Global Celiac Disease Market - Historical and Forecasted Epidemiology and Current Treatment Practices from 2018-2030

DUBLIN, June 30, 2021 /PRNewswire/ -- The "Celiac Disease (CD) Market Insight, Epidemiology and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.

This '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 2018 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.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2018-2030

Celiac Disease (CD) Disease Understanding and Treatment Algorithm


Celiac Disease (CD) Diagnosis

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).

Key Findings

• The total prevalent population of Celiac Disease in the 7 major markets was 6,450,607 in 2020 which is anticipated to increase at a CAGR of 0.53% during the study period (2018-2030).
• The total 7MM diagnosed prevalent cases of Celiac Disease in 2020 were 1,403,779 out of which the highest diagnosed prevalent cases of this disease were in the United States, which was 701,718 which is anticipated to increase at a CAGR of 2.0% during the study period (2018-2030).
• According to the estimates by the publisher, 252,618 and 449,099 cases of males and females were in the United States, in 2020.
• In the United States, the number of cases of Classical, Non-classical and Sub-clinical were 189,464, 364,893 and 147,361 respectively, in 2020.
• In the United States the maximum number of cases of Celiac Disease were in the age group of 19-39 with 256,127 cases in 2020, while the lowest number of cases were in the age group >80 with 14,034 cases in 2020.
• In the EU5 countries the total prevalent population of Celiac Disease was maximum in Germany with 742,796 cases, followed by the United Kingdom with 660,156 cases in 2020. While, the least number of cases were in Spain, i.e., 430,359 in 2020.
• In Japan, the prevalence of Celiac Disease was 66,130 in 2020.

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 2021-2030. 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). In August 2019, ActoBio received IND green light for AG017 for the treatment of CD.

Analyst Comments

• All the current emerging therapies are being investigated as an adjunct to GFD. Therefore, none of these therapies can replace the mainstay treatment option for CD.
• Among these therapies, Larazotide Acetate has the highest success rate and patient share as it showed impressive improvement in average on-treatment CD Gastrointestinal Symptom Rating Scale (GSRS) score. Additionally, 9 Meters Biopharma is aiming to file a petition to the FDA for conditional approval of the drug for treating patients suffering from CD.
• In addition to Larazotide, Latiglutenase and TAK-101 can also present with an impressive success rate as both the therapies achieved the primary endpoints of the trial. However, a major setback for Latiglutenase is that improvement was only reported by study participants whose blood tests were positive for CD. The reason for such an outcome is still being investigated by the company.
• In terms of sample size for the trial, Takeda's TAK-101 investigative phase II trial had the lowest number of patients, i.e., 51 participants.
• Amongst all these emerging therapies, Larazotide Acetate is expected to get launched in the market earlier than other therapies as it is the only therapy which is currently in phase III clinical developmental trial.

Key Questions Answered

• What was the Celiac Disease (CD) market share (%) distribution in 2018 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 (2021-2030)?
• 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 (2021-2030)?
• At what CAGR, the Celiac Disease (CD) market is expected to grow at the 7MM level during the forecast period (2021-2030)?
• What would be the Celiac Disease (CD) market outlook across the 7MM during the forecast period (2021-2030)?
• 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?

Epidemiology Insights:

• 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 (2021-2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2021-2030)?

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)?

Key Topics Covered:

1 Key Insights

2 Celiac Disease Market Overview at a Glance

3 Executive Summary of Celiac Disease (CD)

4 Disease Background and Overview: Celiac Disease

5 Algorithm for Diagnosis of CD

6 Diagnostic Guidelines by the European Society for the Study of Coeliac Disease (ESsCD)

7 Diagnostic Guidelines by the World Gastroenterology Organization (WGO)

8 Epidemiology and Patient Population: Key Findings

9 Country Wise-Epidemiology of Celiac Disease

10 Treatment

11 Treatment Algorithm for CD

12 Treatment Algorithm for CD by BMJ Best Practice

13 European Society for the Study of Coeliac Disease (ESsCD) guideline for coeliac disease and other gluten-related disorders

14 World Gastroenterology Organisation Global Guidelines for CD

15 Recognized Establishments

16 Unmet Needs

17 Emerging Drugs

18 Celiac Disease: 7 Major Market Analysis

19 The United States Market Outlook

20 EU-5 Countries: Market Outlook

21 Japan Market Outlook

22 KOL Reviews

23 Case Reports

24 Market Drivers

25 Market Barriers

26 SWOT Analysis

Companies Mentioned

• 9 Meters Biopharma
• ImmunogenX
• Provention Bio
• Takeda/Cour Pharmaceuticals
• Precigen ActoBio
• Falk Pharma and Zedira

For more information about this report visit https://www.researchandmarkets.com/r/obia6j

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