潰瘍性大腸炎（UC）市場：規模と動向レポート（疫学、疾患管理、パイプライン分析、競合評価、アンメットニーズ、臨床試験戦略、2031年までの予測）

世界の潰瘍性大腸炎（UC）の市場規模は、2031年までに売上にして2.8％のCAGRで成長すると予測されています。これはパイプライン治療薬9種類とバイオシミラーの承認と上市により促進されるものとみられています。

当レポートでは、世界の潰瘍性大腸炎（UC）市場について調査し、疾患の概要、アンメットニーズと機会、パイプライン動向、地域別の動向などをまとめています。

目次

第1章 潰瘍性大腸炎：エグゼクティブサマリー

第2章 イントロダクション

第3章 疾患の概要

• 病因と病態生理学
• 分類または病期システム
• 症状
• 生活の質

第4章 疫学

• 疾患の背景
• 危険因子と合併症
• 世界的および歴史的動向
• 主要8ヶ国予測調査手法
• 潰瘍性大腸炎の疫学的予測（2021年～2031年）
• 議論

第5章 疾病管理

• 診断と治療の概要
• 疾病管理に関するKOLの洞察

第6章 競争力評価

• 概要

第7章 アンメットニーズと機会の評価

第8章 研究開発戦略

• 概要
• 臨床試験デザイン

第9章 パイプラインの評価

第10章 パイプライン評価分析

• 概要
• 競争力評価

第11章 現在および将来の参入企業

第12章 市場の見通し

• 世界市場
• 米国
• EU5ヶ国
• 日本
• カナダ

第13章 付録

List of Tables

List of Tables

• Table 1: UC: Key Metrics in the 8MM
• Table 2: Truelove and Witts categorization of disease severity and clinical parameters
• Table 3: Montreal classification for the distribution of UC
• Table 4: Typical symptoms of UC
• Table 5 presents the risk factors and common comorbidities for UC.
• Table 6: Treatment guidelines for UC
• Table 7: Top 10 deals by value, 2018-22
• Table 8: UC market - global drivers and barriers, 2021-31
• Table 9: Key events impacting sales for UC in the US, 2021-31
• Table 10: UC market - drivers and barriers in the US, 2021-31
• Table 11: Key events impacting sales for UC in the 5EU, 2021-31
• Table 12: UC Market - drivers and barriers in the 5EU, 2021-31
• Table 13: Key events impacting sales for UC in Japan, 2021-31
• Table 14: UC market - drivers and barriers in Japan, 2021-31
• Table 15: Key events impacting sales for UC in Canada, 2021-31
• Table 16: UC market - drivers and barriers in Canada, 2021-31
• Table 17: High-prescribing physicians (non-KOLs) surveyed, by country

List of Figures

List of Figures

• Figure 1: Global sales forecast by country for UC in 2021 and 2031
• Figure 2: Analysis of the company portfolio gap in UC during the forecast period
• Figure 3: Cellular mechanisms involved in the pathogenesis of UC
• Figure 4: Types of UC
• Figure 5: 8MM, diagnosed incidence of UC (cases per 100,000 population), men and women, all ages, 2021
• Figure 6: 8MM, diagnosed prevalence of UC (%), men and women, all ages, 2021
• Figure 7: 8MM, sources used and not used to forecast the diagnosed incident cases of UC
• Figure 8: 8MM, sources used and not used to forecast the diagnosed prevalent cases of UC
• Figure 9: 8MM, sources used to forecast the diagnosed prevalent cases of UC by severity
• Figure 10: 8MM, sources used to forecast the post-operative UC cases
• Figure 11: 8MM, sources used to forecast the pouchitis cases among the diagnosed prevalent cases of UC
• Figure 12: 8MM, sources used to forecast the diagnosed prevalent cases of UC by anti-TNF responsiveness
• Figure 13: 8MM, diagnosed incident cases of UC, N, both sexes, all ages, 2021
• Figure 14: 8MM, diagnosed incident cases of UC by age group, N, both sexes, 2021
• Figure 15: 8MM, diagnosed incident cases of UC by sex, N, all ages, 2021
• Figure 16: 8MM, diagnosed prevalent cases of UC, N, both sexes, all ages, 2021
• Figure 17: 8MM, diagnosed prevalent cases of UC by age group, N, both sexes, 2021
• Figure 18: 8MM, diagnosed prevalent cases of UC by sex, N, all ages, 2021
• Figure 19: 8MM, diagnosed prevalent cases of UC by severity, N, both sexes, ages <18 years, 2021
• Figure 20: 8MM, diagnosed prevalent cases of UC by severity, N, both sexes, ages ≥18 years, 2021
• Figure 21: 8MM, pouchitis cases and post-operative UC cases, N, both sexes, all ages, 2021
• Figure 22: 8MM, diagnosed prevalent cases of UC by anti-TNF responsiveness, N, both sexes, all ages, 2021
• Figure 23: Typical treatment algorithm for newly presenting UC patients
• Figure 24: Unmet needs and opportunities in UC, 2022
• Figure 25: Overview of the development pipeline in UC
• Figure 26: Key late-stage trials for the promising pipeline agents that GlobalData expects be licensed for UC in the 8MM during the forecast period, 2021-31
• Figure 27: Competitive assessment of the marketed and pipeline drugs benchmarked against the SOCs, Remicade and Entyvio
• Figure 28: Analysis of the company portfolio gap in UC dDuring the forecast period
• Figure 29: Global (8MM) sales forecast by country for UC in 2021 and 2031
• Figure 30: Global (8MM) sales forecast by MOA for UC in 2021 and 2031
• Figure 31: Sales forecast by class for UC in the US in 2021 and 2031
• Figure 32: Sales forecast by class for UC in the 5EU in 2021 and 2031
• Figure 33: Sales forecast by class for UC in Japan in 2021 and 2031
• Figure 34: Sales forecast by class for UC in Canada in 2021 and 2031

