Emerging Infectious Disease Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Emerging Infectious Disease Diagnostics Market is projected to expand from USD 16.70 Billion in 2025 to USD 27.41 Billion by 2031, achieving a CAGR of 8.61%. This sector comprises specialized assays and platforms engineered to detect pathogens that have recently appeared or are experiencing rapid increases in incidence and geographic reach. The market is largely driven by the rising prevalence of zoonotic and vector-borne diseases, which necessitates the development of robust surveillance capabilities. Additionally, significant government funding dedicated to biodefense infrastructure and pandemic preparedness programs acts as a vital economic catalyst, encouraging continuous product innovation and deployment.

Despite these drivers, the industry encounters major obstacles regarding the high costs and complex regulatory requirements involved in validating tests for novel pathogens during active outbreaks. These financial and operational hurdles can impede the timely commercialization of essential testing kits when they are most critical. According to the World Health Organization, more than 14.6 million dengue cases were reported worldwide in 2024, underscoring the urgent need for accessible and scalable diagnostic solutions to effectively manage such widespread public health threats.

Market Drivers

The rising frequency of emerging and re-emerging infectious outbreaks serves as a primary catalyst for the market, requiring the rapid implementation of specialized testing solutions to mitigate cross-border threats. As pathogens extend their geographic footprint, public health agencies are increasingly procuring molecular and immunoassay platforms to facilitate early detection and contact tracing. This surge in viral activity drives immediate demand for high-throughput screening kits and point-of-care devices designed to function in resource-limited environments. For example, according to the Africa Centres for Disease Control and Prevention, a total of 21,466 potential Mpox cases were reported across the continent by August 2024, emphasizing the critical need for accessible diagnostic infrastructure to control escalating transmission rates.

Simultaneously, increased government funding for disease surveillance is significantly strengthening the sector's capacity for innovation. Federal agencies are directing substantial capital toward developing next-generation medical countermeasures, thereby reducing the risks associated with the complex validation process for tests targeting novel agents. These investments allow private enterprises to enhance their research capabilities and maintain readiness for future biological threats. A prominent example of this support occurred in January 2024, when ATCC received a five-year, $87 million award from the Biomedical Advanced Research and Development Authority to advance new diagnostic tools. This financial backing ensures market 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 enduring value of infectious disease testing portfolios.

Market Challenges

The substantial costs and regulatory intricacies involved in validating tests for novel pathogens present significant barriers to market expansion. Manufacturers encounter considerable financial risk when developing assays for sporadic outbreaks, as demand may decline before regulatory approval is fully finalized. This economic uncertainty deters sustained investment in research and development for emerging threats, prompting companies to prioritize established markets with predictable revenue streams over volatile infectious disease segments. Consequently, the rigorous validation procedures required by health authorities prolong the time it takes to bring products to market, often leaving healthcare systems without necessary tools during the initial stages of infection waves.

This regulatory burden directly affects product availability and disrupts portfolio continuity. Smaller developers are particularly susceptible to these resource demands, which can compel them to consolidate or withdraw products entirely. According to MedTech Europe, approximately 17 percent of in vitro diagnostic tests were expected to be discontinued in 2024 due to the extensive costs and resources required to comply with new regulatory standards. This reduction in the availability of approved tests limits the overall growth potential of the diagnostics sector.

Market Trends

The expansion of Syndromic Multiplex Diagnostic Panels is revolutionizing clinical management by facilitating the simultaneous detection of multiple pathogens from a single sample, thereby addressing the difficulty of distinguishing symptoms in respiratory and gastrointestinal infections. This methodology improves operational efficiency in healthcare facilities by replacing sequential testing with comprehensive panels that provide rapid, actionable results for co-circulating viruses. The market viability of this trend is highlighted by the strong performance of specialized syndromic platforms; according to bioMérieux’s 'First-Half 2024 Results' in September 2024, sales of BIOFIRE respiratory panels rose by 17 percent in the second quarter, driven by the solution’s competitiveness and the utilization of the existing installed base.

In parallel, the acceleration of decentralized and Point-of-Care (POC) testing is reshaping the diagnostic landscape by 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 shorten turnaround times for treatment initiation, enabling providers to make immediate clinical decisions without the logistical delays associated with central lab transport. Industry leaders are capitalizing on this demand by broadening their portfolios of compact, automated systems. According to Danaher’s 'Third Quarter 2024 Results' in October 2024, Cepheid’s diagnostics revenue for respiratory products reached $425 million for the quarter, underscoring the sustained market reliance on rapid, decentralized molecular testing solutions.

Key Players Profiled in the Emerging Infectious Disease Diagnostics Market

• BioMerieux 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

Report Scope

In this report, the Global Emerging Infectious Disease Diagnostics Market has been segmented into the following categories:

Emerging Infectious Disease Diagnostics Market, by Application:

• Laboratory Testing
• 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)
• Others

Emerging Infectious Disease Diagnostics Market, by Type of Infection:

• Bacterial
• Viral
• Fungal
• Others

Emerging Infectious Disease Diagnostics Market, by Disease Type:

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

Emerging Infectious Disease Diagnostics Market, by End user:

• Hospitals & Clinics
• Diagnostic laboratories
• Others

Emerging Infectious Disease Diagnostics Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Emerging Infectious Disease Diagnostics Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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