Albumin and creatinine test also referred as albumin:creatinine ratio (ACR) is the preferred test for detection of small amounts of albumin in the urine. Proteinuria and microalbuminuria are both signs of renal diseases that possess risk factor for cardiovascular morbidity and mortality. Measurement of ACR forms an integral part of diagnosis and monitoring for detection of chronic kidney disease (CKD). ACR is the recommended method for people with diabetes.

In kidney failure, large amounts of protein are spilled into the urine. Before large amount of damage happens to the kidneys abnormal kidneys secret small amounts of albumin that indicates signs of diabetes mellitus. This condition is called micro albuminuria and the test that measures this very small amount of albumin is called albumin/creatinine ratio urine (ACRU).

Market Insider

According to the National Kidney Foundation, between 2015-2017 47% of the new end-stage kidney disease (ESKD) patients had a primary diagnosis of diabetes that is a leading cause of ESKD while 29% of the new ESKD patients had primary stage hypertension, second leading cause of ESKD. In 2017, 746,557 Americans had kidney failure. Moreover, 125,000 people started ESKD treatment in 2017 of which 120,834 started dialysis and 20,945 received kidney transplant.

Further, Centre for Disease Control and Prevention (CDC), estimates reveal that CKD is more common in people aged 65 years or older (38%) than in people aged 45-64 years (13%) or 18-44 years (7%). Also, CKD is more common in women (15%) than men (12%)

What’s New in Albumin and Creatinine Test Market?

According to the National Institute of Environmental Health Sciences (NIEHS) approx. 30 million undiagnosed CKD cases are registered in the US alone. End-stage renal disease (ESRD) is an outcome of undiagnosed or untreated CKD, In the US each year, around US$ 114 Bn is spent on healthcare for dialysis or transplantation for patients suffering from CKD.  However, proper diagnosis of CKD requires only two simple tests: ACR test and serum creatinine test to estimate the glomerular filtration rate (eGFR).

In September 2020, Scanwell Health, Inc. a digital healthcare provider announced launching of a new product aiming to offer scalable diagnostics and at-home testing for large population pool. Currently, the product is under development phase and estimated completion time will be August 2022. Scanwell Health, Inc. is developing a CKD test kit that enables simple, accurate, and cost-effective assessment of kidney function in the test kit that will be self-administered by the patient in at-home environment. Extensive preliminary data focuses upon accurate and repeatable laboratory measurements of urine albumin, serum creatinine, and urine creatinine by using a smartphone app to read the results. Through correct results when the test is self administered enables low cost and frequent visits in the clinics. Moreover, accurate results and excellent ease of use allows widespread CKD screening, early diagnosis, and efficient monitoring. Such positive influence will lower cost burden of CKD on the healthcare system resulting improved patient outcome.

Market Dynamics

High prevalence of kidney disorders is one such disease that enables the demand for albumin and creatinine tests. Regular monitoring of components like albumin and creatinine and their ratios (ACR) demand use of several product and techniques that drives the albumin and creatinine tests market. Biochemical urine analysis enables clinicians to access the level of compounds that involve creatinine, urobilinogen, bilirubin, ketones, and glucose in the urine drives the demand for ACR test resulting in growth of the global market. Therefore, rising cases of kidney diseases is the primary growth factor that enables the demand for albumin and creatinine tests market.

Segmental Outlook

Albumin and creatinine tests market is based on product, type, and end-user. By product, the market is categorized into dipsticks & kits, analyzers, and cartridges. Based on type, the market is bifurcated into urine test and blood & serum creatinine test. Urine test is further segmented as urine albumin tests, urine creatinine tests, and glycated albumin. Finally, by end-user the market is segmented into hospitals & clinics, diagnostic laboratories, and research laboratories & institutes.

Based on product, dipsticks & kits products will record largest market share owing to large purchase of the product by consumers due to high demand for rapid test at laboratories or clinics. By type, urine test segment will account for largest revenue segment for albumin and creatinine test market. This is attributed by rapid growth in diagnostic segment and rising demand for rapid and easy-to-use urine test that drives the growth of this segment.

Regional Overview

North America is embossing significant market share for albumin and creatinine test market from the past and will continue its trend in the coming years. The factors involve rising government initiatives and collaborations, surge in demand for rapid urine test, increasing prevalence of chronic conditions responsible for CKD, and ever-growing geriatric population.

National Kidney Disease Education Program (NKDEP), an initiative of the National Institutes of Health works to reduce mortality and morbidity caused by CKD coupled with its complications. In addition, NKDEP aims to improve early detection of CKD, identification of patients suffering from greater risk of kidney failure, and promotion of evidence based intervention to slow progression of kidney disease. The screening test for urine albumin creatinine ratio (UACR) and GFR has been hampered due to lack of standardization in measurement and reporting. Therefore, NKDEP align with its laboratory working group (LWG) and partner organization is working to improve standardized creatinine determination and promote routine reporting of eGFR. NKDEP collaborates with other federal agencies and voluntary organizations to promote early detection of CKD in people. One of the important partners is CDC.

As per the estimates by National Health and Nutrition Examination Surveys (NHANES), in the US 16.8% prevalence in the population aged >20 year suffer from CKD. National Kidney Foundation (NKF) estimates that nearly two third of the individuals are identified with CKD that is 11.1% with >20 year old population are diagnosed with abnormal albumin excretion alone. Therefore, urine albumin screening test is considered as an important tool in identification of early CKD in high risk communities globally. The two factors for kidney disease are urine albumin and estimated glomerular filtration rate (eGFR) for patients with type 1 diabetes for 5 years or more or type 2 diabetes American Diabetes Association and National Kidney Disease Education Program (NKDEO) recommend healthcare professionals to check urine albumin secretion each year to diagnose and monitor kidney damage. Apart from that, NKDEP and ADA recommend healthcare professionals to access eGFR from stable serum creatinine levels annually in all patients with diabetes. This results into surge in demand for rapid urine test in laboratory or clinics.

Competitive Landscape

Key companies profiled in this report involve Thermo Fisher Scientific, Inc., Roche Diagnostics, PromoCell GmbH, Abbott Laboratories, Siemens Healthineers, Danaher Corporation, Sysmex Corporation, Ortho Clinical Diagnostics, Randox Laboratories,  FUJIFILM Wako Pure Chemical Corporation, Abbexa Ltd., ACON Laboratories, Inc., Arbor Assays Inc., ARKRAY Global Business Inc., Aviva Systems Biology, Axxora, LLC, BioAssay Systems, Nova Biomedical, Quantimetrix Corporation, RayBiotech Inc., Sekisui Diagnostics PEI Inc., Teco Diagnostics, Tulip Diagnostics, Ulti med Products GmbH, and URIT Medical Electronic Co., Ltd., and among others.

Market Segmentation

Market By Product

Dipsticks & Kits

Analyzers

Cartridges

Market By Type

Urine Tests

• Urine Albumin Test
• Urine Creatinine Test
• Glycated Albumin

Blood & Serum Creatinine Tests

Market By End-User

Hospitals & Clinic's

Diagnostic Laboratories

Research Laboratories & Institutes

Market By Geography

North America

• U.S.
• Canada

Europe

• U.K.
• Germany
• France
• Spain
• Rest of Europe

Asia-Pacific

• China
• Japan
• India
• Australia
• South Korea
• Rest of Asia-Pacific

Latin America

• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC
• South Africa
• Rest of Middle East & Africa