Global Chemiluminescence Immunoassay Market - 2022-2029

Market Overview

The global chemiluminescence immunoassay market size was valued at US$ XX million in 2021 and is estimated to reach US$ XX million by 2029, growing at a CAGR of XX% during the forecast period (2022-2029).

Chemiluminescence (CL) is the emission of electromagnetic radiation resulting from a chemical reaction that produces light. Chemiluminescence immunoassay (CLIA) is a technique that combines chemiluminescence with immunochemical reactions. CLIA uses chemical probes that emit light due to a chemical reaction to label the antibody. CLIA is used in various fields, including life science, clinical diagnosis, environmental monitoring, food safety, and pharmaceutical analysis, due to its high sensitivity, good specificity, simple equipment, and wide linear range.

Market Dynamics

The high prevalence of chronic diseases, several advantages of the chemiluminescence immunoassay (CLIA) technique, and the approval and launch of novel CLIA solutions are expected to be the major driving factors in the market.

Technological Innovations for Chemiluminescence Immunoassay (CLIA) will drive the market growth

The introduction of next-generation integrated immunoassays is a prominent technological trend in the worldwide chemiluminescence immunoassay analyzers market. For example, on October 31, 2017, Abbott reported that the Alinity ci-series, equipment for clinical chemistry and immunoassay diagnostics, had received FDA 510(k) clearance. This innovation in multiplexed assays is expected to drive the worldwide CLIA analyzers market during the forecast period. The introduction of next-generation integrated immunoassays is a significant technological trend in the global chemiluminescence immunoassay analyzers market. For example, on October 31, 2017, Abbott announced that the Alinity ci-series, clinical chemistry and immunoassay diagnostic instruments had received FDA 510(k) clearance. This advancement in multiplexed assays is expected to drive the global CLIA market during the forecast period.

Chronic disease prevalence and incidence are increasing due to sedentary lifestyles and bad diets. According to the World Health Organization (WHO), the global cancer burden increased to 18.1 million new cases and 9.6 million deaths in 2018.Because of the aging population, the prevalence of chronic diseases has risen over time. Furthermore, smoking and BMI, both well-known risk factors for chronic diseases such as cancer and cardiovascular disease, are driving the market growth.

Furthermore, improving the standardization rate of tests is a primary emphasis of physicians and pathologists working in in-patient and out-patient settings of the chemiluminescence immunoassay (CLIA) market. The main goal of assay calibration is to compare test results to well-established standards before giving test results to patients.

CLIA are closed-loop multiplexed automated analyzers with high throughput. The calibration of these systems is relatively simple. CLIA analyzers are manufactured following regulatory criteria. To make their results more comparable when compared to other manual assay systems, CLIA test manufacturers also provide internal reference standard material.

Profit Margin Impacted by a Fragmented Consumables Market is likely to hamper the market growth

As the test-providing portfolio has grown, a growing number of new market participants have begun to offer test kits for specific test applications at cheap costs.Local players with a large distribution network have increased their market penetration in specific geographies by delivering lower average selling prices.This puts pricing pressure on large producers, resulting in more competition. Furthermore, other technology alternatives on the market are accessible at a lower cost per treatment, which is affecting key firms' worldwide expansion.

COVID-19 Impact Analysis

The COVID-19 outbreak and subsequent lockdown in several nations worldwide have had a financial impact on enterprises in all sectors, including the private healthcare sector. The COVID-19 pandemic has significantly influenced the healthcare industry's whole supply chain, owing to stringent lockdown in certain places. The COVID-19 epidemic has had three main effects on the economy of various places worldwide:

Direct effects on production and demand

Disruptions in distribution routes

The financial impact on firms and financial markets

Several countries, including Thailand, Indonesia, and Singapore, are experiencing difficulties with healthcare product shipping and distribution. On the other hand, characterizing disease progression requires understanding the particular antibody profile and immune response in COVID-19 patients. Over the projected period, the impact of the coronavirus (COVID-19) pandemic is expected to drive the worldwide chemiluminescence immunoassay market. A multiplex chemiluminescent immunoassay for serological profiling of COVID-19 was undertaken in a healthy cohort of adults and children in Colorado, according to an article published in Nature Communications in February 2021. The average IgG antibody titers against all antigens were substantially higher in COVID-19-positive symptomatic subjects than in COVID-19-positive asymptomatic persons. As a result, immunological responses to SARS-CoV-2 may differ between COVID-19-positive people who are asymptomatic and those who are symptomatic. These findings could help track individual immune responses in a larger population by differentiating individual immune responses.

