Immunoassay Market Size, Share & Trends Analysis Report By Product (Reagents and Kits, Analyzers/Instruments, Software and Services, By Technology, Radioimmunoassay (RIA), Enzyme Immunoassays (EIA), Rapid Test, Others), By Applications (Therapeutic Drug Monitoring, Oncology, Cardiology, Endocrinology, Infectious Disease Testing, Autoimmune Diseases, Others), By End-User (Hospitals, Blood Banks, Clinical Laboratories, Pharmaceutical and Biotech Companies, Academic Research Centers, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global immunoassay market was valued at USD 24.18 billion in 2022. It is estimated to reach 42.61 billion by 2031, growing at a CAGR of 6.5% during the forecast period (2023–2031). Innovative technical developments are expected to fuel market growth over the forecast period.

The immunoassay (IA) is a biochemical assay utilized to ascertain the presence or concentration of a macromolecule or small molecule within a solution by employing an antibody or antigen. The molecule detected by an immunoassay is commonly referred to as an "analyte" and is typically a protein; however, it can be other types of molecules of various sizes and types, so long as the appropriate antibodies with the necessary properties for the assay are developed. Immunoassays are commonly used for medical and scientific purposes to measure analytes in biological liquids such as serum and urine.

Immunoassays are indispensable for clinical diagnostics, pharmaceutical analysis, environmental monitoring, and security. It is extensively utilized in research centers, hospitals, and laboratories to diagnose various diseases and improve animal and human health. Immunoassay is quickly replacing traditional tests like gas chromatography and high-performance liquid chromatography (HPLC) for on-site food contamination analysis since it is simple, quick, and affordable.

Market Dynamics

Global Immunoassay Market Drivers:

Rising Incidence of Chronic and Infectious Diseases

The increase in the prevalence of chronic conditions, like cancer, cardiovascular diseases, infections, diabetes mellitus, autoimmune diseases, and nephrological diseases, has led to the wide utilization of immunoassay techniques in disease diagnostics. Cancer incidence is increasing steadily, expected to boost the demand for effective diagnostic methods like immunoassay. The American Cancer Society estimated that there were 16.9 million cancer patients and survivors in 2020.

According to the same source, over 1.8 million new cases were diagnosed in the same year. Therefore, there is an increase in the number of cancer cases being diagnosed, which is expected to drive the growth of the market. According to WHO (2020), approximately 71 million people worldwide suffered from chronic hepatitis C infection. These factors indicate the global burden of chronic and infectious diseases, thereby boosting the growth of the immunoassay market.

Increasing Demand for Point-of-Care Diagnostics

Applications of immunoassay-based diagnostics are significantly surging globally. Rapid diagnostic test kits are in higher demand as a result of growing knowledge of infectious diseases and preventive actions, which has raised sales. There's a growing need for quick diagnosis due to the increase in multidrug-resistant bacterium illnesses. Genetic variation in hosts and pathogens, population pressure, and environmental changes are some factors responsible for the growth in the incidence of emerging diseases.

Several smartphone-based devices and related tools have emerged as the next generation's point-of-care diagnostics or testing devices, driving market expansion. For instance, a smartphone application paired with an autonomous microfluidic capillary chip is used to swiftly test cardiac troponin I in myocardial infarction. This platform is simple to use in environments with limited resources and provides test results within 12 minutes. Thus, novel technological advancements are anticipated to continue to drive market expansion.

Global Immunoassay Market Restraint:

Limitations Associated with Immunoassay Techniques

Accurate diagnosis of cancerous growth is important in facilitating effective disease diagnosis. There is a lack of specificity with immunoassay techniques. Some tumors do not have tumor-specific antibodies that can be accepted, for example, malignant mesothelioma. Therefore, supportive confirmatory tests are required, which adds to the financial burden of patients. In order to minimize and avoid false-positive results, the specificity of antibodies needs to be examined. Thus, the lack of specificity associated with immunoassay techniques and the need for multimodal approaches for disease diagnosis is anticipated to impede the growth of the  market.

Global Immunoassay Market Opportunities:

Growing Demand for Portable and Automated Immunoassays

The clinical interpretation of diagnostic tests relies on assay analyzers and a technical and skilled labor force. The time required to interpret assays affects the results. Therefore, technological advancements have led to automated laboratory instruments and apparatus growth. In laboratories, automation has advantages such as increased productivity and decreased space and labor requirements. Thus, the market is witnessing lucrative expansion as some players introduce automated laboratory systems and point-of-care compact, portable assay tests.

