Creatinine Assay Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Test Type (Jaffe Kinetic Method, Enzymatic Method), By Product (Reagents, Kits), By Sample (Blood/Serum, Urine), By End User (Hospitals, Diagnostic Laboratories), By Region and Competition, 2020-2030F

Market Overview

Global Creatinine Assay Market was valued at USD 640.29 Million in 2024 and is expected to reach USD 987.15 Million by 2030 with a CAGR of 7.48% during the forecast period. The creatinine measurement test is performed to assess renal function in the human body. Creatinine is a chemical compound that remains in the body after energy production in the muscles. By measuring creatinine levels in blood and urine samples, the status of the kidneys can be determined as they filter out creatinine. In adults, a normal creatinine measurement ranges from 0.5 to 1.2 milligrams per deciliter of blood. Higher levels of creatinine indicate unhealthy kidney conditions. The increasing prevalence of kidney diseases worldwide, particularly in developing countries, due to unfavorable living conditions, has led to a growing demand for creatinine measurement tests. Additionally, the cost-effectiveness and easy availability of test kits and reagents are contributing to market growth.

Key Market Drivers

Growing Kidney Related Health Problems

Kidney disorder, particularly chronic kidney disease (CKD), is a prominent contributor to global mortality rates. Timely diagnosis and appropriate treatment are crucial in preventing complications. Creatinine testing methods are employed to assess renal functionality. Key market players are prioritizing the production of high-quality products to meet the growing demand. Additionally, the continual increase in research activities in this field is propelling the global market's expansion. With an increasing number of people being diagnosed with kidney-related diseases, there is a higher demand for creatinine testing to assess kidney function and monitor disease progression. Patients with kidney diseases require regular monitoring of their kidney function, including creatinine levels. This ongoing monitoring drives the need for frequent creatinine testing. Creatinine assays are routinely performed in hospitals, clinics, and other healthcare facilities to assess kidney function in patients admitted with kidney-related issues or undergoing treatments that may impact kidney function. The need for rapid results and immediate clinical decision-making in critical care settings has driven the adoption of point-of-care creatinine testing, allowing for timely patient management. In the pharmaceutical industry, creatinine assays are utilized in pre-clinical and clinical research to assess the impact of new drugs on kidney function and potential nephrotoxicity. As awareness about kidney health increases, more people are undergoing routine health check-ups that include creatinine testing to identify early signs of kidney dysfunction which is boosting the global creatinine assay market.

Increasing Demand of Rapid Diagnostic Techniques

The increasing demand for rapid diagnostic techniques and procedures to measure creatinine levels in blood and urine is driving market growth. The prevalence of Diabetes, which negatively affects kidney health, along with the rising incidence of chronic kidney disorders among the aging population and the growing number of patients with kidney cancer, Glomerulonephritis, and renal failures, among others, are fueling the need for rapid diagnostic procedures to measure creatinine levels. Creatinine, an endogenous waste product formed during the breakdown of creatine found in muscles, is utilized by clinical laboratories to test Glomerular Filtration Rate (GFR) and Blood Urea Nitrogen (BUN) for assessing health and kidney function.

Technological advancement in the detection of creatinine

A biosensor construction based on single mode fiber-multicore fiber-multimode fiber-singlemode fiber (SMFMCF-MMF-SMF) configuration is employed for the detection of creatinine in the human body. This construction is characterized by simplicity, portability, and high sensitivity. To enhance the generation of strong evanescent waves, the diameter of the sensing probe was reduced to 90 m using chemical etching. The sensor probe is functionalized with graphene oxide (GO), gold nanoparticles (AuNPs), molybdenum disulfide nanoparticles (MoS2-NPs), and the creatininase (CA) enzyme. The concentration of creatinine is assessed using fiber optic localized surface plasmon resonance (LSPR). Two-dimensional (2D) materials, such as GO and MoS2-NPs, are utilized to promote biocompatibility, while CA increases the probe's specificity. The impact of AuNPs on LSPR is enhanced through the use of evanescent waves (EWs).

In addition, HR-TEM and UV-visible spectroscopy are employed for the analysis and evaluation of the shape and absorption spectra of nanoparticles (NPs). The characterization of NPs adsorbed on the surface of the fiber probe is performed using SEM. The performance of the sensor probe is evaluated in terms of reusability, repeatability, stability, selectivity, and pH tests. The suggested sensor exhibits a sensitivity of 0.0025 nm/M, a standard deviation of 0.107, and a detection limit of 128.4 m within a linear detection range of 0 - 2000 m. Based on these findings, it is anticipated that the market will experience significant growth in the forecast period.

