Celiac Disease Diagnostics Market

Celiac Disease Diagnostics Market Snapshot

According to Future Market Insights (FMI) analysis in a recent market survey, the global celiac disease diagnostics market was valued at USD 271.3 Million in 2022 and is expected to reach USD 647.3 Million by 2033.

Market Outlook:

Data Points	Market Insights
Market Value 2022	USD 271.3 Million
Market Value 2023	USD 292.8 Million
Market Value 2033	USD 647.3 Million
CAGR 2023 to 2033	8.3%
Share of Top 5 Countries	58.4%
Key Players	Thermo Fisher Scientific Inc.; PRIMA Lab SA; Glutenostics; Inc.; NanoRepro AG.; Targeted Genomics; YORKTEST Laboratories; Biohit Oyj; Labsystems Diagnostics Oy; RxHome Test; Biomerica; AESKU.GROUP GmbH; LaCAR MDx Technologies; J. Mitra & Co. Pvt. Ltd.; Imaware; Vitrosens Biotechnology; Bio-Rad Laboratories Inc. Eurofins Scientific.

In Celiac Disease, body's immune system reacts to gluten, a protein found in wheat, rye and barley. This reaction damages the lining of the small intestine and can lead to a range of symptoms, including abdominal pain, bloating, diarrhoea, and weight loss. If left untreated, celiac disease can lead to serious complications, such as malnutrition and an increased risk of certain types of cancer.

Gluten is a protein that is present in wheat, barley, and rye that causes an immunological response in people with celiac disease. In this condition, eating gluten causes the small intestine to launch an immune response, which results in symptoms like diarrhea, bloating, vomiting, or abdominal pain.

Celiac disease is becoming more common across the globe. The increasing cases of celiac disease are linked with decreased microbial diversity compared to our ancestors due to antibiotics, increased C-sections, or low food diversity.

• As per Beyond Celiac, an NGO dedicated to raising awareness about celiac disease, an estimated 1 in 133 Americans has celiac disease. They mentioned that several environmental causes, including, more amount of gluten provide to infants, use of antibiotics during a child's first year of life, early childhood illnesses, and reduced exposure to microbes early in life leads to overactive immune responses later in life and cause celiac diseases. The diagnostics of celiac disease generally involve serology testing that looks for antibodies in blood and genetic testing for human leucocytes antigens.

Thus, the increasing cases of celiac disease will lead to increased demand for diagnostics during the forecast period and drive the market growth at a high pace.

Overall, the adoption of celiac diseases diagnostics in healthcare facilities, which will boost the market in the coming years.

Sales Analysis of Celiac Disease Diagnostics Market from 2012 to 2022 Vs Market Outlook for 2023 to 2033

Sales of the celiac disease diagnostics market grew at a CAGR of 5.6% between 2012 to 2022. The Celiac disease diagnostics market contributes 6.4% revenue share to the global autoimmune diseases diagnostics market which is valued at around  USD 4.25 Billion in 2022.

The usage of home-test kits for the diagnosis of celiac disease is leading to a boost for the market. There are several manufacturers that provide kits that help the patients measure their response to gluten and indicate their likelihood of having the disease.

The sample needed for the home test kits generally includes blood or swab. The results during the home test could be mailed to a lab for analysis. The labs generally provide easy-to-understand results within 5 to 7 business days that could be shown to healthcare professionals.

• A few examples of the home-test kits include the Targeted Genomics Gluten ID Test, imaware Celiac Disease Screening Test, LetsGetChecked Celiac Test, Genovate DNA Celiac Disease Test and empowerDX Celiac Risk Gene Test.

Several manufacturers are involved in increased product launches for at-home test products.

• For instance, on May 5, 2022, empowerDX launched the easy At-Home Celiac Disease Genetic Risk Test. Thus, the increased home-test kit adoption is expected to increase the market growth in the forecast period.

Governments around the world are taking initiatives to increase awareness about celiac disease and improve access to diagnostics and treatment. For example, some countries have introduced screening programs for celiac disease in high-risk populations. Point-of-care testing (POCT) for celiac disease is becoming increasingly popular as it allows for rapid diagnosis and treatment. POCT is especially useful in remote or underserved areas where access to laboratory testing may be limited.

Considering this, FMI expects the global market to grow at a CAGR of 8.3% through the forecasted years.

What are the Key Opportunities in the Celiac Disease Diagnostics Market?

Technological advances related to sample collection and efforts of manufacturers to create easy-to-use kits are increasing the demand for the market.

Manufacturers are focusing on using non-invasive options such as cheek swabs, which are easier to use and do not cause pain. The result could also be obtained in a few days and thus the adoption is high.

