FECAL CALPROTECTIN TEST MARKET ANALYSIS

The global fecal calprotectin test market is projected to reach US$ 276.6 million by 2030, from US$ 122.8 million in 2023, at a CAGR of 12.3% during the forecast period 2023-2030.

The growth of the fecal calprotectin test market is driven by the increasing prevalence of inflammatory bowel diseases (IBD), such as Crohn's disease and ulcerative colitis. IBD is a chronic condition that causes inflammation of the digestive tract. Fecal calprotectin is a protein that is released by white blood cells in the intestines. It is elevated in people with IBD, making it a useful biomarker for diagnosing and monitoring the disease.

The increasing awareness about IBD and its symptoms is also driving the growth of the fecal calprotectin test market. People are more likely to seek medical attention if they are aware of the symptoms of IBD, which can lead to early diagnosis and treatment.

Fecal Calprotectin Test Market Regional Insights

• North America is expected to account for the largest share of the global fecal calprotectin test market in 2023, followed by Europe and Asia Pacific. The high prevalence of inflammatory bowel diseases (IBD) in North America is driving the growth of the market in this region. It holds 41.6% market share.
• Asia Pacific is expected to be the fastest-growing market for fecal calprotectin tests during the forecast period. This growth is attributed to the increasing prevalence of IBD in the region, rising awareness about the disease, and the growing demand for minimally invasive diagnostic tests. It holds 18.9% market share.
• Europe is also expected to witness significant growth in the fecal calprotectin test market during the forecast period. This growth is driven by the increasing prevalence of IBD in the region, rising awareness about the disease, and the availability of reimbursement for fecal calprotectin tests. It holds 25.6% market share.

Figure 1. Global Fecal Calprotectin Test Market Share (%), by Region, 2023

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Analyst’s View

The fecal calprotectin test market is expected to witness steady growth over the forecast period driven by the rising prevalence of inflammatory bowel diseases (IBD) globally. Being a non-invasive diagnostic test, fecal calprotectin testing is gaining more acceptance among healthcare professionals and patients to detect intestinal inflammation. North America currently dominates the market owing to advanced healthcare infrastructure and frequent adoption of new diagnostic technologies in the region. Asia Pacific is anticipated to be the fastest growing region in the fecal calprotectin test market during the next 5-7 years. However, low awareness about fecal calprotectin test in emerging nations may hamper the market expansion. Alternative non-invasive diagnostic methods for gut inflammation can challenge the demand for fecal calprotectin tests. Moreover, complexity in result interpretation and high dependence on experienced pathologists or gastroenterologists are some factors restricting the market growth.

Fecal Calprotectin Test Market Drivers

• Increasing prevalence of gastrointestinal disorders: Gastrointestinal disorders such as inflammatory bowel disease (IBD), Crohn's disease, and ulcerative colitis are becoming more common worldwide. These conditions often involve chronic inflammation in the digestive tract, making the fecal calprotectin test a valuable tool for diagnosis and monitoring disease activity. According to research conducted by Crohn’s and Colitis U.K. in 2022, it was observed that 1 in every 123 people in the UK have either Crohn’s disease or ulcerative colitis.
• Non-invasive and convenient testing: The fecal calprotectin test offers a non-invasive alternative to invasive procedures like colonoscopies or endoscopies. It involves collecting a stool sample, which is more convenient and less uncomfortable for patients. The ease of testing encourages more individuals to undergo screening and monitoring, driving market growth.
• Adoption by healthcare providers: Healthcare providers, including gastroenterologists and primary care physicians, are increasingly recognizing the clinical utility of fecal calprotectin tests. They are incorporating these tests into their diagnostic algorithms and treatment plans, leading to a higher demand for the tests.

Fecal Calprotectin Test Market Opportunities

• Emerging markets: The adoption of fecal calprotectin tests is still relatively low in many emerging markets. As healthcare infrastructure improves and awareness of gastrointestinal disorders increases, there is a significant opportunity for market expansion in these regions. Manufacturers and suppliers can focus on penetrating these untapped markets by providing affordable and accessible testing options.
• Home-based testing kits: Introducing home-based testing kits for fecal calprotectin tests can empower patients to monitor their gastrointestinal health in the comfort of their homes. Home-based testing kits would offer convenience, privacy, and ease of use, enabling individuals to collect stool samples and send them to laboratories for analysis. This approach can encourage regular monitoring and compliance with treatment plans.
• Growing government initiatives for colorectal screening: As colorectal cancer is one of the most dangerous and lethal cancers that starts in the colon or in the rectum. The number of colorectal cancer cases is increasing, which has further resulted in the growing government initiatives taken for colorectal screening. For instance, in April 2023, Sysmex Egypt, a provider of a broad range of medical diagnostic products and solutions, launched an Egypt’s presidential initiative on screening programs. The company has been granted full management on the national colorectal cancer screening using fecal immunochemical testing (FIT) with the high-throughput SENTiFIT 270 and SENTiFIT 800 analyzers.

