Urinalysis Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global urinalysis market growth forecasted to transform from $4.3 billion in 2024 to $6.8 billion by 2029, driven by a CAGR of 9.6%. This market has grown significantly over the last few years due to the increasing adoption of PoC testing products in home care and hospitals. The convenience of these tools has driven their adoption, particularly considering the rising prevalence of chronic and lifestyle diseases, technological advancements in PoC testing products, growing patient awareness of PoC testing, shortage of technicians to conduct conventional lab tests, and the rising number of Clinical Laboratory Improvement Amendments (CLIA) approvals for PoC tests. Point-of-care testing (POCT) in urine analysis positively impacts the operational efficiency and care of patients with CKD.

Urinalysis Market Trends

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Urinalysis Market Dynamics

DRIVER: Rising geriatric population and subsequent increase in age-associated diseases

The demand for urinalysis is propelled by the imperative to manage CKD effectively in the aging population, emphasizing its pivotal role in enhancing healthcare outcomes and addressing the unique needs of elderly patients. Advancements in urinalysis technology, such as automated analyzers and point-of-care testing (POCT), have made the process quicker, more accurate, and more convenient. These innovations are particularly beneficial in managing the health of elderly patients who require frequent testing.

RESTRAINT: High capital investments and lack of skilled laboratory technicians

An increase in the aging population is expected to cause a greater need to diagnose medical conditions, such as cancer or type 2 diabetes, through laboratory procedures.] At present, there is a significant shortage of laboratory technicians in both developed and developing nations. This is mainly attributed to the increasing patient population base, the retirement of elderly technicians, and the increasing number of cash-strapped colleges closing their clinical lab programs. Stringent requirements for licensure in many countries to practice as a clinical laboratory technologist discourage people from this profession. Thus, a gap between the supply and demand of pathologists and lab technicians worldwide restrains the market growth.

OPPORTUNITY: Technological advancements in urine analyzers

Urinalysis has undergone significant technological advancements in the past few decades. Visual analysis of test strips for early screening was initially replaced by manual strip readers, providing a better analysis of test results. With the increasing workload, automated analyzers were developed for biochemical analysis. Such systems minimize operator interference in performing tests.

Sediment analysis is conducted via manual microscopy worldwide, particularly in developing economies. However, with a higher patient count, it is difficult to perform manual sediment analysis for all patient samples. Thus, automated sediment analyzers that utilize digital microscopy or flow cytometry to identify the different infectious agents and other casts and crystals in urine samples entered the market. These devices also help standardize sediment analysis. Urinary flow cytometry is an alternative to automated microscopy, and a more thorough analysis of flow cytometric data has enabled rapid differentiation of urinary microorganisms. By introducing laboratory-on-a-chip approaches and microfluidics, new affordable applications for quantitative urinalysis and readout on cell phones may become available in the coming years.

CHALLENGE: Changing regulatory landscape

Regulatory and legal requirements for in vitro diagnostics (IVD) (including urinalysis) in the US and European countries are becoming more stringent. In the US, IVD products are defined under 21 CFR 809 and regulated under guidelines similar to medical devices. The FDA released new FDA guidance documents. Under US federal regulations, device manufacturers must submit a 510(k) application for further modifications to a device. New applications may be required for software updates, new software installation in an existing device, or any other changes made to these devices.

Urinalysis Ecosystem/Market Map

The largest share in the urinalysis industry in 2023 was held by the consumables segment, by product.

Categorized by various product, the urinalysis market includes consumables and instruments. As of 2023, the largest portion of the market was dominated by the consumables segment. Consumables, such as reagent strips, sample collection cups, and quality control solutions, are integral to urinalysis, providing the necessary materials for accurate and reliable test results. Their recurring nature ensures continuous demand, as each test requires fresh supplies. The increasing frequency of urinalysis, driven by the growing geriatric population and the prevalence of chronic diseases, further fuels the need for consumables.

Disease screening segment dominated the urinalysis industry in 2023, based on application.

On the basis of application, the urinalysis market is segmented into disease screening and pregnancy & fertility testing. The disease screening segment accounted for the largest share of the urinalysis market in 2023. Urinalysis plays a crucial role in the early detection and monitoring of various conditions such as diabetes, kidney disease, urinary tract infections, and liver disease. With an increasing global focus on preventive healthcare and early intervention, healthcare providers are prioritizing routine screenings to identify diseases at an earlier, more treatable stage. This trend is particularly significant given the aging population, which is more susceptible to chronic conditions requiring regular monitoring. The widespread adoption of urinalysis in disease screening programs, along with advancements in testing technologies that enhance accuracy and ease of use, underscores its dominance in the market.

North America accounted for the largest share of the urinalysis industry in 2023.

Categorized into six primary regions, namely North America, Europe, Asia Pacific, Latin America, the Middle East & Africa, and GCC countries, the urinalysis market witnessed North America taking the forefront in 2023. North America, particularly the US and Canada, boasts advanced healthcare systems with well-established infrastructure for early disease diagnosis. This infrastructure supports the adoption of innovative technologies like advanced urine analyzers.

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The major players in this market are Siemens Healthineers AG (Germany), F. Hoffmann-La Roche Ltd. (Switzerland), Cardinal Health (US), Abbott (US), and Danaher (US). These players lead the market because of their extensive product portfolios and wide geographic presence.

Scope of the Urinalysis Industry

This report categorizes the urinalysis market to forecast revenue and analyze trends in each of the following submarkets:

By Product

• Consumables
  • Pregnancy & Fertility Kits
  • Dipsticks
  • Disposables
  • Reagents
• Instruments
  • Automated Urine Analyzers
    • Integrated Urine Analyzers
    • Sediment Urine Analyzers
      • Microscopy Analyzers
      • Flow Cytometry Analyzers
    • Biochemical Urine Analyzers
  • Semi-automated Urine Analyzers
  • Point-of-care Urine Analyzers

By Test Type

• Pregnancy & Fertility Tests
• Biochemical Tests
  • Laboratory Tests
  • PoC Tests
• Sediment Urinalysis

By Application

• Disease Screening
  • Urinary Tract Infections
  • Kidney Diseases
  • Diabetes
  • Liver Diseases
  • Other Disease Screening Applications
• Pregnancy & Fertility Testing

By End User

• Diagnostic Laboratories
• Hospitals & Clinics
• Home Care Settings
• Research Laboratories & Institutes

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of LATAM
• Middle East & Africa
• GCC Countries

Recent Developments of Urinalysis Industry:

• In July 2023, Siemens Healthineers (Germany) opened an Innovation Center in Erlangen, Germany, which focuses on the open innovation concept for collaborations with clinical and academic partners, as well as other companies and startups.
• In April 2023, Cardinal Health (US) announced the opening of two new distribution centers in Central Ohio, which will support its Medical segment, focusing on its US Medical Products and Distribution (USMPD) and At-home Solutions businesses.
• In February 2023, Siemens Healthineers and Unilabs announced a multi-year agreement. Under this agreement, Unilabs will modernize its healthcare infrastructure across its network to improve customer service and quality, thereby improving patient health. Siemens Healthineers’ solutions will enhance Unilabs’ laboratory operations, throughput, and clinical equivalence across its testing network.
• In September 2022, Sysmex Corporation launched the UF-1500 Fully Automated Urine Particle Analyzer (UF-1500) for use in urine sediment testing.
• In May 2022, Quidel Corporation (US), a provider of rapid diagnostic testing solutions, cellular-based virology assays, and molecular diagnostic systems, announced the acquisition of Ortho Clinical Diagnostics (US).

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