Fecal Calprotectin Test Market By Product Type (Enzyme-Linked Immunosorbent Assay (ELISA) Kits, Lateral Flow Assay (LFA) Kits, Point-of-Care Testing (POCT) Kits, Chemiluminescence Immunoassay (CLIA) Kits, Others), By Technology (Quantitative Tests, Qualitative Tests, Semi-Quantitative Tests), By Sample Type (Stool Samples, Urine Samples, Saliva Samples, Others), By Application (Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Colorectal Cancer Screening, Other Gastrointestinal Disorders, Monitoring Disease Progression, Others), and By End User (Hospitals, Diagnostic Laboratories, Clinics, Research & Academic Institutes, Home Healthcare, Others), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

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What trends will shape the Fecal Calprotectin Test Market in the coming years?

The Fecal Calprotectin Test Market accounted for USD 5.32 Billion in 2024 and USD 5.93 Billion in 2025 is expected to reach USD 17.50 Billion by 2035, growing at a CAGR of around 11.43% between 2025 and 2035. The fecal calprotectin test market is dedicated to diagnostic tools to identify the presence of inflammation in the gastrointestinal tract. This test is highly useful in the differentiation between inflammatory bowel diseases, such as Crohn's disease and ulcerative colitis, and non-inflammatory diseases, such as irritable bowel syndrome. It is less invasive, hence a successful first-line screening procedure that avoids more invasive screening procedures such as colonoscopies.

Technology in assay and automation has increased the accuracy and speed of fecal calprotectin testing, which enables faster clinical decision-making. Implications of these tests being incorporated into the normal gastrointestinal assessment are assisting clinicians in following the progression of disease and checking on therapy. Adoption is being spurred by the increased awareness among both healthcare providers and patients of the need to detect intestinal inflammation early.

What do industry experts say about the Fecal Calprotectin Test market trends?

“A simple procedure of slide review is a time-consuming and error-prone activity in any diagnostic laboratory. When automated systematically using the latest automated digital pathology track systems, it can bring numerous additional benefits … saving the time of the pathologist, enhancing the accuracy of results, making progress in their research projects, and training future pathologists…”

• Dr. Rajeev Gautam, President – HORIBA Medical

Which segments and geographies does the report analyze?

What are the key drivers and challenges shaping the Fecal Calprotectin Test market?

How is the rising prevalence of inflammatory bowel disease (IBD) driving the demand for fecal calprotectin tests?

The fecal calprotectin test market is highly propelled by the increasing rate of inflammatory bowel disease (IBD). IBD, which includes such disorders as Crohn's disease and ulcerative colitis, is a chronic inflammation of the gastrointestinal tract and thus requires accurate noninvasive diagnostic procedures. Fecal calprotectin tests are an effective biomarker to indicate intestinal inflammation and can help to discriminate between IBD and other gastrointestinal diseases, including irritable bowel syndrome.

The trend of recent rises in IBD cases all over the world has increased the need for such diagnostic tools, where the early and accurate determination of the disease is paramount in the management and planning of its treatment. The Centers for Disease Control and Prevention (CDC) estimates the prevalence of IBD in the United States to range between 2.4 and 3.1 million people, with dissimilar burdens among the different demographic groups. Such an increase in patients is a key reason why more convenient and effective diagnostic solutions are necessary, which drives the use of fecal calprotectin testing in clinical practices.

Can the non-invasive nature of fecal calprotectin testing encourage higher adoption among patients and clinicians?

The fecal calprotectin test market is highly driven by the ability of the non-invasive nature of fecal calprotectin testing to motivate greater adoption of the test by patients and clinicians. Fecal calprotectin tests provide an alternative to much more distressing tests like colonoscopies, which can often be painful and invasive and are expensive.

The tests can be conducted on stool samples and do not require invasive surgeries, so the patient is not anxious and is even less uncomfortable. The ease of administration of such tests is an advantage to clinicians, and such tests can be performed in an outpatient facility, improving patient management and hence the possibility of shorter diagnostic turnaround periods. Moreover, the fecal calprotectin tests have a high negative predictive value (NPV) of up to 93.1% and can be effectively used to rule out meaningful colorectal diseases to facilitate the triage process and avoid unnecessary referrals to invasive procedures. Such a mix between patient comfort and clinical efficacy supports the increased popularity of noninvasive diagnostic instruments in gastrointestinal health care.

How might the high cost of advanced fecal calprotectin testing kits limit their adoption in developing regions?

The availability of the test kits at a high cost is a major constraint to the Fecal Calprotectin Test Market, especially in developing states. These diagnostic kits, which are necessary in the identification and monitoring of inflammatory bowel diseases (IBD), may be too costly for most healthcare facilities and patients.

This economic constraint restricts the accessibility of timely and correct diagnostics in the low-income neighborhoods, which in most cases postpones the identification of the disease and its proper treatment. Consequently, it can force the patients to turn to more invasive procedures such as colonoscopies, which are also potentially less available or expensive. The Fecal Calprotectin Tests Market costs are prohibitive, and hence, the necessary superiority of the Fecal Calprotectin Tests Market in resource-limited environments requires more cost-effective and widely available diagnostic tools.

How can the development of home-based fecal calprotectin testing kits expand patient access?

The manufacture of home-based fecal calprotectin testing kits creates a massive potential for the Fecal Calprotectin Test Market due to an increase in patient access and convenience. The kits enable people to sample their stools and test them from the comfort of their homes without having to visit a hospital or laboratory so often. This is specifically helpful with patients with chronic illnesses such as inflammatory bowel disease (IBD), who need frequent follow-up.

Home-based testing also reduces the anxiety levels of patients who are subjected to invasive tests and also encourages proactive management of the disease. Moreover, these kits may be useful in earlier gastrointestinal inflammation diagnostics that can be followed by timely medical treatment. Home-based fecal calprotectin kits can help improve adoption rates, patient compliance, and spur growth in the Fecal Calprotectin Test Market by making testing more accessible and patient-friendly.

Can integrating fecal calprotectin tests with digital health platforms improve disease monitoring and patient outcomes?

The Fecal Calprotectin Test Market has a tremendous opportunity to integrate fecal calprotectin tests with digital health platforms that will lead to increased monitoring of the disease and better patient outcomes. Digital platforms enable real-time collection, storage, and analysis of test results and enable healthcare providers to track the trends of inflammation and modify treatment plans.

Patients will be able to get feedback and reminders promptly, which encourages them to start observing the schedule and helps them take charge of managing the disease. It is also possible to have remote consultations through this integration, which makes care more accessible to patients, particularly the rural or underserved ones, because they do not have to visit a hospital as often. The Fecal Calprotectin Test Market can provide a more patient-centered, data-oriented management of gastrointestinal disorders by integrating diagnostic testing and digital technologies, which will eventually lead to better clinical decision-making and quality of care.

What are the key market segments in the Fecal Calprotectin Test industry?

Based on the product type, the Fecal Calprotectin Test Market is classified into Enzyme-Linked Immunosorbent Assay (ELISA) Kits, Lateral Flow Assay (LFA) Kits, Point-of-Care Testing (POCT) Kits, Chemiluminescence Immunoassay (CLIA) Kits, and Others. ELISA kits are the most powerful segment of the fecal calprotectin test market. ELISA kits are popular because of their great sensitivity and ability to determine the level of calprotectin in stool samples, and therefore, they can be reliably used to diagnose and monitor inflammatory bowel diseases. These kits are established in clinical laboratories and can be used with automated systems, hence high-throughput testing and workflow efficiency in hospitals and diagnostic laboratory environments.

ELISA kits also give quantitative values, which allow clinicians to monitor disease progress and treat it more accurately. The prevalence of ELISA is complemented by high sanction approvals and standardization among the laboratories, and therefore, the results are consistent and reproducible. Also, ELISA protocols are well known by many healthcare professionals, minimizing training needs and operational difficulties.

Based on the Technology, the Fecal Calprotectin Test Market is classified into Quantitative Tests, Qualitative Tests, and Semi-Quantitative Tests. The most dominating part of the fecal calprotectin test market is the quantitative tests segment. Quantitative tests give accurate numerical measurements of calprotectin concentration levels of stool samples, and due to this fact, clinicians can effectively determine the degree of intestinal inflammation. Such accuracy is essential in the diagnosis of diseases such as inflammatory bowel disease and in tracking the disease or response to treatment over time.

These tests are very popular in clinical and hospital laboratories since they show reproducible and standardized results that minimize the chances of diagnostic errors. In automated lab systems, quantitative assays, particularly when ELISA kits are used, can be coupled directly with high-throughput testing and streamlined workflows. The qualitative tests also contribute to treatment planning because of the extensive data they provide to physicians on whether to make changes in the medication or the intervention.

Which regions are leading the Fecal Calprotectin Test market, and why?

The North American fecal calprotectin test market is leading in the global environment, with increasing prevalence of gastrointestinal diseases like inflammatory bowel disease (IBD) and colorectal cancer. The developed health care system in the region makes it easy to use sophisticated diagnostic instruments, such as fecal calprotectin tests. This is a non-invasive test that is efficient and convenient, and therefore it is the test of choice in the initial screening to determine the presence of intestinal inflammation.

The United States, in particular, contributes greatly to the growth of the market because of its strong healthcare system and a high level of investment in medical research. The growing awareness of the medical practitioners and the patient about the advantages of early detection of gastrointestinal diseases and their monitoring further drives the demand for fecal calprotectin tests. Besides, the availability and affordability of these diagnostic services in the U.S. are encouraged by favorable reimbursement policies and insurance coverage.

The Asia Pacific fecal calprotectin test market is growing rapidly due to a rise in the rates of gastrointestinal disorders, including inflammatory bowel disease (IBD) and colorectal cancer. There is tremendous growth in the healthcare infrastructure in countries such as China and India, which is causing high accessibility to sophisticated diagnostic tools. This has led to increased use of non-invasive tests such as fecal calprotectin, which is convenient and has early detection abilities.

The healthcare environment in the region is varied and has both opportunities and challenges. Although in urban areas medical facilities might be well developed, rural areas still might experience obstacles to access. The gaps, however, are being bridged by continuing efforts to strengthen access to healthcare. The increased concerns regarding the gastrointestinal health of the citizens are also contributing to the fact that more and more diagnostic tests are in demand.  

What does the competitive landscape of the Fecal Calprotectin Test market look like?

The nature of the fecal calprotectin test market is competition with players on the global market and regionally targeted firms. Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche Ltd., and Becton, Dickinson and Company (BD) are the major multinational companies that dominate the market, having large product lines and vast distribution networks across the globe. These firms leverage their long experience in the field of diagnostics to offer a diversified solution to the fecal calprotectin test solutions that will match different clinical needs.

Along with these world leaders, numerous specialized companies contribute to market development. In this regard, Epitope Diagnostics Inc., Hycult Biotech, Actim, Eagle Biosciences, Inc., OPERON, Svar Life Science, BUHLMANN Laboratories AG, DRG International Inc., ALPCO, and Diazyme Laboratories are involved in developing high-sensitivity and novel assays that benefit fecal calprotectin testing. Such companies are more inclined to automate friendly systems and easy-to-use interfaces to improve efficiency and ease of use in clinical settings.

Fecal Calprotectin Test Market, Company Shares Analysis, 2024

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Which recent mergers, acquisitions, or product launches are shaping the Fecal Calprotectin Test industry?

• In May 2025, Omada Health introduced OmadaSpark, an AI-driven “food hub” within its app that offers personalized nutrition education, photo/barcode meal tracking, and goal-setting, targeting chronic care patients with diabetes, hypertension, and obesity.

Report Coverage:

By Product Type

• Enzyme-Linked Immunosorbent Assay (ELISA) Kits
• Lateral Flow Assay (LFA) Kits
• Point-of-Care Testing (POCT) Kits
• Chemiluminescence Immunoassay (CLIA) Kits
• Others

By Technology

• Quantitative Tests
• Qualitative Tests
• Semi-Quantitative Tests

By Sample Type

• Stool Samples
• Urine Samples
• Saliva Samples
• Others

By Application:

• Inflammatory Bowel Disease (IBD)
• Irritable Bowel Syndrome (IBS)
• Colorectal Cancer Screening
• Other Gastrointestinal Disorders
• Monitoring Disease Progression
• Other

By End User

• Hospitals
• Diagnostic Laboratories
• Clinics
• Research & Academic Institutes
• Home Healthcare
• Others

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of Middle East & Africa

List of Companies:

• Thermo Fisher Scientific Inc.
• Bio-Rad Laboratories, Inc.
• F. Hoffmann-La Roche Ltd.
• Becton, Dickinson and Company (BD)
• Abbexa Limited
• Epitope Diagnostics Inc.
• Hycult Biotech
• Actim
• Eagle Biosciences, Inc.
• OPERON
• Svar Life Science
• BÜHLMANN Laboratories AG
• DRG International Inc.
• ALPCO
• Diazyme Laboratories

Frequently Asked Questions (FAQs)