Immunoassay Market by Product, Technology, Specimen, Indication, End User

List of Tables

[194 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.

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.

KEY MARKET STATISTICS
Base Year [2023]	USD 26.30 billion
Estimated Year [2024]	USD 28.29 billion
Forecast Year [2030]	USD 42.90 billion
CAGR (%)	7.24%

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.

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.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Immunoassay Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis 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: 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 examination of the current state of vendors in the Immunoassay Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. 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 this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

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., bioMerieux 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, Nanomix, 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..

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

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Immunoassay Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Immunoassay Market?

3. What are the technology trends and regulatory frameworks in the Immunoassay Market?

4. What is the market share of the leading vendors in the Immunoassay Market?

5. Which modes and strategic moves are suitable for entering the Immunoassay Market?

Product Code: MRR-43127F7279BC

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Rising chronic and infectious diseases and benefits of early diagnosis
  - 5.1.1.2. Growing usage of immunoassay in the food & beverage sector
  - 5.1.1.3. Emerging application of multiplex detection immunoassay technique in drug development
- 5.1.2. Restraints
  - 5.1.2.1. Cross-reactivity issues associated with immunoassay
- 5.1.3. Opportunities
  - 5.1.3.1. Technological advancements in the number of automated instruments and equipment associated with immunoassay
  - 5.1.3.2. High potential of immunoassay in environment monitoring
- 5.1.4. Challenges
  - 5.1.4.1. Issues with assay validation due to variations in sample quality and reagent performance
5.2. Market Segmentation Analysis
- 5.2.1. Product: Development of novel immunoassay kits for diagnostics of infectious and autoimmune diseases
- 5.2.2. Technology: Utilization of enzyme-linked immunosorbent assay technology for food allergies and drugs of abuse treatment
- 5.2.3. Specimen: Emergence of saliva diagnostics due to its non-invasive collection methods
- 5.2.4. Indication: Optimization within immunoassay technologies to cater growing need across infectious disease
- 5.2.5. End User: Rising demand for immunoassay across emergency care, intensive care units, and outpatient clinics
5.3. Market Trend Analysis
- 5.3.1. Introduction of novel sustainable immunoassays with government funding to scale up of immunoassays in the Americas
- 5.3.2. Prevalence of infectious and autoimmune diseases, and rising need for efficient healthcare solution in the Asia-Pacific region
- 5.3.3. Increasing support by government to expand adoption of immunoassay coupled with strong presence of healthcare companies in EMEA region
5.4. Cumulative Impact of High Inflation
5.5. Porter's Five Forces Analysis
- 5.5.1. Threat of New Entrants
- 5.5.2. Threat of Substitutes
- 5.5.3. Bargaining Power of Customers
- 5.5.4. Bargaining Power of Suppliers
- 5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework Analysis

6. Immunoassay Market, by Product

6.1. Introduction
6.2. Analyzer
6.3. Consumables

7. Immunoassay Market, by Technology

7.1. Introduction
7.2. Chemiluminescence Immunoassay
7.3. Enzyme-linked Immunosorbent Assay
7.4. Fluoroimmunoassay
7.5. Radioimmunoassay
7.6. Rapid Diagnostic Tests (RDTs)/Lateral Flow Immunoassay

8. Immunoassay Market, by Specimen

8.1. Introduction
8.2. Blood
8.3. Saliva
8.4. Urine

9. Immunoassay Market, by Indication

9.1. Introduction
9.2. Cardiology
9.3. Endocrinology
9.4. Infectious Disease
9.5. Oncology
9.6. Orthopedics

10. Immunoassay Market, by End User

10.1. Introduction
10.2. Blood Banks
10.3. Diagnostics Laboratories
10.4. Food & Beverage Companies
10.5. Hospitals
10.6. Pharmaceutical Companies & CROs
10.7. Research & Academic Laboratories

11. Americas Immunoassay Market

11.1. Introduction
11.2. Argentina
11.3. Brazil
11.4. Canada
11.5. Mexico
11.6. United States

12. Asia-Pacific Immunoassay Market

12.1. Introduction
12.2. Australia
12.3. China
12.4. India
12.5. Indonesia
12.6. Japan
12.7. Malaysia
12.8. Philippines
12.9. Singapore
12.10. South Korea
12.11. Taiwan
12.12. Thailand
12.13. Vietnam

13. Europe, Middle East & Africa Immunoassay Market

13.1. Introduction
13.2. Denmark
13.3. Egypt
13.4. Finland
13.5. France
13.6. Germany
13.7. Israel
13.8. Italy
13.9. Netherlands
13.10. Nigeria
13.11. Norway
13.12. Poland
13.13. Qatar
13.14. Russia
13.15. Saudi Arabia
13.16. South Africa
13.17. Spain
13.18. Sweden
13.19. Switzerland
13.20. Turkey
13.21. United Arab Emirates
13.22. United Kingdom

14. Competitive Landscape

14.1. Market Share Analysis, 2023
14.2. FPNV Positioning Matrix, 2023
14.3. Competitive Scenario Analysis
- 14.3.1. Thermo Fisher to Acquire Olink for USD 3.1 billion, Expanding Proteomics Presence
- 14.3.2. Fujirebio and Sysmex to Collaborate On Development of Unique Immunoassays
- 14.3.3. Mindray Has Agreed to Acquire 75% Stake in Germany-Based DiaSys Diagnostic Systems GmbH
- 14.3.4. CVC Fund "Shimadzu Future Innovation Fund" has Invested in IMMUNOSENS Co., Ltd., Developing Immunoassay Technology.
- 14.3.5. Fapon Rolls Out New Chemiluminescence Immunoassay System
- 14.3.6. Beckman Coulter's DxI 9000 Immunoassay Analyzer with Increased Assay Development Sensitivity Makes First North American Appearance at 2023 AACC
- 14.3.7. Beckman Coulter and Fujirebio Partner to Bolster Access to Patient-friendly, Blood-based Alzheimer's Disease Test
- 14.3.8. MakatiMed First PH and ASEAN Hospital to Acquire Atellica VTLi Patient-Side Immunoassay Analyzer
- 14.3.9. QuidelOrtho Receives De Novo FDA Authorization for Sofia 2 SARS Antigen+ FIA
- 14.3.10. SGS Offers Enhanced Automated Immunoassay Testing at Poitiers Laboratory
- 14.3.11. Siemens launches Centre of Excellence for Immunoassay Instrument R&D

15. Competitive Portfolio

15.1. Key Company Profiles
15.2. Key Product Portfolio