Enjoy complimentary customisation on priority with our Enterprise License!
The antinuclear antibody test market size is estimated to grow by USD 392 million at a CAGR of 7.08% between 2023 and 2028. ANA (Antinuclear Antibody) tests have gained significant importance in the medical diagnostics industry due to the increasing prevalence of autoimmune diseases. The demand for ANA tests is on the rise as they are used to identify various autoimmune disorders such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), and Sjogren's syndrome. Furthermore, government initiatives to improve healthcare infrastructure and increase accessibility to diagnostic services have created a favorable environment for the growth of the ANA testing market. Additionally, the rising number of reagent rental agreements between diagnostic laboratories and test kit manufacturers has led to cost savings and increased efficiency in the testing process. These factors collectively contribute to the growing market for ANA tests and are expected to drive its growth in the coming years.
For More Highlights About this Report, Request Free Sample
The Antinuclear Antibody (ANA) testing market refers to the sale and supply of assay kits, reagents, and systems used for diagnosing various autoimmune diseases, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Raynaud’s Syndrome, polymyositis, mixed connective tissue, drug-induced lupus, autoimmune hepatitis, and other systemic autoantibodies. The market is significant due to the increasing prevalence of these diseases and the need for accurate diagnosis. Assays used for ANA testing include Enzyme-linked Immunosorbent Assay (ELISA), Immunofluorescence Assay (IFA), and Multiplex Assay. Clinical laboratories and hospitals are the major end-users of these diagnostic assays. Autoimmune diseases such as Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Scleroderma are common indications for ANA testing. Other diseases like Motor Axonal Neuropathy, Guillain-Barre Syndrome (GBS), and certain autoimmune hepatitis variants also require ANA testing for diagnosis. The development of new variants of autoimmune diseases and the prognostic value of ANA testing in predicting treatment options are key factors driving the growth of the ANA testing market. However, lack of awareness in developing economies and varying reimbursement policies by medical insurance companies pose challenges to the market. The ANA testing market is expected to grow significantly due to ongoing development activities in diagnostic assays and the increasing importance of early and accurate diagnosis in managing autoimmune diseases. The role of ANA testing in the diagnosis of diseases like FANA, AIHA, and motor axonal neuropathy highlights its importance in the healthcare system. Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
Increasing demand for ANA tests is notably driving market growth. The Antinuclear Antibody (ANA) test is a crucial diagnostic tool used to identify the presence of autoantibodies in the blood. These antibodies bind to the body's own tissues, and the ANA test screens for their presence to aid in the diagnosis of various autoimmune disorders. Diseases such as Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), and Sjogren's Syndrome are among those associated with ANA positivity. The test results can exhibit different patterns, including nucleolar, speckled, and homogenous, which further aid in the diagnosis. With an increasing prevalence of autoimmune diseases, the demand for ANA tests is on the rise. For instance, according to the Foundation for Peripheral Neuropathy report, approximately 3,000-6,000 people in the US are diagnosed with Guillain-Barre Syndrome (GBS) every year. This expanding target population base is expected to fuel the demand for early screening and effective treatment, leading to a significant increase in the use of ANA tests. The market for ANA tests is growing, with an emphasis on the development of rapid test results and the use of disposable cartridges to enhance convenience and efficiency. Thus, such factors are driving the growth of the market during the forecast period.
Increasing prevalence of autoimmune diseases is the key trend in the market. The Antinuclear Antibody (ANA) test is a crucial diagnostic tool for identifying autoimmune disorders. Positive ANA results can indicate various autoimmune diseases, including Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), and others. Three common ANA patterns include nucleolar, speckled, and homogenous. Nucleolar patterns are indicative of SLE, while speckled patterns are associated with SLE and other autoimmune diseases. Homogenous patterns may be observed in healthy individuals or those with certain conditions. The increasing prevalence of autoimmune diseases necessitates the need for rapid and accurate ANA testing. Disposable cartridges and salivary ANA IF tests offer convenience and speed in diagnosing these conditions. Arthritis Research and other organizations continue to investigate the causes of autoimmune disorders, including genetic and environmental factors. Despite advancements in testing and research, it is essential to remember that a positive ANA result does not definitively diagnose a disease, and further testing is required for confirmation. Thus, such trends will shape the growth of the market during the forecast period.
Stringent regulations for the approval of medical diagnostics is the major challenge that affects the growth of the market. Antinuclear Antibody (ANA) tests are essential diagnostic tools used to identify autoantibodies associated with various diseases, including Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA). Three common ANA test patterns are nucleolar, speckled, and homogenous. Rapid and accurate test results are crucial for effective disease management and treatment. Arthritis Research and other healthcare organizations rely on ANA tests for diagnosis and monitoring. Manufacturers of ANA test kits must comply with stringent regulations set by government agencies, such as the US Food and Drug Administration (FDA) and the Center for Medicare Services of the U.S. Department of Health and Human Services. These regulations cover the design, testing, manufacture, labeling, promotion, and marketing of medical diagnostic devices, ensuring their safety and efficacy. Compliance with these regulations can be time-consuming and costly for manufacturers. Disposable cartridges are used in ANA testing to ensure consistency and accuracy. Hence, the above factors will impede the growth of the market during the forecast period.
The market forecasting report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.
Customer Landscape
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.
Abbott Laboratories - The company offers antinuclear antibody test such as Agility ELISA automation system which is open, fully automated 12-plate processing system, designed to significantly increase laboratory's efficiency.
The market research and growth report also includes detailed analyses of the competitive landscape of the market and information about key companies, including:
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
The hospitals segment is estimated to witness significant growth during the forecast period. The Antibody market for ANA (Antinuclear Antibody) testing is experiencing significant growth due to the increasing prevalence of autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Raynaud’s Syndrome, polymyositis, mixed connective tissue, drug-induced lupus, autoimmune hepatitis, and other systemic autoimmune disorders. Assay kits, reagents, and systems used in ANA testing are in high demand in clinical laboratories and hospitals.
Get a glance at the market share of various regions Download the PDF Sample
The hospitals segment accounted for USD 473.2 million in 2018. Technologies like Enzyme-linked immunosorbent assay (ELISA), immunofluorescence assay (IFA), and multiplex assay are commonly used for ANA testing. Autoantibody diagnosis plays a crucial role in the early detection and treatment of these diseases. New variants of autoantibodies are being discovered, expanding the scope of ANA testing. Reimbursement policies and medical insurance coverage are essential factors influencing the market growth. Motor axonal neuropathy, GBS, and other neurological disorders are also being investigated for their association with ANA positivity. The healthcare system's development activities and diagnostic assays like FANA, AIHA, and their prognostic value and treatment options are areas of ongoing research.
For more insights on the market share of various regions Download PDF Sample now!
North America is estimated to contribute 31% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.
The Antibody market for ANA (Antinuclear Antibody) testing is witnessing significant growth due to the increasing prevalence of autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Raynaud’s Syndrome, polymyositis, mixed connective tissue, drug-induced lupus, autoimmune hepatitis, encephalitis, motor axonal neuropathy, and Guillain-Barré Syndrome (GBS). Assay kits, reagents, and systems used in ANA testing play a crucial role in the diagnosis of these diseases. Technological advancements in diagnostic assays, including enzyme-linked immunosorbent assay (ELISA), immunofluorescence assay (IFA), and multiplex assay, have improved the accuracy and efficiency of ANA testing. Clinical laboratories and hospitals are the major end-users of ANA testing. Systemic autoantibodies, such as FANA (anti-nuclear antiphospholipid antibodies) and AIHA (antinuclear antibodies in autoimmune hepatitis), have gained considerable attention in recent years due to their prognostic value and treatment options.
The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD million " for the period 2024-2028, as well as historical data from 2018 - 2022 for the following segments.
You may also like:
Antibody Drug Conjugates (ADC) Market - Antibody Drug Conjugates (ADC) Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Germany, UK, China, Japan - Size and Forecast
Bispecific Antibodies for Cancer Market - Bispecific Antibodies for Cancer Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Ireland, China, Hungary, India - Size and Forecast
Anti-CD20 Monoclonal Antibodies (mABs) Market - Anti-CD20 Monoclonal Antibodies (mABs) Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Canada, Germany, UK, China - Size and Forecast
The Antibody (ANA) testing market encompasses the sales of assay kits, reagents, and systems used for detecting systemic autoantibodies in individuals with autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Raynaud’s Syndrome, polymyositis, mixed connective tissue, drug-induced lupus, autoimmune hepatitis, and other related conditions. Technologies used for ANA testing include Enzyme-linked Immunosorbent Assay (ELISA), Immunofluorescence assay (IFA), and Multiplex assay. Clinical laboratories and hospitals are the primary end-users of ANA testing. Rheumatoid arthritis, systemic lupus erythematosus, and systemic autoantibodies are the major indications for ANA testing. New variants of autoantibodies are being discovered, expanding the scope of ANA testing. Autoantibody diagnosis plays a crucial role in the management of autoimmune diseases. The prognostic value of ANA testing in predicting disease progression and treatment options is gaining recognition. However, a lack of awareness and reimbursement policies in developing economies pose challenges to the growth of the ANA testing market. Key players in the ANA testing market include MedRxiv, NCBI, and various diagnostic assay manufacturers like FANA, AIHA, and others. Development activities in the healthcare system, particularly in the area of diagnostic assays, are expected to drive market growth. Motor axonal neuropathy, Guillain-Barré syndrome, and other neurological disorders are emerging indications for ANA testing. The gold standard for ANA testing is immunofluorescence, which provides a high degree of specificity and sensitivity.
Market Scope |
|
Report Coverage |
Details |
Page number |
139 |
Base year |
2023 |
Historic period |
2018 - 2022 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 7.08% |
Market growth 2024-2028 |
USD 392 million |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
6.48 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 31% |
Key countries |
US, Germany, France, UK, and Japan |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
Key companies profiled |
Abbott Laboratories, Abcam plc, Antibodies Inc., Bio Rad Laboratories Inc., BioVision Inc., Grifols SA, Immuno Concepts Ltd., Merck KGaA, Orgentec Diagnostika GmbH, Perkin Elmer Inc., Quidelortho Corp., Seramun Diagnostica GmbH, Thermo Fisher Scientific Inc., Transasia Bio Medicals Ltd., Trinity Biotech Plc, Werfenlife SA, and ZEUS Scientific Inc. |
Market dynamics |
Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for forecast period |
Customization purview |
If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by End-user
7 Customer Landscape
8 Geographic Landscape
9 Drivers, Challenges, and Opportunity/Restraints
10 Competitive Landscape
11 Competitive Analysis
12 Appendix
Get lifetime access to our
Technavio Insights
Quick Report Overview:
Cookie Policy
The Site uses cookies to record users' preferences in relation to the functionality of accessibility. We, our Affiliates, and our Vendors may store and access cookies on a device, and process personal data including unique identifiers sent by a device, to personalise content, tailor, and report on advertising and to analyse our traffic. By clicking “I’m fine with this”, you are allowing the use of these cookies. Please refer to the help guide of your browser for further information on cookies, including how to disable them. Review our Privacy & Cookie Notice.