Prioritising children in the fight against antimalarial resistance

Malaria remains one of the deadliest diseases for children in sub-Saharan Africa, with children under five accounting for over 75% of all malaria fatalities. [1] Two decades of progress – driven by domestic health programmes, international funding and pharmaceutical innovation – have significantly reduced the global malaria burden. Yet this progress is now under threat. 

Antimalarial drugs are steadily losing effectiveness. Artemisinin partial resistance (ART-R), which affects a key component of first-line artemisinin-based combination therapies (ACTs) for uncomplicated P. falciparum malaria, has already emerged in at least eight African countries. At the same time, major cuts to foreign aid are severely undermining malaria control, surveillance and innovation. 

Research-based pharmaceutical companies and generic medicine manufacturers are central to addressing these threats by expanding access to child-friendly formulations and sustaining research and development. These efforts also support the long-term viability of the antimalarial market, currently dominated by artemisinin-based treatments and projected to reach USD 1.60 billion by 2034. [2] Coordinated short- and long-term strategies are essential to combat resistance, protect children and support the market’s growth.  

Short-term strategy: Preserving effectiveness of first-line antimalarial treatments 

Ensuring broad access to a range of existing child-friendly first-line treatments (such as dispersible tablets and granules) is an effective way to combat resistance. It helps address two major drivers of ART-R: overreliance on a single ACT – artemether-lumefantrine (AL), which accounts for 70% of antimalarial treatments in Africa – and persistent sub-therapeutic dosing when children struggle with bitter or hard-to-administer adult formulations. Broad access also supports rotation of different first-line therapies, a proven strategy to slow resistance. 

Encouragingly, the July 2025 approval of Novartis’ Coartem^® Baby (AL dispersible) – the first ACT indicated and formulated for infants weighing between two to five kilograms – marks an important step towards addressing a longstanding treatment gap. The product is already available in Ghana for infants 28 days and older and is expected to receive regulatory approval in eight African countries that participated in Swissmedic’s Marketing Authorisation Procedure for Global Health Products (MAGHP).  

In parallel, Novartis is leveraging the World Health Organization (WHO) Collaborative Registration Procedure (CRP) to expand registrations, while committing to supply the treatment largely at a not-for-profit price to malaria-endemic countries. The company has also responded to the WHO prequalification Expression of Interest for antimalarial medicines, [3] which could facilitate supranational procurement through the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund). 

_{Short-term company action} 

To help slow resistance, companies can improve the availability and affordability of existing and future child-friendly ACTs: 

• Novartis can continue expanding registrations of Coartem^® Baby in all malaria-endemic countries as swiftly as possible.

• Generic medicine manufacturers, including African-based regional manufacturers, can begin or continue developing WHO-prequalified generic versions of ASPY granules and DHA-PPQ dispersible to increase competition and reduce prices. They can work with partners to leverage mechanisms such as volume guarantees, as some companies have been doing with the Gates Foundation, MedAccess and Medicines for Malaria Venture (MMV). [5]

• To expand the range of ACTs suitable for children, generic medicine manufacturers can prioritise developing child-friendly formulations of artesunate-amodiaquine (ASAQ) and explore collaboration with Fluid Pharma, a biotechnology company that has developed a child-friendly taste-masking coating. [7, 8]

Long-term strategy: Accelerating children’s access to next-generation antimalarials 

A wider choice of ACTs and better treatment rotation alone will not be enough to combat resistance. Staying ahead of the parasite requires next-generation therapies that can replace current regimens as their effectiveness declines. 

Novartis is exploring the MAGHP and WHO CRP procedures to accelerate registrations in low- and middle-income countries (LMICs), intends to submit the treatment for adults and children simultaneously and aims to pursue WHO prequalification. The company is expected to begin regulatory submissions for its NACT in the first half of 2026. 

A noticeable shift is underway among Asian manufacturers, with more investing in innovation. These companies now develop or act as a development partner for three of the six next-generation antimalarials in late-stage development (see Figure 2). Fosun Pharma, whose compound is also in Phase III development, reflects this trend. The company is also investing in antimalarial local production in Côte d’Ivoire, which could potentially support future triple artemisinin-based combination therapy (TACT) production. However, Fosun Pharma’s TACT is unlikely to receive regulatory approval before 2027. [10]

Broader patient access to all next-generation treatments could take several additional years, particularly if high prices limit affordability.

_{Long-term company action} 

To improve timely and affordable access to next-generation antimalarials, pharmaceutical companies can take the following steps:  

Research-based pharmaceutical companies can: 

• Develop and register child-friendly formulations simultaneously or shortly after the adult product. 

• Accelerate registration in LMICs by using mechanisms such as Swissmedic’s MAGHP or the European Medicines Agency’s EU-M4all. 

• Pursue WHO prequalification soon after approval to enable supranational procurement via organisations such as the Global Fund.

• Implement equitable pricing strategies at the national level, alongside supranational procurement. 

Generic medicine manufacturers can:  

• Produce WHO-prequalified generic versions as soon as possible, for example by exploring support from product development partners, such as MMV. 

All companies can: 

• Further improve transparency by publicly reporting on product development and future access plans. 

Sustained action is needed

Malaria progress remains fragile, with cuts to foreign aid weakening disease control and limiting access to lifesaving treatments. Rising drug resistance further threatens the effectiveness of existing medicines, making immediate action necessary. Expanding availability and improving affordability of child-friendly ACT formulations can address urgent gaps, while sustaining innovation pipelines ensures the next generation of effective treatments is developed.  

Research-based pharmaceutical companies and generic medicine manufacturers play a pivotal role in closing access gaps and advancing research, with product development partnerships helping them de-risk development and accelerate the delivery of new treatments. Coordinated implementation of short- and long-term strategies is crucial to preserve treatment effectiveness and protect the lives of those most at risk.

Suggested citation: Access to Medicine Foundation. Prioritising children in the fight against antimalarial resistance. 2026. https://accesstomedicinefoundation.org/access-insights/prioritising-children-in-the-fight-against-antimalarial-resistance

References 

​^{1. World Health Organization (WHO). World Malaria Report 2025. 2025. Accessed December 8, 2025. https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2025} 

^{​2. Straits Research Pvt Ltd. Anti-Malarial Drugs Market Size, Share & Demand Trends by 2034. October 2025. Accessed December 3, 2025. https://straitsresearch.com/report/anti-malarial-drugs-market} 

^{​3. World Health Organization (WHO). 23nd Invitation to Manufacturers of Antimalarial Medicines to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit (PQT). 2025. https://extranet.who.int/prequal/sites/default/files/document_files/EOI-MalariaV23_1.pdf} 

^{​4. The Global Fund to Fight AIDS Tuberculosis and Malaria. Pooled Procurement Mechanism Reference Pricing: Antimalarial medicines. 2025. Accessed December 3, 2025. https://www.theglobalfund.org/media/0lpo24ux/ppm_act-reference-pricing_table_en.pdf} 

^{​5. The Global Fund to Fight AIDS Tuberculosis and Malaria. DONOR STATEMENT ON URGENT ACTION REQUIRED TO ADDRESS ANTIMALARIAL DRUG RESISTANCE. 2024. Accessed December 11, 2025. https://www.theglobalfund.org/media/15145/update_2024-09-25-donor-statement-urgent-action-antimalarial-drug-resistance_update_en.pdf} 

^{​6. The Global Fund to Fight AIDS Tuberculosis and Malaria. Workbook: Price & Quality Reporting Transaction Summary. Accessed September 23, 2025. https://insights.theglobalfund.org/t/Public/views/PriceQualityReportingTransactionSummary/TransactionSummary?iframeSizedToWindow=true&%3Aembed=y&%3AshowAppBanner=false&%3Adisplay_count=no&%3AshowVizHome=no} 

^{​7. Global Accelerator for Paediatric formulations (GAP-f). Paediatric Drug Optimization for Malaria. 2025. Accessed December 3, 2025. https://www.who.int/publications/i/item/9789240116986} 

^{​8. Reader A, Shokry D, Grave A, et al. Taste Masked Artesunate/Amodiaquine Micropellets in the Fight Against Malaria. 2023. https://www.pharmaexcipients.com/news/taste-masked-micropellets/} 

^{​9. Medicines for Malaria Venture (MMV). Global portfolio of antimalarial medicines. August 2025. Accessed December 3, 2025. https://www.mmv.org/mmv-pipeline-antimalarial-drugs} 

^{​10. Devex. A crisis in malaria treatment is coming — we must act faster to contain it. 2025. Accessed January 16, 2026. https://www.devex.com/news/a-crisis-in-malaria-treatment-is-coming-we-must-act-faster-to-contain-it-110972?consultant_exists=true&oauth_response=success ​}