Immunoprotein Diagnostic Testing Market to Value USD 21.28 Billion by 2035, Registering at a 7.54% CAGR – SNS Insider

U.S. Market Projected to Reach USD 7.81 Billion and Europe Market to Hit USD 5.83 Billion by 2035 as Demand for Autoimmune, Infectious Disease, and Oncology Biomarker Testing Accelerates.

Austin, United States, June 11, 2026 (GLOBE NEWSWIRE) — According to SNS Insider, the Immunoprotein Diagnostic Testing Market was valued at USD 10.28 billion in 2025 and is projected to reach USD 21.28 billion by 2035, expanding at a CAGR of 7.54% during 2026–2035.

The demand for proper disease diagnosis, monitoring, and effectiveness of its treatment in the areas of autoimmune diseases, infections, hematological cancers, and chronic inflammations is steadily increasing, which is driving the growth of global immunoprotein diagnostic testing market. Targeting biomarkers such as immunoglobulin, free light chain, complement, C-Reactive Protein (CRP), pre-albumin, and haptoglobin and are used to test the performance of immune system. More investment in healthcare facilities, automating laboratories, and the use of advanced immunological assay technology has added to market expansion.

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Growing Burden of Autoimmune and Chronic Diseases Supporting Market Expansion

Increase in the incidences of autoimmune diseases, chronic infections, blood cancer diseases, and immunodeficiencies has fueled the need for immunoglobulin diagnostic tests. Patients suffering from diseases like multiple myeloma, rheumatoid arthritis, and systemic lupus erythematosus are required to undergo tests involving measurement of levels of IgG, complement proteins, and free light chains, thus driving demand for these tests. Moreover, innovations in CLIA, ELISA, and lab automation technologies have boosted the market growth. Increasing use of immunoglobulin tests for diagnosing diseases, monitoring treatment, and providing customized treatments is propelling market growth further.

Leading Market Players Listed in the Immunoprotein Diagnostic Testing Market Report are:

• Beckman Coulter Inc. (Danaher)
• Abbott Diagnostics
• Siemens Healthineers AG
• F. Hoffmann-La Roche Ltd.
• Thermo Fisher Scientific Inc.
• bioMérieux SA
• Bio-Rad Laboratories Inc.
• Qiagen N.V.
• Ortho Clinical Diagnostics (QuidelOrtho)
• Sysmex Corporation
• Luminex Corporation (DiaSorin)
• QuidelOrtho
• Instrumentation Laboratory (Werfen)
• Trinity Biotech plc
• Randox Laboratories Ltd.
• Binding Site Group (Thermo Fisher)
• Sebia SA
• Helena Laboratories
• R&D Systems (Bio-Techne)
• Merck KGaA (MilliporeSigma)

Immunoprotein Diagnostic Testing Market Segmentation Analysis

By Type

In 2025, the market is dominated by the Immunoglobulin Diagnostic Tests segment, which accounted for 28.15% revenue share. The free light chain diagnostic tests segment is expected to witness the fastest growth during the forecast period due to the growing adoption of techniques to manage multiple myeloma and associated plasma cell disorders.

By Technology

In 2025, the ELISA segment accrued around 42% of the market revenue, which is also the highest market share generation segment, owing to its well-documented clinical utility, availability, affordable cost and wide laboratory adoption. The Chemiluminescence Immunoassay (CLIA) segment is expected to be the fastest-growing segment over the forecast period due to its greater sensitivity, suitability for automation, and faster delivery of results.

By Application

The Infectious Disease Testing segment dominated the market and accounted for the largest share of approximately 32% in 2025 with large volumes of testing for inflammatory and immune-response biomarkers. Oncology Testing segment is projected to register rapid growth on account of the rising usage of immunoprotein biomarkers for the diagnosis, monitoring, and assessing the treatment response of cancer.

By End User

The hospitals & clinical laboratories segment accounted for the largest market revenue in 2025, of around 52%, which can be expedited that these are one of the places with the highest volume of patients and they are equipped with advanced testing infrastructure. The growth of Diagnostic Centers is highest owing to increasing expenditure on outpatient diagnostic services and laboratory investment.

Regional Insights

North America held the maximum share of the global immunoprotein diagnostic testing market in 2025, driven by highly developed healthcare infrastructure, large volumes of diagnostic tests being performed, presence of favorable reimbursement systems, and existence of leading companies including Abbott, Roche Diagnostics, Beckman Coulter, Siemens Healthineers, and Thermo Fisher Scientific.

