Autoimmune Disease Diagnosis Market Report 2026

Autoimmune Disease Diagnosis Market Overview

• Autoimmune Disease Diagnosis market size has reached to $6.2 billion in 2025 • Expected to grow to $9.38 billion in 2030 at a compound annual growth rate (CAGR) of 8.6% • Growth Driver: Elevated Incidence Of Autoimmune Diseases A Catalyst For The Autoimmune Disease Diagnosis Market • Market Trend: Adoption Of Multiplex Autoantibody Assays To Enhance Autoimmune Disease Diagnosis • North America was the largest region in 2025 and Western Europe is the fastest growing region.

What Is Covered Under Autoimmune Disease Diagnosis Market?

Autoimmune disease diagnosis refers to the diagnosis of diseases in which the production of antibodies takes place in the body which attacks and destroys healthy cells in the body. These include Crohn's disease, rheumatoid arthritis, Hashimoto’s disease, multiple sclerosis, Grave’s disease, psoriasis, coeliac disease, type 1 diabetes, lupus, and inflammatory bowel syndrome, and are diagnosed by immunological tests. The main test types of autoimmune disease diagnosis are routine laboratory tests, autoantibodies tests, immunologic tests, and other tests. Autoantibody tests are used to aid in the diagnosis of autoimmune diseases. The different products include consumables and assay kits, and instruments and are used by various sectors such as clinical laboratories, hospitals, and others.

What Is The Autoimmune Disease Diagnosis Market Growth Forecast?

The autoimmune disease diagnosis market size is expected to see strong growth in the next few years. It will grow to $9.38 billion in 2030 at a compound annual growth rate (CAGR) of 8.6%. The growth in the forecast period can be attributed to increasing demand for early and accurate diagnosis, rising use of ai-assisted diagnostic analytics, expansion of personalized diagnostic approaches, growing investments in autoimmune research, increased integration of point-of-care testing. Major trends in the forecast period include increasing adoption of advanced immunological testing, rising use of autoantibody panels, growing integration of multiplex diagnostic platforms, expansion of laboratory automation, enhanced focus on early disease detection.

Global Autoimmune Disease Diagnosis Market Segmentation

1) By Product: Consumables And Assay Kits, Instruments 2) By Test Type: Routine Laboratory Tests, Autoantibodies Tests, Immunologic Tests, Other Tests 3) By End User: Clinical Laboratories, Hospitals, Other End Users Subsegments: 1) By Consumables And Assay Kits: ELISA Kits, Reagents And Test Kits, Sample Collection And Preservation Devices, Control And Calibration Materials 2) By Instruments: Immunoassay Analyzers, Flow Cytometers, Luminometers, Microscopes

What Are The Drivers Of The Autoimmune Disease Diagnosis Market?

A high incidence of autoimmune diseases contributed to the growth of the autoimmune disease diagnosis market. Autoimmune diseases refer to conditions in which the body’s immune system mistakenly attacks its own healthy cells, tissues, or organs. Autoimmune diseases are rising due to increasing exposure to environmental triggers such as pollution, infections, and lifestyle changes that can disrupt immune regulation. Autoimmune disease diagnosis is used to accurately identify the specific immune disorder so that appropriate treatment can begin and disease progression can be better managed. For instance, in March 2023, according to Society for Women’s Health Research, U.S-based non-profit organisation, reported that, the autoimmune diseases are estimated to estimated that 23.5 million to 50 million. Further, the global rates of autoimmune diseases are rising by between 3-9 percent each year. Therefore, the increasing incidence of autoimmune diseases across the globe is driving the growth of the autoimmune disease diagnosis industry. Growing healthcare expenditures are expected to propel the growth of the autoimmune disease diagnosis market in the coming years. Healthcare expenditure is defined as the total amount of funds utilized for healthcare products and services. It is a key indication of a population's health and the success of a healthcare system. Increased healthcare spending allows for more prompt healthcare services, which leads to better identification, treatment, and results for people with autoimmune illnesses. For instance, in May 2024, according to the Office for National Statistics, a UK-based government department, total healthcare expenditure grew by 5.6% in nominal terms from 2022 to 2023, showing a notable acceleration compared to the 0.9% increase seen in 2022. Therefore, growing healthcare expenditures are driving the autoimmune disease diagnosis industry.

Key Players In The Global Autoimmune Disease Diagnosis Market

Major companies operating in the autoimmune disease diagnosis market are Siemens Healthineers AG, Abbott Laboratories, Thermo Fisher Scientific Inc, Bio-Rad Laboratories Inc, F. Hoffmann-La Roche Ltd, Danaher Corporation, AESKU Diagnostics GmbH & Co. KG, Trinity Biotech plc, bioMérieux SA, SQI Diagnostics, Philips Healthcare India, Agappe Diagnostics Ltd, Lepu Medical Technology Company (Beijing) Co., Ltd, Shanghai Runda Medical Technology Co., Ltd, GE Healthcare China Co., Ltd, Roche Holding AG, Koninklijke Philips, Theradiag, Becton Dickinson and Company, Ortho Clinical Diagnostics

Global Autoimmune Disease Diagnosis Market Trends and Insights

Major companies are operating in the autoimmune disease diagnosis market, focusing on developing technological advancements such as multiplex autoantibody assay platforms for comprehensive, early, and precise detection of autoimmune disorders to improve diagnostic accuracy and patient management. A multiplex autoantibody assay platform allows simultaneous detection of multiple disease-specific autoantibodies in a single patient sample enhancing sensitivity and specificity compared to traditional single-analyte ELISA or immunofluorescence tests while reducing sample volume and turnaround time. For instance, in January 2025, Exagen Inc., a U.S.-based diagnostics company, launched its AVISE CTD platform with new systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) biomarker assays. The platform detects novel biomarkers such as TIgG, TIgM, and TC4d, enabling clinicians to distinguish overlapping autoimmune conditions more accurately and streamline patient diagnosis while integrating seamlessly with existing testing workflows.

Regional Outlook

North America was the largest region in the autoimmune disease diagnosis market in 2025. Western Europe was the second largest region in the autoimmune disease diagnosis market share. The regions covered in this market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in this market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

What Defines the Autoimmune Disease Diagnosis Market?

The autoimmune disease diagnosis market includes revenue earned by diagnostic assay kits, reagents, consumables, and instruments used for the diagnosis of autoimmune diseases. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

How is Market Value Defined and Measured?

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 that 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.

What Key Data and Analysis Are Included in the Autoimmune Disease Diagnosis Market Report 2026?

The autoimmune disease diagnosis market research report is one of a series of new reports from The Business Research Company that provides market statistics, including industry global market size, regional shares, competitors with the market share, detailed market segments, market trends and opportunities, and any further data you may need to thrive in the autoimmune disease diagnosis industry. The market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future state of the industry.