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Anti-nuclear Antibody Testing Market information, by type (immunofluorescence, enzymelinked, immunosorbent assay (ELISA) and others), by application (Rheumatoid arthritis, Systemic lupus erythematosus (SLE), Polymyositis, Scleroderma, Sjรถgren's syndrome, and others), by End User (Hospitals and clinics, research laboratories, and others) - Forecast to 2032


ID: MRFR/LS/2319-HCR | 72 Pages | Author: Kinjoll Dey| April 2025

Anti-nuclear Antibody Testing Market Overview


The Anti-nuclear Antibody (ANA) testing market size is expected to reach USD 1.6 billion by 2032 at 11.3% CAGR during the forecast period 2023-2032. Antinuclear Antibody (ANA) Test detects antinuclear antibodies in the blood. The immune system makes antibodies to fight infections. Antinuclear antibodies attack on own tissues. It helps to recognize autoimmune diseases such as rheumatoid arthritis and lupus. The rise in technological advancements, higher adoption rate of new techniques, and growing concern of autoimmune diseases are driving the antinuclear antibody (ANA) testing market growth. Major industrial players are investing in research and development for the development of advanced products, which is another key growth factor for the market.


Antinuclear Antibody (ANA) Testing Market


North America holds the prime position in Anti-nuclear Antibody (ANA) Testing market. U.S. hold the largest share and the European region is the second-largest and due to the higher growth rate in west European countries. The Asia-Pacific (APAC) is rapidly growing and significantly maintains a significant growth rate in the forecast period. The Middle East and Africa (ME&A) will show limited growth due to less awareness of devices and treatment. This regional development will boost the global growth rate of the market.


September 2023


Metropolis declares the introduction of a novel antibody assay for severe renal disease.


Nephrotic Syndrome, one of the most serious renal conditions, is characterized by persistent edema and significant loss of urinary proteins.

Membranous Nephropathy, also known as Membranous Glomerulonephritis, is a prominent etiology of Nephrotic Syndrome. It is a chronic inflammatory disorder affecting the glomeruli, the initial capillary network in the kidneys responsible for blood filtration. Membranous nephropathy is characterized by the formation of an immune complex, which is an antibody-antigen complex, within the glomerulus. Ultimately, this results in renal dysfunction and the development of kidney failure.


Primary glomerulonephropathy (idiopathic) occurs when the etiology of the disease is unknown. Secondary glomerulonephropathy may be caused by an underlying condition such as chronic infection, tumor, cancer, or specific medications, among others.


Differentiating primary from secondary is crucial due to the variations in treatment approaches and disease management strategies. Primary Membranous Nephropathy is treated with an immunosuppressive therapy or kidney transplantation; secondary nephropathy involves treatment of the underlying disease.


The PLA2R Antibody Test is utilized to accurately distinguish between the two types of diseases, assess the disease's severity, monitor treatment, and determine the patient's risk following a kidney transplant.

Activity of the disease (proteinuria) is correlated with anti-PLA2R autoantibody results. There exists a direct correlation between elevated titers and the severity of primary MN.

A reduction in the anti-PLA2R autoantibody titer is observed in patients who respond favorably to immunosuppressive therapy. Recurrence of the antibodies is correlated with a relapse of the disease. In addition, a high anti-PLA2R titer was identified as a significant risk factor for patients with primary MN who do not experience proteinuria remission.


After undergoing kidney transplantation, up to 40% of patients with primary MN relapse. A persistent presence of anti-PLA2R autoantibodies for a duration of six months following organ transplantation significantly elevates the associated risk. Consequently, in order to prevent relapses, the titer may be utilized to determine the need for and efficacy of immunosuppressive therapy following a transplant.

Anti-nuclear Antibody Antibody (ANA) Testing Market Segment Insights


Anti-nuclear Antibody Antibody (ANA) Testing Type Insights


Anti-nuclear Antibody (ANA) Testing Market has been segmented on the basis of type which comprise immunofluorescence (Primary or direct and Secondary or indirect), enzymelinked, immunosorbent assay (ELISA) (Direct ELISA, Indirect ELISA, Sandwich ELISA, Competition/Inhibition ELISA), and others. 


Anti-nuclear Antibody (ANA) Testing  Application Insights


On the basis of application, it segmented into Rheumatoid arthritis (Seropositive, Seronegative), Systemic lupus erythematosus (SLE) (Discoid lupus erythematosus, Subacute cutaneous lupus erythematosus, Neonatal lupus), Polymyositis, Scleroderma (localized scleroderma, systemic scleroderma), Sjรถgren's syndrome (Primary, secondary) , and others. 


Anti-nuclear Antibody (ANA) Testing End-user Insights


On the basis of end user, it segmented into Hospitals and clinics, research laboratories, and others.


Anti-nuclear Antibody (ANA) Testing Regional Insights


Considering the global scenario of the market, North America is largest market for Anti-nuclear Antibody (ANA) Testing, in North America region US hold largest market share while European market is second largest, and especially the growth rate is higher in west European countries. On the other hand, Asia-Pacific (APAC) is fastest growing market and expected to grow significantly during the forecast period. Middle East and Africa (ME&A) is likely to have a limited growth in the market due to less awareness of devices and treatment.


Key companies in the Anti-nuclear Antibody (ANA) Testing Market include:



  • Abcam plc. (US)

  • Alere (US)

  • Antibodies Inc.(US)

  • Bio-Rad Laboratories, Inc. (US)

  • Erba Diagnostics (US)

  • Indur Services, Inc. (US)

  • MBL INTERNATIONAL (US)

  • Merck KGaA (Germany)

  • Trinity Biotech (Republic of Ireland)



  •  (ANA) Testing market


Recent Development


In May 2022


The U.S. Food and Drug Administration (FDA) has cleared ZEUS Scientific's dIFineยฎ digital immunofluorescence system* for use with ZEUS' ANA HEp-2 indirect fluorescent antibody (IFA) assay.


The FDA-cleared ZEUS dIFineยฎ digital immunofluorescence system is the next generation in IFA imaging and pattern recognition designed to acquire, analyze, display and store digital images of ZEUS IFA HEp-2 cells. An automated digital scanner with intelligent software, ZEUS dIFine quickly delivers positive/negative results and has been programmed to suggest eight common ANA HEp-2 patterns (homogenous, speckled, centromere, nucleolar, nuclear dots, nuclear membrane, cytoplasmic (ribosomal and mitochondrial)). dIFine also instantly locates and identifies mitotic cells to assist in pattern identification. Quickly viewing and validating all negative samples with a single mouse click saves the user valuable time.


Anti-nuclear Antibody (ANA) Testing Market, by Region


Americas



  • North America

    • US

    • Canada



  • Latin America


Europe



  • Western Europe

    • Germany

    • France

    • Italy

    • Spain

    • UK

    • Rest of Western Europe



  • Eastern Europe


Asia-Pacific



  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Rest of Asia-Pacific


The Middle East & Africa



  • Middle East



  • Africa


Attribute/Metric Details
Market Size 2022 NA (USD Billion)
Market Size 2023 NA (USD Billion)
Market Size 2032 1.6 (USD Billion)
Compound Annual Growth Rate (CAGR) 11.3 % (2024- 2032)
Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Base Year 2022
Market Forecast Period 2023 - 2032
Historical Data 2019 - 2022
Geographies Covered   North America, Europe, Asia-Pacific, and Rest of the World (RoW)
Key Vendors Abcam plc. (US), Alere (US), Antibodies Inc.(US), Bio-Rad Laboratories, Inc. (US), Erba Diagnostics (US), Indur Services, Inc. (US), MBL INTERNATIONAL (US), Merck KGaA (Germany), Trinity Biotech (Republic of Ireland)
Key Market Opportunities Rising awareness about autoimmune diseases among healthcare professionals and patients
Key Market Drivers Awareness of devices and treatment. 


Frequently Asked Questions (FAQ) :

Anti-Nuclear Antibody Testing Market is projected to grow at a 11.20% CAGR between 2023-2032.

Anti-Nuclear Antibody Testing Market predicted to touch USD 1.6 billion by 2032.

North America is expected to dominate the Anti-Nuclear Antibody Testing Market.

Different end user industries of Anti-Nuclear Antibody Testing Market include research laboratories, hospital and clinics, and others.

Different strategies used by market players to create a dominance in the Anti-Nuclear Antibody Testing Market include mergers, acquisitions, collaborations, and product launches.

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