Celiac Disease

Published Date : Nov 2023
Category : Autoimmune Diseases
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Celiac Disease – Gluten-Sensitive Enteropathy

A Complete Overview of Diagnosis and Treatment Market Players

In the realm of celiac disease and non-celiac gluten sensitivity (gluten sensitivity), the power of collective effort cannot be overstated. The significance of raising awareness lies in fostering a better understanding of these conditions among the general populace, healthcare professionals, and policymakers. Heightened awareness is a catalyst for early detection through improved diagnostic practices, ensuring that individuals grappling with gluten-related disorders receive timely and accurate diagnoses. This, in turn, paves the way for effective treatment interventions, allowing those affected to manage their conditions and lead healthier lives. The collaborative push for awareness, diagnosis, and treatment not only enhances the quality of life for individuals with celiac disease or gluten sensitivity but also opens avenues for future research, innovation, and revenue generation in the field of gluten-related health solutions.

Celiac disease is a chronic digestive and immune disorder that damages the small intestine. The damage prevents a person’s body from absorbing vitamins, minerals, and other nutrients from the food. Due to this malnutrition and other serious health problems happen. The use of gluten-containing foods causes celiac disease. Grains such as wheat, barley, rye, and others contain the protein gluten. It might also be present in other goods including lip balm, toothpaste, hair and skin care products, and vitamins and supplements. By systematic review of the global prevalence of celiac disease established a prevalence rate of 1.4%, with prevalence varying by continent from 1.3% to 1.8%. The prevalence of celiac disease is influenced by sex, age, and location.

The World Gastroenterology Organization states that celiac disease is divided into two types: Classical and Non-classical. In classical celiac disease, patients have signs and symptoms of malabsorption, including diarrhoea, steatorrhea, celiac disease, and weight loss or growth failure in children. Patients with non-classical celiac disease experience unrelated celiac symptoms or have minor gastrointestinal problems without clear signs of malabsorption. In addition to iron deficiency anemia, chronic fatigue, chronic migraines, peripheral neuropathy, reduced bone mass and bone fractures, vitamin deficiencies (folic acid and B12), trouble losing weight, late menarche or early menopause and unexplained infertility, dental enamel defects, depression, and anxiety, dermatitis herpetiformis (itchy skin rash), etc.

The small intestine's enterocytes are damaged, which results in the celiac disease symptoms. Chronic inflammation and villi loss are common small intestinal gluten symptoms in the full-blown clinical picture. The exact celiac disease cause is unknown. Research suggests that celiac disease only happens to people who have certain genes and eat food that contains gluten.

In the general community, celiac disease affects 0.5% to 1% of people as stated by NCBI. Throughout the last 10 to 20 years, there has been a rise in genuine prevalence as well as in detection and celiac diagnosis. Those with autoimmune celiac diseases, such as type 1 diabetes, are more likely to experience it. The risk is 1 in 10 for first-degree relatives of celiac disease patients.

Major stakeholders in the healthcare and pharmaceutical sectors have been actively trying to alleviate the burden of the Celiac disease panel in the face of this challenging health crisis. Pharmaceutical firms, medical device makers, and healthcare services are among the market leaders. They are involved in a variety of initiatives aimed at preventing, detecting, and treating heart attacks in novel ways.

DiseaseLandscape Insights assists industry participants by offering extensive knowledge about all current market players, their inventions, tactics, and partnerships, as well as assisting in the selection of the appropriate marketplace to develop exponentially and work for improved health outcomes.

Diagnostic Analysis:

The coeliac diagnosis is frequently made using IgA antibodies against tissue transglutaminase and smooth muscle endomysium. Still, approximately 5 percent of celiac disease patients are immunoglobulin deficient.

For celiac sprue diagnosis, two blood tests are used:

  • Serology Testing - A serology test scans blood for antibodies. Increased concentrations of certain antibody proteins signify an immunological response to gluten disease.
  • Genetic Testing - Genetic testing for celiac disease is ruled out by genetic celiac testing for human leukocyte antigens like human leukocyte antigen, HLA-DQ2, and HLA-DQ8. More than 99 percent of those suffering from celiac disease possess either DQ2 or DQ8, or both. If neither of these haplotypes is present, the likelihood of developing celiac disease is low—nearly 100%. Rarely utilized, genetic testing is sometimes helpful in ruling out disease when the results of other tests are not quite clear. Only about 4% of people with celiac disease have the DQ2 and DQ8 alleles of the human leukocyte antigen, whereas 25% to 30% of people in the general population do not have the condition. As such, it is not appropriate to utilize this testing to haphazardly determine one's genetic predisposition to the disease.

It's crucial to get a celiac disease test before attempting a gluten-free diet. Removing gluten from the celiac diet helps blood test results fall within the normal range.

