Antinuclear Antibody Test Global Market Report 2025

The antinuclear antibody test market size has grown rapidly in recent years. It will grow from $1.54 billion in 2024 to $1.74 billion in 2025 at a compound annual growth rate (CAGR) of 12.9%. The growth in the historic period can be attributed to the rising prevalence of autoimmune diseases, increased awareness about early diagnosis, advancements in diagnostic technologies, growing healthcare expenditure, and an expanding geriatric population.

The antinuclear antibody test market size is expected to see rapid growth in the next few years. It will grow to $2.79 billion in 2029 at a compound annual growth rate (CAGR) of 12.6%. The growth in the forecast period can be attributed to the increasing incidence of autoimmune disorders, advancements in diagnostic technologies, a growing focus on personalized medicine, expanding healthcare infrastructure in developing regions, and rising demand for early disease detection and management. Major trends 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 advancements in automation and high-throughput testing systems.

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.

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.

The antinuclear antibody test market research report is one of a series of new reports 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 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.

This product will be delivered within 3-5 business days.