Celiac Disease Treatment Market Set for Robust Growth Through 2034, Driven by Recent M&A and Advancing Clinical Development Pipeline | DelveInsight

The celiac disease treatment market is experiencing significant expansion, driven by increasing disease awareness, rising prevalence, and breakthrough therapies from key pharmaceutical players, including Entero Therapeutics, Amgen/Provention Bio, Takeda, and Sanofi, among others.

DelveInsight's "Celiac Disease Market Insight, Epidemiology And Market Forecast - 2034" report delivers an in-depth understanding of the celiac disease treatment market, historical and forecasted epidemiology, as well as market trends across the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The report comprehensively evaluates the current treatment landscape, emerging therapies, market share of individual treatments, and celiac disease market forecasts through 2034, providing crucial insights for stakeholders in the celiac disease therapeutic area.

According to DelveInsight's analysis, the United States held the largest share of the celiac disease drugs market in 2023, accounting for approximately 70% of the total market across 7MM. The market in Japan was valued at approximately USD 1.5 billion, demonstrating significant regional market potential. The celiac disease market is set for notable growth, fueled by rising awareness, better diagnostics, and increasing celiac disease prevalence.

The market expansion is further driven by enhanced understanding of celiac disease mechanisms, patient-centric therapeutic trial approaches, and the urgent need for advanced treatment options beyond traditional gluten-free diet management.

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Celiac disease is an autoimmune disorder where ingestion of gluten triggers an immune response that damages the small intestine's lining. It affects approximately 1 in 100 people worldwide, yet only about 30% are properly diagnosed. The disease predominantly impacts females and is most commonly diagnosed in individuals aged 19-39, emphasizing the need for timely detection and management. In Germany, approximately 60% of diagnosed cases are female, highlighting the gender-specific prevalence patterns across different regions.

The DelveInsight report categorizes the celiac disease patient population into several main groups for analysis, including total prevalent population, total diagnosed prevalent population, gender-specific cases, age-specific cases, and type-specific prevalent population. In 2023, classical celiac disease comprised about 30% of all celiac disease cases in Japan, demonstrating regional variations in disease presentation. This classification is essential for understanding the distribution, progression, and treatment responses of different celiac disease types, which is crucial for accurate epidemiological assessment.

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The DelveInsight report further analyzes the current and emerging celiac disease treatment landscape. Currently, there are no FDA-approved celiac disease therapies. The cornerstone of celiac disease management remains a strict, lifelong gluten-free diet, which is essential for alleviating symptoms, promoting intestinal healing, and preventing long-term complications. For patients experiencing celiac crisis or refractory celiac disease type II (RCD II), short-term use of corticosteroids like prednisolone may provide relief until the gluten-free diet becomes effective. Additional treatment options for both RCD I and RCD II include Budesonide, systemic corticosteroids, 6-mercaptopurine, cladribine, mesalamine, mycophenolate mofetil, and methotrexate.

Despite adherence to a gluten-free diet, approximately 5% of celiac disease patients continue to suffer from symptoms, underscoring the urgent need for advanced treatment options and further research. This significant unmet medical need has created substantial opportunities for pharmaceutical companies to develop innovative therapies that can address the limitations of current treatment approaches.

According to the DelveInsight report, the celiac disease therapies pipeline is robust and promising, with several novel treatments in late-stage development. Leading companies are focused on adopting a patient-centric approach to therapeutic trials, aiming to enhance patient involvement while ensuring scientific rigor in the development of new treatments.

Notable drugs in development include Latiglutenase from Entero Therapeutics (formerly First Wave BioPharma); TAK-101, TAK-227, and Zamaglutenase from Takeda, as well as PRV-015 (Provention Bio/Sanofi) and KAN-101 (Kanyos Bio/Anokion), among others. Each of these therapeutic candidates represents a different mechanistic approach to addressing the complex pathophysiology of celiac disease.

