Kidney Function Tests Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Urine Tests, Blood Test, Others), By Component (Dipsticks, Reagents, Kits & Assays, Others), By End User (Hospitals & Clinics, Diagnostic Laboratories, Others), By Region and Competition, 2020-2030F

Market Overview

Global Kidney Function Tests Market was valued at USD 1.02 billion in 2024 and is expected to reach USD 1.59 billion by 2030 with a CAGR of 7.68% during the forecast period. The global market for Kidney Function Tests is experiencing significant growth, driven by the increase in awareness of diagnostic techniques for kidney function. The growing global burden of chronic kidney disease is attributed in huge share to diabetes and high blood pressure. In the upcoming years, rising diabetes rates will influence market expansion. The International Diabetes Atlas' tenth estimates that 537 million adults (20-79 years old), or one in ten people, had diabetes in 2021. It is anticipated that this number will increase to 643 million by 2030 and 783 million by 2045.

Key Market Drivers

Rising Prevalence of Chronic Kidney Disease and Diabetes‑Hypertension Burden

Chronic kidney disease (CKD) now affects an estimated 13% of the global population, meaning more than 800 million individuals worldwide experience some degree of kidney impairment. Major risk factor diabetes (422 million people globally, per WHO) and hypertension (affecting over 1.13 billion people)—drive this burden: together they accounted for around 75% of kidney failure cases between 2014 and 2016. Governments worldwide are responding by embedding kidney function testing into public health policy. For instance, the U.S. Centers for Medicare & Medicaid Services (CMS) mandates annual eGFR and urinary albumin‑creatinine ratio (ACR) tests for adults with type 2 diabetes, coded into quality‑reporting programs to ensure routine screening. In India, the Pradhan Mantri National Dialysis Program is expanding infrastructure for dialysis and preventive screening, reflecting formal government recognition of CKD’s scale. Moreover, national screening efforts like India’s 75/25 hypertension‑diabetes screening initiative aim to screen 75 million people by 2025, improving early detection of CKD in high‑risk groups. These policies create sustained demand for kidney function tests as essential tools for early diagnosis. As a result, public health mandates in both high‑income and emerging economies are key drivers fueling growth in demand for standardized, accurate kidney diagnostics.

Government‑Backed Screening Programs and Preventive Policies

Governments are increasingly launching organized screening programs that incorporate kidney function tests as a core component. In the Philippines, the ACT NOW for CKD initiative expanded to cover 12 provinces, delivering over 1 million free urine ACR tests in high‑risk populations. Similarly, Japan’s national health system shows CKD detection rates of 43.5% when quantitative proteinuria data is collected, versus only 5.9% when protein results are absent, illustrating the impact of structured testing protocols. In the U.S., CMS has integrated kidney health evaluation into major quality reporting tools, creating systematic annual requirements for renal function markers in patients with diabetes and hypertension. The Preventive Services Task Force is under pressure from more than 40 U.S. lawmakers (in 2025) to issue federal CKD screening recommendations, signaling policy momentum. In India, state and central governments now provide free nephrology services, including dialysis and CKD testing, under the Pradhan Mantri scheme to reduce inequities in care access. These top‑down programs not only create cost‑free testing access but also embed kidney diagnostics in standard primary care routines, raising visibility and demand for eGFR, creatinine, and urine albumin tests globally.

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Key Market Challenges

High Cost and Unequal Access to Diagnostic Infrastructure

Despite its growing importance, access to kidney function tests remains uneven across the globe due to the high cost of testing infrastructure and consumables. Advanced diagnostic tools such as automated chemistry analyzers and AI-driven screening platforms require significant investment in both equipment and skilled personnel. This creates a major barrier for low- and middle-income countries (LMICs), where public health budgets are often strained.

According to the World Health Organization, over 50% of the global population lacks access to essential health services, including basic laboratory testing. This is particularly problematic in rural and remote regions where laboratory infrastructure is minimal. In sub-Saharan Africa and parts of South Asia, healthcare facilities often operate without functioning diagnostic labs, leaving many CKD cases undiagnosed until late stages.

Furthermore, even in higher-income countries, disparities exist. A report from the U.S. Department of Health and Human Services (HHS) highlighted that minority populations and low-income groups are less likely to receive timely CKD screening and follow-up testing due to lack of insurance, limited transportation, or awareness. The cost of reagents, calibration standards, and test consumables also adds to recurring healthcare expenditure, discouraging widespread adoption. Without government subsidies, many at-risk individuals cannot afford routine kidney tests. Thus, financial and logistical barriers present a significant challenge to expanding global access to kidney diagnostics.

Lack of Standardized Protocols and Awareness Among At-Risk Populations

Another major challenge for the global kidney function tests market is the lack of standardized testing protocols and insufficient awareness among patients and primary care providers. CKD often progresses silently, and without symptoms in early stages, leading to low testing rates unless systematically enforced. According to the U.S. CDC, about 90% of Americans with CKD are unaware of their condition, even though many have regular interactions with healthcare systems. This underdiagnosis is largely due to missed opportunities for screening in routine primary care, where kidney function tests are not always prioritized.

Globally, the absence of harmonized clinical guidelines has resulted in varied practices for kidney function monitoring. While some countries follow annual eGFR and urine ACR testing for high-risk groups, others rely solely on creatinine or urea, missing important early indicators of kidney damage. In many developing regions, there are no structured guidelines at all for CKD screening. The World Kidney Day campaign, supported by health ministries worldwide, continues to raise awareness about CKD, but gaps remain—especially in rural populations where education and outreach are limited. Even when guidelines exist, adherence among clinicians is inconsistent due to time constraints, competing priorities, or lack of training. Without widespread awareness and standardized practices, many patients progress to end-stage renal disease without early detection—limiting the preventive power of kidney function tests.

Key Market Trends

Growing Adoption of Point-of-Care and At-Home Kidney Testing

The shift towards point-of-care (POC) and home-based kidney testing is transforming how kidney diseases are detected and monitored. As healthcare systems globally push for decentralization and patient-centered care, rapid diagnostic tools are being integrated into both primary care and home-use settings. This trend is especially valuable for remote areas with limited lab infrastructure. POC testing kits for creatinine, eGFR, and microalbumin are increasingly being deployed in community clinics, pharmacies, and mobile health vans. These kits allow near-immediate results and early decision-making. Some home-use platforms, like smartphone-based urine analysis apps, enable patients to self-monitor albuminuria using test strips and AI-driven imaging. These innovations help increase compliance, particularly among patients with diabetes and hypertension who need regular monitoring.

The U.S. Food and Drug Administration (FDA) has approved several home-based test kits for kidney health as part of its digital health and patient access strategy. Similarly, public health programs in countries like India and Indonesia are beginning to use mobile diagnostic tools for on-site kidney screening during health camps. As governments continue investing in telehealth and digital diagnostics post-COVID-19, home and POC testing are expected to become a staple of preventive nephrology. These approaches reduce healthcare burden, increase patient autonomy, and enable earlier intervention—shifting the paradigm from reactive treatment to proactive kidney health management.

Integration of AI, Biomarkers, and Personalized Medicine in Kidney Diagnostics

Artificial intelligence (AI), machine learning, and novel biomarker integration are reshaping the kidney function testing landscape. Conventional tests like creatinine and BUN are now being augmented with next-generation markers—such as cystatin C, NGAL, and beta-2 microglobulin—to improve sensitivity and detect kidney damage earlier. AI algorithms are being used to interpret complex combinations of these markers for risk stratification and disease progression prediction. In countries like the United States, the National Institutes of Health (NIH) has supported multi-center research into new biomarker discovery through initiatives like the Kidney Precision Medicine Project (KPMP). The aim is to map out molecular signatures of kidney disease and enable precision diagnostics that can inform tailored treatment plans.

AI-powered clinical decision support systems are also being integrated into electronic health records (EHRs) to flag patients at risk of CKD based on trends in lab values. These tools help overcome the issue of underdiagnosis by alerting providers when testing or referral is indicated. The UK’s National Health Service (NHS) is piloting AI-assisted kidney care pathways to enhance detection rates and reduce treatment delays. As the global healthcare industry embraces precision medicine, the convergence of AI, advanced biomarkers, and molecular testing is a defining trend in kidney diagnostics. It not only boosts diagnostic accuracy but also aligns with the broader shift toward predictive, preventive, and personalized healthcare.

Segmental Insights

Type Insights

Based on Type, Blood tests hold the largest market share in the global kidney function tests market. Blood-based kidney function tests—such as serum creatinine, blood urea nitrogen (BUN), and estimated glomerular filtration rate (eGFR)—are considered the gold standard for evaluating renal function. These tests are more commonly prescribed and widely accepted in clinical guidelines across the world because they offer direct insights into the kidney’s filtration efficiency and overall metabolic waste clearance. Healthcare providers often prefer blood tests due to their higher diagnostic reliability, sensitivity to early kidney damage, and compatibility with routine biochemical panels. For instance, the Centers for Disease Control and Prevention (CDC) and the National Kidney Foundation (NKF) in the U.S. recommend annual blood tests—specifically serum creatinine and eGFR—for patients with diabetes, hypertension, or a family history of CKD. Furthermore, many government-funded screening programs prioritize blood tests due to their diagnostic value. In Japan and South Korea, for example, national health checkups include blood-based kidney assessments as a standard protocol. Similarly, the Indian Council of Medical Research (ICMR) recommends creatinine and urea testing for early detection of kidney impairment in high-risk populations.

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Regional Insights

Based on the region, North America holds the largest market share in the global kidney function tests market. This dominance is driven by a combination of advanced healthcare infrastructure, high disease prevalence, favorable reimbursement frameworks, and strong government involvement in chronic disease management. The United States plays a major role due to its widespread adoption of routine kidney screening protocols, especially among patients with diabetes and hypertension. According to the Centers for Disease Control and Prevention (CDC), an estimated 37 million adults in the U.S. have chronic kidney disease (CKD), with most remaining undiagnosed in early stages. The high prevalence of CKD risk factors—such as obesity, hypertension, and diabetes—has prompted federal agencies to embed kidney function tests like eGFR (estimated glomerular filtration rate) and urine albumin-to-creatinine ratio (ACR) into national clinical guidelines. The Centers for Medicare & Medicaid Services (CMS) requires these tests to be performed annually for at-risk populations as part of its quality reporting and reimbursement programs.

In addition, the U.S. Department of Health and Human Services (HHS) has launched initiatives like the Advancing American Kidney Health initiative, which emphasizes early detection and aims to reduce the number of Americans developing end-stage renal disease (ESRD) by 25% by 2030. This policy also supports innovative kidney diagnostics, AI-driven decision tools, and telehealth-based monitoring—further reinforcing North America’s leadership in the market.

Recent Developments

• In May 2024, Boditech Med signed an MOU with Bio Preventive Medicine Corp for license of DNlite-IVD103 biomarker for detection of diabetic kidney disease. The test allows early detection of kidney damage up to 5 years prior to actual damage.
• In February 2024, Simple HealthKit launched a kidney test program to study kidney function at home and at a medical center. The Kidney Health Evaluation for Patients with Diabetes initiative focuses on a new kidney health test aimed at helping insurers enhance patient outcomes. This initiative can contribute to improved performance in key metrics, such as Healthcare Effectiveness Data and Information Set and Medicare Advantage star ratings.
• In December 2023, NGAL biomarker developed at the Cincinnati Children’s received U.S. FDA approval for pediatric use. The NGAL test, also referred to as the ProNephro AKI test, is designed to assist healthcare providers in identifying patients who are at risk of developing or currently experiencing moderate to severe acute kidney injury (AKI) within 48-72 hours, particularly in intensive care settings.

Key Market Players

• Baxter International Inc.
• Abbott Laboratories, Inc.
• Sysmex Corporation
• F. Hoffmann-La Roche Ltd.
• Danaher Corporation
• URIT Medical Electronic Co. Ltd.
• Nova Biomedical Corporation
• Laboratory Corporation of America Holdings
• Siemens Healthineers
• ARKRAY Inc.

Report Scope:

In this report, the Global Kidney Function Tests Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Kidney Function Tests Market, By Type:

o   Urine Tests

o   Blood Tests

• Kidney Function Tests Market, By Component:

o   Dipsticks

o   Reagents

o   Kits & Assays

o   Others

• Kidney Function Tests Market, By End User:

o   Hospitals & Clinics

o   Diagnostic Laboratories

o   Others

• Kidney Function Tests Market, By Region:

o   North America

§  United States

§  Mexico

§  Canada

o   Europe

§  France

§  Germany

§  United Kingdom

§  Italy

§  Spain

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Japan

§  Australia

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East and Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Kidney Function Tests Market.

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Company Information

• Detailed analysis and profiling of additional market players (up to five).

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