Celiac Disease Market Expected to Experience Major Growth by 2034, According to DelveInsight | Zedira, Dr. Falk Pharma, Takeda, ImmunoGenX, Provention Bio, Sanofi, Topas Therapeutics GmbH, Pfizer

DelveInsight's "Celiac Disease Market Insights, Epidemiology, and Market Forecast-2034′′ report offers an in-depth understanding of the Celiac Disease, historical and forecasted epidemiology as well as the Celiac Disease market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

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Some of the key facts of the Celiac Disease Market Report:
• The Celiac Disease market size is anticipated to grow with a significant CAGR during the study period (2020-2034).
• In June 2025, Forte Biosciences, Inc. (NASDAQ: FBRX), a clinical-stage biopharmaceutical company specializing in autoimmune and related disorders, has reported positive results from a Phase 1b trial of its lead candidate, FB102 (study FB102-101), in celiac disease.
• In May 2025, Teva Pharmaceutical Industries, Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug TEV-53408, an anti-IL-15 antibody, for the treatment of celiac disease in patients adhering to a gluten-free diet. TEV-53408 is currently undergoing evaluation in a Phase 2a clinical trial to determine its safety and effectiveness in adults with celiac disease. The FDA's Fast Track program aims to speed up the development and review of therapies for serious conditions with significant unmet medical needs.
• In February 2025, PhaseV, a leader in software and machine learning (ML) solutions for clinical trial optimization, announced a strategic partnership with Alimentiv Inc., a global gastrointestinal (GI) contract research organization (CRO). This collaboration aims to enhance the design and execution of advanced adaptive clinical trials targeting various GI disorders, including inflammatory bowel disease (IBD), celiac disease, and eosinophilic gastrointestinal disease (EGID). By applying adaptive trial methodologies, the partnership seeks to boost trial efficiency and improve patient outcomes, ultimately accelerating the development of innovative therapies for individuals suffering from these complex GI conditions.
• In October 2024, Topas Therapeutics reported positive topline results from its Phase IIa trial of TPM502 in celiac disease patients. The findings provide the first clinical proof of concept for the company's proprietary nanoparticle platform, highlighting its potential to induce targeted, antigen-specific tolerogenic effects.
• In September 2024, Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies that direct T cells to manage diseases, has commenced its first-in-human Phase 1 trial of VTP-1000 in adults with celiac disease. This randomized, placebo-controlled study, incorporating a controlled gluten challenge, aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of VTP-1000.
• In May 2024, Entero Therapeutics, Inc. (previously known as First Wave BioPharma, Inc.) has introduced its new corporate identity and website. This rebranding comes after its recent merger with ImmunogenX and underscores the company's commitment to tackling unmet needs in gastrointestinal health, including celiac disease, a condition that currently lacks approved treatments.
• In March 2024, First Wave BioPharma completed an all-stock acquisition of ImmunogenX, forming a unified entity aimed at advancing a gastrointestinal pipeline featuring several late-stage clinical assets, including latiglutenase. Additionally, the company revealed that two abstracts have been accepted for presentation at the 2024 Digestive Disease Week Conference (DDW 2024) in Washington.
• In 2023, the United States represented the largest portion of the celiac disease market among the 7MM, contributing roughly 70% to the overall market.
• Among the EU4 and the UK, Italy had the highest market valuation for celiac disease, estimated at around USD 200 million.
• At present, a gluten-free diet is the sole effective treatment for celiac disease, with the market in Japan valued at around USD 1,500 million in 2023.
• Celiac disease exhibits a significant gender imbalance, primarily affecting females. In Germany, for example, around 60% of diagnosed cases are female.
• In 2023, classical celiac disease accounted for approximately 30% of all celiac disease cases in Japan.
• According to the Beyond Celiac foundation (2024), approximately 1 in 133 Americans, or around 1% of the population, has celiac disease. It is also estimated that up to 83% of Americans with celiac disease remain undiagnosed or are incorrectly diagnosed with other medical conditions.
• According to Stahl et al. (2023), Celiac disease is a prevalent chronic condition globally, with an aggregated prevalence of 1.4%, though it can be significantly higher in specific regions. In a prospective birth cohort study involving infants at risk for celiac disease in Europe and the United States, the incidence was estimated to be 3% in Sweden and 2.4% in Colorado.
• According to the Celiac Disease Foundation, celiac disease is a significant autoimmune disorder estimated to impact 1 in 100 people globally. Additionally, 2.5 million Americans remain undiagnosed and are susceptible to potential long-term health issues.
• Key Celiac Disease Companies: Sanofi (Provention Bio), Zedira, Dr. Falk Pharma, Takeda, ImmunoGenX, Provention Bio, Sanofi, Topas Therapeutics GmbH, Pfizer, 9 Meters Biopharma, Inc., ChemoCentryx, BioLineRx, Ltd., and others
• Key Celiac Disease Therapies: PRV-015, TAK-227/ZED1227, Latiglutenase(IMGX003), Ordesekimab, TAK-101 and Zamaglutenase, TPM502, Ritlecitinib, TAK-062, larazotide acetate, CCX282-B, BL-7010, and others
• The Celiac Disease epidemiology based on gender analyzed that, females are affected more than males
• The Celiac Disease market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Celiac Disease pipeline products will significantly revolutionize the Celiac Disease market dynamics.

