Chemiluminescence Immunoassay Market Size, Share & Trends Analysis Report By Product (Instruments, Consumables, Software & Services), By Application, By End-use, By Region, And Segment Forecasts, 2020 - 2027

Report Overview

The global chemiluminescence immunoassay market size was valued at USD 6.1 billion in 2019 and is expected to expand at a compound annual growth rate (CAGR) of 7.3% from 2020 to 2027. Introduction of technologically advanced chemiluminescence immunoassay (CLIA) systems and high prevalence of chronic diseases are some of the major factors driving the market. Chemiluminescence immunoassay solutions are widely applied in the detection of chronic diseases such as cancer, infectious disease, autoimmune disease, cardiovascular disease, diabetes, obesity. Chemiluminescence immunoassay is also used by various pharmaceutical companies and research institutes for therapeutic drug monitoring. Thus, increasing awareness about early diagnosis of chronic diseases and rising drug discovery &development activities by pharmaceutical companies are considered as high impact rendering drivers, boosting demand for CLIA solutions.

Major players in the market are focused on the development and launch of technologically advanced chemiluminescence immunoassay solutions. For instance, in August 2020, DiaSorin received the FDA’s Emergency Use Authorization (EUA) for its new LIAISON SARS-CoV-2 S1/S2 IgG test. This test is based on chemiluminescence immunoassay technology for the diagnosis of COVID 19. 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, chemiluminescence immunoassay 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 chemiluminescence immunoassay. According to the data published by Globocan, in 2018, around 18,078,957 new cases of cancer were diagnosed globally. Also, 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. are suffering from diabetes. Furthermore, the outbreak of novel COVID-19, also known as coronavirus, is anticipated to upsurge the demand for novel chemiluminescence immunoassay solutions for its diagnosis, thus, driving the market growth. According to the data published by the WHO, as of May 2020, more than 4.2 million people around the globe are suffering from COVID-19.

Chemiluminescence immunoassay 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 chemiluminescence immunoassay technique. One such is the high setup cost involved, which is a major drawback of chemiluminescence immunoassay technique. These costly devices are not easily adopted in emerging economies such as India, Brazil, and South Africa, which is expected to hinder its market growth in the near future.

Product Insights

The consumables dominated the Chemiluminescence Immunoassay (CLIA) market and accounted for the largest revenue share of 77.7% in 2019. The segment is anticipated to hold its dominance over the forecast period. This can be attributed to increased demand for consumables such as reagents and stains in the field of therapeutic drug monitoring, endocrinology, and disease diagnosis. Furthermore, the instruments segment is categorized as automated and semi-automated, wherein automated instruments dominated the market.

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 its Access 2 immunoassay system that provides workflow efficiencies, ease-of-use, system reliability, and customer satisfaction.

Application Insights

The infectious disease segment dominated the CLIA market and held the largest revenue share of 23.3% in 2019. This share is attributed to the introduction of novel chemiluminescence immunoassay assays for the diagnosis of infectious diseases. For instance, in September 2018, DiaSorin and its partner, Qiagen launched its new LIAISON QuantiFERON-TB Gold Plus assay for the detection of latent tuberculosis infection on LIAISON analyzer in the market.

The oncology segment is expected to show 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 the cancer deaths occur in low- and middle-income countries.

End-use Insights

The hospitals' segment dominated the market and accounted for the largest revenue share of 36.9% in 2019. This dominance is attributed to the increasing demand for chemiluminescence immunoassay solutions in hospitals and rising hospital visits due to the growing prevalence of cancer and infectious diseases. Also, the increasing hospitalization due to the outbreak of novel coronavirus is expected to upsurge the demand for chemiluminescence immunoassay solutions in the hospitals.

The clinical laboratories segment accounted for significant market share in 2019. The growth of this segment can be attributed to cost-effective testing services offered by clinical laboratories. Also, the rise in strategic collaborations between key players and clinical laboratories is anticipated to support segment growth. For instance, in August 2017, Abbott Laboratories signed a USD 252.0 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 market share among all the regions in 2019 with a 39.6% share and is expected to dominate the market throughout the forecast period. Key factors contributing to its dominance includes the presence of developed healthcare infrastructure, high adoption of technologically advanced chemiluminescence immunoassay solutions, and increasing prevalence of chronic diseases. Furthermore, increased accessibility of novel CLIA systems in the U.S. due to the local presence of key players such as Abbott Laboratories, Beckman Coulter, Inc., DiaSorin, and Roche is further expected to support the growth of the market in the region.

In the Asia Pacific market, demand is expected to grow at the fastest rate during the forecast period. Increasing awareness about chronic diseases in emerging economies such as China and India is one of the key factors fostering regional growth. Furthermore, growing approval and launch of novel chemiluminescence immunoassay systems by local players is also anticipated to support the growth of the region. In 2018, Shenzhen Mindray Bio-Medical Electronics Co., Ltd., a medical device manufacturer in China 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 market are implementing inorganic growth strategies such as strategic collaborations and partnerships to gain an advantage. For instance, in April 2020, the U.S.-based Accelerate Diagnostics, Inc. and BioCheck, Inc., entered into a strategic distribution agreement for distributing chemiluminescence immunoassay solutions. As per the agreement, Accelerate will distribute BioCheck's fully-automated CLIA analyzer, the BioCheck MS-FAST system, along with BioCheck's SARS-CoV-2 tests for the detection of IgM and IgG antibodies. Some of the prominent players in the chemiluminescence immunoassay (CLIA) 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 global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global chemiluminescence immunoassay (CLIA) market report on the basis of product, application, end-use, and region:

• Product Outlook (Revenue, USD Million, 2016 - 2027)

  • Instruments

    • Automated

    • Semi-automated

  • Consumables

  • Software & Services

• Application Outlook (Revenue, USD Million, 2016 - 2027)

  • Therapeutic Drug Monitoring

  • Oncology

  • Cardiology

  • Endocrinology

  • Infectious Disease

  • Autoimmune Disease

  • Others

• End-use Outlook (Revenue, USD Million, 2016 - 2027)

  • Hospitals

  • Clinical Laboratories

  • Pharmaceutical & Biotechnology Companies

  • Others

• Regional Outlook (Revenue, USD Million, 2016 - 2027)

  • North America

    • The U.S.

    • Canada

  • Europe

    • Germany

    • The 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