Fecal Calprotectin Test Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Fecal Calprotectin Test Market is projected to increase from USD 353.10 Million in 2025 to USD 530.21 Million by 2031, expanding at a CAGR of 7.01%. This market centers on a non-invasive diagnostic immunoassay that measures calprotectin, a neutrophilic protein present in stool, to identify intestinal inflammation. The test is primarily employed to distinguish between Inflammatory Bowel Disease (IBD) and functional gastrointestinal disorders like Irritable Bowel Syndrome (IBS). Growth is largely driven by the rising prevalence of IBD and a clinical shift toward reducing unnecessary invasive procedures, such as colonoscopies, which improves patient compliance and cost-efficiency. Underscoring the need for reliable disease monitoring, Crohn's and Colitis Canada estimates that the prevalence of Inflammatory Bowel Disease will reach 0.8% of the Canadian population in 2025.

However, the lack of assay standardization across commercial manufacturers presents a significant challenge to broader market expansion. Differences in analytical performance and cut-off values among various test kits often result in inconsistent findings, complicating data interpretation for clinicians and preventing the creation of universal reference ranges essential for long-term patient care. This variability generates uncertainty regarding the interchangeability of results, potentially delaying the acceptance of these tests as the primary standard for monitoring disease activity.

Market Drivers

The rising global incidence of Inflammatory Bowel Diseases (IBD) acts as a primary catalyst for the growth of the Global Fecal Calprotectin Test Market. As chronic conditions like Crohn's disease and ulcerative colitis become more widespread, there is a surging demand for reliable, non-invasive monitoring tools to effectively manage long-term inflammation and prevent relapses.

The Centers for Disease Control and Prevention's 'IBD Facts and Stats' report from June 2024 estimated that between 2.4 and 3.1 million individuals in the United States have IBD. This growing patient population requires frequent testing to differentiate active inflammation from functional disorders, thereby fueling the consumption of calprotectin assays. This trend is further supported internationally, with Crohn's & Colitis UK reporting in 2024 that approximately 500,000 people in the United Kingdom live with IBD, highlighting the need for scalable diagnostic solutions.

Concurrent with this demand, technological advancements in home-testing and point-of-care kits are reshaping the market by improving sample stability and patient convenience. Historically, logistical difficulties in preserving fecal samples during transport hindered the adoption of remote monitoring, but recent improvements in buffer stability have addressed these barriers. For example, Sentinel Diagnostics announced in November 2024 the capabilities of its new CALiaGold pierce Tube, which allows patients to store samples at room temperature for up to four weeks before analysis. Such innovations significantly enhance compliance by simplifying the collection process, facilitating consistent disease monitoring outside clinical settings, and accelerating market penetration for patients requiring lifelong management.

Market Challenges

The absence of assay standardization among commercial manufacturers constitutes a major barrier to the Global Fecal Calprotectin Test Market's growth. Because different test kits frequently employ distinct antibodies and capture methods, they often yield inconsistent quantitative results and cut-off values for identical patient samples. This analytical variability complicates clinical interpretation, making it challenging for healthcare providers to define universal reference ranges or compare data across different testing platforms. Consequently, clinicians remain hesitant to rely exclusively on these immunoassays for longitudinal patient monitoring, which limits the widespread integration of this diagnostic tool into routine medical practice.

This inconsistency directly impedes market scalability, particularly given the critical demand for reliable chronic disease management. With the Crohn's & Colitis Foundation estimating in 2024 that approximately 3 million Americans are affected by Inflammatory Bowel Disease, a substantial patient population requires frequent inflammation monitoring. However, the inability to harmonize results across different manufacturers creates an operational bottleneck. Healthcare systems are unlikely to fully commit to a testing modality where data cannot be interchanged between laboratories, thereby restricting the revenue potential and overall market penetration of these diagnostic products.

Market Trends

The market is being transformed by a shift toward Automated High-Throughput Laboratory Immunoassays as clinical laboratories move from manual methods to integrated platforms to manage increasing sample volumes. Traditional Enzyme-Linked Immunosorbent Assays (ELISA) are being replaced by particle-enhanced turbidimetric immunoassays (PETIA) that operate on standard clinical chemistry analyzers, allowing for random-access testing and significantly reduced turnaround times. This automation enables diagnostic facilities to scale operations efficiently to meet the rising demand for gastrointestinal testing. Illustrating this advancement, Sysmex America announced in January 2025 an agreement to distribute the Sentinel Diagnostics SENTiFIT 800 Analyzer in Canada, a high-speed system capable of processing up to 550 tests per hour to handle mass-volume analysis.

Simultaneously, the market is seeing increasing utilization for Longitudinal Treatment Monitoring and Mucosal Healing, expanding beyond the test's original role of distinguishing IBD from IBS. Clinicians are adopting "treat-to-target" strategies that use frequent fecal calprotectin measurements as a non-invasive surrogate for endoscopy to assess therapeutic response and mucosal inflammation in established patients. This clinical shift is validated by evolving reimbursement structures aimed at supporting regular disease tracking. For instance, The Limbic reported in October 2025 that the Australian government introduced a new Medicare item number to subsidize calprotectin testing for the ongoing management of symptomatic patients with an established IBD diagnosis, reflecting global recognition of the test's value in long-term care.

Key Players Profiled in the Fecal Calprotectin Test Market

• Thermo Fisher Scientific Inc.
• Bio-Rad Laboratories, Inc.
• F. Hoffmann-La Roche Ltd.
• Boditech Med Inc.
• Abbexa Ltd.
• Elabscience Bionovation Inc.
• Epitope Diagnostics, Inc.
• R-Biopharm AG
• Sentinel Ch S.p.A.
• LifeSpan BioSciences, Inc.

Report Scope

In this report, the Global Fecal Calprotectin Test Market has been segmented into the following categories:

Fecal Calprotectin Test Market, by Assay Type:

• Enzyme Linked Immunosorbent Assay (ELISA)
• Enzyme Fluoroimmunoassay
• Quantitative Immune-Chromatography

Fecal Calprotectin Test Market, by Indication:

• Inflammatory Bowel Disease (IBD) Diagnosis
• Colorectal Cancer
• Celiac Disease
• others

Fecal Calprotectin Test Market, by End User:

• Hospitals
• Diagnostic Laboratories
• Academic and Research Institutes
• others

Fecal Calprotectin Test Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Fecal Calprotectin Test Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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