Overview


According to FutureWise analysis the market for antinuclear antibody test in 2023 is US$ 1.50 billion, and is expected to reach US$ 4.65 billion by 2031 at a CAGR of 15.20%.

An Antinuclear antibody (ANA) is a blood test that looks for antinuclear antibodies in the blood. ANA (antinuclear antibodies) are produced by the immune system that binds to the body's tissues. Antibodies are proteins the immune system makes to resist foreign particles, such as viruses and bacteria. But an antinuclear antibody attacks its healthy cells instead. It's referred to as "antinuclear" as it targets the nucleus (center) of the cells. Having a few antinuclear antibodies in the blood is normal. However, a large number may be a sign of an autoimmune disorder. These disorders can cause serious health problems. Autoantibodies can damage joints, skin, muscles, and other parts of the body.

ANA is a test used to help diagnose autoimmune diseases, including Systemic lupus, rheumatoid arthritis, Sjogren's syndrome, and other diseases. Systemic lupus is a chronic (long-lasting) disease that affects many body parts, including the joints, skin, heart, lungs, blood vessels, kidneys, and brain. Rheumatoid arthritis is a condition that mainly affects joints, causing pain and swelling in the wrists, hands, and feet. Sjögren's syndrome is a rare disease that affects the glands that make tears, saliva (spit), and other parts of the body. If a diagnosis of Sjögren's disease is suspected, the healthcare provider may test for autoantibodies directed against antigens known as Ro/SSA and La/SSB.

FutureWise Market Research has published a report that provides an insightful analysis antinuclear antibody test market trends that are affecting the overall market growth. This report will provide a detailed analysis of market share, regional insights, and competitor analysis that includes stature of key manufacturers operational in this industry. According to the analysis conducted by FutureWise research analysts, antinuclear antibody test market is estimated to register a considerable growth rate over the forecast period. This report lists the market segments and potential prospects available across this industry, in addition providing crucial information on the total valuation currently held by the industry. Moreover, this report will assist key management individuals in an organisation to enhance their decisions pertaining to business expansion as well as strategic changes for increasing customer base.

  • Alere Inc. 
  • Bio-Rad Laboratories, Inc.
  • Erba Diagnostics, Inc
  • Trinity Biotech plc 
  • Thermo Fisher Scientific, Inc.
  • Antibodies, Inc. 
  • Euroimmun AG 
  • Immuno Concepts 
  • Inova Diagnostics 
  • Zeus Scientific, Inc.

(Note: The list of the major players will be updated with the latest market scenario and trends)

Recent Developments in Antinuclear Antibody Test Market:

  • In 2021, Abbott Laboratories launched its Alinity m system, a compact molecular diagnostic instrument that can perform various tests in a single run, including the Antinuclear Antibody Test. The Alinity m system was created to improve laboratory efficiency and streamline workflows.

The rising prevalence of autoimmune diseases, including systemic lupus, rheumatoid arthritis (RA), Sjogren's syndrome, and other disorders, is expected to drive the growth of the antinuclear antibody test market during the projection period. As awareness about these conditions worsens and diagnostic abilities advance, there is an exceptional surge in the identification of cases. This growth is generating an increased demand for ANA testing as healthcare providers increasingly depend on this diagnostic device to accurately detect and monitor autoimmune diseases, thus propelling the target growth. Moreover, technological advancements in ANA testing methods have seen significant growth toward more advanced and precise techniques and are likely to drive market growth. The field has been developed by introducing highly susceptible and specific techniques like multiplex assay, ELISA (enzyme-linked immunosorbent assay), and immunofluorescence assay. These techniques offer improved accuracy in detecting antinuclear antibodies, allowing for earlier and more precise diagnosis of autoimmune disorders. Also, these assays have enabled a more in-depth understanding of autoimmune disorders, allowing healthcare providers to customize treatment plans as per patients' requirements. However, the possibility for false-positive and false-negative results in antinuclear antibody tests presents a notable restraint in their clinical settings. False positives may incorrectly indicate autoimmune conditions, leading to unnecessary follow-up tests, treatments, and emotional anguish for patients. False negatives may delay or impede the convenient diagnosis of autoimmune disorders, allowing the underlying condition to progress without detection. Thus hindering the market growth.

By Product

  • Reagents and Assay Kits
  • Systems
  • Software and Services

By Technique

  • Elisa
  • Immunofluorescence Assay
  • Multiplex Assay

By Disease

  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus
  • Sjögren’s Syndrome
  • Scleroderma
  • Other Diseases

By End User

  • Hospitals
  • Clinical Laboratories
  • Physician Office Laboratories
  • Other end Users

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

This market research report also emphasis on factors affecting the growth rate in various regions listed above. A deep-down analysis of region will also be provided in the final version of this market which is based on conclusion of primary interviews and secondary data point gathered during the process.

By region, the market is segmented into North America, Latin America, Europe, Asia-Pacific, and Middle East & Africa. North America registered highest share in the market in 2022. This is primarily driven by high incidences of autoimmune diseases such as arthritis, Sjogren’s syndrome, systemic lupus, and other diseases, growing patient population, rising healthcare spending, growth in the medical insurance covered under the number of individuals, and technological developments in the US is driving the market growth. Additionally, rising R&D expenditures for creating fresh products or testing methodologies and increasing investments in the segment to develop a diagnostic platform for autoimmune diseases are further expected to propel the regional market during the forecast period. For instance, in June 2021, Prantae Solutions is being funded under the India-Russia Joint Technology Assessment and Accelerated Commercialization Program to develop a platform for rapid point-of-care diagnosis of Rheumatoid Arthritis (RA) by a technique known as multiplex immunofluorescence analysis based on disposable cartridges.

  • Tier 1 players- established companies in the market with a major market share
  • Tier 2 players
  • Emerging players which are growing rapidly
  • New Entrants

  • Growth prospects
  • SWOT analysis
  • Key trends
  • Key data-points affecting market growth

  • To provide with an exhaustive analysis on the Antinuclear Antibody Test Market By Product, By Technique, By Disease, By End User and By Region.
  • To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
  • To evaluate and forecast micro-markets and the overall market
  • To predict the market size, in key regions— North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
  • To record and evaluate competitive landscape mapping- product launches, technological advancements, mergers and expansions

  • We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement
  • The customization Mobility Care offered are free of charge with purchase of any license of the report
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Table of Contents


  • 1.   Market Introduction

    •   1. Objectives of the Study
        2. Market Definition
        3. Market Scope
         3.1. Years Considered for the Study
         3.2. Market Covered
        4. Currency
        5. Limitations
        6. Stakeholders

  • 2.   Research Methodology

    •   1. Research Data
         1.1. Secondary Data
          1.1.1. Key Data from Secondary Sources
         1.2. Primary Data
          1.2.1. Key Data from Primary Sources
        2. Market Size Estimation
        3. Market Breakdown and Data Triangulation
        4. Assumptions for the Study

  • 3.   Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights
  • 4.   Global Antinuclear Antibody Test Market Variables, Trends and Scope

    •   1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Technology Overview
        6. Regulatory Framework
         6.1. Reimbursement Framework
         6.2. Standards and Compliances

  • 5.   Market Overview
    •   1. Market Dynamics
         1.1. Market Driver Analysis
          1.1.1. Increasing focus of Antinuclear Antibody Test Companies on Brand Protection
          1.1.2. Untapped Opportunities in Emerging Regions
         1.2. Market Restraint Analysis
          1.2.1. High Cost Associated with Implementation of Predictive Analysis
         1.3. Industry Challenges
          1.3.1. Presence of Ambiguous Regulatory Framework
  • 6.   Global Antinuclear Antibody Test Market Analysis Tools
    •   1. Industry Analysis - Porter’s
         1.1. Supplier Power
         1.2. Buyer Power
         1.3. Substitution Threat
         1.4. Threat from New Entrants
         1.5. Competitive Rivalry
        2. Pestel Analysis
         2.1. Political Landscape
         2.2. Environmental Landscape
         2.3. Social Landscape
         2.4. Technology Landscape
         2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
         3.1. Joint Ventures
         3.2. Mergers and Acquisitions
         3.3. Licensing and Partnership
         3.4. Technology Collaborations
         3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies
  • 7.   Global Antinuclear Antibody Test Market, By Product Historical Analysis and Forecast 2024-2032 (USD Million)

    •   1. Reagents and Assay Kits
        2. Systems
        3. Software and Services

  • 8.   Global Antinuclear Antibody Test Market, By Technique Historical Analysis and Forecast 2024-2032 (USD Million)

    •   1. Elisa
        2. Immunofluorescence Assay
        3. Multiplex Assay

  • 9.   Global Antinuclear Antibody Test Market, By Disease Historical Analysis and Forecast 2024-2032 (USD Million)

    •   1. Rheumatoid Arthritis
        2. Systemic Lupus Erythematosus
        3. Sjögren’s Syndrome
        4. Scleroderma
        5. Other Diseases

  • 10.   Global Antinuclear Antibody Test Market, By End User Historical Analysis and Forecast 2024-2032 (USD Million)

    •   1. Hospitals
        2. Clinical Laboratories
        3. Physician Office Laboratories
        4. Other End Users

  • 11.   North America Antinuclear Antibody Test Market Analysis 2018-2023 and Forecast 2024-2032 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2023
         2.1. U.S.A
         2.2. Canada
         2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2024-2032

  • 12.   Latin America Antinuclear Antibody Test Market Analysis 2018-2023 and Forecast 2024-2032 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2023
         2.1. Brazil
         2.2. Venezuela
         2.3. Argentina
         2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2024-2032

  • 13.   Europe Antinuclear Antibody Test Market Analysis 2018-2023 and Forecast 2024-2032 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2023
         2.1. Germany
         2.2. U.K
         2.3. France
         2.4. Italy
         2.5. Spain
         2.6. Russia
         2.7. Poland
         2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2024-2032

  • 14.   Asia Pacific Antinuclear Antibody Test Market Analysis 2018-2023 and Forecast 2024-2032 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2023
         2.1. Japan
         2.2. China
         2.3. India
         2.4. Australia and New Zealand
         2.5. ASEAN
         2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2024-2032

  • 15.   Middle East and Africa Market Analysis 2018-2023 and Forecast 2024-2032 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2023
         2.1. Saudi Arabia
         2.2. UAE
         2.3. South Africa
         2.4. Egypt
        3. Market Size (USD Million) Forecast for MEA 2024-2032

  • 16.   Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix
  • 17.   Company Profiles (Competition Dashboard, Competitors Deep Dive, Products Offered and Financial Layouts)

    •   1. Alere Inc.
         1.1. Company Overview
         1.2. Product Portfolio
         1.3. SWOT Analysis
         1.4. Financial Overview
         1.5. Strategic Overview
        2. Bio-Rad Laboratories, Inc.
         2.1. Company Overview
         2.2. Product Portfolio
         2.3. SWOT Analysis
         2.4. Financial Overview
         2.5. Strategic Overview
        3. Erba Diagnostics Inc.
         3.1. Company Overview
         3.2. Product Portfolio
         3.3. SWOT Analysis
         3.4. Financial Overview
         3.5. Strategic Overview
        4. Trinity Biotech plc 
         4.1. Company Overview
         4.2. Product Portfolio
         4.3. SWOT Analysis
         4.4. Financial Overview
         4.5. Strategic Overview
        5. Thermo Fisher Scientific, Inc.
         5.1. Company Overview
         5.2. Product Portfolio
         5.3. SWOT Analysis
         5.4. Financial Overview
         5.5. Strategic Overview
        6. Antibodies, Inc.
         6.1. Company Overview
         6.2. Product Portfolio
         6.3. SWOT Analysis
         6.4. Financial Overview
         6.5. Strategic Overview
        7. Euroimmun AG
         7.1. Company Overview
         7.2. Product Portfolio
         7.3. SWOT Analysis
         7.4. Financial Overview
         7.5. Strategic Overview
        8. Immuno Concepts 
         8.1. Company Overview
         8.2. Product Portfolio
         8.3. SWOT Analysis
         8.4. Financial Overview
         8.5. Strategic Overview
        9. Inova Diagnostics
         9.1. Company Overview
         9.2. Product Portfolio
         9.3. SWOT Analysis
         9.4. Financial Overview
         9.5. Strategic Overview
        10. Zeus Scientific, Inc.
         10.1. Company Overview
         10.2. Product Portfolio
         10.3. SWOT Analysis
         10.4. Financial Overview
         10.5. Strategic Overview

  • 18.   Pre and Post COVID-19 Impact
    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the healthcare regulations initiated by administrations
        5. The overall economic slowdown of the developing and developed nations
  • 19.   FutureWise SME Key Takeaway Points for Client

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