By Prof. Lere Baale
For decades, Africa’s pharmaceutical markets have lived in the long shadow of multinational drugmakers. Across Nigeria, Kenya, Ghana, South Africa, and much of Francophone Africa, market leadership, pricing power, hospital procurement preferences, and even perceptions of quality were mainly shaped outside the continent. Indigenous manufacturers existed—but mostly at the margins, constrained by structural rather than capability limitations.
Then came a turning point many initially misread as a crisis: the gradual exit or downsizing of global pharmaceutical giants from several African markets.
What has unfolded since 2023—and crystallised powerfully in 2024–2025—is not decline, but realignment. At the heart of this transformation stands a new regulatory confidence, led in Nigeria’s case, by two institutions whose influence now extends well beyond national borders: the National Agency for Food and Drug Administration and Control (NAFDAC) and the Pharmacists Council of Nigeria (PCN).
Together, they represent a regulatory model Africa increasingly needs—firm on standards, enabling growth, and credible on the global stage.
From Multinational Exit to African Opportunity
Across emerging markets, multinational exits often trigger alarm: fears of medicine shortages, loss of trusted brands, and declining care standards. The cardiometabolic segment—hypertension, diabetes, and cardiovascular disease—is especially sensitive because therapy is chronic, adherence-dependent, and interruption carries severe consequences.
The highly credible PBR Life Sciences Insight analysis shows that Nigeria mirrors a broader African reality:
• High cardiometabolic disease burden
• Heavy reliance on out-of-pocket spending (≈80–90%)
• Concentration of essential molecules in a few innovator brands
• Fragile supply chains vulnerable to single-point failure
When multinational Market Authorisation Holders (MAHs) exit—whether Servier in Nigeria or similar innovators elsewhere—the risk is not merely commercial. It is systemic.
Yet, as Nigeria’s experience now demonstrates, when exits are actively managed, they become catalysts rather than calamities.
Regulation as the Enabler of Continental Confidence
The renaissance unfolding in Nigeria—and increasingly relevant for Africa—cannot be understood without recognising the decisive role of regulation.
NAFDAC and PCN have moved beyond the stereotype of passive gatekeepers. Both agencies now operate as market stabilisers and confidence builders, combining:
• Strengthened Good Manufacturing Practice (GMP) enforcement
• Faster but more rigorous product registration pathways
• Targeted post-market surveillance
• Professional regulation that restores trust at the retail and dispensing end
Their recognition at WHO Maturity Level 3 (ML3) and NAFDAC’s admission as the 24th member of the International Council for Harmonisation (ICH) are not ceremonial milestones; they are signals to Africa and the world that credible regulation and local industrial growth can coexist.
For African regulators, the lesson is clear: standards create markets. Without regulatory credibility, growth becomes opportunistic and short-lived. With it, markets deepen sustainably.
Structural Growth, Not a Currency Illusion
Some commentators have attempted to explain Nigeria’s pharmaceutical surge purely through naira depreciation and import substitution. The PBR data decisively rejects this simplistic view.
What we are witnessing is structural growth:
• Prescribers actively switching to quality-assured branded generics
• Hospitals and HMOs are formalising long-term local procurement
• Retail and digital pharmacies expanding access in urbanising populations
• Chronic, refill-driven therapies creating predictable revenue pools
This pattern is not uniquely Nigerian. Similar dynamics exist across African markets, where cardiometabolic disease is on the rise and innovator brands dominate narrow niches.
Nigeria is simply becoming the pilot case.
Import Substitution to Domestic Mastery—Africa’s Industrial Moment
Africa’s pharmaceutical challenge has never been a lack of demand; it has been a lack of confidence, coordination, and capital.
Nigeria’s recent performance, where companies such as Fidson, MeCure, and May & Baker collectively posted ₦15.77 billion in profit over nine months of 2025, demonstrates what happens when indigenous firms are allowed to scale under disciplined regulation.
MeCure’s ₦60 billion Nigeria-only revenue illustrates a more profound truth: local production is no longer a fallback—it is becoming the default.
For Africa, this is the pathway from import substitution to domestic mastery, where medicine security aligns with industrial development.
The Continental Opportunity: From National Success to African Leadership
The next frontier is not merely Nigerian dominance, but African leadership.
The African Continental Free Trade Area (AfCFTA) creates the possibility of regional pharmaceutical hubs serving multiple markets. But this will only materialise if three imperatives are addressed continent-wide:
1. Industrial scale must deepen
In the long term, patient capital—beyond high-interest commercial loans—is necessary for automation, R&D, and API manufacturing.
2. Export ambition must replace survival thinking
African manufacturers must build brands and dossiers that travel—clinically, regulatorily, and commercially.
3. The value chain must be localised end-to-end
APIs, excipients, packaging, and logistics must progressively move closer to home to stabilise cost and supply.
The PBR analysis reveals that cardiometabolic molecules—such as gliclazide, indapamide, and perindopril-based combinations—represent high-value, underserved niches where African manufacturers can establish durable franchises if regulation actively guides entry.
Conclusion: Africa’s 2025 Inflexion Point
The gains of 2024–2025 should not be mistaken for an endpoint. They mark the beginning of a transition.
When macroeconomic pressures ease and multinational re-entry narratives reemerge, African pharmaceutical markets must already be too disciplined, credible, and competitive to be displaced.
The exit of multinationals did not weaken Africa’s pharmaceutical future; it exposed how much potential had been suppressed.
Nigeria’s experience—anchored by NAFDAC and PCN—offers a blueprint for the continent:
Protect standards, enable local champions, and scale with intent.
If Africa sustains this trajectory, the lesson of 2025 will be unmistakable:
The continent does not need to wait for multinationals to secure its healthcare future.
With strong regulation, disciplined local industry, and continental ambition, Africa can build pharmaceutical champions of its own—fit for Africa, and competitive with the world.
Thank you, NAFDAC and PCN, for your leadership in Africa.
Prof. Lere Baale
President & Chairman of Governing Council. Nigeria Academy of Pharmacy.