요검사 시장 기회, 성장요인, 업계 동향 분석 및 예측(2026-2035년)

The Global Urinalysis Market was valued at USD 4.6 billion in 2025 and is estimated to grow at a CAGR of 5.3% to reach USD 7.7 billion by 2035.

Market expansion is supported by a rising burden of urinary tract infections across developing regions, increasing global prevalence of chronic kidney disease, and a rapidly growing elderly population. These factors are collectively strengthening the demand for routine diagnostic screening and early disease detection. Urinalysis, which evaluates the physical, chemical, and microscopic properties of urine, remains a fundamental diagnostic approach for identifying and monitoring urinary tract infections, kidney disorders, diabetes, and various metabolic abnormalities. Growing exposure to risk factors such as poor sanitation, limited access to clean drinking water, and inadequate healthcare infrastructure in developing economies is further increasing infection rates. At the same time, rising incidence of chronic diseases such as diabetes is contributing to higher susceptibility to infections, thereby expanding the patient pool. Healthcare systems are increasingly prioritizing early diagnosis and preventive care, positioning urinalysis as a core diagnostic tool. In addition, the rising global burden of chronic kidney disease is further reinforcing long-term demand for urinalysis-based testing solutions.

The consumables segment accounted for 69.5% share in 2025. This segment includes test strips, reagents, dipsticks, and other disposable testing materials used in routine urine analysis procedures. Demand remains consistently high due to the repetitive nature of diagnostic testing in hospitals, clinical laboratories, and point-of-care environments. Continuous usage cycles, driven by disease monitoring requirements and widespread screening practices, ensure stable and recurring consumption. The growing incidence of urinary tract infections, kidney-related disorders, and chronic illnesses further strengthens sustained demand for these consumable products.

The urinary tract infections segment held a share of 37.3% in 2025. This application area represents one of the most significant uses of urinalysis due to the widespread prevalence of infections across diverse population groups. Urinalysis serves as a primary diagnostic method for detecting bacterial activity and related infection markers, enabling fast and reliable identification of urinary tract infections. Rising infection rates, particularly among women, elderly individuals, and patients with underlying health conditions, continue to drive high testing volumes globally.

North America Urinalysis Market accounted for 35.7% share in 2025. The region continues to exhibit strong growth, supported by advanced healthcare infrastructure, high diagnostic awareness, and well-established disease screening practices. The growing prevalence of chronic kidney disease and other long-term health conditions is significantly contributing to increased diagnostic testing demand. A large patient base requiring continuous monitoring further reinforces the importance of urinalysis in routine healthcare workflows. The widespread availability of automated and high-throughput diagnostic systems enhances testing efficiency and accuracy, supporting improved clinical decision-making and strengthening market growth across the region.

Key players operating in the Global Urinalysis Industry include Abbott Laboratories, Roche Diagnostics, Siemens Healthineers, Thermo Fisher Scientific, Beckman Coulter, Bio-Rad Laboratories, Becton, Dickinson and Company (BD), Sysmex Corporation, QuidelOrtho Corporation, ARKRAY Inc., ACON Laboratories, Cardinal Health, DIRUI Industrial, URIT Medical, and 77 Elektronika. Companies in the urinalysis market are focusing on the development of automated and high-throughput diagnostic systems to improve testing speed, accuracy, and workflow efficiency in clinical settings. They are investing in advanced reagent technologies and digital integration to enhance result interpretation and laboratory connectivity. Expansion of point-of-care testing solutions is another key strategy, enabling faster diagnostics outside traditional laboratory environments. Strategic partnerships with healthcare providers and diagnostic laboratories are strengthening product adoption and distribution reach. Manufacturers are also emphasizing cost-effective consumable innovations to support high-volume testing requirements. In addition, continuous research and development efforts are being directed toward improving sensitivity, reducing turnaround time, and expanding test menus to cover a wider range of diseases and metabolic conditions, thereby reinforcing competitive positioning in the global market.

Table of Contents

Chapter 1 Research Methodology

• 1.1 Research approach
• 1.2 Quality commitments
  • 1.2.1 GMI AI policy and data integrity commitment
    • 1.2.1.1 Source consistency protocol
• 1.3 Research trail and confidence scoring
  • 1.3.1 Research trail components
  • 1.3.2 Scoring components
• 1.4 Data collection
  • 1.4.1 Partial list of primary sources
• 1.5 Data mining sources
  • 1.5.1 Paid sources
    • 1.5.1.1 Sources, by region
• 1.6 Base estimates and calculations
  • 1.6.1 Base year calculation for any one approach
• 1.7 Forecast model
  • 1.7.1 Quantified market impact analysis
    • 1.7.1.1 Mathematical impact of growth parameters on forecast
• 1.8 Research transparency addendum
  • 1.8.1 Source attribution framework
  • 1.8.2 Quality assurance metrics
  • 1.8.3 Our commitment to trust

Chapter 2 Executive Summary

• 2.1 Industry 360⁰ synopsis
• 2.2 Key market trends
  • 2.2.1 Product trends
  • 2.2.2 Test type trends
  • 2.2.3 Application trends
  • 2.2.4 End use trends
  • 2.2.5 Regional trends
• 2.3 CXO perspectives: Strategic imperatives

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Increasing incidence of urinary tract infection in developing regions
    • 3.2.1.2 Increasing prevalence of chronic kidney disease worldwide
    • 3.2.1.3 Increasing geriatric population
    • 3.2.1.4 High pregnancy rates
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 Low awareness about routine check-ups
    • 3.2.2.2 High R&D cost of developing instruments
  • 3.2.3 Market opportunities
    • 3.2.3.1 Development of multiparametric & biomarker-rich tests
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape (Driven by primary research)
  • 3.4.1 North America
  • 3.4.2 Europe
  • 3.4.3 Asia Pacific
  • 3.4.4 Latin America
  • 3.4.5 Middle East and Africa
• 3.5 Technology landscape (Driven by primary research)
  • 3.5.1 Current technological trends
  • 3.5.2 Emerging technologies
• 3.6 Future market trends (Driven by primary research)
• 3.7 Impact of AI and Generative AI on the market (Driven by primary research)
• 3.8 Pricing trend analysis (Driven by primary research)
• 3.9 Porter’s analysis
• 3.10 PESTEL analysis

Chapter 4 Competitive Landscape, 2025

• 4.1 Introduction
• 4.2 Company market share analysis
  • 4.2.1 Global
  • 4.2.2 North America
  • 4.2.3 Europe
  • 4.2.4 Asia Pacific
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Key developments
  • 4.6.1 Mergers and acquisitions
  • 4.6.2 Partnerships and collaborations
  • 4.6.3 New product launches
  • 4.6.4 Expansion plans

Chapter 5 Market Estimates and Forecast, By Product, 2022 - 2035 ($ Mn)

• 5.1 Key trends
• 5.2 Consumables
  • 5.2.1 Dipsticks
  • 5.2.2 Reagents
  • 5.2.3 Disposables
  • 5.2.4 Pregnancy & fertility kits
• 5.3 Instruments
  • 5.3.1 Biochemical urine analyzer
  • 5.3.2 Automated urine sediment analyzer

Chapter 6 Market Estimates and Forecast, By Test Type, 2022 - 2035 ($ Mn)

• 6.1 Key trends
• 6.2 Biochemical urinalysis
• 6.3 Sediment urinalysis
• 6.4 Pregnancy & fertility testing

Chapter 7 Market Estimates and Forecast, By Application, 2022 - 2035 ($ Mn)

• 7.1 Key trends
• 7.2 Urinary tract infections
• 7.3 Kidney disease
• 7.4 Pregnancy
• 7.5 Diabetes
• 7.6 Other applications

Chapter 8 Market Estimates and Forecast, By End Use, 2022 - 2035 ($ Mn)

• 8.1 Key trends
• 8.2 Clinical laboratories
• 8.3 Hospitals
• 8.4 Home healthcare
• 8.5 Other end users

Chapter 9 Market Estimates and Forecast, By Region, 2022 - 2035 ($ Mn)

• 9.1 Key trends
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 France
  • 9.3.4 Spain
  • 9.3.5 Italy
  • 9.3.6 Netherlands
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 Japan
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 South Korea
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Argentina
• 9.6 Middle East and Africa
  • 9.6.1 South Africa
  • 9.6.2 Saudi Arabia
  • 9.6.3 UAE

Chapter 10 Company Profiles

• 10.1 Abbott Laboratories
• 10.2 ACON Laboratories
• 10.3 ARKRAY Inc.
• 10.4 Beckman Coulter
• 10.5 Bio-Rad Laboratories
• 10.6 Becton, Dickinson and Company (BD)
• 10.7 Cardinal Health
• 10.8 DIRUI Industrial
• 10.9 QuidelOrtho Corporation
• 10.10 Roche Diagnostics
• 10.11 Siemens Healthineers
• 10.12 Sysmex Corporation
• 10.13 Thermo Fisher Scientific
• 10.14 URIT Medical
• 10.15 77 Elektronika