Ulcerative Colitis - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• The Ulcerative Colitis Market Size in the 7MM was around USD 8,400 Million in 2023. The Ulcerative Colitis Market is anticipated to witness a positive shift owing to better uptake of existing drugs, and raised awareness.
• 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.
• Currently, several types of medications are used for treatments, namely aminosalicylates, corticosteroids, immunomodulators, biologic therapies, S1P modulators, Janus kinase inhibitors, and others. However, the ulcerative colitis treatment landscape is evolving with many emerging therapies.
• However, due to unfavorable clinical characteristics and the limited efficacy of existing therapies, many patients stop responding and thus require new therapeutic management options.
• In the United States, anti-TNFaagents (adalimumab, infliximab, golimumab), interleukin antagonists (ustekinumab, mirikizumab), anti-integrin agents (vedolizumab), S1P receptor modulator (ozanimod), and JAK inhibitors (tofacitinib, upadacitinib), are approved for the treatment of moderate to severe ulcerative colitis patients.
• In 2023, the market size of ulcerative colitis was the highest in the US among the 7MM, accounting for approximately USD 5,900 million, which is expected to increase by 2034.
• Among emerging therapies, obefazimod (Abivax), Risankizumab(AbbVie/Boehringer Ingelheim), guselkumab (Janssen), and others will be expanding the treatment landscape of ulcerative colitis.

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.

The Ulcerative Colitis Market Research Report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted Ulcerative Colitis market size from 2020 to 2034 in 7MM. The report also covers current Ulcerative Colitis treatment market practices/algorithms and Ulcerative Coliti unmet needs to curate the best opportunities and assess the market's underlying potential.

Ulcerative Colitis Treatment Market: Overview

Ulcerative colitis is one of the two main forms of chronic inflammatory disease of the gastrointestinal tract, called inflammatory bowel disease, the other being Crohn's disease. Ulcerative colitis is an idiopathic, chronic inflammatory disorder of the colonic mucosa and is clinically characterized by diarrhea, abdominal pain, and hematochezia.

There is no one test to diagnose ulcerative colitis; instead, the symptoms of inflammatory bowel diseases are considered together with the results of endoscopies, biopsies, stool tests, x-rays, and imaging procedures (plain radiograph, fluoroscopy, CT, and MRI). Other than this, laboratory tests like full blood count, inflammatory marker tests, liver function tests, urea, electrolytes, etc., are also performed.

Flexible sigmoidoscopy and colonoscopy are the most accurate methods for diagnosing Ulcerative Colitis and ruling out other possible conditions, such as Crohn's disease, diverticular disease, or cancer. Sophisticated blood tests, based on antibody identification can also be used for differential diagnosis. Many patients with Ulcerative Colitis have Perinuclear anti-neutrophil antibodies in their blood, while patients with Crohn's disease are more likely to have Anti-Saccharomyces Cerevisiae antibodies.

The Ulcerative colitis market forecast report provide overview of pathophysiology, diagnostic approaches and detailed treatment algorithm along with real-world scenario of a patient's journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Ulcerative Colitis Treatment

Ulcerative Colitis treatment is individualized to the specific needs of the patient, depending on the severity of the disease and its symptoms. It involves 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.

Several types of drug classes are used in treatment, including Aminosalicylates, Corticosteroids, Immunomodulators, Janus kinase (JAK) inhibitors and Biologics. In addition to this, Ulcerative Colitis patients are also treated with anti-diarrheal medications, painkillers, iron supplements, and dietary supplements.

Clinical and Registrational Updates in 2024

• 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.
• In December 2024, Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, announced that the FDA approved YESINTEK(TM) (Ustekinumab-kfce), a biosimilar to Stelara(R) (Ustekinumab). YESINTEK(TM), a monoclonal antibody, is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
• In November 2024, Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA, seeking approval for a subcutaneous induction regimen of TREMFYA(R) (guselkumab) to treat adults with moderately to severely active ulcerative colitis (UC).
• In February 2024, The European Commission (EC) has granted marketing authorization for VELSIPITY(R) (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC).This decision follows the recommendation by the EMA in December 2023. It also follows VELSIPITY's approval for adults with moderately to severely active UC by the U.S. FDA in October 2023 and Canada in January 2024.

Ulcerative Colitis Epidemiology

The Ulcerative Colitis epidemiology chapter in the report provides historical as well as forecasted epidemiology 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, in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.

• 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).

Ulcerative Colitis Recent Developments

• In December 2024, Celltrion announced that the FDA approved STEQEYMA(R) (ustekinumab-stba), a biosimilar to STELARA(R) (ustekinumab), for subcutaneous injection or intravenous infusion. It is approved for adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis.
• 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. The 12-week, multi-regional, randomized trial will assess its safety and efficacy.
• On October 7, 2024, Spherix Global Insights reported that AbbVie's Skyrizi has rapidly outpaced Eli Lilly's Omvoh in the ulcerative colitis market, securing over double the market share of its competitor just two months post-launch. However, AbbVie is now confronted with a new competitor, as Spherix anticipates a similarly swift market entry for Johnson & Johnson's Tremfya.

Ulcerative Colitis Drug Chapters

The drug chapter segment of the Ulcerative Colitis market outlook report encloses a detailed analysis of Ulcerative Colitis marketed drugs and late-stage (Phase III and Phase II) Ulcerative Colitis pipeline drugs. It also deep dives into the Ulcerative Colitis clinical trials details, recent and expected market approvals, patent details, the latest Ulcerative Colitis news, and recent deals and collaborations.

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.

It is approved to treat moderately to severely active ulcerative colitis in adults. However, it is also being evaluated in pediatric patients with moderately to severely active ulcerative colitis in currently ongoing trials.

• 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.

Currently, it is approved to treat moderately to severely active ulcerative colitis in adults who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFa)-antagonist.

• 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.

Currently, it is approved for adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or an advanced treatment by US FDA and EMA.

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.

Currently, obefazimod is being evaluated in various Phase III trials to treat moderately to severely active ulcerative colitis. Expected to be in the US market by 2026 with slow-medium uptake.

• 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).

SHR0302 is currently being evaluated in a Phase III (NCT05181137) trial to treat moderately to severely active ulcerative colitis in adults.

Drug Class Insights

A diverse class of treatment agents are now been prescribed for Ulcerative Colitis treatment, like anti-TNFa, anti-leukotriene antagonists, anti-integrins, S1P receptor modulators, and JAK inhibitors. Among all classes, anti-TNF alfa is recommended in first-line treatment.

Drugs that block both JAK and tyrosine kinase may also be effective in stopping or slowing the growth of Ulcerative Colitis. Moreover, the upcoming treatment landscape is poised to expand further after new classes emerge, such as toll-like receptor 9 activators, miR-124 enhancers, T-cell therapy, etc.

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]).

Current US guidelines recommend first-line treatment with aminosalicylate or sequential induction with corticosteroids followed by aminosalicylate maintenance therapy in patients with mild-to-moderate Ulcerative Colitis. In patients with moderate-to-severe Ulcerative Colitis, an immunosuppressant such as azathioprine or 6-mercaptopurine may be prescribed as maintenance therapy following corticosteroid induction. Alternatively, a biologic, typically an anti-tumor necrosis factors antibody such as infliximab or adalimumab, can be prescribed with or without a concurrent immunosuppressant to promote and maintain mucosal healing and clinical remission.

The current market has been segmented into different commonly used drugs based on the prevailing treatment pattern across the 7MM, presenting minor variations in the overall prescription pattern. Conventional therapies, anti-TNF agents, anti-adhesion molecules, JAK pathways, and others are the major drug classes covered in the forecast model.

The expected launch of upcoming therapies and greater integration of early patient screening, medication in secondary care and other clinical settings, research on best methods for implementation, and an upsurge in awareness will eventually facilitate the development of effective treatment options. However, the higher cost of new therapies and the higher cost burden of associated complications on patients may hinder the adoption of newer therapies.

Ulcerative Colitis Companies such as obefazimod (Abivax), risankizumab (AbbVie/Boehringer Ingelheim), guselkumab (Janssen), and several others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the Ulcerative Colitis treatment.

• * The total Ulcerative Colitis Market Size in the 7MM was approximately USD 8400 million in 2023 and is projected to increase during the forecast period (2024-2034).
• * The Ulcerative Colitis Market Size in the 7MM will increase due to increased awareness regarding Ulcerative Colitis, and the corresponding rise in product launches, with various awareness campaigns, is expected to increase early diagnosis and Ulcerative Colitis treatment.
• * Among EU4 countries, Germany accounted for the maximum market size in 2023.
• * By 2034, among all the therapies, the highest revenue will be generated by vedolizumab, followed by adalimumab in the United States.

Ulcerative Colitis Drugs Uptake

This section focuses on the uptake rate of potential Ulcerative Colitis drugs expected to be launched in the market during 2024-2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the Ulcerative Colitis companies evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Ulcerative Colitis Pipeline Development Activities

The Ulcerative Colitis pipeline segment provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes Ulcerative Colitis companies involved in developing targeted therapeutics.

Pipeline Development Activities

The Ulcerative Colitis pipeline segment covers information on collaborations, acquisition and merger, licensing, and patent details for Ulcerative Colitis emerging therapies.

KOL Views

To keep up with the real world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Division of Gastroenterology and Hepatology, State Key Laboratory for Oncogenes and Related Genes, Duke Cancer Institute at Duke University School, and others.

Delveinsight's analysts connected with 40+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapy treatment patterns or Ulcerative Colitis market trends.

Qualitative Analysis

We perform qualitative and market intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, treatment duration and frequency of administration, route of administration, patient segment, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in Ulcerative Colitis trials, the most important primary outcome measures are overall survival, progression-free survival, and objective response rate.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Ulcerative Colitis Market Access and Reimbursement

Reimbursement is a crucial factor affecting the drug's market access. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. Drugs approved for Ulcerative Colitis in the United States include SIMPONI (golimumab), ENTYVIO (vedolizumab), XELJANZ (tofacitinib), STELARA (ustekinumab), RINVOQ (upadacitinib), ZEPOSIA (ozanimod), REMICADE (infliximab), and HUMIRA (adalimumab). Market access and reimbursement options can differ depending on regulatory status, the size of the target population, the setting of care, unmet needs, the magnitude of incremental benefit claims, and costs.

Besides the patient assistance programs provided by the companies for their respective drugs, certain organizations also provide reimbursement assistance to Ulcerative Colitis patients. For instance, Medicare reimburses biologics in a clinical setting when used following FDA-approved labeling. Under Section 1861(b) of the statute of Medicare, anti-integrins, such as vedolizumab, are covered.

Additionally, the Health Well Foundation, an independent non-profit, provides a financial lifeline for inadequately insured Americans. The Crohn's & Colitis Foundation provides copayment and premium assistance to eligible Medicare patients. Health Well provides up to USD 10,000 in copayment or premium assistance to individuals with annual household incomes up to 400% of the federal poverty level through the fund.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Ulcerative Colitis Market Forecast Report Scope

• The Ulcerative Colitis Market Forecast report covers a segment of key events, an executive summary, and a descriptive overview, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Ulcerative Colitis market, historical and forecasted Ulcerative Colitis market size, Ulcerative Colitis market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The patient-based Ulcerative Colitis market forecasting report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Ulcerative Colitis market.

Ulcerative Colitis Market Forecast Report Insights

• Patient-based Ulcerative Colitis Market Forecasting
• Therapeutic approaches
• Ulcerative Colitis pipeline analysis
• Ulcerative Colitis Market Size
• Ulcerative Colitis Market Trends
• Existing and future Ulcerative Colitis Market Opportunities

Ulcerative Colitis Market Forecast Report Key Strengths

• 10 years Ulcerative Colitis Market Forecast
• 7MM coverage
• Ulcerative Colitis epidemiology segmentation
• Key cross competition
• Conjoint analysis
• Drugs Uptake and key Ulcerative Colitis Market Forecast Assumptions

Ulcerative Colitis Treatment Market Report Assessment

• Current Ulcerative Colitis Treatment Market practices
• Ulcerative Colitis Unmet needs
• Ulcerative Colitis Pipeline Product profiles
• Ulcerative Colitis Drug Market Attractiveness
• Qualitative analysis (SWOT and Conjoint Analysis)

FAQs:

• What is the historical and forecasted Ulcerative Colitis patient pool/patient buden in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• What was the Ulcerative Colitis market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved therapies?
• How would the Ulcerative Colitis Market Drivers, Barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the Ulcerative Colitis treatment?
• How many Ulcerative Colitis companies are developing therapies for the Ulcerative Colitis treatment?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to Buy:

• The Ulcerative Colitis market forecast report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Ulcerative Colitis Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing Ulcerative Colitis market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis, ranking of class-wise potential current, and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the Ulcerative Colitis unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.