For decades, the centre of gravity for clinical research has sat largely in America, Europe, and parts of Asia. But the next major expansion story is increasingly clear: Africa. Not because it’s a “new emerging market” in a simplistic sense but because the scientific, demographic, public-health, and regulatory conditions are converging in a way that makes Africa essential to the future of better, faster, more representative evidence generation.
1) The evidence gap is now impossible to ignore
Africa still largely under represents in globally registered trials relative to its population and disease burden. WHO’s analysis of trials in the ICTRP shows striking regional imbalances; for example, in 2024 the Western Pacific region recorded around 27,172 trials versus 1,049 in Africa. [1]
That disparity isn’t just a fairness issue, it’s a science issue. When large populations are underrepresented in research, we ignore pharmacogenetics and risk therapies that are less generalisable, dosing guidance that’s less robust across genetic diversity, and real-world outcomes that don’t match trial expectations.edia elements like videos, graphics, interactive questions, and digital signatures to improve patient comprehension and engagement. Unlike static forms, eConsent fosters dynamic participant-researcher interaction, ensuring comprehension and transparency.
2) Africa’s demographics make it central to “future medicine”
Africa is the world’s fastest-growing population base and one of its youngest. The African Development Bank projects Africa’s population could reach at least 2.4 billion by 2050. [2]
At the same time, rapid urbanisation is reshaping how healthcare is delivered and how patients can be identified, followed up, and retained in studies. The UN notes the global urban share is projected to rise to 68% by 2050, and Africa is a major driver of that shift. [3]
For sponsors, this matters because the next wave of product development such as vaccines, infectious disease therapeutics, maternal/child health solutions, oncology, cardiometabolic therapies, digital endpoints etc will be deployed at scale in these emerging, rapidly urbanising populations. Clinical research has to be there early to be relevant.
3) High-burden diseases create uniquely informative trial settings
Africa carries a substantial burden of infectious diseases (including TB, malaria, HIV) while simultaneously experiencing rapid growth in non-communicable diseases (hypertension, diabetes, cancers). That “dual burden” can make African trial sites uniquely valuable, not only for evaluating interventions targeted at infectious disease, but also for understanding comorbidities, polypharmacy realities, and healthcare delivery constraints that mirror many real-world settings.
In oncology specifically, registry-based reviews have highlighted increasing participation but still limited volume and uneven distribution across countries. Another signal that growth potential is large and structured investment can have outsized impact. [4]
4) Research capacity is scaling fast
A common outdated assumption is that Africa lacks the infrastructure and talent to run high-quality trials. In reality, capacity has been expanding through deliberate, multi-year investment (capacity building) in people, institutions, and networks.
For example, EDCTP2 (European & Developing Countries Clinical Trials Partnership) has supported clinical research capacity across 39 countries in sub-Saharan Africa, focusing on GCP-quality trial conduct, training, and institutional strengthening. [5]
This capacity-building is not theoretical, it has translated into more experienced investigators, stronger trial management, better lab and data systems, and improved ethics/regulatory processes in many settings.
5) Regulatory harmonisation is steadily reducing friction
Regulatory complexity and inconsistent timelines have historically been a barrier. But Africa is actively building continent-wide and regional alignment.
- The African Medicines Agency (AMA) treaty entered into force on 5 November 2021, creating a pathway toward stronger collaboration and harmonised oversight across countries. [6]
- The European Medicines Agency summarises AMA’s role as enabling collaboration and harmonisation of regulation and oversight at Africa-wide level, building on the African Medicines Regulatory Harmonisation (AMRH) programme. [7]
- Africa CDC has also reported concrete steps toward greater cooperation among national regulatory authorities. [8]
For sponsors and CROs, the direction of travel is what matters: fewer duplicative steps, more predictable standards, and a stronger ecosystem for multi-country trials.
6) Turning Africa’s Potential into Trial-Ready Reality
Recognising Africa’s importance is only the first step. Executing high-quality clinical trials across the continent requires local insight, regulatory fluency, strong site networks, and realistic operational planning. This is where Biopharmaal Consulting supports sponsors, CROs, and biotech companies.
Biopharmaal Consulting helps organisations:
• assess Africa’s suitability early through rigorous, reality-based feasibility
• identify and qualify trial-ready sites and investigators
• navigate ethics and regulatory pathways across African jurisdictions
• design Africa-inclusive clinical strategies that meet global standards
• build long-term, sustainable research partnerships, not one-off studies
For sponsors looking to future-proof their development programmes, Africa should not be an afterthought, it should be designed in from the outset, with the right ‘boot on the ground’ to partner.
7) Why sponsors and CROs will increasingly “have to” include Africa
Even if you ignore the ethical argument for representation, the operational case is strengthening:
- More representative evidence: Better external validity across genetic diversity, environments, and health-system contexts.
- Faster learning in priority disease areas: Especially vaccines and infectious diseases, but increasingly NCDs and oncology.
- Strategic market relevance: Evidence generated locally supports payer confidence, clinician adoption, and post-approval safety monitoring.
- Resilience and diversification: Overconcentration of trial activity in a few geographies creates risk. Africa is part of a smarter global portfolio.
8) The challenges are real and that’s exactly where smart operators win
Africa is not a monolith. Trial readiness varies by country, city, and even institution. Common challenges include:
- Variability in site infrastructure and staffing depth
- Differences in ethics and regulatory timelines
- Knowledge and attitudes of Africans towards clinical trial.
- Logistics (cold chain, import permits, sample shipping)
- Patient follow-up constraints in certain settings
- Work culture
- Data credibility
But these are solvable with the right training model: deliberate feasibility, investment in site partnerships, strong vendor ecosystems, realistic recruitment planning, and training that’s continuous not one-off.
9) What “good” looks like for responsible growth
If Africa is the next frontier, the goal shouldn’t be volume, it should be quality, sustainability, and mutual value:
• Long-term site partnerships/alliances (not transactional site-hopping)
• Local leadership in protocol development and study governance
• Capacity transfer (data, lab systems, monitoring capability, project leadership)
• Fair contracting and payment discipline to avoid destabilising sites
• Community trust building and culturally competent engagement
This is how you build a durable research footprint that benefits sponsors, investigators, and patients alike.
References
1. WHO Global Observatory on Health R&D. Number of clinical trials by year, country, WHO region and income group (1999–June 2025). (Published Nov 2025; data to Jun 2025).
2. Nyirenda T, et al. Strengthening capacity for clinical research in sub-Saharan Africa (EDCTP2). International Journal of Infectious Diseases (2021).
3. African Union. Treaty for the establishment of the African Medicines Agency (AMA) enters into force (5 Nov 2021).
4. European Medicines Agency. African Medicines Agency (African Union) – overview and harmonisation role. (May 2024).
5. African Development Bank. Tracking Africa’s Progress in Figures – Human Development (population projections).
6. United Nations DESA. 68% of the world population projected to live in urban areas by 2050.
7. Chuck KW, et al. Patterns of oncological clinical trials in African countries (2000–2024). (2025).
8. Africa CDC. Agreement among leading national medicines regulatory authorities to foster collaboration. (Feb 2025).