Product Launch (Blog)

Jul, 03 2023

Anti-Nuclear Antibody Test Revolutionizing Disease Diagnosis

Anti-nuclear antibodies (ANAs) are a class of autoantibodies that specifically target the cell's nucleus. The anti-nuclear antibody test, encompassing fluorescent anti-nuclear antibody (FANA) and anti-nuclear antibody screen, aids in the identification of autoantibodies in human blood serum. Indirect immunofluorescence and enzyme-linked immunosorbent assay (ELISA) tests are the commonly employed methods for ANA testing. These diagnostic tests play a pivotal role in detecting the presence of autoantibodies and are widely utilized in clinical settings for accurate disease identification and management.

According to Data Bridge Market Research, the Anti-Nuclear Antibody Test Market accounted for USD 1,700.75 million in 2022, and is expected to reach USD 4,521.35 million by 2030. The market is expected to grow with a CAGR of 13% in the forecast period of 2023 to 2030.

“Growing R&D activities for anti-nuclear antibody assay”

The utilization of immunofluorescence in the anti-nuclear antibody assay has emerged as a valuable tool for diagnosing various diseases more effectively, exerting a significant impact on the market. A recent study published in Arthritis Research & Therapy in 2022 exemplified this, demonstrating higher salivary ANA immunofluorescence intensities in systemic lupus erythematosus (SLE) patients compared to healthy individuals. The expanding research and development endeavours elucidating the advantages of immunofluorescence tests are expected to drive global demand and foster market growth.

What restraints the growth of the anti-nuclear antibody test market?

“Higher diagnostic errors associated with antibody tests”

The growth of the market may face hindrances due to a rising rate of diagnostic errors. For example, the American College of Rheumatology highlights that individuals without any health conditions or those taking certain medications like isoniazid and procainamide may exhibit false positive results in anti-nuclear antibody tests. This lack of specificity in the test poses challenges. Consequently, the market growth is impeded by the potential for misdiagnosis and inaccurate interpretations, impacting overall market expansion.

Segmentation: Global Anti-Nuclear Antibody Test Market

The anti-nuclear antibody test market is segmented on the basis of product, disease, technique and end users.

  • On the basis of product, the anti-nuclear antibody test market is segmented into reagents and assay kits, systems, software, and services.
  • On the basis of disease, the anti-nuclear antibody test market is segmented into rheumatoid arthritis, systemic lupus erythematosus, sjögren's syndrome, scleroderma, and other diseases.
  • On the basis of technique, the anti-nuclear antibody test market is segmented into enzyme-linked immunoassay, immunofluorescence assay, and multiplex assay.
  • On the basis of end users, the anti-nuclear antibody test market is segmented into hospitals, clinical laboratories, physician office laboratories, and others end users.

Regional Insights: North America dominates the Anti-Nuclear Antibody Test Market

North America and Europe dominate the anti-nuclear antibody test market due to the most well-established markets concerning the adoption of ANA testing, healthcare infrastructure, patient awareness, and the increasing presence of advanced tests. Thus, these factors enhance the growth of the market.

Asia-Pacific is expected to be the fastest developing region during the forecast period of 2023-2030 due to various unmet clinical needs and needs for better diagnosis. Unmet needs for autoimmune disease diagnostics in several countries, such as India, are anticipated to boost the regional demand during the forecast period.

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Recent Developments in Anti-Nuclear Antibody Test Market

  • In 2022, THERADIAG made an agreement with Quotient Limited, a commercial-stage diagnostics company. The two companies will enter into partnership to boost autoimmune diagnostics by leveraging Quotient's MosaiQ platform.
  • In 2022, ZEUS Scientific received FDA clearance for the ZEUS dIFine IFA system for use with ZEUS' ANA HEp-2 indirect fluorescent antibody (IFA) assay. FDA clearance of HEp-2 ANA IFA test system on the dIFine system includes positive and negative determination and eight common ANA HEp-2 staining patterns.

The Prominent Key Players Operating in the Anti-Nuclear Antibody Test Market Include:

  • Erba Mannheim (Germany)
  • Abbott (U.S.)
  • Trinity Biotech (Ireland)
  • Bio-Rad Laboratories, Inc. (U.S.)
  • Thermo Fisher Scientific (U.S.)
  • ZEUS Scientific, Inc. (U.S.),
  • Grifols, S.A (Spain)
  • BioVision Inc (U.S.)
  • PerkinElmer, Inc. (U.S.)
  • F. Hoffmann-La Roche Ltd (Switzerland)
  • EUROIMMUN Medizinische Labordiagnostika AG (Germany)
  • Zimmer Biomet, (U.S.)
  • Smith + Nephew (U.K.)
  • Boston Scientific Corporation (U.S.)
  • Organogenesis Inc. (U.S.)
  • Arthrex, Inc (Germany)

Above are the key players covered in the report, to know about more and exhaustive list of anti-nuclear antibody test market companies contact,

Research Methodology: Global Anti-Nuclear Antibody Test Market

Data collection and base year analysis are done using data collection modules with large sample sizes. The market data is analyzed and estimated using market statistical and coherent models. In addition, market share analysis and key trend analysis are the major success factors in the market report. The key research methodology used by DBMR research team is data triangulation which involves data mining, analysis of the impact of data variables on the market, and primary (industry expert) validation. Apart from this, data models include Vendor Positioning Grid, Market Time Line Analysis, Market Overview and Guide, Company Positioning Grid, Company Market Share Analysis, Standards of Measurement, Global vs Regional and Vendor Share Analysis. Please request analyst call in case of further inquiry.

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