Autoimmune Disease Diagnostics Market Research Report: By Product (Consumables and Assay Kits, Instruments), Test Type (Routine Laboratory, Inflammatory Marker, Autoantibodies and Immunology, Human Leukocyte Antigen, Cytokine, Flow Cytometry), Application (Rheumatoid Arthritis, Multiple Sclerosis, Systemic Lupus Erythematosus, Sjögren’s Syndrome, Scleroderma, Myasthenia Gravis, Sarcoidosis), End User (Hospitals, Diagnosing Centers, Academic Institutes and Research Centers) - Industry Analysis and Growth Forecast to 2030

  • Published: July 2020
  • Report Code: LS12048
  • Available Format: PDF
  • Pages: 266

Market Outlook

The autoimmune disease diagnostics market revenue stood at $4,086.2 million in 2019, and the market is predicted to register a CAGR of 8.5% between 2020 and 2030. The discovery of new biomarkers, increasing number of strategic development activities among major players, growing incidence of autoimmune diseases, and implementation of initiatives by various private and public organizations for raising awareness about autoimmune diseases are the major factors fueling the expansion of the market across the globe.

Autoimmune Disease Diagnostics Market Outlook

Consumable and Assay Kits Held Larger Market Share

The consumables and assay kits category had the larger share in the autoimmune disease diagnostics industry during 2014–2019, under the product segment. This category is predicted to continue its market domination in the future on account of the existence of numerous industry players providing diagnostic test kits. Additionally, the growing prevalence of autoimmune diseases and increasing number of research activities for identifying their underlying causes are driving the advance of the market.

Routine Laboratory Category Predicted To Exhibit Fastest Growth

Out of the routine laboratory, autoantibodies and immunology, inflammatory marker, cytokine, human leukocyte antigen (HLA), and flow cytometry test types, the routine laboratory category contributed the highest revenue in 2019. This category is also predicted to hold the largest share and register the fastest growth in the autoimmune disease diagnostics market in the forthcoming years. This is credited to the fact that serum tests and blood tests are initial procedures, and they need to be conducted multiple times for checking for abnormalities in the bloodstream.

Rheumatic Arthritis (RA) Category Predicted To Exhibit Fastest Growth in Future

The RA category, under the application segment, is predicted to demonstrate the fastest growth in the market for autoimmune disease diagnostics solutions in the coming years because of the high incidence of RA all over the world. In the Global Burden of Diseases (GBD) 2017 report, the worldwide prevalence of RA is mentioned in detail. As per the statistical data, there were 10,226,042 global cases of RA in 1990, and this number grew to 19,965,115 in 2017.
Hospitals Generating Highest Revenue

Hospitals generated the highest revenue in the market in 2019, under the end user segment. This category is also predicted to hold the largest market share till 2030. This is attributed to the growing usage of technologically advanced products, rising incidence of chronic autoimmune diseases, increasing number of conferences and awareness campaigns conducted by private and public organizations, and rapidly improving healthcare infrastructure around the world.

North America Expected To Be Largest Regional Market

North America had the largest share in the autoimmune disease diagnostics market from 2014 to 2019 because of the soaring healthcare spending, growing incidence of autoimmune diseases, surging population of geriatric people, and existence of prominent industry players in the region.

As per an article produced by the National Institute of Environmental Health Sciences (NIEHS), one of the 27 National Institutes of Health (NIH), in May 2020, as many as 80 autoimmune diseases are currently known in North America, including multiple sclerosis, type-1 diabetes, RA, and systemic lupus erythematosus (SLE). Out of these, some are extremely rare and tough to diagnose. In the U.S., nearly 24 million people were diagnosed with autoimmune diseases in 2019. Additionally, nearly 8 million people in the country have autoantibody blood molecules, which can cause autoimmune diseases later in life.

Asia-Pacific (APAC) Set To Be Fastest-Growing Region

The existence of major players is one of the key factors fueling the demand for autoimmune disease diagnostic solutions in the APAC region. Besides this, the availability of cheap labor and cost-effective diagnostic tests, surging geriatric population, and initiatives by private and public entities for raising awareness about autoimmune diseases are positively impacting the autoimmune disease diagnostics market growth in the region. As per the World Bank’s data, the share of people aged 65 years and above in the total population of Japan grew from 22.5% in 2010 to 27.6% in 2018. Furthermore, this share is predicted to rise to 60.0% by 2030, with similar scenarios predicted in other APAC nations.

The COVID-19 pandemic is positively impacting the market for autoimmune disease diagnostics growth. The pandemic has massively pushed up the requirement for diagnostic products all over the world. Moreover, the market is set for lucrative growth once the lockdowns are lifted and export and import activities resume.

Autoimmune Disease Diagnostics Market Regional Analysis

Discovery of New Biomarkers Is Prominent Industry Trend

One of the major trends currently being witnessed in the market is the discovery of new biomarkers for diagnosing autoimmune diseases. For example, researchers working at the University of Alberta identified a new biological marker for identifying the existence of myasthenia gravis, which is a rare autoimmune disease, in August 2019. This biomarker can also be used for predicting the course of the disease and formulating new personalized treatment procedures.

Autoimmune Disease Diagnostics Market Growth Drivers

Growing Public Awareness about Autoimmune Diseases Propelling Diagnostic Product Demand

Another important factor fueling the progress of the autoimmune disease diagnostics market is the growing awareness about autoimmune diseases. For example, in Athens, Greece, the 12th International Congress on Autoimmunity will be held from November 28, 2020, to December 1, 2020. Similarly, several conferences are predicted to be held all over the world throughout 2021 for making people aware of the technological advancements being made in the domain of autoimmune disease diagnosis and treatment.