Segment Analysis

The reagents segment is expected to grow at the fastest CAGR during the forecast period (2022-2029)

Due to the considerably higher frequency of reagent replacement when compared to analyzer systems, the reagents market is likely to maintain its dominance during the forecast period.According to GLOBOCAN 2018 figures, there are 18,078,957 cancer patients globally. With a reported share of 48.4 percent, Asia continues to be the primary contributor to the rising incidence of cancer, followed by Europe, North and Latin America, Africa, and Oceania with 23.4 percent, 13.2 percent, and 7.8 percent, 5.8 percent, and 1.4 percent, respectively.

As a result, the reagents market is predicted to be driven by rising demand for ultra-sensitive illness diagnosis, improved accuracy and quality, and increased development in new testing choices. The increased need for high-content diagnostics and clinical research, particularly for cancer, cardiovascular disease, and other chronic diseases, boosts reagents' market growth.

Geographical Analysis

North America region holds the largest market share of the global chemiluminescence immunoassay market

North America is expected to dominate the entire chemiluminescence immunoassay (CLIA) market throughout the projected period. This is due to several variables, including the increased incidence of chronic conditions such as cardiovascular disease and cancer and the revolution in test options. Because of the growing number of people suffering from cardiovascular illnesses and other chronic conditions, the United States has the greatest market share in North America. According to the CDC and AHA, coronary heart disease is the leading cause of mortality in the United States, followed by stroke, high blood pressure, coronary disease, heart failure, and other CVD. However, the country's growing geriatric population and innovations in the field of chemiluminescence immunoassay (CLIA) would help boost CLIA demand in the region.

In addition, organic and inorganic strategies such as mergers and acquisitions and partnerships within key market players will strengthen their product portfolio in the studied market which will drive the market. Also, several product launches in the market will lead to lucrative growth of the market. For example, on May 17, 2021, PerkinElmer, Inc., a U.S.-based company focused on developing unique solutions for the diagnostic and life science markets, announced the acquisition of Immunodiagnostic Systems Holdings PLC, a manufacturer of in-vitro diagnostic tests. Through this acquisition, PerkinElmer intends to expand its Diagnostics enterprise, particularly its immunodiagnostics segment. Furthermore, the agreement will allow PerkinElmer to combine its expertise and testing capabilities with IDS's chemiluminescence products in endocrinology, autoimmunity, and infectious diseases to serve clients better worldwide. Furthermore, advancements in various chemiluminescence immunoassay from established key players, in the United States, are likely to drive the market growth in North America.

Competitive Landscape

The chemiluminescence immunoassay market is a moderately competitive presence of local as well as global companies. Some of the key players which are contributing to the growth of the market include Hoffmann-La Roche AG, Siemens Healthineers, Abbott Laboratories, Ortho Clinical Diagnostics, Immunodiagnostic Systems, Inova Diagnostics Inc, Shenzhen Mindray Bio-Medical Electronics Co Ltd, Maccura Biotechnology Co Ltd, Tosoh Corporation, Fujirebio among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the chemiluminescence immunoassay market globally. For instance, In June 2020, Abbott announced the availability of its laboratory-based serology blood test to detect the antibody IgG for COVID-19 identification. This enables the ICMR's COVID-19 antibody testing strategy to use IgG CLIA antibody tests to contribute to the ICMR's COVID-19 antibody testing strategy.

Key Developments

In January 2018, DiaSorin S.p.A. teamed up with QIAGEN N.V. to bring the QuantiFERON-TB diagnostic test to the LIAISON family of fully-automated analyzers.

Fujirebio

Overview:

Fujirebio (formerly Innogenetics) is an in vitro diagnostics company that manufactures and sells solutions ranging from specialized manual testing to fully automated routine testing. It provides infectious disease screening and confirmation tests, genotyping tests, drug-resistance tests, and other services.

Product Portfolio:

The LUMIPULSE G1200: The LUMIPULSE G1200 is a dependable mid-sized, fully automated immunoassay instrument from the well-established LUMIPULSE G series.The LUMIPULSE G1200 employs a novel mono test cartridge concept and, among other things, has a true throughput of 120 tests per hour, allowing for exceptional flexibility and ease of use in hospitals and clinical laboratories.

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