Celiac Disease Overview
Celiac disease is a chronic autoimmune disorder triggered by the ingestion of gluten, a protein found in wheat, barley, and rye. When individuals with celiac disease consume gluten, their immune system responds by damaging the lining of the small intestine, leading to malabsorption of nutrients and a range of symptoms.

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Celiac Disease Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Celiac Disease Epidemiology Segmentation:
The Celiac Disease market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
• Total Prevalent Population of Celiac Disease in the 7MM
• Total Diagnosed Prevalent Population of Celiac Disease in the 7MM
• Type-specific Prevalent Population of Celiac Disease in the 7MM
• Gender-specific Prevalent Population of Celiac Disease in the 7MM
• Age-specific Distribution of Celiac Disease in the 7MM

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Celiac Disease Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Celiac Disease market or expected to get launched during the study period. The analysis covers Celiac Disease market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Celiac Disease Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Celiac Disease Therapies and Key Companies
• PRV-015 : Sanofi (Provention Bio)
• TAK-227/ZED1227: Zedira, Dr. Falk Pharma, and Takeda
• Latiglutenase(IMGX003): ImmunoGenX
• Ordesekimab: Provention Bio/Sanofi
• TAK-101 and Zamaglutenase: Takeda
• TPM502: Topas Therapeutics GmbH
• Ritlecitinib: Pfizer
• TAK-062: Takeda
• larazotide acetate: 9 Meters Biopharma, Inc.
• CCX282-B: ChemoCentryx
• BL-7010: BioLineRx, Ltd.

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Celiac Disease Market Strengths
• The pipeline activity of Celiac Disease is quite efficient with the presence of variable key players such as First Wave BioPharma, Sanofi, Takeda, etc., which are efficiently involved in developing milestone treatment options.
• Latiglutenase has the potential to be a first to-market treatment for celiac disease, a GIdisorder that impacts approximately three million people in the US and for which no approved pharmacologic treatment currently exists.

Celiac Disease Market Opportunities
• Several organizations such as Celiac Disease Foundation, National Celiac Association (NCA), American Celiac Disease Alliance (Celiac Disease A), Coelic UK etc. are actively working to provide information and awareness of the disorder.
• There is ongoing research into celiac disease, including potential treatments and therapies. Individuals with celiac disease can contribute to this research by participating in clinical trials or fundraising for research organizations.

Scope of the Celiac Disease Market Report
• Study Period: 2020-2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Celiac Disease Companies: Sanofi (Provention Bio), Zedira, Dr. Falk Pharma, Takeda, ImmunoGenX, Provention Bio, Sanofi, Topas Therapeutics GmbH, Pfizer, 9 Meters Biopharma, Inc., ChemoCentryx, BioLineRx, Ltd., and others
• Key Celiac Disease Therapies: PRV-015, TAK-227/ZED1227, Latiglutenase(IMGX003), Ordesekimab, TAK-101 and Zamaglutenase, TPM502, Ritlecitinib, TAK-062, larazotide acetate, CCX282-B, BL-7010, and others
• Celiac Disease Therapeutic Assessment: Celiac Disease current marketed and Celiac Disease emerging therapies
• Celiac Disease Market Dynamics: Celiac Disease market drivers and Celiac Disease market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Celiac Disease Unmet Needs, KOL's views, Analyst's views, Celiac Disease Market Access and Reimbursement

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Table of Contents
1. Celiac Disease Market Report Introduction
2. Executive Summary for Celiac Disease
3. SWOT analysis of Celiac Disease
4. Celiac Disease Patient Share (%) Overview at a Glance
5. Celiac Disease Market Overview at a Glance
6. Celiac Disease Disease Background and Overview
7. Celiac Disease Epidemiology and Patient Population
8. Country-Specific Patient Population of Celiac Disease
9. Celiac Disease Current Treatment and Medical Practices
10. Celiac Disease Unmet Needs
11. Celiac Disease Emerging Therapies
12. Celiac Disease Market Outlook
13. Country-Wise Celiac Disease Market Analysis (2020-2034)
14. Celiac Disease Market Access and Reimbursement of Therapies
15. Celiac Disease Market Drivers
16. Celiac Disease Market Barriers
17. Celiac Disease Appendix
18. Celiac Disease Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

Related Reports:

Celiac Disease Pipeline https://www.delveinsight.com/report-store/celiac-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
"Celiac Disease Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Celiac Disease market. A detailed picture of the Celiac Disease pipeline landscape is provided, which includes the disease overview and Celiac Disease treatment guidelines.

Celiac Disease Epidemiology https://www.delveinsight.com/report-store/celiac-disease-epidemiology-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
DelveInsight's 'Celiac Disease Epidemiology Forecast to 2034' report delivers an in-depth understanding of the disease, historical and forecasted Celiac Disease epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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