The global autoimmune disease testing market is expected to grow significantly from USD 4.94 billion in 2025 to USD 8.13 billion by 2035, representing a compound annual growth rate (CAGR) of 5.1%. This expansion is driven by the increasing global burden of autoimmune disorders such as rheumatoid arthritis, systemic lupus erythematosus, and celiac disease, alongside rising diagnostic awareness and advancements in testing technologies.
Early and precise diagnosis is crucial in the management of autoimmune diseases, which are often complex and present overlapping symptoms. Modern autoimmune testing includes a combination of immunoassays, autoantibody screening, and molecular diagnostics to ensure better clinical outcomes. Laboratories and diagnostics firms are rapidly investing in high-sensitivity, multiplex assay platforms that can detect multiple markers from a single sample-improving speed and accuracy while reducing costs.
The rise of personalized medicine and the increasing use of companion diagnostics in autoimmune disease treatment are also fueling market growth. Technological innovations, including automated analyzers, AI-integrated diagnostics, and biomarker discovery, are allowing earlier and more targeted intervention strategies.
North America dominates the market, driven by robust healthcare infrastructure, widespread screening programs, and higher disease prevalence. Meanwhile, Asia Pacific is poised to register the fastest growth due to increasing healthcare access, improving lab diagnostics penetration, and government-led awareness programs.
In an official statement published by Bio-Rad Laboratories' Q3 2023 Earnings Call, Norman Schwartz, President and CEO, remarked: “Autoimmune diagnostics remains a strong area of demand for us, especially in light of increased global screening initiatives. Our customers are looking for more efficient, multiplexed, and automation-friendly solutions to address rising caseloads.” This comment reflects both the commercial and clinical momentum behind autoimmune testing worldwide.
With healthcare systems placing increased emphasis on early detection and chronic disease management, the autoimmune disease testing market is well-positioned for sustained innovation and growth through 2035.
Key Industry Attributes
| Attribute | Detail |
|---|---|
| Industry Size (2025) | USD 4.94 billion |
| Industry Size (2035) | USD 8.13 billion |
| CAGR (2025 to 2035) | 5.1% |
Reagents & consumables dominate the market with 43.3% share, while rheumatoid arthritis leads indications at 31.9%. The increasing prevalence of chronic autoimmune diseases and the push for early-stage diagnostics are fueling demand for advanced consumables and precise biomarker detection kits globally.
The reagents & consumables segment commands a 43.3% share of the autoimmune disease testing market in 2025, driven by high testing volumes and the need for precise, repeatable diagnostic results. These consumables include buffers, calibration solutions, antibodies, and substrates essential for running ELISA, immunofluorescence, and chemiluminescence assays.
Hospitals, diagnostic labs, and research institutes depend heavily on high-quality reagents to ensure specificity, reduce cross-reactivity, and increase test throughput. The rise in personalized medicine and disease stratification has further fueled the demand for reliable assay components. Reagents are often bundled with automation-friendly kits that allow quicker turnaround times and reduce human error in testing environments.
Key players like Thermo Fisher Scientific, Bio-Rad, and PerkinElmer are investing in expanding their consumables portfolios with next-generation, ready-to-use reagents designed for multiplexing and automated workflows. With increasing awareness of autoimmune disorders and initiatives for early detection, the reagents & consumables category is expected to remain the largest and most resilient segment in the autoimmune diagnostics market through 2035.
Rheumatoid arthritis (RA) is the leading indication in the autoimmune disease testing market, capturing a 31.9% share in 2025. The global rise in RA prevalence, especially among aging populations and females, is contributing significantly to diagnostic testing volumes. Early identification is crucial for managing joint degeneration and preventing irreversible disability.
Testing for RA includes the detection of biomarkers such as rheumatoid factor (RF), anti-cyclic citrullinated peptide (anti-CCP) antibodies, and inflammatory markers (ESR, CRP). The demand for high-sensitivity tests has risen sharply as physicians aim to initiate disease-modifying antirheumatic drugs (DMARDs) early in the disease course.
Diagnostic laboratories and hospitals are increasingly adopting multiplex immunoassay platforms for faster RA screening. Companies like Siemens Healthineers, Abbott, and Beckman Coulter are focused on developing integrated RA panels with AI-enabled decision support tools for clinicians. Given the irreversible nature of joint damage in RA, routine screening programs and physician education have further boosted testing uptake, making RA the top-revenue generating indication in the autoimmune disease diagnostics landscape.
The global autoimmune disease testing market's compound annual growth rate (CAGR) for the first half of 2024 and 2025 is compared in the table below. This analysis allows the industry performance to be informed about significant trends and shifts regarding revenue generation.
The first half, H1, is from January through June while the second half, H2, is from July up to December. The company is expected to expand at a CAGR of 5.0% in the first half, H1, of the same period running from 2024 to 2034, whereas expansion declines to 5.5% in the second half, H2, of the same period.
| Particular | Value CAGR |
|---|---|
| H1 | 5.0% (2024 to 2034) |
| H2 | 5.5% (2024 to 2034) |
| H1 | 5.1% (2025 to 2035) |
| H2 | 5.5% (2025 to 2035) |
Moving into the subsequent period, from H1 2025 to H2 2035, the CAGR is projected to decrease slightly to 5.1% in the first half and remain relatively moderate at 5.5% in the second half. In the first half (H1) the industry witnessed a decrease of 10 BPS while in the second half (H2), the industry witnessed a decrease of 4 BPS.
Biomarkers Driving Precision Medicine and Early Detection in Autoimmune Disorders Driving Market Growth
Biomarkers have a high utility in the detection, diagnosis, and follow-up of autoimmune disorders because they tend to identify precise molecular, genetic, or protein markers of a disease that corresponds to disease activity. Tests of biomarkers tend to be sensitive and specific rather than conventional means of diagnosis that are susceptible to false positives and negatives. Therefore, accuracy determines the control and early control of autoimmune conditions in relation to how the disease evolves.
Advances in genomics, proteomics, and molecular biology have elevated the scope of detectable biomarkers through which clinicians can identify complex conditions, such as rheumatoid arthritis, lupus, and multiple sclerosis. Such testing for biomarkers also brings personalization into medicine, letting the clinicians construct treatment plans individually based on a particular disease profile. The trend is also witnessing growth in non-invasive, fast diagnostic methods that will further add to the adoption rate of biomarker-based tests.
Pharmaceutical and diagnostic laboratories are investing more in R&D to discover novel biomarker assays to advance technological progress and expand the market further. This is set to continue as healthcare systems increasingly focus on early diagnosis and targeted therapies for better patient results.
Adoption of Point-of-Care and At-Home Testing is Revolutionizing Autoimmune Disease Testing Landscape
The increasing demand for faster, more convenient, and user-friendly diagnostic solutions is strongly driving the use of point-of-care (POC) and at-home testing in the autoimmune disease testing market. POC testing provides the benefit of yielding rapid results without the need for complex laboratory infrastructure, which facilitates faster clinical decisions with timely interventions. This is highly valuable for autoimmune conditions, where early diagnosis is critical to prevent further progression of the disease.
Bio-Rad Laboratories and Thermo Fisher Scientific companies have developed kits that were user-friendly. They made utilization in clinical or at-home settings easier. Results for these kits have been the successful management of diseases such as rheumatoid arthritis and lupus, whereby a patient may follow activity and the response of the disease to the treatment.
The COVID-19 pandemic hastened the transition toward remote healthcare solutions, hence improving confidence in diagnostic tools in home use. Another integration between POC devices and digital health technologies is digital data tracking by mobile apps to support personalized care, improve patient engagement, and create future expansion of market opportunities.
Advancements in Microfluidics and Lab-on-a-Chip Technologies acting as an opportunity for this Market
The novel platforms miniaturize complex laboratory procedures onto a single chip, permitting rapid, inexpensive, and extremely sensitive diagnostic testing. Because such devices consume a minimal amount of sample volume, they can simultaneously perform several assays, which boosts the efficiency of diagnosis and diminishes turnaround time.
Point-of-care and resource-limited settings have a significant benefit from microfluidic-based tests, which do not necessarily require access to the traditional laboratory infrastructure. Compactness, portability, and the ability to provide real-time results make these ideal for remote healthcare, emergency diagnostics, and even at-home testing.
Besides this, microfluidics, coupled with biosensors and AI-driven data analysis, is helping increase the precision in autoimmune disease diagnosis, especially specific autoantibodies and biomarkers. Commercialization of lab-on-a-chip devices by companies continues to expand through investment in R&D, making early disease detection and monitoring as well as treatment strategies more personalized for autoimmune care.
Variability in Test Sensitivity and Specificity Restrict Market Growth
Variability in the sensitivity and specificity of the test is a strong restraint for this market in terms of testing of autoimmune diseases. Autoimmune diseases have diverse, complex, and often unclear symptoms, so testing used for such diseases cannot effectively determine if it is or not. Some tests might give false positives, meaning they indicate the existence of an autoimmune disorder when no such disorder exists, or false negatives, where the disease fails to be detected when it indeed exists. Such inconsistency may result in misdiagnosis or delayed diagnosis, significantly affecting treatment and patient outcomes.
