; Antinuclear antibody test market size, share, forecast

Antinuclear Antibody Test Market

Antinuclear Antibody Test Market Size, Share, and Analysis, By Product (Reagents & Assay Kits, Systems, Software, and Services), By Technique (ELISA, Immunofluorescence Assay, and Multiplex Assay), By Application (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Scleroderma, and Others), By End-use (Hospitals, Clinical Laboratories, Physician Office Laboratories, and Others), and By Region (North America, Europe, Asia-Pacific, And Rest of the World) And Regional Forecast 2024-2034

Published on: Feb-2024
Report Code: FG HC 01854
No. of Pages: 170-350
Report Format: PDF

Antinuclear Antibody Test Market is anticipated to exhibit a Compound Annual Growth Rate (CAGR) of 11.3% during the forecast span from 2024 to 2034. In 2023, the market size was assessed at USD 2 billion and is projected to reach USD 6.6 billion by the completion of 2034.

Product Overview

Antinuclear Antibody (ANA) Test is a diagnostic procedure which is designed to identify antibodies targeting the body's cell nuclei and reveal potential autoimmune disorders such as lupus or rheumatoid arthritis. This examination involves analyzing a patient's blood for antinuclear antibodies, which bind to various components within cell nuclei. A positive result indicates an abnormal immune response, which encourages further investigation into specific autoimmune conditions. Additionally, despite its sensitivity, the ANA Test lacks specificity for a particular disease, and requires additional tests and clinical evaluation for precise diagnosis. Furthermore, the ANA Test, which is widely used by rheumatologists, helps to diagnose autoimmune illnesses early on, thereby allowing for timely medical intervention. This screening is significant for identifying underlying health concerns and developing suitable treatment options.

Market Highlights

Antinuclear Antibody Test Market is expected to grow at a compound annual growth rate (CAGR) of 11.3% from 2024 to 2034

Antinuclear Antibody Test Market is projected to reach USD 6.6 billion over the forecast period, owing to the increasing prevalence of autoimmune diseases. The expansion of the market is attributed to several factors such as heightened awareness, along with early disease detection initiatives and improvements in healthcare infrastructure. Moreover, the rising incidence of autoimmune disorders such as lupus and rheumatoid arthritis, combined with the aging population, is responsible for the growing demand of precise diagnostic tools such as the ANA Test. Additionally, major industry players are actively investing in research & development to introduce innovative products, which further strengthens their market presence. Therefore, the market is expected to experience sustained growth, which highlights the crucial role of antinuclear antibody test in addressing the diagnostic needs associated with autoimmune disorders on a global scale.

Source: Fatpos Global

Antinuclear Antibody Test Market Segmentation

Reagents & Assay Kits segment will lead due to its wide application across medical sector

Based on Product, the Antinuclear Antibody Test Market is segmented into Reagents & Assay Kits, Systems, Software, and Services. The reagents and assay kits segment is expected to hold significant market share in the antinuclear antibody (ANA) test market owing to their vast applications across various domains. These components play an essential role in conducting ANA tests and are widely used in life science research, drug discovery & development, environmental monitoring, and to study the pathway of a disease. Additionally, reagents & assay kits are adaptable instruments which are used to screen new drug candidates and evaluate biopharmaceutical manufacturing processes. These diverse range of applications highlight the importance of reagents and assay kits in ANA testing, making them indispensable to researchers and healthcare providers. Therefore, the important role of reagents & assay kits in various scientific endeavors improves their market appeal and establishes them as fundamental contributors to the ongoing expansion of Antinuclear Antibody Test market.

ELISA segment will dominate owing to its ability to identify antibodies

By Technique, Antinuclear Antibody Test Market is divided into ELISA, Immunofluorescence Assay, Multiplex Assay. The enzyme-linked immunosorbent assay (ELISA) segment in the antinuclear antibody test market is due to the efficiency of this technique in swiftly identifying antibodies produced by the body to combat foreign substances. ELISA, which is commonly employed in ANA testing, plays an important role in precise detection by simplifying the binding of antibodies to specific antigens. The method provides quick and accurate results which contribute to its high adoption in ANA testing field. Furthermore, as the demand for reliable diagnostic tools continues to expand, the ELISA segment is anticipated to experience sustained growth during the forecast period. The inherent benefits of ELISA in antibody detection create a favorable outlook for its dominance in the ANA Test market.

Source: Fatpos Global

Market Dynamics

Growth Drivers

Increased Prevalence of Autoimmune Diseases Will Create Growth Opportunities

Global rise in the prevalence of autoimmune disease, which includes conditions like lupus and rheumatoid arthritis, acts as an important growth driver for the antinuclear antibody (ANA) test market. The growing incidence of these disorders intensifies the need for accurate diagnostic tools, which provides early detection and intervention. Additionally, the ANA Test emerges as a crucial tool in analyzing autoimmune conditions, thereby assisting in patient management and treatment. This growing awareness and focus on early diagnosis create a favorable condition for market growth, with healthcare professionals prioritizing comprehensive testing methods to deal with the increasing occurrence of autoimmune diseases. Thus, the rising demand for accurate diagnosis highlights the important role of ANA Test in addressing the autoimmune health challenge.

Technological Improvements in Diagnostics Will Lead to Market Expansion

Improvement in diagnostic technologies, such as the development of advanced and automated methods for antinuclear antibody (ANA) testing, has a significant impact on the growth of the market. These technological improvements raise the precision, speed, and efficiency of ANA tests, which enhance their appeal to healthcare professionals and researchers. The implementation of automated systems simplifies testing procedures, thereby diminishing the possibility of errors and improving diagnostic accuracy. Additionally, the incorporation of modern technologies fulfills the increasing demand for advanced diagnostics and projects the ANA Test market as a leader in innovating autoimmune disorder monitoring.


