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Home » Healthcare » Immunoassay Market Size, Share, Global Industry Report, 2030

Immunoassay Market By Type/ Platform, By Technique (Western Blotting, Enzyme-Linked Immunosorbent Assays, Immuno-PCR (I-PCR), Rapid Tests, Enzyme-Linked Immunospot, CD/DVD based immunoassay, Other Techniques), By Application (Infectious Diseases, Respiratory Disease, Oncology or Cancer Diagnostics, Hematology, Cardiology, Endocrinology, Thyroid, Allergies, Others), By End-User (Hospitals, Pharma & Biotech Companies, Clinical Laboratories, Others), By Product (Reagents and Kits, Analyzers), By Specimen Type (Blood, Saliva, Urine, Others), By Geography, Size, Share, Global Report, Industry Forecast, 2021-2030

Published On: Jul-2022   |   Base Year: 2021   |   No Of Pages: 135   |   Historical Data: 2015 - 2019   |   Formats: PDF   |   Report ID: 10925883

Report DescriptionTable of Contents

The global immunoassay market size was $24.30 billion in 2021 and is predicted to reach $45.82 billion by 2030 with a CAGR of 7.3% during the forecast period 2021-2030. North America is poised to lead the industry, followed by Europe.

 

Pathogens, such as bacteria, fungus, protozoa, worms, viruses, and prions, cause infectious diseases. The main function of the immunoassay is to defend the body from pathogens. Rapid pathogen identification from patient samples is critical for the proper diagnosis and treatment of infectious disorders.

 

The three categories of pathogen diagnostic instruments are:

  • Microbiology Testing studies the characteristics of pathogens, their modes of transmission, and mechanisms of infection and growth (Diagnosis takes up to 7 days).

 

  • Molecular Testing detects a molecule, often in low concentrations, as a marker of disease or risk in a sample taken from a patient. These tests are sensitive to viral nucleic acids. Hence the use of polymerase chain reaction (PCR) and other comparable nucleic acid amplification methods. (Diagnosed within a day)

 

  • Immunoassays- They are similar to Molecular Testing but detect proteins and antigens.

 

An assay is a process or a way of analyzing a substance to determine its quality or composition. Immunoassays are biochemical tests that use the binding ability of antibodies (immunoglobulin) and antigens (foreign substances) to detect and measure the concentration of target molecules. Traditional methods use cell culture to diagnose viruses, whereas most cultures take up to 7 days for accurate identification. Researchers and health care practitioners use immunoassay testing to detect various antibodies. Immunoassays are fast and accurate tests that can be performed on-site and in the lab to detect specific chemicals. When a patient is infected with a disease, the presence of antigens can be used to directly detect the infection. According to Global Burden of Disease (2017), Lower respiratory infections are the 3rd leading cause of early death and will remain the same till 2040.

 

Procedure- Immunoassay testing is performed by using antibodies to detect and identify small biological substances in the bloodstream and other bodily fluids. The procedure follows the concept that particular antigens bind to certain specific recently introduced antibodies, resulting in the stimulation of an immune response. Antibodies are highly specific to analytes (the substance in a test sample), such as nucleoproteins, hormones, and peptides. Detection of analytes becomes highly successful through the formation of antigen-antibody complexes. A colour change occurs, that indicates the presence of the analyte in question. The observed colour symbolizes the number of targeted molecules present in the test solution. In most cases, immunoassays provide results back in 24 hours. EIAs are less time-consuming than cytotoxicity tests, are less expensive, and provide results in 1 to 6 hours.

 

Cost- Test kits cost from $1.20 per test for ELISA to more than $30 for western blot.

 

According to HTStec Limited's publication Automated Immunoassays Trends, the median capital cost of immunoassay automation already implemented was in the range of $40-$60,000.

 

Benefits- Immunoassays can provide a fast, simple and more cost-effective detection than the conventional methods. It has high sensitivity and specificity, convenience, and the ability to achieve high throughput.

 

Applications- Immunoassays have a wide application that includes:

  • Diagnosis of diseases.

  • Therapeutic drug monitoring.

  • Clinical pharmacokinetics.

  • Bioequivalence studies in drug discovery.

  • Biopharmaceutical analysis.

  • Sports anti-doping analysis.

  • Pregnancy Test to detect the pregnancy marker.

  • Environmental monitoring.

  • Food testing.

