Overview


According to FutureWise analysis the market for autoimmune disease diagnosis is expected to reach US$ 10.64 billion by 2031 at a CAGR of 9.1%.

Autoimmune disease (AD), a non-communicable condition, is characterized by the disruption of normal immunological homeostasis. The low immune response directly results from autoimmune disorders' direct effects on the body's immune system. Overactive immune systems cause the body to harm and attack its own tissues. Basic tests like antinuclear autoantibody, rheumatoid factor (RF), and others are required to diagnose autoimmune diseases because the immune system produces antibodies in response to an unknown trigger that attacks the body's own tissues rather than fighting infections. These tests can assist in managing and diagnosing autoimmune disease patients, offer a prognosis, or reveal the extent of organ involvement or damage.

Autoimmune conditions such as rheumatoid arthritis, Systemic Lupus Erythematosus (SLE), and others are becoming more prevalent globally. It is highly predicted that these trends would increase demand and implementation of these tests. The factors causing the global market to expand includes new product launches linked to autoimmune disease testing and other variables. The American Autoimmune Related Diseases Association Inc. (AARDA) estimates that 50 million Americans today have an autoimmune ailment, with 20–25 percent having several autoimmune diseases. Approximately 75–80 percent of the patients with autoimmune diseases are women.

FutureWise Market Research has published a report that provides an insightful analysis of autoimmune disease diagnosis market trends that are affecting the overall market growth. This report will provide a detailed analysis of market share, regional insights, and competitor analysis that includes stature of key manufacturers operational in this industry. According to the analysis conducted by FutureWise research analysts, the autoimmune disease diagnosis market is estimated to register a considerable growth rate over the forecast period. This report lists the market segments and potential prospects available across this industry, in addition providing crucial information on the total valuation currently held by the industry. Moreover, this report will assist key management individuals in an organisation to enhance their decisions pertaining to business expansion as well as strategic changes for increasing customer base.

  • F. Hoffmann-La Roche Ltd.
  • Siemens Healthineers.
  • Abbott Laboratories,
  • Beckman Coulter Inc.
  • SQI Diagnostics.
  • Quest Diagnostics.
  • EUROIMMUN AG.
  • AESKU Diagnostics GmbH & Co. KG.
  • INOVA Diagnostics Inc.
  • Crescendo Bioscience Inc.
  • BioMerieux SA.
  • Bio-Rad Laboratories Inc.
  • Hemagen Diagnostics Inc.

(Note: The list of the major players will be updated with the latest market scenario and trends)

Recent developments by key players in Autoimmune Disease Diagnosis Market:

In May 2022- The new Phadia 2500+ series of instruments by Thermofisher will be available for autoimmune testing in the United States. It offers reliable and unparalleled high throughput for both allergy diagnostics and autoimmune testing.

The market is expanding due to reasons such as the increasing prevalence of autoimmune diseases, increased knowledge of disease diagnosis, and advancements in technology. Scleroderma, rheumatoid arthritis is among the conditions that are growing in frequency. One of the major elements contributing to the rise in the prevalence of autoimmune disorders is the combination between a person's genetic make-up, hormonal makeup, and sensitivity to specific infections. Scleroderma, for instance, affects 276 persons per million in the United States, according to research from the American Journal of Managed Care (AJMC) in May 2021. Therefore, the rise in autoimmune disease prevalence and public awareness is driving the demand for autoimmune disease diagnosis. Moreover, more product launches and increased growth tactics employed by key players will result in a market expansion. For instance, the most recent technological developments allow for the simultaneous measurement and identification of several antibodies. Numerous techniques, such as mass spectrometry and antigen microarray for antibody profiling, showed improved analytical sensitivity and repeatability. Using automated testing methods like automated indirect immunofluorescence, automated monoplex immunoassays, and automated multiplex immunoassays will also reduce the amount of time needed for diagnosis. Thus, the market is expected to rise over the forecast period. However, autoimmune diagnosis tests must go through several processes in order to reliably determine a positive outcome, so they take time to perform. For instance, it takes more than two days to receive the results of the rheumatoid factor (RF) test used to identify rheumatoid arthritis. The C-reactive protein (CRP) test, which determines the level of CRP in the blood, takes more than three days to get the results. The lengthy turnaround times associated with using traditional disease diagnosis techniques and the dearth of new testing technology are thus, some of the barriers inhibiting the industry's growth.

By Product

  • Consumables and Assay Kits
  • Instruments

By Test Type

  • Inflammatory Markers
  • Routine laboratory Tests
  • Immunologic Tests and Autoantibodies Tests
  • Other Tests

By Disease

  • Rheumatoid Arthritis
  • Systemic Lupus Erythematous
  • Sjögren’s Syndrome
  • Thyroiditis
  • Scleroderma
  • Other Diseases

By End User

  • Clinical Laboratories
  • Hospitals
  • Other End Users

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

This market research report also emphasis on factors affecting the growth rate in various regions listed above. A deep-down analysis of region will also be provided in the final version of this market which is based on conclusion of primary interviews and secondary data point gathered during the process.

By region, the market is segmented into North America, Latin America, Europe, Asia-Pacific, and Middle East & Africa. Europe registered the highest share in the market in 2022. The increase in the elderly population and the frequency of autoimmune diseases among the elderly drive the market's growth. Additionally, rising chronic disease burden and public awareness will fuel market expansion. There are more product releases and collaborations amongst the major market players to accelerate market expansion in Europe. Additionally, the German market for diagnostics of autoimmune diseases retained the biggest market share.

  • Tier 1 players- established companies in the market with a major market share
  • Tier 2 players
  • Emerging players which are growing rapidly
  • New Entrants

  • Growth prospects
  • SWOT analysis
  • Key market trends
  • Key data-points affecting market growth

  • To provide with an exhaustive analysis on the global autoimmune disease diagnosis market By Product, By Test Type, By Disease, By End User and By Region
  • To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
  • To evaluate and forecast micro-markets and the overall market
  • To predict the market size, in key regions (along with countries)— North America, Europe, Asia Pacific, Latin America and Middle East and Africa
  • To record, evaluate and analyze competitive landscape mapping- product launches, technological advancements, mergers and expansions

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Table of Contents


  • 1.   Market Introduction
    •   1. Objectives of the Study
        2. Market Definition
        3. Market Scope
         3.1. Years Considered for the Study
         3.2. Market Covered
        4. Currency
        5. Limitations
        6. Stakeholders
  • 2.   Research Methodology
    •   1. Research Data
         1.1. Secondary Data
          1.1.1. Key Data from Secondary Sources
         1.2. Primary Data
          1.2.1. Key Data from Primary Sources
        2. Market Size Estimation
        3. Market Breakdown and Data Triangulation
        4. Assumptions for the Study
  • 3.   Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights
  • 4.   Autoimmune Disease Test Type Market Variables, Trends and Scope
    •   1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Technology Overview
        6. Regulatory Framework
         6.1. Reimbursement Framework
         6.2. Standards and Compliances

  • 5.   Market Overview
    •   1. Market Dynamics
         1.1. Market Driver Analysis
          1.1.1. Increasing focus of Autoimmune Disease Test Type Market Companies on Brand Protection
          1.1.2. Untapped Opportunities in Emerging Regions
         1.2. Market Restraint Analysis
          1.2.1. High Cost Associated with Implementation of Predictive Analysis
         1.3. Industry Challenges
          1.3.1. Presence of Ambiguous Regulatory Framework
  • 6.   Autoimmune Disease Test Type Market Analysis Tools
    •   1. Industry Analysis - Porter’s
         1.1. Supplier Power
         1.2. Buyer Power
         1.3. Substitution Threat
         1.4. Threat from New Entrants
         1.5. Competitive Rivalry
        2. Pestel Analysis
         2.1. Political Landscape
         2.2. Environmental Landscape
         2.3. Social Landscape
         2.4. Technology Landscape
         2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
         3.1. Joint Ventures
         3.2. Mergers and Acquisitions
         3.3. Licensing and Partnership
         3.4. Technology Collaborations
         3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies
  • 7.   Autoimmune Disease Test Type Market, By Product Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Consumables and Assay Kits
        2. Instruments

  • 8.   Autoimmune Disease Test Type Market, By Test Type Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Inflammatory Markers
        2. Routine laboratory Tests
        3. Immunologic Tests and Autoantibodies Tests
        4. Other Tests

  • 9.   Autoimmune Disease Test Type Market, By Disease Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Rheumatoid Arthritis
        2. Systemic Lupus Erythematous
        3. Sjögren’s Syndrome
        4. Thyroiditis
        5. Scleroderma
        6. Other Diseases

  • 10.   Autoimmune Disease Test Type Market, By End User Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Clinical Laboratories
        2. Hospitals
        3. Other End Users

  • 11.   North America Autoimmune Disease Test Type Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. U.S.A
         2.2. Canada
         2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2023-2031

  • 12.   Latin America Autoimmune Disease Test Type Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Brazil
         2.2. Venezuela
         2.3. Argentina
         2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2023-2031

  • 13.   Europe Autoimmune Disease Test Type Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Germany
         2.2. U.K
         2.3. France
         2.4. Italy
         2.5. Spain
         2.6. Russia
         2.7. Poland
         2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2023-2031

  • 14.   Asia Pacific Autoimmune Disease Test Type Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Japan
         2.2. China
         2.3. India
         2.4. Australia and New Zealand
         2.5. ASEAN
         2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2023-2031

  • 15.   Middle East and Africa Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. GCC
         2.2. Israel
         2.3. South Africa
         2.4. Rest of MEA
        3. Market Size (USD Million) Forecast for MEA 2023-2031

  • 16.   Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix
  • 17.   Company Profiles (Competition Dashboard, Competitors Deep Dive, Products Offered and Financial Layouts)
    •   1. F. Hoffmann-La Roche Ltd.
         1.1. Company Overview
         1.2. Product Portfolio
         1.3. SWOT Analysis
         1.4. Financial Overview
         1.5. Strategic Overview
        2.Siemens Healthineers
         2.1. Company Overview
         2.2. Product Portfolio
         2.3. SWOT Analysis
         2.4. Financial Overview
         2.5. Strategic Overview
        3. Abbott Laboratories
         3.1. Company Overview
         3.2. Product Portfolio
         3.3. SWOT Analysis
         3.4. Financial Overview
         3.5. Strategic Overview
        4. Beckman Coulter Inc.
         4.1. Company Overview
         4.2. Product Portfolio
         4.3. SWOT Analysis
         4.4. Financial Overview
         4.5. Strategic Overview
        5. SQI Diagnostics
         5.1. Company Overview
         5.2. Product Portfolio
         5.3. SWOT Analysis
         5.4. Financial Overview
         5.5. Strategic Overview
        6. Quest Diagnostics
         6.1. Company Overview
         6.2. Product Portfolio
         6.3. SWOT Analysis
         6.4. Financial Overview
         6.5. Strategic Overview
        7. EUROIMMUN AG
         7.1. Company Overview
         7.2. Product Portfolio
         7.3. SWOT Analysis
         7.4. Financial Overview
         7.5. Strategic Overview
        8. AESKU Diagnostics GmbHCo. KG
         8.1. Company Overview
         8.2. Product Portfolio
         8.3. SWOT Analysis
         8.4. Financial Overview
         8.5. Strategic Overview
        9.INOVA Diagnostics Inc.
         9.1. Company Overview
         9.2. Product Portfolio
         9.3. SWOT Analysis
         9.4. Financial Overview
         9.5. Strategic Overview
        10.Crescendo Bioscience Inc.
         10.1. Company Overview
         10.2. Product Portfolio
         10.3. SWOT Analysis
         10.4. Financial Overview
         10.5. Strategic Overview
        11.bioMerieux SA
         11.1. Company Overview
         11.2. Product Portfolio
         11.3. SWOT Analysis
         11.4. Financial Overview
         11.5. Strategic Overview
        12.Bio-Rad Laboratories Inc.
         12.1. Company Overview
         12.2. Product Portfolio
         12.3. SWOT Analysis
         12.4. Financial Overview
         12.5. Strategic Overview
        13.Hemagen Diagnostics Inc.
         13.1. Company Overview
         13.2. Product Portfolio
         13.3. SWOT Analysis
         13.4. Financial Overview
         13.5. Strategic Overview

  • 18.   Pre and Post COVID-19 Impact
    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the healthcare regulations initiated by administrations
        5. The overall economic slowdown of the developing and developed nations
  • 19.   FutureWise SME Key Takeaway Points for Client
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