Inflammatory Bowel Disease - Market Insight, Epidemiology, and Market Forecast - 2036

Inflammatory Bowel Disease (IBD) Insights and Trends

• According to DelveInsight's analysis, the IDB market size was found to be ~USD 21 billion in the 7MM (the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan) in 2025.
• Ulcerative Colitis is classified as mild, moderate, and severe. It has been observed that up to 50% of patients have a mild disease at the time of diagnosis, and up to 20% of patients have a severe disease at the time of diagnosis.
• In 2025, there were approximately 1 million mild cases of IBD in the US, while the majority of cases, around 2 million were classified as moderate to severe, highlighting the significant severity and progression of the disease.
• Companion diagnostics, biomarker-driven treatment selection, and precision medicine approaches are emerging as key areas of focus in IBD management, with ongoing research aiming to optimize therapy sequencing and improve individualized treatment outcomes.
• The IBD market is becoming increasingly crowded with the availability of multiple advanced biologic therapies, including IL-23 inhibitors such as Mirikizumab (OMVOH), Risankizumab (SKYRIZI), and Guselkumab (TREMFYA), alongside established TNF inhibitors such as Adalimumab (HUMIRA) and Infliximab (REMICADE), intensifying competition based on efficacy, safety, dosing convenience, and long-term disease control.
• Risankizumab (SKYRIZI) and Guselkumab (TREMFYA) are key competitors within the rapidly expanding IL-23 inhibitor class, competing for market share across moderate-to-severe IBD populations.
• The pipeline for IBD is currently lucrative, consisting of many key assets in late stage of development. The Key players with some most promising emerging therapies includes Abivax (ABX464 (obefazimod)), Merck (Tulisokibart (MK-7240)), RedHill Biopharma (RHB-204), Teva Pharmaceuticals and Sanofi duvakitug (TEV'574/SAR447189) and others. The market is expected to undergo a positive shift due to emergence of promising therapies.
• The currently available therapies for the treatment of IBD have certain limitations. Although, IBD has plethora of treatment options. Due to lack of predictive biomarkers, patients are unable to receive most effective treatment as a result of which the patient suffers for a long period of time.

DelveInsight's 'Inflammatory Bowel Disease (IBD) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the IBD, historical and forecasted epidemiology, as well as the IBD market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Inflammatory Bowel Disease (IBD) market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, IBD patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in IBD and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Inflammatory Bowel Disease (IBD) Market

Rising Prevalence of IBD

The prevalence of Crohn's disease and ulcerative colitis continues to increase across the globe due to changing lifestyles, urbanization, dietary habits, and improved disease recognition. The growing patient population is significantly expanding the demand for long-term IBD therapies and disease management solutions.

Increasing Adoption of Advanced Biologics

The IBD treatment landscape has shifted toward advanced biologics and targeted therapies such as TNF inhibitors, IL-23 inhibitors, anti-integrins, and JAK inhibitors. These therapies offer improved clinical remission and mucosal healing rates, particularly in moderate-to-severe disease populations.

Emergence of Novel Mechanisms of Action

The market is witnessing rapid innovation with the development of next-generation therapies targeting IL-23, TL1A, and S1P pathways. Emerging therapies are expected to address unmet needs in biologic-refractory patients and provide improved long-term disease control.

Inflammatory Bowel Disease (IBD) Understanding and Treatment Algorithm

Inflammatory Bowel Disease (IBD) Overview and Diagnosis

IBD is a group of chronic, relapsing inflammatory disorders of the gastrointestinal tract, primarily comprising Crohn's disease and ulcerative colitis. Crohn's disease can affect any part of the gastrointestinal tract and is characterized by transmural inflammation, whereas ulcerative colitis is limited to the colon and rectum with inflammation confined mainly to the mucosal layer. The exact etiology of IBD remains unclear. However, genetic susceptibility, immune dysregulation, environmental factors, gut microbiota alterations, and lifestyle changes are considered major contributors to disease development. The prevalence of IBD has increased significantly across the 7MM, particularly in developed countries, creating a substantial clinical and economic burden.

The diagnosis of IBD is based on a combination of clinical evaluation, laboratory testing, endoscopy, histopathology, and imaging studies. Common symptoms include abdominal pain, diarrhea, rectal bleeding, weight loss, fatigue, and urgency. Colonoscopy with biopsy remains the gold standard for diagnosis and disease assessment, while additional tools such as fecal calprotectin testing, C-reactive protein (CRP) measurement, CT enterography, MRI, and capsule endoscopy help evaluate disease activity and complications. Early and accurate diagnosis is important to prevent disease progression, intestinal damage, and complications such as strictures, fistulas, and colorectal cancer.

Current Inflammatory Bowel Disease (IBD) Treatment Landscape

The treatment landscape for IBD has evolved considerably with the introduction of biologics and targeted therapies aimed at achieving long-term remission and mucosal healing. Conventional therapies include corticosteroids, aminosalicylates, and immunomodulators, while advanced treatments include TNF inhibitors, anti-integrins, IL-12/23 inhibitors, and JAK inhibitors. Recently approved therapies such as Mirikizumab (OMVOH), Risankizumab (SKYRIZI) and Guselkumab (TREMFYA) are expanding treatment options for moderate-to-severe disease. Treatment selection is influenced by disease severity, location, prior biologic exposure, patient preference, and safety profile, with increasing emphasis on personalized and early intervention strategies to improve long-term outcomes.

Inflammatory Bowel Disease (IBD) Unmet Needs

The section "unmet needs of Inflammatory Bowel Disease (IBD)" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Need for more convenient oral therapies

2. Safety concerns associated with long-term immunosuppression

3. Persistent symptoms despite clinical remission in many patients

4. Limited pediatric-specific treatment options and long-term safety data, and others.....

Inflammatory Bowel Disease (IBD) Epidemiology

Key Findings from IBD Epidemiological Analysis and Forecast

• In 2025, the total diagnosed prevalent cases of IBD in the United States were found to be ~3 million which was highest among the 7MM.
• Among the total diagnosed prevalent cases of IBD majority of cases were accounted by ulcerative colitis accounting ~57% of total cases of IBD cases in the United States in 2025.
• In 2025, there were more than one million cases falling in the age group of 18-44 years which was highest among other age group for IBD in the United States followed by 45-64 years.
• Ulcerative colitis cases based on severity of disease were more in moderate to severe (~60%) than in mild in EU4 and the UK in 2025.
• Crohn's disease is typically more severe than ulcerative colitis but is slightly less common. The disease can occur at any age, but Crohn's disease is most often diagnosed in adolescents and adults between 20 and 30.

Inflammatory Bowel Disease (IBD) Drug Analysis & Competitive Landscape

The IBD drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Preclinical and Phase III clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships, upcoming Key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the IBD treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the IBD therapeutics market.

Approved Therapies for Inflammatory Bowel Disease (IBD)

Mirikizumab (OMVOH): Eli Lilly and Company

Mirikizumab, is a selective IL-23p19 monoclonal antibody approved for moderately to severely active ulcerative colitis and Crohn's disease. The drug became the first IL-23p19 antagonist approved for ulcerative colitis in 2023 and later received approval for Crohn's disease in 2025. Mirikizumab demonstrated strong efficacy in the Phase III (LUCENT) and (VIVID) clinical programs, showing significant improvements in clinical remission, endoscopic response, and bowel urgency symptoms. It is taken as Intravenous (IV) induction followed by subcutaneous (SC) maintenance.

Risankizumab (SKYRIZI): AbbVie

Risankizumab is a IL-23 inhibitor that has emerged as a major competitor in the inflammatory bowel disease market. Initially approved for Crohn's disease in 2022 and later for ulcerative colitis in 2024. Risankizumab has demonstrated strong induction and maintenance efficacy, particularly in biologic-experienced patients. The therapy is increasingly gaining physician preference due to its favorable efficacy profile, convenient dosing schedule, and expanding clinical experience across immune-mediated diseases including psoriasis and psoriatic arthritis.

Inflammatory Bowel Disease (IBD) Pipeline Analysis

ABX464 (obefazimod): Abivax

ABX464, is an oral small-molecule drug candidate developed by Abivax with potent anti-inflammatory properties. It selectively upregulates microRNA-124 (miR-124), a natural regulator of the inflammatory response, which leads to decreased cytokine production and immune cell activity, helping to reduce inflammation. Currently, it is being evaluated in various Phase III trials to treat moderately to severely active ulcerative colitis.

Tulisokibart (MK-7240): Merck

Tulisokibart (MK-7240) is an investigational humanized monoclonal antibody developed for the treatment of immune-mediated inflammatory diseases, particularly IBD such as Crohn's disease and ulcerative colitis. Originally developed as PRA023 by Prometheus Biosciences, the therapy was acquired by Merck in 2023 as part of its expansion into immunology. The drug has demonstrated encouraging clinical remission, endoscopic improvement, and durable efficacy in Phase II studies such as (APOLLO-CD) and (ARTEMIS-UC), supporting its advancement into Phase III trials including (ARES-CD) for Crohn's disease and (ATLAS-UC) for ulcerative colitis.

Inflammatory Bowel Disease (IBD) Key Players, Market Leaders and Emerging Companies

• Eli Lilly and Company
• AbbVie
• Johnson & Johnson
• Abivax
• Pfizer
• Celltrion
• Merck
• RedHill Biopharma
• Teva Pharmaceuticals
• Sanofi, and others

Inflammatory Bowel Disease (IBD) Drug Updates

• In May 2026, new long-term data from Eli Lilly and Company showed that patients with moderately to severely active ulcerative colitis treated with mirikizumab achieved durable disease clearance through four years of continuous treatment.
• In May 2026, Johnson & Johnson announced results from the Phase III (FUZION) study evaluating guselkumab in adults with active perianal fistulizing Crohn's disease. The study met its primary endpoint of combined fistula remission at Week 24.
• In April 2026, AbbVie announced that it has submitted an application to the US FDA seeking approval for risankizumab for SC induction for the treatment of adult patients with moderately to severely active Crohn's disease.
• In March 2026, AbbVie announced positive topline results from phase III (AFFIRM) study evaluating risankizumab (SKYRIZI) subcutaneous induction in patients with crohn's disease.
• In February 2026, Sanofi and Teva announced that duvakitug (TEV-574/SAR447189) demonstrated clinically meaningful and durable efficacy in Phase IIb maintenance studies across both ulcerative colitis and Crohn's disease, supporting its continued evaluation as a potential next-generation therapy in inflammatory bowel disease.
• In January 2026, Abivax announced that (ABTECT-UC) Phase III maintenance topline results for ABX464 are expected in late Q2 2026, followed by a planned US regulatory filing in late 2026, subject to outcomes. The company also confirmed that the (ENHANCE-CD) Phase IIb Crohn's disease induction study is ongoing, with topline results expected in late 2026, supporting expansion into broader IBD indications.

Inflammatory Bowel Disease (IBD) Market Outlook

The IBD market is undergoing rapid transformation, driven by increasing disease prevalence, earlier diagnosis, and the expanding availability of advanced biologic and targeted therapies. Historically, IBD management relied heavily on corticosteroids, immunomodulators, and TNF inhibitors such as HUMIRA and REMICADE. However, the treatment paradigm has shifted significantly toward precision-based and mechanism-specific therapies with improved efficacy and long-term disease control.

The current market is increasingly centered around the IL-23 pathway. Mirikizumab, risankizumab and guselkumab are competing within the rapidly expanding IL-23 segment, with physicians favoring these agents because of their ability to achieve deep remission, endoscopic improvement, and favorable long-term maintenance outcomes. Risankizumab has emerged as the commercial leader within this class, capturing a substantial share of new IBD patient starts and establishing itself as a preferred biologic in both Crohn's disease and ulcerative colitis.

Investigational therapies such as Obefazimod (ABX464), is being designed to upregulate miR-124 and reduce inflammatory cytokine production, and Tulisokibart (MK-7240) is an anti-TL1A monoclonal antibody that represent next-generation approaches aimed at improving long-term remission and addressing fibrosis-associated disease progression. Tulisokibart has generated significant interest due to its potential anti-inflammatory and anti-fibrotic activity, particularly in difficult-to-treat Crohn's disease populations. Additionally, RHB-204, reflects continued exploration of microbiome- and pathogen-targeted approaches in Crohn's disease management.

• Although effective biologic therapies for Crohn's disease and ulcerative colitis have been available since the late 1990s, treatment options remained limited for many years. The emergence of newer targeted therapies, including IL-23 selective inhibitors, S1P receptor modulators, and JAK inhibitors, has significantly expanded the therapeutic armamentarium by selectively targeting key inflammatory pathways involved in IBD.
• The entry of late-stage and next-generation therapies such as obefazimod (ABX464) and tulisokibart (MK-7240) is expected to intensify competition within the IBD treatment landscape during the latter half of the forecast period, particularly through novel mechanisms targeting inflammatory cytokines, TL1A signaling, and fibrosis-associated disease progression.
• While emerging targets such as IL-7 are expanding the therapeutic landscape, future efforts should focus on achieving durable deep remission, simplifying drug delivery, and developing disease-modifying therapies that reverse intestinal fibrosis. Although no agent has yet demonstrated clear superiority in maintaining long-term deep remission, several novel therapies, including oral peptide therapeutics, are under investigation to address persistent therapeutic challenges.

Drug Class/Insights into Leading Marketed and Emerging Therapies in IBD (2022-2036 Forecast)

The IBD market comprises multiple drug classes, including IL-23 inhibitors, TNF inhibitors, anti-integrins, JAK inhibitors, TL1A inhibitors, and emerging small molecules, each targeting distinct inflammatory pathways involved in Crohn's disease and ulcerative colitis pathogenesis.

• IL-23 inhibitors represent a targeted therapeutic approach in inflammatory bowel disease (IBD), selectively blocking the p19 subunit of IL-23, a key driver of chronic intestinal inflammation. Agents such as mirikizumab (OMVOH), risankizumab (SKYRIZI), and guselkumab (TREMFYA) suppress Th17-mediated inflammatory pathways, leading to improved mucosal healing and sustained clinical remission in patients with moderate-to-severe IBD.
• TL1A inhibitors are an emerging class of targeted therapies in inflammatory bowel disease (IBD) that block tumor necrosis factor-like ligand 1A (TL1A), a cytokine implicated in intestinal inflammation and fibrosis. Agents such as tulisokibart (MK-7240) inhibit TL1A-mediated immune activation, offering the potential to reduce inflammation while also addressing fibrotic disease processes in patients with IBD.

Inflammatory Bowel Disease (IBD) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the IBD drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

Recently approved IL-23 inhibitors such as mirikizumab (OMVOH), risankizumab (SKYRIZI), and guselkumab (TREMFYA) are projected to demonstrate relatively rapid uptake due to their strong efficacy in achieving clinical remission and mucosal healing, along with favorable maintenance outcomes in ulcerative colitis and Crohn's disease. Their expanding positioning in biologic-experienced patients is expected to further support market penetration across the forecast period.

In contrast, investigational therapies such as obefazimod (ABX464) are expected to follow a moderate uptake trajectory as clinical evidence on long-term efficacy and safety continues to emerge. Meanwhile, tulisokibart (MK-7240) is anticipated to attract significant attention following potential launch due to its anti-TL1A mechanism targeting both inflammatory and fibrotic pathways, particularly in difficult-to-treat Crohn's disease populations. The uptake will largely dependent on clinical differentiation, regulatory success, and positioning alongside established biologics and advanced targeted therapies.

Detailed insights of emerging therapies' drug uptake is included in the report...

Market Access and Reimbursement of Approved therapies in Inflammatory Bowel Disease (IBD)

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.

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

NOTE: Further Details are provided in the final report....

Inflammatory Bowel Disease (IBD) Therapies Price Scenario & Trends

Pricing and analogue assessment of IBD therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

Industry Experts and Physician Views for Inflammatory Bowel Disease (IBD)

To keep up with IBD market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the IBD emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in IBD, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 15+ KOLs to gather insights at country level. Centers such as the The Stanford University, University of Munich, and Keio University School of Medicine, etc. were contacted.Their opinion helps understand and validate current and emerging IBD therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in IBD.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of IBD, 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 emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. 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.

Scope of the Report:

• The report covers a segment of key events, an executive summary, a descriptive overview of IBD, explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the IBD market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The 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 in shaping and driving the 7MM IBD market.

Report Insights

• Inflammatory Bowel Disease (IBD) Patient Population Forecast
• Inflammatory Bowel Disease (IBD) Therapeutics Market Size
• Inflammatory Bowel Disease (IBD) Pipeline Analysis
• Inflammatory Bowel Disease (IBD) Market Size and Trends
• Inflammatory Bowel Disease (IBD) Market Opportunity (Current and Forecasted)

Report Key Strengths

• Epidemiology-based (Epi-based) Bottom-up Forecasting
• Artificial Intelligence (AI)-Enabled Market Research Report
• 11-Year Forecast
• Inflammatory Bowel Disease (IBD) Market Outlook (North America, Europe, Asia-Pacific)
• Patient Burden Trends (By Geography)
• Inflammatory Bowel Disease (IBD) Treatment Addressable Market (TAM)
• Inflammatory Bowel Disease (IBD) Competitive Landscape
• Inflammatory Bowel Disease (IBD) Major Companies Insights
• Inflammatory Bowel Disease (IBD) Price Trends and Analogue Assessment
• Inflammatory Bowel Disease (IBD) Therapies Drug Adoption/Uptake
• Inflammatory Bowel Disease (IBD) Therapies Peak Patient Share Analysis

Report Assessment

• Inflammatory Bowel Disease (IBD) Current Treatment Practices
• Inflammatory Bowel Disease (IBD) Unmet Needs
• Inflammatory Bowel Disease (IBD) Clinical Development Analysis
• Inflammatory Bowel Disease (IBD) Emerging Drugs Product Profiles
• Inflammatory Bowel Disease (IBD) Market attractiveness
• Inflammatory Bowel Disease (IBD) Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

• What was the IBD market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
• What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
• What can be the future treatment paradigm of IBD?
• What are the disease risks, burdens, and unmet needs of IBD? What will be the growth opportunities across the 7MM concerning the patient population with IBD?
• Who is the major future competitor in the market, and how will the competitors affect their market share?
• What are the current options for the treatment of IBD? What are the current guidelines for treating IBD in the US, Europe, and Japan?

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the IBD market.
• Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
• This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets with in the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.