The rising rates of antimicrobial resistance have created an urgent need for antibiotics with activity against drug-resistant gram-negative pathogens (GNPs). Antibiotics such as carbapenems, which have historically been reserved for later lines of therapy, are being used earlier in treatment, placing additional pressure on the already-limited gram-negative infection (GNI) armamentarium. Despite the launch of antibiotics, such as Avycaz / Zavicefta, Zerbaxa, Vabomere, Xerava, and Zemdri, unmet need remains for additional effective treatments. Although the recent launches of Recarbrio and Fetroja will partially address this unmet need, commercial opportunities still exist for emerging therapies with efficacy in patients with drug-resistant infections, especially those infections that are associated with high rates of mortality. However, the market is heavily genericized, and cost-containment measures may limit commercial success.

QUESTIONS ANSWERED

  • What are the drivers and constraints in the hospital-treated (HT)-GNI therapy market, and how will the market evolve over the forecast period? How will rising antibiotic resistance rates and the entry of new generics shape the market?
  • How large are the different GNI indications? What are the resistance rates to different classes of antibiotics across several pathogen species?
  • How will different emerging therapies address current unmet needs? What emerging therapies do infectious disease specialists consider most promising, and where will these therapies be used?
  • On what attributes will emerging therapies need to improve to compete with currently marketed products? What challenges will they face?

Geographies: United States, France, Germany, Italy, Spain, United Kingdom, Japan

Primary Research: More than 20 country-specific interviews with thought-leading infectious disease specialists supported by survey data collected for this and other DRG research.

Epidemiology: Diagnosed events of GNIs segmented by key indications (nosocomial pneumonia, complicated skin and skin structure infections / surgical site infections, bloodstream infections, complicated intra-abdominal infections, urinary tract infections), pathogens (E.coli, Pseudomonas, Acinetobacter, Klebsiella), resistance, and country.

FORECAST: Ten-year, annualized, drug-level sales and patient share of key GNI therapies through 2029, segmented by brands / generics, geography, and five key indications.

Emerging Therapies: Phase III/PR: 7 drugs; Phase I/Phase II: 15 drugs; coverage of select preclinical products

PRODUCT DESCRIPTION

Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary market research.

Table of contents

  • Hospital-Treated Gram-Negative Infections - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • Q2 2021
        • June 2021
        • May 2021
        • April 2021
      • Q1 2021
        • March 2021
        • February 2021
        • January 2021
      • Q4 2020
        • December 2020
      • Q3 2020
        • September 2020
    • Key Findings
      • HTGNI - Key Findings
        • September 2020
    • Market Outlook
      • Key Findings
        • Market Overview
        • Market Share of Drug Classes for Gram-Negative Infections: 2019
        • Market Share of Drug Classes for Gram-Negative Infections: 2029
        • Hospital-Treated Gram-Negative Infections SWOT Analysis
      • COVID-19: Areas of Potential Forecast Impact
        • Market Drivers and Constraints
          • What Factors Are Driving the Market for Hospital-Treated Gram-Negative Infections?
          • What Factors Are Constraining the Market for Hospital-Treated Gram-Negative Infections?
        • Drug-Class-Specific Trends
          • Major-Market Sales of Cephalosporins for Hospital-Treated Gram-Negative Infections: 2019-2029
          • Patient Share of Cephalosporins in Hospital-Treated Gram-Negative Infections: 2019-2029
          • Major-Market Sales of Beta-Lactam/Beta-Lactamase Inhibitor Combinations in Hospital-Treated Gram-Negative Infections: 2019-2029
          • Patient Share of Beta-Lactam/Beta-Lactamase Inhibitor Combinations in Hospital-Treated Gram-Negative Infections: 2019-2029
          • Major-Market Sales of Carbapenems for Hospital-Treated Gram-Negative Infections: 2019-2029
          • Patient Share of Carbapenems for Hospital-Treated Gram-Negative Infections: 2019-2029
          • Major-Market Sales of Aminoglycosides for Hospital-Treated Gram-Negative Infections: 2019-2029
          • Patient Share of Aminoglycosides for Hospital-Treated Gram-Negative Infections: 2019-2029
          • Major-Market Sales of Tetracyclines for Hospital-Treated Gram-Negative Infections: 2019-2029
          • Patient Share of Tetracyclines for Hospital-Treated Gram-Negative Infections: 2019-2029
          • Major-Market Sales of Quinolones for Hospital-Treated Gram-Negative Infections: 2019-2029
          • Patient Share of Quinolones for Hospital-Treated Gram-Negative Infections: 2019-2029
          • Major-Market Sales of Fosfomycin for Hospital-Treated Gram-Negative Infections: 2019-2029
          • Patient Share of Fosfomycin for Hospital-Treated Gram-Negative Infections: 2019-2029
      • Forecast
        • Market Forecast Assumptions
        • Market Forecast Dashboard
      • Etiology and Pathophysiology
        • Nosocomial Pneumonia
          • Etiology
          • Pathophysiology
        • Skin and Skin Structure and Surgical-Site Infections
          • Etiology
          • Pathophysiology
        • Urinary Tract Infections
          • Etiology
          • The Urinary System
          • Pathophysiology
        • Intra-Abdominal Infections
          • Etiology
          • Pathophysiology
        • Bloodstream Infections
          • Etiology
          • Pathophysiology
        • Common Gram-Negative Pathogens in Hospital-Treated Infections
          • Enterobacteriaceae
          • Pseudomonads
          • Acinetobacter
        • Key Drug-Resistant Pathogens
          • ESKAPE Pathogens
          • Carbapenem-Resistant Pathogens
          • Quinolone-Resistant Pseudomonas Aeruginosa
          • Third-Generation Cephalosporin-Resistant Klebsiella Pneumoniae
          • Expert Insights on Key Drug-Resistant Pathogens
      • Epidemiology
        • Key Findings
          • Epidemiology Populations
            • Disease Definition
            • Methods
            • Sources Used for Diagnosed Events of Hospital-Treated UTIs due to Gram-Negative Pathogens
            • Number of Diagnosed Events of Hospital-Treated UTIs due to Gram-Negative Pathogens in the Major Pharmaceutical Markets: 2019-2029 (thousands)
            • Disease Definition
            • Diagnosed Events of Hospital-Treated Bloodstream Infections due to Gram-Negative Pathogens
            • Sources Used for Diagnosed Events of Hospital-Treated Bloodstream Infections due to Gram-Negative Pathogens
            • Number of Diagnosed Events of Hospital-Treated Bloodstream Infections due to Gram-Negative Pathogens in the Major Pharmaceutical Markets: 2019-2029 (thousands)
            • Disease Definition
            • Methods
            • Sources Used for Diagnosed Events of Hospital-Treated Nosocomial Pneumonia due to Gram-Negative Pathogens
            • Number of Diagnosed Events of Hospital-Treated Nosocomial Pneumonia due to Gram-Negative Pathogens in the Major Pharmaceutical Markets by Type: 2019-2029 (thousands)
            • Disease Definition
            • Diagnosed Events of Hospital-Treated cIAIs due to Gram-Negative Pathogens
            • Sources Used for Diagnosed Events of Hospital-Treated cIAIs due to Gram-Negative Pathogens
            • Number of Diagnosed Events of Hospital-Treated cIAIs due to Gram-Negative Pathogens in the Major Pharmaceutical Markets: 2019-2029 (thousands)
            • Disease Definition
            • Methods
            • Sources Used for Diagnosed Events of Hospital-Treated SSIs and cSSSIs due to Gram-Negative Pathogens
            • Number of Diagnosed Events of Hospital-Treated SSIs and cSSSIs due to Gram-Negative Pathogens in the Major Pharmaceutical Markets: 2019-2029 (thousands)
            • Percentage Diagnosed
            • Percentage Drug-Treated
            • Number of Diagnosed and Drug-Treated Events of Hospital-Treated UTIs due to Gram-Negative Pathogens in the Major Pharmaceutical Markets: 2019-2029 (thousands)
            • Number of Diagnosed and Drug-Treated Events of Hospital-Treated BSIs Associated with Gram-Negative Pathogens in the Major Pharmaceutical Markets: 2019-2029 (thousands)
            • Number of Diagnosed and Drug-Treated Events of Hospital-Treated SSIs and cSSSIs due to Gram-Negative Pathogens in the Major Pharmaceutical Markets: 2019-2029 (thousands)
            • Number of Diagnosed and Drug-Treated Events of Hospital-Treated Nosocomial Pneumonia due to Gram-Negative Pathogens in the Major Pharmaceutical Markets: 2019-2029 (thousands)
            • Number of Diagnosed and Drug-Treated Events of Hospital-Treated cIAIs due to Gram-Negative Pathogens in the Major Pharmaceutical Markets: 2019-2029 (thousands)
            • Methods
            • Sources Used for Diagnosed Events of Hospital-Treated Infections due to Gram-Negative Pathogens
            • Gram-Negative Pathogens Associated with Hospital-Treated Infections in the Major Pharmaceutical Markets: 2019
            • Gram-Negative Pathogens Associated with Hospital-Treated Nosocomial Pneumonia in the Major Pharmaceutical Markets: 2019
            • Disease Definition
            • Methods
            • Sources Used for Antimicrobial Resistance to Extended-Spectrum Cephalosporins
            • Extended-Spectrum Cephalosporin-Resistant Subpopulations
            • Disease Definition
            • Methods
            • Sources Used for Antimicrobial Resistance to Carbapenems
            • Carbapenem-Resistant Subpopulations
            • Disease Definition
            • Methods
            • Sources Used for Antimicrobial Resistance to Fluoroquinolones
            • Fluoroquinolone-Resistant Subpopulations
        • Current Treatment
          • Key Findings
            • Treatment Goals
              • Key Endpoints Used in Clinical Trials for Hospital-Treated Gram-Negative Infections
              • Key Physician Insights on Clinical Endpoints
            • Key Current Therapies
              • Overview
              • Mechanisms of Action of Key Current Drug Classes Used for Hospital-Treated GNIs
              • Current Treatments Used for Hospital-Treated GNIs
              • Market Events Impacting the Use of Key Current Therapies for Hospital-Treated GNIs
              • Comparison of Gram-Negative Pathogen Susceptibility to Select Antibiotics
              • Advantages and Disadvantages of Cephalosporins
              • Ongoing Clinical Development
              • Key Clinical Trials of Cephalosporins for Hospital-Treated GNIs
              • Expert Insight: Cephalosporins
              • Advantages and Disadvantages of Beta-Lactam/Beta-Lactamase Inhibitor Combinations
              • Ongoing Clinical Development
              • Key Clinical Trials of Beta-Lactam/Beta-Lactamase Inhibitor Combinations for Hospital-Treated GNIs
              • Expert Insight: Beta-Lactam/Beta-Lactamase Inhibitor Combinations
              • Advantages and Disadvantages of Carbapenems
              • Expert Insight: Carbapenems
              • Advantages and Disadvantages of Aminoglycosides
              • Expert Insight: Aminoglycosides
              • Advantages and Disadvantages of Tetracyclines
              • Expert Insight: Tetracyclines
              • Advantages and Disadvantages of Quinolones
              • Expert Insight: Quinolones
            • Medical Practice
              • Overview
              • Treatment Guidelines
              • Drug Selection
              • Factors Influencing Drug Selection in Hospital-Treated GNIs
              • Treatment Decision Tree for Hospital-Treated UTIs Caused by GNPs: United States
              • Treatment Decision Tree for Hospital-Treated NP Caused by GNPs: United States
              • Treatment Decision Tree for Hospital-Treated cIAIs Caused by GNPs: United States
              • Treatment Decision Tree for Hospital-Treated BSIs Caused by GNPs: United States
              • Treatment Decision Tree for Hospital-Treated cSSSIs and SSIs Caused by GNPs: United States
              • Urinary Tract Infections
              • Nosocomial Pneumonia
              • Complicated Intra-Abdominal Infections
              • Bloodstream Infections
              • Complicated Skin and Skin Structure Infections and Surgical-Site Infections
              • Treatment Decision Tree for Hospital-Treated UTIs Caused by GNPs: EU5
              • Treatment Decision Tree for Hospital-Treated NP Caused by GNPs: EU5
              • Treatment Decision Tree for Hospital-Treated cIAIs Caused by GNPs: EU5
              • Treatment Decision Tree for Hospital-Treated BSIs Caused by GNPs: EU5
              • Treatment Decision Tree for Hospital-Treated cSSSIs and SSIs Caused by GNPs: EU5
              • Urinary Tract Infections
              • Nosocomial Pneumonia
              • Complicated Intra-Abdominal Infections
              • Bloodstream Infections
              • Complicated Skin and Skin Structure Infections and Surgical-Site Infections
              • Treatment Decision Tree for Hospital-Treated UTIs Caused by GNPs: Japan
              • Treatment Decision Tree for Hospital-Treated NP Caused by GNPs: Japan
              • Treatment Decision Tree for Hospital-Treated cIAIs Caused by GNPs: Japan
              • Treatment Decision Tree for Hospital-Treated BSIs Caused by GNPs: Japan
              • Treatment Decision Tree for Hospital-Treated cSSSIs and SSIs Caused by GNPs: Japan
              • Urinary Tract Infections
              • Nosocomial Pneumonia
              • Complicated Intra-Abdominal Infections
              • Bloodstream Infections
              • Complicated Skin and Skin Structure Infections and Surgical-Site Infections
          • Unmet Need Overview
            • Attainment of Unmet Needs
              • Current Attainment of Unmet Needs in Hospital-Treated Gram-Negative Infections
              • Future Attainment of Unmet Needs in Hospital-Treated Gram-Negative Infections
              • Top Unmet Needs in Hospital-Treated Gram-Negative Infections: Current and Future Attainment
              • Unmet Need and Opportunities in Gram-Negative Infections due to ESBL-Producing Pathogens
              • Unmet Need and Opportunities in Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia due to Carbapenem-Resistant Organisms
              • Expert Insight on Unmet Needs in Hospital-Treated Gram-Negative Infections
          • Emerging Therapies
            • Key Findings
            • Pipeline Trends for Hospital-Treated Gram-Negative Infections
            • Key Emerging Therapies
              • Key Therapies in Development for Hospital-Treated Gram-Negative Infections
              • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Hospital-Treated Gram-Negative Infections
              • Key Results from Select Clinical Trials Investigating Cefiderocol for the Treatment of Gram-Negative Infections
              • Cefiderocol Clinical Development
              • Expert Insight: Use of Cefiderocol in the Treatment of Hospital-Treated Gram-Negative Infections
              • Expert Insight: Cefiderocol
              • Expectations for Launch and Sales Opportunity of Cefiderocol in Hospital-Treated Gram-Negative Infections
              • Key Results from Select Clinical Trials Investigating Imipenem / Cilastatin / Relebactam for the Treatment of Gram-Negative Infections
              • Key Ongoing Clinical Trials of Imipenem / Cilastatin / Relebactam in Gram-Negative Infections
              • Imipenem / Cilastatin / Relebactam Clinical Development
              • Expert Insight: Use of Imipenem / Cilastatin / Relebactam in the Treatment of Hospital-Treated Gram-Negative Infections
              • Expert Insight: Imipenem/Cilastatin/Relebactam
              • Expectations for Launch and Sales Opportunity of Imipenem/Cilastatin/Relebactam in Hospital-Treated Gram-Negative Infections
              • Key Ongoing Clinical Trials of Aztreonam/Avibactam in Gram-Negative Infections
              • Aztreonam/Avibactam Clinical Development
              • Expert Insight: Use of Aztreonam/Avibactam in the Treatment of Hospital-Treated Gram-Negative Infections
              • Expectations for Launch and Sales Opportunity of Aztreonam/Avibactam in Hospital-Treated Gram-Negative Infections
              • Key Results from Select Clinical Trials Investigating Cefepime/Enmetazobactam for the Treatment of Gram-Negative Infections
              • Cefepime/Enmetazobactam Clinical Development
              • Expert Insight: Cefepime/Enmetazobactam
              • Expectations for Launch and Sales Opportunity of Cefepime/Enmetazobactam in Hospital-Treated Gram-Negative Infections
              • Key Ongoing Clinical Trials of Cefepime/Taniborbactam in Gram-Negative Infections
              • Cefepime/Taniborbactam Clinical Development
              • Expert Insight: Cefepime/Taniborbactam
              • Expectations for Launch and Sales Opportunity of Cefepime/Taniborbactam in Hospital-Treated Gram-Negative Infections
              • Key Results from Select Clinical Trials Investigating Sulbactam/Durlobactam for the Treatment of Gram-Negative Infections
              • Key Ongoing Clinical Trials of Sulbactam/Durlobactam in Gram-Negative Infections
              • Sulbactam/Durlobactam Clinical Development
              • Expert Insight: Sulbactam/Durlobactam
              • Expectations for Launch and Sales Opportunity of Sulbactam/Durlobactam in Hospital-Treated Gram-Negative Infections
              • Key Results from Select Clinical Trials Investigating Sulopenem for the Treatment of Gram-Negative Infections
              • Sulopenem Clinical Development
              • Expectations for Launch and Sales Opportunity of Sulopenem in Hospital-Treated Gram-Negative Infections
              • Key Results from Select Clinical Trials Investigating Tebipenem HBr for the Treatment of Gram-Negative Infections
              • Tebipenem HBr Clinical Development
              • Expectations for Launch and Sales Opportunity of Tebipenem HBr in Hospital-Treated Gram-Negative Infections
              • Delafloxacin Profile
              • Delafloxacin Clinical Development
              • Expert Insight: Use of Delafloxacin in the Treatment of Hospital-Treated Gram-Negative Infections
              • Expert Insight: Delafloxacin
              • Expectations for Launch and Sales Opportunity of Delafloxacin in Hospital-Treated Gram-Negative Infections
              • Key Results from Select Clinical Trials Investigating Phosphomycins for the Treatment of Gram-Negative Infections
              • Clinical Development
              • Expert Insight: Use of Fosfomycin IV in the Treatment of Gram-Negative Infections
              • Expert Insight: Fosfomycin IV
              • Expectations for Launch and Sales Opportunity of Fosfomycin IV in Hospital Treated Gram-Negative Infections
            • Early-Phase Pipeline Analysis
              • Select Compounds in Early-Phase Development for Hospital-Treated Gram-Negative Infections
            • Nontraditional Therapies
              • Select Nontraditional Therapies in Early-Phase Development for Hospital-Treated Gram-Negative Infections
          • Access and Reimbursement Overview
            • Region-Specific Reimbursement Practices
              • Key Market Access Considerations in Hospital-Treated Gram-Negative Infections in the United States
              • General Reimbursement Environment: United States
              • Key Market Access Considerations in Hospital-Treated Gram-Negative Infections in France
              • Key Market Access Considerations in Hospital-Treated Gram-Negative Infections in Germany
              • Key Market Access Considerations in Hospital-Treated Gram-Negative Infections in Italy
              • Key Market Access Considerations in Hospital-Treated Gram-Negative Infections in Spain
              • Key Market Access Considerations in Hospital-Treated Gram-Negative Infections in the United Kingdom
              • General Reimbursement Environment: EU5
              • Key Market Access Considerations in Hospital-Treated Gram-Negative Infections in Japan
              • General Reimbursement Environment: Japan
          • Appendix
            • Brands, Marketers, and Generic Availability of Current Therapies Used for Hospital-Treated Gram-Negative Infections by Market
            • Bibliography

        Author(s): Archita Kukreja; Mariah Scott

        Archita Kukreja, M.B.A., M.S., is a principal analyst on the Infectious, Niche, and Rare Diseases team. 

        Archita Kukreja holds a Master of Science degree in biotechnology from Jamia Millia Islamia, New Delhi, and has completed her MBA from Amity University, Noida. Previously, Archita was Lead Associate, Healthcare Operations at WNS Global Services. She has also worked as an associate analyst for Aspect Ratio, MSD Global Centre for Analytics and Forecasting.

         

        Mariah J. Scott, M.S., M.P.H., is an associate epidemiologist at Clarivate. Previously, she investigated patient-reported outcomes on health-related quality of life during the transition from pediatric to adult care in patients with Sickle Cell Disease throughout the state of New Jersey. Ms. Scott received her B.S. in Molecular Biology from Montclair State University and her M.S. from Seton Hall University where she studied Microbiology and Immunology. She also holds an M.P.H. degree in epidemiology from Rutgers University.