Autoimmune Disease Testing Market Size, Share & COVID-19 Impact Analysis, By Product Type (Instruments and Reagents & Consumables), By Disease Type (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Scleroderma, Vasculitis, Inflammatory Bowel Disease, and Others), By Test Type (Antinuclear Autoantibody, Rheumatoid Factor, C-Reactive Protein, Anti-Thyroglobulin Antibody, and Others), By End-user (Hospital & Clinics, Diagnostic Centers, and Others), and Regional Forecast, 2023-2030

The autoimmune disease testing market size was valued at USD 5.08 billion in 2022. The market is projected to grow from USD 5.56 billion in 2023 to USD 11.29 billion by 2030, exhibiting a CAGR of 10.7% during the forecast period. Moreover, the U.S. autoimmune disease testing market size is projected to grow significantly, reaching an estimated value of USD 4.66 billion by 2030, driven by adoption of technologically advanced autoimmune disease testing kits in the region.

Autoimmune diseases directly impact the body's immune system, causing a low immune response. In cases of over activity of the immune system, the body damages and attacks its own tissues. In response to a new trigger, the immune system starts producing antibodies, instead of fighting infections that attack the body's own tissues and cause autoimmune disorders. Typically, multiple laboratory tests are needed for the diagnosis of systemic autoimmune diseases and include basic tests, such as antinuclear autoantibody, rheumatoid factor, and others. These tests can be useful in managing and diagnosing patients with autoimmune diseases.

Recently, a global surge in the prevalence of autoimmune diseases has been observed. Such trends are strongly anticipated to drive the demand for and adoption of autoimmune disease testing kits. The adoption of these kits is further augmented by new product launches and growth in the number of research activities. Moreover, introduction of tests that can identify specific proteins of various autoimmune diseases is likely to create growth opportunities for the market.

COVID-19 IMPACT

Delayed Diagnosis of New Autoimmune Diseases During COVID-19 Negatively Impacted Market Growth

The autoimmune disease testing market growth was negatively affected by the COVID-19 pandemic. Factors responsible for the market’s decline included reduced number of patient visits to hospitals for the diagnosis of these diseases and decline in the volume of autoimmune disease tests. Additionally, the hospital capacities were reduced for diseases other than COVID-19, which adversely impacted the admission rate of patients diagnosed with autoimmune diseases.

• For instance, according to an article published by Healio Rheumatology in November 2021, in Italy, there were 9,912 autoimmunity laboratory tests, such as rheumatoid factor and complete blood count tests performed at the country’s hospitals in 2020, compared to 14,100 tests in 2019, showcasing a decline of 29.7% in 2020 compared to 2019.

Additionally, major market players faced disruptions in their supply chains during the COVID-19 pandemic. Companies, such as Siemens Healthcare GmbH registered a decline of 5.3% in its diagnostics division revenue generated in 2020. The company’s diagnostics portfolio includes autoimmune disease testing products.

However, the reopening of healthcare facilities and increasing patient visits to clinics for the diagnosis & treatment of autoimmune diseases led to a strong recovery of the market in 2021. Additionally, major players operating in the market, including Exagen Inc., witnessed recovery in 2021 with an increased volume of autoimmune disease tests, leading to a steady market growth during the forecast period. Moreover, the market is projected to grow at a considerable rate during the forecast period owing to new product launches for autoimmune disease testing.

Autoimmune Disease Testing Market Trends

Adoption of Artificial Intelligence for Detection of Autoimmune Diseases to Determine Future Market Growth

Autoimmune diseases have a number of complex symptoms which makes it difficult to be diagnosed. Currently, there are several diagnostic methods that are invasive and painful. To avoid this invasive and painful procedure, there is a need for developing a new diagnostic method that can improve the current process. A research was conducted by Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen to differentiate between psoriatic arthritis, rheumatoid arthritis, and healthy joints using Artificial Intelligence (AI). The results suggested that AI could classify arthritis more easily, providing quicker and more targeted treatments for patients.

Also, there are some companies who are focusing on acquisitions to strengthen their analytics capabilities to develop a more granular and real-time understanding of patients’ treatment pathway for an autoimmune disease.

For instance, in January 2023, Scipher Medicine, a precision immunology company, acquired CrossBridge, a Philadelphia-based data, analytics, and software company, to bolster its data and analytics capabilities. The acquisition provided Scipher Medicine with new data management and analytics capabilities to improve health outcomes for autoimmune disease patients.

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Autoimmune Disease Testing Market Growth Factors

Surge in Prevalence of Autoimmune Diseases and Increased Awareness of Diagnostics to Bolster Market Growth

There is a growing prevalence of autoimmune diseases, such as rheumatoid arthritis, scleroderma, and inflammatory bowel disease among the general population. Environmental factors, genetics, certain hormones, and susceptibility toward certain infections are some of the major factors which are responsible for the growing prevalence of these diseases globally.

• For instance, according to the WHO (World Health Organization) data, in June 2023, around 18 million people globally were living with Rheumatoid Arthritis (RA) in 2019. Out of them, around 70% of people living with rheumatoid arthritis were women, and 55% of the population was above 55 years of age. In addition, RA is a common disease with a global prevalence of nearly 1% and an annual incidence of about 3/10,000 adults.


• According to statistics published by the International Diabetes Federation (IDF) in 2021, around 537 million adults aged between 20 and 79 years were living with Type 1 diabetes, and this number is estimated to rise to 643 million by 2030 and 783 million by 2045. In addition, according to data published by the WHO, in March 2023, Africa recorded a five-time rise in type 1 diabetes among children and teenagers between 2011 and 2021, with cases surging from four per 1,000 children to nearly 20 per 1,000. Moreover, around 24 million people were living with diabetes in Africa in 2021, and this number is projected to increase by 129% to 55 million by 2045.

Thus, the rising prevalence of autoimmune diseases, coupled with increased awareness among people regarding the importance of early detection of these diseases, is leading to an increase in the number of tests conducted at different healthcare centers.

New Product Launches for Autoimmune Disease Diagnostics to Propel Market Growth

Multiple tests are used for the diagnosis of autoimmune diseases. In some cases, they also assist in evaluating the severity of the condition. Utilization of the right autoimmune blood test not only determines the type of the disease, but can also demonstrate the treatment plan and lifestyle modifications for patients. The rising prevalence of autoimmune diseases has contributed to the increase in awareness of the diagnosis of these conditions among the general population. These factors have emphasized the need for key market players to focus on new product launches for the diagnosis of various autoimmune disorders.

• For instance, in May 2022, ZEUS Scientific, Inc. received approval for its dlFine, a digital immunofluorescence system that can be used with the company’s antinuclear autoantibody Hep-2 Indirect Fluorescent Antibody (IFA) assay. This system can detect 8 common antinuclear autoantibodies, and scan and analyze 8 slides in an hour.

Thus, the increased prevalence of autoimmune diseases, coupled with rising awareness about the availability of advanced diagnostics for these ailments, is contributing to the growing demand for new products for autoimmune disease testing. This factor is expected to lead to the introduction of new products, resulting in the market’s growth.

RESTRAINING FACTORS

Lack of Penetration of These Products in Developing Countries to Hamper Market Growth

Factors, such as a surge in the prevalence of various autoimmune diseases, such as inflammatory bowel disease, rheumatoid arthritis, and others are boosting the market growth. However, the lack of penetration of autoimmune disease testing products can limit the market's progress. For instance, inflammatory bowel disease in developing countries, such as Brazil is considered to be an emerging disease, but there are limited number of population-based studies due to a lack of surveillance and databases. The limited availability of epidemiological data and lack of access to efficient diagnostic methods due to a smaller number of experienced healthcare professionals are restricting the penetration of key autoimmune disease testing products in several emerging countries.

Also, the lack of awareness of these diseases among the general population is decreasing the number of new and follow-up appointments among patients. This is expected to hinder the growth of the market during the forecast period.

Autoimmune Disease Testing Market Segmentation Analysis

By Product Type Analysis

Strong Demand for Reagents & Consumables Boosted Led to Their Segmental Dominance

On the basis of product type, the market is segmented into reagents & consumables and instruments.

The reagents & consumables segment held the highest autoimmune disease testing market share in 2022 due to the rising prevalence of autoimmune diseases around the globe.

• For instance, in September 2021, Inova Diagnostics, a manufacturer of in-vitro diagnostic systems and reagents for autoimmune diseases in the clinical laboratory, received the U.S. Food and Drug Administration (FDA) 510(k) clearance for its Aptiva System and Aptiva Celiac Disease IgA assay.

The instruments segment is expected to witness a significant growth during the forecast period due to a number of factors, including a strong emphasis on the R&D of new products, such as molecular diagnostics, and increasing launch of technologically advanced products in the market.