Lack of Specificity in Diagnosis can Prevent Industry Growth

Limited specificity for a particular disease is a significant constraint in the antinuclear antibody test market. ANA tests are sensitive indicators of abnormal immune responses; however, a positive result does not accurately identify the specific autoimmune illness. Given this lack of specificity, proper diagnoses and differentiation between autoimmune illnesses requires further testing and careful clinical evaluation. Moreover, false positives make it difficult to administer targeted medical therapies. Therefore, effectively addressing this issue is important for improving the efficiency and reliability of ANA testing in the identification of certain autoimmune diseases.

Recent Developments

  • In October 2023, Thermo Fisher Scientific launched new ANA test kit with improved sensitivity and specificity. The company also acquired Phadia, a company specializing in allergy and autoimmune testing, for $1.5 billion.
  • In November 2023, Siemens Healthineers launched Atellica LUMIX immunoassay system for automated ANA testing. Siemens also partnered with Inova Diagnostics to offer combined autoimmune testing solutions.
  • In December 2023, Roche Diagnostics launched Elecsys ANA Profile Plus assay for comprehensive autoantibody testing.
  • In January 2024, Bio-Rad Laboratories launched multiplex ANA test kit for simultaneous detection of multiple autoantibodies. They are looking to expand its point-of-care ANA testing offerings.
  • In December 2023, Abbott Laboratories launched ARCHITECT ANA II assay with enhanced performance characteristics.

Antinuclear Antibody Test Market

Key Players:

Regional Analysis

Antinuclear Antibody Test Market is segmented based on regional analysis into five key regions: North America, Latin America, Europe, Asia Pacific and the Middle East and Africa. The North America region leads the antinuclear antibody test market, owing to several factors. The region exhibits well-established markets with vast ANA testing adoption in different sectors. Moreover, North America hosts a strong healthcare infrastructure, which provides efficient diagnostic methods and contributes to the high usage of ANA testing. Additionally, high patient awareness regarding autoimmune diseases is responsible for growing demand of diagnostic tools like antinuclear antibody test.

Simultaneously, Asia-Pacific region is experiencing significant growth in the ANA test market due to clinical needs and a high demand for diagnostic abilities. Additionally, as healthcare awareness and infrastructure continue to improve, the Asia-Pacific region will emerge as an important contributor to the increasing global significance of ANA testing.

Source: Fatpos Global

Impact of Covid-19 on Antinuclear Antibody Test Market

COVID-19 pandemic exerted a mixed influence on the antinuclear antibody test market. Disruptions in global supply networks presented several challenges for diagnostic test manufacturing and distribution. Moreover, changing healthcare priorities to manage the pandemic resulted in delays in standard diagnostic tests, like ANA testing. However, the pandemic increased the awareness about pivotal role of diagnostics and highlighted the need for strong testing tools. Additionally, various opportunities emerged with the rising adoption of telehealth during the pandemic, which created several possibilities for remote consultations and monitoring that influenced the demand for diagnostic tests.

Antinuclear Antibody Test Market is further segmented by region into:

  • North America Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – United States and Canada
  • Latin America Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – Mexico, Argentina, Brazil, and Rest of Latin America
  • Europe Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – United Kingdom, France, Germany, Italy, Spain, Belgium, Hungary, Luxembourg, Netherlands, Poland, NORDIC, Russia, Turkey, and Rest of Europe
  • Asia Pacific Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – India, China, South Korea, Japan, Malaysia, Indonesia, New Zealand, Australia, and Rest of APAC
  • Middle East and Africa Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – North Africa, Israel, GCC, South Africa, and Rest of MENA

Antinuclear Antibody Test Market Scope and Segments:



Study Period


Base Year


Forecast Period


Historical Period


Growth Rate

CAGR of 11.3% from 2024-2034


Value (USD Billion)


Main Segments List

By Product

  • Reagents & Assay Kits
  • Systems
  • Software
  • Services

By Technique

  • Immunofluorescence Assay
  • Multiplex Assay

By Application

  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus
  • Scleroderma
  • Others

By End-Use

  • Hospitals
  • Clinical Laboratories
  • Physician Office Laboratories
  • Others

By Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • Southeast Asia
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa

Frequently Asked Questions (FAQ):

Antinuclear Antibody Test Market size was values at USD 2 billion in 2023 and is projected to reach the value of USD 6.6 billion in 2034, exhibiting a CAGR of 11.3% during the forecast period.

The Antinuclear Antibody (ANA) Test Market involves diagnostic tools for detecting antibodies targeting cell nuclei, aiding in the identification of autoimmune disorders. It plays a crucial role in assessing abnormal immune responses associated with conditions like lupus and rheumatoid arthritis.

Reagents & Assay Kits segment and the ELISA segment accounted for the largest Antinuclear Antibody Test Market share.

Key players in the Antinuclear Antibody Test Market include Thermo Fisher Scientific, Siemens Healthineers, Roche Diagnostics, Bio-Rad Laboratories, Abbott Laboratories, Quest Diagnostics, Beckman Coulter, EUROIMMUN, Inova Diagnostics, Antibodies Incorporated, AESKU Group, Erba Mannheim, Immuno Concepts, Zeus Scientific, Aesku.Diagnostics, and Other Prominent Players.

Increased prevalence of autoimmune diseases and technological improvements in diagnostics are the factors driving the antinuclear antibody test market.

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