Global Celiac Disease Testing Market - 2022-2029

Global Celiac Disease Testing Market - 2022-2029

Market Overview

The global celiac disease testing market size was valued at US$ XX million in 2021 and is estimated to reach US$ XX million by 2029, growing at a CAGR of XX % during the forecast period (2022-2029).

Celiac disease is a digestive disorder that causes the body to have difficulty absorbing nutrients like fat, calcium, iron, and folate. It is an autoimmune disease in which gluten-containing foods cause damage to the small intestine lining.

Market Dynamics

The factors influencing the global celiac disease testing market are the increasing advancement in treatment and the growing prevalence of the celiac disease.

The increasing advancement in disease testing is expected to drive the market growth in the forecast period

Serologic tests and intestinal biopsies are the most common ways doctors diagnose celiac disease. If serologic tests indicate that a patient may have celiac disease, doctors generally order biopsies of the patient's intestines to confirm the diagnosis. Serologic tests that look for IgA antibodies are more sensitive for celiac disease than IgG antibody tests. On the other hand, IgG tests may be useful in people with IgA deficiency. A patient must consume a gluten-free diet to receive accurate diagnostic test results. There are celiac panels available that include a combination of serologic tests. The tests included in a panel vary by lab, and not all are required. To avoid automatically running unnecessary tests, some labs have developed test cascades. Celiac disease has been diagnosed using point-of-care serologic tests. More research into the accuracy of point-of-care tests, however, is required.

Moreover, the tTG-IgA test is most patients' celiac disease serologic test of choice. According to research, the tTG-IgA test has a sensitivity of 78 to 100 percent and a specificity of 90 to 100 percent. This test's sensitivity may be affected by the severity of intestinal damage, making it less sensitive in patients with mild celiac disease. In children under two, the test may be less sensitive. The most common type of tTG-IgA test is an enzyme-linked immunosorbent assay (ELISA). If serologic tests indicate that a patient may have celiac disease, an upper GI endoscopy with biopsies of the duodenum, including the duodenal bulb and distal duodenum, should be ordered to confirm the diagnosis.

Limitations associated with celiac disease testing are expected to hamper the market

Celiac disease is diagnosed using a combination of serologic tests, small bowel biopsy, and a gluten-free diet response. Several serologic antibody tests can be used as initial tests. Antigliadin antibodies are no longer recommended for initial testing due to their low sensitivity and specificity. The endomysial antibody test is more sensitive and specific, but it is also more expensive.

In most cases, serologic tests alone are insufficient to diagnose celiac disease. A small bowel biopsy is required, and those with a positive serologic test result and those with initially negative results but high suspicion should be referred for an esophagogastroduodenoscopy.

COVID-19 Impact Analysis

Celiac disease patients are not considered immunocompromised in general, according to the Celiac Disease Foundation Medical Advisory Board. Patients with severe malnutrition and weight loss, a rare complication of Type 2 refractory celiac disease, immunosuppressive medications, or other serious illnesses may be at an increased risk of severe disease from COVID-19 and should consult their doctors. According to the Celiac Disease Foundation Medical Advisory Board, Cross-contact gluten exposure does not put a patient with celiac disease at increased risk of severe COVID-19 illness. Still, patients should follow a strict gluten-free diet for overall health. There is currently no evidence that people with celiac disease are more likely to develop COVID-19 or its complications.

Segment Analysis

The serologic tests segment is expected to dominate the market growth in the forecast period

The first step in diagnosing celiac disease is ordering serologic tests, which are blood tests that look for antibodies. Celiac disease is diagnosed through a series of serologic tests such as Immunoglobulin A (IgA) and immunoglobulin G (IgG) tests using tissue transglutaminase (tTG). Deamidated gliadin peptide (DGP) -IgA and DGP-IgG tests deamidated gliadin peptide (DGP) -IgA and DGP-IgG tests. Serologic tests that look for IgA antibodies are more sensitive for celiac disease than IgG antibody tests. On the other hand, IgG tests may be useful in people with IgA deficiency. A patient must consume a gluten-free diet to receive accurate diagnostic test results. There are celiac panels available that include a combination of serologic tests. The tests included in a panel vary by lab, and not all are required. To avoid automatically running unnecessary tests, some labs have developed test cascades. Celiac disease has been diagnosed using point-of-care serologic tests. More research into the accuracy of point-of-care tests, however, is required. DGP antibody, the newest CD markers, and point-of-care fingerstick TTG antibody testing are two other serologic testing options.

Geographical Analysis

North America region is expected to hold the largest market share in the global celiac disease testing market

The increasing prevalence of celiac disease and growing healthcare facilities are expected to drive the market growth. For instance, celiac disease affects 1% of healthy people in the United States. That means the celiac disease affects at least 3 million people in the United States, with 97 percent going undiagnosed. 3 million people have type 1 diabetes, with 6 percent (180,000) of those diagnosed with celiac disease.

Moreover, on 18th July 2019, Aesku.NY, a New York startup, received FDA approval for tests to detect two of those autoimmune diseases, with tests for other diseases on the way. Patients who test positive for celiac disease or the connective tissue disorder lupus would still need to be tested further for a specific diagnosis using the approved tests. On the other hand, the tests are designed to be both cost-effective and efficient, potentially expanding the availability of a reliable screening method for diseases that benefit from early detection and treatment.

Competitive Landscape

The global celiac disease testing market is moderately competitive with mergers, acquisitions, and product launches. Some of the key players in the market are PRIMA Lab SA, Glutenostics Inc., NanoRepro AG., Thermo Fisher Scientific Inc., Targeted Genomics, YORKTEST Laboratories, SMARTBLOOD LIMITED, Biohit Oyj, Labsystems Diagnostics Oy, Biomerica

PRIMA Lab SA

Overview: PRIMA Lab SA is a modern Swiss company that develops simple and precise CE-certified diagnostic in-vitro medical devices for people's and pets' health. PRIMA also provides health care professionals with rapid tests and point-of-care analysis to help them improve their services. The company is headquartered in Balerna, Switzerland.

Product Portfolio: CELIAC TEST is an immunochromatographic lateral flow device for detecting IgA and IgG anti-DGP antibodies in whole blood. Antibodies will react with the deamidated gliadin if they are present in the sample.

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