Chemiluminescence Immunoassay Market, By Product (Instrument, Consumable, Reagent [Luminophore, Enzymatic Marker], Software & Service), Technology (CLEIA, ECLI), Sample Type, Application, End-use – Global Forecast (2024 – 2032)

Chemiluminescence Immunoassay Market, By Product (Instrument, Consumable, Reagent [Luminophore, Enzymatic Marker], Software & Service), Technology (CLEIA, ECLI), Sample Type, Application, End-use – Global Forecast (2024 – 2032)

Chemiluminescence Immunoassay Market Size

Chemiluminescence Immunoassay Market size was valued at around USD 9.8 billion in 2023 and is estimated to grow at 7.3% CAGR from 2024 to 2032. Chemiluminescence immunoassay (CLIA) is a laboratory technique used to detect specific molecules (such as proteins, hormones, drugs, or antibodies) in biological samples. It combines the principles of chemiluminescence, which is the emission of light resulting from a chemical reaction, with the specificity of immunoassay techniques.

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The escalating prevalence of chronic conditions such as cardiovascular diseases, diabetes, cancer, and infectious diseases such as COVID-19 has underscored the urgent need for accurate diagnostic solutions. According to the World Health Organization (WHO), Noncommunicable Diseases (NCDs) claim 41 million lives annually, amounting to approximately 74% of global fatalities, with 17 million deaths occurring before age 70. Cardiovascular diseases top the list with 17.9 million fatalities, followed by cancers (9.3 million), chronic respiratory diseases (4.1 million), and diabetes (2.0 million, including deaths from diabetes-related kidney disease). Therefore, as the prevalence of these chronic conditions increases, chemiluminescence immunoassay (CLIA) emerges as a pivotal technology, offering remarkable sensitivity and specificity for the diagnosis and monitoring of various medical conditions.

Furthermore, CLIA has found expanding applications beyond clinical diagnostics, particularly in drug development and clinical research. Pharmaceutical companies use CLIA for biomarker analysis, pharmacokinetic studies, and therapeutic drug monitoring. Its ability to quantify specific analytes with high precision and sensitivity makes CLIA an indispensable tool in these fields.
 

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Chemiluminescence Immunoassay Market Trends

• The field of chemiluminescence immunoassay (CLIA) has undergone significant technological advancements, enhancing its sensitivity, speed, and automation capabilities. These advancements include the introduction of novel assay formats, enhanced instrumentation with advanced optical detection systems, and the development of sophisticated reagents tailored specifically for CLIA applications.
• Moreover, automation features have streamlined laboratory workflows, reducing human error and enabling high-throughput analysis. Therefore, these innovations have transformed CLIA into a versatile and indispensable diagnostic tool, with broad applications in clinical laboratories and research settings worldwide.

Chemiluminescence Immunoassay Market Analysis

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Based on product, the market is divided into instruments, consumables, reagents, and software & services. The consumables segment of the chemiluminescence immunoassay industry is forecast to reach USD 8.2 billion by 2032, displaying robust growth propelled by several key factors.

• There is a growing trend towards decentralized healthcare and point-of-care testing which is estimated to reach USD 78.3 billion, driven by the need for rapid and convenient diagnostic solutions. CLIA consumables, especially those compatible with point-of-care CLIA analyzers, are witnessing increased demand due to their ability to deliver quick and accurate results outside traditional laboratory settings.
• Further, CLIA assays are widely used in pharmaceutical and biotechnology companies for drug discovery, development, and clinical trials. The demand for CLIA consumables is expected to surge as these industries continue to invest in research and development activities aimed at bringing innovative therapies to market.

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Based on technology, the chemiluminescence immunoassay market is bifurcated into chemiluminescence enzyme technology (CLEIA), electrochemiluminescence immunoassay (ECLI), and microparticle chemiluminescence immunoassay. The chemiluminescence enzyme technology (CLEIA) segment accounted for USD 5.8 billion in 2023.

• The exceptional sensitivity and specificity of CLEIA make it essential for precise diagnosis and monitoring of diseases. Its adaptability enables the detection of a wide array of analytes in diverse healthcare and research settings.
• Automated features facilitate efficient high-throughput analysis, streamlining laboratory operations. Moreover, the stability of chemiluminescent enzymes utilized in CLEIA ensures consistent assay performance over extended periods.
• Further, backed by its established market presence, regulatory endorsements, and continual innovations, CLEIA remains at the forefront of technology, making substantial contributions to market revenue.

Based on sample type, the market is divided into blood, urine, saliva, and other sample types. The blood segment of the chemiluminescence immunoassay industry is forecast to reach USD 9 billion by 2032, displaying robust growth propelled by several key factors.

• Blood-based CLIA assays are highly convenient and accessible in healthcare settings due to the routine collection of blood samples during medical examinations. This accessibility enables swift and efficient testing procedures, facilitating timely diagnosis and treatment decisions, thereby enhancing patient care.
• Furthermore, these assays are distinguished by their exceptional accuracy and sensitivity in detecting various biomarkers and analytes. Advancements in assay technologies allow for precise quantification of target molecules in blood samples, including hormones, enzymes, infectious agents, and tumor markers.
• Thus, these factors collectively propel the growth of the segment.

Based on application, the chemiluminescence immunoassay market is bifurcated into therapeutic drug monitoring, oncology, cardiology, endocrinology, infectious diseases, autoimmune diseases, blood screening, toxicology, newborn screening, metabolic disorder, gastroenterology, respiratory, and other applications. The infectious diseases segment accounted for USD 2 billion in 2023.

• Infectious diseases remain a significant global health concern, with conditions such as HIV/AIDS, hepatitis, tuberculosis, and COVID-19 posing ongoing challenges. For instance, according to World Health Organization (WHO), in 2022, TB caused 1.3 million deaths, including 167,000 co-infected with HIV, making it the second leading infectious cause of death worldwide, surpassing HIV/AIDS. There were 10.6 million new TB cases, affecting 5.8 million men, 3.5 million women, and 1.3 million children, highlighting its global prevalence across all demographics.
• Hence, the considerable prevalence and incidence rates of these illnesses underscore the need for efficient diagnostic instruments such as CLIA to promptly detect and address them, thereby driving market expansion.

Based on end-use, the market is bifurcated into hospitals, clinical laboratories, pharmaceutical & biotechnology companies, and other end-users. The hospitals segment accounted for USD 3.9 billion in 2023.

• Hospitals serve as primary healthcare centers where a wide array of diseases and conditions are diagnosed and treated. Given the versatility and reliability of chemiluminescence immunoassay in detecting diseases such as infectious diseases, autoimmune disorders, and cancer markers, hospitals heavily rely on this technology for timely and accurate diagnoses.
• Additionally, the high patient influx in hospitals necessitates efficient diagnostic tools such as CLIA to expedite the diagnostic process and ensure prompt patient management, further bolstering the market share of this segment.

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The U.S. chemiluminescence immunoassay market is forecasted to reach USD 6.6 billion by 2032.

• Ongoing progress in diagnostic technologies, especially in immunoassay methods, is anticipated to fuel market expansion within the nation. Chemiluminescence immunoassay, known for its heightened sensitivity and specificity, emerges as a favored option across diverse diagnostic needs.

The market in UK is expected to experience significant and promising growth from 2024 to 2032.

• Government efforts focused on enhancing healthcare infrastructure, fostering research and development, and bolstering diagnostic capabilities are anticipated to stimulate investments in CLIA technologies. Funding assistance from governmental bodies, research institutions, and private investors will expedite the advancement and market introduction of cutting-edge CLIA platforms, thereby propelling market expansion within the nation.

Japan chemiluminescence immunoassay industry is anticipated to witness lucrative growth between 2024 – 2032.

• There is a growing demand for point-of-care testing (POCT) in Japan, stimulated by the need for rapid diagnosis and decentralized healthcare delivery. CLIA platforms capable of delivering fast and reliable results are well-suited for POCT applications, further fueling market growth.

The market in Saudi Arabia is expected to experience significant and promising growth from 2024 to 2032.

• The prevalence of chronic diseases such as diabetes, cardiovascular diseases, and cancer is on the rise in Saudi Arabia due to changing lifestyles, urbanization, and an aging population. Chemiluminescence immunoassays play a crucial role in the early detection and management of these conditions, driving their adoption in clinical laboratories across the country.

Chemiluminescence Immunoassay Market Share

The chemiluminescence immunoassay sector is competitive in nature, with a mix of major global and smaller to medium-sized companies competing for market share. A pivotal aspect of market strategy involves the continual introduction of innovative products leveraging diverse technologies. Notably, prominent industry players command considerable influence in this dynamic landscape, often driving forward advancements through substantial investments in research and development. Additionally, strategic alliances, acquisitions, and mergers are instrumental in fortifying market positions and expanding global footprint amidst evolving regulatory landscapes.

Chemiluminescence Immunoassay Market Companies

Some of the eminent market participants operating in the chemiluminescence immunoassay industry include

• Abbott Laboratories
• Bio-Rad Laboratories, Inc.
• Danaher corporation
• DiaSorin S.p.A
• Eurofins Scientific SE
• F. Hoffmann-La Roche Ltd
• H.U. Group Holdings, Inc.
• Maccura Biotechnology Co., Ltd.
• Revvity, Inc.
• Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Shenzhen New Industries Biomedical Engineering Co., Ltd.
• Siemens Healthineers AG
• Thermo Fisher Scientific Inc.
• Tosoh Corporation
• Werfen

Chemiluminescence Immunoassay Industry News

• In July 2023, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. acquired DiaSys Diagnostic Systems GmbH (“DiaSys”) from Gorka Holding GmbH. This acquisition enhanced the company's overseas supply chain platform and facilitated the expansion of its in-vitro diagnostics (IVD) business into medium to large customer segments, thereby boosting the company's revenue.
• In February 2023, Siemens Healthineers and Unilabs launched a strategic partnership to enhance patient care through the latest in-vitro diagnostic testing infrastructure. Siemens Healthineers' solutions aim to reduce unnecessary workflow friction with intuitive system user interfaces and improve cost savings and profitability through integrated reagents and consumables. This collaboration enabled the company to harness the power of science and data, enhancing its offerings in the diagnostic healthcare landscape.

The chemiluminescence immunoassay market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments

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Market, By Product

• Instruments
  • Automated
  • Semi-automated
• Consumables
• Reagents
  • Luminophore markers
  • Enzymatic markers
• Software & services

Market, By Technology

• Chemiluminescence enzyme technology (CLEIA)
• Electrochemiluminescence immunoassay (ECLI)
• Microparticle chemiluminescence immunoassay

Market, By Sample Type

• Blood
• Urine
• Saliva
• Other sample types

Market, By Application

• Therapeutic drug monitoring
• Oncology
• Cardiology
• Endocrinology
• Infectious diseases
• Autoimmune diseases
• Blood screening
• Toxicology
• Newborn screening
• Metabolic disorder
• Gastroenterology
• Respiratory
• Other applications

Market, By End-use

• Hospitals
• Clinical laboratories
• Pharmaceutical & biotechnology companies
• Other end-users

The above information is provided for the following regions and countries

• North America 
  • U.S.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
  • Rest of Europe
• Asia Pacific 
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America 
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa 
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa