# US Tissue Transglutaminase Test Market > US Tissue Transglutaminase Test Market Research Report By Type (Serological, Biopsy, others) and By End Users (Hospitals & Clinics, Homecare, Research Organisations, others) - Growth & Industry Forecast 2025 To 2035 - **Forecast Period:** 2025 - 2035 - **CAGR:** 18.94% - **2024:** $ 1,550 Million - **2025:** $ 1,843.57 Million - **2035:** $ 10,450 Million - **Key Players:** Thermo Fisher Scientific (US), Abbott Laboratories (US), Roche Diagnostics (CH), Siemens Healthineers (DE), Bio-Rad Laboratories (US), Ortho Clinical Diagnostics (US), DiaSorin (IT), Quidel Corporation (US) **Report ID:** MRFR/LS/18513-HCR · **Pages:** 100 · **Author:** Rahul Gotadki · **Last Updated:** April 06, 2026 **URL:** https://www.marketresearchfuture.com/reports/us-tissue-transglutaminase-test-market-20060 --- ## Market Summary ## **US Tissue Transglutaminase Test Market Overview** As per MRFR analysis, the US Tissue Transglutaminase Test Market Size was estimated at 713.6 (USD Million) in 2023. The US Tissue Transglutaminase Test Market Industry is expected to grow from 848(USD Million) in 2024 to 7,128 (USD Million) by 2035. The US Tissue Transglutaminase Test Market CAGR (growth rate) is expected to be around 21.353% during the forecast period (2025 - 2035). ### **Key US Tissue Transglutaminase Test Market Trends Highlighted** The US Tissue Transglutaminase Test Market is witnessing significant growth, driven primarily by the increasing prevalence of celiac disease and gluten-related disorders across the country. Many health organizations, including the Centers for Disease Control and Prevention (CDC), have reported a rise in autoimmune diseases, prompting healthcare providers to seek more reliable diagnostic tests like the tissue transglutaminase test for timely and accurate patient assessment. Furthermore, there is a greater emphasis on early diagnosis and management of these conditions, as undiscovered gluten intolerance can lead to severe health risks. With the advancements in point-of-care testing and the development of more precise testing methods, healthcare facilities are now more inclined to adopt these innovative solutions. The opportunities in the US market are also expanding with increased awareness and education among patients and healthcare professionals regarding gluten intolerance. As more people seek testing for celiac disease due to heightened knowledge of symptoms, manufacturers have the chance to enhance their product offerings and broaden their market reach. Additionally, there is a growing trend in e-health and telemedicine, enabling remote diagnostic services, which may incorporate the tissue transglutaminase test into broader health monitoring systems. In recent times, the emphasis on personalized medicine is shaping the direction of testing protocols and management strategies within the US healthcare system. This trend supports the integration of tissue transglutaminase testing within the broader context of tailored healthcare solutions, catering to individual patient profiles. As awareness increases and diagnostic technologies improve, the US Tissue Transglutaminase Test Market is likely to see continued expansion and innovation. Source: Primary Research, Secondary Research, _Market Research Future_ Database and Analyst Review ### **US Tissue Transglutaminase Test Market Drivers** #### **Increasing Prevalence of Celiac Disease in the US** The rising incidence of Celiac Disease in the United States serves as a major driver for the US Tissue Transglutaminase Test Market Industry. According to the National Institute of Diabetes and Digestive and Kidney Diseases, approximately 1 in 133 people in the US have Celiac Disease, translating to about 3 million individuals who could benefit from screening. This highlights a significant patient population in need of testing for conditions related to gluten sensitivity.With organizations like the Celiac Disease Foundation conducting awareness campaigns, the demand for tissue transglutaminase tests is expected to grow. This is further supported by studies indicating a 20% increase in diagnosed cases over the last decade, emphasizing the growing importance of testing methodologies that quickly and accurately diagnose the disease. Overall, these trends strongly position the US [Tissue Transglutaminase Test Market](../../../reports/tissue-transglutaminase-test-market-824) for significant growth as awareness and diagnosis rise amongst providers and patients alike. #### **Enhanced Diagnostic Capabilities** Recent advancements in technology have significantly improved the diagnostic capabilities of the US Tissue Transglutaminase Test Market Industry. Innovations in laboratory testing procedures have led to higher sensitivity and specificity rates in tissue transglutaminase assays. For instance, the American Association for Clinical Chemistry highlights that modern testing methods can achieve over 95% sensitivity. This enhancement in testing accuracy is particularly important in reducing misdiagnosis of Celiac Disease, thereby increasing the demand for reliable tests.With healthcare entities recognizing the importance of precise diagnostics, the adoption of these advanced testing mechanisms will likely proliferate, further propelling market growth. #### **Government Initiatives in Disease Awareness and Screening** Government initiatives to promote awareness and screening for Celiac Disease significantly bolster the US Tissue Transglutaminase Test Market Industry. The Centers for Disease Control and Prevention regularly issues guidelines and funding for educational campaigns aimed at increasing awareness among healthcare providers and the public. For example, the CDC's initiatives have spurred a rise in screening rates by as much as 30% in certain communities. Such programs not only enhance public knowledge about autoimmune disorders like Celiac Disease but also encourage timely testing, thus pushing the testing market forward. As more individuals are educated and encouraged to seek testing, the US Tissue Transglutaminase Test Market is anticipated to expand accordingly. ### **US Tissue Transglutaminase Test Market Segment Insights** #### **Tissue Transglutaminase Test Market Type Insights** The US Tissue Transglutaminase Test Market is experiencing robust growth, significantly driven by advancements in diagnostic procedures and the increasing prevalence of celiac disease across the region. This market is distinctively segmented by Type, incorporating various testing methodologies that are essential for accurate diagnosis and monitoring of gluten-related disorders. The Serological testing approach remains pivotal within this market landscape due to its non-invasive nature, offering timely and efficient results that are crucial for patient outcomes. This method typically incorporates enzyme-linked immunosorbent assay (ELISA) techniques, which have shown high sensitivity and specificity in detecting antibodies related to tissue transglutaminase, making it an integral part of clinical practice in the United States. On a different note, the Biopsy segment plays a critical role for specific cases where serological results may not provide conclusive evidence. It involves obtaining small samples of intestinal tissue to ascertain the degree of damage to the intestinal lining, thus offering invaluable data for healthcare providers in determining the appropriate management strategies. This invasive method, while less common than serological tests, is often employed in clinical scenarios that require comprehensive evaluation, solidifying its importance in the diagnostic process. The others segment encompasses various alternative testing procedures that cater to different patient profiles, maintaining its relevance as healthcare practices continue to evolve. This diversity in testing methods highlights the dynamic nature of the US Tissue Transglutaminase Test Market, where leveraging multiple testing approaches allows clinicians to provide tailored care based on individual patient needs. As the industry progresses, the understanding of each type’s strengths and applicability will be essential in refining diagnostic protocols and improving patient management, contributing to the overall growth of the US Tissue Transglutaminase Test Market. Source: Primary Research, Secondary Research, _Market Research Future_ Database and Analyst Review #### **Tissue Transglutaminase Test Market End Users Insights** The US Tissue Transglutaminase Test Market encompasses a diverse range of End Users that play a pivotal role in driving its growth. Hospitals and Clinics emerge as significant contributors, due to their central role in diagnosing celiac disease and related disorders. The burgeoning trend towards precise and rapid diagnostics in healthcare facilities amplifies their importance in this landscape. Homecare settings are gaining traction as more patients prefer at-home testing for convenience and privacy, thus contributing to increased market penetration.Research Organizations also represent a vital segment, as they facilitate advances in medical research and contribute to the refining of testing methodologies. Collectively, these segments form the backbone of the US Tissue Transglutaminase Test Market industry, showcasing a dynamic and evolving landscape that is characterized by an increasing demand for accurate diagnostic tools. Additionally, the interplay of technological advancements, improved healthcare policies, and rising awareness about gluten-related disorders continues to enhance growth opportunities across all these End User categories, further solidifying their significance in the market's trajectory. ### **US Tissue Transglutaminase Test Market Key Players and Competitive Insights** The US Tissue Transglutaminase Test Market is characterized by a dynamic landscape fueled by advancements in diagnostic technologies and an increasing demand for accurate serological testing for celiac disease. The competitive insights within this market reveal a range of players striving to establish their presence through innovative products, strategic collaborations, and expansion of market