PUBLISHER: The Business Research Company | PRODUCT CODE: 1826867
PUBLISHER: The Business Research Company | PRODUCT CODE: 1826867
An antinuclear antibody (ANA) test is a blood test that detects autoantibodies targeting the body's own cells, serving as a key diagnostic tool for autoimmune diseases such as lupus, rheumatoid arthritis, and other related disorders.
The main product types in ANA testing include assay kits, reagent kits, and software and services. Assay kits are pre-packaged sets of reagents and protocols designed to identify antinuclear antibodies in patient samples. The test utilizes various technologies, including immunofluorescence assays, multiplex assays, and ELISA, for applications such as diagnosing rheumatoid arthritis, systemic lupus erythematosus, and other autoimmune conditions. It is widely used across different end users, including hospitals, clinical laboratories, and physician laboratories.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.
The antinuclear antibody test market research report is one of a series of new reports from The Business Research Company that provides antinuclear antibody test market statistics, including antinuclear antibody test industry global market size, regional shares, competitors with an antinuclear antibody test market share, detailed antinuclear antibody test market segments, market trends and opportunities, and any further data you may need to thrive in the antinuclear antibody test industry. This antinuclear antibody test market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The antinuclear antibody test market size has grown rapidly in recent years. It will grow from $1.54 billion in 2024 to $1.73 billion in 2025 at a compound annual growth rate (CAGR) of 12.6%. The growth in the historic period can be attributed to the increasing prevalence of autoimmune diseases, rising awareness about early diagnosis, advancements in diagnostic technologies, growing healthcare expenditure, and expanding geriatric population.
The antinuclear antibody test market size is expected to see rapid growth in the next few years. It will grow to $2.76 billion in 2029 at a compound annual growth rate (CAGR) of 12.4%. The growth in the forecast period can be attributed to the rising incidence of autoimmune disorders, technological advancements in diagnostic tools, a growing focus on personalized medicine, increasing healthcare infrastructure in developing regions, and rising demand for early disease detection and management. Major trends in the forecast period include the integration of artificial intelligence in diagnostics, the development of point-of-care testing devices, the adoption of multiplex testing technologies, the use of machine learning for data analysis, and improvements in automation and high-throughput testing systems.
The forecast of 12.4% growth over the next five years reflects a slight reduction of 0.2% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. Tariff barriers are expected to hamper the U.S. by increasing the cost of immunofluorescence Antinuclear Antibody(ANA) test kits and automated enzyme-linked immunosorbent assay(ELISA) platforms sourced from Germany and Japan, thereby delaying autoimmune disease diagnosis and elevating rheumatology lab expenditures. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.
The increasing prevalence of autoimmune diseases is expected to drive the expansion of the antinuclear antibody test market. Autoimmune diseases occur when the immune system mistakenly attacks the body's healthy cells and tissues. The growing incidence of these conditions is influenced by factors such as genetic predisposition, environmental triggers, hormonal changes, and lifestyle elements such as diet and stress. The antinuclear antibody test plays a crucial role in the early detection of autoimmune diseases by identifying antibodies that target the body's own cells and tissues. For example, in June 2024, a report published by the Australian Institute of Health and Welfare, an Australian governmental organization, indicated that hospitalizations for rheumatoid arthritis reached 10,000 in 2021-22, reflecting a 25% increase from the previous year's 8,000 cases. This corresponds to a hospitalization rate of 39 per 100,000 people. As a result, the rising prevalence of autoimmune diseases is fueling the growth of the antinuclear antibody test market.
Leading companies in the antinuclear antibody test market are focusing on developing advanced diagnostic technologies, such as digital immunofluorescence systems, to improve the accuracy, efficiency, and automation of ANA testing. Digital immunofluorescence systems automate immunofluorescence assay analysis using high-resolution imaging and AI, enhancing precision in autoimmune disease diagnostics. For instance, in March 2022, ZEUS Scientific Inc., a US-based provider of diagnostic solutions, received FDA clearance for its ZEUS dIFine IFA Imaging and Pattern Recognition System. This approval applies to the HEp-2 ANA IFA test system on the dIFine platform, which enhances ZEUS' ANA HEp-2 indirect fluorescent antibody (IFA) assay. The clearance includes features for determining positive and negative results and recognizing eight common ANA HEp-2 staining patterns. Additionally, the system incorporates a built-in pattern atlas that serves as a reference and training tool, enabling side-by-side image comparisons with ZEUS' proprietary images aligned with ICAP nomenclature.
In June 2022, Quotient Limited, a Switzerland-based diagnostics company, partnered with Theradiag to improve autoimmune disease diagnostics. This collaboration integrates Theradiag's reagents with Quotient's MosaiQ platform, aiming to develop multiplexed microarrays that enable faster, more accurate diagnosis and treatment selection. Theradiag is a France-based company that provides antinuclear antibody (ANA) tests.
Major players in the antinuclear antibody test market are Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., Abbott Laboratories, Becton Dickinson and Company, LabCorp, Quest Diagnostics Incorporated, Grifols SA, PerkinElmer Inc., Bio-Rad Laboratories Inc., Werfen SA, DiaSorin SpA, EUROIMMUN AG, Abcam plc, Trinity Biotech plc, Zeus Scientific Inc., ERBA Diagnostics Inc., Quidel Corporation, Antibodies Incorporated, Immuno Concepts Inc., Inova Diagnostics.
North America was the largest region in the antinuclear antibody test market in 2024. Asia-pacific is expected to be the fastest-growing region in the forecast period. The regions covered in antinuclear antibody test report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the antinuclear antibody test market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The antinuclear antibody test market consists of revenues earned by entities by providing services such as laboratory testing services, specialized testing services, monitoring disease activity, and screening for systemic lupus erythematosus. The market value includes the value of related goods sold by the service provider or included within the service offering. The antinuclear antibody test market also includes sales of diagnostic equipment and instruments, testing kits, western blot kits and luminex multiplex assays. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values and are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Antinuclear Antibody Test Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on antinuclear antibody test market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for antinuclear antibody test ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The antinuclear antibody test market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.