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Immunoassay Market

Immunoassay Market: Information by Product & Service (Analysers, Software & Services), Technology, Platform (ELISA), Specimen (Blood, Saliva), Application, and Region — Forecast till 2030

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Market Overview

The global immunoassay market size was valued at USD 21,360 million in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 6.7% from 2022 to 2030 and reach around USD 38,295 million.

Immunoassays constitute very selectively and touchy strategies that have located software in numerous regions, including scientific chemistry, bioanalysis, pharmaceutical analysis, toxicological analysis, and environmental analysis. The first immunoassays that evolved have been radioimmunoassays, which are very touchy; however, one downside is the want to paint radiochemical. To avert the drawbacks, different labels, which include enzymes in a mixture with photometric dimensions, had been introduced, however, on the fee of sensitivity. With the improvement of fluor immunoassays (FIAs), a development in sensitivity changed into acquired and with the aid of introducing chemiluminescence in immunoassays, a sensitivity equal to radioimmunoassay changed into achieved. The development of novel assays in various autoimmune diseases such as oncology and cardiology and the rising prevalence of infectious and chronic devices are all contributing to the market's growth.

Furthermore, increasing applications in drug monitoring tests, toxicology testing, infectious diseases, and cancer biomarker detection propel the market forward. Moreover, the market for immunoassays is strengthening due to the rising demand for non-invasive diagnostics, the high need for reagents, analytical techniques, and sensitive assays, and the introduction of novel biomarkers. According to the World Health Organization, chronic diseases such as heart disease, stroke, cancer, diabetes, and chronic lung disease account for nearly 71% of deaths worldwide. In middle and low-income countries, 82 percent of the 16 million people die before reaching 70. Compared to other tests, immunoassays have a wide range of applications in disease diagnosis with high sensitivity and specificity.

Market Snapshot

market snapshot
Base Year
: 2021
Study Period
: 2020-2030
: 6.7 %
Fastest Growing Market
: Europe
Largest Market
: North America
Market Size
: USD 21,360 million in 2021
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Market Dynamics

Market Drivers

The Prevalence of Chronic and Infectious Diseases will Drive the Market

Chronic sicknesses like diabetes, coronary heart sickness, and most cancers are at the upward thrust everywhere globally. Infectious sicknesses, Dengue fever, Hepatitis B, C, HIV, Malaria, Tuberculosis, and others are spreading at an alarming rate. Immunoassay prognosis has ended up an essential factor of those sicknesses' prognosis. The immunoassay era improves, resulting in quicker outcomes with better efficacy, detection limits, sensitivity, and cost-effectiveness. The tremendous use of fast checks and point-of-care checking out for sickness prognosis and drug and alcohol abuse has propelled the worldwide immunoassay marketplace.

Public Awareness of Early Disease Detection

Early detection of chronic and infectious diseases will significantly improve the chances of successful treatment. Early diagnosis, downstaging, and screening are the two components of early detection of chronic and contagious diseases. Early diagnosis focuses on detecting symptomatic patients as soon as possible, whereas screening involves testing healthy people to detect cancers before symptoms appear. Early detection programs aim to reduce the number of diagnosed patients too late. They consist of two main components: increased public and professional awareness of early signs of chronic and infectious diseases. It will make diagnosis and treatment services more accessible and affordable and improve referral from primary to secondary and tertiary care. These factors will propel the market forward.

Market Restraints

Immunoassay Instruments and Consumables Must Meet Strict Regulatory Requirements

The regulatory government of numerous countries has jotted stringent policies to approve and commercialize immunoassay consumables and instruments. Also, the technological hurdles posed through the immunoassay kits and reagents, together with cross-reactivity of the antibodies, low detection limits, antibodies, fake negatives, and others, decelerate the boom of the immunoassay market. These are the most significant factor behind the degrowth of the immunoassay market.

