Immunoassay
Immunoassay Market by Product (Analyzer, Consumables), Technology (Chemiluminescence Immunoassay, Enzyme-linked Immunosorbent Assay, Fluoroimmunoassay), Specimen, Indication, End User - Global Forecast 2024-2030
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[199 Pages Report] The Immunoassay Market size was estimated at USD 26.30 billion in 2023 and expected to reach USD 28.29 billion in 2024, at a CAGR 7.24% to reach USD 42.90 billion by 2030.

Immunoassay Market
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An immunoassay is a highly sensitive and specific biochemical technique used to quantify or detect a wide range of molecules, including proteins, hormones, antibodies, and other biologically relevant substances. The growth of the immunoassay market can be attributed to several influencing factors, such as the increasing prevalence of chronic diseases, rising demand for personalized medicine, expanding use of immunoassays in oncology diagnostics, and advancements in technology leading to higher throughput capabilities with improved accuracy. Moreover, the COVID-19 pandemic has also contributed significantly to the growth of this market due to the surge in demand for rapid testing solutions. However, high costs associated with advanced immunoassay systems may hamper their adoption by smaller laboratories or resource-limited settings. Additionally, stringent regulatory guidelines regarding product approvals can prolong the time to market for new products. To overcome these challenges and sustain business growth in the immunoassay market, organizations are exploring potential areas of innovation and research, including focusing on R&D efforts to create cost-effective solutions that cater to a wider user base across different healthcare settings worldwide. Additionally, collaborating with academic institutions and research centers to foster breakthrough innovations in assay design, targeting novel analytes or applications not currently addressed by existing products. Along with these, market participants are developing novel biomarkers for the early detection of diseases, leading to an expansion in clinical applications of immunoassays.

Regional Insights

In the Americas, the United States and Canada have witnessed a growing demand for immunoassays due to a rising prevalence of chronic diseases such as cancer and cardiovascular disorders. Increasing healthcare spending in these countries has also supplemented increased focus on early detection of diseases; laboratories are investing heavily in advanced technologies such as enzyme-linked immunosorbent assays (ELISA) and chemiluminescence immunoassays (CLIA). Apart from these, recent patents filed in this region encompass improvements in assay sensitivity and specificity while reducing cross-reactivity issues. In EU countries, the Middle East and Africa region has seen significant growth in the immunoassay market due to rising consumer health awareness. Initiatives led by governments and healthcare organizations have bolstered public investment in diagnostic services. Key players in this market focus on developing new products catering to specific regional customer requirements. Emerging countries across the Asia Pacific, such as India and China, present a considerable growth opportunity for immunoassay manufacturers due to increasing healthcare expenditure, rising prevalence of chronic diseases requiring diagnostic testing services, improving laboratory infrastructure, and growing awareness about early disease detection. Furthermore, customizing products to cater to specific disease patterns in emerging markets has helped expand key profiles. Additionally, the regional government has launched several initiatives to promote public-private partnerships in developing innovative diagnostic methods, providing support and investment for academic institutions and private enterprises.

Market Dynamics

The market dynamics represent an ever-changing landscape of the Immunoassay Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.

  • Market Drivers
    • Rising chronic and infectious diseases and benefits of early diagnosis
    • Growing usage of immunoassay in the food & beverage sector
    • Emerging application of multiplex detection immunoassay technique in drug development
  • Market Restraints
    • Cross-reactivity issues associated with immunoassay
  • Market Opportunities
    • Technological advancements in the number of automated instruments and equipment associated with immunoassay
    • High potential of immunoassay in environment monitoring
  • Market Challenges
    • Issues with assay validation due to variations in sample quality and reagent performance
Market Segmentation Analysis
  • Product: Development of novel immunoassay kits for diagnostics of infectious and autoimmune diseases

    Analyzers are at the core of immunoassays as they facilitate the detection and measurement of target analytes in samples. These analyzers are typically used in clinical laboratories, hospitals, pharmaceutical companies, and research institutions to screen for various biomarkers and detect specific analytes such as hormones, proteins, and pathogens. There has been a growing need for analyzers with rapid turnaround times (TAT), high-throughput capabilities, and user-friendly interfaces. In response to these needs, manufacturers have introduced innovations such as chemiluminescence-based detection systems, multiplexed assays, and advanced software solutions to improve efficiency and provide accurate results. Consumables play a critical role in immunoassays by ensuring reliable test results through high-quality reagents, kits, and other disposable items. In consumables, reagents play an essential role in performing immunoassays by facilitating specific binding interactions between antibodies and antigens. These include primary and secondary antibodies, enzyme-labeled conjugates, substrates, buffers, and other necessary chemicals. The performance characteristics of these reagents directly affect assay reliability and reproducibility. Immunoassay kits consist of a complete set of pre-packaged reagents, along with detailed protocols for conducting specific assays. Advantages such as ease of use, standardization, and optimized performance have increased demand for ready-to-use kits in laboratories worldwide. Microwell plates and tubes serve as support structures for various immunoassays, offering scalability and high-throughput capabilities by allowing multiple samples to be analyzed simultaneously. Their material composition plays a significant role in minimizing non-specific binding while maintaining optimal conditions for analyte detection.

  • Technology: Utilization of enzyme-linked immunosorbent assay technology for food allergies and drugs of abuse treatment

    The chemiluminescence immunoassay (CLIA) is a highly sensitive and specific technology that measures the concentration of an analyte through the emission of light from a chemical reaction. CLIA has gained popularity recently due to its high throughput, rapid results, and favorable signal-to-noise ratios, which are beneficial in detecting low-abundance biomarkers, infectious diseases, and hormone levels. Enzyme-linked fluorescence assays (ELFA) involve using enzyme-labeled antibodies and fluorescent substrates to quantify specific analytes. ELFA provides a rapid analysis with high sensitivity and specificity while requiring relatively small sample volumes. This technology finds utility in various applications such as infectious disease diagnosis, autoimmune disorders detection, and therapeutic drug monitoring. Enzyme-linked immunosorbent assays (ELISA) are widely used in diagnostics and research applications to detect proteins, peptides, hormones, and antibodies. ELISA offers high sensitivity, specificity, and reproducibility with the convenience of being adaptable to both microplate and bead-based formats. Radioimmunoassay is a well-established technique that uses radioisotopes to detect target molecules in biological samples. Despite its declining popularity due to the emergence of non-radioactive techniques, RIA still holds relevance in specific niche applications such as the measurement of low-concentration hormones, drug monitoring, and assessment of receptor binding studies. Rapid diagnostic tests are point-of-care testing devices offering quick results from a sample such as blood or urine without requiring specialized laboratory equipment or personnel. These tests have become vital tools in diagnosing infectious diseases, pregnancy, and drug abuse screening in resource-limited settings.

  • Specimen: Emergence of saliva diagnostics due to its non-invasive collection methods

    The choice of immunoassay specimen depends on factors such as the type of disease targeted, biomarker availability, ease of sample collection, and patient comfort. Blood is often the preferred specimen type for immunoassays due to its ability to provide comprehensive insights into an individual's health status. It is routinely used to detect infectious diseases, cancer biomarkers, hormone levels, and autoimmune disorders, among other applications. Saliva has emerged as a popular alternative to blood due to its non-invasive collection methods and ease of storage/transportation, which is particularly useful for detecting hormone levels, drug abuse testing, oral pathogens identification, and assessment of overall oral health status. Urine is another widely used specimen type in immunoassays due to its non-invasive collection procedure and ability to detect a wide range of analytes, such as drugs of abuse, pregnancy hormones, kidney function markers, and urinary tract infection indicators.

  • Indication: Optimization within immunoassay technologies to cater growing need across infectious disease

    Cardiology is a major segment in the immunoassay market owing to the high prevalence of cardiovascular diseases (CVDs) worldwide. According to the World Health Organization, cardiovascular diseases account for approximately 17.9 million deaths annually, making it a major cause of mortality globally. Immunoassays play a critical role in diagnosing and monitoring various cardiac conditions such as myocardial infarction, heart failure, and other related disorders. In particular, biomarkers such as troponin are essential for evaluating acute coronary syndrome in patients presenting with chest pain or other symptoms suggestive of myocardial ischemia. Endocrine disorders like diabetes, thyroid dysfunction, and hormonal imbalances are increasingly affecting global populations. Immunoassays cater to this demand by accurately quantifying hormone levels in patients' samples. Infectious Disease represents another significant area within the immunoassay market due to widespread concerns over bacterial, viral, and fungal infections worldwide. The COVID-19 pandemic has further highlighted the importance of rapid and accurate diagnostic tools to identify and monitor the spread of infectious diseases. Immunoassays are valuable in detecting specific pathogens or antibodies produced by the immune system in response to infection, enabling timely intervention and containment measures. In Oncology, immunoassays have become indispensable for cancer screening, diagnosis, and monitoring treatment effectiveness. Immunoassays detect tumor biomarkers such as carcinoembryonic antigen (CEA) or prostate-specific antigen (PSA) that can aid clinicians in early detection, staging, and prognostic evaluation of various malignancies and guiding personalized therapeutic strategies for patients. In the field of orthopedics, immunoassays are used to monitor bone metabolism markers like procollagen type I N-terminal propeptide (PINP) and C-terminal cross-linking telopeptide (CTX), which assist in diagnosing osteoporosis and other bone-related disorders.

