Chemiluminescence Immunoassay Market Size, Growth, Report 2022 to 2030

The chemiluminescence immunoassays market is expected to increase at a compound annual growth rate (CAGR) of about 7.6% from 2022 to 2030.

When a chemical reaction yields light, it can also emit electromagnetic radiation, which is known as chemiluminescence (CL). A method called chemiluminescence immunoassay (CLIA) combines immunochemical reactions with chemiluminescence. Chemical probes that can emit light as a result of a chemical reaction are used by CLIA to label the antibody.

Due to its high sensitivity, excellent specificity, straightforward equipment, and broad linear range, CLIA is employed in a number of industries, including life science, clinical diagnostics, environmental monitoring, food safety, and pharmaceutical analysis. Infectious disorders, autoimmune diseases, cardiovascular diseases, diabetes, obesity, and cancer are just a few of the chronic diseases that can be detected with chemiluminescence immunoassay (CLIA) solutions. For therapeutic medication monitoring, CLIA is also employed by a number of pharmaceutical firms and academic institutions.

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Market Growth

The market's high-impact key drivers are thought to include pharmaceutical companies' increased drug discovery and development efforts as well as the rising awareness of the importance of early identification of chronic diseases. The clinical diagnostic industry's research into assay development and molecular diagnostics has been greatly influenced by the COVID-19 pandemic. The prominent manufacturers' main area of focus is the urgent need to support the development of these diagnostic tools in order to reduce the effect and spread of the virus. With sensitivity rates ranging from 64% to 97%, several CLIA kits have been demonstrated to deliver quick findings.

Regional Analysis

At over 41% of the market in 2021, North America had the greatest share, and it is anticipated that it will continue to rule the market for the entire forecast period. The presence of advanced healthcare infrastructure, the high adoption of cutting-edge CLIA solutions, and the rising incidence of chronic diseases are some of the key drivers driving the regional market.

During the projected period, the CAGR for Asia Pacific is anticipated to be the fastest. One of the important elements driving the expansion of the regional market is the rising awareness of chronic diseases in developing nations like China and India. Additionally, it is expected that the regional market will expand as a result of local players' launches of novel CLIA systems and the expanding approval of CLIA systems.

Competitive Landscape

Some major corporations are actively acquiring other businesses and launching new products alongside them in order to strengthen their market positions globally. F. Hoffmann-La Roche AG, Mindray Medical International Limited, Siemens Healthineers AG, Danaher (Beckman Coulter Inc.), and DiaSorin S.p.A. are a few of the businesses now ruling the market.

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Report Scope

Report Coverage


Largest Market

North America

Fastest Growing Region

Asia Pacific

Growth Rate From 2022 to 2030

CAGR of 7.6%

Base Year


Forecast Period

2022 to 2030

Segments Covered         

  • By Product
  • By Application
  • By End User

Regions Covered

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa 

Report Highlights

Application Insights

  • Disorders, endocrine infectious diseases, cancer, cardiovascular disorders, hepatitis and retrovirus, allergies, drug research & development, autoimmune, and other conditions are among the many applications of the chemiluminescence immunoassay market. Endocrine collected a substantial revenue market share in 2021, and it is anticipated that it will continue to do so during the forecast years. Continuous advancements in test offerings and comprehensive product offerings from leading and regional manufacturers are the primary factors responsible for the development of this application area.

End-user Insights

  • Hospitals account for the majority of the market share in terms of various end-users and reported the highest revenue share of more than 35% in 2021. This administration is attributed to the growing demand for chemiluminescence immunoassay solutions in hospitals and an increase in hospital visits due to the rising incidence of infectious disorders and cancer. In line with this, it is projected that the increased hospitalization caused by the outbreak of novel coronaviruses will raise the need for chemiluminescence immunoassay products in the hospital sector.

Product Insights

  • The consumables sector received a significant share more than 70% of the overall market revenue produced in 2021 among the various product segments examined in this research study. Over the forecast period, this market sector is expected to maintain its dominance. This increase is attributable to the increased need for consumables, such as stains and reagents, in the fields of endocrinology, therapeutic medication monitoring, and disease analysis.

Recent Development

  • In June 2022, the most recent cutting-edge tissue staining platform was unveiled by Roche as the BenchMark ULTRA PLUS system. For use in in vitro diagnostic (IVD) procedures, the BenchMark ULTRA PLUS device is designed to automatically stain histological or cytological specimens on microscope slides with certain immunohistochemistry, immunocytochemistry, or in situ hybridization chemicals.
  • In January 2022, with the recently released Accre system, Wondfo, the Chinese medical firm, hopes to develop its avant-garde layout in CLIA diagnostics and enhance its CLIA platform. The Wondfo-Tisenc PoC chemiluminescence immunoassay (CLIA) product was introduced online with more than 800 spectators.

Market Dynamics

Market Drivers

The chemiluminescence immunoassay (CLIA), a promising method for selective, sensitive, quick, and straightforward analysis, has been used in a variety of fields including environmental monitoring, clinical diagnosis, liquid chromatography, pharmaceutical analysis, food safety, and immuno-and gene probe assays. According to a January 2022 article titled "Detection of Circulating Varicella-Zoster Virus (VZV)-Glycoprotein E (gE)-Specific Antibodies by Chemiluminescent Immunoassay (CLIA) for Varicella-Zoster Diagnosis," a CLIA approach-based detection kit is easy to use, suitable for high-throughput routine analysis situations, and also offers enhanced specificity compared to other (enzyme-linked immunoassay). Therefore, it is hoped that research like this that shows the effectiveness of CLIA procedures would fuel market expansion.

Market Drivers

On the market under study, the Covid-19 pandemic is predicted to have a significant effect. Due to the severe lockdown and shutdown during the early stages of the pandemic, laboratories, diagnostic centers, and research facilities were shuttered. This resulted in a drop in the number of assays carried out, which hampered the market's growth.

Market Opportunities

The market's major players are concentrating on the creation and introduction of cutting-edge CLIA solutions. The U.S. FDA approved Quanta Flash Rheumatoid Factor (RF) IgA and Quanta Flash Rheumatoid Factor (RF) IgM chemiluminescent tests in May 2019, according to Inova Diagnostics. Similar to this, in August 2018, China-based medical equipment maker Mindray Medical International Limited introduced its new CL900i, a fully automated benchtop chemiluminescence immunoassay. During the projection period, it is anticipated that the launch of such unique solutions will promote market expansion.

Market Segmentation

By Product

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

By Application

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

By End-use

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

Regional Segmentation

  • North America (U.S., Canada, Mexico)
  • Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
  • Asia-Pacific (China, Japan, India, Southeast Asia and Rest of APAC)
  • Latin America (Brazil and Rest of Latin America)
  • Middle East and Africa (GCC, North Africa, South Africa, Rest of MEA)

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