Autoimmune Disease Diagnostics Market Size, Share Detailed Report 2026 to 2035

Autoimmune Disease Diagnostics Market Size is valued at USD 6.41 Bn in 2025 and is predicted to reach USD 11.63 Bn by the year 2035 at a 6.0% CAGR during the forecast period for 2026 to 2035.

Autoimmune Disease Diagnostics Market Size, Share & Trends Analysis Distribution by Product (Instruments, Consumables and Assays), Test (C-reactive Protein (CRP), Antinuclear antibody tests, Complete blood count (CBC), Urinalysis, Autoantibody tests, and Others), Type (Localized autoimmune disease diagnostics (Type 1 diabetes, Multiple sclerosis, Hashimoto's Thyroiditis, Idiopathic thrombocytopenic purpura, Others) and Systemic autoimmune disease diagnostics (Ankylosing spondylitis, Rheumatoid arthritis, Systemic lupus erythematosus (SLE), Others)), End-user (Hospitals, Diagnostic centers, and Others), and Segment Forecasts, 2026 to 2035

Autoimmune disease diagnostics refers to the medical tests and procedures used to detect and confirm autoimmune disorders — conditions where the immune system wrongly attacks the body’s own healthy cells, tissues, and organs, causing inflammation, pain, and damage over time. Doctors usually start with blood tests to look for specific autoantibodies (such as ANA, rheumatoid factor, anti-CCP, or anti-dsDNA) and signs of inflammation (like CRP or ESR). Depending on symptoms, they may also order imaging scans (X-ray, ultrasound, MRI) to check for joint, organ, or tissue damage, or perform a tissue biopsy to examine affected areas directly. 

Early and accurate diagnosis is very important because most autoimmune diseases are chronic and progressive; identifying them early helps doctors start the right treatment sooner, control symptoms, prevent serious complications, and greatly improve the patient’s quality of life. Common examples include rheumatoid arthritis, lupus, type 1 diabetes, multiple sclerosis, Hashimoto’s thyroiditis, and celiac disease.

One of the significant driver in the autoimmune disease diagnostics market growth is the development of technological instruments for diagnosis. Innovations such as next-generation sequencing and enhanced biomarker identification are boosting diagnosis accuracy and efficiency. These technologies are making it possible to characterise diseases more precisely, which is essential for individualised treatment plans. Additionally, patients' and healthcare providers' increased knowledge and comprehension of autoimmune illnesses is fueling the demand for autoimmune disease diagnostics. Better disease management and earlier diagnosis are being facilitated by advocacy and educational programs. Furthermore, the autoimmune disease diagnostics market is expanding due to attractive reimbursement policies and regulatory backing. Early diagnosis is crucial for lowering healthcare costs and enhancing patient outcomes, as governments and healthcare institutions are realising.

In addition, more money is being spent on research and development, which results in improved diagnostic instruments. Access to testing services has improved in emerging nations due to the expansion of healthcare infrastructure. Additionally, the increasing use of automation and point-of-care testing in laboratories speeds up diagnosis. The autoimmune disease diagnostics market is expanding, and innovation in diagnostic platforms is being fostered by these combined forces. However, the autoimmune disease diagnostics market faces a number of important obstacles and difficulties. The high cost of diagnostic tests is a major obstacle that restricts patient access, especially in low-income areas. Diagnoses are frequently missed or delayed as a result of this financial obstacle. Additionally, the intricacy of autoimmune diseases with overlapping symptoms makes accurate identification difficult and necessitates numerous tests, which raises expenses and time.

Competitive Landscape

Which are the Leading Players in the autoimmune disease diagnostics market?

