Generic competition has historically been key to reducing prices and increasing access to medicines. Generic drug development processes, from active pharmaceutical ingredient (API) production to finished drug registration, typically takes at least four years with most companies beginning development work once there is certainty of demand. Without market demand security, generic manufacturers may not be willing to invest in development of promising pipeline antitretrovirals (ARVs) and new chemical entitities, even if voluntary licences are in place.
Forecasting the use of ARVs is key to providing generic manufacturers with guidance and motivation for timely generic development of pipeline ARVs for use in developing countries.
Timely generic development of new drugs may help in the prompt adoption of appropriate drugs in treatment recommendations. Moreover, forecasting guides our industry partners on access strategies, prioritization and building capacity, thereby ensuring industry readiness for timely availability of adequate amounts of recommended drugs to help achieve international treatment targets. They also provide broad support to the HIV community and support financing agencies in identifying drugs that may optimise spend on treatment. Policymakers, procurement agencies, regulatory agencies and other public health bodies also rely on these analyses to plan their policies and place new drugs on the market.
For the Medicines Patent Pool, forecasts are needed to engage originator companies into licensing their pipeline ARVs, and facilitate decision-making by generic manufacturers for seeking licences and investing in development, production and regulatory approval of needed ARV formulations.
The MPP and the World Health Organization (WHO) prepare joint forecasts on the use of antiretroviral medicines in developing countries. We work together to pool respective information and insights from our partners. We review epidemiology data from UNAIDS and model the use and uptake of drugs based on, among other factors:
Experts who have worked with us on these forecasts are associated with World Health Organization, UNAIDS, Avenir Health and University of British Colombia.
MPP-WHO’s forecasting methodology is available for all to review, with methods and results shown both here (see below) and on the WHO website. Notably, the forecasts have been published in the peer-reviewed journal PLOS ONE which is openly accessible. Our forecasts have been presented at multiple international meetings, including IAS and the Joint WHO/UNAIDS annual consultations with manufacturers and partners.
We update our forecasts annually and publish them on our website. Read our published studies and presentations on forecasting methodology and findings below: