The global autoimmune disease testing market size is estimated to grow from USD 6.07 billion in 2023 to USD 15.75 billion by 2033. FMI projects that the global demand for autoimmune disease testing could exhibit a CAGR of 10% from 2023 to 2033.
The autoimmune disease testing market is a dynamic and rapidly evolving space, driven by several key factors that are shaping the industry's growth trajectory. These drivers are rooted in various macroeconomic, demographic, technological, and regulatory trends that are fueling demand for innovative diagnostic tools and testing solutions.
The low immune reaction is a direct outcome of autoimmune diseases that affect the immune system severely. When the immune system overreacts, the body strikes and destroys its own tissues. The immune system begins to produce antibodies in response to an unidentified trigger that, instead of protecting the body against infections, targets the body's own tissues and leads to autoimmune diseases.
The increasing prevalence of autoimmune diseases is one of the principal elements driving growth in the autoimmune disease testing market. The American Autoimmune Related Disorders Association Inc. (AARDA) estimates that around 50 million people currently have an autoimmune disease, with about 20 to 25% of them having several autoimmune diseases.
To diagnose and monitor autoimmune illnesses early and facilitate effective therapeutic approaches, doctors now have a substantial need for reliable and precise diagnostic testing methods. They include fundamental exams like those for antinuclear autoantibody and rheumatoid factor (RF), among others. These tests can assist manage and diagnose individuals with autoimmune illnesses, offer a prognosis, or show the extent of organ involvement or damage.
The increasing use of advanced diagnostic technologies, including multiplex assays, next-generation sequencing, and other high-throughput screening techniques, is another important factor influencing market expansion. These tools enable doctors to make fast and accurate diagnoses of autoimmune diseases, track the course of the disease. These tools also allow doctors to create customized treatment regimens by improving sensitivity, specificity, and accuracy.
The demand for screening and diagnostic testing has expanded as autoimmune disorders become widely recognized and understood by patients and healthcare professionals. Government initiatives for autoimmune disease early diagnosis and treatment, which have been linked to better clinical results and lower healthcare costs, have further encouraged this.
| Attributes | Details |
|---|---|
| Autoimmune Disease Testing Market Value (2023) | USD 6.07 billion |
| Autoimmune Disease Testing Market Expected Value (2033) | USD 15.75 billion |
| Autoimmune Disease Testing Market Projected CAGR (2023 to 2033) | 10% |
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Prior to 2020, the market was expanding well enough. Scleroderma, rheumatoid arthritis, and inflammatory bowel disease, among other autoimmune conditions, have all seen an abrupt rise in prevalence. The increase in the incidence of autoimmune disorders throughout the world can be attributed to numerous important variables, including genetics, environmental factors, certain hormones, and susceptibility to particular infections.
The COVID-19 pandemic affected the healthcare industry by interrupting the global supply chain. The pandemic hindered the expansion of the autoimmune disease testing market in the first half of 2020. To stop the COVID-19 virus from spreading, several nations implemented national emergencies and lockdowns. In addition, the hospital's capacity for diseases other than COVID-19 was limited, which affected the admission rate for autoimmune disorders. Nevertheless, the market had a significant comeback in 2021 as a result of the restoration of healthcare facilities and an increase in patient visits to health centers for the diagnosis and treatment of autoimmune illnesses.
Key market participants, such as Exagen Inc., have also seen a market recovery in 2021 owing to a high prevalence of autoimmune disease tests, which could also support consistent market expansion during the forecast period.
Increased use of artificial intelligence-related methods that is anticipated to boost global expansion throughout the projected period is:
The growing number of strategic alliances and partnerships between diagnostic businesses and research facilities are likely to spur creativity and hasten the creation of new autoimmune disease testing methods.
FMI anticipated that during the forecast period, the rising need for reliable and precise autoimmune disease diagnostics could stimulate healthy competition. This makes it possible for new competitors to enter the market, thus fostering healthy competition. Asia Pacific region has more opportunities than ever owing to unrealized development potential and a growing patient base. Increasing research projects could offer profitable prospects for key companies to generate revenue.
The growing number of strategic alliances and partnerships between diagnostic businesses and research facilities are likely to spur creativity and hasten the creation of new autoimmune disease testing methods. In addition to increasing the variety of diagnostic tools accessible to physicians and patients, this is expected to open up new potential for market expansion.
Several reasons, including the region's implementation of technologically advanced testing for the early identification of autoimmune disorders, contribute to North America's dominance in the global market. This region also has a couple of significant projects underway that has helped it achieve its dominant market position.
Progentec Diagnostics, Inc., for instance, obtained USD 5 million in investment in January 2020. Using continuous remote digital monitoring and high levels of sensitivity and specificity, the business intends to use these funds to create a holistic solution for treating lupus patients. Increasing efforts to create new testing varieties are also anticipated to help market expansion over the forecast period.
