 Industry Events, Initiatives, and Trends
10.7 Value Chain Analysis
11 Cystinuria Market Segmentation – 8 Major Markets
11.1 Cystinuria Market by Disease Type
11.1.1 Market Overview
11.1.2 Type I Cystinuria
11.1.3 Type II Cystinuria
11.1.4 Type III Cystinuria
11.2 Cystinuria Market by Drug Type
11.2.1 Market Overview
11.2.2 Tiopronin
11.2.3 Penicillamine
11.2.4 Others
11.3 Cystinuria Market by Dosage Form
11.3.1 Market Overview
11.3.2 Solutions
11.3.3 Tablet
11.3.4 Injection
11.3.5 Others
11.4 Cystinuria Market by Route of Administration
11.4.1 Market Overview
11.4.2 Oral
11.4.3 Intravenous
11.4.4 Topical
11.4.5 Others
11.5 Cystinuria Market by Distribution Channel
11.5.1 Market Overview
11.5.2 Hospital Pharmacy
11.5.3 Online Pharmacy
11.5.4 Retail Pharmacy
11.6 Cystinuria Market by Region
11.6.1 Market Overview
11.6.2 United States
11.6.3 EU-4 and the United Kingdom
11.6.3.1 Germany
11.6.3.2 France
11.6.3.3 Italy
11.6.3.4 Spain
11.6.3.5 United Kingdom
11.6.4 Japan
11.6.5 China
12 United States Cystinuria Market
12.1 United States Cystinuria Market Historical Size (2017-2023)
12.2 United States Cystinuria Market Forecast Size (2024-2032)
12.3 United States Cystinuria Market by Disease Type
12.3.1 Market Overview
12.3.2 Type I Cystinuria
12.3.3 Type II Cystinuria
12.3.4 Type III Cystinuria
12.4 United States Cystinuria Market by Drug Type
12.4.1 Market Overview
12.4.2 Tiopronin
12.4.3 Penicillamine
12.4.4 Others
13 EU-4 and United Kingdom Cystinuria Market
13.1 EU-4 and United Kingdom Cystinuria Market Historical Value (2017-2023)
13.2 EU-4 and United Kingdom Cystinuria Market Forecast Value (2024-2032)
13.3 EU-4 and United Kingdom Cystinuria Market by Disease Type
13.3.1 Market Overview
13.3.2 Type I Cystinuria
13.3.3 Type II Cystinuria
13.3.4 Type III Cystinuria
13.4 EU-4 and United Kingdom Cystinuria Market by Drug Type
13.4.1 Market Overview
13.4.2 Tiopronin
13.4.3 Penicillamine
13.4.4 Others
14 Japan Cystinuria Market
14.1 Japan Cystinuria Market Historical Size (2017-2023)
14.2 Japan Cystinuria Market Forecast Size (2024-2032)
14.3 Japan Cystinuria Market by Disease Type
14.3.1 Market Overview
14.3.2 Type I Cystinuria
14.3.3 Type II Cystinuria
14.3.4 Type III Cystinuria
14.4 Japan Cystinuria Market by Drug Type
14.4.1 Market Overview
14.4.2 Tiopronin
14.4.3 Penicillamine
14.4.4 Others
15 China Cystinuria Market
15.1 China Cystinuria Market Historical Size (2017-2023)
15.2 China Cystinuria Market Forecast Size (2024-2032)
15.3 China Cystinuria Market by Disease Type
15.3.1 Market Overview
15.3.2 Type I Cystinuria
15.3.3 Type II Cystinuria
15.3.4 Type III Cystinuria
15.4 China Cystinuria Market by Drug Type
15.4.1 Market Overview
15.4.2 Tiopronin
15.4.3 Penicillamine
15.4.4 Others
16 Regulatory Framework
16.1 Regulatory Overview
16.1.1 US FDA
16.1.2 EU EMA
16.1.3 Japan PMDA
16.1.4 Others
17 Patent Analysis
17.1 Analysis by Type of Patent
17.2 Analysis by Publication year
17.3 Analysis by Issuing Authority
17.4 Analysis by Patent Age
17.5 Analysis by CPC Analysis
17.6 Analysis by Patent Valuation
17.7 Analysis by Key Players
18 Grants Analysis
18.1 Analysis by Year
18.2 Analysis by Amount Awarded
18.3 Analysis by Issuing Authority
18.4 Analysis by Grant Application
18.5 Analysis by Funding Institute
18.6 Analysis by NIH Departments
18.7 Analysis by Recipient Organization
19 Clinical Trials Analysis
19.1 Analysis by Trial Registration Year
19.2 Analysis by Trial Status
19.3 Analysis by Trial Phase
19.4 Analysis by Therapeutic Area
19.5 Analysis by Geography
20 Funding and Investment Analysis
20.1 Analysis by Funding Instances
20.2 Analysis by Type of Funding
20.3 Analysis by Funding Amount
20.4 Analysis by Leading Players
20.5 Analysis by Leading Investors
20.6 Analysis by Geography
21 Partnership and Collaborations Analysis
21.1 Analysis by Partnership Instances
21.2 Analysis by Type of Partnership
21.3 Analysis by Leading Players
21.4 Analysis by Geography
22 Supplier Landscape
22.1 Retrophin
22.1.1 Financial Analysis
22.1.2 Product Portfolio
22.1.3 Demographic Reach and Achievements
22.1.4 Mergers and Acquisitions
22.1.5 Certifications
22.2 Recordati Rare Diseases Inc.
22.2.1 Financial Analysis
22.2.2 Product Portfolio
22.2.3 Demographic Reach and Achievements
22.2.4 Mergers and Acquisitions
22.2.5 Certifications
22.3 Mission Therapeutics
22.3.1 Financial Analysis
22.3.2 Product Portfolio
22.3.3 Demographic Reach and Achievements
22.3.4 Mergers and Acquisitions
22.3.5 Certifications
22.4 Enterome Bioscience
22.4.1 Financial Analysis
22.4.2 Product Portfolio
22.4.3 Demographic Reach and Achievements
22.4.4 Mergers and Acquisitions
22.4.5 Certifications
22.5 Horizon Therapeutics
22.5.1 Financial Analysis
22.5.2 Product Portfolio
22.5.3 Demographic Reach and Achievements
22.5.4 Mergers and Acquisitions
22.5.5 Certifications
22.6 Arcturus Therapeutics
22.6.1 Financial Analysis
22.6.2 Product Portfolio
22.6.3 Demographic Reach and Achievements
22.6.4 Mergers and Acquisitions
22.6.5 Certifications
22.7 Codexis
22.7.1 Financial Analysis
22.7.2 Product Portfolio
22.7.3 Demographic Reach and Achievements
22.7.4 Mergers and Acquisitions
22.7.5 Certifications
22.8 Mito Pharmaceuticals
22.8.1 Financial Analysis
22.8.2 Product Portfolio
22.8.3 Demographic Reach and Achievements
22.8.4 Mergers and Acquisitions
22.8.5 Certifications
22.9 Abbott
22.9.1 Financial Analysis
22.9.2 Product Portfolio
22.9.3 Demographic Reach and Achievements
22.9.4 Mergers and Acquisitions
22.9.5 Certifications
22.10 Bausch Health Companies
22.10.1 Financial Analysis
22.10.2 Product Portfolio
22.10.3 Demographic Reach and Achievements
22.10.4 Mergers and Acquisitions
22.10.5 Certifications
22.11 Allena Pharmaceuticals
22.11.1 Financial Analysis
22.11.2 Product Portfolio
22.11.3 Demographic Reach and Achievements
22.11.4 Mergers and Acquisitions
22.11.5 Certifications
22.12 Mylan N.V. (now part of Viatris)
22.12.1 Financial Analysis
22.12.2 Product Portfolio
22.12.3 Demographic Reach and Achievements
22.12.4 Mergers and Acquisitions
22.12.5 Certifications
22.13 Chiesi Farmaceutici S.p.A.
22.13.1 Financial Analysis
22.13.2 Product Portfolio
22.13.3 Demographic Reach and Achievements
22.13.4 Mergers and Acquisitions
22.13.5 Certifications
23 Cystinuria Market - Distribution Model (Additional Insight)
23.1 Overview
23.2 Potential Distributors
23.3 Key Parameters for Distribution Partner Assessment
24 Key Opinion Leaders (KOL) Insights (Additional Insight)
25 Company Competitiveness Analysis (Additional Insight)
25.1 Very Small Companies
25.2 Small Companies
25.3 Mid-Sized Companies
25.4 Large Companies
25.5 Very Large Companies
26 Payment Methods (Additional Insight)
26.1 Government Funded
26.2 Private Insurance
26.3 Out-of-Pocket
*Additional insights provided are customisable as per client requirements.
* The coverage of the Market Landscape section depends on the data availability and may cover a minimum of 80% of the total market. The EMR team strives to make this section as comprehensive as possible.
Key Questions Answered in the Report
The market attained a value of about USD 907.19 million in 2023, driven by the rising incidence of the condition.
The market is anticipated to grow at a CAGR of 14.8% during the forecast period of 2024-2032 and is likely to reach a market value of USD 3141.8 million by 2032.
The major factors aiding the market demand include the increasing interest in developing targeted therapies among researchers and healthcare professionals, increasing awareness among people about the available treatments, increasing incidence of cystinuria, research and development activities, regulatory authorities such as the FDA understanding the urgency, increasing number of clinical trials, and introduction of promising treatments.
The market is influenced by trends such as researchers receiving grants to support their research in order to discover an effective and affordable treatment for cystinuria in the market.
The eight major regions of the market include the United States, EU-4, the United Kingdom, Japan, and China.
Types of cystinuria are type I, type II, and type III.
It can be cured with the help of tiopronin and penicillamine, among others.
Dosages could be solutions, tablets, and injections, among others.
Oral, intravenous, and topical, among others are the routes of administration in the market.
Distribution channels include hospital pharmacies, online pharmacies, and retail pharmacies.
Key players involved in the market are Retrophin, Recordati Rare Diseases, Mission Therapeutics, Enterome Bioscience, Horizon Therapeutics, Arcturus Therapeutics, Codexis, Mito Pharmaceuticals, Abbott, Allena Pharmaceuticals, Mylan N.V. (now part of Viatris), Chiesi Farmaceutici S.p.A., and Bausch Health Companies.
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