Autoimmune Disease Diagnostics Market Size, Share, and Growth Analysis

Autoimmune Disease Diagnostics Market By Product(Reagents and consumables, Instruments), By Test Type(Antinuclear antibody tests, Urinalysis, C-reactive protein (CRP), Complete blood count (CBC)), By Disease Type(Systemic autoimmune disease (Rheumatoid arthritis, Systemic lupus erythematosus (SLE), Psoriasis, Multiple sclerosis), By End User(Hospitals, Diagnostics centers, Other end-users), By Region - Industry Forecast 2025-2032


Report ID: SQMIG35D2178 | Region: Global | Published Date: October, 2024
Pages: 157 |Tables: 59 |Figures: 75

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Autoimmune Disease Diagnostics Market Insights

Autoimmune Disease Diagnostics Market size was valued at USD 4.56 Billion in 2023 and is poised to grow from USD 4.75 Billion in 2024 to USD 6.58 Billion by 2032, growing at a CAGR of 4.15% during the forecast period (2025-2032).

Growing incidence of autoimmune diseases and rising awareness regarding the same are forecasted to primarily drive the demand for autoimmune disease diagnostics in the future. Increasing investments by governments and public health organizations to launch new awareness initiatives are also expected to create new opportunities for autoimmune disease diagnostics providers to go forward. Advancements in diagnostics technologies and high demand for personalized medicine are also slated to uplift the demand for autoimmune disease diagnostics over the coming years. Growing adoption of telemedicine and remote healthcare solutions are also anticipated to favor the autoimmune disease diagnostics market growth in the long run. However, the high costs of advanced diagnostics, the dearth of skilled professionals, limited accessibility in developing countries, and complexity of diagnostic procedures are predicted to hurt autoimmune disease diagnostics adoption across the study period and beyond.  .

US Autoimmune Disease Diagnostics Market is poised to grow at a sustainable CAGR for the next forecast year.

Market snapshot - 2025-2032

Global Market Size

USD 4.56 Billion

Largest Segment

Hospitals

Fastest Growth

Diagnostic Centers

Growth Rate

4.15% CAGR

Global Autoimmune Disease Diagnostics Market ($ Bn)
Country Share for North America Region (%)

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Autoimmune Disease Diagnostics Market Segments Analysis

Global Autoimmune Disease Diagnostics Market is segmented by Product, Test Type, Disease Type, End User, and Region. Based on Product, the market is segmented into Reagents and consumables, Instruments. Based on Test Type, the market is segmented into Antinuclear antibody tests, Urinalysis, C-reactive protein (CRP), Complete blood count (CBC), Autoantibody tests, Other tests. Based on Disease Type, the market is segmented into Systemic autoimmune disease (Rheumatoid arthritis, Systemic lupus erythematosus (SLE), Psoriasis, Multiple sclerosis, Other systemic autoimmune diseases), Localized autoimmune disease (Inflammatory bowel disease, Type 1 diabetes, Thyroid, Other localized autoimmune diseases). Based on End User, the market is segmented into Hospitals, Diagnostics centers, Other end-users. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa. 

Analysis by End User 

Hospitals are estimated to bring in the most revenue for autoimmune disease diagnostics providers in the future. Increasing use of advanced diagnostic procedures in hospitals and growing investments in healthcare infrastructure development around the world are cementing the dominance of this segment. Availability of a wide variety of diagnostic procedures and use of hospitals as a central referral point for various patients are also estimated to cement the high autoimmune disease diagnostics market share of this segment going forward. Moreover, the availability of specialized pre and post treatment care in hospitals also allows this segment to bring in more revenue than others in the future.  

Meanwhile, the demand for autoimmune disease diagnostics in diagnostics centers is expected to increase at an impressive pace over the coming years. High investments in the development of new diagnostic centers around the world to satisfy the surging demand for early diagnosis are also slated to create new opportunities going forward. Growing emphasis on improving diagnostic capabilities and availability of easy appointments in diagnostic centers are also estimated to bolster revenue generation for autoimmune disease diagnostics providers focusing on this segment through 2031 and beyond. 

Analysis by Disease Type 

Systemic autoimmune diseases are projected to account for a dominant chunk of the global autoimmune disease diagnostics market share going forward. Systemic autoimmune disease refers to a disorder in which the immune system attacks multiple organs or systems. High prevalence of such diseases around the world is bolstering the demand for autoimmune disease diagnostics. Rheumatoid arthritis, systemic lupus erythematosus (SLE), systemic sclerosis, and Sjögren's syndrome are some of the most commonly occurring systemic autoimmune diseases. The highly complex nature of systemic autoimmune diseases also aids the dominance of this segment and bolsters the demand for advanced autoimmune disease diagnostics.  

On the other hand, the demand for autoimmune disease diagnostics for localized autoimmune disease is slated to increase at a robust pace over the coming years. Rising awareness regarding localized autoimmune diseases and advancements in diagnostics technology are also projected to create new opportunities for autoimmune disease diagnostics companies focusing on this segment going forward. High demand for targeted diagnostics and treatment approach for localized autoimmune diseases is also estimated to create a new business scope for autoimmune disease diagnostics providers in the future. Addison's disease, Autoimmune hepatitis, Celiac disease, Crohn's disease, Diabetes mellitus type 1a, Grave's disease, and Guillain-Barre syndrome are some of the common localized autoimmune diseases.  

Global Autoimmune Disease Diagnostics Market By End User

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Autoimmune Disease Diagnostics Market Regional Insights

North America is predicted to spearhead the demand for autoimmune disease diagnostics in the world. The presence of a strong healthcare ecosystem, high investments in the development of advanced diagnostic technologies, and availability of favorable reimbursement policies are forecasted to bolster the dominance of this region. Rising adoption of telehealth practices are also estimated to uplift the demand for autoimmune disease diagnostics in North America. Canada and the United States are expected to be the most opportune markets for autoimmune disease diagnostics providers operating in this region through 2031.  

Asia Pacific is forecasted to emerge as the fastest-expanding market for autoimmune disease diagnostics companies in the world. Increasing awareness regarding autoimmune diseases, growing geriatric population, and high investments in healthcare infrastructure development are projected to be key factors promoting the demand for autoimmune disease diagnostics going forward. India, China, and Japan are estimated to be the leading markets for autoimmune disease diagnostics companies owing to rising geriatric population in these countries. Changing lifestyles of people in the Asia Pacific region and growing healthcare spending potential are also influencing autoimmune disease diagnostics adoption.  

Global Autoimmune Disease Diagnostics Market By Region
  • Largest
  • Fastest

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Autoimmune Disease Diagnostics Market Dynamics

Autoimmune Disease Diagnostics Market Drivers 

Rising Incidence of Autoimmune Diseases 

  • Changing lifestyles, environmental triggers, and genetic predisposition are some key factors responsible for the increasing prevalence of autoimmune diseases around the world. This surge in the incidence of autoimmune diseases and growing awareness regarding these diseases are expected to subsequently bolster the demand for autoimmune disease diagnostics as well.  

Expansion of Application Scope 

  • As the name suggests, autoimmune disease diagnostics are designed for diagnostic purposes only. However, the trend is changing, and autoimmune disease diagnostics is being used for other applications such as patient monitoring, prognostic assessments, and personalized therapy development. This expansion of application scope is slated to bolster autoimmune disease diagnostics market outlook in the long run 

Autoimmune Disease Diagnostics Market Restraints 

Limited Accessibility in Developing Regions 

  • Poor healthcare infrastructure and limited healthcare spending potential in developing regions is expected to slow down the demand for autoimmune disease diagnostics in the future. Moreover, this limited accessibility is further worsened by lack of awareness regarding autoimmune diseases and their symptoms as well, which further hinders market penetration.  

Dearth of Skilled Professionals 

  • Performing accurate diagnosis and using diagnostic equipment effectively requires technical skills and the world is faced with a major shortage of skilled professionals thereby slowing down the demand for autoimmune disease diagnostics as well. Moreover, the need for highly skilled professionals to interpret results from advanced autoimmune disease diagnostics tests is also expected to hurt autoimmune disease diagnostics market forecast going forward.  

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Autoimmune Disease Diagnostics Market Competitive Landscape

nvesting in generating more awareness regarding autoimmune diseases is also expected to be a key strategy in the future. Developing advanced and easy to use diagnostic tests is projected to be the prime focus of all autoimmune disease diagnostics companies going forward. Targeting countries with high geriatric population is estimated to create new business scope for all market players in the long run.   

Top Players in Autoimmune Disease Diagnostics Market

  • Abbott Laboratories 
  • Thermo Fisher Scientific Inc. 
  • Siemens AG 
  • F. Hoffmann-La Roche Ltd 
  • Bio-Rad Laboratories, Inc. 
  • Quest Diagnostics Incorporated 
  • Hologic, Inc. 
  • Danaher Corporation 
  • Inova Diagnostics, Inc. 
  • PerkinElmer Germany Diagnostics GmbH 
  • Grifols, S.A. 
  • Bio-Techne Corporation 
  • Menarini Group 
  • Myriad Genetics, Inc. 
  • Medac GmbH 
  • ImmunArray 
  • Exagen Inc. 
  • ORGENTEC Diagnostika GmbH 
  • Seramun Diagnostica GmbH 
  • SQI Diagnostics Inc.

