Antinuclear Antibody Test Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

Antinuclear Antibody Test Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The antinuclear antibody test (ANA) market studied was anticipated to grow with a CAGR of 12.5% during the forecast period (2022-2027).

COVID-19 had a significant impact on the growth of the market during the forecast period. The study a 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 “Assessing how autoantibodies in COVID-19 correlate with anti-viral humoral responses,” published 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. This indicates that the demand for test-diagnosing antinuclear antibodies will increase during the study period, impacting the market growth positively in the studied period.

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. The study “Guillain Barre Syndrome,” updated in May 2022 and published in National Center for Biotechnology Information Guillain-Barre Syndrome(GBS), had an incidence rate of 0.4 to 2 per 100,000, indicating that it is a rare disease. The cost of medical care for a patient with GBS has been estimated at up to USD 318,966. Overall, the cost of treating patients with GBS has been estimated at USD 1.7 billion per year. Therefore, the cost burden associated with GBS treatment drives the demand for its effective and very diagnostic assay, thereby driving the antinuclear antibody test market over the study period. Also, rising infections due to Epstein–Barr virus, Campylobacter jejuni, and others will likely drive the global antinuclear antibodies market during the forecast period.

Moreover, rising research and development activities proving the efficacies of diagnostic assays will further increase their adoption,k which will lead to significant growth of the market. For instance, the study titled “Clinical Utility of ANA-ELISA vs. ANA-Immunofluorescence in Connective Tissue Diseases,” published in April 2021, demonstrated that the overall specificity of ANA-ELISA was 89.05%, which was slightly better than ANA-IIF 86.72%. The clinical performance of antinuclear antibodies-ELISA for connective tissue disease screening showed better sensitivity and specificity than the conventional antinuclear antibodies-IIF, increasing the adoption of antinuclear antibodies ELISA tests and their demand.

Further launch of new products is expected to drive the market. For instance, in June 2022, DxTerity Diagnostics launched IFN-1 Test for patients with Systemic Lupus Erythematosus (SLE or lupus). The IFN-1 Test supports the advancement of precision medicine to improve patient's lives with lupus.

Thus, due to the above-mentioned factors, the studied market is expected to grow significantly during the study period. However, increasing concerns about the over reliability of antinuclear antibodies tests and lack of awareness of the disease and effective treatment in developing economies are expected to hinder the market growth.

Key Market TrendsImmunofluorescence Assay is Expected to Hold the Large Market Share in the Antinuclear Antibody Test Market

The immunofluorescence (IFA) assay is expected to account for the largest 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.

The study "Evaluation of a Fully Automated Antinuclear Antibody Indirect Immunofluorescence Assay in Routine Use," published in December 2020, stated that the main benefits of the antinuclear antibody immunofluorescence assay are the detection of wide-ranging autoantibodies, high sensitivity, and the possibility of concurrently determining staining patterns and titers. Thus, rising research and development activities indicating the benefits of immunofluorescence tests will increase its global demand, thereby driving the segment towards growth.

Moreover, 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 Rheumatoid Arthritis to overcome the difficulties associated with ELISA-based serological diagnosis. Such findings will also boost the development of immunofluorescence assays, thereby driving the segment.

Thus, the above-mentioned factors are responsible for adequate segment growth during the study period.

North America Dominates the Market and it is Expected to do the Same Over the Forecast Period

North America will dominate the overall ANA market throughout 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 increasing geriatric population, who are more prone to infections due to decreased immunity leading to high demand for earlier diagnosis and effective treatment in the region. For instance, according to the article titled 'What is Guillain-Barre Syndrome?' published in August 2022 Guillian-Barre Syndrome can happen to anyone, but it's most common in people 50 years old or above. Also, the article titled 'Which United States' States Have the Oldest Populations?" published in December 2021 mentioned that more than 55 million Americans aged 65 or older. The such substantial presence of the senior population in the United States will boost the market.

The presence of key players, such as Alere Inc., Antibodies Inc., Bio-Rad Laboratories, and others in the United States, is expected to fuel the market's growth in the region, contributing to significant revenue share and propelling the ANA market's revenue in the forecast period. Launching new diagnostic tests for autoimmune diseases will drive market growth during the study period. For instance, in June 2021, Mayo Clinic Laboratories launched a first-of-its-kind autoimmune test for the Kelch-like protein 11 antibody, or KLHL11, which is used to detect autoimmune disease associated with testicular cancer.

Furthermore, rising investment in the country will boost advancements in developing antinuclear antibody tests, further driving the market growth during the study period. For instance, in November 2021, the Perelman School of Medicine at the University of Pennsylvania received a grant of USD 10 million from Stewart and Judy Colton for continuing autoimmune research and care with the launch of the Colton Center for Autoimmunity in Pennsylvania. The new center unites research and patient care programs nationwide to drive advances in autoimmune diagnosis, prognosis, and treatment. Therefore, such incidences will develop the market during the study period.

Thus, due to the above-mentioned factors, the studied market is expected to grow during the study period in the country.

Competitive Landscape

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.), BioVision Inc., Antibodies Incorporated, and PerkinElmer Inc.

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