Chemiluminescence Immunoassay Market Size, Share & Trends Analysis Report By Product (Consumables, Instruments, Software & Services), By Application, By End-use, By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global chemiluminescence immunoassay market size was valued at USD 7.34 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 7.9% from 2021 to 2028. Chemiluminescence immunoassay (CLIA) solutions are widely applied in the detection of chronic diseases, such as infectious disease, autoimmune disease, cardiovascular disease, diabetes, obesity, and cancer. CLIA is also used by various pharmaceutical companies and research institutes for therapeutic drug monitoring. The increasing awareness about the early diagnosis of chronic diseases and the rising drug discovery and development activities by pharmaceutical companies are considered to be the high-impact rendering drivers for the market.

The COVID-19 pandemic has been crucial in shaping the clinical diagnostic industry research into the development of assays and molecular diagnostic research. Urgent need to aid the development of these diagnostic devices to curb the impact and the spread of the virus is the major area of focus for the leading manufacturers. Several CLIA kits have been proven to provide rapid results with sensitivity rates between the ranges of 64% and 97%. Several manufacturers have developed antigen tests based on CLIA technology. For instance, in October 2020, DiaSorin, an Italy-based CLIA manufacturer, received FDA’s EUA for its new LIAISON SARS-CoV-2 IgM test. This test is intended to be run on the LIAISON XL platform based on CLIA technology for the determination of IgM antibodies to SARS-CoV-2. Thus, with the onset of the pandemic, a rise in technologically advanced testing kits has created immense demand for CLIA test kits.

Major players in the market are focused on the development and launch of technologically advanced CLIA solutions. In May 2019, Inova Diagnostics received the 510(k) clearance of its new QUANTA Flash RF IgA and QUANTA Flash Rheumatoid Factor (RF) IgM chemiluminescent assays from the U.S. FDA. Similarly, in August 2018, Mindray Medical International Limited, a China-based medical device manufacturer, launched its new CL900i - a fully automated benchtop chemiluminescence immunoassay. The introduction of such novel solutions is anticipated to support the market growth during the forecast period.

In the field of clinical diagnostics, CLIA technique is widely used in the detection of chronic diseases, such as cancer, infections, cardiovascular diseases, autoimmune diseases, diabetes mellitus, and neurological diseases. These chronic diseases are the leading causes of disability and mortality worldwide. The incidence of these diseases is rising significantly and hence is expected to drive the demand for effective diagnostic methods, such as CLIA. According to the data published by Globocan, in 2018, around 18,078,957 new cases of cancer were diagnosed globally. In addition, according to the data published by the American Diabetes Association, in 2018, around 34.2 million (10.5% of the population) people in the U.S. had diabetes.

CLIA is one of the latest and most advanced immunoassay techniques available in the market. CLIA technique offers several advantages over the other traditional techniques, such as ELISA and RIA. Regardless of the various advantages that it offers, there are several limitations related to the CLIA technique. One such is the high setup cost involved, which is a major drawback of CLIA technique. These costly devices are not easily adopted in emerging economies, such as India, Brazil, and South Africa, which is expected to hinder the market growth in the near future.

Product Insights

The consumables segment dominated the market with a share of over 65.0% in 2020 and is anticipated to maintain its lead over the forecast period. This can be attributed to the increased demand for consumables, such as reagents and stains, in the field of therapeutic drug monitoring, endocrinology, and disease diagnosis.

The instruments segment is expected to witness considerable growth during the forecast period. It is further categorized into automated and semi-automated, wherein automated instruments dominated the market in 2020. The growth of the instrument segment is attributed to the rising initiatives by major players for the development and introduction of technologically advanced chemiluminescence immunoassay systems. For instance, in August 2017, Beckman Coulter introduced an enhanced version of the Access 2 immunoassay system. The new features have been added to improve workflow efficiencies, ease of use, system reliability, and customer satisfaction.

Application Insights

The infectious disease segment held the largest share of over 28.0% in 2020. This is attributed to the introduction of novel CLIA assays for the diagnosis of infectious diseases. For instance, in September 2018, DiaSorin and its partner, Qiagen launched the new LIAISON QuantiFERON-TB Gold Plus assay for the detection of latent tuberculosis infection on LIAISON analyzer in the CE market.

