Immunoassay Market

Global Immunoassay Market Size

The global immunoassay market size was valued at USD 26.22 billion in 2024. The immunoassay market is estimated to grow at a CAGR of 9.8% during the forecast period. As a result, the market size is estimated to be USD 60.82 billion by 2033 and USD 28.79 billion by 2025.

MARKET DRIVERS

The growing patient population suffering from chronic & infectious diseases and the increasing use of immunoassays in oncology propel the global immunoassay market growth.

The growing adoption and demand for point-of-care testing devices are expected to boost the immunoassay market growth. In addition, the availability of adequate and sensitive diagnostics tests is also fuelling the growth rate of the immunoassay market. In addition, factors such as increasing awareness among people regarding point-of-care devices and government initiatives on developing testing devices contribute to the growth of the global immunoassay market.

Furthermore, rising focus and increasing initiatives from private and public organizations to develop cost-effective drugs and promote the efficiency of therapies are expected to promote the global immunoassay market growth. Furthermore, the increasing adoption rate of companion diagnostics, which can assist medical professionals in making decisions by analyzing the patient response to the therapy, favors the immunoassay market growth. In addition, the increasing prevalence of diseases such as tuberculosis, HIV, hepatitis C, and dengue among people due to biological factors is offering growth opportunities to the market participants of the global immunoassay market. Furthermore, improving the approval processes of a novel device to develop therapeutic procedures is anticipated to create growth opportunities for the global immunoassay market. In addition, increasing demand for safer drugs and specialist therapies worldwide is likely to create lucrative opportunities for market players during the forecast period.

MARKET RESTRAINTS

The inappropriate functioning of regulatory bodies with stringent rules is hampering the growth of the immunoassay market. In addition, factors such as continually changing reimbursement policies and the high complexity associated with assay procedures are limiting the growth rate of the immunoassay market. Furthermore, the high costs associated with immunoassays further hamper market growth. Furthermore, issues associated with reimbursements in some countries worldwide are anticipated to inhibit the growth rate of the global immunoassay market. Furthermore, the presence of alternative technologies and quality issues of immunoassay are expected to impede market growth during the forecast period.

REPORT COVERAGE

SEGMENTAL ANALYSIS

By Technology Insights

Based on technology, the chemiluminescence segment is anticipated to grow at the fastest CAGR during the forecast period. The increasing adoption of chemiluminescence immunoassays majorly drives segmental growth as they are highly sensitive and useful in the early detection of diseases. In addition, the chemiluminescence immunoassays come with automation possibilities; this will eliminate the chances for human errors and deliver results quickly, due to which the segment's adoption is growing. Furthermore, the chemiluminescence immunoassays do not require a large sample size to deliver results and are compatible with a small sample size, another major factor propelling the segment’s growth rate.

By Application Insights

The infection disease segment dominated the market in 2023, and the trend is expected to continue during the forecast period based on the application. The segment's growth is primarily driven by the increasing amount of infections, such as salmonella infections, among people across the world, leading to the increased adoption rate of Immunoassay for detecting these diseases. The usage of immunoassays in diagnosing infectious diseases is growing rapidly. Immunoassays provide a quick diagnosis to healthcare providers and assist in treating and managing infectious diseases. Such factors are expected to boost the growth rate of the infectious disease segment in the global immunoassay market.

By End User Insights

The hospital segment led the market and accounted for 29.8% in 2023, offering excellent facilities incorporating in-house diagnostic laboratories. In addition, with the prevalence of chronic diseases, such as cancer, infectious diseases, and autoimmune diseases, the need for hospitals and diagnostic centers to detect antigens in cancer cells has increased.

The laboratories segment is expected to grow at a promising CAGR during the forecast period owing to the growing adoption of immunoassays, such as immunohistochemical staining. Additionally, the need for diagnostic centers and clinical laboratories with advanced instruments to perform such tests grew, thereby supplementing the segmental growth.

REGIONAL ANALYSIS

The North American region accounted for the largest share of the global market in 2024 due to the increasing adoption of low-cost immunoassay instruments in research and clinical laboratories, rising immunoassay techniques in cancer research, and increasing infrastructure for a laboratory. As a result, the U.S. market had the largest share of the North American market in 2023 and is estimated to showcase a promising CAGR in the coming years. Factors such as the growing patient population suffering chronic diseases, increasing adoption of technological advancements to develop sophisticated immunoassays, rising investments for R&D, and increasing demand for early and accurate diagnosis are anticipated to favor the immunoassay market in the U.S.

The Asia Pacific is expected to show a high CAGR over the forecast period. The expected growth is attributed to the increasing development of new biologics, drugs, and vaccines, many investment opportunities in these immature/emerging markets, rising diagnostics laboratories in this region, growing government and corporate investment in the pharmaceutical and biotechnology segment, increasing focus on attracting international and domestic leaders in the global immunoassay market.

Europe is anticipated to hold a considerable share of the worldwide market during the forecast period. The increasing awareness among healthcare providers regarding the importance of early detection of diseases and growing healthcare expenditure is expected to boost the regional market growth. Roche Diagnostics, Abbott Laboratories, and Siemens Healthineers are some of the notable players in the European market and account for the major share of the European market. In addition, favorable reimbursement policies and skilled professionals are fuelling the European market's growth rate.

Latin America is expected to grow steadily in the coming years and occupy a considerable share of the worldwide market during the forecast period.

The market in MEA is predicted to occupy a moderate share of the worldwide market during the forecast period.

KEY MARKET PLAYERS

Some of the most promising companies leading the Global Immunoassay Market profiled in this report are Roche Diagnostics, DiaSorin S.p.A, Beckman Coulter, Siemens Healthcare, Ortho Clinical Diagnostics, bioMerieux, Thermo Fisher Scientific, Abbott Laboratories, Akers Biosciences, Inc., Becton Dickinson and Company, Devon Medical Products, EDP Biotech Corporation, Hologic (Gen-Probe) and Intrinsic LifeSciences.

RECENT HAPPENINGS IN THE MARKET

• In 2019, Abbott Laboratories developed a fully automated immunoassay analyzer called Abbott Prism and worked on Chia technology. It is beneficial for screening blood with practical outcomes. Other benefits of these systems are cGMP compliance, error reduction owing to the network's tamper resistance, less human intervention as the system takes care of the monitoring, processing, and documentation, and improved lab efficiency.
• In July 2018, Cygnus Technologies collaborated with Gyros Protein Technologies to develop immunoassay kits to detect biotherapeutics' impurities. The strategic partnership between the two will focus mainly on providing customers with bioanalytical solutions and enhancing biotherapeutics manufacturing productivity.

MARKET SEGMENTATION

This research report on the global immunoassay market has been segmented and sub-segmented based on technology, application, end-user and region.

By Technology

• Enzyme
• Fluorescent
• Chemiluminescence
• Nephelometric
• Radio
• Counting

By Application

• Oncology
• Cancer
• Hematology
• Cardiology
• Thyroid
• Infectious diseases
• Allergies

By End User

• Hospitals
• Clinics
• Academic Research Institute
• Pharmaceutical
• Biotech vendors
• Laboratories

By End User

• Hospitals
• Clinics
• Academic Research Institute
• Pharmaceutical
• Biotech vendors
• Laboratories

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa