Celiac Disease Drug Market Size, Share, and Industry Analysis by Drug Class (NSAIDs, Corticosteroids, TNF-? Inhibitors, and Others), By Disease Type (Classical, Non-Classical, and Others), By Route of Administration (Oral and Parenteral), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and Regional Forecast, 2025-2032

The global celiac disease drug market is increasing rapidly due to a rise in awareness regarding gluten intolerance. Industries are able to progress due to an upswing in the prevalence of celiac disease and other related diseases. Celiac disease is a serious genetic autoimmune condition characterized by the destruction of the villi in the small intestine. Severe inflammation can lead to ulcers in the small intestine, leading to the impaired absorption of nutrients from ingested food.

• According to a 2022 article published by the National Center for Biotechnology Information (NCBI), the occurrence of celiac disease in the general population ranges from 0.5% to 1%. Both the actual prevalence and capability in terms of the detection and the diagnosis of the disease have shown an increase over the past few years.

Celiac Disease Drug Market Driver

Increasing Prevalence of Celiac Disease Among the Population to Boost the Demand for Drugs

Some of the factors contributing to the growth of the market include the increasing prevalence of celiac disease among the population globally coupled with the growing diagnosis of the condition and associated treatment rates in the developed countries. Celiac disease can develop at any stage of an individual’s life, which includes the geriatric stage of the life. This condition is prevalent in the global population, with estimates indicating a prevalence of up to 1%.

• According to a 2023 report published by Coeliac UK, an England-based charitable organization, celiac disease affects around 1 in 100 people in the U.K. and in Europe and around 36% of the patient population is clinically diagnosed with the condition.

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According to several sources including Beyond Celiac, Coeliac UK, the Journal of Gastroenterology, the estimated prevalence of celiac disease across the key countries ranges from 0.05% - 1.6% in general population in 2023.

Celiac Disease Drug Market Restraint

Limited Awareness of Disease Among Population in Emerging Countries Hinders Market Growth

The limited awareness of celiac disease and the delays in terms of diagnosis among the developing countries such as India, China, Brazil, and others are some of the major factors responsible for a lower rate of treatment among these countries. Such factors severely limit the high growth potential of the market.

• According to a 2021 study, which included 350 respondents published by NCBI, less than 15% of the respondents were aware of celiac disease in the country of Kuwait. The limited awareness indicates the need to educate and promote initiatives to improve the uptake of screening services and timely diagnoses and treatment. 

Celiac Disease Drug Market Opportunity

Rising R&D Initiatives to Fare well for Industry Expansion

The celiac disease drug market is advancing through several research and development initiatives and is actively exploring the development of innovative therapeutic medications. The growing efforts of national organizations, companies, and government agencies to boost funding and support the R&D activities is expected to present lucrative opportunities for market growth.

• In 2020, the U.S. Congress showed support for research and development efforts aimed at providing effective treatment for celiac disease. This landmark initiative has the potential to impact and significantly bolster the celiac disease market.

Key Insights

• Prevalence of Celiac Disease, By Key Countries, 2023
• New Product Launches, By Key Players
• Pipeline Analysis, By Key Players
• Key Industry Development (Mergers, Acquisitions, & Partnerships)
• Impact of COVID-19 on the Market

Segmentation

Analysis by Drug Class

Based on drug class, the market for celiac disease drug is divided into NSAIDs, corticosteroids, TNF-α inhibitors, and others.

The corticosteroids segment is anticipated to hold a considerable share of the global market. Corticosteroids are the predominant pharmacological agents utilized in the management of celiac disease. They also mitigate inflammation by enhancing the capillary permeability and concurrently suppressing (PMN) activity. The rising focus on updating treatment guidelines to improve the care delivered to patients is another major factor contributing to the growing demand for corticosteroids.

• According to 2022 clinical updates published by the American Gastroenterological Association (AGA), corticosteroids should be used as the first-line therapy in patients suffering from any form of celiac disease.

Analysis by Route of Administration

Based on the route of administration, the market for celiac disease drug is segmented into oral and parenteral.