  • End User: Rising demand for immunoassay across emergency care, intensive care units, and outpatient clinics

    Blood banks play a critical role in the immunoassay market due to the need for blood transfusions and blood-based products. Immunoassays are employed to screen for infectious diseases such as HIV, Hepatitis B and C, and syphilis in donor blood samples. The results obtained from these tests help ensure the safety of blood supplies before they are used for transfusion purposes. Diagnostic laboratories perform routine medical tests using immunoassays to detect different biomarkers present in biological samples. Across laboratories, assays aid in early diagnostics of diseases such as cancer, diabetes, cardiovascular disorders, and other chronic conditions. The food & beverage industry requires immunoassays for testing allergens in food products and contaminants, including pesticides and toxins in raw materials or finished goods. Food & beverage seek reliable methods with low detection limits to meet regulatory requirements and ensure consumer safety. Hospitals constitute one of the significant end-user segments of the immunoassay market due to their extensive use of these assays for diagnostic purposes across multiple departments, such as emergency care, intensive care units, and outpatient clinics. Immunoassays aid in the rapid diagnosis and monitoring of various diseases and conditions in patients, enabling healthcare professionals to make informed decisions regarding patient treatment plans. Pharmaceutical companies and contract research organizations (CROs) rely on immunoassays for drug discovery, development, and clinical trial phases. Whereas research & academic labs often need specialized immunoassays for basic research studies involving signaling pathways, protein-protein interactions, and applied research projects such as vaccine development and disease surveillance programs.

Market Disruption Analysis

The market disruption analysis delves into the core elements associated with market-influencing changes, including breakthrough technological advancements that introduce novel features, integration capabilities, regulatory shifts that could drive or restrain market growth, and the emergence of innovative market players challenging traditional paradigms. This analysis facilitates a competitive advantage by preparing players in the Immunoassay Market to pre-emptively adapt to these market-influencing changes, enhances risk management by early identification of threats, informs calculated investment decisions, and drives innovation toward areas with the highest demand in the Immunoassay Market.

Porter’s Five Forces Analysis

The porter's five forces analysis offers a simple and powerful tool for understanding, identifying, and analyzing the position, situation, and power of the businesses in the Immunoassay Market. This model is helpful for companies to understand the strength of their current competitive position and the position they are considering repositioning into. With a clear understanding of where power lies, businesses can take advantage of a situation of strength, improve weaknesses, and avoid taking wrong steps. The tool identifies whether new products, services, or companies have the potential to be profitable. In addition, it can be very informative when used to understand the balance of power in exceptional use cases.

Value Chain & Critical Path Analysis

The value chain of the Immunoassay Market encompasses all intermediate value addition activities, including raw materials used, product inception, and final delivery, aiding in identifying competitive advantages and improvement areas. Critical path analysis of the <> market identifies task sequences crucial for timely project completion, aiding resource allocation and bottleneck identification. Value chain and critical path analysis methods optimize efficiency, improve quality, enhance competitiveness, and increase profitability. Value chain analysis targets production inefficiencies, and critical path analysis ensures project timeliness. These analyses facilitate businesses in making informed decisions, responding to market demands swiftly, and achieving sustainable growth by optimizing operations and maximizing resource utilization.

Pricing Analysis

The pricing analysis comprehensively evaluates how a product or service is priced within the Immunoassay Market. This evaluation encompasses various factors that impact the price of a product, including production costs, competition, demand, customer value perception, and changing margins. An essential aspect of this analysis is understanding price elasticity, which measures how sensitive the market for a product is to its price change. It provides insight into competitive pricing strategies, enabling businesses to position their products advantageously in the Immunoassay Market.

