Autoimmune Disease Diagnostics Market

The global autoimmune disease diagnostics market size was valued at USD 4,253.29 million in 2021 and is anticipated to generate 8089.97 million by 2030. The market is projected to grow at a CAGR of 7.17% during the forecast period (2022–2030). Autoimmune disease (AD) is a non-communicable disease that revolves around losing normal immune homeostasis. This organism is responsible for producing an irregular response for its tissue cells. Furthermore, autoimmune diseases revolve around the activation of self-reactive T cells, autoantibodies, and inflammation. Typically, immune cells can identify alien objects such as bacteria and viruses and send out fighter cells to counter their presence. Autoimmune diseases compel the immune system to attack itself. Some autoimmune diseases attack only a certain type of organ. The global autoimmune disease diagnostics market share is divided into type, diagnosis, and regional analysis.  

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 Market Dynamics

Autoimmune Disease Diagnostics Market Drivers

• Rising Public Awareness and Increasing Prevalence of Autoimmune Diseases to Surge Growth

Growing public attention and increasing prevalence of autoimmune diseases are expected to boost the autoimmune disease testing market size during the forecast. According to the National Stem Cell Foundation, around 4% of the global population is affected by one of more than 8o different autoimmune variants. The most common diseases include Crohn’s, scleroderma, psoriasis, Type 1 diabetes, and lupus.

Factors such as changing lifestyles, lack of nutritional diet and exercise, excessive smoking, and irregular sleeping patterns have contributed to the rise of autoimmune diseases and increasing market volume. Additionally, rising autoimmune disease incidences among the elderly population owing to rising affinity towards self-antigens or latent viruses will boost the market growth of autoimmune disease diagnostics.

The focus of prominent players on launching new products and implementing wider growth strategies will further propel market growth. Increasing partnerships, collaborations, and joint ventures, will further push the market towards a booming growth. In February 2021, the American Kidney Fund (AFK) launched an awareness campaign for lupus nephritis, a kidney disease caused by lupus. This campaign aims to provide valuable information about the signs, symptoms, and treatment for lupus nephritis. GSK, a prominent player in the market, aided the campaign by substantiating a huge grant.

• Technological Advancements to Aid in Registering a Substantial Market Growth Rate

The detection of autoantibodies posed a variant challenge in the past. Detecting the presence of autoantibodies is a key attribute of autoimmune diseases. Normally, studies are conducted by analyzing the presence/concentration of individual antibodies in biological fluids. However, the latest technological leaps allow for simultaneous identification/measurement of various antibodies.

Improvement of technologies such as antigen microarray and mass spectrometry for antibody profiling indicated a wide range of positive results for analytical sensitivity and reproducibility. These practices with time can be integrated into normal clinic procedures. Additionally, the development of genomic and proteomic multiplex technologies multiplied biomarker discovery, further increasing its foothold in diagnostics and therapeutic testing.

Laboratory automation plays a pivotal role in shaping the growth patterns for autoimmune disease diagnostics due to decreased human error, increased productivity, low turnaround time, and a small amount of handling steps. Simplification of testing through automated measures is expected to boost the market value. The introduction of new methods through automation, such as automated indirect immunofluorescence, automated monoplex immunoassays, and automated multiplex immunoassays, will increase the ease of testing.

Autoimmune Disease Diagnostics Market Restraints

• Requirement of Multiple Diagnostics Tests and Slow Turnaround Time to Hamper Market Value

Detecting autoimmune diseases is time-consuming and involves various testing scenarios, such as serum testing for rheumatoid arthritis, Addison’s disease, and Hashimoto’s disease. Additionally, no single laboratory test can willfully detect with a great amount of accuracy that a certain autoimmune disease is present.

Multiple laboratory tests are required to present a full picture. These include a complete metabolic panel, blood count report, serologies, flow cytometry, and HLA typing, to name a few. Some tests are only useful for detecting the severity and intensity of the disease and are used to diagnose and manage patients.

