Antinuclear Antibody Test Market Size & Share, by Product (Assay Kits, Reagent kits, Software & Services); Disease (Scleroderma, Rheumatoid Arthritis, Systemic Lupus Erythematosus); Technology (Immunofluorescence, Multiplex Assay, ELISA); End-user (Hospitals, Clinical, Physician Laboratories) - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2023-2035

  • Report ID: 4133
  • Published Date: Mar 10, 2023
  • Report Format: PDF, PPT

Global Market Size, Forecast, and Trend Highlights Over 2023-2035

Antinuclear Antibody Test Market size is expected to surpass USD 4 Billion by the end of 2035, witnessing around 13% CAGR during the forecast period, i.e., 2023-2035. In the year 2022, the market size of antinuclear antibody test was USD 1 Billion. 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, 1.5 million people die due to diabetes every year globally. Autoimmune disorders can be genetic or acquired that cause suppression of the immune system of the patient. The high risk of autoimmune disorders with increasing incidence of viral and bacterial infections among people with suppressed immune systems is estimated to boost the market growth.

Furthermore, rising awareness of the ANA test and increasing use of antibiotics 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. The increasing spending capacity of people on healthcare needs and basic medical treatment is also estimated to propel market growth.

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Antinuclear Antibody Test Market : Key Insights

Base Year


Forecast Year




Base Year Market Size (2022)

   ~ USD 1 Billion

Forecast Year Market Size (2035)

   ~ USD 4 Billion

Regional Scope

  • North America (U.S., and Canada)
  • Latin America (Mexico, Argentina, Rest of Latin America)
  • Asia-Pacific (Japan, China, India, Indonesia, Malaysia, Australia, Rest of Asia-Pacific)
  • Europe (U.K., Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)

Antinuclear Antibody Test Sector: Growth Drivers and Challenges


Growth Drivers

  • Rising Prevalence of Autoimmune Diseases Among the Global Population – The increasing number of people suffering from autoimmune disorders is estimated to boost the market growth in the coming years. The percentage raise of autoimmune diseases across the world in a year was found to be 4%-10% with the impact of many environmental factors. The increasing change in food habits, rising cholesterol levels, blood sugar levels, and less physical work are driving the market growth. The rising number of diabetic cases, rheumatoid arthritis, and multiple sclerosis is boosting the growth of the market in the coming years.  

  • Growing Geriatric Population Across the Globe with Less Immunity Strength – The elderly population in America by 2050 was estimated to reach more than 85 million with twice the population raising from its base of 40 million in just three decades.

  • Increasing the Healthcare Sector with Rising Importance on Health – The national healthcare expenditure of the U.S. is estimated to rise by 7% in the coming five years during 2022-2027 as per the observations.

  • Rising Number of Diagnostic Laboratories with Increasing Incidence of Diseases – According to the estimations, there are over 25,000 diagnostic and medical laboratories around the world in the U.S. as of 2023.


  • Lack of Skilled Professionals who can Handle the Test Kits
  • Risk of Errors During the Diagnosis Process Causing False Positive and Negative Results
  • High Price of Lab Equipment – The laboratory equipment that are used for antinuclear antibody test are often quite high, as a result of which, it cannot be afforded by small laboratories in several developed and developing nations.

Antinuclear Antibody Test Segmentation

Technology (Immunofluorescence, Multiplex Assay, ELISA)

The global antinuclear antibody test market is segmented and analyzed for demand and supply 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 for therapeutic drug monitoring and growing antinuclear antibodies (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. ELISA is a test conducted to detect the presence of antibodies in the patient that is released as a response against foreign particles called antigens. The presence of antibodies indicates the presence of antigens which are disease-causing microorganisms. The increasing awareness among people about the importance of diagnostic tests is estimated to boost the market segment growth. The ELISA test was estimated to share a value of over USD 2000 million across the world as per the estimations by the end of 2022.

Product (Assay Kits, Reagent kits, Software & Services)

The global antinuclear antibody test market is also segmented and analyzed for demand and supply by product into the assay, reagent kits, and software & services. Amongst these three segments, the assay kits segment is expected to garner a significant share. The growth of the assay kits segment is attributed to the increasing use in life science research, drug discovery, and development. Also, the rising advancement in autoimmune disease drugs to prevent the spread of these disorders as they can lead to the death of the patient is estimated to hike the growth of the market. The escalating use in remote areas where campaigns are conducted in less developed or rural areas is increasing the growth of the market segment as per the market analysis. Further, the increasing biopharmaceutical industries producing large numbers of kits for diagnosis are propelling the market growth. As per the estimations, the biopharmaceutical industries are estimated to reach a value of more than USD 850 billion by the end of 2030 as per the market analysis.

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


  • Immunofluorescence
  • Multiplex Assay


  • Assay Kits
  • Reagent kits
  • Software & Services


  • Hospitals
  • Clinical
  • Physician Laboratories

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Antinuclear Antibody Test Industry - Regional Synopsis

North American Market Forecast   

The North American antinuclear antibody test market, amongst the market in all the other regions, is projected to hold the largest market share by the end of 2035. The growth of the market can be attributed majorly to 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.

APAC Market Statistics

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 which are increasing cases of autoimmune diseases, and an 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.

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Companies Dominating the Antinuclear Antibody Test Landscape

    • 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 


In The News

  • F. Hoffmann-La Roche Ltd received 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 of age.

  • The Food and Drug Administration (FDA) provided the clearance for the utilization of dIFine, a digital immunofluorescence system developed by Zeus Scientific Inc.

Author Credits:  Radhika Gupta, Shivam Bhutani

  • Report ID: 4133
  • Published Date: Mar 10, 2023
  • Report Format: PDF, PPT

Frequently Asked Questions (FAQ)

Rising prevalence of autoimmune diseases and the growing population across the globe are the major factors driving the market growth.

The market is anticipated to attain a CAGR of 13% over the forecast period, i.e., 2023-2035.

Lack of skilled professionals and errors during the diagnosis process is estimated to be the growth hindering factors for the market expansion.

The market in the North American region is projected to hold the largest market share by the end of 2035 and provide more business opportunities in the future.

The major players in the market are F. Hoffmann-La Roche Ltd, ERBA Diagnostics, Inc., Zeus Scientific Inc., Trinity Biotech plc, Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Immuno Concepts Inc, and Becton, Dickinson and Company.

The company profiles are selected based on the revenues generated from the product segment, the geographical presence of the company which determines the revenue-generating capacity as well as the new products being launched into the market by the company.

The market is segmented by product, disease, technology, end user, and by region.

The ELISA segment is anticipated to garner the largest market size by the end of 2035 and display significant growth opportunities.
Antinuclear Antibody Test Market Report Scope

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