Chemiluminescence Immunoassay Market – Global Industry Size, Share, Trends, Opportunity, & Forecast Segmented By Product (Instruments {Automated, Semi-automated}, Consumables, Software & Services), By Sample Type (Blood, Urine, Saliva, Other), By Application (Therapeutic Drug Monitoring, Oncology, Cardiology, Endocrinology, Infectious Disease, Autoimmune Disease, Other), By End User (Hospitals, Clinical Laboratories, Pharmaceutical & Biotechnology Companies, Other), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 12.63 Billion
CAGR (2026-2031)	5.02%
Fastest Growing Segment	Consumables
Largest Market	North America
Market Size (2031)	USD 16.94 Billion

Market Overview

The Global Chemiluminescence Immunoassay Market will grow from USD 12.63 Billion in 2025 to USD 16.94 Billion by 2031 at a 5.02% CAGR. Chemiluminescence Immunoassay (CLIA) is a diagnostic technique that employs a chemical reaction to emit light for the precise detection and quantification of antigens or antibodies in clinical samples. The market is fundamentally driven by the escalating global prevalence of chronic and infectious diseases, which necessitates high-throughput and accurate testing methodologies in laboratory settings. This demand is underscored by the significant scale of the diagnostics industry; according to MedTech Europe, in 2024, the European medical technology market was estimated to be roughly €170 billion, with in vitro diagnostics (IVD) constituting the largest sector.

However, the expansion of the Global Chemiluminescence Immunoassay Market is significantly challenged by the substantial capital investment required for automated analyzer platforms. The high acquisition cost of these instruments, combined with ongoing expenses for reagents and the requirement for specialized technical personnel, creates a financial barrier for smaller healthcare facilities and laboratories in resource-limited regions. Consequently, these economic constraints present a primary impediment that could slow the broader adoption of this diagnostic technology.

Key Market Drivers

The escalating global prevalence of chronic and infectious diseases is a primary driver of the Global Chemiluminescence Immunoassay Market. As the burden of these conditions intensifies, clinical laboratories rely on CLIA for its superior sensitivity and wide dynamic range compared to traditional methods. In oncology, precise biomarker detection is critical for early diagnosis and treatment monitoring. According to the American Cancer Society, January 2025, in the 'Cancer Facts & Figures 2025' report, it is projected that 2,041,910 new cancer cases will occur in the United States in 2025, creating substantial demand for immunoassay testing. High-sensitivity diagnostic tools are equally essential for managing infectious diseases, where early detection significantly improves patient outcomes, further cementing the technology's role in modern healthcare strategies.

Technological advancements in automated high-throughput CLIA platforms are simultaneously accelerating market growth by addressing operational challenges in modern laboratories. To manage rising testing volumes, diagnostic centers are transitioning from manual ELISA methods to fully automated chemiluminescence systems that offer faster turnaround times and reduced human error. This shift towards automation is reflected in the financial performance of industry leaders; according to the Roche Annual Report 2024, published in early 2025, the company's Diagnostics Division reported sales of CHF 14.3 billion, with base business growth significantly driven by the increased demand for immunodiagnostic products. Additionally, the broader market demonstrates resilience beyond pandemic-related spikes; according to Abbott, January 2025, in the 'Fourth Quarter and Full-Year 2024 Results', global Diagnostics sales excluding COVID-19 testing increased 4.3 percent, underscoring the sustained adoption of core diagnostic technologies.

Download Free Sample Report

Key Market Challenges

The substantial capital investment required for automated chemiluminescence immunoassay (CLIA) analyzers constitutes a major restraint on market growth. Smaller laboratories and healthcare facilities in resource-limited settings frequently lack the financial capacity to absorb the high upfront acquisition costs of these advanced instruments. Additionally, the recurring operational expenses, including proprietary reagents and specialized technical maintenance, further strain limited budgets. As a result, these economic barriers force many institutions to continue utilizing traditional, lower-cost diagnostic methods such as ELISA, thereby restricting the broader adoption of CLIA technology and directly impeding market expansion.

This financial limitation is clearly reflected in industry spending patterns, which reveal the constrained resources available to diagnostic departments. According to MedTech Europe, in 2024, expenditure on in vitro diagnostics accounted for approximately 0.6% of total healthcare expenditure. This statistic highlights the disproportionately small fraction of funds allocated to the diagnostics sector relative to overall healthcare spending. Such restricted financial allocation limits the purchasing power of laboratories, making the procurement of expensive automated CLIA platforms financially unfeasible for a large segment of the potential customer base, thus directly hampering global market growth.

Key Market Trends

The increased utilization of novel biomarkers for early detection is fundamentally reshaping the market, as clinical laboratories shift focus from routine screening to high-value specialty testing. This trend is characterized by the rapid adoption of advanced chemiluminescence assays designed for complex conditions such as autoimmunity, endocrinology, and latent infectious diseases, which offer higher diagnostic specificity than traditional methods. Manufacturers are aggressively expanding their test menus to include these niche biomarkers, thereby securing higher reimbursement rates and clinical relevance. This strategic pivot towards high-value diagnostics is evident in recent financial performances; according to DiaSorin, March 2025, in the 'FY 2024 Results' report, the company's ex-COVID immunodiagnostic revenues grew by 9% year-over-year, a performance explicitly attributed to the robust expansion of its specialty test menu and hospital strategy.

