Autoimmune Disease Diagnostics Market Global Report by Product (Therapeutic & Monitoring Equipment, Diagnostics Equipment, and Drugs), Types (Systemic Autoimmune Disease Diagnostics, and Localized Autoimmune Disease Diagnostics), Indication (Rheumatic Disease, Diabetes, Multiple Sclerosis, Inflammatory Bowel Disease, and Others), End-Users (Hospitals, Diagnostics Centers, and Others), Countries and Company Analysis 2025-2033
Buy NowGlobal Autoimmune Disease Diagnostics Market Size
Autoimmune Disease Diagnostics market is expected to reach US$ 10.63 billion in 2033 from US$ 5.70 billion in 2024, with a CAGR of 7.17 % from 2025 to 2033. The market is being driven by a number of factors, such as the need for precise diagnostic solutions, the growing emphasis on improving patient outcomes, developments in diagnostic technologies, and partnerships and collaborations among leading players.
Autoimmune Disease Diagnostics Industry Overview
The market for autoimmune illness diagnostics is expanding as a result of greater awareness, the prevalence of autoimmune disorders, and improvements in diagnostic technology. The need for precise, early diagnostic testing has increased as awareness of autoimmune conditions including multiple sclerosis, lupus, and rheumatoid arthritis has grown. Polymerase chain reaction (PCR), immunofluorescence, and enzyme-linked immunosorbent assays (ELISA) are important diagnostic techniques. Improvements in biomarker discovery also benefit the industry by enabling more accurate and individualized diagnosis. The market is growing as a result of rising demand for point-of-care testing, increased healthcare spending, and an emphasis on early detection. But issues like expensive diagnostics, difficult testing methods, and the requirement for specific knowledge continue to exist.
Report Features | Details |
Base Year |
2024 |
Forecast Years |
2025 - 2033 |
Historical Years |
2020 - 2024 |
Market Size in 2024 |
US$ 5.70 Billion |
Market Forecast in 2033 |
US$ 10.63 Billion |
Market Growth Rate (2025-2033) |
7.17% |
According to figures released by the Multiple Sclerosis International Federation in 2020, there were 2.8 billion multiple sclerosis sufferers worldwide in 2020, up from 2.3 million in 2013. In addition, the World Health Organization (WHO) reported in 2023 that over 18 million people with rheumatoid arthritis were affected globally in 2019. According to the same source, women made up about 70% of those with rheumatoid arthritis in 2019, and 55% of them were over 55. As a result, the market for autoimmune disease diagnostics will grow favorably as the prevalence of autoimmune disorders rises and the necessity for autoimmune disorder diagnosis increases.
Growing public awareness of early disease diagnosis is another factor propelling the market for autoimmune disease diagnostics. Every March, for instance, the Autoimmune Association observes Autoimmune Disease Awareness Month. The awareness campaign's main objective is to increase public understanding and knowledge about autoimmune diseases. The market for autoimmune disease diagnostics is therefore driven in large part by the need for early detection of illnesses brought on by greater disease awareness.
Growth Drivers for the Autoimmune Disease Diagnostics Market
Growing Attention on Enhancing Patient Results
On October 16, 2023, Werfen's Aptiva® connective tissue disease (CTD) essential reagent received 510(k) approval from the US Food and Drug Administration (FDA). In autoimmune diseases that are challenging to diagnose, new reagents help to improve patient outcomes and expedite the diagnosis process. Furthermore, the need for autoimmune disease diagnosis is being accelerated by the growing emphasis on early and precise diagnosis for improved patient outcomes. In addition, early detection of autoimmune illnesses allows physicians to initiate therapy promptly, preventing or postponing the onset of conditions such as rheumatoid arthritis, lupus, and multiple sclerosis.
