Bipolar Disorder – Unmet Need – Detailed, Expanded Analysis (US/EU)
Depressive episodes are more common than manic episodes in bipolar disorder (BPD) patients. Of note, BPD II is often characterized by a higher frequency of depressive episodes that last longer compared with BPD I. The symptoms of bipolar depression can include fatigue, insomnia, suicidal ideation, and feelings of worthlessness. Only a few drugs are FDA-approved to treat the depressive symptoms of BPD I, and even fewer drugs are approved for BPD II depression (e.g., Intra-Cellular Therapies’ Caplyta, a newer-to-market antipsychotic). In addition, no drug is approved to treat the suicidality in bipolar depression. Notably, European psychiatrists have more-limited treatment options for bipolar depression than U.S. psychiatrists do, and available therapies have their own shortcomings. Given the longer duration for depressive symptoms and the paucity of therapeutic options in this segment, there is substantial need for novel therapies to treat bipolar depression. Understanding the drivers of clinical decision-making in the treatment of bipolar depression and the areas of opportunity will help drug developers prioritize agents that address the indication’s treatment needs and help marketers determine how to leverage their products’ attributes.
QUESTIONS ANSWERED
- What are the treatment drivers and goals for bipolar depression?
- Which drug attributes are key influences, which have limited impact, and which are hidden opportunities?
- How do current therapies perform on key treatment drivers and goals for bipolar depression?
- What are the prevailing areas of unmet need and opportunity in bipolar depression?
- Which trade-offs across different clinical attributes and price are acceptable to U.S. and European psychiatrists for a hypothetical new bipolar depression 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, Germany
Primary research: Survey of 61 U.S. and 30 European psychiatrists fielded in June 2023
Key companies: AbbVie, Gedeon Richter, Intra-Cellular Therapies, NeuroRx Pharmaceuticals
Key drugs: Lithium, lamotrigine, quetiapine IR/XR, lumateperone, sertraline, cariprazine, olanzapine/fluoxetine combination, NRX-101
Table of contents
- Bipolar Disorder - Unmet Need - Detailed, Expanded Analysis (US/EU)
- Executive summary
- Unmet Need - Bipolar Depression - Executive Summary - October 2023
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Products for bipolar depression and rationale for drug selection
- Treatment drivers and goals
- Key findings: attribute importance
- Relative importance of efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to surveyed psychiatrists' prescribing decisions in bipolar depression
- Importance of efficacy attributes to prescribing decisions in bipolar depression: United States
- Importance of efficacy attributes to prescribing decisions in bipolar depression: Europe
- Importance of safety and tolerability attributes to prescribing decisions in bipolar depression: United States
- Importance of safety and tolerability attributes to prescribing decisions in bipolar depression: Europe
- Importance of convenience of administration attributes to prescribing decisions in bipolar depression: United States
- Importance of convenience of administration attributes to prescribing decisions in bipolar depression: Europe
- Importance of nonclinical factors to prescribing decisions in bipolar depression: United States
- Importance of nonclinical factors to prescribing decisions in bipolar depression: 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 bipolar depression: United States
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in bipolar depression: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for bipolar depression: United States
- Overall performance of key therapies for bipolar depression: Europe
- Mean overall performance of key therapies for bipolar depression: United States and Europe
- Relative performance of key therapies for bipolar depression across select efficacy attributes: United States
- Relative performance of key therapies for bipolar depression across select efficacy attributes: Europe
- Relative performance of key therapies for bipolar depression across select safety and tolerability attributes: United States
- Relative performance of key therapies for bipolar depression across select safety and tolerability attributes: Europe
- Relative performance of key therapies for bipolar depression across select convenience of administration attributes: United States
- Relative performance of key therapies for bipolar depression across select convenience of administration attributes: Europe
- Relative performance of key therapies for bipolar depression across select nonclinical attributes: United States
- Relative performance of key therapies for bipolar depression across select nonclinical attributes: Europe
- Assessment of unmet need
- Key findings: unmet need in bipolar depression
- Surveyed psychiatristsu2019 satisfaction with the performance of key therapies for bipolar depression on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed psychiatristsu2019 satisfaction with the performance of key therapies for bipolar depression on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed psychiatrists' ascribed level of unmet need across key efficacy attributes in bipolar depression: United States
- Surveyed psychiatrists' ascribed level of unmet need across key efficacy attributes in bipolar depression: Europe
- Surveyed psychiatrists' ascribed level of unmet need across key safety and tolerability attributes in bipolar depression: United States
- Surveyed psychiatrists' ascribed level of unmet need across key safety and tolerability attributes in bipolar depression: Europe
- Surveyed psychiatrists' ascribed level of unmet need across key convenience of administration attributes in bipolar depression: United States
- Surveyed psychiatrists' ascribed level of unmet need across key convenience of administration attributes in bipolar depression: Europe
- Surveyed psychiatrists' ascribed level of unmet need across key nonclinical factors in bipolar depression: United States
- Surveyed psychiatrists' ascribed level of unmet need across key nonclinical factors in bipolar depression: Europe
- Key findings: unmet need in bipolar depression and related indications
- Surveyed psychiatrists' ascribed level of unmet need in bipolar depression and related indications: United States
- Surveyed psychiatrists' ascribed level of unmet need in bipolar depression and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the bipolar depression market and emerging therapy insights
- Opportunity: therapies with a rapid onset of therapeutic effect for depressive symptoms
- Opportunity: therapies that effectively reduce depressive symptoms in treatment-resistant bipolar depression
- Opportunity: therapies with improved efficacy as long-term mood stabilizers and favorable long-term tolerability
- Areas of opportunity in the bipolar depression market and emerging therapy insights
- Target product profiles
- Assessing drug development opportunities
- Target product profile methodology
- Attributes and attribute levels
- Attributes of some current therapies for bipolar depression
- Attribute importance and part-worth utilities
- Bipolar depression target product profile: attribute importance
- Mean change from baseline in MADRS total score u2264 8 weeks
- % of patients achieving remission (i.e., MADRS score u2264 12) u2264 8 weeks
- Time to onset of therapeutic effect
- Long-term maintenance efficacy: relapse rate due to a mood event u2264 2 years
- % of patients who experience treatment-emergent mania u2264 8 weeks
- Long-term tolerability: % of patients ceasing therapy due to AEs u2264 2 years
- Price per treated day
- Conjoint analysis-based simulation of a market scenario
- Bipolar depression market simulation: share of preference of target product profiles included in the market scenario
- Bipolar depression market simulation: likelihood to prescribe of target product profiles included in the market scenario
- Bipolar depression market simulation: target product profiles included in the market scenario
- Appendix
- Key abbreviations
- Bibliography
- Executive summary
Matthew D. Litke, M.S., :ead Healthcare Research & Data Analyst, CNS and Ophthalmology. Mr. Litke supports Clarivate’s Treatment Algorithms Claims Data Analysis report series, in addition to authoring syndicated content in the CNS and ophthalmology therapy areas. He holds a B.S. in biochemistry and molecular biology from Penn State University and an M.S. in psychology from Villanova University.