Infectious Disease Testing Product Market to Reach USD 50.22 Billion by 2033 at 7.5% CAGR; North America Leads with 38% Share, Key Players Include F. Hoffmann-La Roche, Abbott

Market Overview

The global infectious disease testing product market reached US$ 24.41 billion in 2023, with a projected rise to US$ 26.12 billion in 2024, and is expected to reach US$ 50.22 billion by 2033, growing at a CAGR of 7.5% during the forecast period 2025-2033. The market is witnessing rapid expansion due to increasing prevalence of infectious diseases worldwide, rising demand for rapid and accurate diagnostics, and technological advancements in testing methodologies.

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Technological innovations are a major growth driver in the market. Advanced diagnostic techniques, such as polymerase chain reaction (PCR), next-generation sequencing (NGS), isothermal amplification, and multiplex panel testing, are enabling faster, more sensitive, and highly specific detection of pathogens. Innovations in point-of-care (POC) devices, automated testing systems, and high-throughput platforms have revolutionized clinical workflows, allowing healthcare professionals to diagnose infections in minutes to hours rather than days. These advances are particularly critical for managing highly contagious or severe infections, including COVID-19, influenza, tuberculosis, and other emerging pathogens, as early detection reduces complications, supports timely treatment, and helps prevent disease transmission.

Recent Developments:

✅ In September 2025, QIAGEN announced that its full QIAstat-Dx portfolio achieved CE-IVDR certification, including an expanded Meningitis/Encephalitis Panel. This certification reinforced the portfolio's role in clinical syndromic testing and highlighted QIAGEN's commitment to delivering high-quality infectious disease diagnostics to healthcare providers worldwide.

✅ in May 2025, SSI Diagnostica Group announced that CTK Biotech received CE-IVDR approval for three key rapid tests: OnSite Syphilis Ab Combo, OnSite Dengue Ag, and OnSite H. pylori Ag. This regulatory milestone enabled broader patient access to critical infectious disease diagnostics and expanded the group's global market footprint, strengthening its position in the competitive diagnostics industry.

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

Market Segmentation:

By product type, reagents dominate the market, accounting for approximately 45%, due to their essential role in sample preparation, amplification, and detection. Consumables hold around 30%, driven by recurring demand in high-throughput testing and routine diagnostics, while instruments represent about 25%, reflecting investment in automated and high-precision platforms.

By technology, polymerase chain reaction (PCR) is the leading technology with a 35% share, owing to its accuracy, sensitivity, and rapid detection capabilities. Sequencing and isothermal nucleic acid amplification technologies (INAAT) follow with shares of 20% and 15%, respectively, driven by applications in pathogen identification and variant detection. Mass spectrometry, chips and microarrays, in situ hybridization, and other emerging technologies collectively contribute 30%, reflecting increasing adoption in research and advanced diagnostic applications.

In terms of application, respiratory diseases testing leads with 28%, largely due to ongoing surveillance for COVID-19, influenza, and other viral infections. Tuberculosis and hepatitis testing follow with 20% and 15%, respectively, supported by government screening programs and global disease burden. Meningitis, human papillomavirus (HPV), and other applications together account for 37%, reflecting growing adoption in specialized clinical diagnostics and preventive care.

Regarding end-users, hospitals hold the largest share at 40%, driven by on-site diagnostics and patient care demands. Diagnostic laboratories contribute 30%, fueled by centralized testing services and high-throughput testing requirements. Clinics represent 20%, catering to point-of-care testing needs, while research institutes account for 10%, reflecting the use of infectious disease testing products in R&D, epidemiological studies, and translational research.

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Regional Insights:

North America dominates the market, accounting for approximately 38% of the global share, due to advanced healthcare systems, high adoption of molecular diagnostics, and substantial R&D investment by key players. The U.S. and Canada lead in deploying PCR, sequencing, and point-of-care testing for both routine and outbreak management.

Europe holds around 25% of the market, supported by stringent regulatory frameworks, government-led disease screening programs, and growing demand for rapid diagnostics. Countries like Germany, the U.K., and France are major contributors, leveraging advanced laboratory networks and public health initiatives.

Market Dynamics:

Drivers: The rising prevalence of infectious diseases is a major factor fueling the growth of the infectious disease testing product market. Increased cases of HIV, tuberculosis (TB), hepatitis, COVID-19, and emerging pathogens are driving demand for accurate, rapid, and accessible diagnostics. For instance, according to WHO, in 2023, an estimated 1.3 million people acquired HIV, with a case-fatality ratio of 0.91%. The Eastern Mediterranean Region reported over 23 million cases, accounting for 3.03% of the global burden, highlighting the ongoing impact. Similarly, respiratory diseases affect over 80 million people, many of whom remain undiagnosed worldwide.

Governments, public health agencies, and global health initiatives are investing heavily in screening, surveillance, and outbreak response, which encourages innovation in molecular diagnostics, point-of-care testing, and home-based technologies. The urgency for early detection and rapid intervention continues to drive demand for infectious disease testing products.

Restraints: The high cost of advanced diagnostic equipment and tests is a significant barrier to market growth. Complex technologies, including multiplex systems, PCR machines, and next-generation sequencing (NGS) platforms, require substantial capital investment. This limits adoption, particularly in rural areas and low- and middle-income countries (LMICs) with constrained healthcare infrastructure and budgets. For example, the Xpert MTB/RIF Ultra test by Cepheid, though WHO-approved and highly accurate, faces adoption challenges due to machine costs of $17,000-$25,000 and per-test costs of $10-$20, restricting accessibility in high-burden regions.

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