Global Infectious Disease Rapid Diagnostics Devices Market to Reach USD 20.2 Billion by 2035, Growing at 6.9% CAGR | TMR

The global infectious disease rapid diagnostics devices market to surpass US$ 20.2 Bn by 2035, growing at a CAGR of 6.9% from US$ 9.7 Bn in 2024.

WILMINGTON, DE, UNITED STATES, October 16, 2025 /EINPresswire.com/ -- The global infectious disease rapid diagnostics devices market is witnessing robust growth, driven by increasing global health challenges, the demand for quick and reliable testing solutions, and technological innovations in molecular and immunodiagnostic platforms. Valued at US$ 9.7 Bn in 2024, the market is projected to expand at a CAGR of 6.9% between 2025 and 2035, reaching an estimated US$ 20.2 Bn by 2035.

The rapid diagnostics ecosystem has evolved into a vital component of modern healthcare, addressing the need for early disease detection and control. As infectious disease outbreaks continue to emerge due to urbanization, globalization, and changing climatic conditions, the need for accurate, fast, and cost-effective diagnostic tools has become indispensable.

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Analysts’ Viewpoint

Analysts observe that the infectious disease rapid diagnostics devices market is growing at a staggering pace under the influence of several interconnected factors. Chief among them are the rising prevalence of infectious diseases, increasing global travel, and growing healthcare awareness. Furthermore, the COVID-19 pandemic has served as a major catalyst, underscoring the importance of rapid diagnostics in global health systems.

From a strategic standpoint, technological breakthroughs—such as CRISPR-based assays, isothermal amplification, and microfluidic lab-on-chip platforms—are revolutionizing how infections are detected and monitored. These technologies are making diagnostics faster, more sensitive, and increasingly accessible, even in low-resource settings.

At the same time, the industry’s economic sustainability is improving, supported by favorable reimbursement policies, increased diagnostic coding, and the shift toward value-based healthcare models. These trends collectively foster market expansion, while promoting better healthcare outcomes globally.

Infectious Disease Rapid Diagnostics Devices Market Introduction

Rapid diagnostic devices are medical tools engineered to identify pathogens such as bacteria, viruses, and parasites within minutes or hours, facilitating early intervention and curbing disease transmission. These systems employ technologies like molecular diagnostics, immunoassays, and microfluidics to provide swift and accurate results.

The fundamental benefit of these devices lies in their ability to deliver results without complex laboratory setups—a vital feature for hospitals, clinics, and field applications. For instance, lateral flow assays (LFAs), also known as immunochromatographic test strips, provide quick visual readouts for antigen or antibody detection, while isothermal amplification methods (like LAMP) eliminate the need for expensive thermal cyclers.

A significant breakthrough in this space is the CRISPR-based diagnostic system, which utilizes gene-editing enzymes to recognize and bind specific genetic sequences of pathogens. With integrated reporter systems, these devices achieve high sensitivity and specificity, even for low-abundance targets—critical for early-stage infection detection.

Key Market Drivers

1. Rising Prevalence of Infectious Diseases

The increasing burden of infectious diseases remains the primary driver of market growth. Recurrent outbreaks of influenza, tuberculosis, malaria, and HIV, along with the persistent threat of emerging viruses like SARS-CoV-2, have emphasized the urgency for rapid diagnostic tools that deliver accurate results in minutes.

Conventional diagnostic systems often take several days to provide results, delaying treatment and containment. Rapid diagnostic devices bridge this gap by offering same-day test outcomes, enabling healthcare providers to initiate immediate treatment and isolation measures.

In high-prevalence regions, such early diagnosis reduces disease spread and lowers treatment costs. Moreover, with antimicrobial resistance (AMR) on the rise, these devices are becoming vital in guiding appropriate antibiotic or antiviral therapy, ensuring optimal patient outcomes while minimizing resistance development.

2. Growing Demand for Point-of-Care (POC) Testing

The increasing demand for point-of-care testing is transforming the landscape of infectious disease diagnostics. POC testing enables healthcare providers to conduct tests near the patient, offering results within minutes instead of waiting for centralized lab analyses.

This model is particularly beneficial in resource-limited environments, such as rural clinics and community health centers, where laboratory infrastructure is minimal. Portable and easy-to-use rapid diagnostic devices enable frontline workers to perform tests without specialized training or complex equipment.

POC testing also plays a crucial role in public health surveillance and outbreak management. During pandemics, these devices support large-scale screening in airports, schools, and workplaces, ensuring quick detection and containment. The shift toward patient-centric healthcare models, emphasizing convenience and accessibility, further propels the adoption of rapid diagnostic tools.

Technological Advancements Powering Market Growth

The infectious disease rapid diagnostics devices market is witnessing a technological renaissance. Innovations such as isothermal amplification, CRISPR-based detection, and ultrasensitive immunoassays have significantly enhanced diagnostic precision. These technologies have drastically reduced turnaround times, enabling clinicians to make real-time decisions.