Therefore, the DelveInsight report shows that the celiac disease treatment market is highly competitive, with major players including Entero Therapeutics, Amgen/Provention Bio, Takeda, and Sanofi, all advancing a variety of therapies through robust R&D and strategic collaborations. These companies are at the forefront of improving the treatment landscape and developing more effective therapies for celiac disease, promising new hope for better management and outcomes.

The celiac disease treatment landscape has witnessed significant advancements in 2025, reflecting growing momentum toward alternatives to the traditionally restrictive gluten-free diet.

In October 2025, Barinthus Biotherapeutics and Clywedog Therapeutics entered into a merger agreement to form the combined company Clywedog Therapeutics, which will have a strong focus on advancing clinical candidates targeting celiac disease.

In September 2025, updated guidelines from the European Society for the Study of Coeliac Disease (ESsCD) were released, enhancing best practices for adult CeD diagnosis. Additionally, a new class of immunotherapy, VTP-1000 (Barinthus Biotherapeutics), is being trialed in the US via a Phase 1 study to help celiac patients develop tolerance to gluten using nanoparticles and rapamycin.

Furthermore, in August 2025, Topas Therapeutics GmbH initiated a Phase 2a study of TPM502, testing its safety and tolerability in adults diagnosed with celiac disease. Additionally, Sanofi announced a new Phase 2a/b, randomized, double-blind, placebo-controlled, parallel-group study of amlitelimab in adults with non-responsive celiac disease in the same month.

In June 2025, the TEV-CeD2 Study, a phase 2 clinical trial of TEV-53408 for celiac disease, was announced, marking an important step toward new therapeutic options and confirming the drug's momentum after Fast Track designation.

In May 2025, ZymagenX was launched as the successor to ImmunogenX to continue developing latiglutenase, now gearing up for a Phase III trial with active preparations in drug manufacturing and FDA protocol alignment. Around the same time, in May, Teva Pharmaceuticals received FDA Fast Track designation for TEV-53408, an anti-IL-15 monoclonal antibody aimed at reducing intestinal damage in patients on a gluten-free diet. Furthermore, Topas Therapeutics shared positive Phase IIa data for TPM502 at Digestive Disease Week in the same month, showing significant, dose-dependent immunomodulation of gluten-specific CD4+ T cells and symptom reduction following gluten challenge.

In March 2025, the FDA approved GlutenID, an over-the-counter genetic test that identifies individuals at risk for celiac disease. Anokion also contributed to the momentum with a January 2025 announcement of promising results from its Phase IIACeD-it trial of KAN-101, which demonstrated clinically meaningful symptom relief across multiple celiac-specific measures, marking the first symptomatic proof of concept for an immune tolerance therapy.

These developments collectively signal a shift toward more effective, immune-targeted therapies and improved patient screening tools in celiac disease care.

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Looking ahead, the celiac disease market is expected to witness continued innovation driven by enhanced understanding of disease pathogenesis, which involves a complex interaction between genetic factors, particularly HLA-DQ2 and HLA-DQ8 haplotypes, and environmental triggers. The market growth is further supported by DelveInsight's comprehensive qualitative analysis using SWOT analysis and conjoint analysis approaches, evaluating multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.
As research continues and awareness grows, the celiac disease market is poised for remarkable expansion and therapeutic innovation in the coming decade.

Related Reports:
Celiac Disease Pipeline Insight [https://www.delveinsight.com/sample-request/celiac-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=xpr]

Celiac Disease Pipeline Insight provides comprehensive insights about the Celiac Disease pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the Celiac Disease companies, including Sanofi, Entero Therapeutics, Takeda, Pfizer, Topas Therapeutics, Anokion SA, Protagonist Therapeutics, Equillium, AMYRA Biotech AG, Forte Biosciences, LAPIX Therapeutics, Ahead Therapeutics, Lumen Bioscience, and IGY Life Sciences, among others.

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About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

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