For instance, in Rome, Italy, the International Conference on Autoimmune Diseases and Dermatology will be held from January 18 to January 19, 2021. These conferences bring together numerous researchers, research scholars, and academic scientists for exchanging thoughts and sharing their experiences and research results on the different aspects of autoimmune diseases.

Growing Incidence of Autoimmune Diseases Supporting Market Value Surge

The rising incidence of autoimmune diseases is also adding wings to the market advance across the world. As per the Johns Hopkins University, nearly 3% of the people of the U.S. are affected by autoimmune diseases every year. This means that such health issues affect around 10 million people in the country. Furthermore, as per a report produced by the Myasthenia Gravis Foundation of America in June 2015, 14–20 individuals out of every 100,000 people, or around 36,000–60,000 people, in the U.S. were affected with myasthenia gravis in 2014.

Autoimmune Disease Diagnostics Market Report Coverage
Report Attribute Details
Historical Years 2014-2019
Forecast Years 2020-2030
Base Year (2019) Market Size $4,086.2 million
Forecast Period (2020-2030) CAGR 8.5%
Report Coverage Market Trends, Revenue Estimation and Forecast, Segmentation Analysis, Regional and Country Breakdown, Companies’ Strategical Developments, Product Benchmarking, Company Share Analysis, Company Profiling
Market Size by Segments Product, Test Type, Application, End User, Region
Market Size of Geographies U.S., Canada, Germany, France, Italy, U.K., Spain, Japan, China, India, Brazil, Mexico, Saudi Arabia, South Africa, Israel, U.A.E.
Secondary Sources and References (Partial List) Centers for Disease Control and Prevention (CDC), Organisation for Economic Co-operation and Development (OECD), World Health Organization (WHO), American Heart Association (AHA), United States Food and Drug Administration (USFDA), National Institute of Environmental Health Sciences (NIEHS), American Autoimmune Related Diseases Association, National Institute for Health and Care Excellence (NICE) Note: Above listed references and organizations are partial; the detailed and complete list is available in the final report.


Market Players Focusing on Product Approvals to Expand Consumer Base

The market for autoimmune disease diagnostics is consolidated in nature, with the presence of market players including Abbott Laboratories, Bio-Rad Laboratories Inc., Thermo Fisher Scientific Inc., Siemens AG, Grifols S.A., Danaher Corporation, F. Hoffmann-La Roche Ltd., PerkinElmer Inc., and bioMérieux S.A.

In recent years, the players in the industry have engaged in strategic developments, such as product launches, in order to stay ahead of their competitors. For instance:

  • In March 2020, Siemens Healthineers announced that its critical care testing solution RAPIDPoint 500e blood gas analyzer received clearance from the United States Food and Drug Administration (USFDA). The analyzer generates results for blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin, which further helps diagnose and monitor critically ill patients in intensive care unit, operating room, or emergency room.
  • In July 2019, Abbott Laboratories announced the USFDA approval for its new blood and plasma screening Alinity s system, which is designed for more efficient screening within a smaller space unlike other commercially available systems.
  • In February 2019, Grifols S.A. announced that it received the USFDA approval for its Procleix Babesia assay, a qualitative assay, for the detection of the ribosomal ribonucleic acid (RNA) from four Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in individual samples or up to 16 pooled lysed specimens from human donors, including donors of whole blood and blood components for transfusion.

Some of the Key Market Players in the Autoimmune Disease Diagnostics Market include:

  • Abbott Laboratories
  • Bio-Rad Laboratories Inc.
  • Thermo Fisher Scientific Inc.
  • Siemens AG
  • Grifols S.A.
  • Danaher Corporation
  • F. Hoffmann-La Roche Ltd.
  • PerkinElmer Inc.
  • DiaSorin S.p.A.
  • Trinity Biotech plc
  • bioMérieux S.A.
  • A. Menarini Diagnostics S.r.l.
  • Cambridge Life Sciences Limited
  • Seramun Diagnostica GmbH
  • Exagen Inc.
  • HYCOR Biomedical
  • ELITech Group
  • Inova Diagnostics
  • Adaltis S.r.l.
  • ORGENTEC Diagnostika GmbH
  • Sigma Diagnostics Inc.

Market Size Breakdown by Segment

The autoimmune disease diagnostics market report offers comprehensive market segmentation analysis along with market estimation for the period 2014–2030.

Based on Product

  • Consumables and Assay Kits
    • Enzyme-linked immunosorbent assay (ELISA)
    • Antinuclear antibody (ANA) immunofluorescence assay (IFA)
    • Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibody
  • Instruments
    • Automated
    • Semi-automated

Based on Test Type

  • Routine Laboratory
  • Inflammatory Marker
  • Autoantibodies and Immunology
  • Human Leukocyte Antigen (HLA)
  • Cytokine
  • Flow Cytometry

Based on Application

  • Rheumatoid Arthritis (RA)
  • Multiple Sclerosis
  • Systemic Lupus Erythematosus (SLE)
  • Sjögren's Syndrome
  • Scleroderma
  • Myasthenia Gravis
  • Sarcoidosis

Based on End User

  • Hospitals
  • Diagnosing Centers
  • Academic Institutes and Research Centers

Geographical Analysis

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
  • Asia-Pacific (APAC)
    • Japan
    • China
    • India
  • Latin America (LATAM)
    • Brazil
    • Mexico
  • Middle East and Africa (MEA)
    • Saudi Arabia
    • South Africa
    • Israel
    • U.A.E.
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