Africa accounts for 19 percent of the world’s population and one-quarter of the global disease burden. However, for a host of reasons – both real and perceptual – the continent does not yet play host to meaningful levels of clinical research, accounting for just 1.1 percent of all clinical trials in 2023. A new report from the Access to Medicine Foundation (AMF) aims to shift the narrative and convince global trial sponsors to situate more of their clinical research in Africa.
This underrepresentation of Africa in clinical research matters because it overlooks genetic diversity and local disease profiles. For example, according to research published in The Lancet, only one percent of global Phase II–IV type 1 diabetes trials in the past decade included a sub-Saharan country, delaying recognition of a new non-autoimmune diabetes subtype in the region.
There are structural barriers underpinning this underrepresentation; Africa has traditionally lagged behind North America, Europe, and Asia in terms of clinical trial sites, trained professionals to lead trials, technical expertise, regulatory capacity, and a support network of service providers on the ground.
However, according to the authors of a new report – which builds on the findings of the 2024 Access to Medicine Index – the green shoots of change have already started to sprout. Emma Cahuzac, the AMF’s Continuous Intelligence Unit Manager, told PharmaBoardroom that “there has been real progress recently, and that creates opportunities.”
On the regulatory front, she notes that “The African Medicines Agency [a European Medicines Agency-style body for Africa – ed.] is moving closer to being operational, while harmonisation, including joint assessments, will make the regulatory process less burdensome. But companies don’t need to wait – there are frameworks they can use now.” Eight African countries have already achieved WHO Maturity Level 3, an important global benchmark for the strength and stability of a nation’s regulatory system.
A broader spectrum of trial stages and in more disease areas are also now being hosted in Africa, with the potential for more. There is a real lack of early-stage trials in Africa, with most trials tending to be late stage, concentrated in a single country (South Africa), and focused on infectious disease (see below map).
However, as the AMF’s Director of Private Sector Engagement Marijn Verhoef points out, “Over the past five or six years, a lot of progress has been made in building regulatory capacity in Africa. Historically, trials focused on HIV and neglected diseases, but companies are shifting toward noncommunicable diseases, including cancer.”
There is potential for much more activity in these areas; the report finds that while 29 percent of global Phase II–IV industry trials are in oncology, only three percent of those included African participants. However, data from the BIO Ventures for Global Health (BVGH)’s African Consortium for Cancer Clinical Trials (AC³T) platform shows that there are now 62 oncology-ready sites across 21 African countries.
The report highlights the African clinical trial work already being undertaken by the likes of Novartis – which ranked first in the 2024 Access to Medicine Index – as well as Pfizer, AstraZeneca, and Roche (see below map), and aims to give actionable recommendations to push other companies to follow in their footsteps.
Beyond the ethical rationale for investing in African clinical research, the report aims to make a clear business case to pharma. After all, these are not charities but global businesses with shareholders and must publish quarterly earnings; the report underlines that investing in Africa can also make commercial sense. Expanding trials in Africa can accelerate recruitment, shorten development timelines, and generate commercial benefits such as additional months of market exclusivity.
“Finding eligible patients can be like searching for a needle in a haystack,” says Verhoef. “By expanding to more countries, hospitals, and sites, your chances of finding them – and finding them faster – improve significantly.”
“Don’t just think about long-term emerging market potential; think about the short-term gains,” he concludes. “As a first mover in Africa, your trial will get the full attention of sites, leading to faster recruitment and extended market exclusivity.”
“There is already capacity, and there are enabling factors on the continent for you to start now”, adds Cahuzac. In the context of a world in which foreign aid budgets are shrinking, she urges immediate action: “There’s no reason to delay, because if everyone waits, progress won’t happen.”
Maps courtesy of the Access to Medicine Foundation, full report available here
