Immunoassay Analyzers Market Size, Share & Trends Analysis Report By Product (CLIA, FIA), By Application (Therapeutic Drug Monitoring, Oncology, Cardiology), By End-use, By Region, And Segment Forecasts, 2024 - 2030

Immunoassay Analyzers Market Trends

The global immunoassay analyzers market size was valued at USD 7.61 billion in 2023 and is projected to grow at a CAGR of 3.2% from 2024 to 2030. An increase in incidences of chronic diseases, such as infectious and noninfectious diseases, is the primary factor driving the market growth. Technological innovations and applications of immunoassay are rapidly expanding due to diseases such as cancer and cardiology.

The rise in the number of chronic and infectious diseases is a leading cause of market growth for immunoassay analyzers. The rising number of cardiology and cancer cases is contributing to the development of new and advanced treatment options, and companies are innovating new treatments. The WHO reported 20 million new cases of cancer in 2022 and has projected the estimated number of cancer diagnoses to 53.5 million.

During the outbreak of the COVID-19 pandemic, the SARS-CoV-2 virus created an urgent need for an accelerated diagnosis, promising precision and affordability combined in one method. RT-PCR tests were conducted for early diagnosis but were considered an expensive approach. That drove immunoassay analyzers to be deployed to detect antibodies for quick and cost-effective methods. For instance, Agilent Technologies, Inc. launched Agilent Dako SARS-CoV-2, an enzyme-linked immunoassay kit to detect SARS-CoV-2 antibodies in human serum or plasma. The pandemic brought awareness of immunoassay analyzers in the market and accelerated technological developments.

The rise in chronic diseases has led to technological advancements in immunoassay analyzers. Emerging diseases, antibiotic resistance, and the demand for personalized medicine drive the advancements of sensitive, specific, and rapid immunoassay tests. Various companies are coming up with technological solutions to fulfill this demand for treatment. For instance, Diamond Diagnostics is ensuring healthcare providers access to advanced immunoassay diagnostics through the manufacturing of high-quality and cost-effective consumables and accessories products of immunoassay analyzers. Such innovations are expected to drive market growth.

The rise in collaboration activities of various companies is another driving factor for market growth. For instance, Beckman Coulter, Inc. and Fujirebio partnered in July 2023 to strengthen respective immunoassay capabilities to support therapeutic advancement, clinical trials, routine clinical adoption, and reimbursement in neurodegenerative diseases. Such partnerships are driving the market growth of immunoassay analyzers.

Product Insights

Consumables and accessories dominated the market and accounted for a share of 36.5% in 2023. The presence of several key companies in the market is driving this product category. Companies such as Diamond Diagnostics, Gyros Protein Technologies AB, and PerkinElmer Inc. have designed and manufactured a series of consumables required for immunoassay analyzers. For instance, Diamond Diagnostics offers consumables for various types of immunoassay analyzers, such as Beckman Coulter Olympus AU, Diamond Carelyte Plus, Diamond Smartlyte Plus, and Siemens Advia Chemistry. The use of immunoassay analyzers to treat increased chronic diseases and the consumables incorporated in analyzers are driving the market grow forward.

The enzyme-linked immunoassay (ELISA) segment is expected to grow at the fastest CAGR over the forecast period. These immunoassays are commonly used for detecting soluble substances such as antibodies, proteins, peptides, and hormones. The key players offering the enzyme-linked immunoassay are Thermo Fisher Scientific Inc., Promega Corporation and Bio-Rad Laboratories, Inc.

Application Insights

The infectious disease testing segment accounted for the largest market revenue share in 2023 and is expected to grow at the fastest CAGR over the forecast period. The rise in the demand for accelerated detection and diagnosis of communicable diseases (infectious and parasitic diseases) drives market growth. According to the World Health Organization (WHO), there is a significant rise in the cases of hepatitis. It is the second leading cause of death globally, claiming 1.3 million lives every year, a similar case for tuberculosis, which is an important infectious disease.

The companies are taking initiatives in offering enzyme immunoassay (EIA) tests to detect the presence of infectious diseases, including hepatitis antibodies in human serum. For instance, Beckman Coulter launched the DxI 9000 Immunoassay Analyzer assays for hepatitis testing in April 2024, which aims to allow accurate and quick detection, enabling healthcare professionals to diagnose infections. The prevalence of infectious diseases and the efforts to develop advanced and efficient diagnosis is driving the market growth of infectious disease testing.

End Use Insights

Hospitals & clinics accounted for the largest market revenue share in 2023. The increasing prevalence of infectious diseases is driving hospitals and clinics to offer advanced diagnosis and treatment solutions. Immunoassay analyzers are used to detect and quantify analytes within a biological sample based on antigen-antibodies reactions. The procedure is technical only to be carried out by healthcare professionals, which drives the hospitals and clinics segment to dominate the market. For instance, Abbott’s antibodies are implemented in many hospitals and labs across India to identify the extent of COVID-19 infection in the population.

Diagnostic laboratories play a crucial role in emerging diseases and their early detection and diagnosis. The treatment of any disease depends on accurate diagnosis. About 70% of medical decisions depend on laboratories’ diagnostic results. Companies are driving market growth by providing these immunoassay analyzers to laboratories for efficient diagnosis. For instance, Beckman Coulter offers various immunoassay analyzers such as Access 2+ Analyzer, UniCel Dxl 600 Analyzer, UniCel Dxl 800 Analyzer, and Dxl 9000 Analyzer to the laboratories surging the market growth.

Regional Insights

North America immunoassay analyzer market dominated the market and accounted for 41.10% in 2023. The growth in the region is mainly attributed to the emergence of companies and their constant technological innovations in assay analyzers. For instance, Thermo Fisher Scientific launched EXENT Solution in August 2023 after receiving IVDR Certification, which is easy to implement in clinical laboratories.

U.S immunoassay analyzers Market Trends

The immunoassay analyzers market in the U.S. accounted for a market share of 88.6% in 2023. Government initiatives and funding are encouraging companies to innovate new diagnostics tests. For instance, Maxim Biomedical received USD 49.5 million from the U.S. Department of Health and Human Services, which can strengthen domestic manufacturing capabilities of diagnostic tests.

U.S. Food and Drug Administration (FDA) clearance increases the authenticity and deems it to provide its potential health benefits. The increasing FDA approvals benefit patients and play a key role in market growth. For instance, Abbott received its FDA approval in August 2023 for the Alinity H-Series hematology system, allowing the labs to run advanced testing of patients’ complete blood counts. Key players in the country are Thermo Fisher Scientific Inc., Abbott, Beckman Coulter, Inc, and Diamond Diagnostics.

Europe Immunoassay Analyzers Market Trends

Europe is the second largest growing market of immunoassay analyzers. Various companies are involved in innovating advanced analyzers for treating infectious diseases. Some key players in the region, such as Roche Diagnostics, bioMérieux, SA, and Siemens Healthineers AG, are driving the market growth through technological innovations. Companies are entering into a collaboration to develop advanced diagnostics tests to detect complex diseases, which drives market growth. For instance, Roche Diagnostics entered a collaboration with Eli Lily and company in March 2023 for the development of Roche Diagnostics’ Elecsys Amyloid Plasma Panel (EAPP). This innovative blood test aims to early diagnosis of Alzheimer’s disease.

The increasing prevalence of chronic diseases and the geriatric population are primary drivers for market growth. The reasons resulted in technological advancements to diagnose the disease and seek better care for the patients. Companies are involved in innovating immunoassay solutions for patient care, which contributes to the growth of the market. For instance, Anbio Biotechnology has introduced a handheld point-of-care fluorescent immunoassay (FIA) solution for quick and precise results for analytes, including enzymes, infectious diseases, and hormones.

UK immunoassay analyzers Market Trends

The rising prevalence of chronic diseases is increasing demand for advanced treatment options such as immunoassay analyzers, resulting in market growth. According to the Diabetes UK (The British Diabetic Association), more than 5.6 million people in the country suffer from diabetes, with 90% diagnosed with type 2 diabetes. The government is also taking initiatives by developing the NHS Diabetes Prevention Programme (DPP), a joint venture between Public Health England and Diabetes UK. Key companies are also contributing to the program. For instance, LumiraDx aims to commercially expand its Rapid Microfluidic Immunoassay HbA1c Test for diabetes diagnosis across multiple care centers.

Asia Pacific Immunoassay Analyzers Market Trends

The Asia Pacific region is expected to register the fastest CAGR over the forecast period. The rising prevalence of chronic diseases in the region has increased the demand for advanced treatment solutions. According to the World Health Organization, the Southeast Asia region accounted for about two-thirds of deaths in 2021 owing to chronic diseases such as cardiovascular disease, cancer, and diabetes. Observing such critical health conditions and helping in reducing the number of deaths caused by these diseases, companies are innovating and launching new products to facilitate early diagnosis and treatment, which is expected to drive market growth. For instance, Zybio Inc. launched Chemiluminescence Immunoassay Analyzer in February 2021 to detect SARS-CoV-2, cardiac, diabetes, and bone metabolism. The emergence of the COVID-19 pandemic also accelerated the growth of the market.

Singapore Immunoassay Analyzers Market Trends

Singapore’s aging population and unhealthy lifestyle adoption are contributing to the rise in chronic disease. According to the National University Polyclinics (NUP), nearly 1 million of the Singapore population may be affected due to diabetes by 2050. The government is taking initiatives to improve the health conditions of the nation through the Healthier SG initiative, contributing to market growth. The program led by the Singapore Ministry of Health aims to develop comprehensive health plans and gather family physicians to deliver preventive care against chronic diseases. Singapore is estimated to spend USD 750 million over the next four years as per the report published in April 2023.

China Immunoassay Analyzers Market Trends

China has fastest growing aging population in the world, contributing to an increase in chronic diseases. The government is also taking initiatives to help in the prevention, diagnosis, and treatment of various diseases. It launched the Proteomics Research Initiative, which aims to map human proteome levels, while also considering multiplexed immunoassay platforms from Olink and SomaLogic. Some key players in China, such as Getein Biotech Inc., and Biobase Biodusty are contributing to the growth of the market by manufacturing various immunofluorescence test kits and immunoassay analyzers, respectively.

Immunoassay Analyzers Company Insights

Some key companies in the immunoassay analyzers market include Siemens Healthineers AG, BIOMÉRIEUX, Abbott, Thermo Fisher Scientific Inc., and Beckman Coulter, Inc. Key companies are involved in strategic initiatives such as in innovating new products, collaborating with institutions and other industries, and establishing partnerships.

• Siemens Healthineers AG is a global company that aims to provide healthcare services. The company leads in medical imaging and laboratory diagnostics, offering immunoassay systems. Siemens unites innovative chemistry and immunoassay workflow solutions to provide laboratory efficiency and continuous operations. The company is taking strategic initiatives to expand its immunoassay portfolio to deliver solutions.

• BIOMÉRIEUX provides diagnostics solutions specializing in clinical applications and industry applications. The company provides immunoassay solutions to laboratories worldwide, enabling a wide range of diagnostic tests, including immunoassays, infectious diseases, and diagnostic tests, to be performed quickly and by key team members.

Recent Developments

• Fujirebio and Agappe entered a business collaboration in January 2024 in the field of CLIA-based immunoassay, aiming to accelerate the Contract Development and Manufacturing Organization (CDMO) strategy.

• Siemens Healthineers launched the Atellica CI Analyzer for immunoassay and clinical chemistry testing in July 2023.

• DiaSorin S.p.A launched LIAISON legionella urinary assay in July 2023 accepting CE Mark to improve the legionnaires’ disease diagnosis.

Immunoassay Analyzers Market Report Scope

Global Immunoassay Analyzers Market Report Segmentation

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 2018 to 2030. For this study, Grand View Research has segmented the global immunoassay analyzers market report based on product, application, end use, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Chemiluminescence Immunoassay (CLIA)

  • Fluorescence Immunoassay (FIA)

  • Radioimmunoassay

  • Enzyme-Linked Immunoassay

  • Consumables and Accessories

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Therapeutic Drug Monitoring

  • Oncology

  • Cardiology

  • Endocrinology

  • Infectious Disease Testing

  • Autoimmune Disease

  • Others

• End Use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals

  • Diagnostic Laboratories

  • Research Institutes

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • Germany

    • UK

    • France

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

  • Latin America

    • Brazil

  • Middle East and Africa (MEA)

    • KSA

    • UAE

    • South Africa