PharmaPoint: Irritable Bowel Syndrome(IBS) – Global Drug Forecast and Market Analysis to 2026

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Irritable bowel syndrome (IBS) is a common disorder characterized by abdominal discomfort associated with altered bowel function. IBS is defined as recurrent abdominal pain or discomfort that occurs in association with altered bowel habits over a period of at least three months. IBS is classified into three main subtypes, according to the predominant bowel habit: constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), and mixed-presentation (IBS-M) IBS.
The IBS treatment landscape remains largely underserved, and ample opportunity exists for pharmaceutical companies to address the numerous unmet needs in this therapy area. Based on insights gathered from primary and secondary research, GlobalData anticipates that two of the new drugs, tenapanor and SYN-010, will have an initial slow uptake, as opposed to Trulance (plecanatide), which has a similar mode of action (MOA) to that of Linzess/Constella (linaclotide). The sales are expected to grow steadily over the forecast period, primarily due to the increased prevalent population and the launch of novel agents to treat IBS-C.
This model covers the market forecast for IBS marketed therapies and late-stage pipeline candidates. The base year of this model is 2016 and the forecast period is 2017–2026.

Scope

Overview of IBS, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

Topline market revenue from 2016–2026 for IBS. Annual cost of therapy (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 prescription drug 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 prescription drug market for IBS. 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 prescription drug market for IBS.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the prescription drug market for IBS 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.

Allergan
Astellas
Ironwood Pharmaceuticals
Takeda
Sucampo
Sebela Pharmaceuticals
Salix
Synergy Pharma
Ardelyx
Synthetic Biologics
AstraZeneca
Menarini
Sumitomo Dainippon
Napo Pharmaceuticals
Axim Biotechnologies
GlaxoSmithKline

Table of Contents

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

2.1 The IBS Market Expected to Experience Solid Growth from 2016–2026

2.2 Companies Leverage Partnerships to Successfully Develop and Commercialize IBS Products

2.3 The IBS Market is Characterized by Significant Unmet Needs

2.4 Products With Improved Efficacy Will Have Significant Opportunities in the IBS Market

2.5 The Potential Introduction of Late-Stage Pipeline Products Will Drive Growth in the IBS 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

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Classification or Staging Systems

4.3 Symptoms

4.4 Prognosis

4.5 Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.3.1 US

5.3.2 5EU

5.3.3 Japan

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for IBS (2016–2026)

