Industry Trends Unveiled: Chemiluminescence Immunoassay Market Analysis, Leading Players, and 2028 Forecast
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.
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Key Market Players:
The CLIA market is moderately competitive, with certain companies holding substantial market shares. The prominent players in chemiluminescence immunoassay market are Danaher Corporation (US), Siemens Healthineers AG (Germany), and F. Hoffmann-La Roche AG (Switzerland). Companies adopt organic and inorganic growth strategies such as product launches & approvals, expansions, and partnerships to increase their product offerings and expand their presence in the global CLIA market.
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.
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In 2022, the consumables segment held the largest share of the chemiluminescence market, by product segment
Based on product, the global chemiluminescence immunoassay market is categorized into consumables and instruments. The repetitive purchase of consumables such as reagents for every test is a major factor driving the growth of the segment. Besides the availability of efficient assays and reagents for diagnostic purposes has propelled its demand among end users.
In 2022, the infectious disease diagnostics segment held the largest share of the chemiluminescence market, by application segment
The chemiluminescence immunoassay market, by application, has been segmented into infectious diseases, endocrinology, oncology, bone & mineral disorders, cardiology, blood screening, autoimmune disorders, allergy diagnostics, toxicology, newborn screening, gastroenterology, neurology, respiratory, therapeutic drug monitoring, metabolic disorders, and other applications. The large share of this segment can be attributed to the development and introduction of advanced assays for the diagnosis of different diseases & conditions, and the increase in the population with infectious diseases.
North America dominates the global chemiluminescence immunoassay market
Based on the region, the chemiluminescence immunoassay market is segmented into North America, Europe, Asia Pacific, and Rest of the world. In 2022, North America accounted for the largest share of the chemiluminescence immunoassay market. The large share of North America in this market can be attributed to the increasing prevalence of infectious diseases and cancer and rising healthcare spending, which is highly developed in the US and Canada.
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Recent Developments:
- 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.