Major Depressive Disorder (DSM-V) – Unmet Need – Detailed, Expanded Analysis: Treatment-Resistant Depression (US/EU)
Major depressive disorder is a chronic drug-treated condition, and treatment of it is ingrained with generic therapies. However, many of these therapies suffer from shortcomings in efficacy and/or safety and tolerability, resulting in treatment-resistant depression (TRD) and creating opportunity for improved therapies. Although branded agents such as Lundbeck / Takeda’s Trintellix / Brintellix (vortioxetine) and Janssen’s Spravato (esketamine) have expanded the armamentarium of therapeutic options, opportunity remains for new therapies. This report provides quantitative insight into psychiatrists’ perceptions of key treatment drivers and goals and assesses the current level of unmet need and opportunity in the treatment of TRD.
QUESTIONS ANSWERED
- What are the treatment drivers and goals for TRD?
- What are surveyed psychiatrists’ opinions of the relative performance of select therapies, including Trintellix / Brintellix, Spravato, Rexulti, aripiprazole, duloxetine, and off-label ketamine on key efficacy, safety / tolerability, and convenience of administration attributes in TRD patients?
- What drug attributes are key influencers, which have limited impact, and which are hidden opportunities in the treatment of TRD?
- What trade-offs across different clinical attributes and prices are acceptable to U.S. and European psychiatrists for a hypothetical new drug to treat TRD?
PRODUCT DESCRIPTION
Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. One market scenario is profiled in detail by Clarivate experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.
Markets covered: United States, United Kingdom, France, Germany.
Primary research: Survey of 62 U.S. and 30 European psychiatrists fielded in April 2022.
Key companies: Lundbeck, Takeda, Janssen, COMPASS Pathways.
Key drugs: Aripiprazole, Rexulti, bupropion SR, duloxetine, Trintellix / Brintellix, Spravato, ketamine (intravenous).
Content highlights
- Target Product Profile (TPP) simulator based on conjoint analysis methodology.
- Stated versus derived importance of product attributes on prescribing behavior.
- Assessment of current drug performance against treatment drivers and goals.
- Physician perceptions of unmet needs in the indication and related indications.
- Analysis of remaining drug development opportunities.
Table of contents
- Major Depressive Disorder (DSM-V) - Unmet Need - Detailed, Expanded Analysis: Treatment-Resistant Depression (US/EU)
- Executive summary
- Unmet need - TRD - executive summary - July 2022
- Introduction
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Products for TRD and rationale for drug selection
- Rationale for treatment drivers and goals 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 TRD
- Importance of efficacy attributes to prescribing decisions in TRD: United States
- Importance of efficacy attributes to prescribing decisions in TRD: Europe
- Importance of safety and tolerability attributes to prescribing decisions in TRD: United States
- Importance of safety and tolerability attributes to prescribing decisions in TRD: Europe
- Importance of convenience of administration attributes to prescribing decisions in TRD: United States
- Importance of convenience of administration attributes to prescribing decisions in TRD: 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 TRD: United States
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in TRD: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for TRD: United States
- Overall performance of key therapies for TRD: Europe
- Mean overall performance of key therapies for TRD: United States and Europe
- Relative performance of key therapies for TRD across select efficacy attributes: United States
- Relative performance of key therapies for TRD across select efficacy attributes: Europe
- Relative performance of key therapies for TRD across select safety and tolerability attributes: United States
- Relative performance of key therapies for TRD across select safety and tolerability attributes: Europe
- Relative performance of key therapies for TRD across select convenience of administration attributes: United States
- Relative performance of key therapies for TRD across select convenience of administration attributes: Europe
- Assessment of unmet need
- Key findings: unmet need in TRD
- Surveyed psychiatristsu2019 satisfaction with the performance of key therapies for TRD on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed psychiatristsu2019 satisfaction with the performance of key therapies for TRD on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed psychiatrists' ascribed level of unmet need across key efficacy attributes in TRD: United States
- Surveyed psychiatrists' ascribed level of unmet need across key efficacy attributes in TRD: Europe
- Surveyed psychiatrists' ascribed level of unmet need across key safety and tolerability attributes in TRD: United States
- Surveyed psychiatrists' ascribed level of unmet need across key safety and tolerability attributes in TRD: Europe
- Surveyed psychiatrists' ascribed level of unmet need across key convenience of administration attributes in TRD: United States
- Surveyed psychiatrists' ascribed level of unmet need across key convenience of administration attributes in TRD: Europe
- Key findings: unmet need in TRD and related indications
- Surveyed psychiatrists' ascribed level of unmet need in TRD and related indications: United States
- Surveyed psychiatrists' ascribed level of unmet need in TRD and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the TRD market and emerging therapy insights
- Opportunity: a new therapy with improvements on several key efficacy attributes
- Opportunity: a new therapy offering minimal or no warnings / restrictions due to safety concerns
- Areas of opportunity in the TRD market and emerging therapy insights
- Target product profiles
- Assessing drug development opportunities
- Target product profile methodology
- Attributes and attribute levels
- Attributes of key current and late-phase emerging therapies for TRD
- Attribute importance and part-worth utilities
- TRD target product profile: attribute importance
- MADRS score improvement as adjunct to ADT therapy at week 4
- Percentage of TRD patients achieving remission as adjunct to ADT therapy at week 4
- Time to onset of therapeutic effect as adjunct to ADT therapy
- Percentage relapse for TRD patients with stable remission during maintenance as adjunct to ADT
- Warnings / restrictions due to safety concerns
- Delivery profile
- Price per treated day
- Conjoint analysis-based simulation of a market scenario
- TRD market simulation: share of preference of target product profiles included in the market scenario
- TRD market simulation: likelihood to prescribe target product profiles included in the market scenario
- TRD market simulation: target product profiles included in the market scenario
- Appendix
- Key abbreviations
- Bibliography
- Executive summary
Aru Sharma, M.B.A., is an associate analyst on the CNS/Ophthalmology Disorders team at Clarivate, where he has worked on diverse projects, including unipolar depression and epilepsy. Mr. Sharma previously worked in market research and consulting. He holds an M.B.A. degree in health and hospital management from the Indian Institute of Health Management Research (IIHMR University).