Celiac Disease Market Analysis 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Statistics, Revenue, Prevalence, Medication, Treatment Market and Companies by DelveInsight

Celiac Disease Companies working in the treatment market are 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
(Albany, USA) 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.

The Celiac Disease market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Celiac Disease market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Celiac Disease treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Celiac Disease market.

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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 May 2025, Teva Pharmaceutical Industries, Ltd. (NYSE and TASE: TEVA) today announced that the US Food and Drug Administration (FDA) granted Fast Track designation for investigational TEV-53408, an anti-IL-15 antibody, for the treatment of people with celiac disease on a gluten-free diet. TEV-53408 is currently being evaluated in a Phase 2a trial to assess the efficacy and safety in adults with celiac disease.
* In March 2025, Barinthus Biotherapeutics plc (NASDAQ: BRNS) has entered 2025 with a renewed strategic focus on immunological and inflammatory diseases. Following its restructuring, the company is well-positioned to advance its lead asset, VTP-1000, along with the SNAP-TI platform, for the treatment of celiac disease. With innovative design features that enhance antigen targeting, allow intramuscular administration, and potentially improve tolerability, VTP-1000 has the potential to become a leading therapy for the approximately 80 million people worldwide affected by celiac disease.
* In February 2025, PhaseV, a leader in software and machine learning (ML) 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 for various GI conditions, including inflammatory bowel disease (IBD), celiac disease, eosinophilic gastrointestinal disease (EGID), and other related disorders.
* 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 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. Celiac Disease causes an immune response that damages the lining of the small intestine, leading to malabsorption of essential nutrients. Celiac Disease affects both children and adults and can present with a wide range of gastrointestinal and non-gastrointestinal symptoms.

Celiac Disease symptoms commonly include abdominal pain, bloating, diarrhea, constipation, fatigue, weight loss, and nutrient deficiencies. Celiac Disease may also manifest through skin rashes, neurological issues, anemia, osteoporosis, and infertility in some individuals. Celiac Disease is strongly associated with genetic factors, particularly the HLA-DQ2 and HLA-DQ8 genes.

Celiac Disease diagnosis involves a combination of serologic testing for specific antibodies and confirmation through a small intestinal biopsy. Celiac Disease management requires a strict lifelong gluten-free diet, which helps in healing the intestinal lining and preventing further complications. Celiac Disease patients must avoid even trace amounts of gluten to maintain health and prevent flare-ups.

Celiac Disease awareness and early detection are crucial to preventing long-term health consequences. Celiac Disease research continues to explore potential therapies beyond dietary management, including enzyme treatments and immune-modulating agents to improve patient outcomes.

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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

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

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