When considering whether or not to submit an in vitro diagnostic (IVD) or male circumcision device (MCD) to WHO for evaluation for prequalification, manufacturers seek to understand and review the potential donor-funded procurement market for the product concerned.
WHO does not generate its own information regarding markets for quality-assured IVDs or MCDs. Rather, its role focuses on verifying the quality of urgently-needed IVDs.
However, market information is prepared and made publicly-available by several other organizations. This information includes substantial "market landscape" reports that review recent product procurement (within a specific therapeutic area), including pricing, and outline anticipated market trends. Additionally, some organizations make publicly available information regarding IVDs or MCDs that they have procured and what price, and/or what they are currently procuring (including price range information).
Current bidding opportunities will also provide manufacturers with important information about procurement opportunities.
As well as submitting an IVD for evaluation for prequalification, applicants may consider submission for assessment by the Expert Review Panel for Diagnostics (ERPD). WHO-prequalified or products approved by a stringent regulatory authority are not always available on all markets or may be in short supply. Procurers may therefore find themselves in the position of having to urgently procure products about which little is known in terms of quality risk. ERP was created to help procurers assess such risk. The results of ERPD assessments enable procurers – such as the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria and UNFPA – to make an informed decision regarding time-limited procurement of the products assessed. ERPD assessment is therefore another route to markets.
Links to all this information can be found below.
Diagnostics Eligible Product Lists (The Global Fund)
- List of rapid diagnostic test kits for malaria classified according to the quality assurance policy (September 2021)
- List of HIV diagnostic test kits and equipments classified according to the quality assurance policy (September 2021)