Antinuclear Antibody Test Market

Global Antinuclear Antibody Test Market Size

The global antinuclear antibody test market was valued at USD 1665.90 million in 2024. The global antinuclear antibody test market size is forecasted to be worth USD 4816.33 million by 2033 from USD 1874.47 million in 2025, growing at a CAGR of 12.52% from 2025 to 2033.

The antinuclear antibody test market showcases evident potential in the mentioned forecasting period. It is an initial test to check a person's autoimmune disorders, affecting many tissues and organs in the body. This test is often used to diagnose Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis. When the Individual immune system fails to differentiate between foreign and self-particles, it produces a group of antinuclear antibodies. These antibodies attack their cells and cause signs and symptoms such as muscle and joint pain, tissue and organ inflammation, and fatigue. Antinuclear antibody tests (ANA) evaluate the blood's patterns and quantity of antibodies. If the test detects the presence of antinuclear antibodies in the individual's blood, it could mean that the person has an immune disorder. The immune disorders might affect the organs and healthy tissues in the body.

MARKET DRIVERS

Primarily factors such as an increase in the prevalence of autoimmune diseases, such as rheumatoid arthritis and SLE, and growth in people's awareness about these diseases are driving the global antinuclear antibody test market. Autoimmune diseases can also cause type I diabetes. According to WHO, from 1980 to 2014, the diabetes population increased from 108 million to 422 million. Other factors, such as an increase in healthcare expenditure of people due to developing economies and government healthcare insurance & reimbursement policies, are fuelling this market. Furthermore, the allowance of ANA for SLE tests for autoimmune diseases is boosting the use of antinuclear antibody testing, which is expected to grow more in the future. In addition, the demand for ANA is increasing due to factors such as the role of the primary healthcare physician's delivery system. Furthermore, rising incidences of autoimmune disorders such as lupus erythematosus and rheumatoid arthritis elevate the market demand.

Similarly, the government initiatives for early diagnosis and increasing research & development activities of autoimmune disorders are further expected to fuel the market demand. In addition, the ANA tests are accurate. Thus, it will help to drive the global antinuclear antibody test market.

The diagnostic advantages of antinuclear antibody testing are expected to support market growth. The market revenue is rising due to the increasing concerns among individuals regarding their healthcare, especially in the post covid era. In addition, the increasing focus on personalized treatment regimens and emphasis on point-of-care diagnosis procedures are supporting the advancement of the market. Furthermore, antinuclear antibody testing helps determine the possibilities of autoimmune disorders, which can be present in any individual regardless of their medical history and is difficult to detect due to low symptoms. Therefore, the market is on the rise with rising healthcare quality.

MARKET RESTRAINTS

Factors such as diagnostic errors, product approval, and skilled labor unavailability hinder the global antinuclear antibody test market growth. Furthermore, the cost of these tests is less affordable for the patients, which can hamper the sale in the global market. Also, factors like the availability of skilled labor, product approval, and diagnostics faults hamper the antinuclear antibody test market growth. The lack of skilled lab experts in the field makes it challenging to obtain accurate diagnostic readings, and consumers often question the tests' credibility.

REPORT COVERAGE

SEGMENTAL ANALYSIS

By Disease Insights

Based on Diseases, Rheumatoid Arthritis is expected to have the largest share in the market until the end of the forecast period due to the increased incidences of rheumatoid arthritis. According to reports from the CDC, approximately 58.5% of U.S. adults have rheumatoid arthritis every year. In addition, the rising geriatric populations are supporting the growth of the condition, further pushing the revenue for the segment.

SLE is projected to be the quickest-growing segment due to the growing awareness integrated with the initiatives taken by the government and the large number of tests endorsed by the U.S. FDA to identify the disease. In addition, the condition affects over 322,000 and 1.5 million adults in the U.S. every year, making it a severe problem. Therefore, the market for SLE is also expected to grow second only to rheumatoid arthritis during the forecast period.

By Technique Insights

Based on the technique, ELISA is currently leading the market based on the technique used for testing. However, the segment is likely to experience growth due to the implementation of the antinuclear antibody for testing autoimmune diseases and therapeutic level monitoring. Testing the antibody count in the patient's body can diagnose many conditions, and antibodies are the first to be impacted by severe diseases. In addition, antibody testing was also used during the Covid era to measure the immunity levels of individuals supporting the revenue for the segment.

The immunofluorescence segment is likely to have a quick growth rate during the period, and the growth is due to high obtainment in terms of revenue. Additionally, immunofluorescence is used in laboratory research, developing several drugs, and discoveries in life sciences/biologics.

By Product Insights

The Assay Kits & reagents segment accounts for the largest share of the global ANA testing market. It can be because of the growth in several reagent rental agreements. In addition, the growth is associated with factors like an average increase of autoimmune diseases, high acquisition of reagents & assay kits, better changes in efficiency, worth of results, and cost-saving.

