Hematuria Treatment Market Size & Outlook, 2026-2034

Hematuria Treatment Market Overview

The global hematuria treatment market size is estimated at USD 10.88 billion in 2025 and is projected to reach USD 14.60 billion by 2034, growing at a CAGR of 3.37% during the forecast period. Remarkable growth of the market is due to the advancements in imaging modalities, urine biomarker testing, and minimally invasive procedures that have improved early detection and treatment precision, which further supports the market expansion.

Key Market Trends & Insights

• North America held a dominant share of the global market with a market share of 44.17% in 2025.
• The Asia Pacific region is growing at the fastest pace, with a CAGR of 5.26%.
• Based on the Type, the gross hematuria segment is anticipated to register the fastest CAGR of 4.52% during the forecast period.
• By Indication, the urinary tract infection segment dominated the market in 2025, with a revenue share of 26.52%.
• Based on Treatment, the pharmacotherapy segment accounted for the largest revenue share of 68.20% in 2025.
• Based on End Users, the hospitals segment dominated the market in 2025, with a revenue share of 39.86%
• The U.S. dominates the market, valued at USD 4.23 billion in 2024 and reaching USD 4.36 billion in 2025.

Graph: U.S. Market Revenue Forecast (2022 – 2034)

Source: Straits Research

Market Size & Forecast

• 2025 Market Size: USD 10.88 billion
• 2034 Projected Market Size: USD 14.60 billion
• CAGR (2025 to 2034): 3.37%
• Dominating Region: North America
• Fastest-Growing Region: Asia Pacific

The hematuria treatment market refers to the comprehensive range of diagnostic, therapeutic, and management solutions developed to address the presence of blood in urine, a condition that may result from various underlying disorders of the urinary tract. It includes approaches for both visible or gross hematuria and non-visible or microscopic hematuria, emphasizing early detection and targeted intervention to prevent complications. The market is segmented by type, indication, treatment, and end user. Based on the indication, it covers urinary tract infection, kidney stones, urethritis, blood cancer, bladder stones, prostate cancer, cystitis, trauma, and endometriosis, each requiring specific diagnostic and therapeutic strategies. By treatment it includes pharmacotherapy, procedural or interventional therapies, and adjunctive or supportive therapies aimed at controlling symptoms, addressing underlying causes, and improving patient outcomes. By end user, the market encompasses hospitals, home care, specialty clinics, and others, such as diagnostic and ambulatory care centers. Overall, the market plays a crucial role within the urology healthcare domain, supported by technological advancements in diagnostic imaging, urine biomarker testing, and minimally invasive interventions that enhance disease management and patient care efficiency.

Latest Market Trends

Integration of Artificial Intelligence in Diagnostic Evaluation

A major trend in the hematuria treatment market is the incorporation of artificial intelligence (AI) and machine learning algorithms into diagnostic workflows. AI-powered urinalysis systems and predictive imaging tools assist clinicians in differentiating between benign and malignant causes of hematuria with higher precision. Companies have developed automated urine microscopy platforms capable of detecting red blood cell morphology abnormalities, which further supports in enabling faster triage and reducing diagnostic errors. This integration of data-driven diagnostic support improves clinical decision-making, enhances workflow efficiency, and minimizes unnecessary invasive procedures.

Shift Toward Ambulatory and Same-Day Urological Interventions

The emerging trend is the increasing preference for outpatient and same-day procedures for hematuria management. Advances in endoscopic and catheter-based technologies allow for quick cystoscopy evaluations, laser ablations, and stone removals without overnight hospital stays. This trend is supported by the expansion of ambulatory surgical centers and cost-containment initiatives by insurers. The shift toward same-day urology care increases patient convenience, reduces healthcare costs, and accelerates procedure turnover, creating a scalable care delivery model.

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Hematuria Treatment Market Driver

Technological Advancements in Diagnostic Imaging and Urine Biomarkers

Continuous innovation in non-invasive diagnostic technologies is propelling market expansion. The emergence of advanced imaging modalities such as multiparametric MRI and low-radiation CT urography, along with the development of novel urine biomarkers for early cancer detection, is transforming hematuria diagnosis. These technologies enable rapid differentiation of underlying causes and support precision-targeted treatment, improving patient outcomes and encouraging clinical adoption.

Market Restraint

Limited Awareness and Delayed Clinical Presentation

A major restraint for the hematuria treatment market is the lack of awareness among patients regarding the potential seriousness of urinary bleeding. Several individuals dismiss early symptoms or self-medicate, resulting in delayed diagnosis of underlying conditions such as bladder cancer or glomerular disease. This delayed presentation limits treatment efficiency and reduces screening volumes, particularly in low- and middle-income countries where urology awareness campaigns are minimal.

