Cystatin C Assay Market - By Product (Kits, Reagents, Analyzers), By Sample Type (Blood, Urine), By Method (ELISA, PETIA, PENIA, CLIA, Immunofluorescence Assay), By Application, End use & Forecast, 2024-2032

Cystatin C Assay Market Size

Cystatin C Assay Market was valued at USD 269.6 million in 2023 and is anticipated to grow at a CAGR of over 7.7% between 2024 & 2032. A cystatin C assay is a laboratory test designed to measure the concentration of cystatin C in biological samples, typically in blood or serum. It is commonly used as a biomarker for estimating glomerular filtration rate (GFR). The assays play a vital role in the early diagnosis, monitoring, and kidney stone management, contributing to improved patient outcomes and driving innovation in the field of renal function assessment.
 

The increasing prevalence of chronic kidney diseases is anticipated to augment the cystatin C assay market. According to the report published by the Centers for Disease Control and Prevention (CDC) in 2022, more than 1 in 7 U.S. adults, about 14% or an estimated 37 million people are affected by CKD. Thus, as the incidence of chronic kidney diseases increases globally the demand for effective diagnostic solutions to measure the concentration of cystatin C, stimulating market growth.
 

Cystatin C Assay Market Trends

The increasing geriatric population has created a larger pool of individuals at risk of kidney-related issues, making reliable and accurate renal function assessments crucial. For instance, according to the World Health Organization (WHO) estimates, the global population of individuals aged 60 years and above is anticipated to increase from 1 billion in 2020 to 1.4 billion by 2040. Cystatin C assays offer a valuable solution contributing to the growth of the market for assessing kidney function particularly in the elderly population. Additionally, advances in diagnostic technologies, such as point-of-care testing, are making cystatin C assays more accessible and convenient, ultimately improving patient care and helping clinicians make informed decisions about renal health among elderly population.
 

Cystatin C Assay Market Analysis

The cystatin C assay industry by product is categorized into kits, reagents, and analyzers. The kits segment garnered USD 116.8 million revenue size in the year 2023 and is projected to have the fastest-growing CAGR in the forecast period.
 

• Kits are intended to provide a complete solution for performing the cystatin C assay, and they 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, and kits frequently include all necessary components, eliminating the need for lengthy planning and computations.
   
• The convenience and ease of use of kits are contributing factor to the growth of the kits segment in the cystatin C assay market.
   

Therefore, the increasing preference for these kits will play a pivotal role in propelling the market growth.
 

Based on sample type, the market is segmented into blood and urine. Blood segment garnered USD 183.9 million revenue size in 2023.
 

• Blood samples are widely used in clinical diagnostics and research settings. They allow for standardized and consistent measurements of cystatin C levels, making it easier to compare results across different studies and populations.
   
• Use of blood as a sample for cystatin C assays is crucial for accurately assessing renal function. It allows for the sensitive detection of changes in GFR, provides quantitative and standardized measurements, and is well-suited for routine clinical laboratory procedures, ensuring the clinical relevance of the results. Thus, abovementioned factors are anticipated to accelerate the market growth.
   

Based on method, the market is segmented into enzyme-linked immunosorbent assay (ELISA), particle-enhanced turbidimetric immunoassay (PETIA), particle-enhanced nephelometric immunoassay (PENIA), chemiluminescent immunoassay (CLIA), immunofluorescence assay, and other methods. Enzyme-linked immunosorbent assay (ELISA) segment garnered USD 78.8 million revenue in 2023.
 

• Enzyme-Linked Immunosorbent Assay (ELISA) is a widely used method for quantifying the concentration of cystatin C in biological samples.
   
• ELISA method is relatively straightforward and easily performed in laboratory settings. Additionally, the method is well-established, and easily available that simplify the process for researchers and clinicians.
   

Thus, its high sensitivity and specificity, quantitative capabilities, ease of use, adaptability to automation, cost-effectiveness, and widespread acceptance in both research and clinical settings is anticipated to boost demand for enzyme-linked immunosorbent assay (ELISA) method.
 

