USD 35.8 billion
Immunoassay Market Size, Share, and Growth Analysis
Immunoassay Market By Product (Reagents & Kits, Analyzers), By Technology (ELISA, Chemiluminescence Immunoassay (CLIA)), By Specimen (Blood, Saliva), By Application (Infectious Diseases, Endocrinology), By End User, By Region - Industry Forecast 2025-2032
Report ID:
SQMIG35H2054 |
Region:
Global |
Published Date: September, 2024
Pages:
242
|Tables:
164
|Figures:
78
Format -
Immunoassay Market Insights
Immunoassay Market size was valued at USD 35.8 billion in 2023 and is poised to grow from USD 38.06 billion in 2024 to USD 62.04 billion by 2032, growing at a CAGR of 6.3% during the forecast period (2025-2032).
As the name suggests, immunoassay is engaged in the detection of lipids, proteins, small molecules, and nucleic acids that are used to diagnose or aid in planning treatments for patients. The global immunoassay market is witnessing significant growth impacted by growing technological advancements, rising demand for diagnostic testing, and expanding applications in environmental testing, clinical diagnostics, and biopharmaceuticals. Nonetheless, the market is hampered by the variability of assays and the growing complexity and significantly priced development of immunoassays. Developing novel immunoassays is expensive and needs major investment, thus negatively impacting the market. A few opportunities witnessed in the market include the rising demand for personalized medicine that increases the use of immunoassays and increasing funding for research by private and public entities.
US Immunoassay Market is poised to grow at a sustainable CAGR for the next forecast year.
Market snapshot - 2025-2032
Global Market Size
Largest Segment
Hospitals & Clinics
Fastest Growth
Clinical Laboratories
Growth Rate
6.3% CAGR
Global Immunoassay Market ($ Bn)
Country Share for North America Region (%)
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Immunoassay Market Segments Analysis
Global Immunoassay Market is segmented by Product, Technology, Specimen, Application, End User and region. Based on Product, the market is segmented into Reagents & Kits and Analyzers. Based on Technology, the market is segmented into ELISA, Chemiluminescence Immunoassay (CLIA), Immunofluorescence assay (IFA), Rapid Tests, ELISpot, Western Blotting and Other Technologies. Based on Specimen, the market is segmented into Blood, Saliva, Urine and Other Specimens. Based on Application, the market is segmented into Infectious Diseases, Endocrinology, Oncology, Bone & Mineral Disorders, Cardiology, Blood Screening, Autoimmune Disorders, Allergy Diagnostics, Toxicology, Newborn Screening and Other Applications. Based on End User, the market is segmented into Hospitals & Clinics, Clinical Laboratories, Pharmaceutical & Biotechnology Companies and CROs, Blood Banks, Research & Academic Laboratories and Home Care Settings. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.
Immunoassay Market Analysis by Technology
Based on technology, the immunoassay market is categorized into ELISA, CLIA, IFA, rapid tests, blotting, ELISPOT, and other technologies. The ELISA segment held a notable share of the market in the previous years and is expected to lead over the forecast period as well owing to its increased preference due to features like versatility, sensitivity, and specificity, which make it ideal for broader applications like hormone testing, safety of food, and disease diagnosis. Its ability to process numerous samples at the same time and user-friendly format is impacting its demand and the segmental growth.
On the other hand, the rapid tests segment is projected to grow considerably over the forecast period owing to its increased use for diagnosing infectious diseases like monitoring diverse health diseases and COVID-19. Their easy usage, capability to offer quick results, and convenience make it a suitable and highly preferred technology, mainly in pharmacies, clinics, and home. This notably impacts the growth of the segment. Rapid tests comprise a key segment of the immunoassays market. They are specially designed for on-site, quick results, mostly within minutes, increasing their preference in POC applications.
