Summary

The Ulcerative Colitis Market is expected to register a CAGR of 5.3% during the forecast period.

COVID-19 has been a threat multiplier that affects all aspects of life. The medical and psycho-socioeconomic effects of the COVID-19 pandemic and pre-existing medical conditions such as acute severe ulcerative colitis are multidirectional and include the impacts of COVID-19 and acute severe ulcerative colitis on each other and their influences on the welfare of patients, their families, the healthcare system and health-care providers. According to a research study by Bo Shen et al., published in Gastroenterology and Hepatology Journal, February 2021, the risk of adverse outcomes of COVID-19 has been reported to be higher in patients with ulcerative colitis. It continues to be a threat to patients with acute severe ulcerative colitis, posing an ever-growing risk to the global healthcare system. According to a research study by Garcia K.S. et al., published in Inflammatory Intestinal Diseases Journal, June 2020, the study results found that management of inflammatory bowel disease (IBD) patients (Ulcerative Colitis and Crohn's disease) during the COVID-19 pandemic has been challenging. Measures to minimize the potential risk of SARS-CoV-2 infection, including strict social distancing and self-isolation, in the IBD population have been recommended, especially for high-risk patients.

Ulcerative colitis (UC) is the most common form of inflammatory bowel disease which affects several people. It is common in most of Europe and North America and uncommon in most of the developing Asian countries. UC is more prevalent among males and has a regional north-to-south variation. One potential explanation is the differences in exposure to ultraviolet light, resulting in relative vitamin D deficiency in countries close to the Arctic. People who live in lower latitudes are more likely to develop UC than those in higher latitudes. According to a research article by Whitney D. Lynch et al., published in National Center for Biotechnology Information (NCBI) June 2020, globaly, the Ulcerative colitis has an incidence of 9 to 20 cases per 100,000 persons per year. Its prevalence is 156 to 291 cases per 100,000 persons per year. Ulcerative colitis has a higher prevalence in adults. There is an increased prevalence of ulcerative colitis in non-smokers or those who recently quit smoking.

The emergence of biosimilars is also one of the major factors governing the overall market. Biosimilars are expected to be less costly than biologics, making them more accessible in developing countries. The expected patent expiration of some of the drugs is one of the factors responsible for the launch of new biosimilars. Moreover, increasing involvement of key players in product development related in the field is anticipated to drive the segment. For instance, in June 2021, Pfizer Inc., intiated a phase III clinical trial to assess the efficacy, safety and pharmacokinetics (PK) of tofacitinib in pediatric patients with moderately to severely active Ulcerative Colitis. The trial is expected to complete in October 2028. In addition, in June 2021, in Japan, Takeda Pharmaceutical Company Limited started a phase III clinical trial to assess the efficacy and safety of intravenous (IV) Vedolizumab in Japanese patients with moderate to severe Ulcerative Colitis. The trial is expected to complete in September 2024. However, factors such as high levels of unmet clinical need in ulcerative colitis (UC) and side-effects of medications is expected to impede market growth over the forecast period.

Key Market Trends

Ulcerative Proctitis Segment is Expected to Experience the Fastest Growth during the Forecast Period

Ulcerative proctitis is one of the types of ulcerative colitis. It is considered as the initial manifestation of ulcerative colitis, in which fine ulcerations in the inner linings of the mucosa of the large intestine are seen.

According to a research study by Anupam Kumar Singh et al., published in United European Gastroenterology Journal, March 2021, the incidence rate of COVID-19 per 1,000 patients of inflammatory bowel disease (ulcerative colitis) and the general population were 4.02 and 6.59, respectively. The proportion of COVID-19-positive inflammatory bowel disease patients requiring hospitalization and intensive care unit care was 27.29% and 5.33%. The relative risks of hospitalization, intensive care unit admission, and mortality were lower for patients on biological agents but higher with steroids or 5-aminosalicylate use. Thus, SARS-CoV-2 infection risk in patients with inflammatory bowel disease is comparable to the general population. Outcomes of COVID-19-positive inflammatory bowel disease patients are worse in ulcerative colitis, those on steroids or 5-aminosalicylates but outcomes are better with biological agents.

Globally, high burden of Ulcerative proctitis is boosting the segment growth. For instance, according to a research study by Wing Yan Mak et al., published in Journal of Gastroenterology and Hepatology 2020, the study results found that in Europe, North America and Australia, 23–34% of ulcerative colitis (UC) patients presented with proctitis. Similarly in Asia, where 35–37% of patients presented with proctitis.

The number of patients with inflammatory bowel disease (IBD) diagnosed older than 65 years is rising. This is due to the rising incidence of IBD and to an ageing population. According to a research study by Irene Zammarchi et al., published in BMC Gastroenterology Journal, May 2020, almost 25–35% of IBD patients are ≥60 years old. Ulcerative Colitis has similar presentation and behaviour in elderly and adults patients. However, the elderly are more fragile because of comorbidities, increased risk of infections and disease-related complications.

Increasing research and development activities in the development of novel therapies for the Ulcerative proctitis is likely to drive the segment growth. For instance, in, December 2020, Cristcot LLC, initiated a phase III clinical trial to evaluate the safety and efficacy of hydrocortisone acetate 90 mg suppository administered with the Sephure applicator for the treatment of ulcerative colitis of the rectum in patients with Ulcerative Proctitis. The trial is expected to complete in December 2021.

