Immunoprotein Diagnostic Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Test (Complement System Proteins Diagnostic Tests, Free Light Chain Diagnostic Tests, Haptoglobin Diagnostic Tests, Immunoglobulin Diagnostic Tests, Prealbumin Diagnostic Tests, and C-Reactive Protein (CRP) Diagnostic Tests), By Technology (Radioimmunoassay, Enzyme Based Immunoassay, Chemiluminescence Assay, Immunofluorescence Assay, Immunoturbidity Assay, and Immunoprotein Electrophoresis), By Application (Infectious Disease Testing, Oncology Testing, Endocrine Testing, Toxicology Testing, Allergy Testing, and Autoimmune Disease Testing), By Distribution Channel (Direct Tender and Retail Sales), By End Use (Hospitals & Clinics, Diagnostic Laboratories and Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 10.88 Billion
CAGR (2026-2031)	7.65%
Fastest Growing Segment	Immunoglobulin Diagnostic Tests
Largest Market	North America
Market Size (2031)	USD 16.93 Billion

Market Overview

The Global Immunoprotein Diagnostic Testing Market will grow from USD 10.88 Billion in 2025 to USD 16.93 Billion by 2031 at a 7.65% CAGR. Immunoprotein diagnostic testing constitutes the qualitative and quantitative analysis of specific proteins such as immunoglobulins and cytokines to detect health conditions ranging from autoimmune disorders to infectious diseases. The primary factors propelling market expansion include the escalating global prevalence of chronic conditions and the critical necessity for early disease intervention to improve patient outcomes. Furthermore, the rising geriatric population significantly contributes to the sustained demand for accurate diagnostic protocols as this demographic typically requires frequent and comprehensive clinical evaluations.

Despite these strong growth drivers, the high implementation cost associated with automated diagnostic systems poses a substantial barrier to market penetration in regions with limited healthcare resources. To illustrate the growing disease burden necessitating these tests, according to the American Cancer Society, in 2024, approximately 2,001,140 new cancer cases are projected to occur in the United States. This significant projected volume of disease incidence highlights the urgent need for robust diagnostic testing infrastructure to facilitate timely and effective patient management strategies.

Key Market Drivers

The escalating prevalence of chronic and infectious diseases serves as a primary catalyst for the Global Immunoprotein Diagnostic Testing Market. This surge necessitates precise immunological assays to identify specific biomarkers, such as cytokines and immunoglobulins, which are essential for confirming diagnoses and monitoring disease progression. As infectious agents evolve and chronic conditions become more widespread, healthcare systems rely heavily on these diagnostic tools for effective patient management and early intervention. Highlighting the severity of infectious disease burdens, according to the World Health Organization, April 2024, in the 'Global Hepatitis Report 2024', the estimated number of deaths related to viral hepatitis rose to 1.3 million in 2022. Such statistics underscore the critical requirement for robust immunoprotein testing frameworks to mitigate global health threats and improve long-term epidemiological control.

Technological advancements in immunoassay platforms and the growing adoption of point-of-care testing further accelerate market expansion by improving accessibility and efficiency. Modern diagnostic laboratories are increasingly integrating high-throughput analyzers to handle the immense testing volumes required by widespread chronic conditions. Illustrating this burden, according to the American Heart Association, in 2024, approximately 48.6% of adults in the United States were reported to have some form of cardiovascular disease, a condition heavily reliant on protein biomarkers for risk stratification. Consequently, diagnostic developers are witnessing substantial financial engagement due to the uptake of these systems; according to Danaher Corporation, February 2024, in the '2023 Annual Report', the Diagnostics segment generated revenues of $9.6 billion. These advancements ensure that diagnostic capabilities remain scalable to meet the rising global clinical demand.

