The Chemiluminescence Immunoassay Market, estimated at USD 14.00 Bn in 2025, is expected to exhibit a CAGR of 6.8% and reach USD 22.21 Bn by 2032.
The market growth is driven by rising demand for accurate and early disease detection, supported by advances in molecular diagnostics, imaging, and point-of-care testing. Growing focus on personalized medicine, supportive healthcare policies, and ongoing R&D investments are creating new opportunities for industry players.
Market Dynamics:
Global chemiluminescence immunoassay market growth is driven by rising preferences for CLIA assays and technological advancements. CLIA assays are highly sensitive and specific, requiring only minute samples for analysis. This has led to their increased adoption over other immunoassay techniques. Furthermore, advancements such as automated immunoassay systems integrated with robotics are making CLIA testing more efficient and cost-effective. This is expected to increase their use in clinical diagnostic applications. Rising geriatric population susceptible to chronic diseases can also drive the market growth. According to WHO, the proportion of the world’s population over 60 years will nearly double from 12% to 22% between 2015 and 2050.
Increasing prevalence of chronic and infectious diseases can boost demand for chemiluminescence immunoassays
Rising incidence of chronic and infectious diseases across the globe boosts demand for efficient diagnostics. Diseases such as cancer, cardiovascular diseases, diabetes and HIV/AIDS are becoming increasingly common. Chemiluminescence immunoassays provide an accurate, sensitive and affordable method for detecting biomarkers related to these conditions. Hospitals and diagnostic labs are adopting CLIA testing to screen for cancers, screen and monitor disease progression as well as assess therapeutic effectiveness. Rising worldwide disease burden will boost need for CLIA.
Growing geriatric population boosts use of CLIA tests
Older adults are more susceptible to various illnesses due to age-related weakening of immunity. CLIA tests play a vital role in monitoring health conditions prevalent in the elderly like osteoporosis, arthritis, thyroid disorders, and others. These provide crucial biomarkers and insights to manage care for this vulnerable section of society. With over a billion people forecast to be aged 65 years and above globally by 2050, the aged demographic will boost demand for CLIA testing to improve senior health outcomes.
High cost of CLIA equipment can hamper its widespread adoption
While CLIA offers considerable advantages over other immunoassay techniques, the expensive instrumentation required poses a barrier for smaller laboratories and facilities in developing nations. Chemiluminescence immunoanalyzers are expensive, restricting their installation base primarily to large hospitals and reference laboratories. The high capital investment and maintenance expenditure associated with CLIA equipment also impacts its affordability in resource-constrained settings. Frequent upgrades needed to analyze new biomarkers further increase costs and hamper procurement possibilities.
Shortage of skilled operators can hamper optimal CLIA usage
CLIA assays involve complex analytical protocols that necessitate specialized training to perform. However, there is a significant dearth of trained medical technologists and laboratory technicians proficient in running CLIA tests worldwide. Limited educational opportunities and inadequate incentives further exacerbate this skills gap issue. Unless addressed proactively, the talent crunch could negatively impact infrastructure expansion, assay accuracy and turnaround times in the market. It may also necessitate automation adoption at a higher price point in many regions.
Novel biomarker discovery offers fresh application possibilities
Continual breakthroughs in genomics and proteomics research leads to identification of many new biomarkers linked with various diseases. As the biomarker landscape evolves rapidly, it provides tremendous opportunities to expand CLIA usage into newer clinical areas. Tests for conditions like Alzheimer’s disease, metabolic syndrome, autoimmune disorders and mental illnesses are slated to augment the menu of analytes measured by CLIA. This ongoing discovery and validation of novel disease markers can boost demand for evolving CLIA panels.
Point-of-Care testing trend may shift assay volumes to CLIA alternatives
There is a growing global momentum towards shifting diagnostics from centralized laboratories closer to patients via point-of-care technologies. POC devices enable testing almost anywhere without requiring specialized operators or facilities. While traditional CLIA remains crucial for detailed profiling and screening, portable immunoassay platforms are gaining preference in ambulatory and home care settings due to instant outcomes and rapid turnaround. This emerging trend could potentially divert some testing volumes away from standard CLIA to alternative near-patient solutions over the long run.
Link - https://www.coherentmarketinsights.com/market-insight/chemiluminescence-immunoassay-market-4656
Key Development
- In November 2023, Medical & Biological Laboratories Co., Ltd., a JSR Life Sciences Company, launched the "iStar 500," an automated mono-test chemiluminescence immunoassay (CLIA) analyzer worldwide. This compact and highly sensitive analyzer is ideal for emergency and small- to medium-sized labs, offering a wide range of testing parameters including cardiac markers, reproductive health, liver health, tumor markers, and autoimmunity.
- In July 2023, Fapon, a prominent global life sciences company, unveiled its newest chemiluminescence immunoassay system, the Shine i8000/9000, at the 2023 AACC exhibition. This advanced analyzer is fully automated and operates at high speed, boasting an ultra-high throughput of 900 tests per hour. It is designed to enable Fapon's partners to develop top-tier clinical diagnostic solutions.
- In May 2023, PerkinElmer, a global provider of technology and service solutions, introduced Revvity, a pioneering science-driven solutions company that leverages advanced innovation to improve lives through a diverse array of products
- In December 2022, Sysmex obtained approval in Japan for manufacturing and marketing the HISCL β-Amyloid 1-42 Assay Kit and the HISCL β-Amyloid 1-40 Assay Kit, designed to detect levels of amyloid beta (Aβ) in blood
- In June 2020, Abbott, a global healthcare company, initiated supply of its laboratory-based serology blood test for detecting COVID-19 antibodies (IgG) in India. The company is delivering millions of tests to hospitals and labs across Maharashtra, Delhi, West Bengal, Uttar Pradesh, Jammu & Kashmir, and Gujarat, both government and private.
Key Players: Siemens AG, Abbott Laboratories, F. Hoffmann-La Roche Ltd., Danaher Corporation, bioMérieux SA, Johnson & Johnson, Tosoh Corporation, Randox Laboratories, DiaSorin S.p.A., PerkinElmer, Inc., Mindray Bio-Medical Electronics Co., Ltd., Getein Biotech, Inc., QuidelOrtho Corporation, Sysmex Corporation, Ortho Clinical Diagnostics, Abcam plc, Thermo Fisher Scientific Inc., Hologic, Inc.
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