United States Celiac Disease Testing Market 2025: Latest innovations, Trends, Analysis, Industry insights | Top Companies - PRIMA Lab SA, Glutenostics Inc., NanoRepro AG

"Celiac Disease Testing Market is growing at a high CAGR during the forecast period (2024-2031)." As per DataM intelligence research report

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United States: Recent Industry Developments

✅ In September 2025, U.S. researchers introduced a new blood test that measures IL-2 immune response to detect celiac disease without requiring patients to consume gluten. The test achieved high accuracy in early trials and simplifies diagnosis for individuals already following a gluten-free diet. It marks a major advancement toward non-invasive and patient-friendly testing options.

✅ In June 2025, the FDA approved the at-home "GlutenID" genetic testing kit designed to identify HLA gene variants linked to celiac disease susceptibility. The test allows at-risk individuals to understand their genetic predisposition through a simple saliva sample. It expands early screening accessibility and promotes proactive health monitoring across U.S. households.

✅ In May 2025, scientists at the Mayo Clinic reported improved accuracy in pediatric celiac testing by optimizing TTG-IgA antibody cut-off values. The refined thresholds help reduce false positives and enhance diagnosis in children with autoimmune disorders. It represents a significant refinement in antibody-based diagnostic methods for clinical use.

✅ In March 2025, Everlywell announced its investment in developing next-generation at-home celiac testing kits featuring integrated digital interpretation tools. The new kits combine antibody screening and AI-based result tracking for improved reliability. It reinforces the company's leadership in accessible, consumer-focused health diagnostics in the U.S.

Japan: Recent Industry Developments

✅ In September 2025, researchers at Kyoto University developed an AI-powered system that interprets duodenal biopsy images to identify celiac disease with over 95% accuracy. The tool automates pathology analysis and reduces diagnostic delays in hospital settings. It represents Japan's growing adoption of digital health technologies in clinical diagnostics.

✅ In August 2025, Takeda Pharmaceutical initiated a clinical collaboration to evaluate biomarker-based assays for early celiac disease detection. The project integrates genetic profiling with advanced immunoassay technology to enhance sensitivity in asymptomatic patients. It underscores Japan's investment in precision-based gastrointestinal diagnostics.

✅ In July 2025, Fujirebio expanded production of autoimmune diagnostic reagents to include celiac-specific antibody tests. The expansion supports growing regional demand for serological assays and hospital-based screening solutions. It strengthens Japan's domestic testing capacity and global supply chain in specialized diagnostics.

✅ In June 2025, the Japan Gastroenterological Association announced awareness initiatives promoting celiac disease testing among high-risk groups. The campaign emphasizes physician education and adoption of standardized antibody panels across medical centers. It highlights Japan's gradual shift toward structured early detection and disease management.

Celiac Disease Testing Market: Drivers

The celiac disease testing market is expanding rapidly as awareness of gluten intolerance and autoimmune disorders grows worldwide. Celiac disease, triggered by gluten consumption, is increasingly diagnosed due to better clinical understanding and improved screening technologies. Rising prevalence, particularly in North America and Europe, is driving demand for accurate, non-invasive, and rapid testing solutions. Serological tests such as tissue transglutaminase (tTG) and deamidated gliadin peptide (DGP) antibody assays remain the primary diagnostic tools, while genetic testing for HLA-DQ2 and HLA-DQ8 markers is gaining traction for risk assessment. Growing patient awareness, coupled with early detection initiatives by healthcare providers, is further fueling market expansion.

Technological advancements in immunoassays, point-of-care diagnostics, and molecular testing are enhancing test accuracy, accessibility, and turnaround time. The increasing availability of at-home celiac testing kits is empowering consumers to take proactive control of their digestive health. Pharmaceutical research focusing on gluten-degrading enzymes and vaccine development is also boosting diagnostic testing as part of clinical trials and disease monitoring. Additionally, supportive healthcare reimbursement policies and digital health integration are strengthening adoption. With rising diagnosis rates, growing emphasis on personalized medicine, and continuous innovation in diagnostic platforms, the celiac disease testing market is poised for strong and sustained growth globally.

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Celiac Disease Testing Market: Major Players

PRIMA Lab SA, Glutenostics Inc., NanoRepro AG., Thermo Fisher Scientific Inc., Targeted Genomics, YORKTEST Laboratories, SMARTBLOOD LIMITED, Biohit Oyj, Labsystems Diagnostics Oy, Biomerica

Segment Covered in the Celiac Disease Testing Market:

By Type
The market is segmented into Serologic Tests, Genetic Tests, and Intestinal Biopsies. Serologic tests hold the largest share owing to their cost-effectiveness and rapid results in celiac disease diagnosis, while genetic tests are gaining traction due to their high accuracy and ability to identify predisposition. Intestinal biopsies remain the gold standard for confirmatory diagnosis but are less preferred due to their invasive nature.

By Product Type
Based on product type, the market includes Test Kits, Reagents, and Others. Test kits dominate the market as they enable convenient, point-of-care testing and faster turnaround times, while reagents play a critical role in laboratory-based assays and confirmatory testing procedures.

By End-User
End-users comprise Hospitals, Diagnostic Laboratories, Home Care, and Others. Hospitals and diagnostic laboratories lead the market due to their advanced infrastructure and availability of skilled professionals, whereas home care testing is expanding with the rise of self-testing kits and increasing patient awareness.

Research Process:

Both primary and secondary data sources have been used in the Celiac Disease Testing Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

Most Frequently Asked Questions in the Celiac Disease Testing Market Research Industry:

➠ Who leads the Celiac Disease Testing industry and what's their competitive positioning regarding capacity, performance, and profitability?
➠ What growth opportunities and market challenges do Celiac Disease Testing market vendors face?
➠ Which segments show the highest growth potential and market share distribution?
➠ What factors are driving or limiting Celiac Disease Testing market growth?
➠ What are the dominant sales and distribution strategies in the Celiac Disease Testing industry?

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Regional Analysis:

⇥ North America (U.S., Canada, Mexico)
⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)
⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)
⇥ South America (Colombia, Brazil, Argentina, Rest of South America)
⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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✅ Competitive Landscape
✅ Technology Roadmap Analysis
✅ Sustainability Impact Analysis
✅ KOL / Stakeholder Insights
✅ Consumer Behavior & Demand Analysis
✅ Import-Export Data Monitoring
✅ Live Market & Pricing Trends

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