Immunoassay Market Analysis by End User
Based on end user, the market is segmented into hospitals & clinics, clinical laboratories, pharmaceutical & biotechnology companies, and contract research organizations, home care settings, blood banks, and research & academic laboratories. The hospitals & clinics segment held a notable market share in the previous years and is expected to continue dominance over the forecast period as well owing to its increased demand for diagnostics, high-tech infrastructure, and POC testing. Hospitals and clinics need a broader range of tests to aid better patient care, impacting and increasing the demand for immunoassays. These facilities offer well-trained professionals and require equipment to conduct different immunoassays, improving their efficacy in clinics. Also, increasing demand for POC testing in hospitals enables rapid tests, thus impacting the demand for immunoassay technologies.
On the other hand, the clinical laboratories segment will hold a notable market share in the forthcoming years owing to high volume tests, access to improved technologies, and better quality control and standardization. Clinical labs manage a high volume of diagnostic tests on a daily basis, increasing their importance and leading adopters of immunoassay solutions. These laboratories are well-equipped with high-tech instruments and technology, allowing the use of diverse immunoassays technologies like CLIA and ELISA. These labs emphasize quality control and standardized procedures, boosting the segment growth.
Global Immunoassay Market Size By End User
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Immunoassay Market Regional Insights
Geographically, North America dominated the immunoassay market in the previous years and is expected to lead over the forecast period owing to the presence of improved healthcare infrastructure, increasing investment for research and development, and supportive regulations for the use of immunoassay. North America brags its well-developed healthcare infrastructure with cutting-edge diagnostic and laboratories facilities, which simplifies the broader use of the said technology. Major R&D funding from private and government sectors encourages modernizations in diagnostic methods. Moreover, simplified approval process and supportive regulatory environments allow speedy market entry of novel solutions. The key players profiled in the region include Abbott Laboratories, Danaher Corporation, Revvity, Bio-Rad Laboratories, Inc., Agilent Technologies, Inc., QuidelOrtho Corporation, and more.
Asia-Pacific is the fastest-growing region in the global immunoassay market due to rising healthcare investments, growing cases of chronic diseases, and expanding diagnostic capabilities. Rising investments in healthcare technology and infrastructure from both private sector and governments increases the availability of improved diagnostic technologies. The rising cases of infectious diseases and chronic illnesses are boosting the demand for reliable diagnostic solutions like immunoassay. Several nations in the region are enhancing their diagnostic capabilities, resulting in increased adoption of the said technology in clinics and hospitals.
Global Immunoassay Market Size By Geography
- Largest
- Fastest
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Immunoassay Market Dynamics
Immunoassay Market Driver
Heavy Funding for Healthcare Research
- Mounting funding from organizations and governments for healthcare development and research is encouraging the emergence and progress of superior immunoassay solutions. Moreover, rising investments from private sectors in therapeutic research and diagnostic research is fueling the demand and improvements in immunoassay solutions. Hence, private investments and supportive government initiatives are driving the immunoassay market.
Growing Adoption and Awareness for Preventive Healthcare
- Growing health awareness and screening programs are majorly driving the growth of the immunoassay market. Rising awareness among a large population regarding measures of preventive healthcare is significantly demanding diagnostic capabilities like immunoassay. Moreover, supportive initiatives for early disease detection like community screening are increasing the demand and adoption of immunoassay.
Immunoassay Market Restraints
Low Awareness in Developing Regions
- In a few developing markets, insufficient infrastructure of healthcare and low awareness of immunoassay techniques is remarkably negatively affecting the growth of the immunoassay market. Also, the growing need for education and training may be challenging and expensive. Lack of trained professionals understanding results and operating of immunoassays may restrict the adoption and demand of immunoassay technologies.
Dependency on Certain Reagents and Instruments
- Several immunoassays need particular instruments, which could restrict the flexibility and spur the cost for labs. This might notably hinder the growth of the immunoassay market. Also, disturbances in the supply chain for key components and reagents may negatively impact the reliability and availability of these tests, thus hampering market growth.
