Malaria Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Technology (Molecular Diagnostic Tests, Rapid Diagnostic Test, Others), By End User (Hospitals & Clinics, Diagnostic Centers, Home care, Others), By Region and By Competition 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 0.86 Billion
CAGR (2026-2031)	5.86%
Fastest Growing Segment	Rapid Diagnostic Test
Largest Market	Asia Pacific
Market Size (2031)	USD 1.21 Billion

Market Overview

The Global Malaria Diagnostics Market will grow from USD 0.86 Billion in 2025 to USD 1.21 Billion by 2031 at a 5.86% CAGR. The Global Malaria Diagnostics Market encompasses the development and supply of medical devices and reagents, primarily including microscopy, Rapid Diagnostic Tests, and molecular assays, intended to detect the presence of Plasmodium parasites. The primary drivers supporting market growth include sustained international funding for malaria elimination programs and the critical necessity for accurate point-of-care testing to guide treatment in high-burden regions. According to 'The Global Fund', in '2024', '360 million suspected cases of malaria were tested'. This robust testing volume highlights the continued prioritization of diagnostic coverage in global health strategies.

One significant challenge impeding market expansion is the increasing prevalence of pfhrp2 and pfhrp3 gene deletions in parasites which renders the most widely used antigen-based Rapid Diagnostic Tests ineffective. This biological resistance necessitates the deployment of alternative and often more expensive diagnostic tools which complicates supply chain logistics and budget allocation for national health programs in resource-limited settings.

Key Market Drivers

Escalating international funding and grant support serves as the foundational pillar for the Global Malaria Diagnostics Market, particularly given the reliance of high-burden nations on external aid. Organizations such as The Global Fund and the U.S. President’s Malaria Initiative provide the essential capital required to procure rapid diagnostic tests and microscopy reagents on a massive scale for resource-limited settings. This financial backing stabilizes the supply chain and incentivizes manufacturers to maintain production volumes despite low profit margins per unit. According to Devex, March 2024, in the 'Congress releases spending deal' article, the United States government approved US$ 795 million specifically for bilateral malaria programs in the fiscal year 2024 budget. However, financial sustainability remains a critical concern for market longevity. According to Health Policy Watch, April 2024, in the 'World Malaria Day' report, the annual funding gap between the resources invested and those needed for global malaria goals has widened to approximately US$ 3.7 billion, underscoring the intense pressure on diagnostic procurement budgets.

The rising disease burden in endemic regions, exacerbated by climate-induced expansion of transmission zones, is directly propelling the demand for diagnostic testing volume. As weather patterns shift, mosquitoes migrate to higher altitudes and previously malaria-free latitudes, exposing naive populations to infection and necessitating the rapid deployment of screening tools. This demographic and geographic expansion forces national health systems to increase their inventory of point-of-care solutions to effectively manage the surge in suspected cases and prevent outbreaks. According to Reuters, December 2023, in the 'Global malaria cases rise' article, the estimated number of global malaria cases reached 249 million in 2022, a figure driven largely by outbreaks in countries like Pakistan and Ethiopia. Consequently, manufacturers are compelled to scale distribution networks to these expanding hot spots to meet the growing necessity for accurate case identification.

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Key Market Challenges

The increasing prevalence of pfhrp2 and pfhrp3 gene deletions represents a critical biological barrier impeding the growth of the Global Malaria Diagnostics Market. This genetic mutation causes the standard, cost-effective rapid diagnostic tests to produce false-negative results, which fundamentally undermines the reliability of primary testing protocols. As a result, health systems are forced to pivot toward alternative diagnostic methods that are typically more expensive and logistically complex. This sudden need for substitution creates significant friction within the market, as supply chains must be overhauled to accommodate non-HRP2 tests, leading to delays in procurement and distribution efficiency.

This challenge hampers market expansion by diverting essential financial resources away from growth initiatives. National health programs are compelled to reallocate limited budgets to validate and purchase these pricier alternative tools rather than extending diagnostic coverage to underserved populations. The magnitude of this disruption is substantial and geographically widespread. According to the 'World Health Organization', in '2024', 'pfhrp2 and pfhrp3 gene deletions were reported in over 40 countries'. This extensive footprint forces the market into a costly phase of product restructuring, slowing the momentum of volume adoption in high-burden regions.

Key Market Trends

The Integration of Artificial Intelligence and Machine Learning in Digital Microscopy is fundamentally reshaping diagnostic protocols by automating the detection and quantification of parasites, thereby addressing the critical shortage of skilled microscopists in endemic regions. These advanced optical platforms utilize deep learning algorithms to analyze blood smears with consistent precision, significantly reducing the human error rates associated with manual slide reading in high-throughput settings. This technological shift is particularly vital for accurately identifying non-falciparum species and low-parasitemia cases that are frequently missed by conventional visual inspection. According to Korea Biomedical Review, November 2024, in the 'Noul showcases AI-powered malaria diagnostic tool with superior accuracy at US meet' article, a clinical study conducted in Nigeria demonstrated that the AI-driven miLab MAL platform achieved a sensitivity of 94.4 percent, significantly outperforming traditional manual microscopy in field settings.

The Transition to Point-of-Care Molecular Diagnostic Platforms is rapidly gaining traction as health systems seek to bypass the sensitivity limitations of antigen-based rapid tests and the logistical bottlenecks of central laboratory PCR. By miniaturizing nucleic acid amplification technology into battery-operated, portable devices, manufacturers are enabling district-level facilities to confirm suspected cases with genomic accuracy, which is essential for detecting drug-resistance markers and managing elimination campaigns. This decentralization of molecular testing stabilizes the market by creating a new revenue stream driven by instrument placement and consumable cartridge sales. According to BioSpectrum India, May 2024, in the 'MolBio Diagnostics deploys new-age technologies to launch innovative products in 2024' article, Molbio Diagnostics projected a revenue of Rs 1200 crore for the fiscal year 2024-25, driven largely by the expanded deployment of its Truenat molecular platform in resource-limited markets.

Segmental Insights

The Rapid Diagnostic Test segment is identified as the fastest-growing category within the global malaria diagnostics market due to its high utility in resource-limited settings. This growth is primarily driven by the ability of these tests to provide immediate and accurate results without requiring electricity or extensive technical training, unlike traditional microscopy. Furthermore, the World Health Organization advocates for a test-and-treat strategy, which encourages the widespread procurement of these point-of-care solutions to ensure confirmed diagnosis prior to medication administration, thereby significantly fueling segmental expansion.

Regional Insights

Asia Pacific stands as a leading region in the Global Malaria Diagnostics Market, distinguished by its rapid expansion and strategic focus on disease eradication. The region dominates the market landscape through a combination of high population density in endemic zones and stringent government mandates aligned with World Health Organization elimination milestones. Countries such as India are actively scaling up diagnostic accessibility, supported by rising healthcare expenditures and a strengthening local manufacturing sector. This concerted focus on comprehensive testing and surveillance ensures Asia Pacific remains a primary driver of global market demand and strategic development.

Recent Developments

• In April 2025, Premier Medical Corporation announced the launch of the First Response Malaria Ag. P. falciparum (HRP2/pLDH) Combo Card Test. This next-generation rapid diagnostic solution was engineered for use by trained healthcare professionals in both laboratory and point-of-care settings to deliver qualitative screening for Histidine Rich Protein 2 (HRP2) and Plasmodium lactate dehydrogenase (pLDH). The test offered high sensitivity and specificity with results available in 20 to 30 minutes, aiming to support timely diagnosis and intervention in high-burden regions. The launch underscored the company's commitment to providing accessible and reliable diagnostic tools for malaria eradication.
• In December 2024, bioMérieux announced that its BIOFIRE FILMARRAY Tropical Fever Panel had received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA). This syndromic polymerase chain reaction (PCR) testing solution was designed to identify pathogens in patients with unexplained fevers, including the differentiation of Plasmodium species which is vital for effective malaria treatment. The panel allows healthcare providers to quickly detect pathogens prevalent in tropical and subtropical regions. The company planned a commercial launch in targeted countries, including the United States, in early 2025, aiming to improve patient management and clinical outcomes in infectious disease diagnostics.
• In December 2024, SD Biosensor achieved World Health Organization (WHO) prequalification for its STANDARD G6PD Test, a point-of-care diagnostic device developed in collaboration with PATH. This milestone marked the first time a diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency received such validation, supporting the safe administration of radical cure treatments for Plasmodium vivax malaria. The handheld device provides quantitative measurements of enzyme activity in minutes, enabling healthcare workers to identify patients at risk of severe hemolysis before prescribing medications like tafenoquine. This development was expected to significantly enhance global efforts to eliminate relapsing malaria strains by ensuring treatment safety.
• In May 2024, Sysmex Corporation received the 11th Zero Malaria Award from the non-profit organization Malaria No More Japan. This recognition highlighted the company's contribution to the global effort to eliminate malaria through the development and dissemination of its Automated Hematology Analyzer XN-31. The diagnostic device, which utilizes flow cytometry technology to detect malaria-infected red blood cells in approximately one minute, was acknowledged for its role in strengthening local health systems and enabling early diagnosis. The award ceremony emphasized the importance of cross-sector collaboration and the utilization of advanced diagnostic technologies to achieve the goal of eradicating malaria.

Key Market Players

• Access Bio., Inc.
• Abbott Laboratories
• Premier Medical Corporation Pvt. Ltd.
• Sysmex Partec GmbH
• bioMérieux
• Beckman Coulter, Inc.
• Siemens Healthineers
• Leica Microsystems GmbH
• Nikon Corporation
• Olympus Corporation
• Bio-Rad Laboratories, Inc.

By Technology	By End User	By Region
Molecular Diagnostic Tests Rapid Diagnostic Test Others	Hospitals & Clinics Diagnostic Centers Home care Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Malaria Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Malaria Diagnostics Market, By Technology:

• Molecular Diagnostic Tests
• Rapid Diagnostic Test
• Others

• Malaria Diagnostics Market, By End User:

• Hospitals & Clinics
• Diagnostic Centers
• Home care
• Others

• Malaria Diagnostics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE