Allergy And Autoimmune Disease Diagnostics Market (2025 - 2033) Size, Share & Trends Analysis Report By Product & Service (Allergy Diagnostics), By Test Type, By Diagnostics Type, By End Use, By Region, And Segment Forecasts

Allergy And Autoimmune Disease Diagnostics Market Summary

The global allergy and autoimmune disease diagnostics market size was estimated at USD 11.38 billion in 2024 and is projected to reach USD 25.02 billion by 2033, growing at a CAGR of 5.41% from 2025 to 2033. This market addresses the detection and monitoring of immune-related conditions, spanning a wide range of allergic reactions and autoimmune disorders.

Growth is being supported by the rising incidence of chronic immune conditions, greater public and clinical awareness, and technological improvements in diagnostic modalities such as immunoassays and molecular platforms. Ongoing efforts to improve diagnostic accuracy, speed, and accessibility, especially through point-of-care formats and multiplex testing, are reshaping the landscape. Expanding laboratory infrastructure, integration of digital tools, and interest in personalized immunodiagnostics are contributing to early disease detection and long-term management strategies. Innovations in biomarker research and AI-driven analysis are expected to further support diagnostic precision in complex autoimmune profiles.

According to the National Health Interview Survey (NHIS), 2021, published by the U.S. Centers for Disease Control and Prevention (CDC) in a press release dated January 2023, nearly 1 in 3 adults and more than 1 in 4 children in the U.S. reported having a seasonal allergy, eczema, or food allergy. Around 6% of both adults and children suffer from a food allergy, with the rate being notably higher among Black, non-Hispanic individuals compared to other racial and ethnic groups. These figures reflect the growing diagnostic demand for allergy-related conditions across diverse populations, emphasizing the need for more accurate and inclusive testing approaches in the allergy and autoimmune disease diagnostics industry.

In addition, the market is witnessing greater integration of home-based and decentralized testing solutions, enabling broader access to diagnostics beyond traditional clinical settings. Collaborations between diagnostic developers, public health agencies, and private providers are enhancing the availability of tests in community health centers and pharmacies. These developments, combined with rising investments in immunology research and the expansion of diagnostic coverage under national health programs, are expected to strengthen the position of the allergy and autoimmune disease diagnostics market over the coming years.

Market Drivers

Rising Prevalence of Immune-Related Disorders: The increasing global incidence of allergies and autoimmune diseases is driving demand for accurate diagnostic solutions to support timely intervention and long-term disease monitoring.

Shift toward Early and Personalized Diagnosis: Emphasis on early detection and individualized care is encouraging the adoption of advanced diagnostic tools such as autoantibody panels and multiplex immunoassays.

Expansion of Decentralized and Home-Based Testing: Growth in point-of-care and at-home diagnostic formats is enhancing accessibility, particularly in rural and underserved regions, improving patient engagement and diagnostic reach.

Market Restraints

High Cost of Advanced Diagnostic Technologies:  The expense associated with molecular and multiplex diagnostic platforms may limit adoption in low-resource settings and among smaller healthcare providers.

Underdiagnosis and Limited Awareness in Emerging Markets: Inadequate awareness and healthcare infrastructure in several developing regions contribute to delayed or missed diagnoses, restricting market growth.

Regulatory and Reimbursement Barriers: Inconsistent regulatory frameworks and unclear reimbursement pathways in some countries can hinder the approval and widespread adoption of new diagnostic products.

Market Concentration & Characteristics

Innovation is high, driven by the demand for faster, more accurate, and user-friendly diagnostic methods. Advancements such as multiplex testing, digital immunoassays, and AI-based result interpretation are improving diagnostic precision and efficiency. The integration of wearable biosensors, smartphone-compatible test readers, and non-invasive sampling (e.g., saliva-based assays) is enhancing patient convenience and expanding diagnostic capabilities outside traditional laboratories.

Mergers and acquisitions are moderately active, with diagnostics firms acquiring companies specializing in allergy and autoimmune assays to strengthen their test portfolios. These activities aim to integrate proprietary technologies, expand global access, and speed up biomarker discovery. Strategic partnerships, especially between biotech firms and digital health startups, are also increasing to develop AI-enabled diagnostic platforms and decentralized testing models.

Regulatory oversight plays a significant role in shaping the allergy and autoimmune disease diagnostics market. Agencies such as the FDA and EMA ensure the safety, accuracy, and quality of diagnostic kits through rigorous review processes. While approvals can delay market entry, clear regulatory pathways support innovation and market confidence. Growing emphasis on diagnostic accuracy and test validation, particularly for autoimmune conditions, adds both complexity and opportunity for product differentiation.

Product development is robust, with companies focusing on multiplex panels, digital assay readers, and non-invasive diagnostic solutions for both allergy and autoimmune conditions. There is growing interest in compact, connected devices that support point-of-care and home-based testing. Efforts are also underway to introduce disease-specific panels that improve sensitivity, reduce diagnostic ambiguity, and cater to underserved conditions such as rare autoimmune disorders.

Regional growth is accelerating in Asia Pacific, Latin America, and the Middle East, where rising diagnostic awareness and healthcare investments are driving demand. Companies are entering these markets with cost-effective, easy-to-use platforms, often in partnership with local distributors or public health programs. While North America and Europe remain key revenue centers, emerging markets are gaining strategic importance due to growing testing volumes and population-level screening initiatives.

Product And Service Insights

The allergy segment accounted for the largest market share of 35.75% in 2024, supported by the high global prevalence of allergic conditions such as asthma, allergic rhinitis, and food allergies. Demand for reliable and accessible testing methods, such as specific IgE assays, skin prick tests, and allergen panels, has grown across clinical, outpatient, and home-based settings. The segment continues to benefit from increasing public awareness, rising test availability, and advancements in in vitro diagnostic platforms. In addition, the expansion of decentralized care models and the emergence of at-home allergy test kits further contribute to segment growth by offering convenient and cost-effective solutions for early detection and monitoring.This segment is also projected to register the fastest CAGR over the forecast period, driven by ongoing innovation in self-testing technologies and growing integration of allergy diagnostics into digital health platforms.

The autoimmune disease segment is expected to register notable growth during the forecast period, driven by the rising global incidence of chronic immune-mediated conditions such as rheumatoid arthritis, systemic lupus erythematosus, and type 1 diabetes. This expansion is supported by increasing awareness of autoimmune disorders, advancements in autoantibody-based testing, and the growing availability of disease-specific diagnostic panels. Demand for early and accurate detection is also rising to guide long-term disease management and personalized treatment plans. Molecular diagnostics, biomarker discovery, and digital immunoassay platform improvements are enhancing test precision and accelerating adoption across hospitals, specialty clinics, and diagnostic laboratories. As autoimmune conditions continue to present diagnostic challenges due to overlapping symptoms, this segment is gaining importance for its clinical relevance and expanding diagnostic options.

Test Type Insights

The allergy segment led the allergy and autoimmune disease diagnostics industry with the largest share of 29.57% in 2024, due to its wide use in detecting reactions to pollen, food, and skin contact allergens. Specific IgE blood tests, skin prick tests, and patch tests are commonly used because they are reliable, easy to use, and helpful in everyday medical care. The CDC estimates that over 50 million people in America have allergies each year, making allergies the sixth most common long-term health problem in the country. As more people look for early testing and use at-home allergy kits, and testing methods become more accurate, this segment continues to lead the market. Allergy tests are widely used because they are simple, useful in many situations, and based on well-known procedures.

The autoimmune disease segment is expected to showcase notable growth over the forecast period, driven by increasing awareness, rising incidence of chronic immune conditions, and greater demand for early and accurate diagnosis. This growth is supported by the broader adoption of specialized tests such as autoantibody panels, antinuclear antibody (ANA) tests, and molecular-based diagnostics that help detect complex autoimmune disorders. As these conditions often have overlapping symptoms, timely and precise testing is essential for guiding treatment. Advances in diagnostic accuracy, test automation, and accessibility-combined with growing interest in personalized care-are helping expand the use of autoimmune disease diagnostics across hospitals, specialty labs, and outpatient settings. With ongoing immunology and biomarker research improvements, this segment is becoming increasingly important in the overall diagnostics landscape.

Diagnostics Type Insights

The allergy diagnostics segment dominated the market in terms of revenue in 2024 and is also projected to grow at the fastest CAGR over the forecast period, driven by increasing awareness of allergic conditions and growing demand for timely and accurate testing. This segment benefits from the widespread use of immunoassays, skin prick tests, and specific IgE blood tests, which are widely accepted for their speed, ease of use, and clinical accuracy. Allergy diagnostics are well-suited for both centralized laboratories and decentralized settings, including outpatient clinics and home environments. Technological improvements-such as automated allergen panels, enhanced assay sensitivity, and digital interpretation tools-are further supporting segment growth. The rising availability of at-home kits, coupled with growing public interest in identifying allergy triggers early, continues to strengthen this segment’s market position. The combination of ease, speed, and adaptability makes allergy diagnostics a key driver in the global market.

