MARKET OUTLOOK

Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) are among the most common and serious infections in the hospital setting. HABP/VABP due to carbapenem-resistant organisms (CROs) are particularly difficult-to-treat and life-threatening. No current antibiotic was specifically developed for CROs. Allergan/Pfizer’s Avycaz/Zavicefta and Melinta’s Vabomere address some of the unmet need in this area, but most current treatments are combinations of generically available antibiotics and have significant side effects and/or suboptimal efficacy.

QUESTIONS ANSWERED

  • What clinical and nonclinical factors are the key influences on ID specialists’ prescribing decisions for HABP/VABP due to CROs? How do these different factors compare in terms of importance?
  • How do current therapies for HABP/VABP due to CROs—including Avycaz/Zavicefta and Vabomere—perform on clinical and nonclinical attributes?
  • What are the key areas of unmet need that represent opportunities for developers of therapies for the treatment of HABP/VABP due to CROs?
  • What trade-offs across clinical and nonclinical attributes and price are acceptable to U.S. and European ID specialists for a hypothetical new agent for the treatment of HABP/VABP due to CROs?

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.

Markets covered: United States, United Kingdom, France, Germany

Primary research: Survey of 61 U.S. and 30 European ID specialists fielded in February 2019

Key drugs: Avycaz/Zavicefta, Vabomere, tigecycline, meropenem, imipenem/cilastatin, colistin

Key metrics included: 

  • Target Product Profile (TPP) simulator based on conjoint analysis methodology.
  • Stated vs. 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

  • Hospital-Treated Gram-Negative Infections - Unmet Need - Detailed, Expanded Analysis: Hospital-Acquired And Ventilator-Associated Bacterial Pneumonia Due To Carbapenem-Resistant Organisms (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 HABP/VABP Gram-Negative Infections due to CROs
    • 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 for HABP/VABP due to CROs
      • Importance of Efficacy Attributes to Prescribing Decisions for HABP/VABP due to CROs: United States
      • Importance of Efficacy Attributes to Prescribing Decisions for HABP/VABP due to CROs: Europe
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions for HABP/VABP due to CROs: United States
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions for HABP/VABP due to CROs: Europe
      • Importance of Convenience of Administration Attributes to Prescribing Decisions for HABP/VABP due to CROs: United States
      • Importance of Convenience of Administration Attributes to Prescribing Decisions for HABP/VABP due to CROs: Europe
      • Importance of Nonclinical Factors to Prescribing Decisions for HABP/VABP due to CROs: United States
      • Importance of Nonclinical Factors to Prescribing Decisions for HABP/VABP due to CROs: 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 for HABP/VABP due to CROs: United States
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions for HABP/VABP due to CROs: Europe
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
      • Overall Performance of Key Therapies for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms: United States
      • Overall Performance of Key Therapies for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms: Europe
      • Mean Overall Performance of Key Therapies for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms: United States and Europe
      • Relative Performance of Key Therapies for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Across Select Efficacy Attributes: United States
      • Relative Performance of Key Therapies for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Across Select Efficacy Attributes: Europe
      • Relative Performance of Key Therapies for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Across Select Safety and Tolerability Attributes: United States
      • Relative Performance of Key Therapies for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Across Select Safety and Tolerability Attributes: Europe
      • Relative Performance of Key Therapies for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Across Select Convenience of Administration Attributes: United States
      • Relative Performance of Key Therapies for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Across Select Convenience of Administration Attributes: Europe
      • Relative Performance of Key Therapies for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Across Select Nonclinical Attributes: United States
      • Relative Performance of Key Therapies for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Across Select Nonclinical Attributes: Europe
    • Assessment of Unmet Need
      • Key Findings: Unmet Need in Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms
      • Surveyed Infectious Disease Specialists’ Satisfaction with the Performance of Key Therapies for HABP/VABP due to CROs on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
      • Surveyed Infectious Disease Specialists’ Satisfaction with the Performance of Key Therapies for HABP/VABP due to CROs 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 HABP/VABP due to CROs: United States
      • Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in HABP/VABP due to CROs: Europe
      • Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in HABP/VABP due to CROs: United States
      • Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in HABP/VABP due to CROs: Europe
      • Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in HABP/VABP due to CROs: United States
      • Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in HABP/VABP due to CROs: Europe
      • Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in HABP/VABP due to CROs: United States
      • Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in HABP/VABP due to CROs: Europe
      • Key Findings: Unmet Need in Hospital-Acquired and Ventilator-Associated Pneumonia due to Carbapenem-Resistant Organisms and Related Indications
      • Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need in HABP/VABP due to CROs and Related Indications: United States
      • Surveyed Infectious Disease Specialists' Ascribed Level of Unmet Need in HABP/VABP due to CROs and Related Indications: Europe
    • Opportunity Analysis
      • Areas of Opportunity in the Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms and Related Indications Market and Emerging Therapy Insights
        • Opportunity: An Antibiotic with a Lower ACM Rate and Improved Clinical Cure Rate in HABP/VABP due to CROs
        • Opportunity: A Non-Beta-Lactam Antibiotic with Less-Severe Side Effects
        • Opportunity: An Antibiotic with a Shorter Treatment Duration
        • Opportunity: Source of Clinical Data in HABP/VABP
    • Target Product Profiles
      • Assessing Drug Development Opportunities
      • Target Product Profile Methodology
        • Attributes and Attribute Levels
      • Attribute Importance and Part-Worth Utilities
        • Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Target Product Profile: Attribute Importance
        • All-Cause Mortality Rate in HABP/VABP at 28 Days Following Treatment Initiation
        • Clinical Cure Rate in HABP/VABP at the Test-of-Cure Visit
        • Incidence of Nephrotoxicity
        • Source of Clinical Data in HABP/VABP
        • Spectrum of Activity
        • Length of ICU Stay
        • Price per Day
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Market Simulations: Target Product Profiles Included in Scenario 1
        • Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations
      • Bibliography

Author(s): Natasha Bardhan, M.Pharm.

Natasha Bardhan is an Associate Analyst on the Infectious, Niche, and Rare Diseases team at DRG, part of Clarivate. She conducts primary and secondary research for a range of antibacterial and antiviral indications, as well as niche and rare diseases. She has also authored content on the treatment of HABP/VABP gram-negative infections. She holds a bachelor’s degree in pharmacy from the Delhi Institute of Pharmaceutical Sciences and Research and a master’s degree in pharmaceutics from Amity University in Noida.