Global Immunoassay Market, By Product, By Technology, By Application, By End-Use, As well as by Region and Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends, and Forecast: 2023-2032

Report Overview

The global immunoassay market was valued at USD 27.8 billion in 2021. This market is expected to reach USD 46.56 billion in 2032 at a CAGR of 4.8%, between 2023-2032. The increase in infectious and chronic diseases, such as COVID-19, is a primary element responsible for market growth.

Further expansion prospects are expected to be supported by an increase in geriatric populations who are more vulnerable to chronic and other infectious diseases. A surge in chronic conditions like cancer, infections, heart disease, diabetes mellitus, and autoimmune diseases has resulted in the widespread usage of immunoassay methods in disease diagnostics.

There continues to be a steady rise in the incidence of cancer, which will subsequently increase the demand for reliable diagnostic methods like immunoassays. This technique is crucial in the diagnosis and determination of oncogenesis, as well as for diagnosing various stages of cancer.

It allows for the use of monoclonal as well as polyclonal antibodies to detect tumor antigens in tissues. This market report gives a detailed analysis of the Immunoassay market size, share, industry growth, key trends, competitive landscape, and other key factors.

Global Immunoassay Market

Product Analysis

On the basis of ‘Product’, the immunoassay market in 2021 was dominated by the ‘Kits and Reagents’ segment. This segment accounted for more than 59.2% of market revenues. It is expected that this segment will continue to lead this industry over the forecast period.

Due to the growing incidence of infectious and autoimmune diseases, immunoassay reagents and kits are in high demand, garnering a significant share of this market. This segment is expected to grow on account of the approval and release of novel immunoassay products.

Over the forecast period, the ‘Software & Services segment will index a 5.1% CAGR. This can be accredited to the high demand for affordable immunoassay services in emerging markets. Sysmex Corporation began offering novel coronavirus antibody lab assays services in June 2020.

Technology Analysis

In terms of ‘Technology’, the ‘EIA/ELISA’ segment dominated the immunoassays market, with a 59.8% revenue share in 2021. This method has a number of significant advantages over immunoelectrophoresis and immunodiffusion, including faster assays, more precise results, and a need for fewer antisera for analysis.

A rapid test also called lateral flow immunoassay or lateral flow immunoassay is used to detect the presence of the target substance without the use of specialized equipment. It is useful in detecting infections such as dengue, salmonella, Campylobacter, or Zika. monoclonal antibodies are used for Immunoglobulin H (IgG), Immunoglobulin B (IgM), Immunoglobulin C (IgA), and Immunoglobulin D (IgD). This allows for the precise identification of the target analyte.

Application Analysis

With respect to ‘Application’, this market was dominated by the ‘Infectious Disease Testing’ segment, accounting for a 30.5% revenue share in 2021. This segment is expected to continue its lead over the forecast period.

This is due to an increase in the prevalence of infectious diseases like HIV/Malaria, Influenza, and COVID-19. Further driving this market’s growth is the introduction of new products for infectious disease testing. One of the main factors driving revenue growth in the immunoassay market is the increasing incidence of cancer across the world.

According to the International Agency for Research on Cancer’s report, 18.1 million cases of cancer were reported in 2018, and 9.6 million deaths from the disease. The spike in the incidence of cancer will likely increase the demand for immunoassays.

End Use Analysis

With regards to ‘End-Use’, the immunoassay market was dominated by the ‘Hospitals’ segment, which accounted for over 29.5% of total revenues in 2021. This market experienced a rapid rate of growth due to the increase in the number of hospitals. Due to constant changes in the healthcare industry, the demand for hospitals with modern facilities has increased.

The increasing incidence of infectious diseases in blood banks is also expected to drive growth prospects over the forecast period. ELISA requires very little equipment and instruments, making it easy to use in blood banks.

Key Market Segmentation:

Segmentation is given on the basis of Product, Technology, Application, and End-use.

Product

• Reagents & Kits
• Instruments/Analyzers
  • Closed-Ended Systems
  • Open-Ended Systems
• Software & Services

Technology

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

Application

• Therapeutic Drug Monitoring
• Cardiology
• Infectious Disease Testing
• Oncology
• Endocrinology
• Autoimmune Diseases
• Others

End-use

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

Market Dynamics

The number of global applications of immunoassay-based diagnostics is on the rise. Public awareness campaigns that target the identification of symptoms and prevention strategies for infectious diseases play an important part in controlling this pandemic.

Increased patient awareness has resulted in a large demand for immunoassays. The International Society for Infectious Diseases has an advocacy program that supports collaboration with clinicians and other public health professionals. The rising demand for early-stage diagnosis of disease with the help of immunoassays is a major factor driving the immunoassay market expansion.

This includes supporting the exchange and application of scientific knowledge, evidence-based medicine, and public health practices. The World Hepatitis Alliance created the campaign “Finding the Missing Millions” in 2018 to raise awareness about hepatitis and remove any barriers in clinical diagnostic settings.

The clinical interpretation of diagnostic tests depends on the ability of assay analysts and the availability of skilled workers. The time taken to interpret an assay can have an impact on the outcome. Technological advancements have led to an increase in the number of automated instruments and equipment in laboratories.

Automation brings benefits like higher efficiency and less labor use in laboratories. The market is indexing a boom in automation as market leaders introduce point-of-care portable assay test systems and automated laboratory systems.

Immunoassays use antibodies based on the immune response to an antigen specific to a microorganism. In molecular diagnostics, however, nucleic-acid probes are determined by specific genetic makeup. Therefore, it is likely that molecular diagnostic tests will be more popular over the forecast period. This could limit the market growth for immunoassays.

The coronavirus spread can be controlled by the immunoassay product. Without a vaccine or any medication, diagnosing the disease is the best way to stop its spread and minimize the number of casualties.

Rapid testing has proved to be an efficient, fast, and simple molecular test for large COVID-19 monitoring. SARS-CoV2 detection issues have been made much easier thanks to extensive research and appraisals. Their use has increased for immunoassays, such as chemiluminescence, lateral flow-based point diagnostics, rapid tests, and other techniques.

This market was impacted by strict regulatory standards and technical difficulties associated with immunoassay products. The widespread diagnosis of COVID-19 in many countries has caused a surge in the growth of the immunoassay market. Furthermore, this industry is predicted to grow substantially as more COVID-19 patients are diagnosed in the third and subsequent waves.

The role of immunoassays in diverse bioanalytical applications like medical diagnostics, biological monitoring along with food testing is driving the expansion of this market.

Regional Analysis

North America accounted for the largest revenue share of 34.6% and is anticipated to continue to be the dominant market over the forecast timeline. This is due to the increasing incidence of cancer and easy access to technologically advanced diagnostic tools.

Additionally, there is a high prevalence of infectious diseases such as HIV/TBI and influenza in the region. This has boosted the demand for diagnosis and treatment. The Asia Pacific is expected to be the fastest-growing industry over the forecast period. This is due to the growing geriatric populations in the region and the high incidence of infectious diseases.

The immunoassay market growth is being driven by innovative laboratory techniques and processes that allow for faster diagnosis and treatment of chronic diseases and other infectious disorders. Market drivers include the introduction and demand for molecular kits as well as reagents that aid in diagnosis.

Key Regions and Countries Covered іn This Rероrt:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Russia
  • Spain
  • Rest of Europe
• APAC
  • China
  • Japan
  • South Korea
  • India
  • Rest of Asia-Pacific
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Middle East & Africa
  • GCC
  • South Africa
  • Israel
  • Rest of the Middle East & Africa

Market Share Analysis

In order to cater to the unmet medical needs of patients, major companies are taking significant strategic initiatives in immunoassays. This includes mergers & acquisitions, regional expansion efforts, and new product development. Siemens Healthineers announced that their SARS-CoV-2 IgG antibody test has been validated to measure neutralizing antibodies.

It has also received CE Marking. This test is an improvement of its COVID-19 antibody test. BioMerieux also purchased a majority interest in Suzhou Hybiome Biomedical Engineering Co. Ltd., in November 2018. This acquisition will strengthen the company’s presence in the Chinese market.

Abbott Laboratories is also focused on Chemiluminescent immunoassay (ChLIA) and offers an auto-immunoassay analyzer, the Abbott prism. It’s quite efficient for blood screening and provides practical results. The system’s other benefits include compliance with cGMP, error reduction through the network’s tampering resistance, increased lab productivity, reduced human involvement, and routine details like monitoring and documentation.

Immunoassay Market Key Players

There are several prominent players in the global immunoassay industry:

• Siemens Healthineers
• Abbott Laboratories Inc.
• Becton, Dickinson & Company
• Bio-Rad Laboratories Inc.
• Thermo Fisher Scientific, Inc.
• Hoffmann-La Roche AG
• bioMerieux SA
• Quidel Corporation
• Danaher Corporation (Beckman Coulter)
• Agilent Technologies, Inc.
• Randox Laboratories Ltd
• Ortho Clinical Diagnostics Holdings
• Other Key Players

These are the major players in this industry.