Immunoassay Market

The global 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.

Attractive Opportunities in the Immunoassay Market

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Immunoassay Market Dynamics

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—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 radioimmunoassays 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.

These developments and the emerging biotech and diagnostic companies would fuel the growth of the market.

RESTRAINT: Stringent requirements for the approval of immunoassay instruments and consumables

Regulatory authorities have laid down stringent regulations for the approval and commercialization of immunoassay instruments and consumables. The US FDA, the European Medical Device Directives (CE), and the National Medical Products Association (NMPA, formerly the China Food and Drug Administration or CFDA) are responsible for the approval of immunoassay instruments and consumables in the US, Europe, and China.

US

The FDA regulates the design and manufacturing of immunoassay instruments and consumables in the US. The design and construction of these instruments, which are considered Class II medical devices in the US, should adhere to precisely documented processes. Their performance should meet stringent documentation, development testing, production testing, and field maintenance requirements. The products should also include comprehensive self-test and fault indication capabilities. Manufacturers of immunoassay instruments and consumables must also submit a premarket notification or 510(k) to prove substantial equivalence to a legally marketed device. The stringent and long process for obtaining regulatory approval can hamper the rate product launches and approvals in the market.

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.

Immunoassay Market Ecosystem /Market Map

In 2022, ELISA accounted for the largest share in the immunoassay industry, by technology.

The immunoassay market is segmented into ELISA, Chemiluminescence Immunoassay (CLIA), https://www.marketsandmarkets.com/Market-Reports/immunofluorescence-assay-market-255585571.htmlImmunofluorescence assay (IFA), rapid tests, ELISpot, western blotting, and other technologies. ELISA accounted for the largest share of the market in 2022 by technology. Increasing use of ELISA tests for the diagnosis of chronic conditions such as cancer and infectious diseases detection is expected to contribute to the significant share of the technology segment.

In 2022, blood specimen segment accounted for the largest share in the immunoassay industry, by specimen.

Based on specimens, the immunoassay market is segmented into blood, urine, saliva, and other specimens. In 2022, blood specimens accounted for the largest share of the market, by specimen. The detection of various medical conditions is possible through blood samples as compared to other specimens such as urine or saliva. Moreover, with a rise in blood donation activities, the segment is expected to witness considerable growth during the forecast period.

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

The immunoassay market is segmented into hospitals & clinics, pharmaceutical & biotechnology companies, clinical laboratories, and CROs, blood banks, research & academic laboratories, and home care settings. Hospitals & clinics accounted for the largest share of the market by end user. The share of the end user segment is owing to the rise in prevalence of conditions such as cancer and infectious diseases, which require frequent visits to the hospitals for diagnostic checkups.

In 2022, North America accounted for the largest share of the immunoassay industry.

The global immunoassay market is segmented into five major regions: North America, Europe, the Asia Pacific, Middle East & Africa, and Latin America. North America accounted for the largest share of the market in 2022. The availability of government funds, the increasing use of immunoassays in clinical diagnostics, and the presence of key players in the region contribute to this regional segment’s large share.

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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.

Scope of the Immunoassay Industry:

This report categorizes the immunoassay market to forecast revenue and analyze trends in each of the following submarkets:

By Product

• Reagents & Kits
  • ELISA Reagents & Kits
  • CLIA Reagents & Kits
  • IFA Reagents & Kits
  • Rapid Test Reagent & Kits
  • ELISpot Reagent & Kits
  • Western Blot Reagent & Kits
  • Other Reagents & Kits
• Analyzers
  • By Type
    • Open-ended Systems
    • Closed-ended Systems
  • By Purchase Mode
    • Rental Purchase
    • Outright Purchase

By Technology

• ELISA
• Chemiluminescence Immunoassay (CLIA)
• Immunofluorescence assay (IFA)
• Rapid Tests
• ELISpot
• Western Blotting
• Other Technologies

By Specimen

• Blood
• Saliva
• Urine
• Other Specimens

By Application

• Infectious Diseases
• Endocrinology
• Oncology
• Bone & Mineral Disorders
• Cardiology
• Blood Screening
• Autoimmune Disorders
• Allergy Diagnostics
• Toxicology
• Newborn Screening
• Other Applications

By End User

• Hospitals & Clinics
• Clinical Laboratories
• Pharmaceutical & Biotechnology Companies and CROs
• Blood Banks
• Research & Academic Laboratories
• Home Care Settings

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Indonesia
  • Australia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa

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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