The report "Immunoassay Market by Product (Reagents & Kits, Analyzers), Technology (ELISA, CLIA, Rapid Tests), Specimen (Blood, Saliva, Urine), Application (Infectious Diseases, Endocrinology), End User (Hospitals & Clinics, Blood Banks) - Global Forecast to 2028", is projected to reach USD 46.7 billion by 2028 from USD 35.0 billion in 2023, at a CAGR of 5.9% during the forecast period. The immunoassay market is driven by the increasing incidence of infectious and chronic diseases, increasing adoption of immunoassay-based POC testing and rapid testing, and introduction of innovative products by leading players operating in the immunoassay market. Growth in emerging countries and development of condition specific biomarkers and tests are anticipated to offer lucrative growth opportunities for the immunoassay market.
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Browse in-depth TOC on "Immunoassay Market”
307 – Tables
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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.
CHALLENGE: Design challenges, complexities, and the quality of antibodies
The validation of immunoassays is a complex process that relies on sensitivity and specificity. The diagnosis is often misinterpreted due to false negatives and false positives. As a result, technicians face operational challenges in ensuring effective sample procurement, storage, and transportation, especially while adopting novel technologies such as chemiluminescent immunoassays and multiplex flow immunoassays (MFI).
Laboratory space also needs to be reconfigured to meet the requirements of conducting specific immunoassay tests used for pathogen detection to avoid cross-contamination and ensure efficient time management. This results in considerable cost escalation to maintain and operate advanced immunoassay instruments, particularly those capable of handling a single sample type.
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.
Key Players:
The major players in this market are Abbott Laboratories (US), F. Hoffmann-La Roche (Switzerland), and Thermo Fisher Scientific, Inc. (US). These players’ market leadership is due to their broad product portfolios and vast global footprint. These dominant market players have advantages, including strong research and development budgets, better marketing and distribution networks, and established brand recognition.
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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.
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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