Insomnia – Unmet Need – Detailed, Expanded Analysis (US/EU5)
Insomnia is a highly prevalent sleep disorder characterized by daytime dysfunction resulting from sleep problems. The treatment of insomnia is highly individualized, and physicians consider multiple factors when selecting an appropriate treatment regimen. Despite the availability of numerous pharmacological agents from a variety of drug classes, commercial opportunity remains for therapies that offer improved efficacy and/or improved safety and tolerability—including improved next-day functioning and a lower risk of next-day effects—over available treatments. Considering the long-standing market availability and low prices of generic sedatives and antidepressants commonly used for insomnia, emerging therapies will face obstacles to market access unless they can provide a compelling clinical and economic proposition.
QUESTIONS ANSWERED
- What are surveyed psychiatrists’ opinions of the relative performance of select therapies, including zolpidem IR, ramelteon (Takeda’s Rozerem), and suvorexant (Merck & Co.’s Belsomra) on key efficacy, safety/tolerability, and convenience of administration attributes?
- Based on the responses of surveyed psychiatrists, what level of unmet need exists on key drug performance attributes?
- What attributes drive decision-making in the treatment of insomnia, which have limited impact, and which are hidden opportunities?
- What trade-offs between efficacy, safety, convenience of administration, and price are acceptable to psychiatrists for a hypothetical new drug to treat insomnia?
Geographies: United States, United Kingdom, France, Germany
Primary research: Survey of 60 U.S. and 30 European psychiatrists fielded in January 2019
Key drugs covered: Belsomra, doxepin (Silenor, generics), trazodone, Rozerem, and zolpidem IR
Key metrics included: 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, and analysis of remaining drug development opportunities
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. Two market scenarios are profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.
Table of contents
- Insomnia - Unmet Need - Detailed, Expanded Analysis (US/EU5)
- Introduction
- Overview
- Methodology
- Rationale for Treatment Drivers and Goals Selection
- Efficacy
- Safety and Tolerability
- Convenience of Administration
- Rationale for Drug Selection
- Products for Insomnia
- 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 Insomnia
- Importance of Efficacy Attributes to Prescribing Decisions in Insomnia: United States
- Importance of Efficacy Attributes to Prescribing Decisions in Insomnia: Europe
- Importance of Safety and Tolerability Attributes to Prescribing Decisions in Insomnia: United States
- Importance of Safety and Tolerability Attributes to Prescribing Decisions in Insomnia: Europe
- Importance of Convenience of Administration Attributes to Prescribing Decisions in Insomnia: United States
- Importance of Convenience of Administration Attributes to Prescribing Decisions in Insomnia: 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 Insomnia: United States
- Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Insomnia: Europe
- Product Performance Against Treatment Drivers and Goals
- Key Findings
- Overall Performance of Key Therapies for Insomnia: United States
- Overall Performance of Key Therapies for Insomnia: Europe
- Mean Overall Performance of Key Therapies for Insomnia: United States and Europe
- Relative Performance of Key Therapies for Insomnia Across Select Efficacy Attributes: United States
- Relative Performance of Key Therapies for Insomnia Across Select Efficacy Attributes: Europe
- Relative Performance of Key Therapies for Insomnia Across Select Safety and Tolerability Attributes: United States
- Relative Performance of Key Therapies for Insomnia Across Select Safety and Tolerability Attributes: Europe
- Relative Performance of Key Therapies for Insomnia Across Select Convenience of Administration Attributes: United States
- Relative Performance of Key Therapies for Insomnia Across Select Convenience of Administration Attributes: Europe
- Assessment of Unmet Need
- Key Findings: Unmet Need in Insomnia
- Surveyed Psychiatristsu2019 Satisfaction with the Performance of Key Therapies for Insomnia on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
- Surveyed Psychiatristsu2019 Satisfaction with the Performance of Key Therapies for Insomnia on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
- Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Insomnia: United States
- Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Insomnia: Europe
- Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Insomnia: United States
- Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Insomnia: Europe
- Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Insomnia: United States
- Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Insomnia: Europe
- Key Findings: Unmet Need in Insomnia and Related Indications
- Surveyed Psychiatrists' Ascribed Level of Unmet Need in Insomnia and Related Indications: United States
- Surveyed Psychiatrists' Ascribed Level of Unmet Need in Insomnia and Related Indications: Europe
- Opportunity Analysis
- Areas of Opportunity in the Insomnia Market and Emerging Therapy Insights
- Opportunity: Insomnia Therapies That Improve Daytime Functioning
- Opportunity: Drugs Lacking Residual Next-Day Side Effects
- Opportunity: Drugs for the Treatment of Chronic Insomnia That Lack Abuse Potential
- Areas of Opportunity in the Insomnia 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
- Insomnia Target Product Profile: Attribute Importance
- Mean Increase in Patient-Reported Total Sleep Time at One Month
- Mean Reduction in Patient-Reported Latency to Persistent Sleep at One Month
- Risk of Abnormal Behavior or Thinking: Percentage of Patients Reporting Hallucinations
- Risk of Residual Next-Day Effects: Percentage of Patients Reporting Next-Day Sleepiness
- Risk of Dependence: Percentage of Patients Reporting Withdrawal Symptoms
- Duration of Therapeutic Effect
- Price per Treated Day
- Conjoint Analysis-Based Simulations of Market Scenarios
- Insomnia Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
- Insomnia Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
- Insomnia Market Simulations: Target Product Profiles Included in Scenario 1
- Insomnia Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
- Insomnia Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
- Insomnia Market Simulations: Target Product Profiles Included in Scenario 2
- Appendix
- Key Abbreviations
- Experts Interviewed
- Bibliography
- Introduction
Natalie Taylor, Ph.D., is a principal business insights analyst on the CNS/Ophthalmology Disorders team at Clarivate. She has more than ten years of experience authoring primary and market research reports for pharmaceutical industry clients in the fields of psychiatry, pain, neurology, and ophthalmology. Previously, Dr. Taylor worked at QuintilesIMS as manager of its CNS portfolio. She completed her Ph.D. in physiology at Dartmouth College in New Hampshire, where she studied the role of serotonergic neurons in the medullary raphe on modulating respiratory responses in mammals. She holds a B.S. in biology from Dickinson College in Pennsylvania.