The global celiac disease diagnostics market is poised for significant growth, projected to reach a valuation of US$ 626.2 million in 2024 and expected to expand at a CAGR of 8.5% through 2034, according to a recent report by Fact.MR, a leading market research and competitive intelligence provider.
Advancements in diagnostic technology are playing a pivotal role in driving this market expansion. Newer serological diagnostics, such as improved lateral flow assays and complex ELISA assays, offer higher sensitivity and specificity in detecting antibodies associated with celiac disease, leading to fewer false positives and negatives. These modern techniques allow for the simultaneous detection of multiple antibodies, providing a comprehensive diagnostic profile from a single sample.
Furthermore, advancements in technology have made it faster and more precise to identify HLA-DQ2 and HLA-DQ8 genotypes, which are linked to a higher predisposition to celiac disease. This leads to early detection and enhanced risk assessment capabilities, ultimately contributing to optimized diagnosis.
The increasing use of home-test kits is another key factor driving market growth. These kits provide rapid results, making it easier to examine patients and accelerate decision-making in clinical or home settings. Manufacturers are actively introducing new at-home test kits, further fueling this trend. For example, empowerDX launched a simple test for Celiac Disease Genetic Risk in May 2022.
The United States market, in particular, is witnessing robust growth, fueled by increased public awareness about celiac disease. Organizations like the Celiac Disease Foundation and the National Celiac Association, along with various medical institutions, have significantly raised awareness about the condition. Consequently, more people are seeking medical advice when experiencing symptoms of gluten intolerance, leading to a rise in testing and diagnosis rates.
Several leading players are driving innovation in the celiac disease diagnostics market, including 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), and Everlywell, Inc.
The market is further bolstered by recent industry news, such as Inova Diagnostics receiving FDA clearance for their Aptiva System and IgA test for celiac disease in 2021. This allows clinical laboratories to handle data at high throughput, paving the way for next-generation diagnostics. Similarly, Everlywell, Inc. introduced new nutritional and digestive health solutions, including at-home celiac disease collection tests, in 2022. Collaboration agreements like the one between EmpowerDx and NIMA to jointly market genetic tests for celiac disease identification further highlight the industry’s focus on innovation and collaboration.
In conclusion, the celiac disease diagnostics market is on a trajectory of significant growth, driven by advancements in technology, increased awareness, and the convenience of home-test kits. This trend is expected to continue in the years to come, leading to improved diagnosis and management of celiac disease globally.
