The ELISA diagnostic test market size is expected to grow from US$ 1,285.49 million in 2022 to US$ 2,271.23 million by 2030; it is estimated to register a CAGR of 7.37% from 2022 to 2030.
Analyst’s Viewpoint
The ELISA diagnostic test market analysis explains market drivers such as the rising infectious diseases among animals and increasing incidence of human infections. Further, advancements in ELISA-based procedures are expected to introduce new trends in the market during 2022–2030. Based on adoption, the ELISA diagnostic test market is bifurcated into human and veterinary. The human segment held a larger market share in 2022 and is anticipated to register a higher CAGR during 2022–2030. Based on test type, the market is segmented into sandwich ELISA, indirect ELISA, competitive ELISA, and multiple & portable ELISA. The indirect ELISA segment held the largest market share in 2022 and is anticipated to register the highest CAGR during 2020–2030. By application, the market is segmented into autoimmune diseases, infectious diseases, cancer diagnosis, protein quantification, and others. The infectious disease segment held the largest share of the market in 2022 and is anticipated to register the highest CAGR in the market during the forecast period. By end user, the ELISA market is segmented into hospitals & diagnostic centers, pharmaceutical & biotechnology companies, veterinary hospitals & diagnostic laboratories, and others. The hospital & diagnostic centers segment held the largest market share in 2022 and is anticipated to register the highest CAGR in the market during the forecast period.
An enzyme-linked immunosorbent assay (ELISA) test detects and measures antibodies in a patient's blood. The test can be used to determine if the patient has antibodies related to certain infectious conditions. An ELISA test is used to diagnose HIV-causing AIDS, Lyme disease, pernicious anemia, rotavirus, and other conditions.
Market Insights
Rising Infectious Diseases Among Animals Drive ELISA Diagnostic Test Market Growth
According to the Centers for Disease Control and Prevention (CDC) report, enteric diseases linked to animals or environments account for 450,000 cases of illnesses, 5,000 hospitalizations, and 76 deaths among humans in the US alone. These illnesses are observed in humans in contact with animal feces or body fluids, and the pathogens transmitted through animal contact can prove dangerous for humans. Additionally, the World Organization for Animal Health published a report revealing that 60% of human infections comprise animal-related diseases. It also mentioned that 75% of emerging animal diseases can be transmitted to humans, and there are five emerging diseases among animals annually. Every year, about 55,000 healthcare claims are associated with rabies infection worldwide, comprising mainly children due to infected dog bites, as per the WHO report. Further, the Health for Animals report reveals that six animal-related diseases, including Hantavirus, Lymphocytic, Choriomeningitis virus (LCMV), plague, salmonella, rat bite fever, and tularemia, caused economic losses worth US$ 80 billion within 12 years. Among six, just one animal-related disease, "Foot and Mouth," costs farmers up to US$ 21 billion globally every year. Also, the Australian Government estimated that an outbreak of Foot and Mouth disease costs farmers US$ 50.98 billion in direct costs over 10 years.
The persistent lymphocytosis (PL) present among cows can infect their calves during pregnancy. Cows can suffer from serious milk production declines and may infect other surrounding animals. In this scenario, Enzyme-Linked Immunosorbent Assay (ELISA) test is best suited to test infected cows positive for PL disease as it reveals proper lymphocyte count clinical results on testing. Further, the test is reported by veterinarian to be 95% sensitive for animals infected with 55 days of infection. Therefore, the ELISA test is commonly recommended by veterinarian for animals aged 8 months and above. Thus, rising incidence of animal-associated diseases propels the demand for ELISA tests.
Market Opportunities
Innovative Product Launches to Offer Lucrative Opportunities for ELISA Diagnostic Test Market During Forecast Period
ELISA is one of the most popular immunoassay tests owing to its various advantages such as flexibility, sensitivity, and easy-to-use features. Also, the low cost of ELISA test kit and multifaceted applicability associated with high-throughput testing make it an ideal solution for various research and IVD requirements. With low-cost applicability, product innovations in the test kits enhance the demand for human and animal research. Also, manufacturers focus on developing ELISA test kits with in-house facilities.
Innovative Research company sells a wide range of ELISA kits with selectivity to a broad range in identifying coagulants, species, and antibodies. "Human Factor IX Kit" is one such example manufactured by Innovative Research. The human coagulation Factor IX antigen assay is intended for the quantitative determination of total Factor IX antigen in human plasma. The kit is recommended to be used only for research purposes, and reagents can be utilized for up to 96 clinical tests.
Additionally, innovative product launches for ELISA tests by the manufacturers amid the COVID-19 pandemic accelerate the adoption of ELISA testing among humans.
