Celiac Disease Treatment Market By Treatment Type (Drug Class {Immunosuppressants, Enzyme Replacement Therapy, Corticosteroids, Biologics, Others} Therapeutic Treatments, Dietary Management, Surgical Interventions), By Mode of Administration (Oral, Injectables, Topical), By End-User (Hospitals, Clinics, Home Care Settings), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The Celiac Disease Treatment market accounted for USD 0.88 Billion in 2024 and is expected to reach USD 3.0 Billion by 2035, growing at a CAGR of around 11.8% between 2025 and 2035.  The celiac disease treatment market understands the industry, which is involved in providing various therapies likely to manage or treat celiac disease, an autoimmune disorder caused by the reaction to gluten.

All available treatments may be given only in the form of a strict gluten-free diet. Immune tonics are new, while there are newer drugs in development targeting the mentioned causes with enzyme therapies. The market is growing, particularly due to market awareness, rising patterns of diagnosis, and research on the development of new treatments. Other considerations are also made, such as the advances in extending biopharmaceuticals as well as a new path for therapeutic approaches.

Report Scope:

Market Dynamics

The rising prevalence of celiac disease boosts treatment market demand globally.

The increasing diagnosis of celiac disease is creating a marked increase in global demand for celiac disease therapies as many more people are diagnosed with this autoimmune condition, which drives the celiac disease treatment market. Rise in awareness, technical progress in the diagnostic field, and better availability in medical care are resulting in increasing accuracy and speed in diagnosing processes, which, consequently, are attracting a higher number of patients to treatment. Currently, dietary treatment (i.e., the gluten-free diet) has been the only strategy used to treat the disease, but there is a pressing requirement for other therapeutic approaches that can ameliorate patients' quality of life and alleviate lifelong dietary restrictions.

With the increasing prevalence of celiac disease, especially in developed countries such as North America and Europe, healthcare systems face more pressure to offer comprehensive treatment solutions. Together with the rising number of clinical trials and advances in drug development, the globalization of awareness and expanding scientific evidence are transforming the celiac disease treatment landscape and driving market expansion.

Increasing awareness of gluten-related disorders fuels treatment innovations worldwide.

The celiac disease treatment market is growing due to the rising number of people diagnosed with the condition. Due to improved understanding, technological breakthroughs in diagnostics, and easier access to health services, more patients in need of treatment are leading to more fast and accurate diagnoses. Currently, the condition is mostly treated with a gluten-free diet, although more therapeutic options are being sought to improve patients' quality of life and reduce long-term dietary limitations.

Expanding Markets Result in Increased R&D Spending As R&D spending rises, pharmaceutical corporations are making a concerted effort to promote novel medicines. As celiac disease rates increase in industrialized countries like North America and Europe, pressure is mounting on the healthcare system to better address management options.

High Costs Limit Accessibility, Particularly in Low-Income and Uninsured Populations.

The high cost of therapy for gluten-associated disease, especially celiac disease, is a major obstacle for the market, which limits its accessibility. Although quality of life can be greatly improved by treatment techniques like gluten-free diets and adjuvant therapies, these approaches are sometimes linked to exorbitant expenditures. Lower socioeconomic groups face financial strain since gluten-free, celiac disease-controlling diets are typically more expensive than regular food items.

Furthermore, many patients from these nations cannot afford the cost of newer medications, such as enzyme therapy and biologics. Low-income areas' limited access to diagnostic equipment and poor healthcare infrastructure are exacerbating issues that, taken alone, lead to further delays in diagnosis and subpar treatment outcomes.

Therefore, patients with celiac disease can suffer complications from neglected or poorly controlled disease. There is more and more evidence that governments as well as international organizations realize the importance of providing affordable treatment options, where examples of such solutions are subsidized healthcare, public information campaigns, or successful development of cost-sensitive therapies. Yet, the continuing high cost of healthcare is a major challenge that limits the scaling up of treatment innovations in low-resource countries.

Emerging therapies targeting non-dietary treatments expand market potential.

Emerging therapies targeting non-dietary treatments expand the market potential. Even though a strict gluten-free diet is the treatment mainstay, it does not completely cover all disease manifestations and restricts the patient's opportunities to control the disease situation.

Immunotherapies and biologics, targeting the modulation of the immune response to gluten, can offer more specific, enduring solutions and reduce dependence on dietary interventions. Researchers and pharmaceutical companies are becoming more interested in these non-diet therapies because they provide the potential to improve patient outcomes, especially for patients with remitting symptoms who do not react well to a gluten-free diet.

The promise of oral therapies, which can prevent patients from eating gluten and causing an immune response, continues to fuel the growth of the market. It is anticipated that these treatments will increase treatment options and enable more effective and compliant management of celiac disease when they move through clinical trials and are ready to hit the market. The market is continuously expanding as a result of the tendency toward a bigger range of treatment alternatives, which is also altering the market environment and increasing demand for innovative medicines that target the disease through underlying disease mechanisms.

Growing investment in research fuels the development of innovative treatment options.

One of the major prospects for the market to develop innovative approaches in the treatment of celiac disease and other gluten-related disorders is the subsequent investment in research. As a result of increased awareness of the condition and calls for a more effective treatment, both the public and commercial sectors have increased their funding for research at a nearly unprecedented rate.

Advances in genetic research and personalized medicine both make it possible for more targeted therapeutic interventions based on the specific patient situation, increase the efficacy of therapeutic interventions, and reduce collateral damage. As clinical trials increase in numbers and new drugs become available in the pipeline, continuous funding of research will be required to lead to further progress, better patients' quality of life, and expansion of the global business of celiac disease medications. These developments are not only interesting for patients but also play a role in the economic recovery (boom) of the health and pharmaceutical industries.