reach. The growing awareness of celiac disease and the importance of early diagnosis have created a conducive environment for companies developing tissue transglutaminase tests. Companies are investing in research and development to enhance the accuracy and efficiency of these tests, which is likely to intensify competition. The market is marked by a blend of established companies and emerging players, all vying for a share in response to the evolving healthcare trends and the growing need for reliable diagnostic solutions in the United States. #### **Siemens Healthineers** Siemens Healthineers stands out in the US Tissue Transglutaminase Test Market with a formidable reputation for delivering high-quality medical diagnostics. Known for its innovation and technological excellence, Siemens Healthineers leverages its extensive expertise in laboratory diagnostics to offer superior testing solutions. The company’s strengths lie in its strong R&D capabilities, allowing it to continuously enhance test performance and accuracy. With a robust distribution network, Siemens Healthineers has secured a significant market presence across the United States, ensuring its products are readily available to a wide range of healthcare providers. The integration of advanced technologies into their testing platforms not only improves the overall user experience but also strengthens their competitive advantage in a rapidly evolving market. #### **Biomerica** Biomerica is another key player in the US Tissue Transglutaminase Test Market, known for its focus on developing diagnostic products aimed at improving health outcomes. Biomerica specializes in offering a range of diagnostic tests related to celiac disease, contributing to its presence in the market. The company emphasizes innovation in its test development, working on delivering effective and user-friendly diagnostic solutions for healthcare providers. Biomerica’s strengths include its commitment to research and customer-centric product development, which allows for the timely introduction of new tests and solutions. The company also engages in strategic partnerships and collaborations to enhance its product offerings and expand its market footprint. While Biomerica continues to innovate, it remains dedicated to improving celiac disease diagnostics in the United States, thereby solidifying its competitive position in the market. ### **Key Companies in the US Tissue Transglutaminase Test Market Include** ### **US Tissue Transglutaminase Test Market Industry Developments** Recent developments in the US Tissue Transglutaminase Test Market are significantly shaping the landscape. Siemens Healthineers has been focusing on enhancing its diagnostic capabilities to cater to the growing demand for autoimmune disease testing, demonstrating a trend toward precision diagnostics in this sector. Biomerica and Inova Diagnostics are also gaining traction with their innovative enzyme-linked immunosorbent assays, contributing to the increasing adoption of antibody tests for celiac disease. In terms of market activity, DiaSorin announced its strategic acquisition of a diagnostic company in March 2023 to expand its product offerings in autoimmune testing, further indicating a consolidating market landscape. Additionally, Abbott Laboratories continues to invest heavily in Research and Development to address larger patient populations and improve testing accuracy. The market valuation for tissue transglutaminase tests has shown a growth trajectory, reflecting heightened awareness of celiac disease amongst healthcare professionals and patients alike. In recent years, regulatory approvals from the Food and Drug Administration have bolstered confidence in test methodologies, with significant advancements noted as early as September 2022, which have positioned major companies like Roche and Thermo Fisher Scientific favorably in this competitive market. ### **US Tissue Transglutaminase Test Market Segmentation Insights** #### **Tissue Transglutaminase Test Market Type Outlook** #### **Tissue Transglutaminase Test Market End Users Outlook** ## Market Drivers ### Increased Healthcare Expenditure The rising healthcare expenditure in the US is contributing to the growth of the tissue transglutaminase-test market. With healthcare spending projected to reach approximately $4.1 trillion by 2025, there is a greater allocation of funds towards diagnostic testing and preventive care. This financial commitment allows for the integration of advanced testing methods, including tissue transglutaminase tests, into routine healthcare practices. As healthcare providers invest in better diagnostic tools, the demand for these tests is likely to rise, reflecting a shift towards more proactive healthcare management. Consequently, the tissue transglutaminase-test market is positioned to benefit from this trend, as more patients are screened for celiac disease and related conditions. ### Rising Consumer Health Awareness There is a notable increase in consumer health awareness in the US, which is driving the tissue transglutaminase-test