Antinuclear Antibody Test Market Size, Share & Trends Analysis Report By Product, By Technique (ELISA, Immunofluorescence Assay), By Application (Rheumatoid Arthritis, SLE), By End Use, And Segment Forecasts, 2018 - 2025

Industry Insights

The global antinuclear antibody test market size was valued at USD 923.1 million in 2017. It is projected to expand at a CAGR of 12.5% over the forecast period. High prevalence of autoimmune disorders coupled with awareness regarding these diseases is likely to drive the market over the forecast period.

According to the American Autoimmune Related Disease Association (AARDA), around 50 million people in the U.S. suffer from autoimmune diseases in the U.S. and the prevalence is rising every year. It is one of the top 10 leading causes of death in women of all groups up to 65 years of age. As per AARDA, women account for 75% of all patients with autoimmune diseases.

Antinuclear antibody (ANA) testing is an important tool to diagnose and manage autoimmune diseases such as Systemic Lupus Erythematosus (SLE) and rheumatoid arthritis, at both the subspecialty settings and primary care. Repurposing of ANA from a test for SLE to a test for any autoimmune disorders has increased the adoption of these tests.

The current upsurge in demand for ANA may also be due to the factors such as expanded and central role of primary care physicians in healthcare delivery system. Furthermore, rising R&D activities and advancements in medical infrastructure mainly in developing economies including Brazil and China has triggered demand for ANA tests.

However, there have been rising concerns over unreliability of ANA tests. According to a study conducted by the Lupus Research Alliance, not all people who have been detected with lupus remain positive for ANA tests. In addition, the study revealed that whether an individual with long-standing lupus tests ANA negative or positive can differ widely based on the specific diagnostic procedures being used. Hence, inconsistency of antinuclear antibody tests can be a restraining factor for the market.

Product Insights

Based on products, the market for antinuclear antibody test is categorized into reagents and assay kits, systems, and software and services. The reagents and assay kits was estimated to be the largest segment in 2017. It is likely to witness the fastest growth over the forecast period owing to high adoption of the product in clinical and research settings. 

Reagents and assay kits influence the overall performance of an assay. They help create standardized workflows to support researchers in various fields. Standard reagents help achieve accurate and efficient results. Improved efficiency, standardized results, and cost-effectiveness are projected to further support market growth in the near future.

In addition, increasing number of reagent rental agreements is anticipated to help the segment maintain its market position. The key market players providing reagents and assay kits are Thermo Fisher Scientific, Bio-Rad Laboratories, and Zeus Scientific.

Technique Insights

Based on technique, the antinuclear antibody test market is segmented into ELISA, immunofluorescence assay, and multiplex assay. Immunofluorescence assay dominated the market in terms of revenue in 2017 owing to their high adoption. Immunofluorescence assay is considered to be the gold standard for ANA testing as it offers a superior sensitivity compared to other available techniques.

In addition, it can identify patterns indicating associated autoantibodies and underlying diseases such as nucleolar, speckled, homogenous, and others. ELISA is likely to witness the fastest growth over the forecast period due to its rising adoption. These tests are easily automated and do not need a high level of operator skill to perform. This factor is anticipated to bode well for market growth over the forecast period. Furthermore, ELISA provides higher specificity than immunofluorescence assay. It is generally used but as a screening tool for profiling an ANA positive.

Application Insights

Based on application, the market is categorized into rheumatoid arthritis, Systemic Lupus Erythematosus (SLE), Sjogren’s syndrome, scleroderma, and others. Rheumatoid arthritis segment is expected to hold the largest market share, mainly due to the increasing incidence of the disease. 

According to the U.S. Centers for Disease Control and Prevention (CDC), in March 2017, around 54.4 million adults in the U.S. had arthritis - equating to around 25% of population. It has been projected that by 2040, around 78 million (26%) adults in U.S. aging 18 years or above will have doctor-diagnosed arthritis. Rheumatoid arthritis and osteoarthritis are the most common types of the disease.

SLE is estimated to be the fastest growing segment owing to rising awareness coupled with government initiatives and number of tests approved by the U.S. Food and Drug Administration (FDA) to diagnose the disease.

End-use Insights

Based on end-use, the market for antinuclear antibody test is segmented into hospitals, clinical laboratories, and physician office laboratories. Hospitals was estimated to be the largest segment in 2017. Maximum number of diagnostic examinations are performed in hospitals, mainly due to easy access.

It is estimated that over the forecast period the hospital segment will hold the largest share of the global market. The physician office laboratories segment is expected to witness substantial growth over the forecast period. Expanded and essential role of physician in the healthcare delivery system is anticipated to propel segment growth in the forthcoming years.

Regional Insights

North America was the largest regional segment in terms of revenue in 2017, followed by Europe. Geographically, North America and Europe are the most well-established markets in terms of adoption of ANA testing, healthcare infrastructure, patient awareness, and the presence of advanced tests. Hence they make up most of the existing market for ANA.

Asia Pacific is projected to be the fastest growing region during the forecast period owing to unmet clinical needs and need for better diagnosis. Unmet needs for autoimmune disease diagnostics in countries like India are anticipated to boost the regional demand during the forecast period.

Antinuclear Antibody Test Market Share Insights

Major players in the global market are Thermo Fisher Scientific Inc.; Alere Inc.; Bio-Rad Laboratories.; Antibodies Inc.; Immuno Concepts; Zeus Scientific; Inova Diagnostics; Erba Diagnostics; Euroimmun AG; and Trinity Biotech PLC. Key companies are adopting different business strategies such as expanding their geographic presence, R&D activities, new product approvals, and collaborations to increase market share.

For instance, in 2018, Grifols received the U.S. FDA approval for their new diagnostic examinations for Antineutrophil Cytoplasmic Antibodies (ANCA)-associated vasculitis and lupus. These tests will enable labs to standardize and speed up diagnosis using immunofluorescence assay. Recent approvals by the U.S. FDA will provide laboratories with a reliable and an efficient way to diagnose for autoimmune diseases such as lupus, scleroderma, and vasculitis.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis on the latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global antinuclear antibody test market report based on product, technique, application, end use, and region:

• Product Outlook (Revenue, USD Million, 2014 - 2025)

  • Reagents & Assay Kits

  • Systems

  • Software & Services

• Technique Outlook (Revenue, USD Million, 2014 - 2025)

  • ELISA

  • Immunofluorescence Assay

  • Multiplex Assay

• Application Outlook (Revenue, USD Million, 2014 - 2025)

  • Rheumatoid Arthritis

  • Systemic Lupus Erythematosus

  • Sjogren’s Syndrome

  • Scleroderma

  • Others

• End-use Outlook (Revenue, USD Million, 2014 - 2025)

  • Hospitals

  • Clinical Laboratories

  • Physician Office Laboratories

  • Others

• Regional Outlook (Revenue, USD Million, 2014 - 2025)

  • North America

    • The U.S.

    • Canada

  • Europe

    • The U.K.

    • Germany

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

  • MEA

    • South Africa