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  • For instance, in June 2021, Progentec Diagnostics, Inc., one of the leading companies in diagnostics and digital technologies to manage autoimmune disorders, collaborated with GSK plc. The aim of the collaboration was to evaluate novel measurements and develop management tools for the diagnosis of systemic lupus erythematosus.
  
  
  
  

By Disease Type Analysis

Increasing Incidence of Rheumatoid Arthritis Boosted the Demand for These Diagnostics in 2022

On the basis of disease type, the market is segmented into rheumatoid arthritis, systemic lupus erythematosus, scleroderma, vasculitis, inflammatory bowel disease, and others.

The rheumatoid arthritis segment was recording the fastest CAGR in 2022. The growth of the segment is due to the introduction of new test platforms for the detection of rheumatoid arthritis and surge in the prevalence of this ailment globally.

The inflammatory bowel disease segment is expected to record a significant CAGR during the forecast period due to several factors, such as rising incidence of ulcerative colitis and Crohn’s disease around the world.

The systemic lupus erythematosus segment is projected to record a robust CAGR owing to factors, such as the utilization of new diagnosis & treatment options.

• For instance, according to an article on the discovery of new serum biomarker panels for the diagnosis of Systemic Lupus Erythematosus (SLE) published on ResearchGate in January 2021, the combined autoantibody panels, such as anti-RPLP2, anti-MAK16, and anti- RPL7A demonstrated results for the diagnosis of SLE and other major rheumatic immune diseases.

The scleroderma segment will account for a limited share of the market during the forecast period.

The others segment is projected to register a significant CAGR owing to factors, such as increasing diagnosis rate of autoimmune diseases, such as celiac disease, Graves' disease, and Hashimoto disease, among others.

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By Test Type Analysis

C-Reactive Protein Tests Gained Notable Market Share Due to Their Key Role in Diagnosing Autoimmune Diseases 

On the basis of test type, the market is segmented into antinuclear autoantibody, rheumatoid factor, C-reactive protein, anti-thyroglobulin antibody, and others.

The C-reactive protein segment dominated the market with the highest share in 2022. The increasing applications of the C-reactive protein test in the diagnosis of various autoimmune diseases is projected to support the segment’s growth during the forecast period.

• For instance, according to an article published by HMP Global Learning Network in 2022, the C-Reactive Protein (CRP) test was more widely used in Europe than other key regions, including the U.S., in the diagnosis and management of psoriatic arthritis.

The growth of the antinuclear antibody (ANA) segment is due to the repetitive antinuclear antibody testing in patients. For instance, according to an article published on the frequency of repeat antinuclear antibody testing in PubMed Central in March 2020, around 587,357 ANA tests were performed in Ontario Laboratories Information System. Out of these, 164,913 tests, i.e., around 28.1% were repeatable tests asked by the physicians.

The rheumatoid factor segment is projected to display a significant CAGR owing to factors, such as the increasing prevalence of rheumatoid arthritis globally.

The anti-thyroglobulin antibody segment is also growing due to factors, such as companies' emphasis on introducing new diagnostic tests for the detection of thyroid.

The others segment is projected to register a significant CAGR during the forecast period owing to factors, such as the increasing incidence of various autoimmune diseases and rising number of product launches by key market players.

By End-user Analysis

Hospital & Clinics Emerges as Fastest Growing End-User Due to Growing Diagnosis of Autoimmune Diseases in These Settings

On the basis of end-user, the market is segmented into hospital & clinics, diagnostic centers, and others.

The hospital & clinics segment is recording the highest CAGR owing to factors, such as growth in the number of hospitals along with increasing rate of diagnosis & treatment of autoimmune diseases in these settings.

• For instance, according to an article published by Statistisches Bundesamt, in September 2022, the number of hospitals in Germany stood at 1,903. The presence of a large number of hospitals in key European countries indicates that a substantial number of autoimmune testing procedures will be conducted in these institutions in Europe.

The diagnostic centers segment is projected to record a significant CAGR owing to a number of factors, such as growth in the number of these institutions in several emerging countries during the forecast period.

REGIONAL INSIGHTS

On the basis of region, the market can be segmented into North America, Europe, Asia Pacific, and the Rest of the World.

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The market in North America was valued at USD 2.24 billion in 2022. The dominance of the region in the global market is due to a wide range of factors, such as the adoption of technologically advanced autoimmune disease testing kits in the region.

Additionally, there are several strategic initiatives undertaken in this region, leading to the region’s apex market position. For instance, in January 2020, Progentec Diagnostics, Inc. raised funds worth USD 5 million. The company is planning to invest these funds in developing a comprehensive solution for managing lupus patients with high levels of sensitivity and specificity with the help of continuous remote digital monitoring. Additionally, increasing focus on R&D for the development of new testing options is projected to support the regional market growth during the forecast period.

The Asia Pacific market is anticipated to record the highest growth rate owing to the increasing product launches by major market players, coupled with a strong incidence of these diseases in several countries across the region.

In Europe, the market is projected to register a significant CAGR owing to factors, such as the increasing number of collaborations between market players, leading to the introduction of several novel products. For instance, in June 2022, Quotient Limited, a commercial-stage diagnostics company, collaborated with France-based Theradiag, a leader in this market. The aim of the collaboration is to develop an advanced autoimmune diagnostics solution by leveraging Quotient’s MosaiQ platform.

The Rest of the World accounted for the smallest share in the global market in 2022. However, establishment of advanced testing facilities and launch of new products in the region are expected to offer growth opportunities for the market during the forecast period.

List of Key Autoimmune Disease Testing Market Companies 

Siemens Healthcare GmbH Led Market with Strong Portfolio of Autoimmune Disease Testing in 2022

In terms of the competitive landscape, the market reflects a consolidated structure, with few players holding a major share of the market. Industry leader Siemens Healthcare GmbH holds a dominating position with a strong portfolio of autoimmune disease testing instruments and consumables. For instance, in January 2022, Siemens Healthcare GmbH entered a global distribution contract with Gentian Diagnostics ASA, one of the fastest-growing manufacturers of efficient diagnostics solutions. The company offers assays through Siemens Healthineers Antellica NEPH platforms, which are focused on the diagnosis of rheumatoid arthritis.

F. Hoffmann-La Roche Ltd., Abbott Laboratories, Quest Diagnostics Incorporated, and Thermo Fisher Scientific Inc. are few prominent players operating in the market. The dominance of these companies is attributed to their increasing focus on the launch of new products and collaborations with the other market players.

LIST OF KEY CPMPANIES PROFILED:

• F. Hoffmann-La Roche Ltd (Switzerland)


• Siemens Healthcare GmbH (Germany)


• Thermo Fisher Scientific Inc. (U.S.)


• Quest Diagnostics Incorporated (U.S.)


• Abbott (U.S.)


• Werfen (Spain)


• Trinity Biotech (Ireland)


• Bio-Rad Laboratories, Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• July 2023- F. Hoffmann-La Roche Ltd. announced the launch of Elecsys HCV Duo, an antigen and antibody diagnostic test, to support India’s fight against hepatitis C.


• January 2023- Scipher Medicine acquired CrossBridge, a Philadelphia-based data, analytics, and software company to bolster its data and analytics capabilities. The acquisition provided Scipher Medicine with new data management and analytics capabilities to improve health outcomes for autoimmune disease patients.


• March 2022- Siemens Healthcare GmbH received the designation of a breakthrough device for its ADVIA Centaur serum Neurofilament Light Chain (sNfL) assay, which was developed in collaboration with Novartis AG, for the identification of adult patients with multiple sclerosis.


• May 2022- Thermo Fisher Scientific Inc. announced the availability of its new Phadia 2500+ series of instruments in the U.S. The instruments are used for testing autoimmune diseases, such as celiac disease, rheumatoid arthritis, autoimmune liver disease, and autoimmune thyroid disease.


• March 2021- EUROIMMUN, a PerkinElmer, Inc. company, launched EUROPattern Microscope Live (EMPL), a compact immunofluorescence microscope to be used in autoimmune diagnostics. The product was a combined system of hardware and software which allowed ultrafast automated immunofluorescence image acquisition, pattern recognition, and titer estimation with modern diagnostics at the screen.

REPORT COVERAGE

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The report includes detailed market analysis. It focuses on key aspects, such as leading companies, product types, disease types, test types, and end-users. Besides this, it offers insights into the market trends, prevalence of key autoimmune diseases, new product launches, top industry developments, technological advancements in testing products, and the impact of COVID-19 on the market. In addition to the factors mentioned above, the report encompasses several factors that have contributed to the growth of the market in recent years.

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