Market Opportunities

Companion Diagnostics, Emerging Economies, and Other Advancing Technologies Are Great Opportunities

Emerging economies, including the Asia Pacific, are predicted to offer sizable boom possibilities to gamers working within the immunoassay market. The huge greying populace of Asian countries, including Taiwan, Japan, China, and India, is growing. The growing importance of the accomplice diagnostics, technological development of immunoassay products, condition-unique biomarkers immunoassays, and different rising technology are propelling the boom of the immunoassay market.

Segmental Analysis

The market is divided into three categories: Reagents and Kits, Analysers, and Software and Services. The fastest CAGR is expected in the reagents and kits segment. The increase can be attributed to repeated purchases of kits and reagents and an increase in the number of immunoassays conducted.

Chemiluminescence immunoassays (CLIAs), colorimetric immunoassays (CIs), fluorescence immunoassays (FIAs), radioimmunoassays (RIAs), and other platforms make up the global immunoassay market. Chemiluminescence immunoassays are expected to have the largest market share due to their low cost and high sensitivity.

The immunoassays market is divided into enzyme-linked immunosorbent assays (ELISA), rapid tests, western blotting, enzyme-linked immunospot (ELISPOT), immuno-PCR, and other technologies, by technology. Because it is the most preferred immunoassay test for cancer diagnosis, infectious diseases, and therapeutic drug level monitoring, the ELISA segment is expected to generate the most revenue during the forecast period.

The market is divided into blood, urine, saliva, and other specimens based on specimen type. The highest register is expected for blood samples. The high prevalence of the chronic disease is to blame for this.

Bone and mineral disorders, infectious diseases, endocrinology, oncology, hematology, cardiology and toxicology, blood screening, neonatal screening, autoimmune disorders, and other applications make up the global immunoassays market. Because of the high number of infectious diseases and increasing product approvals, the infectious diseases segment is expected to grow at the fastest rate during the assessment period.

Blood banks, hospitals, clinical laboratories, research and academic laboratories, pharmaceutical and biotechnology companies, contract research organizations (CROs), and other end users make up the end-user segment. Diagnostic tests in hospitals are easily accessible, time-saving, and provide a smooth process so that they may account for the largest share.

Regional Analysis

North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa are the four regions that make up the global immunoassay market (LAMEA).

Because of the growing use of immunoassay techniques in cancer research, the adoption of low-cost and compact immunoassay instruments, and the demand for high-quality laboratory and clinical research infrastructure, North America is expected to dominate the immunoassay market. Early detection and prevention of these life-threatening diseases can be aided by early screening.

Europe is expected to become the world's second-largest immunoassay market. This is due to the rising cancer disease burden and strong government policies to reduce chronic disease rates. After cardiovascular diseases, cancer is the second leading cause of death in the EU.

Due to the increased development and production of vaccines and drugs, growing medical treatment for infectious and chronic diseases, a large number of investment opportunities for market players, and an increasing number of diagnostics laboratories, the Asia-Pacific immunoassay market is expected to grow significantly.

Latin America's governments have low health budgets compared to developed economies; the region is expected to grow steadily. There are also various cancer-awareness programs available, but knowledge of cancer risks is still lacking. According to the American Cancer Society, 1.1 million new cancer cases and 600,000 cancer deaths occur in Latin America and the Caribbean.

Immunoassay Market Regional Analysis
Regional Growth Insights Download Free Sample

Top Key Players of Immunoassay Market

  1. Abbott Laboratories
  2. Becton
  3. Dickinson and Company
  4. Hoffmann-La Roche Ltd
  5. Ortho Clinical Diagnostic
  6. Danaher Corporation
  7. Siemens Healthineers
  8. DiaSorin S.p.A.
  9. Sysmex Corporation
  10. bioMérieux SA.

Report Scope

Report Metric Details
CAGR 6.7%
Forecast Period 2023-2031
Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends
Segments Covered
  1. By Product & Service
    1. Reagents & Kits
    2. Enzyme-linked Immunosorbent Assay (ELISA) Reagents and Kits
    3. Rapid Test Reagents and Kits
    4. Enzyme-linked immunospot ELISPOT Reagents and Kits
    5. Western Blot Reagents and Kits
    6. Other Reagents & Kits
    7. Analyzers
    8. Open-ended System
    9. Closed-ended systems
    10. Software & Services
  2. By Platform
    1. Chemiluminescence Immunoassays (CLIAs)
    2. Fluorescence Immunoassays (FIAs)
    3. Colourimetric Immunoassays (CIs)
    4. Radioimmunoassays (RIAs)
    5. Other Platforms
  3. By Technology
    1. ELISA
    2. First-generation
    3. Second-generation
    4. Third-generation
    5. Fourth-generation
    6. Rapid Tests
    7. Western Blotting
    8. ELISPOT
    9. Immuno-PCR
    10. Other Technologies
  4. By Specimen
    1. Blood
    2. Saliva
    3. Urine
    4. Other Specimens
  5. By Application
    1. Infectious Diseases
    2. Endocrinology
    3. Oncology
    4. Bone & Mineral Disorders
    5. Cardiology
    6. Haematology & Blood Screening
    7. Autoimmune Disorders
    8. Toxicology
    9. Neonatal Screening
    10. Other Applications
  6. By End-User
    1. Hospitals
    2. Clinical Laboratories
    3. Pharmaceutical and Biotechnology Companies & Contract Research Organizations (CROs)
    4. Blood Banks
    5. Research & Academic Laboratories
    6. Other End Users
Geographies Covered
  • North America
  • Europe
  • APAC
  • Middle East and Africa

Recent Developments

  • 25, 2022, Sysmex Forms Capital and Business Tie-up with KAINOS Laboratories to Drive Growth in the Immunochemistry Field
  • - Deepening Alliance in Reagent Development/Production to Create a Win-Win Situation
  • 05, 2022, Sysmex Files for Manufacturing and Marketing Approval for an Assay Kit that Assists in Identification of Amyloid Beta (Aβ) Accumulation in the Brain
  • Measurement of Plasma Aβ Using Automated Immunoassay System HISCL™-5000/HISCL™-800

Immunoassay Market Segmentation

 By Product & Service

  • Reagents & Kits
  • Enzyme-linked Immunosorbent Assay (ELISA) Reagents and Kits
  • Rapid Test Reagents and Kits
  • Enzyme-linked immunospot ELISPOT Reagents and Kits
  • Western Blot Reagents and Kits
  • Other Reagents & Kits
  • Analyzers
  • Open-ended System
  • Closed-ended systems
  • Software & Services

By Platform

  • Chemiluminescence Immunoassays (CLIAs)
  • Fluorescence Immunoassays (FIAs)
  • Colourimetric Immunoassays (CIs)
  • Radioimmunoassays (RIAs)
  • Other Platforms

By Technology

  • First-generation
  • Second-generation
  • Third-generation
  • Fourth-generation
  • Rapid Tests
  • Western Blotting
  • Immuno-PCR
  • Other Technologies

By Specimen

  • Blood
  • Saliva
  • Urine
  • Other Specimens

By Application

  • Infectious Diseases
  • Endocrinology
  • Oncology
  • Bone & Mineral Disorders
  • Cardiology
  • Haematology & Blood Screening
  • Autoimmune Disorders
  • Toxicology
  • Neonatal Screening
  • Other Applications

By End-User

  • Hospitals
  • Clinical Laboratories
  • Pharmaceutical and Biotechnology Companies & Contract Research Organizations (CROs)
  • Blood Banks
  • Research & Academic Laboratories
  • Other End Users

By Regions

North America

  • U.S.
  • Canada
  • Mexico


  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Rest of Europe


  • China
  • India
  • Japan
  • South Korea
  • Australia
  • Rest of Asia-Pacific


  • Brazil
  • Saudi Arabia
  • South Africa
  • Rest of LAMEA
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