Chemiluminescence Immunoassay Market

Market Overview

The global chemiluminescence immunoassay market size was valued at USD 6.64 billion in 2021 and is projected to reach USD 12.73 billion by 2030 at a CAGR of 7.5% from 2022 to 2030.

Chemiluminescence immunoassay (CLIA) is a biochemical technique that is used for the detection and monitoring of 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 provides a significant boost to the existing healthcare diagnostics and monitoring domain and provides key insights to physicians and medical practitioners enabling them to identify and treat various disorders.

Market Dynamics

Rising Demand for Chemiluminescence Immunoassay to Address the Surging Prevalence of Chronic Diseases 

The chemiluminescence immunoassay technique finds wide application in the field of clinical diagnostics for the detection of chronic diseases, such as cancer, infectious diseases, cardiovascular diseases, autoimmune diseases, diabetes mellitus, and neurological diseases. Chronic diseases are the leading causes of disability and mortality across the globe. Thus, the use of CLIA based clinical diagnostics is very pronounced within the healthcare system, owing to the rising incidence of these diseases.

As per the reports from the World Health Organization (WHO), in 2019, an estimated 1.76 million new cases of cancer have been diagnosed and accounted for 606,880 deaths within the U.S. Further, infectious diseases, cardiovascular diseases, and others have been on the rise across all regions. For instance, according to the American Heart Association, in the U.S., in 2019, coronary diseases were expected to occur in about 1.05 million individuals that include 720,000 new and 335,000 existing coronary disease cases.

Product Developments and Technological Advancements 

The chemiluminescence immunoassay market is primarily driven by the continuous developments within the market, such as product launches, key technological advancements, business strategies, and other progressions in the market. As the market is growing steadily, the players in the market are showing great focus and investing heavily in the development and launch of technologically advanced chemiluminescence immunoassay solutions.

For instance, in August 2020, DiaSorin, an Italian multinational biotechnology company, received approval as Emergency Use Authorization (EUA) from the U.S. FDAfor the latest product LIAISON SARS-CoV-2 S1/S2 IgG test. This test is primarily based on chemiluminescence immunoassay (CLIA)technology and is aimed to address the accurate diagnosis of COVID-19 positive patients.

Furthermore, in August 2018, Mindray Medical International Limited, a medical device manufacturer based out of China, released CL900i, which is a fully automated benchtop chemiluminescence immunoassay. Thus, the continuous and frequent introduction of products and growing activities from market players are expected to support market growth during the forecast period.

Segmental Analysis

Shifting Focus on the Development of Technologically Advanced Chemiluminescence Immunoassay Systems Drives the Instruments Segment Growth

By products, the consumables segment dominated the chemiluminescence immunoassay (CLIA) market in 2019 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, every time a specific quantity and number of consumables are utilized. Thus, as more and more tests are been run, the demand and hence adoption of consumables is sky-rocketed.

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.

Infectious Disease Segment Dominates the Global Market

By application, the infectious disease segment dominated the global market, owing to the growing demand of 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 LIAISON QuantiFERON-TB Gold Plus assay that is aimed to be used for the detection of latent tuberculosis infection on 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 is 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, owing to such high patient volume, the diagnostic demand has been immense, which directly influences the segment growth.

Regional Analysis

Presence of Developed Healthcare Infrastructure and High Disposable Income Drives North America’s Chemiluminescence Immunoassay Market

North America’s chemiluminescence immunoassay market is largely driven by the presence of developed healthcare infrastructure, high disposable income, high adoption of CLIA systems, and increasing prevalence of chronic diseases. The regional market witnesses easier and higher accessibility to novel CLIA systems as many market players, such as Abbott Laboratories, Beckman Coulter, Inc., DiaSorin, and Roche, are based out of the region and have a primary business focus on the regional market.

Additionally, emerging business strategies such as collaborations and partnerships provide a significant boost to the regional market. For instance, in April 2020, the U.S.based startups, Accelerate Diagnostics, Inc. and BioCheck, Inc. agreed on a distribution agreement for sales and distribution of BioCheck's fully-automated CLIA analyzer, BioCheck’s MS-FAST system, and BioCheck's SARS-CoV-2 tests in the regional market.

APAC’s Chemiluminescence Immunoassay Market to Attain High Growth Rate

Increasing awareness about chronic diseases in emerging economies, such as China and India, which also houses a major chunk of the global population, drives Asia-Pacific’s market growth. Furthermore, growing developments and launches in the regional market, coupled with increasing approval of novel chemiluminescence immunoassay systems by regulatory bodies, is expected to boost the market. Several local players are also anticipated to support regional market growth through innovations and product launches. For instance, in 2018, Shenzhen Mindray Bio-Medical Electronics Co., Ltd., an Asian medical device manufacturer based out of China, released its new product called CL-6000i CLIA analyzer at the China International Medical Equipment Fair.

Chemiluminescence Immunoassay Market Segmentation

By Product

• Instruments
  • Automated
  • Semi-Automated
• Consumables
• Software and Services

By Application

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

By End-User

• Hospitals and Clinics
• Medical and Diagnostic Laboratories
• Pharmaceutical and Biotechnology Companies
• Research Institutes

By Region

• Americas
• Europe
• Asia-Pacific
• The Middle East and Africa