Chemiluminescence Immunoassay (CLIA) Market
Number of pages: 100 | Report Format: PDF | Published date: April 28, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023 to 2031
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Report Attribute |
Details |
|
Market Size Value in 2022 |
US$ 5.70 billion |
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Revenue Forecast in 2031 |
US$ 9.51 billion |
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CAGR |
5.67% |
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Base Year for Estimation |
2022 |
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Forecast Period |
2023 to 2031 |
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Historical Year |
2021 |
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Segments Covered |
Product Type, Application, End User, and Region |
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Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global chemiluminescence immunoassay (CLIA) market was valued at US$ 5.70 billion in 2022 and is expected to register a revenue CAGR of 5.67% to reach US$ 9.51 billion by 2031.
Chemiluminescence Immunoassay (CLIA) Market Fundamentals
Chemiluminescence (CL) is defined as the discharge of electromagnetic radiation caused by a compound response to produce light. Chemiluminescence immunoassay (CLIA) is a test that combines chemiluminescence and immunochemical reactions. Compared to other recognized immunoassays (RIA, FIA, ELISA), CLIA employs compound tests that can cause light emission via synthetic response to identify the immunizer. Because of its high sensitivity, good specificity, a wide range of applications, simple equipment, and wide linear range, chemiluminescent immunoassay (CLIA) has gained increasing attention in various fields. It has gained attention in fields including life science, clinical diagnosis, environmental monitoring, food safety, and pharmaceutical analysis. Chemiluminescent analytical methods have several advantages, including high signal intensity, low reagent consumption, high stability of reagents-their conjugates, random access, reduced incubation time, wide dynamic range, high specificity, and compatibility with immunology assay protocols (homogeneous or heterogeneous).
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Chemiluminescence Immunoassay (CLIA) Market Dynamics
With the increasing demand for accurate and reliable diagnostic tests, there is a growing need for CLIA assays with high sensitivity and specificity. New CLIA assays are being developed to detect very low concentrations of analytes in complex matrices, making them ideal for clinical and environmental testing. There is a trend toward automating CLIA assays to improve efficiency, reduce errors, and provide faster results. Advances in robotic technology, miniaturization, and integration with data management software are driving this trend. Multiplexing refers to the simultaneous measurement of multiple analytes in a single sample. This is becoming increasingly important in clinical diagnostics, where clinicians must quickly and accurately identify multiple biomarkers to diagnose complex diseases. CLIA assays are well-suited to multiplexing, as they can be easily adapted to measure multiple analytes in a single assay. Point-of-care testing (POCT) is diagnostic testing performed at the patient's bedside or in a physician's office. This approach offers several benefits, including faster turnaround time, reduced healthcare costs, and improved patient outcomes. CLIA assays are well-suited for POCT due to their high sensitivity, specificity, and ease of use. There is ongoing research to develop new chemistries for CLIA assays that can improve performance and reduce costs. For instance, researchers are exploring using nanoparticles, microfluidics, and new luminescent materials to enhance sensitivity, selectivity, and signal-to-noise ratios.
The rising prevalence of chronic illnesses such as cancer, cardiovascular disease, and infectious diseases is growing demand for CLIA analyzers. Various analyzers aid in properly diagnosing and monitoring various disorders, both of which are required for efficient therapy. Adoption is driven by developing sophisticated CLIA analyzers that provide faster and more accurate readings. These analyzers also include characteristics that improve their use and efficiency, including automation, fast throughput, and connection.
However, CLIA requires specialized equipment, reagents, and expertise, making it more expensive than other immunoassay techniques. CLIA involves several steps, including sample preparation, incubation with specific antibodies, and detection using chemiluminescent substrates. Each step requires careful optimization and control, making the process time-consuming and technically demanding. CLIA relies on the specificity of antibodies for detecting analytes. However, some antibodies may cross-react with structurally similar molecules, leading to false-positive or false-negative results. CLIA is typically performed to detect a single analyte at a time, making it less suitable for high-throughput or multiplexed analysis. The presence of other components in the sample matrix, such as proteins, lipids, and ions, can interfere with the chemiluminescence reaction, affecting the sensitivity and accuracy of CLIA. Although CLIA is highly sensitive, it may not detect analytes present at very low concentrations or in complex matrices.
Chemiluminescence Immunoassay (CLIA) Market Ecosystem
The global chemiluminescence immunoassay market has been analyzed from the following perspectives: product type, application, end user, and region.
Chemiluminescence Immunoassay (CLIA) Market by Product Type
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Based on the product type, the global chemiluminescence immunoassay market can be further segmented into analyzers, reagents, and consumables.
Analyzers segment accounts for a prominent revenue share in the global market. Analyzers are automated systems that allow for high standardization and reproducibility, reducing variability in the assay results. This makes them highly attractive to clinical laboratories and diagnostic centers. Analyzers can process a large number of samples in a relatively short period, making them ideal for high-throughput testing. This is particularly important for clinical laboratories that must process large volumes of samples daily. Many analyzers allow for multiplexing, enabling simultaneous detection of multiple analytes in a single sample. This reduces the time and cost of running multiple assays for different analytes. Analyzers have a high degree of accuracy and precision due to the automation of the assay steps, which reduces the risk of human error and increases the reliability of the results. Analyzers are user-friendly, with most systems requiring minimal training to operate. This makes them accessible to a wider range of laboratories, including those with limited resources.
Similarly, the reagents segment is also expected to account for a notable revenue share in the global market. Reagents are an essential component of chemiluminescence immunoassay tests and are required for every test that is performed. As a result, the reagents segment experiences a consistent demand from the market. Chemiluminescence immunoassay reagents can be used to detect and monitor a wide range of diseases, including infectious diseases, autoimmune disorders, and cancer. This broad range of applications ensures a consistent demand for reagents in the market. The development of new reagents with improved sensitivity and specificity has driven the growth of the reagents segment. As a result, many companies are investing in research and development to develop new and improved chemiluminescence immunoassay reagents. The rising prevalence of chronic diseases such as diabetes and cancer is expected to drive the demand for chemiluminescence immunoassay reagents in the coming years. Chemiluminescence immunoassay reagents are affordable, making them accessible to many customers. This affordability ensures that the reagents segment experiences a consistent demand from the market.
Chemiluminescence Immunoassay (CLIA) Market by Application
Based on the application, the global chemiluminescence immunoassay market can be further segmented into oncology, autoimmune disorder, cardiological diseases, infectious disease, endocrine disorders, and others.
Cancer is a leading cause of mortality worldwide, with millions of new cases diagnosed yearly. As such, there is a significant demand for diagnostic and monitoring tools for cancer patients. Chemiluminescence immunoassays are highly accurate, making them ideal for diagnosing and monitoring cancer. These assays can detect cancer-specific markers in blood or tissue samples with high sensitivity and specificity, enabling early detection and accurate diagnosis. Chemiluminescence immunoassays can also be used to monitor disease progression and response to treatment. By measuring the levels of cancer-specific markers in blood or tissue samples, doctors can assess the effectiveness of treatment and make appropriate adjustments. Chemiluminescence immunoassays can also be used to tailor treatment to individual patients based on their unique tumor biology. By measuring the levels of specific markers, doctors can identify patients likely to respond to certain treatments and avoid ineffective or harmful therapies. Chemiluminescence immunoassays are also widely used in cancer research to identify new biomarkers and develop new therapies.
Chemiluminescence Immunoassay (CLIA) Market by End User
Based on the end user, the global chemiluminescence immunoassay market can be segmented into pharmaceutical and biotechnology companies, hospital and clinical laboratories, and others.
Hospitals typically have a high patient volume, creating a significant demand for diagnostic testing. Chemiluminescence immunoassays are highly accurate and can be used to diagnose a wide range of diseases, making them ideal for use in hospitals. Hospitals treat patients with many diseases, many requiring diagnostic testing. Chemiluminescence immunoassays can be used to detect and monitor various diseases, including infectious diseases, autoimmune disorders, and cancer. Hospitals typically have access to advanced diagnostic testing capabilities, including automated chemiluminescence immunoassay analyzers. This enables them to process large volumes of samples quickly and accurately. Hospitals employ highly trained personnel, including laboratory technicians and pathologists, skilled in using and interpreting diagnostic tests such as chemiluminescence immunoassays. Hospitals typically use electronic medical records to manage patient data. Chemiluminescence immunoassays can be easily integrated with electronic medical records, allowing for seamless data transfer and analysis.
Chemiluminescence Immunoassay (CLIA) Market by Region
Based on the region, the global chemiluminescence immunoassay market can be further segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
North America has a large and aging population, which creates a significant demand for diagnostic testing. Chemiluminescence Immunoassays are highly accurate and can be used to diagnose a wide range of diseases, making them ideal for use in North America. North America has a well-developed healthcare infrastructure with advanced diagnostic testing capabilities. This enables healthcare providers to offer various diagnostic tests, including chemiluminescence immunoassays. North America is a leader in technological advancements, including in the field of medical diagnostics. This has led to the development of advanced chemiluminescence immunoassay analyzers that can process large volumes of samples quickly and accurately. North American governments provide significant support for healthcare and medical research, including funding for developing and adopting new diagnostic technologies such as chemiluminescence immunoassays.
Europe has a high prevalence of chronic diseases such as cardiovascular disease, diabetes, and cancer. Chemiluminescence immunoassays are highly accurate and can be used to diagnose and monitor these diseases, making them a valuable diagnostic tool in Europe. Europe has a well-developed healthcare infrastructure with advanced diagnostic testing capabilities. This enables healthcare providers to offer various diagnostic tests, including chemiluminescence immunoassays. Europe is a leader in technological advancements, including in the field of medical diagnostics. This has led to the development of advanced chemiluminescence immunoassay analyzers that can process large volumes of samples quickly and accurately. Europe’s aging population creates a significant demand for diagnostic testing. Chemiluminescence immunoassays are highly accurate and can be used to diagnose a wide range of diseases in older patients, making them an important diagnostic tool in Europe. European governments provide significant support for healthcare and medical research, including funding for developing and adopting new diagnostic technologies such as chemiluminescence immunoassays.
Competitive Landscape
The prominent players operating in the global chemiluminescence immunoassay market are:
Strategic Development
The estimated market size of the global chemiluminescence immunoassay market in 2031 is US$ 9.51 billion.
The revenue CAGR for the chemiluminescence immunoassay market is 5.67% during the forecast period.
F. Hoffmann-La Roche AG, Siemens Healthineers AG, DiaSorin S.p.A., and Tosoh Corporation are some of the major key players in the chemiluminescence immunoassay market.
The Asia Pacific region is projected to grow at high revenue CAGR in the global chemiluminescence immunoassay market.
CLIA requires specialized equipment, reagents, and expertise, making it more expensive than other immunoassay techniques. Thus, the high cost of this technique is a major restraining factor in the global market growth.
*Insights on financial performance are subject to the availability of information in the public domain
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