United States Food Celiac Disease Drugs Market 2031 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

The Global Celiac Disease Drugs Market is estimated to reach at a CAGR of 8.28% during the forecast period (2024-2031).

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Key Development:

United States: Recent Celiac Disease Drug Developments

✅ In December 2025, Barinthus Biotherapeutics announced positive early results from its first‐in‐human Phase 1 AVALON trial of VTP‐1000, an antigen‐specific immunotherapy for celiac disease; the single ascending dose portion showed a dose‐dependent pharmacological effect and was well‐tolerated, with the multiple ascending dose phase (including gluten challenge) ongoing.

✅ In May 2025, the FDA granted Fast Track designation to TEV‐53408, an investigational anti‐IL‐15 monoclonal antibody from Teva Pharmaceuticals aimed at reducing gluten‐induced intestinal damage in adults with celiac disease, accelerating its development and review.

Japan: Celiac Disease Drug Developments

✅ In November-December 2025, global clinical pipeline reports highlighted that innovative therapeutic candidates for celiac disease including immunotherapies, cytokine inhibitors and regulatory‐tolerance approaches continue advancing internationally, and Japanese researchers and companies remain part of broader collaborative research on next‐gen therapies.

✅ In November-December 2025, industry overviews showed that research across Asia‐Pacific including Japan is gaining traction with enhanced clinical research infrastructure and rising awareness of celiac and related autoimmune disease treatment needs, potentially supporting future Japan‐led trials and drug development.

✅ In 2025 (ongoing), Japanese pharmaceutical R&D groups have ongoing exploratory work on novel immune‐modulating therapies and protein‐targeted approaches relevant to autoimmune conditions like celiac disease, suggesting early‐stage research activity may translate into future clinical programs.

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Europe : Recent Celiac Disease Drug Developments

✅ In December 2025, multiple companies are advancing innovative therapeutic candidates including immunotherapies, cytokine inhibitors, enzyme therapies, and regulatory‐tolerance approaches broadening the treatment landscape for celiac disease beyond strict gluten avoidance.

✅ In November 2025, pipeline overviews indicated a diverse clinical ecosystem involving novel mechanisms (anti‐IL‐15, regulatory T‐cell approaches, transglutaminase inhibitors and more), signaling that international research toward disease‐modifying therapies is expanding across regions including Europe, Asia‐Pacific and North America.

Key Players:

=> Innovate Biopharmaceuticals, Teva Pharmaceutical Industries Ltd, ImmunogenX, LLC, Amgen, ChemoCentryx, Inc, Anokion SA, COUR Pharmaceutical, F. Hoffmann-La Roche Ltd, ImmusanT, Inc, BioLineRx Ltd, and Takeda Pharmaceutical Company Limited, among others.

Key Segments:

By Enzyme Type

Distension - 20% share, targeting bloating and digestive discomfort.
Diarrhea - 15% share, key segment for gastrointestinal disorder management.
Anorexia - 10% share, relevant in appetite-stimulating therapies.
Bloating - 12% share, driven by lifestyle and digestive health concerns.
Gas - 8% share, common symptom-focused treatment.
Fatigue - 5% share, associated with enzyme deficiencies affecting energy metabolism.
Others - 30% share, including multi-symptom enzyme therapies and rare digestive disorders.

By Drugs

First Line of Treatment - 60% share, includes primary enzyme therapies prescribed initially for digestive disorders.
Second Line of Treatment - 40% share, used when initial treatments are ineffective or for severe conditions.

By Distribution Channel

Hospitals - 40% share, major segment for severe or inpatient enzyme therapies.
Research Centers - 10% share, primarily for clinical trials and new enzyme development.
Clinics - 35% share, focus on outpatient treatment and routine digestive care.
Others - 15% share, includes online pharmacies, specialty stores, and home healthcare delivery.

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By Region

North America - 35% Share
Driven by high awareness of digestive health and advanced healthcare infrastructure.

Europe - 25% Share
Regulatory approvals and presence of specialized clinics drive market growth.

Asia Pacific - 20% Share
Rapid adoption due to increasing digestive health concerns and healthcare access.

South America - 10% Share
Emerging opportunities in urban healthcare and digestive disorder treatments.

Middle East & Africa - 10% Share
Growth driven by awareness programs and improved hospital and clinic infrastructure.

FAQ

Q: What is the growth rate of the Celiac Disease Drugs Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 8.28% during the forecast period from 2024 to 2031.

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