Cystatin C Assay Market by Product, Method, Sample Type, Setting, Application, End-user

List of Tables

[194 Pages Report] The Cystatin C Assay Market size was estimated at USD 427.47 million in 2023 and expected to reach USD 459.83 million in 2024, at a CAGR 7.24% to reach USD 697.41 million by 2030.

The cystatin C assay is a laboratory test utilized to measure the levels of cystatin C, a protein produced by nearly all cells in the body. It is most useful in exceptional cases where creatinine measurement could be misleading. The increasing prevalence of kidney diseases and the growing geriatric population drive the need for cystatin C assay. Furthermore, the increasing availability and clinical adoption of cystatin C with the introduction of advanced automated testing methods have led to its market growth. In contrast, the high manufacturing costs of cystatin C assays and strict interpretation guidelines restrict their adoption. However, several vendors are investing in R&D to overcome its issues. Furthermore, advancements in diagnostics technologies, emerging research, and ongoing publishing of clinical guidelines for cystatin C assay provide substantial market growth opportunities.

KEY MARKET STATISTICS
Base Year [2023]	USD 427.47 million
Estimated Year [2024]	USD 459.83 million
Forecast Year [2030]	USD 697.41 million
CAGR (%)	7.24%

Product: Consumer preference cystatin C analyzer for diagnosis and monitoring conditions

A cystatin C analyzer is a medical device used to measure cystatin c concentration. This device is crucial for diagnosing and monitoring conditions such as kidney disease. Cystatin C kits are designed to accurately measure human cystatin c in cell culture supernatants, serum, plasma, saliva, urine, and human milk. Cystatin C reagents are recognized as being of the highest quality, producing accurate and precise results. It is a chemical substance used in the laboratory to measure cystatin C levels in the sample. A wide range of methods and formats provide greater flexibility and choice for any laboratory size.

Method: Expanding usage of enzyme-linked immunosorbent assay (ELISA) for cystatin C assays

The enzyme-linked immunosorbent assay (ELISA) method involves using antibodies using antibodies to detect and quantify the cystatin c levels in a sample. ELISA is known for its sensitivity and specificity, making it a widely used method in clinical laboratories for assessing cystatin C levels as a marker for renal function. A chemiluminescent immunoassay for cystatin C offers high sensitivity and wide dynamic range and is often automated, enabling efficient high-throughput testing. It is commonly used in clinical laboratories for its precision and accuracy in quantifying cystatin C levels. Immunofluorescence assay utilizes fluorescent dyes or proteins to label cystatin C antibodies, and fluorescence is detected under a microscope or specialized instrument. It is useful in research settings and specific clinical scenarios requiring visual confirmation of cystatin C presence. Particle-enhanced nephelometric immunoassay (PENIA) offers high sensitivity and precision, is suitable for low-concentration samples, and is widely used in clinical laboratories for its accuracy and reliability in quantifying cystatin C, especially in renal function assessment. Particle-enhanced turbidimetric immunoassay (PETIA) measures the degree of turbidity caused by the formation of antigen-antibody complexes in the presence of cystatin C. It is simple, cost-effective, suitable for routine clinical use, and commonly employed in clinical laboratories to quantify cystatin C levels, especially in large-scale testing.

Setting: Expanding usage of point-of-care setting for cystatin C assays

In a laboratory setting, cystatin C assay is performed in clinical laboratories equipped with specialized equipment and trained personnel. Blood samples are collected from patients and then processed using advanced laboratory instruments to measure the levels of cystatin C. This setting allows for meticulous analysis and precise measurements, often offering a wider range of tests and higher throughput, although it might take longer to generate results compared to point-of-care settings. In a point-of-care setting, the cystatin C assay is conducted at or near the patient's location, such as within a clinic, doctor's office, or at the bedside in a hospital. Point-of-care tests for cystatin C are designed to provide rapid results, allowing healthcare providers to make immediate clinical decisions. These tests are often simpler, quicker, and require minimal equipment or specialized training. They are beneficial for quick assessments or situations where rapid results are crucial for immediate treatment decisions.

