Fecal Calprotectin Test Market

Market Definition

The market covers a range of diagnostic solutions used to evaluate inflammation in the gastrointestinal tract. It includes various test types, such as lateral flow immunoassay and enzyme-linked immunosorbent assay (ELISA), which are widely adopted for their accuracy and usability in clinical and laboratory settings.

Key applications include the diagnosis of inflammatory bowel disease (IBD), early screening and detection of gastrointestinal disorders, and disease monitoring. The report provides a comprehensive analysis of key drivers, emerging trends, and the competitive landscape expected to influence the market over the forecast period.

Fecal Calprotectin Test Market Overview

The global fecal calprotectin test market size was valued at USD 2,865.3 million in 2024 and is projected to grow from USD 3,026.2 million in 2025 to USD 4,687.1 million by 2032, exhibiting a CAGR of 6.45% during the forecast period.

Market growth is driven by the increasing prevalence of gastrointestinal disorders, particularly inflammatory bowel diseases (IBD) such as Crohn’s disease and ulcerative colitis, which has led to a greater demand for non-invasive diagnostic tools.

The market is also benefiting from the growing demand for early disease detection, as fecal calprotectin tests enable accurate differentiation between inflammatory and non-inflammatory conditions.

Major companies operating in the fecal calprotectin test industry are ALPCO, ORGENTEC Diagnostika, EagleBio, F. Hoffmann-La Roche Ltd, Alpha Laboratories, DiaSorin S.p.A., Immundiagnostik AG, BÜHLMANN, Epitope Diagnostics, Inc., Thermo Fisher Scientific Inc., Biohit Oyj, Svar Life Science AB, Abbott, DRG INSTRUMENTS GMBH, and Sysmex Corporation.

Technological advancements in assay sensitivity, automation, and point-of-care testing are further contributing to market growth by improving diagnostic speed and ease of use. The expanding healthcare infrastructure, particularly in emerging markets, is fostering wider access to these diagnostic tools, supporting market expansion.

Key Highlights:

1. The fecal calprotectin test industry size was recorded at USD 2,865.3 million in 2024.
2. The market is projected to grow at a CAGR of 6.45% from 2025 to 2032.
3. North America held a market share of 36.73% in 2024, with a valuation of USD 1,052.4 million.
4. The enzyme-linked immunosorbent assay segment garnered USD 1,658.5 million in revenue in 2024.
5. The inflammatory bowel disease (IBD) diagnosis segment is expected to reach USD 1,602.6 million by 2032.
6. The diagnostic laboratories segment is estimated to generate a valuation of USD 2,254.2 million by 2032.
7. Asia Pacific is anticipated to grow at a CAGR of 7.45% over the forecast period.

Market Driver

Rising Prevalence of Inflammatory Bowel Diseases

The growth of the fecal calprotectin test market is driven by the rising prevalence of inflammatory bowel diseases (IBD), including Crohn’s disease and ulcerative colitis. These chronic gastrointestinal conditions are increasing globally, particularly in developed regions with changing dietary patterns and lifestyle factors.

As IBD requires timely diagnosis and long-term monitoring, healthcare providers are relying more on non-invasive diagnostic tools to reduce the need for colonoscopies and improve patient compliance.

Fecal calprotectin testing offers a reliable biomarker for intestinal inflammation, making it an essential tool for early detection, disease differentiation, and monitoring treatment response.

• In 2024, the Centers for Disease Control and Prevention reported that the prevalence of inflammatory bowel disease (IBD) in the U.S. ranged between 2.4 million and 3.1 million, with varying impact across demographic groups.

Market Challenge

High Cost of Testing

A significant challenge hampering the progress of the fecal calprotectin test market is the high cost of testing, particularly in regions with limited healthcare budgets. The expense of specialized equipment, reagents, and the need for trained personnel can make these tests less accessible to a broader patient population, particularly in low-income areas.

This challenge can be mitigated through the development of cost-effective, simplified testing methods that reduce the need for expensive infrastructure and skilled labor. Additionally, increased competition and technological advancements in diagnostics could reduce prices while improving accessibility and affordability, making fecal calprotectin tests more widely available in diverse healthcare settings.

Market Trend

Shift Toward Point-Of-Care Fecal Calprotectin Assays

A significant trend in the fecal calprotectin test market is the shift toward point-of-care fecal calprotectin assays. This trend is supported by the growing demand for rapid, on-site diagnostic tools that can provide quick and accurate results, allowing healthcare providers to make timely decisions.

Point-of-care tests eliminate the need for centralized laboratories, reducing both turnaround time and patient waiting periods. These tests are designed to be user-friendly, portable, and cost-effective, enabling healthcare professionals to perform tests in clinics, hospitals, and remote settings.