market. As individuals become more informed about health issues, including celiac disease, they are more likely to seek diagnostic testing. This trend is reflected in the growing number of health campaigns and educational initiatives aimed at promoting awareness of gluten-related disorders. Consequently, patients are proactively requesting tissue transglutaminase tests, leading to an uptick in demand. The tissue transglutaminase-test market is likely to experience growth as consumers prioritize their health and seek out reliable testing options to address their concerns. ### Rising Prevalence of Celiac Disease The increasing incidence of celiac disease in the US is a primary driver for the tissue transglutaminase-test market. Recent estimates suggest that approximately 1 in 100 individuals are affected by this autoimmune disorder, leading to a heightened demand for accurate diagnostic tests. As awareness of celiac disease grows, healthcare providers are more likely to recommend tissue transglutaminase testing as a reliable method for diagnosis. This trend is further supported by the fact that early detection can significantly improve patient outcomes, thereby driving the market forward. The tissue transglutaminase-test market is expected to see substantial growth as more individuals seek testing, with projections indicating a potential increase in market value by over 20% in the coming years. ### Growing Demand for Point-of-Care Testing The tissue transglutaminase-test market is experiencing a shift towards point-of-care testing solutions. This trend is driven by the need for rapid and accurate diagnostic results, which are essential for timely treatment decisions. Point-of-care testing allows healthcare providers to conduct tests in various settings, including clinics and physician offices, thereby increasing accessibility for patients. The convenience of obtaining results within minutes rather than days is appealing to both patients and providers. As the demand for point-of-care testing continues to rise, the tissue transglutaminase-test market is likely to expand, with innovations in testing technology playing a crucial role in this transformation. ### Regulatory Support for Diagnostic Innovations Regulatory bodies in the US are increasingly supporting innovations in diagnostic testing, which positively impacts the tissue transglutaminase-test market. The Food and Drug Administration (FDA) has streamlined the approval process for new diagnostic tests, encouraging the development of advanced testing methodologies. This regulatory support fosters an environment conducive to innovation, allowing manufacturers to introduce new and improved tissue transglutaminase tests. As a result, healthcare providers gain access to more reliable and efficient testing options, which can enhance patient care. The tissue transglutaminase-test market stands to benefit from this trend, as regulatory advancements may lead to a broader range of testing solutions available to clinicians. ## Future Outlook The [Tissue Transglutaminase Test Market](https://www.marketresearchfuture.com/reports/tissue-transglutaminase-test-market-824) is projected to grow at an 18.94% CAGR from 2025 to 2035, driven by increasing celiac disease diagnoses and advancements in diagnostic technologies. **New opportunities:** - Development of mobile testing units for remote diagnostics. - Partnerships with healthcare providers for integrated testing solutions. - Investment in AI-driven data analytics for personalized treatment plans. By 2035, the market is expected to achieve substantial growth, reflecting evolving healthcare needs. ## Segment Insights ### By Type: Serological Testing (Largest) vs. Biopsy (Fastest-Growing) In the US tissue transglutaminase-test market, the market share distribution reveals that serological testing holds the largest segment value, commanding a significant portion of market activity. On the other hand, biopsy, although smaller in share, is experiencing rapid growth and emerging as a valuable tool in diagnostic processes. This dynamic creates a competitive landscape where both technologies are critical for patient care. Growth trends for these segment values indicate a shift towards higher accuracy and reliability in testing methods. The increasing prevalence of celiac disease and rising awareness among healthcare providers drive demand for serological testing. Additionally, advancements in biopsy techniques, coupled with the growing need for precise diagnostics, position biopsy as the fastest-growing segment, indicating its crucial role in the future market. Testing Methods: Serological Testing (Dominant) vs. Biopsy (Emerging) Serological testing is recognized as the dominant testing method in the US tissue transglutaminase-test market due to its high accuracy and non-invasive nature, making it the preferred choice among clinicians. This method leverages antibodies for diagnostic purposes and is widely accepted in routine screenings. Conversely, biopsy is gaining traction as an emerging method, known for its definitive results and ability to provide histological insights. As medical technology advances, the efficiency and precision of biopsy procedures continue to improve, thereby attracting interest from healthcare professionals who seek reliable diagnoses. Together, these two methods highlight a comprehensive approach to addressing the needs in the diagnostic landscape. ### By End User: Clinics and Hospitals (Largest) vs. Home Care (Fastest-Growing) In the US tissue transglutaminase-test market, Clinics and Hospitals dominate the end user segment, capturing a significant share due to their established infrastructure and high patient volumes. Their extensive use of diagnostic tests to monitor and manage patients with gluten-related disorders solidifies their market position. Home Care is gaining traction, driven by a shift towards patient-centric healthcare and increased adoption of at-home testing solutions. This segment is supported by the convenience it offers patients and improved health technology that allows remote monitoring. As the demand for rapid and accurate diagnostic tools rises, the Home Care segment is expected to experience the fastest growth. The increasing prevalence of gluten sensitivity and celiac disease awareness, coupled with advancements in diagnostic technologies, propels this trend. Furthermore, the facilitation of telehealth services has been a significant driver, allowing for better accessibility and follow-up care, thereby contributing to the segment's expansion. Clinics and Hospitals (Dominant) vs. Home Care (Emerging) Clinics and Hospitals are the dominant players in the US tissue transglutaminase-test market due to their critical role in disease diagnosis and management. Their facilities are equipped with advanced technologies and skilled personnel, enabling comprehensive patient care. Furthermore, their established relationships with healthcare providers lead to increased test demand. On the other hand, the Home Care segment is emerging rapidly, characterized by an increasing preference for home-based testing options. Patients are increasingly seeking convenience and autonomy in managing their health. The rise in telehealth services and remote monitoring tools has catalyzed this segment's growth, allowing patients to access essential tests without frequent hospital visits. The ongoing development of user-friendly home testing kits is expected to further enhance this segment's appeal. ## Competitive Benchmarking The tissue transglutaminase-test market exhibits a dynamic competitive landscape characterized by innovation and strategic partnerships. Key players such as Thermo Fisher Scientific (US), Abbott Laboratories (US), and Roche Diagnostics (CH) are at the forefront, leveraging their extensive research capabilities and technological advancements to enhance product offerings. These companies focus on developing highly sensitive and specific diagnostic tests, which are crucial for the early detection of celiac disease. Their strategies, including mergers and acquisitions, regional expansions, and digital transformation initiatives, collectively shape a competitive environment that is increasingly focused on precision medicine and patient-centric solutions.In terms of business tactics, companies are localizing manufacturing and optimizing supply chains to enhance operational efficiency and reduce costs. The market structure appears moderately fragmented, with several players vying for market share. However, the collective influence of major companies like Siemens Healthineers (DE) and Bio-Rad Laboratories (US) suggests a trend towards consolidation, as these firms seek to strengthen their market positions through strategic collaborations and technological advancements. In October Abbott Laboratories (US) announced a partnership with a leading biotechnology firm to develop next-generation tissue transglutaminase tests that utilize artificial intelligence for improved diagnostic accuracy. This strategic move is likely to enhance Abbott's competitive edge by integrating cutting-edge technology into their product line, thereby addressing the growing demand for rapid and reliable diagnostic solutions in the healthcare sector.Similarly, in September 2025, Thermo Fisher Scientific (US) launched a new line of tissue transglutaminase assays designed for high-throughput screening in clinical laboratories. This initiative not only expands their product portfolio but also positions them as a leader in the market by catering to the increasing need for efficient diagnostic tools. The introduction of these assays is expected to streamline laboratory workflows and improve patient outcomes through timely diagnosis.Moreover, in August 2025, Roche Diagnostics (CH) unveiled a digital platform that integrates tissue transglutaminase testing with electronic health records, facilitating seamless data sharing among healthcare providers. This strategic action underscores Roche's commitment to digital transformation and enhances the overall efficiency of patient management, potentially leading to better health outcomes. As of November current competitive