Fecal Calprotectin Test Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Assay Type, By Indication, By End User, By Region and Competition, 2019-2029F

Global Fecal Calprotectin Test Market was valued at USD 275.65 Million in 2023 and and is expected to reach USD 405.64 Million by 2029 with a CAGR of 6.85% during the forecast period. The calprotectin stool test, also known as the fecal calprotectin test, evaluates the presence of calprotectin protein in a stool sample to assess intestinal inflammation. Calprotectin, a protein found in white blood cells, increases in the stool when there is gut inflammation. This test is a highly sensitive marker for gastrointestinal inflammation and helps differentiate between inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). It is used for diagnosing, monitoring disease activity, guiding treatment, and predicting relapses or post-operative recurrence in IBD patients. For those already diagnosed with IBD, the test helps track inflammation levels and evaluate treatment efficacy. The Enzyme-Linked Immunosorbent Assay (ELISA) is the most widely used method due to its accuracy and reliability, while Lateral Flow Immunoassays offer rapid results and are suitable for point-of-care settings. The high cost of some diagnostic tests can hinder widespread use, and compliance with diverse regulatory standards poses challenges. Despite a competitive market with established and emerging players, the global increase in healthcare expenditure is driving the growth of advanced diagnostic tests. The fecal calprotectin test market is anticipated to expand further due to rising disease prevalence, greater healthcare investments, and ongoing technological advancements. Innovations in testing methods and broader market reach are expected to fuel continued growth and adoption.

Key Market Drivers

Increasing Prevalence of Inflammatory Bowel Disease

The incidence and prevalence of inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, have significantly increased. In 2023, global cases of ulcerative colitis were estimated at 5 million, with a rising incidence reported worldwide according to a study by *The Lancet*. In the U.S., the prevalence of IBD is estimated to be between 2.4 and 3.1 million, varying across different populations as reported by the Centers for Disease Control and Prevention (CDC). This expanding patient base necessitates regular monitoring and management, driving up the demand for diagnostic tools such as fecal calprotectin tests.

Regular testing is crucial for IBD patients to monitor disease activity, evaluate treatment effectiveness, and detect potential relapses. The fecal calprotectin test plays a vital role in these processes, leading to increased market demand. Effective management of IBD relies on frequent assessment of inflammation levels to customize treatment plans, and the fecal calprotectin test provides essential data for personalized care.

As IBD prevalence grows, healthcare systems are investing more in specialized diagnostic tools and treatments, which supports the adoption of advanced tests like fecal calprotectin. Early and accurate diagnosis enhances patient outcomes, and fecal calprotectin tests are integral to the diagnostic process, contributing to market growth. Ongoing research into IBD drives innovation, leading to the development of more precise and efficient fecal calprotectin assays. This research supports continued market expansion, as the rising prevalence of IBD fuels the ongoing demand for effective diagnostic tools.

Rising Demand for Non-invasive Diagnostic Tools

Non-invasive diagnostic tests, such as fecal calprotectin assays, are increasingly favored by patients for their convenience and comfort compared to invasive procedures like endoscopies or biopsies. These tests reduce the risk of complications and discomfort associated with more invasive methods, making them more appealing to both patients and healthcare providers. A study published in Frontline Gastroenterology in May 2024 by researchers at the Birmingham HIHR Biomedical Research Centre, University of Birmingham, examined a new protocol designed to expedite IBD diagnosis for patients referred to the Birmingham IBD inception pathway between January 2021 and August 2023. This rapid-access clinic aims to accelerate the diagnosis process for patients over 16 with suspected IBD.

Non-invasive tests can be performed in diverse settings, including at home or in primary care facilities, enhancing accessibility for patients who might otherwise encounter barriers with invasive procedures. As patients increasingly seek convenient testing options that fit their lifestyles, fecal calprotectin tests offer an easy way to monitor gastrointestinal health without the need for extensive clinical visits. For chronic conditions like IBD, non-invasive tests enable regular monitoring and management, promoting consistent testing and follow-up care. A study published in Nature in July 2024 explored the diagnostic capabilities of near-infrared spectroscopy and aquaphotomics for IBD and its variants. The research used blood plasma and saliva samples analyzed with techniques such as Principal Component Analysis and Support Vector Machine, achieving 100% accuracy in distinguishing between healthy individuals and those with IBD, as well as between different types of IBD. This study highlighted the potential of non-invasive methods to monitor biofluids and changes in their spectral patterns, providing valuable insights into IBD.

A new PET radiotracer, detailed in the November 2023 issue of the *Journal of Nuclear Medicine*, creates comprehensive inflammation maps of the gastrointestinal tract. This tool targets the IBD biomarker IL12/23p40, offering a minimally invasive approach to detect and stage IBD, thereby guiding treatment decisions. Ongoing research and advancements in non-invasive diagnostic technologies enhance the accuracy and reliability of tests like fecal calprotectin assays, driving their adoption in clinical practice. As non-invasive testing gains traction, the market for these diagnostic tools expands, presenting opportunities for further growth and innovation.

Key Market Challenges

Variability in Test Accuracy

Variability in test accuracy represents a major challenge for the fecal calprotectin test market. Inconsistent results can undermine the diagnostic reliability of these tests, potentially diminishing clinician confidence and impacting patient outcomes. Differences in testing protocols, sample handling, and laboratory practices contribute to this variability. The absence of standardization among laboratories further exacerbates discrepancies in results. Ensuring accurate test outcomes depends heavily on proper stool sample collection, handling, and storage; any issues in these areas can compromise test performance and reliability.

Regulatory authorities demand high accuracy and consistency for diagnostic tests. Variability in test accuracy can attract increased scrutiny and regulatory hurdles, potentially delaying market approval and adoption. Additionally, inconsistent results can erode trust among healthcare providers and patients, making it essential to maintain high and consistent accuracy to foster confidence in the test.

The need for additional follow-up testing or confirmatory procedures due to variability can increase overall healthcare costs and affect the economic feasibility of using fecal calprotectin tests. Addressing this challenge requires ongoing research and development to improve test accuracy and reliability, implementing standardized testing procedures, and enforcing rigorous quality control measures to ensure consistent performance across different settings and laboratories.

Limited Awareness and Education

Limited awareness of the benefits and availability of fecal calprotectin tests among both healthcare providers and patients can result in reduced adoption rates. A lack of education and training for healthcare professionals on the use and interpretation of these tests can hinder their effective implementation, potentially leading to suboptimal use and missed diagnostic opportunities. This insufficient awareness can impede the market growth and expansion of fecal calprotectin tests, as widespread recognition and understanding are essential for market penetration.

Patients who do not know about the test or its importance in managing conditions such as inflammatory bowel disease (IBD) cannot seek or follow through with testing recommendations. Enhancing patient education is vital for improving both engagement and adherence. Additionally, variations in clinical guidelines and diagnostic protocols across different regions or institutions can result in inconsistent use of fecal calprotectin tests. Standardizing these guidelines and protocols can facilitate greater adoption. Financial constraints in certain healthcare settings can also impact the adoption of new diagnostic tests. Addressing these financial barriers through cost-effective solutions and clearly demonstrating the value of fecal calprotectin tests can help overcome this challenge.

Key Market Trends

Focus on Early Diagnosis and Personalized Medicine

The emphasis on early disease detection is increasing, aiming to enable timely interventions. Fecal calprotectin tests are increasingly utilized for the early identification of inflammation, particularly in inflammatory bowel disease (IBD), where early diagnosis and management are crucial. In 2023, Meta-Spec, an AI-driven diagnostic tool developed collaboratively by researchers in China and the United States, evaluates a range of factors beyond microbiome data. This approach offers a more comprehensive and nuanced disease detection and prediction model compared to existing options, considering aspects such as the frequency of vivid dreams and the quality of bowel movements.

The move towards personalized medicine focuses on customizing treatment strategies to individual patient profiles. Fecal calprotectin tests provide critical insights into disease activity, allowing healthcare providers to tailor treatment plans to meet each patient's specific needs. These tests are increasingly being integrated into personalized care approaches, offering a reliable, non-invasive method for continuous monitoring of disease activity and treatment effectiveness. Prometheus Laboratories Inc. partnered with Takeda Pharmaceutical Company Limited to introduce CDPATH, an innovative prognostic tool for Crohn's disease (CD) patients. CDPATH is designed to work alongside clinical assessments to evaluate an adult patient's risk for severe CD complications, such as bowel strictures or internal penetrating disease, within three years. As the focus on early diagnosis and personalized medicine intensifies, fecal calprotectin tests are becoming more standard in clinical practice for managing chronic gastrointestinal conditions. Institutions like The Ohio State University Wexner Medical Center's IBD Center are incorporating these tests into their diagnostic and treatment protocols, including a pediatric-to-adult transition program.