One of the following tests will probably be ordered if the findings of these tests point to celiac disease:

  • Endoscopy - A long tube with a tiny camera is inserted into the mouth and passed down the throat during this procedure. Using a camera, the doctor sees within the small intestine and removes a biopsy sample of tissue to check for villi damage.
  • Capsule Endoscopy - This test takes photos of the entire small intestine using a tiny wireless camera. Swallow a capsule the size of a vitamin that contains the camera. The camera in the capsule takes hundreds of images as it passes through the digestive system and sends them to a recorder. When a complete or terminal examination of the small intestine is required, this test is utilized.

It is advised to undergo extra testing to assess nutritional condition if diagnosed with celiac allergy disease. This comprises the following: mineral levels, hemoglobin, liver enzymes, and the levels of vitamins A, B-12, D, and E. A bone density scan also be used to assess the health of bones.

Diagnostic Market Players:

Diagnostic Market Players

Diagnostic Products

J. Mitra and Co. Pvt.Ltd

Diagnos Celiac Card


Everlywell Celiac Disease Screening Test


Labcorp Celiac Disease Antibody Test

Targeted Genomics



DNA Celiac Disease Test

RX HomeTest Celiac Genetic Test


Biohit Oyj

Celiac disease test kit 602070

Elisabeth Pharmacon spol

EliGene® Coeliac

Personal Diagnostics


WISAP Medical Technology



Endo GIA™

Boston Scientific



Treatment Analysis:

For the treatment of coeliac disease various treatment options are available but most importantly it is treated by avoiding foods that contain gluten from the diet. This avoids damage to the lining of the intestines and the related symptoms, such as diarrhea and stomach pain. Gluten is a protein found naturally in certain grains such as wheat, barley, and rye. Gluten is also added to numerous other foods and products. In people with celiac disease, consuming gluten triggers an abnormal immune system reaction that causes the small intestine to become sick.

Regular Gluten-free Diet - All individuals with celiac disease are advised to adhere to regular gluten-free diet food. On a gluten-free diet, symptoms of gluten allergy typically get better after a few days or weeks. A strict, lifetime gluten-free coeliac disease diet is the only way to manage celiac disease. Besides wheat, gluten-free food options are.

Barley, bulgur, durum, farina, graham flour, malt, rye, and semolina. Removing gluten from the diet typically reduces inflammation in the small intestine, causing it to feel better and eventually heal. Children recover more quickly than adults.

The public has become more aware of gluten-free goods (GFPs) over the past few decades. This is most likely because of the general belief that eating a gluten-free (GF) diet has health benefits, and since GFPs are currently commonly used by people who do not have GRDs. The below table highlights the market players and the products they produce -

Vitamin and mineral supplements - If anemia or nutritional deficiencies are severe, supplements are recommended, including copper, folic acid, iron, vitamin B-12, vitamin D, vitamin K, and zinc. Vitamins and supplements are usually taken in tablet form. If the digestive tract has trouble absorbing vitamins, it might be able to get them by injection.

For those with celiac disease who are reluctant to absorb nutrients from their diet, Inovera Bioscience's - Forvia is one of the best multivitamins available. It is made to be gentle to the digestive system and is available in chewable and tablet form.

Medications - To control intestinal inflammation, if the small intestine is severely damaged or has refractory celiac disease, steroids are recommended to control inflammation. Steroids ease severe symptoms of gluten intolerance of celiac disease while the intestine heals. Other drugs, such as azathioprine (Azasan, Imuran) and Budesonide (Entocort EC, Uceris), are used. Medication excipients might involve gluten. The binders that keep medication together are called excipients. To ensure that their drugs are gluten-free, it is crucial for individuals with celiac disease to collaborate with their physician or pharmacist.

It is controversial how to treat patients whose duodenal biopsies reveal no abnormalities but who have positive serology. There are numerous situations where the celiac disease diagnosis is unclear. Some patients have pertinent symptoms even though a tiny gut sample reveals no abnormalities. Seronegative celiac disease also exists. This name refers to the opposite scenario, where there is considerable villous atrophy of duodenal biopsies but no serological evidence of the disease despite typical symptoms.

As of now, a gluten-free diet is the sole recommended course of treatment for celiac disease. This is difficult to sustain and has a big influence on the lives of those who are impacted. Research into non-dietary celiac treatment that might help celiac disease sufferers tolerate gluten is ongoing. Immune modulators are one of the primary subjects of this field's research. Alternative strategies, including as vaccinations or the consumption of chemicals that alter the toxicity of gluten, are also being investigated. None have, however, advanced to the point where they are suggested or authorized for this kind of treatment.

A tiny proportion of celiac disease patients benefit from corticosteroids.

Treatment Market Players:



Healthy Life Pharma Pvt Ltd


Rashe Lifesciences Pvt. Ltd

AZR 500



Bausch Health Companies Inc.





Zymurine 50mg


Azapure 50mg

Tillotts Pharma


Cosmo Pharmaceuticals NV.





Regulatory Assessment:

The FDA published a final regulation on August 12, 2020, regarding the labelling of fermented or hydrolysed goods as gluten-free. This includes foods like yogurt, sauerkraut, pickles, cheese, green olives, wines, and beers authorized by the FDA (usually less than 7 percent alcohol), and hydrolyzed plant proteins that are added to processed foods like soups, sauces, and seasonings to enhance their flavor or texture. The rule creates compliance standards for these fermented and hydrolyzed foods, but it does not modify the definition of "gluten-free." It also talks about how the FDA will check for compliance with distilled goods like vinegar.

However, a GFD may not result in clinical or histological improvement, and some patients may have difficulty adhering strictly to a GFD for other reasons. Despite this, there are currently no FDA-approved drugs for the treatment of Celiac Disease.

Clinical Trial Assessment:

The crucial role of clinical trials in the practice of evidence-based medicine and health care reform is highlighted by the government's increasing concentration on comparing the effectiveness of studies. One of the main goals of reforming healthcare is achieved by the market participants accurately examining medical therapy with the use of clinical data.

The below table shows the name of the study title ongoing in phases.

Phase 1

Phase 2

Phase 3

Phase 4

Use of an Orally Administered Antibody to Gluten to Prevent the Recurrence of Symptoms and Laboratory Parameters in Persons with Celiac Disease (Gluten-Sensitive Enteropathy)

A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants with Celiac Disease

Protocol for Correlating Enteropathic Severity and Small Intestinal CYP3A4 Activity in Patients with Celiac Disease

Effect of Intravenous Iron Supplementation on Celiac Disease Remission in Patients with Iron Deficiency and Intestinal Villous Atrophy: a Randomized Trial

A Phase 1B Open-label/Phase 2 Double-blind Placebo-Controlled Study for Pharmacodynamic (PD) Activity, Pharmacokinetics (PK), Safety, and Tolerability of KAN-101 In Patients with Celiac Disease (CeD

A Double-blind, Randomized, Placebo-controlled, Phase 2a Study to Evaluate the Safety, Tolerability, and Pharmacodynamic (PD) Effects of Two Infusions of Escalating Doses of TPM502 in Adults Diagnosed with Celiac Disease

Effect of Addition of Short Course of Prednisolone to Gluten Free Diet and Gluten Free Diet Alone in the Recovery of Clinical, Histological and Immunological Features in Naive Adult Patients with Celiac Disease

Celiac Disease and Vitamin Status: Evaluation of the Effect of Supplementation with a Probiotic (VIVOMIXX®) on Vitamin B6, B12, 25'OH D, Folic Acid and Omocystein Levels, Metabolic and Inflammatory Status, and Gut Microbiota Metabolomics in a Cohoort of Celiac Patients

A Phase 1b Study of PTG-100 in Patients with Celiac Disease

A Phase 1B Open-label/Phase 2 Double-blind Placebo-Controlled Study for Pharmacodynamic (PD) Activity, Pharmacokinetics (PK), Safety, and Tolerability of KAN-101 In Patients with Celiac Disease (CeD)

Assessment of the Effect of Gluten-Free Toothpaste on Ulcerative Events in Children with Celiac Disease (Before and After Pilot Study)

Pilot Study of the Efficacy of Pancreatic Enzyme Supplementation for Symptom Control in Celiac Disease Not Responding to the Gluten-Free Diet

A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Patients with Celiac Disease (ACeD)

A Probiotic Blend in the Improvement of Gastrointestinal Symptoms and Life Quality in Patients with Celiac Disease

Double Blind Randomized Placebo Controlled Multicentre Trial (Gluten vs Placebo) in Gluten Sensitive Subjects

Effect of the Endopeptidase AN-PEP on Gluten Exposure in Real Life in Celiac Disease Patients Treated with a Long-term Gluten-Free Diet. Exploratory, Interventional, Prospective, Controlled, and Double-Blind Study

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Biomarkers of DONQ52 in Celiac Disease Patients (LILY Study)

A Phase 2a, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of 6-weeks Treatment with ALV003 In Patients with Well-Controlled Celiac Disease

A Randomized, Triple-Blinded Study of Endoscopic Ultrasound-Guided Celiac Plexus Blockade (EUS-CPB) With Bupivacaine and Triamcinolone vs. Bupivacaine Alone for the Treatment of Pain in Chronic Pancreatitis

Does Bowel Preparation (Either as a Single or Divided Dose) Produce Better Cleansing and Diagnostic Yield Than no Preparation at All in Small Bowel Capsule Endoscopy



DiseaseLandscape Insights (DLI) gives important stakeholders in the development of novel diagnostic kits and the introduction of treatment solutions a critical piece of information and data. Nonetheless, there is a rise in demand for novel detection methods, other forms of treatment, and the development of vaccines because of growing public knowledge of gluten disease and outbreaks of Celiac Disease.

DiseaseLandscape Insights provides stakeholders with guidance on patient recruiting tactics, regulatory compliance, and the simple setup of clinical trials for innovative celiac disease therapies. Additionally, DLI helps with the analysis of global regulations, competition in the diagnosis and treatment market, and industry participant expectations for market growth.

This enables market leaders to conduct focused research and development, find sources of raw materials, research contract manufacturing companies, and ensure legal compliance for the company. DiseaseLandscape Insights (DLI) helps all market players have a better foothold in the celiac disease industry.

Vishal SawantBusiness Development

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