The oral segment is anticipated to grow at a substantial CAGR during the forecast period. The oral route of drug administration is widely recognized for its convenience, cost-effectiveness, and safety. Additionally, the growing focus of companies on the development and introduction of novel therapies for the condition is another major factor expected to support the growth of the segment.

• Entero Therapeutics, Inc., is currently developing a first-in-class oral drug, latiglutenase, for the treatment of celiac disease. The drug has demonstrated efficacy in the alleviation of the GI symptoms of the celiac disease and preventing or improving the intestinal damage in Phase 2 trials.

Analysis by Disease Type

On the basis of disease type, the market for celiac disease drug is categorized into hospital pharmacies, retail pharmacies, and online pharmacies.

The increasing incidence of classical celiac disease worldwide is a significant factor contributing to the expanding patient population with this condition. This growing patient pool is driving the rising demand for effective treatment to manage the symptoms and complications associated with classical celiac disease. As the prevalence of the classical disease continues to rise globally, the need for accessible and efficient treatment options becomes more pressing to address the health concerns of these.

• According to a 2022 article published by Scientific Research, among 128 cases of celiac disease, around 66% of them were classical.

Regional Analysis

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Based on region, the market for celiac disease drug has been studied across North America, Asia Pacific, Europe, Latin America, and the Middle East & Africa.

North America dominated the market in 2023. The primary factor contributing to the dominance is the rising prevalence of the condition among the population in the countries such as the U.S. and Canada. Along with this, the growing focus of the market players on the development and introduction of the novel therapeutics for the treatment of the condition is another factor supporting the growth of the region.

• According to a 2018 report published by the Canadian Digestive Health Foundation, it is estimated that nearly 1.0% of the population in Canada is affected by celiac disease.

The growing awareness regarding the condition, early diagnosis and treatment of celiac disease among the population in the U.K., France, and others contributes to the growth of the market in the region.

• In 2020, according to an article published by the Celiac Disease Foundation, the prevalence of celiac disease has been on the rise in Europe, exceeding 12.7 per 100,000 people. This increase has prompted advances in research and development, with 34 clinical trials currently underway to provide the proper treatment for celiac disease.

The rising incidence of celiac disease and improved diagnosis rates in the Asia Pacific region have led to more people seeking treatment.

• In November 2023, a Queensland-based biotechnology startup, in collaboration with the Australian researchers, is developing and planning to commercialize a novel blood test that measures rare T-cells in the immune system that specifically respond to gluten, which is the cause of celiac disease. This breakthrough has significantly increased the diagnosis rate in the Asia Pacific region.

Key Players Covered

The global celiac disease drug market is fragmented, with a large number of pipeline product portfolios and various generic drugs.

• Takeda Pharmaceutical Company Limited (Japan)
• Dr. Falk Pharma GmbH (Germany)
• ZEDIRA GmbH (Germany)
• Entero Therapeutics, Inc. (U.S.)
• Immunic Therapeutics (U.S.)
• Topas Therapeutics (U.S.)
• Anokion SA (Switzerland)
• Nemysis Ltd  (Ireland)
• Allero Therapeutics B.V.​ (Netherlands)

Key Industry Developments

• In March 2024, the Phase 3 clinical development plan for latiglutenase was reviewed by the GI Division of the U.S. Food and Drug Administration (FDA). Entero Therapeutics is currently in the process of developing latiglutenase as an orally administered, recombinant digestive enzyme therapy. This therapy is intended to address celiac disease as an adjunct to a gluten-free diet.
• In October 2023, Immunic, Inc. announced the results from its phase 1b clinical trial of IMU-856 in celiac disease, showing positive effects; IMU-856 was also found to be safe and well tolerated, with pharmacokinetics.
• In October 2022, Zedira, Dr. Falk Pharma GmbH, and Takeda announced a collaboration to develop ZED1227/TAK-227, which is a potential Phase 2b therapy for the treatment of the celiac disease. This treatment aims to benefit the patients experiencing symptoms and ongoing intestinal injury despite maintaining a gluten-free diet.