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Key Market Challenges

The high implementation cost associated with automated diagnostic systems stands as a significant impediment to the expansion of the Global Immunoprotein Diagnostic Testing Market. Advanced immunoprotein analyzers require substantial initial capital expenditure, which encompasses not only the procurement of instrumentation but also expenses related to installation, calibration, and personnel training. This financial burden creates a formidable barrier to entry, particularly for smaller laboratories and healthcare facilities operating within tight fiscal constraints. Consequently, many institutions are forced to defer the acquisition of modern diagnostic technologies, opting instead to maintain legacy systems that may lack the efficiency or throughput of newer automated platforms.

This trend of postponing necessary technological upgrades is evident in recent industry data regarding hospital spending. According to the 'American Hospital Association', in '2024', the average age of capital investments for medical equipment and infrastructure increased by 7.1% during the preceding year as facilities delayed purchasing decisions to manage escalating operational expenses. Such financial hesitation directly hampers market growth, as the inability of healthcare providers to invest in updated infrastructure restricts the penetration of high-throughput immunoprotein testing solutions.

Key Market Trends

The Integration of Artificial Intelligence and Machine Learning in Diagnostic Workflows is fundamentally reshaping the Global Immunoprotein Diagnostic Testing Market by enhancing analytical precision and operational efficiency. Laboratories are increasingly deploying AI algorithms to interpret complex protein patterns and automate the evaluation of digital pathology slides, thereby reducing human error and expediting result delivery. This technological convergence allows for the processing of vast datasets required for precision medicine, particularly in oncology and immunology. Validating this expansion, according to Roche, September 2024, in the press release 'Roche advances AI-driven cancer diagnostics', the company integrated more than 20 new artificial intelligence algorithms into its digital pathology open environment to support clinicians in detecting specific biomarkers and tumor gradings.

The Expansion of Direct-to-Consumer and At-Home Sample Collection Models represents a transformative shift toward decentralized, patient-centric healthcare access. Market leaders are rapidly broadening their service portfolios to allow individuals to order specific immunoprotein and wellness tests online, bypassing traditional clinical gatekeepers and facilitating proactive health management. This democratization of diagnostics is driving significant volume growth outside of standard hospital settings. Illustrating this rapid adoption, according to Quest Diagnostics, June 2024, in the '2023 Corporate Responsibility Report', the organization nearly doubled the number of tests available on its consumer-initiated platform, reducing barriers to entry for patients seeking convenient and immediate diagnostic information.

Segmental Insights

The Immunoglobulin Diagnostic Tests segment is emerging as the fastest-growing category in the Global Immunoprotein Diagnostic Testing Market. This surge is fundamentally driven by the rising incidence of autoimmune disorders and infectious diseases, which increases the critical need for precise antibody detection in clinical settings. Additionally, ongoing authorizations from regulatory bodies like the U.S. FDA for novel serological assays have expanded test availability and adoption. The growing emphasis on early diagnosis combined with advancements in automated diagnostic platforms continues to propel the rapid development of this market segment.

Regional Insights

North America leads the Global Immunoprotein Diagnostic Testing Market due to the high prevalence of chronic conditions, such as cancer and autoimmune disorders, which necessitate frequent screening and monitoring. The region benefits from a robust healthcare infrastructure that facilitates the early adoption of automated diagnostic technologies. Additionally, the strong presence of major industry players ensures continuous innovation and widespread product accessibility. This market position is supported by the U.S. Food and Drug Administration (FDA), whose stringent approval processes maintain high safety standards and foster confidence in new diagnostic assays among healthcare providers.

Recent Developments

• In October 2024, Roche announced that it had obtained approval from the U.S. Food and Drug Administration for the VENTANA Claudin 18 (43-14A) RxDx Assay. This test served as the first approved immunohistochemistry companion diagnostic designed to detect CLDN18 protein expression in tumor tissue from patients with gastric or gastroesophageal junction adenocarcinoma. By utilizing specific antibody-based detection methods, the assay enabled clinicians to identify individuals eligible for targeted treatment regimens. This launch reinforced the company's strategy to expand its portfolio of tissue diagnostics, specifically focusing on protein biomarkers that facilitate the precise application of personalized oncology therapies.
• In July 2024, Siemens Healthineers highlighted a significant advancement in neurological diagnostics during the Annual Scientific Meeting & Clinical Lab Expo. The company presented its Neurofilament Light Chain (NfL) assay, a blood-based biomarker for assessing disease activity in Multiple Sclerosis, which was developed through a strategic collaboration with Novartis. This immunoassay, having achieved CE mark certification, was introduced for use on the company’s established laboratory platforms. The partnership focused on transitioning this testing capability from research environments into routine clinical practice, thereby aiming to enhance the management of neurodegenerative diseases through accessible and frequent monitoring of patient protein levels.
• In April 2024, Beckman Coulter Diagnostics expanded the clinical menu of its high-throughput immunoassay system by securing CE mark approval for assays targeting Hepatitis B and C viruses. The launch included the Access anti-HCV, Access HBsAg, and Access HBsAg Confirmatory tests, which detect specific viral proteins and antibodies essential for infectious disease diagnosis. The company introduced a validated algorithm capable of reporting high-positive samples directly, which significantly reduced the operational burden of repeat testing. This product launch demonstrated the organization's continued focus on delivering automated immunodiagnostic solutions that improve workflow efficiency and result turnaround times for laboratories.
• In March 2024, Sebia received 510(k) clearance from the U.S. Food and Drug Administration for its kappa and lambda free light chain assays. These immunoprotein diagnostic tests, utilizing the enzyme-linked immunosorbent assay method, were developed to assist in the diagnosis and monitoring of disorders such as multiple myeloma and immunoglobulin light chain amyloidosis. The company stated that this regulatory milestone allowed for the expansion of its specialized diagnostic portfolio in the United States. The new assays were designed to integrate seamlessly into automated laboratory workflows, providing a reliable and efficient alternative for quantifying these specific serum proteins in clinical settings.

Key Market Players

• Agilent Technologies, Inc.
• Danaher Corporation
• Thermo Fisher Scientific Inc.
• PerkinElmer, Inc.
• Bio-Rad Laboratories, Inc.
• Aurora Biomed Inc.
• Tecan Trading AG
• Promega Corporation
• Charles River Laboratories International, Inc.
• Creative Biolabs, Inc

By Test	By Technology	By Application	By Distribution Channel	By End Use	By Region
Complement System Proteins Diagnostic Tests Free Light Chain Diagnostic Tests Haptoglobin Diagnostic Tests Immunoglobulin Diagnostic Tests Prealbumin Diagnostic Tests and C-Reactive Protein (CRP) Diagnostic Tests	Radioimmunoassay Enzyme Based Immunoassay Chemiluminescence Assay Immunofluorescence Assay Immunoturbidity Assay and Immunoprotein Electrophoresis	Infectious Disease Testing Oncology Testing Endocrine Testing Toxicology Testing Allergy Testing and Autoimmune Disease Testing	Direct Tender and Retail Sales	Hospitals & Clinics Diagnostic Laboratories and Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Immunoprotein Diagnostic Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Immunoprotein Diagnostic Testing Market, By Test:

• Complement System Proteins Diagnostic Tests
• Free Light Chain Diagnostic Tests
• Haptoglobin Diagnostic Tests
• Immunoglobulin Diagnostic Tests
• Prealbumin Diagnostic Tests
• and C-Reactive Protein (CRP) Diagnostic Tests

• Immunoprotein Diagnostic Testing Market, By Technology:

• Radioimmunoassay
• Enzyme Based Immunoassay
• Chemiluminescence Assay
• Immunofluorescence Assay
• Immunoturbidity Assay
• and Immunoprotein Electrophoresis

• Immunoprotein Diagnostic Testing Market, By Application:

• Infectious Disease Testing
• Oncology Testing
• Endocrine Testing
• Toxicology Testing
• Allergy Testing
• and Autoimmune Disease Testing

• Immunoprotein Diagnostic Testing Market, By Distribution Channel:

• Direct Tender and Retail Sales

• Immunoprotein Diagnostic Testing Market, By End Use:

• Hospitals & Clinics
• Diagnostic Laboratories and Others

• Immunoprotein Diagnostic Testing Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE