Celiac Disease Drugs Market to Reach USD 4.92 Billion by 2034

Pune, India, November 2025 - According to a recent report published by Exactitude Consultancy, the global Celiac Disease Drugs Market is projected to reach USD 4.92 billion by 2034, growing at a CAGR of 16.5% from 2025 to 2034. The market's momentum is fueled by rising global awareness of gluten intolerance, ongoing advancements in non-dietary therapies, and the increasing prevalence of autoimmune and gastrointestinal disorders.

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Key Takeaways
• The global celiac disease drugs market was valued at USD 1.16 billion in 2024.
• North America dominates the market, accounting for over 40% of the global share, followed by Europe.
• Oral therapeutics remain the preferred drug form, offering improved patient compliance.
• Major companies operating in the market include Takeda Pharmaceutical Company Ltd., ImmunogenX Inc., 9 Meters Biopharma Inc., Amgen Inc., and Glutenostics LLC.
• Development of enzymatic therapies, peptide-based drugs, and immune-modulating agents is driving future growth.

Market Story
Celiac disease, an autoimmune disorder triggered by gluten ingestion, affects millions of people globally. Traditionally managed through a lifelong gluten-free diet, treatment gaps have spurred pharmaceutical companies to develop targeted drug therapies that minimize immune response and intestinal damage.

Emerging drug classes-such as tight junction modulators, glutenases, and immunotherapies-are showing significant promise in clinical trials. Increasing collaborations between biopharma companies and research institutions are also accelerating the clinical pipeline. In addition, enhanced diagnostic screening programs and patient awareness initiatives are expanding the diagnosed population base, supporting drug adoption globally.

Market Segmentation
By Drug Type:
• Enzyme Therapy
• Immunomodulators
• Gluten Absorbents
• Anti-inflammatory Drugs
• Others

By Route of Administration:
• Oral
• Parenteral

By Distribution Channel:
• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region:
• North America (U.S., Canada)
• Europe (Germany, UK, France, Italy, Spain)
• Asia-Pacific (China, Japan, India, South Korea, Australia)
• Latin America (Brazil, Mexico)
• Middle East & Africa

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Recent Developments
• 2025: Takeda Pharmaceutical initiated late-stage clinical trials for TAK-101, a novel immune tolerance therapy for celiac disease.
• 2024: ImmunogenX Inc. received fast-track designation from the U.S. FDA for latiglutenase, an oral enzyme therapy.
• 2023: 9 Meters Biopharma Inc. launched new clinical data supporting larazotide acetate for celiac disease symptom management.
• 2022: Amgen Inc. announced collaboration with Glutenostics LLC for biomarker-based diagnostic-drug integration.

Expert Insight
"Celiac disease treatment is shifting from dietary restriction to targeted medical intervention," said Irfan Tamboli, Business Development Executive at Exactitude Consultancy. "As advanced immunotherapies and enzyme-based drugs enter late-stage trials, the market is poised for rapid adoption over the next decade."

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Market Drivers
1. Growing prevalence of celiac disease and gluten sensitivity worldwide.
2. Advancements in enzyme-based and peptide-targeted drug development.
3. Rising awareness and diagnostic rates in both developed and emerging markets.
4. Strategic collaborations between pharmaceutical firms and research institutes.

Forecast & Regional Insights
The North American market leads the industry, supported by high diagnostic rates and strong R&D investments in the U.S. and Canada. Europe follows closely, benefiting from established patient registries and robust healthcare systems. Meanwhile, Asia-Pacific is projected to exhibit the fastest CAGR (18.2%) due to growing awareness, changing dietary habits, and government-led screening initiatives in India, Japan, and Australia.

Conclusion
The Celiac Disease Drugs Market is entering a transformative phase marked by scientific innovation and increased patient-centric care. As drug developers focus on immune tolerance and enzyme-based therapies, the next decade promises more effective, accessible treatment options for millions affected by gluten-related disorders.

This report is also available in the following languages : Japanese (セリアック病治療薬), Korean (셀리악병 치료제), Chinese (乳糜泻药物), French (Médicaments contre la maladie cœliaque), German (Zöliakie-Medikamente), and Italian (Farmaci per la celiachia), etc.

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