Sample Type: Significant role urine sample for cystatin C assay for measuring the amount of creatinine in a sample

The cystatin C assay employs blood samples, specifically serum and plasma. These samples are vital for evaluating cystatin C levels as a biomarker for kidney function. Blood samples provide clinicians with valuable information to diagnose and monitor conditions, including chronic kidney disease, offering insights into renal health and processes. Urine samples for cystatin c assay involve measuring the concentration of cystatin c in the urine. Cystatin C in urine indicates tubular dysfunction and other renal issues.The choice between blood and urine assays for cystatin C often relies on individual patient needs and circumstances. These methods provide valuable diagnostic insight, with blood assays offering a more traditional approach and urine assays providing a viable alternative when blood sampling is untenable.

Application: Increasing application of cystatin C assays for diagnosis of renal function

For diagnostic use, cystatin C assays are vital for assessing renal function, enabling early detection and monitoring of kidney diseases. It is used in differential diagnosis, risk stratification, and personalized healthcare in clinical settings. For research & development, cystatin C assays are integral in biomarker discovery for understanding kidney function and diseases. It is applied in clinical trials and studies to evaluate the impact of interventions on kidney health, and supports the exploration of disease mechanisms, contributing to advancements in renal research.

End-user: Expanding usage of cystatin C assays in academic research centers for studying biomarkers

Academic research centers often utilize cystatin C assays to investigate kidney function and diseases. This includes studying biomarkers for early detection, understanding the progression of renal disorders, and assessing the effectiveness of potential treatments. Academic researchers can use cystatin C assays in biomarker discovery projects to identify novel indicators of kidney function or diseases. Diagnostic laboratories routinely employ cystatin C assays as part of comprehensive renal function testing panels. This helps in the early detection of kidney dysfunction and provides clinicians with valuable information for patient management. In cases of chronic kidney diseases, diagnostic laboratories utilize cystatin C assays for ongoing monitoring of patients. Regular testing helps track changes in kidney function and allows for timely adjustments to treatment plans. In hospitals and clinics, cystatin C assays aid healthcare professionals in making clinical decisions related to kidney function. Elevated levels may prompt further investigation or adjustments in patient care. The objective of academic research centers to use cystatin C assays is to focus on advancing scientific knowledge, while diagnostic laboratories use it for routine kidney function testing and differential diagnosis. Hospitals & clinics use cystatin C assays for clinical decision-making and management of patients with kidney disorders.

