혈뇨 치료 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the hematuria treatment market size is projected to expand from USD 1.14 billion in 2025 and USD 1.18 billion in 2026 to USD 1.37 billion by 2031, registering a CAGR of 3.12% between 2026 to 2031.

This report is Segmented by Hematuria Type (Gross, Microscopic), Treatment Type (Pharmacotherapy, Procedural and Interventional, Adjunctive and Supportive), Cause (UTI, Urolithiasis, Bladder Cancer, BPH, Glomerular Disorders, Iatrogenic), End User (Hospitals, Urology Clinics, Ascs, Others), and Geography (North America, Europe, Asia-Pacific, MEA, South America). Forecasts in Value (USD).

Global Hematuria Treatment Market Trends and Insights

Rising Burden of Urological Disorders and Hematuria-Linked Conditions

The hematuria treatment market is driven by the high prevalence of conditions associated with blood in urine. In 2025, bladder cancer had an age-standardized incidence rate of 6.35 per 100,000 persons. Urinary tract infections were the only major urological disease among six studied to show both rising incidence and mortality from 1990 to 2025. Urolithiasis affected 105.98 million people globally in 2025, with the disease burden concentrated in the 50 to 65 age group, aligning with those undergoing hematuria evaluations. Smoking caused 26.48% of global bladder cancer deaths and 28.15% of bladder cancer DALYs in 2025, linking future demand for hematuria treatments to tobacco-heavy regions like Southeast Asia and Sub-Saharan Africa. Additionally, high BMI contributed to 20.07% of kidney cancer deaths in 2025, reinforcing the need for evaluations and treatments in the hematuria market.

Wider Use of Risk-Stratified Hematuria Pathways in Routine Care

The hematuria treatment market is evolving with the adoption of risk-based evaluations. The AUA/SUFU 2025 Microhematuria Guideline Amendment categorized evaluations into negligible, low, intermediate, and high-risk groups. This approach reduced unnecessary cystoscopies for lower-risk patients while focusing on those with higher malignancy risks. The updated framework supports repeat urinalysis at six months for negligible-risk patients, extending outpatient contact points and reducing reliance on immediate procedural escalation. This shift emphasizes structured triage and follow-up testing, reshaping the market dynamics.

Guideline-Driven Reduction in Unnecessary Testing for Low-Risk Patients

A key restraint in the hematuria treatment market is the strategic reduction of invasive testing for low-risk patients. The AUA 2025 amendment recommends repeat urinalysis within 6 months instead of immediate cystoscopy for negligible-risk patients, directly reducing near-term procedure demand in this group. The guideline also highlights that cancer detection rates in low-risk groups range from 0% to 0.4% over a median follow-up of 26 months, weakening the justification for broad invasive workups at initial presentation. While this does not eliminate demand, it shifts spending toward observation, repeat urinalysis, and selective escalation, slowing procedural revenue growth in lower-risk populations while higher-risk pathways remain active.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Urine-Based Biomarker Use in Intermediate-Risk Hematuria Patients
2. Growth of Outpatient, Lower-Acuity Evaluation Pathways
3. High Dependence on Cystoscopy and Imaging Infrastructure for Definitive Workup

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

In 2025, gross hematuria accounted for a 56.6% market share, highlighting its tendency to prompt immediate referrals and evaluations in emergency and urology settings. Patients with gross hematuria often undergo cystoscopy and upper-tract imaging, leading to a more intense procedural focus. However, the market sees greater long-term growth potential in microscopic hematuria, projected to expand at a 3.66% CAGR through 2031. A 2024 prevalence study highlighted that 34.1% of a surveyed adult cohort exhibited asymptomatic microscopic hematuria, a finding echoed by managed care data over a two-year span.

This is significant as the microscopic hematuria demographic offers the treatment market a broader base for recurring follow-ups compared to its gross counterpart. The 2025 AUA guideline shifted its approach, suggesting a 6-month repeat urinalysis for low-risk microhematuria, rather than an immediate invasive evaluation. This change potentially extends the duration patients remain within monitored care pathways. Given the emphasis on consistent urine microscopy and evaluations, standardized laboratory handling becomes paramount. Thus, while microscopic hematuria may seem less urgent initially, it proves to be a more sustainable focus for the treatment industry, as patients frequently return for monitoring, reclassification, and potential escalation of care.

In 2025, pharmacotherapy dominated the market with a 36.75% share, driven by antibiotics for urinary tract infections, agents for symptom relief, and intravesical therapies for bladder-cancer-related hematuria. Despite this lead, procedural and interventional therapies are growing faster, with a projected 3.95% CAGR through 2031. The FDA approved Zusduri, an intravesical mitomycin solution from UroGen Pharma, in 2025 for recurrent low-grade, intermediate-risk, non-muscle invasive bladder cancer. This approval was supported by the ENVISION trial, which reported a 78% complete response rate at 3 months, with 79% maintaining their status for a year or more.

Later in 2025, the FDA approved Inlexzo, a gemcitabine intravesical system from Janssen Biotech, for BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ. The SunRISe-1 trial highlighted an 82% complete response rate, marking it as the highest for any approved therapy in this category at the time. These approvals broaden treatment options and enhance pricing leverage for patients needing more than just antibiotics or basic care. Supportive therapies like bladder irrigation and anticoagulant management play a crucial role, bridging the gap between standard infection treatments and premium cancer interventions.

