Market Size & Trends
Estimated to be USD 5.72 billion in 2024, the worldwide autoimmune disease diagnostics market is expected to rise at a CAGR of 6.18% from 2025 to 2030. The main driver stressing development is the rising frequency of autoimmune diseases, including type 1 diabetes in newborns, along with the desire for quick diagnosis.
Key Highlights
- The North America region dominated the market with a share of over 42.70% in 2024.
- The U.S. autoimmune disease diagnostics industry is anticipated to experience a substantial influence on the market
- In terms of type segment, the localized segment dominated the autoimmune disease diagnostics market. It accounted for 64.25% of the global revenue in 2024
- In terms of product segment, the consumables & assays segment accounted for the largest revenue share of 70.43% in 2024.
- In terms of test type segment, the antinuclear antibody tests dominated the market with a revenue share of 42.62% in 2024
In addition, there is an increasing focus on investments and funding for research related to autoimmune diseases, further propelling market growth. Furthermore, developing countries offer untapped opportunities for market expansion, presenting significant growth prospects in the coming years.
We anticipate that the establishment of technological advancements and expanding lab automation rates will boost market growth. Clinicians are implementing advanced technology to conduct several tests at the same time, with faster and more precise results.
Autoimmune diseases are a group of more than 100 chronic, debilitating conditions that affect approximately 3% of the US population, or about 10 million people. Some of the most common autoimmune diseases include obesity, cardiovascular diseases, type 2 diabetes mellitus, and all cancers. Thus, genetic factors, environmental influences, specific hormones, and susceptibility to certain infections are key contributors to the rising prevalence of autoimmune diseases globally. For instance, a study published in the American Journal of Managed Care (AJMC) in May 2021 reported an estimated prevalence of 276 cases per million adults for scleroderma in the U.S. A recent study found that autoimmune disorders now affect approximately one in ten individuals, with 80–100 known autoimmune diseases affecting more than 14 million Americans.
An increasing rate of novel technological advancements and the corresponding emergence of laboratory automation technologies significantly contribute to market expansion. This trend is driven by the growing adoption of advanced technologies among clinicians, enabling them to conduct a wide range of tests while achieving faster and more accurate results. In addition, the implementation of government initiatives across economies supports market developments. Work by organizations such as the Autoimmunity Centers of Excellence (ACE), Cooperative Study Group for Autoimmune Disease Prevention (CSGADP), and North American Rheumatoid Arthritis Consortium (NARAC) contributes to market growth as it raises awareness among patients and healthcare professionals regarding proper diagnosis and treatment protocols.
The participation of groups like the Autoimmunity Centers of Excellence, Cooperative Study Group for Autoimmune Disease Prevention, and North American Rheumatoid Arthritis Consortium in teaching patients and healthcare professionals about correct diagnosis and treatment is expected to positively influence the market by raising awareness and encouraging early action in autoimmune diseases. This, in turn, is expected to drive the market growth. In addition, favorable government initiatives aimed at increasing access to diagnostic tests, improving disease management, and reducing healthcare costs, among others, are also expected to boost market growth during the forecast period.
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Market Concentration & Characteristics
The autoimmune disease diagnostics market is witnessing a high degree of innovation as advancements in technology and increasing research efforts are driving the development of new diagnostic tools. The emergence of novel biomarkers, molecular diagnostics, and personalized medicine approaches is transforming the landscape of autoimmune disease diagnosis. The use of artificial intelligence and machine learning algorithms in diagnosis is also gaining traction, improving accuracy and reducing diagnostic errors. Furthermore, the integration of digital health technologies such as wearables, mobile apps, and telemedicine platforms is facilitating remote monitoring and early detection of autoimmune diseases, leading to better patient outcomes and reduced healthcare costs.
The mergers and acquisitions (M&A) activity in the autoimmune disease diagnostics market is currently medium-high, as major players in the industry are actively seeking to expand their portfolios and strengthen their market positions through strategic acquisitions. In December 2023, AstraZeneca acquired Gracell Biotechnologies, a global clinical-stage biopharmaceutical company dedicated to developing innovative cell therapies for the furthering of AstraZeneca's cell therapy ambition across oncology and autoimmune diseases.
Such acquisitions are aimed at enhancing the companies' capabilities in research and development, manufacturing, and sales and marketing, as well as expanding their geographic reach. The M&A activity is driven by the increasing prevalence of autoimmune diseases, growing demand for personalized medicine, and the need for more accurate and efficient diagnostic tools.
The impact of regulation on the autoimmune disease diagnostics market is significant, as regulatory approval is a critical step in bringing new diagnostic products to market. The regulatory environment is complex and varies by region, with different requirements for clinical trials, data submission, and product approval. This can add significant costs and time to the development process, which can impact the profitability and competitiveness of companies operating in the market. However, regulatory approval also provides a level of assurance regarding the safety, efficacy, and quality of diagnostic products, which can help build trust with healthcare providers, patients, and payers. Some recent regulatory developments in the market include the approval of Roche's Elecsys Anti-MDA Plus assay for the diagnosis of systemic lupus erythematosus and the approval of Quanterix's Simoa HD-1 Analyzer System, which uses single-molecule array (Simoa) technology for the detection of autoantibodies.
Product expansion is a key strategy being adopted by major players in the autoimmune disease diagnostics market, as companies seek new growth opportunities through the development of innovative diagnostic products. The market is highly competitive, with several large players as well as emerging players vying for market share. To differentiate themselves from competitors, companies are investing in research & development activities aimed at expanding their product portfolios. This includes the development of new diagnostic tests for emerging autoimmune diseases, as well as the expansion of existing diagnostic tests to cover a broader range of autoimmune diseases. For instance, in May 2022, Thermo Fisher Scientific, a company based in the U.S., introduced new instruments under its Phadia 2500+ series for autoimmune testing and allergy diagnostics. These instruments offer exceptional and consistently high throughput for autoimmune testing and allergy diagnostics, setting a new standard in the industry.
Regional expansion is another key growth strategy being adopted by major players in the autoimmune disease diagnostics industry, as companies seek to expand their customer base and increase their market share in new geographic regions. The market is highly fragmented, with significant variations in diagnostic practices and healthcare infrastructure across different regions. To capitalize on these opportunities, companies are investing in regional expansion initiatives, such as setting up new manufacturing facilities, establishing distribution networks, and partnering with local healthcare providers.
Type Insights
The localized segment dominated the autoimmune disease diagnostics market. It accounted for 64.25% of the global revenue in 2024, owing to factors including autoimmune disease prevalence, diagnostic advancements, awareness, technological innovations, and research, which contribute to the growth and improvement of localized and systemic autoimmune disorder diagnostics. Technological advancements, such as antigen microarray and mass spectrometry, have significantly improved antibody profiling in autoimmune diagnostics. These advancements have demonstrated positive outcomes in terms of analytical sensitivity and reproducibility. With further refinement and validation, these practices have the potential to be integrated into routine clinical procedures.
Systemic disorder diagnostics are expected to have the fastest CAGR over the forecast period. Systemic autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), psoriasis, and multiple sclerosis are significant contributors to the market. According to the reports from the National Center of Biotechnology Information (NCBI), the annual incidence of rheumatoid arthritis in countries such as the U.S. and certain nations in northern Europe is approximately 40 per 100,000 individuals. Furthermore, the prevalence of rheumatoid arthritis in the U.S. alone exceeds 1.3 million people, and this number is expected to increase in the future, owing to the growing use of antinuclear antibody tests in diagnosing various autoimmune diseases, which are anticipated to support market growth.
Product Insights
The consumables & assays segment accounted for the largest revenue share of 70.43% in 2024. Every laboratory diagnostic test utilizes test kits, reagents, and antibodies. Advancements in novel biomarkers and specific assays for autoimmune diseases fuel the demand for specialized consumables. In addition, advancements in consumable technologies have led to the emergence of cost-effective alternatives to traditional diagnostic instruments, particularly in resource-constrained settings. Moreover, there are numerous types of autoimmune diseases, each requiring specific tests and assays. This translates to a wider range of consumables and assays needed to diagnose such conditions, leading to a higher market share of these products.
The instruments segment is expected to experience significant CAGR during the forecast period. In contrast to consumables, instruments are typically used for multiple tests and have a longer lifespan, leading to a lower need for replacements. Instruments often run various tests but may not be specific to autoimmune diseases. In addition, high-end diagnostic instruments are usually designed for long-term use with a high initial investment. With the emergence of new instrument models, the overall replacement cycle for these products is expected to remain longer compared to consumables, leading to their lower market share.
Test Type Insights
The antinuclear antibody tests dominated the market with a revenue share of 42.62% in 2024 and are expected to have a significant growth rate, owing to the increasing applications of the antinuclear antibody tests in the diagnosis of various autoimmune diseases, which is anticipated to support the market growth projection period. In January 2025, an article published by the Journal of Clinical Laboratory Analysis cites that the flow cytometry-based Coombs test detects antinuclear antibodies (ANA) bound to red blood cells in autoimmune patients. The method demonstrated high sensitivity and accuracy, revealing significant ANA agglutination in patients versus healthy controls (p < 0.0001) and stable serum results over ten days, highlighting its potential to improve autoimmune disease diagnostics in clinical laboratories.
Throughout the forecast period, we expect autoantibody tests to emerge as the second dominant segment in the autoimmune disease diagnostics industry. The factors driving the growth of the segment include autoantibody testing, encompassing the need for accurate diagnosis and management of autoimmune diseases, advancements in diagnostic technologies, the adoption of personalized medicine, and ongoing research and development activities in the field.
End Use Insights
The hospital segment dominated the market in 2024 with a revenue share of 53.32%. Various factors, including the increasing number of hospitals and the rising rate of diagnosis and treatment of autoimmune diseases within these healthcare settings, drive the segment growth; for instance, in a February 2024 article published by Statistisches Bundesamt, it stated that Germany had a total of 1,887 hospitals. The significant presence of hospitals in key European countries indicates a substantial volume of autoimmune testing procedures being performed within these institutions across Europe. This trend highlights the growing demand for autoantibody testing services in hospital settings and their potential impact on the market.
The diagnostic centers segment is expected to grow at the fastest CAGR during the forecast period. The growth in autoantibody testing within diagnostic centers can be attributed to several factors, such as the expanding diagnostic capabilities of these centers, which enable them to provide comprehensive testing services, including autoantibody testing, to their patients. Patients often prefer diagnostic centers because they offer comprehensive care that includes diagnosis, treatment, surgical procedures, and physiotherapy. This preference for diagnostic centers contributes to the increased demand for autoantibody testing services within diagnostic center settings.
Regional Insights
North America is expected to dominate the autoimmune disease diagnostics market, primarily driven by the escalating burden of the disease and support from the government in the region. The North America region dominated the market with a share of over 42.70% in 2024. The growth of the market is propelled by increased healthcare spending and increased awareness among the general population.
U.S. Autoimmune Disease Diagnostics Market Trends
The U.S. autoimmune disease diagnostics industry is anticipated to experience a substantial influence on the market because of its high prevalence of these conditions. Although autoimmune diseases are rare, the National Institutes of Health (NIH) estimates that approximately 5% to 8% of the U.S. population is affected by these diseases. This expanding patient pool further strengthens the market prospects.
Europe Autoimmune Disease Diagnostics Market Trends
The autoimmune disease diagnostics industry in Europe is expected to grow at a significant rate during the forecast period, driven by factors such as increasing prevalence of autoimmune diseases, rising awareness about early diagnosis of these diseases, and growing demand for personalized medicine. In addition, advancements in diagnostic technologies are increasing healthcare expenditure, and collaborations between research institutes and diagnostic companies further fuel market expansion in the region.
The autoimmune disease diagnostics market in the UK is expected to grow over the forecast period, driven by factors such as increasing prevalence of autoimmune diseases, rising awareness about early diagnosis of these diseases, and growing demand for personalized medicine. According to a recent report by NHS Digital, around 4 million people in England are affected by autoimmune diseases, making it a major public health challenge in the country. A new population-based study of 22 million people in the UK shows that autoimmune disorders now affect about one in ten individuals, which is higher than previous estimates, ranging from 3-9%, and often relied on smaller sample sizes and included fewer autoimmune diseases.
