Cystatin C Assay Market by Product (Analyzer, Kits, Reagents), Method (Chemiluminescence Immunoassay, Enzyme linked Immunosorbent Assay, Immunofluorescence Assay), Sample Type, Setting, Application, End-user - Global Forecast 2024-2030
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.
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.
Market Insights
Market Dynamics
The market dynamics represent an ever-changing landscape of the Cystatin C Assay Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.
Market Drivers
Rising prevalence of kidney diseases and growing geriatric population
Progressive investments in healthcare infrastructures for renal disorders
Market Restraints
High development costs of cystatin C assays and incidences of product recalls
Market Opportunities
Advances in cystatin C assay testing
Emerging research for adoption of cystatin C assays as alternative to creatinine-based tests
Market Challenges
Dearth of skilled lab professionals and technical challenges associated with cystatin C assay
Market Segmentation Analysis
Product: Consumer preference cystatin C analyzer for diagnosis and monitoring conditions
Method: Expanding usage of enzyme-linked immunosorbent assay (ELISA) for cystatin C assays
Setting: Expanding usage of point-of-care setting for cystatin C assays
Sample Type: Significant role urine sample for cystatin C assay for measuring the amount of creatinine in a sample
Application: Increasing application of cystatin C assays for diagnosis of renal function
End-user: Expanding usage of cystatin C assays in academic research centers for studying biomarkers
Market Disruption Analysis
Porter’s Five Forces Analysis
Value Chain & Critical Path Analysis
Pricing Analysis
Technology Analysis
Patent Analysis
Trade Analysis
Regulatory Framework Analysis
FPNV Positioning Matrix
The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Cystatin C Assay Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment 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, namely 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 assessment of the current state of vendors in the Cystatin C Assay Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. 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 these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Recent Developments
Jana Care Raises USD 6 Million for Commercialisation of Self-Administered Blood Tests
Jana Care raised USD 6 million in Series B funding to support the commercialization of its self-administered blood tests for kidney and heart disease. The funds further enhance Jana Care's quantitative blood testing platform. This platform is designed to enable individuals to self-administer tests at home while facilitating remote review by healthcare professionals.
LordsMed Announces the Launch of its First Pathology Centre in Maharashtra
LordsMed, the healthcare division of Lords Mark Industries Pvt. Ltd., launched pathology centers in Kalyan and Dombivli. The company has plans to open ten more centers in and around Mumbai by December 2023. The establishment of this pathology center greatly facilitates patient access to critical diagnostic tests, ultimately improving healthcare outcomes.
Renalyse Closes a EUR 1 Million Funding Round with the Participation of GENESIS Ventures
Renalyse, a company dedicated to developing innovative bioanalytical assays, recently concluded a successful EUR 1 million funding round with Genesis Ventures. The investment round aims to support the industrialization and certification of Renalyse's diagnostic and monitoring device for chronic kidney disease.
Strategy Analysis & Recommendation
The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Cystatin C Assay Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.
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 – Laboratorní medicína 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
Please Note: PDF & Excel + Online Access - 1 Year
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