Dublin, Sept. 28, 2020 (GLOBE NEWSWIRE) -- The "Celiac Disease (CD) - Market Insights, Epidemiology and Market Forecast- 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
The Celiac Disease (CD) - Market Insights, Epidemiology and Market Forecast- 2030' report delivers an in-depth understanding of the Celiac Disease (CD), historical and forecasted epidemiology as well as the Celiac Disease (CD) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The Celiac Disease (CD) market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Celiac Disease (CD) market size from 2017 to 2030. The report also covers current Celiac Disease (CD) treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Celiac Disease (CD) Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Population of Celiac Disease (CD), Total Diagnosed Prevalent Population of Celiac Disease (CD), Gender-specific Prevalent Population of Celiac Disease (CD), Type-specific Prevalent Population of Celiac Disease (CD) and Age-specific Distribution of Celiac Disease (CD) in the 7MM market covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2017 to 2030.
The total prevalent population of Celiac Disease in the 7 major markets was found to be 6,334,993 in 2017.
The total 7MM diagnosed prevalent cases of Celiac Disease in 2017 were 1,303,459 out of which the highest diagnosed prevalent cases of this disease were seen in the United States, which was 661,244.
The publisher has found 238,048 and 423,196 cases of males and females in the United States, in 2017.
It was found that in the United States the number of cases of Classical, Non-classical and Sub-clinical were 178,536, 343,847 and 138,861 respectively, in 2017.
In the United States the maximum number of cases of Celiac Disease were found in the age group of 19-39 with 241,354 cases in 2017, while the lowest number of cases were found in the age group >80 with 13,224 cases in 2017.
In the EU5 countries the total prevalent population of Celiac Disease was found to be maximum in Germany with 738,357 cases, followed by the United Kingdom with 650,676 cases in 2017. While, the least number of cases were found in Spain, i.e., 421,326 in 2017.
In Japan, the prevalence of CD was found to be 65,148 in 2017.
Celiac Disease (CD) Emerging Drugs
Larazotide Acetate (INN-202/AT-1001): 9 Meters Biopharma
Larazotide is an oral peptide that normalizes the disrupted tight junctions between cells in the gut seen in celiac disease patients. It prevents the gluten breakdown of product gliadin from entering systemic circulation and propagating an inflammatory response. The drug has been assessed in multiple phase I and II trials, and currently, it is the only late-stage drug, which is being investigated in phase III clinical developmental trial for the relief of persistent symptoms in adult CD patients. 9 Meters Biopharma expects to release the interim results of this trial in the second half of 2021. The company aims to introduce larazotide as adjunctive therapy in CD to restore physiology, thereby minimizing symptoms in tandem with a gluten-free diet.
Latiglutenase (IMGX003/ALV003): ImmunogenX
Latiglutenase (IMGX003) is an orally administered mixture of two gluten-specific recombinant proteases that degrades gluten proteins into small physiologically irrelevant fragments and is to be delivered as an adjunct to a gluten-free diet (GFD). The two-component proteases of IMGX003 are IMGX001, which is effective at breaking glutamine-leucine bonds and the other protease is IMGX002, which targets most proline bonds. ImmunogenX is currently investigating the drug in phase II gluten-challenge study to find out both mucosal and symptomatic protection in a general population of CD patients. The company claims that this study will be followed shortly by a phase II/III real-world trial that will focus on symptom improvement in seropositive patients as a prelude to a phase III trial. The company started enrollment of patients in phase IIb CD study in January 2020.
PRV-015: Provention Bio
PRV-015 (formerly known as AMG 714 and HuMax IL-15) is a fully human immunoglobulin (IgG1) monoclonal antibody that is being developed by Provention Bio for the treatment of gluten-free diet non-responsive CD (NRCD). Amgen initially developed it in rheumatoid arthritis. The drug has already completed a phase II clinical developmental trial for patients suffering from RCD II and another phase II trial for CD patients, which was conducted only in Finland. Currently, another phase II trial has been planned by Prevention Bio, which is estimated to initiate in August 2020 for treating CD patients and the company expects to report top-line results of this trial by 2022.
TAK-101: Takeda/Cour Pharmaceuticals
TAK-101 (formerly known as CNP-101 and TIMP-GLIA) is a first-in-class, immune modifying biodegradable nanoparticle encapsulating gliadin proteins that are being developed by Takeda for the treatment of CD. It uses COUR's proprietary immune modifying nanoparticles, which are designed to bind inflammatory cells to initiate tolerogenic immune reprogramming. The interior core can be loaded with disease-specific antigen, such as gliadin proteins to induce tolerance in CD and other autoimmune conditions. In October 2019, Takeda acquired an exclusive global license for COUR Pharmaceuticals' investigational drug CNP-101, which is now known as TAK-101 following the presentation of phase IIa data. The results regarding efficacy and safety of TAK-101 in 34 adults with proven CD was presented as a late-breaking abstract at UEG Week 2019, Spain in October 2019 itself.
According to the clinicaltrials.gov, the phase II developmental trial of TAK-101 for treating CD patients was estimated to be completed in July 2019, but it is still in active, not recruiting phase.
Celiac Disease (CD) Market Outlook
According to the University of Chicago Medicine, celiac disease is an inherited autoimmune disorder that primarily affects the digestive process of the small intestine. In this disorder, gluten intake causes the individual's immune system to attack the small intestine and inhibit the absorption of important nutrients into the body. Even after advancement in the diagnostic tests, the CD is still highly undiagnosed and untreated, which can lead to the development of other autoimmune disorders, as well as osteoporosis, infertility, neurological conditions and in rare cases, cancer. It is estimated that 1 in 133 Americans or about 1% of the American population develop CD, which means at least 3 million people in the United States are living with CD. However, 97% of these cases remain undiagnosed or misdiagnosed with other conditions.
The mainstay treatment for CD simply involves excluding foods that contain gluten from the diet. Lifelong adherence to a gluten-free diet (GFD) has been proved to promote mucosal healing, reduce serum levels of celiac antibodies, improve protein-energy deficiencies, improve bone health, and lead to increases in body fat.
The dynamics of the CD market is anticipated to change in the coming years owing to the expected launch of emerging therapies during the forecast period of 2020-2030. The emerging therapies focused on the treatment of CD include Larazotide Acetate (9 Meters Biopharma), Latiglutenase/IMGX003 (Immuno-genX), PRV-015 (Provention Bio), and CNP-101/ TAK-101 (Takeda/ Cour Pharma).
In addition to these emerging therapies, certain other therapies were not considered in the forecast model of CD as their results were not published yet. These therapies include ZED1227 (Falk Pharma and Zedira), which is in its phase II clinical developmental stage and two early phase therapies, namely, AG017 (Precigen ActoBio) and TAK-062 (Takeda).
The market size of CD in the seven major markets was estimated to be USD 1,242.8 Million in 2017.
The United States accounts for the largest market size of CD, in comparison to EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
Among the EU5 countries, Italy had the highest market size with USD 146.6 Million in 2017, while France had the lowest market size of CD with USD 39.1 Million in 2017.
The Japan CD market accounted for USD 0.7 Million in 2017. Japan has witnessed least revenue across the 7MM due to low awareness and considering the disease rare in the region.
9 Meters Biopharma
Falk Pharma and Zedira
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