Autoimmune Disease Testing Market Size, Share, and Growth Forecast from 2024 - 2031

Autoimmune Disease Testing Market by Product Type (Instruments, Reagents & Consumables), Disease Type (Systemic Lupus Erythematosus, Scleroderma, Vasculitis, Inflammatory Bowel Disease, Rheumatoid Arthritis), Test Type (Inflammatory Markers, Routine Laboratory Tests, Anti-Thyroglobulin Antibody, Antibodies and Immunology Test), End User (Hospitals and Clinics, Diagnostic Laboratories, Research Laboratories), and Regional Analysis from 2024 to 2031

Autoimmune Disease Testing Market

Industry: Healthcare

Published Date: November-2024

Format: PPT*, PDF, EXCEL

Delivery Timelines: Contact Sales

Number of Pages: 192

Report ID: PMRREP34958

Report Price

$ 4900*

Buy Now

Autoimmune Disease Testing Market Size and Share Analysis

The global autoimmune disease testing market is anticipated to reach a value of US$ 6 Bn by 2024. It is anticipated to witness a CAGR of 9.2% during the forecast period to reach the size of US$ 12.6 Bn by 2031. Low immune reaction is a direct outcome of autoimmune diseases that severely impact the immune system.

The American Autoimmune Related Disorders Association Inc. (AARDA) estimated 50 million people to currently have autoimmune disease with a 20% to 25% of these individuals having several at once. The number of people living with autoimmune conditions by 2024 is estimated to reach 350 million individuals worldwide.

The dominance of the autoimmune disease testing market is attributed to a robust healthcare infrastructure in developed as well as developing countries and substantial investments in research and development.

Healthcare providers are posing a demand reliable and precise testing methods for early diagnosis and monitoring of autoimmune illnesses while facilitating effective therapeutic approaches. This includes fundamental tests that can assist manage, and diagnose individuals having autoimmune illnesses, provide a prognosis, or show the extent of organ involvement or damage.

Key Highlights of the Industry

  • Rising adoption of advanced diagnostic technologies like next-generation sequencing, multiplex assays, and other high-throughput screening techniques are fostering expansion.
  • Healthcare providers are also using modern testing technologies to create tailored treatment regimens and enhancing sensitivity, specificity, and accuracy.
  • As autoimmune disorders become widely recognized and understood by patients as well as healthcare professionals, there is a rising demand for screening and diagnostic testing.
  • Government initiatives for early diagnosis and treatment of autoimmune disease have resulted in better clinical results and reduced healthcare costs.
  • AI-related diagnostics methods like decision trees, vector support machines, and artificial neutral networks are witnessing global expansion.
  • In terms of product type, the instruments category is anticipated to hold a CAGR of 10.8% through 2031 as the demand for swift and reliable testing increase.
  • By test type, routine laboratory tests segment is estimated to showcase a CAGR of 8.6% through 2031 owing to their cost-effectiveness.
  • India autoimmune disease testing market is expected to hold a CAGR of 8.2% through the forecast period as authorities are expanding diagnostic centers in rural areas.
  • Autoimmune disease testing market in U.S. is set to register a CAGR of 11.1% through 2031 due to an increase in healthcare awareness fueled by government authorities and non-profit organizations.

Market Attributes

Key Insights

Market Size (2024E)

US$ 6 Bn

Projected Market Value (2031F)

US$ 12.6 Bn

Global Market Growth Rate (CAGR 2024 to 2031)

9.2%

Historical Market Growth Rate (CAGR 2019 to 2023)

10.9%

Rising Healthcare Investments in India Make it a Dominating Country in Asia Pacific

India is estimated to emerge as the leading country in Asia autoimmune disease testing market during the forecast period. The rapid rise in healthcare investments coupled with advancements in diagnostic infrastructure in the country are key factors facilitating growth.

India is witnessing a expansion in its diagnostic capabilities with a growing individual preference for tests like C-reactive protein (CRP) tests, autoantibody panels, and antinuclear antibody (ANA) tests that are critical for diagnosing several autoimmune conditions. The government of India has a high focus on affordable healthcare. Authorities are looking after establishing diagnostic centers in rural area to make autoimmune testing more accessible.

U.S. Maintains Primacy in North America Autoimmune Disease Testing Market

U.S. is estimated to lead the North America market with over 50 million Americans living with autoimmune diseases as of 2024. The aging demographics of the country along with lifestyle changes and environmental influences are further expected to increase this number. Integration of advanced diagnostic technologies are the primary drivers of market growth.

Adoption of point-of-care testing and automated diagnostic tools is improving the speed and accuracy of autoimmune disease testing, thereby making it accessible and convenient for healthcare providers. Increasing healthcare awareness fuelled by government and non-profit organizations in the country is encouraging individuals to seeks early diagnostic testing that is crucial for enhancing patient outcomes.

Automated Instruments to Gain Traction in the Market

Category

CAGR through 2031

Product Type - Instruments

10.8%

Instruments are emerging as the leading product type owing to their pivotal role in improving diagnostic accuracy, efficiency, and throughput. The market for advanced diagnostic instruments is projected to grow with an increase in demand for faster and reliable testing, especially in hospitals, diagnostic laboratories, and point-of-care settings.

Advancements in automated diagnostic technologies that streamline testing process, decrease human error, and enable higher test volumes are estimated to further bolster growth of the instruments in autoimmune disease testing market. Instruments offering automation in tasks are gaining traction owing to their ability to swiftly and accurately handle complex assays.

Widespread Use and Accessibility of Routine Laboratory Tests Foster their Demand

Category

CAGR through 2031

Test Type - Routine Laboratory Tests

8.6%

Routine laboratory tests are gaining traction owing to their widespread use, cost-effectiveness, and ability to accurately diagnose an array of autoimmune conditions. The reliability and accessibility of routine laboratory tests are the key drivers influencing growth. These tests are considered standard in diagnostic processes for autoimmune diseases and are therefore widely available in hospitals and outpatient clinics.

The affordability of these tests makes them an attractive choice for patients and healthcare providers, especially in regions having limited healthcare budgets. Rising emphasis on early detection and preventive healthcare has made routine laboratory tests crucial.

Market Introduction and Trend Analysis

The emergence of point of care testing (POCT) that offers convenience and swift diagnostics along with the integration of AI to improve the accuracy of disease prediction and progression monitoring are shaping the future of the market.

Rapid innovations in biomarker discovery are transforming the diagnosis process by allowing differentiation among diseases having overlapping symptoms. It is one of the common challenges in autoimmune diagnostics. Automation and multiplex testing platforms are further assisting in streamlining workflows in laboratories, thereby boosting efficiency while decreasing turnaround times.

Historical Growth and Course Ahead

The autoimmune disease testing market growth was steady at a CAGR of 10.9% during the historical period. Increasing prevalence of autoimmune disease across the globe like systemic lupus erythematosus (SLE), type 1 diabetes, and multiple sclerosis are impacted the growth of the market. 

The period also witnessed the development of new biomarkers, automation in laboratory diagnostics, and integration of AI to improve efficiency and accuracy. Rising awareness campaigns for the early diagnosis and access to healthcare facilities highly contributed to increased testing.

The global aging population is more susceptible to autoimmune conditions, thereby driving demand. Developed countries with a well-established healthcare infrastructure and higher diagnostic rates saw substantial growth. Government support coupled with a rise in healthcare expenditure and awareness campaigns play a key role in supporting growth.

Market Growth Drivers

Advancements in Laboratory Automation Platforms to Foster Swift Testing

Rising incidence of autoimmune diseases is increasing across the globe, thereby elevating the volume of samples being collected for analysis purposes. This has resulted in a growing demand for automation in autoimmune disease testing for swift analysis and interpretation of results.

Automation in autoimmune testing involves a series of integrated steps including pre-analytical and post-analytical stages to minimize the requirement for manual intervention, thereby avoiding errors. Central laboratories resort to the use of automation as they conduct large-scale analyses of samples. Leading manufacturers in the autoimmune disease testing market are offering automated systems to central and medium-sized laboratories for sample analysis.

Decentralized testing for autoimmune disease diagnosis is gaining popularity among medical facilities. This procedure decreases the time required for sending samples for analysis from the central laboratories. The limited understanding of autoimmune diseases along with the requirement for confirmatory results for effective therapy are posing a need for centralized testing of samples for disease diagnosis.

Increasing Prevalence of Autoimmune Diseases to Foster Demand

The synovial tissues within the joints are majorly attacked by the autoimmune disease and elderly patients are predominantly affected by this. Technological advancements and the aging population are also major factors that have elevated the growth of autoimmune disease diagnostics market.

Rheumatoid arthritis has become a common disease that is being diagnosed in the aging population with an increase in the burden of the senior population. The high risk of an upsurge of rheumatoid arthritis is driving growth in the sales of autoimmune disease diagnostics market. According to the reports published by the World Population prospect 2022, there were about 771 million people aged 65 years and above in 2022 and the figures are estimated to approach 994 million by the year 2030 and 1.60 billion by 2050.

Launch of new products are also driving growth in autoimmune disease diagnostics market. For instance, in June 2022, PEPperPrint GmbH launched a biomarker set at the 13th International Congress on Autoimmunity organized in Athens, Greece. This product is used in the early diagnosis of Rheumatoid arthritis (RA). Such innovations for early disease diagnosis are predicted to elevate autoimmune disease testing market growth.

Market Restraining Factors

Lack of Standardization in Quality of Immunoassay Kits

Accuracy and consistency are prominent factors influencing the quality of diagnostic tests. Results obtained from commercialized immunoassay kits have marked variations in quality. This is prominently evident in the diagnosis of systemic vasculitis using ANCA testing. For instance, granulomatosis with polyangiitis can be life-threatening when the disease is not diagnosed quickly and accurately.

There is, however, a large range of varied performance characteristics for immunoassay tests in laboratories across the globe, particularly in Europe. Such inconsistencies pose a serious challenge to diagnosis and treatment and will in turn affect the brand equity of the manufacturers.

Market Growth Opportunities

Focus on Companion Diagnostic Tests to have a Positive Impact on the Market

Companion diagnostics enable the screening of individuals or groups who are likely to respond better to a therapeutic agent. Advances in companion diagnostic test for an autoimmune disease involves the use of a diagnostic test and monitoring of disease prognosis in individuals undergoing therapy. The test also offers insights into the therapeutic regimen's positive impact on these people by decreasing the intensity of autoimmune diseases.

Advancements in Autoimmune Disease Diagnosis with Personalized Medicine and POCT

The shift toward personalized medicine is playing a substantial role in shaping the landscape of autoimmune disease diagnosis. This trend is being propelled by advancements in molecular diagnostics and the integration of genomic data, that enable customized treatment strategies based on individual patient profiles.

Healthcare providers can offer precise and effective interventions by leveraging these innovative approaches, thereby driving the demand for personalized diagnostic tests in the autoimmune disease sector. There is an increasing adoption of point-of-care testing (POCT) in the autoimmune disease diagnostics market.

The preference for POCT devices emerges from their ability to offer rapid results and convenience, enabling timely diagnosis and management of autoimmune conditions. As a result, POCT devices are gaining traction across several healthcare settings, contributing to the evolving landscape of autoimmune disease diagnosis market.

Competitive Landscape for the Autoimmune Disease Testing Market

The autoimmune disease testing market has a consolidated structure with a competitive environment. Market leaders maintain a commanding position with a array of autoimmune disease diagnostic equipment and supplies. They have a robust presence in the industry along with an extensive global distribution network and considerable knowledge in the healthcare and diagnostics sectors.

Other manufacturers in the industry actively engage in developing innovative products to expand their product portfolio. They are also exploring geographical expansion through mergers and acquisitions to gain market share.

Recent Industry Developments

  • In October 2024, Pathkind Diagnostics, headquartered in Gurgaon, expanded its autoimmunity testing with an innovative Alegra Monotest technology through its partnership with Sebia.
  • In September 2024, Eugenia Chock, MD, MPH, an assistant professor of medicine at Yale School of Medicine and Yale Center for Clinical Investigation Scholar, received funding from the Yale Center of Excellence in Regulatory Science and Innovation-Food and Drug Administration Office of Women’s Health. It is to develop the use of AI to remove barriers to diagnosing and addressing autoimmune diseases in women.
  • In July 2024, Cell Therapy like Car-T or Chimeric Antigen Receptor Cell Therapy emerges as a single shot hope to autoimmune disease patients.

Autoimmune Disease Testing Industry Report Scope

Attributes

Details

Forecast Period

2024 to 2031

Historical Data Available for

2019 to 2023

Market Analysis

US$ Billion for Value

Key Regions Covered

  • North America
  • Europe
  • East Asia
  • South Asia and Oceania
  • The Middle East and Africa
  • Latin America

Key Market Segments Covered

  • Product Type
  • Disease Type
  • Test Type
  • End User
  • Region

Key Companies Profiled in the Report

  • Abbott Laboratories
  • Thermo Fisher Scientific
  • F. Hoffmann-La Roche Ltd
  • Siemens Healthineers
  • Bio-Rad Laboratories
  • Beckman Coulter (Danaher Corporation)
  • Quest Diagnostics
  • PerkinElmer, Inc.
  • Hologic, Inc.
  • Grifols
  • bioMérieux
  • Werfen (Inova Diagnostics)
  • Ortho Clinical Diagnostics
  • Trinity Biotech
  • EUROIMMUN (A PerkinElmer Company)

Report Coverage

  • Market Forecast and Trends
  • Company Share Analysis
  • Competitive Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives  

Customization and Pricing

Available upon request

Autoimmune Disease Testing Industry Segmentation

By Product Type

  • Instruments
  • Reagents and Consumables

By Disease Type

  • Systemic Lupus Erythematosus
  • Scleroderma
  • Vasculitis
  • Inflammatory Bowel Disease
  • Rheumatoid Arthritis
  • Others

By Test Type

  • Inflammatory Markers
  • Routine Laboratory Tests
  • Anti-Thyroglobulin Antibody
  • Antibodies and Immunology Test
  • Others

By End User

  • Hospitals and Clinics
  • Diagnostic Laboratories
  • Research Laboratories
  • Others

By Region

  • North America
  • Europe
  • East Asia
  • South Asia and Oceania
  • Latin America
  • The Middle East and Africa

To know more about delivery timeline for this report Contact Sales

Companies Covered in This Report

  • Abbott Laboratories
  • Thermo Fisher Scientific
  • F. Hoffmann-La Roche Ltd
  • Siemens Healthineers
  • Bio-Rad Laboratories
  • Beckman Coulter (Danaher Corporation)
  • Quest Diagnostics
  • PerkinElmer, Inc.
  • Hologic, Inc.
  • Grifols
  • bioMérieux
  • Werfen (Inova Diagnostics)
  • Ortho Clinical Diagnostics
  • Trinity Biotech
  • EUROIMMUN (A PerkinElmer Company)

Frequently Asked Questions

The market is anticipated to reach a value of US$ 12.6 Bn by 2031.

Eating healthy and balanced meals, regular physical activity, and enough rest can assist in decreasing the effects autoimmune diseases.

Autoimmune diseases can be caused by too much exposure to sun, genetics, and injury or tissue damage.

Supplements that replace the substance that the body lacks are a prominent treatment for autoimmune disease.

The market is anticiapted to experience a CAGR of 9.2% through the assessment period.

Thank you for taking time to visit our website, click like if you found the information on this page useful?

This site uses cookies, including third-party cookies, that help us to provide and improve our services.
Google translate