Antinuclear Antibody Test Market Snapshot

The Antinuclear Antibody Test is projected to grow at 14.5% CAGR from 2023 to 2030. It is expected to reach above USD 3.69 billion by 2030, from USD 1.34 billion in 2022.

Antibodies that target the nucleus of body cells are found using a blood test known as the antinuclear antibody (ANA) test. Antinuclear antibodies are created when the immune system unintentionally targets the body's own cells, specifically the cell nucleus. Systemic lupus erythematosus (SLE) and rheumatoid arthritis are two autoimmune diseases for which the ANA test is primarily used as a diagnostic tool. These diseases develop when the immune system misbehaves and unintentionally targets healthy body tissues. Antinuclear antibodies, which may be a sign of an autoimmune disorder, can be found using the ANA test.

A blood sample is drawn for the ANA test, which is then subjected to laboratory analysis. The blood sample is exposed to human body cells during the test in order to identify the presence of particular antibodies. Antinuclear antibodies will bind to the cells in the blood sample if they are present, and this binding can be seen using fluorescent dyes or other methods. It's crucial to understand that a positive ANA test does not always signify a particular illness or condition. The patient's symptoms, medical history, and physical examination must all be carefully examined, and additional tests may be necessary. In conclusion, the ANA test is an effective method for identifying autoimmune diseases. It aids medical professionals in determining whether antinuclear antibodies are present in the blood, which can offer crucial hints in the assessment and management of patients with suspected autoimmune disorders.

The market is likely to be driven by the high prevalence of autoimmune disorders and public awareness of these diseases over the forecast period. There may also be a rise in ANA demand right now as a result of factors like the expanded and crucial role of primary care doctors in the healthcare delivery system. Additionally, the demand for ANA tests has been sparked by rising R&D activities and improvements in medical infrastructure, particularly in developing economies like Brazil and China.

However, there are growing worries regarding the validity of ANA tests. Not every person with lupus continues to test positive for ANA tests, according to a study done by the Lupus Research Alliance. The study also showed that depending on the particular diagnostic techniques used, whether a person with long-standing lupus tests ANA negatively or positively can vary significantly. Therefore, the variability of antinuclear antibody tests may act as a market restraint.

The antinuclear antibody (ANA) test market offers numerous chances for expansion and improvement. The demand for ANA testing is predicted to increase as autoimmune diseases become more common. Technology advancements like automated systems and multiplex assays offer increased accuracy and effectiveness. The market's potential growth is also influenced by rising awareness, expanding healthcare infrastructure, and research initiatives.

COVID-19 Impact

The COVID-19 pandemic is anticipated to have a positive effect on the market for anti-nuclear antibody testing because COVID-19 patients have a high risk of developing autoimmune disorders, which necessitates early diagnosis using anti-nuclear antibody testing as a screening tool. For instance, a study conducted by the Department of Laboratory Medicine and Pathology at the University of Washington in the United States in 2020 found that 30% of COVID-19 patients had anti-nuclear antibodies that could be detected. The development of a COVID-19 vaccine and the treatment of COVID-19 have both been the subject of extensive research and clinical trials involving antinuclear antibody testing, which will further fuel the market's expansion.

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Growth Drivers

The rise in autoimmune disorders like SLE and rheumatoid arthritis has led to a surge in demand for antinuclear antibody testing. The CDC predicts a 49% increase in arthritis cases in the US over the next 20-25 years. The Lupus Foundation estimates 5 million people worldwide suffer from SLE, with 16,000 new cases each year.

The anti-nuclear antibody testing industry is growing due to government healthcare insurance, increased autoimmune awareness programs, and reimbursement rules. The World Lupus Federation (WLF) is a collaboration of over 250 lupus organizations to improve healthcare for Lupus patients. Technological advances and increased R&D spending are driving the growth of the market, aiming to create novel products or methodologies.

Market Restraints

The US FDA's strict product approval requirements, shortage of qualified labor, and diagnostic errors are expected to hinder the global growth of the anti-nuclear antibody testing industry. The American College of Rheumatology warns that false positive tests may occur in healthy individuals or those using drugs like isoniazid and procainamide.

Antinuclear Antibody Test Market Segment Analysis

The antinuclear antibody test market is segmented based on type, application, component, water depth and region. By product the market is bifurcated into reagents & assay kits, systems, software & services; by technique the market is bifurcated into ELISA, immunofluorescence assay, multiplex assay; by disease the market is bifurcated into rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, scleroderma, others; by end user the market is bifurcated into hospitals, clinical laboratories, physician office laboratories, others.

The reagents & assay kits sub-segment dominated the market in 2021 in terms of product. The test kits are primarily used in life science research, drug discovery and development, environmental monitoring, and the study of disease pathways, as well as for various research and development goals like screening for potential drug candidates and assessing biopharmaceutical manufacturing procedures. It is anticipated that the market will grow throughout the anticipated timeframe due to the wide variety of applications. These are anticipated to have a significant impact on the antinuclear antibody test market size over the course of the forecast period.

The ELISA sub-segment dominated the global antinuclear antibody test market share in 2021, according to technique industry. The body produces antibodies to fight antigens or foreign substances more quickly, and these antibodies can be found using an ELISA test, also known as an enzyme-linked immunosorbent assay (ELISA). During the forecast period, the antinuclear antibody test method used in ELISA is certain to open up growth opportunities for the sub segment.

Due to the rising prevalence of rheumatoid arthritis, rheumatoid arthritis is anticipated to hold the largest market share by disease until the end of the forecast period. The CDC estimates that 58.5% of adult Americans suffer from rheumatoid arthritis each year. Additionally, the growing elderly population is fostering the condition's expansion and driving up the segment's revenue.

In 2021, it is anticipated that the hospitals sub-segment will hold a commanding market share. High revenue share can be attributed to factors like the increasing prevalence of autoimmune diseases and the requirement for quick diagnosis. A rise in patient satisfaction, improved outpatient services, and improved home care facilities provided by hospitals are predicted to drive the hospital sub-segment market over the forecasted period.

Antinuclear Antibody Test Market Key Players

The antinuclear antibody test market key players include Erba Diagnostics, Bio-Rad Laboratories Inc., Trinity Biotech Plc., Thermo Fisher Scientific, Antibodies Incorporated, EUROIMMUN AG, Immuno Concepts NA Ltd., Inova Diagnostics Inc., ZEUS Scientific Inc., Alere Inc., and others.

New Developments

09 May 2023: Pfizer and Thermo Fisher Scientific Inc. (NYSE: TMO) announced they have entered into a collaboration agreement to help increase local access to next-generation sequencing (NGS)-based testing for lung and breast cancer patients.

25 February 2021: Antibodies Incorporated announced that Immunochemistry Technologies (ICT) has joined our growing family of Janel Life Sciences companies that now includes Antibodies Incorporated, PhosphoSolutions, AvesLabs, and Immunochemistry Technologies (ICT).

Antinuclear Antibody Test Market Regional Analysis

In terms of revenue, North America was the largest regional segment in 2022, followed by Europe. In terms of ANA testing adoption, healthcare infrastructure, patient awareness, and the availability of advanced tests, North America and Europe are the two regions with the most established markets. As a result, they account for the majority of the ANA market.

Due to unmet clinical needs and the need for improved diagnosis, Asia Pacific is expected to experience the fastest growth during the forecast period. During the forecast period, it is anticipated that unmet needs for diagnostics for autoimmune diseases in nations like India will increase regional demand.

Segments Covered in the Antibiotics Market Report

Antinuclear Antibody Test Market by Product

• Reagents & Assay Kits
• Systems
• Software & Services

Antinuclear Antibody Test Market by Technique

• ELISA
• Immunofluorescence Assay
• Multiplex Assay

Antinuclear Antibody Test Market by Disease

• Rheumatoid Arthritis
• Systemic Lupus Erythematosus
• Sjogren’s Syndrome
• Scleroderma
• Others

Antinuclear Antibody Test Market by End User

• Hospitals
• Clinical Laboratories
• Physician Office Laboratories
• Others

Antinuclear Antibody Test Market by Region

• North America
• Asia Pacific
• Europe
• South America
• Middle East and Africa

Frequently Asked Questions

What is the expected CAGR in terms of revenue for the global antinuclear antibody test market over the forecast period (2023–2030)?

The global antinuclear antibody test market is expected to grow at 14.5% CAGR from 2023 to 2030. It is expected to reach above USD 3.69 billion by 2030. from USD 1.34 billion in 2022.

What was the global antinuclear antibody test market valued at in 2022?

The global antinuclear antibody test market was valued at USD 1.34 billion in 2022.

Who are the key players in the antinuclear antibody test market?

Some key players operating in Erba Diagnostics, Bio-Rad Laboratories Inc., Trinity Biotech Plc., Thermo Fisher Scientific, Antibodies Incorporated, EUROIMMUN AG, Immuno Concepts NA Ltd., Inova Diagnostics Inc., ZEUS Scientific Inc., and Alere Inc.

Which region held the largest market share in the antinuclear antibody test market?

North America had the largest share of the global antinuclear antibody test market.

What are the driving factors and opportunities in the global antinuclear antibody test market?

The diverse use of antinuclear antibody test, worldwide, to identify the occurrence of autoimmune diseases like rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, scleroderma and other sectors is the major market driver. In addition, increasing investments for the establishment of medical laboratories especially in the developing countries, due to rising investments for healthcare infrastructure and test kits, is estimated to generate ample growth opportunities for the antinuclear antibody market in the estimated timeframe.