The global immunoassay market is experiencing robust growth, driven by the increasing prevalence of chronic diseases, advancements in technology, and a growing emphasis on early disease detection. As of 2023, immunoassays, which encompass a diverse range of diagnostic techniques, play a pivotal role in the detection and quantification of various analytes, including proteins, hormones, and biomarkers. These assays find extensive application in clinical diagnostics, pharmaceutical research, and food testing, contributing to the overall improvement of healthcare and life sciences.

Over the projection period of 2022–2032, the global immunoassay market is expected to increase at a 6% compound annual growth rate (CAGR) and reach a market size of US$ 53 billion. With a 5.7% year-over-year growth rate, the market, estimated at US$ 28 billion in 2021, is expected to expand to US$ 29.6 billion in 2022.

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Competitive Landscape

The key players are taking on extensive initiatives to address the unmet needs of patients in the domain of immunoassays and stressing more on new product development, mergers and acquisitions, and regional expansion.

  • Molecular biology subsidiary BioFire Diagnostics, a subsidiary of BioMérieux SA, filed an application with the Food and Drug Administration in January 2020 for clearance of its BIOFIRE Blood Culture Identification 2 (BCID2) Panel. The BIOFIRE BCID2 Panel has an expanded list of antibiotic resistance genes, considerably more pathogens, and several revised targets compared to the previous BIOFIRE BCID Panel.
  • Siemens Healthineers announced in November 2020 that its SARS-CoV-2 IgG Antibody Test has been certified as a CE mark measurement of neutralizing antibodies. The test is an improved version of the COVID-19 antibody test it previously launched.
  • Maglumi HIV Ab/Ag Combi CLIA kit, Snibe Diagnostics’ fourth-generation chemiluminescence immunoassay that can detect HIV-1 and HIV-2 antibodies as well as the HIV-1 p24 antigen, obtained CE marking in April 2021, allowing it to be sold in the European Union and other regions accepting the designation.

Key Companies Profiled

  • DiaSorin S.p.A.
  • Sysmex Corporation
  • bioMerieux SA
  • Ortho Clinical Diagnostics
  • Thermo Fisher Scientific Inc.
  • Becton
  • Dickinson and Company 
  • Merck KGaA.

Increased prevalence of infectious and chronic illnesses, such as COVID-19, is linked to market expansion. Further driving increase will be the ageing population, which is more prone to infectious and chronic illnesses.

Key Market Drivers:

  • Rising Disease Burden: The escalating burden of chronic diseases, such as cardiovascular disorders, cancer, and infectious diseases, is a primary driver for the immunoassay market. The need for accurate and timely diagnosis to initiate appropriate treatment regimens has spurred the demand for immunoassay-based diagnostic solutions.

  • Technological Advancements: Ongoing advancements in immunoassay technologies are enhancing the sensitivity, specificity, and speed of diagnostic tests. Automation, multiplexing, and the integration of novel detection platforms are improving the efficiency of immunoassays, making them invaluable tools in clinical laboratories and research settings.

  • Point-of-Care Testing (POCT): The growing trend towards decentralized testing and the demand for rapid diagnostic results have propelled the adoption of immunoassays in point-of-care settings. Portable immunoassay devices allow for quick on-site testing, enabling healthcare providers to make immediate clinical decisions and improve patient outcomes.

Challenges and Opportunities:

  • Complexity of Assay Development: The complexity associated with the development of immunoassays, including the selection of appropriate antibodies, assay optimization, and standardization, poses a challenge to market growth. However, overcoming these challenges presents opportunities for innovation and the creation of more sophisticated and reliable immunoassay platforms.

  • Competitive Landscape: The immunoassay market is highly competitive, with numerous players offering a wide array of products. To thrive in this landscape, companies are exploring niche markets, developing specialized assays, and engaging in strategic collaborations to expand their product portfolios and gain a competitive edge.

Current Industry Trends (2023):

  • Expansion of Biomarker Discovery: Immunoassays are integral in the discovery and validation of biomarkers for various diseases. The emphasis on precision medicine and personalized treatment approaches has fueled the expansion of biomarker research, driving the demand for immunoassay platforms capable of detecting specific biomolecules indicative of disease states.

  • Adoption of Multiplex Immunoassays: Multiplex immunoassays, allowing the simultaneous detection of multiple analytes in a single sample, are gaining prominence. These assays streamline the diagnostic process, conserve sample volumes, and provide a comprehensive understanding of the patient's health status. The adoption of multiplexing is particularly notable in cancer research and autoimmune disease diagnostics.

  • Integration of Artificial Intelligence (AI): The integration of artificial intelligence and machine learning in immunoassay data analysis is a growing trend. AI algorithms enhance the accuracy and speed of result interpretation, aiding healthcare professionals in making more informed decisions. This integration contributes to the evolving landscape of precision diagnostics.

Key Segments Covered in the Immunoassay Market Report

  • By Technology Type :

    • Chemiluminescence Immunoassay (CLIA)

    • Enzyme Linked Fluorescence Assay (ELFA)

    • Enzyme-linked Immunosorbent Assay (ELISA)

    • Radioimmunoassay (RIA)

    • Others

  • By Product :

    • Analyzer Immunoassay

    • Consumable Immunoassay

  • By Application :

    • Infectious Diseases

    • Orthopedics

    • Cardiology

    • Oncology

    • Endocrinology

    • Other Applications

  • By End-User :

    • Immunoassay for Blood Banks

    • Immunoassay for Hospitals & Diagnostic Laboratories

    • Immunoassay for Others (Pharmaceutical & Biotech Companies, Forensic Labs, Academic & Research Institutes, etc.)

  • By Region :

    • North America

    • Western Europe

    • Asia Pacific

    • Middle East & Africa

    • Eastern Europe

    • Latin America

Global Industry News (2023):

  • Rapid COVID-19 Diagnostics: The ongoing global response to the COVID-19 pandemic has highlighted the pivotal role of immunoassays in infectious disease diagnostics. Rapid immunoassay tests for detecting SARS-CoV-2 antigens and antibodies have been pivotal in mass testing efforts, emphasizing the adaptability and versatility of immunoassay technologies in addressing emerging health challenges.

  • Investments in Research and Development: Key players in the immunoassay market are actively investing in research and development to introduce novel assays with enhanced performance characteristics. This includes the development of ultrasensitive assays, novel biomarker panels, and innovative detection methodologies to meet the evolving needs of the healthcare and research communities.

  • Strategic Collaborations: Strategic collaborations and partnerships between diagnostic companies, pharmaceutical firms, and research institutions are prevalent in the immunoassay market. These collaborations aim to leverage collective expertise, access shared resources, and accelerate the development and commercialization of novel immunoassay-based diagnostics.

  • Focus on Sustainability: Sustainability is gaining traction in the immunoassay market, with a focus on developing eco-friendly assay components, reducing waste generation, and adopting green laboratory practices. This aligns with broader industry efforts to minimize environmental impact and promote sustainable healthcare solutions.

The immunoassay market continues to be a dynamic and vital component of the diagnostics and life sciences landscape. The ongoing convergence of technological advancements, the expansion of biomarker research, and the market's response to global health challenges underscore the adaptability and resilience of immunoassay technologies. As the industry navigates complexities and embraces opportunities for innovation, immunoassays are expected to play an increasingly integral role in shaping the future of diagnostics and healthcare.