Hospital-Treated Gram-Negative Infections – Landscape & Forecast – Disease Landscape & Forecast
The rising rates of antimicrobial resistance (AMR) have created an emergent need for antibiotics with activity against drug-resistant gram-negative pathogens (GNPs). Since the emergence of the COVID-19 pandemic, a potential public health threat of antibiotic-resistant bacteria is now becoming increasingly urgent. 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 GNI armamentarium. Despite the launch of novel antibiotics, such as AbbVie / Pfizer’s Avycaz / Zavicefta, Merck & Co.’s Zerbaxa and Recarbrio, and Shionogi’s Fetroja / Fetcroja, unmet need remains for additional treatment options with novel mechanisms of action and with efficacy in patients with drug-resistant infections, which are associated with high rates of mortality. Although the market is heavily genericized and cost-containment measures have limited commercial success of emerging therapies, innovative market push and pull approaches such as value-based pricing (VBP) and de-linked drug reimbursement models promise to encourage and support future antibiotics development.
QUESTIONS ANSWERED
- How large are the treatable HABP / VABP / HCAP, cSSSI / SSI, cIAI, BSI, and UTI populations? What are the resistance rates to different classes of antibiotics across several pathogen species?
- What is the state of treatment for hospital-treated GNIs? What are the most important drugs, and why? What clinical needs remain unfulfilled?
- What impact will the emerging antibiotic therapies have on the GNI therapy market? Which emerging therapies generate the most enthusiasm among thought leaders? How will ID specialists in different markets make treatment decisions among the emerging therapies in the future?
- On what attributes will pipeline therapies need to improve in order to compete with currently marketed products?
Geographies: United States, France, Germany, Italy, Spain, United Kingdom, Japan
Primary research: 20 country-specific interviews with thought-leading infectious disease specialists. Supported by survey data collected for this and other Clarivate research
Epidemiology: Diagnosed cases of GNIs by country, segmented by key infections (HABP / VABP/ HCAP, CSSSI / SSI, cIAI, BSI, and UTI), pathogens (E. coli, Pseudomonas, Acinetobacter, Klebsiella), and resistance types
Forecast: 10-year, annualized, drug-level sales and patient share of key GNI therapies through 2031, segmented by brands / generics, geography, and five key infection types
Emerging therapies: Phase III/PR: 8 drugs; Phase I/Phase II: 10 drugs
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 research.
SOLUTION ENHANCEMENT
Disease Landscape & Forecast will feature continual updates in 2022 to provide timely insights and analyses as meaningful indication-specific news and events unfold.
Table of contents
- Hospital-Treated Gram-Negative Infections - Landscape & Forecast - Disease Landscape & Forecast
- Key findings
- HTGNI - Key findings
- Key updates
- February 2023
- Q4 2022
- December 2022
- Q3 2022
- September 2022
- August 2022
- July 2022
- Q2 2022
- June 2022
- May 2022
- April 2022
- Q1 2022
- March 2022
- February 2022
- January 2022
- Market outlook
- Key findings
- Market overview
- Market share of drug classes for gram-negative infections: 2021
- Market share of drug classes for gram-negative infections: 2031
- Hospital-treated gram-negative infections SWOT analysis
- 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: 2021-2031
- Patient share of cephalosporins in hospital-treated gram-negative infections: 2021-2031
- Major-market sales of beta-lactam / beta-lactamase inhibitor combinations in hospital-treated gram-negative infections: 2021-2031
- Patient share of beta-lactam / beta-lactamase inhibitor combinations in hospital-treated gram-negative infections: 2021-2031
- Major-market sales of carbapenems for hospital-treated gram-negative infections: 2021-2031
- Patient share of carbapenems for hospital-treated gram-negative infections: 2021-2031
- Major-market sales of aminoglycosides for hospital-treated gram-negative infections: 2021-2031
- Patient share of aminoglycosides for hospital-treated gram-negative infections: 2021-2031
- Major-market sales of tetracyclines for hospital-treated gram-negative infections: 2021-2031
- Patient share of tetracyclines for hospital-treated gram-negative infections: 2021-2031
- Major-market sales of quinolones for hospital-treated gram-negative infections: 2021-2031
- Patient share of quinolones for hospital-treated gram-negative infections: 2021-2031
- Key findings
- 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
- Common drug-resistant pathogens in hospital-treated infections
- ESKAPE pathogens
- Nosocomial pneumonia
- Epidemiology
- Key findings
- Epidemiology populations
- Disease definition, methods, and sources used
- Diagnosed events of hospital-treated UTIs due to gram-negative pathogens: 2021-2031 (thousands)
- Disease definition, methods, and sources used
- Diagnosed events of hospital-treated bloodstream infections due to gram-negative pathogens: 2021-2031 (thousands)
- Disease definition, methods, and sources used
- Diagnosed events of hospital-treated nosocomial pneumonia due to gram-negative pathogens by type: 2021-2031 (thousands)
- Disease definition, methods, and sources used
- Diagnosed events of hospital-treated cIAIs due to gram-negative pathogens: 2021-2031 (thousands)
- Disease definition, methods, and sources used
- Diagnosed events of hospital-treated SSIs and cSSSIs due to gram-negative pathogens: 2021-2031 (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: 2021-2031 (thousands)
- Number of diagnosed and drug-treated events of hospital-treated BSIs associated with gram-negative pathogens in the major pharmaceutical markets: 2021-2031 (thousands)
- Number of diagnosed and drug-treated events of hospital-treated SSIs and cSSSIs due to gram-negative pathogens in the major pharmaceutical markets: 2021-2031 (thousands)
- Number of diagnosed and drug-treated events of hospital-treated nosocomial pneumonia due to gram-negative pathogens in the major pharmaceutical markets: 2021-2031 (thousands)
- Number of diagnosed and drug-treated events of hospital-treated cIAIs due to gram-negative pathogens in the major pharmaceutical markets: 2021-2031 (thousands)
- Methods and sources used
- Gram-negative pathogens associated with hospital-treated infections: 2021
- Gram-negative pathogens associated with hospital-treated nosocomial pneumonia: 2021
- Disease definition, methods, and sources used
- Extended-spectrum cephalosporin-resistant subpopulations
- Disease definition, methods, and sources used
- Carbapenem-resistant subpopulations
- Disease definition, methods, and sources used
- Fluoroquinolone-resistant subpopulations
- Key findings
- 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
- IDSA guidance for the treatment of infections caused by antimicrobial-resistant pathogens
- 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
- Urinary tract infections
- Treatment decision tree for hospital-treated NP caused by GNPs: United States
- Nosocomial pneumonia
- Treatment decision tree for hospital-treated cIAIs caused by GNPs: United States
- Complicated intra-abdominal infections
- Bloodstream infections
- Treatment decision tree for hospital-treated cSSSIs and SSIs caused by GNPs: United States
- Complicated skin and skin structure infections and surgical-site infections
- Treatment decision tree for hospital-treated UTIs caused by GNPs: EU5
- Urinary tract infections
- Treatment decision tree for hospital-treated NP caused by GNPs: EU5
- Nosocomial pneumonia
- Treatment decision tree for hospital-treated cIAIs caused by GNPs: EU5
- Complicated intra-abdominal infections
- Treatment decision tree for hospital-treated BSIs caused by GNPs: EU5
- Bloodstream infections
- Treatment decision tree for hospital-treated cSSSIs and SSIs caused by GNPs: EU5
- Complicated skin and skin structure infections and surgical-site infections
- Treatment decision tree for hospital-treated UTIs caused by GNPs: Japan
- Urinary tract infections
- Treatment decision tree for hospital-treated NP caused by GNPs: Japan
- Nosocomial pneumonia
- Treatment decision tree for hospital-treated cIAIs caused by GNPs: Japan
- Complicated intra-abdominal infections
- Treatment decision tree for hospital-treated BSIs caused by GNPs: Japan
- Bloodstream infections
- Treatment decision tree for hospital-treated cSSSIs and SSIs caused by GNPs: Japan
- Complicated skin and skin structure infections and surgical-site infections
- Key findings
- 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
- Expert insight on unmet needs in hospital-treated gram-negative infections
- Attainment of unmet needs
- Emerging therapies
- Key findings
- Key emerging therapies
- Estimated launch dates of key emerging therapies for the treatment of hospital-treated gram-negative infections
- Key results from select clinical trials investigating aztreonam / avibactam for the treatment of gram-negative infections
- Key ongoing clinical trials of aztreonam / avibactam in gram-negative infections
- Aztreonam / avibactam clinical development
- Expert insight: aztreonam / avibactam
- 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 results from select clinical trials investigating cefepime / taniborbactam for the treatment of 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 ongoing clinical trials of cefepime / zidebactam in gram-negative infections
- Cefepime / zidebactam clinical development
- Expert insight: cefepime / zidebactam
- Expectations for launch and sales opportunity of cefepime / zidebactam in hospital-treated gram-negative infections
- Key results from select clinical trials investigating sulbactam / durlobactam for the treatment of 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 tebipenem HBr for the treatment of gram-negative infections
- Tebipenem HBr clinical development
- Expert insight: tebipenem Hbr
- Expectations for launch and sales opportunity of tebipenem HBr in hospital-treated gram-negative infections
- Key results from select clinical trials investigating fosfomycin IV for the treatment of gram-negative infections
- Fosfomycin IV clinical development
- Expert insight: fosfomycin IV
- Expectations for launch and sales opportunity of fosfomycin IV in hospital treated gram-negative infections
- Key results from select clinical trials investigating LBP-EC01 for the treatment of gram-negative infections
- Key ongoing clinical trials of LBP-EC01 in gram-negative infections
- LBP-EC01 clinical development
- Expert insight: non-traditional therapies
- Expectations for launch and sales opportunity of LBP-EC01 in hospital treated gram-negative infections
- Early-phase pipeline analysis
- Select compounds in early-phase development for hospital-treated gram-negative infections
- Early-phase non-traditional antibacterial agents
- 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
- Key U.S. congressional legislation relating to antibiotics
- General reimbursement environment: United States
- Key market access considerations in hospital-treated gram-negative infections in EU5
- General reimbursement environment: EU5
- Key market access considerations in hospital-treated gram-negative infections in Japan
- General reimbursement environment: Japan
- Region-specific reimbursement practices
- Appendix
- Abbreviations
- Bibliography
- Key findings
Archita Kukreja, M.B.A., M.S., is a principal analyst on the Infectious, Niche, and Rare Diseases team at Clarivate. Prior to joining the company, she was a lead associate of healthcare operations at WNS Global Services. She has also worked as an associate analyst at Aspect Ratio. Ms. Kukreja holds a master of science degree in biotechnology from Jamia Millia Islamia in New Delhi and an M.B.A. from Amity University in Noida.
Mariah J. Scott, M.S., M.P.H., is an associate epidemiologist at Clarivate. Prior to joining the company, 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; her M.S. from Seton Hall University, where she studied microbiology and immunology; and her M.P.H. in epidemiology from Rutgers University.