INFECTIOUS DISEASE R&D TRACKER

The Infectious Disease R&D pipeline tracker contains a comprehensive list of approved health products and technologies, as well as candidates in the development pipeline for global health priority issues. It currently reflects the pipeline as of August 2023.

The Infectious Disease R&D pipeline tracker presents data collected as part of the Evidence for Impact project. This project aims to assess the health and economic impact of the past 20 years of investment in R&D for neglected and emerging infectious diseases and it seeks to establish a framework that the community can leverage to track and evaluate the impact of investment in global health R&D on an ongoing basis. The project has been funded by the Bill and Melinda Gates Foundation, Open Philanthropy and Wellcome, supported by an advisory group of more than 40 experts and developed through engagement with more than 100 stakeholders across the entire global health R&D eco-system.

The Infectious Disease R&D pipeline tracker grew out of previous R&D pipeline mapping work undertaken by Policy Cures (published in 2015) and then again by Policy Cures Research in 2019, which was supported by the WHO-TDR and Duke University.

In line with Policy Cures Research’s mission, this tracker provides information on products and candidates for diseases and issues that disproportionately affect people in low- and middle-income countries. It covers all product categories including drugs, vaccines, diagnostics and vector control products, and all stages of research, from early-stage R&D through to product registration. See the ‘Scope’ section below for exact details on the diseases and product areas included in the tracker.

  • Download the full database in Excel here.
  • An interactive data dashboard is available below.

The Infectious Disease R&D Tracker includes drugs, vaccines, biologics, diagnostics, and vector control products for neglected and emerging infectious diseases.

The neglected disease scope mirrors the G-FINDER scope for neglected diseases, including diseases and health issues if they meet all three of the following criteria:

  1. The disease or health issue disproportionately affects populations in low- and middle-income countries;
  2. There is a need for new products (i.e. there is no existing product, or improved or additional products are needed); and
  3. There is market failure (i.e. there is insufficient commercial market to attract R&D investment by private industry).

The emerging infectious disease scope is based upon the priority diseases identified in the World Health Organization’s R&D Blueprint for Action to Prevent Epidemics (R&D Blueprint) and some of the priority diseases identified by CEPI.

The tracker includes products approved since 1999, as well as active pipeline candidates. Not all product types are included for all areas: product/neglected disease pathogen combinations for which there is a viable commercial market are excluded, and COVID-19 pre-clinical vaccine candidates and diagnostics are excluded. Additionally, diagnostics for select diseases have been grouped under technology categories.

More details on the scope can be found here.

To curate the Infectious Disease R&D Tracker and capture a snapshot of the pipeline as of August 2023, Policy Cures Research undertook a review of approved products, candidates, and R&D priorities.

Approved products were defined as finished pharmaceutical products, drugs, vaccines, biologics, vector control products or diagnostics that had been granted a marketing authorisation by a medicines regulatory authority or had obtained WHO prequalification. A preliminary list of approved products was identified through a normative literature review of treatment guidelines, WHO position papers, and essential medicines and diagnostic list databases. This preliminary list was then cross-referenced against regulatory authority databases.

Candidates were defined as potential drugs, vaccines, vector control products, diagnostics, or platform technologies, currently under investigation that had yet to be approved by a medicines regulatory authority.

A preliminary list of candidates was available from previous pipeline reviews conducted by Policy Cures Research in 2017 and 2019, which were commissioned and funded by WHO-TDR and Duke University. These also build on the 2015 neglected diseases product pipeline review, and pipeline data collected for the 2012 Policy Cures/ Global Health Technologies (GHTC) report ‘Saving lives and creating impact: Why investing in global health R&D works’, which in turn was based on BIO Ventures for Global Health (BVGH) Global Health Primer, with additional research and analysis by Policy Cures Research.

To update the list of candidates, several sources of data were reviewed, including publicly available product databases, academic literature, conference abstracts and presentations and developer websites.

R&D priorities were defined as active “widely accepted” target product profiles or product profile characteristics which had undergo extensive public consultation with diverse relevant stakeholders before publication. We included those published by the WHO and malaria drug priorities set out by Medicines for Malaria Venture – stating the intended use, target populations and other desired attributes of products, to guide product R&D for a particular disease. R&D priorities were identified from WHO’s database of target product profiles (TPPs) and product profile characteristics (PPCs) and from Medicines for Malaria Venture’s pipeline. For each disease and product area that had defined TPPs or PPCs, active pipeline candidates were evaluated on whether they met the defined characteristics on indication, intended use, efficacy, safety and target population.

More details on the methodology can be found here.

Since 1999, 323 products that are aligned with the G-FINDER scope for neglected diseases and emerging infectious diseases have been approved. This represents 215 products for neglected diseases and 108 for emerging infectious diseases, including diagnostics, drugs, vaccines, microbicides and vector control products (VCPs).

Neglected disease products

The vast majority of the neglected disease products are malaria innovations (79 products, 37%). Within that, VCPs are the most common at 56 products, representing nearly three-quarters of the malaria product landscape (72%) and more than a quarter of all products approved during that period for neglected diseases (27%).

Diagnostics were the most prevalent product type, making up 42% (91 products) of the neglected disease landscape and spread across all diseases in scope except for histoplasmosis, hookworm, trachoma and scabies. Note: where there are a number of “me too” diagnostics, these were captured by technology type to avoid duplication and artificial inflation of the landscape. Individual test names are captured as “alternative names” but the list is not an exhaustive.

Infectious disease products

The 108 emerging infectious disease products identified represent the landscape of finished pharmaceutical products relevant to the WHO R&D Blueprint priority pathogens (with the exception of COVID-19 diagnostics which were excluded – further details available in the scope document). Like the neglected disease landscape, the most common product type is diagnostics representing 51% of the landscape (55 approved products), followed by vaccines (40, 37%), biologics (8, 7%) and drugs (5, 5%). Only two diseases have approved products for vaccines and therapeutics: COVID-19 and Ebola (targeting Zaire ebolavirus only).

Note: As part of the Evidence for Impact project, Policy Cures Research and the African Population and Health Research Centre (APHRC) undertook a systematic literature review of peer-reviewed studies assessing the health and/ or economic impact of the identified approved products. A summary of the literature review is available here.

As of August 2023, a total of 1,287 active candidates have been identified in the neglected and emerging infectious diseases pipeline.

Neglected disease candidates

The neglected disease pipeline boasts 753 active candidates, marking a 27% growth since 2019 (an increase of 159 candidates in four years). Half of the neglected disease pipeline (377 candidates) is made up of candidates for three major diseases: malaria (20%), TB and HIV (15% each).

  • Malaria has 66 vaccines and 41 drug candidates.
  • Tuberculosis has 20 vaccines and 55 drug candidates
  • HIV/AIDS has 56 vaccine and 23 biologics candidates.

Promisingly, a significant proportion of the pipeline of vaccines, drugs and biologics for neglected diseases is in Phase II and III trials (180 candidates, 32%).

One notable shift in the neglected disease pipeline is in biologics. Four years ago, only a handful of biologics were in development, and there are now 65 in the pipeline, representing 8% of the total neglected disease pipeline and nearly 25% of the therapeutics pipeline. Over half of all biologics are monoclonal antibodies (mAbs) which are being developed for HIV/AIDs, dengue, malaria, hepatitis B and diarrhoeal diseases. There are also several therapeutic vaccines for tuberculosis. This growth underscores the significant advancements being made in this domain.

Despite significant growth in some areas, for more than a third of the diseases in the neglected diseases scope (10 out of 27), there are fewer than 10 candidates in the pipeline combined across all product areas.

Emerging infectious disease candidates

The pipeline for emerging infectious diseases includes 534 candidates.

Vaccine candidates for COVID-19 represent 39% of the total candidates in the pipeline (174 candidates). 37% of these COVID-19 vaccines are in Phase III trials (64 candidates), 33% are in Phase I (57) and 30% are in Phase II (52).

For the remainder 360 candidates, vaccines represent 42% of the pipeline with 150 candidates, followed by 88 diagnostics candidates (24%), 68 drugs candidates (19%) and 54 biologics (15%). Candidates for filoviruses (Ebola and Marburg) make up the largest proportion of the pipeline (88 products, 24%). Bunyaviral disease (Crimean-Congo Hemorrhagic Fever and Rift Valley Fever) and Chikungunya candidates sit at 19% and 18% of the pipeline respectively. The remainder is made up of Lassa fever candidates (43, 12%), Nipah (37, 10%), MERS (33, 9%), and Zika (27, 8%).

Regarding development phases, 75% of vaccine and therapeutics candidates for emerging infectious diseases (excluding COVID-19) are in preclinical development (204), 38 (14%) are in Phase I (of which 29 are vaccines), and just 11 (4%) are in Phase II. Phase III trials feature four candidates: three Chikungunya vaccines and one Ebola drug.