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Immunoassay Market Competitive Landscape
The global immunoassay market is impacted by improvements in technologies like incorporation of automation technologies. The market vendors operating, including Abbott Laboratories, Thermo Fisher Scientific Inc., Becton, Dickinson and Company, Siemens Healthineers AG are increasingly adopting strategies like new product development, launches, and advancements in technologies for providing better solutions to cure chronic illnesses and infectious diseases effectively. Other market players like BioMérieux, Qiagen N.V., and Sysmex Corporation are integrating AI in the development of assays, shaping competitive strategies.
Top Players in Immunoassay Market
- Abbott Laboratories (USA)
- F. Hoffmann-La Roche AG (Switzerland)
- Thermo Fisher Scientific Inc. (USA)
- Siemens Healthineers AG (Germany)
- Danaher Corporation (USA)
- Becton, Dickinson and Company (BD) (USA)
- Bio-Rad Laboratories, Inc. (USA)
- QIAGEN N.V. (Germany/Netherlands)
- Sysmex Corporation (Japan)
- Merck KGaA (Germany)
- DiaSorin S.p.A. (Italy)
- bioMérieux SA (France)
- QuidelOrtho Corporation (USA)
- Agilent Technologies, Inc. (USA)
- Hologic Inc. (USA)
- PerkinElmer, Inc. (USA)
- Luminex Corporation (USA)
- Autobio Diagnostics Co., Ltd. (China)
- Beckman Coulter, Inc. (USA)
- Randox Laboratories (UK)
Immunoassay Market Recent Developments
- In July 2024, Abbott presented its product line of Alinity ci-series, which are incorporated with immunoassay systems and clinical chemistry. They offer strong integration in immunoassays and clinical chemistry. These products can effortlessly scale, amalgamating nearly 4 modules in numerous configurations to cater to any laboratory’s requirements and optimize its operational efficacy.
- In July 2023, Roche Diagnostics India introduces its original dual antibody and antigen diagnostic test, aiding India’s battle against hepatitis C. The company introduced Elecsys® HCV Duo, nation’s first marketable fully automated immunoassays that enable independent and simultaneous determination of HCV antibody and antigen status from sole serum or human plasma sample.
- In March 2024, Siemens Healthineers introduces fresh addition to Siemens Healthineers Atellica product line, named Atellica CI Analyzer that received the U.S. FDA clearance and is currently being marketed in several key markets.
Immunoassay Key Market Trends
- Expanding Applications of Immunoassays: The growth of infections and chronic diseases has propelled the demand of immunoassays for disease monitoring and detection. Immunoassays are actively demanded by the biopharmaceutical industry for therapeutic monitoring and development of drugs. Moreover, the application of immunoassays in environmental monitoring, especially for discovering contaminants is gaining prominence, impacting the growth of the market.
- Technological Improvements in Immunoassays: High-throughput screenings and automation technologies are widely adopted to improve speed and efficiency of immunoassays. Also, there is an increasing inclination towards speedy testing devices, enabling faster results in clinics, mainly in remote areas. The integration of AI and digital technologies is also simplifying data analysis, allowing monitoring in real-time and enhancing accuracy.
Immunoassay Market SkyQuest Analysis
SkyQuest's ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, the Immunoassay market is considerably progressing due to the expanding applications in numerous sectors, growing adoption of preventive healthcare, and growth of home-based tests. However, the market is hampered by the changing regulations, growing competition from alternate diagnostic methods, and legal and ethical considerations. North America is anticipated to lead the market owing to rising incidences of chronic and infectious diseases, high research and development investment, and favorable regulatory policies. Nonetheless, a few opportunities for the growth of the immunoassay market include the integration of telemedicine, growing sustainability initiatives, and the development of combination tests.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 35.8 billion |
| Market size value in 2032 | USD 62.04 billion |
| Growth Rate | 6.3% |
| Base year | 2024 |
| Forecast period | 2025-2032 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Immunoassay Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Immunoassay Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Immunoassay Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Immunoassay Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Immunoassay Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Immunoassay Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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