Immunoassay Market worth $44.49 billion by 2031 - Exclusive Report by MarketsandMarkets™

DELRAY BEACH, Fla., Oct. 22, 2026 /PRNewswire/ -- According to MarketsandMarkets™, the Immunoassay Market is projected to reach USD 44.49 billion by 2031 from USD 31.65 billion in 2026, at a CAGR of 7.0% during the forecast period.

Browse 550 market data tables and 70 figures spread through 500 pages and in-depth TOC on the "Immunoassay Market- Global Forecast to 2031"

Immunoassay Market Size & Forecast:

• Market Size Available for Years: 2026–2031
• 2026 Market Size: USD 31.65 billion
• 2031 Projected Market Size: USD 44.49 billion
• CAGR (2026–2031): 7.0%

Immunoassay Market Trends & Insights:

• By region, Asia Pacific is expected to register the fastest growth in the immunoassay market during the forecast period, driven by rising healthcare expenditure, the growing prevalence of chronic and infectious diseases, expanding diagnostic infrastructure, and the increasing adoption of advanced immunoassay technologies across emerging economies.
• By product, the reagents & kits segment accounted for the largest market share of 84.1% in 2025, primarily due to their recurring use across a broad range of immunoassay tests, increasing testing volumes, and continuous demand for consumable reagents and kits in hospitals, clinical laboratories, and other healthcare settings.
• By technology, the chemiluminescence immunoassay (CLIA) segment accounted for the largest market share of 49.7% in 2025, driven by its high sensitivity and specificity, broad dynamic range, rapid turnaround time, and compatibility with automated and high-throughput laboratory systems.

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The immunoassay market is driven by the increasing incidence of chronic and infectious diseases, growing demand for early and accurate disease diagnosis, and expanding use of immunoassays across infectious diseases, oncology, endocrinology, cardiology, blood screening, and other diagnostic applications. Rising adoption of automated and high-throughput testing systems, increasing demand for point-of-care and rapid testing, expansion of the biotechnology and biopharmaceutical industries, and growing drug, alcohol, and cannabis screening requirements further support market growth. Increasing healthcare expenditure and diagnostic infrastructure development in emerging economies are also contributing to the adoption of immunoassay technologies. Chemiluminescence immunoassay (CLIA) remains widely adopted because of its high sensitivity and specificity, rapid turnaround time, broad dynamic range, and compatibility with automated laboratory systems.

Continued technological advancements are improving assay sensitivity, specificity, automation, throughput, and workflow efficiency. Manufacturers are expanding assay menus, developing condition-specific biomarkers and tests, integrating microfluidics, and introducing automated and multiplexed immunoassay platforms. Increasing integration of immunoassay systems with laboratory automation, connectivity, and digital diagnostic solutions is also enabling streamlined workflows and improved data management. These developments are expected to support the broader adoption of advanced immunoassay technologies across clinical laboratories, hospitals, blood banks, and other healthcare settings.

By technology, the chemiluminescence immunoassay (CLIA) segment accounted for the largest share of the global immunoassay market in 2025.

Based on technology, the global immunoassay market is segmented into ELISA, chemiluminescence immunoassay (CLIA), immunofluorescence assay (IFA), rapid tests, western blotting, and other technologies. Among these, CLIA is expected to account for the largest share of the market because of its high sensitivity and specificity, faster turnaround time, broad dynamic range, and compatibility with automated and high-throughput testing platforms. The increasing demand for rapid, accurate diagnostic testing, coupled with the growing adoption of automated immunoassay systems across clinical laboratories and healthcare settings, further supports the widespread use of CLIA globally.

"By end user, hospitals & clinics accounted for the largest share of the immunoassay market in 2025."

By end user, the immunoassay market is segmented into hospitals & clinics, clinical laboratories, blood banks, and home care settings. In 2025, hospitals & clinics accounted for the largest share of the market, mainly because of their central role in diagnostic testing across a broad range of acute and chronic conditions. The availability of advanced immunoassay platforms, high patient volumes, and the increasing adoption of automated and multiplexed testing systems further support the use of immunoassays in these settings. In addition, integrating immunoassay testing into routine diagnostics, disease screening, and patient monitoring is expected to sustain demand for immunoassay products in hospitals & clinics.

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North America accounted for the largest share of the immunoassay market in 2025.

North America held the largest share of the immunoassay market in 2025, supported by well-established diagnostic companies, advanced healthcare infrastructure, and high adoption of sophisticated diagnostic technologies. The US was a major contributor to the region's market share, driven by strong demand for immunoassay-based testing across clinical and research settings. The increasing burden of chronic and infectious diseases, along with the widespread adoption of automated and point-of-care immunoassay platforms, further supported market growth in the region.

In addition, strong collaboration among regulatory agencies, healthcare institutions, and research organizations has supported advancements in immunoassay technologies and diagnostic testing standards. Regulatory oversight and research initiatives have improved assay validation, accuracy, traceability, and reproducibility, facilitating the adoption of advanced immunoassay technologies across healthcare settings. These factors, combined with continued investments in diagnostic infrastructure and technological advancements, are expected to reinforce North America's position as a major market for immunoassay technologies during the forecast period.

Key Players

Leading players in the Immunoassay companies include Abbott Laboratories (US), F. Hoffmann-La Roche (Switzerland), Siemens Healthineers (Germany), Thermo Fisher Scientific Inc. (US), Danaher Corporation (US), Revvity (US), Becton, Dickinson and Company (US), DiaSorin S.p.A. (Italy), and Bio-Rad Laboratories (US).

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Immunoassay Market- Investment & funding +Merger & Acquisition

Investment & Funding Context

The immunoassay market has witnessed continued product development, strategic investment, and acquisition activity during 2023–2026, supported by rising demand for automated diagnostics, point-of-care testing, and advanced assay technologies. Companies are investing in solutions that improve testing speed, accuracy, automation, and workflow efficiency. Recent transactions include Roche's acquisition of LumiraDx's point-of-care technology and bioMérieux's acquisition of SpinChip Diagnostics, strengthening their portfolios in integrated and point-of-care immunoassay testing. Strategic investments and acquisitions are also supporting the expansion of assay menus, diagnostic platforms, and geographic market reach.

Revenue Shift Context

The immunoassay market is shifting toward higher-value, automated, and technologically advanced diagnostic solutions, supported by rising demand for accurate, rapid testing, automated laboratory workflows, high-throughput platforms, and advanced assay technologies. Revenue growth is increasingly supported by chemiluminescence immunoassay (CLIA) platforms, particularly those integrated with automated and high-throughput laboratory systems, as well as growing adoption across infectious disease testing, oncology, cardiology, endocrinology, and blood screening. The global immunoassay market is projected to grow from USD 31.65 billion in 2026 to USD 44.49 billion by 2031, at a CAGR of 7.0%.

Mergers & Acquisitions

Mergers & acquisitions in the immunoassay market are primarily focused on expanding diagnostic portfolios, strengthening point-of-care capabilities, and advancing assay technologies. Recent transactions, including Roche's acquisition of LumiraDx's point-of-care technology and bioMérieux's acquisition of SpinChip Diagnostics, highlight growing interest in integrated and point-of-care immunoassay platforms.

IMMUNOASSAY MARKET: MERGERS & ACQUISITIONS, JANUARY 2024–AUGUST 2026

Company Revenue Share Details

The top five players in the global immunoassay market are estimated to account for a significant portion of total market revenue in 2025, reflecting a highly consolidated competitive landscape. Abbott Laboratories (US), F. Hoffmann-La Roche Ltd. (Switzerland), Siemens Healthineers AG (Germany), Danaher Corporation (US), and Bio-Rad Laboratories, Inc. (US) are among the leading participants, supported by established immunoassay platforms, broad assay portfolios, extensive distribution networks, and strong relationships with hospitals, clinical laboratories, blood banks, and research institutions. These leading companies benefit from growing demand for automated, high-throughput immunoassay testing, particularly for infectious diseases, oncology, endocrinology, cardiology, and blood screening. Continued investments in assay development, automation, platform integration, diagnostic accuracy, workflow efficiency, and expansion of testing menus further support their competitive positions.

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