C-reactive Protein Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Assay Type (Immunoturbidimetric Assay, ELISA, Chemiluminescence Immunoassay, Others), By Detection Range (hs-CRP, Conventional CRP, cCRP), By Disease Area (Cardiovascular Diseases, Cancer, Rheumatoid Arthritis, Inflammatory Bowel Disease, Endometriosis, Lupus, Others), By End-Use Industry (Hospitals & Clinics, Laboratories, Assisted Living Healthcare Facilities, Homecare, Others), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.95 Billion
CAGR (2026-2031)	2.11%
Fastest Growing Segment	Immunoturbidimetric Assays
Largest Market	North America
Market Size (2031)	USD 2.21 Billion

Market Overview

The Global C-reactive Protein Testing Market will grow from USD 1.95 Billion in 2025 to USD 2.21 Billion by 2031 at a 2.11% CAGR. C-reactive protein testing is a diagnostic procedure performed on blood samples to measure the concentration of C-reactive protein, serving as a critical indicator for systemic inflammation, bacterial infections, and cardiovascular risk. The market is primarily supported by the escalating prevalence of chronic diseases, particularly cardiovascular and inflammatory disorders, which necessitates frequent patient monitoring and risk stratification. According to the American Heart Association, in 2025, the global prevalence of cardiovascular disease was reported to be approximately 612 million cases, underscoring the substantial clinical demand for inflammatory markers. Additionally, the aging global population and a distinct shift toward decentralized point-of-care testing are key factors propelling market growth.

However, a significant challenge impeding market expansion is the stringent regulatory environment and inconsistent reimbursement policies for diagnostic assays across different regions. These administrative and economic barriers often delay the commercial approval of new testing platforms and limit the financial accessibility of high-sensitivity diagnostic solutions for healthcare providers, thereby restricting broader market penetration.

Key Market Drivers

The rising prevalence of chronic and inflammatory diseases serves as a primary catalyst for the expansion of the Global C-reactive Protein Testing Market. As systemic inflammation is a key underlying factor in conditions such as cardiovascular diseases, diabetes, and autoimmune disorders, the clinical necessity for accurate biomarkers to monitor disease progression has intensified. Healthcare providers increasingly rely on C-reactive protein assays to detect inflammation early and manage patient therapy effectively, particularly given the heavy global burden of noncommunicable diseases. According to the World Health Organization, April 2024, in the 'Noncommunicable diseases' fact sheet, noncommunicable diseases kill 41 million people each year, equivalent to 74% of all deaths globally. This substantial disease burden necessitates robust diagnostic protocols, thereby sustaining the high demand for inflammatory marker testing in both hospital and outpatient settings.

The increasing adoption of point-of-care testing platforms significantly influences market dynamics by decentralizing diagnostic procedures and enabling rapid clinical decision-making. These portable solutions allow for the immediate assessment of protein levels in non-laboratory environments, which is crucial for distinguishing between bacterial and viral infections and reducing unnecessary antibiotic prescriptions. Major industry players are responding to this trend by scaling their diagnostic capabilities to meet the diverse needs of decentralized care. According to Abbott, October 2024, in the 'Abbott Reports Third-Quarter 2024 Results', worldwide Diagnostics sales reached USD 2.4 billion, reflecting the sustained demand for accessible diagnostic modalities. Furthermore, the market benefits from demographic shifts that increase susceptibility to inflammatory conditions, widening the patient base requiring regular monitoring. According to the United Nations, in 2024, the global population aged 65 and older is projected to rise significantly, further driving the requirement for regular health monitoring and diagnostic testing.

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Key Market Challenges

The stringent regulatory environment and inconsistent reimbursement policies significantly restrict the growth of the Global C-reactive Protein Testing Market. Manufacturers face complex and evolving compliance requirements that extend approval timelines and inflate development costs. This regulatory burden diverts essential capital away from the research needed to create high-sensitivity assays, effectively delaying the commercial availability of advanced diagnostic solutions. Consequently, the unpredictable nature of these approval pathways discourages companies from introducing new products in key regions, limiting the options available to healthcare providers for patient monitoring.

Furthermore, uncertain reimbursement frameworks create financial risks that hamper the adoption of these tests. Laboratories are often reluctant to invest in new diagnostic platforms without clear payment guarantees, which directly impacts market penetration. According to MedTech Europe, in 2025, industry data revealed that certification costs under the In Vitro Diagnostic Regulation escalated by up to 100% compared to previous standards, leading to a 40% decline in large manufacturers selecting the European Union as their primary launch geography. This evidence highlights how administrative and economic barriers directly stifle the market’s potential for expansion.

Key Market Trends

The application of CRP testing in Antimicrobial Stewardship Programs is fundamentally reshaping market demand as healthcare systems integrate diagnostic algorithms into national resistance strategies. Institutional protocols are increasingly mandating CRP screening prior to antibiotic administration to ensure compliance with global stewardship goals, moving the assay beyond simple clinical diagnosis into a core component of regulatory adherence. This programmatic shift is driving the procurement of rapid testing platforms as essential infrastructure for public health compliance, specifically to validate treatment decisions in respiratory cases. According to Abbott, January 2024, in the 'Reduce antibiotic use with point-of-care testing' article, C-reactive protein point-of-care testing has been shown to reduce antibiotic prescribing by more than 60% when combined with communication training.

