Chemiluminescence Immunoassay Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global chemiluminescence immunoassay market growth forecasted to transform from $13.2 billion in 2023 to $19.0 billion by 2028, driven by a CAGR of 7.5%. 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

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.

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