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R&D across health areas | Malaria

R&D for Malaria

How new tools can transform the fight

About half of the world’s population is at risk of malaria—a common but deadly disease that undermines health, productivity, and economic development. In 2024, there were an estimated 282 million cases of malaria in 80 countries and approximately 610,000 deaths, 95% of which occurred in sub-Saharan Africa, with more than 75% of those in young children. Thanks to malaria control interventions, more than 2.3 billion malaria cases and 14 million deaths were averted between 2000 and 2024. Yet, despite this progress, challenges like growing drug and insecticide resistance hinder control efforts. Unfortunately, 2024 saw a continued increase in new cases—indicating stalled progress and underscoring the urgent need for new solutions to complement existing interventions.

  • Nearly half
    the world’s population is at risk
  • 282 million
    cases of malaria in 2024
  • 610,000
    deaths from malaria worldwide in 2024

Research successes

Technologies have transformed the fight against malaria:

  • Vector control tools, including insecticide-treated nets (ITNs) and indoor residual spraying, have driven dramatic declines in malaria. More recently, new dual-ingredient ITNs have helped confront rising insecticide resistance, while spatial emanators—a new vector control category that releases active airborne ingredients—offer complementary indoor protection.
  • Medicines for treatment and prevention have drastically improved survival, helping avert 1.5 billion cases over the past two decades. More recent innovations include Coartem® Dispersible, the most widely used medicine for children; injectable artesunate for severe malaria; tafenoquine for relapsing Plasmodium vivax malaria; Coartem® Baby, the first-ever medicine for newborns and young infants; the first-ever pediatric formulations of primaquine for relapsing malaria; and the scale-up of chemoprevention approaches that deliver preventive antimalaria medicines during periods of high risk.
  • Two malaria vaccines have been recommended for widespread use since 2021 to reduce illness and deaths in children, with 25 countries now offering malaria vaccination through routine childhood immunization programs.
  • Diagnostic innovations have transformed malaria detection and care, with rapid diagnostic tests (RDTs), widely introduced in the late 2000s, expanding access to confirmatory testing before treatment and reducing antimalarial overuse. Newer, more sensitive RDTs can detect parasite mutations that evade earlier tests, while molecular methods and digital tools are improving surveillance and detection accuracy.

Continued progress is possible, not inevitable Continued progress is possible, not inevitable

Continued progress is possible, not inevitable

Key missing tools Key missing tools

To end malaria, we need new prevention and treatment tools including:

  • New vector control tools, including novel and longer-lasting insecticides to address resistance and biological control methods to reduce mosquito populations.
  • New treatments and approaches to stem drug resistance, including artemisinin alternatives, novel regimens, easier-to-administer options such as single-dose cures, and innovative delivery approaches to reduce pressure on existing treatments.
  • Novel drugs to block transmission and prevent reinfection, as well as to treat severe malaria; endectocides to kill the mosquito vector; and additional antimalarials approved for vulnerable populations, including children, those suffering from malnutrition or co-infection with other pathogens, and pregnant individuals, especially those in their first trimester.
  • Novel, single-dose preventative therapies, such as monoclonal antibodies and long-acting injectables, that can complement other prevention tools like bednets, vaccines, and malaria chemoprevention.
  • Improved rapid diagnostic tests for low-resource settings that can detect all stages and species of malaria equally well for early, accurate diagnosis and effective surveillance, as well as tests that can distinguish malaria from other similar illnesses and detect asymptomatic cases.
  • Next-generation malaria vaccines with longer duration, increased efficacy, and simpler implementation, including vaccines that block human-to-mosquito transmission of the parasite for use in elimination campaigns.

