PharmaPoint: Ulcerative Colitis– Global Drug Forecast and Market Analysis to 2025

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Ulcerative Colitis (UC) is a type of chronic IBD that causes inflammation and ulcers in the innermost lining of the colon and rectum. As a result, the colon's ability to absorb water is decreased, which leads to progressive loosening of the stool, bloody stool, and sometimes cramping or abdominal pain, with urgency for bowel movement. Other associated symptoms of UC include loss of appetite, weight loss, fatigue, and anaemia in cases of severe bleeding. The exact causes or triggers of the disease are yet to be identified; however, it is known that in people with UC, the body's immune system mistakes bacteria, food, and other materials in the intestine for foreign substances and attacks the colon tissues, leading to chronic inflammation of the colon linings. UC is a relapsing, remitting chronic disease that requires life long medical management and patients. Attributing to unknown aetiology of UC, all current pharmacopoeia provide immunosuppressive, symptomatic relief, as no curative disease therapy is available yet. Based on disease location and severity, patients receive different treatment alternatives either for induction or maintenance of remission.

Scope

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

Annualized UC therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the UC therapeutics market.

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 newly launched anti-integrin antibody Entyvio and Remicade biosimilars, will see an increase in patient shares for the treatment of severe UC. Will these newly marketed make a significant impact on the UC market? Which of these drugs will have the highest peak sales at the highest CAGR, and why?

The most notable candidate in the current late-stage UC pipeline is new generation ozanimod hydrochloride and Xeljanz (tofacitinib), which are predicted to have a notable impact in the moderate to severe UC space over this forecast period. However, there are still considerably high unmet needs within the indication. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the UC market?

We have seen a notable increase in the UC population in terms of diagnosed prevalent UC cases for mild to moderate and moderate to severe disease. How will epidemiological changes impact the growth of the future market?

Johnson & Johnson
AbbVie
Takeda Pharmaceuticals
Salix Pharmaceuticals
Pfizer
Roche
InDeX Pharmaceuticals
Lipid Therapeutics
Celgene
EA Pharma
Ferring
Tillotts Pharma

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Classification or Staging Systems

3.3Symptoms

3.4Quality of Life

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.1Incidence

4.3.2Prevalence

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Forecast Assumptions and Methods

4.4.3Sources Not Used

4.5Epidemiological Forecast for UC (2015–2025)

4.5.1Diagnosed Incident Cases of UC

4.5.2Diagnosed Prevalent Cases of UC

4.5.3Undiagnosed Prevalent Cases of UC

4.5.4Total Prevalent Cases of UC

4.5.5Diagnosed Incident Cases of IC

4.5.6Diagnosed Prevalent Cases of IC

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

4.6.4Strengths of the Analysis

5Disease Management

5.1Diagnosis and Treatment Overview

5.1.1Diagnosis

5.1.2Treatment Guidelines and Leading Prescribed Drugs

5.1.3Clinical Practice

5.2US

5.35EU

5.4Japan

6Competitive Assessment

6.1Overview

6.2Product Profiles – Ulcerative Colitis

6.2.15-ASAs

6.2.2Steroids

6.2.3Thiopurines

6.2.4Other Immunomodulators

6.2.5Anti-TNFa drugs (Remicade, Humira, Simponi)

6.2.6Anti-integrins (Entyvio)

6.2.7Biosimilars

7Unmet Needs Assessment and Opportunity Analysis

7.1Overview

7.2Inadequacy of current anti-TNF- a drug treatment

7.2.1Unmet need

7.2.2Gap Analysis

7.2.3Opportunity

7.3Patient Adherence

7.3.1Unmet Need

7.3.2Gap Analysis

7.3.3Opportunity

7.4Lack of safe, efficacious and less costly treatment alternatives

7.4.1Unmet Need

7.4.2Gap Analysis

7.4.3Opportunity

7.5Need for novel oral therapies

7.5.1Unmet Need

7.5.2Gap Analysis

7.5.3Opportunity

7.6Preventative Medicine for Lowering the Associated Colorectal Cancer Risk

7.6.1Unmet Need

7.6.2Gap Analysis

7.6.3Opportunity

8Pipeline Assessment

8.1Overview

8.2Promising Drugs in Clinical Development

8.2.1Ustekinumab (Stelara, Suterara, CNTO-1275)

