Access to monoclonal antibodies in Africa: a call to action

In partnership with IAVI, and with the support of Wellcome, Impact Global Health has published a new report evaluating the current state of R&D and access for monoclonal antibodies (mAbs) and related products. The report examines the global landscape of approved mAbs and biosimilars with a deep dive into the current situation in Africa. This builds upon IAVI's previous work on mAbs, including the 2020 roadmap to making monoclonal antibodies affordable and available to all.

This new report takes a deep dive into mAb availability in Africa to explore trends in mAbs access and research and development for mAbs of regional relevance since the original roadmap was released. Progress in tackling major barriers to mAbs access in Africa could serve as a bellwether for progress globally.

To explore these trends, the report reviews the status of monoclonal R&D and access globally, and in the Africa region in 2024 compared to 2020. In 2020, there were just over 650 mAbs in development for various medical conditions. 570 were in clinical testing, more than 60% of which targeted oncology indications. By 2024, the clinical pipeline had nearly doubled, with over 1,000 innovative candidates, and with cancer mAbs still dominating the landscape.

In Africa, encouragingly, the current landscape of approved mAb-based products has also grown compared to 2020, although access gaps remain relative to the United States and Europe. More mAbs are being developed for high-priority African diseases, such as HIV and malaria, but fewer than a quarter of existing mAbs are available in Africa. In all, Africa accounts for only roughly 1% of overall mAbs sales globally, despite accounting for 20% of the global population. Funding for mAbs for endemic infectious diseases (IDs) has increased but still pales in comparison to that for infectious diseases with epidemic potential, such as those for COVID-19 and Ebola.

Some clinical trials for monoclonal antibodies (mAbs) are being conducted in Africa, with the majority (77%) in South Africa. However, the overall number of active mAb trials between 2023 and 2024 on the continent remains modest compared to those conducted in high-income countries. Nonetheless, Africa's clinical trial capacity is steadily growing, expanding the potential for more mAb trials in the region.   

While progress has been made in developing and approving mAbs, particularly with biosimilars, in the four years since the IAVI/Wellcome roadmap, more is needed to make mAbs accessible to all. This report offers specific recommendations and issues a renewed call to action amongst all stakeholders – governments, healthcare providers, pharmaceutical companies, the private sector, funders, civil society, and international organizations – to develop innovative, scalable, and cost-effective models for mAbs R&D, manufacturing, and distribution tailored to the unique needs in different geographies.