The immunodiagnostics market was valued at USD 21.66 Billion in 2025 and is expected to grow at a CAGR of 8.70%, reaching USD 49.88 Billion by 2035. The market growth is driven by rising prevalence of infectious and autoimmune diseases, technological advancements in assay development, and growing adoption of point-of-care testing.
Base Year
Historical Period
Forecast Period
Infectious diseases, respiratory infections, HIV, and cancer, among others, have become widely prevalent. Early diagnostics can significantly improve patient outcomes, thereby increasing the demand for the immunodiagnostics and fuelling the market growth.
Advancements in the assays, diagnostic kits, modules, and analyzers is expected to impact the market value positively.
Beyond clinical uses, additional applications of immunodiagnostics in areas such as forensic science, food analysis, and environmental analysis are expected to be an emerging trend in the market, that would help in examining parasite and pathogen presence.
Compound Annual Growth Rate
8.7%
Value in USD Billion
2026-2035
*this image is indicative*
Immunodiagnostics is a novel in-vitro diagnostic technique that focuses on the reaction between antigens and antibodies for diagnosing infections and chronic conditions. It involves the application of a variety of methods, including radiological, fluorescent, color-forming enzymes, and probes. This innovative approach facilitates the detection of specific antibodies related to diseases, widening the possibilities of disease analysis and diagnosis. Immunodiagnostics employs various reagents, instruments, and software solutions. Some of the tools used are enzyme linked immunosorbent assay (ELISA), chemiluminescence immunoassays (CLIA), as well as rapid tests including radioimmunoassay (RIA), and rapid testing. Its uses are widespread within numerous branches of medicine, such as oncology, immunology, pulmonology, endocrinology, oncology, forensic psychology, and the analysis of environmental and food samples. Essentially a crucial utility for medical practitioners, immunodiagnostics is widely used in healthcare centers, hospitals, labs, and research and academic institutions, which require precise diagnosis and rapid disease detection.
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Increasing Prevalence of Chronic and Infectious Diseases
The increase in the number of patients suffering from serious conditions such as cancer, autoimmune disorders, and infections is the primary reason behind the growing demand for immunodiagnostics. Due to these conditions, it has become essential to have accurate diagnosis measures that will not only quickly identify these conditions but also monitor the patients progressively to ensure better results and halt the advancement of the diseases. Serological tests, therefore, act as crucial diagnostic tools in identifying specific markers that are associated with these diseases to enable healthcare practitioners make conclusive diagnoses and subsequent treatment at the right time. Hence, the growing global incidence of diseases points to the centrality of immunodiagnostics in modern medical practice and fosters market growth for immunodiagnostic products.
Technological Advancements in Immunoassay Techniques
CLIA and ELISA have spotted tremendous growth in immunodiagnostics research because of the relative enhancements in assay technologies over time. These advances have indeed changed the way in which diagnostic tests are performed and offer high sensitivity, specificity, and effectiveness in detecting diseases. Highly sensitive biomarkers can also be identified by these advanced tools. Therefore, it becomes easier to diagnose diseases at an earlier stage and continuously monitor the stages of the disease. Moreover, computers and the application of the internet in the analytic field have made work more efficient by cutting down on the time it takes to carry out tests. The improved performances and dependability of present-day immunoassay procedures contribute to their increased popularity and development in the immunodiagnostics industry.
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Several trends and developments are being observed in the market to enhance the current situation. Some of the noteworthy trends are as follows:
Immunodiagnostics Market Report and Forecast 2026-2035 offers a detailed analysis of the market based on the following segments:
Market Breakup by Product Type
Market Breakup by Technology
Market Breakup by Application
Market Breakup by End User
Market Breakup by Region
Market Segmentation Based on Product Types Poised for Growth
In terms of market breakup based on product types, the report offers an insight into reagents and kits, consumables, instruments, software, and services. Reagents and consumables dominate the overall market. This is because there has been tremendous development of new reagents over time to cater the increasing demand in immunoassay tests. Consumable items are products that are constantly being used and must be replaced periodically, leading to recurrent demand. In addition, there is a rise in immunodiagnostic tests and the globalization of reagents, especially in chemiluminescence and fluorescence assays, which contributes to market growth. On the other hand, the software, and services subsegment comes out as the most promising one, due to increased applications of digital solutions in immunodiagnostic platforms. This growth trajectory is driven by the need for efficient management of data, an increase in workflow, and the health improvement and care of patients, especially within the healthcare sector.
Market Breakup by Applications Set to Drive Market Growth
In market segmentation by type of application, there is a range of segments including infectious diseases, drug monitoring, oncology and endocrinology, bone and mineral diseases, cardiac biomarkers, autoimmune diseases, and others. The oncology domain stands out as the overall fastest-growing segment, as immunodiagnostics has become essential for diverse roles, such as screening, diagnosis, prognosis, and managing responses to cancer treatments. The incorporation of immunodiagnostics into oncological settings suggests a rapidly expanding market for the oncology segment in the forecast period.
The regional analysis offers an insight on North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa. Immunodiagnostics in the Asia Pacific are anticipated to have the highest demand, owing to the increased prevalence rate of infectious diseases in the region. Constant efforts to prevent and control the spread of infections has led to introduction of new products on the market. Other factors that are likely to propel market growth include growing emphasis on healthcare expenditure and increased consciousness among patients. North America is expected to hold a significant market share, driven by advanced healthcare infrastructure and healthcare spending.
The key features of the market report include strategic initiatives made patent analysis, and strategic initiatives including funding and investment analysis, partnerships, and collaborations analysis by the leading players. The major companies in the market are as follows:
Abbott Laboratories is an American multinational corporation that deals in health care and medical devices. It was founded in 1888 in Illinois, United States. It creates devices that can be useful for individuals to monitor their health conditions as well as their daily habits.
ARKRAY Inc., was established in 1960 and is located in Kyoto, Japan. It is a healthcare agency that produces clinical diagnostic equipment that can be used in urine testing, diabetes, and other related diseases. They have manufactured new products, devices, and gadgets that are easy to use and function in a simple manner.
DiaSorin S.p.A., headquartered in Italy specializes in the manufacturing of diagnostic systems for infectious diseases. It was established in 2000 and boasts a wide range of diagnostic reagents, including molecular and immunological diagnostic reagent kits.
The company was founded in 1886 and has a strong range of immunodiagnostics products. It possesses ID NOWTM, Deep GeneXpert® Systems to detect infectious diseases, tuberculosis, respiratory tract infections, malaria, and herpes simplex virus. The company also boasts CELLSEARCH® System which targets cancer patients to identify circulating tumor cells.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other companies in the market include Biotest AG, Immunodiagnostic Systems Holdings plc, F. Hoffmann-La Roche Ltd, Siemens AG, Sysmex Corporation, Danaher Corporation, Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., PerkinElmer Inc., and Shenzhen Mindray Bio-Medical Electronics Co Ltd.
Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Product Type |
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| Breakup by Technology |
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| Breakup by Application |
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| Breakup by End User |
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| Breakup by Region |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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