DelveInsight’s ‘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.
• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Study Period: 2017–2030
Celiac Disease (CD) Disease Understanding and Treatment Algorithm
Celiac Disease (CD) Overview
Celiac Disease (CD)—also known by coeliac disease, celiac sprue, non-tropical sprue, and gluten-sensitive enteropathy—is a chronic, immune-mediated enteropathy in which dietary gluten triggers an inflammatory reaction in the small intestine of genetically predisposed individuals. Gluten is a water-insoluble protein mass that remains when the wheat dough is washed to remove starch, albumins and other water-soluble proteins. Gluten and gluten-related proteins are present in wheat, rye and barley and are used widely in food processing to give the dough the desired baking properties, add flavors and improve texture. In celiac subjects, the ingestion of gluten leads to an enteropathy with an impairment of the mucosal surface and, consequently, abnormal absorption of nutrients. CD might be considered a syndrome, because of the wide spectrum of clinical manifestations and the involvement of various human systems.
CD shows atypical features in comparison to other autoimmune disorders, including the complete recovery of the mucosal damage as well as the reversibility of its progression and chronic dynamics, with total avoidance of gluten. Alternatively, it is now established that undiagnosed CD, might have severe consequences in children as well as in adult subjects.
CD is one of the better-characterized diseases related to the immune system with all the affected patients having the following:
• a genetic predisposition (either HLA-DQ2 or HLA-DQ8)
• a well-defined precipitating factor (gluten)
• highly sensitive and specific autoantibodies against the naturally occurring human enzyme, tissue transglutaminase (TG2)
According to the World Gastroenterology Organization, CD may be divided into two types: classical and non-classical. However, silent type CD also exits, which is also known as an asymptomatic CD. In case of silent type, patients do not complain of any symptoms, but still, experience villous atrophy damage to their small intestine. Studies have shown that even though patients thought they had no symptoms, after going on a strict gluten-free diet, they report better health and a reduction in acid reflux, abdominal bloating and distention and flatulence.
Celiac Disease (CD) Diagnosis
The gold standard for CD diagnosis is represented by the combination of mucosal changes detected by duodenal biopsy and by the positivity of serological tests (anti-tTG antibodies, anti-endomysium antibodies (EMA), and deamidated gliadin peptide (DGP) antibodies). Despite the progress made in serology, no antibody test currently available results in sensitivity and specificity of 100%, thus requiring intestinal biopsy as a key adjunct for establishing a correct diagnosis. Pediatric patients with high titers (over 10 times the cut-off) of anti-tTG antibodies, detectable EMA, HLA-DQ2/HLA-DQ8 positivity, and signs/symptoms suggestive of CD may skip duodenal biopsy as recommended by recent guidelines by the European Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN). Although a large multicenter European study showed a diagnostic accuracy of ESPGHAN criteria in identifying CD in children, it should be pointed out that these criteria are not followed worldwide. In fact, in some countries such as the USA, ESPGHAN criteria are not recommended because of the poor reproducibility of the anti-tTG assays. Both advantages and disadvantages exist to biopsy for children with suspected CD; however, most pediatric cases, especially those with low to medium anti-tTG2 titers, require a histopathological assessment to confirm CD diagnosis. Research has shown that the combination of anti-tTG (over 10 times the cut-off), EmA, and HLA-DQ2/HLA-DQ8 positivity (triple criteria) had a good accuracy across the range of pre-test probabilities in detecting adult patients with CD. Nonetheless, duodenal biopsy still represents a pillar in the diagnosis of adult patients with suspected CD.
The current standard of care is based on the “four out of five rule,” which indicates that four out of five of the following criteria are enough to establish CD diagnosis:
• typical signs and symptoms (diarrhea and malabsorption)
• antibody positivity
• HLA-DQ2 and/or HLA-DQ8 positivity
• intestinal damage (i.e., villous atrophy and minor lesions)
• clinical response to GFD—Additionally, this rule helps physicians to identify the various subtypes of CD, i.e., seronegative CD (absence of point 2), potential CD (absence of point 4), non-classic CD (absence of point 1), and non-responsive CD (absence of point 5).
Celiac Disease (CD) Treatment
Celiac Disease (CD) is usually treated by simply excluding foods that contain gluten from the diet. This prevents damage to the lining of the intestines (gut) and the associated symptoms, such as diarrhea and stomach pain. Symptoms generally return if the patient starts eating foods containing gluten, and it will cause long-term damage to the patient’s health. Symptoms often start improving considerably within weeks of starting a gluten-free diet. However, it may take up to 2 years for the digestive system to heal completely.
Lifelong adherence to a GFD, the mainstay of treatment for CD, promotes mucosal healing, reduce serum levels of celiac antibodies, improve protein-energy deficiencies, improve bone health, and lead to increases in body fat. Non-adherent or partially adherent patients have been reported to have more fatigue, pruritus, and abdominal bloating than fully adherent patients. Similarly, the persistence of villous atrophy (VA) is less frequently reported in patients who adhere to their GFD.
Apart from avoiding gluten in the day-to-day diet, intake of certain supplements (vitamin and mineral supplements) may also be recommended, at least for the first 6 months after the diagnosis. This will ensure that the patient gets all the nutrients that are needed while the digestive system repairs itself. Taking supplements can also help correct any deficiencies, such as anemia.
In Rule Out Refractory CD I (RCDI) and RCDII, pharmacologic treatment improves symptoms and histology in only 30–40% of patients. In RCDI, symptoms often improve after treatment, while RCDII is generally less responsive to available therapies. For both RCDI and RCDII, therapeutic options reported include budesonide, systemic corticosteroids, 6-mercaptopurine, cladribine, and mesalamine. Mycophenolate mofetil and methotrexate have also been reported as therapeutic options for RCDI.
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.
This section provides glimpse of the Celiac Disease (CD) epidemiology in the 7MM.
• 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.
• DelveInsight 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.
Country Wise- Celiac Disease (CD) Epidemiology
The epidemiology segment also provides the Celiac Disease (CD) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
Celiac Disease (CD) Drug Chapters
The drug chapter segment of the Celiac Disease (CD) report encloses the detailed analysis of Celiac Disease (CD) marketed drugs and mid and late stage pipeline drugs. It also helps to understand the Celiac Disease (CD) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.
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.
Product details in the report…
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.
Product details in the report…
PRV-015: Provention Bio
PRV-015 (formerly known as AMG 714 and HuMax IL-15) is a fully human immunoglobulin (IgG1κ) 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.
Product details in the report…
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.
Product details in the report…
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).
This section includes a glimpse of the Celiac Disease (CD) 7MM market.
• 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.
The United States Market Outlook
This section provides the total Celiac Disease (CD) market size and market size by therapies in the United States.
EU-5 Market Outlook
The total Celiac Disease (CD) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
Japan Market Outlook
The total Celiac Disease (CD) market size and market size by therapies in Japan are provided.
Celiac Disease (CD) Drugs Uptake
This section focusses on the rate of uptake of the potential drugs recently launched in the Celiac Disease (CD) market or expected to get launched in the market during the study period 2017–2030. The analysis covers Celiac Disease (CD) market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Celiac Disease (CD) Development Activities
The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for Celiac Disease (CD) emerging therapies.
Competitive Intelligence Analysis
We perform competitive and market Intelligence analysis of the Celiac Disease (CD) market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
• The report covers the descriptive overview of Celiac Disease (CD), explaining its causes, signs and symptoms, pathogenesis and currently available therapies.
• Comprehensive insight has been provided into the Celiac Disease (CD) epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Celiac Disease (CD) are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of Celiac Disease (CD) market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Celiac Disease (CD) market.
• In the coming years, Celiac Disease (CD) market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Celiac Disease (CD) R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Through several secondary sources it is quite evident that the prevalence of Celiac Disease (CD) is higher among females than in males.
• DelveInsight has analyzed type-based data for Celiac Disease (CD). Celiac Disease (CD) can be of three types based on this data, namely, Classical, Non-classical and Sub-clinical Celiac Disease.
• The report also encompasses another major segment, i.e., Age-specific Prevalent Population of Celiac Disease (CD), wherein various age groups have been considered, such as 0–18, 19–39, 49–59, 60–79 and >80. It has been found that the prevalence of Celiac Disease (CD) is maximum in the 19–39 age group.
• Expected Launch of potential therapies, Larazotide Acetate (9 Meters Biopharma), Latiglutenase (ImmunogenX), PRV-015 (Provention Bio) and CNP-101/TAK-101 (Cour Pharmaceuticals/Takeda), may increase the market size in the coming years, assisted by an increase in diagnosed prevalent population of Celiac Disease (CD). Other early phase players include ActoBio Therapeutics and Falk Pharma.
• The current treatment of CD is mainly dominated by the use of diet which is free of gluten so that immunological cascade does not get triggered. CD being an autoimmune indication greatly affects and damages the small intestine. The market of CD faces a major unmet need, i.e., lack of currently available treatment interventions.
Celiac Disease (CD) Report Insights
• Patient Population
• Therapeutic Approaches
• Celiac Disease (CD) Pipeline Analysis
• Celiac Disease (CD) Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies
Celiac Disease (CD) Report Key Strengths
• Eleven Years Forecast
• 7MM Coverage
• Celiac Disease (CD) Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake
Celiac Disease (CD) Report Assessment
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• What was the Celiac Disease (CD) market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the Celiac Disease (CD) total market size as well as market size by therapies across the 7MM during the forecast period (2020–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Celiac Disease (CD) market size during the forecast period (2020–2030)?
• At what CAGR, the Celiac Disease (CD) market is expected to grow at the 7MM level during the forecast period (2020–2030)?
• What would be the Celiac Disease (CD) market outlook across the 7MM during the forecast period (2020–2030)?
• What would be the Celiac Disease (CD) market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What is the disease risk, burden and unmet needs of Celiac Disease (CD)?
• What is the historical Celiac Disease (CD) patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
• What would be the forecasted patient pool of Celiac Disease (CD) at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Celiac Disease (CD)?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Celiac Disease (CD) during the forecast period (2020–2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2020–2030)?
Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
• What are the current options for the treatment of Celiac Disease (CD) along with the approved therapy?
• What are the current treatment guidelines for the treatment of Celiac Disease (CD) in the US and Europe?
• What are the Celiac Disease (CD) marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of Celiac Disease (CD)?
• How many therapies are developed by each company for the treatment of Celiac Disease (CD)?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Celiac Disease (CD)?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Celiac Disease (CD) therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Celiac Disease (CD) and their status?
• What are the key designations that have been granted for the emerging therapies for Celiac Disease (CD)?
• What are the 7MM historical and forecasted market of Celiac Disease (CD)?
Reasons to buy
• The report will help in developing business strategies by understanding trends shaping and driving the Celiac Disease (CD).
• To understand the future market competition in the Celiac Disease (CD) market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Celiac Disease (CD) in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for Celiac Disease (CD) market.
• To understand the future market competition in the Celiac Disease (CD) market.
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