Global Antinuclear Antibody (ANA) Test Market By Type (Reagents & Assay Kits, Systems, and Software & Service), By Application (Hospitals Clinical Laboratories Physician Office Laboratories Others, ), By Region, and Key Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2022-2032

Antinuclear Antibody Test Market Overview:

The market for antinuclear antibody tests was worth USD 1,388.6 million in 2021. It is projected to grow at a CAGR of 11.8% between 2023 and 2032. The market will be driven by the high prevalence of autoimmune diseases and increased awareness about these conditions.

Global Antinuclear Antibody Test Market Scope:

Product Analysis

The market for antinuclear antibodies test can be divided into products and systems. 2021 was the year that the largest market segment was reagents & assay kits. This segment is expected to grow the fastest due to its high adoption in research and clinical settings.

Assay kits and assay agents have a significant impact on the assay’s overall performance. They facilitate researchers from different fields by creating standard workflows. Standard reagents are essential for achieving accurate and efficient results. Market growth will be supported by increased efficiency, standard results, and greater cost-effectiveness in the near future. The segment is expected to maintain its market position due to an increase in reagent rental agreements. Thermo Fisher Scientific and Bio-Rad Laboratories are the key players in this market that provide reagents or assay kits.

Technique Analysis

The market for antinuclear antibody tests can be divided into three types of techniques: ELISA (embolization), immunofluorescence assay (multiplex assay), and immunofluorescence. The market’s largest revenue generator was the immunofluorescence assay in 2021, due to its high adoption. Because it has a higher sensitivity than other methods, the immunofluorescence assay can be considered the gold standard in ANA testing. It can also identify patterns that indicate associated autoantibodies or underlying diseases like nucleolar, speckled, and homogenous. ELISA will likely see the most rapid growth due to its increasing adoption. These tests can be automated easily and don’t require any operator skills. This is expected to be a positive factor for market growth during the estimated period. Moreover, ELISA has a higher specificity than the immunofluorescence assay. It is used to screen for ANA positives.

Application Analysis

The market can be classified based on its application to systemic Lupus Erythematosus, rheumatoid, scleroderma, and systemic lupus erythematosus. Due to increasing incidence, the market share for rheumatoid arthritis is expected to be the largest. The U.S. Centers for Disease Control and Prevention reported that arthritis affected approximately 28% of the population in March 2021. According to projections, approximately 76 million (17%) Americans aged 18 and over will have arthritis diagnosed by a doctor by 2032. The most common forms of arthritis are osteoarthritis and rheumatoid. SLE is the fastest-growing segment due to increasing awareness and government initiatives.

End-Use Analysis

The market for antinuclear antibody tests can be divided into three segments based on end-use: hospitals, physician offices laboratories, and clinical laboratories. In 2021, hospitals were the largest segment. Hospitals receive the highest number of diagnostic exams, due to their accessibility. The hospital segment is expected to hold the largest market share over the estimated period. Over the forecast period, significant growth is expected in physician office laboratories. The segment growth is expected to be driven by the expanding and important role of physicians in the healthcare delivery system in the coming years.

Key Market Segments:

By Product

• Reagents & Assay Kits
• Software & Services
• Systems

By Technique

• ELISA
• Multiplex Assay
• Immunofluorescence Assay

By Application

• Rheumatoid Arthritis
• Sjogren’s Syndrome
• Scleroderma
• Systemic Lupus Erythematosus
• Other Applications

By End-Use

• Hospitals
• Physician Office Laboratories
• Clinical Laboratories
• Other End-use

Market Dynamics:

The American Autoimmune Related Disease Association, (AARDA) estimates that approximately 50 million Americans are affected by autoimmune diseases. This number is increasing each year. It is the leading cause of death for women in all age groups, up to 65. According to AARDA, 80% of patients with autoimmune diseases are women.

Antinuclear antibody testing (ANA) is an important tool for diagnosing and managing autoimmune diseases, such as Systemic Lupus Erythematosus and Rheumatoid Arthritis (RA), at both subspecialty and primary care. These tests are now more popular because they can be used to test for all autoimmune disorders. The increased demand for ANA could also be due to factors like the expanded and central role played by primary care physicians in the healthcare delivery system. ANA tests are also in demand due to rising R&D and improvements in medical infrastructure, mainly in developing countries like Brazil and China. There have been growing concerns about the reliability of ANA tests. The Lupus Research Alliance found that not all people with lupus are eligible for ANA testing. The study also revealed that the diagnostic procedures used can have an impact on whether a person with lupus has ANA positive or negative over time. Inconsistency in antinuclear antibody tests can hinder the market.

Regional Analysis:

North America was the dominant market, accounting for over 39.8% of global revenue in 2021, followed by Europe. The most established markets geographically are North America and Europe in terms of ANA testing adoption, healthcare infrastructure, patient awareness, and advanced tests. They make up the majority of the ANA market. The Asia Pacific will be the fastest-growing region in the forecast period due to unmet medical needs and the need for better diagnoses. The forecast period will see an increase in demand for regional autoimmune disease diagnostics services in India and other countries.

Key Regions and Countries covered in the report:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Russia
  • Spain
  • Rest of Europe
• APAC
  • China
  • Japan
  • South Korea
  • India
  • Rest of Asia-Pacific
• South America
  • Brazil
  • Argentina
  • Rest of South America
• MEA
  • GCC
  • South Africa
  • Israel
  • Rest of MEA

Market Share & Key Players Analysis:

Grifols was approved by the FDA in 2018 for its new diagnostic tests for ANCA-associated vasculitis or lupus. Labs will be able to quickly and efficiently diagnose using immunofluorescence assay by standardizing these tests. The U.S. FDA has recently approved a method that will allow laboratories to quickly diagnose autoimmune diseases like lupus, vasculitis, and scleroderma.

Market Key Players:

• Thermo Fisher Scientific Inc.
• Alere Inc.
• Bio-Rad Laboratories
• Antibodies Inc.
• Immuno Concepts
• Zeus Scientific
• Inova Diagnostics
• Erba Diagnostics
• Euroimmun AG
• Trinity Biotech PLC
• Other Key Players

For the Antinuclear Antibody (ANA) Test Market research study, the following years have been considered to estimate the market size: