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염증성 장질환(IBD) : 시장 인사이트, 역학 및 시장 예측(2036년)

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

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 200 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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염증성 장질환(IBD)에 대한 인사이트와 동향

  • DelveInsight의 분석에 따르면, 2025년 주요 7개국(미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국, 일본)의 IBD 시장 규모는 약 210억 달러인 것으로 나타났습니다.
  • 궤양성 대장염은 경증, 중등도, 중증으로 분류됩니다. 진단 시점에서 최대 50%의 환자가 경증이며, 최대 20%의 환자가 중증인 것으로 확인되었습니다.
  • 2025년, 미국에서 경증 IBD 사례는 약 100만 건이었으나, 전체 사례의 대부분을 차지하는 약 200만 건은 중등도에서 중증으로 분류되어, 이 질환의 심각성과 진행 속도가 여실히 드러나고 있습니다.
  • 동반 진단, 바이오마커에 기반한 치료법 선택, 그리고 정밀 의학 접근법이 IBD 관리의 중요한 초점으로 부상하고 있으며, 치료 순서의 최적화와 개인 맞춤형 치료 결과 향상을 목표로 한 연구가 현재도 진행되고 있습니다.
  • 밀리키주맙(OMVOH) 등의 IL-23 억제제, 리산키주맙(SKYRIZI), 구셀쿠맙(TREMFYA)과 같은 여러 첨단 생물학적 제제에 더해, 아달리무맙(HUMIRA)이나 인플릭시맙(REMICADE)과 같은 확립된 TNF 억제제도 이용 가능해지면서 시장은 점점 더 혼전 양상을 띠고 있으며, 유효성, 안전성, 투여 편의성 및 장기적인 질환 관리에 기반하여 경쟁이 격화되고 있습니다.
  • 리산키주맙(SKYRIZI)과 구셀쿠맙(TREMFYA)은 급속히 성장하고 있는 IL-23 억제제 계열의 주요 경쟁 제품으로, 중등도에서 중증의 IBD 환자층을 대상으로 시장 점유율을 놓고 경쟁하고 있습니다.
  • IBD를 대상으로 하는 파이프라인은 현재 개발 후기 단계에 있는 다수의 주요 자산으로 구성되어 있으며, 수익성이 높은 분야로 자리매김하고 있습니다. 가장 유망한 신약 후보 물질을 보유한 주요 기업으로는 아비박스(ABX464(오베파지모드)), 머크(투리소키바트(MK-7240)), 레드힐 바이오파마(RHB-204), 테바 파마슈티컬스, 사노피의 두바키투그(TEV'574/SAR447189) 등이 있습니다. 유망한 치료법의 등장으로 시장이 호전될 것으로 예측됩니다.
  • 현재 이용 가능한 IBD 치료법에는 일정한 한계가 있습니다. 그렇긴 하지만, IBD에는 다양한 치료 옵션이 존재합니다. 그러나 예측 바이오마커가 부족하기 때문에 환자들은 가장 효과적인 치료를 받지 못하게 되며, 그 결과 장기간 고통을 겪게 됩니다.

염증성 장질환(IBD) 시장 보고서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. 또한, IBD 환자의 부담 추이, 수익 및 시장 점유율 동향, 정점 시기의 환자 점유율 및 치료법 보급 현황에 대한 분석을 평가하고, 세계 각 지역 시장 규모에 대한 상세한 평가와 성장률 예측(과거 데이터 및 2022년-2036년 예측)을 제시하고 있습니다. 본 보고서에서는 IBD 분야의 주요 미충족 의료 수요를 부각시키고, 경쟁 구도 및 임상 현황을 분석하여 고부가가치 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

염증성 장질환(IBD) 시장을 주도하는 주요 요인

IBD 유병률 증가

생활 습관의 변화, 도시화, 식습관의 변화, 그리고 질병에 대한 인식 제고로 인해 크론병과 궤양성 대장염의 유병률은 전 세계적으로 계속 증가하고 있습니다. 환자 수가 증가함에 따라, 장기적인 IBD 치료 및 질환 관리 솔루션에 대한 수요가 크게 확대되고 있습니다.

첨단 생물학적 제제의 도입 확대

IBD의 치료 환경은 TNF 억제제, IL-23 억제제, 항인테그린제, JAK 억제제 등 첨단 바이오의약품 및 표적 치료제로 전환되고 있습니다. 이러한 치료법은 특히 중등도에서 중증 환자군에서 임상적 관해율 및 점막 치유율의 향상을 가져오고 있습니다.

새로운 작용기전의 등장

IL-23, TL1A, S1P 경로를 표적으로 하는 차세대 치료법의 개발로 인해, 시장에서는 급속한 혁신이 진행되고 있습니다. 이러한 새로운 치료법은 생물학적 제제에 내성을 보이는 환자들의 미충족 의료 수요를 해소하고, 장기적인 질환 관리의 개선을 가져올 것으로 기대됩니다.

염증성 장질환(IBD)의 이해와 치료 알고리즘

염증성 장질환(IBD)의 개요와 진단

IBD는 주로 크론병과 궤양성 대장염으로 구성된, 소화관의 만성적이고 재발성인 염증성 질환군입니다. 크론병은 소화관의 모든 부위에 영향을 미칠 수 있으며 전층성 염증을 특징으로 하는 반면, 궤양성 대장염은 결장과 직장에 국한되며 염증은 주로 점막층에 머무릅니다. IBD의 정확한 원인은 여전히 밝혀지지 않았습니다. 그러나 유전적 소인, 면역계의 조절 이상, 환경적 요인, 장내 미생물 군집의 변화, 그리고 생활 습관의 변화가 이 질환의 발병에 크게 관여하는 것으로 여겨집니다. IBD의 유병률은 주요 7개국 전체, 특히 선진국에서 현저히 증가하고 있으며, 이는 임상적·경제적으로 큰 부담이 되고 있습니다.

IBD의 진단은 임상 평가, 검사 소견, 내시경 검사, 조직병리학적 소견 및 영상 검사를 종합하여 이루어집니다. 일반적인 증상으로는 복통, 설사, 직장 출혈, 체중 감소, 피로감, 배변 절박감 등이 있습니다. 생검을 동반한 대장내시경 검사는 여전히 진단 및 질환 평가의 표준 방법이지만, 대변 칼프로텍틴 검사, C-반응성 단백질(CRP) 측정, CT 장조영술, MRI, 캡슐 내시경 검사 등의 추가 검사도 질환의 활동성이나 합병증 평가에 도움이 됩니다. 질환의 진행, 장관 손상 및 협착, 누공, 대장암 등의 합병증을 예방하기 위해서는 조기적이고 정확한 진단이 중요합니다.

현재 염증성 장질환(IBD)의 치료 현황

IBD의 치료 현황은 장기적인 관해와 점막 치유를 목표로 한 생물학적 제제 및 표적 치료법의 도입으로 인해 현저하게 발전해 왔습니다. 기존 치료법에는 코르티코스테로이드, 아미노살리실산 제제, 면역조절제가 포함되며, 첨단 치료법으로는 TNF 억제제, 항인테그린제, IL-12/23 억제제, JAK 억제제 등이 있습니다. 최근 승인된 밀리키주맙(OMVOH), 리산키주맙(SKYRIZI), 구셀쿠맙(TREMFYA) 등의 치료법으로 인해 중등도에서 중증 질환에 대한 치료 선택지가 확대되고 있습니다. 치료법 선택에는 질환의 중증도, 병변 부위, 과거 생물학적 제제 사용 이력, 환자의 희망 및 안전성 프로파일이 영향을 미치지만, 장기적인 예후를 개선하기 위해 개인 맞춤형 조기 개입 전략이 점점 더 중요시되고 있습니다.

염증성 장질환(IBD)의 역학

IBD의 역학 분석 및 예측에 관한 주요 조사 결과

  • 2025년, 미국의 IBD 확진 환자 총수는 약 300만 명으로 추산되었으며, 이는 주요 7개국 중 가장 높은 수치였습니다.
  • IBD로 진단받은 환자 총수 중 대다수는 궤양성 대장염 환자가 차지하며, 2025년 미국의 IBD 전체 환자 수의 약 57%를 차지할 것으로 예측됩니다.
  • 2025년, 미국의 IBD 환자 수를 연령대별로 보면 18-44세가 100만 명 이상으로 가장 많았고, 그 다음으로 45-64세 순이었습니다.
  • 2025년 EU4 및 영국에서 질환의 중증도에 따른 궤양성 대장염 환자 수는 경증보다 중등도에서 중증(약 60%)인 경우가 더 많아졌습니다.
  • 크론병은 일반적으로 궤양성 대장염보다 중증도가 높지만, 발병 빈도는 약간 낮습니다. 이 질환은 모든 연령대에서 발병할 가능성이 있지만, 크론병은 20세에서 30세 사이의 청년 및 성인에게서 가장 많이 진단됩니다.

염증성 장 질환(IBD) 시장 전망

IBD 시장은 질환 유병률 증가, 조기 진단, 그리고 첨단 생물학적 제제 및 표적 치료제의 활용 확대에 힘입어 급속한 변화를 겪고 있습니다. 그동안 IBD 치료는 코르티코스테로이드, 면역조절제, 그리고 ‘휴미라’나 ‘레미케이드’와 같은 TNF 억제제에 크게 의존해 왔습니다. 그러나 치료 패러다임은 유효성 향상과 장기적인 질환 관리를 가능하게 하는 정밀 의학에 기반한 작용기전 특이적 치료법으로 크게 전환되고 있습니다.

현재 시장은 점점 더 IL-23 경로를 중심으로 전개되고 있습니다. 밀리키주맙, 리산키주맙, 구셀쿠맙은 급속히 성장하는 IL-23 부문에서 경쟁하고 있으며, 의료진들은 이 약제들이 깊은 관해, 내시경적 개선, 그리고 양호한 장기 유지 효과를 달성할 수 있다는 점에서 이를 선호하고 있습니다. 리산키주맙은 이 계열에서 시장을 선도하는 제품으로 부상하고 있으며, IBD 신규 환자 대상 투여 시작에서 상당한 점유율을 확보하고, 크론병과 궤양성 대장염 모두에서 우선적으로 선택되는 생물학적 제제로서의 입지를 확고히 하고 있습니다.

오베파지모드(ABX464) 등 임상시험 중인 치료법은 miR-124의 발현을 촉진하여, 염증성 사이토카인의 생성을 억제하도록 설계되었으며, 또한 투리소키바트(MK-7240)는 항-TL1A 단일클론 항체로, 이들은 장기 관해의 개선과 섬유화에 따른 질환 진행에 대처하는 것을 목표로 하는 차세대 접근법을 구현하고 있습니다. 트리소키바트는 특히 치료가 어려운 크론병 환자 집단에서 그 잠재적인 항염증 작용 및 항섬유화 작용을 통해 큰 관심을 받고 있습니다. 또한, RHB-204는 크론병 관리에 있어 미생물군집 및 병원체를 표적으로 하는 접근법에 대한 지속적인 탐구를 반영하고 있습니다.

  • 1990년대 후반부터 크론병과 궤양성 대장염에 효과적인 생물학적 제제가 사용 가능해졌지만, 오랫동안 치료 선택지는 제한된 상태로 남아 있었습니다. IL-23 선택적 억제제, S1P 수용체 조절제, JAK 억제제 등 새로운 표적 치료제의 등장으로, IBD와 관련된 주요 염증 경로를 표적으로 삼음으로써 치료 선택지가 대폭 확대되었습니다.
  • 오베파지모드(ABX464)나 투리소키바트(MK-7240)와 같은 후기 임상시험 단계에 있는 신약 및 차세대 치료제의 등장으로, 특히 염증성 사이토카인, TL1A 신호전달, 그리고 섬유화와 관련된 질환 진행을 표적으로 하는 새로운 작용기전을 통해, 예측 기간 후반에 IBD 치료 분야에서의 경쟁이 격화될 것으로 예측됩니다.
  • IL-7 등 새로운 표적 치료제가 치료 선택의 폭을 넓혀주고 있는 한편, 향후 연구는 지속적인 완전 관해 달성, 약물 전달 방식의 간소화, 그리고 장 섬유화를 역전시키는 질환 수정 요법의 개발에 초점을 맞추어야 합니다. 장기적인 완전 관해 유지에 있어, 현재로서는 명확한 우위를 보인 약물은 없지만, 뿌리 깊은 치료상의 과제를 해결하기 위해 경구용 펩타이드 치료제를 포함한 몇 가지 새로운 치료법이 현재 연구되고 있습니다.

약제 분류별/IBD 분야의 주요 기존 치료법 및 신흥 치료법에 대한 인사이트(2022-2036년 전망)

IBD 시장은 IL-23 억제제, TNF 억제제, 항인테그린제, JAK 억제제, TL1A 억제제, 그리고 새롭게 등장한 저분자 화합물 등 여러 약물 군으로 구성되어 있으며, 각각 크론병이나 궤양성 대장염의 병태에 관여하는 서로 다른 염증 경로를 표적으로 삼고 있습니다.

  • IL-23 억제제는 염증성 장질환(IBD)의 표적 치료법 중 하나로, 만성 장 염증의 주요 원인인 IL-23의 p19 서브유닛을 선택적으로 억제합니다. 밀리키주맙(OMVOH), 리산키주맙(SKYRIZI), 구셀쿠맙(TREMFYA) 등의 약물은 Th17을 매개로 하는 염증 경로를 억제하여, 중등도에서 중증의 IBD 환자에게 점막 치유를 촉진하고 지속적인 임상적 관해를 가져옵니다.
  • TL1A 억제제는 염증성 장질환(IBD)에 대한 새로운 표적 치료법 중 하나로, 장의 염증 및 섬유화에 관여하는 사이토카인인 종양괴사인자 유사 리간드 1A(TL1A)를 억제합니다. 트리소키바트(MK-7240) 등의 약제는 TL1A를 매개로 하는 면역 활성화를 억제하여, IBD 환자의 염증을 완화하는 동시에 섬유화를 동반하는 질환 경과에도 대처할 가능성을 지니고 있습니다.

자주 묻는 질문

  • 2025년 염증성 장질환(IBD) 시장 규모는 어떻게 예상되나요?
  • IBD 환자의 유병률은 어떻게 변화하고 있나요?
  • IBD 치료에 사용되는 주요 생물학적 제제는 무엇인가요?
  • IBD의 진단 방법은 무엇인가요?
  • IBD 치료의 현재 현황은 어떤가요?
  • IBD 시장의 주요 경쟁 제품은 무엇인가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 염증성 장질환 : 주요 요약

제4장 주요 이벤트

제5장 염증성 장질환 : 역학 및 시장 조사 방법

제6장 염증성 장질환 : 시장 개요

제7장 염증성 장질환 : 질환 배경과 개요

제8장 염증성 장질환 : 역학 및 환자 인구

제9장 염증성 장질환 : 환자 경과

제10장 염증성 장질환 : 시판 치료제

제11장 염증성 장질환 : 신흥 치료법

제12장 염증성 장질환 : 주요 7개국 분석

제13장 염증성 장질환 : 미충족 요구

제14장 염증성 장질환 : SWOT 분석

제15장 염증성 장질환 : KOL(Key Opinion Leader)의 견해

제16장 염증성 장질환 : 시장 참여 및 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight에 대해

LSH

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.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Inflammatory Bowel Disease (IBD)

4. Key Events

  • 4.1. Upcoming Key Catalyst
  • 4.2. Key Conferences And Meetings
  • 4.3. Key Transactions And Collaborations
  • 4.4. News Flow

5. Epidemiology and Market Methodology of Inflammatory Bowel Disease (IBD)

6. Inflammatory Bowel Disease (IBD) Market Overview at a Glance

  • 6.1. Clinical Landscape Analysis (By Molecule Type, Phase, and Route of Administration [ROA])
  • 6.2. Market Share of Inflammatory Bowel Disease (IBD) By Therapies (%) in the 7MM in 2025
  • 6.3. Market Share of Inflammatory Bowel Disease (IBD) By Therapies (%) in the 7MM in 2036

7. Disease Background And Overview of Inflammatory Bowel Disease (IBD)

  • 7.1. Introduction
  • 7.2. Causes
  • 7.3. Signs And Symptoms
  • 7.4. Diagnosis
    • 7.4.1. Differential Diagnosis
    • 7.4.2. Diagnostic Algorithm
  • 7.5. Treatment and Management
    • 7.5.1. Treatment Algorithm

8. Epidemiology and Patient Population of Inflammatory Bowel Disease (IBD)

  • 8.1. Key Findings
  • 8.2. Assumption and Rationale
  • 8.3. Inflammatory Bowel Disease (IBD) . Prevalent Cases in the 7MM
  • 8.4. The United States
    • 8.4.1. Inflammatory Bowel Disease (IBD) Diagnosed Prevalent Cases in the United States
    • 8.4.2. Inflammatory Bowel Disease (IBD) Type-specific Diagnosed Cases in the United States
    • 8.4.3. Inflammatory Bowel Disease (IBD) Severity-specific Diagnosed Cases in the United States
    • 8.4.4. Inflammatory Bowel Disease (IBD) Age-specific Diagnosed Cases in the United States
    • 8.4.5. Inflammatory Bowel Disease (IBD) Treated Cases in the United States
  • 8.5. EU4 and the UK
    • 8.5.1. Inflammatory Bowel Disease (IBD) Diagnosed Prevalent Cases in EU4 and the UK
    • 8.5.2. Inflammatory Bowel Disease (IBD) Type-specific Diagnosed Cases in EU4 and the UK
    • 8.5.3. Inflammatory Bowel Disease (IBD) Severity-specific Diagnosed Cases in EU4 and the UK
    • 8.5.4. Inflammatory Bowel Disease (IBD) Age-specific Diagnosed Cases in EU4 and the UK
    • 8.4.5. Inflammatory Bowel Disease (IBD) Treated Cases in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Inflammatory Bowel Disease (IBD) Diagnosed Prevalent Cases in Japan
    • 8.6.2. Inflammatory Bowel Disease (IBD) Type-specific Diagnosed Cases in Japan
    • 8.6.3. Inflammatory Bowel Disease (IBD) Severity-specific Diagnosed Cases in Japan
    • 8.6.4. Inflammatory Bowel Disease (IBD) Age-specific Diagnosed Cases in Japan
    • 8.4.5. Inflammatory Bowel Disease (IBD) Treated Cases in Japan

9. Patient Journey of Inflammatory Bowel Disease (IBD)

10. Marketed Therapies of Inflammatory Bowel Disease (IBD)

  • 10.1. Marketed Competitive Landscape of Inflammatory Bowel Disease (IBD)
  • 10.2. Mirikizumab (OMVOH): Eli Lilly and Company
    • 10.2.1. Product Description
    • 10.2.2. Regulatory Milestones
    • 10.2.3. Other Developmental Activities
    • 10.2.4. Summary of Pivotal Trials
    • 10.2.5. Analyst Views
  • 10.3. Risankizumab (SKYRIZI): AbbVie
    • 10.3.1. Product Description
    • 10.3.2. Regulatory Milestones
    • 10.3.3. Other Developmental Activities
    • 10.3.4. Summary of Pivotal Trials
    • 10.3.5. Analyst Views

11. Emerging Therapies of Inflammatory Bowel Disease (IBD)

  • 11.1. Emerging Competitive Landscape of Inflammatory Bowel Disease (IBD)
  • 11.2. ABX464 (obefazimod): Abivax
    • 11.2.1. Product Description
    • 11.2.2. Other Developmental Activities
    • 11.2.3. Clinical Development
      • 11.2.3.1. Clinical Trial Information
    • 11.2.4. Safety and Efficacy
    • 11.2.5. Analyst Views
  • 11.3. Tulisokibart (MK-7240): Merck
    • 11.3.1. Product Description
    • 11.3.2. Other Developmental Activities
      • 1.1.3.3. Clinical Development
      • 11.3.3.1. Clinical Trial Information
      • 1.1.3.4. Safety and Efficacy
      • 1.1.3.5. Analyst Views

12. Inflammatory Bowel Disease (IBD): Seven Major Market Analysis

  • 12.1. Key Findings
  • 12.2. Market Outlook of Inflammatory Bowel Disease (IBD)
  • 12.3. Conjoint Analysis of Inflammatory Bowel Disease (IBD)
  • 12.4. Key Market Forecast Assumptions
    • 12.4.1. Cost Assumptions
    • 12.4.2. Pricing Trends
    • 12.4.3. Analogue Assessment
    • 12.4.4. Launch Year and Therapy Uptakes
  • 12.5. Total Market Size of Inflammatory Bowel Disease (IBD) in the 7MM
  • 12.6. The United States
    • 12.6.1. Total Market Size of Inflammatory Bowel Disease (IBD) in the United States
    • 12.6.2. Market Size of Inflammatory Bowel Disease (IBD) by Therapies in the United States
  • 12.7. EU4 and the UK
    • 12.7.1. Total Market Size of Inflammatory Bowel Disease (IBD) in EU4 and the UK
    • 12.7.2. Market Size of Inflammatory Bowel Disease (IBD) by Therapies in EU4 and the UK
  • 12.8. Japan
    • 12.8.1. Total Market Size of Inflammatory Bowel Disease (IBD) in Japan
    • 12.8.2. Market Size of Inflammatory Bowel Disease (IBD) by Therapies in Japan

13. Unmet Needs of Inflammatory Bowel Disease (IBD)

14. SWOT Analysis of Inflammatory Bowel Disease (IBD)

15. KOL Views of Inflammatory Bowel Disease (IBD)

  • 15.1. Expert/KOL Interview Highlights

16. Market Access and Reimbursement of Inflammatory Bowel Disease (IBD)

  • 16.1. The US
  • 16.2. In EU4 and the UK
    • 16.2.1. Germany
    • 16.2.2. France
    • 16.2.3. Italy
    • 16.2.4. Spain
    • 16.2.5. United Kingdom
  • 16.3. Japan
  • 16.4. Summary and Comparison of Market Access and Pricing Policy Developments in 2025
  • 16.5. Market Access and Reimbursement of Inflammatory Bowel Disease (IBD) Therapies

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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