Immunoassay Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

The report covers Global Immunoassay Market Size & Companies. The market is Segmented by Type (Radioimmunoassay, Enzyme Immunoassays, Fluoroimmnoassay, Chemiluminescence Immunoassay, Others), Application (Disease Diagnosis, Therapeutic Drug Monitoring, Drug Discovery, Clinical Chemistry, Hematology, Others), End-User (Hospitals, Pharma & Biotech Companies, Clinical Laboratories Others), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, and South America). The market size and forecasts are provided in terms of value (USD million) for all the above segments.

Immunoassays Market Size

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Immunoassays Market Summary
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Study Period 2021 - 2029
Base Year For Estimation 2023
Forecast Data Period 2024 - 2029
CAGR 7.70 %
Fastest Growing Market Asia Pacific
Largest Market North America

Major Players

Immunoassays Market Major Players

*Disclaimer: Major Players sorted in no particular order

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Immunoassays Market Analysis

The Immunoassays Market is projected to register a CAGR of 7.7% during the forecast period.

During the COVID-19 pandemic, the need for diagnostic solutions for the accurate and rapid diagnosis of SARS-CoV-2 infection increased significantly. In particular, serological and immunological testing of infected asymptomatic and symptomatic individuals was in high demand. Though RT-PCR for the detection of COVID-19 disease was widely used there was also a great demand for immunological assays. The results provided by immunological tests play an important role in the development of the COVID-19 vaccine, which also increased the need for immunoassay testing. Furthermore, post-pandemic, immunoassays are still in demand due to their significance in the development of vaccines and the diagnosis of various diseases. For instance, according to the article published in 'SelectScience' in January 2021, the use of vaccines as immunotherapies for various disorders, such as some malignancies and Alzheimer's disease, has led to increased development of advanced immunotherapies. This has led to increased adoption of immunoassays during the testing of immunotherapies, driving market growth.

The major factors that are driving the market growth include the rising prevalence and incidence of chronic as well as infectious diseases along with the technological advancements in immunoassay instruments and the high sensitivity and specificity of the immunoassays. Immunoassays are also suitable for diagnosing asymptomatic diseases, which otherwise cannot be diagnosed. The ultrasensitive immunoassay has been proven to detect HIV and is demonstrated to detect limits of less than 1fg/ml. This high sensitivity helps to detect one virus particle per 25 μl of the sample. The versatile applications and ease of automation have made immunoassay quite popular which is supporting the market growth.

The rising number of people affected by these infectious diseases is further contributing to the market growth. According to the WHO's key facts on HIV published in July 2022, around 38.4 million people around the world were affected by HIV in 2021 with around 1.5 million new cases being registered in 2021 alone. Therefore, the rising number of infectious diseases is expected to drive market growth due to the increased adoption of immunoassays for the diagnosis of infectious diseases.

Besides, the launch of products by the key market players is also aiding in the growth of the market. For instance, in November 2021, Boditech Med launched its new automated immunoassay analyzer with a blood collection tube, including an all-in-one cartridge system, at MEDICA 2021. The immunoassay analyzer, AFIAS-10, is a unique integrated Sample-to-Answer system that can execute 10 parallel tests for each different parameter. Such progress in immune analyzers is expected to propel the growth of the market over the forecast period due to the increased adoption of parallel testing of different parameters at once.

Thus, the high sensitivity, specificity, and cost-saving nature of immunoassays are driving the growth of the immunoassays market. However, factors, such as complex assay procedures and stringent regulatory scenarios for the approval of immunoassays, may hinder market growth.

Immunoassays Market Trends

This section covers the major market trends shaping the Immunoassays Market according to our research experts:

Enzyme Immunoassays (EIA) Segment is Expected to Hold Significant Market Share in Immunoassay Market

An enzyme immunoassay commonly known as enzyme-linked immunosorbent assay (ELISA) is used to detect the presence of a target protein in a biological sample. These assays serve as the foundation for the majority of well-established clinical tests and are frequently the most accurate way to make diagnoses. ELISA tests can also be used for the detection of viral components. ELISA is compatible with various samples increasing its demand for COVID-19 testing. Besides, enzyme immunoassays are also the most affordable of all immunoassays, which is the major factor behind the market growth.

The rising launches in EIA by key market players are also expected to propel market growth. For instance, in September 2021, Bio-Rad launched the Bio-PlexPro Human IgA and IgM SARS-CoV-2 panels to detect IgA and IgM antibodies against four SARS-CoV-2 antigens. The multiplex immunoassay panels helped the vaccine developers to determine therapeutic efficacy, from development through clinical phases and also in postmarket surveillance studies.

Furthermore, in December 2021, ArcticZymes Technologies launched a new ELISA immunoassay product, an essential support product for consumers which used the M-SAN HQ enzyme in biomanufacturing processes for gene therapy and viral vaccine production. Therefore, the significance of enzyme immunoassays in R&D for the development of vaccines and other therapeutics is expected to drive this segment's growth.

Immunoassays Market : Estimates of Funding for Immunotherapies (in USD Million), United States, 2019-2021

North America Holds a Major Share and is Expected to do Same during the Forecast Period

This can be majorly attributed to the increasing incidence rates of chronic disorders, infectious diseases, and the increasing geriatric population, as well as due to the well-developed healthcare infrastructure and increasing penetration of medical devices in the region.

The increase in per capita health expenditures, the advancement in healthcare infrastructure, and the increase in the number of infectious diseases and cancer cases in the United States have led to an increased demand for immunoassays driving the market growth in the region. For instance, according to the ACS 'Cancer Facts & Figures 2022', around 1,918,030 new cancer cases are estimated to be reported in the United States in the year 2022. Such a high incidence of cancers in the United States is anticipated to rise in the adoption of immunoassays for the diagnosis of cancer, driving the market growth in the region.

Moreover, high expenditure on R&D by government organizations and pharmaceutical companies, for disorders and diseases, such as chronic ailments and diabetes, are some of the primary factors driving the regional market. For instance, as per Pharmaceutical Research and Manufacturers of America, the biopharmaceutical industry invested an estimated USD 102.3 billion in R&D in 2021.

Furthermore, the increasing launches, collaborations, and acquisitions between the companies are boosting the market growth in the country. For instance, in May 2022, Abbott launched HBsAg Next Assay in India to accelerate the early and enhanced detection of Hepatitis B. In addition, Thermo Fisher Scientific, Inc. acquired the private point-of-care molecular diagnostic company Mesa Biotech, in February 2021, making it more strong in the field of immunoassays in the country. Such launches and acquisitions help in the increased development and adoption of innovative immunoassays, thereby expected to drive market growth.

Immunoassays Market- Growth Rate by Region

Immunoassays Industry Overview

The immunoassays market is highly competitive and consists of several major players. In terms of market share, few of the major players currently dominate the market. With the rising need for healthcare development and the advances in immunoassays, a few other smaller players are expected to enter the market. Some of the players operating in the market include Abbott Laboratories Inc., Becton Dickinson and Company, Danaher Corporation, Hologic Inc., and Qiagen NV, among others.

Immunoassays Market Leaders

  1. Abbott Laboratories Inc.

  2. Becton Dickinson and Company

  3. Danaher Corporation

  4. Hologic Inc.

  5. Qiagen NV

*Disclaimer: Major Players sorted in no particular order

Immunoassays Market Concentration
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Immunoassays Market News

  • In November 2022, Getein launched MAGICL 6000 CLIA analyzer at MEDICA 2022. MAGICL 6000 is a compact and innovative CLIA analyzer, with optimal choice for mid to high-workflow laboratories that require a one-step CLIA solution.
  • In November 2022, LumiraDx launched a rapid microfluidic immunoassay HbA1c test in Europe, parts of the Middle East, Asia, Latin America, and Africa.

Immunoassays Market Report - Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 High Sensitivity and Specificity of Immunoassays

      2. 4.2.2 Technological Advancements in Immunoassay Instruments

      3. 4.2.3 Increasing Prevalence of Chronic and Infectious Diseases

    3. 4.3 Market Restraints

      1. 4.3.1 Stringent Regulatory Scenario for Approval of Immunoassays

      2. 4.3.2 Complexity of Procedures

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value - USD million)

    1. 5.1 By Type

      1. 5.1.1 Radioimmunoassay (RIA)

      2. 5.1.2 Enzyme Immunoassays (EIA)

      3. 5.1.3 Fluoroimmnoassay (FIA)

      4. 5.1.4 Chemiluminescence Immunoassay (CLIA)

      5. 5.1.5 Others

    2. 5.2 By Application

      1. 5.2.1 Disease Diagnosis

      2. 5.2.2 Therapeutic Drug Monitoring

      3. 5.2.3 Drug Discovery

      4. 5.2.4 Clinical Chemistry

      5. 5.2.5 Hematology

      6. 5.2.6 Others

    3. 5.3 By End User

      1. 5.3.1 Hospitals

      2. 5.3.2 Pharma & Biotech Companies

      3. 5.3.3 Clinical Laboratories

      4. 5.3.4 Others

    4. 5.4 Geography

      1. 5.4.1 North America

        1. 5.4.1.1 United States

        2. 5.4.1.2 Canada

        3. 5.4.1.3 Mexico

      2. 5.4.2 Europe

        1. 5.4.2.1 Germany

        2. 5.4.2.2 United Kingdom

        3. 5.4.2.3 France

        4. 5.4.2.4 Italy

        5. 5.4.2.5 Spain

        6. 5.4.2.6 Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. 5.4.3.1 China

        2. 5.4.3.2 Japan

        3. 5.4.3.3 India

        4. 5.4.3.4 Australia

        5. 5.4.3.5 South Korea

        6. 5.4.3.6 Rest of Asia-Pacific

      4. 5.4.4 Middle East and Africa

        1. 5.4.4.1 GCC

        2. 5.4.4.2 South Africa

        3. 5.4.4.3 Rest of Middle East and Africa

      5. 5.4.5 South America

        1. 5.4.5.1 Brazil

        2. 5.4.5.2 Argentina

        3. 5.4.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Abbott Laboratories

      2. 6.1.2 Becton Dickinson and Company

      3. 6.1.3 Danaher Corporation (Beckman Coulter, Inc)

      4. 6.1.4 Hologic Inc.

      5. 6.1.5 Luminex Corporation

      6. 6.1.6 Qiagen NV

      7. 6.1.7 F. Hoffmann-La Roche AG

      8. 6.1.8 Sysmex Corporation

      9. 6.1.9 Thermo Fisher Scientific

      10. 6.1.10 Bio-Rad Laboratories, Inc.

      11. 6.1.11 Agilent Technologies, Inc.

      12. 6.1.12 PerkinElmer, Inc.

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape Covers - Business Overview, Financials, Products and Strategies, and Recent Developments
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Immunoassays Industry Segmentation

As per the scope of this report, an immunoassay is a test that relies on biochemistry to measure the presence and concentration of an analyte. The analyte can be large proteins, antibodies that a person has produced as a result of an infection, or small molecules. Immunoassays are highly sensitive and specific. Their high specificity results from the use of antibodies and purified antigens as reagents. The Immunoassays Market is Segmented by Type (Radioimmunoassay, Enzyme Immunoassays, Fluoroimmnoassay, Chemiluminescence Immunoassay, Others), Application (Disease Diagnosis, Therapeutic Drug Monitoring, Drug Discovery, Clinical Chemistry, Hematology, Others), End-User (Hospitals, Pharma & Biotech Companies, Clinical Laboratories Others) and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.

By Type
Radioimmunoassay (RIA)
Enzyme Immunoassays (EIA)
Fluoroimmnoassay (FIA)
Chemiluminescence Immunoassay (CLIA)
Others
By Application
Disease Diagnosis
Therapeutic Drug Monitoring
Drug Discovery
Clinical Chemistry
Hematology
Others
By End User
Hospitals
Pharma & Biotech Companies
Clinical Laboratories
Others
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa
GCC
South Africa
Rest of Middle East and Africa
South America
Brazil
Argentina
Rest of South America
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Immunoassays Market Research FAQs

The Immunoassays Market is projected to register a CAGR of 7.70% during the forecast period (2024-2029)

Abbott Laboratories Inc., Becton Dickinson and Company, Danaher Corporation, Hologic Inc. and Qiagen NV are the major companies operating in the Immunoassays Market.

Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).

In 2024, the North America accounts for the largest market share in Immunoassays Market.

The report covers the Immunoassays Market historical market size for years: 2021, 2022 and 2023. The report also forecasts the Immunoassays Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.

Immunoassay Industry Report

Statistics for the 2024 Immunoassay market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Immunoassay analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.

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Immunoassay Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)