Rapid Diagnostic Tests (RDTs) Market Revenue, Opportunity, Business Segment Overview and Key Trends 2031

Rapid Diagnostic Tests (RDTs) Market Overview:

The Rapid Diagnostic Tests (RDTs) market is projected to grow at a compound annual growth rate (CAGR) of 4.5% between 2026 and 2031. This growth is driven by the increasing adoption of point-of-care (POC) diagnostics, the availability of technologically advanced rapid testing devices, a rising prevalence of infectious and chronic diseases, and the expanding global geriatric population.

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Rapid diagnostic tests are easy-to-use diagnostic procedures that deliver results in under 20 minutes. Unlike conventional diagnostic tests that require laboratory analysis, RDTs are performed and interpreted directly at the point of care. These tests are widely used for the detection of infectious diseases such as influenza, malaria, HIV, and COVID-19, among others. Key advantages—including rapid turnaround time, minimal training requirements, ease of use, and limited or no need for specialized equipment—have significantly accelerated their adoption across healthcare settings.

Impact of COVID-19 on the Rapid Diagnostic Tests Market

The COVID-19 pandemic had a substantial and largely positive impact on the RDTs market. Demand for rapid tests designed to detect SARS-CoV-2 surged dramatically during 2020 and 2021. However, the pandemic also temporarily disrupted sales of RDTs used for cancer screening, blood glucose monitoring, cardiac markers, and other infectious disease diagnostics. Despite these challenges, the past two years have seen notable advancements and strategic developments in the RDTs market.

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Key developments include:

• October 2021: The NIH Rapid Acceleration of Diagnostics (RADx) initiative awarded $77.7 million in contracts to support the development and manufacturing of 12 high-performance, low-cost rapid diagnostic tests for SARS-CoV-2, including home-based and POC solutions.
• September 2021: LumiraDx launched its SARS-CoV-2 Antigen Surveillance Test in the U.S. for use in schools and workplaces. The test enables simultaneous analysis of up to five samples, delivers digital results within 12 minutes, and costs approximately $4 per sample.
• July 2021: The U.S. Department of Defense, in collaboration with the Department of Health and Human Services, awarded LightDeck Diagnostics a $35.1 million contract to expand production of its ultra-rapid SARS-CoV-2 antigen and total antibody tests.
• March 2021: FUJIFILM Corporation introduced the FUJIFILM COVID-19 Ag Test, leveraging highly sensitive silver halide amplification technology for SARS-CoV-2 detection.
• March 2020: Becton, Dickinson and Company and BioMedomics released a point-of-care antibody test capable of confirming COVID-19 exposure from a blood sample within 15 minutes.

Collaborations and Acquisitions Driving Market Expansion

Strategic collaborations and acquisitions have played a crucial role in boosting RDT adoption and accelerating the development of advanced diagnostic solutions. Notable initiatives include:

• April 2022: bioMérieux entered into an agreement to acquire Specific Diagnostics, a developer of rapid antimicrobial susceptibility testing (AST) systems, aimed at combating antimicrobial resistance.
• February 2022: Sorrento Therapeutics acquired a majority stake in Zhengzhou Fortune Bioscience Co., Ltd., enhancing manufacturing capabilities for COVISTIX—a rapid antigen test with improved sensitivity for detecting the Omicron variant and other SARS-CoV-2 variants of concern.
• February 2021: Becton, Dickinson and Company partnered with Scanwell Health to develop a smartphone-enabled at-home rapid SARS-CoV-2 test combining antigen testing with mobile app integration.
• February 2021: Thermo Fisher Scientific completed its acquisition of Mesa Biotech, strengthening its point-of-care molecular diagnostics portfolio and enabling faster scale-up of RDT manufacturing.

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Technical Limitations Hindering Market Growth

Despite their advantages, RDTs face several technical challenges that may limit market expansion. These include lower sensitivity compared to laboratory-based tests, the risk of false-negative results, and the absence of robust evaluative processes in certain regions.

• Lower sensitivity: RDTs generally exhibit lower sensitivity than diagnostic methods such as ELISA and PCR, often necessitating confirmatory laboratory testing.
• False negatives: Early-stage infections may not be detected by RDTs, potentially delaying treatment initiation and contributing to disease progression.
• Lack of evaluative frameworks: In low-resource settings, inadequate assessment mechanisms and limited diagnostic accuracy studies raise concerns about real-world test performance.

To address quality and reliability concerns, the World Health Organization (WHO) is independently evaluating and pre-qualifying RDTs for diseases such as HIV and malaria. Despite existing limitations, ongoing technological advancements and the growing global burden of infectious diseases are expected to sustain strong growth in the rapid diagnostic tests market.

Competitive Landscape

The global rapid diagnostic tests market is highly competitive and includes major players such as Abbott Laboratories, Bio-Rad Laboratories, F. Hoffmann-La Roche Ltd., Becton, Dickinson and Company, ACON Laboratories, and several other regional and international manufacturers.

Related Report:

HPV Testing and PAP Test Market - https://www.pharmiweb.com/press-release/2025-12-18/hpv-testing-and-pap-test-market-share-size-growth-forecast-till-2030

Cellular Health Screening Market - https://www.pharmiweb.com/press-release/2025-12-18/cellular-health-screening-market-2030-analysis-size-share-growth-trends-and-forecast

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