The autoimmune disease diagnostics segment is expected to witness notable growth over the forecast period, supported by increasing demand for accurate and early detection of complex immune-related disorders. This growth is driven by the broader use of advanced diagnostic methods such as multiplex immunoassays, indirect immunofluorescence, and molecular diagnostics, which help detect specific autoantibodies and genetic markers. These tools are essential in diagnosing conditions like lupus, rheumatoid arthritis, and celiac disease, where overlapping symptoms often delay clinical decisions. Recent advancements such as high-throughput autoantibody screening platforms, AI-assisted image interpretation, and digital immunoassay systems are improving diagnostic precision and speed. As healthcare systems focus more on long-term disease monitoring and personalized care pathways, the autoimmune diagnostics segment is becoming a more prominent contributor to the overall market.

End Use Insights

The allergy segment dominated the global allergy and autoimmune disease diagnostics industry by end use in 2024 and is projected to register the highest CAGR over the forecast period. Key end users include hospitals and clinics, diagnostic laboratories, and research institutions, all of which play a central role in diagnosis and long-term disease management. Hospitals and clinics, in particular, serve as the primary point of care for allergy testing due to their access to advanced tools and broad patient reach. For instance, according to a February 2024 a rticle by Statistisches Bundesamt, Germany had a total of 1,887 hospitals, reflecting the scale of clinical infrastructure available to support diagnostic services. Diagnostic laboratories contribute through high-throughput and specialized testing, while research institutions continue to develop improved testing platforms. These combined factors support the segment’s strong presence and continued growth across key end-use categories.

The autoimmune disease segment is expected to have notable growth over the forecast period by end use, driven by growing awareness of immune-related conditions and the increasing need for reliable, early-stage diagnostics. Major end users, including hospitals and clinics, diagnostic laboratories, and research institutions, are expanding their use of autoimmune testing to support accurate diagnosis and long-term patient management. Hospitals and clinics rely on diagnostic tools for conditions like rheumatoid arthritis and lupus, where early intervention can improve outcomes. Diagnostic laboratories perform high-volume testing using specialized panels and molecular assays, while research institutions contribute through biomarker identification and test innovation. Continued improvements in testing platforms and a growing focus on personalized care are expected to further support the expansion of autoimmune diagnostics across these settings.

Regional Insights

North America dominates the allergy and autoimmune disease diagnostics market due to the high burden of immune-related disorders, strong healthcare infrastructure, and widespread use of advanced diagnostic technologies. The region benefits from supportive government initiatives, growing adoption of digital and point-of-care diagnostic tools, and increasing awareness among healthcare providers and patients. Technological advancements-such as automated immunoassay platforms, multiplex testing, and telehealth-enabled diagnostics-are driving adoption across hospitals, clinics, and home care environments. These factors collectively reinforce North America's leading position in both market revenue and diagnostic innovation for allergy and autoimmune conditions.

U.S. Allergy and Autoimmune Disease Diagnostics Market Trends

The U.S. leads the global allergy and autoimmune disease diagnostics industry, driven by the high prevalence of immune-related conditions, strong clinical infrastructure, and demand for accurate, rapid testing. Increased focus on early diagnosis, chronic disease management, and personalized treatment has expanded the use of diagnostic tools across hospitals, clinics, and at-home settings. Although many autoimmune diseases are rare, the National Institutes of Health (NIH) estimates that they collectively affect between 5% and 8% of the U.S. population, highlighting the widespread need for effective diagnostics. Widespread adoption of immunoassays, molecular tests, and digital diagnostic platforms supports growth, along with rising awareness campaigns and public health efforts targeting allergy and autoimmune disorders. These trends continue to strengthen the U.S. market’s position in both diagnostic volume and innovation.

Europe Allergy and Autoimmune Disease Diagnostics Market Trends

Europe is witnessing steady growth in the allergy and autoimmune disease diagnostics industry, driven by the rising incidence of chronic immune conditions and growing public awareness across the region. Countries such as Germany, the UK, and France are at the forefront of diagnostic adoption, supported by strong healthcare systems and national screening programs. The increasing availability of specific IgE testing, autoantibody panels, and molecular diagnostics in both public and private healthcare settings is improving early detection and disease management. In addition, the shift toward non-invasive testing formats and the integration of digital tools are improving accessibility across outpatient and primary care environments. These factors are supporting consistent regional demand and advancing Europe’s position in the global diagnostics landscape.

The UK allergy and autoimmune disease diagnostics market is expanding steadily, supported by growing awareness and national efforts to improve early diagnosis. Government support for healthcare digitization and preventive screening is helping expand the use of diagnostic tools across hospitals, clinics, and community health services. According to NHS Digital, around 4 million people in England have autoimmune diseases, highlighting a major public health issue. In addition, Allergy UK reports that approximately 21 million people in the UK (one in three) are living with an allergic condition, with 5 million requiring specialist care. Demand for allergy and autoimmune tests is increasing across both public and private sectors, driven by the need for speedy diagnosis and long-term monitoring. The adoption of digital platforms, home-based testing kits, and streamlined laboratory workflows is improving access and efficiency, positioning the UK as a key growth hub in Europe’s diagnostics landscape.

The allergy and autoimmune disease diagnostics market in Germany showcases strong growth, supported by a well-developed healthcare system and increasing focus on early and accurate diagnosis. Widespread adoption of immunoassays, molecular tests, and autoantibody screening is evident across hospitals, outpatient clinics, and diagnostic laboratories. Rising healthcare spending, public health awareness, and the integration of diagnostics into routine care pathways are boosting test volumes. The use of automated platforms and digital reporting tools is enhancing efficiency and diagnostic precision. With continued investments in healthcare infrastructure and research, Germany remains a key market for allergy and autoimmune diagnostics in Europe.

Asia Pacific Allergy and Autoimmune Disease Diagnostics Market Trends

Asia Pacific is the fastest-growing region in the allergy and autoimmune disease diagnostics industry, driven by rising awareness, increasing diagnosis rates, and expanding access to healthcare services. Countries such as China, India, and Japan are investing in preventive healthcare and early detection programs, which is supporting the adoption of allergy and autoimmune tests across hospitals, clinics, and diagnostic laboratories. The availability of cost-effective testing kits and the growing demand for non-invasive diagnostic methods are improving accessibility across both urban and rural areas. In addition, government-led health initiatives, rising prevalence of chronic immune conditions, and greater integration of mobile and digital health technologies are accelerating regional growth. These combined factors position Asia Pacific as a key area of opportunity for market expansion over the forecast period.

The Japan allergy and autoimmune disease diagnostics market is expanding gradually, supported by rising awareness of immune-related disorders and the healthcare demands of an aging population. The need for early diagnosis and personalized treatment is driving the adoption of diagnostic tools in hospitals, specialty clinics, and research centers. Allergy testing is gaining wider acceptance due to the growing incidence of respiratory allergies and food sensitivities, particularly among children and older adults. Autoimmune diagnostics are also becoming more common as clinical guidelines emphasize early detection to manage chronic conditions effectively. While the regulatory environment remains structured, the demand for accurate, non-invasive, and automated testing platforms is steadily increasing, positioning Japan as an important contributor to regional market growth.

The allergy and autoimmune disease diagnostics market in China represents a significant growth opportunity, driven by rising healthcare awareness, improved diagnostic infrastructure, and growing demand for early detection. Government healthcare reforms and broader insurance coverage are expanding access to allergy and autoimmune testing in hospitals, clinics, and community settings. A systematic review and meta-analysis published via PubMed in December 2024 estimated that 2.7-3.0% of Chinese adults-over 31 million people-have one or more autoimmune diseases. In addition, A nationwide study published in May 2023, indexed on PubMed, reported a 4.0% prevalence of self-reported food allergy among adults in Jiangxi Province, China. These figures highlight a rising public health need for accessible diagnostic services. With ongoing initiatives to improve testing affordability, digital health integration, and a growing middle class, China is fast becoming a key driver of regional and global market growth.

Latin America Allergy and Autoimmune Disease Diagnostics Market Trends

Latin America is experiencing moderate but rising demand in the allergy and autoimmune disease diagnostics industry, supported by growing public health awareness and improvements in diagnostic infrastructure. Countries such as Brazil and Argentina are expanding access to allergy and autoimmune testing through public healthcare systems and partnerships with private diagnostic labs. The increasing burden of chronic immune conditions, combined with limited early detection in rural and underserved areas, is pushing the adoption of rapid, affordable diagnostic solutions. Efforts to decentralize care, rising investment in laboratory capabilities, and interest in telehealth and mobile diagnostics are also contributing to broader market uptake across the region.

The Brazil allergy and autoimmune disease diagnostics market is expanding steadily, driven by rising awareness of chronic immune conditions and efforts to improve access to diagnostic services. Public health campaigns and government-supported healthcare programs are increasing the use of allergy and autoimmune testing in both urban hospitals and rural clinics. Demand is particularly growing for accessible and cost-effective testing solutions, such as IgE assays and autoantibody panels. With telehealth and mobile health platforms gaining traction, home-based and community-level diagnostics are becoming more viable. These developments, along with investment in laboratory infrastructure and increased training of healthcare professionals, are positioning Brazil as a key growth market within Latin America.

Middle East and Africa Allergy and Autoimmune Disease Diagnostics Market Trends

The Middle East and Africa region is showing emerging growth in the allergy and autoimmune disease diagnostics industry, supported by increasing awareness of immune-related conditions and expanding access to healthcare services. Countries such as Saudi Arabia, the UAE, and South Africa are gradually adopting allergy and autoimmune testing in hospitals, diagnostic labs, and primary care centers. While infrastructure limitations and uneven resource distribution remain challenges, the demand for early and accurate diagnosis is rising. Public health initiatives, growing investments in laboratory capacity, and partnerships with international organizations are helping to improve diagnostic outreach and build local capabilities across underserved regions.

Key Allergy And Autoimmune Disease Diagnostics Company Insights

Some key players operating in the allergy and autoimmune disease diagnostics market are focusing on innovation, expanding test portfolios, and improving diagnostic accuracy to strengthen their competitive position. These companies are actively pursuing regulatory approvals such as FDA clearance and CE-IVD certification to ensure compliance and broaden their global reach. Strategies also include investing in biomarker discovery, digital diagnostics, and partnerships to support product development and increase adoption across clinical and decentralized settings.

Recent Developments

• 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.

• In January 2025, RheumaGen, a biotechnology company based in Aurora, Colorado, secured USD 15 million 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.

• In October 2024 - ALK received U.S. FDA clearance for its AccuTest-1, AccuTest-8, and AccuTest-10 skin-prick testing products, along with compatible allergen trays. The products offer improved ergonomics, consistent pressure application, and enhanced tray design to support better test accuracy and user experience. This development reinforces ALK’s role in the allergy diagnostics space by focusing on skin-prick testing innovation.

Allergy And Autoimmune Disease Diagnostics Market Report Scope

Global Allergy And Autoimmune Disease Diagnostics Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global allergy and autoimmune disease diagnostics market report based on product and service, diagnostics type, test type, end use, and region:

• Product and Service Outlook (Revenue, USD Million, 2021 - 2033)

  • Allergy Diagnostics

    • Instruments

    • Consumables

    • Services

  • Autoimmune Disease Diagnostics

    • Instruments

    • Consumables

    • Services

• Test Type Outlook (Revenue, USD Million, 2021 - 2033)

  • Allergy Diagnostics

    • In vivo Test

      • Skin Prick Test

      • Intradermal Test

      • Patch Test

    • In vitro Test

      • Autoimmune Disease Diagnostics

      • Antinuclear Antibody Tests

      • Autoantibody Tests

      • C-reactive Protein (CRP)

      • Complete Blood Count (CBC)

      • Urinalysis

      • Others

• Diagnostics Type Outlook (Revenue, USD Million, 2021 - 2033)

  • Allergy Diagnostics

    • Food

      • Dairy Products

      • Poultry Products

      • Tree Nuts

      • Peanuts

      • Shellfish

      • Wheat

      • Soys

      • Other Food Allergens

    • Inhaled

    • Drug

    • Other Allergens

  • Autoimmune Disease Diagnostics

    • Systemic Autoimmune Disease Diagnostics

      • Rheumatoid Arthritis

      • Ankylosing Spondylitis

      • Systemic Lupus Erythematosus (SLE)

      • Others

    • Localized Autoimmune Disease Diagnostics

      • Multiple Sclerosis

      • Type 1 Diabetes

      • Hashimoto's Thyroiditis

      • Idiopathic Thrombocytopenic Purpura

      • Others

• End Use Outlook (Revenue, USD Million, 2021 - 2033)

  • Allergy Diagnostics

    • Hospitals & Clinics

    • Diagnostics Laboratories

    • Research Institutions

    • Others

  • Autoimmune Diagnostics

    • Hospitals & Clinics

    • Diagnostics Laboratories

    • Research Institutions

    • Others

• Regional Outlook (Revenue, USD Million, 2021 - 2033)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait