INTRODUCTION

The COVID-19 pandemic exposed Africa’s heavy reliance on external supply chains and its limited capacity to manufacture pharmaceuticals, medical supplies, and vaccines. When high-income countries closed their borders and restricted exports of medical supplies, African nations faced significant difficulties regarding vaccine availability and distribution. Of the more than 13.5 billion COVID-19 vaccine doses administered worldwide, only 6% were received by African populations, far below the threshold for herd immunity. Today, Africa still imports 99% of its routine vaccines and 95% of its pharmaceuticals.1 In fact, although the continent accounts for roughly 25% of global vaccine demand, Africa produces less than 1% of the global supply, instead importing approximately 75% of its vaccines and pharmaceuticals from the European Union, India, China, and the United States.2,3 This overreliance and asymmetry leave Africa highly vulnerable to disruptions in global supply chains, ultimately leading to limited access to essential medicines and vaccines.

Africa’s pharmaceutical vulnerability has galvanized efforts to build local capacities as part of the World Health Organization (WHO)'s broader African 2030 Vision for healthcare resilience and economic independence. The initiative aims to strengthen Africa’s response to “disruptive events” in the public health sphere after the COVID-19 pandemic.4 While the existing local pharmaceutical sphere has made significant strides, capacity still remains limited and concentrated in a few countries, lacking the scale and the scope to meet the continent’s full healthcare demands. Thus, African governments and stakeholders are prioritizing the development of a robust local pharmaceutical industry that enhances health security, economic growth, regional leadership, and supply chain management.

Currently, Africa is at a pivotal moment as it embarks on an ambitious journey to transform its pharmaceutical industry. One key institution involved in this endeavor is the African Development Bank Group (AfDB), a financial institution with the goal of enhancing living conditions and promoting investments. In collaboration with the International Finance Corporation (IFC; a member of the World Bank group), the AfDB aims to invest in African infrastructure and economic development through the pharmaceutical sector.

Lessons from the COVID-19 Pandemic

The COVID-19 pandemic specifically served as a powerful wake-up call, exposing the depth of Africa’s dependency on imported pharmaceuticals and vaccines. Critically, African nations were left reliant on foreign suppliers during a time of global crisis; high-income countries prioritized their own populations and placed export restrictions on essential medical supplies.5 This lack of transparency and solidarity prevented African countries from meeting vaccination goals. In response to these global disparities, the WHO, in collaboration with partners, launched the COVID-19 Vaccines Global Access (COVAX) initiative, aimed at ensuring equitable access to global vaccines. However, many high-income nations were initially reluctant in their support. Notably, the European Union ordered approximately 1.6 billion vaccine doses by February 2021, enough to fully immunize its 375 million residents and still retain a surplus of over 500 million doses. Such vaccine accumulation reflected a deeper geopolitical imbalance in global health governance.

Yet, vaccine inequity was only part of the challenge. The pandemic also exposed critical weaknesses in Africa’s healthcare logistics and pharmaceutical supply chains. Even when vaccines were made available—such as the 860 million doses delivered to the continent through COVAX—many failed to reach patients in a timely manner due to fragmented and underdeveloped distribution systems.6 A striking example was the Democratic Republic of the Congo, which received 1.7 million doses of the AstraZeneca vaccine, only to return 1.3 million doses for redistribution because of logistical hurdles and inadequate coordination between key stakeholders.7

Logistic inefficiencies were not isolated incidents but rather symptoms of systemic issues. Long-standing problems such as medicine shortages, delayed restocking of pharmacies, and erratic distribution patterns had persisted across countries like Rwanda, Kenya, and South Africa. Patients regularly encountered stockouts of essential drugs, including psychiatric medications, oral contraceptives, cancer treatments, HIV therapies, and antihypertensive medicines.8

A growing body of analysis suggests that these bottlenecks are symptomatic of Africa’s overreliance on foreign-led medical supply chains and aid-based procurement systems.9 Without robust local logistics and manufacturing infrastructure, African countries remain vulnerable to global disruptions and priorities that may not align with local health needs.

Investing in local pharmaceutical production not only builds regional resilience but also offers an opportunity to develop the supply chain ecosystem. This would enable African nations to scale operations, achieve cost efficacy, and ensure more equitable and timely access to life-saving medicines and vaccines. Ultimately, local production is a strategic pathway toward ending dependency and achieving health sovereignty.

Enablers of Pharmaceutical Self-Reliance: Infrastructure, Standards, and Investment

Achieving long-term pharmaceutical self-reliance in Africa demands strong advocacy from regional bodies such as the WHO Regional Office for Africa, Africa Centers for Disease Control (Africa CDC), the East, Central and Southern Africa Health Community (ECSA-HC; an intergovernmental health organization), and AfDB, specifically through well-coordinated investments in local drug manufacturing, infrastructure, and regulatory systems. As part of a continent-wide strategy, AfDB advocates for emphasis on the local manufacturing of 30 high-demand pharmaceutical products, which include treatments for hypertension, diabetes, HIV/AIDS, and other priority conditions. Collectively, these medicines represent approximately 27% of total pharmaceutical consumption in Africa and span across multiple therapeutic areas.10 Increasing the proportion of these drugs manufactured locally, from under 25% today to over 67% by 2030, could ultimately enable the continent to meet up to 55% of its own pharmaceutical needs.10 This strategic focus offers an important gateway to broader production capacity that could gradually fulfill the rest of the continent’s pharmaceutical requirements, while reducing dependence on external markets.

To operationalize this vision, Africa will require an estimated $111 billion in investment across infrastructure, technology, skills, and regulatory systems. Improving these foundations is necessary to expand capacity and to enhance healthcare delivery, reduce strain on fragile health systems, and foster economic growth.

A central pillar of Africa’s strategy for pharmaceutical self-reliance is the establishment of new vaccine manufacturing hubs alongside the strengthening of existing ones such as the Biovac Institute (a biopharmaceutical company in South Africa), Institut Pasteur de Dakar (IPD) (a biomedical research center in Senegal), Vacsera (VACSERA) (a prominent vaccine supplier in Egypt), and Aspen Pharmacare (a pharmaceutical company in South Africa). These efforts are reinforced by continent-wide initiatives designed to build sustainable local production capacity, including the Partnership for African Vaccine Manufacturing (PAVM) led by Africa CDC, the African Medicines Agency (AMA) under the African Union (a governing body focused on solidarity amongst African nations), and BioNTech’s mRNA manufacturing hubs (BioNTainers) in Rwanda and Ghana.

In pursuit of the aforementioned goals, the AfDB is spearheading plans to establish five regional vaccine hubs with a projected combined capacity of 300 to 500 million doses annually—a dramatic increase from the 20.7 million doses produced across the continent in 2022. Pioneering initiatives such as Institut Pasteur de Dakar, Biovac, and Industrial Promotion Services (IPS, focused on developing sustainable businesses) in East Africa offer compelling models for building local production ecosystems rooted in quality, sustainability, and regional equity. Furthermore, scheduling and making available routine vaccinations via the vaccine hubs can help move towards more equitable health outcomes.11

In parallel, collaborative financing initiatives are playing a catalytic role in developing Africa’s pharmaceutical hubs. For example, in partnership with Gavi, the African Vaccine Manufacturing Accelerator (AVMA) is mobilizing up to $1 billion in funding through 2033 to strengthen Africa’s vaccine manufacturing base.12 This initiative supports supply-chain resilience and outbreak preparedness while sparking a broader biotechnology sector across the continent. Complementing these investments, the International Finance Corporation (IFC) emphasizes the importance of improving local health systems as a way to retain skilled professionals, build centers of pharmaceutical excellence, and foster institutional trust.8 While mobilizing the required investment and implementation support presents significant challenges, sustained public-private collaboration, bolstered by regional leadership, offers a viable pathway toward building long-term pharmaceutical capacity.

Equally critical to Africa’s pharmaceutical self-sufficiency is the elevation of regulatory and manufacturing standards. The strategic goal is for at least 50% of local manufacturers to meet Good Manufacturing Practice (GMP) standards by 2030.10 However, achieving this benchmark is complicated by financial and technical capacity limitations. Nonetheless, attaining GMP compliance is pivotal for manufacturers to receive WHO prequalification—an endorsement that facilitates access to wider markets and investment funds.13 Moreover, the long-term cost-benefit profile of GMP compliance is favorable; certification reduces the risk of costly product recalls and strengthens consumer trust through consistent product quality. As such, countries should be incentivized—financially and technically—to adopt GMP standards not only as a regulatory necessity but also as a vehicle to strengthen health system credibility and market stability.

Africa’s Economic Growth and Emergence as a Global Leader in Pharmaceuticals

With one of the world’s youngest and fastest-growing populations, Africa is uniquely positioned to emerge as a global leader in pharmaceutical manufacturing and innovation. By 2030, it is projected that 42% of the world’s youth will be African.14 Investing in the pharmaceutical sector presents a significant opportunity to harness this demographic dividend, generate employment, and drive long-term economic growth. Local pharmaceutical manufacturing can create jobs and simultaneously strengthen trade balances, reducing dependence on external imports, and fostering more resilient, integrated economies. Building technical expertise will require a skilled workforce, which remains scarce in Africa. Expanding on-site practical training and specialty programs, as well as integrating online global specialized training, could be vital steps. Additionally, other African countries can look to Rwanda as a model, where government collaboration with the AfDB has accelerated the development of a skilled biomedical workforce.15

Furthermore, local manufacturing reduces supply chain complexity by shortening distribution networks, lowering quality assurance costs, and enabling cost-effective procurement of Active Pharmaceutical Ingredients (APIs) through smaller, more efficient shipments.16 Expanding drug development capacities within the continent may also lead to significant healthcare savings; for example, greater access to prescription medicines has been shown to reduce hospitalizations, which account for a large portion of healthcare expenditures.17

As of 2022, health expenditures in sub-Saharan Africa stood at 5.08% of GDP, representing both a challenge and an opportunity.18 Strategic pharmaceutical interventions can spur economic returns. For instance, reducing malaria incidence by 90% by 2030 is projected to yield up to $16 billion annually in GDP gains for the continent.19 These figures underscore the catalytic potential of regional pharmaceutical expansion, not only for public health but also for inclusive economic development.

Africa’s growing pursuit of regional harmonization and regulatory integration will also be vital for positioning the continent as a unified and competitive player in the global pharmaceutical landscape. Regional regulatory cohesion will allow Africa to operate more efficiently as a single market and enhance its reputation as a manufacturer and exporter. The continent has the potential to offer lower-cost pharmaceutical production compared to high-income regions such as Europe and North America, benefiting both local populations and global partners seeking cost-effective supply chains.

In this context, clinical research and drug development conducted in Africa represent a win-win scenario: offering therapeutic innovations tailored to African health needs while advancing outcomes for the broader African diaspora.20 Africa’s recent regulatory strides indicate that this vision is beginning to take shape. A landmark step was the recent inauguration of the North Africa Medicines Regulatory Authority—a move that brings North Africa into closer alignment with existing efforts under the African Medicines Regulatory Harmonization (AMRH) initiative. Joining long-standing participants from West, East, Central, and Southern Africa, North Africa’s entry completes a unified network dedicated to creating a continent-wide standard for medicine regulation. The AMRH initiative aims to overcome fragmented legislative environments, inefficiencies in medicine approval processes, and variable product standards across countries. With this comprehensive continental engagement, Africa is fortifying a critical foundation for pharmaceutical cooperation—laying the groundwork for health sovereignty, high-quality manufacturing, and an internationally respected regulatory architecture.

CONCLUSION

Africa stands at a pivotal moment to transform its pharmaceutical landscape by advancing local manufacturing, strengthening regulatory harmonization, and investing in health infrastructure. The COVID-19 pandemic highlighted the continent’s overreliance on external suppliers and associated vulnerabilities, while also sparking a renewed commitment to self-reliance and health sovereignty. With strategic investments, targeted drug production, and a unified regulatory framework, Africa can meet its own healthcare needs and position itself as a competitive global player in the pharmaceutical industry. By harnessing its demographic potential and fostering regional collaboration, Africa can build a resilient, innovative, and inclusive pharmaceutical ecosystem that supports both economic growth and public health.

FUNDING

The research presented in the manuscript received no external funding.

AUTHORSHIP CONTRIBUTIONS

  1. Huda Haque: Conceptualization, original draft writing, thorough review and editing, approval of the final version.

  2. Faraan O. Rahim: Conceptualization, original draft writing, thorough review and editing, approval of the final version.

  3. Zaheer Rik Munshi: Conceptualization, original draft writing, thorough review and editing, approval of the final version.

  4. Maryam Sandhu: Thorough review and editing, approval of the final version.

  5. Toheeb Ojelade: Thorough review and editing, approval of the final version.

  6. Emaad Khan: Thorough review and editing, approval of the final version.

  7. Eeshaan Malladi: Thorough review and editing, approval of the final version.

  8. Almotsim B. Hmeda: Thorough review and editing, approval of the final version.

  9. Alison S. Jang: Thorough review and editing, approval of the final version.

  10. Erick Mahatara: Thorough review and editing, approval of the final version.

  11. Yuda Sule: Thorough review and editing, approval of the final version.

  12. Ntuli A. Kapologwe: Expert supervision, thorough review and editing, approval of the final version.

DISCLOSURE OF INTEREST

The authors completed the ICMJE Disclosure of Interest Form and disclosed no relevant interests.

CORRESPONDING AUTHOR

Ntuli A. Kapologwe, MD, PhD
East, Central and Southern Africa Health Community (ECSA-HC)
157 Olorien, Njiro Road
P.O Box 1009, Arusha, Tanzania
Email: nkapologwe2002@gmail.com