Key Players' Partnerships and Collaborations
To improve its data and analytics capabilities, ScipherMedicine purchased Philadelphia-based CrossBridge, a data, analytics, and software business, on January 10, 2023. This makes it possible to comprehend patients' treatment pathways more precisely and in real time. While improving patient outcomes, the software as a service (SaaS) value-based care platform helps reduce healthcare expenditures. Companies combine their knowledge of immunology, molecular biology, and bioinformatics through a variety of partnerships, which is bolstering the growth of the autoimmune disease diagnosis industry. In order to identify which patients will benefit most from specific therapies, many pharmaceutical companies are working with diagnostic companies to offer companion diagnostics tests. By helping patients receive the optimum biologic therapy for autoimmune diseases, these diagnostics improve outcomes and reduce trial-and-error in treatment selection. Co-development of therapies and diagnostic instruments is another aspect of these collaborations. Pharmaceutical businesses, for example, may collaborate with diagnostics companies to develop tests that track the effectiveness of treatments, enabling physicians to make real-time therapy adjustments to enhance patient outcomes.
Developments in Diagnostic Technologies
To detect certain autoimmune disorders like lupus, rheumatoid arthritis, and celiac disease, new biomarkers such as autoantibodies are found. More accurate categorization and early detection of autoimmune disorders can be achieved by biomarkers. Only because to advancements in proteomics and metabolomics are more customized diagnostics making it possible to identify unique protein signatures or metabolic profiles connected to autoimmune illnesses. Additionally, the simultaneous assessment of several biomarkers made possible by microarray technology facilitates the diagnosis of complicated autoimmune disorders involving numerous genetic or protein components. Furthermore, businesses are introducing innovative goods and technology, which is improving the outlook for the autoimmune disease diagnosis market.
For example, on March 25, 2024, AbbVie Inc. and Landos Biopharma, Inc. announced a final agreement wherein AbbVie will purchase Landos, a biopharmaceutical business in the clinical stage that specializes in developing innovative oral therapies for patients with autoimmune illnesses. NX-13, a first-in-class oral NLRX1 agonist with a bimodal mode of action (MOA), is Landos' primary research asset.
Challenges in the Autoimmune Disease Diagnostics Market
Products' low penetration in developing nations is impeding the growth of the market
The market is expanding due to a number of factors, including an increase in the prevalence of autoimmune illnesses such rheumatoid arthritis and inflammatory bowel disease. However, the market's growth may be constrained by the underutilization of autoimmune disease testing products. For example, inflammatory bowel disease is seen as an emerging disease in developing nations like Brazil, yet there aren't many population-based research because of a lack of databases and surveillance. The adoption of important autoimmune disease testing items is being hampered in a number of developing nations by the scarcity of epidemiological data and the lack of access to effective diagnostic techniques brought on by a shortage of qualified medical personnel.
Additionally, fewer patients are scheduling follow-up and new appointments as a result of the general public's ignorance of these illnesses. During the projected period, this is anticipated to impede market growth.
Competitive pricing and low equipment costs limit market expansion
The market for autoimmune disease diagnostics is very competitive, with local manufacturers offering low-cost devices. Consequently, heightened rivalry from low-cost local producers may restrict market growth. Because the market for autoimmune disease diagnosis is always evolving technologically, manufacturers are expected to provide the most recent solutions.
Because they must pay more money to get technologically improved products and procedures, customers are hesitant to adopt costly upgrade methods. There will be fierce rivalry in the autoimmune disease diagnostics market as a result, which may result in reduced costs and a slower rate of expansion.
Diagnostics equipment leads the global autoimmune disease diagnostics market growth
An accurate and well-timed prognosis is vital in dealing with autoimmune diseases. Diagnostics Equipment, from blood analyzers to imaging systems, identifies situations early, improving effects. With a vast variety of tests, such as specialized imaging, it caters to various needs. Technological advancements, like AI and automation, drive growth. Rising occurrence fuels demand for supporting innovation. Personalized treatment is based on correct analysis. Supportive regulations and insurance coverage enhance accessibility. Streamlined workflows and automation lessen mistakes. Early intervention ability promises disease prevention.