Complete Report Scope:

• By Hematuria Type
  • Gross Hematuria
  • Microscopic Hematuria
• By Treatment Type
  • Pharmacotherapy
  • Procedural and Interventional Therapies
  • Adjunctive and Supportive Therapies
• By Cause
  • Urinary Tract Infection
  • Urolithiasis
  • Bladder Cancer and Upper Tract Urothelial Cancer
  • Benign Prostatic Hyperplasia
  • Glomerular and Renal Disorders
  • Iatrogenic and Anticoagulant-Associated Hematuria
• By End User
  • Hospitals
  • Specialty Urology Clinics
  • Ambulatory Surgical Centers
  • Diagnostic Laboratories
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

In 2025, North America led the hematuria treatment market with a 41.25% share, driven by high awareness of urological cancers, better access to specialists, and rapid adoption of new therapies. The United States remained the primary revenue contributor, supported by two FDA approvals for intravesical therapies critical to managing bladder cancer-associated hematuria. Additionally, hematuria affected 8% to 11% of men over 40 with benign prostatic hyperplasia, ensuring steady demand for treatments beyond oncology.

Asia-Pacific is the fastest-growing region in the hematuria treatment market, with a projected 4.88% CAGR through 2031. Japan plays a key role, as national health checks identify 5% to 10% of the population as urine dipstick positive for hematuria, creating a consistent diagnostic funnel. In 2025, Ferring reported a 75% complete response rate for ADSTILADRIN in Phase 3 trials for BCG-unresponsive non-muscle invasive bladder cancer, enhancing the treatment outlook. China also contributes significantly, with Phase 3 data showing blue light cystoscopy with Hexvix improves bladder cancer detection compared to white light cystoscopy.

Europe remains a major market due to reimbursement systems in large countries that support cystoscopy, pathology, and intravesical therapies in routine care. The region benefits from established hospital and laboratory networks, ensuring smooth transitions from detection to treatment. Although growth is slower than in Asia-Pacific, standardized clinical pathways and high specialist evaluation rates maintain Europe's market appeal. The Middle East, Africa, and South America, while smaller in market value, offer growth potential as urology infrastructure improves and more patients transition from underdiagnosis to formal treatment.

1. Abbott Laboratories
2. Amneal Pharmaceuticals
3. Astellas Pharma
4. Boston Scientific
5. Bristol-Myers Squibb
6. Cipla
7. Cook Group
8. Dr. Reddy's Laboratories
9. Roche
10. Ferring Pharmaceuticals
11. GlaxoSmithKline
12. Johnson & Johnson
13. Karl Storz SE and Co. KG
14. Merck
15. Novartis
16. Olympus
17. Pacific Edge
18. Pfizer
19. Photocure ASA

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET LANDSCAPE

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Burden of Urological Disorders and Hematuria-Linked Complications
  • 4.2.2 Wider Use of Risk-Stratified Hematuria Pathways in Routine Urology Practice
  • 4.2.3 Expansion of Urine-Based Biomarker Use in Intermediate-Risk Evaluation
  • 4.2.4 Growth of Outpatient, Lower-Acuity Evaluation Pathways for Stable Patients
  • 4.2.5 Delayed Referral and Under-Evaluation of Women and Older Adults in Primary Care
  • 4.2.6 Rising Need for Cause-Specific Management Beyond Empiric Symptom Treatment
• 4.3 Market Restraints
  • 4.3.1 Guideline-Driven Reduction in Unnecessary Testing for Low-Risk Patients
  • 4.3.2 Limited Clinical Acceptance of Urinary Biomarkers in Initial Workups
  • 4.3.3 High Dependence on Cystoscopy and Imaging Infrastructure
  • 4.3.4 Treatment Heterogeneity Linked to the Underlying Cause of Hematuria
• 4.4 Value/Supply Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Hematuria Type
  • 5.1.1 Gross Hematuria
  • 5.1.2 Microscopic Hematuria
• 5.2 By Treatment Type
  • 5.2.1 Pharmacotherapy
  • 5.2.2 Procedural and Interventional Therapies
  • 5.2.3 Adjunctive and Supportive Therapies
• 5.3 By Cause
  • 5.3.1 Urinary Tract Infection
  • 5.3.2 Urolithiasis
  • 5.3.3 Bladder Cancer and Upper Tract Urothelial Cancer
  • 5.3.4 Benign Prostatic Hyperplasia
  • 5.3.5 Glomerular and Renal Disorders
  • 5.3.6 Iatrogenic and Anticoagulant-Associated Hematuria
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Specialty Urology Clinics
  • 5.4.3 Ambulatory Surgical Centers
  • 5.4.4 Diagnostic Laboratories
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Amneal Pharmaceuticals LLC
  • 6.3.3 Astellas Pharma Inc.
  • 6.3.4 Boston Scientific Corporation
  • 6.3.5 Bristol-Myers Squibb Company
  • 6.3.6 Cipla Limited
  • 6.3.7 Cook Medical LLC
  • 6.3.8 Dr. Reddy's Laboratories Limited
  • 6.3.9 F. Hoffmann-La Roche Ltd
  • 6.3.10 Ferring Pharmaceuticals Inc.
  • 6.3.11 GSK plc
  • 6.3.12 Johnson and Johnson
  • 6.3.13 Karl Storz SE and Co. KG
  • 6.3.14 Merck and Co., Inc.
  • 6.3.15 Novartis AG
  • 6.3.16 Olympus Corporation
  • 6.3.17 Pacific Edge Limited
  • 6.3.18 Pfizer Inc.
  • 6.3.19 Photocure ASA

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment