Antiretroviral Generics in Africa: How Local Production Is Transforming HIV Treatment Access

For decades, Africa relied on medicine shipped from halfway across the world to keep people alive with HIV. In 2000, a year of treatment cost more than $10,000. By 2015, thanks to Indian generics, that dropped to under $100. But even at that price, supply chains broke during pandemics, customs delays left clinics empty, and stockouts forced patients to go without. That changed on May 6, 2025, when the Global Fund delivered its first-ever shipment of African-made antiretroviral drugs to Mozambique. This wasn’t just another shipment-it was a turning point.

The TLD Breakthrough: Africa’s First WHO-Prequalified ARV

The drug? TLD: a single tablet combining tenofovir, lamivudine, and dolutegravir. It’s now the global gold standard for first-line HIV treatment. Why? Because it’s more effective, has fewer side effects, and makes drug resistance much harder to develop. Before 2023, no African company had ever passed the World Health Organization’s strict prequalification for TLD. Then, Universal Corporation Ltd in Kenya did. Their factory met the same quality standards as top European and U.S. labs. That meant the Global Fund could finally buy from Africa without risking safety or efficacy.

The first order? Enough TLD to treat 72,000 people a year. That’s not the whole continent’s need-but it’s the first real step toward self-reliance. For the first time, African countries weren’t just recipients of aid. They were suppliers.

Why Local Production Matters More Than Cheap Imports

India made HIV drugs affordable. But affordability alone doesn’t fix broken systems. When COVID-19 hit, global supply chains froze. African nations waited months for basic medicines. Some clinics ran out of ARVs for over six weeks. Patients stopped taking pills. Viral loads rose. Transmission spiked.

Local manufacturing solves this. When a country makes its own drugs, it doesn’t depend on shipping lanes, customs inspections, or foreign currency reserves. It can respond fast. If a new strain emerges, or a seasonal surge hits, local factories can ramp up production in weeks-not months.

And it’s not just about pills. Nigeria’s Codix Bio now makes HIV rapid tests under a WHO-backed technology transfer deal. South Africa registered the twice-yearly injectable cabotegravir in record time. These aren’t isolated wins. They’re pieces of a new system: diagnostics, treatment, and delivery-all built on African soil.

The Numbers Behind the Shift

Sub-Saharan Africa has 65% of the world’s HIV cases. Yet it produces less than 3% of its own medicines. That’s not sustainable. The continent needs about 15 million person-years of first-line ARVs every year. Right now, African manufacturers can cover maybe 5% of that.

But that’s changing fast. New factories are coming online by the end of 2025. The Clinton Health Access Initiative predicts African-made ARVs could supply 20-30% of the continent’s needs by 2030-if funding and policy stay on track.

Progress is visible in the treatment cascade. In Eastern and Southern Africa, 93% of people with HIV know their status, 83% are on treatment, and 78% have suppressed viral loads. That’s up from 50% on treatment in 2010. In Western and Central Africa, those numbers are lower-81%, 76%, 70%-but they’re rising. Every percentage point means fewer deaths, fewer transmissions, and more lives lived fully.

Long-Acting Injectables and the Next Frontier

The future of HIV treatment isn’t just daily pills. It’s injections that last six months. South Africa became the first African country to approve the long-acting cabotegravir injection in October 2025. That’s huge. For people who struggle with daily pills-because of stigma, work schedules, or mental health-this is life-changing.

Gilead Sciences licensed six African manufacturers to produce generic versions of this injection. Experts say prices could drop 80-90% below brand cost once generics flood the market. That’s not speculation. It’s what happened with TLD tablets. When Indian generics entered, prices fell from $10,000 to under $100. The same pattern is playing out now, but this time, African companies are leading the charge.

Even more promising: Gilead is giving away lenacapavir, a new long-acting PrEP drug, at no profit until generics arrive. They’re working with PEPFAR and the Global Fund to get it to 18 high-burden countries by the end of 2025. This isn’t charity. It’s strategy. They’re buying time for African manufacturers to build capacity-and ensuring no one gets left behind in the transition.

The Bigger Picture: Health Sovereignty, Not Just HIV

This isn’t just about HIV. It’s about building a health system that can handle the next pandemic, the next outbreak, the next crisis. Right now, Africa imports 80% of its medicines. That makes every country vulnerable. If a single factory in India shuts down, or a port closes, millions go without.

The African Union’s Pharmaceutical Manufacturing Plan for Africa (PMPA) aims to raise local production from 3% to 40% by 2040. That’s ambitious. But it’s possible-if regulators harmonize standards, governments invest in training, and international partners keep funding.

It’s also about leadership. For too long, research on African health needs was done by outsiders. Now, African scientists are designing trials for local strains, tailoring formulations for regional diets, and training local pharmacists. This isn’t just manufacturing. It’s Africanizing medicine.

Challenges Still Standing in the Way

Progress isn’t automatic. Regulatory systems vary wildly between countries. Some lack the labs to test drug quality. Others don’t have the staff to manage complex supply chains. Financing is still patchy. Most new factories rely on grants from the Gates Foundation, Unitaid, or CIFF. Once that money runs out, will they survive?

And then there’s the market. If African manufacturers produce 10 million doses but only 5 million are needed, they lose money. That’s why the Global Fund’s procurement strategy is so smart. They’re guaranteeing demand. They’re signing multi-year contracts. They’re telling manufacturers: “We’ll buy from you, if you meet the standard.” That gives them the confidence to invest in new equipment, hire engineers, train workers.

There’s also the issue of scale. One factory in Kenya can’t supply all of Africa. But five? Ten? That’s possible. And with six companies licensed to make the long-acting injection, the momentum is building.

What Comes Next?

The Global Fund’s Grant Cycle 7 (GC7) will announce its next round of eligible countries soon. That means more African-made ARVs heading to more clinics. More jobs. More local expertise. More control.

This isn’t about replacing Indian generics. It’s about adding African ones to the mix. A diversified supply chain is a resilient one. And for a continent that’s lost too many lives to delays, shortages, and dependence-it’s not just smart. It’s necessary.

By 2030, a child born with HIV in Uganda might never need to wait for a shipment from abroad. Their treatment could come from a factory in Kampala, tested in a lab in Kigali, and delivered by a local health worker who lives down the street. That’s the future. And it’s already starting.