Industry Experts Opinion

"Innovative therapies, such as enzyme-based treatments and immunomodulatory drugs, hold significant promise for patients with celiac disease. Our ongoing research aims to provide safe, effective options that address the root cause of gluten sensitivity, and we believe these advancements will expand the therapeutic landscape dramatically."

• Dr. Bruce A. S. Copley, Senior Vice President, Scientific Affairs, ImmunogenX

Segment Analysis

Based on treatment type, the celiac disease treatment market is categorized into Drug Class, Therapeutic Treatments, Dietary Management, and Surgical Interventions. Drug Class is the leading and most significant segment of the celiac disease treatment market, especially immunosuppressants and enzyme replacement therapy. These will include immunosuppressants because they are essential in reducing inflammation and the immune response in patients with celiac disease.

Enzyme replacement therapy is also finding attention because it may assist in breaking down gluten, making it easier to digest and consequently helping the patient reduce symptoms. Although biologics and corticosteroids are also significant, their role is often more limited to specific cases or complications of celiac disease.

Based on treatment type, the celiac disease treatment market has been classified into Oral, Injectables, and Topical. In the celiac disease treatment market, oral administration is the most prominent and significant route. This is because the primary treatment for celiac disease revolves around dietary management, which is typically done orally, with patients adhering to a gluten-free diet to manage symptoms.

Oral medications are also crucial for treating related conditions, and several potential therapies are being explored in pill form to target immune responses. The oral route is more convenient, easier to follow, and less invasive; therefore, it is the preference of the patients. Even though injectables and topical treatments are found useful for managing some symptoms or related conditions, oral routes continue to dominate current treatment protocols as well as underway research for celiac disease therapies.

Regional Analysis

The North American celiac disease treatment market is experiencing rapid growth due to the increased incidence of the disease, well-developed healthcare systems across the region, and increased awareness of gluten-related diseases. The USA stands first due to the high investment made in the research, newer diagnostic tools available, and the developed gluten-free food market. Moreover, good legislation and practices governing the management of celiac disease, as well as government programs that support the market, also boost the market. Essential pharmaceutical and biotechnology organizations engaged in creating novel treatments have established North America as the dominant global market.

The Asia-Pacific celiac disease treatment market is growing rapidly due to increasing awareness, growth in healthcare expenditure, and advanced diagnostics. The demand for food and pharmaceutical products free from gluten and other natural proteins has grown in countries like India, China, Japan, and many others because of increased awareness of gluten sensitivity and altered lifestyles.

Furthermore, increasing urbanization and growing middle-income consumers also influence the use of specialized treatment. This has opened a massive growth opportunity in the regional market as governments and healthcare providers increase awareness drives and make enormous investments in advanced diagnostic equipment.

Competitive Landscape

The competitive environment of the celiac disease treatment market now comprises a range of large pharmaceuticals and innovative biotech companies. Industry leaders like Takeda Pharmaceutical, Pfizer, and GlaxoSmithKline induce innovations in biologics and small molecule drugs. In contrast, players like ImmusanT and Innovate Biopharmaceuticals also develop new technologies like vaccines and enzyme therapies. The market is now active as a result of new competitors like Zedira GmbH and Calypso Biotech spreading attention to the treatment component.

Development is accelerating due to a synergistic link between research institutions and industrial actors, yet rivalry for development is becoming fiercer because there aren't many acceptable solutions to address the issue. The market is influenced by non-pharmaceutical treatments used by gluten-free diet suppliers like Dr. Schär. For companies looking for fresh development chances, expanding into new geographic areas and placing more attention on medicine customization are becoming crucial tasks. In this instance, the pharmaceutical and dietary management solutions engage in a wide range of competitive activities to encourage the pursuit of improved therapies.

Celiac Disease Treatment Market, Company Shares Analysis, 2024

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Recent Developments:

• In February 2024 Novartis FDA approved Xolair (omalizumab) in February 2024, as the first-and-only treatment for alleviating allergic symptoms in people aged (1 year of age) or older with IgE-mediated food allergy. This approval followed the successful Phase III OUtMATCH study, demonstrating that Xolair significantly helps patients tolerate small amounts of allergens including peanuts and milk.
• In October 2022, Takeda, Zedira, and Dr. Falk Pharma GmbH (all located in Germany) entered into a collaboration and licensing agreement with the overall goal of discovering and developing ZED1227/TAK-227, a Phase 2b investigational agent for celiac disease treatment.

Report Coverage:

By Treatment Type

• Drug Class
  • Immunosuppressants
  • Enzyme Replacement Therapy
  • Corticosteroids
  • Biologics
  • Others
• Therapeutic Treatments
• Dietary Management
• Surgical Interventions

By Mode of Administration

• Oral
• Injectables
• Topical

By End-User

• Hospitals
• Clinics
• Home Care Settings

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of the Middle East & Africa

List of Companies:

• Pfizer Inc.
• Takeda Pharmaceutical Company Limited
• Amgen Inc.
• Innovate Biopharmaceuticals, Inc.
• ImmunogenX
• ImmusanT Inc.
• Alvine Pharmaceuticals, Inc.
• GlaxoSmithKline plc
• F. Hoffmann-La Roche Ltd.
• AbbVie Inc.
• Eli Lilly and Company
• Merck & Co., Inc.
• Sanofi S.A.
• Biomedal S.L.
• Dr. Schär AG
• Celimmune LLC
• Calypso Biotech BV
• ActoBio Therapeutics

Frequently Asked Questions (FAQs)