Based on application, the market is segmented into diagnostics and research. The diagnostics segment held substantial revenue in the market accounting for USD 192 million in the year 2023.
 

• Cystatin C assays are employed in diagnostic screening to detect early signs of kidney dysfunction. Early diagnosis is crucial for implementing timely interventions and preventing the progression of kidney diseases to more advanced stages.
   
• The need for more accurate diagnoses and better patient care has led increase demand for cystatin C assays in upcoming years.

Based on end-use, the cystatin C assay market is segmented into hospitals, clinical laboratories, pharmaceutical and biotechnology companies, and other end-users. The hospital segment accounted for largest share of 32.3% in 2023 in the market. The large share of this segment can be attributed to large patient pool and easy access. Hospitals adhere to stringent quality control and assurance standards when conducting cystatin C assays. This ensures the accuracy and reliability of test results, meeting regulatory requirements.
 

The U.S. market accounted for USD 102.4 million revenue size in 2023 and is predicted to witness substantial market growth over the analysis timeline.
 

• The U.S. has taken a commanding position in the cystatin C assay market, primarily due to its advanced healthcare infrastructure, widespread access to cutting-edge diagnostic technologies, and increasing prevalence of chronic kidney disease.
   
• For instance, the U.S. has a well-developed healthcare infrastructure, including advanced laboratories and diagnostic facilities. This facilitates the adoption of sophisticated assays, such as cystatin C, for precise kidney function assessment.
   
• Therefore, with a large patient pool and a strong emphasis on preventive healthcare, the U.S. plays a pivotal role in propelling market growth.
   

Cystatin C Assay Market Share

The cystatin C assay industry is consolidated, with key players including, Roche Diagnostics Limited, Siemens Healthineers AG, Abbott Laboratories, Beckman Coulter (Danaher Corporation), and others dominating the market space. These companies focus on ongoing product innovation, geographical expansion, and partnerships to secure substantial market shares. For instance, in January 2021, Roche acquired GenMark, which is involved in the development and manufacturing of cystatin C assays. This acquisition strengthened Roche's position in the cystatin C assay industry and expanded its product portfolio.
 

Cystatin C Assay Market Companies

Some of the eminent market participants operating in the cystatin C assay industry include:

• Roche Diagnostics Limited
• Siemens Healthineers AG
• Abbott Laboratories
• Beckman Coulter (Danaher Corporation)
• Thermo Fisher Scientific Inc
• bioMérieux SA
• Sysmex Corporation
• Randox Laboratories
• DiaSorin
• Agilent Technologies Inc.
• Bio-Rad Laboratories Inc
• Abcam Plc
• DiaSys Diagnostic Systems GmbH
• Sino Biological, Inc.
• Bio-Techne Corporation
   

Cystatin C Assay Industry News

• In March 2022, Gentian, a key player in the cystatin C assay market, announced that its Cystatin C and GCAL assays have been IVDR (In-Vitro Diagnostic Regulation) certified by TüV SÜD. This certification signifies that the assays comply with the regulatory standards set forth by IVDR. This strategic introduction aimed to diversify the company's offering and enhance revenue.
   

Cystatin C assay market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2018 to 2032 for the following segments:

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Market, By Product

• Kits
• Reagents
• Analyzers

Market, By Sample Type

• Blood
• Urine

Market, By Method

• Enzyme-linked immunosorbent assay (ELISA)
• Particle-enhanced turbidimetric immunoassay (PETIA)
• Particle-enhanced nephelometric immunoassay (PENIA)
• Chemiluminescent immunoassay (CLIA)
• Immunofluorescence assay
• Other methods

Market, By Application

• Diagnostics
• Research

Market, By End-use

• Hospitals
• Clinical laboratories
• Pharmaceutical and biotechnology companies
• Other end-users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East & Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East & Africa