Ulcerative Colitis Treatment Landscape Undergoes Rapid Transformation with FDA Approvals and Robust Pipeline: DelveInsight | Arena Pharmaceuticals, Pfizer, Abivax, Reistone Biopharma, InDex, AbbVie, Boehringer Ingelheim, Janssen, Landos Biopharma, NImmune

The Ulcerative Colitis treatment paradigm is undergoing a dynamic evolution, marked by increasing therapeutic interventions by companies such as Arena Pharmaceuticals, Pfizer, Abivax, Reistone Biopharma, InDex Pharmaceuticals, AbbVie, Boehringer Ingelheim, Janssen Pharmaceuticals, Landos Biopharma, NImmune, Merck and Mesoblast, among others.

DelveInsight's "Ulcerative Colitis Market Insight, Epidemiology And Market Forecast - 2034" report delivers comprehensive insights into the ulcerative colitis market dynamics, epidemiological trends, and treatment landscape across the 7MM which include the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The ulcerative colitis market size in the 7MM was USD 8.4 billion in 2023, with the United States accounting for the largest share at USD 5.9 billion. This market is poised for significant growth during the forecast period (2024-2034), driven by improved drug uptake, increased disease awareness, and a robust pipeline of innovative therapies.

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The report also provides a detailed epidemiological analysis and forecasts up to 2034, segmented by Total Diagnosed Prevalent Cases of Ulcerative Colitis, Age-specific Cases of Ulcerative Colitis, Severity-specific Cases of Ulcerative Colitis, and Total Treated Patients of Ulcerative Colitis.

According to the latest epidemiological analysis, the total diagnosed prevalent cases of ulcerative colitis in the 7MM comprised approximately 3 Million in 2023, with projections indicating continued growth through 2034. The United States contributed the largest share, with approximately 47% of the diagnosed prevalent population, while Germany and Japan each accounted for roughly 10% of the total 7MM patient pool. When examining disease severity, approximately 521K mild cases and 860K moderate to severe cases were identified across these markets.

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The ulcerative colitis treatment market currently encompasses multiple therapeutic approaches, including aminosalicylates, corticosteroids, immunomodulators, biologic therapies, S1P modulators, and Janus kinase inhibitors. Anti-TNF alpha agents remain the recommended first-line treatment option for many patients. Among the currently approved therapies, HUMIRA (AbbVie), REMICADE (Janssen Pharmaceuticals), SIMPONI (Janssen Pharmaceuticals), ENTYVIO (Takeda Pharmaceuticals), XELJANZ (Pfizer), STELARA (Janssen Pharmaceuticals), CAROGRA (EA Pharma/Kissei Pharma), JYSELECA (Gilead Sciences and Galapagos NV), OMVOH (Eli Lilly), SKYRIZI (AbbVie/Boehringer Ingelheim), RINVOQ (AbbVie), and ZEPOSIA (Bristol-Myers Squibb), among others have established strong market positions. By 2034, ENTYVIO is projected to generate the highest revenue in the United States, followed by HUMIRA (AbbVie).

In December 2024, Biocon Biologics and Celltrion received FDA approval for their respective biosimilars to STELARA (Janssen Pharmaceuticals) - YESINTEK (Biocon Biologics) and STEQEYMA (Celltrion) - expanding treatment options for patients with ulcerative colitis. In February 2024, the European Commission granted marketing authorization for VELSIPITY (etrasimod) for patients 16 years and older with moderately to severely active ulcerative colitis following its FDA approval in October 2023.

The ulcerative colitis therapeutics market is witnessing significant innovation with several emerging therapies such as, Etrasimod (Arena Pharmaceuticals/Pfizer), ABX464 (Abivax), SHR0302 (Reistone Biopharma), Cobitolimod (InDex Pharmaceuticals), TREMFYA (Janssen Pharmaceuticals), BT-11 (Landos Biopharma/NImmune), PRA023 (Merck), Remestemcel-L (Mesoblast), PF-06651600 (Pfizer) and PF-06700841 (Pfizer) among others.

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Recent developments have further enriched the ulcerative colitis market with several regulatory approvals and clinical advancements. In December 2024, Accropeutics Inc. announced FDA clearance for a Phase II trial of its RIPK2 inhibitor, AC-101, for moderate-to-severe Ulcerative Colitis. Additionally, in November 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of TREMFYA (guselkumab). In late 2024, AbbVie's SKYRIZI had rapidly outpaced Eli Lilly's OMVOH in the ulcerative colitis market, securing over double the market share just two months post-launch.

In January 2025, the FDA granted investigational new drug (IND) clearance for R-5780 (Rise Therapeutics). This innovative therapy leverages gut-regulated immune pathways to enhance the efficacy of immune checkpoint inhibitors, offering a novel approach to treating cancers that are refractory or unresponsive to these therapies.

Looking ahead, the ulcerative colitis market is expected to witness significant transformation with the introduction of novel therapeutic classes, including toll-like receptor 9 activators, miR-124 enhancers, and T-cell therapies. While high therapy costs and complications pose challenges, rising awareness, early screening, and advanced treatment strategies are fueling ulcerative colitis treatment market growth.

The ulcerative colitis epidemiology and the market landscape present both opportunities and challenges for stakeholders. As treatment paradigms continue to evolve, focusing on personalized medicine and improved patient outcomes, the ulcerative colitis treatment market is positioned for substantial growth, offering new hope for the millions affected by this chronic inflammatory condition worldwide.

Scope of the Ulcerative Colitis Market Report

Study Period: 2020-2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key Ulcerative Colitis Companies
Key Ulcerative Colitis Therapies
Ulcerative Colitis Therapeutic Assessment: Ulcerative Colitis current marketed and Ulcerative Colitis emerging therapies
Ulcerative Colitis Market Dynamics: Ulcerative Colitis market drivers and Ulcerative Colitis market barriers
Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
Ulcerative Colitis Unmet Needs, KOL's views, Analyst's views, Ulcerative Colitis Market Access and Reimbursement
Table of Contents

1. Key Insights
2. Report Introduction
3. Executive Summary
4. Ulcerative Colitis Market Overview at a Glance
5. Epidemiology and Market Forecast Methodology
6. Key Events
7. Ulcerative Colitis Background and Overview
8. Ulcerative Colitis Treatment
9. Ulcerative Colitis Epidemiology and Patient Population in the 7MM
10. Ulcerative Colitis Patient Journey
11. Ulcerative Colitis Marketed Drug
12. Ulcerative Colitis Emerging Drugs
13. Ulcerative Colitis: 7MM Analysis
14. Unmet needs
15. SWOT Analysis
16. KOL Views
17. Market Access and Reimbursement
18. Appendix
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

Company Name: DelveInsight Business Research LLP
Contact Person: Arpit Anand
Email: info@delveinsight.com
Phone: +14699457679
Address: 304 S. Jones Blvd #2432
City: Las Vegas
State: Nevada
Country: United States
Website: https://www.delveinsight.com/

About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

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