Emerging Infectious Disease Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Application (Laboratory Testing and Point of Care Testing), By Technology (Polymerase chain reaction, Immunodiagnostics, Isothermal Nucleic Acid Amplification Technology (INAAT), Next-Generation Sequencing (NGS), and Others), By Type of Infection (Bacterial, Viral, Fungal, and Others), By Disease Type (Respiratory Infections, Gastrointestinal Infections, Sexually Transmitted Infections (STIs), and Others), By End user (Hospitals & Clinics, Diagnostic laboratories, and Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 16.70 Billion
CAGR (2026-2031)	8.61%
Fastest Growing Segment	Laboratory Testing
Largest Market	North America
Market Size (2031)	USD 27.41 Billion

Market Overview

The Global Emerging Infectious Disease Diagnostics Market will grow from USD 16.70 Billion in 2025 to USD 27.41 Billion by 2031 at a 8.61% CAGR. Emerging infectious disease diagnostics encompass specialized assays and platforms designed to detect pathogens that have recently appeared or are rapidly increasing in incidence and geographic range. The market is primarily propelled by the escalating prevalence of zoonotic and vector borne diseases which necessitates robust surveillance capabilities. Furthermore, substantial government investments in biodefense infrastructure and pandemic preparedness initiatives serve as critical economic drivers that foster continuous product development and deployment.

However, the sector faces a significant challenge regarding the high costs and regulatory complexities associated with validating tests for novel pathogens during active outbreaks. This financial and operational hurdle can delay the commercialization of essential testing kits when they are most needed. According to the World Health Organization, in 2024, over 14.6 million dengue cases were reported globally, highlighting the acute demand for accessible and scalable diagnostic solutions to manage such expansive public health threats.

Key Market Drivers

The increasing incidence of emerging and re-emerging infectious outbreaks acts as a primary catalyst for the market, necessitating the rapid deployment of specialized testing solutions to contain cross-border threats. As pathogens expand their geographic footprint, public health agencies are ramping up procurement of molecular and immunoassay platforms to facilitate early detection and contact tracing. This heightened viral activity drives immediate demand for high-throughput screening kits and point-of-care devices capable of functioning in resource-limited settings. For instance, according to the Africa Centres for Disease Control and Prevention, in August 2024, a total of 21,466 potential Mpox cases were reported across the continent since the start of the year, highlighting the acute need for accessible diagnostic infrastructure to manage escalating transmission rates.

Concurrently, a surge in government funding for disease surveillance is significantly bolstering the sector's innovation capacity. Federal bodies are channeling substantial capital into developing next-generation medical countermeasures, thereby de-risking the complex validation process for tests targeting novel agents. These investments enable private enterprises to upgrade their research capabilities and maintain readiness for future biological threats. A notable example of this support occurred when, according to ATCC, in January 2024, the organization received a five-year, $87 million award from the Biomedical Advanced Research and Development Authority to support the development of new diagnostic tools. This financial backing underpins the market's stability; according to Roche, in October 2024, its Diagnostics division reported sales of CHF 10.7 billion for the first nine months of the year, reflecting the sustained value of infectious disease testing portfolios.

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Key Market Challenges

The high costs and regulatory complexities associated with validating tests for novel pathogens create substantial barriers to market expansion. Manufacturers face significant financial risk when developing assays for sporadic outbreaks, as the demand may subside before regulatory approval is completely finalized. This economic uncertainty discourages sustained investment in research and development for emerging threats, leading companies to prioritize established markets with predictable revenue streams over volatile infectious disease segments. Consequently, the rigorous validation processes required by health authorities prolong the time it takes to bring products to market, often leaving healthcare systems without necessary tools during initial infection waves.

This regulatory burden directly impacts product availability and disrupts portfolio continuity. Smaller developers are particularly vulnerable to these resource demands, which can force market consolidation or product withdrawal. According to MedTech Europe, in 2024, approximately 17 percent of in vitro diagnostic tests were expected to be discontinued due to the extensive costs and resources required for compliance with new regulatory standards. This contraction in the availability of approved tests limits the overall growth potential of the diagnostics sector.

Key Market Trends

The Expansion of Syndromic Multiplex Diagnostic Panels is transforming clinical management by enabling the simultaneous detection of multiple pathogens from a single sample, addressing the challenge of indistinguishable symptoms in respiratory and gastrointestinal infections. This approach enhances operational efficiency in healthcare facilities by replacing sequential testing methods with comprehensive panels that deliver rapid, actionable results for co-circulating viruses. The market viability of this trend is evidenced by the robust performance of specialized syndromic platforms. According to bioMérieux, September 2024, in the 'First-Half 2024 Results', sales of BIOFIRE respiratory panels increased by 17 percent in the second quarter, driven by the competitiveness of the solution and the leverage of the existing installed base.

The Acceleration of Decentralized and Point-of-Care Testing is decentralizing the diagnostic landscape, moving complex molecular testing capabilities from reference laboratories to near-patient settings such as urgent care clinics and physician offices. This shift is fueled by the need to reduce turnaround times for treatment initiation, allowing providers to make immediate clinical decisions without the logistical delays associated with central lab transport. Industry leaders are capitalizing on this demand by expanding their portfolios of compact, automated systems. According to Danaher, October 2024, in the 'Third Quarter 2024 Results', Cepheid’s diagnostics revenue for respiratory products reached $425 million for the quarter, highlighting the sustained market reliance on rapid, decentralized molecular testing solutions.

Segmental Insights

The Laboratory Testing segment is the fastest-growing division of the Global Emerging Infectious Disease Diagnostics Market, largely due to the essential requirement for high-precision diagnostic standards during epidemiological crises. This segment's expansion is fueled by the robust demand for molecular reference testing, which offers superior sensitivity compared to rapid alternatives for identifying novel pathogens. Regulatory frameworks established by organizations like the Centers for Disease Control and Prevention (CDC) further mandate rigorous laboratory verification for outbreak containment. As a result, substantial investments are being directed toward automated high-throughput laboratory infrastructure to ensure reliable disease surveillance and management.

Regional Insights

North America maintains a leading position in the Global Emerging Infectious Disease Diagnostics Market due to its well-established healthcare infrastructure and significant investment in research and development. This dominance is supported by the presence of key industry players and favorable government policies that encourage diagnostic advancements. The U.S. Food and Drug Administration plays a central role by implementing streamlined approval pathways for new assays, while the Centers for Disease Control and Prevention actively strengthens disease surveillance networks. These factors collectively ensure high adoption rates of diagnostic solutions across the region.

Recent Developments

• In December 2024, bioMérieux received U.S. Food and Drug Administration (FDA) Special 510(k) clearance for its BIOFIRE FILMARRAY Tropical Fever Panel. This syndromic polymerase chain reaction (PCR) test was designed to identify pathogens responsible for tropical fever infections, including malaria, dengue, chikungunya, and leptospirosis, from a single whole blood sample. The panel aimed to assist healthcare providers in rapidly distinguishing between these often indistinguishable febrile illnesses, particularly in travelers and patients in endemic regions. The clearance of this panel expanded the company's portfolio of infectious disease diagnostics and addressed the critical need for accurate testing of emerging vector-borne diseases.
• In December 2024, Hologic entered into an agreement with the U.S. Centers for Disease Control and Prevention (CDC) to develop analyte-specific reagents for the detection of H5N1 avian influenza. Under the collaboration, the company agreed to create primers and probes for the H5N1 virus on its fully automated Panther Fusion system. This initiative was part of a broader preparedness strategy to address the potential spread of the avian flu virus to humans. While the reagents were intended for laboratory-developed tests rather than immediate commercial release, the partnership sought to ensure rapid diagnostic scalability in the event of a public health emergency related to H5N1.
• In November 2024, Cepheid announced that the World Health Organization (WHO) had listed its Xpert Mpox test under the Emergency Use Listing (EUL) procedure. This approval represented a significant milestone as the first point-of-care molecular test for Mpox to receive such a listing, which is intended to expedite the availability of diagnostics during public health emergencies. The test, designed to run on the company's GeneXpert systems, was capable of providing results in under 40 minutes and detecting Mpox clade II as well as non-variola Orthopoxviruses. This development aimed to support global outbreak management by facilitating decentralized testing in regions with limited laboratory infrastructure.
• In September 2024, Roche launched the cobas Respiratory flex test, the first diagnostic assay to utilize its proprietary Temperature-Activated Generation of Signal (TAGS) technology. This high-throughput test was developed for use on the cobas 5800, 6800, and 8800 molecular analyzers and allowed for the simultaneous detection and differentiation of up to 15 pathogens, including influenza A and B, Respiratory Syncytial Virus (RSV), and SARS-CoV-2. The integration of TAGS technology enabled extensive multiplexing capabilities within a single PCR test, allowing clinical laboratories to perform syndromic panel testing more efficiently and identify specific respiratory viruses during seasonal outbreaks.

Key Market Players

• BioMérieux SA
• Bio-Rad Laboratories, Inc.
• Becton, Dickinson and Company
• Agilent Technologies, Inc.
• Abbott Laboratories, Inc.
• Thermo Fisher Scientific, Inc.
• Roche Diagnostics Corporation
• DiaSorin SpA
• F. Hoffmann-La Roche Ltd.
• Danaher Corporation

By Application	By Technology	By Type of Infection	By Disease Type	By End user	By Region
Laboratory Testing and Point of Care Testing	Polymerase chain reaction Immunodiagnostics Isothermal Nucleic Acid Amplification Technology (INAAT) Next-Generation Sequencing (NGS) and Others	Bacterial Viral Fungal and Others	Respiratory Infections Gastrointestinal Infections Sexually Transmitted Infections (STIs) and Others	Hospitals & Clinics Diagnostic laboratories and Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Emerging Infectious Disease Diagnostics Market, By Application:

• Laboratory Testing and Point of Care Testing

• Emerging Infectious Disease Diagnostics Market, By Technology:

• Polymerase chain reaction
• Immunodiagnostics
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• Next-Generation Sequencing (NGS)
• and Others

• Emerging Infectious Disease Diagnostics Market, By Type of Infection:

• Bacterial
• Viral
• Fungal
• and Others

• Emerging Infectious Disease Diagnostics Market, By Disease Type:

• Respiratory Infections
• Gastrointestinal Infections
• Sexually Transmitted Infections (STIs)
• and Others

• Emerging Infectious Disease Diagnostics Market, By End user:

• Hospitals & Clinics
• Diagnostic laboratories
• and Others

• Emerging Infectious Disease 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