The oncology segment is expected to witness significant growth over the forecast period. This growth is attributed to the high prevalence of cancer and increasing awareness about its early diagnosis in emerging economies. As per the study published by the WHO in September 2018, cancer is the second leading cause of death worldwide. In 2018, globally around 1 in 6 deaths is due to cancer and an estimated 9.6 million people died due to the disease. The same source also states that around 70.0% of cancer deaths occur in low- and middle-income countries.

End-use Insights

Hospitals dominated the market in 2020 with a share of over 35.0%. This is attributed to the increasing demand for CLIA solutions in hospitals, coupled with the rising hospital visits due to the growing prevalence of cancer and infectious diseases. In addition, the increasing hospitalization due to the outbreak of novel coronavirus is expected to upsurge the demand for CLIA solutions in hospitals.

The clinical laboratories segment accounted for a significant share in 2020. The growth of this segment can be attributed to cost-effective testing services offered by clinical laboratories. Furthermore, a rise in strategic collaborations between key players and clinical laboratories is anticipated to support the segment growth. For instance, in August 2017, Abbott Laboratories signed a USD 252 million contract with North West London Pathology (NWLP) to supply diagnostic equipment and consumables, including Abbott's Alinity ci-series diagnostics instruments.

Regional Insights

North America held the largest share of over 40.0% share in 2020 and is expected to dominate the market throughout the forecast period. Key factors driving the regional market include the presence of developed healthcare infrastructure, the high adoption of technologically advanced CLIA solutions, and the increasing prevalence of chronic diseases. Furthermore, increased accessibility of novel CLIA systems in the U.S. due to the presence of key players, such as Abbott Laboratories; Beckman Coulter, Inc.; DiaSorin; and Roche, is expected to support the regional market growth.

Asia Pacific is expected to expand at the fastest CAGR during the forecast period. The increasing awareness about chronic diseases in emerging economies, such as China and India, is one of the key factors fostering the regional market growth. Furthermore, the growing approval of CLIA systems and the launch of novel CLIA systems by local players are anticipated to support the growth of the regional market. In 2018, Shenzhen Mindray Bio-Medical Electronics Co., Ltd., a Chinese medical device manufacturer, launched its new CL-6000i CLIA analyzer at the China International Medical Equipment Fair (CIMEF Spring 2018).

Key Companies & Market Share Insights

Emerging players in the CLIA market are implementing inorganic growth strategies, such as strategic collaborations and partnerships, to gain an advantage over other players. For instance, in April 2020, the U.S.-based Accelerate Diagnostics, Inc. & BioCheck, Inc. entered into a strategic distribution agreement for distributing CLIA solutions. As per the agreement, Accelerate will distribute the BioCheck MS-FAST system, which is a fully automated CLIA analyzer, along with BioCheck's SARS-CoV-2 tests for the detection of IgM and IgG antibodies. Some prominent players in the global chemiluminescence immunoassay market include:

• DiaSorin S.p.A.

• Abbott Laboratories

• Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

• Immunodiagnostic Systems

• Siemens Healthineers

• Beckman Coulter Inc.

• F. Hoffmann-La Roche AG

• Inova Diagnostics, Inc.

• Maccura Biotechnology Co., Ltd.

• Ortho Clinical Diagnostics

Chemiluminescence Immunoassay Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global chemiluminescence immunoassay market report on the basis of product, application, end-use, and region:

• Product Outlook (Revenue, USD Million, 2016 - 2028)

  • Instruments

    • Automated

    • Semi-automated

  • Consumables

  • Software & Services

• Application Outlook (Revenue, USD Million, 2016 - 2028)

  • Therapeutic Drug Monitoring

  • Oncology

  • Cardiology

  • Endocrinology

  • Infectious Disease

  • Autoimmune Disease

  • Others

• End-use Outlook (Revenue, USD Million, 2016 - 2028)

  • Hospitals

  • Clinical Laboratories

  • Pharmaceutical & Biotechnology Companies

  • Others

• Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • Spain

    • France

    • Italy

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Singapore

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE