Fecal Calprotectin Test Market Size, Share, Growth & Industry Analysis, By Test Type (Lateral Flow Immunoassay, Enzyme-Linked Immunosorbent Assay), By End-User (Hospitals, Diagnostic Laboratories, Clinics), By Application (Inflammatory Bowel Disease (IBD) Diagnosis, Screening & Early Detection, Disease Monitoring) and Regional Analysis, 2023-2030

Fecal Calprotectin Test Market Size

The global Fecal Calprotectin Test Market size was valued at USD 2,360 Million in 2022 and is projected to reach USD 3,938.9 Million by 2030, growing at a CAGR of 6.78% from 2023 to 2030. In the scope of work, the report includes products offered by companies such as Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Alpha Laboratories Ltd., EagleBio, Meridian Bioscience, Inc., Svar Life Science, BÜHLMANN, DRG International, Inc., DIAZYME LABORATORIES, INC., ALPCO and Others.

The fecal calprotectin test has emerged as a pivotal diagnostic tool in the realm of gastrointestinal health. By detecting levels of the calprotectin protein in stool samples, it offers a non-invasive means to assess bowel inflammation, aiding in the diagnosis and management of inflammatory bowel diseases (IBD) and related conditions. This innovative test addresses the limitations of invasive procedures and enhances patient compliance. The global market for fecal calprotectin tests is experiencing robust growth driven by the increasing prevalence of IBD and the demand for early, accurate diagnoses.

Opportunities lie in the development of more sensitive and user-friendly test kits, and the integration of advanced technologies like artificial intelligence for result interpretation. In light of the surging focus on improved patient outcomes and the growing adoption of non-invasive diagnostics, the fecal calprotectin test market holds promising future prospects, extending its impact on gastrointestinal healthcare worldwide. Despite the projected growth and opportunities, the market is likely to face certain hindrances, such as lack of awareness and variability in results owing to technical limitations.

Analyst’s Review

The fecal calprotectin test market exhibits robust growth driven by rising gastrointestinal disorders globally. Analyzing market dynamics reveals an increasing demand for non-invasive diagnostic tools, positioning fecal calprotectin assays as pivotal in inflammatory bowel disease detection. The market thrives on increased awareness among healthcare professionals and patients about the diagnostic accuracy and cost-effectiveness of calprotectin testing. Key market players strategically focus on technological advancements, introducing innovative testing methods.

Additionally, a surge in research and development activities enhances product portfolios, maintaining competitiveness. The market trajectory foresees sustained growth, propelled by evolving diagnostic preferences and an expanding spectrum of gastrointestinal health concerns.

Market Definition

Fecal calprotectin is a protein biomarker majorly utilized in the diagnosis, screening, early detection, and disease monitoring of inflammatory bowel disease (IBD). fecal calprotectin test market is characterized by various test types, including the lateral flow immunoassay and the enzyme-linked immunosorbent assay, which are commonly employed in detecting and quantifying fecal calprotectin levels.

In terms of end-users, the market caters to hospitals, diagnostic laboratories, and clinics, where these tests are conducted to aid in the identification and management of IBD. Hospitals serve as primary settings for comprehensive diagnostic procedures, while diagnostic laboratories and clinics offer specialized testing services.

The applications of the market encompass IBD diagnosis, screening, early detection, and disease monitoring. These tests play a critical role in differentiating IBD from other gastrointestinal conditions, enabling early detection to facilitate timely intervention and treatment. Additionally, the ongoing monitoring of fecal calprotectin levels assists in assessing disease activity and evaluating treatment response.

The market segmentation based on test types, end-users, and applications provides a comprehensive framework for understanding the distinct aspects of the global market.

Fecal Calprotectin Test Market Dynamics

The integration of advanced technologies presents a promising opportunity within the market. As the demand for accurate and efficient diagnostic tools continues to rise, leveraging technologies such as artificial intelligence (AI) and machine learning could significantly enhance the performance and value of these tests. AI-powered algorithms can aid in the interpretation of test results, taking into account various influencing factors and providing more precise assessments of bowel inflammation. Automation of result analysis could streamline the diagnostic process, reducing the burden on healthcare professionals and enhancing the consistency of interpretations.

Furthermore, the incorporation of user-friendly interfaces and digital platforms could empower patients to monitor their health more actively. Embracing these technological advancements not only elevates the utility of fecal calprotectin tests but also aligns with the broader trend toward digitized healthcare solutions and personalized medicine.

The challenge of interpreting variability in test results emerges as a significant hurdle in the fecal calprotectin test market. Various factors such as diet, age, medications, and coexisting gastrointestinal conditions can influence calprotectin levels in stool samples. This variability in results can lead to ambiguous diagnostic conclusions and hinder the precision of disease assessment. Healthcare professionals must navigate through these complexities to ensure accurate and consistent interpretations of test outcomes. Addressing this challenge requires the development of standardized protocols, advanced algorithms, and educational efforts to enhance the understanding of the test's limitations and factors affecting its results. As the market strives for heightened reliability and confidence in fecal calprotectin testing, overcoming the intricacies of result variability becomes pivotal to fulfilling the test's potential as a robust diagnostic tool for gastrointestinal health.

