The chemiluminescence immunoassay market is projected to reach USD 19.0 billion by 2028 from USD 13.2 billion in 2023, at a CAGR of 7.5% during the forecast period. Factors such as increasing incidence of chronic and infectious diseases and advancements in CLIA technologies will boost the growth of CLIA. For Instance, in 2021, DiaSorin and MeMed received the CE Mark for Liaison MeMed BV, which is a high-throughput chemiluminescent immunoassay enabling physicians to differentiate between bacterial and viral infections. Similarly, Inova Diagnostics Inc. received approval from the US FDA for its QUANTA Flash SARS-CoV-2 IgG chemiluminescent immunoassay under emergency use status. Some of the latest advancements seen in the CLIA systems include enhanced chemiluminescent substrate, multiplex CLIA assay, automation and highthroughput, and the development of point-of-care CLIA devices.
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.
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F. HOFFMAN-LA ROCHE
F. Hoffmann-La Roche is one of the key players in the global CLIA market. The company is an established player in the Diagnostics segment, and its products are well-accepted in the market. The company’s wide product portfolio and strong geographic presence have helped it gain a competitive edge in the market.
In the CLIA market, Roche offers a dedicated technology -Elecsys technology ECL (ElectroChemiLuminescence) is the company’s technology for immunoassay detection. ECL technology is suitable for various immunoassay principles hence providing excellent performance.
Danaher Corporation is held the second position in the global CLIA Market in 2022. The company operates through four business segments: biotechnology, life sciences, diagnostics, and environmental & applied solutions. Through the Diagnostics segment, the company offers CLIA products. During the fiscal year 2022, the Diagnostics business segment accounted for the highest share by business segment. The highest revenue for the diagnostics segment was generated from the region of North America, primarily due to the increased purchase of consumables for the purpose of diagnostic tests.
The company offers analyzers as well as assays for the diagnosis of cancer, infectious diseases, bone disorders, diabetes, inflammation, and other metabolic conditions. The company offers CLIA products through its subsidiary- Beckman Coulter.
Siemens Healthineers AG held the third largest share of the global CLIA market in 2022. The company has a direct presence in 70 countries across the globe, with over 4,000 collaborations worldwide. The company has regional headquarters in the US and Germany and has manufacturing sites in the US, the UK, Germany, Spain, South Korea, China, and India. The company’s focus on product development and launches helps it to maintain its market position.
The business model of the company’s Diagnostics segment is mainly based on long-term contracts that include an initial instrument placement followed by ongoing reagent sales, which results in a predictive and resilient revenue stream. The company sells its products to healthcare providers in more than 180 countries. The distribution of its R&D workforce across international sites enables it to better meet the needs of local markets. The company also focuses on product development, expansions, and assessing new market entry strategies by opting for partnerships.
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
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