This shift towards personalized medicine aligns with patient-centric approaches that prioritize individual needs and preferences. Fecal calprotectin tests enhance patient engagement by offering a non-invasive method for ongoing health and disease monitoring.

Segmental Insights

Assay Type Insights

Based on Assay Type, the Enzyme Linked Immunosorbent Assay (ELISA) emerged as the dominating segment in the global market for Fecal Calprotectin Test in 2023. ELISA is widely recognized for its exceptional accuracy and reliability in detecting and quantifying specific biomarkers, such as calprotectin. This precision is critical for diagnosing and monitoring conditions like inflammatory bowel disease (IBD), where precise measurement of inflammation levels is vital. Due to its proven effectiveness and reliability, ELISA is extensively used in clinical laboratories. Its long-standing track record across various diagnostic applications has cemented its status as a trusted method, leading to its market dominance. ELISA's versatility allows it to be adapted for different assay types, including high-throughput screening and detailed biomarker quantification, making it suitable for a broad range of diagnostic applications, such as fecal calprotectin tests. The method's high sensitivity and specificity enable the detection of low calprotectin levels in stool samples, which is essential for early diagnosis and monitoring of diseases with minimal biomarker concentrations. The well-established and standardized procedures for conducting ELISA assays facilitate its integration into routine laboratory practices, further reinforcing its leading position in the market.

Indication Insights

Based on Indication Type, Inflammatory Bowel Disease (IBD) emerged as the fastest growing segment in the global market for Fecal Calprotectin Test during forecast period. The global rise in inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is increasing the demand for diagnostic tools such as fecal calprotectin tests. These tests are essential for diagnosing and monitoring IBD. Growing awareness among healthcare providers and patients is leading to earlier diagnoses and more frequent monitoring, with fecal calprotectin tests being central to this effort. Recent updates in clinical guidelines, such as those from the American Gastroenterological Association in 2023, stress the importance of fecal calprotectin for managing IBD, which is driving its greater adoption. Advances in testing technology have improved the accuracy and reliability of these tests, making them more attractive to healthcare providers. Expanding healthcare infrastructure, especially in emerging markets, is enhancing the accessibility and availability of these diagnostic tools, further accelerating growth in the IBD diagnosis segment.

Regional Insights

Based on Region, North America emerged as the dominant region in the Global Fecal Calprotectin Test Market in 2023. North America, particularly the United States and Canada, dedicates a significant portion of its GDP to healthcare. This substantial investment facilitates the acquisition and implementation of advanced diagnostic tools, such as fecal calprotectin tests. The region is equipped with a sophisticated healthcare infrastructure, including state-of-the-art diagnostic labs and hospitals, which supports the widespread adoption and integration of these tests. The high prevalence of inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, in North America further drives the demand for effective diagnostic solutions. According to Crohn's and Colitis Canada, the number of individuals with IBD in Canada is projected to rise from 322,600 in 2023 to 470,000 by 2035, highlighting the growing need for reliable diagnostic tools like fecal calprotectin tests for managing and monitoring these conditions.

There is also a strong level of awareness and education among healthcare providers and patients regarding gastrointestinal health and the benefits of fecal calprotectin tests, contributing to their increased adoption and use. In 2023, the American Gastroenterological Association issued new practice guidelines on the use of biomarkers in managing Crohn's disease. These guidelines provide 11 conditional recommendations to assist clinicians in utilizing various biomarkers, including fecal calprotectin, for both cross-sectional and longitudinal monitoring of disease activity in Crohn's disease patients. The region benefits from a robust regulatory framework that maintains high standards for medical and diagnostic products, supporting the approval and widespread use of fecal calprotectin tests.

Key Market Players

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, in addition to the industry trends which have also been detailed below:

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
• 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

Competitive Landscape

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

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Company Information

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