trends in the tissue transglutaminase-test market are heavily influenced by digitalization, sustainability, and the integration of AI technologies. Strategic alliances are increasingly shaping the landscape, enabling companies to pool resources and expertise to drive innovation. The shift from price-based competition to a focus on technological advancements and supply chain reliability is evident, suggesting that future competitive differentiation will hinge on the ability to deliver innovative, high-quality diagnostic solutions that meet the evolving needs of healthcare providers and patients alike. ## Recent News & Developments Recent developments in the US Tissue Transglutaminase Test Market are significantly shaping the landscape. Siemens Healthineers has been focusing on enhancing its diagnostic capabilities to cater to the growing demand for autoimmune disease testing, demonstrating a trend toward precision diagnostics in this sector. Biomerica and Inova Diagnostics are also gaining traction with their innovative enzyme-linked immunosorbent assays, contributing to the increasing adoption of antibody tests for celiac disease. In terms of market activity, DiaSorin announced its strategic acquisition of a diagnostic company in March 2023 to expand its product offerings in autoimmune testing, further indicating a consolidating market landscape. Additionally, Abbott Laboratories continues to invest heavily in Research and Development to address larger patient populations and improve testing accuracy. The market valuation for tissue transglutaminase tests has shown a growth trajectory, reflecting heightened awareness of celiac disease amongst healthcare professionals and patients alike. In recent years, regulatory approvals from the Food and Drug Administration have bolstered confidence in test methodologies, with significant advancements noted as early as September 2022, which have positioned major companies like Roche and Thermo Fisher Scientific favorably in this competitive market. ## Report Scope | MARKET SIZE 2024 | 1550.0(USD Million) | | --- | --- | | MARKET SIZE 2025 | 1843.57(USD Million) | | MARKET SIZE 2035 | 10450.0(USD Million) | | COMPOUND ANNUAL GROWTH RATE (CAGR) | 18.94% (2025 - 2035) | | REPORT COVERAGE | Revenue Forecast, Competitive Landscape, Growth Factors, and Trends | | BASE YEAR | 2024 | | Market Forecast Period | 2025 - 2035 | | Historical Data | 2019 - 2024 | | Market Forecast Units | USD Million | | Key Companies Profiled | Thermo Fisher Scientific (US), Abbott Laboratories (US), Roche Diagnostics (CH), Siemens Healthineers (DE), Bio-Rad Laboratories (US), Ortho Clinical Diagnostics (US), DiaSorin (IT), Quidel Corporation (US) | | Segments Covered | Type, End User | | Key Market Opportunities | Growing demand for accurate celiac disease diagnostics drives innovation in the tissue transglutaminase-test market. | | Key Market Dynamics | Rising demand for accurate celiac disease diagnostics drives innovation in tissue transglutaminase testing methodologies. | | Countries Covered | US | ## Frequently Asked Questions **Q: What was the market valuation of the US tissue transglutaminase-test market in 2024?** A: The market valuation was $1550.0 Million in 2024. **Q: What is the projected market valuation for the US tissue transglutaminase-test market by 2035?** A: The projected valuation for 2035 is $10450.0 Million. **Q: What is the expected CAGR for the US tissue transglutaminase-test market during the forecast period 2025 - 2035?** A: The expected CAGR during this period is 18.94%. **Q: Which segment had the highest valuation in the US tissue transglutaminase-test market in 2024?** A: The Biopsy segment had the highest valuation at $680.0 Million in 2024. **Q: What are the key players in the US tissue transglutaminase-test market?** A: Key players include Thermo Fisher Scientific, Abbott Laboratories, Roche Diagnostics, Siemens Healthineers, Bio-Rad Laboratories, Ortho Clinical Diagnostics, DiaSorin, and Quidel Corporation. **Q: How much did the Serological Testing segment contribute to the market in 2024?** A: The Serological Testing segment contributed $620.0 Million to the market in 2024. **Q: What is the projected growth for the Home Care segment in the US tissue transglutaminase-test market?** A: The Home Care segment is expected to grow significantly, with a valuation of $310.0 Million in 2024. **Q: What is the market size for Clinics and Hospitals in the US tissue transglutaminase-test market?** A: Clinics and Hospitals accounted for $620.0 Million in 2024. **Q: What is the expected trend for the Others segment in the US tissue transglutaminase-test market?** A: The Others segment had a valuation of $250.0 Million in 2024 and may see growth in the coming years. **Q: How do research organizations fit into the US tissue transglutaminase-test market?** A: Research Organizations represented a valuation of $310.0 Million in 2024, indicating their role in the market. --- *This Markdown endpoint is provided for AI systems and LLM crawlers. 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