The report “Immunoassay Market in terms of revenue was estimated to be worth $35.0 billion in 2023 and is poised to reach $46.7 billion by 2028, growing at a CAGR of 5.9% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. Market growth is driven by the rising incidence of chronic and infectious diseases, and growth in the biotechnology and biopharmaceutical industries. On the other hand, stringent requirements for approval of immunoassay instruments and consumables are expected to restrain the growth of this market to a certain extent.

The top players in this market are Abbott Laboratories (US), F. Hoffmann-La Roche (Switzerland), and Thermo Fisher Scientific, Inc. (US). These players hold leading positions in the market owing to their broad product offerings in the immunoassay market. These mentioned players have undertaken various organic and inorganic growth strategies such as product launches and approvals, collaborations, acquisitions, and agreements to retain their position in the market.

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Browse in-depth TOC on “Immunoassay Market”

307 – Tables

54 – Figures

394 – Pages

DRIVER: Growth in the biotechnology and biopharmaceutical industries

The demand for immunoassay instruments and consumables is considerably high in the bio-pharma industries. Hence, growth in these industries is anticipated to drive the demand for immunoassay products during the forecast period. In these industries, the increase in the demand from end users has provided an opportunity to various companies to launch new products in the market, hence enabling product innovation. Besides, immunoassays are applied at many stages in biopharma and biotechnology industries’s from product development and manufacturing to quality control in production.

The biotechnology and pharmaceutical sectors have experienced various developments and changes in the past few years. Immunoassays have an extensive role in drug discovery and monitoring; ELISA and radioimmunoassay are utilized for the immunogenicity assessment of certain biologics such as adalimumab and infliximab.

In the past few years, many healthcare start-ups have emerged that offer diagnostic assays such as immunoassays and the related kits reagents.

• In December 2021, a Canadian start-up company, Nomic (Canada), collected over USD 17 million for its automated, high-throughput ELISA platform.
• In September 2021, Biotech start-up company, immunitoAI Private Limited (India) raised over USD 1 million in seed funding.

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OPPORTUNITY: Growth opportunities in emerging economies

Developing economies such as India, China, Taiwan, South Korea, South Africa, Brazil, and Turkey, are expected to offer growth opportunities for major players operating in the market. This can be attributed to the growing geriatric population, increasing prevalence of chronic and infectious diseases, improvement in the healthcare infrastructure, and increasing disposable income in these countries. Some of the major statistics related to the rising geriatric population and growing disease burden in developing economies have been mentioned below:

• According to the National Development Council, the geriatric population of Taiwan will reach 19.9% in 2025, 23.9% in 2030, and 27.3% in 2035.
• According to the 13th Five-year Plan on Development of Undertakings on Ageing and Old Age Support System by the State Council, the geriatric population of China will reach up to 255 million by 2020. The official website of the Central Government of China in 2017 highlighted the rise of the old-age dependency ratio up to 28%.

The Asia Pacific has emerged as a business-friendly hub due to relatively less stringent regulations and data requirements. This encourages biopharmaceutical and pharmaceutical companies to outsource their drug discovery activities to the APAC. Asian markets, especially China and India, have many contract research organizations (CROs) that offer drug discovery services for pharmaceutical and biotechnology companies.

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The reagents & kits accounted for the largest share of the immunoassay Industry, by product segment, in 2022.

The global immunoassay market is segmented into analyzers and reagents & kits based on product. High consumption of consumables such as kits and reagents and their repeated purchases along with the increasing number of immunoassay tests performed across the globe, are the factors supporting the growth of the reagents & kits product segment.

The hospitals & clinics segment accounted for the largest share of the immunoassay industry share, by end user, in 2022.

The increasing prevalence of chronic and infectious diseases and the availability of advanced technologies for their detection have led to significant growth of the hospitals & clinics end user segment. The segment is also anticipated to register the highest growth rate during the forecast period, owing to better testing facilities.

North America is the largest regional market for immunoassay market.

The global immunoassay market has been segmented into five major regions—North America, Europe, the Asia Pacific, the Middle East & Africa, and Latin America. In 2022, North America dominated the global immunoassay market in 2022. The large share of the North American market is primarily driven by the increasing geriatric population and the subsequent prevalence of chronic diseases, and the easy accessibility of technologically advanced instruments.

Recent Developments of Immunoassay Industry:

• In August 2023, Abbott received FDA approval for its Alinity h-series hematology system, enabling laboratories nationwide to run complete blood counts (CBC).
• In July 2023, Siemens received FDA clearance and launched its Atellica CI Analyzer for immunoassay and clinical chemistry in the world’s major markets.
• In June 2023, DiaSorin launched its CE marked LIAISON B.R.A.H.M.S MR-proADM assay to be used for the diagnosis of conditions, such as kidney diseases, sepsis, septic shock, lower respiratory and urinary tract infections.
• In December 2022, QuidelOrtho received approval from Health Canada for use of the Quidel TriageTrue High-Sensitivity Troponin I(hsTnl) Test to aid in the diagnosis of myocardial infarction.
• In October 2022, Roche received U.S. FDA granted Emergency Use Authorization (EUA) for its cobas MPXV for use on the cobas 6800/8800 immunoassay Systems.

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 Recent Developments of Immunoassay Industry

• In August 2023, Abbott received FDA approval for its Alinity h-series hematology system, enabling laboratories nationwide to run complete blood counts (CBC).
• In July 2023, Siemens received FDA clearance and launched its Atellica CI Analyzer for immunoassay and clinical chemistry in the world’s major markets.
• In June 2023, DiaSorin launched its CE marked LIAISON B·R·A·H·M·S MR-proADM assay to be used for the diagnosis of conditions, such as kidney diseases, sepsis, septic shock, lower respiratory and urinary tract infections.
• In December 2022, QuidelOrtho received approval from Health Canada for use of the Quidel TriageTrue High-Sensitivity Troponin I (hsTnl) Test to aid in the diagnosis of myocardial infarction.
• In October 2022, Roche received U.S. FDA granted Emergency Use Authorization (EUA) for its cobas MPXV for use on the cobas 6800/8800 immunoassay Systems.