Market Opportunity

Growing Focus on Personalised and Preventive Urology

The transition toward precision medicine and preventive urology represents a major growth avenue for the hematuria treatment market. Increasing use of patient-specific risk profiling based on genetic, metabolic, and lifestyle parameters is enabling customised screening schedules and tailored treatment plans. Integration of predictive analytics and teleurology platforms allows continuous monitoring, supporting physicians to detect recurrence early and optimising therapy outcomes. This patient-centred approach is expected to foster long-term adoption of advanced diagnostic and therapeutic solutions.

Regional Analysis

North America holds the largest revenue share in 2025 at 44.17%, driven by high healthcare spending, widespread diagnostic infrastructure (advanced imaging and urology clinics), and strong reimbursement frameworks that accelerate uptake of novel diagnostic kits and minimally invasive procedures. The presence of large urology device manufacturers further concentrates market value in this region.

Market expansion in the U.S. is primarily supported by increased utilization of outpatient cystoscopy services and greater adoption of urine-based molecular tests that triage patients with painless hematuria. Private payer reimbursement for early diagnostic pathways and investment in ambulatory surgical centers have reduced time-to-treatment and encouraged volume growth for both pharmacologic and interventional therapies.

Asia Pacific Market Insights

Asia Pacific is the fastest-growing region with a CAGR of 5.26% during the forecast period, led by expanding hospital networks, rising per capita healthcare expenditure, and scale-up of point-of-care urine diagnostics in tier-2 and tier-3 cities. Growing awareness of urologic disorders through telehealth screening campaigns is increasing diagnosis rates and creating demand for both conservative and procedural treatments.

In India, growth is primarily fuelled by rapidly increasing capacity in diagnostic laboratories and a surge in low-cost, locally manufactured urine analytical devices that improve rural access. Large private hospital chains and public health screening drives focused on early detection of urinary abnormalities are expanding the treated patient pool and boosting demand for outpatient hematuria management solutions.

Pie Chart: Regional Market Share, 2025

Source: Straits Research

Europe Market Insights

The market is supported by standardized clinical guidelines for hematuria workup across several countries, high penetration of electronic health records enabling care-pathway optimization, and strong clinical trial activity in uro-oncology treatments, which indirectly increases diagnostic throughput for hematuria patients.

Germany’s market strength stems from its integrated care networks and high specialist density, which favor uptake of image-guided therapies and advanced endoscopic devices. Hospital-led comparative efficiency studies and regional reimbursement pilots for non-invasive hematuria diagnostics have encouraged hospitals to trial novel diagnostic algorithms, increasing device and pharmaceutical adoption.

Middle East & Africa Market Insights

The market in the Middle East and Africa is driven by concentrated healthcare investments in major urban centers and the rapid development of specialized urology services within private hospitals. The funding toward tertiary care facilities and the rise of medical tourism are expanding access to advanced diagnostic modalities such as cystoscopy and CT urography. Increasing adoption of minimally invasive interventional procedures, along with growing collaborations between regional hospitals and international medical device companies, is further propelling market growth across the region.

In South Africa, expansion is driven by private-sector modernization of urology suites and targeted public health education emphasizing early evaluation of visible hematuria. Strategic partnerships between local hospitals and international device suppliers are improving access to flexible cystoscopes and single-use diagnostic kits, increasing both procedural volumes and outpatient treatment options.

Latin America Market Insights

Supported by increasing integration of urology services into primary care networks, growing clinical awareness of bladder and kidney pathologies, and gradual expansion of insurance coverage that enables diagnostic follow-up for symptomatic patients, the market growth.

Argentina’s market is being propelled by community health programs that emphasize early referral for hematuria and by a growing network of private diagnostic centers offering same-day urine cytology and ultrasound. Local clinical education initiatives aimed at general practitioners have shortened referral delays, increasing diagnostic throughput and demand for both pharmacologic management and endoscopic treatments.

Type Insights

The gross hematuria segment is anticipated to register the fastest CAGR of 4.52% owing to its higher rate of clinical presentation and increased need for comprehensive diagnostic evaluation. The visible nature of blood in urine prompts faster patient reporting, leading to early hospital visits and higher utilization of diagnostic imaging and cystoscopy services. The segment also benefits from the introduction of advanced urine analyzers and real-time monitoring systems for hematuria detection in emergency departments.

The microscopic hematuria segment dominated the market in 2025 due to growing adoption of urine sediment microscopy and automated urinalysis technologies in primary care settings. Increased focus on preventive screening programs, especially among high-risk populations with hypertension and diabetes, is enhancing the early identification of asymptomatic hematuria cases.

Indication Insights

The urinary tract infection segment leads the market, with a revenue share of 26.52% as recurrent infections are among the most frequent causes of hematuria globally. Rising antimicrobial resistance has encouraged the adoption of advanced diagnostic panels and targeted antibiotic therapies, improving management outcomes.

The kidney stones segment is anticipated to register the fastest CAGR of 4.78% due to an increasing prevalence of nephrolithiasis driven by dietary changes and dehydration trends. Growing preference for non-invasive lithotripsy and advanced imaging modalities such as low-dose CT scans supports the demand for diagnostic and treatment solutions.

Treatment Insights

Pharmacotherapy dominated the treatment landscape in 2025, with a revenue share of 68.20% due to its widespread application in managing underlying causes such as infections, inflammation, and clotting disorders. Increased introduction of targeted antibiotics, antispasmodics, and novel anti-inflammatory formulations has strengthened this segment.

The procedural or interventional therapies segment is projected to register the fastest CAGR of 4.12% during the forecast period, owing to the rising use of minimally invasive surgical techniques, including cystoscopic coagulation, ureteroscopy, and lithotripsy. Growing hospital investments in image-guided and robotic-assisted platforms further enhance procedural precision and recovery outcomes.

End User Insights

Hospitals dominate the hematuria treatment market, with a revenue share of 39.86% owing to their advanced diagnostic infrastructure, multidisciplinary urology teams, and access to imaging modalities such as CT and MRI. The growing number of urology-focused centers within tertiary hospitals enhances comprehensive treatment delivery.

The specialty clinics is anticipated to register the fastest CAGR of 5.09% due to the rising demand for personalized and continuous urological care. Integration of point-of-care diagnostics and customized follow-up programs in these clinics has improved treatment adherence and patient satisfaction.

Pie Chart: Segmentation by End User in 2025 (%)

Source: Straits Research

Competitive Landscape

The global hematuria treatment market is moderately fragmented in nature due to the presence of large multinational pharmaceutical and medical device companies, along with specialized urology-focused firms and diagnostic innovators spanning hospital, clinical, and homecare channels.

MacroLux Medical Technology Co., Ltd.: An emerging market player

MacroLux Medical Technology Co., Ltd. is a medical device company based in Shenzhen, China, specializing in the development of advanced single-use endoscopic solutions for urological procedures, including cystoscopy and ureteroscopy, which are both essential in diagnosing and treating conditions associated with hematuria.

• In September 2025, MacroLux Medical entered into an exclusive global distribution partnership with Olympus Corporation to commercialize its single-use urology product line across key markets, including the U.S., Canada, Europe, and Asia-Pacific. This collaboration enabled MacroLux to leverage Olympus’s extensive global footprint and established urology network, positioning the company as an emerging innovator in minimally invasive urological care and hematuria-related diagnostic solutions.

List of key players in Hematuria Treatment Market

1. Vesica Health, Inc.
2. GSK plc
3. Vera Therapeutics, Inc. 
4. Pfizer Inc.
5. Novartis AG
6. Merck & Co., Inc.
7. Hoffmann-La Roche Ltd.
8. AstraZeneca
9. Janssen Pharmaceuticals, Inc. 
10. Danaher Corporation
11. BD
12. Siemens Healthineers AG
13. Abbott
14. Reddy’s Laboratories Ltd
15. Teva Pharmaceutical Industries Ltd
16. Others

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Strategic Initiatives

• September 2025: Vesica Health, Inc. announced that its urine-based genomic assay AssureMDx was formally included in the updated American Urological Association (AUA) guidelines for the evaluation of patients with microscopic hematuria, which marked as a key milestone for non-invasive diagnostics in the hematuria treatment market.
• August 2025: GSK plc announced that its antibiotic Gepotidacin was accepted for priority review by the U.S. Food and Drug Administration (FDA) as an oral treatment for uncomplicated urogenital gonorrhoea in patients aged 12 and above, with a Prescription Drug User Fee Act (PDUFA) target decision date set for 11 December 2025.
• October 2024: Vera Therapeutics, Inc. announced that its lead investigational therapy Atacicept achieved 96 week stability of kidney function in its Phase 2b ORIGIN study in patients with IgA nephropathy (IgAN), depicting a 66% reduction in galactose deficient IgA1, 75% resolution of hematuria, 52% reduction in proteinuria, and a mean annualised eGFR slope of  0.6 mL/min/1.73 m² per year.