The global antinuclear antibody test market size is projected to expand at a substantial CAGR during the forecast period, 2021 – 2028. The growth of the market is attributed to the high occurrence of autoimmune disorders along with increasing awareness of these diseases.

Antinuclear antibody (ANA) tests, also known as fluorescent antinuclear antibody tests, are blood tests that locates certain antibodies present in the host. Antibodies are various proteins found in the immune system of the host to ward off viruses, bacteria, and other germs. However, there are times when the immune system categorize the parts of the host’s body as foreign invaders and releases antibodies to harm the host. ANA tests are conducted to identify these mistakes taking place in the host’s body and rectify this situation.
The American Autoimmune Related Disease Association (AARDA) conducted a survey, which reported that over 50 million people suffered from autoimmune disorders and diseases in the US. The occurrence of these kinds of diseases is increasing every year, not only in the US, but also across the world. According to the AARDA, women also accounted for 80% of all patients suffering from autoimmune diseases and was one of the major diseases responsible for several death of women. One common method to diagnose this disease is done by using the antinuclear antibody testing. The ANA is currently used as an important tool for the diagnosis and management of autoimmune diseases and illness such as rheumatoid arthritis and systemic lupus erythematosus or the SLE, monitored at both primary care and sub-specialty settings.
The COVID-19 pandemic has reduced the growth of the global antinuclear antibody test market initially. However, upon further studies, researchers and scientists found out that the coronavirus has the viral gene of accelerating illness of the hosts. This steered to hospitals, clinics, and healthcare laboratories to focus more on the treatment of autoimmune disorders for the prevention and treatment of diseases and this led to its market growth.
Market Trends, Drivers, Restraints, and Opportunities
- The major driver for the global antinuclear antibody test market is the increasing demand of antinuclear antibody testing, particularly in the interests of primary care physicians at hospitals and other healthcare delivery systems.
- The increase in funding and investments from both the government and private investors to the diagnosis to autoimmune disorders has become a huge driver for the growth in this market.
- In the recent ANA testing, there has been multiple concerns regarding the procedure and results due to lack of accuracy. This can be a key restraining factor for the global antinuclear antibody test market size.
- High cost in performing of the ANA diagnosis and lack of advanced healthcare facilities especially in developing regions present a major restraint in the global antinuclear antibody test market size.
- Ongoing R&D activities to enhance the testing technique and kits are key opportunities that can propel the market expansion in a long run.
Scope of the Report
The report on the global antinuclear antibody test market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.
Attributes
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Details
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Report Title
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Antinuclear Antibody Test Market Size - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast
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Base Year
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2020
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Historic Data
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2018–2019
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Forecast Period
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2021–2028
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Segmentation
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Products (Reagents & Assay Kits, Systems, and Software & Services), Techniques (ELISA, Immunofluorescence Assay, and Multiplex Assay), Applications (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren’s Syndrome, Scleroderma, and Others), and End-users (Hospitals, Clinical Laboratories, Physician Office Laboratories, and Others)
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Regional Scope
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Asia Pacific, North America, Latin America, Europe, and Middle East & Africa
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Report Coverage
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Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, Trends, and Revenue Forecast
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Key Players Covered in the Report
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Thermo Fisher Scientific Inc.; Alere Inc.; Grifols Inc.; Bio-Rad Laboratories; Antibodies Inc.; Immuno Concepts; Zeus Scientific; Inova Diagnostics; Erba Diagnostics; Euroimmun AG; and Trinity Biotech PLC
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Global Antibody Antinuclear Test Market Segment Insights
Reagents & assay kits segment to constitute a largest share
Based on products, the global antinuclear antibody test market is segmented into reagents & assay kits, systems, and software & services. The reagents & assay kits is expected to constitute a large market share during the period 2021-2028. Reagents and assay kits can easily impact the entire execution of an assay and also help in the creation of standardized workflows in order to help the researchers and scientists upon various fields. Standard reagents and assay kits play an integral part in the achieving efficient and accurate results besides offering other advantages such as improved efficiency, cost-effectiveness, and standardized results. Rising number of reagents and assay kits agreements are key factors pushing the segment growth.

Immunofluorescence assay to dominate the market
On the basis of techniques, the market is segmented into ELISA, immunofluorescence assay, and multiplex assay. The immunofluorescence assay is likely to dominate the global antinuclear antibody test market due to the high adoption of this assay diagnosis. Immunofluorescence assay is benchmarked for the gold standard of ANA testing owing to the superior sensitivity of this technique compared to other methods. It is able to identify various patterns that can indicate associated antibodies along with underlying disorders such as speckled, homogeneous, and others. On the other hand, the ELISA segment is anticipated to register a high CAGR during the forecast period 2021-2028 owing to its increasing adoption. ELISA is running mostly on automation, which do not require high skill level operators.
Rheumatoid arthritis segment to hold a major share
Based on applications, the global antinuclear antibody test market is divided into rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, Scleroderma, and others. The rheumatoid arthritis segment is projected to hold a major share in the market owing to the increasing occurrences of this disease. As per a data published by the US Centers of Disease Control and Prevention (CDC), approximately 54 million adults were suffering from arthritis that constituted nearly one fourth of Americans. The CDC further stated that by 2040, 78 million adults could have been facing arthritis and doctoral had to be diagnosed properly. Meanwhile, the systemic lupus erythematosus segment is a fast-growing segment due to the increasing awareness along with wide government initiatives and funding to improve the number of approvals for this test.
Hospitals segment to dominate the market
On the basis of end-users, the market is divided into hospitals, clinical laboratories, physician office laboratories, and others. The hospitals segment is projected to dominate the market share in the coming years owing to easy and safe access. Rising preference for patients visiting hospitals for the testing is due to the wide presence of medical staffs including doctors and technicians. This is expected to boost the segment growth. On the other hand, the physician office laboratories segment is anticipated to register a considerable CAGR during the forecast period due to the increased essential role of physician’s role in the present healthcare delivery system.
North America is projected to account for a key revenue market share
In terms of regions, the market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is projected to account for a key market share in terms of revenue during the forecast period, 2021-2028. The presence of key regional players in this region especially in the US is a major factor boosting the regional market growth. Moreover, existing advanced healthcare infrastructure and favorable insurance rules to its citizens as well as massive funding for research and development along with the early adoption of advanced technology in medicine are key factors fueling the regional market growth.
The market in Asia Pacific is, however, anticipated to expand at a high CAGR during the forecast period owing to rising awareness of the diseases and growing demand for tests in the region.

Segments
Segments Covered in the Report
The global antinuclear antibody test market has been segmented in terms of
Products
- Reagents & Assay Kits
- Systems
- Software & Services
Techniques
- ELISA
- Immunofluorescence Assay
- Multiplex Assay
Applications
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus
- Sjogren’s Syndrome
- Scleroderma
- Others
End-users
- Hospitals
- Clinical Laboratories
- Physician Office Laboratories
- Others
Regions
- Asia Pacific
- North America
- Latin America
- Europe
- Middle East & Africa
Key Players
- Thermo Fisher Scientific Inc.
- Alere Inc.
- Grifols Inc.
- Bio-Rad Laboratories
- Antibodies Inc.
- Immuno Concepts
- Zeus Scientific
- Inova Diagnostics
- Erba Diagnostics
- Euroimmun AG
- Trinity Biotech PLC
Competitive Landscape
Some of the major players competing in the global antinuclear antibody test market size are Thermo Fisher Scientific Inc.; Alere Inc.; Grifols Inc.; Bio-Rad Laboratories; Antibodies Inc.; Immuno Concepts; Zeus Scientific; Inova Diagnostics; Erba Diagnostics; Euroimmun AG; and Trinity Biotech PLC. These players are actively focusing on the research and development activities to provide advanced ANA diagnostics to all the people around the globe with lower cost and increasing time efficiency. Grifols Inc., in 2018, have received the US Food and Drug Administration (FDA) approval to launch their new diagnostic treatment and examinations for lupus and other autoimmune disorders.