Segmentation Analysis

The global market is segmented based on material type, end-use, application, and geography.

By Test Type

Based on test type, the fecal calprotectin test market is further bifurcated into lateral flow immunoassay and enzyme-linked immunosorbent assay. The enzyme-linked immunosorbent assay (ELISA) held the highest revenue in 2022, accounting for USD 1,538.7 million. The high demand for this test type can be attributed to its convenient procedure, efficiency, and reduced reliance on radioactive substances. This category is anticipated to dominate the revenue through the forecast period. However, lateral flow immunoassay is estimated to experience a faster growth rate by 2030 owing to its cost-effectiveness and quicker response time.

By End-User

Based on end-user, the market is further categorized into hospitals, diagnostic laboratories, and clinics. The diagnostic laboratories sub-segment dominated the segment’s share and contributed to 48.50% of the revenue in 2022. However, the development of advanced testing kits is estimated to support faster growth of the clinics segment over the review period. Clinics category is estimated to rise at a CAGR of 8.34% over the forecast period.

By Application

Based on application, the market is divided into inflammatory bowel disease (IBD) diagnosis, screening & early detection, and disease monitoring. IBD diagnosis accounted for the dominating market share of 47.10% in 2022 and is estimated to reach revenue of USD 1,747.4 million by 2030. This trend is substantiated by the critical role fecal calprotectin plays in accurately diagnosing IBD, including Crohn's disease and ulcerative colitis. The high sensitivity and specificity of fecal calprotectin tests make them instrumental in distinguishing between IBD and other gastrointestinal conditions. Furthermore, the non-invasive nature of these tests aligns with the increasing preference for patient-friendly diagnostic approaches. As a result, the prevalence of IBD and the growing emphasis on early and accurate diagnoses have propelled inflammatory bowel disease (IBD) Diagnosis to the forefront of fecal calprotectin applications, shaping the market landscape.

Fecal Calprotectin Test Market Regional Analysis

Based on region, the global market is classified into North America, Europe, Asia-Pacific, MEA, and Latin America.

The North America Fecal Calprotectin Test Market share stood around 36.50% in 2022 in the global market, with a valuation of USD 861.4 million. The region has a well-established healthcare infrastructure and high awareness about gastrointestinal diseases, which has led to increased adoption of advanced diagnostic tests like the fecal calprotectin test. Additionally, the prevalence of inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis is relatively high in North America, further fueling the demand for this test. One of the key driving factors in North America is the rising incidence of IBD. According to the Crohn's & Colitis Foundation, nearly 3 million Americans are affected by IBD, with approximately 1.6 million suffering from Crohn's disease or ulcerative colitis.

Asia-Pacific is experiencing a rising burden of gastrointestinal diseases, including IBD, which is driving the demand for accurate diagnostic tools like the fecal calprotectin test. Changing lifestyle patterns, increasing urbanization, and dietary transitions are believed to be contributing factors to the increasing prevalence of gastrointestinal disorders in the region. Asia-Pacific accounted for 12.20% of the global value in 2022 and is estimated to offer growth opportunities for the market players over the forecast period. Furthermore, the growing awareness about the importance of early disease detection and the availability of advanced healthcare facilities in countries like China, Japan, and South Korea are propelling the adoption of fecal calprotectin testing.

Competitive Landscape

The fecal calprotectin test market report will provide valuable insight with an emphasis on the fragmented nature of the industry. Prominent players are focusing on several key business strategies such as partnerships, mergers and acquisitions, product innovations, and joint ventures to expand their product portfolio and increase their respective market shares across different regions. Expansion & investments are the major strategic initiatives adopted by companies in this sector. Industry players are investing extensively in R&D activities, building new manufacturing facilities, and supply chain optimization.

List of Key Companies in Fecal Calprotectin Test Market

• Thermo Fisher Scientific Inc.
• Bio-Rad Laboratories, Inc.
• Alpha Laboratories Ltd.
• EagleBio
• Meridian Bioscience, Inc.
• Svar Life Science
• BÜHLMANN
• DRG International, Inc.
• DIAZYME LABORATORIES, INC.
• ALPCO

Key Industry Development

• July 2023 (Acquisition): Thermo Fisher Scientific Inc. finalized the purchase of CorEvitas, LLC (“CorEvitas”), a prominent supplier of high-quality, real-world evidence for authorized medical treatments and therapies, from Audax Private Equity (“Audax”), for a cash amount of $912.5 million. Thermo Fisher confirmed the deal to acquire CorEvitas.

The global Fecal Calprotectin Test Market is segmented as:

By Test Type

• Lateral Flow Immunoassay
• Enzyme-Linked Immunosorbent Assay

By End-User

• Hospitals
• Diagnostic Laboratories
• Clinics

By Application

• Inflammatory Bowel Disease (IBD) Diagnosis
• Screening & Early Detection
• Disease Monitoring
• Others

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • France
  • U.K.
  • Spain
  • Germany
  • Italy
  • Russia
  • Rest of Europe
• Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Rest of Asia-Pacific
• Middle East & Africa
  • GCC
  • North Africa
  • South Africa
  • Rest of Middle East & Africa
• Latin America
  • Brazil
  • Argentina
  • Rest of Latin America