Need for ARV projections

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.

Projecting 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, projections guide 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, projections 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.

MPP-WHO collaboration on projections

The MPP and the World Health Organization (WHO) prepare joint projections 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:

  • Past trends
  • WHO guidelines
  • Clinical data, including safety and efficacy of drugs
  • Expected date of generic availability
  • Degree of generic competition
  • Availability of FDCs
  • Extent of generic distribution
  • Expected price of drugs over the years
  • Expert opinion.

Experts who have worked with us on these projections are associated with World Health Organization, UNAIDS, Avenir Health and University of British Colombia.

MPP-WHO’s projection methodology is available for all to review, with methods and results shown both here (see below) and on the WHO website. Notably, the projections have been published in the peer-reviewed journal PLOS ONE which is openly accessible. Our projections have been presented at multiple international meetings, including IAS and the Joint WHO/UNAIDS annual consultations with manufacturers and partners.

We update our projections annually and publish them on our website. Read our published studies and presentations on our methodology and findings below:

MPP/Havard T.H. Chan School of Public Health: Projected savings through public health voluntary licences of HIV drugs negotiated by the MPP
Harvard T.H. Chan School of Public Health/MPP study in peer-reviewed journal PLOS ONE estimating that savings of its licensing agreements for antiretrovirals (ARVs) to treat HIV in low- and middle-income countries could reach US$ 2.3 billion by 2028 – May 2017
Forecasted demand for current and new ARV medicines in low- and middle-income countries, 2016-2026
WHO/MPP joint forecast presentation prepared for WHO/UNAIDS’s AIDS Medicines and Diagnostics Service (AMDS) event – March 2017
Projected Uptake of New Antiretroviral (ARV) Medicines in Adults in Low- and Middle-Income Countries: A Forecast Analysis 2015-2025
WHO/MPP’s joint work on forecasting the use of antiretrovirals in low and middle-income countries, published in peer-reviewed journal PLOS ONE – October 2016
Forecasted demand for current and new ARV medicines in low and middle income countries, 2015-2025
WHO/MPP forecast excerpts from the Joint WHO/UNAIDS Meeting with Manufacturers and Partners on Global ARV Demand Forecast – March 2016
Forecasted demand for current and new ARV medicines in low and middle income countries, 2014-2025
Presentation prepared for the International AIDS Conference – July 2015
Forecasting Pipeline ARVs
Presented at WHO/UNAIDS Annual meeting with Pharmaceutical Companies and Stakeholders – March 2015
Forecasting Pipeline ARVs for Paediatrics
Presented at WHO/UNAIDS Annual meeting with Pharmaceutical Companies and Stakeholders – March 2015
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