REDDING, Calif., March 14, 2022 /PRNewswire/ -- According to the research report titled, "Immunoassay Market by Product & Solution (Immunoassay Kits [ELISA, Rapid Tests], Immunoassay Analyzers, Software & Services), Platform (Chemiluminescence, Radioimmunoassay), Application (Infectious Diseases, Oncology, Allergy), End User - Global Forecast to 2028", published by Meticulous Research, the overall immunoassay market is projected to reach $46.49 billion by 2028, at a CAGR of 7.5% from 2021.
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Immunoassays have played a vital role in pharmaceutical analysis, such as diagnosing diseases, therapeutic drug monitoring, clinical pharmacokinetics, and bioequivalence studies in drug discovery and pharmaceutical industries.
The immunoassay industry is growing steadily due to factors, such as the growing prevalence of chronic and infectious diseases, the increasing geriatric population, technological advancements in immunoassay, the increasing use of immunoassay in oncology, the role of immunoassay in drug & alcohol testing, and the outbreak of the COVID-19 pandemic. Furthermore, the integration of microfluidics technology into immunoassays and emerging economies are expected to offer significant opportunities for players operating in the immunoassay market.
Impact of COVID-19 on the Immunoassay Market
The outbreak of the COVID-19 pandemic resulted in public health experts emphasizing testing, tracking infected people, and tracing their contacts as an effective strategy to curb the spread of the virus. Several diagnostic methods are used for detecting the SARS-CoV-2 virus in clinical, research, and public health laboratories. Immunoassays are used to measure the antibodies against the SARS-CoV-2.
Pre-existing medical conditions, such as cardiovascular and respiratory illnesses, have been shown to increase the risk of death from COVID-19. Researchers also found that just 9% of original cases were responsible for 80% of infections detected in close contacts. Therefore, it is important to diagnose the disease early to help prevent its spread.
A peptide-based magnetic chemiluminescence enzyme immunoassay was developed for the diagnosis of COVID-19. The test has high throughput and can perform simultaneous clinical tests for other biomarkers, such as C-reactive protein (CRP), which should also be tracked in COVID-19 suspects. Enzyme-linked immunosorbent assays (ELISAs) and lateral flow immunoassays (LFIAs) are the most widely practiced techniques to detect antibodies in SARS-CoV-2.
The outbreak of the COVID-19 pandemic has impacted the immunoassays market in three areas, i.e., price impact, impact on demand, and impact on the supply chain.
- Price Impact: The need for immunoassay kits for reliable COVID-19 testing has urged governments to bring down the price of these tests. In some government laboratories, these kits are available free of cost. The pandemic has increased the adoption of immunoassay products and reduced the price of these kits.
- Effect on Demand: Due to the disadvantages conferred by molecular assays, there is greater demand for immunoassays. Furthermore, immunoassays play a vital role in vaccine development, which increases its demand. For instance, lateral flow immunoassays provide rapid diagnostic tests to detect viral antigens within 10-30 minutes.
- Effect on the Supply Chain: Governments worldwide imposed lockdowns and social distancing norms due to the emergence of COVID-19. These restrictions led to a shortage in the supply of immunoassay kits. However, even though there were disruptions in the supply chain, the joint efforts by government bodies and manufacturers enabled companies to maintain the supply chain.
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Increasing Use of Immunoassay in Oncology is Driving the Market Growth
Cancer is one of the most frequent causes of death, globally. Immune oncological approaches help drive new levels of curative cancer treatment and could even lead to the eradication of most types of cancer. But, the development of these tools requires specific and sensitive bioanalytical methods and customized oncology assays. Since cancer is not a single disease but a composite of multiple diseases, an effective strategy for early detection using plasma tumor markers will likely require a panel of biomarkers instead of a single biomarker.
The prevalence and incidences of cancer cases are dramatically increasing, globally. Thus, the application of immunoassays for early diagnosis and monitoring of cancer is also growing gradually. According to GLOBOCAN 2020, the cancer incidence rate had increased from 17.0 million in 2018 to 19.3 million in 2020. Moreover, the mortality due to cancer has also witnessed a rise from 9.4 million deaths in 2018 to 10 million deaths in 2020. Lung and breast cancers were the most common cancers worldwide. Breast cancer accounted for 24.5 %, and lung cancer accounted for 14.5% of the total cancers.
Clinical laboratories play a key role in the early detection of cancer, which drives the course of successful treatments. In addition, oncology biomarkers can provide affordable, reliable, accurate, non-invasive, and sensitive information to help effectively manage cancer. The emergence of a greater number of biomarkers and growing awareness of immunoassay technologies drive the technological growth of cancer diagnostics. This, coupled with the rise in awareness for early cancer detection using immunoassay technologies, propels market growth.
Key Findings in the Immunoassay Market Study
Based on product and solutions, the immunoassay kits & reagents segment is expected to grow at the fastest CAGR during the forecast period. While immunoassay analyzers are a one-time investment for diagnostic labs, kits and reagents are purchased repeatedly to perform individual tests, contributing to this segment's high growth rate. Furthermore, the increasing incidences of infectious diseases, such as HIV, the growing awareness regarding the diagnosis of cancer and autoimmune diseases, and the outbreak of the COVID-19 pandemic contribute to the growth of this segment.
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The immunoassay kits & reagents segment is further sub segmented into enzyme-linked immunosorbent assay (ELISA) kits & reagents, rapid test kits & reagents, western blot kits & reagents, enzyme-linked immunospot (ELISPOT) kits & reagents, and other immunoassay kits & reagents, which include radioimmunoassay, microarray immunoassays, immunohistochemistry assays, bead-based immunoassays, and multiplex microarray assays.
Based on application, the immunoassay market is segmented into infectious diseases, oncology, cardiology, endocrinology, bone and mineral diseases, autoimmune disorders, and other applications, which include toxicology, hematology, neonatal testing, blood screening, allergy, and gastrology. The infectious diseases segment accounted for the largest share of the overall immunoassays market in 2021. The large share of this segment is attributed to the increasing regulatory approvals for infectious disease screening products, product launches, rising incidence of infectious diseases, and an increase in the availability of COVID-19 test kits across the globe.
Based on end user, the immunoassays market is broadly segmented into diagnostic reference laboratories, hospitals & clinics, academic and research institutions, pharmaceutical and biotechnology companies, and other end users, which comprise nursing homes, ambulatory care centers, blood banks, and home healthcare agencies. The hospitals & clinics segment is expected to register the highest CAGR during the forecast period due to factors such as the increasing use of immunoassay in hospitals for early disease diagnoses, minimizing treatment costs, and improving healthcare outcomes. Furthermore, the outbreak of the COVID-19 pandemic increased the number of hospital admissions which boosted the demand for immunoassay diagnostic products.
Based on geography, in 2021, North America accounted for the largest share of the global immunoassay market. However, Asia Pacific region is expected to grow at the fastest CAGR during the forecast period. The large market share of North America is attributed to the rising prevalence of various infectious diseases, well-established healthcare sector, higher awareness regarding early disease diagnosis, increasing penetration of advanced medical devices, and increasing funding activities coupled with the development of novel advanced immunoassay solutions.
The key players operating in the global immunoassay market are F. Hoffman-La Roche AG (Switzerland), Abbott Laboratories (U.S.), Siemens AG (Germany), Danaher Corporation (U.S.), Sysmex Corporation (Japan), bioMérieux SA (France), Thermo Fisher Scientific (U.S.), Becton, Dickinson and Company (U.S.), Merck KGaA (Germany), Bio-Rad Laboratories, Inc. (U.S.), Agilent Technologies, Inc. (U.S.), and PerkinElmer, Inc. (U.S.) among others.
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Scope of the Report:
Immunoassay Market, by Product & Solution
- Immunoassay Kits and Reagents
- ELISA Kits and Reagents
- Rapid Test Kits and Reagents
- Western Blot Kits and Reagents
- ELISPOT Kits and Reagents
- Other Immunoassay Kits and Reagents
- Immunoassay Analyzers
- Immunoassay Software and Services
Other immunoassay kits and reagents comprise radioimmunoassay, microarray immunoassays, immunohistochemistry assays, bead-based immunoassays, and multiplex microarray assays
Immunoassay Market, by Platform
- Chemiluminescence Immunoassay
- Fluorescence Immunoassay
- Colorimetric Immunoassay
- Radioimmunoassay
- Other Immunoassay Platforms
Other immunoassay platforms comprise turbidimetric immunoassays, chromatographic immunoassays, microarray immunoassays, immunohistochemistry, and counting immunoassays
Immunoassay Market, by Application
- Infectious Diseases
- Oncology
- Endocrinology
- Cardiology
- Bone and Mineral Diseases
- Autoimmune Disorders
- Other Applications
Other applications comprise toxicology, hematology, neonatal testing, allergy, and gastrology.
Immunoassay Market, by End User
- Diagnostics Reference Laboratories
- Hospitals and Clinics
- Academic and Research Institutions
- Pharmaceutical and Biotechnology Companies
- Other End Users
Other end users comprise nursing homes, ambulatory care centers, blood banks, and home healthcare agencies
Immunoassay Market, by Geography
- North America
- U.S.
- Canada
- Europe
- Germany
- U.K.
- France
- Italy
- Spain
- Rest of Europe (RoE)
- Asia-Pacific (APAC)
- China
- Japan
- India
- Australia
- Indonesia
- Rest of APAC (RoAPAC)
- Latin America
- Brazil
- Mexico
- Rest of Latin America
- Middle East & Africa
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