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Antinuclear Antibody Test Market Segmentation by Product (Assay, Reagent kits, and Software & Services); by Disease (Scleroderma, Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Others); by Technology (Immunofluorescence and Multiplex Assay, and ELISA); and by End-User (Hospitals, Clinical and Physician Laboratories, and Others) – Global Demand Analysis & Opportunity Outlook 2031

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  • May 31, 2022: F. Hoffmann-La Roche Ltd receives approval from the Food and Drug Administration (FDA) for its Evrysdi, a prescription medicine, to treat spinal muscular atrophy (SMA) in babies under two months’ age.

  • May 3, 2022: Food and Drug Administration (FDA) provides the clearance for the utilization of dIFine, a digital immunofluorescence system developed by Zeus Scientific Inc.

Global Antinuclear Antibody Test Market Highlights Over 2022 - 2031

The global antinuclear antibody test market is estimated to garner noteworthy revenue by growing at a CAGR of ~13% over the forecast period, i.e., 2022 – 2031. The growth of the market can be attributed to the higher prevalence of autoimmune diseases and the growing number of reagent rental agreements across the globe. According to a report published by World Health Organization (WHO), in 2017, there were 9 million people suffering from type 1 diabetes, while 422 million people in the global population have some sort of diabetes. Moreover, in 2019, 1.5 million people die due to diabetes every year. Furthermore, rising awareness of the ANA test is also projected to propel the growth of the market over the forecast period. Data released by the National Library of Medicine (NLM) in 2020 showed that 587,357 ANA tests were conducted while 437,966 patients took ANA tests worldwide. In modern times, both technology and awareness of health are growing exponentially. Hence, all these factors are anticipated to hike the growth of the market during the forecast period.

Antinuclear Antibody Test Market

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The market is segmented by technology into immunofluorescence and multiplex assay, and ELISA, out of which, the ELISA segment is anticipated to hold a notable share in the global antinuclear antibody test market during the forecast period on account of its utilization to monitor therapeutic drug level and growing ANA application in autoimmune diseases. Furthermore, the expanded form for ELISA is an enzyme-linked immunoassay and it is generally utilized to examine antibodies in the blood.

Major Macro-Economic Indicators Impacting the Market Growth

Healthcare Expenditure per Capita, (USD), 2015-2018

According to the statistics by the World Health Organization, the global per capita healthcare expenditure amounted to USD 1,064.741 in the year 2017. The worldwide healthcare expenditure per person grew from USD 864.313 in 2008 to USD 1,110.841 in 2018, where the U.S. is the top country that amounted to healthcare expenditure of USD 10, 623.85 per capita in 2018. As of 2018, the domestic general government healthcare spending in the U.S. was USD 5355.79, which grew from USD 3515.82 in 2008. These are some of the factors responsible for market growth over the past few years. Moreover, as per the projections by the Centers for Medicare & Medicaid Services (CMS), the estimated average annual percent change related to National Health Expenditures (NHE) in the U.S. was 5.2% in 2020 as compared to 2019 (4.5%). Furthermore, the National Health Expenditures are projected to reach USD 6,192.5 Billion in 2028, where the per capita expenditure is estimated to touch USD 17,611 in the same year. These are notable indicators that are anticipated to create lucrative business opportunities in upcoming years.

Global Antinuclear Antibody Test Market Regional Synopsis

Regionally, the global antinuclear antibody test market is segmented into five major regions including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa region. The market in the North America region is estimated to witness noteworthy growth over the forecast period on the back of the growing geriatric population and rising cases of autoimmune diseases. Based on the report provided by the American Autoimmune Related Diseases Association (AARDA), it was stated that over 100 types of autoimmune diseases are found in the region while 50 million Americans suffer from some sort of autoimmune disease. Furthermore, rising cases of arthritis in North America are also projected to hike the growth of the market over the forecast period. According to the report published by the Centers for Disease Control and Prevention, the number of arthritis patients is projected to reach 78 million adults over the forecast period.

Furthermore, the market is anticipated to grow rapidly in the Asia Pacific region during the forecast period. The growth of the market in the region can be attributed to similar factors that are increasing cases of autoimmune diseases, and increment in the geriatric population. Additionally, escalating government initiatives in the healthcare sector can also be the major growth factor of the market during the forecast period.

Antinuclear Antibody Test Market Share

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The global antinuclear antibody test market is further classified on the basis of region as follows:

  • North America (U.S. & Canada) Market size, Y-O-Y growth, Market Players Analysis & Opportunity Outlook

  • Latin America (Brazil, Mexico, Argentina, Rest of Latin America) Market size, Y-O-Y growth & Market Players Analysis & Opportunity Outlook

  • Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC (Finland, Sweden, Norway, Denmark), Ireland, Switzerland, Austria, Poland, Turkey, Russia, Rest of Europe), Poland, Turkey, Russia, Rest of Europe) Market size, Y-O-Y Growth Market Players Analysis & Opportunity Outlook

  • Asia-Pacific (China, India, Japan, South Korea, Singapore, Indonesia, Malaysia, Australia, New Zealand, Rest of Asia-Pacific) Market size, Y-O-Y Growth & Market Players Analysis & Opportunity Outlook

  • Middle East and Africa (Israel, GCC (Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman), North Africa, South Africa, Rest of the Middle East and Africa) Market size, Y-O-Y Growth Market Players Analysis & Opportunity Outlook

Market Segmentation

Our in-depth analysis of the global antinuclear antibody test market includes the following segments:

By Product

  • Assay
  • Reagent Kits
  • Software & Services

By Disease

  • Scleroderma
  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus
  • Others

By Technology

  • Immunofluorescence
  • Multiplex Assay

By End-User

  • Hospitals
  • Clinical
  • Physician Laboratories
  • Others

Growth Drivers

  • Rising Prevalence of Autoimmune Diseases
  • Growing Geriatric Population Across the Globe


  • Lack of Skilled Professionals
  • Risk of Errors During Diagnosis Process

Top Featured Companies Dominating the Market

  • F. Hoffmann-La Roche Ltd.
    • Company Overview
    • Business Strategy
    • Key Product Offerings
    • Financial Performance
    • Key Performance Indicators
    • Risk Analysis
    • Recent Development
    • Regional Presence
    • SWOT Analysis 
  • ERBA Diagnostics, Inc.
  • Zeus Scientific Inc.
  • Trinity Biotech plc
  • Thermo Fisher Scientific Inc.
  • Bio-Rad Laboratories, Inc.
  • Immuno Concepts Inc.
  • Euroimmun Medizinische Labordiagnostika AG
  • Antibodies Incorporated
  • Becton, Dickinson and Company 


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