Immunodiagnostics Market Size Expected to Reach USD 70.9 Bn by 2034

The global immunodiagnostics market size is calculated at USD 24.20 billion in 2025 and is expected to reach around USD 70.9 billion by 2034, growing at a CAGR of 12.84% for the forecasted period.

/EIN News/ -- Ottawa, Feb. 07, 2025 (GLOBE NEWSWIRE) -- The global immunodiagnostics market size was valued at USD 21.50 billion in 2024 and is predicted to hit around USD 62.90 billion by 2033, a study published by Towards Healthcare a sister firm of Precedence Statistics.

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Market Overview

The market growth continues to surge as the prevalence of infectious diseases, cancer, and autoimmune disorders keeps rising. According to the World Health Organization (WHO), non-communicable diseases, which encompass autoimmune conditions and cancer, were responsible for 71% of global mortality in 2023. This highlights the need for immunodiagnostic tests, which are important in early detection diagnostics. Furthermore, rising advancements in diagnostic technologies and increasing awareness about early disease detection and prevention contribute to the growth of the market.

Major Trends in the Immunodiagnostics Market

Increasing Prevalence of Chronic and Infectious Diseases

Increased cases of chronic conditions, including cancer, cardiovascular disorders, and autoimmune conditions, act as primary drivers for the market. As per the WHO, cardiovascular diseases result in 17.9 million years yearly. Most CVDs are associated with increased inflammation from the innate immune system. Moreover, the continuous spread of infectious diseases, including tuberculosis, hepatitis, and viral infections, contributes to market expansion. These diseases require effective diagnostic solutions for managing symptoms.

Technological Advancements in Immunoassay Techniques

Technological advancements in immunodiagnostic technologies drive the growth of the market. Immunoassay technologies, including chemiluminescence immunoassays (CLIA), enzyme-linked immunosorbent assays (ELISA), and multiplex assays, have the ability to improve diagnostic precision and testing efficacy. The application range of CLIA instruments now includes hormone measurement, drug testing, vitamin evaluation, as well as tumor and infectious disease and myocardial damage and autoimmune marker detection, which strengthens diagnostic outcomes in different medical specialties. Artificial intelligence systems are now integrated into immunodiagnostics, enhancing the speed and precision of test reading results. The rising development of multiplex assays and immunodiagnostic automation technologies is expected to drive market growth further.

Growing Adoption of Point-of-Care Testing

The adoption of point-of-care testing is increasing at a rapid pace, as this test helps make timely treatment decisions by providing rapid and accurate results. The COVID-19 pandemic has accelerated the adoption of point-of-care testing for infectious diseases. The need for innovative molecular diagnostics has risen as people seek precise and rapid diagnostic solutions that help manage disease and public health emergencies.

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Regional Insights

North America’s Sustain Dominance in the Market: What till 2034?

North America dominated the immunodiagnostics market in 2024 by capturing the largest share. This is mainly due to robust healthcare infrastructure, high R&D investments, and a strong presence of key market players. The U.S. Food and Drug Administration continues to authorize new immunodiagnostic tests, supporting the region's active involvement in developing diagnostic technologies. The market in the region continues to expand rapidly during the forecast period due to the rising advancements in diagnostic technologies and the increasing approval for immunodiagnostic tests. The U.S. Food and Drug Administration (FDA) approved VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack in May 2023 as a device for detecting SARS-CoV-2 IgG antibodies in human serum and plasma samples. In addition, the rising healthcare expenditures and availability of advanced diagnostic technologies contribute to regional market growth.

Rising Government Initiatives to Drive the Markt Growth in Asia Pacific

Asia Pacific is expected to witness rapid growth in the market during the forecast period. This is mainly due to the increasing healthcare expenditures, rising awareness about early disease detection, and government initiatives to improve healthcare infrastructure and diagnostic capabilities. The "Healthy China 2030" plan concentrates on medical health service improvement as well as healthcare provision mode reform to achieve better health service quality alongside expanded accessibility. The National Health Mission in India works to build health infrastructure and create access to fair-priced quality healthcare that serves everyone. In addition, the Asia Pacific immunodiagnostics market is expanding rapidly due to the rising government initiatives to curb the spread of infectious diseases.

Market Segmentation

• By product, the reagents and consumables segment led the market by holding the largest share in 2024. This is mainly due to their essential role in diagnostic procedures and widespread use in various immunoassay techniques. With the rising diagnostic testing volumes, the need for reagents and consumables is also rising. Moreover, technological advancements in diagnostic assays contribute to segmental growth.
• By technology, the enzyme-linked immunosorbent assay (ELISA) segment registered its dominance in the market in 2024. This is mainly due to its high sensitivity, versatility, and wide application in detecting a range of diseases. ELISA remains the leading diagnostic technology for large-scale rapid medical assessment because it delivers rapid results for multiple medical situations.
• By application, the oncology and endocrinology segment dominated the immunodiagnostics market due to the increasing prevalence of cancer and hormonal disorders. These diseases require early and accurate diagnostic testing.
• By end-user, the clinical laboratories segment led the market and is continues to grow at the fastest rate over the studied period. This is due to the increasing adoption of advanced diagnostic technologies in clinical laboratories and the rising demand for accurate and timely disease detection techniques. The rising government funding to improve clinical laboratory infrastructure contributes to segmental growth.

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Competitive Landscape

The market continues to evolve rapidly, with 2024 witnessing significant advancements and a dynamic competitive landscape. Key players operating in the market are Abbott, NeoGenomics Laboratories, Thermo Fisher Scientific Inc., Agilent Technologies, QIAGEN, Hoffmann La Roche AG, Siemens, Protagen Protein Services GmbH, Amarantus Bioscience Holdings Inc., Omega Diagnostics Group Plc., Nexus-Dx, and Adaptive Biotechnologies. These players are making efforts to bring innovations to the market and stay ahead of the competition.

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Recent Developments

• In October 2024, Bio-Rad Laboratories launched its External Quality Assurance Services (EQAS) Specialty Immunoassay (SPIA) Program. This new program offers a liquid, independent, and confidential external assessment service that consolidates 13 complex and highly tested specialty immunoassay analytes, including procalcitonin, active vitamin B12, interleukin-6, and fructosamine, across both normal and abnormal levels.
• In September 2024, Agappe Diagnostics Ltd. collaborated with Fujirebio Holdings Inc. of Japan and launched an advanced range of In-Vitro diagnostic tools using the cutting-edge Chemiluminescent Enzyme Immunoassay (CLEIA) technology. 

Segments Covered in the Report

By Product

• Reagents
• Instruments
• Software and Services
  

By Technology

• Enzyme-Linked Immunosorbent Assay
• Chemiluminescence Immunoassay
• Fluorescent Immunoassay
• Radioimmunoassay
• Rapid Test
• Others

By Application

• Infectious Diseases
• Oncology and Endocrinology
• Hepatitis and Retrovirus
• Bone and Mineral
• Autoimmunity
• Cardiac Biomarker
• Others
  

By End User

• Clinical Laboratories
• Hospitals
• Academic and Research Centers
• Pharmaceutical and Biotechnology Industry
• Others
  

By Region

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

Discover our detailed Table of Contents (TOC) for the Immunodiagnostics Market @ https://www.towardshealthcare.com/table-of-content/immunodiagnostics-market-sizing

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Towards Healthcare is a leading global provider of technological solutions, clinical research services, and advanced analytics to the healthcare sector, committed to forming creative connections that result in actionable insights and creative innovations. We are a global strategy consulting firm that assists business leaders in gaining a competitive edge and accelerating growth. We are a provider of technological solutions, clinical research services, and advanced analytics to the healthcare sector, committed to forming creative connections that result in actionable insights and creative innovations.

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