8.2.2Etrolizumab

8.2.3LT-02 (phosphatidylcholine)

8.2.4Kappaproct

8.2.5Xeljanz (Tofacitinib, Cp-690,550)

8.2.6Ozanimod hydrochloride

8.2.7Carotegrast (AJM300)

8.2.8Mesalamine (TP-05)

8.2.9AJG511

8.3Biosimilars

8.3.1Overview

8.3.2Infliximab biosimilars

8.3.3Adalimumab biosimilars

8.3.4Forecast

9Current and Future Players

9.1Overview

9.2Trends in Corporate Strategy

9.3Company Profiles

9.3.1Johnson & Johnson (J&J)

9.3.2AbbVie

9.3.3Takeda Pharmaceuticals

9.3.4Salix Pharmaceuticals

9.3.5Pfizer Inc.

9.3.6F. Hoffmann-La Roche Ltd.

9.3.7InDex Pharmaceuticals

9.3.8Lipid Therapeutics GmbH

9.3.9Celgene Corporation

9.3.10EA Pharma

9.3.11Ferring International

9.3.12Tillotts Pharma

10Market Outlook

10.1Global Markets

10.1.1Forecast

10.1.2Drivers and Barriers – Global Issues

10.2US

10.2.1Forecast

10.2.2Key Events

10.2.3Drivers and Barriers

10.3France

10.3.1Forecast

10.3.2Key Events

10.3.3Drivers and Barriers

10.4Germany

10.4.1Forecast

10.4.2Key Events

10.4.3Drivers and Barriers

10.5Italy

10.5.1Forecast

10.5.2Key Events

10.5.3Drivers and Barriers

10.6Spain

10.6.1Forecast

10.6.2Key Events

10.6.3Drivers and Barriers

10.7United Kingdom

10.7.1Forecast

10.7.2Key Events

10.7.3Drivers and Barriers

10.8Japan

10.8.1Forecast

10.8.2Key Events

10.8.3Drivers and Barriers

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Diagnosed Prevalent Patients

11.4.2Percent Drug-Treated Patients

11.4.3Drugs Included in Each Therapeutic Class

11.4.4Launch and Patent Expiry Dates

11.4.5General Pricing Assumptions

11.4.6Individual Drug Assumptions

11.4.7Generic Erosion

11.4.8Pricing of Pipeline Agents

11.5Primary Research – KOLs Interviewed for this Report

11.6Primary Research – Prescriber Survey

11.7About the Authors

11.7.1Analyst

11.7.2Analyst

11.7.3Reviewer

11.7.4Therapy Area Director

11.7.5Epidemiologist

11.7.6Managing Epidemiologist

11.7.7Global Director of Therapy Analysis and Epidemiology

11.8About GlobalData

11.9Disclaimer

Table

Table 1: Genetic factors implicated in UC causation

Table 2: Truelove and Witts categorization of disease severity and clinical parameters

Table 3: Pediatric Ulcerative Colitis Activity Index

Table 4: Typical Symptoms of UC

Table 5: Risk Factors and Comorbidities for UC and IBD

Table 6: Incidence of UC in the 5EU

Table 7: Prevalence of UC in Italy, Spain, and the UK

Table 8: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of UC

Table 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of UC

Table 10: 7MM, Sources Used to Forecast Undiagnosed Prevalent Cases of UC

Table 11: 7MM, Sources Used to Forecast the Total Prevalent Cases of UC

Table 12: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of UC by Stage at Diagnosis

Table 13: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Incident/Prevalent Cases of UC by Severity

Table 14: 7MM, Sources of Epidemiological Data used to Forecast Mortality Due to CRC and TMC Among the Diagnosed Prevalent Cases of UC

Table 15: 7MM, Sources Used to Forecast Autoimmune Comorbidities Among the Diagnosed Prevalent Cases of UC

Table 16: 7MM, Sources Used to Forecast UC Cases Requiring Colectomy Among the Diagnosed Prevalent Cases of UC Due to Failure of Medical Management

Table 17: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of IC

Table 18: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of IC

Table 19: 7MM, Sources Not Used in Epidemiological Analysis of UC

Table 20: 7MM, Diagnosed Incident Cases of UC, Both Sexes, All Ages, N, Selected Years 2015–2025

Table 21: 7MM, Age-Specific Diagnosed Incident Cases of UC, Both Sexes, N (Row %), 2015

Table 22: 7MM, Sex-Specific Diagnosed Incident Cases of UC, All Ages, N (Row %), 2015

Table 23: 7MM, Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, Selected Years, 2015–2025

Table 24: 7MM, Age-Specific Diagnosed Prevalent Cases of UC, Both Sexes, N (Row %), 2015

Table 25: 7MM, Sex-Specific Diagnosed Prevalent Cases of UC, All Ages, N (Row %), 2015

Table 26: 7MM, Undiagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, Select Years, 2015–2025

Table 27: 7MM, Age-Specific Undiagnosed Prevalent Cases of UC, Both Sexes, N (Row %), 2015

Table 28: 7MM, Sex-Specific Undiagnosed Prevalent Cases of UC, All Ages, N (Row %), 2015

Table 29: 7MM, Total Prevalent Cases of UC, Both Sexes, All Ages, N, Selected Years, 2015–2025

Table 30: 7MM, Age-Specific Total Prevalent Cases of UC, Both Sexes, N (Row %), 2015

Table 31: 7MM, Sex-Specific Total Prevalent Cases of UC, All Ages, N (Row %), 2015

Table 32: 7MM, Diagnosed Incident Cases of IC, Both Sexes, All Ages, N, Selected Years, 2015–2025

Table 33: 7MM, Diagnosed Prevalent Cases of IC, Both Sexes, All Ages, N, Selected Years, 2015–2025

Table 34: Diagnostic features of UC

Table 35: Truelove and Witts categorization of disease severity and clinical parameters

Table 36: UCDAI

Table 37: Pediatric Ulcerative Colitis Activity Index

Table 38: Treatment Guidelines for Ulcerative Colitis

Table 39: Most Prescribed Drugs for Ulcerative Colitis by Class in the Global Markets, 2015

Table 40: Different 5-ASAs used for managing UC

Table 41: Different corticosteroids used for managing UC

Table 42: Country Profile – US

Table 43: Region Profile – 5EU

Table 44: Country Profile – Japan

Table 45: Leading Treatments for UC, 2015

Table 46: Product Profile – Lialda

Table 47: Efficacy of different drugs in 5-ASA class in inducing remission in UC patients

Table 48: Efficacy of different drugs in 5-ASA class in preventing disease relapse in UC patients

Table 49: Percentage of patients experiencing adverse events with 5-ASAs

Table 50: 5-ASA SWOT Analysis, 2015

Table 51: Product Profile –Steroids

Table 52: Efficacy of Uceris

Table 53: Safety of Uceris

Table 54: Uceris SWOT Analysis, 2016

Table 55: Product Profile –Azathioprine

Table 56: Percentage of patients experiencing adverse events with AZA and 6-MP therapy

Table 57: Azathioprine SWOT Analysis, 2015

Table 58: Product Profile –MTX

Table 59: MTX SWOT Analysis, 2015

Table 60: Product Profile –Remicade

Table 61: Efficacy data for ACT 1 and ACT 2 trials

Table 62: Safety of Remicade

Table 63: SWOT Analysis, Remicade 2016

Table 64: Product Profile -Humira

Table 65: Efficacy of Humira – Primary and Secondary Endpoints-ULTRA 2 Phase III Program

Table 66: SWOT Analysis, Humira 2016

Table 67: Product Profile -Simponi

Table 68: Efficacy of Simponi

Table 69: Safety of Simponi

Table 70: Simponi SWOT Analysis, 2016

Table 71: Product Profile – Entyvio

Table 72: Efficacy of Entyvio

Table 73: Efficacy of Entyvio

Table 74: Safety of Entyvio

Table 75: Entyvio SWOT Analysis

Table 76: Infliximab Biosimilars for UC Treatment

Table 77: Product Profile –Infliximab biosimilar

Table 78: Percentage of patients experiencing adverse events with infliximab biosimilars

Table 79: Biosimilars SWOT Analysis, 2015

Table 80: Unmet Need and Opportunity in UC, 2015

Table 81: Late stage development drugs for UC, 2015–2025

Table 82: Product Profile – Ustekinumab

Table 83: Ustekinumab SWOT Analysis, 2015

Table 84: Product Profile – Etrolizumab

Table 85: Efficacy of Etrolizumab

Table 86:Safety of Etrolizumab

Table 87 : Pipeline Drug Etrolizumab SWOT Analysis, 2016

Table 88: Product Profile – LT-02

Table 89: Efficacy Analysis for LT-02

Table 90: Efficacy Analysis for Different Doses of LT-02

Table 91: LT-02 SWOT Analysis, 2015

Table 92: Product Profile – Kappaproct

Table 93: Safety of Kappaproct

Table 94: Kappaproct SWOT Analysis, 2016

Table 95: Product Profile – Xeljanz

Table 96: Patient reported outcomes for Xeljanz compared to placebo

Table 97: Mean change from baseline in partial Mayo score in Xeljanz and placebo groups

Table 98: Mean change from baseline in partial Mayo score in Xeljanz and placebo groups

Table 99: Rates of various adverse events experienced in Xeljanz and placebo groups

Table 100: Xeljanz SWOT Analysis, 2015

Table 101: Product Profile – Ozanimod hydrochloride

Table 102: Efficacy analysis of Ozanimod

Table 103: Safety of Ozanimod

Table 104: Pipeline Drug Ozanimod SWOT Analysis, 2015

Table 105: Product Profile – Carotegrast

Table 106: Efficacy analysis in carotegrast and placebo groups

Table 107: Safety analysis of carotegrast

Table 108: Carotegrast SWOT Analysis, 2015

Table 109: Product Profile – Mesalamine (TP-05)

Table 110: Pipeline Drug TP-05 SWOT Analysis, 2016

Table 111: Product Profile – AJG511

Table 112: Efficacy analysis of AJG511

Table 113: Carotegrast SWOT Analysis, 2015

Table 114: Product Profile – Infliximab biosimilars

Table 115: Infliximab biosimilars SWOT Analysis, 2015

Table 116: Product Profile – Amjevita

Table 117: Amjevita SWOT Analysis, 2016

Table 118: Key Companies in the Ulcerative Colitis Market in the 7MM, 2015

Table 119: J&J’s UC Portfolio Assessment, 2015

Table 120: AbbVie’s UC Portfolio Assessment, 2015

Table 121: Takeda’s UC Portfolio Assessment, 2015

Table 122: Salix Pharmaceuticals’ UC Portfolio Assessment, 2015

Table 123: Pfizer’s UC Portfolio Assessment, 2015

Table 124: Roches UC Portfolio Assessment, 2015

Table 125: InDex Pharmaceutical’s UC Portfolio Assessment, 2015

Table 126: Lipid Therapeutics’ UC Portfolio Assessment, 2015

Table 127: Celgene’s UC Portfolio Assessment, 2015

Table 128: EA Pharma’s UC Portfolio Assessment, 2015

Table 129: Ferring Pharmaceuticals’ UC Portfolio Assessment, 2015

Table 130: Tillotts Pharma’s UC Portfolio Assessment, 2015

Table 131:Ulcerative Colitis Market – Global Drivers and Barriers, 2015?2025

Table 132: Key Events Impacting Sales for Ulcerative Colitis in the US, 2015–2025

Table 133: Ulcerative Colitis Market – Drivers and Barriers in the US, 2015?2025

Table 134: Key Events Impacting Sales for Ulcerative Colitis in France, 2015–2025

Table 135: Ulcerative Colitis Market – Drivers and Barriers in France, 2015?2025

Table 136: Key Events Impacting Sales for Ulcerative Colitis in Germany, 2015–2025

Table 137: Ulcerative Colitis Market – Drivers and Barriers in Germany, 2015?2025

Table 138: Key Events Impacting Sales for Ulcerative Colitis in Italy, 2015–2025

Table 139: Ulcerative Colitis Market – Drivers and Barriers in Italy, 2015?2025

Table 140: Key Events Impacting Sales for Ulcerative Colitis in Spain, 2015–2025

Table 141: Ulcerative Colitis Market – Drivers and Barriers in Spain, 2015?2025

Table 142: Key Events Impacting Sales for Ulcerative Colitis in the UK, 2015–2025

Table 143: Ulcerative Colitis Market – Drivers and Barriers in UK, 2015?2025

Table 144: Key Events Impacting Sales for Ulcerative Colitis in Japan, 2015–2025

Table 145: Ulcerative Colitis Market – Drivers and Barriers in Japan, 2015?2025

Table 146: Key Projected Launch Dates for UC

Table 147: Key Historical and Projected Patent Expiry Dates for UC

Table 148: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figures

Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC

Figure 2: 7MM, Diagnosed Incident Cases of UC, Both Sexes, All Ages, Selected Years, 2015–2025

Figure 3: 7MM, Age–Specific Diagnosed Incident Cases of UC, Both Sexes, All Ages, N, 2015

Figure 4: 7MM, Sex-Specific Diagnosed Incident Cases of UC, All Ages, N, 2015

Figure 5: 7MM, Age-Standardized Diagnosed Incidence of UC (Cases per 100,000 Population), All Ages, Both Sexes, N, 2015

Figure 6: 7MM, Diagnosed Incident Cases of UC Segmented by Stage at Diagnosis, Both Sexes, All Ages, N, 2015

Figure 7: 7MM, Diagnosed Incident Cases of UC Segmented by Severity, Both Sexes, All ages, N, 2015

Figure 8: 7MM, Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, Selected Years, 2015–2025

Figure 9: 7MM, Age-Specific Diagnosed Prevalent Cases of UC, Both Sexes, N, 2015

Figure 10: 7MM, Sex-Specific Diagnosed Prevalent Cases of UC, All Ages, N, 2015

Figure 11:7MM, Age-Standardized Diagnosed Prevalence of UC, All Ages, Both Sexes, %, 2015

Figure 12: 7MM, Diagnosed Prevalent Cases of UC Segmented by Severity, Both Cases, All Ages, N, 2015

Figure 13: 7MM, Mortality Due to Complications Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2015

Figure 14: 7MM, Colectomy Due to Failure of Medical Management Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2015

Figure 15: 7MM. Comorbidities Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2015

Figure 16: 7MM, Undiagnosed Prevalent Cases of UC, Both Sexes, All Ages, Selected Years, N, 2015–2025

Figure 17: 7MM, Age-Specific Undiagnosed Prevalent Cases of UC, Both Sexes, N, 2015

Figure 18: 7MM, Sex-Specific Undiagnosed Prevalent Cases of UC, All Ages, N, 2015

Figure 19: 7MM, Age-Standardized Undiagnosed Prevalence of UC, All Ages, Both Sexes, %, 2015

Figure 20: 7MM, Total Prevalent Cases of UC, Both Sexes, All Ages, Selected Years, N, 2015–2025

Figure 21: 7MM, Age-Specific Total Prevalent Cases of UC, Both Sexes, N, 2015

Figure 22: 7MM, Sex-Specific Total Prevalent Cases of UC, All Ages, N, 2015

Figure 23: 7MM, Age-Standardized Total Prevalence of UC, All Ages, Both Sexes, %, 2015

Figure 24: 7MM, Diagnosed Incident Cases of IC, Both Sexes, All Ages, Selected Years, N, 2015–2025

Figure 25: 7MM, Diagnosed Prevalent Cases of IC, Both Sexes, All Ages, Selected Years, N, 2015–2025

Figure 26 : Ulcerative Colitis Treatment Algorithm

Figure 27: Global Sales for Ulcerative Colitis by Drug Class, 2015 and 2025

Figure 28: Sales for Ulcerative Colitis by Drug Class in the US, 2015 and 2025

Figure 29: Sales for Ulcerative Colitis by Drug Class in France, 2015 and 2025

Figure 30: Sales for Ulcerative Colitis by Drug Class in Germany, 2015 and 2025

Figure 31: Sales for Ulcerative Colitis by Drug Class in Italy, 2015 and 2025

Figure 32: Sales for Ulcerative Colitis by Drug Class in Spain, 2015 and 2025

Figure 33: Sales for Ulcerative Colitis by Drug Class in the UK, 2015 and 2025

Figure 34: Sales for Ulcerative Colitis by Drug Class in Japan, 2015 and 2025

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