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Next-Generation ELISA (ELISA 2.0) Market Size is predicted to grow at a 9.6 % CAGR during the forecast period for 2025-2034.
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The next-generation enzyme-linked immunosorbent assay (ELISA) is an advanced modification of the conventional technique intended to overcome its drawbacks in terms of multiplexing, sensitivity, and specificity. These contemporary platforms provide highly accurate and reliable biomolecule analysis by incorporating technologies such as digital detection, single-molecule sensing, and nanomaterials. For instance, paper-based ELISA uses filter paper as a portable, affordable substrate that can be chemically altered, for instance, via periodate oxidation, to improve biomolecule binding.
Traditional chromogenic substrates are being replaced by alternative signal reporters, such as fluorogenic, electrochemiluminescent, and qPCR-based systems, which provide better quantification and detection of low-abundance biomarkers, essential for the early diagnosis of illnesses like cancer, HIV, hepatitis, and neurological disorders. In addition to their clinical uses, extremely sensitive ELISA techniques are useful in disciplines such as conservation and archaeology, where they aid in identifying protein-based components in artifacts and offer insights into cultural heritage analysis and historical preservation.
Due to the growing global burden of infectious and chronic diseases, which is increasing the demand for sensitive and reliable diagnostic assays, the market for next-generation ELISA (ELISA 2.0) is expanding significantly. This expansion is primarily driven by ongoing innovation across a number of technological platforms. Important developments in detection techniques include a shift away from conventional colorimetric assays and toward more quantitative and sensitive alternatives such as electrochemical, fluorescent, and chemiluminescent ELISA. Additionally, cutting-edge formats including digital ELISA for ultra-sensitive, single-molecule detection, automation-integrated ELISA for high-throughput processes, and microfluidic & lab-on-chip ELISA for reducing costs are revolutionizing the market.
The speed, precision, and multiplexing capabilities of examinations are all being improved by these technological advancements. Additionally, ELISA's uses are expanding beyond conventional diagnostics to include research, cell and gene therapy quality control, biopharma quality control, and other fields, which is expanding the market's potential. Additionally, use is fast in developing economies due to improved healthcare infrastructure, making ELISA 2.0 a rapidly expanding segment of the worldwide diagnostics and life sciences sector.
Some of the Major Key Players in the Next-Generation ELISA (ELISA 2.0) Market are
· Cygnus Technologies
· BioGenes GmbH
· Rockland Immunochemicals, Inc.
· Enzo Life Sciences
· Bio-Rad Laboratories, Inc.
· R&D Systems (Bio-Techne)
· Quansys Biosciences
· Meso Scale Discovery (MSD)
· Abcam plc
· Aushon BioSystems
· Luminex Corporation (DiaSorin Group)
· Opus Bio
· Diagnostics For All (DFA)
· MBio Diagnostics (LightDeck Diagnostics)
· InBios International, Inc.
· Greiner Bio-One
· Thermo Fisher Scientific
· BioVision Inc. (Abcam)
· Tecan Group Ltd.
· Hamilton Company
· Dynex Technologies
· Agilent Technologies
· Arbor Assays
· Creative Diagnostics
· Eagle Biosciences, Inc.
· MyBioSource, Inc.
The next-generation ELISA (ELISA 2.0) market is segmented into product type, technology platform, application, and end user. Based on the product type, the market is segmented into kits & reagents, instruments & analyzers, software & services. Based on the technology platform, the market is divided into detection methods, advanced formats. Based on the application, the market is divided into biopharma & QC, diagnostics, research & development, and others. Based on the end-user industry, the market is divided into pharmaceutical & biotechnology companies, cell & gene therapy developers, vaccine manufacturers, academic & research institutes, contract testing laboratories (CROS/CDMOS), hospitals & diagnostic labs.
The next-generation ELISA market is expected to experience the most significant growth rate in the detection method segment, which is primarily driven by its direct contribution to the improvement of critical assay performance metrics. A critical market driver is the segment's transition from fundamental colorimetric detection to the integration of advanced techniques, such as chemiluminescence, fluorescence, and electrochemiluminescence.
These techniques facilitate the quantitative precision and ultra-sensitive detection that are essential for contemporary diagnostic and research applications. Additionally, they are essential to the fundamental benefits of ELISA 2.0, including multiplexing. This feature enables the simultaneous analysis of multiple analytes from a single sample, thereby enhancing efficiency, through the use of fluorogenic and electrochemiluminescent reporters.
Furthermore, the segment's status as the primary driver of market expansion is strengthened further by the inherent compatibility of methods such as chemiluminescence with automated, high-throughput systems, which directly addresses the increasing demand for streamlined workflows in clinical diagnostics and biopharmaceutical development.
The diagnostics segment is a cornerstone of the market, driven by the increasing demand for early, accurate, and cost-effective diagnosis of chronic and infectious diseases, including cancer, HIV, hepatitis, and autoimmune disorders. Next-generation ELISA improves upon traditional ELISA by offering ultra-high sensitivity (e.g., subfemtomolar detection limits), multiplexing capabilities, and compatibility with automated and point-of-care (POC) systems, making it indispensable in clinical diagnostics, personalized medicine, and public health.
The Diagnostics Segment leverages multiplexing capabilities of ELISA 2.0 to simultaneously detect multiple biomarkers in a single sample, reducing sample volume and assay time. This is particularly valuable for profiling complex diseases like cancer or monitoring immune responses in infectious diseases.
North America leads in adopting next-gen technologies like AI-integrated ELISA, nanomaterials for signal amplification, and portable POC devices. This is supported by a robust ecosystem for innovation, including academic and industry partnerships. The region boasts well-established healthcare systems with widespread access to advanced diagnostic tools. High spending on cancer research and in vitro diagnostics (IVD) supports the integration of ELISA 2.0 into clinical workflows.
Pharmaceutical companies in North America emphasize R&D for personalized medicine and biomarker-driven therapies, increasing demand for ultra-sensitive ELISA platforms. However, Tecan Group (with North American operations) acquired Cisbio Bioassays' ELISA kit assets in April 2025, strengthening specialty diagnostics for neuroendocrine tumors and expanding high-sensitivity chemiluminescent assays in the region.
· In April 2023, Thermo Fisher Scientific Inc. introduced a platform for next-generation ELISA kits that are intended to provide faster and more sensitive findings for clinical and research purposes. With their sophisticated signal detecting methods, these kits shorten test durations and increase repeatability for a variety of biomarker investigations. This development underscores Thermo Fisher's strategy goal of increasing diagnostic efficiency and accuracy in labs across the globe.
· In March 2023, Bio-Techne Corporation declared the integration of its automated ELISA product line with the Simple Plex platform, under the Ella brand. This advancement satisfies the increasing need for precision diagnostics in neurology, inflammation, and oncology by providing high-throughput, completely automated solutions for immunoassay operations. The business is well-positioned in the cutthroat ELISA industry due to its dedication to lab automation and streamlined processes.
· In November 2022, Rockland collaborated with Cytiva Life Sciences to introduced the PrismA ELISA kit for the production of monoclonal antibodies. This kit facilitates high-throughput screening and improves the detection of Protein A contaminants, a crucial stage in bioprocessing. When employing Fibro™ PrismA chromatography adsorbers and MabSelect PrismA™ chromatography resin, the PrismA ELISA kit is an enzyme-linked immunosorbent test that measures residual ligand leakage. The kit is utilized in the creation and production of biopharmaceuticals containing monoclonal antibodies (mAb).
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Report Attribute |
Specifications |
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Growth Rate CAGR |
CAGR of 9.6% from 2025 to 2034 |
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Quantitative Units |
Representation of revenue in US$ Mn and CAGR from 2025 to 2034 |
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Historic Year |
2021 to 2024 |
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Forecast Year |
2025-2034 |
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Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
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Segments Covered |
By Product Type, Technology Platform, Application, End User |
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Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
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Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; The UK; France; Italy; Spain; China; Japan; India; South Korea; Southeast Asia; South Korea; South East Asia |
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Competitive Landscape |
Cygnus Technologies, BioGenes GmbH, Rockland Immunochemicals, Inc, Enzo Life Sciences, Bio-Rad Laboratories, Inc, R&D Systems (Bio-Techne), Quansys Biosciences, Meso Scale Discovery (MSD), Abcam plc, Aushon BioSystems, Luminex Corporation (DiaSorin Group), Opus Bio, Diagnostics For All (DFA), MBio Diagnostics (LightDeck Diagnostics), InBios International, Inc, Greiner Bio-One, Thermo Fisher Scientific, BioVision Inc. (Abcam), Tecan Group Ltd, Hamilton Company, Dynex Technologies, Agilent Technologies, Arbor Assays, Creative Diagnostics, Eagle Biosciences, Inc, MyBioSource, Inc. |
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Customization Scope |
Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape. |
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Pricing and Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
Chapter 2. Executive Summary
Chapter 3. Global Next-Generation ELISA (ELISA 2.0) Market Snapshot
Chapter 4. Global Next-Generation ELISA (ELISA 2.0) Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Porter's Five Forces Analysis
4.7. Incremental Opportunity Analysis (US$ MN), 2024-2034
4.8. Competitive Landscape & Market Share Analysis, By Key Player (2023)
4.9. Use/impact of AI on Next-Generation ELISA (ELISA 2.0) Market Industry Trends
4.10. Global Next-Generation ELISA (ELISA 2.0) Market Penetration & Growth Prospect Mapping (US$ Mn), 2021-2034
Chapter 5. Next-Generation ELISA (ELISA 2.0) Market Segmentation 1: By Product Type, Estimates & Trend Analysis
5.1. Market Share by Product Type, 2024 & 2034
5.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following Product Type:
5.2.1. Kits & Reagents
5.2.1.1. Multiplex ELISA Kits
5.2.1.2. Platform-Specific HCP ELISA Kits
5.2.1.3. Digital/Smart ELISA Kits
5.2.1.4. Point-of-Care (POC) ELISA Kits
5.2.1.5. Eco-Friendly ELISA Kits
5.2.1.6. Others
5.2.2. Instruments & Analyzers
5.2.3. Software & Services
Chapter 6. Next-Generation ELISA (ELISA 2.0) Market Segmentation 2: By Technology Platform, Estimates & Trend Analysis
6.1. Market Share by Technology Platform, 2024 & 2034
6.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following Technology Platform:
6.2.1. Detection Method
6.2.1.1. Colorimetric ELISA
6.2.1.2. Chemiluminescent ELISA
6.2.1.3. Fluorescent ELISA
6.2.1.4. Electrochemical ELISA
6.2.2. Advanced Formats
6.2.2.1. Microfluidic & Lab-on-Chip ELISA
6.2.2.2. Automation-Integrated ELISA
6.2.2.3. Digital ELISA
6.2.2.4. Others
Chapter 7. Next-Generation ELISA (ELISA 2.0) Market Segmentation 3: By Application, Estimates & Trend Analysis
7.1. Market Share by Application, 2024 & 2034
7.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following Application:
7.2.1. Biopharma & QC
7.2.1.1. Bioprocess Impurity Testing
7.2.1.2. Cell & Gene Therapy QC
7.2.2. Diagnostics
7.2.3. Research & Development
7.2.4. Others
Chapter 8. Next-Generation ELISA (ELISA 2.0) Market Segmentation 4: By End User, Estimates & Trend Analysis
8.1. Market Share by End User, 2024 & 2034
8.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following End User:
8.2.1. Pharmaceutical & Biotechnology Companies
8.2.2. Cell & Gene Therapy Developers
8.2.3. Vaccine Manufacturers
8.2.4. Academic & Research Institutes
8.2.5. Contract Testing Laboratories (CROs/CDMOs)
8.2.6. Hospitals & Diagnostic Labs
Chapter 9. Next-Generation ELISA (ELISA 2.0) Market Segmentation 5: Regional Estimates & Trend Analysis
9.1. Global Next-Generation ELISA (ELISA 2.0) Market, Regional Snapshot 2024 & 2034
9.2. North America
9.2.1. North America Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
9.2.1.1. US
9.2.1.2. Canada
9.2.2. North America Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Product Type, 2021-2034
9.2.3. North America Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Technology Platform, 2021-2034
9.2.4. North America Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
9.2.5. North America Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
9.3. Europe
9.3.1. Europe Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
9.3.1.1. Germany
9.3.1.2. U.K.
9.3.1.3. France
9.3.1.4. Italy
9.3.1.5. Spain
9.3.1.6. Rest of Europe
9.3.2. Europe Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Product Type, 2021-2034
9.3.3. Europe Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Technology Platform, 2021-2034
9.3.4. Europe Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
9.3.5. Europe Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
9.4. Asia Pacific
9.4.1. Asia Pacific Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
9.4.1.1. India
9.4.1.2. China
9.4.1.3. Japan
9.4.1.4. Australia
9.4.1.5. South Korea
9.4.1.6. Hong Kong
9.4.1.7. Southeast Asia
9.4.1.8. Rest of Asia Pacific
9.4.2. Asia Pacific Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Product Type, 2021-2034
9.4.3. Asia Pacific Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Technology Platform, 2021-2034
9.4.4. Asia Pacific Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
9.4.5. Asia Pacific Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
9.5. Latin America
9.5.1. Latin America Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
9.5.1.1. Brazil
9.5.1.2. Mexico
9.5.1.3. Rest of Latin America
9.5.2. Latin America Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Product Type, 2021-2034
9.5.3. Latin America Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Technology Platform, 2021-2034
9.5.4. Latin America Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
9.5.5. Latin America Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
9.6. Middle East & Africa
9.6.1. Middle East & Africa Wind Turbine Rotor Blade Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
9.6.1.1. GCC Countries
9.6.1.2. Israel
9.6.1.3. South Africa
9.6.1.4. Rest of Middle East and Africa
9.6.2. Middle East & Africa Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Product Type, 2021-2034
9.6.3. Middle East & Africa Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Technology Platform, 2021-2034
9.6.4. Middle East & Africa Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
9.6.5. Middle East & Africa Next-Generation ELISA (ELISA 2.0) Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
Chapter 10. Competitive Landscape
10.1. Major Mergers and Acquisitions/Strategic Alliances
10.2. Company Profiles
10.2.1. Cygnus Technologies
10.2.1.1. Business Overview
10.2.1.2. Key Product Type/Service Overview
10.2.1.3. Financial Performance
10.2.1.4. Geographical Presence
10.2.1.5. Recent Developments with Business Strategy
10.2.2. BioGenes GmbH
10.2.3. Rockland Immunochemicals, Inc.
10.2.4. Enzo Life Sciences
10.2.5. Bio-Rad Laboratories, Inc.
10.2.6. R&D Systems (Bio-Techne)
10.2.7. Quansys Biosciences
10.2.8. Meso Scale Discovery (MSD)
10.2.9. Abcam plc
10.2.10. Aushon BioSystems
10.2.11. Luminex Corporation (DiaSorin Group)
10.2.12. Opus Bio
10.2.13. Diagnostics For All (DFA)
10.2.14. MBio Diagnostics (LightDeck Diagnostics)
10.2.15. InBios International, Inc.
10.2.16. Greiner Bio-One
10.2.17. Thermo Fisher Scientific
10.2.18. BioVision Inc. (Abcam)
10.2.19. Tecan Group Ltd.
10.2.20. Hamilton Company
10.2.21. Dynex Technologies
10.2.22. Agilent Technologies
10.2.23. Arbor Assays
10.2.24. Creative Diagnostics
10.2.25. Eagle Biosciences, Inc.
10.2.26. MyBioSource, Inc.
Global Next-Generation ELISA (ELISA 2.0) Market- By Product Type
· Kits & Reagents
o Multiplex ELISA Kits
o Platform-Specific HCP ELISA Kits
o Digital/Smart ELISA Kits
o Point-of-Care (POC) ELISA Kits
o Eco-Friendly ELISA Kits
o Others (4th generation ELISA test, etc)
· Instruments & Analyzers
· Software & Services
-Market-seg.webp "Next-Generation ELISA (ELISA 2.0) Market seg")
· Detection Method
o Colorimetric ELISA
o Chemiluminescent ELISA
o Fluorescent ELISA
o Electrochemical ELISA
· Advanced Formats
o Microfluidic & Lab-on-Chip ELISA
o Automation-Integrated ELISA
o Digital ELISA
o Others
Global Next-Generation ELISA (ELISA 2.0) Market – By Application
· Biopharma & QC
o Bioprocess Impurity Testing
o Cell & Gene Therapy QC
· Diagnostics
· Research & Development
· Others (e.g., Transplantation, Immunology)
Global Next-Generation ELISA (ELISA 2.0) Market- By End User
· Pharmaceutical & Biotechnology Companies
· Cell & Gene Therapy Developers
· Vaccine Manufacturers
· Academic & Research Institutes
· Contract Testing Laboratories (CROs/CDMOs)
· Hospitals & Diagnostic Labs
Global Next-Generation ELISA (ELISA 2.0) Market – By Region
North America-
· The US
· Canada
Europe-
· Germany
· The UK
· France
· Italy
· Spain
· Rest of Europe
Asia-Pacific-
· China
· Japan
· India
· South Korea
· Southeast Asia
· Rest of Asia Pacific
Latin America-
· Brazil
· Argentina
· Mexico
· Rest of Latin America
Middle East & Africa-
· GCC Countries
· South Africa
· Rest of the Middle East and Africa
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
To know more about the research methodology used for this study, kindly contact us/click here.
