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

Autoimmune Disease Diagnostics Market Overview

The global autoimmune disease diagnostics market generated $4,086.2 million revenue in 2019, and it is projected to witness a CAGR of 8.5% during 2020–2030. Rising discoveries of new biomarkers, increasing strategic development activities among key players, widespread burden of autoimmune diseases, and initiatives taken by several public and private organizations to raise awareness about autoimmune diseases are the key growth factors driving the autoimmune disease diagnostics industry.

Autoimmune Disease Diagnostics Market

Consumables and Assay Kits Accounted for Larger Share in the Autoimmune Disease Diagnostics Industry

The consumables and assay kits category in terms of product accounted for the larger share in the market. The category is further expected to retain its market dominance, owing to presence of large number of market players offering diagnostic test kits. Other factors responsible for the market growth in this category include rising prevalence of autoimmune diseases and growing research activities to identify the underlying cause of autoimmune diseases.

Routine Laboratory Category Is Expected to Be Largest and Fastest-Growing

The autoimmune disease diagnostics market based on test type is classified into routine laboratory, inflammatory marker, autoantibodies and immunology, human leukocyte antigen (HLA), cytokine, flow cytometry, and others. Of these, the routine laboratory test category generated the largest revenue in 2019. It is also expected to remain largest and grow fastest in the forecast period. This can be ascribed to the fact the blood tests and serum tests are the initial procedures and require repeated diagnosis to check the abnormality in the bloodstream.

Rheumatic Arthritis (RA) Category Is Expected to Witness Fastest Growth in Coming Years

The RA category is projected to grow at the highest rate in the market, owing to the high prevalence of RA across the globe. The global prevalence and incidence of RA was also studied in the Global Burden of Diseases (GBD) 2017 report. Based on the statistical data, a total of 10,226,042 prevalent cases of RA were reported in 1990, which increased to 19,965,115 in 2017.

Hospitals Are Highest-Revenue-Generating End Users

Hospitals were the largest end users of autoimmune disease diagnostics and related products in 2019. The category is further expected to remain largest in the market for autoimmune disease diagnostics during the forecast years. The increasing adoption of technologically advanced products, surging prevalence of chronic autoimmune diseases, rising number of awareness campaigns and conferences conducted by a number of public and private organizations, and improving healthcare infrastructure are some of the major factors contributing to the market growth.

North America Is Projected to Be Largest Market for Autoimmune Disease Diagnostics

During the historical period (2014–2019), North America accounted for the largest share in the market for autoimmune disease diagnostics, due to the rising healthcare spending, increasing prevalence of autoimmune diseases, surging geriatric population, and presence of big market players.

According to an article published by the National Institute of Environmental Health Sciences (NIEHS), NIH in May 2020, a total of 80 autoimmune diseases are known in the North American region, including type-1 diabetes, multiple sclerosis, systemic lupus erythematosus (SLE), and RA, of which some are rare and difficult to diagnose. In 2019, approximately 24 million people in the U.S. were affected by autoimmune diseases. In addition, approximately eight million people in the U.S. have auto-antibodies blood molecules that can lead to the risk of developing autoimmune diseases. Therefore, all these factors are expected to boost the demand for the autoimmune disease diagnostics market.

Fastest Growth to Be Witnessed by the APAC Region

One of the major factors responsible for driving the market growth in the Asia-Pacific (APAC) region is the presence of key players. Other major factors include cost-effective diagnostic tests, cheap labor, increasing geriatric population, and rise in initiatives by public and private organizations to raise awareness about autoimmune diseases. According to the World Bank data, the proportion of people aged 65 years and above in 2010 in Japan was 22.5%, which increased to 27.6% in 2018. Also, the number is projected to increase up to 60.0% by 2030. Furthermore, somehow similar scenario is observed for other APAC countries.

Autoimmune Disease Diagnostics Market

COVID-19 is having a positive impact on the global autoimmune disease diagnostics market. Due to this pandemic, the outlook for the industry has changed significantly, with predicted increase in the demand for diagnostic products in the short run, across the globe. Further, significant growth is likely to be witnessed with the proper lifting of lockdowns in several cities and resumption of import and export activities worldwide.

Discovering New Biomarkers Is Key Market Trend

The prominent trend in the market for autoimmune disease diagnostics is the discovery of new biomarkers to diagnose autoimmune diseases. For instance, in August 2019, researchers of the University of Alberta identified a unique biological marker that can be used to identify the presence of rare autoimmune disease, myasthenia gravis. The biomarker can also be used to predict the course of the disease and identify new, personalized treatments, contributing to the significant growth of the autoimmune disease diagnostics industry.

Autoimmune Disease Diagnostics Market

Increasing Awareness about Autoimmune Diseases Is Expected to Boost the Demand for Diagnostic Products

Increasing awareness about autoimmune diseases is a major driver for the growth of the autoimmune disease diagnostics market. A number of conferences are expected to be held in later half of 2020 and throughout 2021 to raise awareness and serve as a platform to share knowledge about advancements in the field of autoimmune diseases. For instance, the 12th International Congress on Autoimmunity is to be held from November 28, 2020, to December 1, 2020, in Athens, Greece. Similarly, the International Conference on Autoimmune Diseases and Dermatology will be held on January 18–19, 2021, in Rome, Italy. The purpose of these conferences is to bring together academic scientists, researchers, and research scholars to exchange thoughts and share their experience and research results on all aspects of autoimmune diseases and dermatology. All these factors propel the growth of the market.

Widespread Burden of Autoimmune Diseases Has High Impact on the Market

Increasing incidences and high prevalence of autoimmune diseases are boosting the growth of the market. According to the John Hopkin’s University, autoimmune diseases affect around 3% of the U.S. population every year, that is, approximately 10 million people. Also, the Myasthenia Gravis Foundation of America in June 2015 reported that myasthenia gravis was found in 14–20 individuals per each 100,000 U.S. population in 2014, affecting approximately 36,000–60,000 people in the country.

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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