Lower penetration of autoimmune techniques further makes the turnaround time for such tests a long-awaited process. Delivery of all tests can take up to several days. For instance, autoimmune lymph proliferative syndrome can take up to 12 weeks, with single-gene sequencing tests taking up to 4 weeks. Also, higher costs of tests and issues related to reimbursement policies will further drain the market to a slowed growth rate. The lack of skilled professionals is also expected to hamper the market to a certain extent.

Autoimmune Disease Diagnostics Market Opportunities

• New Entrants and Novel Methods for Detecting Autoimmune Diagnostics to Present New Opportunities for Market

The ever-increasing demand for effective and accurate autoimmune disease diagnosis is expected to stir the competition positively. This paves the way for new entrants to enter the market, further creating a healthy space for competition. This creates an environment for competitive pricing among the dominant players. The Asia-Pacific region's increasing opportunity is due to untapped growth potential and enlarging patient pool. Rising research studies are expected to present lucrative opportunities for revenue generation for the dominant players.

Rising awareness about autoimmune diseases creates a breeding ground for developing unique and accurate diagnosis techniques for diagnostics measures. Automation of laboratories and increasing shift towards replacing conventional technologies is expected to pave the groundwork for increasing the global autoimmune disease diagnostics market size to a greater extent.

COVID-19 Pandemic to Affect Market in a Mixed Manner

The COVID-19 pandemic was categorized as an infectious disease by the World Health Organization. A majority of the population was plagued with mild to moderate respiratory illness during the tenure of the pandemic. As the situation unfolded, many pharmaceutical and biological companies shifted their focus on identifying new molecules and leads for treatment. Additional research from Springer Nature Limited in 2020 indicated that the pandemic would lead to an increased prevalence of Type 1 diabetes. The virus destroyed β-cells in patients, which led to an increase in Type 1 diabetes cases.

A research study titled “Thyroid Function Analysis in 50 Patients with COVID-19: A Retrospective Study” stated that the more severe the virus present lowers TSH and TT3 levels. The National Psoriasis Foundation (NPF) collected and distributed critical information for healthcare providers and individuals living with the psoriatic disease in terms of management and further alleviation. As countries-imposed lockdowns during the ongoing pandemic, trade practices were suspended globally. Furthermore, travel restrictions on regional and global levels were enforced, leaving a majority of the population to resort to their homes.

As in-patient visits to hospitals, clinics, and laboratories decline, the market for autoimmune disease diagnostics faced a decline. As the pandemic runs its course, the market is expected to pick up the pace owing to ease in lockdown measures along with increasing movement capabilities among the general population.

Segmental Insights of Global Autoimmune Disease Diagnostics Market

The market of autoimmune disease diagnostics is categorized as systemic autoimmune disease and localized autoimmune disease based on disease type. Furthermore, systemic autoimmune disease can be broken down into rheumatoid arthritis, psoriasis, systemic lupus erythematosus (SLE), multiple sclerosis, and other systemic autoimmune diseases. Localized autoimmune disease is further segmented into inflammatory bowel disease, type 1 diabetes, thyroid, and other localized autoimmune diseases. The localized autoimmune disease segment is expected to be valued at 5209.99 million by 2030 at a CAGR of 7.05% during the forecast period.

The thyroid is expected to contribute with the largest value in terms of subsegmental growth due to the increasing prevalence of thyroid among the general population, increased healthcare spending, and rocketing adoption of thyroxin in Europe. The American Thyroid Association estimates that more than 20 million Americans suffered from some form of thyroid disease in 2019.

Based on the diagnosis, the market can be broken down into antinuclear antibody tests, autoantibody tests, complete blood count (CBC), c-reactive protein (CRP), urinalysis, and other tests. The segment of autoantibody tests is expected to occupy the largest market value with the market size to be estimated at USD 2105.77 million in 2030 with a CAGR of 7.60% during the forecast period. Factors such as the tests being the most common diagnostics tests for detecting autoimmune diseases coupled with the presence of a large number of market players supporting increased product launches.

Regional Insights of Global Autoimmune Disease Diagnostics Market

North America to Witness Largest Global Autoimmune Disease Diagnostics Market Share due to Increasing Burden of Chronic Diseases and Huge Patient Pool

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North America is anticipated to hold the largest market share of 114.60 million by 2030 at a CAGR of 7.12% during the forecast period. Rising healthcare spending and increasing awareness among the general population will contribute to the market value. Additionally, the rising prevalence of chronic diseases will give rise to a large patient pool in the U.S. According to the Autoimmune Registry, the United States alone has the highest incidences of AD, with an estimated 15-30 million patients suffering from a form of AD variant.

Additionally, rising expenditure on R&D activities for autoimmune diseases drives the growth of the autoimmune disease diagnostics market. Prominent players in the region are developing new products that boost the market value.

Europe will account for the second-largest market share, with Germany contributing the largest market value. The increasing aging population coupled with rising incidences of autoimmune disease among the elderly population is fueling the growth of the market. Moreover, rising public awareness and increasing the burden of chronic diseases will also surge the market growth. A rising number of collaborations among the players in the market and an increased amount of product launches are expected to boost the market growth in Europe.

Key Companies

List of Top Key Players in Autoimmune Disease Diagnostics Market

• Abbott Laboratories
• Biomerieux SA
• Bio-rad Laboratories Inc
• PerkinElmer Inc. (Euroimmun AG)
• Hoffmann-la Roche Ltd
• Werfen Company (Inova Diagnostics Inc.)
• Myriad Genetics Inc
• Siemens Healthineers Inc
• Thermo Fisher Scientific Inc
• Trinity Biotech PLC

Recent Developments

• In October 2021, Exagen Inc. announced that it launched AVISE CTD and AVISE Lupus, a contracted covered service with Inland Empire Health Plan (IEHP). It provides enhanced care to approx. 1.4 million members.
• In March 2021, Roche and GenMark Diagnostics entered into a definitive merger agreement for Roche to fully acquire GenMark at a price of USD 24.05 per share in an all-cash transaction.
• In February 2021, Myriad Genetics Inc. launched a new enhancement on its Vectra test report. The new test report provides an individualized estimate of a patient’s one-year risk of rapid radiographic progression (RP). The RP result in every report is personalized based on the patient’s age, gender, and adiposity.
• In January 2021, Exagen Inc. announced that all AVISE test offerings (SLE Monitor, CTD, APS, Lupus, MTX, SLE Prognostic, Vasculitis AAV, MTX, and HCQ) contracted in-network service with Tufts Medical Center.
• In January 2021, Thermo Fisher Scientific Inc. launched the Phadia 200, which enables new levels of flexibility and automation for laboratory testing facilities to aid in the diagnosis of allergy and autoimmunity conditions in Europe.
• In September 2020 the Canadian company, SQI Diagnostics Inc. announced the expansion of its rapid diagnostic testing portfolio, which has been targeting organ transplants, autoimmune disease, and serological testing.
• In July 2020, BioMérieux SA acquired Invisible Sentinel, a United States-based company that specialized in food and beverage molecular testing.
• In June 2020, Abbott and Tandem Diabetes Care signed a partnership agreement to develop and commercialize integrated diabetes solutions.
• In March 2019, PerkinElmer, Inc., received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its EUROIMMUN Anti-TissueTransglutaminase (tTG) ELISA. The test system is designed in a way to help clinicians confirm or it can be used to exclude a celiac disease diagnosis.

Global Autoimmune Disease Diagnostics Market: Segmentation

By Disease Type

• Systemic Autoimmune Disease
  • Rheumatoid Arthritis
  • Psoriasis
  • Systemic Lupus Erythematosus (SLE)
  • Multiple Sclerosis
  • Other Systemic Autoimmune Diseases
• Localized Autoimmune Disease
  • Inflammatory Bowel Disease
  • Type 1 Diabetes
  • Thyroid
  • Other Localized Autoimmune Diseases

By Diagnosis

• Antinuclear Antibody Tests
• Autoantibody Tests
• Complete Blood Count (CBC)
• C-reactive Protein (CRP)
• Urinalysis
• Other Tests

By Region

• North America
• Europe
• Asia-Pacific
• Middle East & Africa
• South America