Clinical pipeline analysis for antibacterial products, trends from 2017 to current

Published: June 2024

WHO analysed the pipeline of antibacterial products (antibiotics and biologicals) that were in phase I-III of clinical development (from 1 July 2017 to December 2023), those products that received market authorization for human use anywhere in the world or were either discontinued or there was no recent available information about them.

This annual report evaluates whether the current R&D pipeline addresses infections caused by bacterial priority pathogens according to 2024 WHO bacterial priority pathogen list (BPPL). It also evaluates its innovativeness potential and presents trends in R&D such as the availability of oral formulation, the range of indications addressed by traditional agents, their spectrum of actions, and the current R&D on paediatric indications and/or formulations.

Candidate products are reported by type, pathogen category, phase of clinical development, expected activity against priority pathogens, route of administration, and innovativeness with a focus on new chemical entities. See below for details on the scope, analysis and limitations. 

See also:

What you see | Scope, analysis and limitations | Data sources | Previous versions

What you see

The data visualization is organized as follows:

• Panel A: annual trend of antibacterial agents,
• numbers of antibacterial products by pathogen category (chart A.1) product type (chart A.2) and phase of development (chart A.3)
• number of approved and discontinued antibacterial agents (chart B)
• number of antibacterial products by route of administration (chart C),
• country location (chart D) income group (chart E.1) and WHO region (chart E.2)
• list of products (by pathogen category and product type) with further information on each product (hover on the phase to open a popup window for additional information) (chart F).

Points to note:

• As of 31 December 2023,
  1. a total of 128 unique programmes have been analysed (chart A). Of these, 16 antibacterial agents have received market approval by any stringent regulatory authority or WHO-listed authority (chart B).
  2. There are 40 antibacterials (traditional and non-traditional) currently in development in oral form that target bacterial priority pathogens; the proportion and number of oral medications in the pipeline have remained relatively stable (chart C).
  3. Antibiotics targeting M. tuberculosis have increased from 7 in 2017 to 19 in 2023 (click on chart A.1 to see other pathogen specific trends).

• Since the first pipeline analysis in 2017, over 90% of clinical antibacterial product development takes place in high-income and upper-middle-income settings. 

To explore the data further

• Select a product type, pathogen category, pathogen, phase of development or other element – or a combination of elements (e.g., by clicking on a bar in a chart or a cell in a table) – to display the corresponding data in the other charts.
• Hover the cursor on a bar, a slice in a pie or a cell in a table to see more information in a popup window.
• Hold the ‘Ctrl’ key on your keyboard to select more than one option.
• Undo a selection by clicking ‘undo’ or ‘reset’ near the bottom of the page or by clicking the same element again.

Scope, analysis and limitations of the data

Scope

• This pipeline trend analysis focuses on products developed to address drug-resistant infections caused priority pathogen according to the WHO 2024 bacterial priority pathogen list. The data cut-off for the analysis is 31 December 2023 and is limited to products in phases I-III of clinical development that do not have market authorization anywhere in the world and intended for human use. 
• The analysis does not include:
  -- vaccines;
  -- topical decolonizing agents;
  -- nonspecific inorganic substances;
  -- biodefense agents;
  -- agents only developed for topical application (e.g. creams or eye drops); 
  -- new formulations of existing treatments.

Analysis

• The analysis was conducted by the WHO IRC Team. The WHO Advisory Group on the R&D of Antibacterial Treatments was also consulted and comprised of clinicians, microbiologists, and leading experts in antibiotic R&D, pharmacokinetics/pharmacodynamics (PK/PD) and antibiotic resistance.
• Products under development were assessed against the available evidence of activity against the priority pathogens according to the WHO 2024 bacterial priority pathogen list. Assessment for use against OPPs was done for products not active against critical priority pathogens.
• Products developed against C. difficile were not included in the trend analysis; however, they can be viewed on the annual clinical pipeline dashboards. 
• Four criteria were used to assess if a product could be considered as innovative (at least one should be present):
  -- no (known) cross resistance to existing antibiotics;
  -- new class (scaffold);
  -- new target (new molecular binding site); and/or
  -- new mode of action.

Limitations of the data

The analysis relies on data available in the public domain such as scientific articles, presentation, poster abstract and input from the WHO advisory group on the R&D of antibacterial treatments. Some of the products in this analysis are not listed in any clinical trial registry and many registered trials have not disclosed results within the recommended 12 months after completion.

The WHO Secretariat welcomes additional information and/or feedback on the data presented in this analysis. Feedback should be sent to antibacterialpipeline@who.int.

Data sources