The global sales of autoimmune disease testing are expected to be approximately USD 4,943.0 million in 2025 and is likely to expand up to approximately USD 8,128.6 million by the end of 2035. The sales are believed to rise with a CAGR of 5.1% during the period of 2025 to 2035. Autoimmune disease testing produced revenue worth approximately USD 4,712.1 million in 2024.
Autoimmune disease means that one's immune system attack its cells, tissues, or organs themselves in a chronic, inflammatory manner of damage. One of the common examples of autoimmunity in diseases is when it affects almost all parts of the body which brings various symptoms such as an organ dysfunction or joint pain in rheumatoid arthritis, Lupus, type 1 diabetes, and the multiple sclerosis as well.
With this growth of autoimmunity to hundreds of millions in the entire globe, the auto-disease-testing market continues driving upwards. This boost increases the number of early accurate diagnostic tests performed on patients so that they get proper treatment following an effective health care strategy.
Autoimmune Disease Testing Industry Analysis
| Attributes | Key Insights |
|---|---|
| Industry Size (2025E) | USD 4,943.0 million |
| Industry Value (2035F) | USD 8,128.6 million |
| CAGR (2025 to 2035) | 5.1% |
Growth drivers in this autoimmune disease testing market are due mainly to technology advances. Advanced diagnostics through NGS have given diagnostic capabilities through identification of specific genetic markers or mutations that indicate particular autoimmune conditions. This implies the possibility for much more directed, personalized testing methods, ultimately helping in very early detection with treatment.
Similarly, multiplex immunoassays have dramatically enhanced the capabilities for detecting simultaneously from a patient sample multiple autoantibodies. It is also associated with higher accuracy, decreased testing time, and lower costs, thus more efficient for laboratories and healthcare providers.
Another development that's changing the course of autoimmune disease diagnostics is artificial intelligence and machine learning algorithms. AI-based tools can process huge amounts of data to detect patterns, predict the progression of disease, and even assist in making clinical decisions better than conventional approaches.
Furthermore, companies are launching automated and high-throughput testing platforms that help streamline laboratory workflows, reduce human error, and improve turnaround times. Advanced testing is thus more accessible, especially in high-demand clinical settings. Collectively, these technological innovations are driving the demand for autoimmune disease testing by offering faster, more accurate, and cost-effective diagnostic solutions.
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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.
The global autoimmune disease testing industry recorded a CAGR of 4.6% during the historical period between 2020 and 2024. The growth of autoimmune disease testing industry was positive as it reached a value of USD 4,712.1 million in 2024 from USD 3,936.3 million in 2020.
Traditionally, the testing of autoimmune diseases has relied on serological assays such as ELISA and IFA, which measure the presence of autoantibodies in patient samples. These tests, though reliable, are time-consuming and lack sensitivity and specificity, which can lead to potential misdiagnosis or delayed results.
Next-generation sequencing, multiplex immunoassays, and AI-based diagnostics have substantially increased the efficiency of tests as their accuracy goes to a far wider range than traditional methods where several biomarkers and autoantibodies were found simultaneously. Technologies like Lab-on-a-Chip and Point-of-Care (POC) devices ensure greater efficiency while also providing immediate results with lesser amounts of the samples. As these technologies tend to provide accurate and faster diagnoses, they better aid in handling the disease management with more advanced treatments than previously thought.
Governments and health care organizations, such as the Autoimmune Association (AA) and the American Autoimmune Related Diseases Association does strive to promote education about autoimmune diseases. Awareness campaigns usually are designed to increase the chances of early diagnosis to prevent long-term complications and to control symptoms. Consequently, there is an increasing need for diagnostic testing to detect autoimmune conditions at their onset, before they progress into more severe stages.
These awareness campaigns are driving engagement among the public and healthcare professionals, who then encourage people to get tested early. The prevention of health conditions and early interventions are leading to the adoption of advanced autoimmune disease tests, promoting market growth and increasing opportunities for diagnostic companies in meeting the ever-growing demand.
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.
The section contains information about the leading segments in the industry. Based on product, the reagents & consumables segment is expected to account for 43.3% of the global share in 2023.
| By Product | Value Share (2025) |
|---|---|
| Reagents & consumables | 43.3% |
The reagents & consumables segment is projected to be a dominating segment in terms of revenue, accounting for almost 43.3% of the market share in 2025.
The Reagents & Consumables segment is expected to be the market leader for autoimmune disease testing due to the core requirement in all diagnostic procedures. The immediate consumables-the reagents-used in the tests, such as ELISA and immunoassay, include antibodies, antigens, and biomarkers, used directly with each test cycle, thus sustaining demand. As the market for autoimmune disease testing continues to grow, most especially with higher throughput and multiplex assays that are increasingly on the rise, the demand for reagents and consumables shall continue to build up.
In addition, the chronic nature of autoimmune diseases necessitates repeated monitoring, and hence, sustained testing. Therefore, the product demand will continue for a longer period. Moreover, recurrent use in healthcare settings is another significant factor that propels the market segment to generate the highest revenues through reagents and consumables in the autoimmune testing market.
| By Indication | Value Share (2025) |
|---|---|
| Rheumatoid Arthritis (RA) | 31.9% |
The rheumatoid arthritis (RA) segment will lead the market in terms of revenue, accounting for nearly 31.9% of the market share in 2025.
This is likely to be dominated by the Rheumatoid Arthritis (RA) segment, considering that the disease is of a chronic nature and highly prevalent in the global market. RA is one of the most common autoimmune disorders, afflicting millions, primarily old subjects. Early diagnosis and also observation of disease progression are critical to avoid further damage to the joints and to ameliorate patient outcomes, thus propelling demand for reliable testing solutions.
The availability of biomarkers specific for RA, such as rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA), has ensured the development of accurate diagnostic assays. The pressure from healthcare providers to diagnose more patients at a younger age as well as customized treatment is probable to fuel a demand for autoimmune disease testing linked to RA diagnosis, and therefore, this application is expected to continue to have a significant dominance in the industry.
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
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 8,128.6 million 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
| Current Year Value (2023) | USD 71,466.47 million |
|---|---|
| Expected Forecast Value (2033) | USD 123,507.30 million |
| Projected CAGR (2023 to 2033) | 5.6% |
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