A report from GHTC and Policy Cures Research examines how US federal funding for global health R&D is delivering impact both abroad and at home.

Search the GHTC website

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 life-threatening mosquito-borne disease that devastates communities and countries. In 2022, there were an estimated 249 million cases of malaria in 85 countries, claiming the lives of approximately 608,000 people—80% of whom were young children. Thanks to malaria control interventions, more than 1.5 billion malaria cases and 7.6 million deaths were successfully averted between 2000 and 2019. Yet, despite this progress, challenges like growing drug and insecticide resistance hinder control efforts. Unfortunately, 2022 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
  • 249 million
    cases of malaria in 2022
  • 608,000
    deaths from malaria worldwide in 2022

Research successes

Technologies have transformed the fight against malaria:

  • Vector control tools, like insecticide-treated nets (ITNs) and indoor residual spraying, have driven dramatic declines in malaria. Recently, a new generation of dual-ingredient ITNs was introduced to respond to rising insecticide resistance.
  • Artemisinin-based combination therapies (ACTs), first developed in the 1990s, have become the gold standard treatment. Child-friendly ACTs followed, like Coartem® Dispersible, which has saved more than 1 million child lives since 2009.
  • Seasonal malaria chemoprevention (SMC), the use of antimalarials for prevention, was first introduced in 2012. It has saved 700,000 child lives and prevented 160 million infections.
  • Rectal artesunate and injectable artesunate, key combined medicines addressing severe malaria, have saved more than 98,000 and 1.25 million additional child lives, respectively.
  • Two malaria vaccines have been approved since 2021. Eight countries now offer one in their childhood immunization programs.
  • Tafenoquine, a single-dose medicine for Plasmodium vivax malaria, was approved in 2018, with a pediatric version approved in 2022. A point-of-care diagnostic test to guide its use was approved in 2019
  • Since 2019, more than 1 billion genetically modified mosquitoes have been released globally to reduce malaria’s spread.

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 new 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 solutions like single-dose cures, and innovative delivery approaches to reduce pressure on existing treatments.
  • Novel drugs to block transmission and prevent reinfection, endectocides to kill the mosquito vector, and more antimalarials approved for children and pregnant individuals.
  • Novel, single-dose preventative therapies like monoclonal antibodies and long-acting injectables, which can complement other prevention tools like bednets, vaccines, and SMC.
  • Improved rapid diagnostic tests for low-resource settings that can detect all stages and all species of malaria equally well for early, accurate diagnosis and effective surveillance.
  • Next-generation malaria vaccines with longer duration and/or increased efficacy, including vaccines that block human-to-mosquito transmission of the parasite.

Breakthroughs on the brink Breakthroughs on the brink

  • Three promising monoclonal antibodies for malaria, all supported by NIH, are in development, as well as several long-acting injectable malaria prevention drugs, including one supported by NIH, which could not only simplify and improve malaria prevention by eliminating the need for daily pills but could also reduce the emergence of drug resistance.
  • More than a dozen malaria vaccine candidates are in late-stage clinical development, including candidates supported by NIH, DoD, and USAID.
  • A novel vector control solution called Attractive Targeted Sugar Bait, which uses plant sugars to attract mosquitoes combined with an ingestible toxin that kills them but is safe for humans, holds promise to address the growing threat of outdoor biting by mosquitoes. The tool, which is commercially available in the United States, is undergoing validation testing for malaria control in Africa.
  • A first-of-its-kind test that diagnoses malaria using a patient’s saliva, rather than blood, is in commercial development. Developed with NIH support, the test is less invasive than other methods and delivers results quickly at the point of care.
  • A first-of-its-kind malaria treatment designed specifically for babies less than 10 pounds has completed Phase 2/3 trials. There is no approved treatment for small babies, who are currently treated with a partial dose of medicines made for larger children, which can heighten the risk of overdose among this very vulnerable population.
  • A new malaria treatment combination, gananplacide/lumefantrine-SDF, which consists of a novel drug and a new, optimized formulation of an existing drug, is currently in Phase 3 trials. It has the potential to clear malaria infection, including drug-resistant strains, and block transmission of the malaria parasite.
  • Progress is being made toward additional simpler dosing treatment regimens that could require as little as one dose.

