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US Malaria Diagnostics Market

ID: MRFR/LS/13113-HCR
100 Pages
Rahul Gotadki
October 2025

US Malaria Diagnostics Market Research Report By Technology (Rapid Diagnostic Tests, Microscopy, Polymerase Chain Reaction, Serology Tests, Loop-Mediated Isothermal Amplification), By End User (Hospitals, Diagnostic Laboratories, Research Institutes, Home Care Settings), By Product Type (Test Kits, Reagents, Instruments) and By Application (Clinical Diagnosis, Epidemiological Studies, Drug Efficacy Studies) - Forecast to 2035

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US Malaria Diagnostics Market Summary

As per analysis, the US malaria diagnostics market size was estimated at 7.05 USD Million in 2024.. The US malaria diagnostics market is projected to grow from 7.49 USD Million in 2025 to 13.71 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 6.23% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The US malaria diagnostics market is experiencing a transformative shift driven by technological advancements and increased awareness.

  • Advancements in molecular diagnostics are enhancing the accuracy and speed of malaria detection.
  • The rise of point-of-care testing is facilitating immediate diagnosis, particularly in remote areas.
  • Increased collaboration among stakeholders is fostering innovation in diagnostic tools and methodologies.
  • Key market drivers include growing awareness of malaria risks and technological advancements in diagnostic tools.

Market Size & Forecast

2024 Market Size 7.05 (USD Million)
2035 Market Size 13.71 (USD Million)

Major Players

Roche (CH), Abbott (US), Siemens Healthineers (DE), BD (US), Cepheid (US), Hologic (US), Thermo Fisher Scientific (US), Diatheva (IT)

US Malaria Diagnostics Market Trends

This market is currently experiencing a notable evolution., driven by advancements in technology and an increasing emphasis on rapid and accurate testing methods. The integration of molecular diagnostics, such as PCR and LAMP, appears to enhance the sensitivity and specificity of malaria detection, which is crucial for effective treatment and control strategies. Furthermore, the growing awareness of malaria's impact on public health is prompting healthcare providers to adopt more sophisticated diagnostic tools. This shift is likely to improve patient outcomes and reduce transmission rates, as timely diagnosis is essential for effective management of the disease. In addition, the malaria diagnostics market is witnessing a trend towards point-of-care testing, which offers the advantage of immediate results in various settings, including remote areas. This approach not only facilitates quicker decision-making but also aligns with the broader goal of increasing accessibility to healthcare services. The ongoing collaboration between public health organizations and private sector entities is fostering innovation and ensuring that diagnostic solutions are tailored to meet the specific needs of diverse populations. As the landscape continues to evolve, the focus on enhancing diagnostic capabilities is expected to play a pivotal role in malaria control efforts.

Advancements in Molecular Diagnostics

Recent developments in molecular diagnostics are transforming the malaria diagnostics market. Techniques such as PCR and LAMP are becoming more prevalent, offering higher accuracy in detecting malaria parasites. These methods are particularly beneficial in identifying low-level infections that traditional methods may miss, thus improving overall disease management.

Rise of Point-of-Care Testing

Point-of-care testing is gaining traction within the malaria diagnostics market, providing immediate results that are crucial for timely treatment. This trend is particularly significant in remote and underserved regions, where access to laboratory facilities is limited. The convenience of rapid tests enhances patient care and supports effective disease control.

Increased Collaboration for Innovation

Collaboration between public health organizations and private companies is fostering innovation in the malaria diagnostics market. These partnerships aim to develop and distribute advanced diagnostic tools that are both effective and accessible. Such initiatives are essential for addressing the unique challenges faced in malaria-endemic areas.

US Malaria Diagnostics Market Drivers

Rising Incidence of Malaria Cases

The rising incidence of malaria cases in certain regions is a significant driver for the malaria diagnostics market. Although the US has made considerable progress in controlling malaria, sporadic outbreaks still occur, necessitating effective diagnostic tools. the malaria diagnostics market is projected to experience growth as healthcare providers respond to these outbreaks by increasing testing capabilities.. According to the Centers for Disease Control and Prevention (CDC), there were approximately 2,000 reported cases of malaria in the US in recent years, underscoring the need for reliable diagnostic methods. This trend may prompt healthcare systems to invest more in malaria diagnostics, thereby expanding the market.

Government Initiatives and Funding

Government initiatives and funding play a pivotal role in shaping the malaria diagnostics market. In the US, various federal and state programs aim to combat malaria through improved diagnostic capabilities. Increased funding for research and development in malaria diagnostics has led to the emergence of innovative testing methods. For instance, the National Institutes of Health (NIH) has allocated substantial resources to support studies focused on malaria detection technologies. This financial backing is expected to drive growth in the malaria diagnostics market, as it encourages collaboration between public health organizations and private sector companies to develop effective diagnostic solutions.

Growing Awareness of Malaria Risks

The increasing awareness of malaria risks among the population is a crucial driver for the malaria diagnostics market. Educational campaigns and public health initiatives have highlighted the dangers of malaria, particularly in regions where the disease is endemic. This heightened awareness has led to a greater demand for effective diagnostic tools, as individuals and healthcare providers seek to identify and treat malaria cases promptly. In the US, over the next five years., driven by this awareness. As more people understand the importance of early detection, the market for malaria diagnostics is likely to expand, fostering innovation and the development of new diagnostic technologies.

Increased Focus on Global Health Security

The increased focus on The malaria diagnostics market. As the world becomes more interconnected, the potential for malaria to spread beyond endemic regions has raised concerns among public health officials. This has led to a greater emphasis on surveillance and early detection of malaria cases. the malaria diagnostics market is projected to benefit from this trend., as governments and health organizations prioritize investments in diagnostic technologies to enhance preparedness. The commitment to global health security may result in collaborative efforts to develop and distribute advanced diagnostic tools, ultimately strengthening the malaria diagnostics market.

Technological Advancements in Diagnostic Tools

Technological advancements in diagnostic tools are significantly influencing the malaria diagnostics market. Innovations such as rapid diagnostic tests (RDTs) and molecular techniques have improved the accuracy and speed of malaria detection. These advancements enable healthcare providers to diagnose malaria more efficiently, which is essential for effective treatment. the malaria diagnostics market is projected to reach a valuation of $1.5 billion by 2027., largely due to these technological improvements. Furthermore, the integration of digital health solutions, such as mobile applications for data collection and analysis, is likely to enhance the overall diagnostic process, making it more accessible and user-friendly.

Market Segment Insights

By Technology: Rapid Diagnostic Tests (Largest) vs. Polymerase Chain Reaction (Fastest-Growing)

In the US malaria diagnostics market, Rapid Diagnostic Tests (RDTs) dominate the landscape, holding a significant market share due to their ease of use and quick results. Microscopy and Serology Tests follow, with RDTs accounting for a large portion of malaria diagnostics, favored for their comprehensive applications in low-resource settings. Meanwhile, Polymerase Chain Reaction (PCR) is gaining traction, representing a growing interest for its high sensitivity and specificity, with the other technologies integrating to create a multifaceted approach to diagnosis. Growth trends in this segment illustrate a shift towards more advanced technologies. PCR is rapidly emerging as the fastest-growing method, driven by rising demand for accurate and fast diagnostic tools in response to prevention and treatment efforts. As healthcare providers seek to enhance their diagnostic capabilities, investments in RDTs continue, supported by favorable reimbursement policies. The increasing focus on integration of innovative technologies to improve malaria diagnosis reflects broader trends in healthcare and technology.

Technology: RDTs (Dominant) vs. PCR (Emerging)

Rapid Diagnostic Tests (RDTs) are characterized by their user-friendly design and speed, allowing for immediate diagnosis, which is particularly crucial in malaria management. They are widely adopted in various healthcare settings, from urban hospitals to remote clinics. In contrast, Polymerase Chain Reaction (PCR) is an emerging technology that offers advanced detection capabilities, particularly for low-parasite-density infections. PCR's ability to provide precise and reliable results positions it as a preferred choice for specialized laboratories. As the US malaria diagnostics market evolves, both RDTs and PCR will play significant roles, catering to diverse requirements, from routine screening to complex diagnostic scenarios.

