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Antinuclear Antibody Test Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023-2028)

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  • 120 Pages
  • April 2023
  • Region: Global
  • Mordor Intelligence
  • ID: 5529284
UP TO OFF until Mar 31st 2024
The antinuclear antibody test (ANA) market studied was anticipated to grow with a CAGR of 12.5% over the forecast period.

COVID-19 had a significant impact on the growth of the market during the forecast period. The study was conducted where a team of researchers screened several systemic autoantibodies to assess their association with the severity of COVID-19. The results were published in the article of medRxiv in January 2022, which stated that antinuclear antibodies (ANA) would be prevalent in COVID-19 patients up to one year after recovering from the SARS-CoV-2 infection. As a result, there is a good chance that the need for autoantibody diagnosis in COVID-19-infected patients will rise. This diagnosis may be done using an antinuclear antibody test. However, the number of COVID-19 cases has been subsidized but the risk of spread of infection due to new variants still persists and as the antinuclear antibody test is used in such diagnosis, the market is anticipated to have stable growth over the next 2-3 years.

Factors such as rising government initiatives with growing incidences of autoimmune diseases and favorable medical insurance and reimbursement policies are expected to drive market growth. Additionally, rising product launches will also boost the market. The increasing prevalence of autoimmune disorders, such as Sjogren’s syndrome, acute motor axonal neuropathy, and others, increased the adoption of ANA testing. As per NCBI updated in July 2022, Guillain-Barre syndrome (GBS), which has an incidence of 0.4 to 2 per 100,000, has a significant impact on the healthcare system. Therefore, the increasing burden associated with GBS drives the demand for its effective diagnostic assay, thereby driving the antinuclear antibody test market over the study period.

Moreover, rising research and development activities proving the efficacies of diagnostic assays will further increase their adoption and is expected to have significant growth in the market. For instance, according to a study published in March 2022 in the journal Hematology, Transfusion and Cell Therapy, every patient must have a baseline level of the fluorescent antinuclear antibody (FANA) when they are diagnosed with autoimmune hemolytic anemia (AIHA). The presence of FANA gives a prognostic value and helps in deciding the treatment options which is expected to have a positive impact on the market.

Thus, the above-mentioned factors like the increasing burden of autoimmune diseases and new developments in the market are likely to increase the demand for the ANA test and the studied market is expected to grow significantly during the study period. However, increasing concerns about the reliability of antinuclear antibody tests and lack of awareness of the disease and effective treatment in developing economies are expected to hinder the market growth.

Antinuclear Antibody Test Market Trends

Immunofluorescence Assay is Expected to Hold the Major Share Over the Forecast Period

The immunofluorescence (IFA) assay is expected to account for the major share of the market. Dominance can be attributed to the increased adoption of the technique as the gold standard for antinuclear antibody testing. Highly sensitive and rapid test results compared to other methods increased their preference among clinicians. Furthermore, their ability to identify the various patterns, such as nucleolar, speckled, and homogenous, indicate autoantibodies associated with diseases and fuel the segment's growth.

Moreover, the new research studies using immunofluorescence in the anti-nuclear antibody assay help to diagnose diseases more effectively and are expected to have growth in the market through this segment. For instance, as per the study published by Arthritis Research & Therapy in January 2022, systemic lupus erythematosus (SLE) patients' saliva was assayed for ANA using immunofluorescence (IF) and showed that salivary ANA IF intensities were significantly higher in SLE patients than in healthy controls, irrespective of SLE patient disease activity. Thus, rising research and development activities indicating the benefits of immunofluorescence tests will increase its global demand, thereby driving the segment toward growth.

Furthermore, rising investments in the segment to develop a diagnostic platform for autoimmune diseases such as rheumatoid arthritis and others are further expected to drive market growth. 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 called multiplex immunofluorescence analysis based on disposable cartridges. The company aims to create a mobile point-of-care technology for rapid identification of RA to overcome the difficulties associated with ELISA-based serological diagnosis. Such findings will also boost the development of immunofluorescence assays, thereby driving the market through this segment.

Thus, the above-mentioned factors like the increasing burden of autoimmune diseases and investments in new developments, increase the widespread of immunofluorescence assays due to their comparative advantages and are responsible for adequate segment growth during the study period.

North America is Expected to Have a Significant Growth in the Market Over the Forecast Period

North America is expected to dominate the market during the forecast period. The United States within the North American region is expected to account for the largest market during the study period. The dominance is due to several factors, such as the high burden of autoimmune diseases and the increasing geriatric population, who are more prone to infections leading to high demand for earlier diagnosis and effective treatment in the region.