Clinicians become less confident with the reliability of some diagnostic tests, especially with variability between the results of these tests. This may lead to an increased number of tests and late decisions, thereby increasing the cost and burden on healthcare systems. In turn, this may impede the adoption of such tests and thus hinder their expansion and uptake in clinical settings. However, since their accuracy and consistency will be further developed to expand the market, it is important to drive the industry forward.
Tier 1 companies are the industry leaders with 46.8% of the global industry. These companies stand out for having a large product portfolio and a high production capacity. These industry leaders also stand out for having a wide geographic reach, a strong customer base, and substantial experience in manufacturing and having enough financial resources, which enables them to enhance their research and development efforts and expand into new industries.
The companies within tier 1 have a good reputation and high brand value. These companies frequently get involved in strategies such as acquisition and product launches. Prominent companies within tier 1 include F. Hoffmann-La Roche Ltd, Becton, Dickinson and Company, Thermo Fisher Scientific Inc., PerkinElmer Inc. and Abbott.
Tier 2 companies are relatively smaller as compared with tier 1 players. The tier 2 companies hold a market share of 32.7% worldwide. These firms may not have cutting-edge technology or a broad global reach, but they do ensure regulatory compliance and have good technology. The players are more competitive when it comes to pricing and target niche markets. Key Companies under this category include Werfen, DiaSorin S.p.A, BIOMÉRIEUX, Bio-Rad Laboratories, Inc.
Compared to Tiers 1 and 2, Tier 3 companies offer autoimmune disease testing, but with smaller revenue spouts and less influence. These companies mostly operate in one or two countries and have limited customer base. The companies such as Danahar, Siemens Healthineers AG, and others falls under tier 3 category. They specialize in specific products and cater to niche markets, adding diversity to the industry.
The market analysis for autoimmune disease testing in various nations is covered in the section below. The list given below presents the analysis of critical countries from the world such as North America, Latin America, Western Europe, Eastern Europe, East Asia, South Asia & Pacific, and Middle East & Africa. Based on these factors, the United States is projected to hold a value share of 81.7% for the market during the estimated period of 2035. Meanwhile, for China, in the Asia-Pacific region, by the end of the forecasted year 2035, there would be a growth rate of CAGR at around 5.8%.
| Country | Value CAGR (2025 to 2035) |
|---|---|
| United States | 3.7% |
| Germany | 3.4% |
| Japan | 3.5% |
| China | 5.8% |
| South Korea | 5.2% |
| India | 6.2% |
Germany’s autoimmune disease testing market is poised to exhibit a CAGR of 3.4% between 2025 and 2035. The Germany holds highest market share in European market.
Strong healthcare research funding by Germany is one of the main driving factors behind the autoimmune disease testing market. The government has also invested a lot in R&D in the health sector, specifically diagnostic technologies and precision medicine. Such investment can provide the advent of advanced diagnosis tools and biomarkers responsible for the early detection and monitoring of autoimmune diseases.
Programs, including national health care and the German research scheme, promote alliances between universities and medical institutions to advance diagnostic technique with private industries. These initiatives help improve the sensitivity and specificity of tests, which are more reliable and accessible to clinicians.
This involved support from the DFG and BMBF for various studies focusing on the innovation of diagnostic methodologies for the disease, creating an enabling environment for commercialization of new technologies and enhancing the market for testing the autoimmune disease.
The United States is supposed to exhibit a CAGR of 3.7% between 2025 and 2035.
Autoimmune diseases are a very common feature in the USA The increasing incidence rate is one of the major driving factors for the autoimmune disease testing market. This is because the incidence of rheumatoid arthritis, lupus, and multiple sclerosis has been constantly on the rise, primarily due to lifestyle issues such as inappropriate diet, stress, and other environmental exposures.
One observes another burden related to aging that takes the shape of high vulnerability towards autoimmune conditions in its midst. The Centers for Disease Control reported that it ranks as a common cause for death and impairment across chronic illness patterns in United States.
These needs have resulted in a higher demand for full diagnostics tests that may diagnose these conditions at the very early stages so that patients might have better clinical outcomes and consequently lower healthcare spending. This thus presents a considerable market opportunity in innovative testing technologies such as AI-driven diagnostics, biomarker panels, and genetic testing for autoimmune diseases management and monitoring within the USA healthcare system.
