Ulcerative Colitis – Global Drug Forecast and Market Analysis to 2029

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Published: December 31, 2020 Report Code: GDHC205PIDR-ST

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Ulcerative colitis (UC) is a type of inflammatory bowel disease. In UC, chronic inflammation affects the colon (also known as the large intestines). Initially, 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 current 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 10 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. Furthermore, all but one drug are being developed for moderate to severe UC, which will result in a crowded market.

This model covers the market forecast for the marketed and late-stage pipeline UC therapeutics. The model segments patients by severity, with mild-moderate, moderate-severe, and severe/fulminant segments. The base year of this model is 2019, and the forecast period is 2020–2029.

KEY QUESTIONS ANSWERED

Which unmet needs are limiting the treatment of ulcerative colitis in the 8MM?
What strategies can the pharmaceutical industry employ to increase treatment rates for ulcerative colitis? How should these strategies differ across different geographical markets?
What effect will the launch of biosimilars and generics have on the sales of branded agents?
What are the main R&D trends in the ulcerative colitis market and which companies are leading the way? Are there major differences in the mechanisms of action used by therapies in late-stage versus early-stage clinical development?

Scope

Overview of UC including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Topline UC market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.

Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting UC therapeutics sales in the 8MM.

Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.

Analysis of the current and future market competition in the global UC therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

The greatest drivers of growth in the global UC market include the launch of 10 new pipeline therapies during the forecast period and an increasing diagnosed prevalence in many 8MM countries.

The main barriers to growth in the UC market include the crowded and competitive market as well as patent expiration of key biologic brands with subsequent biosimilar launch.

Novel drug classes in the UC pipeline include IL-23 inhibitors and S1P receptor modulators. In addition, Takeda will launch a subcutaneous version of their product, Entyvio, and two additional JAK inhibitors are expected to make their appearance on the market.

The most important unmet needs in the UC market are for safer and more effective therapies, an improvement in management of fulminant patients, biomarkers to predict responsiveness to therapy, and standardization of patient-reported outcomes.

Reasons to Buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.

Develop business strategies by understanding the trends shaping and driving the global UC therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global UC 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.

Track drug sales in the global UC therapeutics market from 2019-2029.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

J&J
AbbVie
Takeda
Pfizer
Eli Lilly
EA Pharma
Galapagos
BMS
Arena Pharmaceuticals

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Ulcerative Colitis: Executive Summary

2.1 Large Growth is Expected for UC Market from 2019–2029

2.2 Competition and Biosimilar Threat Defines UC Market

2.3 Pipeline Products Partially Address Unmet Needs

2.4 Opportunities for Managing Severe/Fulminant Patients Remain

2.5 Subcutaneous Biologics and Oral Therapies to Drive Growth in UC Market

2.6 What Do Physicians and Payers Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Gut Dysbiosis

4.1.2 The Significance of Diet

4.1.3 The Role of Interleukins

4.1.4 Environmental Factors

4.1.5 Epigenetics

4.1.6 Pathophysiology

4.1.7 Biomarkers/Targets of Interest

4.2 Classification or Staging Systems

4.3 Symptoms

4.4 Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Sources Not Used

5.4.3 Forecast Assumptions and Methods

5.4.4 Forecast Assumptions and Methods: Diagnosed Incident Cases of UC

5.4.5 Forecast Assumptions and Methods: Total and Diagnosed Prevalent Cases of UC

5.4.6 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of UC by Severity

5.4.7 Forecast Assumptions and Methods: Post-operative UC Cases

5.5 Epidemiological Forecast for UC (2019–2029)

5.5.1 Diagnosed Incident Cases of UC

5.5.2 Age-Specific Diagnosed Incident Cases of UC

5.5.3 Sex-Specific Diagnosed Incident Cases of UC

5.5.4 Diagnosed Prevalent Cases of UC

5.5.5 Age-Specific Diagnosed Prevalent Cases of UC

5.5.6 Sex-Specific Diagnosed Prevalent Cases of UC

5.5.7 Diagnosed Prevalent Cases of UC by Severity for Ages Under 18 Years

5.5.8 Diagnosed Prevalent Cases of UC by Severity for Ages ≥18 Years

5.5.9 Post-Operative UC Cases Among Diagnosed Prevalent Cases of UC

5.5.10 Total Prevalent Cases of UC

5.5.11 Age-Specific Total Prevalent Cases of UC

5.5.12 Sex-Specific Total Prevalent Cases of UC

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Coronavirus Disease 2019 Impact

5.6.3 Limitations of the Analysis

5.6.4 Strengths of the Analysis

6 Disease Management

6.1 Diagnosis and Treatment Overview

6.2 Treatment Overview

6.3 Treatment Guidelines and Leading Prescribed Drugs

6.3.1 Clinical Practice

6.3.2 Treat to Target Approach

6.4 US

6.5 5EU

6.6 Japan

6.7 Canada

7 Competitive Assessment

7.1 Overview

7.2 KOL and Payer Opinion on the Impact of COVID-19

8 Unmet Needs and Opportunity Assessment

8.1 Overview

8.2 Lack of Safe and Efficacious Treatment Alternatives

8.3 Improved Medical Management for Severe/Fulminant Patients

8.4 Biomarkers to Predict Responsiveness to Therapy and Prognosis

8.5 Standardization of Patient-Reported Outcomes

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Johnson & Johnson

10.4 AbbVie

10.5 Takeda

10.6 Pfizer

10.7 Eli Lilly

10.8 EA Pharma

10.9 Galapagos

10.10 Bristol-Myers Squibb

10.11 Arena Pharmaceuticals

11 Market Outlook

11.1 Global Markets

11.1.1 Forecast

11.1.2 Drivers and Barriers – Global Issues

11.2 US

11.2.1 Forecast

11.2.2 Key Events

11.2.3 Drivers and Barriers

11.3 5EU

11.3.1 Forecast

11.3.2 Key Events

11.3.3 Drivers and Barriers

11.4 Japan

11.4.1 Forecast

11.4.2 Key Events

11.4.3 Drivers and Barriers

11.5 Canada

11.5.1 Forecast

11.5.2 Key Events

11.5.3 Drivers and Barriers

12 Appendix

12.1 Bibliography

12.2 Abbreviations

12.3 Methodology

12.3.1 Forecasting Methodology

12.3.2 Diagnosed Patients

12.3.3 Percent Drug-Treated Patients

12.3.4 Drugs Included in Each Therapeutic Class

12.3.5 Launch and Patent Expiry Dates

12.3.6 General Pricing Assumptions

12.3.7 Individual Drug Assumptions

12.3.8 Generic/Biosimilar Erosion

12.3.9 Pricing of Pipeline Agents

12.3.10 Compliance

12.4 Primary Research – KOLs and Payers Interviewed for This Report

12.4.1 KOLs

12.4.2 Payers

12.5 Primary Research – Prescriber Survey

12.6 About the Authors

12.6.1 Analyst

12.6.2 Therapy Area Director

12.6.3 Epidemiologist

12.6.4 Managing Epidemiologist

12.6.5 Global Director of Therapy Analysis and Epidemiology

12.6.6 Global Head and EVP of Healthcare Operations and Strategy

12.7 About GlobalData

12.8 Contact Us

12.9 Disclaimer

Table

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: Risk Factors and Comorbidities for UC and IBD

Table 6: Guidelines Used for Managing UC

Table 7: Country Profile – US

Table 8: Country Profile – 5EU

Table 9: Country Profile – Japan

Table 10: Country Profile – Canada

Table 11: Leading Treatments for UC, 2020

Table 12: Johnson & Johnson’s Disease Portfolio Assessment, 2020

Table 13: AbbVie’s Disease Portfolio Assessment, 2020

Table 14: Takeda’s Disease Portfolio Assessment, 2020

Table 15: Pfizer’s Disease Portfolio Assessment, 2020

Table 16: Eli Lilly’s Disease Portfolio Assessment, 2020

Table 17: EA Pharma’s Disease Portfolio Assessment, 2020

Table 18: Galapagos’ Disease Portfolio Assessment, 2020

Table 19: Bristol-Myers Squibb’s Disease Portfolio Assessment, 2019

Table 20: Arena’s Disease Portfolio Assessment, 2020

Table 21: Disease UC Market – Global Drivers and Barriers, 2019–2029

Table 22: Key Events Impacting Sales for Disease UC in the US, 2019–2029

Table 23: Disease UC Market – Drivers and Barriers in the US, 2019–2029

Table 24: Key Events Impacting Sales for Disease UC in the 5EU, 2019–2029

Table 25: Disease UC Market – Drivers and Barriers in the 5EU, 2019–2029

Table 26: Key Events Impacting Sales for Disease UC in Japan, 2019–2029

Table 27: Disease UC Market – Drivers and Barriers in Japan, 2019–2029

Table 28: Key Events Impacting Sales for Disease UC in Canada, 2019–2029

Table 29: UC Market –Drivers and Barriers in Canada, 2019–2029

Table 30: Key Historical and Projected Launch Dates for UC

Table 31: Key Historical and Projected Patent Expiry Dates for UC

Table 32: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figures

Figure 1: Global Sales Forecast by Country for Ulcerative Colitis in 2019 and 2029

Figure 2: Analysis of the Company Portfolio Gap in UC During the Forecast Period

Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of UC During the Forecast Period

Figure 4: Cellular Mechanisms Involved in the Pathogenesis of UC

Figure 5: Types of UC

Figure 6: 8MM, Diagnosed Incidence of UC, Men and Women, Cases per 100,000 Population, All Ages, 2019

Figure 7: 8MM, Diagnosed Prevalence of UC, Men and Women, %, All Ages, 2019

Figure 8: 8MM, Total Prevalence of UC, Men and Women, %, All Ages, 2019

Figure 9: 8MM, Sources Used and Not Used to Forecast the Diagnosed Incident Cases of UC

Figure 10: 8MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of UC

Figure 11: 8MM, Sources Used and Not Used to Forecast the Total Prevalent Cases of UC

Figure 12: 8MM, Sources Used to Forecast the Post-Operative UC Cases Among Diagnosed Prevalent Cases of UC

Figure 13: 8MM, Sources Used to Forecast the Severity of Diagnosed Prevalent Cases of UC for Ages <18 years

Figure 14: 8MM, Diagnosed Incident Cases of UC, N, Both Sexes, All Ages, 2019

Figure 15: 8MM, Diagnosed Incident Cases of UC by Age, N, Both Sexes, 2019

Figure 16: 8MM, Diagnosed Incident Cases of UC by Sex, N, All Ages, 2019

Figure 17: 8MM, Diagnosed Prevalent Cases of UC, N, Both Sexes, All Ages, 2019

Figure 18: 8MM, Diagnosed Prevalent Cases of UC by Age, N, Both Sexes, 2019

Figure 19: 8MM, Diagnosed Prevalent Cases of UC by Sex, N, All Ages, 2019

Figure 20: 8MM, Diagnosed Prevalent Cases of UC by Severity, N, Ages <18 years, 2019

Figure 21: 8MM, Diagnosed Prevalent Cases of UC by Severity, N, Ages ≥18 Years, 2019

Figure 22: 8MM, Post-Operative UC Cases Among Diagnosed Prevalent Cases of UC, 2019

Figure 23: 8MM, Total Prevalent Cases of UC, N, Both Sexes, All Ages, 2019

Figure 24: 8MM, Total Prevalent Cases of UC by Age, N, Both Sexes, 2019

Figure 25: 8MM, Total Prevalent Cases of UC by Sex, N, All Ages, 2019

Figure 26: UC Treatment Algorithm

Figure 27: Unmet Need and Opportunity in UC, 2020

Figure 28: Overview of the Development Pipeline in UC

Figure 29: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for UC in the 8MM During the Forecast Period

Figure 30: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of UC During the Forecast Period

Figure 31: Analysis of the Company Portfolio Gap in UC During the Forecast Period

Figure 32: Global (8MM) Sales Forecast by Country for UC in 2019 and 2029

Figure 33: Global (8MM) Sales Forecast by Class for UC in 2019 and 2029

Figure 34: Sales Forecast by Class for UC in the US in 2019 and 2029

Figure 35: Sales Forecast by Class for UC in the 5EU in 2019 and 2029

Figure 36: Sales Forecast by Class for UC in Japan in 2019 and 2029

Figure 37: Sales Forecast by Class for UC in Canada in 2019 and 2029

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