Systemic autoimmune diseases dominate the global autoimmune diseases diagnostics market share
The global autoimmune diseases diagnostics market is segmented into Systemic Autoimmune Disease Diagnostics and Localized Autoimmune Disease Diagnostics. Systemic autoimmune diseases (SADs) impose considerable morbidity and mortality, often necessitating lifelong treatment and monitoring, hence driving demand for specialized diagnostics. Notable improvements, including noticeably precise autoantibody assays, genetic testing for susceptibility markers, and advanced imaging strategies, enhance diagnostics accuracy and efficiency, bolstering market growth. Early detection is pivotal in coping with SADs efficaciously, lowering disease development and organ damage, thereby fostering demand for reachable and precise diagnostics tools. With elevated consciousness of SADs and their effects, individuals are proactively in search of medical interest and screening tests, in addition to stimulating market enlargement.
Rheumatic disease diagnostics occupy a substantial share
Rheumatic diseases, affecting 1 in 4 adults globally, fuel tremendous demand for diagnostics. Diverse subtypes like rheumatoid arthritis and lupus require precise diagnostics techniques, propelling the improvement of a vast range of tests. Diagnosis complexity, with overlapping signs, mandates advanced strategies like autoantibody assays and genetic testing. Early detection is essential for capable management and decreasing joint damage. Research emphasizes novel diagnostics Equipment, enhancing accuracy and permitting personalized medicine. This shift towards tailor-made remedies underscores the significance of correct diagnostics in predicting disorder development and guiding interventions.
Diagnostics centers are expected to hold the largest market share
Specialized diagnostics centers excel in autoimmune disease, testing with targeted expertise, and providing quicker, correct diagnoses using cutting-edge technology. They prioritize patient satisfaction because they are cost-effective, easily located, and aligned with value-based care. Collaboration with primary care physicians streamlines referrals, ensuring suitable testing is done. Integrated digital structures enhance efficiency. Amidst the surge in outpatient services, diagnostics facilities become pivotal in autoimmune disease diagnosis and control, playing a valuable function in the evolving healthcare panorama.
Autoimmune Disease Diagnostics Market Overview by Regions
By regions, the global autoimmune diseases diagnostics market is broken up into North America (United States, Canada), Europe (France, Germany, Italy, Spain, United Kingdom, Belgium, Netherlands, Turkey), Asia Pacific (China, Japan, India, Australia, South Korea, Thailand, Malaysia, Indonesia, New Zealand), Latin America (Brazil, Mexico, Argentina), Middle East & Africa (South Africa, Saudi Arabia, and UAE).
United States Autoimmune Disease Diagnostics Market
The rising incidence of autoimmune diseases such as multiple sclerosis, lupus, and rheumatoid arthritis is propelling the market for autoimmune disease diagnostics in the United States. Early detection and accuracy are being improved by developments in diagnostic technology, such as high-throughput screening, genetic testing, and biomarker identification. Important diagnostic techniques like polymerase chain reaction (PCR), enzyme-linked immunosorbent assays (ELISA), and immunofluorescence are frequently employed. The need for diagnostic tests is being further fueled by increased healthcare spending and growing awareness of autoimmune illnesses. Furthermore, point-of-care diagnostics and the move toward personalized treatment are anticipated to propel market expansion. But issues like exorbitant diagnostic fees, restricted access to expert care, and the difficulty of certain tests still exist.
One in ten of the 22 million people in the world suffer from an autoimmune disease, according to a May 2023 study from the University of Oxford. In recent years, there has been an increase in the prevalence of autoimmune disorders, such as type 1 diabetes.
Germany Autoimmune Disease Diagnostics Market
The rising prevalence of autoimmune diseases like lupus, type 1 diabetes, and rheumatoid arthritis is propelling the growth of the German market for autoimmune disease diagnostics. The nation's sophisticated healthcare system and widespread knowledge of autoimmune disorders fuel the rising need for diagnostic testing. Important technologies for early and precise diagnosis include PCR, immunofluorescence, and enzyme-linked immunosorbent tests (ELISA). The market expansion is further supported by Germany's significant emphasis on precision diagnostics and tailored medicine. New opportunities are also presented by the growth of point-of-care testing and home-based diagnostic kits. Nevertheless, issues like exorbitant testing expenses, the requirement for certain knowledge, and regulatory barriers continue to exist. The market is anticipated to keep growing in the upcoming years due to an aging population and rising healthcare costs.
Australia Autoimmune Disease Diagnostics Market
Because autoimmune diseases including lupus, multiple sclerosis, and rheumatoid arthritis are becoming more common in Australia, the market for autoimmune disease diagnostics is expanding. The precision and speed of diagnosis are being improved by developments in diagnostic technology, including high-throughput screening, molecular testing, and biomarker discovery. The demand for diagnostic tests is being driven by Australia's robust healthcare system and rising public awareness of autoimmune illnesses. Polymerase chain reaction (PCR), immunofluorescence, and enzyme-linked immunosorbent assays (ELISA) are important diagnostic techniques. The industry is also growing as a result of the move toward personalized care and the focus on early diagnosis. There are still issues, though, such as the high expense of diagnostics, the difficulty of some tests, and the lack of access to expert treatment in remote areas. The industry is anticipated to keep growing in spite of these challenges.
Additionally, according to the International Diabetes Federation's Diabetes Altas, 2021 Edition, the incidence of type 1 diabetes in Australia was 1,500 in 2021, and 14,900 people between the ages of 0 and 19 had the disease. A high disease burden necessitates accurate diagnosis and treatment, which propels the market's expansion. The market is expanding as a result of the strategic actions that the market participants have taken.
United Arab Emirates Autoimmune Disease Diagnostics Market
The rising incidence of autoimmune diseases such as diabetes, lupus, and rheumatoid arthritis is propelling the growth of the autoimmune disease diagnostics market in the United Arab Emirates. The UAE is investing in better diagnostic techniques like enzyme-linked immunosorbent assays (ELISA), PCR, and next-generation sequencing as a result of an increasing emphasis on healthcare modernization and cutting-edge medical technologies. The demand for precise and timely diagnostics is expanding as a result of the nation's well-established healthcare system as well as increased knowledge and education regarding autoimmune illnesses. Additionally, the industry is expanding due to an increasing emphasis on genetic testing and tailored therapy. But there are still issues like the need for sophisticated training programs for medical professionals, the high cost of diagnostics, and the scarcity of specialist healthcare practitioners in rural areas. The market is expected to increase in spite of these obstacles.
Product – Market breakup in 3 viewpoints:
1. Therapeutic & Monitoring Equipment
2. Diagnostics Equipment
3. Drugs
Types – Market breakup in 2 viewpoints:
1. Systemic Autoimmune Disease Diagnostics
2. Localized Autoimmune Disease Diagnostics
Indication – Market breakup in 5 viewpoints:
1. Rheumatic Disease
2. Diabetes
3. Multiple Sclerosis
4. Inflammatory Bowel Disease
5. Others
End-Users – Market breakup in 3 viewpoints:
1. Hospitals
2. Diagnostics Centers
3. Others
Countries – Market breakup from 25 Country viewpoints:
1. North America
1.1 United States
1.2 Canada
2. Europe
2.1 France
2.2 Germany
2.3 Italy
2.4 Spain
2.5 United Kingdom
2.6 Belgium
2.7 Netherlands
2.8 Turkey
3. Asia Pacific
3.1 China
3.2 Japan
3.3 India
3.4 South Korea
3.5 Thailand
3.6 Malaysia
3.7 Indonesia
3.8 Australia
3.9 New Zealand
4. Latin America
4.1 Brazil
4.2 Mexico
4.3 Argentina
5. Middle East & Africa
5.1 Saudi Arabia
5.2 UAE
5.3 South Africa
All the Key players have been covered from 3 Viewpoints:
• Overview
• Recent Developments
• Revenue Analysis
Company Analysis:
1. Abbott Laboratories
2. Bio-Rad Laboratories
3. Roche Diagnostics
4. Siemens Healthineers
5. Bio Merieux SA
6. Myriad Genetics, Inc.
7. Quest Diagnostics Incorporated
8. Thermo Fisher Scientific Inc.
Report Details:
Report Features | Details |
Base Year |
2024 |
Historical Period |
2020 - 2024 |
Forecast Period |
2025 - 2033 |
Market |
US$ Billion |
Segment Covered |
Product, Type, Indication, End User, and Countries |
Countries Covered |
|
Companies Covered |
|
Customization Scope |
20% Free Customization |
Post-Sale Analyst Support |
1 Year (52 Weeks) |
Delivery Format |
PDF and Excel through Email (We can also provide the editable version of the report in PPT/Word format on request) |
Customization Services available
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1. Introduction
2. Research Methodology
3. Executive Summary
4. Market Dynamics
4.1 Growth Drivers
4.2 Challenges
5. Global Autoimmune Disease Diagnostics Market
6. Market Share
6.1 By Product
6.2 By Type
6.3 By Indication
6.4 By End Users
6.5 By Country
7. Product
7.1 Therapeutic & Monitoring Equipment
7.2 Diagnostics Equipment
7.3 Drugs
8. Type
8.1 Systemic Autoimmune Disease Diagnostics
8.2 Localized Autoimmune Disease Diagnostics
9. Indication
9.1 Rheumatic Disease
9.2 Diabetes
9.3 Multiple Sclerosis
9.4 Inflammatory Bowel Disease
9.5 Others
10. End Users
10.1 Hospitals
10.2 Diagnostics Centers
10.3 Others
11. Country
11.1 North America
11.1.1 United States
11.1.2 Canada
11.2 Europe
11.2.1 France
11.2.2 Germany
11.2.3 Italy
11.2.4 Spain
11.2.5 United Kingdom
11.2.6 Belgium
11.2.7 Netherlands
11.2.8 Turkey
11.3 Asia Pacific
11.3.1 China
11.3.2 Japan
11.3.3 India
11.3.4 South Korea
11.3.5 Thailand
11.3.6 Malaysia
11.3.7 Indonesia
11.3.8 Australia
11.3.9 New Zealand
11.4 Latin America
11.4.1 Brazil
11.4.2 Mexico
11.4.3 Argentina
11.5 Middle East & Africa
11.5.1 Saudi Arabia
11.5.2 UAE
11.5.3 South Africa
12. Porter’s Five Analysis
12.1 Bargaining Power of Buyers
12.2 Bargaining Power of Suppliers
12.3 Degree of Rivalry
12.4 Threat of New Entrants
12.5 Threat of Substitutes
13. SWOT Analysis
13.1 Strength
13.2 Weakness
13.3 Opportunity
13.4 Threat
14. Companies Analysis
14.1 Abbott Laboratories
14.1.1 Overview
14.1.2 Recent Development
14.1.3 Financial Insights
14.2 Bio-Rad Laboratories
14.2.1 Overview
14.2.2 Recent Development
14.2.3 Financial Insights
14.3 Roche Diagnostics
14.3.1 Overview
14.3.2 Recent Development
14.3.3 Financial Insights
14.4 Siemens Healthineers
14.4.1 Overview
14.4.2 Recent Development
14.4.3 Financial Insights
14.5 BioMerieux SA
14.5.1 Overview
14.5.2 Recent Development
14.5.3 Financial Insights
14.6 Myriad Genetics, Inc.
14.6.1 Overview
14.6.2 Recent Development
14.6.3 Financial Insights
14.7 Quest Diagnostics Incorporated
14.7.1 Overview
14.7.2 Recent Development
14.7.3 Financial Insights
14.8 Thermo Fisher Scientific Inc.
14.8.1 Overview
14.8.2 Recent Development
14.8.3 Financial Insights
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