Immunoassay Market by Product (Reagents & Kits, Analyzers), Technology (ELISA, CLIA, Western Blot), Specimen (Blood, Saliva, Urine), Application (Infectious Diseases, Endocrinology), End User (Hospitals & Clinics, Laboratories) - Global Forecast to 2030

The global immunoassay market is valued at an estimated USD 35.5 billion in 2025 and is projected to reach USD 47.7 billion by 2030, at a CAGR of 6.1% during the forecast period. Key factors driving this growth include the increasing rates of chronic and infectious diseases, continuous technological progress in immunoassay systems, supportive government policies, and a growing emphasis on drug and alcohol testing due to strict regulations.

“The reagents & kits accounted for the largest share of the immunoassay products market.”

On the basis of products, the global immunoassay market is segmented into reagents & kits and analyzers. Reagents & kits represent the most substantial segment in the diagnostic market, primarily due to their frequent application in a wide array of diagnostic assays. The ongoing demand for these consumables is fueled by the increasing global incidence of immunoassay procedures. Furthermore, the introduction of high-performance reagents and kits, which enhance diagnostic precision and operational efficiency, has facilitated their broader adoption and subsequently spurred growth within this sector.

“The chemiluminescence Immunoassay (CLIA) segment is projected to grow at a considerable rate in the immunoassay technology segment during the forecast period.”

The immunoassay market is categorized by technology into ELISA, chemiluminescence immunoassay (CLIA), immunofluorescence assay (IFA), rapid tests, ELISpot, western blotting, and other methods. The CLIA (Chemiluminescent Immunoassays) segment is forecasted to experience substantial growth, largely due to its advanced diagnostic capabilities applicable to both chronic and infectious diseases. When contrasted with conventional methods like ELISA (Enzyme-Linked Immunosorbent Assay) and radioimmunoassays, CLIA demonstrates superior sensitivity, an extended dynamic range, expedited turnaround times, minimized background interference, and enhanced specificity. These attributes make CLIA the preferred choice for clinical diagnostics, particularly in situations demanding high accuracy and reliability.

“Infectious diseases held the largest share of the immunoassay applications market.”

The global immunoassay market is categorized by application into infectious diseases, cardiology, endocrinology, oncology, bone & mineral disorders, autoimmune disorders, blood screening, allergy diagnostics, drug monitoring & testing, newborn screening, and other applicatons. In 2022, the market for diagnostic testing was predominantly influenced by infectious diseases, largely due to the increasing incidence of conditions like HIV/AIDS, hepatitis, malaria, and influenza. The utilization of immunoassays has played a critical role in this trend, as these tests facilitate rapid and precise diagnoses, thereby enhancing the management of global infectious disease outbreaks.

“Asia Pacific is expected to be the fastest-growing region in the immunoassay market.”

The immunoassay market is regionally segmented into North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. The Asia Pacific region is anticipated to experience the most significant growth during the forecast period. This rapid expansion can be attributed to several interrelated factors: a substantial and expanding patient demographic, an escalating prevalence of chronic diseases, heightened awareness of the importance of early disease detection, and continuous enhancements in healthcare infrastructure in nations such as China, India, and various Southeast Asian countries.

The break-up of the profile of primary participants in the immunoassay market:

• By Respondent: Tier 1-25%, Tier 2-35%, and Tier 3- 40%
• By Designation: CXOs and Directors- 30%, Managers- 45%, and Executives- 25%
• By Region: North America -35%, Europe - 25%, Asia Pacific -15%, Latin America -10%, Middle East- 10%, and Africa- 5%

The key players in this market are Abbott (US), F. Hoffmann-La Roche Ltd. (Switzerland), Siemens Healthineers AG (Germany), Danaher (US), Thermo Fisher Scientific Inc. (US), Revvity (US), Becton, Dickinson and Company (BD) (US), DiaSorin S.p.A (Italy), Bio-Rad Laboratories, Inc. (US), QuidelOrtho Corporation (US), bioMérieux (France), QIAGEN (Germany), Sysmex Corporation (Japan), Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (China), Agilent Technologies, Inc. (US), Merck KGaA (Germany), Meridian Bioscience (US), Bio-Techne (US), Cellabs (Australia), Abnova Corporation (Taiwan), J. Mitra & Co. Pvt. Ltd. (India), Tosoh Corporation (Japan), Cell Sciences (US), Enzo Biochem (US), Creative Diagnostics (US), Boster Biological Technology (US), Elabscience (US), WAK-Chemie Medical GmbH (Germany), Sera Care (US), Epitope Diagnostics Inc. (US), Kamiya Biomedical Company (US), Gyros Protein Technologies (Sweden), Trivitron Healthcare (India), InBios International Inc. (India), and Maccura Biotechnology Co., Ltd. (China).

Research Coverage:

This research report categorizes the immunoassay market by product (reagents & kits and analyzers), specimen (blood, urine, saliva, and other specimens), technology (ELISA, CLIA, IFA, rapid tests, ELISpot, western blotting, and other technologies), application (infectious diseases, blood screening, oncology, endocrinology, bone & mineral disorders, autoimmune disorders, cardiology, drug monitoring & testing, allergy diagnostics, newborn screening, and other applications), end user (clinical laboratories, hospitals & clinics, blood banks, and home care settings), and region (North America, Europe, Asia Pacific, Middle East & Africa, and Latin America). The scope of the report covers detailed information regarding the major factors such as drivers, restraints, opportunities, and challenges influencing the growth of the immunoassay market. A detailed analysis of the key industry players has been conducted to provide insights into their business overview, products offered, key strategies, acquisitions, and partnerships. New product launches and approvals, as well as recent developments associated with the immunoassay market, are also included. This report covers the competitive landscape of upcoming startups in the immunoassay market ecosystem.

Key Benefits of Buying the Report:

The report provides market leaders and new entrants with estimates of revenue figures for the overall immunoassay market and its subsegments. It helps stakeholders understand the competitive landscape and gain insights to better position their businesses and develop effective go-to-market strategies. Additionally, the report offers insights into market dynamics, including key drivers, restraints, challenges, and opportunities.

The report provides insights on the following pointers:

• Analysis of key drivers (increasing incidence of chronic and infectious diseases and growing awareness about early disease diagnosis, growth in biotechnology and biopharmaceutical industries, supportive government policies, increasing adoption of immunoassay-based poc testing and rapid testing, increasing drug and alcohol abuse and stringent laws mandating drug and alcohol testing), restraints (stringent requirements for approval of immunoassay instruments and consumables, technical hurdles of immunoassay kits), opportunities (growth opportunities in emerging economies, importance of companion diagnostics, development of condition-specific biomarkers and tests, integration of microfluidics in immunoassays, improving immunoassay diagnostic technologies), and challenges (design challenges, complexities, and quality of antibodies, dearth of skilled professionals, unfavorable reimbursement scenario, influencing the growth of the immunoassay market
• Product Development/Innovation: Detailed insights on upcoming technologies, research & development activities, and new product launches in the immunoassay market.
• Market Development: Comprehensive information about lucrative markets – the report analyses the immunoassay market across varied regions.
• Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the immunoassay market
• Competitive Assessment: In-depth assessment of market shares, growth strategies, and product offerings of leading players such as Abbott (US), F. Hoffmann-La Roche Ltd. (Switzerland), Siemens Healthineers AG (Germany), Danaher (US), and Bio-Rad Laboratories, Inc. (US), among others, in the immunoassay market strategies.

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