 

immunoassay market regional coverage 2020-2030

 

Types of Immunoassay Platforms

 

  • Radioimmunoassay (RIA)- RIA is an immunoassay that uses radioactive isotopes (e.g. I-235) to label the antibody/antigen. It detects radioactivity to measure the antibody-antigen compound with very high sensitivity.

 

  • Enzyme Immunoassays (EIA)- EIA is possibly one of the most popular immunoassays. Instead of radioactive isotopes, Enzymes (such as HRP and AP) are used as probes in EIA. These enzymes are frequently detected because their enzymatic reactions result in a visible colour change.

 

  • Fluoroimmnoassay (FIA)- FIA is analogous to RIA except that the label which is a fluorophore (e.g. FITC, phycoerythrin) rather than radioisotope. A detecting device can directly measure the fluorescence signal.

 

  • Chemiluminescence immunoassay (CLIA)- CLIA is a method for determining sample concentrations based on the amount of luminescence produced by a chemical reaction.

 

  • Colloidal Gold Immunochromatographic Assay- ICA, also known as lateral flow immunoassay, is a rapid test immunoassay to detect a target analyte's presence (or absence) in a sample (matrix) without the need for specialized and costly equipment.

 

  • Electrochemiluminescence immunoassay (ECL)- When Electrochemiluminescent tags are triggered by electricity in the right chemical environment, they produce light.

 

Types of Immunoassay Techniques

  • Western Blotting-Western Blotting detects and identifies viral antigens (proteins usually on the surface of viruses) using antibodies against those particular proteins.

 

  • Enzyme-Linked Immunosorbent Assays-ELISA (Enzyme-Linked ImmunoSorbent Assay) uses virus antigen to detect antibodies.

 

  • Immuno-PCR -Compared to similar ELISA, I-PCR combines the simplicity and versatility of an enzyme-linked immunosorbent test (ELISA) with the exponential amplification capacity and sensitivity of PCR.

 

  • Rapid Tests-The rapid test involves the same technique as ELISA. However, it is low in sensitivity and specificity as compared to ELISA.

 

  • Enzyme-Linked Immunospot-It is a hybrid essay that combines the features of an MLR (Mixed leukocyte reaction), and ELISA used to determine HIV-1 specific CD8 T-cell responses.

 

  • CD/DVD-based immunoassay- It includes the disk (grey), gold nanoparticle (red), a probe (green), analyte (yellow), and silver particle (blue).

 

Market Dynamics

Key Industry Drivers (Rising Infections, Cancer Patients, old age population and Automation)

Key factors that promote the growth of the Immunoassay market

  • Rising Infections- Some of the conditions that may increase susceptibility to infectious diseases are cancers, particularly patients on chemo- or radiotherapy, leukaemia, lymphoma, Hodgkin's disease, immune suppression (HIV infection), long-term steroid use, liver disease, hemochromatosis, diabetes, alcoholism, chronic kidney disease, and dialysis patients who are diagnosed by immunoassays. According to the WHO, the last decade witnessed 20% of death worldwide due to infections. The most common causes of death related to infectious diseases were lower respiratory infections (6.1%), diarrheal diseases (4.3%), HIV/AIDS (3.1%), tuberculosis (2.4%), malaria (2%), and measles (1.6%).

 

  • Rising cases of Cancer Patients-The incidence of cancer is increasing steadily, which is expected to drive the demand for effective diagnostic methods such as immunoassay. This growth is due to chronic and infectious disorders, such as the COVID-19 outbreak. Infectious disorders including SARS-CoV2 (COVID-19), Hepatitis B, C, HIV, Dengue Malaria, Tuberculosis, and others are on the rise. According to the findings of the International Agency for Research on Cancer's GLOBOCAN 2020, there were 19.3 million new cancer cases and over 10.0 million cancer deaths in the year 2020.

 

  • Rise in the old age population- Old age people are more prone to chronic infectious and Immunodeficiency Diseases which is driving growth of the market. According to World Population Ageing 2019, the number of people aged 65 years or over will double in 30 years. Meanwhile, the number of people aged 80 years or over will rise threefold.

 

  • Automation-Fully automated immunoassays can provide high throughput, reproducibility, and ease of assay transfer. Process automation provides the dual benefits of time savings and reduction in operator-dependent variability.

 

Restraints (Wide Adoption of Molecular diagnostics and Operational Hurdles)

  • Wide Adoption of molecular diagnostic tests-Despite the fact that many laboratories now utilize molecular assays to detect viruses, immunoassays are still commonly used in the identification process because of their speed, sensitivity, accuracy, cost-effectiveness and convenience of use.

