PharmaPoint: Irritable Bowel Syndrome – Global Drug Forecast and Market Analysis to 2023

Pages: 257 Published: December 01, 2014 Report Code: GDHC97PIDR

Irritable Bowel Syndrome (IBS) is a common disorder characterized by abdominal discomfort associated with altered bowel function. Although IBS is not a life-threatening disorder, it has a considerable effect on patients’ quality of life (QOL). In terms of volume, the IBS market is a large, albeit naïve, one, with only a small number of pharmacotherapies indicated for the treatment of the disorder, and it is also characterized by significant unmet needs.

As of October 2014, there were four products indicated for IBS in the 7MM. These include the constipation-predominant IBS (IBS-C) therapies, Sucampo/Takeda/Abbott’s Amitiza (lubiprostone) and Ironwood/Actavis/Almirall/Astellas’ Linzess (linaclotide), and the diarrhea-predominant IBS (IBS-D) therapies, Prometheus’ Lotronex (alosetron) and Astellas’ Irribow (ramosetron). Antidepressants and antibiotics (mainly Salix/Alfa Wassermann/Norgine/Bama-Geve’s Xifaxan [rifaximin]), are also commonly used off-label to treat IBS. GlobalData anticipates that four new therapies have the potential to enter the IBS market during the 2013–2023 forecast period. This includes Furiex’s (Actavis’) eluxadoline and Menarini’s ibodutant for IBS-D, and Synergy’s plecanatide and AstraZeneca/Ardelyx’s tenapanor for IBS-C. In addition, Xifaxan is in development for IBS-D, and has the potential to gain a label expansion for this indication during the forecast period.

Scope

Overview of IBS, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.

Annualized IBS therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2013 and forecast for ten years to 2023.

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

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

Analysis of the current and future market competition in the global IBS 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

What do physicians think about Ironwood/Actavis/Almirall/Astellas’ Linzess and what will be the impact in the IBS market following its launch in 2012 in the US and 2013 in the 5EU region?

What will be the uptake of Salix/Alfa Wassermann/Norgine/Bama-Geve’s Xifaxan following its anticipated label-expansion for IBS-D and how will it impact the treatment paradigm for IBS?

What is the significance of late-phase pipeline products for IBS and how will their launch shape the future treatment landscape in IBS?

What are the significant unmet needs in the IBS market?

What are the remaining opportunities in the IBS market?

Key Players

Abbott
Actavis
Ajinomoto
Alba
Albireo
Alfa Wassermann
Almirall
AltheRx
Ardelyx
Astellas
AstraZeneca
Bama-Geve
Dong-A Socio
Drais
Ferring
Furiex (Actavis)
Ironwood
Menarini
Norgine
Ono
Prometheus
Salix
Sucampo
Sumitomo Dainippon
Synergy
Takeda
Teva
Yuhan

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Classification

3.3Symptoms

3.4Prognosis

3.5Quality of Life

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.1US

4.3.25EU

4.3.3Japan

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Sources Not Used

4.4.3Forecast Assumptions and Methods – Total Prevalent Cases of IBS

4.4.4Forecast Assumptions and Methods – IBS Subtype Segmentations

4.5Epidemiological Forecast for IBS (2013–2023)

4.5.1Total Prevalent Cases of IBS

4.5.2Age-Specific Total Prevalent Cases of IBS

4.5.3Sex-Specific Total Prevalent Cases of IBS

4.5.4Age-Standardized Total Prevalence of IBS

4.5.5Total Prevalent Cases of IBS by Clinical Subtype

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths 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

5.3France

5.4Germany

5.5Italy

5.6Spain

5.7UK

5.8Japan

6Competitive Assessment

6.1Overview

6.2Product Profiles – Major Brands, IBS-C

6.2.1Amitiza (lubiprostone)

6.2.2Linzess (linaclotide)

6.3Product Profiles – Major Brands, IBS-D

6.3.1Lotronex (alosetron)

6.3.2Irribow (ramosetron)

6.4Product Profiles – Major Brands, Other

6.4.1Antidepressants

6.5Other Therapeutic Classes

7Unmet Need and Opportunity

7.1Overview

7.2More Effective Pharmacotherapies

7.2.1Unmet Need

7.2.2Gap Analysis

7.2.3Opportunity

7.3Therapies for the IBS-D Subtype

7.3.1Unmet Need

7.3.2Gap Analysis

7.3.3Opportunity

7.4Therapies for the IBS-M Subtype

7.4.1Unmet Need

7.4.2Gap Analysis

7.4.3Opportunity

7.5Therapies to Address Abdominal Pain and Bloating Symptoms

7.5.1Unmet Need

7.5.2Gap Analysis

7.5.3Opportunity

7.6Improved Diagnosis Rate for IBS

7.6.1Unmet Need

7.6.2Gap Analysis

7.6.3Opportunity

8Pipeline Assessment

8.1Overview

8.2Clinical Trial Mapping

8.2.1Clinical Trials by Therapy Type

8.3Promising Drugs in Clinical Development

8.4Product Profiles – Late-Stage Pipeline, IBS-D

8.4.1Eluxadoline

8.4.2Ibodutant (MEN-15596)

