Autoimmune Disease Diagnostics Market Analysis

Global Autoimmune Disease Diagnostics Market Overview

Autoimmune Disease Diagnostics Market Size was valued at USD 4.9 billion in 2022 and is projected to grow from USD 5.23 Billion in 2023 to USD 8.78 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 6.7% during the forecast period (2023 - 2032). The rising frequency of disorders and illnesses such as rheumatoid arthritis and Hashimoto's thyroiditis, and the upsurge in government laws support, are the key market drivers enhancing the market growth of the autoimmune disease diagnostics business.

  Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

The FDA has approved RYSTIGGO® (rozanolixizumab-noli)* for the treatment of generalized myasthenia gravis (gMG) in adult patients who have antibodies against either the muscle-specific tyrosine kinase (MuSK) or the acetylcholine receptor (AchR). This announcement was made today by UCB, a global biopharmaceutical company.

UNIQO 160 is a new automated indirect immunofluorescence test (IIFT) technology for autoimmune disease diagnosis that was introduced in 2023 by Revvity's EUROIMMUN division. The company has secured the certificate of compliance with the European In Vitro Diagnostic Medical Device Regulation and is now offering the new all-in-one solution in countries that accept the CE mark. The efficiency of the entire IIFT procedure—from sample preparation and incubation through slide washing and mounting to image acquisition and analysis—is increased by the new test.

The US Food and Drug Administration (FDA) granted Werfen's Aptiva® Connective Tissue Disease (CTD) Essential reagent 510(k) clearance in 2023. Werfen's previously approved Aptiva Celiac Disease reagent is enhanced by the Aptiva CTD Essential supplement. Aptiva has over 60 analytes in various stages of advanced research and will target additional autoimmune disease states in addition to CTD and Celiac disease testing. These analytes may speed up the diagnosis process for autoimmune disorders and aid in improved patient care.

BD (Becton, Dickinson and Company) (NYSE: BDX), a large multinational medical technology corporation, has been mentioned in Fortune’s 2024 list of America’s Most Innovative Companies. “For BD, innovation means an ethos of excellence and incremental improvement that dares to look forward as well as partnering with our clients to comprehend the changing needs of countless patients globally who use our medical care products as well as solutions,” said Tom Polen, Chairman/CEO/President at BD.

Merck invested over € 300 million into a new Bioprocessing Production Center located in Daejeon, South Korea, on March 20th, 2024.

KSL Beutner Laboratories (Beutner) released a blood test for the diagnosis of an antigen linked with mucous membrane pemphigoid (MMP)—an autoimmune blistering disorder that frequently leads to painful oral mucosal sores—back in August 2022.

Avesthagen Limited entered into a four-year strategic alliance with Wipro Limited for commercializing its genetic testing portfolio in India in June 2022, when it included genome panels with highly specific disease-centricanalysiscoveringcancers like neurodegenerative diseases as well as autoimmune disorders and rare diseases. This is expected to improve market demand through partnership.

Thermofisher’s new Phadia 2500+ range of autoimmunity tests will be available from May 2022 in the US. It gives unparalleled reliability and high throughput for autoimmune and allergy tests.

The ZEUS Scientific dlFine digital immunofluorescence system, which received clearance in May 2022, can be used together with the ANA Hep-2 indirect fluorescent antibody (IFA) test, hence taking one hour to scan and analyze up to eight slides whereby it identifies eight common antinuclear autoantibodies (ANA).

Autoimmune Disease Diagnostics Market Trends

• Increasing prevalence of autoimmune diseases is driving the market growth of autoimmune disease diagnostics

The synovial tissues within the joints are majorly attacked by the autoimmune disease - Rheumatoid arthritis (RA). Elderly patients are predominantly affected by the disease. Technological advancements and the aging population are also major factors that have enhanced the autoimmune disease diagnostics market CAGR globally in recent years.

Rheumatoid arthritis is diagnosed through a C-reactive protein test, ESR test, rheumatoid factor test, antinuclear antibodies (ANA) test, cyclic citrullinated peptide (CCP) antibodies, and other imaging techniques.

With the increase in the burden of the senior population, Rheumatoid arthritis is a common disease being diagnosed in the aging population; there is a high risk of an upsurge of rheumatoid arthritis, thus driving the growth in autoimmune disease diagnostics market revenue. For instance, as per the reports of the World Population prospect 2022, in 2022, there were about 771 million people aged 65 years or over, and it is estimated to approach 994 million by the year 2030 and up to 1.60 billion by 2050.

There is also growth in autoimmune disease diagnostics due to the launch of new products by the key market players. PEPperPrint GmbH launched a novel biomarker set in June 2022, at the 13th International Congress on Autoimmunity organized in Athens, Greece. This is used for the early diagnosis of Rheumatoid arthritis (RA). Such advancements and innovations for early disease diagnosis are anticipated to increase the global market growth. Therefore, considering the factors mentioned earlier, the Autoimmune Disease Diagnosis market segment is expected to grow significantly from the forecast period till 2030.

Autoimmune Disease Diagnostics Market Segment Insights

Autoimmune Disease Diagnostics Disease Type Insights

The global autoimmune disease diagnostics segmentation, based on disease type, includes systemic and localized autoimmune diseases. The Systemic Autoimmune Disease segment held the majority share in 2022 due to the rapidly increasing mortality rate and morbidity of the disease. This disease is anticipated to rise at a significant CAGR over the projected market forecast period and will drive the Autoimmune Disease Diagnostics Market revenue. For instance, according to WHO (World Health Organization), as of the 2021 year, globally around 14 million people had rheumatoid arthritis.

Figure 1: Autoimmune Disease Diagnostics Market, by Disease Type, 2022 & 2030 (USD Million)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Autoimmune Disease Diagnostics Test Type Insights

Based on test type, the global autoimmune disease diagnostics segmentation includes Western Blotting, Enzyme-linked Immunosorbent Assay (ELISA), Double Immune Diffusion, Dot Blot, Counter Immune-electrophoresis, Line Blot, Immunofluorescence assays (IFA), Multiplex Immunoassay, Agglutination. The western Blotting segment had the largest share of the autoimmune disease diagnosis market in 2022 and is expected to increase the market growth.

Autoimmune Disease Diagnostics End-User Insights

Based on End-User, the global autoimmune disease diagnostics segmentation includes Hospitals, Diagnostics Centers, and Others. The hospital's segment had the largest share of the autoimmune disease diagnosis market in 2022 and is expected to increase the market growth. The major factors contributing to this largest segment share are an expansion of diagnostic capabilities throughout the hospitals, and high patient preference for the hospitals as the hospitals now offer complete care such as diagnosis, surgeries or treatment, and physiotherapy. There is an increase in the expansion of the existing technologies by the hospitals and the high adoption rate of testing technologies to provide time-efficient and cost-efficient tests to the masses.

Autoimmune Disease Diagnostics Regional Insights

By Region, the study provides market insights into North America, Europe, Asia-Pacific and Rest of the World. North America Autoimmune Disease Diagnosis market accounted for USD 2.24 billion in 2022. The market is expected to exhibit significant CAGR growth during the forecast period. This is attributed to the increasing burden of the huge patient pool and chronic diseases. The rising spending on healthcare and increased awareness among the general population will lead to the growth of the market value.

Further, the major countries studied in the market report are The U.S., Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, Africa, Middle East, and Latin America.

Figure 3: AUTOIMMUNE DISEASE DIAGNOSTICS MARKET SHARE BY REGION 2022 (%)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe's autoimmune disease diagnostics market accounts for the second-largest market share, with Germany autoimmune disease diagnostics market being the largest market value contributor. The factors surging the growth of the market are the rise in the geriatric population coupled with an increase in autoimmune disease incidences among the aging population. Additionally, public awareness and the rise of the burden of chronic diseases will fuel market growth. To boost the market growth in Europe, there is a rise in the number of product launches and an increased number of collaborations among the key market players. Further, the German autoimmune disease diagnostics market held the largest market share, and the U.K. autoimmune disease diagnostics market was the fastest-growing market in the European Region.

The Asia-Pacific Autoimmune Disease Diagnostics Market is expected to grow at the fastest CAGR in the forecast period from 2022 to 2030. This is due to increasing discretionary money and a huge patient base in developing markets. Moreover, some important drivers are infrastructure construction and the rise in the requirement for accurate diagnosis. As per the Arthritis Foundation of Asia, among adults, about 47 percent with diabetes and 49 percent of heart patients are diagnosed with arthritis. This percentage is more likely to grow in the future, and the rise of the burden of autoimmune diseases will enhance the market revenue. Hence, Asia-Pacific is expected to register the highest growth rate over the Autoimmune Disease Diagnosis market forecast period. Moreover, the China autoimmune disease diagnostics market held the largest market share, and the Indian autoimmune disease diagnostics market was the fastest-growing in Asia-Pacific.

Due to a lack of technological expertise, an underdeveloped healthcare sector, and inferior medical facilities, the African and Middle East autoimmune disease diagnostics market is expected to demonstrate the smallest share of the global market.

Autoimmune Disease Diagnostics Key Market Players & Competitive Insights

Major market players are spending much on R&D to increase their product lines, which will help the Autoimmune Disease Diagnostics  market grow even more. Market participants are also taking various strategic initiatives to grow their worldwide footprint, with key market developments such as new product launches, contractual agreements, mergers and acquisitions, increased investments, and collaboration with other organizations. Competitors in the Autoimmune Disease Diagnostics  industry must offer cost-effective items to expand and survive in an increasingly competitive and rising market environment.

Manufacturing locally to reduce operating costs is one of the primary business strategies manufacturers adopt in the Global Autoimmune Disease Diagnostics  industry to benefit clients and expand the market sector. In recent years, the Autoimmune Disease Diagnostics  industry has provided medicine with some of the most significant benefits. In the Autoimmune Disease Diagnostics  markets, major players such as  such as Siemens Healthcare Private Limited, bioMérieux SA, Bio-rad Laboratories, Beckman Coulter, and others, are working on expanding the market demand by investing in research and development activities.

The American company Bio-Rad Laboratories, Inc. designs and produces specialized technology products for clinical diagnostics and life science research markets. David and Alice Schwartz, a married couple who both attended the University of California, Berkeley, launched the business in Berkeley, California, in 1952. Bio-Rad has offices worldwide and is headquartered in Hercules, California. Most of Bio-life Rad's science offerings include instruments, software, consumables, reagents, and content for cell biology, gene expression, protein purification, protein quantitation, drug discovery and production, food safety, and scientific education. A cooperation between Bio-Rad and Roche was declared in March 2021.

A subsidiary of Danaher Corporation, Beckman Coulter Inc. creates, produces, and sells goods that innovate, automate, and streamline challenging biomedical tests. It works in the diagnostics and life sciences sectors. Beckman Coulter Inc. has aided healthcare and laboratory professionals, pharmaceutical and biotechnology firms, universities, medical schools, and research organizations worldwide for over 80 years. Brea, California, is currently home to its headquarters. Danaher Company purchased Beckman Coulter in 2011. Beckman Coulter completed the acquisition of EDC Biosciences, a privately held company that makes acoustic liquid handlers, in May 2019.

Key Companies in the autoimmune disease diagnostics market include

• Siemens Healthcare Private Limited


• bioMérieux SA


• Bio-rad Laboratories


• Beckman Coulter


• AstraZeneca


• EUROIMMUN AG


• Hoffmann-la Roche


• Inova Diagnostics


• Myriad Genetics


• Thermo Fisher Scientific


• Trinity Biotech Plc.


• Hemagen Diagnostics

Autoimmune Disease Diagnostics Industry Developments

July 2020:BioMérieux SA has acquired a United States-based company called Invisible Sentinel. This company specializes in molecular testing of food and beverages.

February 2021:Myriad Genetics has launched its new novel enhancement globally on its Vecta test report. This test report is used to identify any individual estimate of a patient's risk over a period of one year for rapid radiographic progression (RP). The new test report provides personalized RP results based on the gender, age and adiposity of a patient.

August 2022:KSL Beutner Laboratories (Beutner) have launched a blood test technique to detect any antigen linked with Autoimmune Blistering disease called MMP (Mucous Membrane Pemphigoid), which causes painful lesions occurring in the oral cavity.

May 2022:Thermo Fisher Scientific (United States) has launched new instruments under Phadia 2500+ series. These instruments are used for autoimmune testing and offer unparalleled and consistently high throughput for autoimmune testing and allergy diagnostics.

Autoimmune Disease Diagnostics Market Segmentation

Autoimmune Disease Diagnostics Disease Type Outlook

• Systemic Autoimmune Disease


• Localized Autoimmune Disease

Autoimmune Disease Diagnostics Test Type Outlook

• Western Blotting


• Enzyme-linked Immunosorbent Assay (ELISA)


• Double Immune Diffusion


• Dot Blot


• Counter Immune-electrophoresis


• Line Blot


• Immunofluorescence assays (IFA)


• Multiplex Immunoassay


• Agglutination

Autoimmune Disease Diagnostics End User Outlook

• Hospitals


• Diagnostics Centers


• Others

Autoimmune Disease Diagnostics Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America