New York, Jan. 24, 2024 (GLOBE NEWSWIRE) -- According to Market.us, the Immunoassays market size is forecasted to exceed USD 58.2 Billion by 2033, with a promising CAGR of 6.2% from 2024 to 2033.
Immunoassay is a laboratory technique that utilizes principles from immunology to detect or quantify specific substances in a sample. It relies on the interaction between antibodies and antigens, where antibodies, proteins from the immune system, bind with target antigens. The accuracy of immunoassay depends on the specificity of this interaction. Usually, one of the molecules involved is labeled with a detectable marker like a fluorescent dye, enzyme, or radioactive substance. This labeled component enables the detection of the target substance by producing a measurable signal, such as a color change or emitted radiation.
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Key Takeaway:
- Based on product, the market is segmented into 3 distinct segments, namely reagent & kits, analyzers / instruments, and software & services. The reagent & kits segment has emerged as the dominant segment in the previous year.
- When classified on the basis of specimen, the segments observed in the market are blood, saliva, urine, and others. Out of these, blood segment remained the largest contributor to the market.
- By technology, the market shows segments such as Radioimmunoassay (RIA), Enzyme Immunoassays (EIA) Rapid Test, Chemiluminescence Immunoassays (CLIA), Fluorescence Immunoassays (FIA) and others. The Enzyme Immunoassays generated the most revenue for the market in 2023.
- As far as application is concerned, the market is segmented into Therapeutic Drug Monitoring, Oncology, Cardiology, Endocrinology, Infectious Disease Testing, Autoimmune Diseases and others. Among these, the Infectious Disease Testing remained the most dominant in 2023.
- Based on end-use, the segments observed in the market are hospitals, blood banks, clinical laboratories, pharmaceuticals and biotech companies and others.
- Region wise, North America remained the top contributor to the market, with a market share of 8.5%.
Factors affecting the growth of the Immunoassays market
- Rising demand for the effective diagnostic techniques have in turn boosted the demand for immunoassays.
- Technological advancements have enabled in improving the efficacy and accuracy, which has effectively aided in the growth of the market.
- The increasing prevalence of chronic illnesses has also influenced the growth of the market.
- The high costs associated with immunoassays may hamper the growth of the market.
- Additionally, the complicated nature of regulations and approval processes also impacts the immunoassays market negatively.
- Immunoassays can be rendered inefficient due to limited sensitivity, which may hinder the process of market expansion.
- Point of Care Testing expansion along with personalized medicine present the market with many unexplored authorities.
- Increasing popularity of multiplex immunoassays can encourage evolution of the immunoassays.
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Top Trends in the Global Immunoassays Market
- The trend towards streamlining the miniaturization of immunoassay platforms for point-of-care testing is gaining momentum, responding to the increasing demand for convenient and efficient diagnostic processes. This technological advancement aims to make health assessments more accessible and immediate.
- Another notable trend is the rise of multiplex immunoassays, allowing for the simultaneous detection of multiple analytes. This not only enhances the comprehensiveness of diagnostic results but also streamlines testing procedures.
- The adoption of AI for data analysis in immunoassays is another significant trend, contributing to improved accuracy and efficiency in interpreting test results. The integration of AI capabilities enhances the precision of diagnostic processes, reducing the likelihood of errors and providing a more reliable interpretation of immunoassay data, thereby advancing the overall effectiveness of diagnostic procedures.
Market Growth:
The immunoassays market is witnessing robust growth attributed to the increasing demand for diagnostic tools in the healthcare sector. Advancements in technology, particularly the rise of multiplex immunoassays and the integration of artificial intelligence for data analysis, are enhancing the accuracy and efficiency of diagnostic processes. The market is driven by a surge in chronic diseases, prompting the adoption of immunoassays for early detection and continuous monitoring. Additionally, the expansion of Point-of-Care Testing (POCT) and opportunities in untapped markets, especially in developing regions with evolving healthcare infrastructure, contribute to the market's growth. The focus on personalized healthcare further propels the industry, allowing for the customization of immunoassays to individual patient profiles, leading to more precise and targeted medical interventions. Despite challenges related to affordability and regulatory complexities, the immunoassays market remains dynamic and poised for continued expansion.
Macroeconomic Factors:
The immunoassays market is significantly influenced by various macroeconomic factors that shape its dynamics. Economic conditions play a crucial role as they impact healthcare spending, affecting the adoption of diagnostic technologies like immunoassays. Government policies and regulations related to healthcare funding and reimbursement policies also shape the market landscape. Moreover, global economic trends, such as GDP growth and fluctuations, influence overall healthcare investments and innovation in the industry. The market is sensitive to changes in currency exchange rates, affecting the cost of imported technologies and raw materials. Additionally, demographic factors, including population growth and aging, contribute to the increasing demand for diagnostic tools, driving the immunoassays market. Overall, the macroeconomic environment plays a pivotal role in shaping the trajectory and growth prospects of the immunoassays market.
Regional Analysis:
As of 2023, North America commands the leading share, exceeding 38.5%, in the global immunoassays market, reaching a market value of US$12.3 billion. Several favorable factors contribute to the region's dominant position. North America boasts a well-established healthcare system with high per capita health spending, facilitating widespread adoption of immunoassay technologies. The presence of key industry players like Abbott Laboratories, Roche Diagnostics, and Thermo Fisher Scientific ensures easy accessibility to the latest immunoassay products. Stringent regulatory standards set by entities such as the FDA have fueled significant growth in the clinical diagnostics application of immunoassays.
Also, substantial investments in biomedical research by organizations like the NIH are expanding the utilization of immunoassays in academic laboratories. The increasing prevalence of chronic and infectious diseases is driving a heightened demand for immunoassays in patient diagnosis and treatment monitoring. These trends collectively contribute to the continued dominance of North America in the global immunoassays industry.
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Scope of the Report
| Report Attributes | Details |
| Market Value (2023) | USD 31.9 Billion |
| Forecast Revenue 2033 | USD 58.2 Billion |
| CAGR (2024 to 2033) | 6.2% |
| North America Revenue Share | 38.5% |
| Base Year | 2023 |
| Historic Period | 2018 to 2022 |
| Forecast Year | 2024 to 2033 |
Market Drivers:
The immunoassays market is experiencing growth driven by a rising demand for diagnostic tools as more individuals prioritize healthcare. Immunoassays play a crucial role in detecting various diseases, enabling early intervention and enhancing patient outcomes.
Continuous technological enhancements in immunoassay methods are contributing to increased accuracy and efficiency. This progress is essential in ensuring that these diagnostic tools remain at the forefront of medical advancements, facilitating improved disease detection and monitoring. The surge in the prevalence of chronic illnesses is a key factor propelling the adoption of immunoassays. These tests provide effective means of early detection and continuous monitoring, addressing the growing healthcare needs associated with chronic conditions.
Market Restraints:
Affordability emerges as a challenge to the widespread adoption of immunoassays, especially in economically constrained settings. The market is tasked with making these diagnostic solutions more accessible without compromising quality.
Intricate regulatory processes surrounding immunoassays present obstacles, impacting the timely development and approval of these diagnostic products. Navigating these complexities requires careful attention and resources.
Immunoassays encounter limitations in precisely detecting certain biomarkers, affecting their versatility in medical applications. Addressing this challenge involves ongoing research and development efforts to enhance sensitivity and broaden the range of detectable targets.
Market Opportunities:
The immunoassays market is poised for opportunities with the expansion of Point-of-Care Testing (POCT). As healthcare trends shift towards decentralized testing, immunoassays can play a pivotal role in providing rapid and on-the-spot diagnostics.
Untapped markets present significant growth potential for immunoassay providers, particularly in developing regions with evolving healthcare infrastructure. The industry can capitalize on these opportunities to broaden its reach and impact.
With the increasing focus on personalized healthcare, there is a growing opportunity for tailoring immunoassays to individual patient profiles. This customization enhances the precision of diagnostics, contributing to more effective and targeted medical interventions.
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Report Segmentation of the Immunoassays Market:
Product Insight
In 2023, Reagents and Kits dominated the immunoassays market, capturing over 65% market share. This category, encompassing ELISA, rapid tests, ELISPOT, Western blot, and other test kits, experienced high demand, driven by immunoassays' broad applications in disease diagnosis, food safety, drug development, and life science research. Analyzers and instruments constituted approximately 20% of the market revenue, with open-ended automated systems prevailing over closed-ended ones due to their flexibility and customization capabilities. Ongoing advancements in analyzer technology focus on enhancing throughput, reducing turnaround times, and integrating software solutions. Software and services constituted the remaining 15%, witnessing an uptake driven by trends such as laboratory automation and consolidation. This includes software solutions for result interpretation, data management, and workflow optimization, with cloud-based informatics platforms and end-to-end lab services gaining momentum. The immunoassays market is projected for steady growth, propelled by the increasing global prevalence of chronic and infectious diseases.
Technology Insight
In the dynamic realm of immunoassays, the year 2023 witnessed the Enzyme Immunoassays (EIA) technology reigning supreme, capturing an impressive market share of 64.66%. Recognized for its precision and adaptability, EIA employs enzymes as labels to detect a spectrum of analytes, making it a preferred choice in diagnostics and research. Rapid Test technology, renowned for its swift results and user-friendly nature, has also left a significant imprint, particularly in point-of-care testing. Chemiluminescence Immunoassays (CLIA) utilize light for highly sensitive results, finding extensive use in clinical labs. Fluorescence Immunoassays (FIA) are gaining traction due to their heightened sensitivity, especially in cancer biomarker detection. Beyond these, diverse technologies like Radioimmunoassay (RIA) and emerging methods further enrich the multifaceted immunoassays market.
Application Insight
In 2023, the immunoassays market witnessed Infectious Disease Testing claiming a dominant market share exceeding 29%, establishing itself as the most significant application. Concurrently, Oncology emerged as a pivotal segment, progressively expanding its market presence by playing a crucial role in detecting and monitoring cancer-related markers. The field of Cardiology, addressing heart-related conditions, emerged as another vital player due to the global prevalence of heart diseases. Endocrinology, focusing on hormonal disorders like diabetes and thyroid issues, showcased a rising demand for immunoassays in diagnosis and management. Therapeutic Drug Monitoring, a critical application, ensured optimal drug levels in patients for effective treatment. Autoimmune Diseases, involving the immune system attacking healthy cells, constituted a substantial market segment with immunoassays aiding in identification and monitoring. Additionally, the diverse realm of Other Applications, encompassing allergy testing and biomarker monitoring, anticipated steady growth, reflecting the broad utility of immunoassays in various healthcare domains.
End-Use Insight
In 2023, hospitals took the lead in the immunoassays market, claiming a substantial 34.1% share, underscoring their pivotal role in healthcare. Another significant player, Blood Banks, relies on immunoassays to ensure the safety of blood products, serving a crucial function in transfusion medicine and disease screening. Clinical Laboratories also heavily utilize immunoassays, playing a vital role in diagnostics by offering a diverse range of tests to patients. Pharmaceutical and Biotech Companies leverage immunoassays for drug development and quality control, driven by research imperatives to guarantee pharmaceutical product safety and efficacy. Academic Research Centers contribute to medical science advancements, employing immunoassays for diverse research purposes. Additionally, the immunoassays market extends to Other End-Users, such as veterinary clinics, forensic labs, and environmental testing agencies, showcasing the adaptability of immunoassays across various fields.
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Recent Development of the Immunoassays Market:
- In February 2023, Thermo Fisher Scientific acquired Mesa Biotech, expanding its portfolio in rapid disease tests and strengthening its position in the quick disease testing market.
- In June 2023, DiaSorin introduced the LIAISON B·R·A·H·M·S MR-proADM assay, designed to analyze proADM in the blood, aiding doctors in identifying infections like sepsis and monitoring treatment progress.
- In July 2023, Siemens received FDA approval for the Atellica CI Analyzer, a cutting-edge machine capable of conducting both immune and clinical chemistry tests. This advanced analyzer offers improved speed, requires less blood, and delivers superior results compared to older models.
- In August 2023, Abbott launched the Alinity h-series hematology system, a sophisticated device designed for rapid blood count tests. This smart system automates processes, enhancing the efficiency of blood tests and ensuring precise results.
Market Segmentation:
Product
- Reagents & Kits
-
- ELISA Reagents & Kits
- Rapid Test Reagents & Kits
- ELISPOT Reagents & Kits
- Western Blot Reagents & Kits
- Other Reagents & Kits
- Analyzers/Instruments
-
- Open Ended Systems
- Closed Ended Systems
- Software & Services
Specimen
- Blood
- Saliva
- Urine
- Other Specimens
Technology
- Radioimmunoassay (RIA)
- Enzyme Immunoassays (EIA) Rapid Test
- Chemiluminescence Immunoassays (CLIA)
- Fluorescence Immunoassays (FIA)
- Other Technologies
Application
- Therapeutic Drug Monitoring
- Oncology
- Cardiology
- Endocrinology
- Infectious Disease Testing
- Autoimmune Diseases
- Other Applications
End-use
- Hospitals
- Blood Banks
- Clinical Laboratories
- Pharmaceutical and Biotech Companies
- Academic Research Centers
- Other End-Users
By Geography
- North America
- US
- Canada
- Europe
- Germany
- France
- The UK
- Spain
- Italy
- Russia
- Netherland
- Rest of Europe
- Asia Pacific
- China
- Japan
- South Korea
- India
- New Zealand
- Singapore
- Thailand
- Vietnam
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Rest of Latin America
- Middle East & Africa
- South Africa
- Saudi Arabia
- UAE
- Rest of MEA
Competitive Landscape:
The global immunoassays market features a highly competitive landscape with key players vying for market share. Major companies such as Abbott Laboratories, Roche Diagnostics, and Thermo Fisher Scientific play pivotal roles, leveraging their extensive product portfolios and robust market presence. These industry leaders consistently strive for innovation, introducing advanced immunoassay technologies. Additionally, strategic collaborations, partnerships, and mergers and acquisitions are prevalent in the market, contributing to the overall competitiveness. Emerging players and niche-focused companies also contribute to the dynamic nature of the immunoassays market, creating a scenario where technological advancements, regulatory compliance, and market penetration strategies become crucial factors in sustaining and enhancing competitive positions.
Market Key Players:
- Siemens Healthineers
- bioMérieux SA
- Abbott Laboratories
- Danaher Corporation (Beckman Coulter)
- Quidel Corporation
- Ortho Clinical Diagnostics
- Sysmex Corporation
- Bio-Rad Laboratories Inc.
- Becton, Dickinson, and Company
- Hoffmann-La Roche AG
- Thermo Fisher Scientific Inc.
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