Technology Analysis

The technology analysis involves evaluating the current and emerging technologies relevant to a specific industry or market. This analysis includes breakthrough trends across the value chain that directly define the future course of long-term profitability and overall advancement in the Immunoassay Market.

Patent Analysis

The patent analysis involves evaluating patent filing trends, assessing patent ownership, analyzing the legal status and compliance, and collecting competitive intelligence from patents within the Immunoassay Market and its parent industry. Analyzing the ownership of patents, assessing their legal status, and interpreting the patents to gather insights into competitors' technology strategies assist businesses in strategizing and optimizing product positioning and investment decisions.

Trade Analysis

The trade analysis of the Immunoassay Market explores the complex interplay of import and export activities, emphasizing the critical role played by key trading nations. This analysis identifies geographical discrepancies in trade flows, offering a deep insight into regional disparities to identify geographic areas suitable for market expansion. A detailed analysis of the regulatory landscape focuses on tariffs, taxes, and customs procedures that significantly determine international trade flows. This analysis is crucial for understanding the overarching legal framework that businesses must navigate.

Regulatory Framework Analysis

The regulatory framework analysis for the Immunoassay Market is essential for ensuring legal compliance, managing risks, shaping business strategies, fostering innovation, protecting consumers, accessing markets, maintaining reputation, and managing stakeholder relations. Regulatory frameworks shape business strategies and expansion initiatives, guiding informed decision-making processes. Furthermore, this analysis uncovers avenues for innovation within existing regulations or by advocating for regulatory changes to foster innovation.

FPNV Positioning Matrix

The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Immunoassay Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Immunoassay Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Recent Developments
  • Thermo Fisher to Acquire Olink for USD 3.1 billion, Expanding Proteomics Presence

    Thermo Fisher Scientific, Inc. has acquired Olink Holding for approximately USD 3.1 billion to enhance its presence in proteomics. The acquisition of Olink underscores the profound impact of proteomics as Thermo Fisher's customers continue to advance life science research and precision medicine. [Published On: 2023-10-17]

  • Fujirebio and Sysmex to Collaborate On Development of Unique Immunoassays

    Fujirebio Holdings, Inc. and Sysmex Corporation expanded their partnership in immunoassay tests. This partnership encompasses various areas such as research, manufacturing, clinical development, and sales and marketing. [Published On: 2023-10-11]

  • Mindray Has Agreed to Acquire 75% Stake in Germany-Based DiaSys Diagnostic Systems GmbH

    Mindray acquired a 75% equity interest in DiaSys Diagnostic Systems GmbH from Gorka Holding GmbH for approximately Euro 115 million. This acquisition enhanced Mindray's overseas supply chain platform and facilitated penetration into medium to large customer segments. By acquiring DiaSys, Mindray aims to strengthen its position in the market, delivering innovative solutions and high-quality products to meet the growing needs of healthcare professionals and patients worldwide. [Published On: 2023-07-31]

Strategy Analysis & Recommendation

The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Immunoassay Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.

Key Company Profiles

The report delves into recent significant developments in the Immunoassay Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, Agilent Technologies Inc., Almac Group Limited, ANP Technologies, Inc., Autobio Diagnostics Co., Ltd., Becton, Dickinson, and Company, Bio-Rad Laboratories, Inc., Bio-Techne Corporation, BioLegend, Inc., bioMérieux S.A., Biosurfit SA, Boditech Med Inc., Charles River Laboratories International, Inc., Danaher Corporation, Diasorin S.p.A., Dynex Technologies, Inc., Epitope Diagnostics Inc., F. Hoffmann-La Roche Ltd., Fapon Biotech Inc., Gyros Protein Technologies AB, H.U. Group Holdings Inc., J. Mitra & Co. Pvt. Ltd., Kamiya Biomedical Company, Koninklijke Philips N.V., Merck KGaA, MiCo BioMed, Inc., NanoEntek, Nanōmix, Inc., OPKO Health, Inc., PerkinElmer, Inc., Promega Corporation, QIAGEN N.V., Quanterix Corporation, QuidelOrtho Corporation, Randox Laboratories Ltd., Shenzhen Micropoint Biotechnologies Co., Ltd., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Siemens Healthineers AG, Sysmex Corporation, Tecan Trading AG, Thermo Fisher Scientific Inc., Tosoh Corporation, WAK-Chemie Medical GmbH, Zoetis Inc., and Zybio Inc..

Immunoassay Market - Global Forecast 2024-2030
To learn more about this report, request a free PDF copy
Market Segmentation & Coverage

This research report categorizes the Immunoassay Market to forecast the revenues and analyze trends in each of the following sub-markets:

  • Product
    • Analyzer
    • Consumables
      • Assay Kits
      • Microwell Plates & Tubes
      • Reagents
  • Technology
    • Chemiluminescence Immunoassay
    • Enzyme-linked Immunosorbent Assay
    • Fluoroimmunoassay
    • Radioimmunoassay
    • Rapid Diagnostic Tests (RDTs)/Lateral Flow Immunoassay
  • Specimen
    • Blood
    • Saliva
    • Urine
  • Indication
    • Cardiology
    • Endocrinology
    • Infectious Disease
    • Oncology
    • Orthopedics
  • End User
    • Blood Banks
    • Diagnostics Laboratories
    • Food & Beverage Companies
    • Hospitals
    • Pharmaceutical Companies & CROs
    • Research & Academic Laboratories

  • Region
    • Americas
      • Argentina
      • Brazil
      • Canada
      • Mexico
      • United States
        • California
        • Florida
        • Illinois
        • New York
        • Ohio
        • Pennsylvania
        • Texas
    • Asia-Pacific
      • Australia
      • China
      • India
      • Indonesia
      • Japan
      • Malaysia
      • Philippines
      • Singapore
      • South Korea
      • Taiwan
      • Thailand
      • Vietnam
    • Europe, Middle East & Africa
      • Denmark
      • Egypt
      • Finland
      • France
      • Germany
      • Israel
      • Italy
      • Netherlands
      • Nigeria
      • Norway
      • Poland
      • Qatar
      • Russia
      • Saudi Arabia
      • South Africa
      • Spain
      • Sweden
      • Switzerland
      • Turkey
      • United Arab Emirates
      • United Kingdom

This research report offers invaluable insights into various crucial aspects of the Immunoassay Market:

  1. Market Penetration: This section thoroughly overviews the current market landscape, incorporating detailed data from key industry players.
  2. Market Development: The report examines potential growth prospects in emerging markets and assesses expansion opportunities in mature segments.
  3. Market Diversification: This includes detailed information on recent product launches, untapped geographic regions, recent industry developments, and strategic investments.
  4. Competitive Assessment & Intelligence: An in-depth analysis of the competitive landscape is conducted, covering market share, strategic approaches, product range, certifications, regulatory approvals, patent analysis, technology developments, and advancements in the manufacturing capabilities of leading market players.
  5. Product Development & Innovation: This section offers insights into upcoming technologies, research and development efforts, and notable advancements in product innovation.

Additionally, the report addresses key questions to assist stakeholders in making informed decisions:

  1. What is the current market size and projected growth?
  2. Which products, segments, applications, and regions offer promising investment opportunities?
  3. What are the prevailing technology trends and regulatory frameworks?
  4. What is the market share and positioning of the leading vendors?
  5. What revenue sources and strategic opportunities do vendors in the market consider when deciding to enter or exit?

Table of Contents
  1. Preface
  2. Research Methodology
  3. Executive Summary
  4. Market Overview
  5. Market Insights
  6. Immunoassay Market, by Product
  7. Immunoassay Market, by Technology
  8. Immunoassay Market, by Specimen
  9. Immunoassay Market, by Indication
  10. Immunoassay Market, by End User
  11. Americas Immunoassay Market
  12. Asia-Pacific Immunoassay Market
  13. Europe, Middle East & Africa Immunoassay Market
  14. Competitive Landscape
  15. Competitive Portfolio
  16. List of Figures [Total: 26]
  17. List of Tables [Total: 568]
  18. List of Companies Mentioned [Total: 45]
Frequently Asked Questions
  1. How big is the Immunoassay Market?
    Ans. The Global Immunoassay Market size was estimated at USD 26.30 billion in 2023 and expected to reach USD 28.29 billion in 2024.
  2. What is the Immunoassay Market growth?
    Ans. The Global Immunoassay Market to grow USD 42.90 billion by 2030, at a CAGR of 7.24%
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