Antinuclear Antibody Test Market To Reach $5.47 Billion By 2033

Antinuclear Antibody Test Market Growth & Trends

The global antinuclear antibody test market size is expected to reach USD 5.47 billion by 2033, registering a CAGR of 13.49% from 2025 to 2033, according to a new report by Grand View Research, Inc. Rising adoption of ANA test coupled with government initiatives to treat autoimmune disorders is likely to drive the market. Furthermore, rising incidence of autoimmune disorders is projected to fuel the growth.

Antinuclear Antibody (ANA) testing is an important tool to diagnose and manage autoimmune diseases such as Systemic Lupus Erythematosus (SLE) and rheumatoid arthritis. According to the Lupus Foundation of America, at least 5 million people globally and around 1.5 million people in U.S. have a form of lupus. Around 16,000 new cases are registered every year. The disease mostly affects women of childbearing age. SLE accounts for almost 70% of all cases of lupus. The high prevalence of autoimmune disorders is one of the factors driving the market.

Extension of ANA from a test for SLE to a test for any autoimmune diseases has boosted the usage of antinuclear antibody testing. An increase in ANA demand may also be due to the factors such as expanded role of primary care physicians in healthcare delivery systems. In addition, rising R&D activities and government initiatives regarding early diagnosis of autoimmune disorders have triggered the demand for ANA tests.

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Antinuclear Antibody Test Market Report Highlights

• Reagents and assay kits was the largest segment in 2024. It is likely to witness fastest growth over the forecast period due to wide usage and rise in a number of reagent rental agreements

• Immunofluorescence assay led the market in terms of market share in 2024 owing to superior sensitivity compared to other available techniques

• ELISA is expected to be the fastest growing segment over the forecast period. Increasing adoption of these tests is attributed to easy automation and handling without high level of operator skill

• Rheumatoid arthritis segment is projected to hold largest market share, mainly due to high prevalence of the disease

• North America was the largest region in terms of revenue in 2024, followed by Europe. Both are the most well-established regions in terms of the adoption of ANA testing and make up most of the existing market

• Asia Pacific is likely to be the fastest growing region over the forecast period due to unmet clinical needs and need for better diagnosis. Rising government initiatives and clinical research activities for advanced diagnostics are expected to further fuel growth

Antinuclear Antibody Test Market Segmentation

Grand View Research has segmented the global antinuclear antibody test based on product, test technique, application, end use, and region:

Antinuclear Antibody Test Product Outlook (Revenue, USD Million, 2021 - 2033)

• Reagents & Assay Kits

• Systems

• Software & Services

Antinuclear Antibody Test Test Technique Outlook (Revenue, USD Million, 2021 - 2033)

• ELISA

• Immunofluorescence Assay

• Multiplex Assay

Antinuclear Antibody Test Application Outlook (Revenue, USD Million, 2021 - 2033)

• Rheumatoid Arthritis

• Systemic Lupus Erythematosus

• Sjogren’s Syndrome

• Scleroderma

• Other Diseases

Antinuclear Antibody Test End Use Outlook (Revenue, USD Million, 2021 - 2033)

• Hospitals

• Clinical Laboratories

• Physician Office Laboratories

• Others

Antinuclear Antibody Test Regional Outlook (Revenue, USD Million, 2021 - 2033)

•  North America

  • U.S.

  • Canada

  • Mexico

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Thailand

• Latin America

  • Brazil

  • Argentina

• Middle East & Africa

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

List Of Key Players Antinuclear Antibody Test Market

• Abbott

• Bio-Rad Laboratories, Inc.

• Erba Mannheim

• Trinity Biotech Plc.

• Thermo Fisher Scientific, Inc.

• Antibodies Incorporated

• QuidelOrtho Corporation

• ZEUS Scientific, Inc.

• Merck KGaA

• Revvity

• EUROIMMUN Medizinische Labordiagnostika AG

• Immuno Concepts NA Ltd.

• ORGENTEC

• Transasia Bio-Medicals.