The French autoimmune disease diagnostics market is expected to grow significantly during the forecast period due to factors such as the increasing prevalence of autoimmune diseases in the country and the growing demand for personalized medicine. In addition, the aging population and a shift toward preventive healthcare contribute to the rising adoption of advanced diagnostic solutions across France. Moreover, advancements in diagnostic technologies, rising awareness about early disease detection, and supportive healthcare infrastructure are accelerating market growth in the region.
The autoimmune disease diagnostics market in Germany is expected to grow at a significant rate due to several factors, including government initiatives and funding. For instance, the West German Genome Center received a two-year 8.98 million funding package from the government. The German government's funding for research and development of diagnostic tools for autoimmune diseases is expected to drive market growth. This funding is expected to enable the development of new diagnostic tools and technologies for autoimmune diseases and their commercialization in the marketplace through initiatives such as "Innovationsprogramm Medizintechnik" and "Zentrum für Innovationskompetenz Medizintechnik."
Asia Pacific Autoimmune Disease Diagnostics Market Trends
The Asia Pacific autoimmune disease diagnostics industry is expected to witness significant growth during the forecast period, primarily due to the increasing burden of autoimmune diseases and the growing awareness regarding their diagnosis. In addition, as reported in June 2022 by Janssen, a division of Johnson & Johnson Pte. Ltd., inflammatory, autoimmune, and pulmonary diseases, including psoriasis, rheumatoid arthritis, and inflammatory bowel disease, are witnessing a notable increase in the Asia Pacific. Moreover, the region already holds the distinction of having the world's highest burden of chronic obstructive pulmonary disease (COPD), along with the highest prevalence of systemic lupus erythematosus (SLE) in China and Southeast Asia. These concerning trends are expected to drive significant demand for diagnostics in the Asia Pacific region in the forthcoming years.
The China autoimmune disease diagnostics market is expected to grow during the forecast period. The increasing prevalence of autoimmune diseases, such as rheumatoid arthritis and type 1 diabetes, is a major driver of market demand. Rapid urbanization, changing lifestyles, and environmental factors contribute to the rise of these chronic conditions. In addition, growing awareness about early diagnosis and treatment options among patients and healthcare providers encourages the use of advanced diagnostic tools. Supportive government policies, increased investment in healthcare infrastructure, and growing collaborations between international and domestic diagnostic companies are further accelerating the adoption of innovative testing solutions across urban and rural healthcare settings in the country.
The autoimmune disease diagnostics market in Japan is anticipated to grow over the forecast period. Japan's elderly population has reached a record 36.25 million, comprising 29.3% of its total population, the highest proportion globally, according to an article by Al Jazeera in September 2024. This demographic trend has resulted in an increased prevalence of autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, and thyroid disorders among older individuals, driving demand for autoimmune disease diagnostics. This trend is expected to continue as Japan's population continues to age due to low birth rates and increasing life expectancy. As a result, the demand for autoimmune disease diagnostic services is expected to increase in Japan over the coming years.
Key Autoimmune Disease Diagnostics Company Insights
Key players are undertaking various strategic initiatives to increase their market share. New product development, collaborations, and partnerships are some such endeavors. For instance, in June 2023, TruDiagnostic RVTY recently announced that its subsidiary, EUROIMMUN, launched the UNIQO 160 (CE-IVDR), a novel automated system designed for indirect immunofluorescence tests (IIFT) used in autoimmune disease diagnostics.
Key Autoimmune Disease Diagnostics Companies
The following are the leading companies in the autoimmune disease diagnostics market. These companies collectively hold the largest market share and dictate industry trends.
- Hoffmann-La Roche Ltd
- Siemens Healthcare Private Limited
- Abbott
- Beckman Coulter, Inc.
- Danaher Corporation
- Quest Diagnostics
- EUROIMMUN Medizinische Labordiagnostika AG
- Nova Diagnostics Pte Ltd.
- BIOMÉRIEUX
- Hemagen Diagnostics, Inc.
Recent Developments
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In February 2025, The Benaroya Research Institute is starting a new way to find autoimmune diseases early. They are adding a special blood test, called an autoantibody test, to regular checkups at the doctor’s office. This test can help spot diseases like type 1 diabetes and rheumatoid arthritis before any symptoms appear. Finding these diseases early can help doctors treat them sooner and possibly stop serious problems. Right now, pilot testing is underway.
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In January 2025, RheumaGen, a biotechnology company based in Aurora, Colorado, secured $15 million in Series A financing co-led by SPRIM Global Investments and William Taylor Nominees. The funds will support Phase I trials of RG0401, a gene-editing therapy targeting treatment-resistant rheumatoid arthritis by modifying HLA genes to prevent autoimmune responses. The company aims to develop one-time, curative treatments for autoimmune diseases, including multiple sclerosis and type 1 diabetes.
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In June 2023, AstraZeneca entered into an agreement with Quell Therapeutics to develop, manufacture, and commercialize engineered T-regulatory cell therapies for autoimmune diseases. The collaboration focuses on Type 1 Diabetes and Inflammatory Bowel Disease using Quell's proprietary multi-modular T-regulatory cell engineering.
Autoimmune Disease Diagnostics Market Report Scopes
|
Report Attribute |
Details |
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Market size value in 2025 |
USD 6.07 billion |
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Revenue forecast in 2030 |
USD 8.20 billion |
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Growth rate |
CAGR of 6.18% from 2025 to 2030 |
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Historical data |
2018-2024 |
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Forecast period |
2025-2030 |
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Quantitative units |
Revenue in USD million/billion and CAGR from 2025 to 2030 |
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Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
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Segments covered |
Type, product, test type, end use, region |
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Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
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Country scope |
U.S.; Canada; UK; Mexico; Germany; France; Italy; Spain; Denmark; Sweden; Norway; Japan; China; India; Australia; Thailand; South Korea; Brazil; Argentina; South Africa; Saudi Arabia; UAE; Kuwait |
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Key companies profiled |
The key companies profiled in this report include F. Hoffmann-La Roche Ltd., Siemens Healthcare Private Limited, Abbott, Beckman Coulter, Inc., Danaher Corporation, Quest Diagnostics, EUROIMMUN Medizinische Labordiagnostika AG, Nova Diagnostics Pte Ltd., BIOMÉRIEUX, and Hemagen Diagnostics, Inc. |
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Customization scope |
We offer free report customization with every purchase, which equates to up to 8 working days for analysts. Addition or alteration to country, regional & segment scope. |
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Pricing and purchase options |
Avail yourself of customized purchase options to meet your exact research needs. Explore purchase options |
Global Autoimmune Disease Diagnostics Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, MIR has segmented the global autoimmune disease diagnostics market report based on type, product, test type, end use, and region
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Type Outlook (Revenue, USD Million, 2018-2030)
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Systemic autoimmune disease diagnostics
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Rheumatoid arthritis
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Ankylosing spondylitis
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Systemic lupus erythematosus (SLE)
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Others
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Localized autoimmune disease diagnostics
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Multiple sclerosis
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Type 1 diabetes
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Hashimoto's Thyroiditis
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Idiopathic thrombocytopenic purpura
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Others
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Product Outlook (Revenue, USD Million, 2018-2030)
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Instruments
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Consumables and Assays
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Test Type Outlook (Revenue, USD Million, 2018-2030)
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Antinuclear antibody tests
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Autoantibody tests
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C-reactive Protein (CRP)
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Complete blood count (CBC)
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Urinalysis
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Others
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End Use Outlook (Revenue, USD Million, 2018-2030)
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Hospitals
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Diagnostic centers
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Others
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Regional Outlook (Revenue, USD Million, 2018-2030)
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North America
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U.S.
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Canada
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Mexico
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Europe
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UK
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Germany
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France
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Italy
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Spain
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Sweden
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Norway
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Denmark
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Asia Pacific
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Japan
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China
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India
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Australia
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Thailand
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South Korea
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Latin America
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Brazil
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Argentina
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Middle East and Africa (MEA)
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South Africa
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Saudi Arabia
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UAE
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Kuwait
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