Cystatin C Assay Market

Market Overview

The global cystatin C assay market size was valued at USD 258 million in 2022 and is projected to reach USD 528.7 million by 2031, registering a CAGR of 8.3% during the forecast period (2023-2031). The increasing acceptance of POC testing and the availability of supporting government policies are driving the cystatin C assay market growth.

A cystatin C assay is a laboratory test that measures cystatin C levels in a patient's blood or serum. Cystatin C is a tiny protein that is produced at a constant rate by most human cells and is mostly filtered from the blood by the kidneys. Cystatin C concentrations in the blood can be used as a biomarker to quantify kidney function and assess renal health. Cystatin C assays are useful for identifying kidney disorders, monitoring kidney transplant recipients, and determining the risk of cardiovascular events.

As the global cystatin C assay market trend continues, more technological breakthroughs, usage, and a wider variety of diagnostic applications are expected, eventually benefiting patients with kidney illnesses and those at risk of renal dysfunction. The market is expected to grow and play an important role in the early detection and therapy of kidney-related illnesses.

Market Dynamics

Global Cystatin C Assay Market Drivers

Rising Prevalence of Kidney Diseases

The rising frequency of chronic kidney disease (CKD) and other kidney-related illnesses drives the cystatin C assay market. Kidney disorders have grown from the world's 13th to the 10th largest cause of mortality, according to the World Health Organization. The number of deaths has risen from 813,000 in 2000 to 1.3 million in 2019. The number of people affected with CKD is increasing, making early detection and monitoring critical.

According to the National Kidney Foundation, an estimated 37 million Americans have CKD, with millions more at risk. Furthermore, according to the World Kidney Day 2021 campaign, CKD is expected to be the fifth leading cause of years of life lost globally by 2040.

The increasing frequency of kidney diseases emphasizes the necessity of precise and dependable diagnostic techniques, such as cystatin C assays, for the early diagnosis, monitoring, and successful therapy of renal disorders. It also emphasizes the importance of continued research and development to increase diagnosis accuracy and accessibility.

Global Cystatin C Assay Market Restraints

Limited Reimbursement Policies

Reimbursement policies for cystatin C assays may be limited or uneven in various areas. This may discourage healthcare providers from adopting these tests because patients may be required to shoulder a considerable percentage of the testing cost, limiting market expansion.

In the United States, reimbursement policies for cystatin C assays might be restrictive, making it difficult to implement these tests. Medicare, the federal health insurance program, reimburses serum creatinine-based estimated glomerular filtration rate (eGFR) testing, although cystatin C-based eGFR tests are less prevalent. This disparity may influence healthcare professionals' willingness to use cystatin C testing. For example, according to the American Kidney Fund, while serum creatinine-based eGFR testing is generally funded by Medicare, cystatin C-based eGFR testing may not be covered. Patients may incur additional fees as a result of this.

According to a study published in the Journal of the American Society of Nephrology, the underutilization of cystatin C testing is partly due to reimbursement issues in the United States, which affect the adoption of this more reliable marker for kidney function.

Global Cystatin C Assay Market Opportunities

Emerging Markets

Emerging economies with expanding healthcare infrastructure present a considerable opportunity for market expansion. As these regions grow, there is a greater need for improved diagnostic tests, such as cystatin C assays. Rising healthcare awareness, rising healthcare expenditure, and a growing patient population drive this trend.

India is a rising market with a high need for modern diagnostic testing. The Indian healthcare sector has grown significantly due to increased healthcare awareness, government initiatives, and a growing middle-class population. This expansion allows the cystatin C test business to establish a foothold in the country. According to a report by the India Brand Equity Foundation (IBEF), India's healthcare industry will be worth USD 372 billion by 2022, thanks to considerable investments in healthcare infrastructure such as diagnostic laboratories and hospitals. The "Ayushman Bharat" program of the Indian government, which aims to offer healthcare access to millions of people, is increasing demand for advanced diagnostic services such as kidney function assessments. As a result, as healthcare access and knowledge improve, the need for precise diagnostic tools such as cystatin C tests is predicted to rise, contributing to market growth.

Regional Analysis

The global cystatin C assay market analysis is conducted across North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global Cystatin C Assay market shareholder and is estimated to grow at a CAGR of 8.5% over the forecast period. During the projected period, the market is expected to accelerate due to the region's developing healthcare sector and the introduction of fresh products. According to data given by the American Kidney Fund, Inc., roughly 37.0 million persons in the United States will suffer from kidney problems in 2023. Kidney failure affects approximately 8,10,000 Americans.

Additionally, the primary driver is North America's aging population. The risk of kidney-related disorders, including CKD, rises with age. In 2022, approximately 17.3 percent of the American population was 65 or older, an increase from previous years and a figure predicted to reach 22 percent by 2050. The American Association of Renal Patients emphasizes the rising prevalence of renal disease in the elderly. Furthermore, clinical guidelines from healthcare organizations such as the National Kidney Foundation and the American Society of Nephrology propose using Cystatin C in addition to or instead of creatinine-based tests for assessing kidney function. These suggestions drive clinical uptake.

Europe is anticipated to exhibit a CAGR of 8.6% over the forecast period, owing to improved and established healthcare facilities. Chronic kidney disease (CKD) is a huge financial and social burden for both patients and society. CKD affects 100 million people in Europe, and forecasts indicate that it will be the sixth biggest cause of mortality globally by 2040. The European market has the potential for the growth of point-of-care Cystatin C testing. Point-of-care healthcare focuses on decentralizing healthcare and providing rapid outcomes. Cystatin C tests may find a home in primary care, outpatient settings, and even at home.

Asia-Pacific contributes significantly to the global cystatin C assay market share. The rising disposable income, increased health awareness, and demand for diagnostic procedures, particularly in the senior population, will likely drive market expansion in the Asia-Pacific region. Chronic kidney disease (CKD) is a major public health issue in the Asia-Pacific area. The number of CKD cases is significant in a large population. For example, CKD is a major health concern in nations such as India and China, resulting in an increasing demand for precise kidney function evaluation methodologies. Cystatin C tests will lead to more accurate and rapid kidney function assessments as the market grows, benefiting patients and healthcare professionals in Asia-Pacific.

Segmental Analysis

The global cystatin C assay market is segmented based on products, tests, applications, end-users, and regions.

The market is further segmented by product into Instruments, Regents, and Kits.

Kits influenced the market growth. In the cystatin C assay market, kits typically include a combination of reagents, calibrators, controls, and test instructions. These kits are intended to provide a complete solution for performing the cystatin C assay. Kits provide laboratories and healthcare facilities with a convenient and ready-to-use solution. Simplifying the assay method makes it easier for healthcare providers to measure cystatin C levels. Kits frequently include all necessary components, eliminating the need for lengthy planning and computations.

The equipment and devices used to measure cystatin C levels in patient samples are instruments in the cystatin C assay market. These tools are intended to produce accurate and exact findings and are frequently equipped with automation capabilities.

Based on the test, the market is sub-segmented into Colorimetric Assay Based Tests, Enzymatic Tests, Point of Care Tests, and ELISA-Based Tests.

ELISA-Based Tests are a significant contributor to the market. The enzyme-linked immunosorbent test (ELISA) is a sensitive immunoassay that uses antibodies that bind to the protein to measure cystatin C levels. To generate a detectable signal, the assay relies on the reaction of an enzyme with a substrate. In research, clinical laboratories, and diagnostics, ELISA-based tests are extensively employed. They are excellent for various clinical and scientific applications due to their sensitivity and specificity.

Enzymatic assays use enzymes to react with cystatin C, producing a quantifiable signal. The enzymatic reaction provides the quantitative determination of cystatin C concentration.

The segment can be bifurcated by application into Research and Development and diagnosis.

Diagnosis generates the most income. Cystatin C assays are generally used in diagnostic settings to monitor kidney function and diagnose kidney-related diseases. Clinical laboratories, hospitals, and healthcare facilities perform these diagnostic tests. Diagnosis with cystatin C assays is critical in patient care. It assists healthcare providers in identifying renal illnesses, monitoring kidney function, and making informed treatment and disease management decisions. Accurate diagnosis is critical for patient safety and timely treatment of kidney-related disorders.

In R&D contexts, cystatin C assays may involve developing new diagnostic procedures, studying kidney function in disease models, or researching the utility of cystatin C as a biomarker in various medical disorders. These applications help to increase medical knowledge and the creation of novel diagnostic methods.

Based on end-users, the market is fragmented into Hospitals, Clinics, Diagnostic Laboratories, Renal Care Centers, and Academic Research Institutes.

Hospitals are the major end-users of the market. Hospitals are a major end-user of cystatin C tests. Cystatin C testing is used in hospitals to evaluate kidney function in patients admitted for various medical reasons. It is an important tool for clinicians to use in monitoring patients' renal health, especially those with chronic conditions or surgical operations. Cystatin C assays in hospitals are critical for identifying and controlling renal disorders, improving patient care, and making informed treatment decisions.

Cystatin C assays are used in general medical and specialty clinics to evaluate patients' kidney function during routine check-ups, screenings, and specialized care. These tests are useful in outpatient settings where early diagnosis of renal diseases is critical.

Recent Developments

• November 2023- Abbott (NYSE: ABT) gained FDA approval for its molecular human papillomavirus (HPV) screening solution, bringing to the Alinity m family of diagnostic tests a strong cancer screening tool for detecting high-risk HPV infections.
• October 2023- The Randox Acute Kidney Injury (AKI) array, available on the Evidence Investigator, used patented Biochip Technology to simultaneously test for four novel biomarkers (KIM-1, NGAL, Clusterin, and Cystatin C), allowing for early diagnosis and monitoring of therapy efficacy.
• February 2023- Carolina Liquid Chemistries Corp. and Diazyme Laboratories form a joint venture.