SARS-CoV-2 Product Launches by Manufacturers Amid COVID-19 Pandemic
Sr. No. | Manufacturers | ELISA Kit Name |
1 | Abbott | PANBIO SARS-CoV-2 IgG ELISA |
2 | Bio-Techne | SARS-CoV-2 Variant Inhibitor Screening Kit |
3 | Cellex, Inc. | qSARS-CoV-2 IgG/IgM Rapid Test |
4 | DiaSorin S.p.A. | LIAISON SARS-CoV-2 S1/S2 IgG |
5 | Roche Diagnostics | Elecsys Anti-SARS-CoV-2 |
Source: The Insight Partners Analysis
In December 2022, Pictor Limited announced a new product launch of the "PictArray SARS-CoV-2 Antibody Test," which has demonstrated real clinical utility intended for patients and doctors. The new product detects the infection associated with the COVID-19 virus, and the clinical results produced assist the patients and doctors in treating and managing SARS-CoV-2 infection. Launches of innovative ELISA test kits by manufacturers are expected to provide effective clinical results for diagnosing varied infections associated with different types of species with low cost and multifaceted applications. Thus, innovative product launches would provide lucrative opportunities for manufacturers in the long run.
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ELISA Diagnostic Test Market: Strategic Insights
Market Size Value in US$ 1,285.49 million in 2022 Market Size Value by US$ 2,271.23 million by 2030 Growth rate CAGR of 7.37% from 2022 to 2030 Forecast Period 2022-2030 Base Year 2022
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ELISA Diagnostic Test Market: Strategic Insights
| Market Size Value in | US$ 1,285.49 million in 2022 |
| Market Size Value by | US$ 2,271.23 million by 2030 |
| Growth rate | CAGR of 7.37% from 2022 to 2030 |
| Forecast Period | 2022-2030 |
| Base Year | 2022 |
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Report Segmentation and Scope
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Adoption-Based Insights
Based on adoption, the ELISA diagnostic test market is bifurcated into human and veterinary. The human segment held a larger market share in 2022 and is anticipated to register a higher CAGR of 7.88% during the forecast period. Infectious diseases are caused by infectious agents such as bacteria, parasites, viruses, fungi, and other pathogens. With the growing environmental changes and poor sanitation conditions, infection cases are rising among humans, and new diseases are emerging worldwide. In January 2020, the World Health Organization (WHO) declared the COVID-19 outbreak as a Public Health Emergency of International Concern (PHEIC) with a preliminary estimate of a total number of least 3 million, representing 1.2 million more deaths due to COVID-19 in 2020 globally. Similarly, according to the WHO, tuberculosis (TB) is the 13th top cause of death globally and the second leading infectious disease after COVID-19. As per the same source, globally, 10.6 million people contracted TB, while a total of 1.6 million people died from TB, including 187,000 people with HIV in 2021.
Additionally, hepatitis, a viral infection with the five main strains of A, B, C, D, and E, is a major disease threat worldwide. According to the WHO, around 58 million people across the world suffer from chronic hepatitis C virus infection, and ~1.5 million new infections are recorded every year. Infectious diseases such as HIV/AIDS, influenza, tuberculosis, and many sexually transmitted diseases need early diagnosis for disease management and control. Serological tests such as ELISA test can detect viral and bacterial antigens and antibodies to help diagnose these diseases in their early stage in the biological samples such as blood, plasma, urine, and stool samples. Therefore, the incidence of these infectious diseases among the population is boosting the global ELISA diagnostic test market growth for the human segment.
Test Type-Based Insights
Based on test type, the global ELISA diagnostic test market is segmented into sandwich ELISA, indirect ELISA, competitive ELISA, and multiple & portable ELISA. The indirect ELISA segment held the largest market share in 2022 and is anticipated to register the highest CAGR of 8.58% during the forecast period. The indirect ELISA technique is widely utilized to determine the consequence of an immunological reaction by calculating the amount of antibody present in a sample. It is a two-step detection technique that involves the use of a primary antibody, which specifically binds to the target antigen. A labeled secondary antibody is then used to detect the primary antibody by binding to its host species. The method can detect specific antibodies in a serum sample by substituting the serum for the primary antibody. According to an article published by Frontiers in 2023, a study was presented using the indirect ELISA method and monoclonal antibodies against the African swine fever virus (ASFV) pK205R. The study revealed effective detection and potential application possibilities, making them perfect for ASF vaccine research and epidemiological surveillance. Therefore, owing to potential future advancements and applications of the indirect ELISA tests, the ELISA diagnostic test market is anticipated to grow significantly during 2022–2030.
ELISA Diagnostic Test Market, by Adoption – 2022 and 2030
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- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
Regional Analysis
The North America ELISA diagnostic test market is segmented into the US, Canada, and Mexico. The market growth in this region is attributed to the rising infectious diseases among humans and technological advancements in ELISA diagnostic kits. According to the Centers for Disease Control and Prevention (CDC) 2023 report, there is a rise in the incidence of infectious diseases among humans that are linked to animal contact.
Following is a list of zoonotic disease outbreaks spread between animals and people.
Zoonotic Bacterial Etiology in US | |||
Genus Disease | Disease | Pathogen | Structure |
Brucella | Brucellosis | Bacteria | Gram -ve coccobacilli |
Salmonella | Campulobacteriosis | Bacteria | Gram -ve Rods |
Shigella | Shigellosis | Bacteria | Gram -ve Rods |
Leptospira interrogans | Septospirosis Causing bacteremia | Bacteria | Gram -ve Spirochete |
Borrelia recurrentis | Bacteremia | Bacteria | Gram -ve Spirochete |
Spirillum | Spiremia | Bacteria | Gram -ve |
Francisella tularensis | Septicemia | Bacteria | Gram -ve coccobacilli |
Bacillus anthracis | Anthrax | Bacteria | Gram +ve Rod-Shaped |
Source: The Insight Partners Analysis
The ClinMed International Library 2017 report reveals that “Giardia Intestinalis” is the most common intestinal parasitic infection in the US. Moreover, in the country, 22.5% of the population over 12 years of age gets infected with “Toxoplasma Gondii”. Further, in the last two decades, there has been a rise in the incidence of zoonotic diseases in the US, becoming a significant cause of rising infectious disease cases among the US population. Additionally, the CDC 2023 report reveals that the incidence of avian influenza (AI) was on the rise in the US in January 2022. It stated that 59,031,321 birds were affected due to AI in the US as per the CDC report. Therefore, to control AI infections in the US, commercial ELISA test kits were made available to confirm any positives. Thus, rising incidences of infectious diseases among humans due to high zoonotic disease cases boost the adoption of ELISA diagnostic tests in the US.
The report profiles leading players operating in the global ELISA diagnostic test market. Bio-Rad Laboratories Inc, Idexx Laboratories Inc, F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc, Abbott Laboratories, Danaher Corp, Innovative Diagnostics SAS, Pictor Ltd, DiaSorin SpA, Elabscience Biotechnology Inc, and Bio-Techne Corp are a few market players.
- In October 2022, Roche announced the release of their next-generation portfolio SARS-CoV-2 fast antigen assays ("2.0") for self-TEST and professional usage in CE-marked countries. The new fast test portfolio is expected to be distributed in the following weeks. The test include the SARS-CoV-2 Rapid Antigen Test 2.0, the SARS-CoV-2 Rapid Antigen Test 2.0 Nasal intended for professional use, and the SARS-CoV-2 Antigen Self-Test Nasal intended for self-testing.
- In February 2020, Bio-Techne Corp launched next-generation ELISA kits. The launch of Quantikine and QuicKitTM ELISA product line was announced by Bio-Techne Corp. The capabilities of the Quantikine ELISA kits from the previous generation are increased by this new product line, allowing researchers to work longer hours without sacrificing quality. In under 90 minutes, these assays accurately quantify the proteins in serum, plasma, and cell supernates.
Company Profiles
- Bio-Rad Laboratories Inc
- Idexx Laboratories Inc
- F. Hoffmann-La Roche Ltd
- Thermo Fisher Scientific Inc
- Abbott Laboratories
- Danaher Corp
- Innovative Diagnostics SAS
- Pictor Ltd
- DiaSorin SpA
- Elabscience Biotechnology Inc
- Bio-Techne Corp
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Adoption, Test Type, Application, End User, and Geography
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
This text is related
to country scope.
Frequently Asked Questions
Key factors that such as rising infectious diseases among animals and increasing incidence of human infections are expected to boost the market growth for the ELISA diagnostic test market over the years.
Enzyme-Linked Immunosorbent Assay (ELISA) is a diagnostic technique that helps detect antibodies or infectious agents present in a biological fluid. Antibodies are produced by the body in response to an infection, and hence, an antibody ELISA test can help determine if an animal has come in contact with a specific virus. On the other hand, an antigen ELISA test can directly detect the virus in an infected animal.
The CAGR value of the surgical navigation system market during the forecasted period of 2020-2030 is 7.37%.
The ELISA diagnostic test market is segmented into adoption, test type, application and end user. Based on adoption the ELISA diagnostic test market is segmented in human and veterinary. Based on test type ELISA diagnostic test market is segmented into sandwich ELISA, indirect ELISA, competitive ELISA, and multiple and portable ELISA. Based on application the market is segmented into auto-immune disease, infectious disease, cancer diagnosis, protein quantification, and others. Based on end user is segmented into hospitals& diagnostic centers, pharmaceutical & biotechnology companies, veterinary hospitals & diagnostic laboratories and others.
Global ELISA diagnostic test market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa and South & Central America. North America held the largest market share of the ELISA diagnostic test market in 2022. With several North American market players focusing on research and development activities in serological diagnostic testing, the regional market for ELISA diagnostic test market is likely to propel in North America region during the forecast period.
The infectious disease segment held the largest share of the market and dominated the global ELISA diagnostic test market in 2022.
The ELISA diagnostic test market majorly consists of the players such Bio-Rad Laboratories Inc., Idexx Laboratories Inc., F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corp., Innovative Diagnostics SAS, Pictor Ltd., DiaSorin SpA, Elabscience Biotechnology Inc., Bio-Techne Corp. and others.
The List of Companies - ELISA Diagnostic Test Market
- Bio-Rad Laboratories Inc.
- Idexx Laboratories Inc.
- F. Hoffmann-La Roche Ltd.
- Thermo Fisher Scientific Inc.
- Abbott Laboratories
- Danaher Corp.
- Innovative Diagnostics SAS
- Pictor Ltd.
- DiaSorin SpA
- Elabscience Biotechnology Inc.
- Bio-Techne Corp.
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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