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

US government investment in malaria R&D
US Government R&D efforts US 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 Defense (DoD) 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.
  • US Agency for International Development (USAID) leads the interagency President’s Malaria Initiative (PMI) and supports the development of new vaccines, antimalarials, insecticides, and novel vector control tools for low-resource settings.
  • Centers for Disease Control and Prevention jointly implements PMI, conducts surveillance and monitoring research, and develops and evaluates malaria control interventions such as bednets and other tools to improve public health efforts.
  • Food and Drug Administration administers the Tropical Disease Priority Review Voucher Program to incentivize investment in products for neglected diseases, including malaria.
Download PDF

Introduction

249 million cases in 2022, 608,000 deaths in 2022: World Health Organization. Malaria. Updated December 4, 2023. Accessed July 17, 2024. https://www.who.int/news-room/fact-sheets/detail/malaria

Nearly half of world’s population at risk: US Centers for Disease Control and Prevention. Malaria’s impact worldwide. Updated April 1, 2024. Accessed July 17, 2024. https://www.cdc.gov/malaria/php/impact/index.html

1.5 billion cases, 7.6 million deaths averted: World Health Organization. World Malaria Report 2020: 20 Years of Global Heath Progress & Challenges. World Health Organization; 2020. https://www.who.int/publications/i/item/9789240015791

Continued increase in cases: World Health Organization. World Malaria Report 2023. World Health Organization; 2023. https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2023

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, recent introduction of new generation of dual-ingredient ITNs: World Health Organization. World Malaria Report 2023. World Health Organization; 2023. https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2023

Artemisinin-based combination therapies:

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

Tse EG, Korsik M, Todd MH. The past, present and future of anti-malarial medicines. Malaria Journal. 2019;18(93). doi:10.1186/s12936-019-2724-z

Artemisinin-based combination therapies, Coartem® dispersible: Medicines for Malaria Venture. Antimalarial drugs for children. Accessed July 22, 2024. https://www.mmv.org/our-work/antimalarial-drugs-children

Artemisinin-based combination therapies, Coartem® dispersible, 1 million lives saved: Data provided from Medicines for Malaria Venture.

Seasonal malaria chemoprevention, 700,000 children saved, 160 million infections prevented: 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

Rectal artesunate:

Medicines for Malaria Venture. Artesunate rectal capsules. Accessed August 12, 2024. https://www.mmv.org/mmv-pipeline-antimalarial-drugs/artesunate-rectal-capsules-0

Medicines for Malaria Venture. Artesunate rectal capsules, Artecap™, Larinate® 60 mg for injection. Accessed August 12, 2024. https://www.mmv.org/mmv-pipeline-antimalarial-drugs/artesunate-rectal-capsules

Lives saved is compared to prior standard of care.

Injectable artesunate:

Medicines for Malaria Venture. Artesunate for injection, Larinate® 60 mg for injection. Accessed August 12, 2024. https://www.mmv.org/mmv-pipeline-antimalarial-drugs/artesunate-injection

Medicines for Malaria Venture. Artesunate for injection, Artesun®. Accessed August 12, 2024. https://www.mmv.org/mmv-pipeline-antimalarial-drugs/artesunate-injection-0

Rectal artesunate, injectable artesunate, lives saved: Data provided from Medicines for Malaria Venture. Lives saved is compared to prior standard of care.

Two approved malaria vaccines: Malaria vaccines (RTS,S and R21). World Health Organization. July 19, 2024. Accessed July 24, 2024. https://www.who.int/news-room/questions-and-answers/item/q-a-on-rts-s-malaria-vaccine

Tafenoquine, approval: 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/

Tafenoquine, pediatric version: 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

Tafenoquine, companion diagnostic test approval: Expert review panel for diagnostics approval expands access to a G6PD deficiency test that supports P. vivax malaria treatment and elimination initiatives. PATH. October 3, 2019. Accessed July 22, 2024. https://www.path.org/our-impact/articles/expert-review-panel-diagnostics-approval-expands-access-g6pd-deficiency-test-supports-p-vivax-malaria-treatment-and-elimination-initiatives/

Genetically modified mosquitoes:

Wangira D. GMO mosquitoes released in Djibouti to fight malaria. BBC. May 23, 2024. Accessed July 22, 2024. https://www.bbc.com/news/articles/cw551yelwz5o

Nolen S. The gamble: Can genetically modified mosquitoes end disease? The New York Times. September 29, 2023. Accessed July 22, 2024. https://www.nytimes.com/2023/09/29/health/mosquitoes-genetic-engineering.html

Continued progress is possible, not inevitable

Bill & Melinda Gates Foundation. Goalkeepers 2024 Report. The Race to Nourish a Warming World. Bill & Melinda Gates Foundation; 2024. https://www.gatesfoundation.org/goalkeepers/report/2024-report/

Key missing tools

World Health Organization. World Malaria Report 2023. World Health Organization; 2023. https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2023

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

Breakthroughs 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.

Johns Hopkins study supports potential for injectable ‘chemical vaccine’ for malaria using atovaquone. Press release. Johns Hopkins Bloomberg School of Public Health; October 20, 2023. https://publichealth.jhu.edu/2023/johns-hopkins-study-supports-potential-for-injectable-chemical-vaccine-for-malaria-using-atovaquone

Malaria vaccine candidates: Infectious disease R&D tracker. 2023. Accessed July 22, Policy Cures Research; 2024. https://www.policycuresresearch.org/pipeline-database/

Attractive Targeted Sugar Bait:

Innovative Vector Control Consortium. Attractive Targeted Sugar Baits (ATSB®). Accessed July 22, 2024. https://www.ivcc.com/research-development/atsb/

Westham Co. Accessed July 22, 2024. https://westhamco.com/

Saliva-based malaria test: Diaz J, Gusto C, McCoy K, et al. A mixed methods study assessing the adoption potential of a saliva-based malaria rapid test in the Democratic Republic of Congo. Malaria Journal. 2023;22(180). https://doi.org/10.1186/s12936-023-04599-y

Malaria treatment for babies under 10 pounds: Medicines for Malaria Venture and Novartis announce positive efficacy and safety data for a novel treatment for babies <5 kg with malaria. Press release. Medicines for Malaria Venture; April 24, 2024. https://www.mmv.org/newsroom/news-resources-search/medicines-malaria-venture-and-novartis-announce-positive-efficacy

Simpler dosing treatment regimens:

Medicines for Malaria Venture. MMV533. Accessed July 22, 2024. https://www.mmv.org/mmv-pipeline-antimalarial-drugs/mmv533

Medicines for Malaria Venture. MMV183. Accessed July 22, 2024. https://www.mmv.org/mmv-pipeline-antimalarial-drugs/mmv183

US government investment in malaria R&D

G-FINDER data portal: Tracking funding for global health R&D. Policy Cures Research; 2023. Accessed July 22, 2024. https://gfinderdata.policycuresresearch.org/

US government R&D efforts

USAID: The President’s Malaria Initiative and other US government global malaria efforts. KFF. December 20, 2023. Accessed July 22, 2024. https://www.kff.org/global-health-policy/fact-sheet/the-presidents-malaria-initiative-and-other-u-s-government-global-malaria-efforts/

DoD: The US Department of Defense & global health. KFF. September 29, 2012. Accessed July 22, 2024. https://www.kff.org/global-health-policy/report/the-u-s-department-of-defense-global/

FDA: US Food & 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

Click here to go back to the Fact sheet series: R&D across health areas page