Fecal Calprotectin Test Market Trends

• Increasing adoption of non-invasive diagnostic tools: Non-invasive diagnostic tests, such as the fecal calprotectin test, are gaining popularity across various medical fields. Patients and healthcare providers alike are recognizing the value of non-invasive options that offer accurate and reliable results without the need for invasive procedures. The fecal calprotectin test aligns with this trend, as it provides a non-invasive approach to assessing gastrointestinal inflammation.
• Shift toward personalized medicine: The healthcare industry is moving toward personalized medicine, where treatments are tailored to individual patients based on their specific characteristics and needs. In the context of the fecal calprotectin test, this trend involves using calprotectin levels as a biomarker to guide treatment decisions. By monitoring calprotectin levels over time, healthcare providers can customize treatment plans for patients, optimizing therapy and improving patient outcomes.

Fecal Calprotectin Test Market Restraints

• Limited reimbursement coverage: In some healthcare systems, the reimbursement coverage for fecal calprotectin tests may be limited or insufficient. This can hinder the widespread adoption of these tests, as healthcare providers and patients may face financial barriers. The lack of adequate reimbursement policies and inconsistent coverage can limit market growth and accessibility of fecal calprotectin tests.
• Variability in test results: Fecal calprotectin test results can exhibit variability due to factors such as sample collection and handling, laboratory techniques, and inter-laboratory variations. This variability can raise concerns about the reliability and consistency of test results. Efforts to standardize protocols, improve testing methodologies, and provide clear guidelines for sample collection and processing can help mitigate this restraint.
• Limited awareness and physician knowledge: While awareness of fecal calprotectin tests is growing, there may still be limited awareness among healthcare professionals, particularly in certain regions or medical specialties. Physicians who are not familiar with the test or its interpretation may be hesitant to order or rely on fecal calprotectin tests in their clinical practice. Increasing physician education and awareness programs can address this restraint and promote broader adoption of the test.

Recent Developments

New product launches

• In June 2022, Meridian Bioscience, Inc., a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic products, announced the launch of two new sample-specific master mixes, Lyo-Ready Direct DNA qPCR Stool Mix, and Lyo-Ready™ Direct RNA/DNA qPCR Stool Mix. These two master mixes improve the molecular detection of DNA and RNA from crude fecal specimens while allowing room-temperature stabilization of diagnostic assays.

Acquisition and partnerships

• In 2022, Meridian Bioscience acquired Calpro, a Norwegian company that develops and manufactures calprotectin-based diagnostic tests. This acquisition helped Meridian Bioscience expand its presence in the fecal calprotectin test market and to offer a wider range of products to its customers.
• In 2020, Bio-Rad Laboratories, a company focused in developing and manufacturing various products associated with healthcare; acquired Enzo Biochem, a company that develops and manufactures diagnostic tests. This acquisition helped Bio-Rad Laboratories expand its presence in the fecal calprotectin test market and offer a wider range of products to its customers.

Figure 2. Global Fecal Calprotectin Test Market Share (%), by Assay Type, 2023

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Top companies in Fecal Calprotectin Test Market

• Thermo Fisher Scientific Inc.
• Bio-Rad Laboratories, Inc.
• Hoffmann-La Roche Ltd.
• Becton, Dickinson and Company
• Abbexa Limited
• Bioserv Diagnostics Gmbh
• Epitope Diagnostics, Inc.
• LifeSpan BioSciences, Inc.
• RayBiotech, Inc.
• ALPCO

Definition: The fecal calprotectin test market refers to the diagnostic tests that measure the level of calprotectin, a protein biomarker, in fecal samples. This non-invasive test is primarily used for the detection and monitoring of inflammatory bowel diseases (IBD), such as Crohn's disease and ulcerative colitis. The test includes various components, such as assay kits, instruments, and software, used for conducting and analyzing these tests. The fecal calprotectin test is done owing to the various factors like the increasing prevalence of IBD and the demand for accurate, non-invasive diagnostic tools in the field of gastroenterology.