However, the antinuclear antibody testing software segment is also expected to show fast growth due to the usability of software in disease testing and the requirement of software for research purposes as well as record-keeping activities.

By End-User Insights

The hospital's segment will likely hold the market's largest share based on the end-user. The growth is attributed to the diagnostic assays executed at hospitals and laboratories. In addition, easy accessibility of reports to collect and smooth logistics are propelling the demand of the market. Furthermore, hospitals have well-developed infrastructures, economic stability, and widespread connections to obtain high-end equipment and facilities to support the market. Therefore, the facilities for testing in hospital settings are expected to help its growth position.

The clinical lab segment, however, is also expected to show significant growth due to the rising locations of clinics worldwide and the fast results and better individual care at clinical centers.

REGIONAL ANALYSIS

Regionally, The North American region accounted for the most significant share of the global antinuclear antibody test market due to the growing population and healthcare spending and the growth of people under medical insurance in the United States. The growth of the North American market is further driven by factors such as well-established medical management healthcare, advanced technologies, and increasing awareness among the people. In this region, the U.S. market is predicted to dominate during the forecast period due to the growing number of independents that offer medical insurance.

The European market was the second-largest regional market in the global antinuclear antibody test market and was estimated to register a healthy CAGR during the forecast period. Countries like the UK, France, Spain, Germany, and Italy are expected to have healthy growth rates during the forecast period.

The Asia-Pacific is growing at the fastest rate. The growth is primarily driven by the massive increase in the incidence of autoimmune diseases in countries such as India and China. The growth of the APAC market is further favored by the fulfilled requirements for autoimmune diseases and a rising number of clinical trials to develop a drug for novel diseases.

The Latin America market is growing at a CAGR of 3.58% during the forecast period. Countries such as Brazil and Mexico are expected to lead this regional market. The growth is due to rising disposable income in urban areas and making betterment changes in the healthcare sector, accelerating the market growth.

The Middle East & Africa region is expected to have a sluggish growth rate in the antinuclear antibody test market during the forecast period. The growth is accredited due to the lack of awareness among the people about the devices and the treatment to be done.

KEY MARKET PLAYERS

Major companies profiled in the report's global antinuclear antibody test market are Zeus Scientific Inc., Inova Diagnostics, Immuno Concepts, Euroimmun AG, Antibodies Inc., Thermo Fisher Scientific Inc., Trinity Biotech plc, ERBA Diagnostics Inc., Bio-Rad Laboratories Inc., and Alere Inc.

RECENT MARKET HAPPENINGS

• In June 2022, the FDA approved Thermo Fisher autoimmune disease tests. To identify systemic sclerosis and systemic lupus erythematosus, Thermo Fisher Scientific's Elia RNA Pol III and Elia Rib-P blood tests have been approved by the U.S. Food and Drug Administration (FDA). According to the Waltham, Massachusetts-based company, the Elia RNA Pol III test for systemic sclerosis is the country's first utterly automated RNA polymerase test. In addition, its Elia Rib-P test can help confirm the diagnosis of systemic lupus erythematosus, especially in individuals without antinuclear antibodies.
• In June 2022, Theradiag and Quotient Limited announced a partnership to advance the diagnosis of autoimmune diseases. Theranostics pioneer and market leader in autoimmune disease testing, Theradiag and Quotient Limited, a commercial-stage diagnostics firm, have entered a partnership agreement to enhance autoimmune diagnostics using Quotient's MosaiQ platform. Threading will provide Quotient with autoimmune reagents and multi-constituent quality controls under the new contract for creating autoimmune microarrays for the MosaiQ solution. The parties expect their new partnership's initial application to be a treatment for connective tissue diseases (CTD). The complicated diagnostic method used for CTD testing is based on the screening for extractable nuclear antigen antibodies (ENAA) and antinuclear antibodies (ANA) (ENA),
• In September 2022, The Treatment of Lupus Joint Pain by an Experimental Drug is Looking Good. Currently, researchers are examining whether the experimental drug litifilimab will lessen lupus symptoms. Researchers have examined the medication litifilimab to see whether it may lessen swollen and painful joints in lupus patients. A monoclonal antibody generated in a lab is called litifilimab. It was created to target an immune cell protein linked to lupus inflammation specifically. 132 individuals in the latest research had lupus and at least four sore and sensitive joints.

MARKET SEGMENTATION

This research report on the global antinuclear antibody test market has been segmented and sub-segmented based on the disease, technique, product, end-user, and region.

By Disease

• SLE
• Rheumatoid Arthritis

By Technique

• Immunofluorescence
• Multiplex
• ELISA

By Product

• Software
• Systems
• Services
• Reagents & Assay Kits

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• The Middle East and Africa