The use of newer diagnostic tools, including deamidated gliadin peptide, serologic tests for antibodies against tissue transglutaminase (tTG), greatly facilitates diagnosis. Tests for DQ8 molecules and celiac-permissive HLA DQ2 are also useful in defined clinical situations. These diagnostic options are widely being adopted to improve the diagnostic approaches for celiac disease.

Thus, with the easy diagnosis of celiac disease, there are increased opportunities for new and emerging manufacturers in the market of celiac disease diagnostics. Further investment by key players could also create opportunities in the market of celiac disease diagnostics.

Which Factors Could Possibly Restrain the Growth of Celiac Disease Diagnostics Market?

The procedure of testing for celiac disease is quite simple and the at-home celiac disease testing rate is also high. Although the testing kits claim to have high precision, there could be chances of inconsistency in the result as a result of false results.

There are several factors that lead to such instances such as the type of test, type of sample, and other similar factors.

• For instance, as per the Celiac Disease Foundation, the convenient way to test for celiac disease is with the Tissue Transglutaminase IgA antibody (tTG-IgA). A chance of a false positive test result exists, particularly in persons without celiac disease who have concomitant autoimmune diseases such as autoimmune liver disease, type 1 diabetes, Hashimoto's thyroiditis, psoriatic or rheumatoid arthritis, or heart failure. Thus, other antibody tests are also available to confirm potential false positives or false negatives, but a biopsy of the small intestine is the only way to definitively diagnose celiac disease due to the risk of misleading antibody test results.

These factors are expected to hamper revenue growth of the celiac disease diagnostics market over the forecast period.

Country-wise Insights

What Makes the USA the Dominating Country in the Global Market?

The USA market is expected to register a CAGR of 7.6% during the forecast period.

Celiac disease is a relatively common autoimmune disorder, but its prevalence can vary across different populations and regions. In the United States, celiac disease is considered to be underdiagnosed, with a significant number of cases remaining undiagnosed or misdiagnosed.

• According to estimates from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), approximately 1 in 141 Americans have celiac disease. However, it's important to note that this figure represents diagnosed cases, and the actual prevalence may be higher.

Due to the high prevalence, more treatments, products will experience a high adoption rate among patients. The demand for celiac disease diagnostics will increase due to high prevalence, which will drive the expansion of the market.

Why is Germany considered to be a Lucrative Segment for Celiac Disease Diagnostics Market in Europe?

Germany dominated the European market for celiac disease diagnostics and accounted for around 25.6% of the market share in 2022.

Increasing technological advancements in celiac disease diagnostics in Germany is driving the overall Europe market. These advancements aim to improve the accuracy, efficiency, and convenience of diagnosing and managing the condition. Here are a few notable technological advancements in Germany for celiac disease diagnostics

Additionally, Genetic testing plays a role in identifying certain genetic markers associated with celiac disease. Germany, like other countries, has seen advancements in genetic testing technologies, making it easier and more accessible to analyze an individual's genetic profile to determine the presence of genes like HLA-DQ2 and HLA-DQ8, which are associated with an increased risk of developing celiac disease. Genetic testing can help in cases where there is diagnostic uncertainty or when other diagnostic methods are inconclusive, ultimately expanding the overall market.

What Makes China an Emerging Market for Celiac Disease Diagnostics?

China is projected to be the most attractive market in the celiac disease diagnostics, and is expected to grow over a significant CAGR of 9.9%.

The celiac disease diagnostics market in China is expected to grow significantly in the coming years due to several factors.

One of the main factors driving the growth of the celiac disease diagnostics in China is the increasing awareness of the condition among the general public and healthcare professionals. As more people become aware of the condition, they are more likely to seek diagnostics and treatment, which is leading to increased demand for diagnostics for celiac disease.

Another factor contributing to the growth of the China market is the increasing availability of advanced medical technologies and treatments. China has made significant investments in its healthcare infrastructure, and many new hospitals and clinics have been built in recent years.

Category-wise Insights

Why Product Is Largely Adopted Diagnostics Test for Celiac Disease?

The serology rapid testing kits segment held the major chunk of about 72.4% in global market by the end of 2022.

Serology rapid testing kits provide quick results, often within minutes, allowing for immediate diagnosis or screening. This speed is particularly beneficial in situations where prompt decision-making is necessary, such as in point-of-care settings or during emergency situations.

Serology rapid testing kits enable testing to be conducted at the point of care, eliminating the need for sending samples to a laboratory. This convenience improves accessibility, especially in remote or resource-limited areas, where access to laboratory facilities may be challenging.

Why ELISA (enzyme-linked immunosorbent assay) Is Dominating Technique for Celiac Disease Diagnostics?

The ELISA segment held the major chunk of about 56.7% in global market by the end of 2022.

The enzyme-linked immunosorbent assay (ELISA) technique has been widely used in celiac disease diagnostics for many years and continues to be an essential tool in this field. ELISA is a laboratory-based test that measures the presence and concentration of specific antibodies in a patient's blood sample.

ELISA has demonstrated high sensitivity and specificity in detecting celiac-specific antibodies. Sensitivity refers to the ability of the test to correctly identify individuals with celiac disease, while specificity refers to its ability to correctly identify individuals without the disease. ELISA tests designed for celiac disease diagnostics have been optimized to achieve reliable and accurate results. This is adding value to the market.

Which Sample Dominates the Global Market in 2022?

The blood serum segment accounted for revenue share of 74.1% in the global market at the end of 2022.

Blood serum plays a crucial role in celiac disease diagnostics. It is used to analyze various biomarkers and antibodies associated with the condition. Serologic tests measure specific antibodies present in the blood serum that indicate an immune response to gluten. These tests are the primary screening method for celiac disease. The most commonly measured antibodies include tissue transglutaminase antibodies (tTG), deamidated gliadin peptide antibodies (DGP), and endomysial antibodies (EMA).

Blood serum provides valuable information in celiac disease diagnostics, allowing healthcare professionals to assess antibody levels, detect IgA deficiency, monitor disease progression, and evaluate treatment response.

Which End User Dominates the Global Market in 2022?

The diagnostic laboratories segment accounted for revenue share of 44.0% in the global market at the end of 2022.

Diagnostic laboratories play a crucial role in celiac disease diagnostics. These specialized laboratories perform a range of tests and analyses to aid in the accurate diagnosis and monitoring of the condition. Diagnostic laboratories also contribute to research and development efforts in celiac disease diagnostics. They participate in studies and clinical trials to explore new diagnostic methods, evaluate the performance of novel biomarkers, and enhance the accuracy and efficiency of existing tests.

Competitive Landscape

Key players in the market are focused on increase their product portfolio to strengthen their position in the market, and also to expand their footprint in emerging markets. The key strategy adopted by manufacturers to gain competitive edge in the market are the partnerships and acquisition of other companies to expand their business.

For instance:

• Thermo Fisher Scientific Inc. announced in December 2021 that it would purchase PPD Inc., a significant global provider of clinical research services to the biopharmaceutical and biotech industries.
• In November 2017, The company Glutenostics announced the partnership with Major US Celiac Advocacy Groups

Similarly, recent developments have been tracked by the team at Future Market Insights related to companies in the celiac disease diagnostics market space, which are available in the full report

Scope of the Celiac Disease Diagnostics Report

Attribute	Details
Forecast Period	2023 to 2033
Historical Data Available for	2012 to 2022
Market Analysis	USD Million for Value
Key Regions Covered	North America; Latin America; Europe; South Asia; East Asia; Oceania; Middle East; and Africa (MEA)
Key Countries Covered	US, Canada, Brazil, Mexico, Argentina, Germany, UK., France, Italy, Spain, Russia, BENELUX, Nordics, India, Thailand, Indonesia, Malaysia, Philippines, Vietnam, China, Japan, South Korea, Australia, New Zealand, Türkiye, Israel, South Africa, North Africa, and GCC Countries
Key Segments Covered	Product, Technique, Sample, End User, and Region
Key Companies Profiled	Thermo Fisher Scientific Inc.; PRIMA Lab SA; Glutenostics, Inc.; NanoRepro AG.; Targeted Genomics; YORKTEST Laboratories; Biohit Oyj; Labsystems Diagnostics Oy; RxHome Test; Biomerica; AESKU.GROUP GmbH; LaCAR MDx Technologies; J. Mitra & Co. Pvt. Ltd.; Imaware; Vitrosens Biotechnology; Bio-Rad Laboratories Inc.; Eurofins Scientific
Report Coverage	Market Forecast, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, Strategic Growth Initiatives
Customization & Pricing	Available upon Request

Key Segments Covered in Celiac Disease Diagnostics Industry Research

By Product Type:

• 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)
• enzyme-linked immunosorbent assay (ELISA)

By Sample:

• Blood Serum
• Body Fluids

By End User:

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

By Region:

• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East and Africa (MEA)

Frequently Asked Questions

What Company Macarons are Best in the United States and Europe?

Chantal Guillon, Dana’s Bakery, and Dollayau are the top manufacturers in the United States and Europe.

How Big is the Global Celiac Disease Diagnostics Market?

The net worth of the market is almost USD 292.8 million in 2023.

What is the Estimated Revenue from Celiac Disease Diagnostics by 2033?

The net revenue is likely to surpass USD 647.3 million by 2033.

What is the Market Size for the Celiac Disease Diagnostics in China?

The demand in China is expected to surge at 9.9% CAGR through 2033.

Which is the Dominating Segment in the Global Celiac Disease Diagnostics Market?

Serology rapid testing kit segment share was nearly 72.4% in 2022.