The United States autoimmune disease testing market is projected to grow notably during the forecast period. The increased prevalence of autoimmune diseases, rising healthcare expenditures, new product introductions, and the presence of significant companies across the nation are just a handful of the reasons contributing to this market dominance. Around 5% to 8% of the entire population in the country suffers from several autoimmune illnesses, making up about 1 in 15 persons who are receiving treatment for an autoimmune disease, according to the National Stem Cell Foundation.
Antinuclear antibody testing reveals the presence of antinuclear antibodies in the blood. An autoimmune condition with a hereditary susceptibility is myasthenia gravis. Myasthenia gravis frequency in the United States was about 20 cases per 100,000 people in 2021, and it is steadily rising, according to NCBI. As a result, the autoimmune disease testing industry is anticipated to grow quickly in the United States during the forecast period given the high frequency of hereditary autoimmune illnesses.
The competitive landscape of the market in the United States is dynamic, with numerous companies offering different tests targeting different autoimmune diseases. For instance, Thermo Fisher Scientific confirmed in May 2022 that the Phadia 2500+ Instrument for autoimmune testing is now available in the United States.
With the use of this technology, autoimmune disorders such as celiac disease, rheumatoid arthritis, autoimmune liver disease, and autoimmune thyroid disease can be diagnosed. The organization was able to grow its client base and business income owing to this smart launch.
The prevalence of autoimmune diseases is rising, which is a concern for the countries of Europe. According to the Multiple Sclerosis Trust, there were 2.5 million persons with multiple sclerosis globally in 2020, with Europe having the maximum frequency. The market expansion in Europe is anticipated to be boosted by a rise in product launches and the number of partnerships between industry participants.
With Germany contributing the maximum market value, Europe is likely to have the second-leading market share. The market is expanding due to an aging population and an increase in autoimmune disease cases among the old population. Also, growing public awareness and the burden of chronic illnesses are expected to accelerate market expansion.
Germany autoimmune disease testing market is a part of the overall diagnostics industry. It is influenced by various factors such as:
The autoimmune disease testing industry in Germany is regulated by the Federal Ministry of Health and other relevant authorities, which ensure the safety, efficacy, and quality of diagnostic products and services. Additionally, reimbursement policies and insurance coverage for autoimmune disease testing may impact the market dynamics.
The development of numerous products in this region as a result of growing cooperation amongst industry participants is also forcing market expansion. For instance, Theradiag, teamed up with Quotient Ltd, a diagnostics business in the commercial stage, in June 2022. By utilising the MosaiQ technology from Quotient, the cooperation aims to create a cutting-edge autoimmune diagnostics solution.
Given the increasing prevalence of autoimmune conditions and a deep understanding of their diagnosis, Asia-Pacific is predicted to have significant market expansion over the forecast period. Rheumatoid arthritis, psoriasis, and inflammatory bowel disease are a few examples of autoimmune, inflammatory, and pulmonary disorders that are becoming prevalent in Asia Pacific, according to a June 2022 article by Janssen Asia Pacific, a branch of Johnson & Johnson Pte. Ltd.
In addition to having the maximum frequency of systemic lupus erythematosus (SLE) in China, the region currently bears the huge burden of chronic obstructive pulmonary disease (COPD) across the world. Hence, in the upcoming years, there is likely to be a demand for diagnostics.
China autoimmune disease testing market has been growing steadily in recent years due to various factors such as:
Additionally, advancements in diagnostic technologies and testing methods have also contributed to the growth of the autoimmune disease testing industry in China.
Principal Consultant
Reagents and consumables play a crucial role in enabling precise and reliable diagnostic testing, which explains their dominance in the market. Reagents and consumables are the cornerstones for the identification and measurement of autoimmune markers since they are essential parts of the diagnostic workflow. These crucial elements make it possible to process samples precisely and effectively, amplify target biomolecules, and produce diagnostic findings.
The dominance of this segment is being supported by laboratories, hospitals, and diagnostic centers investing continuously in different reagents and consumables to meet the rising testing needs. The constant advances in research and development, along with technological innovations, have resulted in the introduction of novel reagents and consumables with improved performance characteristics.
In 2019, Bio-Rad Laboratories, Inc. released various specialized reagents and consumables for autoimmune disease testing, including the BioPlex 2200 APLS IgG kit for antiphospholipid syndrome testing and the BioPlex 2200 ANA screen for antinuclear antibody testing.
The preeminence of the C-Reactive Protein (CRP) segment in the market can be attributed to its multifaceted role as a robust biomarker of inflammation and tissue damage. This is pivotal in the diagnosis and monitoring of autoimmune diseases.
