Global Immunoassay Market - 2024-2031

Overview

The global immunoassay market reached US$ 34.6 billion in 2023 and is expected to reach US$ 59.2 billion by 2031, growing at a CAGR of 7.1% during the forecast period 2024-2031.

Immunoassay is a bioanalytical technique that uses antigen-antibody affinity to differentiate and measure molecules of interest in biological samples. Immunoassays are laboratory procedures that can identify particular compounds quickly and precisely.

Immunoassays are widely used in various fields, including clinical diagnostics, drug discovery, and food testing, to identify and measure the presence of specific substances in a sample.

The market is driven by factors such as technological advancements in immunoassay instruments, rising prevalence of chronic & infectious diseases, and increasing demand for point-of-care diagnostics.

Market Dynamics

Drivers

Technological Advancements in Immunoassay Instruments

The demand for the global immunoassay market is driven by multiple factors. Key factors driving the market are the technological advancements in the immunoassay instruments owing to the capability of identifying and measuring particular molecules present in biological samples, immunoassay tools are essential to medical diagnostic procedures.

Antibodies, antigens, proteins, hormones, or medications are examples of these compounds. Due to the growing need in healthcare for quick and precise diagnostic tools, the immunoassay industry has grown significantly and witnessed technical developments over the years.

Moreover, key players in the industry launch technological systems in the immunoassay market help to drive this market growth. For instance, in July 2023- Siemens Healthineers introduced the Atellica CI Analyzer for clinical chemistry and immunoassay testing.

Also, in August 2023- Shine i8000/9000, Fapon's newest chemiluminescence immunoassay system, was introduced at the 2023 Clinical Lab Expo and Meeting of the American Association of Clinical Chemistry (AACC). The fully automated, high-speed analyzer has an incredibly high throughput of 900 tests per hour and an integrated, compact design with consistent performance.

Similarly in November 2022, Gethin Biotech launched the new MAGICAL 6000 chemiluminescence immunoassay Analyzer at MEDICA. It is a compact and innovative chemiluminescence immunoassay analyzer that is ideal for mid to high-workflow laboratories that require a one-step chemiluminescence solution. The instrument is highly productive and compact, allowing for fully automated operation and the fastest testing speed of any device of its size.

Restraints

Factors such as the high cost of instruments and reagents, complex assay procedures, the stringent regulatory framework for the approval of immunoassays, and limited reimbursement policies, are expected to hamper the market.

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Segment Analysis

The global immunoassay market is segmented based on product type, technology, specimen, application, end-user, and region.

The ELISA segment accounted for approximately 45.1% of the global immunoassay market share

The ELISA segment is expected to hold the largest market share over the forecast period. ELISA is an immunological assay commonly used to measure antibodies, antigens, proteins, and glycoproteins in biological samples. Some examples include diagnosis of HIV infection, pregnancy tests, and measurement of cytokines or soluble receptors in cell supernatant or serum.

In addition, major players in the industry's innovative new launches drive this market growth. For instance, in February 2023, Charles River Laboratories International, Inc. announced the launch of its first Enzyme-Linked Immunosorbent Assay (ELISA) Kit for the detection and quantitation of residual host cell proteins (HCP) in CHO-based biotherapeutics.

Also, in September 2022, Neogen launched an immunoassay (Veratox VIP) to detect cashew allergens. The Veratox VIP for Cashew allergen test is the second in Neogen's Veratox VIP series of enhanced quantitative enzyme-linked immunoassay (ELISA) products. It has a high level of specificity to deficient levels of cashew protein.

Geographical Analysis

North America accounted for approximately 41.3% of the global immunoassay market share

North America region is expected to hold the largest market share over the forecast period. The rise in demand for diagnostics related to chronic diseases and the availability of technologically advanced diagnostic techniques are expected to propel market growth over the forecast period.

Furthermore, in the U.S., there were 55.7 million people aged over 65 years in 2022 (~17% of the population in the country). Nearly 25% of this senior population suffers from cancer of which 30% are obese, creating an opportunity for local market players to boost their sales of diagnostic products for cancer, cardiology, endocrinology, infectious diseases, and other tests.

Moreover, key players in the industry launch new products, and mergers & acquisitions, would drive this market growth. For instance, in April 2022, GeneProof, a prominent molecular diagnostics firm based in Brno, Czech Republic, merged with American Laboratory Products Company, Ltd. (ALPCO), a specialty in vitro diagnostics company.

The merger made them a global market leader in diagnostic products with extensive capabilities covering innovative immunoassay testing kits, real-time PCR testing products, and automated laboratory instrumentation systems.

Also, in February 2022, Agilent Technologies, Inc. introduced Dako SARS-CoV-2 lgG linked immunosorbent assay in the U.S. with plans to launch in other regions, such as Canada, Europe, Latin America, and some parts of Asia Pacific shortly.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the global Immunoassay market. The sudden increase in COVID-19 cases increased efforts in R&D in the diagnostics process aided by government funding. The increasing number of COVID-19 instances in 2020 and 2021 fueled the demand for immunoassay kits. The government is working on expanding the market for COVID-19 diagnostics to prevent further disease spread, vaccine supply, and a rise in demand for timely diagnostics.

The emphasis on critical patients has also shifted to developing time-efficient and accurate COVID-19 diagnostic kits. For instance, the FDA approved approximately 88 antibody-based and 256 molecular tests, totaling over 350 diagnostic test kits in 2021.

Market Segmentation

By Product Type

• Reagents & kits
  • ELISA Reagents & Kits
  • Rapid Test Reagents & Kits
  • ELISPOT Reagents & Kits
  • Western Blot Reagents & Kits
  • Other Reagents & Kits
• Analyzers
  • Open-ended Systems
  • Closed-ended Systems
• Software & Services

By Technology

• Radioimmunoassay (RIA)
• Enzyme Immunoassay (EIA)
  • Fluorescence Immunoassays (FIA)
  • Chemiluminescence Immunoassays (CLIA)
• Rapid Assays
• Others

By Specimen

• Blood
• Saliva
• Urine
• Other Specimens

By Application

• Therapeutic Drug Monitoring
• Drug Discovery
• Disease Diagnosis
  • Infectious Disease
  • Cancer
  • Endocrinology
  • Autoimmune Disorders
  • Cardiology
  • Hematology
  • Clinical Chemistry
• Others

By End-Users

• Hospitals
• Blood Banks
• Clinical Laboratories
• Pharmaceutical and Biotech Companies
• Academic Research Centers
• Others

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Middle East and Africa

Competitive Landscape

The major global players in the immunoassay market include Abbott, Beckman Coulter, Inc, F. Hoffmann-La Roche Ltd, Siemens Healthcare Private Limited, bioMerieux SA, Bio-Rad Laboratories, Inc., DiaSorin S.p.A., BD, Thermo Fisher Scientific Inc., Merck KGaA among others.

Key Developments

• In July 2023, Sysmex Corporation introduced a novel fully automated, and high-speed chemiluminescence immunoassay system at the 2023 AACC exhibition.
• In July 2023, SEKISUI Diagnostics, introduced the OSOM COVID-19 Antigen Home Test, a lateral flow immunoassay for diagnosis of SARS-CoV-2 virus.
• In March 2023, F. Hoffmann-La Roche Ltd. collaborated with Eli Lily and Company to support the development of Roche's Elecsys Amyloid Plasma Panel (EAPP).
• In February 2023, bioMerieux company received 510(k) clearance and the CLIA waiver for their BIOFIRE SPOTFIRE system and BIOFIRE SPOTFIRE respiratory panel.
• In February 2022, bioMerieux launched VIDAS KUBE, a next-generation system for automated immunoassay testing. At the beginning of 2023, it was planned in selected countries and the rest of the world, extending gradually as of Q2.
• In April 2022, The Simple Plex HEK 293 HCP 3G assay for automated process impurity detection on the Ella immunoassay platform was launched by Bio-Techne Corporation and Cygnus Technologies, a division of Maravai LifeSciences. In Gene and Cell Therapy applications, purifying viral particles to reduce host cell protein (HCP) contamination is an important part of the viral production workflow. Impurity clearance is performed according to regulatory criteria to guarantee HCP and accurate quantification throughout process phases is required.
• In November 2022, LumiraDx launched a rapid microfluidic immunoassay HbA1c test in Europe, parts of the Middle East, Asia, Latin America, and Africa.
• In February 2022, NOVEOS Immunoassay Analyzer gained additional FDA 510(k) clearance from Hycor Biomedical Inc., a medical device firm that makes and supplies in-vitro diagnostic equipment. The NOVEOS Immunoassay Analyzer is a chemiluminescent immunoassay analyzer that can diagnose allergies. It's made to assist with analyte concentration measurements in human samples.

Why Purchase the Report?

• To visualize the global immunoassay market segmentation based on product type, technology, specimen, application, end-user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of global immunoassay market level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in excel consisting of key products of all the major players.

The global immunoassay market report would provide approximately 78 tables, 94 figures, and 181 Pages.

Target Audience 2024

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies