Infectious Disease Testing Products Market to Reach US$ 50.22 Billion by 2033, Growing at a CAGR of 7.5% | North America Leads with 40% Share | Key Players: Roche, Abbott, Cepheid

Market Overview

The global infectious disease testing product market reached US$ 24.41 billion in 2023 and is projected to rise to US$ 26.12 billion in 2024, ultimately reaching US$ 50.22 billion by 2033, growing at a CAGR of 7.5% during the forecast period 2025-2033. Market growth is primarily driven by technological advancements in infectious disease diagnostics. Innovations such as polymerase chain reaction (PCR), next-generation sequencing, isothermal amplification, and multiplex panels allow faster, highly sensitive, and specific detection of pathogens.

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Point-of-care (POC) devices, automated systems, and high-throughput platforms are enabling healthcare providers to identify infections in minutes to hours rather than days, improving patient outcomes and facilitating early intervention. For highly contagious or severe diseases such as COVID-19, influenza, and tuberculosis, early and accurate detection is crucial for reducing complications, initiating prompt treatment, and controlling disease transmission.

Recent Key Developments:

✅ January 2026: Abbott Laboratories received regulatory clearance for its next-generation multiplex PCR assay, capable of simultaneous detection of multiple respiratory pathogens, enabling faster and more comprehensive diagnostic results at point of care.

✅ December 2025: Roche Diagnostics launched the cobas® BV/CV PCR assay, designed for rapid and accurate detection of bacterial vaginosis and candida vaginitis from a single patient sample, enhancing laboratory testing efficiency.

✅ November 2025: bioMérieux expanded its BIOFIRE® FILMARRAY® multiplex PCR portfolio with FDA clearance for new syndromic panels, improving comprehensive pathogen detection across gastrointestinal and other infectious disease categories.

✅ October 2025: Becton, Dickinson and Company (BD) received FDA 510(k) clearance for its BD Phoenix M50 and BDXpert informatics system, integrating rapid identification and antimicrobial susceptibility testing to support more accurate infectious disease diagnostics.

✅ September 2025: Thermo Fisher Scientific expanded its molecular diagnostics capacity by investing in increased manufacturing and distribution capabilities, bolstering availability of high-throughput PCR reagents and instruments in the Asia-Pacific region.

Mergers & Acquisitions
✅ January 2026: Becton, Dickinson and Company (BD) agreed to merge its Biosciences & Diagnostic Solutions business with Waters Corporation in a strategic reverse Morris Trust transaction valued at US$ 17.5 billion, creating a stronger combined diagnostics and life‐science tools platform that enhances infectious disease and molecular testing capabilities.

✅ October 2025: Abbott Laboratories announced a definitive agreement to acquire Exact Sciences in a major healthcare acquisition valued at approximately US$ 21 billion, expanding its diagnostics division and broadening its testing portfolio, with implications for infectious disease screening and molecular diagnostics.

Key Players:
F. Hoffmann-La Roche Ltd | Abbott Laboratories | Cepheid | Bio-Rad Laboratories | QIAGEN | Siemens Healthcare | Hologic, Inc. | Others

Key Highlights
F. Hoffmann-La Roche Ltd: Holds 20% market share, driven by its strong molecular diagnostics portfolio, high-throughput PCR platforms, and global presence in infectious disease testing.

Abbott Laboratories: 18% share; supported by multiplex PCR assays, point-of-care rapid testing devices, and extensive distribution in clinical and decentralized settings.

Cepheid: 15% share; specializes in rapid, fully automated molecular diagnostics systems, including the widely used GeneXpert® platform.

Bio-Rad Laboratories: 12% share; provides instruments, reagents, and consumables for molecular and immunology-based infectious disease testing.

QIAGEN: 10% share; leverages its sample-to-answer solutions and bioinformatics expertise for pathogen detection and outbreak surveillance.

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Regional Insights:

North America: 40% (Largest share, driven by well-established healthcare infrastructure, high adoption of advanced molecular diagnostics, and strong R&D investments by key players such as Roche and Abbott).

Europe: 25% (Significant market presence due to stringent regulatory frameworks, adoption of point-of-care testing, and widespread implementation of infectious disease surveillance programs).

Asia Pacific: 25% (Fastest growing region, fueled by rising healthcare awareness, expanding clinical laboratories, government initiatives to control infectious diseases, and increasing adoption of rapid diagnostic technologies in China, India, Japan, and South Korea).

Rest of the World (RoW): 10% (Gradual adoption in Latin America, Middle East, and Africa, supported by increasing investments in diagnostic laboratories, awareness campaigns, and partnerships with global diagnostics providers).

Market Dynamics:

Drivers:
The increasing prevalence of infectious diseases is a major driver of the infectious disease testing product market. Rising cases of HIV, tuberculosis (TB), hepatitis, COVID-19, and other emerging pathogens are fueling demand for rapid, accurate, and accessible diagnostic solutions.

For example, in 2023, an estimated 1.3 million people acquired HIV, with a case-fatality ratio of 0.91%, while the Eastern Mediterranean Region reported over 23 million cases, accounting for 3.03% of the global burden. Respiratory diseases affect more than 80 million people worldwide, many of whom remain undiagnosed, highlighting the critical need for widespread testing.

Governments, public health agencies, and global health initiatives are investing heavily in screening programs, surveillance, and outbreak response, which is accelerating innovation in molecular diagnostics, point-of-care testing, and home-based platforms. These initiatives are expanding access and improving early detection, which in turn drives market growth.

Restraints:
The high cost of advanced diagnostic tools and testing platforms remains a significant restraint. Technologies such as multiplex PCR systems, next-generation sequencing (NGS) platforms, and automated molecular analyzers require substantial initial capital investment, which limits adoption in low- and middle-income countries (LMICs) and rural healthcare settings.

For instance, the Xpert MTB/RIF Ultra test by Cepheid, despite being WHO-approved and highly accurate, faces adoption challenges due to high costs approximately $17,000-$25,000 for the instrument and $10-$20 per test making it less accessible in resource-limited, high-burden regions.

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Market Segmentation:

By Product Type
The market is segmented into reagents, consumables, and instruments. Reagents dominate with 45% share, as they are essential for molecular, immunological, and point-of-care assays. Instruments account for 35%, driven by increasing adoption of automated PCR systems, sequencers, and high-throughput platforms. Consumables make up 20%, including pipettes, tips, plates, and other single-use items required for testing workflows.

By Technology
In terms of technology, polymerase chain reaction (PCR) holds the largest share at 40%, owing to its high sensitivity, specificity, and broad adoption for infectious disease diagnostics. Sequencing technologies follow with 20%, fueled by next-generation sequencing (NGS) platforms for pathogen surveillance. Isothermal nucleic acid amplification technologies account for 15%, popular in rapid and point-of-care testing. Chips and microarrays hold 10%, mass spectrometry contributes 5%, and in situ hybridization and other emerging technologies together account for 10% of the market.

By Application
By application, respiratory diseases dominate with 35% share, driven by high prevalence of influenza, COVID-19, and other respiratory infections. Tuberculosis (TB) accounts for 20%, reflecting ongoing global TB burden and screening initiatives. Hepatitis and human papillomavirus (HPV) testing hold 15% and 10% shares, respectively. Meningitis accounts for 10%, and other infectious diseases such as HIV, dengue, and malaria make up 10% of the market.

By End User
By end user, hospitals are the largest segment at 40%, followed by diagnostic laboratories at 30%, reflecting centralized testing and high patient volumes. Clinics account for 20%, driven by rapid and point-of-care testing adoption. Research institutes hold 10%, focusing on infectious disease research, pathogen discovery, and epidemiological studies.

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