Antinuclear Antibody Testing Market Size, Share, Growth, Trends, and Global Industry Analysis: By Product Type (Reagents & Assay Kits, Systems, and Software & Services), By Technique Type (ELISA, Immunofluorescence Assay, and Multiplex Assay), By Application (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Scleroderma, and Others), By End Users (Hospitals, Clinical Laboratories, Physician Office Laboratories, and Others), and Region Forecast 2020-2031

Antinuclear Antibody Testing Market size was valued at US$ 652.6 million in 2024 and is expected to reach US$ 1,507.1 million by 2031, growing at a significant CAGR of 12.7% from 2025-2031. Antinuclear antibody (ANA) testing is done to check whether there are any autoimmune disorders that disturb the body's organs and tissues. These examinations search for antinuclear antibodies in the blood serum. The human immune system develops antibodies against foreign attackers like bacteria and viruses.

However, an antinuclear antibody attacks the normal cells of the patient and causes autoimmune disease. Some of the most common approaches to diagnose the occurrence of antinuclear antibodies in diseased patients are ELISA and indirect immunofluorescence. The screening test helps to check whether the body has these antibodies or not. The growing prevalence of autoimmune diseases among individuals across the world can lead to the growth of the market. Moreover, the increasing use of antinuclear antibody tests to diagnose autoimmune diseases such as Systemic Lupus Erythematosus, rheumatoid arthritis, Sjogren's Syndrome, and many more are some primary factors that can boost the market growth.

However, some factors, such as stringent U.S. Food and Drugs Administration rules for approval of the product, the absence of skilled laboratory technicians, and diagnostic mistakes, can restrain the growth of the market. Also, despite being a susceptible diagnostic tool, the anti-nuclear antibody test absences specificity, which may restrict its commercial growth soon, which can hinder the market growth. The rising number of diagnostic laboratories, accompanied by growing investments in lab automation, can create an opportunity to grow the market. Moreover, changing lifestyles and eating habits have led to an increase in autoimmune diseases can further provide a lucrative opportunity for market growth.  

Key Developments

• In November 2021, Stewart and Judy Colton from Colton Center for Autoimmunity in Pennsylvania donated US$10 million to the Perelman School of Medicine at the University of Pennsylvania to enhance the ongoing autoimmune research and care.
• In October 2020, Johnson & Johnson acquired Momenta to grow its concentration on autoimmune diseases.