Regional Insights

In North America, particularly in the U.S., the presence of major healthcare and diagnostic companies, research institutions, and well-established healthcare infrastructure is a significant contributor to the cystatin C assay market. Moreover, stringent regulatory standards laid by government regulatory agencies, including the U.S. Food and Drug Administration (FDA) and Health Canada, play a crucial role in product approvals for cystatin c assay. In South America, increasing awareness about the importance of early disease diagnosis and a growing healthcare sector is expected to contribute to the expanding need for cystatin C assay. In Europe, countries such as Germany, France, Switzerland, and the United Kingdom are contributing to the growing adoption of cystatin C assay as they have well-established healthcare infrastructure with high spending and a focus on technological advancements in the pharmaceutical and biotechnology sectors. In the Middle East and Africa, the growing prevalence of chronic diseases with increasing population and a focus on improving diagnostic capabilities with investing heavily in the healthcare sector is expected to bolster the usage of cystatin C assay in the region. In APAC countries, including China and Japan, the increasing number of geriatric residents and the rising prevalence of chronic diseases contribute to the expansion of the market. In countries including China, India, and Australia, increasing awareness of kidney diseases and proactive health screening initiatives by government and regional healthcare companies increase the need for diagnostic tests such as cystatin c assay. In emerging nations such as Indonesia, Thailand, and Vietnam, economic development, expanding healthcare access, and an emphasis on preventive healthcare support the application of cystatin C assay in the region.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Cystatin C Assay Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Cystatin C Assay Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Cystatin C Assay Market, highlighting leading vendors and their innovative profiles. These include Abbexa Limited, Abbott Laboratories, Abcam PLC, Advy Chemical Pvt. Ltd., Agilent Technologies, Inc., AOBIOUS Inc., Arbor Assays Inc., Aviva Systems Biology Corporation, BBI Solutions OEM Limited, Bio-Rad Laboratories, Inc., Bio-Techne Corporation, Biorbyt Ltd, BioVendor - Laboratorni medicina a.s., Boditech Med Inc., Cepham Life Sciences, Inc., Cusabio Technology LLC, DIALAB GmbH, DiaSys Diagnostic Systems GmbH, Diazyme Laboratories, Inc. by General Atomics, Eagle Biosciences, Inc., Elabscience Biotechnology Inc., Ethos Biosciences, Inc., Eurolyser Diagnostica GmbH by Mars, Incorporated, F. Hoffmann-La Roche Ltd, Fapon Biotech Inc., Fortress Diagnostics Ltd., Gentian Diagnostics ASA, Getein Biotech, Inc., ImmunoDiagnostics Limited, Kamiya Biomedical Company, Laboratory Corporation of America Holdings, Merck KGaA, Proteintech Group, Inc., PZ CORMAY S.A., Randox Laboratories Ltd., RayBiotech, Inc., Sekisui Diagnostics, LLC, Siemens Healthineers AG, Sino Biological, Inc., Thermo Fisher Scientific Inc., Tosoh Corporation, Weldon Biotech, and Zhejiang Kangte Biotechnology Co., Ltd..

Market Segmentation & Coverage

This research report categorizes the Cystatin C Assay Market to forecast the revenues and analyze trends in each of the following sub-markets:

Product
- Analyzer
- Kits
- Reagents

Method
- Chemiluminescence Immunoassay
- Enzyme linked Immunosorbent Assay
- Immunofluorescence Assay
- Particle-enhanced Nephelometric Immunoassay
- Particle-enhanced Turbidimetric Immunoassay

Sample Type
- Blood
- Urine

Setting
- Laboratory Setting
- Point of Care Setting

Application
- Diagnosis Use
- Research & Development

End-user
- Academic Research Centers
- Diagnostic Laboratories
- Hospitals & Clinics

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Cystatin C Assay Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Cystatin C Assay Market?

3. What are the technology trends and regulatory frameworks in the Cystatin C Assay Market?

4. What is the market share of the leading vendors in the Cystatin C Assay Market?

5. Which modes and strategic moves are suitable for entering the Cystatin C Assay Market?

Product Code: MRR-2E76C3E47F4F

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Rising prevalence of kidney diseases and growing geriatric population
  - 5.1.1.2. Progressive investments in healthcare infrastructures for renal disorders
- 5.1.2. Restraints
  - 5.1.2.1. High development costs of cystatin C assays and incidences of product recalls
- 5.1.3. Opportunities
  - 5.1.3.1. Advances in cystatin C assay testing
  - 5.1.3.2. Emerging research for adoption of cystatin C assays as alternative to creatinine-based tests
- 5.1.4. Challenges
  - 5.1.4.1. Dearth of skilled lab professionals and technical challenges associated with cystatin C assay
5.2. Market Segmentation Analysis
- 5.2.1. Product: Consumer preference cystatin C analyzer for diagnosis and monitoring conditions
- 5.2.2. Method: Expanding usage of enzyme-linked immunosorbent assay (ELISA) for cystatin C assays
- 5.2.3. Setting: Expanding usage of point-of-care setting for cystatin C assays
- 5.2.4. Sample Type: Significant role urine sample for cystatin C assay for measuring the amount of creatinine in a sample
- 5.2.5. Application: Increasing application of cystatin C assays for diagnosis of renal function
- 5.2.6. End-user: Expanding usage of cystatin C assays in academic research centers for studying biomarkers
5.3. Market Trend Analysis
- 5.3.1. Well-established healthcare infrastructure coupled with emphasis on commercializing Cystatin C Assay solutions in the Americas
- 5.3.2. Supportive government programs to reduce the burden of renal disorders in the Asia-Pacific region
- 5.3.3. Growing focus on developing and expanding novel cystatin C assays products in the EMEA region
5.4. Cumulative Impact of High Inflation
5.5. Porter's Five Forces Analysis
- 5.5.1. Threat of New Entrants
- 5.5.2. Threat of Substitutes
- 5.5.3. Bargaining Power of Customers
- 5.5.4. Bargaining Power of Suppliers
- 5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework Analysis

6. Cystatin C Assay Market, by Product

6.1. Introduction
6.2. Analyzer
6.3. Kits
6.4. Reagents

7. Cystatin C Assay Market, by Method

7.1. Introduction
7.2. Chemiluminescence Immunoassay
7.3. Enzyme linked Immunosorbent Assay
7.4. Immunofluorescence Assay
7.5. Particle-enhanced Nephelometric Immunoassay
7.6. Particle-enhanced Turbidimetric Immunoassay

8. Cystatin C Assay Market, by Sample Type

8.1. Introduction
8.2. Blood
8.3. Urine

9. Cystatin C Assay Market, by Setting

9.1. Introduction
9.2. Laboratory Setting
9.3. Point of Care Setting

10. Cystatin C Assay Market, by Application

10.1. Introduction
10.2. Diagnosis Use
10.3. Research & Development

11. Cystatin C Assay Market, by End-user

11.1. Introduction
11.2. Academic Research Centers
11.3. Diagnostic Laboratories
11.4. Hospitals & Clinics

12. Americas Cystatin C Assay Market

12.1. Introduction
12.2. Argentina
12.3. Brazil
12.4. Canada
12.5. Mexico
12.6. United States

13. Asia-Pacific Cystatin C Assay Market

13.1. Introduction
13.2. Australia
13.3. China
13.4. India
13.5. Indonesia
13.6. Japan
13.7. Malaysia
13.8. Philippines
13.9. Singapore
13.10. South Korea
13.11. Taiwan
13.12. Thailand
13.13. Vietnam

14. Europe, Middle East & Africa Cystatin C Assay Market

14.1. Introduction
14.2. Denmark
14.3. Egypt
14.4. Finland
14.5. France
14.6. Germany
14.7. Israel
14.8. Italy
14.9. Netherlands
14.10. Nigeria
14.11. Norway
14.12. Poland
14.13. Qatar
14.14. Russia
14.15. Saudi Arabia
14.16. South Africa
14.17. Spain
14.18. Sweden
14.19. Switzerland
14.20. Turkey
14.21. United Arab Emirates
14.22. United Kingdom

15. Competitive Landscape

15.1. Market Share Analysis, 2023
15.2. FPNV Positioning Matrix, 2023
15.3. Competitive Scenario Analysis
- 15.3.1. Jana Care Raises USD 6 Million for Commercialisation of Self-Administered Blood Tests
- 15.3.2. LordsMed Announces the Launch of its First Pathology Centre in Maharashtra
- 15.3.3. Renalyse Closes a EUR 1 Million Funding Round with the Participation of GENESIS Ventures
- 15.3.4. Renalytix Selects EVERSANA to Expand Commercialization of KidneyIntelX for Early-Stage Kidney Disease Prognosis Detection in Patients with Type 2 Diabetes
- 15.3.5. New European Cystatin C Equation for eGFR May Be More Accurate
- 15.3.6. Jana Care to Enter Collaboration with Roche to Develop and Distribute Blood Testing Platform to Improve Remote Care for Patients With Chronic Kidney and Heart Disease
- 15.3.7. Gentian Diagnostics ASA Signs Distribution Agreement for Cystatin C
- 15.3.8. Bloom Diagnostics Launches New Kidney Test

16. Competitive Portfolio

16.1. Key Company Profiles
16.2. Key Product Portfolio