• Hoffmann-La Roche Ltd
• Abbott
• Siemens Healthineers AG
• Quest Diagnostics
• Nova Diagnostics Pte Ltd.
• Beckman Coulter, Inc.
• Danaher Corporation
• BIOMÉRIEUX
• Hemagen Diagnostics, Inc.
• EUROIMMUN Medizinische Labordiagnostika AG

Market Dynamics

Driver

Rising Incidence of Various Autoimmune Disorders

One important factor contributing to the growth of the global autoimmune disease diagnostics market is the rising incidence rates of various autoimmune disorders. Rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, type 1 diabetes, autoimmune thyroid disorders, and many more conditions are examples of autoimmune diseases. Due to rising prevalence rates and other environmental factors that contribute to diverse pro-disease circumstances, several diseases exhibit an increased occurrence globally. In order to effectively manage autoimmune illnesses, a more accurate diagnosis is required due to their chronic and progressive nature. As a result, the rising prevalence of these illnesses guarantees an ongoing need for more effective autoimmune disease diagnosis services throughout the global health system. In September 2024, the National Health Council issued a paper stating that 50 million Americans suffer from autoimmune disorders, with women making up 80% of the affected population. This is significant because diagnosing autoimmune diseases can be difficult. Thus, this will boost the autoimmune disease diagnostics market growth over the forecast period. 

Restrain/Challenge

High Costs of Autoimmune Disease Diagnostic Testing

The market's growth is hampered by the high costs of autoimmune disease diagnostic testing, particularly in developing countries with tight healthcare budgets. The adoption of cutting-edge diagnostic technology may be hampered by these financial constraints, which could impede the advancement of the autoimmune disease diagnostics industry. The cost of diagnostic testing becomes a crucial concern in nations with limited healthcare resources. Furthermore, a significant portion of the population, especially those from lower socioeconomic backgrounds, frequently cannot afford these tests due to their high cost. As a result, people may have trouble getting prompt and accurate diagnoses for autoimmune disorders, which could cause delays in starting treatment and worsen health outcomes. Additionally, it may be difficult for healthcare facilities in resource-constrained places to maintain the necessary infrastructure and purchase pricey diagnostic equipment.

Antinuclear Antibody Tests Segment is Expected to Drive the Autoimmune Disease Diagnostics Market

The antinuclear antibody tests category held the largest share in the Autoimmune Disease Diagnostics market in 2025. Tests for antinuclear antibodies (ANA) are essential because they can identify autoimmune activity prior to the onset of severe symptoms. Additionally, they can assist the physician in tracking the course of the illness and determining whether the treatment is effective. Consequently, habitual use in clinical practice is encouraged due to their dual role in diagnosis and monitoring, which drives market demand. Furthermore, additional access to ANA tests is being made possible by the growth of clinical laboratories, hospital diagnostic centres, and special autoimmune clinics. Higher throughput and automated platforms that streamline testing are combined in centralised laboratories. As a result, there is a steady and expandable need for ANA reagents and kits with better infrastructure.

The Hospitals Segment is Growing at the Highest Rate in the Autoimmune Disease Diagnostics Market

In 2025, the hospitals category dominated the Autoimmune Disease Diagnostics market. As autoimmune diseases become more common and people become more aware of them, hospitals are seeing an increase in the number of patients with these ailments. In-house diagnostic services are in high demand due to this patient surge. Hospitals are investing more in autoimmune diagnostics because they prefer complete testing facilities to offer prompt diagnosis and therapy. In addition, a lot of hospitals are setting up specialised departments for rheumatology and immunology to handle complicated autoimmune conditions. These specialised units need sophisticated diagnostic instruments, such as autoantibody panels, immunoassays, and molecular tests. The acquisition of consumables, reagents, and diagnostic equipment is increased by the growth of these divisions.

Why North America Led the Autoimmune Disease Diagnostics Market?

The Autoimmune Disease Diagnostics market was dominated by the North America region in 2025 because of the rise in chronic autoimmune diseases, better healthcare facilities, and a move toward cutting-edge technologies such as multiplex immunoassays and ELISA. In order to satisfy growing clinical demand and enhance early diagnosis and illness surveillance, diagnostic providers are broadening their test offerings. With greater volume and accuracy, ELISA and chemiluminescence immunoassays are transforming autoimmune disease diagnostics in the United States. Nearly 23.5 million Americans suffer from chronic illnesses, according to the CDC, underscoring the importance of accurate diagnosis. 

Autoimmune Disease Diagnostics Market Report Scope: