Chemiluminescence Immunoassay Market by Product (Instrument, Consumable), Technology (Chemiluminescence Enzyme, Microparticle Chemiluminescence), Sample (Blood, Urine), Application (Infectious Disease, Oncology), End User - Global Forecast to 2028
Updated on : Aug 22, 2024
The global chemiluminescence immunoassay market in terms of revenue was estimated to be worth $13.2 billion in 2023 and is poised to reach $19.0 billion by 2028, growing at a CAGR of 7.5% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. Market growth is largely driven by the increasing prevalence of infectious diseases and cancer and the growing geriatric population in chemiluminescence immunoassay.
On the other hand, the unfavorable reimbursement scenario and lack of skilled professionals may restrain the growth of this market to a certain extent.
Attractive Opportunities in the Chemiluminescence Immunoassay Market
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Chemiluminescence Immunoassay Market Dynamics
DRIVER: Rising incidence of chronic and infectious diseases across the globe
During recent years, there has been a significant rise in the occurrence of infectious as well as diseases. With rising prevalence the rate of their diagnosis has increased significantly across the globe. The WHO underlined the global concern of HIV, which claimed over 38.4 million in 2021. Due to the efforts of international organizations and the WHO, the disease has been managed with antiviral therapies. Diagnosis has substantially helped disease management. Besides, according to the IDF Diabetes Atlas, globally, about 537 million adults (20–79 years) are living with diabetes—1 in 10. This number is predicted to rise to 643 million by 2030 and 783 million by 2045. Over 3 in 4 adults with diabetes live in low- and middle-income countries. Diabetes is responsible for 6.7 million deaths in 2021—1 every 5 seconds. The increased prevalence of infectious and chronic diseases is hence a driving factor for the growth of the CLIA market.
OPPORTUNITY: Increasing number of collaborations and partnerships in the CLIA market
Collaboration and partnership are essential in the field of CLIA to drive innovation, expand applications, and advance the development and adoption of new technologies. Here are some key aspects of collaboration and partnership in the context of CLIA. Some of the recent developments include in February 2022, Sysmex established a business tie-up with KAINOS Laboratories to strengthen the former company’s offering of immunochemistry diagnostic reagents and develop diagnostic reagents for HISCL systems. These developments help in the growth of both the players involved, which eventually helps in the growth of the market.
RESTRAINT: High cost of CLIA related products
The high cost of CLIA systems and reagents can be a significant challenge to its widespread adoption and implementation. CLIA requires specialized equipment and instrumentation, including chemiluminescence analyzers, luminometers, and other laboratory devices. These instruments are often high-end and technologically advanced, which come with significantly higher costs for their purchase, maintenance, and calibration. Also, CLIA utilizes specific reagents and consumables, such as antibodies, detection agents, substrates, and assay plates. These systems may be sometimes unaffordable to small scale laboratories, or academic or research organizations which can hamper the adoption of CLIA systems, hence impacting growth of the market.
CHALLENGE: Lack of skilled professionals and aging workforce
The dearth of a skilled workforce has been a challenge for several decades, resulting in an aging workforce and declining enrolment in training programs. It takes almost five to ten years of continuous practice in clinical laboratory work for technicians to gain expertise.
Europe reportedly has low numbers of clinical technicians. The Gatsby Foundation stated in 2019 that over 1.5 million people serve in the health, engineering, science, and technology domains. Over 50,000 retire every year, and 700,000 technicians will be required to meet the soaring demands in the next decade. The Duquesne University School of Nursing has stated that by 2025, there will be a shortage of over 29,400 nurse practitioners and more than 400,000 home health aides.
Chemiluminescence Immunoassay Ecosystem/Market Map
Consumables segment accounted for the largest share of the chemiluminescence immunoassay industry in 2022, by product
Based on product, the chemiluminescence immunoassay market is segmented as instruments and consumables. The consumables segment accounted for a significant share in the market in 2022. The recurring expenses associated with the frequent purchase of reagents & kits is a significant factor contributing to the market's growth. Besides, the availability of advanced consumables that offer better performance and reliability attributes to their widespread adoption resulting to the segment's growth.
Lab tests segment accounted for the largest share in the chemiluminescence immunoassay industry in 2022, by test type
On the basis of technology, the global chemiluminescence immunoassay market is categorized into Chemiluminescence Enzyme Technology (CLEIA), Electrochemiluminescence immunoassay (ECLI), and Microparticle Chemiluminescence Immunoassay. In 2022, the CLEIA segment held the largest share in the market, by technology. The growth of the segment can be attributed to its high sensitivity and a broad dynamic range of applications ranging from clinical diagnostics, pharmaceutical research, environmental analysis, and food safety testing, among others.
Blood sample segment accounted for the largest share in the chemiluminescence immunoassay industry in 2022, by sample type
Based on sample type, the chemiluminescence immunoassay market has been segmented into blood, saliva, urine, and other sample types. In 2022, the blood segment accounted for the largest share of the market. Blood enables the diagnosis of various indications that are not easily diagnosed using urine or saliva sample. Besides, with the rise in the number of blood donations and initiatives in support of blood screening, the segment is anticipated to also grow at the highest rate during the forecast period.
North America accounted for the largest share of the chemiluminescence immunoassay industry in 2022
The chemiluminescence immunoassay market is segmented into four major regions: North America, Europe, the Asia Pacific, and the Rest of the World. In 2022, North America emerged as the leading contributor, claiming the largest portion of the market share in the chemiluminescence immunoassay industry. With the presence of major players in the region, North America has witnessed various technological advancements in the field of chemiluminescence immunoassay. These companies have significant expertise, resources, and established sales networks, which contribute to the region’s market dominance. Examples of prominent chemiluminescence immunoassay companies in North America include Danaher Corporation (US) and Abbott Laboratories (US).
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The major players in this market are F. Hoffmann-La Roche Ltd. (Switzerland), Danaher Corporation. (US), Siemens Healthineers AG (Germany), Abbott Laboratories (US), and DiaSorin S.p.A. (Italy). The market leadership of these players is owing to their comprehensive product portfolios and expansive global footprint. These dominant market players have several advantages, including strong research and development budgets,strong marketing and distribution networks, and well-established brand recognition.
Scope of the Chemiluminescence Immunoassay Industry
Report Metric |
Details |
Market Revenue in 2023 |
$13.2 billion |
Projected Revenue by 2028 |
$19.0 billion |
Revenue Rate |
Poised to Grow at a CAGR of 7.5% |
Market Driver |
Rising incidence of chronic and infectious diseases across the globe |
Market Opportunity |
Increasing number of collaborations and partnerships in the CLIA market |
This research report categorizes the Chemiluminescence Immunoassay Market to forecast revenue and analyze trends in each of the following submarkets:
By Region
- North America
- Europe
- Asia Pacific
- Rest of the World
By Product
- Consumables
- Instruments
By Technology
- Chemiluminescence Enzyme Technology (CLEIA)
- Electrochemiluminescence immunoassay (ECLI)
- Microparticle Chemiluminescence Immunoassay
By Sample Type
- Blood
- Urine
- Saliva
- Other Sample Types
By Application
- Infectious Disease
- Endocrinology
- Oncology
- Cardiology
- Allergy Diagnostics
- Autoimmune Disorders
- Blood Screening
- Bone & Mineral Disorders
- Toxicology
- Newborn Screening
- Therapeutic Drug Monitoring
- Metabolic Disorder
- Gastroenterology
- Neurology
- Respiratory
- Other Applications
By End User
- Hospitals
- Clinical Laboratories
- Pharmaceuticals & Biotechnology Companies and Contract Research Organizations
- Other End Users
Recent Developments of Chemiluminescence Immunoassay Industry
- In May 2023, EUROIMMUN’s parent company PerkinElmer’s life science and diagnostics business segment, has been rebranded as Revvity.
- In December 2022, Mindray launched CLIA-based assays, IL-6, PCT, and sCD14-S, which have high sensitivity, a wide linearity range, great precision, and good anti-interference ability.
- In December 2022, Sysmex received manufacturing and marketing approval in Japan for the HISCL β-Amyloid 1-42 Assay Kit and the HISCL β-Amyloid 1-40 Assay Kit to measure amyloid beta (Aβ) in the blood.
- In November 2022 Getein Biotech, Inc. launched MAGICL 6000, a compact and innovative chemiluminescence immunoassay analyzer used in mid to high-workflow laboratories
- In June 2022, QuidelOrtho Corporation was formed through a transaction between Quidel Corporation and Ortho Clinical Diagnostics to form a leading in vitro diagnostics company.
Frequently Asked Questions (FAQ):
What is the projected market revenue value of the global chemiluminescence immunoassay market?
The global chemiluminescence immunoassay market boasts a total revenue value of $19.0 billion by 2028.
What is the estimated growth rate (CAGR) of the global chemiluminescence immunoassay market?
The global chemiluminescence immunoassay market has an estimated compound annual growth rate (CAGR) of 7.5% and a revenue size in the region of $13.2 billion in 2023.
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The objective of the study is analyze the key market dynamics such as drivers, opportunities, challenges, restraints, and key player strategies. To track companies developments such as product launches and approvals, expansions, collaborations, agreements, and partnerships of the leading players, the competitive landscape of the chemiluminescence immunoassay market to analyzes market players on various parameters within the broad categories of business and product strategy. Top-down and bottom-up approaches were use to estimate the market size. To estimate the market size of segments and subsegments the market breakdown and data triangulation were used.
The four steps involved in estimating the market size are
Collecting Secondary Data
The secondary research data collection process involves the usage of secondary sources, directories, databases (such as Bloomberg Businessweek, Factiva, and D&B), annual reports, investor presentations, and SEC filings of companies. Secondary research was used to identify and collect information useful for the extensive, technical, market-oriented, and commercial study of the chemiluminescence immunoassay market. A database of the key industry leaders was also prepared using secondary research.
Collecting Primary Data
The primary research data was conducted after acquiring knowledge about the chemiluminescence immunoassay market scenario through secondary research. A significant number of primary interviews were conducted with stakeholders from both the demand side (such clinical laboratories, hospitals, and academic & research institutes) and supply-side (such as included various industry experts, such as Directors, Chief X Officers (CXOs), Vice Presidents (VPs) from business development, marketing and product development teams, product manufacturers, wholesalers, channel partners, and distributors) across major countries of North America, Europe, Asia Pacific, the Middle East & Africa, and Latin America. Approximately 40% of the primary interviews were conducted with stakeholders from the demand side while those from the supply side accounted for the remaining 60%. Primary data for this report was collected through questionnaires, emails, and telephonic interviews.
A breakdown of the primary respondents is provided below:
Breakdown of Primary Participants
Note 1: Others include sales managers, marketing managers, and product managers.
Note 2: Tiers are defined based on a company’s total revenue. As of 2022: Tier 1 = >USD 1 billion, Tier 2 = USD 500 million to USD 1 billion, and Tier 3 <USD 500 million.
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COMPANY NAME |
DESIGNATION |
F. Hoffmann-La Roche Ltd. (Switzerland) |
Regional Head of Sales |
Danaher Corporation (US) |
Senior Product Manager |
Siemens Healthineers (Germany) |
Regional Manager |
Abbott Laboratories (US) |
General Manager |
Market Size Estimation
All major product manufacturers offering various chemiluminescence immunoassay were identified at the global/regional level. Revenue mapping was done for the major players and was extrapolated to arrive at the global market value of each type of segment. The market value chemiluminescence immunoassay market was also split into various segments and subsegments at the region and country level based on:
- Product mapping of various manufacturers for each type of chemiluminescence immunoassay market at the regional and country-level
- Relative adoption pattern of each chemiluminescence immunoassay market among key application segments at the regional and/or country-level
- Detailed primary research to gather qualitative and quantitative information related to segments and subsegments at the regional and/or country level.
- Detailed secondary research to gauge the prevailing market trends at the regional and/or country-level
Global Chemiluminescence Immunoassay Market Size: Botton Up Approach
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Global Chemiluminescence Immunoassay Market Size: Top Down Approach
Data Triangulation
After arriving at the overall market size—using the market size estimation processes—the market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics of each market segment and subsegment, the data triangulation, and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides in the chemiluminescence immunoassay industry.
Market Definition
Chemiluminescent immunoassay (CLIA) is an immunoassay technique where the label, i.e., the indicator of the analytic reaction, is a luminescent molecule. CLIA is a variation of the standard enzyme immunoassay (EIA), a biochemical technique used in immunology. This variation technique can be used for diagnosis in medicine and in several other different industries for various applications. In recent years, CLIA has gained increasing attention in different fields, including clinical diagnosis, life science, food safety, environmental monitoring, and pharmaceutical analysis, due to its good specificity, high sensitivity, wide applications, simple equipment, and wide linear range.
Key Stakeholders
- Senior Management
- End User
- Finance/Procurement Department
- R&D Department
Report Objectives
- To provide detailed information about the factors influencing the market growth (such as drivers, restraints, opportunities, and challenges)
- To define, describe, segment, and forecast the chemiluminescence immunoassay market by product, technology, sample type, application, end user, and region
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
- To analyze micromarkets with respect to individual growth trends, prospects, and contributions to the overall chemiluminescence immunoassay market
- To forecast the size of the chemiluminescence immunoassay market in four main regions along with their respective key countries, namely, North America, Europe, the Asia Pacific and Rest of the world
- To profile key players in the chemiluminescence immunoassay market and comprehensively analyze their core competencies and market shares
- To track and analyze competitive developments, such as product launches and approvals; expansions; collaborations, and agreements, & partnerships; of the leading players in the chemiluminescence immunoassay market
- To benchmark players within the chemiluminescence immunoassay market using the Competitive Leadership Mapping framework, which analyzes market players on various parameters within the broad categories of business and product strategy
Available Customizations
MarketsandMarkets offers the following customizations for this market report
Country Information
- Additional country-level analysis of the chemiluminescence immunoassay market
Company profiles
- Additional three company profiles of players operating in the chemiluminescence immunoassay market.
Product Analysis
- Product matrix, which provides a detailed comparison of the product portfolio of each company in the chemiluminescence immunoassay market
Growth opportunities and latent adjacency in Chemiluminescence Immunoassay Market