Celiac Disease Diagnostics Market

Celiac Disease Diagnostics Market Outlook (2024 to 2034)

The global celiac disease diagnostics market was valued at around US$ 582.6 million at the end of 2023. The market is projected to register a 8.5% CAGR and top a valuation of US$ 1,420.7 Million by 2034.

Celiac disease is a type of chronic digestive and immune disorder that damages the small intestine. This immune reaction is triggered by eating gluten-containing foods and causes severe inflammation damaging the linings of the small intestine leading to the inadequate absorption of nutrients and causing malabsorption. Although it is one of the rare diseases, if remains untreated this condition can cause serious complications. Increasing disease prevalence, awareness among the population, technological advancements in diagnostic techniques, rising healthcare expenditure, and increasing demand for accurate and early diagnosis are some of the key factors driving the growth of the celiac disease diagnostics market.

According to the celiac disease foundation, the first-degree relatives of celiac disease patients have a 1 in 10 risk of developing the condition. The National Institute of Health (NIH) has stated that in the general population, the prevalence of celiac disease is about 0.5% to 1%. People with autoimmune diseases like type of diabetes are more prone to developing this disease.

The key diagnostic methods used for detecting celiac disease are serological testing, genetic testing, and intestinal biopsies. The most commonly used screening method is a serological test detecting transglutaminase antibodies (tTG-IgA). Serological tests have high sensitivity, and specificity and are relatively inexpensive and non-invasive.

Report Attributes	Details
Celiac Disease Diagnostics Market Size (2023A)	US$ 582.6 Million
Estimated Market Value (2024E)	US$ 626.2 Million
Forecasted Market Value (2034F)	US$ 1,420.7 Million
Global Market Growth Rate (2024-2034)	8.5% CAGR
Western Europe Market Share (2024)	17.8%
Spain Market Growth Rate (2024-2034)	10.3% CAGR
Key Companies Profiled	Thermo Fisher Scientific Inc.; PRIMA Lab SA; Glutenostics, Inc.; NanoRepro AG; Targeted Genomics; Bio-Rad Laboratories Inc.; Biohit Oyj; Labsystems Diagnostics Oy; RxHome Test; AESKU.GROUP GmbH; LaCAR MDx Technologies; Vitrosens Biotechnology; Inova Diagnostics; EmpowerDx (Eurofins Scientific); Everlywell, Inc.

Historic Analysis (2019 to 2023) and Future (2024 to 2034) Pathway Analysis for the Celiac Disease Diagnostics Market

The market for Celiac Disease Diagnostics grew at a growth rate of 7.0% from 2019 to 2023, and by the end of 2023, it was valued at US$ 582.6 million. Rapid growth in technological advancements, increased awareness and growing focus on early detection are the major factors responsible for the increase of the market during the forecasted period.

Historical Report Attributes	Details
Market Size (2019A)	US$ 444.6 million
Market Size (2023A)	US$ 582.6 million
Historical CAGR (2019-2023)	7.0%
Forecasted CAGR (2024-2034)	8.5%

• Short Term (2024 to 2028): increasing diagnosis rate, rising awareness along with the rising healthcare expenditure in developed and developing countries are the key elements driving celiac disease diagnostics market in this period. Dominance of serological tests and demand for point-of-care testing devices can be the key focus in this era.
• Medium Term (2028 to 2030): Rising shift towards personalized diagnostics, increased focus on early detection are the key factors driving celiac disease diagnostics. Manufacturers can focus on developing home testing kits in this period.
• Long Term (2030 to 2034): Advancements in genetic research, potential development of curative diagnostic and treatment methods along with the changes in dietary habits will be the elements responsible for the growth of celiac disease diagnostics market. Integration of celiac disease testing with broader autoimmune testing and use of multi-omics approach in diagnostics are the factors which can revolutionize the market.

On the basis of the aforementioned facts, the Celiac Disease Diagnostics market is anticipated to grow at a CAGR of 8.5% during the forecast period from 2024-2034, According to the Fact.MR, a market research and competitive intelligence provider.

Market Dynamics

What are the Factors Propelling Global Sales of Celiac Disease Diagnostics?

