Ulcerative Colitis Drugs Market 2034: Clinical trials, EMA, PDMA, FDA Approvals, Medication, Statistics, Revenue, Therapies, Prevalence and Companies by DelveInsight

Ulcerative Colitis Drugs Market

(Albany, USA) DelveInsight’s Ulcerative Colitis Market report offers a detailed comprehension of the Ulcerative Colitis market size by treatment, epidemiology, and emerging therapies. The report also provides an understanding of Ulcerative Colitis market share of the individual therapies, current and forecasted Ulcerative Colitis market size from 2020 to 2034 segmented into 7MM (the USA, EU5 (the UK, Italy, Spain, France, and Germany), and Japan).

The Ulcerative Colitis market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Ulcerative Colitis market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Ulcerative Colitis treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Ulcerative Colitis market.

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Key highlights from the Ulcerative Colitis Market Insight report

• According to DelveInsight, the Ulcerative Colitis market size is expected to grow at a decent CAGR by 2034.
• The total Ulcerative Colitis Market Size in the 7MM was approximately USD 8090 million in 2022 and is projected to increase during the forecast period (2023–2034).
• In the United States, the total number of diagnosed prevalent cases of ulcerative colitis was 1,437,600 in 2022.
• Leading Ulcerative Colitis companies working proactively in the therapeutic market are 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 several others in the clinical development stage for Ulcerative Colitis will lead to a significant increase in the market size during the forecast period.
• The key Ulcerative Colitis therapies expected to launch in the market include Jyseleca (filgotinib), Rinvoq (Upadacitinib), Skyrizi (Risankizumab), Mirikizumab (LY-3074828), Etrasimod, Tremfya (Guselkumab), Izencitinib (TD-1473/ JNJ 8398), BT-11, and others.
• According to DelveInsight analysis, the Ulcerative Colitis market is expected to rise in the coming years due to the entry of novel therapies with better clinical profile and patient convenient RoA, increase in market penetration of targeted/ advanced therapies, increasing prevalence of Ulcerative Colitis, and new biomarkers for diagnosis of Ulcerative Colitis.
• In March 2025, Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio”, or the “Company”), a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today provided an update on its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC).
• In February 2025, Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, and Biocon Limited (BSE code: 532523, NSE: BIOCON), an innovation-led global biopharmaceutical company, today announced positive topline results from the Phase 2 study evaluating itolizumab in the treatment of moderate to severe ulcerative colitis (UC).
• In January 2025, Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company developing innovative therapies to address chronic inflammatory diseases, today announced a significant milestone in the Phase 3 ABTECT clinical trial evaluating obefazimod for the treatment of moderately to severely active UC.
• In September 2024, Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic disease of the large intestine in which the lining of the colon becomes inflamed. TREMFYA® is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC.
• In August 2024, Abivax SA (Euronext Paris & Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, announced today that in July 2024, the 600th participant was enrolled in the Phase 3 ABTECT Trial. Based on this milestone and current enrollment pace, the Company reaffirms expectations to reach full enrollment in early Q1 2025.
• On April 2024, Vedanta Biosciences announced results of A Phase 2 double-blind, placebo-controlled, randomized study to evaluate the safety, efficacy, and microbiota changes of VE202 in biologic-naïve patients with mild to moderate Ulcerative Colitis. 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.
• On March 2024, Eli Lilly announced results of a Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and Its Relationship with Other Outcome Measures in Adults With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab.

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Ulcerative Colitis Overview

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that causes inflammation and ulcers in the lining of the colon and rectum. It is an autoimmune condition in which the immune system mistakenly attacks the intestinal lining, leading to symptoms such as abdominal pain, persistent diarrhea, rectal bleeding, weight loss, and fatigue. The severity of symptoms varies, with periods of flare-ups and remission.

The exact cause of ulcerative colitis is unknown, but genetic factors, immune system dysfunction, and environmental triggers are believed to play a role. It is commonly diagnosed in young adults between 15 and 30 years old. Diagnosis involves clinical evaluation, blood tests, stool tests, colonoscopy, and imaging studies.

Treatment focuses on reducing inflammation and managing symptoms. Mild to moderate cases are treated with aminosalicylates (5-ASA drugs) like mesalamine, while corticosteroids, immunosuppressants, and biologic therapies (such as TNF inhibitors and JAK inhibitors) are used for more severe cases. In refractory cases or complications like toxic megacolon, surgery (colectomy) may be required.

While ulcerative colitis has no cure, early diagnosis and proper treatment can improve quality of life. Ongoing research into new biologics and microbiome-based therapies offers hope for better disease management.