• In February 2025, BIOHIT partnered with Celltrion Healthcare UK Ltd to provide point-of-care assays for the Celltrion Connect Dedicated Homecare Service. The collaboration includes the supply of Preventis SmarTest Calprotectin Home test, a digital self-test system designed for remote monitoring of inflammatory bowel disease (IBD).

Fecal Calprotectin Test Market Report Snapshot

Market Segmentation

• By Test Type (Enzyme-linked Immunosorbent Assay and Lateral Flow Immunoassay): The enzyme-linked immunosorbent assay segment earned USD 1,658.5 million in 2024 due to its high sensitivity, widespread adoption, and suitability for quantitative analysis in clinical laboratories.
• By Application (Inflammatory Bowel Disease (IBD) Diagnosis, Screening & Early Detection, Disease Monitoring, and Others): The inflammatory bowel disease (IBD) diagnosis segment held a share of 36.99% in 2024, fueled by the rising global prevalence of IBD and the growing preference for non-invasive diagnostic tools.
• By End User (Hospitals and Clinics, Diagnostic Laboratories, and Academic and Research Institutes): The diagnostic laboratories segment is projected to reach USD 2,254.2 million by 2032, owing to increased testing volumes, improved infrastructure, and growing demand for accurate gastrointestinal diagnostics.

Fecal Calprotectin Test Market Regional Analysis

Based on region, the market has been classified into North America, Europe, Asia Pacific, Middle East & Africa, and South America.

The North America fecal calprotectin test market share stood at around 36.73% in 2024, valued at USD 1,052.4 million. This dominance is attributed to a high prevalence of inflammatory bowel diseases and widespread clinical adoption of non-invasive diagnostics.

The regional market further benefits from advanced healthcare infrastructure, strong reimbursement frameworks, and the presence of key diagnostic companies. Continued investments in precision medicine and early disease detection have supported the uptake of fecal calprotectin testing across hospitals and diagnostic laboratories.

• In January 2025, Sysmex America, Inc. signed an agreement with Sentinel Diagnostics to distribute and service the SENTiFIT 270 and SENTiFIT 800 analyzers in Canada. The collaboration aims to support colorectal cancer screening and laboratory testing by providing automated solutions for fecal occult blood and calprotectin tests.

The Asia Pacific fecal calprotectin test industry is poised to grow at a CAGR of 7.45% over the forecast period. This rapid growth is bolstered by rising gastrointestinal disease prevalence, increasing healthcare spending, and improved access to diagnostic technologies.

Governments across major countries are investing in healthcare modernization, while private players are expanding laboratory networks. Growing awareness of early screening and non-invasive diagnostics is prompting higher test adoption across both urban and emerging healthcare settings.

Regulatory Frameworks

• In the U.S., fecal calprotectin tests are regulated by the Food and Drug Administration (FDA) as in vitro diagnostic (IVD) devices. These tests must undergo review under the 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device before commercialization.
• In Europe, fecal calprotectin tests fall under the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746. Manufacturers must comply with strict requirements related to safety, clinical evidence, and performance evaluation.
• In Japan, these tests are overseen by the Pharmaceuticals and Medical Devices Agency (PMDA) under the Pharmaceutical and Medical Device Act (PMD Act). Approval requires submission of clinical data, quality control documentation, and compliance with Japanese IVD standards.

Competitive Landscape

Key players in fecal calprotectin test industry are investing in the development of high-sensitivity assays and automation-compatible platforms to improve efficiency and ease of use in clinical settings.

Many companies are expanding their product portfolios through in-house innovation and licensing agreements to strengthen their presence across diagnostic laboratories and healthcare facilities. Several participants are pursuing regulatory approvals across major regions to facilitate market entry and compliance.

Strategic collaborations with research institutions and clinical networks are enhancing product validation and expanding clinical applications. Geographic expansion remains a key focus, with companies establishing regional manufacturing units, strengthening local distribution networks, and entering underserved markets to improve accessibility.

• In July 2024, Eurofins Scientific began performing stool calprotectin testing onsite at its Dublin facility. This move marked the first local offering of the test in the country and aligns with the company’s ongoing investment strategy to enhance diagnostic services.

List of Key Companies in Fecal Calprotectin Test Market:

• ALPCO
• ORGENTEC Diagnostika
• EagleBio
• F. Hoffmann-La Roche Ltd
• Alpha Laboratories
• DiaSorin S.p.A.
• Immundiagnostik AG
• BÜHLMANN
• Epitope Diagnostics, Inc.
• Thermo Fisher Scientific Inc.
• Biohit Oyj
• Svar Life Science AB
• Abbott
• DRG INSTRUMENTS GMBH
• Sysmex Corporation

Recent Developments (Product Launch)

• In May 2025, ALPCO announced the European commercial launch of its FDA 510(k) cleared Calprotectin Immunoturbidimetric Assay and the enrollment of the first patient in a pivotal U.S. clinical trial for its automated chemiluminescent version, aimed at enhancing automation in gastrointestinal diagnostics.