“Development of New Testing Methods is driving the Demand for Celiac Disease Diagnostics Market”

More accessible, efficient, and accurate testing results from advancements in diagnostic technology, which impacts the growth of the celiac disease diagnostic market. Newer serological diagnostics, like improved lateral flow assays and complex ELISA assays, offer higher sensitivity and specificity in detecting antibodies associated with celiac disease. Fewer false positives and negatives occur as a result. Modern serological techniques allow for the simultaneous detection of many antibodies, such as tTG-IgA, DGP-IgA, and DGP-IgG, providing a comprehensive diagnostic profile from a single sample.

Identifying HLA-DQ2 and HLA-DQ8 genotypes that are associated with higher predisposition to celiac disease has become fast and precise due to advancements in technology. This results in early detection and enhanced risk assessment capabilities providing means for optimized diagnosis. NGS serves to expand knowledge on genetic susceptibility and provides better diagnosis through its detailed genomic information that reveals infrequent mutations associated with coeliac disease. New point-of-care testing kits make it easier to examine patients and speed up decision-making in clinical or home settings by providing rapid results.

“Increasing Usage of Home-Test Kits Boosts the Market Growth”

The home test kits are increasingly popular as the method of diagnosing celiac disease, thus boosting the market. Many equipment makers offer kits for measuring gluten responses and thereby show the likelihood of getting the disease.

Blood or swab are generally used in testing and these tests can be sent to a laboratory so as to analyze results collected during a home test. All results obtained in labs are usually easy to comprehend, and which can be accessible in 5-7 working days. Some examples of home-test kits include imaware Celiac Disease Screening Test, Targeted Genomics Gluten ID Test, LetsGetChecked Celiac Test, EmpowerDX Celiac Risk Gene Test and Genovate DNA Celiac Disease Test. There is increasing involvement of different manufacturers in more product releases of at-home test kits. For example, empowerDX launched a simple test for Celiac Disease Genetic Risk on May 5, 2022. Hence, it is anticipated that the rise in usage of home-test kits will promote market expansion during the prediction time.

What are the Challenges Encountered by Manufacturers of Celiac Disease Diagnostics?

“Lack of Awareness among Health-Care Professionals in Certain Under-Developed and Developing Countries”

Celiac disease is less prevalent in the Middle East than it is in the United States and other Asian and European countries. Consequently, constructing efficient diagnostic tools for celiac disease is hard, thus inhibiting proper examination of various signs and symptoms such as diarrhea, anemia or wasting syndrome. Therefore, late treatment of celiac patients who consume gluten in their diet can lead to serious complications like colon cancer, T-cell lymphoma-associated enteropathy or chronic diarrhea.

A research revealed by Shahid Beheshti University of Medical Sciences, Iranian capital Tehran and other parties claims that internal health specialists’ area of expertise is not enough to meet the demands of the health systems while offering services for diagnosis and treatment of celiac disease. There is no evidence to prove any consciousness about celiac disease among Iranian healthcare providers although this condition comes very close to them. The study discovered that 9.8% of specialists in Iran have received top marks for diagnosing and treating celiac disease. Therefore, insufficient awareness precludes some nations from effectively diagnosing these diseases.

Country-wise Insights

Why is Adoption of Celiac Disease Diagnostics High in the United States?

“Increased Awareness and Education among Healthcare Providers and General Public”

United States Celiac Disease Diagnostics Market is estimated at US$ 234.3 million in 2024 and is projected to expand at a CAGR of 8.4% through 2034.

With the initiatives of celiac disease foundation, national celiac association and various medical institutions U.S. is significantly making efforts to educate people regarding the disease conditions like celiac disease and other rare diseases. As a result of this, healthcare providers are able to efficiently diagnose the conditions such as celiac disease due to increased testing and diagnosis rates.

At the same time, public awareness campaigns as well as media reporting have greatly contributed to enlightening the population on celiac syndrome. Because of these activities people were encouraged to visit their physicians and ask for examinations when they show signs indicative of gluten intolerance. In addition, social networking sites and internet-based health groups have increased this trend by enabling individuals to easily communicate their stories or disclose information concerning celiac disease. According to a study published in The American Journal of Gastroenterology, over the past decade the diagnosis rate of celiac disease has increased significantly. A major factor contributing to this rise is increased knowledge among pediatricians.

China Is Expected to Register High Growth Rate in Forecast Period.

Expanding at a CAGR of 11.1%, the China’s celiac disease diagnostics market is projected to increase from a valuation of US$ 48.6 million in 2024 to US$ 138.6 million by 2034.

