Ulcerative Colitis (UC) - Market Insight, Epidemiology And Market Forecast - 2032

Ulcerative Colitis (UC) - Market Insight, Epidemiology And Market Forecast - 2032

DelveInsight’s ‘Ulcerative Colitis (UC) - Market Insights, Epidemiology, and Market Forecast—2032’ report delivers an in-depth understanding of the UC, historical and forecasted epidemiology as well as the UC market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom), and Japan.

The UC market report provides current treatment practices, emerging drugs, UC market share of the individual therapies, current and forecasted UC market size from 2019 to 2032 segmented by seven major markets. The Report also covers current UC 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: 2019–2032

UC Disease Understanding and Treatment Algorithm

UC Overview

Ulcerative colitis is an inflammatory bowel idiopathic condition that affects the colonic mucosa and is characterized clinically by diarrhea, stomach discomfort, pain, and hematochezia. The extent of the disease is variable and may include either the rectum (ulcerative proctitis), the splenic flexure of the left side of the colon, or the whole of the rectum and bowel. Histologically, the severity of the disorder can also be very complex, varying from minimal to florid ulceration and dysplasia. Carcinoma can be considered developing. The usual histological (microscopic) UC lesion is the crypt abscess, where the crypt’s epithelium breaks down, and polymorphonuclear cells fill the lumen. Approximately 10% of cases of inflammatory bowel diseases exhibit the features of both CD and ulcerative colitis. These are typically known as indeterminate colitis (IC). IC originally refers to IBD cases in which there was difficulty distinguishing between UC and CD in the colectomy specimen. However, IC is increasingly used when a definitive diagnosis of UC or CD cannot be made at colonoscopy, in colonic biopsies or at colectomy.

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UC Diagnosis

UC diagnosis is based on medical history and clinical judgment. Laboratory, radiologic, endoscopic, histologic, and subsequently authenticated. Serological observations and findings. UC patients may be identified by degree of disease, severity of disease, age of onset, extraintestinal symptoms, and genetic markers. Before making the diagnosis, infective, ischemic and irradiation causes of colitis must be excluded. The diagnosis of UC relies on the presence of (a) bloody diarrhea with negative stool cultures and (b) endoscopic evidence of diffuse, continuous mucosal inflammation involving the rectum and extending to a point more proximal in the colon. However, a commonly accepted catalogue of well-defined criteria or a point score for the classification of UC does not exist.

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UC Treatment

Treatment for UC is complex and comprises the use of medication, alterations in diet and nutrition, and at times surgical procedures to repair or remove affected portions of patient’s GI tract. Currently, there are several type of medications used for the treatment purpose, namely Aminosalicylates, Corticosteroids, Immunomodulators, Biologic therapies and Janus kinase (JAK) inhibitors. At times, combination therapy and dietary supplementation is also prescribed.

If the patient has stopped responding to their medication or if their medication is no longer working effectively as it was used to or the patient have frequent flare-ups then in such cases surgery is suggested as the best option.

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UC Epidemiology

Key Findings

In 2021, the overall prevalent cases of UC accessed to be around 2,221,400 in the 7MM, which are expected to grow during the forecast period, i.e., 2022–2032.

The disease epidemiology covered in the report provides historical as well as forecasted UC epidemiology [segmented as Total Prevalent cases of UC, Total Diagnosed Prevalent cases of UC, Age-specific Diagnosed Prevalent Cases of UC, and Severity-Specific Diagnosed Prevalent Cases of UC in the 7MM, covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), and Japan from 2022 to 2032.

Country Wise- UC Epidemiology

• In the United States, the total number of prevalent cases of UC were around 1,017,400 in the year 2021, which are expected to grow during the study period, i.e., 2019–2032.
• In the year 2021, the total prevalent cases of UC were around 1,020,600 in EU-5, which are expected to grow during the study period, i.e., 2019–2032.
• In Japan, the total number of prevalent cases of UC were around 183,400 in the year 2021 which are expected to grow during the study period, i.e., 2019–2032.
• In 2021, mild and moderate-to-severe cases of UC were accounted for around 327,500 and 400,300 in the United States.
• In the 7MM, the age-specific diagnosed prevalent cases of UC were around 953500; 445,000; 174,800; and 15,900 for the age-groups 18-44, 45-64, 65-84, and ≥85 years respectively, in 2021.

UC Drug Chapters

Drug chapter segment of the UC report encloses the detailed analysis of UC developmental stage pipeline drugs. It also helps to understand the UC clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

UC Marketed Therapies

Entyvio (Vedolizumab): Takeda Pharmaceutical

Entyvio (Vedolizumab) is a gut-selective biologic developed by Takeda Pharmaceutical and marketed under the trade name Entyvio. It is approved in the US for the treatment of adult patients with moderately to severely active UC and Crohn’s disease (CD), who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα)-antagonist. It is a humanized monoclonal antibody designed to specifically antagonize the alpha 4 beta 7 integrin, inhibiting the binding of alpha 4 beta 7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), but not Vascular Cell Adhesion Molecule 1 (VCAM-1).

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Stelara (Ustekinumab): Janssen Pharmaceuticals

Stelara is a human IgG1κ monoclonal antibody and a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab comprises 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Da.

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Remicade (Infliximab): Janssen Biotech

Remicade is a product developed by Janssen Biotech (formerly known as Centocor), a subsidiary of Johnson & Johnson. The active ingredient in Remicade is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions) specific for human tumor necrosis factor-alpha (TNFα). It has a molecular weight of approximately 149.1 kDa. Infliximab is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses, reducing the effects of a substance in the body that can cause inflammation.

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Simponi (Golimumab): Janssen Pharmaceuticals

Simponi is a human monoclonal antibody that targets and neutralizes excess tumor necrosis factor (TNF)-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. Simponi is the first and only subcutaneous anti–tumor necrosis factor (TNF)-alpha treatment administered as an every-4-week maintenance therapy for UC.

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Xeljanz (Tofacitinib): Pfizer

Xeljanz (tofacitinib) is an orally administered, small molecule, JAK inhibitor being developed by Pfizer to treat adults with moderately to severely active UC when medicines called TNF blockers do not work well or cannot be tolerated. Xeljanz is the first oral medication approved for chronic use in this indication. Tofacitinib works by blocking the body’s production of enzymes called Janus kinases (JAKs).

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Humira (Adalimumab): AbbVie

Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human-derived heavy and light chain variable regions and human IgG1 constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.

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Note: Full and detailed list of marketed therapies will be provided in the final report.

UC Emerging Drugs

Skyrizi (Risankizumab): AbbVie/Boehringer Ingelheim

Risankizumab (ABBV-066) is an anti-IL-23 antibody being investigated to treat multiple inflammatory diseases, including psoriasis CD, UC, and psoriatic arthritis (abbvie, 2022a). Risankizumab is a humanized monoclonal antibody that blocks the binding of IL-23R and activation of the pro-inflammatory JAK/STAT intracellular signaling cascade by targeting the p19 component of IL-23. The cytokine IL-23, which plays a role in inflammatory processes, is thought to be associated with various chronic immune-mediated illnesses.

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Etrasimod (APD334): Arena Pharmaceuticals

Etrasimod (APD334) is a next-generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator discovered by Arena and designed for optimized pharmacology and engagement of S1P receptors 1, 4, and 5 which may lead to an improved efficacy and safety profile. Etrasimod provides systemic and local effects on specific immune cell types and has the potential to treat multiple immune-mediated inflammatory diseases, including CD and UC.

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Mirikizumab (LY-3074828): Eli Lilly and Company

LY3074828 (formerly known as IL-23 antibody) is a biological entity that blocks the activity of the cytokine interleukin 23. Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23, and it is being studied to treat immune-mediated diseases, including UC.

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Note: Full and detailed list of emerging therapies will be provided in the final report.

UC Market Outlook

Key Findings

The UC market size in the 7MM is expected to change during the study period 2019–2032, at a CAGR of 9.4%. According to the estimates, the highest market size of UC is accessed in the United States followed by Germany, and the United Kingdom, in 2021.

The United States Market Outlook

In United States, the total market size of UC therapies is expected to increase at a CAGR of 10% during the study period (2019–2032).

EU-5 Countries: Market Outlook

In EU-5, the total market size of UC therapies is expected to increase at a CAGR of 8% during the study period (2019–2032).

Japan Market Outlook

The total market size of UC therapies in Japan is estimated to rise at a CAGR of 6%, during the study period (2019–2032).

UC Pipeline Development Activities

The drugs which are in pipeline include:

1. Skyrizi (Risankizumab): AbbVie/Boehringer Ingelheim

2. Etrasimod (APD334): Arena Pharmaceuticals

3. Mirikizumab (LY-3074828): Eli Lilly and Company

4. Tremfya (Guselkumab): Janssen (Johnson & Johnson)

5. BT 11: Landos Biopharma

6. Deucravacitinib (BMS-986165): Bristol-Myers Squibb

7. SHR 0302: Reistone Biopharma

Note: Detailed emerging therapies assessment will be provided in the final report.

UC Drugs Uptake

Access and Reimbursement Scenario in UC Therapies

For UC, most medications are covered under both the pharmacy and medical benefits with some limitations. For all of the drugs, more than half of covered lives are under the preferred tier/preferred with prior authorization or step therapy and covered tier/covered with PA/ST under the pharmacy benefit.

Entyvio Patient Assistance Programs offer product support for eligible individuals who are diagnosed with UC. This program is designed to help patients by providing co-pay assistance, nurse support, and valuable tips. Once the patients have been prescribed Entyvio, EntyvioConnect can partner with them at every step of the insurance approval process and also works closely with eligible patients to help them afford their treatment.

The support offered by the Entyvio covers:

• The benefit of the investigations
• Prior authorization of information and support
• Denials and appeals support

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KOL-Views

To keep up with current market trends, we take KOLs and SME’s opinion working in the UC domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or UC market trend. This will support the clients in potential upcoming novel treatment by identifying the over UC scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the UC Market by using various Competitive Intelligence tools that includes – 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 UC, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies.
• Comprehensive insight has been provided into the UC epidemiology and treatment in the 7MM.
• Additionally, an all-inclusive account of both the current and emerging therapies for UC is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of UC market; historical and forecasted is included in the report, covering drug outreach in the 7MM.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the global UC market.

Report Highlights

• In the coming years, UC 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 UC R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for UC.
• Our in-depth analysis of the pipeline assets across different stages of development different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the over UC scenario of the research and development activities.

UC Report Insights

• Patient Population
• Therapeutic Approaches
• UC Pipeline Analysis
• UC Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

UC Report Key Strengths

• 11 Years Forecast
• 7MM Coverage
• UC Epidemiology Segmentation
• Highly Analyzed Market
• Drugs Uptake

UC Report Assessment

• SWOT Analysis
• Current Treatment Practices
• Unmet Needs
• Market Attractiveness
• Market Drivers and Barriers

Key Questions

Market Insights:

• What was the UC Market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the UC total market size as well as market size by therapies across the 7MM during the study period (2019–2032)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest UC market size during the study period (2019–2032)?
• At what CAGR, the UC market is expected to grow in the 7MM during the study period (2019–2032)?
• What would be the UC market outlook across the 7MM during the study period (2019–2032)?
• What would be the UC market growth till 2032 and what will be the resultant market size in the year 2032?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• UC patient types/pool where unmet need is more and whether emerging therapies will be able to address the residual unmet need?
• How emerging therapies are performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration and frequencies on the basis of their clinical trial results?
• Among the emerging therapies, what are the potential therapies which are expected to disrupt the UC market?

Epidemiology Insights:

• What is the disease risk, burden and unmet needs of the UC?
• What is the historical UC patient pool in the seven major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
• What would be the forecasted patient pool of UC in the 7 major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
• What will be the growth opportunities in the 7MM with respect to the patient population pertaining to UC?
• Out of UC the 7MM countries, which country would have the highest prevalent population of UC during the study period (2019–2032)?
• At what CAGR the population is expected to grow in the 7MM during the study period (2019–2032)?
• What are the various recent and upcoming events which are expected to improve the diagnosis of UC?

Current Treatment Scenario and Emerging Therapies:

• What are the current options for the treatment of UC?
• What are the current treatment guidelines for the treatment of UC in the US, Europe and Japan?
• How many companies are developing therapies for the treatment of UC ?
• How many therapies are developed by each company for the treatment of UC?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of UC?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, and licensing activities related to the UC 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 UC and their status?
• What are the key designations that have been granted for the emerging therapies for UC?
• What is the global historical and forecasted market of UC?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the UC market.
• To understand the future market competition in the UC market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for UC in the US, Europe (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
• Identification of strong upcoming players in 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 UC market.
• To understand the future market competition in the UC market.