Chemiluminescence Immunoassay Market Size, Share & Trends Analysis Report By Product (Instruments, Consumables, Software & Services), By Sample Type (Blood, Urine, Saliva, Others), By Application (Therapeutic Drug Monitoring, Oncology, Cardiology, Endocrinology, Infectious Disease, Autoimmune Disease, Others), By End User (Hospitals and Clinics, Medical and Diagnostic Laboratories, Pharmaceutical and Biotechnology Companies, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2025-2033

Chemiluminescence Immunoassay Market Size

The global chemiluminescence immunoassay market size was valued at USD 12.25 billion in 2024 and is projected to grow from USD 12.79 billion in 2025 to reach USD 17.21 billion by 2033, exhibiting a CAGR of 3.78% during the forecast period (2025-2033).

Chemiluminescence immunoassay (CLIA) is a biochemical technique used to detect and monitor chronic disorders. The process is a quantitative and qualitative diagnostic testing technique carried out in a CLIA analyzer. These chemiluminescence immunoassays (CLIA) analyzers are used extensively to run a diagnosis of various diseases, such as inherited genetic disease, infectious disease, and cardiovascular disease, among others. Thus, it significantly boosts the existing healthcare diagnostics and monitoring domain and provides key insights to physicians and medical practitioners, enabling them to identify and treat various disorders.

Chemiluminescence Immunoassay Market Growth Factors

In the global market for chemiluminescence immunoassay analyzers, the presentation of cutting-edge coordinated immunoassays is an unmistakable mechanical trend. On October 31, 2017, Abbott disclosed that the Alinity ci-series, hardware for clinical science and immunoassay diagnostics, had been granted FDA 510(k) exemption. This development in multiplexed tests is anticipated to drive the CLIA analyzers market over the forecast period. The introduction of cutting-edge coordinated immunoassays on the market for chemiluminescence immunoassay analyzers is a significant mechanical trend.

• For example, on October 31, 2017, Abbott announced that the Alinity ci-series, clinical science, and immunoassay indicative instruments had been granted FDA 510(k) clearance. This development in multiplexed tests is anticipated to drive the global CLIA market over the forecast period.

Due to sedentary lifestyles and poor weight management, the prevalence and incidence of chronic diseases are increasing. According to the World Health Organization (WHO), there were 18,1 million new cases of cancer and 9,6 million deaths worldwide in 2018. Due to the aging population, chronic disease prevalence has increased over time. In addition, smoking and BMI, both significant risk factors for chronic infections such as disease and cardiovascular disease, are driving the market growth.

Market Restraining Factors

CLIA is one of the market's most recent and sophisticated immunoassay techniques. CLIA technique has a number of advantages over other conventional techniques, including ELISA and RIA. In spite of its numerous benefits, the CLIA technique has a number of limitations. A significant disadvantage of the CLIA technique is the high cost of initialization. In emerging economies such as India, Brazil, and South Africa, these expensive devices are not widely adopted, which is anticipated to impede the market's growth in the near future.

Market Opportunity

CLIA technique is widely used in clinical diagnostics to detect chronic diseases such as infections, cardiovascular diseases, cancer, autoimmune diseases, diabetes mellitus, and neurological disorders. These chronic diseases are the leading worldwide causes of disability and death. CLIA is anticipated to be in high demand because the incidence of these diseases is on the rise, thereby increasing their prevalence. According to data published by Globocan, approximately 18,078,957 new cancer cases were diagnosed worldwide in 2018. In addition, the American Diabetes Association reported that approximately 34,2 million (10.5% of the population) Americans had diabetes in 2018.

Regional Insights

It is anticipated that North America will continue to be the most dominant region in the market throughout the forecast period. In 2021, North America held the largest share of the market, accounting for more than 40 percent of the total market share. There is a developed healthcare infrastructure present, there is a high adoption rate of technologically advanced CLIA solutions, and there is an increasing prevalence of chronic diseases. These are key factors that are driving the market in this region. In addition, the presence of key players in the United States market, such as Abbott Laboratories, Beckman Coulter, Inc., DiaSorin, and Roche, is anticipated to support the growth of the regional market. This growth is anticipated to be supported by the presence of key players in the United States market. It is anticipated that this factor will contribute, at least in part, to the availability of novel CLIA systems in the United States.

Asia Pacific: fastest growing region with the highest CAGR

It is anticipated that Asia Pacific will experience growth at the highest CAGR during the period under consideration. One of the primary factors that are contributing to the expansion of the regional market is the growing consciousness about the prevalence of chronic diseases in developing economies like China and India. In addition, it is anticipated that the increasing approval of CLIA systems and the launch of novel CLIA systems by local players will support the expansion of the regional market. At the China International, Medical Equipment Fair in 2018, the Chinese medical device manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd. debuted its brand new CL-6000i CLIA analyzer (CIMEF Spring 2018).

