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US Tissue Transglutaminase Test Market

ID: MRFR/LS/18513-HCR
100 Pages
Rahul Gotadki
October 2025

US Tissue Transglutaminase Test Market Research Report By Type (Serological, Biopsy, others) and By End Users (Hospitals & Clinics, Homecare, Research Organisations, others) - Forecast to 2035

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US Tissue Transglutaminase Test Market Infographic
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US Tissue Transglutaminase Test Market Summary

As per MRFR analysis, the US tissue transglutaminase test market size was estimated at 1550.0 USD Million in 2024. The US tissue transglutaminase-test market is projected to grow from 1843.57 USD Million in 2025 to 10450.0 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 18.94% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The US tissue transglutaminase-test market is poised for growth driven by rising awareness and technological advancements.

  • Increased awareness and diagnosis of celiac disease are propelling market growth.
  • Technological advancements in testing methodologies enhance accuracy and efficiency.
  • Integration of tissue transglutaminase tests into healthcare protocols is becoming more prevalent.
  • Rising prevalence of celiac disease and increased healthcare expenditure are key market drivers.

Market Size & Forecast

2024 Market Size 1550.0 (USD Million)
2035 Market Size 10450.0 (USD Million)

Major 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)

US Tissue Transglutaminase Test Market Trends

The tissue transglutaminase-test market is currently experiencing notable growth, driven by an increasing awareness of celiac disease and gluten sensitivity among the population. This heightened awareness has led to a greater demand for accurate diagnostic tools, as healthcare providers seek to identify these conditions more effectively. Furthermore, advancements in testing technologies are enhancing the reliability and speed of results, which is crucial for timely patient management. As a result, laboratories and healthcare facilities are increasingly adopting these tests, contributing to the overall expansion of the market. In addition, the tissue transglutaminase-test market is influenced by the rising prevalence of autoimmune disorders, which has prompted healthcare systems to prioritize early diagnosis and intervention. The integration of these tests into routine screening protocols is becoming more common, reflecting a shift towards proactive healthcare measures. Moreover, ongoing research into the role of gluten in various health conditions is likely to further stimulate interest in these diagnostic tests, suggesting a promising outlook for the market in the coming years.

Increased Awareness and Diagnosis

There is a growing recognition of celiac disease and gluten-related disorders, leading to more individuals seeking testing. This trend is supported by educational campaigns and healthcare initiatives aimed at improving understanding of these conditions.

Technological Advancements in Testing

Innovations in testing methodologies are enhancing the accuracy and efficiency of tissue transglutaminase tests. These advancements are likely to improve patient outcomes by facilitating quicker and more reliable diagnoses.

Integration into Healthcare Protocols

The incorporation of tissue transglutaminase tests into standard healthcare practices is becoming more prevalent. This trend reflects a broader commitment to early detection and management of gluten-related disorders.

US Tissue Transglutaminase Test 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.

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.

Get more detailed insights about US Tissue Transglutaminase Test Market

Key Players and Competitive Insights

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 2025, 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 2025, 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.

Key Companies in the US Tissue Transglutaminase Test Market market include

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.

Future Outlook

US Tissue Transglutaminase Test Market Future Outlook

The tissue transglutaminase-test market is projected to grow at an 18.94% CAGR from 2024 to 2035, driven by increasing celiac disease diagnoses and advancements in diagnostic technologies.

New opportunities lie in:

  • 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.

Market Segmentation

US Tissue Transglutaminase Test Market Type Outlook

  • Serological Testing
  • Biopsy
  • Others

US Tissue Transglutaminase Test Market End User Outlook

  • Clinics and Hospitals
  • Home Care
  • Research Organizations
  • Others

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% (2024 - 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

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FAQs

What is the expected market size of the US Tissue Transglutaminase Test Market in 2024?

The US Tissue Transglutaminase Test Market is anticipated to be valued at 848.0 USD Million in 2024.

What is the projected market size for the US Tissue Transglutaminase Test Market by 2035?

By 2035, the market is expected to reach a value of 7128.0 USD Million.

What is the expected compound annual growth rate (CAGR) for the US Tissue Transglutaminase Test Market from 2025 to 2035?

The market is expected to grow at a CAGR of 21.353% during the forecast period from 2025 to 2035.

Which type of testing is projected to dominate the market in 2024?

The Serological testing segment is expected to hold a significant share, valued at 350.0 USD Million in 2024.

How much is the Biopsy segment projected to be valued in 2035?

The Biopsy segment is expected to grow significantly, reaching a value of 3200.0 USD Million by 2035.

What is the anticipated market size for 'others' segment in 2024?

The 'others' segment of the US Tissue Transglutaminase Test Market is estimated to be valued at 98.0 USD Million in 2024.

Who are some key players in the US Tissue Transglutaminase Test Market?

Major players include Siemens Healthineers, Biomerica, DiaSorin, and Roche among others.

What are the expected growth drivers for the US Tissue Transglutaminase Test Market?

Factors such as increasing prevalence of celiac disease and advancements in diagnostic technologies are key growth drivers.

How much will the Serological segment grow by 2035?

The Serological segment is projected to expand to 3120.0 USD Million by 2035.

What challenges might the US Tissue Transglutaminase Test Market face in the coming years?

Challenges may include regulatory hurdles and competition from alternative diagnostic methods.

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