Abstract

Inflammatory bowel disease (IBD) refers to two chronic autoimmune diseases that cause intestinal inflammation: Crohn's disease (CD) and Ulcerative Colitis (UC). In Ulcerative Colitis (UC), chronic inflammation affects the colon (also known as the large intestine). Initially, Ulcerative Colitis (UC) usually manifests in the terminal part of the colon, the rectum, and is termed ulcerative proctitis. It can extend to the entire left part of the colon (left-sided proctitis) or the entire colon (pancolitis).

The etiology of Ulcerative Colitis (UC) is classified as idiopathic, although there are numerous theories regarding possible causes. The following hypotheses and factors have been proposed to explain the source of the continuous inflammation of the colon seen in Ulcerative Colitis (UC) patients. For the analysis in this report, patients are segmented by severity: mild to moderate, moderate to severe, and severe to fulminant.

GlobalData estimates by 2031 Ulcerative Colitis (UC) drug sales to grow at a compound annual growth rate (CAGR) of 2.8%, which will be driven by the approvals and launches of nine pipeline therapies and biosimilars.

The current Ulcerative Colitis (UC) market is overcrowded with cheap generic drugs for mild to moderate disease, expensive biologics such as anti-tumor necrosis factors (TNFs) and anti-integrins, and biosimilars for severe disease that are used as short- or long-term alternatives to surgical options. The R&D within this space consists of 11 late-stage pipeline drugs with five oral formulations, more convenient dosing frequencies, novel mechanisms of action (MOAs), and improved safety profiles and drug availability. However, the pipeline products will be challenged by the increasing emergence of biosimilars, since the major brands will experience patent cliffs throughout the forecast period.

There are still high levels of unmet clinical need in the Ulcerative Colitis (UC) market, especially relating to the lack of safe and efficacious treatment alternatives. Additionally, key opinion leaders (KOLs) interviewed by GlobalData indicated the need for biomarkers to predict responsiveness to therapy and prognosis, the lack of highly efficacious treatment alternatives, the low availability of treatments for patients with comorbidities, as well as the standardization of patient-reported outcomes (PROs).

Major drivers of growth in the Ulcerative Colitis (UC) market over the forecast period include:

An increase in prevalence rates in four of the eight major markets and an increase in diagnosed

prevalent cases in seven markets.

The approval and launch of 11 pipeline products into the market during the forecast period, some of which are directed towards significant unmet needs

The high treatment rates across the 8MM

The high unmet need for safe efficacious therapies.

The major barriers of growth in the Ulcerative Colitis (UC) market during the forecast period include:

The high prices of biologic agents, which will prevent physicians from prescribing them to all

severe patients.

The crowded market dynamics, including the already established biologics market, which will

make the uptake of pipeline drugs more difficult.

Patent expiries of key biologics, which will decrease sales due to the launch of biosimilars and

subsequent brand erosion, as well as adding to the overall competitiveness of the market for

newcomers.

Scope

• Overview of ulcerative colitis, including epidemiology, symptoms, diagnosis, and disease management.
• Annualized ulcerative colitis therapeutics market revenue, cost of therapy per patient, and treatment usage patterns forecast from 2021 to 2031.
• Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications of these factors for the ulcerative colitis market.
• Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for ulcerative colitis treatment. The most promising candidates in Phase III and Phase IIb development are profiled.
• Analysis of the current and future market competition in the global ulcerative colitis therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications

Reasons to Buy

• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
• Develop business strategies by understanding the trends shaping and driving the global ulcerative colitis therapeutics market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global ulcerative colitis therapeutics market in the future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships

Table of Contents

Table of Contents

• 1 Ulcerative Colitis: Executive Summary
• 1.1 Moderate growth is expected for the UC market from 2021-31
• 1.2 New competition and biosimilar threats in the UC market
• 1.3 Novel pipeline to partially address unmet needs
• 1.4 What do physicians think?
• 2 Introduction
• 2.1 Catalyst
• 2.2 Related Reports
• 2.3 Upcoming Reports
• 3 Disease Overview
• 3.1 Etiology and pathophysiology
  • 3.1.1 Gut dysbiosis
  • 3.1.2 The significance of diet
  • 3.1.3 The role of interleukins
  • 3.1.4 Environmental factors
  • 3.1.5 Epigenetics
  • 3.1.6 Pathophysiology
  • 3.1.7 Biomarkers/targets of interest
• 3.2 Classification or staging systems
• 3.3 Symptoms
• 3.4 Quality of life
• 4 Epidemiology
• 4.1 Disease background
• 4.2 Risk factors and comorbidities
• 4.3 Global and historical trends
• 4.4 8MM forecast methodology
  • 4.4.1 Sources used
  • 4.4.2 Forecast assumptions and methods
  • 4.4.3 Diagnosed incident cases of UC
  • 4.4.4 Forecast assumptions and methods: diagnosed prevalent cases of UC
  • 4.4.5 Diagnosed prevalent cases of UC by severity
  • 4.4.6 Post-operative UC cases
  • 4.4.7 Pouchitis in diagnosed prevalent cases of UC
  • 4.4.8 Diagnosed prevalent cases of UC by anti- TNF- responsiveness
• 4.5 Epidemiological forecast for UC (2021-31)
  • 4.5.1 Diagnosed incident cases of UC
  • 4.5.2 Age-specific diagnosed incident cases of UC
  • 4.5.3 Sex-specific diagnosed incident cases of UC
  • 4.5.4 Diagnosed prevalent cases of UC
  • 4.5.5 Age-specific diagnosed prevalent cases of UC
  • 4.5.6 Sex-specific diagnosed prevalent cases of UC
  • 4.5.7 Diagnosed prevalent cases of UC by severity
  • 4.5.8 Pouchitis cases and post-operative UC cases
  • 4.5.9 Diagnosed prevalent cases of UC by anti-TNF responsiveness
• 4.6 Discussion
  • 4.6.1 Epidemiological forecast insight
  • 4.6.2 COVID-19 impact
  • 4.6.3 Limitations of analysis
  • 4.6.4 Strengths of analysis
• 5 Disease Management
• 5.1 Diagnosis and treatment overview
• 5.2 KOL insights on disease management
  • 5.2.1 Preferred treatment options for UC
• 6 Competitive Assessment
• 6.1 Overview
• 7 Unmet Needs and Opportunity Assessment
• 7.1 Overview
• 7.2 Biomarkers or diagnostics to predict responsiveness to therapy
• 7.3 Lack of highly efficacious treatment alternatives
• 7.4 Availability of treatments for patients with certain comorbidities
• 7.5 Standardization of patient-reported outcomes
• 8 R&D Strategies
• 8.1 Overview
  • 8.1.1 A focus on interleukin-inhibiting biologics
  • 8.1.2 Targeting new signaling pathways and novel targets
  • 8.1.3 Exploring effective oral therapies
• 8.2 Clinical trials design
  • 8.2.1 Common efficacy measures in UC clinical trials
  • 8.2.2 Head-to-head clinical trials in UC
• 9 Pipeline Assessment
• 9.1 Overview
• 9.2 Promising drugs in clinical development
• 10 Pipeline Valuation Analysis
• 10.1 Overview
• 10.2 Competitive assessment
• 11 Current and Future Players
• 11.1 Overview
• 11.2 Deal-making trends
• 12 Market Outlook
• 12.1 Global markets
  • 12.1.1 Forecast
  • 12.1.2 Drivers and barriers - global issues
• 12.2 US
  • 12.2.1 Forecast
  • 12.2.2 Key events
  • 12.2.3 Drivers and barriers
• 12.3 5EU
  • 12.3.1 Forecast
  • 12.3.2 Key Events
  • 12.3.3 Drivers and barriers
• 12.4 Japan
  • 12.4.1 Forecast
  • 12.4.2 Key Events
  • 12.4.3 Drivers and barriers
• 12.5 Canada
  • 12.5.1 Forecast
  • 12.5.2 Key events
  • 12.5.3 Drivers and barriers
• 13 Appendix
• 13.1 Bibliography
• 13.2 Abbreviations
• 13.3 Methodology
  • 13.3.1 Forecasting methodology
• 13.4 Primary Research - KOLs Interviewed for This Report
  • 13.4.1 KOLs
• 13.5 Primary Research - Prescriber Survey
• 13.6 About the authors
  • 13.6.1 Analyst
  • 13.6.2 Managing Analyst
  • 13.6.3 Epidemiologist
  • 13.6.4 Epidemiology reviewers
  • 13.6.5 Vice President of Disease Analysis and Intelligence
  • 13.6.6 Global Head and EVP of Healthcare Operations and Strategy
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