8.4.3Xifaxan (rifaximin)

8.5Product Profiles – Late-Stage Pipeline, IBS-C

8.5.1Plecanatide

8.5.2Tenapanor (AZD1722, RDX5791)

8.6Other Drugs in Development for IBS

9Current and Future Players

9.1Overview

9.2Trends in Corporate Strategy

9.3Company Profiles

9.3.1Actavis

9.3.2Astellas

9.3.3Almirall

9.3.4Ironwood

9.3.5Takeda

9.3.6Sucampo

9.3.7Prometheus

9.3.8Salix

9.3.9Menarini

9.3.10Synergy

9.3.11AstraZeneca

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

10.7UK

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 IBS Patients

11.4.2Drugs Included in Each Therapy Type

11.4.3Launch and Patent Expiry Dates

11.4.4General Pricing Assumptions

11.4.5Individual Drug Assumptions

11.4.6Generic Erosion

11.4.7Pricing of Pipeline Agents

11.5Primary Research – KOLs Interviewed for This Report

11.6Primary Research – Prescriber Survey

11.7About the Authors

11.7.1Analyst

11.7.2Therapy Area Director

11.7.3Epidemiologist

11.7.4Global Head of Healthcare

11.8About GlobalData

11.9Contact Us

11.10Disclaimer

List of Tables

Table 1: Common Symptoms of IBS

Table 2: Risk Factors and Comorbidities for IBS

Table 3: Comparison of the IBS Diagnostic Criteria Used in Epidemiological Studies

Table 4: Total Prevalence (%) of IBS in the 7MM, as Reported in Epidemiological Studies

Table 5: Total Prevalence (%) of IBS in the US, as Reported in Epidemiological Studies

Table 6: 7MM, Sources of Total Prevalence Data Used to Forecast the Total Prevalent Cases of IBS

Table 7: 7MM, Sources of IBS Subtype Data Used to Forecast the Total Prevalent Cases of IBS by Subtype

Table 8: 7MM, Total Prevalent Cases of IBS, Ages =10 Years, Both Sexes, N, Selected Years 2013–2023

Table 9: 7MM, Age-Specific Total Prevalent Cases of IBS, Both Sexes, N (Row %), 2013

Table 10: 7MM, Sex-Specific Prevalent Cases of IBS, Ages =10 Years, N (Row %), 2013

Table 11: 7MM Total Prevalent Cases of IBS, N (%), by Clinical Subtype, Both Sexes, Ages =10 Years, 2013

Table 12: Summary of the Various Diagnostic Criteria Used for the Diagnosis of IBS

Table 13: Treatment Guidelines for IBS

Table 14: Leading Prescribed Drugs for IBS by Predominant Symptoms in the 7MM, 2014†

Table 15: IBS Diagnosis and Treatment Country Profile – US

Table 16: IBS Diagnosis and Treatment, Country Profile – France

Table 17: IBS Diagnosis and Treatment, Country Profile – Germany

Table 18: IBS Diagnosis and Treatment, Country Profile – Italy

Table 19: IBS Diagnosis and Treatment, Country Profile – Spain

Table 20: IBS Diagnosis and Treatment, Country Profile – UK

Table 21: IBS Diagnosis and Treatment, Country Profile – Japan

Table 22: Leading Branded Treatments for IBS, 2014

Table 23: Product Profile – Amitiza

Table 24: Safety of Amitiza – Most Frequently Reported Adverse Events

Table 25: Amitiza SWOT Analysis, 2014

Table 26: Global IBS Sales Forecasts ($m) for Amitiza, 2013–2023

Table 27: Product Profile – Linzess

Table 28: Efficacy Responder Rates in Linzess’ Two Placebo-Controlled IBS-C Trials: At Least Nine Out of 12 Weeks

Table 29: Efficacy Responder Rates in Linzess’ Two Placebo-Controlled IBS-C Trials: At Least Six Out of 12 Weeks

Table 30: Safety of Linzess – Most Frequently Reported Adverse Events

Table 31: Linzess SWOT Analysis, 2014

Table 32: Global IBS Sales Forecasts ($m) for Linzess, 2013–2023

Table 33: Product Profile – Lotronex

Table 34: Safety of Lotronex – Most Frequently Reported Adverse Events

Table 35: Lotronex SWOT Analysis, 2014

Table 36: Global IBS Sales Forecasts ($m) for Lotronex, 2013–2023

Table 37: Product Profile – Irribow

Table 38: Irribow SWOT Analysis, 2014

Table 39: Global IBS Sales Forecasts ($m) for Irribow, 2013–2023

Table 40: Use of Antidepressants in IBS, SWOT Analysis, 2014

Table 41: Global IBS Sales Forecasts ($m) for Antidepressants, 2013–2023

Table 42: Summary of Other Therapeutic Classes of Pharmacologics in IBS, 2014

Table 43: Unmet Needs and Opportunities in IBS

Table 44: Drugs in Late-Stage Clinical Development for IBS, 2014

Table 45: Product Profile – Eluxadoline

Table 46: Eluxadoline SWOT Analysis, 2014

Table 47: Global IBS Sales Forecasts ($m) for Eluxadoline, 2013–2023

Table 48: Product Profile – Ibodutant

Table 49: Ibodutant SWOT Analysis, 2014

Table 50: Global IBS Sales Forecasts ($m) for Ibodutant, 2013–2023

Table 51: Product Profile – Xifaxan

Table 52: Safety of Xifaxan – Most Frequently Reported Adverse Events

Table 53: Xifaxan SWOT Analysis, 2014

Table 54: Global IBS Sales Forecasts ($m) for Xifaxan, 2013–2023

Table 55: Product Profile – Plecanatide

Table 56: Plecanatide SWOT Analysis, 2014

Table 57: Global IBS Sales Forecasts ($m) for Plecanatide, 2013–2023

Table 58: Product Profile – Tenapanor

Table 59: Tenapanor SWOT Analysis, 2014

Table 60: Global IBS Sales Forecasts ($m) for Tenapanor, 2013–2023

Table 61: Drugs in Early-Stage Clinical Development for IBS, 2014

Table 62: Key Companies in the IBS Market in the 7MM, 2014

Table 63: Actavis’ IBS Portfolio Assessment, 2014

Table 64: Astellas’ IBS Portfolio Assessment, 2014

Table 65: Almirall’s IBS Portfolio Assessment, 2014

Table 66: Ironwood’s IBS Portfolio Assessment, 2014

Table 67: Takeda’s IBS Portfolio Assessment, 2014

Table 68: Sucampo’s IBS Portfolio Assessment, 2014

Table 69: Prometheus’ IBS Portfolio Assessment, 2014

Table 70: Salix’s IBS Portfolio Assessment, 2014

Table 71: Menarini’s IBS Portfolio Assessment, 2014

Table 72: Synergy’s IBS Portfolio Assessment, 2014

Table 73: AstraZeneca’s IBS Portfolio Assessment, 2014

Table 74: Global Sales Forecasts ($m) for IBS, 2013–2023

Table 75: Global IBS Market – Drivers and Barriers, 2013–2023

Table 76: Sales Forecasts ($m) for IBS in the US, 2013–2023

Table 77: Key Events Impacting Sales for IBS in the US, 2013–2023

Table 78: IBS Market in the US – Drivers and Barriers, 2013–2023

Table 79: Sales Forecasts ($m) for IBS in France, 2013–2023

Table 80: Key Events Impacting Sales for IBS in France, 2013–2023

Table 81: IBS Market in France – Drivers and Barriers, 2013–2023

Table 82: Sales Forecasts ($m) for IBS in Germany, 2013–2023

Table 83: Key Events Impacting Sales for IBS in Germany, 2013–2023

Table 84: IBS Market in Germany – Drivers and Barriers, 2013–2023

Table 85: Sales Forecasts ($m) for IBS in Italy, 2013–2023

Table 86: Key Events Impacting Sales for IBS in Italy, 2013–2023

Table 87: IBS Market in Italy – Drivers and Barriers, 2013–2023

Table 88: Sales Forecasts ($m) for IBS in Spain, 2013–2023

Table 89: Key Events Impacting Sales for IBS in Spain, 2013–2023

Table 90: IBS Market in Spain – Drivers and Barriers, 2013–2023

Table 91: Sales Forecasts ($m) for IBS in the UK, 2013–2023

Table 92: Key Events Impacting Sales for IBS in the UK, 2013–2023

Table 93: IBS Market in the UK – Drivers and Barriers, 2013–2023

Table 94: Sales Forecasts ($m) for IBS in Japan, 2013–2023

Table 95: Key Events Impacting Sales for IBS in Japan, 2013–2023

Table 96: IBS Market in Japan – Drivers and Barriers, 2013–2023

Table 97: Key Launch Dates

Table 98: Key Patent Expiries

Table 99: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country

List of Figures

Figure 1: 7MM, Total Prevalent Cases of IBS Ages =10 Years, Both Sexes, N, 2013–2023

Figure 2: 7MM, Age-Specific Total Prevalent Cases of IBS, Both Sexes, N, 2013

Figure 3: 7MM, Sex-Specific Total Prevalent Cases of IBS, Ages =10 Years, N, 2013

Figure 4: 7MM, Age-Standardized Total Prevalence of IBS (%), Ages =10 Years, by Sex, 2013

Figure 5: 7MM Total Prevalent Cases of IBS (%), by Clinical Subtype, Both Sexes, Ages =10 Years, 2013

Figure 6: Summary of Pharmacotherapies Used to Treat IBS

Figure 7: IBS Therapeutics – Clinical Trials by Therapy Type and Development Stage, October 2014

Figure 8: IBS – Phase IIb–III Pipeline, October 2014

Figure 9: Competitive Assessment of Late-Stage Pipeline Agents in IBS, 2013–2023

Figure 10: Clinical and Commercial Positioning of Eluxadoline

Figure 11: Clinical and Commercial Positioning of Ibodutant

Figure 12: Clinical and Commercial Positioning of Xifaxan

Figure 13: Clinical and Commercial Positioning of Plecanatide

Figure 14: Clinical and Commercial Positioning of Tenapanor

Figure 15: Company Portfolio Gap Analysis in IBS, 2013–2023

Figure 16: Actavis’ SWOT Analysis in IBS, 2013–2023

Figure 17: Astellas’ SWOT Analysis in IBS, 2013–2023

Figure 18: Almirall’s SWOT Analysis in IBS, 2013–2023

Figure 19: Ironwood’s SWOT Analysis in IBS, 2013–2023

Figure 20: Takeda’s SWOT Analysis in IBS, 2013–2023

Figure 21: Sucampo’s SWOT Analysis in IBS, 2013–2023

Figure 22: Prometheus’ SWOT Analysis in IBS, 2013–2023

Figure 23: Salix’s SWOT Analysis in IBS, 2013–2023

Figure 24: Menarini’s SWOT Analysis in IBS, 2013–2023

Figure 25: Synergy’s SWOT Analysis in IBS, 2013–2023

Figure 26: AstraZeneca’s SWOT Analysis in IBS, 2013–2023

Figure 27: Global Sales for IBS by Region, 2013–2023

Figure 28: Sales for IBS in the US by Therapy Type, 2013–2023

Figure 29: Sales for IBS in France by Therapy Type, 2013–2023

Figure 30: Sales for IBS in Germany by Therapy Type, 2013–2023

Figure 31: Sales for IBS in Italy by Therapy Type, 2013–2023

Figure 32: Sales for IBS in Spain by Therapy Type, 2013–2023

Figure 33: Sales for IBS in the UK by Therapy Type, 2013–2023

Figure 34:Sales for IBS in Japan by Therapy Type, 2013–2023

$10,995

Can be used by individual purchaser only

$32,985

Can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company

Get in touch to find out about our multi-purchase discounts

reportstore@globaldata.com
Tel +44 (0) 20 7947 2960

Every customer’s requirement is unique. We understand that and can customize the report basis your exact research requirements pertaining to market insights, innovation insights, strategy and planning, and competitive intelligence. You can also avail the option of purchasing stand-alone sections of the report or request for a country specific report.

GDPR + CCPA Compliant

Personal and transaction information are kept safe from unauthorised use.

Recently Viewed Reports

Testimonial

“The GlobalData platform is our go-to tool for intelligence services. GlobalData provides an easy way to access comprehensive intelligence data around multiple sectors, which essentially makes it a one-for-all intelligence platform, for tendering and approaching customers.

GlobalData is very customer orientated, with a high degree of personalised services, which benefits everyday use. The highly detailed project intelligence and forecast reports can be utilised across multiple departments and workflow scopes, from operational to strategic level, and often support strategic decisions. GlobalData Analytics and visualisation solutions has contributed positively when preparing management presentations and strategic papers.”

Business Intelligence & Marketing Manager, SAL Heavy Lift

“COVID-19 has caused significant interference to our business and the COVID-19 intelligence from GlobalData has helped us reach better decisions around strategy. These two highlights have helped enormously to understand the projections into the future concerning our business units, we also utilise the project database to source new projects for Liebherr-Werk to use as an additional source to pitch for new business.”

Market Analyst & Management, Liebherr-Werk

Your daily news has saved me a lot of time and keeps me up-to-date with what is happening in the market, I like that you almost always have a link to the source origin. We also use your market data in our Strategic Business Process to support our business decisions. By having everything in one place on the Intelligence Center it has saved me a lot of time versus looking on different sources, the alert function also helps with this.

Head of Key Accounts, Saab AB

Having used several other market research companies, I find that GlobalData manages to provide that ‘difficult-to-get’ market data that others can’t, as well as very diverse and complete consumer surveys.

Marketing Intelligence Manager, Portugal Foods
Looking to stay on top of industry & market trends?

Sign up to receive regular alerts for our latest analysis and reports. No matter your industry focus, you can keep your finger on the pulse with our timely updates.