Irritable Bowel Syndrome – Unmet Need – Detailed, Expanded Analysis (US/EU): Irritable Bowel Syndrome – Constipation Predominant
IBS-C is an indication ripe for emerging therapies; only three drugs have a label approval for this disease across the major U.S. and European markets, although many therapies are used off-label from indications such as CIC or OIC. Therapies are currently approved primarily based on the patient response rate to various end points, but physicians indicate that drugs capable of delivering superior relief and improving QOL metrics are a key unmet need.
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QUESTIONS ANSWERED
- What are the treatment drivers and goals for IBS-C?
- What drug attributes are key influencers, which have limited impact, and which are hidden opportunities?
- How do current therapies perform on key treatment drivers and goals for IBS-C?
- What are the prevailing areas of unmet need and opportunity in IBS-C?
- What trade-offs across different clinical attributes and price are acceptable to U.S. and European gastroenterologists for a hypothetical new IBS-C drug?
PRODUCT DESCRIPTION
Provides quantitative insight into U.S. and European physician perceptions of key treatment drivers and goals and the current level of unmet need for a specific disease. Commercial opportunities are analyzed, and the extent to which emerging therapies may capitalize on these opportunities is evaluated.
Markets covered: United States, United Kingdom, France, and Germany.
Primary research: Survey of 60 U.S. and 32 European gastroenterologists fielded in January 2018.
Key companies: Allergan/Ironwood, Mallinckrodt/Takeda, and Synergy.
Key drugs: Linzess/Constella, Amitiza, and Trulance.
Table of contents
- Irritable Bowel Syndrome - Unmet Need - Detailed, Expanded Analysis (US/EU): Irritable Bowel Syndrome - Constipation Predominant
- Introduction
- Overview
- Methodology
- Rationale for Treatment Drivers and Goals Selection
- Efficacy
- Safety and Tolerability
- Convenience of Administration
- Nonclinical Factors
- Rationale for Drug Selection
- Products for IBS-C
- Treatment Drivers and Goals
- Key Findings: Attribute Importance
- Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Gastroenterologists' Prescribing Decisions in IBS-C
- Importance of Efficacy Attributes to Prescribing Decisions in IBS-C: United States
- Importance of Efficacy Attributes to Prescribing Decisions in IBS-C: Europe
- Importance of Safety and Tolerability Attributes to Prescribing Decisions in IBS-C: United States
- Importance of Safety and Tolerability Attributes to Prescribing Decisions in IBS-C: Europe
- Importance of Convenience of Administration Attributes to Prescribing Decisions in IBS-C: United States
- Importance of Convenience of Administration Attributes to Prescribing Decisions in IBS-C: Europe
- Importance of Nonclinical Factors to Prescribing Decisions in IBS-C: United States
- Importance of Nonclinical Factors to Prescribing Decisions in IBS-C: Europe
- Key Findings: Stated vs. Derived Importance
- Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in IBS-C: United States
- Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in IBS-C: Europe
- Product Performance Against Treatment Drivers and Goals
- Key Findings
- Overall Performance of Key Therapies for IBS-C: United States
- Overall Performance of Key Therapies for IBS-C: Europe
- Relative Performance of Key Therapies for IBS-C Across Select Efficacy Attributes: United States
- Relative Performance of Key Therapies for IBS-C Across Select Efficacy Attributes: Europe
- Relative Performance of Key Therapies for IBS-C Across Select Safety and Tolerability Attributes: United States
- Relative Performance of Key Therapies for IBS-C Across Select Safety and Tolerability Attributes: Europe
- Relative Performance of Key Therapies for IBS-C Across Select Convenience of Administration Attributes: United States
- Relative Performance of Key Therapies for IBS-C Across Select Convenience of Administration Attributes: Europe
- Relative Performance of Key Therapies for IBS-C Across Select Nonclinical Attributes: United States
- Relative Performance of Key Therapies for IBS-C Across Select Nonclinical Attributes: Europe
- Assessment of Unmet Need
- Key Findings: Unmet Need in IBS-C
- Surveyed Gastroenterologists' Satisfaction with the Performance of Key Therapies for IBS-C on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
- Surveyed Gastroenterologists' Satisfaction with the Performance of Key Therapies for IBS-C on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
- Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in IBS-C: United States
- Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in IBS-C: Europe
- Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in IBS-C: United States
- Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in IBS-C: Europe
- Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in IBS-C: United States
- Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in IBS-C: Europe
- Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in IBS-C: United States
- Surveyed Gastroenterologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in IBS-C: Europe
- Key Findings: Unmet Need in IBS-C and Related Indications
- Surveyed Gastroenterologists' Ascribed Level of Unmet Need in IBS-C and Related Indications: United States
- Surveyed Gastroenterologists' Ascribed Level of Unmet Need in IBS-C and Related Indications: Europe
- Opportunity Analysis
- Areas of Opportunity in the IBS-C Market and Emerging Therapy Insights
- Opportunity: A New Agent Improving Health-Related Quality of Life
- Opportunity: A Therapy with a Higher Overall Responder Rate
- Areas of Opportunity in the IBS-C Market and Emerging Therapy Insights
- Target Product Profiles
- Assessing Drug Development Opportunities
- Target Product Profile Methodology
- Attributes and Attribute Levels
- Attribute Importance and Part-Worth Utilities
- IBS-C Target Product Profile: Attribute Importance
- Percentage of Patients Reporting Improvement in Global Symptoms for 6/12 Weeks
- Percentage of Patients with u2265 30% Abdominal Pain Reduction from Baseline for 6/12 Weeks
- Rate of Adverse Events (incl. diarrhea, abdominal pain, flatulence, headache, etc.)
- Health-Related Quality of Life (change from baseline in IBS-QOL score at 12 weeks)
- Percentage of Patients CSBM Responder for 6/12 Weeks (Increase u2265 1 CSBM from Baseline)
- Dosing Frequency
- Price per Day
- Conjoint Analysis-Based Simulations of Market Scenarios
- IBS-C Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
- IBS-C Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
- IBS-C Market Simulations: Target Product Profiles Included in Scenario 1
- IBS-C Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
- IBS-C Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
- IBS-C Market Simulations: Target Product Profiles Included in Scenario 2
- Appendix
- Key Abbreviations
- Experts Interviewed
- Bibliography
- Introduction
Kristine Mackin, Ph.D., is a principal analyst on the Immune and Inflammatory Disorders team at Clarivate. Her expertise includes emerging microbiome-based therapies, psoriatic arthritis, chronic obstructive pulmonary disease, and asthma. Previously, Dr. Mackin was involved with a new company pitch focusing on the infant microbiome, now realized as Commense, during an internship at Puretech Ventures in Boston. She holds a doctorate in biochemistry from Brandeis University, where she studied the evolution of bacteriorhodopsin and the relationship between type I and type II rhodopsins.