Hospital-Treated Gram-Negative Infections – Unmet Need – Detailed, Expanded Analysis: Gram-Negative Infections (US & EU)
Market Outlook
Carbapenem-resistant organisms (CROs) are responsible for difficult-to-treat, life-threatening gram-negative infections that require hospitalization. Of the currently marketed antibiotics, none were specifically developed for CROs. The recent launch of Merck & Co.’s Avycaz/Zaviceftaaddresses some of the unmet need in this area, but the majority of current treatments are combinations of generically available antibiotics, which have significant sideeffects and may extend the length of hospital stay. Thus, a high unmet need exists for the treatment of infections caused by CROs, witha significant commercial opportunity for novel agents.
Questions Answered
- What clinical and nonclinical factors are the key influencers in ID specialists’ prescribing decisions for the treatment of infections due to CROs? How do these different factors compare in terms of importance?
- How do current therapies used in the treatment of CROs—including Avycaz/Zavicefta or tigecycline—perform on clinical and nonclinical attributes?
- What are the key areas of unmet need that represent opportunities for developers of therapies in the treatment of CROs? How do these needs differ between European and U.S. ID specialists?
- What trade-offs across different clinical and nonclinical attributes and price are acceptable to U.S. and European ID specialists for a hypothetical new agent for the treatment of CROs?
Product Description
Unmet Need: 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 62 U.S. and 35 European ID specialists fielded in March 2018.
Key companies: Achaogen, Allergan, Merck & Co., Melinta Therapeutics, Pfizer, Polyphor, Shionogi, and Tetraphase.
Key drugs: Avycaz/Zavicefta, cefiderocol, eravacycline, imipenem/cilastatin, colistin, imipenem/cilastatin/relebactam, meropenem, murepavadin, tigecycline, and Vabomere.
Table of contents
- Hospital-Treated Gram-Negative Infections - Unmet Need - Detailed, Expanded Analysis: Gram-Negative Infections (US & EU)
- Introduction
- Overview
- Methodology
- Rationale for Treatment Drivers and Goals Selection
- Efficacy
- Safety and Tolerability
- Convenience of Administration
- Nonclinical Factors
- Rationale for Drug Selection
- Regimens for Hospital-Treated Gram-Negative Infections: Carbapenem-Resistant Organisms
- Treatment Drivers and Goals
- Key Findings: Attribute Importance
- Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Infectious Disease Specialists' Prescribing Decisions in HTGNI Due to Carbapenem-Resistant Organisms
- Importance of Efficacy Attributes to Prescribing Decisions in Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms: United States
- Importance of Efficacy Attributes to Prescribing Decisions in Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms: Europe
- Importance of Safety and Tolerability Attributes to Prescribing Decisions in Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms: United States
- Importance of Safety and Tolerability Attributes to Prescribing Decisions in Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms: Europe
- Importance of Convenience of Administration Attributes to Prescribing Decisions in Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms: United States
- Importance of Convenience of Administration Attributes to Prescribing Decisions in Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms: Europe
- Importance of Nonclinical Factors to Prescribing Decisions in Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms: United States
- Importance of Nonclinical Factors to Prescribing Decisions in Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms: 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 Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms: United States
- Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms: Europe
- Product Performance Against Treatment Drivers and Goals
- Key Findings
- Overall Performance of Key Therapies for Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms: United States
- Overall Performance of Key Therapies for Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms: Europe
- Relative Performance of Key Therapies for Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Across Select Efficacy Attributes: United States
- Relative Performance of Key Therapies for Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Across Select Efficacy Attributes: Europe
- Relative Performance of Key Therapies for Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Across Select Safety and Tolerability Attributes: United States
- Relative Performance of Key Therapies for Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Across Select Safety and Tolerability Attributes: Europe
- Relative Performance of Key Therapies for Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Across Select Convenience of Administration Attributes: United States
- Relative Performance of Key Therapies for Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Across Select Convenience of Administration Attributes: Europe
- Relative Performance of Key Therapies for Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Across Select Nonclinical Attributes: United States
- Relative Performance of Key Therapies for Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Across Select Nonclinical Attributes: Europe
- Assessment of Unmet Need
- Key Findings: Unmet Need in HT-GNI Due to Carbapenem-Resistant Organisms
- Surveyed Infectious Disease Specialistsu2019 Satisfaction with the Performance of Key Therapies for HT-GNI Due to Carbapenem-Resistant Organisms on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
- Surveyed Infectious Disease Specialistsu2019 Satisfaction with the Performance of Key Therapies for HT-GNI Due to Carbapenem-Resistant Organisms on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
- Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in HT-GNI Due to Carbapenem-Resistant Organisms: United States
- Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in HT-GNI Due to Carbapenem-Resistant Organisms: Europe
- Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in HT-GNI Due to Carbapenem-Resistant Organisms: United States
- Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in HT-GNI Due to Carbapenem-Resistant Organisms: Europe
- Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in HT-GNI Due to Carbapenem-Resistant Organisms: United States
- Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in HT-GNI Due to Carbapenem-Resistant Organisms: Europe
- Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in HT-GNI Due to Carbapenem-Resistant Organisms: United States
- Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in HT-GNI Due to Carbapenem-Resistant Organisms: Europe
- Key Findings: Unmet Need in HT-GNI Due to Carbapenem-Resistant Organisms and Related Indications
- Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need in HT-GNI Due to Carbapenem-Resistant Organisms and Related Indications: United States
- Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need in HT-GNI Due to Carbapenem-Resistant Organisms and Related Indications: Europe
- Opportunity Analysis
- Areas of Opportunity in the Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Market and Emerging Therapy Insights
- Opportunity: Improved Cure Rate and Decreased All-Cause Mortality Against CROs
- Opportunity: Clinical Trials in Less Commonly Studied Indications
- Opportunity: A Non-Beta-Lactam Antibiotic with Low Nephrotoxicity
- Opportunity: Shorter Treatment Duration
- Areas of Opportunity in the Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms 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
- Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Target Product Profile: Attribute Importance
- Clinical Cure Rate for GNIs Due to CROs
- Spectrum of Activity to GNPs
- Clinical Trials Supporting the FDA/EMA Label
- Incidence of Nephrotoxicity
- Treatment Duration
- All-Cause Mortality Rate at 28 Days Following Treatment Initiation for CROs
- Price per Treated Day
- Conjoint Analysis-Based Simulations of Market Scenarios
- Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
- Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
- Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Market Simulations: Target Product Profiles Included in Scenario 1
- Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
- Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
- Hospital-Treated Gram-Negative Infections Due to Carbapenem-Resistant Organisms Market Simulations: Target Product Profiles Included in Scenario 2
- Appendix
- Key Abbreviations
- Introduction
Nuno Antunes, D.V.M., Ph.D., is a director on the Infectious, Niche, and Rare Diseases team at Decision Resources Group. Prior to this role, he was a senior analyst on the Global Market Access Insights team, where he served as a lead expert in market access, pricing and reimbursement, health technology assessment, and health policy in Latin American countries. He has extensive experience in the study of mechanisms of antibiotic resistance and in the development of novel antibiotics. He obtained his Ph.D. from the Universidad de Las Palmas de Gran Canaria in Spain.