Immunodiagnostics - Market Insights, Competitive Landscape, and Market Forecast - 2032

Immunodiagnostics Market by Product (Instruments and Kits & Reagents), Type (Enzyme-Linked Immunosorbent Assay (ELISA), Radioimmunoassay, Chemiluminescent Immunoassay (CLIA), and Others), Disease (Infectious Diseases, Autoimmune Disorders, Oncological Disorders, and Others), End-User (Hospitals and Clinics, Diagnostics Centres, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the increasing prevalence of chronic and infectious diseases and rising demand for point of care testing.

The immunodiagnostics market was valued at USD 19,836.2 million in 2024, growing at a CAGR of 6.28% during the forecast period from 2025 to 2032 to reach USD 32,159.36 million by 2032. The demand for immunodiagnostics is primarily being boosted by the increasing prevalence of chronic and infectious diseases. Additionally, rising demand for point-of-care testing and increasing product launches in the domain of immunodiagnostics are some of the key factors, which are contributing to the growth of the immunodiagnostics market during the forecast period from 2025 to 2032.

Immunodiagnostics Market Dynamics:

According to the Centers for Disease Control and Prevention (CDC) 2023, an estimated 1.2 million people in the United States were living with HIV in 2021, with approximately 13% unaware of their infection, highlighting the urgent need for early diagnostic solutions. Similarly, the American Cancer Society (ACS) 2023 projected approximately 238,340 new cases of lung cancer in the U.S. in 2023, emphasizing the rising burden of cancer and the importance of timely diagnosis.

Globally, the World Health Organization (WHO) 2023 reported that around 18 million people were living with rheumatoid arthritis (RA), with 70% of those affected being women of whom 55% were aged over 55 years. The growing prevalence of chronic and infectious diseases globally underscores the critical need for accurate, early, and accessible diagnostic tools, thereby driving the positive growth of the immunodiagnostics market during the forecast period.

Another significant factor contributing to market growth is the rising demand for point-of-care (POC) testing. Healthcare systems worldwide are increasingly prioritizing faster and more efficient diagnostic solutions, with POC testing offering rapid results at the patient's bedside, in remote locations, or in outpatient settings. This decentralization reduces reliance on centralized laboratories, enabling quicker clinical decision-making, particularly for infectious diseases (e.g., COVID-19, influenza, tuberculosis), chronic conditions (e.g., diabetes, cardiovascular diseases), and acute medical emergencies.

Immunodiagnostic tests, renowned for their accuracy and reliability in detecting a variety of biomarkers (such as hormones, infectious agents, and autoimmune markers), are increasingly integrated into POC platforms. This synergy between advanced immunodiagnostic technologies and accessible POC solutions is spurring technological innovations such as microfluidic devices, biosensors, and AI-based diagnostics which are expected to further expand the immunodiagnostics market.

Despite these growth drivers, certain market restraints persist. Stringent regulatory approval processes especially in the U.S. (FDA) and Europe (CE marking) can delay product launches. Additionally, limited availability and awareness of immunodiagnostic solutions in low- and middle-income countries (LMICs), coupled with high costs of advanced diagnostics, and may hinder widespread adoption. Addressing these barriers through regulatory harmonization, public-private partnerships, and cost-effective innovations will be crucial to unlocking the full potential of the immunodiagnostics market.

Immunodiagnostics Market Segment Analysis:

Immunodiagnostics Market by Product (Instruments and Kits & Reagents), Type (Enzyme-Linked Immunosorbent Assay (ELISA), Radioimmunoassay, Chemiluminescent Immunoassay (CLIA), and Others), Disease (Infectious Diseases, Autoimmune Disorders, Oncological Disorders, and Others), End-User (Hospitals and Clinics, Diagnostics Centres, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the type segment of the immunodiagnostics market, the Enzyme-Linked Immunosorbent Assay (ELISA) category is projected to amass a significant revenue share in 2024. ELISA remains a cornerstone diagnostic technique due to its widespread application, high sensitivity, specificity, and versatility in detecting and quantifying antigens or antibodies. Its extensive use spans the diagnosis of infectious diseases (e.g., HIV, hepatitis, COVID-19), autoimmune disorders (e.g., rheumatoid arthritis, lupus), cancer biomarkers, and allergen detection, making it indispensable in both clinical and research settings.

One of the primary drivers of ELISA's market dominance is its ability to process large sample volumes with high throughput, enabling mass screening and epidemiological studies. Recent technological advancements including improved detection methods (e.g., chemiluminescent and fluorescent ELISA), automation, and microplate innovations have enhanced accuracy, processing speed, and user-friendliness. The cost-effectiveness of ELISA kits, along with the availability of a wide range of commercially available tests, further strengthens its market position, especially in resource-limited settings where affordability is crucial.

Moreover, the continuous introduction of innovative ELISA-based products is significantly fueling market growth. For instance, in February 2023, Charles River Laboratories International, Inc. launched its first ELISA kit for detecting and quantifying residual host cell proteins (HCP) in CHO-based biotherapeutics, addressing a critical need in biopharmaceutical manufacturing and ensuring product safety and compliance with regulatory standards. Such product developments underscore ELISA's expanding applications beyond traditional diagnostics into biopharma quality control and therapeutic monitoring.

Furthermore, the growing prevalence of chronic and infectious diseases, increased focus on early disease detection, and government initiatives promoting public health screening programs are expected to bolster the adoption of ELISA globally. The integration of digital platforms with ELISA systems for data management and remote diagnostics is another emerging trend driving market expansion.

Considering the broad applicability, continuous technological innovations, cost advantages, and new product launches, the ELISA category is anticipated to maintain its significant market share and continue its robust growth trajectory in the immunodiagnostics market during the forecast period.

North America is expected to dominate the overall immunodiagnostics market:

In 2023, North America is projected to hold the largest share of the immunodiagnostics market among all regions. This dominant position is primarily driven by the increasing prevalence of chronic and infectious diseases, growing patient awareness regarding early and accurate diagnosis, robust research and development (R&D) initiatives, and a rapidly aging population prone to various chronic conditions.

According to GLOBOCAN 2022, approximately 2.6 million individuals in North America were living with cancer in 2022, underscoring the region's significant oncological diagnostic needs. Furthermore, data from the Centers for Disease Control and Prevention (CDC) 2022 revealed that approximately 283,000 children and adolescents under 20 years in the United States had been diagnosed with diabetes, with 244,000 cases attributed to Type 1 Diabetes. Chronic infectious diseases also remain a pressing health concern, with the CDC 2023 estimating that around 880,000 people in the U.S. are living with long-term hepatitis B. The rising burden of such diseases necessitates the early detection and continuous monitoring of biomarkers, thus significantly increasing the demand for immunodiagnostic solutions across the region.

Additionally, North America's advanced healthcare infrastructure, combined with strong reimbursement frameworks and supportive government initiatives, further accelerates market growth. For example, public health programs emphasizing early disease detection and preventive care have fueled the adoption of point-of-care (POC) immunodiagnostics and automated laboratory-based testing platforms.

Another key growth driver in the region is the steady stream of product launches and regulatory approvals that enhance diagnostic capabilities. Notably, in June 2023, American Laboratory Products Company, Ltd. (ALPCO) a leading provider of specialty diagnostic solutions received FDA 510(k) clearance for its Calprotectin Immunoturbidimetric Assay, aimed at assisting in the diagnosis and management of inflammatory bowel diseases (IBD). Such regulatory milestones not only reflect the region's dynamic innovation landscape but also improve patient access to advanced diagnostic tools.

Furthermore, increasing investments by key industry players in research collaborations, technological advancements (e.g., AI-integrated immunodiagnostics and digital health platforms), and the expansion of clinical laboratories are expected to bolster market penetration in both urban and remote areas.

In summary, factors such as the rising prevalence of chronic and infectious diseases, heightened patient awareness, aging population, technological innovations, and favorable regulatory environment are collectively driving the positive growth trajectory of the immunodiagnostics market in North America. With continued product development, regulatory approvals, and healthcare infrastructure enhancements, the region is poised to maintain its market leadership throughout the forecast period.

Immunodiagnostics Market Key Players:

Some of the key market players operating in the immunodiagnostics market include Thermo Fisher Scientific, Abbott, F. Hoffmann-La Roche Ltd., Bio-Rad Laboratories, Beckman Coulter, Inc., Cytiva, ImmunoDX, DiaSorin S.p.A, Quest Diagnostics, Creative Diagnostics, Danaher Corporation, Merck KGaA, Siemens Healthineers, DiaSorin S.p.A, Werfen, Autobio, ZECEN Biotech Co., Ltd, PHC Corporation, BD, and Quidel Corporation.

Recent Developmental Activities in the Immunodiagnostics Market:

• In August 2023, Fapon Biotech launched its latest chemiluminescence immunoassay analyzer. The Shine i8000/9000 consists of innovative features and has an ultra-high throughput of 900 tests per hour.
• In November 2022, Gethin Biotech introduced the new MAGICAL 6000 chemiluminescence immunoassay Analyzer at MEDICA.
• In February 2021, Agilent Technologies Inc. announced the launch of the Agilent Dako SARS-CoV-2 IgG Enzyme-Linked Immunosorbent Assay (ELISA) kit for the qualitative detection of immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum or plasma.

Key Takeaways from the Immunodiagnostics Market Report Study

• Market size analysis for current immunodiagnostics market size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the immunodiagnostics market.
• Various opportunities available for the other competitors in the immunodiagnostics market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current immunodiagnostics market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for immunodiagnostics market growth in the coming future?

Target Audience Who Can Be Benefited From This Immunodiagnostics Market Report Study

• Immunodiagnostics product providers
• Research organizations and consulting companies
• Immunodiagnostics - related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in immunodiagnostics
• Various end-users who want to know more about the immunodiagnostics market and the latest technological developments in the immunodiagnostics market.

Frequently Asked Questions for the Immunodiagnostics Market:

1. What is immunodiagnostics?

• Immunodiagnostics refers to a branch of diagnostic testing that utilizes the principles of immunology to detect and measure specific biomolecules, such as antigens or antibodies, in a sample. These tests are based on the specific binding between an antigen (a molecule capable of inducing an immune response) and an antibody (a protein produced by the immune system to recognize and neutralize antigens).

2. What is the market for immunodiagnostics?

• The immunodiagnostics market was valued at USD 19,836.2 million in 2024, growing at a CAGR of 6.28% during the forecast period from 2025 to 2032 to reach USD 32,159.36 million by 2032.

3. What are the drivers for the global immunodiagnostics market?

• The immunodiagnostics market is primarily driven by the increasing prevalence of chronic and infectious diseases globally. The rising burden of conditions such as cancer, diabetes, cardiovascular diseases, autoimmune disorders, and infectious diseases like HIV, hepatitis, and COVID-19 has heightened the need for accurate and early diagnostic solutions, thereby propelling market growth. In addition, the growing demand for point-of-care (POC) testing is significantly contributing to market expansion. POC immunodiagnostics offers rapid, reliable results at the patient's bedside, in remote locations, and in outpatient settings, enabling quicker clinical decisions and improved patient management. The increasing emphasis on decentralized healthcare and home-based diagnostics further fuels the adoption of POC solutions. Moreover, the market is witnessing a surge in new product launches and technological innovations. Leading companies are investing in the development of advanced immunodiagnostic platforms featuring automation, enhanced detection methods (e.g., chemiluminescence, fluorescence), and integration with digital health technologies. Such innovations improve test accuracy, efficiency, and user-friendliness, broadening their applications across clinical laboratories, hospitals, and research institutions.

4. Who are the key players operating in the global immunodiagnostics market?

• Some of the key market players operating in the immunodiagnostics market include Thermo Fisher Scientific, Abbott, F. Hoffmann-La Roche Ltd., Bio-Rad Laboratories, Beckman Coulter, Inc., Cytiva, ImmunoDX, DiaSorin S.p.A, Quest Diagnostics, Creative Diagnostics, Danaher Corporation, Merck KGaA, Siemens Healthineers, DiaSorin S.p.A, Werfen, Autobio, ZECEN Biotech Co., Ltd, PHC Corporation, BD, and Quidel Corporation.

5. Which region has the highest share in the global immunodiagnostics market?

• North America is expected to dominate the overall immunodiagnostics market during the forecast period, 2025 to 2032. This is due to the growing prevalence of chronic and infectious diseases in the region. Additionally, growing awareness among patients about the importance of early and accurate diagnosis in disease management, the presence of robust research and development initiatives, and the presence of an aging population that is prone to various chronic disorders are some of the key factors driving the growth of the immunodiagnostics market in North America.