By End User: Hospitals (Largest) vs. Diagnostic Laboratories (Fastest-Growing)

In the US malaria diagnostics market, hospitals dominate the end user segment, capturing a significant share due to their substantial resources and the critical need for timely diagnostics. Diagnostic laboratories follow closely, representing a vital resource for pathogen identification and analysis. Research institutes and home care settings, while smaller in market share, play essential roles in advancing research and improving accessibility to diagnostics. The growth trends for the end user segment are driven by advancements in diagnostic technologies, increased awareness of malaria, and rising government initiatives to enhance healthcare infrastructure. Hospitals are expected to remain dominant due to their integrated approach to patient care. Meanwhile, diagnostic laboratories are the fastest-growing segment, fueled by the demand for rapid and accurate testing methods, particularly in outbreak situations.

Hospitals (Dominant) vs. Diagnostic Laboratories (Emerging)

Hospitals are the dominant end users in the malaria diagnostics arena, primarily due to their critical role in patient care and comprehensive diagnostic services. Equipped with advanced technology, they can provide timely and accurate diagnoses. Their ability to integrate various medical services enhances their position within the market. On the other hand, diagnostic laboratories are emerging as a crucial player in the market landscape. They focus on specialized testing and analysis, catering to both hospitals and direct consumers. The growing prevalence of malaria concerns and the need for efficient diagnostics is propelling laboratories to innovate and expand their services, establishing themselves as a key component in combating malaria effectively.

By Product Type: Test Kits (Largest) vs. Reagents (Fastest-Growing)

In the US malaria diagnostics market, the distribution of market share among product types reveals that test kits dominate the landscape, capturing the majority of market interest and sales. Their widespread acceptance is due to user-friendly features and rapid diagnostic capabilities. In contrast, reagents hold a smaller share; however, their importance cannot be underestimated as they are essential for performing tests, thereby facilitating the operations of laboratories and healthcare facilities. Growth trends in this segment are primarily driven by advancements in diagnostic technologies and an increase in malaria cases in certain regions. The demand for rapid testing solutions has significantly bolstered the test kits market, while the reagents segment is experiencing fast-paced growth as healthcare providers seek reliable components for effective diagnostics. This overall trend indicates a robust future for both segments in the evolving landscape of malaria diagnostics.

Test Kits (Dominant) vs. Reagents (Emerging)

Test kits in the US malaria diagnostics market are characterized by their convenience, speed, and reliability, making them the preferred choice for rapid detection of malaria. Their dominant market position is attributed to their ease of use and minimal need for specialized training, allowing for widespread application in clinics and remote settings. On the other hand, reagents are emerging as crucial components in the diagnostics process, with growing attention to their quality and effectiveness. As laboratories increasingly rely on sophisticated tests, the demand for quality reagents is rising, indicating a shift towards the optimization of diagnostic accuracy. This duality between dominant test kits and emerging reagents highlights the interdependence within the market.

By Application: Clinical Diagnosis (Largest) vs. Epidemiological Studies (Fastest-Growing)

In the US malaria diagnostics market, Clinical Diagnosis holds the largest share, driven by its critical role in the immediate detection and treatment of malaria cases. Epidemiological Studies, while currently smaller in market share, are rapidly growing as public health initiatives increasingly focus on surveillance and control of malaria outbreaks, highlighting the importance of this segment in broader health strategies. Growth in the US malaria diagnostics market is largely influenced by advancements in diagnostic technology and increasing awareness of malaria's public health impact. The rising demand for efficient and quick diagnostic methods supports the Clinical Diagnosis segment's dominance, whereas the growing funding for research and development is propelling Epidemiological Studies as the fastest-growing segment, reflecting a shift towards proactive malaria management and prevention strategies.

Clinical Diagnosis: Dominant vs. Epidemiological Studies: Emerging

Clinical Diagnosis remains the dominant segment within the US malaria diagnostics market due to its established infrastructure and essential role in patient care. The segment benefits from a wide range of diagnostic tests that provide quick results, aiding in timely treatment decisions. On the other hand, Epidemiological Studies represent an emerging segment focusing on the collection and analysis of data to track malaria transmission patterns. This segment is characterized by partnerships between governmental and non-governmental organizations to enhance surveillance systems and improve public health responses, marking a significant shift towards data-driven malaria management.

Get more detailed insights about US Malaria Diagnostics Market

Key Players and Competitive Insights

The malaria diagnostics market is currently characterized by a dynamic competitive landscape, driven by a confluence of technological advancements, increasing awareness of malaria's impact, and a growing emphasis on rapid and accurate diagnostics. Key players such as Roche (CH), Abbott (US), and BD (US) are strategically positioned to leverage their extensive research capabilities and established market presence. Roche (CH) focuses on innovation in molecular diagnostics, while Abbott (US) emphasizes the integration of digital health solutions into its diagnostic platforms. BD (US) is enhancing its operational focus on point-of-care testing, which is crucial for timely malaria detection. Collectively, these strategies not only enhance their competitive edge but also contribute to a more robust market environment.

In terms of business tactics, companies are increasingly localizing manufacturing to reduce costs and improve supply chain efficiency. This approach appears to be particularly relevant in the context of the malaria diagnostics market, which is moderately fragmented, with several players vying for market share. The collective influence of these key players is shaping a competitive structure that encourages innovation and responsiveness to market demands, thereby fostering a more resilient supply chain.

In October 2025, Abbott (US) announced a partnership with a leading telehealth provider to enhance remote diagnostic capabilities for malaria. This strategic move is significant as it aligns with the growing trend of digital health integration, allowing for quicker diagnosis and treatment recommendations, particularly in remote areas where access to healthcare is limited. Such partnerships may enhance Abbott's market position by expanding its reach and improving patient outcomes.

In September 2025, Roche (CH) launched a new rapid diagnostic test that utilizes advanced molecular techniques to detect malaria with higher sensitivity and specificity. This innovation is crucial as it addresses the need for more accurate diagnostics in endemic regions, potentially reducing misdiagnosis and improving treatment efficacy. Roche's commitment to advancing diagnostic technology underscores its strategic focus on innovation as a key differentiator in the market.

In August 2025, BD (US) expanded its point-of-care testing portfolio by introducing a new device specifically designed for malaria detection. This expansion is indicative of BD's strategy to enhance accessibility to rapid testing solutions, which is vital in controlling malaria outbreaks. By focusing on point-of-care solutions, BD is likely to strengthen its competitive position in a market that increasingly values speed and accuracy in diagnostics.

As of November 2025, current trends in the malaria diagnostics market are heavily influenced by digitalization, sustainability, and the integration of artificial intelligence (AI) into diagnostic processes. Strategic alliances are becoming increasingly important, as they enable companies to pool resources and expertise, thereby enhancing innovation. The competitive landscape is shifting from traditional price-based competition to a focus on technological advancements and supply chain reliability. This evolution suggests that companies that prioritize innovation and strategic partnerships will likely emerge as leaders in the malaria diagnostics market.

Key Companies in the US Malaria Diagnostics Market market include

Industry Developments

The US Malaria Diagnostics Market has seen significant developments recently, with companies like Hologic and Thermo Fisher Scientific focusing on enhancing their diagnostic capabilities amidst a rise in malaria cases linked to climate factors. In September 2023, Abbott launched a rapid malaria test aimed at improving detection rates in endemic regions within the US. Growth in market valuation is evident, as evidenced by Danaher's acquisition strategy aimed at broadening its diagnostic portfolio through innovations.

Grifols and BioRad Laboratories are exploring partnerships to enhance their diagnostics solutions, reflecting a trend toward collaborative efforts in technology advancement. Additionally, in July 2023, Roche announced the launch of a new diagnostic platform that enhances sensitivity and specificity for malaria detection. Furthermore, Meridian Bioscience reported a steady rise in revenue during 2022 due to increased demand for malaria diagnostic tests.

Current affairs also reflect a heightened emphasis on R&D investments targeted at malaria diagnostics, with agencies such as the Centers for Disease Control and Prevention emphasizing the need for more robust testing solutions in response to rising global malaria cases. These trends depict an evolving market landscape, driven by innovations and strategic collaborations among major companies.

Future Outlook

US Malaria Diagnostics Market Future Outlook

The malaria diagnostics market is projected to grow at a 6.23% CAGR from 2024 to 2035, driven by technological advancements, increased funding, and rising awareness.

New opportunities lie in:

  • Development of rapid diagnostic test kits for remote areas.
  • Integration of AI for predictive analytics in diagnostics.
  • Expansion of telemedicine platforms for remote consultations.

By 2035, the market is expected to achieve substantial growth, enhancing diagnostic capabilities and accessibility.

Market Segmentation

US Malaria Diagnostics Market End User Outlook

  • Hospitals
  • Diagnostic Laboratories
  • Research Institutes
  • Home Care Settings

US Malaria Diagnostics Market Technology Outlook

  • Rapid Diagnostic Tests
  • Microscopy
  • Polymerase Chain Reaction
  • Serology Tests
  • Loop-Mediated Isothermal Amplification

US Malaria Diagnostics Market Application Outlook

  • Clinical Diagnosis
  • Epidemiological Studies
  • Drug Efficacy Studies

US Malaria Diagnostics Market Product Type Outlook

  • Test Kits
  • Reagents
  • Instruments

Report Scope

MARKET SIZE 2024 7.05(USD Million)
MARKET SIZE 2025 7.49(USD Million)
MARKET SIZE 2035 13.71(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR) 6.23% (2024 - 2035)
REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR 2024
Market Forecast Period 2025 - 2035
Historical Data 2019 - 2024
Market Forecast Units USD Million
Key Companies Profiled Roche (CH), Abbott (US), Siemens Healthineers (DE), BD (US), Cepheid (US), Hologic (US), Thermo Fisher Scientific (US), Diatheva (IT)
Segments Covered Technology, End User, Product Type, Application
Key Market Opportunities Integration of advanced molecular diagnostics enhances accuracy and speed in malaria detection.
Key Market Dynamics Technological advancements drive innovation in malaria diagnostics, enhancing accuracy and speed of detection methods.
Countries Covered US

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FAQs

What is the expected market size of the US Malaria Diagnostics Market in 2024?

The US Malaria Diagnostics Market is expected to be valued at 750.0 USD Million in 2024.

What will be the projected market size of the US Malaria Diagnostics Market by 2035?

By 2035, the market is projected to reach a valuation of 1450.0 USD Million.

What is the expected CAGR for the US Malaria Diagnostics Market from 2025 to 2035?

The expected CAGR for the market from 2025 to 2035 is 6.176%.

Which technology segment is expected to dominate the US Malaria Diagnostics Market in 2024?

The Rapid Diagnostic Tests segment is expected to have a market value of 300.0 USD Million in 2024.

What will be the market value of the Microscopy segment by 2035?

The Microscopy segment is expected to reach a market value of 300.0 USD Million by 2035.

Who are the key players in the US Malaria Diagnostics Market?

Major players include Hologic, Genzyme, BioRad Laboratories, Grifols, and Danaher among others.

What market value is anticipated for the Polymerase Chain Reaction technology segment in 2024?

The Polymerase Chain Reaction segment is anticipated to be valued at 100.0 USD Million in 2024.

What challenges could impact the growth of the US Malaria Diagnostics Market?

Challenges may include issues with accessibility and affordability of diagnostic tests in certain regions.

What are the anticipated growth rates for specific technology segments from 2025 to 2035?

Segments like Rapid Diagnostic Tests are expected to grow significantly, reaching 600.0 USD Million by 2035.

What factors are driving the growth of the US Malaria Diagnostics Market?

The growth is driven by increased awareness, rising incidence of malaria, and advancements in diagnostic technologies.

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