Antinuclear Antibody Test Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The Antinuclear Antibody Test Market is Segmented by Technique (Immunofluorescence Assay, ELISA, and Multiplex Assay), Products and Services, Application, Distribution Channel, and Geography.

Antinuclear Antibody Test Market Snapshot

anti-nuclear antibody testing industry research
Study Period: 2018 - 2026
Base Year: 2021
Fastest Growing Market: Asia Pacific
Largest Market: North America
CAGR: >12.5 %
anti-nuclear antibody testing market major players

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Market Overview

The antinuclear antibody test (ANA) market studied was anticipated to grow with a CAGR of 12.5% during the forecast period. Increasing prevalence of autoimmune disorders, such as Sjogren’s Syndrome, Acute Motor Axonal Neuropathy, and others increased the adoption of ANA testing. According to the Foundation for Peripheral Neuropathy report, in 2019, Guillain-Barre Syndrome(GBS) affected about 3,000-6,000 people each year in the United States. Thus, a rise in the huge target population base is expected to fuel the demand for earlier screening for effective treatment. Also, rising infections due to Epstein–Barr virus, Campylobacter jejuni, and others are likely to drive the global ANA market during the forecast period

Scope of the Report

Antinuclear antibodies (ANA) are a group of autoantibodies that bind to the contents of the cell nucleus. These are produced by an individual’s immune system when it fails to differentiate one's own and foreign cells adequately. The ANA test detects these autoantibodies in the blood and thus, serve as a crucial tool in diagnosis and management of autoimmune disorders such as GBS, systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).

Immunofluorescence Assay
Multiplex Assay
Products and Services
Reagents and Assay Kits
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Other Applications
Distribution Channel
Clinical Laboratories
Other Distribution Channels
North America
United States
United Kingdom
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle-East and Africa
South Africa
Rest of Middle-East and Africa
South America
Rest of South America

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Key Market Trends

Immunofluorescence Assay is Expected to Hold the Largest Market Share in the Antinuclear Antibody Test Market

The immunofluorescence (IFA) assay is expected to account for the largest share in the market. Dominance can be attributed to the increased adoption of the technique as the gold standard for ANA testing. Highly sensitive and rapid test results compared to other techniques increased their preference among the clinicians. Furthermore, their ability to identify the various patterns, such as nucleolar, speckled, and homogenous, indicate autoantibodies associated with diseases, fuels the growth of the segment. On the other hand, the ELISA is anticipated to witness the highest CAGR over the forecast period owing to the advancements in the segment. Decreased labor costs to perform the test and operate the systems with highly automated systems reduced the overall cost of analysis. Their higher specificity in the results compared to that of IFA is likely to drive the market during the forecast period.

anti-nuclear antibody testing market share

North America Dominates the Market and it is Expected to do the Same in the Forecast Period

North America is expected to dominate the overall ANA market throughout the forecast period. The dominance is due to several factors such as increasing geriatric population who are more prone to infections due to decreased immunity leading to high demand for earlier diagnosis and effective treatment in the region. For instance, according to the report published by the Centers for Disease Control & Prevention (CDC) in December 2019, people of any age group can develop GBS, but the prevalence of GBS is at increases in the people aged over 65 years which necessitates huge demand due to presence substantial geriatric population in the United States. The presence of key players, such as Alere Inc., Antibodies Inc., Bio-Rad Laboratories, and others in the United States, is expected to fuel the growth of the market in the region, contributing to significant revenue share and propelling the ANA market's revenue in the forecast period.

anti-nuclear antibody testing market growth

Competitive Landscape

The ANA market is moderately competitive and consists of several major players. Few of the prominent players currently dominating the market are acquiring the products or other companies to consolidate their market positions across the globe. Launching new products with advanced technologies coupled with recent approvals to diagnose for autoimmune diseases is trending in the market. For example, in June 2018, Grifols received the US Food and Drug Administration (FDA) approval for its novel HELIOS Automated System for IFA used as diagnosis examination for Lupus and ANCA-associated Vasculitis. The automated tests enable labs to standardize and speed up diagnosis using IFA driving the market growth. Some of the companies which are currently dominating the market are Grifols SA, Abbott Laboratories (Alere Inc.), BioVision Inc., Antibodies Incorporated, and PerkinElmer Inc.

Table of Contents


    1. 1.1 Study Deliverables

    2. 1.2 Study Assumptions

    3. 1.3 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Rising Government Initiatives with Growing Incidences of Autoimmune Diseases

      2. 4.2.2 Favorable Medical Insurance and Reimbuirsement Policies

    3. 4.3 Market Restraints

      1. 4.3.1 Increasing Concerns with Over Reliability of ANA Tests

      2. 4.3.2 Lack of Awareness of Disease and Effective Treatment in the Developing Economies

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry


    1. 5.1 Technique

      1. 5.1.1 ELISA

      2. 5.1.2 Immunofluorescence Assay

      3. 5.1.3 Multiplex Assay

    2. 5.2 Products and Services

      1. 5.2.1 Reagents and Assay Kits

      2. 5.2.2 Systems

      3. 5.2.3 Services

    3. 5.3 Application

      1. 5.3.1 Rheumatoid Arthritis

      2. 5.3.2 Systemic Lupus Erythematosus

      3. 5.3.3 Other Applications

    4. 5.4 Distribution Channel

      1. 5.4.1 Hospitals

      2. 5.4.2 Clinical Laboratories

      3. 5.4.3 Other Distribution Channels

    5. 5.5 Geography

      1. 5.5.1 North America

        1. United States

        2. Canada

        3. Mexico

      2. 5.5.2 Europe

        1. Germany

        2. United Kingdom

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.5.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.5.4 Middle-East and Africa

        1. GCC

        2. South Africa

        3. Rest of Middle-East and Africa

      5. 5.5.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 Abbott Laboratories (Alere Inc.)

      2. 6.1.2 BioVision Inc.

      3. 6.1.3 Antibodies Incorporated

      4. 6.1.4 Grifols SA

      5. 6.1.5 PerkinElmer Inc.

      6. 6.1.6 Quidel Corporation

      7. 6.1.7 Orgentec Diagnostika GmbH

      8. 6.1.8 Immuno Concepts Inc.

      9. 6.1.9 ZEUS Scientific Inc.

      10. 6.1.10 Inova Diagnostics Inc.

    2. *List Not Exhaustive

**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments

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Frequently Asked Questions

The Antinuclear Antibody Test Market market is studied from 2018 - 2026.

The Antinuclear Antibody Test Market is growing at a CAGR of >12.5% over the next 5 years.

Asia Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2020.

Abbott Laboratories (Alere Inc), BioVision Inc, Antibodies Incorporated , Grifols SA, PerkinElmer Inc are the major companies operating in Antinuclear Antibody Test Market.

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