China is anticipated to show a CAGR of 5.8% between 2025 and 2035.
China's government has strongly invested in the healthcare infrastructure with an emphasis on developing the diagnostics capacity to enhance disease management. In recent years, health reforms have featured China's efforts to upgrade technologies in keeping with the upsurge in chronic and autoimmune diseases. Initiatives such as Healthy China 2030 have been focused on the inclusion of next-generation diagnostics within both the city-based and rural health systems.
These initiatives would include increasing access to high-quality diagnostic testing, more so in regions that are most underserved by using point-of-care devices and AI-based diagnostic platforms. Further, the government has provided incentives for the research and development of precision medicine and genetic testing which further encourages establishing more accurate solutions for detecting diseases with higher efficacy and at costs that are very low.. The renewed focus on modernizing diagnostics has fostered an environment that allows for the growth and adoption of new advanced autoimmune disease testing technologies across the country, further fueling expansion in the market.
Key players in the autoimmune disease testing market utilize a host of strategies to stay ahead in the competition. These include product innovation; key focuses are made on developing more advanced diagnostic devices, such as highly sensitive panels of biomarkers, to improve speed and accuracy. Companies also maintain strategic partnerships and acquisitions to enhance their product portfolio and expand their business bases.
Geographical expansion is one of the key strategies, wherein players are targeting the emerging markets and trying to capitalize on increasing demand coming forth from advanced diagnostic solutions. Further, investing in R&D for next-generation testing platforms such as AI-driven diagnostics and point-of-care devices along with improvement in distribution channels will be imperative to fuel long-term growth and get a larger market share.
Recent Industry Developments in Autoimmune Disease Testing Market
| Report Attributes | Details |
|---|---|
| Market Size (2025) | USD 4.94 billion |
| Projected Market Size (2035) | USD 8.13 billion |
| CAGR (2025 to 2035) | 5.1% |
| Base Year for Estimation | 2024 |
| Historical Period | 2020 to 2024 |
| Projections Period | 2025 to 2035 |
| Quantitative Units | USD billion for value and million units for volume |
| Product Types Analyzed (Segment 1) | Instruments, Assay Kits, Reagents & Consumables |
| Testing Modes Analyzed (Segment 2) | Lab-Based Testing, Point-of-Care Testing |
| Indications Analyzed (Segment 3) | Rheumatoid Arthritis (RA), Type 1 Diabetes, Inflammatory Bowel Disease (IBD), Multiple Sclerosis (MS), Celiac Disease, Graves' Disease (Hyperthyroidism), Hashimoto's Thyroiditis (Hypothyroidism), Psoriasis, Systemic Lupus Erythematosus (SLE), Others |
| End Users Analyzed (Segment 4) | Hospitals, Diagnostic Laboratories, Reference Laboratories, Specialized Clinics, Academic & Research Institutes, Home Care Settings (Self-Testing), Point-of-Care Testing Centers |
| Regions Covered | North America; Latin America; Western Europe; Eastern Europe; East Asia; South Asia & Pacific; Middle East & Africa |
| Countries Covered | United States, Canada, Brazil, Mexico, Germany, United Kingdom, France, Italy, Spain, China, Japan, South Korea, India, Australia, UAE, Saudi Arabia, South Africa |
| Key Players Influencing the Market | F. Hoffmann-La Roche Ltd, Becton, Dickinson and Company, Thermo Fisher Scientific Inc., PerkinElmer Inc., Abbott, Werfen, DiaSorin S.p.A, BIOMÉRIEUX, Bio-Rad Laboratories, Inc., Danaher, Siemens Healthineers AG, Others |
| Additional Attributes | Manufacturers would want insights on dollar sales, share, competitive landscape, top-selling assay kits, growth by indication, regional demand shifts, lab vs point-of-care trends, regulatory pathways, and technology adoption forecasts. |
The global autoimmune disease testing industry is projected to witness CAGR of 5.1% between 2025 and 2035.
The global autoimmune disease testing industry stood at USD 4,712.1 million in 2024.
The global autoimmune disease testing industry is anticipated to reach USD 8.13 billion by 2035 end.
China is expected to show a CAGR of 5.8% in the assessment period.
The key players operating in the global autoimmune disease testing industry F. Hoffmann-La Roche Ltd, Becton, Dickinson and Company, Thermo Fisher Scientific Inc., PerkinElmer Inc., Abbott, Werfen , DiaSorin S.p.A, BIOMÉRIEUX, Bio-Rad Laboratories, Inc., Danahar, Siemens Healthineers AG and Others
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Autoimmune Disease Testing Market
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