In recent years, the world has witnessed a notable surge in the prevalence of celiac disease, emerging as a significant health concern. Celiac disease is an autoimmune disorder characterized by an intolerance to gluten, a protein found in wheat, barley, and rye. The prevalence of celiac disease has been on the rise in recent years, and several factors contribute to this increase.
Celiac disease has a strong genetic component. Individuals with a family history of the disease are at a higher risk of developing it. The strongest genetic risk factor for celiac disease is the presence of specific Human Leukocyte Antigen (HLA) genes, particularly HLA-DQ2 and HLA-DQ8. More individuals at risk are identified, leading to increased diagnoses as genetic screening becomes more common.
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Data Bridge Market Research analyzes that the North America and Europe Celiac Disease Market is expected to grow with a CAGR of 9.8% in North America and 8.8% in Europe in the forecast period of 2024 to 2031 and is expected to reach USD 193,364.33 thousand in North America and 150,949.09 thousand in Europe by 2031. The corticosteriods segment is projected to propel the market growth due to due to their anti-inflammatory properties, which effectively alleviate symptoms and promote mucosal healing in individuals with celiac disease.
Key Findings of the Study
Emerging Biological Therapies For Celiac Disease
Emerging biological therapies for celiac disease represent a promising avenue for developing alternative treatments beyond the current standard of care, which is a lifelong strict gluten-free diet. While these therapies are still in the experimental stages and undergoing clinical trials, they hold the potential to address the complexity associated with celiac disease, offering new possibilities for individuals affected by this autoimmune disorder.
Some of the emerging biological therapies for celiac disease are:
- Immunomodulatory Therapies: Some biological therapies focus on modulating the immune response associated with celiac disease. This includes interventions aimed at dampening the aberrant immune reaction triggered by gluten ingestion. Researchers are exploring the use of immunomodulatory agents to achieve gluten tolerance without causing generalized immunosuppression
- Gluten-specific Immunotherapy: Gluten-specific immunotherapy is a targeted approach that aims to induce immune tolerance to gluten proteins. This involves exposing individuals with celiac disease to controlled and gradually increasing amounts of gluten to desensitize the immune system. Clinical trials are investigating the safety and efficacy of various forms of gluten immunotherapy, including oral, sublingual, and percutaneous delivery
- Enzyme Therapies: Enzyme-based therapies are being explored as a means to break down gluten in the digestive system, potentially mitigating the immune response. Research is underway to develop enzymes that can efficiently degrade gluten into non-immunogenic fragments, reducing the likelihood of triggering an immune reaction. These enzymes could be administered alongside meals to aid in the digestion of inadvertent gluten exposure
Report Scope and Market Segmentation
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Report Metric
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Details
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Forecast Period
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2024 to 2031
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Base Year
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2023
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Historic Years
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2022 (Customizable to 2020-2021)
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Quantitative Units
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Revenue in USD Thousand, Volumes in Units
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Segments Covered
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Treatment Type (Corticosteroids, Immunosuppressants, and Others), Disease Type (Classical Celiac Disease, Non-Classical Celiac Disease, Refractory Celiac Disease, Potential Celiac Disease, and Dermatitis Herpetiformis), Drug Type (Generics and Branded), Prescription Type (Prescription and Over The Counter), Dosage Form (Tablet, Capsules, Injection, and Other), Route of Administration (Oral, Intravenous, and Topical), Population Type (Children, Adults, and Geriatric), End User (Hospitals, Clinics, Diagnostic Centres, Home Care Settings, and Others), Distribution Channel (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy, and Others)
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Countries Covered
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U.S., Canada, Mexico, U.K., Germany, France, Italy, Spain, Russia, Turkey, Belgium, Netherlands, Switzerland, Denmark, Norway, Sweden, Finland, Poland and Rest of Europe
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Market Players Covered
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GSK plc. (U.K.) Janssen Pharmaceuticals, Inc. (U.S.), Pfizer Inc. (U.S.), Teva Pharmaceuticals USA, Inc (Israel), Tillotts Pharma AG. (Switzerland) Novartis AG (Switzerland), Amgen Inc.(U.S.) Salix Pharmaceuticals AdvaCare Pharma (U.S.), ImmunogenX.,Inc. (U.S), ANOKION (Switzerland), Topas Therapeutics (Germany), Immunic Therapeutics (U.S.), Equillium Bio. (U.S.), and Takeda Pharmaceutical Company Limited (Japan)
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Data Points Covered in the Report
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In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include in-depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.
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Segment Analysis:
The North America and Europe celiac disease market is segmented into nine notable segments based on treatment type, disease type, drug type, prescription type, dosage form, route of administration, population type, end user, and distribution channel.
- On the basis of treatment type, the market is segmented into corticosteroids, immunosuppressants, and others
In 2024, the corticosteroids segment is expected to dominate the North America and Europe celiac disease market
In 2024, the corticosteroids segment is expected to dominate the North America market with a 69.01% market share and the Europe market with a 71.56% market share, due to their anti-inflammatory properties, which effectively alleviate symptoms and promote mucosal healing in individuals with celiac disease.
- On the basis of disease type, the market is segmented into refractory celiac disease, dermatitis herpetiformis, potential celiac disease, classical celiac disease, and non-classical celiac disease
In 2024, the refractory celiac disease segment is expected to dominate the North America and Europe celiac disease market
In 2024, the refractory celiac disease segment is expected to dominate the North America market with a 50.39% market share and the Europe market with a 54.47% market share, due to its challenging and persistent nature, requiring specialized management and contributing to a significant healthcare burden in these regions.
- On the basis of drug type, the market is segmented into branded and generics. In 2024, the generics segment is expected to dominate the North America market with a 79.24% market share and the Europe market with an 80.95% market share
- On the basis of prescription type, the market is segmented into prescription and over the counter. In 2024, the prescription segment is expected to dominate the North America market with a 92.45% market share and the Europe market with a 93.07% market share
- On the basis of dosage form, the market is segmented into tablet, capsules, injections, and others. In 2024, the tablet segment is expected to dominate the North America market with a 75.94% market share and the Europe market with a 77.92% market share
- On the basis of route of administration, the market is segmented into oral, intravenous, and topical. In 2024, the oral segment is expected to dominate the North America market with a 74.88% market share and the Europe market with a 74.86% market share
- On the basis of population type, the market is segmented into adults, children, and geriatric. In 2024, the adults segment is expected to dominate the North America market with a 59.52% market share and the Europe market with a 62.85% market share
- On the basis of end user, the market is segmented into hospitals, clinics, home care settings, and others. In 2024, the hospitals segment is expected to dominate the North America market with a 66.54% market share and the Europe market with a 69.30% market share
- On the basis of distribution channel, the market is segmented into hospital pharmacy, retail pharmacy, online pharmacy, and others. In 2024, the hospital pharmacy segment is expected to dominate the North America market with a 66.40% market share and the Europe market with a 69.17% market share
Major Players
Data Bridge Market Research analyzez GSK plc. (U.K.) Janssen Pharmaceuticals, Inc. (U.S.), Pfizer Inc. (U.S.), Teva Pharmaceuticals USA, Inc (Israel), Tillotts Pharma AG. (Switzerland) as the market players in the North America and Europe celiac disease market.
Market Development
- In May 2023, Topas Therapeutics, a clinical-stage biotech company developing novel antigen-specific immune tolerance therapies to treat autoimmune disorders, announced today the launch of a Phase 2a clinical study (NCT05660109) evaluating the safety, tolerability, and pharmacodynamics of TPM502 in patients with celiac disease. The Phase 2a study will determine the capacity of TPM502 to promote immune tolerization in celiac disease patients and will confirm the safety profile of TPCs. It will also strengthen the potential of the Topas platform to generate new therapeutic agents for the treatment of T-cell-mediated diseases.n November 2023, Minerva Surgical, Inc., a women's health company focused on treating abnormal uterine bleeding (AUB), announces the launch of a new consumer education experience for women: www.aubandme.com. The company will present the site at the 50th World Congress of the American Association of Gynecologic Laparoscopes (AAGL) in Austin, Texas. This innovation has helped to create awareness among women about uterine abnormal bleeding
- In June 2023, Teva Pharmaceutical Industries Ltd. announced a new strategic framework with four key pillars that will position the company for a new era of growth. This strategy aims to strengthen the company's strong commercial portfolio and biosimilar, strengthen its innovation pipeline, maintain its generic power, and centralize the business. These four pillars are expected to add value and increase patient impact. Teva aims to expand its innovative product line and focus on its core therapeutic areas of neuroscience, immunology, and immuno-oncology, aiming to be first and best in class
- In October 2023 , Anokion, a clinical stage biotechnology company focused on the treatment of autoimmune diseases by restoring normal immune tolerance, announced that it has presented data from the completed Phase 1 ACeD (Evaluation of KAN-101 in Celiac Disease) clinical trial of KAN-101 for the treatment of celiac disease in an oral presentation at the 2023 United European Gastroenterology (UEG) Week. Encore's presentation features favorable pharmacodynamics and pharmacokinetic data from a Phase 1 study that showed KAN-101 is safe and tolerable in humans with celiac disease and induced functional tolerance to gliadin-specific T-cell responses following gluten challenge. The oral presentation titled, “Pharmacodynamic Demonstration of Immunological Tolerance Induced by KAN-101”, a novel liver-targeted therapy for celiac disease, will help the company in easy drug clearance
- In November 2023, Hologic, Inc., a world leader in women's healthcare, introduced the NovaSure V5 device, a global endometrial ablation (GEA) device, at the American Association of Gynecologic Laparoscopy (AAGL) 50th World Congress. The most researched and trusted endometrial ablation method in the United States, the innovative new NovaSure V5 device represents Hologic's continued commitment to improving the physician experience
- In October 2022, Pfizer Inc. invested USD 35 million in equity capital in Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune diseases by restoring normal immune tolerance. Anokion and Pfizer entered an agreement for the continued clinical development of KAN-101, Anokion’s lead candidate for the treatment of celiac disease
Regional Analysis
Geographically, the countries covered in the celiac disease market report are, U.S., Canada, Mexico, U.K., Germany, France, Italy, Spain, Russia, Turkey, Belgium, Netherlands, Switzerland, Denmark, Norway, Sweden, Finland, Poland and rest of Europe
As per Data Bridge Market Research analysis:
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