CRP is an acute-phase protein produced by the liver in response to interleukin-6. This protein exhibits unparalleled sensitivity and specificity, allowing for the accurate detection of even subtle changes in inflammatory activity. The availability, affordability, and ease of use of CRP tests make them a popular option for everyday clinical practice.
The prognostic indicator of disease severity and therapeutic response in numerous autoimmune disorders has made CRP a versatile diagnostic tool that goes beyond its role as an inflammatory marker. It is a useful tool for monitoring disease development, determining the effectiveness of treatments, and directing treatment choices due to its dynamic and quick responsiveness to changes in disease activity.
Improving the accuracy and usefulness of CRP testing is the availability of high-sensitivity CRP (hsCRP) tests, which enable sensitive and specific early identification and surveillance of autoimmune disorders.
The market has a consolidated structure in terms of the competitive environment, with a few autoimmune disease testing companies controlling a sizable portion of the market. For example:
Siemens Healthcare GmbH, the market leader, maintains a commanding position with a comprehensive array of autoimmune disease diagnostic equipment and supplies. It has a strong market presence and an extensive global distribution network in addition to considerable knowledge in the healthcare and diagnostics sectors.
Siemens Healthcare GmbH, a subsidiary of Siemens Healthineers AG, is a leading global manufacturer of medical equipment, including in-vitro diagnostic (IVD) tests for autoimmune diseases. It offers different autoimmune disease testing solutions, including immunoassays, chemiluminescent assays, and molecular assays.
With the ADVIA Centaur serum Neurofilament Light Chain (sNfL) test, created in conjunction with Novartis AG, Siemens Healthcare GmbH was awarded the distinction of a breakthrough device in March 2022. This assay is used to identify adult individuals suffering from multiple sclerosis.
Siemens Healthcare GmbH has engaged in strategic collaborations and acquisitions to expand its autoimmune disease testing portfolio further. For instance, the acquisition of United States-based Biogenix Inc. in 2020 has strengthened Siemens Healthcare GmbH's capabilities in autoimmune disease testing by adding advanced multiplexing technology for autoantibody detection to its product offerings. Furthermore, Siemens Healthcare GmbH engaged in a global distribution agreement with Gentian Diagnostics ASA in January 2022. The business provides rheumatoid arthritis diagnosis-focused assays using Siemens Healthineers Antellica NEPH systems.
Other important market players are F. Hoffmann-La Roche Ltd, ZEUS Scientific, Inc., Thermo Fisher Scientific Inc., Quest Diagnostics Incorporated, Abbott, SQI Diagnostics Inc., Werfen, Trinity Biotech, KSL Beutner Laboratories (Beutner), Bio-Rad Laboratories, Inc. and others.
These market players are also actively engaged in developing innovative products, expanding their product portfolio, forming collaborations, expanding their geographic presence, conducting marketing and promotional activities, and exploring mergers and acquisitions. These actions are aimed at capitalizing on the growing demand for autoimmune disease testing and staying competitive in the market.
Recent Developments by Other Key Players
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The market is valued at USD 6.07 billion in 2023.
Thermo Fisher Scientific and Siemens Healthineers are key market players.
India, Japan, and China dominate the Asian market.
The market is estimated to reach USD 15.75 billion by 2033.
Asia-Pacific is projected to emerge as a lucrative market.
1. Executive Summary 2. Market Overview 3. Market Background 4. Global Market Analysis 2018 to 2022 and Forecast, 2023 to 2033 5. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Product Type 5.1. Instruments 5.2. Reagents & Consumables 6. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Disease Type 6.1. Rheumatoid Arthritis 6.2. Systemic Lupus Erythematosus 6.3. Scleroderma 6.4. Vasculitis 6.5. Inflammatory Bowel Disease 6.6. Others 7. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Test Type 7.1. Antinuclear Autoantibody 7.2. Rheumatoid Factor 7.3. C-Reactive Protein 7.4. Anti-Thyroglobulin Antibody 7.5. Others 8. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By End-user 8.1. Hospital & Clinics 8.2. Diagnostic Centres 9. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region 9.1. North America 9.2. Latin America 9.3. Europe 9.4. South Asia 9.5. East Asia 9.6. Oceania 9.7. MEA 10. North America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 11. Latin America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 12. Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 13. South Asia Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 14. East Asia Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 15. Oceania Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 16. MEA Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 17. Key Countries Market Analysis 18. Market Structure Analysis 19. Competition Analysis 19.1. F. Hoffmann-La Roche Ltd 19.2. Siemens Healthcare GmbH 19.3. Thermo Fisher Scientific Inc. 19.4. Quest Diagnostics Incorporated 19.5. Abbott 19.6. Werfen 19.7. Trinity Biotech 19.8. Bio-Rad Laboratories, Inc. 19.9. GlaxoSmithKline plc 19.10. Merck & Co., Inc. 20. Assumptions & Acronyms Used 21. Research Methodology
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Autoimmune Disease Testing Market