 

  • Operational hurdles- Immunoassay reagents and kits face operating issues like cross-reactivity of antibodies, low detection limits of the available antibody, and false negatives.

 

Various Opportunities Covered on the basis of  Evolution of Companion diagnostics, High Success rate, Increase in Incidence of Sepsis, Emergence of Condition-specific biomarkers

  • Evolution of Companion diagnostics - The drug diagnostic co-development model is commonly used to create companion diagnostic assays parallel with a medication. There is an increase observed in the number of predictive biomarker assays being developed in recent years to guide the usage of targeted cancer therapies.

 

  • High Success rate - Immunoassays have grown in popularity to evaluate biological analytes due to their sensitivity, specificity, and ease of use. Furthermore, some immunoassay procedures are quick, precise, and simple to automate, needing minimal human intervention. The recent estimates published in The Lancet on the Performance characteristics of five immunoassays for SARS-CoV-2 accounted for sensitivity and specificity of more than 98%.

 

  • Increase in Incidence of Sepsis - Sepsis is a fatal disease when the body's response to an infection causes tissue damage. While bacterial infections are the most prevalent cause of sepsis, they can also be caused by viral infections. As Per the global Immunoassay market report on the Epidemiology and Burden of Sepsis 2017, sepsis led to 20% of annual global deaths (11 million deaths) and affected 49 million people.

 

  • The emergence of Condition-specific biomarkers - Many biomolecules are used as biomarkers, including antigens, DNA, mRNA, and enzymes. However, protein biomarkers are the most common biomarkers used in medical diagnostics. Tumour tissues, serum, and other bodily fluids all contain biomarkers. The field of biomarker detection technology has made tremendous progress. Various biomarker detection approaches have been developed based on extremely specific identification biomarkers. According to the article published in Infection & Chemotherapy Journal, biomarkers can be used for risk stratification, diagnosis, monitoring of treatment responses, and outcome prediction. C-reactive protein, procalcitonin, different cytokines, and cell surface markers are among the 170 biomarkers that have been useful for diagnosing infections.

 

immunoassay market infographics with segmentation coverage 2020-2030

 

Global Immunoassay Market Segments Analysis

The industry has been ramified based on Type/ Platform, Technique, Application End-user, Product, Specimen type and Region.

By Type/ Platform

  • Radioimmunoassay (RIA)

  • Enzyme Immunoassays (EIA)

  • Fluoroimmnoassay (FIA)

  • Chemiluminescenceimmunoassay (CLIA)

  • Electrochemiluminescence immunoassay (ECL)

  • Colloidal Gold Immunochromatographic Assay

 

By Technique

  • Western Blotting

  • Enzyme-Linked Immunosorbent Assays

  • Immuno-PCR (I-PCR)

  • Rapid Tests

  • Enzyme-Linked Immunospot

  • CD/DVD-based immunoassay

  • Other Techniques

 

By Application

  • Infectious Diseases

  • Respiratory Disease

  • Oncology or Cancer Diagnostics

  • Hematology

  • Cardiology

  • Endocrinology

  • Thyroid

  • Allergies

  • Others

 

By End-User

  • Hospitals

  • Pharma & Biotech Companies

  • Clinical Laboratories

  • Others

 

By Product

  • Reagents and Kits

  • Analyzers

 

By Specimen Type

  • Blood

  • Saliva

  • Urine

  • Others

 

By Region

  • North America

  • Europe

  • Asia-Pacific

  • Latin America

  • The Middle East and Africa

 

immunoassay market share coverage 2020-2030

 

By Type/ Platform, Enzyme Immunoassays (EIA) are the most cost-effective since they are quick, easy to use, and do not require additional handling or disposal procedures. As a result, they control the majority of the market.

 

By Technique, Enzyme-linked immunosorbent assay (ELISA) leads the market segment of Immunoscreening. Certain diseases aren't easy to identify with other means like swab tests. An ELISA blood test can help spot signs of infection or disease in your system. The gold standard of immunoassays is the enzyme-linked immunosorbent assay (ELISA), a labelled immunoassay. This very sensitive immunological test detects and measures molecules such as antibodies, antigens, proteins, glycoproteins, and hormones. The significant industry share is due to the high use of immunoassay tests to detect and diagnose cancer, chronic complications and other infectious diseases.

 

Based on application, the Infectious diseases segment is leading the global Immunoassay market share due to the high incidence of infectious diseases, rising number of regulatory approvals & product launches, increased Adoption of kits, and increasing demand for COVID-19 test kits.