In addition, in May 2018, in Italy, First Wave Bio, Inc., started a phase I/II clinical trial to evaluate the safety and efficacy of Niclosamide in patients with mild-to-moderate Ulcerative Proctitis. The trial is expected to complete in December 2021. Thus, owing to above mentioned factors it is expected to drive the segment growth over the forecast period.

North America is Expected to Hold a Significant Share in the Market Over the Forecasted Period

North America is expected to lead the ulcerative colitis market, owing to the presence of key players and increasing prevalence of Ulcerative Colitis in the region, along with the continuing funding for the development of new therapeutics for the treatment of the condition.

According to a research study by Shailendra Singh et al., published in Gastroenterology Journal 2020, Patients with ulcerative colitis (UC), maybe at an increased risk for COVID-19 owing to their immunosuppressant medications or the chronic inflammatory disease state. Patients with IBD and COVID-19 on long-term biologics or non-steroid immunomodulatory therapies did not have a higher risk of poor COVID-19 outcomes. However, recent corticosteroid use that may as well imply poor disease control may be related to worse outcomes. The risk for severe COVID-19 in patients with IBD is also similar to the widely recognized risk factors for COVID-19 outcomes, such as advanced age and comorbidities, and such patients should be closely monitored.

In addition, as per above source, in the United States, IBD patients in remission and on immunomodulators and biologics should stay on their medications and should exercise social distancing principles like the general population. Patients with IBD such as ulcerative colitis with advanced age, multiple comorbidities, or with a poorly controlled disease requiring corticosteroids who develop COVID-19 infection should be aggressively managed, given the increased risk of worse outcomes.

A survey was conducted by Marc D Basson on Ulcerative Colitis in 2019, in the United States, where about one million people were affected with ulcerative colitis. The annual incidence is 10.4 -12 cases per 100,000 people and the prevalence rate is 35-100 cases per 100,000 people.

Moreover, the increasing involvement of key players in product development related to the field is anticipated to drive the segment. For instance, in March 2019, Johnson & Johnson Services Inc. announced new data from its Phase III UNIFI study showing positive results of STELARA in adults suffering from moderate to severe ulcerative colitis. In addition, in March 2021, in Canada, Eli Lilly and Company initiated a phase II clinical trial to assess the efficay and safety of LY3471851 in adult patients with active ulcerative colitis (UC). The study is expected to complete in October 2024. Thus, the above factors is expected to drive the market growth over the forecast period in the region.

Competitive Landscape

The Ulcerative Colitis Market is consolidated competitive. The companies implement certain strategic initiatives, such as merger, new product launch, acquisition, and partnerships that help them in strengthening their market position. For instance, in May 2018, Takeda Pharmaceutical Company Limited and Shire Plc announced that they reached an agreement on the terms of a recommended offer pursuant to which Takeda will acquire the entire issued and to be issued ordinary share capital of Shire. Some of the market players include Bausch Health Companies Inc. (Salix Pharmaceutical), Johnson and Johnson, Merck & Co., Inc., AbbVie Inc. (Allergan, Inc.), Novartis AG, among others.

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Table of Contents

1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 High Global Incidence and Prevalence of Ulcerative Colitis
4.2.2 Technological Advancements
4.2.3 Increase in Patient Assistance Programs
4.3 Market Restraints
4.3.1 High Levels of Unmet Clinical Need in Ulcerative Colitis (UC)
4.3.2 Side-effects of Medications
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION
5.1 By Drug Type
5.1.1 Anti-Inflammatory Drugs
5.1.1.1 Aminosalicylates
5.1.1.2 Corticosteroids
5.1.2 Anti-TNF biologics
5.1.3 Immunosuppressant
5.1.4 Calcineurin Inhibitors
5.1.5 Other Drug Types
5.2 By Disease Type
5.2.1 Ulcerative Proctitis
5.2.2 Proctosigmoiditis
5.2.3 Left-sided Colitis
5.2.4 Pancolitis or Universal Colitis
5.2.5 Fulminant Colitis
5.3 Geography
5.3.1 North America
5.3.1.1 United States
5.3.1.2 Canada
5.3.1.3 Mexico
5.3.2 Europe
5.3.2.1 Germany
5.3.2.2 United Kingdom
5.3.2.3 France
5.3.2.4 Italy
5.3.2.5 Spain
5.3.2.6 Rest of Europe
5.3.3 Asia-Pacific
5.3.3.1 China
5.3.3.2 Japan
5.3.3.3 India
5.3.3.4 Australia
5.3.3.5 South Korea
5.3.3.6 Rest of Asia-Pacific
5.3.4 Middle East and Africa
5.3.4.1 GCC
5.3.4.2 South Africa
5.3.4.3 Rest of Middle East and Africa
5.3.5 South America
5.3.5.1 Brazil
5.3.5.2 Argentina
5.3.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 AbbVie Inc. (Allergan, Inc.)
6.1.2 Bausch Health Companies Inc. (Salix Pharmaceutical)
6.1.3 Boehringer Ingelheim GmbH
6.1.4 Johnson and Johnson
6.1.5 Merck & Co., Inc.,
6.1.6 Novartis AG
6.1.7 Takeda Pharmaceutical Company Limited
6.1.8 Teva Pharmaceutical Industries Ltd
6.1.9 Pfizer Inc.
6.1.10 Eli Lilly and Company
6.1.11 Arena Pharmaceuticals, Inc.
6.1.12 Bridge Biotherapeutics, Inc.

7 MARKET OPPORTUNITIES AND FUTURE TRENDS