Furthermore, launching innovative products, such as the Elecsys SARS-CoV-2 Antigen test developed by Roche, an automated laboratory assay used to diagnose the novel coronavirus, is expected to boost the market. With the advent of advanced technologies, such as PCR and molecular diagnostics, the demand for lateral flow assays is witnessing sluggish growth. Such technological advancements are expected to create opportunities for market growth.

Regional Analysis

North America Dominates the Global Market

Based on region, the global market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global immunoassay market shareholder and is anticipated to exhibit a CAGR of 5.4% during the forecast period. North America dominated the global market, which can be attributed to the development in demand for diagnostics because of the increase in the incidence of chronic diseases and the easy availability of technologically advanced diagnostic techniques. The prevalence of infectious diseases in the geographic area, including but not limited to COVID-19, HIV, tuberculosis, and influenza, is contributing to an increased need to identify and manage these conditions.

Furthermore, well-established healthcare infrastructure and the availability of government funding for research are anticipated to augment the growth of the market in this region. In July 2020, NIH invested USD 248.7 million in developing new technologies to address challenges that are associated with testing for COVID-19. NIH's Rapid Acceleration of Diagnostics (RADx) initiative awarded contracts to seven biomedical diagnostic companies to support the development of COVID-19 POC and lab-based tests and enhance availability.

Europe is estimated to exhibit a CAGR of 6.2% over the forecast period. The prevalence of sexually transmitted diseases is very high in Europe, with an estimated 2.4 million people suffering from the disease as of 2017. A shortage of skilled professionals has increased the demand for automated laboratory analyzer systems. Compact, portable, and easy-to-operate instruments are being increasingly adopted in the region. Moreover, the growth in chronic and infectious disease prevalence and investments in developing advanced immunoassays are expected to drive the market in this region.

Some prominent companies operating in the market are Siemens Healthineers, F. Hoffmann-La Roche, BioMérieux, and QIAGEN. Furthermore, a flourishing number of product approvals and the launch of novel immunoassay products by leading manufacturers are anticipated to spur market growth in the region. For instance, in February 2021, Roche received clearance from the German Federal Institute for Drugs and Medical Devices for its SARS-CoV-2 Rapid Antigen Test.

Asia-Pacific is the fastest-growing market due to a huge target population in potential regions such as India, China, Japan, and South Korea. The surging adoption of innovative laboratory techniques and procedures for faster investigation and diagnosis of infectious and chronic disorders is among the factors driving the market. Moreover, the introduction of molecular kits and increased demand for reagents used in diagnosis are also among the factors driving growth. With growing awareness and increased funding from the private sector, care-based surveillance systems, and governments, the availability of diagnostic testing is anticipated to increase, thereby impelling regional market growth.

In Latin America, the market growth is associated with a high incidence of life-threatening diseases, such as cancer, cardiovascular diseases, and infectious diseases, including the outbreak of COVID-19, in key countries such as Brazil, Argentina, and Mexico. Globocan estimated that in 2020, around 1,470,274 new cancer cases were diagnosed in Latin America and the Caribbean, leading to around 713,414 deaths. Brazil dominates this region in terms of market size. This dominance can be attributed to a large target population and increasing entry of leading players with innovative immunoassay solutions. However, low affordability and adoption of advanced immunoassay solutions in underdeveloped economies of the region are expected to hinder growth over the forecast period.

In the Middle East and Africa, the immunoassay market can be attributed to ongoing government initiatives focused on improving early diagnosis and treatment of various chronic diseases in the Middle East and Africa region. The high incidence of infectious and cardiovascular diseases in countries such as South Africa is also expected to create a demand for immunoassay solutions. However, low awareness about diseases, uncertain reimbursement scenarios, and lack of skilled professionals in some countries of the Middle East and Africa region are expected to be major threats to market growth.

Segmental Analysis

The global immunoassay market is segmented by product, technology, application, and end-user.

Based on product, the global market is bifurcated into reagents and kits, analyzers/instruments, and software and services. 

The reagent and kits segment dominates the global market and is expected to exhibit a CAGR of 6.7% over the forecast period. Reagents and kits detect and measure small molecules that cause diseases. The reagents used incorporate antibodies and change the color to identify analytes. Various reagents and kits needed to identify analytes include antigens for coating microtiter plate wells, antibodies, blocking reagents, anti-IgG species, and substrates, which react with the enzyme to form a colored product. The surging prevalence of cancer, infectious diseases, and autoimmune diseases has generated a high demand for immunoassay reagents and kits, thus fueling the segment growth.

Similarly, approval and launch of novel immunoassay kits and reagents to diagnose life-threatening diseases are expected to support the segment's growth. For instance, in October 2020, U.S. biotechnology company Creative Diagnostics introduced its new SARS-CoV-2 immunoassay assays for direct detection of SARS-CoV-2 antigens and antibodies.

Based on technology, the global immunoassay market is divided into radioimmunoassay (RIA), enzyme immunoassays (EIA), rapid tests, and others. 

The enzyme immunoassays (EIA)segment contributed to the highest market share and is estimated to exhibit a CAGR of 6.9% over the forecast period. EIA, called an Enzyme-linked Immunosorbent Assay (ELISA), detects specific antigens or antibodies in samples. Reagents and consumables used in this technique help construct and run enzyme immunoassays. These include conjugates and probes, blocking buffers, enzyme substrates, antibody pair kits, microplates and plastic wares, and instruments and other equipment. Some of the major advantages of this method over immunodiffusion and immunoelectrophoresis are quantitative results, reduced assay time, and the necessity of fewer antisera for analysis.

Other benefits of this method include high sensitivity and the need for radioactivity. These devices have been developed to detect microbial antigens in bodily fluids. Some common microbes diagnosed using this method are Haemophilus influenzae type B, rotavirus, and hepatitis B virus.

Based on application, the global immunoassay market is divided into therapeutic drug monitoring, oncology, cardiology, endocrinology, infectious disease testing, autoimmune disease, and others. 

The infectious disease testing segment is the biggest revenue contributor to the market and is expected to exhibit a CAGR of 7.71% over the forecast period. Qualitative immunoassays and instruments detect antigens and antibodies produced in response to them. Immunoassays are important diagnostic tools for detecting life-threatening infectious diseases such as HIV/AIDS, influenza, malaria, hepatitis, and measles. The outbreak of COVID-19 has also driven the demand for effective immunoassays for conducting mass testing, thus propelling the market growth.

Key participants in the market are undertaking extensive R&D initiatives to develop and approve novel COVID-19 diagnostic tests. For instance, in December 2020, Abbott received the FDA's EUA for its new BinaxNOW COVID-19 Ag Card rapid test. This test is a lateral flow immunoassay designed for the detection of COVID-19. Approval and launch of such new tests are anticipated to support the segment's growth.

Based on end-users, the global immunoassay market is segmented into hospitals, blood banks, clinical laboratories, pharmaceutical and biotechnology companies, academic research centers, and others. 

The hospitals segment owns the highest market share and is estimated to exhibit a CAGR of 6.2% during the forecast period. Hospitals and clinics are primary care settings for the diagnosis and treatment of medical conditions. Most of the general population relies on these long-term facilities to diagnose, treat, and manage diseases. Therefore, the hospital segment held the largest market share in 2022. In addition, constant changes in the healthcare industry have increased the need for hospitals with enhanced diagnostic services. The increase in healthcare expenditure globally has significantly contributed to the segment growth. As hospitals maintain and collect data on disease prevalence, regulatory bodies often collaborate with them for disease surveillance.

The need for hospitals with advanced facilities has surged with ongoing changes in the healthcare industry. The rise in the number of hospitals and diagnostic laboratories has also led to the high growth of this segment. With the increase in the prevalence of chronic diseases, such as cancer and infectious and autoimmune illnesses, the need for hospitals and diagnostic centers to diagnose antigens in cancer cells is increasing.

Impact of covid-19

After the COVID-19 pandemic, there has been a shift in lifestyle among several people, and the adoption of a healthy lifestyle has increased. The health benefits of beetroot powder have increased its popularity among health-conscious people. Nitrates are a component of beet powder in addition to vitamins and minerals. Beets and many other vegetables contain nitrates, which occur naturally. The healthy flow of blood is improved by dietary nitrate. According to studies, beetroot powder may assist individuals in maintaining lower blood sugar levels after meals. People who are obese may benefit from using beetroot powder to increase their insulin sensitivity and lower their blood sugar levels. Although more research is required, these findings may hold promise for those who have diabetes or other blood sugar-related problems.

Recent Developments

• August 2023- Shine i8000/9000, Fapon's newest chemiluminescence immunoassay system, was introduced at the 2023 Clinical Lab Expo and Meeting of the American Association of Clinical Chemistry (AACC). The fully automated, high-speed analyzer has an incredibly high throughput of 900 tests per hour and an integrated, compact design with consistent performance.
• July 2023- Siemens Healthineers introduced the Atellica CI Analyzer for clinical chemistry and immunoassay testing.