 

By End Users, the Hospital segment leads the market share as it facilitates in-house diagnostic laboratories. Rise in infectious diseases, which are mostly Hospital Acquired Infections are treatable in hospitals. The expanding number of tests performed in diagnostic labs, rising laboratory automation, availability of well-equipped immunoassay systems, rising prevalence of infectious disorders, and rising government initiatives drive this segment's expansion. The CDC estimates that Out of All 1.7 Million Hospital Acquired Infections (HAIs) in the US, 32% are urinary tract infections, 22% are surgical site infections, 15% are lung infections, and 14% are bloodstream infections.

 

By Product Type, the Reagents and kits segment is destined to dominate the immunoassay reagents and devices market because of its increased use in illness detection and drug development. The large industry share is attributed to their repetitive purchase and high consumption for diagnostic purposes.

 

By Specimen Type, the Blood segment is poised to lead the market share by revenue due to a large number of tests requiring high specificity performed using blood samples. Blood tests provide a crucial picture of overall health and well-being

 

By Region, North America is expected to dominate the market. The surge in the market share is due to the rise in the prevalence rates of chronic disorders and infectious diseases. Furthermore, the growing elderly population and well-established healthcare infrastructure will boost the growth of the region's immunoassay reagents and devices market. In nations like the United States with established market economies, infectious diseases account for 4.2% of all disability-adjusted life years lost (DALYs), whereas chronic and neoplastic diseases account for 81%, according to estimates from the Global Burden of Disease Study.

Asia-Pacific is projected to observe signs of growth during the forecast period due to the highest number of immunoassay reagents and device providers. According to the World Health Organization, ICU-acquired infections, such as UTIs and surgical-site wound infections, are two to three times greater in developing nations than in developed countries.

 

Report Attribute

Details

Forecast Period

2021 - 2030

The market size value in 2021

USD 24.30 Billion

The revenue forecast in 2030

USD 45.82 Billion

Growth rate

CAGR of 7.30%

The base year for estimation

2021

Historical data

2015 – 2021

Unit

USD Billion, CAGR (2021 - 2030)

Segmentation

By Type/ Platform, By Technique, By Application, By End-user, By Product, By Specimen Type and By Region.

By Type/ Platform

Radioimmunoassay (RIA), Enzyme Immunoassays (EIA), Fluoroimmnoassay (FIA), Chemiluminescence immunoassay (CLIA), Electrochemiluminescence immunoassay (ECL), Colloidal Gold Immunochromatographic Assay

By Technique

Western Blotting, Enzyme-Linked Immunosorbent Assays, Immuno-PCR (I-PCR), Rapid Tests, Enzyme-Linked Immunospot, CD/DVD-based immunoassay, Other Techniques

By Application

Infectious Diseases, Respiratory Disease, Oncology or Cancer Diagnostics,    Hematology, Cardiology, Endocrinology, Thyroid, Allergies and Others

By End-user

Hospitals, Pharma & Biotech Companies, Clinical Laboratories and Others

By Product

Reagents and Kits and Analyzers

By Specimen Type

Blood, Saliva, Urine, Others

By Region

North America, Europe, Asia-Pacific, Middle-East and Africa, and South America.

Country Scope

Canada, Germany, UK, US, Mexico, France, India, Japan, China etc.

Company  Profiles

BD, Bio-Techne, Abbott, Agilent Technologies, Beckman Coulter, BioCheck,bioMérieux SA, Merck KGaA, Ortho Clinical Diagnostics, Randox Laboratories Ltd, Siemens, Thermo Fisher Scientific, Shenzhen Mindray Bio-Medical Electronics Co, QIAGEN, PerkinElmer Inc, Meso Scale Diagnostics, F. Hoffmann-La Roche Ltd, DiaSorin S.p.A

 Luminex Corporation, Bio-Rad Laboratories,

 

Global Immunoassay Market Competitive Landscape Analysis

The report has the competitive landscape analysis, which details the most significant competitors operating in a global industry. The overall comparison is done on the basis of overall revenue generation, key investments by venture capitalists, market initiatives, company overview, production analysis, value chain optimization, R&D investment, share financials, global presence, production capacity, production sites and facilities, potential, and various other factors.

 

Key Players currently dominating the industry are: 

  • Abbott

  • Agilent Technologies

  • BD

  • Beckman Coulter

  • BioCheck

  • bioMérieux SA

  • Bio-Rad Laboratories

  • Bio-Techne

  • DiaSorin S.p.A

  • F. Hoffmann-La Roche Ltd

  • Luminex Corporation

  • Merck KGaA

  • Meso Scale Diagnostics

  • Ortho Clinical Diagnostics

  • PerkinElmer Inc

  • QIAGEN

  • Quidel Corporation

  • Randox Laboratories Ltd

  • Shenzhen Mindray Bio-Medical Electronics Co

  • Siemens

  • Thermo Fisher Scientific

 

Recent Developments

  • In April 2022, GeneProof, a prominent molecular diagnostics firm based in Brno, Czech Republic, merged with American Laboratory Products Company, Ltd. (ALPCO), a speciality 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.

 

  • 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, the purification of viral particles to reduce host cell protein (HCP) contamination is an important part of the viral production workflow. To guarantee HCP, impurity clearance is performed according to regulatory criteria, and accurate quantification throughout process phases is required.

 

  • 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.

 

  • In September 2021, The FDA granted breakthrough device Designation to Oncuria, a revolutionary non-invasive multiplex immunoassay used to predict therapeutic response in patients with bladder cancer, as a. Nonagen Bioscience Corp's gadget analyses ten protein biomarkers in a single urine sample. Biomarker levels are then used to help predict Bacillus Calmette-Guerin (BCG) response in patients with intermediate-to-high-risk, early-stage bladder cancer using a weighted algorithm.

 

Various products that key market leaders develop

 

Product

Function

Key players

ABBOTT PRISM System

Automated immunoassay analyzer designed to perform Chemiluminescent immunoassay (ChLIA) technology.

Abbott

Phadia 250

Immunoassay Analyzers that Provide optimal allergy and autoimmunity testing solutions.

Thermo Fisher Scientific,

VIDAS

Automated immunoassay system based on the Enzyme-Linked Fluorescent Assay (ELFA) principles.

bioMérieux

Cobas e 411

The fully automated analyser that uses ElectroChemiLuminescence (ECL) technology for immunoassay analysis.

Roche

 

Frequently Asked Question About This Report

b: The global immunoassay market size was $24.30 Bn in 2021 and is predicted to reach $45.82 Bn by 2030 with a CAGR of 7.3% during 2021-2030.

b: The global immunoassay market analysis shows a valuation of USD 24.30 Bn in 2021.

b: The global immunoassay market is expected to grow at a compound annual growth rate (CAGR) of 7.3% from 2021 to 2030 to reach USD 45.82 billion by 2030.

b: The global immunoassay market forecasts a CAGR of 7.3%.

b: Immunoassays are often used in drug discovery and pharmaceutical industries, including illness diagnostics, therapeutic medication monitoring, clinical pharmacokinetics and bioequivalence investigations.

b: Global Immunoassay market trends forecast North America with the largest share.

b: Asia-Pacific is projected to have the fastest growth rate in the Global Immunoassays Market. Factors affecting the Immunoassay market growth rate include high incidence rate rising Population, the evolution of the immunoassay market in India and the growing ELISA market size.

b: Key players in Immunoassays Market Include- BD, Bio-Techne, Abbott, Agilent Technologies, Beckman Coulter, BioCheck, bioMérieux SA, Merck KGaA, Ortho Clinical Diagnostics, Randox Laboratories Ltd, Siemens, Thermo Fisher Scientific, Shenzhen Mindray Bio-Medical Electronics Co, QIAGEN, PerkinElmer Inc, Meso Scale Diagnostics, F. Hoffmann-La Roche Ltd, DiaSorin S.p.A, Luminex Corporation, Bio-Rad Laboratories.

b: Clinical diagnostics and drug monitoring applications rapidly gain market share and vaccine development, Nephelometry and Protein microarrays.

b: Cloned enzyme donor immunoassay (CEDIA), heterogeneous immunoassays, Label-free immunoassays, Magnetic immunoassay, Memory Lymphocyte Immunostimulant Assay (MELISA), non-competitive immunoassays, Photoacoustic Immunoassay, real-time quantitative polymerase chain reaction (RT qPCR) and Surround Optical Fiber Immunoassay (SOFIA).

Source:

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https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660

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https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6245375/

https://www.healthdata.org/sites/default/files/files/policy_report/2019/GBD_2017_Booklet.pdf

https://jamanetwork.com/journals/jama/fullarticle/768249

https://www.icjournal.org/DOIx.php?id=10.3947/ic.2014.46.1.1

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220162