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시장보고서
상품코드
2082949
염증성 장질환(IBD) : 시장 인사이트, 역학 및 시장 예측(2036년)Inflammatory Bowel Disease - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
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.
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 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.
IBD의 역학 분석 및 예측에 관한 주요 조사 결과
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.
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.
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) 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.
Key Findings from IBD Epidemiological Analysis and Forecast
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
Inflammatory Bowel Disease (IBD) Drug Updates
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.
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.
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.
Market Insights