Multiplexing—the ability to detect multiple pathogens or resistance genes in a single test—is among the most transformative advancements. Multiplex assays facilitate comprehensive diagnosis using minimal sample volumes, making them invaluable for syndromic testing, especially in cases of respiratory or gastrointestinal infections.

The integration of robotic automation and microfluidic cartridges is simplifying laboratory workflows, reducing human error, and increasing throughput. Similarly, lab-on-chip devices are miniaturizing laboratory functions onto compact platforms, making diagnostics more portable and efficient.

In parallel, the market is witnessing a shift toward digital connectivity and data analytics. Smart diagnostic devices capable of remote monitoring, cloud-based data storage, and AI-assisted interpretation are enabling real-time disease tracking and epidemiological insights, vital for pandemic preparedness.
Market Segmentation Insights

By Product Type: Antigen Tests Leading the Market

Among product categories, antigen tests dominate the global infectious disease rapid diagnostics devices market. These tests are valued for their affordability, ease of use, and ability to deliver results within 15–30 minutes. Antigen-based rapid tests detect pathogen-specific proteins without the need for specialized laboratory infrastructure, making them ideal for mass screening and community testing programs.

Their widespread adoption during the COVID-19 pandemic demonstrated their value in public health. Moreover, home-use antigen kits have empowered individuals to take greater control over their health, fostering market expansion into the consumer diagnostics segment.

Other Product Segments

• Antibody Tests: Useful for detecting past infections and evaluating immunity levels.
• Nucleic Acid Tests (NAT): Offer superior accuracy and sensitivity through molecular amplification.
• Isothermal Amplification Tests: Enable rapid detection without thermal cycling equipment.
• Microfluidic and Other Emerging Tests: Represent the next frontier of miniaturized, integrated diagnostics.

Regional Outlook

North America: The Market Leader

North America held the dominant share of the global infectious disease rapid diagnostics devices market in 2024. The region benefits from advanced healthcare infrastructure, government funding, and favorable reimbursement mechanisms. Continuous investments in R&D and the strong presence of leading diagnostic companies such as Abbott, Roche, and Thermo Fisher Scientific contribute to its leadership.

The high prevalence of infectious diseases, coupled with proactive government initiatives for disease surveillance and antimicrobial resistance management, further strengthens market growth in the U.S. and Canada. Additionally, regulatory flexibility—with emergency use authorizations and fast-track approvals—has accelerated the deployment of innovative diagnostic solutions.

Asia Pacific: Rapidly Emerging Hub

Asia Pacific is expected to witness the fastest growth during the forecast period, fueled by population growth, urbanization, and expanding healthcare infrastructure. Countries such as China, India, and Japan are heavily investing in local manufacturing and diagnostic R&D. The increasing adoption of POC testing in rural and semi-urban areas and the rising awareness about infectious diseases will contribute significantly to the region’s market expansion.

Europe and Other Regions

Europe remains a vital market due to strong regulatory frameworks, while Latin America and the Middle East & Africa are emerging markets benefiting from improved healthcare access and global health collaborations aimed at infectious disease control.

Competitive Landscape

The infectious disease rapid diagnostics devices market is highly competitive, with global leaders focusing on innovation, strategic partnerships, and portfolio expansion. Companies are emphasizing multiplex platforms, digital integration, and miniaturized device design to enhance product usability.

Key players include:

• F. Hoffmann-La Roche AG
• Abbott Laboratories
• Bio-Rad Laboratories, Inc.
• Thermo Fisher Scientific Inc.
• Becton, Dickinson and Company (BD)
• bioMérieux SA
• Diasorin S.p.A.
• Hologic, Inc.
• QuidelOrtho Corporation
• Siemens Healthineers AG
• Seegene Inc.
• QIAGEN
• Danaher Corporation
• Trinity Biotech
• Grifols

These firms are increasingly engaging in collaborations with academic institutions and healthcare providers to accelerate R&D and market penetration.

Recent Developments

• July 2025 – Seegene Inc. launched STAgora, a next-generation infectious disease analytics platform integrating real-time diagnostic data with statistical modeling to revolutionize outbreak detection and response.

• January 2024 – QIAGEN introduced new syndromic test panels (Gastrointestinal Panel 2 and Meningitis/Encephalitis Panel) for its QIAstat-Dx system in India, expanding its reach in emerging markets.

These developments underscore the ongoing industry emphasis on data-driven diagnostics and syndromic testing, which are poised to reshape the global diagnostics landscape.

The infectious disease rapid diagnostics devices market is at the forefront of a technological and healthcare transformation. With its valuation expected to more than double—from US$ 9.7 Bn in 2024 to US$ 20.2 Bn by 2035—the industry is becoming indispensable in modern medicine.

As infectious diseases continue to challenge global health, rapid diagnostics provide the key to early detection, timely treatment, and effective containment. Driven by innovation, affordability, and accessibility, the market is poised to play a pivotal role in safeguarding global populations and strengthening healthcare resilience in the years ahead.

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