5.5.1 Total Prevalent Cases of IBS

5.5.2 Diagnosed Prevalent Cases of IBS

5.5.3 Age-Specific Diagnosed Prevalent Cases of IBS

5.5.4 Sex-Specific Diagnosed Prevalent Cases of IBS

5.5.5 Diagnosed Prevalent Cases of IBS by Clinical Subtype

5.5.6 Diagnosed Prevalent Cases of IBS Clinical Subtype by Comorbidity

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of the Analysis

5.6.3 Strengths of the Analysis

6 Disease Management

6.1 Diagnosis Overview

6.2 Treatment Overview

6.2.1 Treatment Guidelines

6.2.2 Clinical Practice

6.3 US

6.4 5EU

6.5 Japan

7 Competitive Assessment

7.1 Overview

7.2 Product Profiles – Major Brands, IBS-C Therapy

7.2.1 Linzess (linaclotide)

7.2.2 Amitiza (lubiprostone)

7.3 Product Profiles – Major Brands, IBS-D Therapy

7.3.1 Xifaxan (rifaximin)

7.3.2 Viberzi (eluxadoline)

7.3.3 Lotronex (alosetron)

7.3.4 Irribow (ramosetron)

7.4 Product Profiles – Therapeutic Agents for All IBS Clinical Subtypes

7.4.1 Antidepressants

7.5 Other Minor Therapeutic Classes

7.5.1 OTCs and Non-pharmacological Treatment Options for IBS

7.5.2 Off-Label Prescription Treatment Alternatives for IBS

8 Unmet Needs and Opportunity Analysis

8.1 Overview

8.2 More Efficacious Prescription Drugs Indicated for IBS

8.2.1 Unmet Need

8.2.2 Gap Analysis

8.2.3 Opportunity

8.3 Novel Therapies for IBS-D Patients

8.3.1 Unmet Need

8.3.2 Gap Analysis

8.3.3 Opportunity

8.4 Drugs Specifically Approved for IBS-M Patients

8.4.1 Unmet Need

8.4.2 Gap Analysis

8.4.3 Opportunity

8.5 Therapies to Address Abdominal Pain and Bloating Associated with IBS

8.5.1 Unmet Need

8.5.2 Gap Analysis

8.5.3 Opportunity

8.6 More Accurate Diagnosis of Appropriate IBS Clinical Subtype

8.6.1 Unmet Need

8.6.2 Gap Analysis

8.6.3 Opportunity

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

9.2.1 Trulance (plecanatide)

9.2.2 Tenapanor

9.2.3 SYN-010 (oral modified-release lovastatin lactone)

9.3 Other Drugs in Development

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Company Profiles

10.3.1 Allergan

10.3.2 Astellas

10.3.3 Ironwood Pharmaceuticals

10.3.4 Takeda

10.3.5 Sucampo

10.3.6 Sebela Pharmaceuticals

10.3.7 Salix

10.3.8 Synergy

10.3.9 Ardelyx

10.3.10 Synthetic Biologics

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

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 Erosion

12.3.9 Pricing of Pipeline Agents

12.4 Primary Research – KOLs Interviewed for this Report

12.5 Primary Research – Prescriber Survey

12.6 About the Authors

12.6.1 Analyst

12.6.2 Therapy Area Directors

12.6.3 Epidemiologists

12.6.4 Global Director of Therapy Analysis and Epidemiology

12.6.5 Global Head and EVP of Healthcare Operations and Strategy

12.7 About GlobalData

12.8 Contact Us

12.9 Disclaimer

Table

Table 1: Irritable Bowel Syndrome (IBS): Key Metrics in Seven Major Pharmaceutical Markets

Table 2: Symptoms of IBS

Table 3: Risk Factors and Comorbidities for IBS

Table 4: Comparison of the IBS Diagnostic Criteria Used in Epidemiological Studies

Table 5: 7MM, Total Prevalent Cases of IBS, Both Sexes, Ages ≥18 Years, N, Selected Years from 2016–2026

Table 6: 7MM, Diagnosed Prevalent Cases of IBS, Both Sexes, Ages ≥18 Years, N, Selected Years from 2016–2026

Table 7: 7MM, Diagnosed Prevalent Cases of IBS by Clinical Subtypes, Both Sexes, Ages ≥18 Years, N, 2016

Table 8: 7MM, Diagnosed Prevalent Cases of IBS Subtypes with Comorbidity, Both Sexes, Ages ≥18 Years, N, 2016

Table 9: Summary of the Various Diagnostic Criteria Used for the Diagnosis of IBS

Table 10: Treatment Guidelines for IBS

Table 11: Country Profile – US

Table 12: Country Profile – 5EU

Table 13: Country Profile – Japan

Table 14: Leading Treatments for IBS, 2017

Table 15: Product Profile – Linzess

Table 16: Efficacy Responder Rates in Linzess’ Two Placebo-Controlled IBS-C Trials: At Least Nine Out of 12 Weeks

Table 17: Efficacy Responder Rates in Linzess’ Two Placebo-Controlled IBS-C Trials: At Least Six Out of 12 Weeks

Table 18: Safety of Linzess – Most Frequently Reported AEs

Table 19: Linzess SWOT Analysis, 2017

Table 20: Product Profile – Amitiza

Table 21: Safety of Amitiza – Most Frequently Reported AEs

Table 22: Amitiza SWOT Analysis, 2017

Table 23: Product Profile – Xifaxan

Table 24: Efficacy Analysis of Xifaxan in Target 1 and 2 Trials

Table 25: Efficacy Responder Rates in Target 3 Trial in a Given Week for at Least 2 Weeks During Weeks 3 to 6 of the Double-Blind, First Repeat Treatment Phase

Table 26: Safety Analysis of Xifaxan in Target 1 and 2 Trials

Table 27: Safety Analysis of Xifaxan in Target 3 Trial

Table 28: Xifaxan SWOT Analysis, 2017

Table 29: Product Profile – Viberzi

Table 30: Efficacy Analysis of Viberzi in IBS-3001 and IBS-3002 Trials

Table 31: Common AEs of Viberzi

Table 32: Viberzi SWOT Analysis, 2017

Table 33: Product Profile – Lotronex

Table 34: Safety of Lotronex – Most Frequently Reported AEs

Table 35: Lotronex SWOT Analysis, 2017

Table 36: Product Profile – Irribow

Table 37: Irribow SWOT Analysis, 2017

Table 38: Antidepressants in IBS, SWOT Analysis, 2017

Table 39: Summary of Minor Therapeutic Classes, 2016

Table 40: Mechanisms of Action and AEs of Minor Therapeutic Classes, 2016

Table 41: Product Profile – Trulance

Table 42: Trulance SWOT Analysis, 2017

Table 43: Product Profile – Tenapanor

Table 44: T3MPO-1 Trial—Tenapanor 6 of 12 Week Treatment Results

Table 45: T3MPO-2 Trial—Tenapanor 6 of 12 Week Treatment Results

Table 46: Tenapanor SWOT Analysis, 2017

Table 47: Product Profile – SYN-010

Table 48: SYN-010 SWOT Analysis, 2017

Table 49: Other Drugs in Development for IBS, 2017

Table 50: Key Companies in the IBS Market in the 7MM, 2017

Table 51: Allergan’s IBS Portfolio Assessment, 2017

Table 52: Astellas’ IBS Portfolio Assessment, 2017

Table 53: Ironwood’s IBS Portfolio Assessment, 2017

Table 54: Takeda’s IBS Portfolio Assessment, 2017

Table 55: Sucampo’s IBS Portfolio Assessment, 2017

Table 56: Prometheus/Sebela Ireland’s IBS Portfolio Assessment, 2017

Table 57: Salix’s IBS Portfolio Assessment, 2017

Table 58: Synergy’s IBS Portfolio Assessment, 2017

Table 59: Ardelyx’s IBS Portfolio Assessment, 2017

Table 60: Synthetic Biologics’ IBS Portfolio Assessment, 2017

Table 61: IBS – Global Drivers and Barriers, 2016–2026

Table 62: Key Events Impacting Sales for IBS in the US, 2016–2026

Table 63: IBS – US Drivers and Barriers, 2016–2026

Table 64: Key Events Impacting Sales for IBS in the 5EU, 2016–2026

Table 65: IBS – 5EU Drivers and Barriers, 2016–2026

Table 66: Key Events Impacting Sales for IBS in Japan, 2016–2026

Table 67: IBS – Japan Drivers and Barriers, 2016–2026

Table 68: Key Historical and Projected Launch Dates for IBS

Table 69: Key Patent Expiry Dates for IBS

Table 70: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figures

Figure 1: Global (7MM) Sales for IBS by Region, 2016 and 2026

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

Figure 3: Competitive Assessment of the Late-Stage Pipeline Products Under Development for IBS

Figure 4: IBS Pathophysiology

Figure 5: 7MM, Age-Standardized Diagnosed Prevalence of IBS, Ages ≥18 Years, 2016

Figure 6: 7MM, Sources Used and Not Used, Total Prevalent Cases of IBS

Figure 7: 7MM, Sources Used, Diagnosed Prevalent Cases of IBS

Figure 8: 7MM, Sources Used, Diagnosed Prevalent Cases of IBS Clinical Subtypes

Figure 9: 7MM, Sources Used, Diagnosed Prevalent Cases of IBS With Comorbidity

Figure 10: 7MM, Age-Specific Diagnosed Prevalent Cases of IBS, Both Sexes, Ages ≥18 Years, N, 2016

Figure 11: 7MM, Sex-Specific Diagnosed Prevalent Cases of IBS, Both Sexes, Ages ≥18 Years, N, 2016

Figure 12: Unmet Need and Opportunity in IBS, 2017

Figure 13: Bullseye Diagram of Products in Clinical Development for IBS, 2017

Figure 14: Key Phase II/III Trials for Promising Pipeline Agents for IBS, 7MM, 2016–2026

Figure 15: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of IBS in the Forecast Period

Figure 16: Clinical and Commercial Positioning of Trulance

Figure 17: Clinical and Commercial Positioning of Tenapanor

Figure 18: Clinical and Commercial Positioning of SYN-010

Figure 19: Analysis of the Company Portfolio Gap in IBS During the Forecast Period

Figure 20: Global (7MM) Sales for IBS by Region, 2016 and 2026

Figure 21: Global (7MM) Sales for IBS by Drug, 2016 and 2026

Figure 22: Sales for IBS in the US, 2016 and 2026

Figure 23: Sales for IBS in the US by clinical subtype, 2016–2026

Figure 24: Sales for IBS in the 5EU, 2016 and 2026

Figure 25: Sales for IBS in the 5EU by clinical subtype, 2016–2026

Figure 26: Sales for IBS in Japan, 2016 and 2026

Figure 27: Sales for IBS in Japan by clinical subtype, 2016–2026

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