Chemiluminescence Immunoassay (CLIA) Market Size
| Study Period | 2019 - 2029 |
| Base Year For Estimation | 2023 |
| Forecast Data Period | 2024 - 2029 |
| CAGR | 6.60 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Need a report that reflects how COVID-19 has impacted this market and its growth?
Chemiluminescence Immunoassay (CLIA) Market Analysis
The chemiluminescence immunoassay market is expected to grow at a CAGR of 6.6% during the forecast period (2022-2027).
The Covid-19 pandemic is anticipated to have a considerable impact on the studied market. During the initial phase of the pandemic due to strict lockdown and shut down the laboratories, diagnostic centers, and research units were closed, so there was a decline in the number of assays performed, which hampered the market growth. However, soon after the situation stabilized population across the globe returned to work and it was critical to develop tests that reliably detect SARS-CoV-2-specific antibodies. Hence researchers started procuring different assays for the detection of the virus. For instance, research conducted by a group of scientists in the United States presented their results from a multiplex serology test for assessing the antibody responses to COVID-19. And their research was published in February 2021 titled 'A multiplex chemiluminescent immunoassay for serological profiling of COVID-19-positive symptomatic and asymptomatic patients'. As per the research article, the chemiluminescent immunoassay (CLIA) can demonstrate high clinical sensitivity and specificity and can reliably be used to diagnose infection by SARS-CoV-2. Such research provided information on the efficiency of the CLIA tests, which is expected to impact the demand for CLIA methods. Therefore, the pandemic is expected to have a significant impact on the market studied.
The chemiluminescence immunoassay (CLIA) has been applied in different fields including environmental monitoring, liquid chromatography, clinical diagnosis, food safety, pharmaceutical analysis, immuno-, and gene probe assays, as a promising approach for selective, sensitive, rapid, and simple analysis. The article 'Detection of Circulating varicella-zoster virus (VZV)-Glycoprotein E (gE)-Specific Antibodies by Chemiluminescent Immunoassay (CLIA) for Varicella-Zoster Diagnosis' published in January 2022 stated that the CLIA approach-based detection kit for diagnosing VZV-gE-specific IgA (immunoglobulin-A), IgG (immunoglobulin-G), and IgM (immunoglobulin-M) is simple, and suitable for high-throughput routine analysis situations, also provides enhanced specificity compared to ELISA (enzyme-linked immunoassay). Thus, such research providing positive results of CLIA methods is anticipated to drive market growth.
Furthermore, chronic diseases such as cancer, cardiovascular diseases, diabetes, Alzheimer's diseases, and respiratory disorders are increasing day by day globally. And the detection of the mechanism behind the disease is crucial to further accelerate the drug development and treatment process. Thus, scientists are recently adopting the CLIA method for such research purposes. The research article 'Machine Learning Reveals a Multipredictor Nomogram for Diagnosing the Alzheimer's Disease Based on Chemiluminescence Immunoassay for Total Tau in Plasma' published in May 2022 stated that the researchers established a direct standard CLIA curve under optimized conditions for total tau detection in Alzheimer's patients and the results showed that CLIA provided fairly repeatability and reliability compared to other detection technologies. Such reliability of the detection method is creating demand for the use of the methods, thereby contributing to the growth of the market studied.
Therefore, owing to the aforesaid factors the studied market is predicted to witness growth over the forecast period. However, the lack of skilled professionals to handle these methods is anticipated to hinder market growth over the forecast period.
Chemiluminescence Immunoassay (CLIA) Market Trends
This section covers the major market trends shaping the Chemiluminescence Immunoassay (CLIA) Market according to our research experts:
Oncology Segment is Expected to Hold the Largest Market Share
The increasing number of cancer cases globally has led to the development of several research and developments for the detection, diagnosis, and treatment of the disease. As cancer is one of the most diagnosed rare diseases, the development of treatment and diagnosis methods for the disease remains a priority for researchers and scientists. Several research has found that the use of novel and verified biomarkers can lead to the early diagnosis of various cancers, the demand for the chemiluminescence immunoassay (CLIA) for oncology studies increased, and the demand is expected to grow over the forecast period. This is expected to fuel the segment growth.
There is an increase in cancer cases globally. According to Global Cancer Observatory data updated in 2021, the new cancer cases that were diagnosed in the previous year accounted for 19.3 million globally. Additionally, World Health Organization (WHO) data updated in February 2022 stated that nearly 400,000 children develop cancer, and the most common cancers vary between countries. While breast, lung, colon and rectum, and prostate cancers are the most common cancers globally. In addition, several research has proven the efficiency of sensitive chemiluminescence (CL) imaging immunoassay methods for the detection of multiple tumor markers with high throughput and easy operation. Thus, this burden of cancer globally is anticipated to create demand for the CLIA methods, driving the segment growth.
Furthermore, the research article 'A novel automated immunoassay for serum NY-ESO-1 and XAGE1 antibodies in the combinatory prediction of response to anti-programmed cell death-1 therapy in non-small-cell lung cancer' published in August 2021 stated that when the researchers conducted the research with the aim to develop a fully automated immunoassay system measuring NY-ESO-1/XAGE1 antibodies (Abs), they automated the procedures using high sensitivity chemiluminescent enzyme immunoassay (HISCL) and the results were positive and the immunoassay method using HISCL found to be useful to predict clinical benefits with non-small-cell lung cancer (NSCLC) immune-checkpoint therapy. Thus, such research is increasing in the oncology segment and showing the benefits of the CLIA methods, driving the segment growth.
Thus, owing to advanced research and development the segment is expected to witness growth over the forecast period.
North America is Expected to Dominate the Market Over the Forecast Period
North America is expected to dominate the overall chemiluminescence immunoassay (CLIA) market, throughout the forecast period. This is owing to factors such as the rising incidence of chronic diseases such as cardiovascular diseases and cancer and the revolution in test offerings is among the major factors driving the market over the forecast period.
The United States holds the largest market share owing to factors such as the increasing number of populations suffering from cardiovascular diseases and other chronic diseases. As per the CDC (Centers for Disease Control and Prevention) data updated in February 2022, coronary artery disease, ischemic heart disease, or history of myocardial infarction accounted for 7.2% of emergency room visits currently, and the data updated in January 2022 by CDC shows that number of visits to emergency departments with stroke as the primary diagnosis was 432,000 in the previous year.
In addition, according to the American Academy of Dermatology Association, more than 1 million Americans are living with melanoma. In the United States, 197,700 new cases of melanoma will be diagnosed in 2022, with 97,920 non-invasive (in situ) and 99,780 invasive cases. Melanoma claims the lives of over 20 Americans every day. Melanoma is anticipated to kill 7,650 people in 2022, with 5,080 males and 2,570 women dying. Thus, the increasing prevalence and burden of chronic diseases in the country demand for effective diagnosis and treatment methods, thereby resulting in increased use of CLIA methods. This is expected to contribute to the growth of the studied market.
Therefore, owing to the factors mentioned above, the market studied is expected to grow in the region over the forecast period.
Chemiluminescence Immunoassay (CLIA) Industry Overview
The chemiluminescence immunoassay (CLIA) market is moderately competitive and consists of major players. In terms of market share, few of the major players are currently dominating the market. Some prominent players are vigorously making acquisitions and new product launches with the other companies to consolidate their market positions across the globe. Some of the companies which are currently dominating the market are F. Hoffmann-La Roche AG, Mindray Medical International Limited, Siemens Healthineers AG, Danaher (Beckman Coulter Inc.), and DiaSorin S.p.A.
Chemiluminescence Immunoassay (CLIA) Market Leaders
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DiaSorin S.p.A.
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Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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Siemens Healthineers AG
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Danaher (Beckman Coulter Inc.)
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F. Hoffmann-La Roche
*Disclaimer: Major Players sorted in no particular order
Chemiluminescence Immunoassay (CLIA) Market News
- In June 2022, Roche launched the BenchMark ULTRA PLUS system, the newest advanced tissue staining platform. The BenchMark ULTRA PLUS instrument is intended to automatically stain histological or cytological specimens on microscopic slides with specific immunohistochemistry, immunocytochemistry, or in situ hybridization reagents for in vitro diagnostic (IVD) use.
- In January 2022, the Wondfo-Tisenc PoC chemiluminescence immunoassay (CLIA) product was launched online with more than 800 viewers, and with the newly launched Accre system, Wondfo, the Chinese medical enterprise aims to expand its innovative layout in CLIA diagnostics and improve its CLIA platform.
Chemiluminescence Immunoassay (CLIA) Market Report - Table of Contents
1. INTRODUCTION
- 1.1 Study Assumptions and Market Definition
- 1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
- 4.1 Market Overview
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4.2 Market Drivers
- 4.2.1 Rising Incidence of Chronic Diseases
- 4.2.2 Increasing Technological Advancements
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4.3 Market Restraints
- 4.3.1 Lack of Skilled Professionals
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4.4 Porter's Five Force Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD million)
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5.1 By Product Type
- 5.1.1 Analyzers
- 5.1.1.1 Automated
- 5.1.1.2 Semi-Automated
- 5.1.2 Reagents
- 5.1.2.1 Luminophore Markers
- 5.1.2.2 Enzymatic Markers
- 5.1.3 Consumables
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5.2 By Application
- 5.2.1 Oncology
- 5.2.2 Autoimmune Disorder
- 5.2.3 Infectious Disease
- 5.2.4 Cardiovascular Disease
- 5.2.5 Endocrine Disorders
- 5.2.6 Others
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5.3 By End User
- 5.3.1 Pharmaceutical and Biotechnology Companies
- 5.3.2 Hospital and Clinical Laboratories
- 5.3.3 Others
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5.4 Geography
- 5.4.1 North America
- 5.4.1.1 United States
- 5.4.1.2 Canada
- 5.4.1.3 Mexico
- 5.4.2 Europe
- 5.4.2.1 Germany
- 5.4.2.2 United Kingdom
- 5.4.2.3 France
- 5.4.2.4 Italy
- 5.4.2.5 Spain
- 5.4.2.6 Rest of Europe
- 5.4.3 Asia-Pacific
- 5.4.3.1 China
- 5.4.3.2 Japan
- 5.4.3.3 India
- 5.4.3.4 Australia
- 5.4.3.5 South Korea
- 5.4.3.6 Rest of Asia-Pacific
- 5.4.4 Middle-East and Africa
- 5.4.4.1 GCC
- 5.4.4.2 South Africa
- 5.4.4.3 Rest of Middle-East and Africa
- 5.4.5 South America
- 5.4.5.1 Brazil
- 5.4.5.2 Argentina
- 5.4.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
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6.1 Company Profiles
- 6.1.1 F. Hoffmann-La Roche AG
- 6.1.2 Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- 6.1.3 Siemens Healthineers AG
- 6.1.4 Danaher (Beckman Coulter Inc.)
- 6.1.5 DiaSorin S.p.A.
- 6.1.6 Sysmex Corporation
- 6.1.7 Randox Laboratories Ltd.
- 6.1.8 Tosoh Corporation
- 6.1.9 Shenzhen New Industries Biomedical Engineering Co., Ltd.
- 6.1.10 BioMerieux
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Chemiluminescence Immunoassay (CLIA) Industry Segmentation
As per the scope of the report, chemiluminescence (CL) is described as the discharge of electromagnetic radiation owing to the production of light by a chemical reaction. Chemiluminescence immunoassay (CLIA) is an assay incorporating the technique of chemiluminescence with immunochemical reactions. The chemiluminescence immunoassay (CLIA) market is segmented by Product Type (Analyzers, Reagents, and Consumables), Application (Oncology, Autoimmune Disorder, Infectious Disease, Cardiovascular Disease, Endocrine Disorders and Others), End-User (Pharmaceutical and Biotechnology Companies, Hospital and Clinical Laboratories and Others), and Geography (North America, Europe, Asia Pacific, Middle East, and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD million) for the above segments.
| By Product Type | Analyzers | Automated |
| Semi-Automated | ||
| By Product Type | Reagents | Luminophore Markers |
| Enzymatic Markers | ||
| By Product Type | Consumables | |
| By Application | Oncology | |
| Autoimmune Disorder | ||
| Infectious Disease | ||
| Cardiovascular Disease | ||
| Endocrine Disorders | ||
| Others | ||
| By End User | Pharmaceutical and Biotechnology Companies | |
| Hospital and Clinical Laboratories | ||
| Others | ||
| Geography | North America | United States |
| Canada | ||
| Mexico | ||
| Geography | Europe | Germany |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Rest of Europe | ||
| Geography | Asia-Pacific | China |
| Japan | ||
| India | ||
| Australia | ||
| South Korea | ||
| Rest of Asia-Pacific | ||
| Geography | Middle-East and Africa | GCC |
| South Africa | ||
| Rest of Middle-East and Africa | ||
| Geography | South America | Brazil |
| Argentina | ||
| Rest of South America |
Chemiluminescence Immunoassay (CLIA) Market Research FAQs
What is the current Global Chemiluminescence Immunoassay (CLIA) Market size?
The Global Chemiluminescence Immunoassay (CLIA) Market is projected to register a CAGR of 6.60% during the forecast period (2024-2029)
Who are the key players in Global Chemiluminescence Immunoassay (CLIA) Market?
DiaSorin S.p.A., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Siemens Healthineers AG, Danaher (Beckman Coulter Inc.) and F. Hoffmann-La Roche are the major companies operating in the Global Chemiluminescence Immunoassay (CLIA) Market.
Which is the fastest growing region in Global Chemiluminescence Immunoassay (CLIA) Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Global Chemiluminescence Immunoassay (CLIA) Market?
In 2024, the North America accounts for the largest market share in Global Chemiluminescence Immunoassay (CLIA) Market.
What years does this Global Chemiluminescence Immunoassay (CLIA) Market cover?
The report covers the Global Chemiluminescence Immunoassay (CLIA) Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Global Chemiluminescence Immunoassay (CLIA) Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
What are the key factors driving the Chemiluminescence Immunoassay (CLIA) Industry?
The key factors driving the Chemiluminescence Immunoassay (CLIA) Industry are a) Development of portable and user-friendly CLIA analyzers for on-site testing in clinics and remote locations b) Growing number of diagnostic centers and reference labs creating higher demand for CLIA instruments and assays
Chemiluminescence Immunoassay Analyzers Industry Report
The chemiluminescence immunoassay (CLIA) industry is on a significant upswing, fueled by the increasing prevalence of chronic and infectious diseases globally, alongside a growing geriatric population prone to such conditions. This surge in demand for advanced diagnostic solutions positions CLIA as a top choice due to its exceptional sensitivity, specificity, and versatility in applications ranging from clinical diagnosis to environmental monitoring and food safety. The industry is evolving through strategic collaborations and partnerships to boost innovation and broaden CLIA technologies' application scope. Despite facing challenges like high costs and a shortage of skilled professionals, the market sees promising opportunities, especially in consumables driven by the ongoing need for reagents and kits. North America leads the market, benefiting from advanced technologies and the presence of key players. The CLIA industry's growth is further evidenced by Mordor Intelligence™ reports, highlighting market share, size, and revenue trends, with detailed forecasts and historical analyses available for comprehensive understanding. This sector remains vital for developing accurate, efficient diagnostic methods to meet the increasing health challenges worldwide.
