The global chemiluminescence immunoassay market size was valued at USD 6.63 billion in 2020 and is projected to expand at a substantial CAGR during the forecast period, 2021 – 2028. The growth of the market is attributed to the introduction of the technological advancement of chemiluminescence immunoassay systems along with the superior occurrence of chronic diseases.
Chemiluminescence immunoassay (CLIA) involves a testing procedure that combines the chemiluminescence technique with the immunochemical reactions. It mainly involves the emission of radiation to produce light by using electromagnetic means. Owing to its wide applications, CLIA as a main testing technique is widely adopted in various fields such as life sciences, environmental monitoring, pharmaceutical analysis, clinical diagnosis, and food safety.
With reference to the difference of chemistry mechanism, CLIA follows three label systems such as direct involvement on light emission reaction, enzyme catalyzed reaction, and redox mediated reaction. In a direct involvement, photons will be exposed when the present chemicals reach ground state from excited state. This process is basically done with light emissions alone, which was one of the first processes followed by the hospitals and clinics to analyze diseases such as tumors and cancer. In the enzyme catalyzed reaction, an enzyme is directly linked to the parent immunoassay which acts as a chemical substrate in the place of chromogen. In other words, an enzyme is used as a catalyst to speed up the light emissions to the treatment. The final redox mediated reaction works on this same principle, the difference being instead of the enzyme acting as the catalyst, a mediated redox reaction or a chemical flow acts as the catalyst. This process requires more precision but is incredibly accurate. This process is widely followed by the new innovative clinics which charges exorbitantly but shows results immediately.
Market Trends, Drivers, Restraints, and Opportunities
- The major driver for the chemiluminescence immunoassay market is the increasing awareness by the pharmaceutical companies about the importance of early diagnosis and drug discovery.
- The key players in the market have started focusing on technologically advanced solutions with respect to the chemiluminescence immunoassay. The solutions produced by these companies can also act as a major driver to the market.
- Expensive in the setup for the chemiluminescence immunoassay and lack of feasible healthcare infrastructures in emerging economies such as India, South Africa, and Brazil are key challenges that can restrain the market growth.
- Massive R&D studies have found new methodologies to prevent the widespread of the coronavirus using chemiluminescence immunoassay. This is expected to create several opportunities for the market expansion.
Scope of the Report
The report on the global chemiluminescence immunoassay market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.
Attributes | Details |
Report Title | Chemiluminescence Immunoassay Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast |
Base Year | 2020 |
Historic Data | 2018–2019 |
Forecast Period | 2021–2028 |
Segmentation | Products (Instruments [Automated and Semi Automated], Consumables, and Software & Services), Application Areas (Therapeutic Drug Monitoring, Oncology, Cardiology, Endocrinology, Infectious Disease, Autoimmune Disease, and Others), and End-users (Hospitals, Clinic Laboratories, Pharmaceutical & Biotechnology Companies and Others) |
Regional Scope | Asia Pacific, North America, Latin America, Europe, and Middle East & Africa |
Report Coverage | Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, Trends, and Revenue Forecast |
Key Players Covered in the Report | |
Global Chemiluminescence Immunoassay Market Segment Insights
Consumables segment dominated the market
On the basis of products, the chemiluminescence immunoassay market is segmented into instruments, consumables, and software & services. The instruments segment is further bifurcated into automated and semi-automated. The consumables segment held over 75.7% of the global market in 2020 and is anticipated to constitute a high market share expanding at 7.5% CAGR during the forecast period. The segment growth is attributed to the increase in demands for various consumables such as the reagents & stains found in therapeutic drug monitoring, disease and endocrinology diagnosis. Within the segment, the automated instruments occupies a share of more than 75% of the total share owing to the growing dependence of instruments especially in the developing economies such as India, South Africa, and Brazil. Moreover, these equipment are cost effective compared to the entire setup of the chemiluminescence immunoassay redox mediated reaction.
Infectious disease segment to account for a large market share
Based on application areas, the market is divided into therapeutic drug monitoring, oncology, cardiology, endocrinology, infectious disease, autoimmune disease, and others. The infectious disease segment represented a revenue share of over 20.3% of the market in 2020 and is projected to account for a large market share in the coming years. The segment growth can be attributed to the rapid establishment of novel chemiluminescence immunoassay required for the study of infectious diseases. In September 2018, for instance, DiaSorin launched a new assay called the QuantiFERON-TB Gold Plus for the identification of tuberculosis infection. DiaSorin made a partnership with LIASION for this project and later went on to acquire the company.
On the other hand, the oncology segment is anticipated to exhibit a large CAGR during the forecast period owing to the rising demand for diagnosis due to rising prevalence of fatal illness such as cancer, tumors, and now the COVID-19. Moreover, vast oncology studies and research activities conducted by various promising players for finding treatments and cures is a key driver for the segment growth.
Hospitals segment is anticipated to represent a large revenue share
Based on the end-users, the chemiluminescence immunoassay market is divided into hospitals, clinic laboratories, pharmaceutical & biotechnology companies and others. Of these segments, the hospitals segment is anticipated to register a large share, expanding at a substantial CAGR during the forecast period due to the rising demand of chemiluminescence immunoassay solutions required in hospitals. Requirement to frequent visits to hospitals for the treatment of many fatal illnesses is another key driver for the segment growth. As the COVID-19 pandemic reaching its second wave, governments and other administrative bodies across the globe have advised people to get vaccinated and many testing kits are being widely distributed in hospitals. Moreover, several researchers and scientists are using the chemiluminescence immunoassay solutions to try find a treatment plan and hospitals provide the perfect platform for vaccination distribution.
On the other hand, the clinical laboratories segment is expected to account for a significant market share in the coming years owing to rising deployment of cost effective equipment in these laboratories. The increase in number of strategic partnerships between the clinical laboratories and the key players present another key factor pushing the growth of this segment.
North America to hold a large market share
In terms of regions, the market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America dominated the market in terms of revenue in 2020 and is projected to hold a large market share in the coming years. Exiting advanced healthcare infrastructure, technological superiority, increasing prevalence of chronic diseases, and the high adaption of chemiluminescence immunoassay solutions are some of the key factors driving the regional market growth. Additionally, the presence of key global players in the region especially in the US acts as key driver for the market expansion in North America. Most of the major regional companies in this market are Beckman Coulter Inc, Roche, Abbott Laboratories, or DiaSorin S.p.A.
The market in Asia Pacific, however, is projected to exhibit a high CAGR during the forecast period, 2021-2028 owing to increase in awareness of the importance of chemiluminescence immunoassay and the rapid adoption of the technology to implement in the healthcare infrastructure products. For example, in 2018, a China-based medical device manufacturer, the Shenzhen Mindray Bio-Medical Electronics Co Ltd launched its new chemiluminescence immunoassay analyzer called the CL-6000i to double the efficiency of the analyzers used in North America with less prices. DiaSorin S.p.A., in August 2020, received the Emergency Use Authorization for the launch of their new test called the LIAISON SARS-CoV-2 S1/S2 IgG. The test is studied and researched upon the chemiluminescence immunoassay principle and technology used for the analysis of COVID-19.

Segments
Segments Covered in the Report
The global chemiluminescence immunoassay market has been segmented in terms of
Products
- Instruments
- Consumables
- Software & Services
Application Areas
- Therapeutic Drug Monitoring
- Oncology
- Cardiology
- Endocrinology
- Infectious Disease
- Autoimmune Disease
- Others
End-users
- Hospitals
- Clinic Laboratories
- Pharmaceutical & Biotechnology Companies
- Others
Regions
- Asia Pacific
- North America
- Latin America
- Europe
- Middle East & Africa
Key Players
- DiaSorin S.p.A
- Abbott Laboratories
- Shenzhen Mindray Bio-Medical Electronics Co.Ltd
- Immunodiagnostic Systems
- Siemens Healthineers
- Beckman Coulter Inc
- F.Hoffmann-La Roche AG
- Inova Diagnostics Inc
- Maccura Biotechnology Co Ltd
- Ortho Clinical Diagnostics.
Competitive Landscape
Some of the key players competing in the chemiluminescence immunoassay market are DiaSorin S.p.A; Abbott Laboratories; Shenzhen Mindray Bio-Medical Electronics Co.Ltd; Immunodiagnostic Systems; Siemens Healthineers; Beckman Coulter Inc; F.Hoffmann-La Roche AG; Inova Diagnostics Inc; Maccura Biotechnology Co Ltd; and Ortho Clinical Diagnostics. The emerging players, on the other hand, have started implementing growth strategies such as partnerships and collaborations to achieve a competitive edge with respect to other key players. For instance, in April 2020, two US-based companies Accelerate Diagnostic and BioCheck have entered into a strategic partnership for the distribution of chemiluminescence immunoassay solutions, which are proven to be more efficient than some of the competitive products in this market.