Breakthroughs on the brink Breakthroughs on the brink

  • Four promising monoclonal antibodies for malaria are undergoing clinical testing in Africa, including two supported by NIH. Three of these—CIS43LS, L9LS, and MAM01—are intended to provide seasonal protection against infection, similar to a vaccine, while TB31F prevents onward transmission by blocking parasite development in mosquitoes.
  • Several long-acting injectable malaria prevention drugs are in development, including one candidate now being tested in a first-in-human trial.
  • Dozens of malaria vaccine candidates are in clinical development, including multi-antigen, multi-stage vaccines that aim to build on the success of current vaccines and several candidates currently or previously supported by NIH, DoW, and USAID.
  • An affordable, AI-powered microscope that quickly diagnoses malaria in blood samples, supported by NIH, could help improve access to early, accurate diagnosis in resource-limited settings.
  • New malaria treatment combinations with the potential to combat drug-resistant malaria, including gananplacide/lumefantrine, a novel drug that showed positive Phase 3 results in 2025, and triple artemisinin-based combination therapies, including the first fixed-dose triple-drug combination to reach Phase 3 clinical development.
  • A historic Phase 3 trial is testing the safety and efficacy of antimalarial drugs for women in their first trimester of pregnancy, a high-risk group long excluded from clinical research, leaving them without an adequate treatment option.
  • Gene drive approaches that genetically modify mosquitoes to suppress population growth or block malaria transmission, which have shown strong proof-of-concept in laboratory studies and are moving toward carefully controlled field evaluations, representing a potentially transformative new vector control strategy.

US government investment in malaria R&D (in 2018) US$ millions

US government investment in malaria R&D
US Government R&D effortsUS Government R&D efforts

The US government is leading efforts to advance research and development (R&D) to combat malaria through a whole-of-government approach:

  • National Institutes of Health (NIH) conducts basic and clinical research for new treatments, vaccines, diagnostics, and vector control products.
  • Department of War (DoW) undertakes research to protect US service members against malaria—the leading infectious disease threat to US service members abroad—including drug, vaccine, and vector control research.
  • Department of State supports the delivery and scale-up of malaria products and services globally. Following the integration of the US Agency for International Development (USAID), the State Department has the opportunity to support R&D efforts for new vaccines, antimalarials, and vector control products for low-resource settings, efforts previously led by USAID.
  • Centers for Disease Control and Prevention (CDC) conducts surveillance and monitoring research and develops and evaluates malaria control interventions such as bednets and other tools to improve public health efforts. It has historically implemented global malaria activities with USAID, but the future of the State Department and CDC’s collaboration on malaria remains unclear.
  • Food and Drug Administration, alongside approving products for use in the United States, administers the Tropical Disease Priority Review Voucher Program to incentivize investment in products for neglected diseases, including malaria.

Introduction

282 million cases, 610,000 deaths: World Health Organization. Malaria. December 4, 2025. Accessed February 10, 2026. https://www.who.int/news-room/fact-sheets/detail/malaria

Nearly half the world's population at risk: US Centers for Disease Control and Prevention. Malaria's impact worldwide. April 1, 2024. Accessed February 10, 2026. https://www.cdc.gov/malaria/php/impact/index.html

More than 70% young children: Impact Global Health. Malaria. Accessed February 10, 2026. https://www.impactglobalhealth.org/insights/health-areas/malaria

2.3 billion cases and 14 million deaths averted; continued increase in cases: World Health Organization. World Malaria Report 2025. World Health Organization; 2025. https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2025

Research Successes

Vector-control tools, driven dramatic declines in malaria: Bhatt S, Weiss DJ, Cameron E, et al. The effect of malaria control on Plasmodium falciparum in Africa between 2000 and 2015. Nature. 2015;526:207–211. https://doi.org/10.1038/nature15535

Vector-control tools, expanded global rollout: World Health Organization. Expanded use of new dual-insecticide nets offers hope for malaria control efforts in Africa. World Health Organization. April 24, 2025. Accessed February 10, 2026. https://www.who.int/news-room/feature-stories/detail/expanded-use-of-new-dual-insecticide-nets-offers-hope-for-malaria-control-efforts-in-africa

Spatial emanators:

Kupferschmidt K. New vapor tool fights mosquitoes by slowly releasing insecticide in homes. Will it catch on? Science. November 24, 2025. Accessed February 10, 2026. https://www.science.org/content/article/new-vapor-tool-fights-mosquitoes-slowly-releasing-insecticide-homes-will-it-catch

Colliver V. How a malaria-fighting breakthrough provides lasting protection. University of California San Francisco. August 26, 2025. Accessed February 27, 2026. https://www.ucsf.edu/news/2025/08/430586/how-malaria-fighting-breakthrough-provides-lasting-protection

Allan RJ, Scherrer R, Estecha-Querol S, et al. The effectiveness of long-lasting spatial repellent emanators against malaria in humanitarian crisis settings in northern Nigeria: a two-arm pragmatic, open-label, controlled trial. Lancet Infectious Diseases. 2026. doi:10.1016/S1473-3099(25)00684-X.

Medicines for treatment and prevention: Medicines for Malaria Venture. History of antimalarial drugs. Accessed July 17, 2024. https://www.mmv.org/malaria-medicines/history-antimalarials-drugs

Medicines for treatment and prevention, 1.5 billion cases averted: World Health Organization. World Malaria Report 2020. World Health Organization; 2020. https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2020

Medicines for treatment and prevention, Coartem® Dispersible: First quality-approved malaria treatment for children reaches landmark 500 million treatments delivered. Press release. Medicines for Malaria Venture; April 25, 2025. https://www.mmv.org/newsroom/news-resources-search/first-quality-approved-malaria-treatment-children-reaches-landmark

Medicines for treatment and prevention, artesunate:

Medicines for Malaria Venture. Artesunate for injection, Larinate® 60 mg for injection. Accessed February 10, 2026. https://www.mmv.org/mmv-pipeline-antimalarial-drugs/artesunate-injection

Medicines for Malaria Venture. Artesunate for injection, Artesun®. Accessed February 10, 2026. https://www.mmv.org/mmv-pipeline-antimalarial-drugs/artesunate-injection-0

Medicines for treatment and prevention, tafenoquine:

US FDA approves Krintafel (tafenoquine) for the radical cure of P. vivax malaria. Press release. GSK; July 20, 2018. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-krintafel-tafenoquine-for-the-radical-cure-of-p-vivax-malaria/

Single-dose Kozenis (tafenoquine) approved for children with Plasmodium vivax malaria by Australian Therapeutic Goods Administration. Press release. Medicines for Malaria Venture; March 14, 2022. https://www.mmv.org/newsroom/news-resources-search/single-dose-kozenis-tafenoquine-approved-children-plasmodium-vivax

Medicines for Malaria Venture. Tafenoquine. Accessed February 10, 2026. https://www.mmv.org/mmv-pipeline-antimalarial-drugs/tafenoquine

Medicines for treatment and prevention, Coartem® Baby: Novartis receives approval for first malaria medicine for newborn babies and young infants. Press release. Novartis; July 8, 2025. https://www.novartis.com/news/media-releases/novartis-receives-approval-first-malaria-medicine-newborn-babies-and-young-infants

Medicines for treatment and prevention, pediatric formulations of primaquine: WHO approves first child-friendly formulations for treating relapsing malaria. Press release. Medicines for Malaria Venture; November 19, 2025. https://www.mmv.org/newsroom/news-resources-search/who-approves-first-child-friendly-formulations-treating-relapsing

Medicines for treatment and prevention, scale-up of chemoprevention approaches:

SMC Alliance. From Concept to Scale: Celebrating 10 Years of Seasonal Malaria Chemoprevention. SMC Alliance; 2023. https://www.smc-alliance.org/resources/from-concept-to-scale-celebrating-10-years-of-seasonal-malaria-chemoprevention

Medicines for Malaria Venture. Optimizing seasonal malaria chemoprevention (SMC) implementation. Accessed February 10, 2026. https://www.mmv.org/our-work/access-medicines/seasonal-malaria-chemoprevention

Two approved malaria vaccines: World Health Organization. Malaria vaccines (RTS,S and R21). February 4, 2026. Accessed February 10, 2026. https://www.who.int/news-room/questions-and-answers/item/q-a-on-rts-s-malaria-vaccine

Diagnostics innovations: Kavanaugh MJ, Azzam SE, Rockabrand DM. Malaria rapid diagnostic tests: literary review and recommendation for a quality assurance, quality control algorithm. Diagnostics. 2021;11(5):768. doi:10.3390/diagnostics11050768

Continued Progress Is Possible, Not Inevitable

Gates Foundation. Goalkeepers 2025 Report. We can't stop at almost. Gates Foundation; 2025. https://www.gatesfoundation.org/goalkeepers/report/2025-report/

Key Missing Tools

World Health Organization. World Malaria Report 2025. World Health Organization; 2025. https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2025

Medicines for Malaria Venture. Target product profiles & target candidate profiles. Accessed February 10, 2026. https://www.mmv.org/research-development/information-scientists/target-product-profiles-target-candidate-profiles

Impact Global Health. Malaria. Accessed February 10, 2026. https://www.impactglobalhealth.org/insights/health-areas/malaria

Based on consultation with topic area experts from GHTC member organizations.

Breakthrough on the Brink

Monoclonal antibodies:

Mundel T. The quest for transformative tools to eradicate malaria. The New England Journal of Medicine. 2024;390(17):1620–1621. doi:10.1056/NEJMe2402430

Global Health Technologies Coalition, Policy Cures Research. Doing Well by Doing Good: Why Investing in Global Health R&D Benefits the United States and the World. Global Health Technologies Coalition; 2024. https://www.ghtcoalition.org/resources-item/doing-well-by-doing-good-why-investing-in-global-health-r-d-benefits-the-united-states-and-the-world

Long-acting injectable malaria prevention drug trial: Long-acting injectable malaria drug enters first-in-human study. Press release. Scripps Research Calibr-Skaggs Institute for Innovative Medicines and Medicines for Malaria Venture; January 23, 2025. https://www.scripps.edu/news-and-events/press-room/2025/20250123-calibr-lai.html

Malaria vaccine candidates, DoW & NIH: Infectious Disease R&D Tracker. Impact Global Health; 2025. Accessed February 10, 2026. https://www.impactglobalhealth.org/data/infectious-disease

Malaria vaccine candidates, USAID: Lay K. Trump aid spending freeze halts leading malaria vaccine programme. The Guardian. February 2, 2025. Accessed February 27, 2026. https://www.theguardian.com/global-development/2025/feb/02/trump-aid-spending-freeze-halts-leading-mvdp-malaria-vaccine-programme

AI-powered microscope:

Kubota T. Affordable microscope speeds up malaria diagnosis with AI. MedicalXpress. February 10, 2026. Accessed February 10, 2026. https://medicalxpress.com/news/2026-02-microscope-malaria-diagnosis-ai.html

Li H, Lin H, Shrestha P, et al. Octopi 2.0: open and scalable microscopy platform for AI-powered diagnostic applications. medRxiv. 2025. https://doi.org/10.1101/2025.03.21.25324364

New malaria treatment combinations, ganaplacide/lumefantrine-SDF: Phase 3 trial for next-generation malaria treatment GanLum meets primary endpoint, with potential to combat antimalarial resistance. Press release. Medicines for Malaria Venture; November 12, 2025. https://www.mmv.org/newsroom/news-resources-search/phase-3-trial-next-generation-malaria-treatment-ganaplacide-lumefantrine

New malaria treatment combinations, triple ACT in Phase 3 trial: Centre for Tropical Medicine and Global Health. FD-TACT malaria treatment trial launches patient recruitment in Rwanda. October 8, 2025. Accessed April 14, 2026. https://www.tropicalmedicine.ox.ac.uk/news/fd-tact-malaria-treatment-trial-launches-patient-recruitment-in-rwanda

Antimalarial drugs for women in their first trimester: First patient enrolled in historic Phase 3 clinical trial to treat malaria in first-trimester pregnancy. Press release. Medicines for Malaria Venture; October 6, 2025. https://www.mmv.org/SAFIREtrial

Simpler dosing treatment regimens:

Medicines for Malaria Venture. MMV533. Accessed February 10, 2026. https://www.mmv.org/mmv-pipeline-antimalarial-drugs/mmv533

Medicines for Malaria Venture. MMV183. Accessed February 10, 2026. https://www.mmv.org/mmv-pipeline-antimalarial-drugs/mmv183

US Government Investment in Malaria R&D

G-FINDER data portal. Policy Cures Research; 2026. Accessed February 10, 2026. https://gfinderdata.policycuresresearch.org/

US Government R&D Efforts

DoW: KFF. The US Department of Defense & Global Health. KFF; 2012. https://www.kff.org/global-health-policy/report/the-u-s-department-of-defense-global/

FDA: US Food and Drug Administration. Tropical Disease Priority Review Voucher Program. Updated June 13, 2024. Accessed July 22, 2024. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-review-voucher-program

PMI: KFF. The Trump Administration's foreign aid review: Status of the President's Malaria Initiative (PMI). KFF. October 16, 2025. Accessed February 10, 2026. https://www.kff.org/global-health-policy/the-trump-administrations-foreign-aid-review-status-of-the-presidents-malaria-initiative-pmi/

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