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Ulcerative Colitis: Global Drug Forecast and Market Analysis to 2026

Ulcerative Colitis: Global Drug Forecast and Market Analysis to 2026

Summary


The current Ulcerative Colitis (UC) market is overcrowded with cheap generic drugs for mild to moderate disease, as well as expensive biologics (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 four 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 could crowd the market place.

2016 sales for the Ulcerative Colitis (UC) market is estimated at approximately $5.4 billion across the 7MM, encompassing the US, the five major European Union countries (5EU: France, Germany, Italy, Spain, and UK), and Japan. Over the course of the 10-year forecast period, the Ulcerative Colitis (UC) market is expected to grow at a Compound Annual Growth Rate (CAGR) of 2.5% across the 7MM. Each of the 7MM are anticipated to grow, recording CAGRs of 2.7%, 1.2%, and 4.3% across the US, 5EU, and Japan, respectively.

At the end of 2026, the US will account for 80.4% of sales across the 7MM, while the 5EU and Japan, will account for around 16.1% and 3.4% of sales, respectively. The higher sales numbers for the US can be attributed to the higher prices of pharmaceuticals and the greater diagnosed prevalence of Ulcerative Colitis (UC) in the region, as well as the high annual cost of therapy (ACOT) of J&J’s Stelara and the anticipated ACOT of AbbVie’srisankizumab and Eli Lilly’s mirikizumab in the US market.

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. Current therapies have low safety profiles and can cause immunosuppression, leading to severe treatment-emergent adverse events (TEAE), which results in discontinuation of treatment in a significant number of patients. The need for novel oral therapies, medical management of severe to fulminant patients, and lower cost of therapy are significant unmet needs in the Ulcerative Colitis (UC) space.

The report, Ulcerative Colitis: Global Drug Forecast and Market Analysis to 2026, analyzes the Ulcerative Colitis (UC) treatment landscape and provides detailed insights into the market dynamics of this rapidly developing space.

The report specifically helps in answering -

  • How will the Ulcerative Colitis (UC) market landscape in the 7MM (US, France, Germany, Italy, Spain, UK , and Japan) change from 2016-2026?
  • What are the most promising late-stage pipeline drugs in UC?
  • How do the clinical and commercial attributes of late-stage pipeline therapies compare with one another and against existing treatment options?
  • What are the greatest unmet needs in UC? Will the pipeline drugs fulfill these needs of the market?
  • What are the largest opportunities in the Ulcerative Colitis (UC) landscape?
Scope
  • Overview of UC, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
  • Topline UC market revenue from 2016-2026. ACOT and major pipeline product sales in this forecast period are included.
  • Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting UC therapeutics sales in the 7MM.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
  • 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.
Reasons to buy

The report will enable you to -
  • 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 UC therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the UC 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.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Ulcerative Colitis: Executive Summary
2.1 Moderate Growth is Expected for UC Market from 2016-2026
2.2 R&D and Corporate Strategies
2.3 Current and Pipeline Products Partially Address Unmet Needs
2.4 Opportunities for Managing Severe to Fulminant Patients Remain
2.5 Oral Therapies and Biosimilars to Drive Growth in UC Market
2.6 What Do Physicians Think?
3 Introduction
3.1 Catalyst
3.2 Related Reports
3.3 Upcoming Related Reports
4 Disease Overview
4.1 Etiology and Pathophysiology
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
5.5 Epidemiological Forecast for UC (2016-2026)
5.6 Discussion
6 Disease Management
6.1 Diagnosis Overview
6.2 Treatment Overview
6.3 Treatment Guidelines and Leading Prescribed Drugs
6.4 US
6.5 5EU
6.6 Japan
7 Competitive Assessment
7.1 Overview
7.2 5-ASAs
7.3 Steroids
7.4 Thiopurines
7.5 Other Immunomodulators
7.6 Remicade
7.7 Humira
7.8 Simponi
7.9 Entyvio
7.10 Xeljanz
7.11 Biosimilar Assessment
7.12 Infliximab Biosimilars
7.13 Adalimumab Biosimilars
8 Unmet Needs and Opportunity Assessment
8.1 Overview
8.2 Lack of Safe and Efficacious Treatment Alternatives
8.3 Need for Novel Oral Therapies
8.4 Improved Medical Management for Severe to Fulminant Patients
8.5 Cost of Therapy
9 Pipeline Assessment
9.1 Overview
9.2 Promising Drugs in Clinical Development
9.3 Stelara
9.4 Etrolizumab
9.5 Ozanimod Hydrochloride
9.6 Carotegrast (AJM300)
9.7 SHP-647
9.8 Upadacitinib Tartrate
9.9 Filgotinib
9.10 Kappaproct
9.11 Risankizumab
9.12 Mirikizumab
9.13 Other Drugs in 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 Pharmaceuticals
10.6 Pfizer
10.7 Roche
10.8 InDex Pharmaceuticals
10.9 Celgene Corporation
10.10 EA Pharma
10.11 Galapagos
10.12 Eli Lilly
10.13 Shire
11 Market Outlook
11.1 Global Markets
11.2 US
11.3 5EU
11.4 Japan
12 Appendix
12.1 Bibliography
12.2 Abbreviations
12.3 Methodology
12.4 Primary Research - KOLs Interviewed for This Report
12.5 Primary Research - Prescriber Survey
12.6 About the Authors
12.7 About GlobalData
12.8 Contact Us
12.9 Disclaimer
1.1 List of Tables
Table 1: Ulcerative Colitis: Key Metrics in the 7MM
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: Truelove and Witts Categorization of Disease Severity and Clinical Parameters
Table 7: Different Guidelines Used for Managing UC
Table 8: Country Profile - US
Table 9: Country Profile - 5EU
Table 10: Country Profile - Japan
Table 11: Leading Treatments for UC, 2017
Table 12: Product Profile - Pentasa
Table 13: Efficacy of Different Drugs in the 5-ASA Class in Inducing Remission in UC Patients
Table 14: Efficacy of Different Drugs in the 5-ASA Class in Preventing Disease Relapse in UC Patients
Table 15: Percentage of Patients Experiencing AEs with 5-ASAs
Table 16: 5-ASA SWOT Analysis, 2018
Table 17: Product Profile - Uceris
Table 18: Efficacy of Uceris
Table 19: Uceris SWOT Analysis, 2018
Table 20: Product Profile - AZA
Table 21: Percentage of Patients Experiencing AEs with AZA and 6-MP Therapy
Table 22: AZA SWOT Analysis, 2018
Table 23: Product Profile - MTX
Table 24: MTX SWOT Analysis, 2018
Table 25: Product Profile - Remicade
Table 26: Efficacy Data for the ACT 1 and ACT 2 Trials
Table 27: Safety of Remicade
Table 28: Remicade SWOT Analysis, 2018
Table 29: Product Profile - Humira
Table 30: Efficacy of Humira - Primary and Secondary
Table 31: Humira SWOT Analysis, 2018
Table 32: Product Profile - Simponi
Table 33: Efficacy of Simponi
Table 34: Safety of Simponi
Table 35: Simponi SWOT Analysis, 2018
Table 36: Product Profile - Entyvio
Table 37: Efficacy of Entyvio
Table 38: Efficacy of Entyvio
Table 39: Safety of Entyvio
Table 40: Entyvio SWOT Analysis, 2018
Table 41: Product Profile - Xeljanz
Table 42: Mean change in Mayo score from OCTAVE Sustain
Table 43: Safety analysis from OCTAVE Induction 1 and 2 Trials
Table 44: Rates of various AEs from OCTAVE Induction 1 and 2
Table 45: Xeljanz SWOT Analysis, 2018
Table 46: Marketed and Pipeline Biosimilars for UC, 2018
Table 47: Average price of Remicade discount accross the 7MM
Table 48: Product Profile - Inflectra/Remsima
Table 49: Infliximab Biosimilars SWOT Analysis, 2018
Table 50: Product Profile - Amjevita
Table 51: Adalimumab Biosimilars SWOT Analysis, 2018
Table 52: Unmet Need and Opportunity in UC, 2017
Table 53: Product Profile - Stelara
Table 54: Stelara SWOT Analysis, 2018
Table 55: Product Profile - Etrolizumab
Table 56: Efficacy Data for Etrolizumab
Table 57: Etrolizumab SWOT Analysis, 2018
Table 58: Product Profile - Ozanimod Hydrochloride
Table 59: Efficacy Analysis of Ozanimod Hydrochloride from the Phase II TOUCHSTONE Trial
Table 60: Summary of the AEs Associated with Ozanimod Use in the TOUCHSTONE Phase ll Trial.
Table 61: Ozanimod SWOT Analysis, 2018
Table 62: Product Profile - Carotegrast
Table 63: Efficacy Analysis of Carotegrast
Table 64: AEs Seen in Patients Treated with Carotegrast and Placebo
Table 65: Carotegrast SWOT Analysis, 2018
Table 66: Product Profile - SHP-647
Table 67: SHP-647 - Remission, Response, and Mucosal Healing Rates at Week 12 with Local Endoscopy Readings
Table 68: SHP-647 SWOT Analysis, 2018
Table 69: Product Profile - Upadacitinib
Table 70: Upadacitinib SWOT Analysis, 2018
Table 71: Product Profile - Filgotinib
Table 72: Filgotinib SWOT Analysis, 2018
Table 73: Product Profile - Kappaproct
Table 74: Safety Data for Kappaproct
Table 75: Kappaproct SWOT Analysis, 2018
Table 76: Product Profile - Risankizumab
Table 77: Phase II Safety Data for Risankizumab in CD
Table 78: Risankizumab SWOT Analysis, 2018
Table 79: Product Profile - Mirikizumab
Table 80: Mirikizumab SWOT Analysis, 2018
Table 81: Drugs in Development for UC, 2018
Table 82: 7MM, Key Companies in the UC Market, 2018
Table 83: J&J’s Disease Portfolio Assessment, 2018
Table 84: J&J SWOT Analysis, 2018
Table 85: AbbVie’s Disease Portfolio Assessment, 2018
Table 86: AbbVie’s SWOT Analysis, 2018
Table 87: Takeda’s Disease Portfolio Assessment, 2018
Table 88: Takeda’s SWOT Analysis, 2018
Table 89: Pfizer’s Disease Portfolio Assessment, 2018
Table 90: Pfizer SWOT Analysis, 2018
Table 91: Roche’s Disease Portfolio Assessment, 2018
Table 92: Roche SWOT Analysis, 2018
Table 93: InDex’s Disease Portfolio Assessment, 2018
Table 94: InDex SWOT Analysis, 2018
Table 95: Celgene’s Disease Portfolio Assessment, 2018
Table 96: Celgene SWOT Analysis, 2018
Table 97: EA Pharma’s Disease Portfolio Assessment, 2018
Table 98: EA Pharma SWOT Analysis, 2018
Table 99: Galapagos’ Disease Portfolio Assessment, 2018
Table 100: Galapagos SWOT Analysis, 2018
Table 101: Eli Lilly’s Disease Portfolio Assessment, 2018
Table 102: Eli Lilly SWOT Analysis, 2018
Table 103: Shire’s Disease Portfolio Assessment, 2018
Table 104: Shire SWOT Analysis, 2018
Table 105: UC Market - Global Drivers and Barriers, 2016-2026
Table 106: Key Events Impacting Sales for UC in the US, 2016-2026
Table 107: UC Market - Global Drivers and Barriers in the US, 2016-2026
Table 108: Key Events Impacting Sales for UC in the 5EU, 2016-2026
Table 109: UC Market - Global Drivers and Barriers in the 5EU, 2016-2026
Table 110: Key Events Impacting Sales for UC in Japan, 2016-2026
Table 111: UC Market - Global Drivers and Barriers in Japan, 2016-2026
Table 112: Key Historical and Projected Launch Dates for UC
Table 113: Key Historical and Projected Patent Expiry Dates for UC
Table 114: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
1.2 List of Figures
Figure 1: Global Sales Forecast by Country for UC, 2016 and 2026
Figure 2: Company Portfolio Gap Analysis in UC, 2016-2026
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of UC, 2016-2026
Figure 4: Cellular Mechanisms Involved in the Pathogenesis of UC
Figure 5: Types of UC
Figure 6: 7MM, Age-Standardized Diagnosed Incidence of UC (Cases per 100,000 Population), All Ages, Both Sexes, N, 2016
Figure 7: 7MM, Age-Standardized Diagnosed Prevalence of UC (%), All Ages, Both Sexes, N, 2016
Figure 8: 7MM, Sources Used, Diagnosed Incident Cases of UC
Figure 9: 7MM, Sources Used, Diagnosed Prevalent Cases of UC
Figure 10: 7MM, Sources Used, Undiagnosed Prevalent Cases of UC
Figure 11: 7MM, Sources Used, Total Prevalent Cases of UC
Figure 12: 7MM, Sources Used, Diagnosed Incident Cases of UC by Stage at Diagnosis
Figure 13: 7MM, Sources Used, Diagnosed Incident Cases of UC by Severity
Figure 14: 7MM, Sources Used, Diagnosed Prevalent Cases of UC by Severity
Figure 15: 7MM, Sources Used, Mortality Due to CRC and TMC Among the Diagnosed Prevalent Cases of UC
Figure 16: 7MM, Sources Used, UC Cases Requiring Colectomy Among the Diagnosed Prevalent Cases of UC Due to Failure of Medical Management
Figure 17: 7MM, Sources Used, Diagnosed Incident Cases of IC
Figure 18: 7MM, Sources Used, Diagnosed Prevalent Cases of IC
Figure 19: Diagnosed Incident Cases of UC, 7MM, Men and Women, All Ages, 2016
Figure 20: 7MM, Age-Specific Diagnosed Incident Cases of UC, Both Sexes, N, 2016
Figure 21: 7MM, Sex-Specific Diagnosed Incident Cases of UC, All Ages, N, 2016
Figure 22: 7MM, Diagnosed Incident Cases of UC Segmented by Stage at Diagnosis, Both Sexes, All Ages, N, 2016
Figure 23: 7MM, Diagnosed Incident Cases of UC Segmented by Severity, Both Sexes, All ages, N, 2016
Figure 24: Diagnosed Prevalent Cases of UC, 7MM, Men and Women, All Ages, 2016
Figure 25: 7MM, Age-Specific Diagnosed Prevalent Cases of UC, Both Sexes, N, 2016
Figure 26: 7MM, Sex-Specific Diagnosed Prevalent Cases of UC, All Ages, N, 2016
Figure 27: 7MM, Diagnosed Prevalent Cases of UC by Severity, Both Sexes, ≥18 Years, N, 2016
Figure 28: 7MM, Mortality Due to Complications Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2016
Figure 29: 7MM, Colectomy Due to Failure of Medical Management Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2016
Figure 30: 7MM, Comorbidities Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2016
Figure 31: Undiagnosed Prevalent Cases of UC, 7MM, Men and Women, All Ages, 2016
Figure 32: Total Prevalent Cases of UC, 7MM, Men and Women, All Ages, 2016
Figure 33: Diagnosed Incident Cases of IC, 7MM, Men and Women, All Ages, 2016
Figure 34: Diagnosed Prevalent Cases of IC, 7MM, Men and Women, All Ages, 2016
Figure 35: UC Treatment Algorithm
Figure 36: Unmet Need and Opportunity in UC, 2018
Figure 37: Overview of the Development Pipeline in UC
Figure 38: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for UC in the 7MM During the Forecast Period
Figure 39: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of UC During the Forecast Period
Figure 40: Global Sales of Branded Products for UC by Company in 2016 and 2026
Figure 41: Company Portfolio Gap Analysis in UC During the Forecast Period
Figure 42: Global (7MM) Sales Forecast by Country for UC, 2016 and 2026
Figure 43: Sales Forecast by Class for UC in the US, 2016 and 2026

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