Ulcerative Colitis Epidemiology Segmentation

DelveInsight’s analysts indicate that the total diagnosed cases of Ulcerative Colitis in the 7MM were 1,577,979 in 2020. These cases are expected to rise by 2034, during the forecast period.

The Ulcerative Colitis market report proffers epidemiological analysis for the study period 2020-32 in the 7MM segmented into:

• Total Prevalent Ulcerative Colitis Cases
• Total Diagnosed Prevalent Ulcerative Colitis Cases
• Age-Specific Diagnosed Prevalent Cases of Ulcerative Colitis
• Severity-Specific Diagnosed Prevalent Cases of Ulcerative Colitis
• Total Treated Ulcerative Colitis Cases

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Ulcerative Colitis Pipeline Therapies and Key Companies

• Jyseleca (filgotinib): Gilead Sciences/Galapagos NV
• Rinvoq (Upadacitinib) & Skyrizi(Risankizumab): AbbVie
• Risankizumab (ABBV-066): AbbVie and Boehringer Ingelheim
• Mirikizumab (LY-3074828): Eli Lilly and Company
• Etrasimod: Arena Pharmaceuticals
• Tremfya (Guselkumab): Janssen (Johnson & Johnson)
• Izencitinib (TD-1473/ JNJ 8398): Theravance Biopharma/Johnson & Johnson
• BT-11: Landos Biopharma

Ulcerative Colitis Market Dynamics

The current therapeutic landscape of Ulcerative Colitis in the 7MM is driven by several approved therapies. Also, the Ulcerative Colitis market is expected to surge due to factors such as the increasing prevalence of Ulcerative Colitis, entry of novel therapies with better clinical profile and patient convenient RoA, increase in market penetration of targeted/ advanced therapies, new biomarkers for diagnosis of Ulcerative Colitis and also the involvement of digital technology for diagnosis and treatment.

A high number of undiagnosed and unreported cases contribute to the lack of awareness of Ulcerative Colitis. The entry of biosimilars in the Ulcerative Colitis Market, insufficient knowledge of the disease, and significant drawbacks of existing therapeutic options may act as certain obstructions in the Ulcerative Colitis market.

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Scope of the Ulcerative Colitis Market Report

• Study Period: 2020-34
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Ulcerative Colitis Companies: Takeda Pharmaceutical, Pfizer, Celgene (Bristol-Myers Squibb), Gilead Sciences, Galapagos NV, AbbVie, Eli Lilly and Company, Arena Pharmaceuticals, Janssen (Johnson & Johnson), Theravance Biopharma, Landos Biopharma
• Key Ulcerative Colitis Drugs: Jyseleca (filgotinib), Rinvoq (Upadacitinib), Skyrizi(Risankizumab), Mirikizumab (LY-3074828), Etrasimod, Tremfya (Guselkumab), Izencitinib (TD-1473/ JNJ 8398), BT-11
• Ulcerative Colitis Therapeutic Assessment: Ulcerative Colitis current marketed and emerging therapies
• Ulcerative Colitis Market Dynamics: Ulcerative Colitis market drivers and barriers
• Competitive Intelligence Analysis: Porter’s five forces, SWOT analysis, PESTLE analysis, Market entry strategies, BCG Matrix, Unmet Needs
• KOL views
• Reimbursement Scenario

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Table of Contents

1. Key Insights

2. Report Introduction of Ulcerative Colitis

3. Ulcerative Colitis Market Overview at a Glance

4. Executive Summary of Ulcerative Colitis

5. Ulcerative Colitis Epidemiology and Market Forecast Flow

6. Ulcerative Colitis: Disease Background and Overview

7. Ulcerative Colitis Diagnosis

8. Ulcerative Colitis Current Treatment

9. Ulcerative Colitis Epidemiology and Patient Population

10. Ulcerative Colitis Patient Journey

11. Key Endpoints in Ulcerative Colitis Clinical Trials

12. Ulcerative Colitis Marketed Therapies of Ulcerative Colitis

13. Ulcerative Colitis Emerging Therapies

14. Conjoint Analysis of Ulcerative Colitis

15. Ulcerative Colitis: Seven Major Market Analysis

16. The United States Market Size

17. Ulcerative Colitis Market Access and Reimbursement

18. Ulcerative Colitis Market Drivers

19. Ulcerative Colitis Market Barriers

20. Ulcerative Colitis SWOT Analysis

21. Ulcerative Colitis Unmet Needs

22. Appendix

23. DelveInsight Capabilities

24. Disclaimer

25. About DelveInsight

About DelveInsight

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