DelveInsight’s “Ulcerative Colitis Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of the Ulcerative Colitis, historical and forecasted epidemiology as well as the Ulcerative Colitis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

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Key Takeaways from the Ulcerative Colitis Market Report

• In April 2025, Vedanta Biosciences Inc. announced a phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in biologic-naïve patients with mild to moderate UC. In Parts 1 and 2 of the study, patients will receive VE202 or placebo for 8 weeks or 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.
• In April 2025, Eli Lilly and Company announced a study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including screening. The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).
• In April 2025, AbbVie announced a study is to assess how safe and effective lutikizumab is in adult participants with moderate to severe UC and how lutikizumab compares to adalimumab in the treatment of UC. Adverse events and changes in disease activity will be assessed.
• In March 2025, Celltrion announced the U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), following FDA approval in December 2024. STEQEYMA is approved for the same indications as STELARA, offering consistent treatment for patients and healthcare providers.
• In January 2025, Rise Therapeutics announced that the FDA has accepted its IND application to begin a Phase 1 cancer trial for R-5780, marking the company’s fourth clinical program. Ongoing studies for other products are focused on ulcerative colitis, rheumatoid arthritis, and type 1 diabetes.
• The total Ulcerative Colitis diagnosed prevalent cases in the 7MM comprised approximately 3,114,000 cases in 2023 and are projected to increase during the forecasted period.
• The United States contributed to the largest diagnosed prevalent ulcerative colitis population, acquiring ~47% of the 7MM in 2023. Whereas Germany and Japan accounted for around 10% each of the total 7MM population share in 2023.
• According to DelveInsight estimates, the severity-specific diagnosed prevalent cases of Ulcerative colitis were approximately 521,000 mild and 860,000 total moderate to severe cases in 2023 in EU4 and the UK. These cases are projected to increase during the forecasted period.
• In 2023, among the total number of treated patients of ulcerative colitis in Japan, moderate-to-severe patients treated in first-line were highest and are expected to rise in the forecasted period (2024-2034).
• The leading Ulcerative Colitis Companies such as Janssen Pharmaceuticals, Takeda Pharmaceuticals, Pfizer, EA Pharma, Kissei Pharma, Gilead Sciences, Galapagos NV, Celgene (Bristol-Myers Squibb), AbbVie, Arena Pharmaceuticals, Reistone Biopharma, Landos Biopharma, Bridge Biotherapeutics, Applied Molecular Transport, AbGenomics (AltruBio), Abivax, Connect Biopharma, Boehringer Ingelheim, Eli Lilly and Company, InDex Pharmaceuticals, Bristol-Myers Squibb, Protagonist Therapeutics, Mesoblast Ltd, and others.
• Promising Ulcerative Colitis Pipeline Therapies such as VE202, PL8177, Eltrekibart, Mirikizumab, Etrasimod, Vixarelimab and others.

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Ulcerative Colitis Epidemiology Segmentation in the 7MM

• Total Ulcerative Colitis Diagnosed Prevalent Cases
• Ulcerative Colitis Age-specific Cases
• Ulcerative Colitis Severity-specific Cases
• Total Ulcerative Colitis Treated Patients

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Ulcerative Colitis Marketed Drugs

• 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 the bones, cartilage, and tissue. SIMPONI is the first subcutaneous anti-tumor necrosis factor (TNF)-alpha treatment administered as an every 4-week maintenance therapy for ulcerative colitis.

• ENTYVIO (vedolizumab): Takeda Pharmaceuticals

It is a humanized monoclonal antibody designed to antagonize the alpha 4 beta 7 integrin specifically, inhibiting the binding of alpha 4 beta 7 integrins to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1). The alpha 4 beta 7 integrin is expressed on a subset of circulating white blood cells, and these cells have been shown to mediate the inflammatory process in ulcerative colitis and Crohn’s disease. By inhibiting alpha 4 beta 7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.

• Etrasimod (APD334): Arena Pharmaceuticals/Pfizer

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 can potentially treat multiple immune-mediated inflammatory diseases, including Crohn’s disease and ulcerative colitis.

Ulcerative Colitis Emerging Drugs

• ABX464 (obefazimod): Abivax

ABX464 is an oral, first-in-class, small molecule that selectively upregulates miR-124 in immune cells. Because of its ability to greatly upregulate the production of a unique RNA splicing product and anti-inflammatory agent, miR-124, ABX464’s mechanism of action is unique. It has shown promise in clinical trials in bringing patients into remission and healing inflammatory lesions in ulcerative colitis.

• SHR0302 (Ivarmacitinib): Reistone Biopharma

SHR0302 is a novel, potent, orally administered selective JAK 1 inhibitor in development by Reistone Biopharma to treat IBD, such as ulcerative colitis and Crohn’s disease. JAK1 selectivity could potentially provide a favorable safety and efficacy profile compared to the pan-JAK inhibitor. Longer-term clinical studies are ongoing to confirm a favorable risk-benefit of JAK1 selectivity by avoiding the hematological side effects of JAK2 inhibition (Reistone Biopharma, 2021a).

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Ulcerative Colitis Companies

Janssen Pharmaceuticals, Takeda Pharmaceuticals, Pfizer, EA Pharma, Kissei Pharma, Gilead Sciences, Galapagos NV, Celgene (Bristol-Myers Squibb), AbbVie, Arena Pharmaceuticals, Reistone Biopharma, Landos Biopharma, Bridge Biotherapeutics, Applied Molecular Transport, AbGenomics (AltruBio), Abivax, Connect Biopharma, Boehringer Ingelheim, Eli Lilly and Company, InDex Pharmaceuticals, Bristol-Myers Squibb, Protagonist Therapeutics, Mesoblast Ltd, and others.

Ulcerative Colitis Market Outlook

Ulcerative Colitis treatment 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 the patient’s gastrointestinal tract. The current treatment landscape of Ulcerative Colitis consists of conventional choices such as aminosalicylates, corticosteroids, thiopurines, calcineurin inhibitors, anti-TNF agents (HUMIRA [adalimumab], REMICADE [infliximab], and SIMPONI [golimumab]), antiadhesion molecules (ENTYVIO [vedolizumab]), and, more recently, small molecule directed against the JAK pathways (XELJANZ [tofacitinib]), anti-IL12/23 (STELARA [ustekinumab]), and S1P receptor modulator (ZEPOSIA [ozanimod]).

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Scope of the Ulcerative Colitis Market Report

• Coverage- 7MM
• Study Period- 2020-2034
• Ulcerative Colitis Companies- Janssen Pharmaceuticals, Takeda Pharmaceuticals, Pfizer, EA Pharma, Kissei Pharma, Gilead Sciences, Galapagos NV, Celgene (Bristol-Myers Squibb), AbbVie, Arena Pharmaceuticals, Reistone Biopharma, Landos Biopharma, Bridge Biotherapeutics, Applied Molecular Transport, AbGenomics (AltruBio), Abivax, Connect Biopharma, Boehringer Ingelheim, Eli Lilly and Company, InDex Pharmaceuticals, Bristol-Myers Squibb, Protagonist Therapeutics, Mesoblast Ltd, and others.
• Ulcerative Colitis Pipeline Therapies- VE202, PL8177, Eltrekibart, Mirikizumab, Etrasimod, Vixarelimab and others.
• Ulcerative Colitis Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Ulcerative Colitis Unmet Needs, KOL’s views, Analyst’s views, Ulcerative Colitis Market Access and Reimbursement

Table of Content

1. Key Insights

2. Report Introduction

3. Ulcerative Colitis Market Overview at a Glance

4. Epidemiology and Market Methodology

5. Ulcerative Colitis Executive Summary

6. Ulcerative Colitis Market Disease Background and Overview

7. Ulcerative Colitis Epidemiology and Patient Population

8. Patient Journey

9. Ulcerative Colitis Marketed Therapies

10. Ulcerative Colitis Emerging Drugs

11. Ulcerative Colitis: The 7MM Analysis

12. Ulcerative Colitis Market Access and Reimbursement

13. Ulcerative Colitis KOL Views

14. Ulcerative Colitis SWOT Analysis

15. Ulcerative Colitis Unmet Needs

16. Appendix

17. DelveInsight Capabilities

18. Disclaimer

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