Autoimmune Disease Diagnostics Market Recent Developments

  • In November 2024, Augurex Life Sciences Corp., a leading healthcare organization announced the launch of new reagents to support the development of a new diagnostic test for axial spondyloarthritis (axSpA). Anti-14-3-3eta Multiplex Analyte Specific Reagents (ASRs) are projected to improve the diagnostic scope of autoimmune diseases.  
  • In June 2022, Quotient Limited, a leading diagnostics company, and Theradiag, a renowned name in autoimmune disease testing came together to sign a partnership. The companies had plans to develop novel zzz by leveraging Quotient’s MosaiQ platform.  

Autoimmune Disease Diagnostics Key Market Trends

Autoimmune Disease Diagnostics Market SkyQuest Analysis

SkyQuest's ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.  

As per SkyQuest analysis, growing incidence of autoimmune diseases and advancements in diagnostics technologies are forecasted to be key drivers for autoimmune disease diagnostics market going forward. However, limited accessibility in developing regions and a shortage of skilled professionals are expected to impede autoimmune disease diagnostics demand outlook in the future. Rising spending on healthcare and the growing adoption of point-of-care testing are expected to make the Asia Pacific region the fastest-expanding market for autoimmune disease diagnostics providers in the long run. Integration of artificial intelligence and rising use of telehealth technologies are key trends for autoimmune disease diagnostics providers over the coming years.  

Report Metric Details
Market size value in 2023 USD 4.56 Billion
Market size value in 2032 USD 6.58 Billion
Growth Rate 4.15%
Base year 2024
Forecast period 2025-2032
Forecast Unit (Value) USD Billion
Segments covered
  • Product
    • Reagents and consumables, Instruments
  • Test Type
    • Antinuclear antibody tests, Urinalysis, C-reactive protein (CRP), Complete blood count (CBC), Autoantibody tests, Other tests
  • Disease Type
    • Systemic autoimmune disease (Rheumatoid arthritis, Systemic lupus erythematosus (SLE), Psoriasis, Multiple sclerosis, Other systemic autoimmune diseases), Localized autoimmune disease (Inflammatory bowel disease, Type 1 diabetes, Thyroid, Other localized autoimmune diseases)
  • End User
    • Hospitals, Diagnostics centers, Other end-users
Regions covered North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA)
Companies covered
  • Abbott Laboratories 
  • Thermo Fisher Scientific Inc. 
  • Siemens AG 
  • F. Hoffmann-La Roche Ltd 
  • Bio-Rad Laboratories, Inc. 
  • Quest Diagnostics Incorporated 
  • Hologic, Inc. 
  • Danaher Corporation 
  • Inova Diagnostics, Inc. 
  • PerkinElmer Germany Diagnostics GmbH 
  • Grifols, S.A. 
  • Bio-Techne Corporation 
  • Menarini Group 
  • Myriad Genetics, Inc. 
  • Medac GmbH 
  • ImmunArray 
  • Exagen Inc. 
  • ORGENTEC Diagnostika GmbH 
  • Seramun Diagnostica GmbH 
  • SQI Diagnostics Inc.
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Table Of Content

Executive Summary

Market overview

  • Exhibit: Executive Summary – Chart on Market Overview
  • Exhibit: Executive Summary – Data Table on Market Overview
  • Exhibit: Executive Summary – Chart on Autoimmune Disease Diagnostics Market Characteristics
  • Exhibit: Executive Summary – Chart on Market by Geography
  • Exhibit: Executive Summary – Chart on Market Segmentation
  • Exhibit: Executive Summary – Chart on Incremental Growth
  • Exhibit: Executive Summary – Data Table on Incremental Growth
  • Exhibit: Executive Summary – Chart on Vendor Market Positioning

Parent Market Analysis

Market overview

Market size

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • SWOT Analysis

KEY MARKET INSIGHTS

  • Technology Analysis
    • (Exhibit: Data Table: Name of technology and details)
  • Pricing Analysis
    • (Exhibit: Data Table: Name of technology and pricing details)
  • Supply Chain Analysis
    • (Exhibit: Detailed Supply Chain Presentation)
  • Value Chain Analysis
    • (Exhibit: Detailed Value Chain Presentation)
  • Ecosystem Of the Market
    • Exhibit: Parent Market Ecosystem Market Analysis
    • Exhibit: Market Characteristics of Parent Market
  • IP Analysis
    • (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
  • Trade Analysis
    • (Exhibit: Data Table: Import and Export data details)
  • Startup Analysis
    • (Exhibit: Data Table: Emerging startups details)
  • Raw Material Analysis
    • (Exhibit: Data Table: Mapping of key raw materials)
  • Innovation Matrix
    • (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
  • Pipeline product Analysis
    • (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
  • Macroeconomic Indicators

COVID IMPACT

  • Introduction
  • Impact On Economy—scenario Assessment
    • Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
  • Revised Market Size
    • Exhibit: Data Table on Autoimmune Disease Diagnostics Market size and forecast 2021-2027 ($ million)
  • Impact Of COVID On Key Segments
    • Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
  • COVID Strategies By Company
    • Exhibit: Analysis on key strategies adopted by companies

MARKET DYNAMICS & OUTLOOK

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • Regulatory Landscape
    • Exhibit: Data Table on regulation from different region
  • SWOT Analysis
  • Porters Analysis
    • Competitive rivalry
      • Exhibit: Competitive rivalry Impact of key factors, 2021
    • Threat of substitute products
      • Exhibit: Threat of Substitute Products Impact of key factors, 2021
    • Bargaining power of buyers
      • Exhibit: buyers bargaining power Impact of key factors, 2021
    • Threat of new entrants
      • Exhibit: Threat of new entrants Impact of key factors, 2021
    • Bargaining power of suppliers
      • Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
  • Skyquest special insights on future disruptions
    • Political Impact
    • Economic impact
    • Social Impact
    • Technical Impact
    • Environmental Impact
    • Legal Impact

Market Size by Region

  • Chart on Market share by geography 2021-2027 (%)
  • Data Table on Market share by geography 2021-2027(%)
  • North America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • USA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Canada
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Europe
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Germany
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Spain
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • France
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • UK
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Europe
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Asia Pacific
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • China
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • India
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Japan
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Korea
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Asia Pacific
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Latin America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Brazil
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of South America
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Middle East & Africa (MEA)
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • GCC Countries
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Africa
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of MEA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)

KEY COMPANY PROFILES

  • Competitive Landscape
    • Total number of companies covered
      • Exhibit: companies covered in the report, 2021
    • Top companies market positioning
      • Exhibit: company positioning matrix, 2021
    • Top companies market Share
      • Exhibit: Pie chart analysis on company market share, 2021(%)

Methodology

For the Autoimmune Disease Diagnostics Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:

1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.

2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Autoimmune Disease Diagnostics Market.

3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.

4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.

Analyst Support

Customization Options

With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Autoimmune Disease Diagnostics Market:

Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.

Regional Analysis: Further analysis of the Autoimmune Disease Diagnostics Market for additional countries.

Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.

Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.

Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.

Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.

Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.

Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.

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FAQs

Autoimmune Disease Diagnostics Market size was valued at USD 4.56 Billion in 2023 and is poised to grow from USD 4.75 Billion in 2024 to USD 6.58 Billion by 2032, growing at a CAGR of 4.15% during the forecast period (2025-2032).

nvesting in generating more awareness regarding autoimmune diseases is also expected to be a key strategy in the future. Developing advanced and easy to use diagnostic tests is projected to be the prime focus of all autoimmune disease diagnostics companies going forward. Targeting countries with high geriatric population is estimated to create new business scope for all market players in the long run.    'Abbott Laboratories ', 'Thermo Fisher Scientific Inc. ', 'Siemens AG ', 'F. Hoffmann-La Roche Ltd ', 'Bio-Rad Laboratories, Inc. ', 'Quest Diagnostics Incorporated ', 'Hologic, Inc. ', 'Danaher Corporation ', 'Inova Diagnostics, Inc. ', 'PerkinElmer Germany Diagnostics GmbH ', 'Grifols, S.A. ', 'Bio-Techne Corporation ', 'Menarini Group ', 'Myriad Genetics, Inc. ', 'Medac GmbH ', 'ImmunArray ', 'Exagen Inc. ', 'ORGENTEC Diagnostika GmbH ', 'Seramun Diagnostica GmbH ', 'SQI Diagnostics Inc.'

Use of AI for Diagnostics: Autoimmune disease diagnostics companies can focus on integrating artificial intelligence technology to analyze large datasets of results to find patterns and improve the diagnostic and treatment outcomes for patients in the future. Use of artificial intelligence can also help autoimmune disease diagnostics providers enhance their scope of automation in the long run.  

North America is predicted to spearhead the demand for autoimmune disease diagnostics in the world. The presence of a strong healthcare ecosystem, high investments in the development of advanced diagnostic technologies, and availability of favorable reimbursement policies are forecasted to bolster the dominance of this region. Rising adoption of telehealth practices are also estimated to uplift the demand for autoimmune disease diagnostics in North America. Canada and the United States are expected to be the most opportune markets for autoimmune disease diagnostics providers operating in this region through 2031.  

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