Moreover, due to the introduction of new products and approvals by market participants, the global chemiluminescence immunoassay market is anticipated to expand significantly in Europe over the forecast period. On July 13, 2021, for instance, Sysmex Europe GmbH, a subsidiary of the Sysmex Corporation located near Hamburg, Germany, announced the launch of new hemostasis products in specific EMEA countries: the automated blood coagulation analyzers CN-3500 and CN-6500, aimed at medium- and large-scale hospitals, commercial labs, and other facilities. The new instruments from Sysmex feature a measuring unit that utilizes the chemiluminescence enzyme immunoassay technique.

Product Insights

The global chemiluminescence immunoassay market is segmented into instruments, consumables, and software & services. The consumables segment dominated the chemiluminescence immunoassay (CLIA) market in 2021 as consumables, such as reagents and stains, used in immunoassays during diagnostics or drug monitoring, endocrinology and disease diagnosis are consumed more often than other market products.

• For instance, for running a single diagnostic, a specific quantity and number of consumables are utilized every time. Thus, as more and more tests are run, the demand and hence adoption of consumables skyrocketed.

On the other hand, the instruments segment holds a significant share of the global market on account of the rising initiatives by key players, shifting focus on the development of technologically advanced chemiluminescence immunoassay systems, and growing product launch with high throughput and accuracy. For instance, in August 2017, Beckman Coulter, a renowned medical device manufacturer, introduced an improved version of its existing Access 2 immunoassay system that now provides higher workflow efficiency, ease of use, reliability, and enhanced customer satisfaction.

Application Areas Insights

The market is divided into therapeutic drug monitoring, oncology, cardiology, endocrinology, infectious disease, autoimmune disease, and others. The infectious disease segment dominated the global market, owing to the growing demand for diagnostic means for infectious diseases within the healthcare network. Further, the introduction of novel chemiluminescence immunoassay assays for the diagnosis of infectious diseases and various beneficial features are influencing great adoption within the end-users. For instance, in September 2018, DiaSorin and Qiagencollaboratively launched the LIAISON QuantiFERON-TB Gold Plus assay that aims to be used to detect latent tuberculosis infection on the LIAISON analyzer.

The oncology segment, on the other hand, is witnessing significant growth on account of the high prevalence of cancer across the globe and increasing awareness about the positives of early diagnosis. As per the WHO, in September 2018, cancer was recognized as the second leading cause of mortality globally. Statistically, in 2018, it has been estimated that cancer is responsible for around one in six deaths globally. Thus, due to such a high patient volume, the diagnostic demand has been immense, directly influencing segment growth.

End-Users Insights

The chemiluminescence immunoassay market is divided into hospitals, clinic laboratories, pharmaceutical & biotechnology companies, and others. In 2021, hospitals dominated the market with a share of more than 35.0%. This is attributable to the rising demand for CLIA solutions in hospitals and the rise in hospital visits resulting from the increasing prevalence of cancer and infectious diseases. In addition, the rise in hospitalization due to the outbreak of a novel coronavirus is anticipated to increase hospitals' demand for CLIA-compliant solutions.

In 2021, the clinical laboratories segment held a sizeable market share. The expansion of this market segment can be attributed to clinical laboratories' cost-effective testing services. In addition, an increase in strategic partnerships between major players and clinical laboratories is anticipated to contribute to the segment's growth.

Recent Developments

• In June 2022, Roche introduced the BenchMark ULTRA PLUS system as the most cutting-edge platform for tissue staining.
• In January 2022, With the newly released Accre system, Wondfo, a Chinese medical company, intends to develop its cutting-edge CLIA diagnostics layout and CLIA platform. More than 800 individuals observed the introduction of the Wondfo-Tisenc PoC chemiluminescence immunoassay (CLIA) product.
• In June 2020, Abbott announced that it had begun shipping its laboratory-based serology blood test to detect the IgG antibody for COVID-19 identification. This contributes to the ICMR's COVID-19 antibody testing strategy utilizing IgG CLIA antibody tests.
• In January 2018, DiaSorin S.p.A. collaborated with QIAGEN N.V. to incorporate the QuantiFERON-TB diagnostic test into its LIAISON family of fully automated analyzers.
• In October 2017, Abbott announced the acquisition of Alere Inc., a provider of diagnostic devices and services.