The global infectious disease in vitro diagnostics market size was estimated at USD 24.30 billion in 2024 and is projected to reach USD 28.05 billion by 2030, growing at a CAGR of 2.5% from 2025 to 2030. The market’s growth is primarily driven by several key factors, including the increasing geriatric population that is more vulnerable to infectious diseases, rising awareness about the importance of early testing, high demand for point-of-care (PoC) diagnostics following the COVID-19 pandemic, and the rising global prevalence of infectious diseases. These factors collectively contribute to the steady expansion of the market over the forecast period.

The industry experienced a significant transformation during the COVID-19 pandemic, which acted as a catalyst for innovation and rapid product development. The introduction of novel diagnostic tools and test kits for SARS-CoV-2 testing marked a major shift in the market landscape. The heightened demand for rapid, accurate, and accessible testing solutions led to widespread adoption of advanced diagnostic technologies, which fueled exponential market growth in recent years.

Looking ahead, the expanding elderly population worldwide and the presence of untapped market opportunities in developing economies are expected to further accelerate market growth. An example of this is the initiative by the Moroccan biotech company Moldiag, which, in December 2024, launched Africa’s first domestically produced mpox (monkeypox) test kits. This milestone represented a major advancement toward reducing the continent’s dependence on imported medical supplies. The kits, developed in response to the World Health Organization’s declaration of mpox as a global emergency, have been approved by the Africa CDC and priced at USD 5 per kit. They are currently being distributed across several African countries, including Burundi, Uganda, Congo, Senegal, and Nigeria. Such developments underscore the growing emphasis on local manufacturing and self-reliance in diagnostic testing.

Furthermore, the increasing prevalence of infectious diseases continues to be a major driver of revenue growth in the IVD sector. The aging population, in particular, contributes significantly to testing demand, as older adults require frequent diagnostic evaluations to prevent or manage infections effectively. Countries with higher elderly populations—such as Japan, Germany, Russia, and the U.S.—are expected to see strong adoption of in vitro diagnostic tests. As healthcare systems worldwide prioritize early detection, disease prevention, and improved patient outcomes, the infectious disease IVD market is poised for steady and sustained expansion in the coming years.

Key Market Trends & Insights:

• In 2024, North America held a dominant position in the infectious disease in vitro diagnostics (IVD) market, accounting for 39.56% of the global market share. The region’s strong market presence can be attributed to advanced healthcare infrastructure, early adoption of innovative diagnostic technologies, and a high awareness level regarding infectious disease testing and prevention. These factors, combined with continuous R&D investments and favorable regulatory frameworks, have reinforced North America’s leadership in the global market.

• Within the region, the U.S. infectious disease in vitro diagnostics market is anticipated to witness consistent growth over the forecast period. This growth is driven by the country’s increasing emphasis on preventive healthcare, rising prevalence of infectious diseases, and ongoing technological advancements in diagnostic testing. Moreover, strong government support, the presence of leading diagnostic manufacturers, and high healthcare expenditure further contribute to the market’s expansion in the U.S.

• Based on product type, the reagents segment led the global market in 2024, capturing 67.63% of the total revenue share. Reagents play a crucial role in diagnostic testing processes, as they are essential for accurate and reliable test results. The rising demand for high-quality, cost-effective reagents—particularly in molecular and immunoassay testing—continues to drive segment growth. Frequent purchases of reagents for routine and specialized diagnostic testing also contribute to the segment’s dominant position in the market.

• When analyzed by technology, the immunoassay technology segment accounted for the largest revenue share of 35.73% in 2024. Immunoassay-based diagnostics are widely used due to their high specificity, sensitivity, and rapid detection capabilities. These tests are extensively applied in detecting various infectious agents, including bacteria, viruses, and fungi. Continuous innovation in automated immunoassay platforms and the growing preference for point-of-care immunodiagnostics are further enhancing this segment’s growth potential.

• In terms of application, the COVID-19 testing segment represented the largest market revenue share of 14.86% in 2024. The ongoing need for COVID-19 detection, surveillance, and monitoring has maintained significant testing volumes even after the peak of the pandemic. Additionally, the continued emergence of new variants and the integration of COVID-19 testing into broader infectious disease panels have sustained this segment’s prominence in the overall market.

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Market Size & Forecast:

• 2024 Market Size: USD 24.30 Billion

• 2030 Projected Market Size: USD 28.05 Billion

• CAGR (2025-2030): 2.5%

• North America: Largest market in 2024

Key Companies & Market Share Insights:

Key players operating in the infectious disease in vitro diagnostics (IVD) market are actively implementing a range of strategic initiatives aimed at reinforcing their market position and expanding the global reach of their products and services. These companies are focusing on business expansion activities, such as establishing new production facilities, enhancing distribution networks, and entering emerging markets to cater to the growing demand for advanced diagnostic solutions.

In addition to expansion, strategic partnerships, collaborations, and alliances with healthcare institutions, diagnostic laboratories, and technology providers are playing a crucial role in driving market growth. Such partnerships enable companies to integrate innovative technologies, improve test accuracy, and accelerate the development of next-generation diagnostic platforms.

Furthermore, these initiatives allow key players to strengthen their competitive edge by combining resources, sharing expertise, and enhancing their ability to respond to evolving healthcare challenges. Collectively, these strategic efforts are fostering innovation, improving accessibility to diagnostic solutions, and ultimately propelling the overall growth of the infectious disease in vitro diagnostics market.

Key Players

• QIAGEN

• BD

• bioMérieux SA

• F. Hoffmann-La Roche, Ltd.

• Hologic, Inc. (Gen Probe)

• Abbott

• Quidel Corporation

• Siemens Healthineers AG

• Bio-Rad Laboratories, Inc.

• Danaher

• OraSure Technologies, Inc.

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Conclusion:

The global infectious disease in vitro diagnostics (IVD) market is witnessing steady growth, driven by rising awareness about early disease detection, increasing prevalence of infectious diseases, and a growing elderly population prone to infections. The COVID-19 pandemic significantly accelerated product innovation and adoption of diagnostic technologies, particularly in point-of-care testing. Expanding diagnostic access in emerging markets and continuous advancements in reagents and immunoassay technologies are further supporting market expansion. Moreover, strategic initiatives such as partnerships, product launches, and geographic expansion by key players are enhancing global reach and strengthening the market’s position across both developed and developing regions.