DelveInsight's "Celiac Disease Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of Celiac Disease, historical and forecasted epidemiology as well as the Celiac Disease market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
The Celiac Disease market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Celiac Disease market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Celiac Disease treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Celiac Disease market.
Recent breakthroughs in the Celiac Disease Market Report:
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Celiac disease is an autoimmune disorder triggered by the ingestion of gluten, which prompts an immune response that damages the lining of the small intestine. It affects approximately 1 in 100 people globally, but only about 30% are accurately diagnosed. The condition predominantly impacts females and is most commonly diagnosed in individuals aged 19-39, highlighting the importance of early detection and proper management.
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The primary treatment for celiac disease is a lifelong, strict gluten-free diet, which is crucial 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 such as prednisolone may provide relief until the gluten-free diet begins to take effect. Other treatment options for both RCD I and RCD II include budesonide, systemic corticosteroids, 6-mercaptopurine, cladribine, mesalamine, mycophenolate mofetil, and methotrexate.
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Despite following a gluten-free diet, about 5% of patients continue to experience symptoms, underscoring the urgent need for advanced treatment options and further research. In 2024, a pivotal study demonstrated that ZED1227, an investigational drug, successfully prevented gluten-induced intestinal damage by targeting specific molecular mechanisms, representing a significant advancement in celiac disease therapy.
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Recent progress was further highlighted in a July 2024 meeting, where the Beyond Celiac Coalition—a collaborative alliance of multidisciplinary experts—engaged with the FDA to promote a patient-centric approach to therapeutic trials. The aim was to enhance patient involvement while maintaining scientific rigor in developing new treatments.
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Leading pharmaceutical companies such as Entero Therapeutics, Amgen/Provention Bio, Takeda, and Sanofi are at the forefront of developing more effective therapies for celiac disease, offering new hope for improved management and better patient outcomes.
Celiac Disease Overview
Celiac disease is a chronic autoimmune disorder triggered by an abnormal immune response to gluten, a protein found in wheat, barley, and rye, in genetically predisposed individuals. The condition primarily affects the small intestine, causing inflammation and damage to the mucosal lining, leading to a range of gastrointestinal symptoms such as chronic diarrhea, abdominal pain, and malabsorption. It can also result in extraintestinal manifestations like anemia, osteoporosis, and neurological disturbances. The pathogenesis of celiac disease involves a complex interaction between genetic factors, notably the HLA-DQ2 and HLA-DQ8 haplotypes, and environmental triggers such as viral infections and changes in the gut microbiota. These factors disrupt gluten tolerance, activating T cells and inducing the production of autoantibodies, primarily targeting tissue transglutaminase (tTG), a key enzyme involved in gluten metabolism. Diagnosis can be challenging due to the wide range of clinical presentations and is typically confirmed through serological tests for specific antibodies and histological examination of intestinal biopsies.
This report provides an overview of the pathophysiology of celiac disease, diagnostic approaches, and a detailed treatment algorithm, alongside a real-world scenario illustrating a patient's journey—from the onset of symptoms and the time to diagnosis, to the entire treatment process.
The cornerstone of celiac disease management is a strict, lifelong gluten-free diet, which allows the small intestine to heal and alleviates symptoms. Symptoms usually improve within weeks to months of dietary changes. A registered dietitian plays an essential role in helping patients with meal planning, label reading, and making healthy food choices. In some cases, additional treatments, such as vitamin and mineral supplements or corticosteroids to address persistent inflammation, may be required. Ongoing follow-up with a healthcare provider is essential for monitoring progress and ensuring nutritional adequacy. However, despite strict adherence to the gluten-free diet, some individuals may develop refractory celiac disease, necessitating further evaluation and alternative treatment options.
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Celiac Disease Market
The celiac disease market is poised for significant growth, driven by increased awareness, improved diagnostics, and a rising prevalence of the condition. As more cases are diagnosed, there is a growing demand for gluten-free products, specialized therapies, and advanced diagnostic tools. Major pharmaceutical companies, such as Entero Therapeutics, Amgen, Takeda, and Sanofi, are at the forefront of developing innovative treatments to meet the evolving needs of this expanding market.
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In 2023, the United States dominated the celiac disease market within the 7MM, representing around 70% of the total market share.
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Among the EU4 and the UK, Italy led with an estimated market value of approximately USD 200 million for celiac disease.
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In Japan, where the gluten-free diet remains the only effective treatment, the market for gluten-free products was valued at about USD 1,500 million in 2023.
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Celiac Disease Epidemiology
The Celiac Disease epidemiology section provides insights into the historical and current Celiac Disease patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Celiac Disease market report also provides the diagnosed patient pool, trends, and assumptions.
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In 2023, the United States accounted for nearly 50% of the diagnosed prevalent cases of celiac disease across the 7MM.
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Celiac disease exhibits a significant gender imbalance, with females being more commonly affected. For example, in Germany, approximately 60% of diagnosed cases are in women.
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In Japan, classical celiac disease represented about 30% of all celiac disease cases in 2023.
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Celiac Disease Drugs Uptake
This section focuses on the uptake rate of the potential Celiac Disease drugs recently launched in the Celiac Disease market or expected to be launched in 2020-2034. The analysis covers the Celiac Disease market uptake by drugs, patient uptake by therapies, and sales of each drug.
Celiac Disease Drugs Uptake helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on Celiac Disease market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
The Celiac Disease report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Celiac Disease key players involved in developing targeted therapeutics.
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Celiac Disease Emerging Therapy Assessment
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Larazotide Acetate (INN-202/AT-1001): 9 Meters Biopharma
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Latiglutenase (IMGX003/ALV003): ImmunogenX
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PRV-015: Provention Bio
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TAK-101: Takeda/Cour Pharmaceuticals
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AG017: Precigen ActoBio
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ZED1227: Falk Pharma and Zedira
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Celiac Disease Pipeline Development Activities
Celiac Disease Therapeutics Assessment
Major key companies are working proactively in the Celiac Disease Therapeutics market to develop novel therapies which will drive the Celiac Disease treatment markets in the upcoming years.
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Celiac Disease Report Key Insights
1. Celiac Disease Patient Population
2. Celiac Disease Market Size and Trends
3. Key Cross Competition in the Celiac Disease Market
4. Celiac Disease Market Dynamics (Key Drivers and Barriers)
5. Celiac Disease Market Opportunities
6. Celiac Disease Therapeutic Approaches
7. Celiac Disease Pipeline Analysis
8. Celiac Disease Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the Celiac Disease Market
Table of Contents
1. Key Insights
2. Executive Summary
3. Celiac Disease Competitive Intelligence Analysis
4. Celiac Disease Market Overview at a Glance
5. Celiac Disease Disease Background and Overview
6. Celiac Disease Patient Journey
7. Celiac Disease Epidemiology and Patient Population
8. Celiac Disease Treatment Algorithm, Current Treatment, and Medical Practices
9. Celiac Disease Unmet Needs
10. Key Endpoints of Celiac Disease Treatment
11. Celiac Disease Marketed Products
12. Celiac Disease Emerging Therapies
13. Celiac Disease Seven Major Market Analysis
14. Attribute Analysis
15. Celiac Disease Market Outlook (7 major markets)
16. Celiac Disease Access and Reimbursement Overview
17. KOL Views on the Celiac Disease Market
18. Celiac Disease Market Drivers
19. Celiac Disease Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
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