Rheumatoid Arthritis Diagnostic Tests Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Test Type (Serology Test {Erythrocyte Sedimentation Rate (ESR), Rheumatoid Factor (RF), Anti-cyclic Citrullinated Peptide (anti-CCP), Antinuclear Antibody (ANA), Uric Acid, Other Tests}, Monitoring RA Treatment Efficiency Tests {Salicylate Level Count, Muscle Enzyme Tests (CPK, Aldolase), Creatinine Test}), By End User (Diagnostic Laboratories, Private Laboratories, Public Laboratories, Ambulatory Surgical Centers), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 3.31 Billion
CAGR (2026-2031)	6.09%
Fastest Growing Segment	Serology Test
Largest Market	North America
Market Size (2031)	USD 4.72 Billion

Market Overview

The Global Rheumatoid Arthritis Diagnostic Tests Market will grow from USD 3.31 Billion in 2025 to USD 4.72 Billion by 2031 at a 6.09% CAGR. Rheumatoid arthritis diagnostic tests consist of laboratory and imaging solutions used to identify autoimmune markers and evaluate joint inflammation. These products are essential for confirming diagnoses and tracking disease progression through the detection of specific antibodies and inflammatory indicators. The market is primarily supported by the increasing prevalence of autoimmune disorders and an expanding geriatric population. Moreover, the clinical prioritization of early treatment to avoid permanent joint damage acts as a primary catalyst for the adoption of precise screening methods. According to the Arthritis Foundation, in 2025, rheumatoid arthritis affects approximately 1.3 million adults in the United States.

However, the market encounters a substantial obstacle concerning the high expense of advanced diagnostic tools in developing economies. The substantial costs attached to specialized assays and modern imaging equipment restrict their broad implementation in areas with limited financial resources. This economic barrier, combined with the difficulty of identifying patients who do not display standard biomarkers, presents a considerable challenge to global market expansion.

Key Market Drivers

The increasing global prevalence of rheumatoid arthritis constitutes a fundamental driver for the diagnostic tests market, necessitating scalable and accurate screening solutions. As the incidence of autoimmune disorders rises worldwide, healthcare systems are under growing pressure to implement robust diagnostic frameworks that can identify patients at the earliest stages of disease onset. This demand is further amplified by the significant economic and health burden associated with delayed diagnoses in the working-age demographic. According to PLOS, June 2025, in the 'Global burden and regional disparities of rheumatoid arthritis among the working-age population' article, there were 11.88 million cases of rheumatoid arthritis in the working-age population globally in 2021. Such high case volumes underscore the critical need for widely accessible serological and imaging tests to manage the expanding patient pool effectively and mitigate long-term joint damage.

Simultaneously, advancements in novel biomarker and immunoassay technologies are reshaping the market by enhancing test sensitivity and enabling personalized treatment strategies. Innovations in artificial intelligence and machine learning are now being integrated with traditional diagnostic modalities to predict therapeutic responses and optimize clinical decision-making. For instance, according to Scipher Medicine, June 2025, in the 'Scipher Medicine Unveils New Tool to Predict Rheumatoid Arthritis Treatment Success at EULAR 2025' press release, the company utilized data from nearly 1,500 patients to validate its AI-driven RA Response Calculator, which improves the objective evaluation of treatment efficacy. This surge in technological innovation is bolstered by substantial industry investment; according to Diagnostics World News, in 2025, Aqtual secured $31 million in Series B funding to advance the commercialization of its precision medicine diagnostic solutions.

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Key Market Challenges

The high expense of advanced diagnostic tools in developing economies acts as a substantial barrier to the growth of the rheumatoid arthritis diagnostic tests market. The significant costs associated with specialized assays and modern imaging equipment often exceed the financial capabilities of healthcare systems in these regions. Consequently, medical providers in low-resource settings frequently rely on basic clinical evaluations rather than precise screening methods. This affordability gap restricts the volume of advanced test kits and equipment sold, directly limiting revenue potential in emerging markets where budget constraints are paramount.

Moreover, this economic obstacle impedes the detection of patients who do not display standard biomarkers, as the necessary comprehensive testing is often cost-prohibitive. The market’s expansion is therefore stalled by the inability to scale operations in price-sensitive areas. According to the International Society for Pharmacoeconomics and Outcomes Research, in 2025, the average annual direct costs for managing rheumatoid arthritis in low- and middle-income countries were reported to range from USD 523 to USD 2,838 per patient. This data underscores the severe financial constraints that prevent the widespread implementation of premium diagnostic solutions.

Key Market Trends

The Growth of Tele-Rheumatology and Remote Monitoring Tools allows for continuous disease activity tracking outside of traditional clinical settings. This shift overcomes the limitations of episodic evaluations by utilizing smartphone-based applications to capture real-time data on joint inflammation and symptom fluctuation. Such technologies facilitate timely therapeutic adjustments and provide clinicians with objective longitudinal insights, effectively bridging the gap between patient home life and medical oversight. According to Medscape, March 2025, in the 'Remote Patient Monitoring Is the Future in Rheumatology, But What's Holding It Back?' article, the DETECTRA mobile application demonstrated a diagnostic accuracy of 84% in discriminating swollen from non-swollen joints, validating the efficacy of digital solutions in decentralized care.

The Development of Novel Biomarkers for Seronegative Patients aims to resolve diagnostic gaps for individuals testing negative for standard indicators like Rheumatoid Factor. This trend involves identifying alternative autoantibodies to confirm the disease in its seronegative form, preventing treatment delays caused by inconclusive standard tests. These advancements are crucial for stratifying patients who do not display conventional immunological signatures, thereby expanding the reach of accurate diagnostics. According to AiArthritis, April 2025, in the 'New Biomarkers in Rheumatoid Arthritis: A Step Toward Better Care' article, the anti-RA 33 biomarker was detected in 42% of patients who later developed seronegative rheumatoid arthritis, significantly improving screening capabilities for this difficult-to-diagnose subgroup.

Segmental Insights

The Serology Test segment is positioned as the fastest-growing category within the Global Rheumatoid Arthritis Diagnostic Tests Market driven by the critical need for early and accurate disease detection. This growth is largely attributed to the superior specificity of biomarkers like Anti-Cyclic Citrullinated Peptide which significantly aids in clinical decision-making. Guidelines from the American College of Rheumatology strongly advocate for these serological evaluations during the diagnostic process to confirm patient status. Consequently, medical facilities are increasingly adopting these assays to ensure timely intervention and improve patient management outcomes.

Regional Insights

North America maintains a leading position in the Global Rheumatoid Arthritis Diagnostic Tests Market, primarily driven by the rising incidence of autoimmune conditions and a well-developed healthcare system. This regional dominance is reinforced by the presence of major diagnostic manufacturers and widespread availability of medical reimbursement coverage. Additionally, the U.S. Food and Drug Administration facilitates the introduction of effective testing methods through rigorous approval processes. High levels of public awareness regarding early diagnosis and disease management further solidify the region's strong market standing.

Recent Developments

• In July 2025, Aqtual, Inc. secured $31 million in Series B financing to support the commercialization of its novel therapy selection test for rheumatoid arthritis. The capital was intended to advance the company's blood-based diagnostic platform, which utilizes cell-free DNA analysis to predict patient response to specific drug classes. At the time of the funding, the company was actively enrolling patients in a prospective observational clinical trial to validate the test's utility. This investment marked a significant step toward bringing a new precision medicine tool to market that addresses the critical challenge of treatment non-response in the management of chronic autoimmune conditions.
• In April 2025, Scipher Medicine formed a strategic partnership with Kythera Labs to advance the discovery and development of treatments for autoimmune diseases. The collaboration focused on integrating a proprietary blood-based molecular signature test for rheumatoid arthritis with a large-scale real-world data platform containing electronic health records and claims data. By combining genomic insights with clinical information, the companies aimed to generate novel evidence to support precision medicine diagnostics. This initiative was designed to empower researchers with a more holistic view of the patient journey and improve therapeutic decision-making for individuals who do not respond to standard therapies.
• In January 2025, Exagen Inc. announced the commercial launch of new biomarker assays for its proprietary connective tissue disease testing platform, following conditional approval from the New York State Department of Health. The enhanced profile for rheumatoid arthritis included the addition of anti-RA33 biomarkers (IgA, IgG, and IgM) to provide clinicians with comprehensive data for identifying patients, particularly those with seronegative disease. This product advancement was part of the company's strategy to improve the clinical utility of its diagnostic offerings and assist healthcare providers in definitively diagnosing complex autoimmune disorders earlier and with greater accuracy.
• In November 2024, Augurex Life Sciences Corp. entered into a non-exclusive agreement with Quest Diagnostics to enhance the availability of a key rheumatoid arthritis biomarker test in the United States. Under this collaboration, the partner laboratory agreed to validate and offer a lab-developed test based on the 14-3-3η (eta) protein, a marker linked to severe disease and joint damage risk. The testing service was scheduled to be available to physicians by early December, allowing patients to provide blood specimens at over 2,000 patient service centers nationwide. This partnership aimed to expand access to diagnostic tools that facilitate expedited treatment decisions for autoimmune conditions.

Key Market Players

• Abbott Laboratories Inc.
• Siemens Healthineers AG
• Thermo Fisher Scientific Inc.
• Exagen Inc.
• Augurex Life Sciences Corp.
• Danaher Corporation
• Bio-Rad Laboratories, Inc.
• Tulip Diagnostics (P) Ltd
• Boditech Med Inc.
• Getein Biotech, Inc.

By Test Type	By End User	By Region
Serology Test {Erythrocyte Sedimentation Rate (ESR) Rheumatoid Factor (RF) Anti-cyclic Citrullinated Peptide (anti-CCP) Antinuclear Antibody (ANA) Uric Acid Other Tests} Monitoring RA Treatment Efficiency Tests {Salicylate Level Count Muscle Enzyme Tests (CPK, Aldolase) Creatinine Test}	Diagnostic Laboratories Private Laboratories Public Laboratories Ambulatory Surgical Centers	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Rheumatoid Arthritis Diagnostic Tests Market, By Test Type:

• Serology Test {Erythrocyte Sedimentation Rate (ESR)
• Rheumatoid Factor (RF)
• Anti-cyclic Citrullinated Peptide (anti-CCP)
• Antinuclear Antibody (ANA)
• Uric Acid
• Other Tests}
• Monitoring RA Treatment Efficiency Tests {Salicylate Level Count
• Muscle Enzyme Tests (CPK, Aldolase)
• Creatinine Test}

• Rheumatoid Arthritis Diagnostic Tests Market, By End User:

• Diagnostic Laboratories
• Private Laboratories
• Public Laboratories
• Ambulatory Surgical Centers

• Rheumatoid Arthritis Diagnostic Tests 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