Simultaneously, the market is undergoing strategic consolidation through mergers and technology acquisitions, driven by the need for operational efficiency and comprehensive portfolio integration. As the industry matures, major diagnostic players are combining point-of-care capabilities with core laboratory infrastructure to create unified diagnostic ecosystems that address the fragmented nature of healthcare delivery. These mergers allow companies to realize significant cost synergies and streamline manufacturing processes, effectively countering the economic pressures of high capital equipment costs. This focus on integration and efficiency is delivering tangible financial results; according to QuidelOrtho, August 2025, in the 'Second Quarter 2025 Results' announcement, the corporation reported the successful realization of $100 million in annualized cost savings, validating the strategic operational efficiencies gained from its recent integration initiatives.

Segmental Insights

The Consumables segment is experiencing the most rapid expansion in the Global Chemiluminescence Immunoassay Market, driven by the continuous requirement for reagents and test kits in clinical laboratories. This growth is largely sustained by the rising volume of diagnostic tests performed for infectious and chronic disease management, which necessitates the frequent replenishment of supplies. Unlike instruments that represent singular capital investments, consumables generate recurring revenue streams due to their single-use nature. Additionally, the introduction of new test kits approved by regulatory bodies like the U.S. FDA broadens diagnostic capabilities, further ensuring a consistent and escalating demand for these essential materials.

Regional Insights

North America maintains a dominant position in the global chemiluminescence immunoassay market, driven by the rising incidence of chronic conditions and infectious diseases that necessitate precise diagnostic tools. This leadership is supported by a robust healthcare infrastructure and the concentrated presence of key industry manufacturers within the region. Additionally, the U.S. Food and Drug Administration plays a critical role by streamlining approvals for new diagnostic assays, thereby encouraging market expansion. The widespread adoption of automated laboratory systems in clinical settings further reinforces the region's strong market standing by improving testing throughput and reliability.

Recent Developments

• In September 2024, Sysmex Corporation announced the launch of the HISCL HIT IgG Assay Kit in Japan, specifically designed for use with its automated blood coagulation analyzers that incorporate chemiluminescence enzyme immunoassay technology. This new kit allows for the rapid and high-sensitivity measurement of IgG antibodies associated with heparin-induced thrombocytopenia, a potentially severe adverse drug reaction. By integrating this advanced chemiluminescent testing capability into their coagulation platforms, the company aims to improve the Global Chemiluminescence Immunoassay Market landscape by enabling faster diagnosis and better therapeutic management of platelet-related conditions, thereby enhancing patient safety and operational efficiency in hospitals.
• In April 2024, Beckman Coulter Diagnostics expanded the capabilities of its high-throughput chemiluminescence system by introducing new CE-marked hepatitis assays for the DxI 9000 Immunoassay Analyzer. Announced ahead of the ESCMID Global congress, the menu extension included tests for Hepatitis B and C viruses, specifically Access anti-HCV, Access HBsAg, and Access HBsAg Confirmatory assays. This advancement strengthens the company's position in the Global Chemiluminescence Immunoassay Market by providing laboratories with enhanced confidence in reporting accurate results for infectious diseases. The assays utilize validated algorithms that significantly reduce the need for repeat testing, thereby improving laboratory turnaround times and overall productivity.
• In April 2024, Mindray hosted a global launch event to introduce its new integrated diagnostic solutions designed for mid-sized laboratories, featuring the CL-2600i Chemiluminescence Immunoassay Analyzer. As a key component of the M680 integrated solution, this analyzer was developed to provide high throughput and robust performance in a compact footprint, specifically addressing the operational requirements of medium-volume facilities. This strategic launch underscores the company's commitment to advancing the Global Chemiluminescence Immunoassay Market by offering cost-effective, space-saving, and efficient automated systems that significantly streamline laboratory workflows and reduce the need for manual intervention in clinical diagnostic environments.
• In March 2024, DiaSorin S.p.A. announced that it received 510(k) clearance from the U.S. Food and Drug Administration for its new LIAISON PLEX platform and its first test panel, the Respiratory Flex Assay. This development is significant for the Global Chemiluminescence Immunoassay Market as it introduces a fully automated, multiplexing system that allows for the customization of syndromic panels. The platform supports a unique "Flex" testing capability, which enables laboratories to process and pay for only specific results based on a patient's clinical needs. This innovative approach is designed to optimize diagnostic stewardship and enhance cost-efficiency in clinical settings.

Key Market Players

• Abbott Laboratories Inc.
• Beckman Coulter, Inc
• DiaSorin S.p.A
• Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• F. Hoffmann-La Roche Ltd
• Siemens Healthineers AG
• QuidelOrtho Corporation

By Product	By Sample Type	By Application	By End User	By Region
Instruments {Automated Semi-automated} Consumables Software & Services	Blood Urine Saliva Other	Therapeutic Drug Monitoring Oncology Cardiology Endocrinology Infectious Disease Autoimmune Disease Other	Hospitals Clinical Laboratories Pharmaceutical & Biotechnology Companies Other	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Chemiluminescence Immunoassay Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Chemiluminescence Immunoassay Market, By Product:

• Instruments {Automated
• Semi-automated}
• Consumables
• Software & Services

• Chemiluminescence Immunoassay Market, By Sample Type:

• Blood
• Urine
• Saliva
• Other

• Chemiluminescence Immunoassay Market, By Application:

• Therapeutic Drug Monitoring
• Oncology
• Cardiology
• Endocrinology
• Infectious Disease
• Autoimmune Disease
• Other

• Chemiluminescence Immunoassay Market, By End User:

• Hospitals
• Clinical Laboratories
• Pharmaceutical & Biotechnology Companies
• Other

• Chemiluminescence Immunoassay Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE