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).
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, MRFR Database and Analyst Review
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 for significant growth as awareness and diagnosis rise amongst providers and patients alike.
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 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.
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, MRFR Database and Analyst Review
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.
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 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 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.
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 Attribute/Metric Source: | Details |
| MARKET SIZE 2018 | 713.6(USD Million) |
| MARKET SIZE 2024 | 848.0(USD Million) |
| MARKET SIZE 2035 | 7128.0(USD Million) |
| COMPOUND ANNUAL GROWTH RATE (CAGR) | 21.353% (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 | Siemens Healthineers, Biomerica, Cypress Diagnostics, Inova Diagnostics, DiaSorin, Scimedex Pharmaceuticals, Roche, HoffmannLa Roche, Thermo Fisher Scientific, Antu Diagnostics, F. HoffmannLa Roche AG, Ortho Clinical Diagnostics, Abbott Laboratories, Medac GmbH, Celerion |
| SEGMENTS COVERED | Type, End Users |
| KEY MARKET OPPORTUNITIES | Rising prevalence of celiac disease, Increased awareness and early diagnosis, Advancements in diagnostic technologies, Growth in point-of-care testing, Expanding applications in autoimmune disorders |
| KEY MARKET DYNAMICS | growing prevalence of celiac disease, increasing awareness and diagnosis, advancements in testing technology, rising demand for accurate results, favorable reimbursement policies |
| COUNTRIES COVERED | US |
Frequently Asked Questions (FAQ) :
The US Tissue Transglutaminase Test Market is anticipated to be valued at 848.0 USD Million in 2024.
By 2035, the market is expected to reach a value of 7128.0 USD Million.
The market is expected to grow at a CAGR of 21.353% during the forecast period from 2025 to 2035.
The Serological testing segment is expected to hold a significant share, valued at 350.0 USD Million in 2024.
The Biopsy segment is expected to grow significantly, reaching a value of 3200.0 USD Million by 2035.
The 'others' segment of the US Tissue Transglutaminase Test Market is estimated to be valued at 98.0 USD Million in 2024.
Major players include Siemens Healthineers, Biomerica, DiaSorin, and Roche among others.
Factors such as increasing prevalence of celiac disease and advancements in diagnostic technologies are key growth drivers.
The Serological segment is projected to expand to 3120.0 USD Million by 2035.
Challenges may include regulatory hurdles and competition from alternative diagnostic methods.
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Assistant Manager He holds an experience of about 7+ years in market research and business consulting, working under the spectrum of life sciences and healthcare domains. rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. his expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. in addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives
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