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The Antinuclear Antibody Test Market Projected to Grow at a CAGR of 14.97% and Generate a Revenue of $ 4,999.40 million by 2031

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The global antinuclear antibody test market is predicted to be valued at $ 4,999.40 million by 2031, surging from $ 1,294.90 million in 2021, at a noteworthy CAGR of 14.97%.

Impact Analysis of COVID-19 on the Antinuclear Antibody Test Market

The global antinuclear antibody testing market showed positive growth during the COVID-19 Pandemic. Due to the novel coronavirus outbreak, most industrial sites have been closed, and many businesses have implemented work-from-home policies. However, healthcare institutions have taken several initiatives and actively working toward vaccine development and treating patients. The market for antinuclear antibody tests is expected to grow significantly during the forecast period as people are getting these tests to monitor their health during the pandemic and assess their risk for autoimmune illnesses. This element, which has a direct effect on the demand for antinuclear antibody tests, is anticipated to drive the market's expansion during the COVID-19 pandemic.

Several initiatives launched by the government are helping society to recover from the pandemic. For instance, In May 2022, the United States Food and Drug Administration (FDA) cleared ZEUS Scientific’s dIFine digital immunofluorescence system for use with ZEUS’s ANA HEp-2 indirect fluorescent antibody (IFA) assay.

Global Antinuclear Antibody Test Market Analysis

The incidence of autoimmune disorder is rising, globally. However, the exact cause of increasing incidence rate of autoimmune diseases is unknown. As per the scientist, increasing consumption of fancy and junk food can be of the cause for rising incidence rate of autoimmune disease. Furthermore, growing demand for preventive diagnostics, increasing prevalence of systemic lupus erythematous disorders and rheumatoid arthritis will contribute to the growth of ANA test market. These are the major factors anticipated to boost the antinuclear antibody test market share during the analysis timeframe.

Several techniques and methods such as ELISA, Immunofluorescence Assay, and Multiplex Assay are being used to screen blood for the presence of antinuclear antibodies. However, these methods are sensitive and may provide positive results even in healthy and fit individuals. As a result, the screening of specimens should be done by trained and skilled individuals to avoid errors. These factors are expected to hinder the growth of the ANA test market.

The number of advanced and automated diagnostic centers is increasing in developing countries. Furthermore, the government is increasingly spending on improving healthcare infrastructure by building specialty hospitals, diagnostic labs, and research centers. These initiatives are expected to increase awareness among people and thereby increase ANA testing. Such factors are anticipated to provide growth opportunities for the global antinuclear antibody test market.

Global Antinuclear Antibody Test Market Share, Segmentation

The global antinuclear antibody test market is segmented based on product, technique, application, end-use and region.


The product segment is further classified into reagents & assay kits, systems, software & services. Among these, the reagents & assay kits sub-segment is anticipated to have a dominant market share and shall surpass $3,153.10 million by 2031, with an increase from $777.70  million in 2021. Reagents & kits are commonly used in laboratory or field settings to detect the presence of antinuclear antibodies in the specimens. The growing demand for reagents & kits due to the increasing number of ANA test is the main factor driving the demand for ANA tests during the forecast period.


The technique segment is further classified into ELISA, immunofluorescence assay, and multiplex Assay. Among these, the ELISA sub-segment is anticipated to have a dominant market share and shall surpass $2,167.70 million by 2031. ELISA is a quick test that provides more reliable results than other testing methods. Furthermore, the ELISA test is less sensitive compared to other methods. Higher acceptance of the ELISA test for screening antinuclear antibodies is the key factor driving the market for the ELISA technique during the forecast period.


The application segment is further classified into rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s Syndrome, Scleroderma, and others. Among these, the rheumatoid arthritis sub-segment is anticipated to have a dominant market share and shall surpass $ 3,622.40 million by 2031. The increasing cases of rheumatoid arthritis in elderly people is the key factor propelling growth ANA test for rheumatoid arthritis application. The key factor responsible for the increase in rheumatoid arthritis among the elderly can be attributed to early diagnosis and living longer due to better management. 

End Use:

The end-use segment is further classified into hospitals, clinical laboratories, physician office laboratories, and others. Among these, the Physician Office Laboratories sub-segment is anticipated to have the fastest growth and shall surpass $1,194.30 million by 2031. The growing number of advanced laboratories and the independent diagnostic lab is the main factor driving the ANA test market in Physician Office Laboratories end-use.


The antinuclear antibody test market in the Asia-Pacific region is projected to show the fastest growth. This region’s market generated a revenue of $ 266.70 million in 2021 and is projected to reach up to $ 1,239.90 million by 2031. The regional market is expected to be significantly impacted by rising healthcare spending and an increase in autoimmune illnesses such as rheumatoid arthritis throughout the forecasted period. Major companies in the antinuclear antibody market in the Asia-Pacific region are also employing a variety of techniques to expand in the international arena. For instance, in March 2020, Indian pharmaceutical giant Cadila Healthcare acquired Heinz India and announced that it had been permitted to undertake clinical studies for a novel medication that might treat rheumatoid arthritis in India.

Key Players in the Global Antinuclear Antibody Test Market

Some of the leading antinuclear antibody test market players are

  1. Erba Diagnostics
  2. Bio-Rad Laboratories, Inc.
  3. Trinity Biotech Plc.
  4. Thermo Fisher Scientific
  5. Antibodies Incorporated
  6. EUROIMMUN Medizinische Labordiagnostika AG
  7. Immuno Concepts NA Ltd.
  8. Alere Inc.
  9. Inova Diagnostics, Inc
  10. ZEUS Scientific, Inc.
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