For instance, as per CDC, April 2022 update, In the United States, 58.5 million were estimated to have arthritis which is expected to increase as the country's population ages. It also stated that an estimated 25.7 million persons experience arthritis-related limitations in their daily activities. By 2040, the number is projected to increase to 35 million. Similarly, as per Statistics Canada 2022, the total arthritis patients aged 15 and above were estimated as 19.5% which is compared to 19.1% in the previous year. Hence, the rising prevalence of autoimmune disease increases the demand for effective diagnosis using antinuclear antibody test and drive the market over the forecast period.

Furthermore, launching new diagnostic products for autoimmune diseases will drive market growth during the study period. For instance, in March 2021, EUROIMMUN, a PerkinElmer, Inc. company, launched the EUROPattern Microscope Live (EPML) compact immunofluorescence microscope that allows for ultrafast automated immunofluorescence image acquisition. Indirect immunofluorescence tests (IIFT) are diagnostic assays used to detect antibodies in a patient sample. In addition to its other capabilities, this microscope will aid in the diagnosis and testing of antinuclear antibodies, which will aid in fully meeting the expectations of the healthcare industry and boost the market to grow.

Thus, the above-mentioned factors like the rising prevalence of autoimmune diseases and new product launches increase the demand for the test and are expected to grow the market during the study period in the country.

Antinuclear Antibody Test Market Competitive Analysis

The antinuclear antibody test market is moderately competitive and consists of several major players. Few of the prominent players currently dominating the market are acquiring the products or other companies to consolidate their global market positions. Launching new products with advanced technologies coupled with recent approvals to diagnose autoimmune diseases is trending in the market. Some companies currently dominating the market are Grifols SA, Abbott Laboratories (Alere Inc.), Abcam plc (BioVision Inc), Antibodies Incorporated, and PerkinElmer Inc.

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Table of Contents

1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rising Government Initiatives with Growing Incidences of Autoimmune Diseases
4.2.2 Favorable Medical Insurance and Reimbuirsement Policies
4.3 Market Restraints
4.3.1 Increasing Concerns with Over Reliability of ANA Tests
4.3.2 Lack of Awareness of Disease and Effective Treatment in the Developing Economies
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION (Market Size by Value - in USD Million)
5.1 By Technique
5.1.1 ELISA
5.1.2 Immunofluorescence Assay
5.1.3 Multiplex Assay
5.2 By Products and Services
5.2.1 Reagents and Assay Kits
5.2.2 Systems
5.2.3 Services
5.3 By Application
5.3.1 Rheumatoid Arthritis
5.3.2 Systemic Lupus Erythematosus
5.3.3 Other Applications
5.4 By Distribution Channel
5.4.1 Hospitals
5.4.2 Clinical Laboratories
5.4.3 Other Distribution Channels
5.5 Geography
5.5.1 North America United States Canada Mexico
5.5.2 Europe Germany United Kingdom France Italy Spain Rest of Europe
5.5.3 Asia-Pacific China Japan India Australia South Korea Rest of Asia-Pacific
5.5.4 Middle East and Africa GCC South Africa Rest of Middle-East and Africa
5.5.5 South America Brazil Argentina Rest of South America
6.1 Company Profiles
6.1.1 Abbott Laboratories (Alere Inc.)
6.1.2 Abcam plc (BioVision Inc)
6.1.3 Antibodies Incorporated
6.1.4 Grifols SA
6.1.5 PerkinElmer Inc.
6.1.6 Quidel Corporation
6.1.7 Orgentec Diagnostika GmbH
6.1.8 Immuno Concepts Inc.
6.1.9 ZEUS Scientific Inc.
6.1.10 Inova Diagnostics Inc.
6.1.11 Bio-Rad Laboratories, Inc.
6.1.12 Thermo Fisher Scientific Inc.

Companies Mentioned

A selection of companies mentioned in this report includes:

  • Abbott Laboratories (Alere Inc.)
  • Abcam plc (BioVision Inc)
  • Antibodies Incorporated
  • Grifols SA
  • PerkinElmer Inc.
  • Quidel Corporation
  • Orgentec Diagnostika GmbH
  • Immuno Concepts Inc.
  • ZEUS Scientific Inc.
  • Inova Diagnostics Inc.
  • Bio-Rad Laboratories, Inc.
  • Thermo Fisher Scientific Inc.