Widespread adoption of High-Sensitivity CRP (hs-CRP) for cardiovascular risk stratification is expanding the test's utility from acute inflammation monitoring to long-term preventative cardiology. Clinicians are prioritizing hs-CRP to identify residual inflammatory risk in asymptomatic individuals, facilitating early intervention strategies distinct from traditional lipid management. This trend is accelerating as new clinical evidence validates the biomarker's predictive capability for future adverse events over extended horizons, compelling providers to incorporate these assays into routine screening panels. According to the European Society of Cardiology, August 2024, in research presented at the 'ESC Congress 2024', women with the highest levels of C-reactive protein had a 70% increased associated risk for heart disease compared to those with the lowest levels.

Segmental Insights

Immunoturbidimetric assays represent the fastest-growing segment in the global C-reactive protein testing market, driven by their extensive application in automated clinical chemistry analyzers. This method gains preference due to its ability to process high sample volumes rapidly while maintaining diagnostic accuracy, a critical factor for hospitals managing heavy patient loads. Additionally, the reliable quantification of protein levels provided by this technique meets the stringent validation requirements of regulatory entities such as the US Food and Drug Administration, further encouraging its widespread implementation in diagnostic laboratories worldwide.

Regional Insights

North America maintains a leading position in the Global C-reactive Protein Testing Market, driven primarily by the high incidence of cardiovascular and chronic inflammatory diseases. The region benefits from a robust healthcare system that prioritizes early diagnosis and preventative monitoring. Market expansion is further fueled by the proactive role of the US Food and Drug Administration in streamlining product approvals, which encourages continuous product development by established manufacturers. Furthermore, wide acceptance of testing guidelines for cardiac risk assessment supports the sustained demand for C-reactive protein assays throughout the United States and Canada.

Recent Developments

• In July 2025, Boditech Med unveiled its comprehensive veterinary diagnostic solutions at the Association for Diagnostics & Laboratory Medicine (ADLM) Annual Scientific Meeting. The company introduced advanced analyzers, such as the AFIAS-VET and VETCHROMA 3, which are capable of performing immunoassays including C-reactive protein (CRP) testing for animal health. This expansion into the veterinary market highlights the company's strategy to broaden its global footprint and leverage its existing diagnostic technologies for new applications. The launch aims to provide veterinary clinics with rapid, accurate, and automated testing options for inflammation and other conditions.
• In March 2025, Beckman Coulter Diagnostics announced that it had received FDA 510(k) clearance for its integrated clinical chemistry and immunoassay analyzer. The DxC 500i Clinical Analyzer, which had previously launched in markets accepting the CE mark in July 2024, consolidates testing workflows including those for C-reactive protein (CRP) into a single, compact system. This launch addresses the needs of low-volume and satellite laboratories within integrated delivery networks by providing standardized reagents and consistent performance. The system features automated protocols that prioritize urgent samples, thereby improving turnaround times for critical inflammation and cardiac markers.
• In January 2024, Roche announced that it had entered into a definitive agreement to acquire the point-of-care technology platform from LumiraDx, a UK-based diagnostics company. The transaction, valued at $295 million with an additional payment of up to $55 million, aimed to integrate the acquired company's innovative technology, which consolidates multiple tests including C-reactive protein (CRP) on a single instrument, into Roche’s diagnostics portfolio. This strategic collaboration was designed to expand the company's decentralized testing capabilities, enabling faster and more accessible diagnostic results for patients worldwide in settings such as primary care and emergency rooms.
• In January 2024, Siemens Healthineers received FDA 510(k) clearance for its new high-sensitivity C-reactive protein (hsCRP) assay designed for use on its high-volume clinical chemistry analyzers. The newly cleared Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay is intended to quantitatively measure CRP levels in human serum and plasma. It serves as an aid in identifying individuals at risk for future cardiovascular disease. This regulatory milestone allowed the company to offer enhanced cardiac risk assessment tools to laboratories, supporting better clinical decision-making for patients with cardiovascular conditions.

Key Market Players

• Thermo Fisher Scientific, Inc.
• F. Hoffmann-La Roche Ltd.
• Danaher Corp
• Quest Diagnostics
• Siemens Healthineers AG
• Abbott Laboratories Inc.
• Merck KGaAA
• Zoetis Inc.
• Ortho Clinical Diagnostics
• Getein Biotech, Inc.

By Assay Type	By Detection Range	By Disease Area	By End-Use Industry	By Region
Immunoturbidimetric Assay ELISA Chemiluminescence Immunoassay Others	hs-CRP Conventional CRP cCRP	Cardiovascular Diseases Cancer Rheumatoid Arthritis Inflammatory Bowel Disease Endometriosis Lupus Others	Hospitals & Clinics Laboratories Assisted Living Healthcare Facilities Homecare Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global C-reactive Protein Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• C-reactive Protein Testing Market, By Assay Type:

• Immunoturbidimetric Assay
• ELISA
• Chemiluminescence Immunoassay
• Others

• C-reactive Protein Testing Market, By Detection Range:

• hs-CRP
• Conventional CRP
• cCRP

• C-reactive Protein Testing Market, By Disease Area:

• Cardiovascular Diseases
• Cancer
• Rheumatoid Arthritis
• Inflammatory Bowel Disease
• Endometriosis
• Lupus
• Others

• C-reactive Protein Testing Market, By End-Use Industry:

• Hospitals & Clinics
• Laboratories
• Assisted Living Healthcare Facilities
• Homecare
• Others

• C-reactive Protein Testing 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