Over the past few decades, China has seen fast economic expansion and urbanization. The number of people living urban lifestyles and adopting the West has led to a rise in the consumption of gluten-containing foods. In the past, rice, vegetables, and meat made up the majority of the Chinese diet, with very little gluten. But the introduction and increasing acceptance of Western-style cuisine, particularly among younger generations, has led to a substantial rise in the population's gluten consumption.

As per the recent researches, the awareness of gluten related disorders have significantly increased in China. For instance, the Chinese medical community is starting to understand the significance of celiac disease early detection, and attempts have been made to include celiac disease screening in standard medical examinations, particularly for patients presenting with symptoms like anemia, weight loss, or chronic diarrhea. The healthcare providers in urban areas like Beijing and Shanghai are providing celiac disease testing solutions in their offerings. Also, the public health and educational initiatives are getting organized in the country to increase awareness among both general population and healthcare providers.

Category-wise Insights

Which Product Type is expected to Grow Rapidly in the Celiac Disease Diagnostics Market?

“Serology Rapid Testing Kits is expected to Witness a Significant Demand due to Early, Accessible, and Accurate Diagnosis”

Demand for serology rapid testing kits is projected to increase from US$ 455.4 million to US$ 1,073.9 million at a CAGR of 9.0% from 2024 to 2034. The necessity for early and accessible diagnosis, the rising incidence of celiac disease globally, and the growing public and healthcare professional knowledge about disease are some of the factors contributing to this surge.

Serology rapid testing kits are non-invasive, less expensive and convenient alternative method than traditional diagnostic methods such as endoscopic biopsy. Tissue transglutaminase antibody (tTG-IgA) test, have high sensitivity in detecting celiac disease and is most commonly used in the diagnosis. It allows quick results, often within minutes and can be administered even at home along with variety of healthcare settings, such as primary care clinics and community health centers. For instance, Simtomax® test developed by Augurix Diagnostics SA is an effective tool detecting IgA and IgG antibody and offers results within 10 minutes.

Competitive Landscape

Key players in the celiac disease diagnostics market are Thermo Fisher Scientific Inc., PRIMA Lab SA, Glutenostics, Inc., NanoRepro AG, Targeted Genomics, Bio-Rad Laboratories Inc., Biohit Oyj, Labsystems Diagnostics Oy, RxHome Test, AESKU.GROUP GmbH, LaCAR MDx Technologies, Inova Diagnostics, EmpowerDx (Eurofins Scientific) , Everlywell, Inc., and Vitrosens Biotechnology.

Companies are focusing on innovation in testing technology to develop rapid, non-invasive and more accurate testing kits along with advanced genetic tests. Companies are also entering into collaborations and partnerships to retain the market.

• In September 2021, Inova Diagnostics received FDA (510k) clearance for its Aptiva celiac disease IgA assay and Aptiva System. It is fully automated digital system which allows next generation high throughput processing for clinical laboratory.
• In June 2022, Everlywell, Inc. released new nutritional and digestive health solutions including at-home collection tests for celiac disease.
• In September 2022, EmpowerDx and NIMA signed a partnership to collaborately promote EmpowrDx’s genetic test for the detection of celiac disease.
• In October 2022, Takeda entered into collaboration and licensing agreement with Zedira and Dr. Falk Pharma to develop ZED1227/TAK-227, a Phase 2b investigational therapy for celiac disease.

Fact.MR has provided detailed information about the price points of key manufacturers of celiac disease diagnostic products positioned across regions, sales growth, production capacity, and speculative technological expansion, in the recently published report.

Segmentation of Celiac Disease Diagnostics Industry Research

• By Product :

  • Serology Rapid Testing Kits
    • Transglutaminase Antibody Test Kits
    • Endomysial Antibody Test Kits
    • Anti-Giladin Antibody Test Kits
  • Genetic Rapid Testing Kits

• By Technique :

  • Immunochromatography (Lateral Flow)
  • ELISA

• By Sample :

  • Blood Serum
  • Body Fluids

• By End User :

  • Hospitals
  • Diagnostic Laboratories
  • Specialty Clinics
  • Home Care Setting

• By Region :

  • North America
  • Latin America
  • Western Europe
  • Eastern Europe
  • East Asia
  • South Asia & Pacific
  • Middle East & Africa