Global progress is off-track to meet 2030 targets of ending the AIDS, TB, and malaria epidemics, as well as preventable deaths of newborns and children under five. In addition, the world is increasingly vulnerable to health emergencies which in turn lead to further delays in meeting public health objectives.
While a well-established formulary exists for leading infectious diseases and new options have recently been added, challenges persistent. Challenges are largely due to limited options for vulnerable populations, options with complex implementation requirements, and a lack of vaccines for certain diseases. Innovative solutions are required to help meet the needs of the most vulnerable populations, enable the global response to efficiently advance on targets, contribute to universal health care, and prepare for responding to emerging threats.
Monoclonal antibodies can be developed to treat or prevent a wide range of diseases and have enormous potential to address unmet health needs by providing a faster, more tolerable, and highly efficacious response, complementing other strategies using small molecules and vaccines. They are already transforming modern medicine in high-income countries and hold great potential for the management of major public health conditions in LMICs. In addition, mAbs are one of the quickest medical countermeasures that can be leveraged during a health emergency due to their ability to be quickly isolated from those who have recovered from a disease and provide rapid protection against infection once administered to others.
Despite this promise, however, there is stark global inequity in access to mAbs. Very high prices, insufficient production capacity and limited visibility on demand are amongst the key barriers that compromise the use of mAbs in LMICs. This perpetuates the lack of commercial interest in infectious disease markets and does not incentivize innovation to reduce the cost of production and delivery of mAbs to meet the needs of LMICs.
A paradigm shift in business models and collaboration across sectors is essential to enable the availability, affordability, and acceptability of mAbs in LMICs. Efforts are needed to investigate which products in the pipeline will have a use case most conducive to scaled use in LMICs and what the demand and funding channels for such products could be, with due consideration for other tools that may be available or emerging.
In March 2023, Unitaid co-convened a global, multistakeholder consultation on Novel Business Models for Accessible mAbs for Infectious Diseases in LMICs with the Medicines Patent Pool, Wellcome, and IAVI with support from the Bill and Melinda Gates Foundation. The recommendations from the consultation are summarized in a report available online, highlighting the need for concerted efforts to conduct deep analysis and validation of viable business models including further definition of product use cases, market size, sustainable product portfolios, production capacity, and cost-saving opportunities.