• The U.S. Immunoprotein Diagnostic Testing Market was valued at approximately USD 3.77 billion in 2025 and is projected to reach approximately USD 7.81 billion by 2035, growing at a CAGR of 7.56% from 2026–2035. The growth is driven by the rising prevalence of autoimmune diseases and more cancer diagnostics across the globe, developing laboratory networks and increased uptake of automated immunoassay systems.

The Europe Immunoprotein Diagnostic Testing Market is estimated at USD 2.88 billion in 2025 and is expected to reach USD 5.83 billion by 2035, registering a CAGR of 7.30% during 2026–2035. Europe considers as a mature market, primarily due to the growing reimbursement framework and developed laboratory infrastructure, and demand for diagnostics during the predicted period.

The Asia Pacific region is anticipated to achieve the highest CAGR during the forecast period. Factors such as expansion of healthcare infrastructure in China and India, increased adoption of laboratory automation, rising burden of chronic diseases, and awareness on immunoprotein biomarkers are driving the growth of the market. China continues to account for the largest regional contribution, and both India, Japan, and South Korea persist in building diagnostic testing capabilities.

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Recent Developments

• January 2026: Thermo Fisher Scientific expanded its specialty diagnostics portfolio through continued integration and commercialization of advanced protein analysis solutions designed to support hematology and immune disorder testing workflows.
• October 2025: Siemens Healthineers enhanced its Atellica laboratory automation ecosystem with expanded immunoassay capabilities aimed at improving testing throughput and operational efficiency for hospital laboratories.
• September 2025: Roche Diagnostics introduced additional automated immunoassay applications on its cobas platform to support broader biomarker testing and faster clinical decision-making.
• August 2025: Beckman Coulter announced laboratory workflow optimization initiatives focused on high-volume immunoassay testing, helping healthcare facilities improve turnaround times and testing accuracy.

Exclusive Sections of the Report (The USPs)

• TEST VOLUME & UTILIZATION ANALYSIS – Evaluates diagnostic testing demand across autoimmune diseases, infectious diseases, hematological malignancies, and chronic inflammatory conditions.
• TECHNOLOGY ADOPTION BENCHMARKING – Assesses market penetration of ELISA, CLIA, nephelometry, turbidimetry, and emerging immunoassay platforms across major healthcare markets.
• REGULATORY & REIMBURSEMENT LANDSCAPE – Examines approval pathways, reimbursement trends, quality standards, and regulatory developments influencing market growth.
• LABORATORY AUTOMATION & WORKFLOW INSIGHTS – Analyzes automation adoption, testing efficiency improvements, and laboratory infrastructure investments.
• BIOMARKER UTILIZATION & CLINICAL APPLICATION ANALYSIS – Provides insights into immunoglobulin, free light chain, CRP, complement protein, and specialty biomarker testing trends.
• COMPETITIVE INTELLIGENCE & MARKET SHARE ANALYSIS – Reviews company positioning, product portfolios, strategic collaborations, technological innovations, and expansion initiatives across the global market.

Immunoprotein Diagnostic Testing Market Report Scope

Report Attributes	Details
Market Size in 2025	USD 10.28 Billion
Market Size by 2035	USD 21.28 Billion
CAGR	CAGR of 7.54% From 2026 to 2035
Base Year	2025
Forecast Period	2026-2035
Historical Data	2022-2024
Key Segments	• By Type (Immunoglobulin Diagnostic Tests, C-Reactive Protein Diagnostic Tests, Free Light Chain Diagnostic Tests, Complement System Protein Tests, Pre-Albumin Tests, Haptoglobin Tests, Others) • By Technology (ELISA, Chemiluminescence Immunoassay/CLIA, Radioimmunoassay/RIA, Immunoturbidity Assay, Immunoprotein Electrophoresis, Others) • By Application (Infectious Disease Testing, Autoimmune Disease Testing, Oncology Testing, Allergy Testing, Endocrine Testing, Cardiovascular Testing, Others) • By End User (Hospitals & Clinical Laboratories, Diagnostic Centres, Academic & Research Institutes, Pharmaceutical & Biotechnology Companies)
Regional Analysis/Coverage	North America (US, Canada), Europe (Germany, UK, France, Italy, Spain, Russia, Poland, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Australia, ASEAN Countries, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Mexico, Colombia, Rest of Latin America).

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