Cystatin C Testing Market Size, Share, and Industry Analysis, By Product Type (Instruments and Reagents & Consumables), By Setting (Laboratory Tests and Point-of-Care Tests), By Test (Colorimetric Assay-Based Tests, Immunoturbidimetric-Assay Based Tests, and Others) By End User (Hospitals & Clinics, Diagnostic Centres, and Others), and Regional Forecast, 2026-2034

Cystatin C is a protein produced in different fluids of the body, such as blood, spinal fluid, and breast milk. A healthy kidney filters cystatin C from the blood, which is excreted in the urine. Cystatin C test measures this protein in the body. The measured cystatin C value estimates the glomerular filtration rate (GFR), representing how well kidneys filter blood. This test is used to diagnose renal impairment, monitor the effectiveness of the ongoing treatment, and assess the risk of developing any renal disease.

Cystatin C is a superior marker for kidney function analysis. This protein is unaffected by age, sex, race, liver illness, inflammation, and muscle mass. Its accuracy, sensitivity, and other advantages are increasing its market adoption. Also, the increasing prevalence of kidney disorders is elevating the number of cystatin C testing procedures across the globe.  

• For instance, as per the data published by Agappe Diagnostics Ltd. in 2022, Cystatin C is a better predictor of glomerular filtration rate (GFR) than Creatinine. It responds more quickly to changes in the GFR. Also, cystatin C can be used to assess the GFR of newborns and even fetus.
• According to data from the National Library of Medicine in 2021, chronic kidney disease (CKD) is a leading public health problem worldwide. Every 1 in 10 people suffer from CKD.

However, the adoption of the cystatin C test is majorly affected by the high prices of the reagents used, the concern about accuracy, and the lack of awareness.

• For instance, according to a review article published by Wolters Kluwer Health, Inc. in 2022, the cost of reagents used in the cystatin C test is more than thrice the cost of reagents used for the creatinine test. Also, less awareness among clinicians is a major barrier to the routine use of the cystatin C test. These factors are hampering the market growth.

Impact of COVID-19 on the Cystatin C Testing Market

Cystatin C test witnessed a positive impact during the COVID-19 pandemic. The patients with COVID-19 had also experienced several other dysfunctions, including kidney, liver, etc. Cystatin C test was extensively used to monitor the risk of kidney infection and mortality. Cystatin C could be used as a marker of renal complications in COVID-19 other than AKI due to the need to monitor patients even long after leaving the hospital.

• For instance, a report published by Springer Nature Switzerland AG in 2021 reported that acute kidney injuries (AKI) were common among hospitalized COVID-19 patients. 

Moreover,  the pandemic had created a crisis for patients with chronic kidney disease regarding getting treatment facilities. Still, the market boomed since the second wave of the COVID-19 pandemic.

Key Insights

The report will cover the following key insights:

• Prevalence of Chronic Kidney Disease (CKD), By Key Countries, 2022.
• Key Industry Developments: Acquisitions, Mergers, Partnerships.
• New Product Launches, By Key Players.
• Impact of Covid-19 on the Global Cystatin C Testing Market.

Analysis by Product Type

Based on product type, the Cystatin C testing market is classified into instruments and reagents & consumables. Reagents & consumables accounted for the most significant proportion of the market. The growth is mainly attributed to the strong utilization of these products for diagnosis and continuous research purposes.

• In September 2022, a clinical trial was done on chronic kidney disease patients to assess the effect of oral supplementation of probiotics using an ELISA kit.
• For instance, in 2022, according to an article published in the National Library of Medicine, a novel double indirect sandwich ELISA was used to measure the total and uncleaved cystatin C used in Alzheimer’s disease.

Regional Analysis

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North America dominated the cystatin C testing market due to the growing population of kidney disorders and increased awareness regarding early detection measures.

• For instance, as per the data published by American Kidney Fund, Inc., in 2023, approximately 37.0 million people suffer from kidney disorders in the U.S. About 8,10,000 Americans have kidney failure.

Key Players Covered

The report will include the profiles of key players such as Randox Laboratories Ltd., Diasys Diagnostic Systems GmbH, Diazyme Laboratories, Inc., F. Hoffman-LA Roche Ltd., Abbott, Tosoh Bioscience LLC., Eurolyser Diagnostica GmbH, and others.

Segmentation

Key Industry Developments

• April 2023: Medtronic and DaVita Inc. launched a new company, Mozarc Medical Holding LLC. It aims to reshape kidney health and drive patient-centered technology solutions.
• January 2023: Diazyme Laboratories, Inc. partnered with Carolina Liquid Chemistries Corp. (CLC) to expand the test menu on the Diazyme DZ-Lite c270.
• August 2022: Bloom Diagnostics launched Bloom Kidney Test. It is a single-use semi-automated testing kit for the quantitative measurement of cystatin C in the bloodstream to estimate GFR