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Immunoassay Market Research Report Information by Product (Reagents and Kits, Analyzers/Instruments, Software and Services), Technology [Radioimmunoassay (RIA), Enzyme-linked Immunosorbent Assay (ELISA), Enzyme-linked Fluorescent Assay (ELFA), Chemiluminescence Immunoassay (CLIA), Rapid Test, Others], Indication (Therapeutic Drug Monitoring, Oncology, Cardiology, Endocrinology, Infectious Diseases, Autoimmune Diseases, Others), End User (Hospitals, Clinical Laboratories, Blood Banks, Pharmaceutical and Biotechnology Companies, Academic and

ID: MRFR/HC/4385-HCR | 90 Pages | Author: Kinjoll Dey| July 2024

Immunoassay Market overview

The Immunoassay market size is expected to reach USD 53 Billion by 2032 at 7.2% CAGR during the forecast period (2023-2032). Immunoassay is a method of detecting or measuring a specific type of protein. The market uses different types of antibody-antigen reactions to detect the biological substance in the fluid and blood. Immunoassay test uses binding of antibodies to confirm the presence of certain types of substances, and it is highly used to detect diseases. Immunoassay also provides the detail about the disease that help to plan the treatment procedure, for instance, the detection of estrogen receptors in breast cancer, and it can be applied in various formats depending on the requirements. 

The major job of Immunoassay is to measure the presence of chemical constituents. Technological advancement has led to easy application of Immunoassay, and it is boosting the Immunoassay market growth. Immunoassay plays a huge role in clinical diagnostics, environmental monitoring, and pharmaceutical analysis. It is wildly used in research centers, laboratories, hospitals to detect different diseases and come up with an effective treatment plan for both humans and animals. Additionally, this method is fast and cost-effective. Due to the wide range of applications, the market is growing rapidly, and the market size is increasing. Apart from that, the rapid growth in the individual suffering from the chronic disease propelling the Immunoassay industry growth.

The rising demand for advanced devices and the increasing adoption of these devices have a positive influence on the Immunoassay industry. The availability of sensitive diagnostics tests is also fueling the Immunoassay market trends. Increasing focus on private and public initiatives and increasing demand for cost-effective drugs will boost the market in the coming years. Apart from the growing prevalence of diseases such as HIV, dengue, hepatitis will have a good impact on the market growth. 

Covid-19 analysis

Due to the coronavirus outbreak, the world is going through a financial crisis. The covid-19 had a negative impact on the global economy as well and other businesses around the world. The government took several safety measures such as lockdown and social distancing guidelines to reduce the spread of the virus. However, it had a negative impact on the economic growth of the countries. But the Immunoassay product played a huge role in reducing the spread of the virus without the vaccine or medicines. The Immunoassay was the only method to control and manage the rapid spread of the virus. There is huge demand and use of Immunoassay can be seen during the period. Due to this, the Immunoassay market demand has increased a lot in the countries. But due to travel restrictions and the lockdown, the supply chain was highly affected. There are many rules imposed by the government bodies in several countries; due to the lack of supply of Immunoassay and the disruption in the supply chain, there was a negative impact on the market. So, overall, the market had a moderate growth due to the covid-19 pandemic.

Market dynamics

  • Drivers

There are many factors that are responsible for driving the Immunoassay market. One of the major drivers in the market is the rising chronic diseases, diabetes diseases, and cardiovascular diseases. Apart from that prevalence of infections such as covid-19, dengue, hepatitis, HIV, Malaria, and other diseases is propelling the Immunoassay industry demand. According to the world health organization (WHO), 19,655,3009 have tested positive for the covid-19 to date. As a result, the use of Immunoassay has increased in recent times. The Immunoassay test is cost-effective and offering expedited results with detection limits, higher efficiency, and it is one of the major drivers in the Immunoassay industry. ELISA is a widely used Immunoassay method to detect infectious diseases, and this method is to measure antigens, antibodies, proteins in samples. With the development of signal generation methods, the focus has shifted on the development of the many instruments to offer convenient and high performance. And it is driving the Immunoassay industry.

  • Opportunities

Immunoassay is widely sued for various applications such as pharmaceutical analysis, food safety, medical diagnostics, and basic science investigations. Usage of Immunoassay in a wide range of areas will bring opportunities to the Immunoassay market. The rising demand for safer drugs and specialist therapies across the world is generating opportunities for the market. Developing counties like Asia-pacific are expected to offer significant growth opportunities for the market. 

Apart from that, the rapid growth of the population in the Asian region and will drive the need for Immunoassay tests. All these factors will bring opportunities to the market, and the Immunoassay market will grow higher in the forecast period.

  • Restraints

The government and the regulatory authorities in several nations have imposed regulation on the commercialization and of the Immunoassay instrument and consumables. It has become and a big challenge for the Immunoassay market. Apart from that, technological hurdles imposed by the Immunoassay reagents and kits, such as low detection limits of the available antibodies, cross-reactivity of the antibodies, and false results, will hamper the Immunoassay industry.

  • Challenges

There are many challenges faced by the Immunoassay market, just like another market. One of the major challenges is the design challenge associated with the Immunoassay. Due to design, the misinterpretation of the results can happen. Also, the lack of skilled professionals in the diagnostics domain is a big challenge for the market. The key players are trying their best to overcome these challenges and boost the Immunoassay industry demand.

Cumulative growth analysis

With the wide range of applications of Immunoassay in various areas, the Immunoassay industry will show rapid growth in the forecast period. The market is expected to register to a healthy CAGR of 5.9% in the Immunoassay market forecast period. 

Market segmentation

The Immunoassay market is segmented on the basis of product, specimen, application, technology, and end-user

By product

On the basis of product, the market is divided into reagents and kits, and Immunoassay analyzers. Regents and kits are further carried out into ELISPOT Reagents & Kits ELISA Reagents & Kits, Western Blot Reagents & Kits Rapid Test Reagents & Kits, and others. Analyzers include Open-Ended Systems and Closed-Ended Systems. Reagents and Kits hold a huge Immunoassay market share.

By specimen

On the basis of the specimen, the Immunoassay industry is divided into Blood, Saliva, Urine, and others. The Immunoassay involves the use of fluid and blood to check the presence of antibodies. 

By application

On the basis of application, the Immunoassay industry is segmented into Endocrinology, Oncology, Cardiology, Blood Screening, Toxicology, Newborn Screening, Infectious Diseases, Autoimmune Disorders, Allergy Diagnostics, Bone & Mineral Disorders, and Others. The infectious disease was accounted for the highest Immunoassay industry share with 25% in 2020. 

By technology

On the basis of technology, the Immunoassay industry is segmented into Western Blotting, Enzyme-Linked Immunospot, ELISA, Rapid Tests, Radio-Immuno Assay, and Other Technologies. ELISA segment was accounted for the highest Immunoassay industry with 60%.

By end-user 

The end-user segment of the market is divided into Blood Banks, Research & Academic Laboratories, Home Care Settings Hospitals and Clinics, Pharmaceutical and Biotechnology Companies & CROs, and Clinical Laboratories. The hospital segment was responsible for the largest share, over 30%, in the year 2020.

Regional analysis

The major regions in the Immunoassay industry are America, Europe, Asia-pacific, and Middle East & Africa. America held the highest Immunoassay market share in 2018 due to the contribution of government funds, increasing the number of research projects, and the increasing adoption of Immunoassay in this region. Europe holds the second-highest share in the Immunoassay industry due to the presence of big companies. Asia-pacific is expected to witness rapid growth due to the rising geriatric population. The market in the middle east & Africa will see moderate growth due to the growth of the healthcare sector in this region. 

Competitive landscape

The major key players in the Immunoassay market are:

  • Siemens Healthineers,¬†

  • Abbott Laboratories,¬†

  • Becton Merck KGaA,¬†

  • Sysmex Corporation,¬†

  • Ortho-Clinical Diagnostics/Carlyle Group,

  • Dickinson and Company,¬†

  • Danaher Corporation,¬†

  • Thermo Fisher Scientific Inc.,

  • Hoffmann-La Roche Ltd,¬†

  • bioM√©rieux SA,Quidel Corporation,¬†

  • DiaSorin S.p. A.

Recent developments 

  • In February 2021, Thermo Fisher Scientific Inc. acquired Mesa Biotech which is the private point- of care molecular diagnostic company.

Report overview

This Immunoassay Market report is based on the qualitative and quantitative analysis of the Immunoassay industry. This report highlights the Immunoassay industry outlook on the market overviews, covid-19 analysis, market dynamics, and Immunoassay industry analysis. This Immunoassay industry also shows the regional analysis, competitive landscape, and recent development of the market.

Segmental table

By product 

  • Reagents and Kits

  • Analyzers/Instruments

  • Software and Services

By specimen

  • Blood

  • Saliva

  • Urine

  • Others

By technology

  • Radioimmunoassay (RIA)

  • Enzyme-linked Immunosorbent Assay (ELISA)

  • Enzyme-linked Fluorescent Assay (ELFA)

  • Chemiluminescence Immunoassay (CLIA)

  • Rapid Test

  • Others¬†

By application

  • Therapeutic Drug Monitoring

  • Oncology

  • Cardiology

  • Endocrinology

  • Infectious Diseases

  • Autoimmune Diseases

  • Others

By end-user

  • Hospitals

  • Clinical Laboratories

  • Blood Banks

  • Pharmaceutical and Biotechnology Companies

  • Academic and Research Institutes

  • Others

Report Attribute/Metric Details
  Market Size   USD 53 Billion
  CAGR   7.2%
  Base Year   2022
  Forecast Period   2023-2032
  Historical Data   2021
  Forecast Units   Value (USD Billion)
  Report Coverage   Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
  Segments Covered   Product, Indication, End User
  Geographies Covered   North America, Europe, Asia-Pacific, and Rest of the World (RoW)
  Key Vendors   Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd, bioMérieux SA, Siemens Healthineers, Abbott Laboratories, Becton, Dickinson and Company, Danaher Corporation, Merck KGaA, Sysmex Corporation, Ortho-Clinical Diagnostics/Carlyle Group, Quidel Corporation, and DiaSorin S.P.A.
  Key Market Opportunities   Increasing Adoption of immunoassay-based point-of-care (POC) testing and rapid testing
  Key Market Drivers   The Rising prevalence of chronic and infectious diseases

Frequently Asked Questions (FAQ) :

Immunoassay Market was valued at over USD 18.6 billion in 2018.

Immunoassay Market is expected to exhibit a strong 7.2%% CAGR over the forecast period from 2023-2032.

Immunoassays are used to detect the concentration of a wide range of biological substances in blood.

The rising prevalence of chronic and infectious diseases is the major driver for the global immunoassay market.

Lack of support from reimbursement agencies and strict regulatory requirements are the major restraint on the global immunoassay market.

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