Growing Geriatric Population

The growing geriatric population and the associated increase in age-related health conditions are significant drivers of the demand for creatinine assay. As people age, the risk of kidney-related diseases and impairments in kidney function tends to rise. The creatinine assay plays a crucial role in assessing kidney function and monitoring renal health in the elderly population. The kidneys naturally undergo age-related changes, resulting in reduced kidney function and a decline in the glomerular filtration rate (GFR) with advancing age. The creatinine assay is essential for detecting kidney dysfunction in older adults. Elderly individuals often require multiple medications for managing chronic conditions. Kidney function is crucial for the clearance of medications from the body. Creatinine assays help healthcare providers adjust drug dosages to avoid potential toxicity and adverse effects in older patients. Routine creatinine testing enables the early detection of kidney disease in older adults, allowing for timely interventions and management to prevent disease progression and complications. The demand for creatinine assay is expected to remain high as the geriatric population continues to grow. Ensuring kidney health and early detection of kidney diseases will be paramount in managing the health and well-being of the elderly population, making creatinine testing an essential tool in geriatric care and medicine. According to WHO, By 2030, 1 in 6 people in the world will be aged 60 years or over. At this time the share of the population aged 60 years and over will increase from 1 billion in 2020 to 1.4 billion. By 2050, the world’s population of people aged 60 years and older will double (2.1 billion). The number of persons aged 80 years or older is expected to triple between 2020 and 2050 to reach 426 million.

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Key Market Challenges

Lack Of Awareness About Creatinine Testing Methods

Many patients may not be aware of the importance of creatinine testing in assessing kidney function and may not understand its significance in their overall health. Different healthcare settings may use various methods for creatinine testing, leading to confusion among patients and providers about the accuracy and reliability of results. In some cases, healthcare providers may prioritize other health parameters over creatinine testing, potentially overlooking early signs of kidney dysfunction. Public health initiatives and awareness campaigns may not adequately address the importance of kidney health and creatinine testing in promoting overall well-being.

Limited Usage of Creatinine Assay Kits In IVD

If there is limited availability or usage of creatinine assay kits in IVD, it can lead to restricted access to these diagnostic tests for healthcare providers and patients. This could potentially result in underdiagnosis or delayed diagnosis of kidney-related conditions. Limited usage of creatinine assay kits may lead to a lack of standardization in creatinine testing across different healthcare settings. Standardization is essential for ensuring consistent and reliable results, and the absence of widely used assay kits can hinder this process. Limited usage of creatinine assay kits may lead to healthcare providers exploring alternative diagnostic methods for assessing kidney function. This could include point-of-care tests or other biomarkers, potentially diverting demand away from traditional creatinine assays. Manufacturers of creatinine assay kits might experience reduced demand for their products, affecting their revenue and profitability. This, in turn, could impact their ability to invest in research and development or improvements to their assay kits.

Key Market Trends

Point-of-Care Testing

POCT can be performed at the patient's bedside, in outpatient clinics, or even in remote or resource-limited areas. It eliminates the need for patients to visit a centralized laboratory for creatinine testing, enhancing accessibility to diagnostic services. For patients with chronic kidney disease (CKD) or those undergoing treatments that may impact kidney function, POCT allows for frequent and easy monitoring of creatinine levels, enabling timely adjustments to treatment plans. In telemedicine or remote healthcare settings, POCT of creatinine allows for remote monitoring of kidney function, promoting continuity of care and personalized treatment plans. POCT can lead to cost savings by reducing the need for multiple visits or sample transportation to centralized laboratories.

Growing Demand in Emerging Markets

As access to healthcare improves in emerging markets, the demand for cost-effective and easy-to-use creatinine kits is expected to rise. Manufacturers will likely focus on developing affordable and reliable solutions for these markets. Improving healthcare infrastructure and expanding access to medical services in emerging markets mean more people can undergo regular health check-ups, including kidney function assessments. Growing awareness about the importance of preventive healthcare is encouraging individuals to seek regular screenings, including creatinine testing, to identify early signs of kidney dysfunction. Government initiatives to improve healthcare access and quality, along with initiatives to address NCDs, can further boost the demand for creatinine assays.

Segmental Insights

Test Type Insights

Based on test type, the dominant segment in the market is Jaffe's Kinetic Test Kits, which holds the largest market share due to its status as the oldest and most traditional method for creatinine measurement. The Jaffe method is a simple colorimetric assay that uses the reaction of creatinine with picric acid under alkaline conditions to form a red-orange chromophore. The color change is proportional to the creatinine concentration, making it easy to measure. The reagents for the Jaffe method are readily available and relatively inexpensive, making it accessible for many laboratories. The Jaffe method has been widely used for creatinine testing for decades, leading to its standardization and acceptance as a reference method for clinical laboratories. Its use in clinical trials and research studies has further established its credibility. Other key factors contributing to the significant share of this segment include the widespread availability of products and the cost-effectiveness of these kits.

Sample Type Insights

Based on Sample Type, Blood Sample is the dominant segment for Creatinine Assay Kits Market and held the largest market share due to the accessibility of sample availability. The primary reason for using blood samples for creatinine testing is that creatinine is a waste product produced by muscle metabolism and is released into the bloodstream. It is then filtered by the kidneys and excreted in urine. The concentration of creatinine in blood is relatively stable and reflects the glomerular filtration rate (GFR), which is a key indicator of kidney function. However, urine sample segment is the fastest growing segment owing to increasing sample use for creatinine measurements, especially when assessing kidney function. Urine creatinine is commonly used to calculate creatinine clearance, which is another method for estimating GFR. However, urine creatinine assays are typically used in conjunction with blood creatinine measurements due to which blood sample is dominating the sample type segment.

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Regional Insights

Based on Region, Based on region, North America holds the largest market share in the global Creatinine Assay Market. This dominance is attributed to the region's advanced healthcare infrastructure, high prevalence of chronic kidney diseases, and strong presence of leading diagnostic companies. According to the Centers for Disease Control and Prevention (CDC), over 37 million adults in the United States are estimated to have chronic kidney disease (CKD), many of whom require regular monitoring of kidney function through creatinine testing. In addition, the high adoption rate of advanced diagnostic technologies and automation in clinical laboratories further supports the market growth. The National Institutes of Health (NIH) continuously funds kidney health research and initiatives aimed at improving diagnostic accuracy and early detection, indirectly boosting demand for reliable assay kits, including creatinine assays. Moreover, public and private health insurance coverage across the U.S. and Canada ensures broader access to kidney function tests, while routine health screening programs increase the frequency of testing. The American Society of Nephrology (ASN) also plays a critical role in promoting education and awareness among healthcare professionals regarding the importance of timely CKD detection and monitoring.

Recent Developments

• In October 2023, Everly Health introduced a convenient at-home kidney health test that combines an estimated glomerular filtration rate (eGFR) obtained from a blood sample to evaluate kidney function, along with a urinary albumin-to-creatinine ratio (UACR) measured through urine collection to further assess kidney health. This convenience is particularly beneficial for patients with CKD, diabetes, or hypertension who require regular monitoring to manage their conditions effectively, positively influencing creatinine test market trends.
• In March 2023, Phoenix, Arizona-based Dignity Health St. Joseph’s Hospital and Medical Center launched a new initiative this week to address the use of race-based algorithms in the early diagnosis of chronic kidney disease (CKD) and combatting health disparities. It is designed to help improve health equity and outcomes for Black patients. Diagnosing kidney disease can be complicated by the use of biased assessment tools, such as the estimated glomerular filtration rate (eGFR).
• In July 2022, the United States Food and Drug Administration (FDA) granted 510(k) clearance to Healthy.io for the home use of the Minuteful Kidney test. This innovative smartphone-powered at-home assay is among the first to be approved by the FDA for measuring albumin to creatinine ratio (ACR).
• On June 01, 2020, Akcea received approval for the reimbursement of TEGSEDI in Portugal for the treatment of hereditary transthyretin amyloidosis with polyneuropathy. TEGSEDI, the pioneering antisense oligonucleotide medicine, became available to patients in Portugal.
• At ASCO 2020, on May 13, 2020, Amgen presented updates on their Oncology Pipeline, including data evaluation of Sotorasib, an investigational KRASG12C inhibitor.
• In June 2020, the United States Food and Drug Administration (FDA) granted 510(k) clearance to Healthy.io for the home use of the Minuteful Kidney test. This innovative smartphone-powered at-home assay is among the first to be approved by the FDA for measuring albumin to creatinine ratio (ACR).

Key Market Players

• Abbott Laboratories
• Thermo Fisher Scientific
• Merck KGaA
• Quidel Corporation
• Cell Biolabs, Inc.
• Genway Biotech
• Randox Laboratories Ltd.
• ACON Laboratories
• Nova Biomedical
• Sysmex India Pvt. Ltd.

Report Scope:

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

• Creatinine Assay Market, By Test Type:
  • Jaffe Kinetic Method
  • Enzymatic Method
• Creatinine Assay Market, By Product:
  • Reagents
  • Kits
• Creatinine Assay Market, By Sample:
  • Blood/Serum
  • Urine
• Creatinine Assay Market, By End User:
  • Hospitals
  • Diagnostic Laboratories
• Creatinine Assay Market, By Region:
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Creatinine Assay Market.

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Global Creatinine Assay market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

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