Autoimmune Disease Diagnostics Market Size, Share & Trends Analysis Report By Disease Type (Systemic Autoimmune Disease, Localized Autoimmune Disease), By Diagnosis (Antinuclear Antibody Tests, Autoantibody Tests, Complete Blood Count (CBC), C-reactive Protein (CRP), Urinalysis, Comprehensive Metabolic Panel, Erythrocyte Sedimentation Rate (ESR), Other Tests) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2022-2030

Market Overview

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.

Major factors propelling the growth of the global autoimmune disease diagnostics market include rising disease incidence, rising demand for better and more accurate diagnostic procedures, rising adoption of advanced rapid recognition, various development activities, and initiatives taken by favorable federal regulations. For instance, The American Autoimmune Related Diseases Association estimates that 60 million people in the United States currently have one or more autoimmune diseases. These numbers will increase as the study continues. Additionally, the lengthy wait times for diagnostic test results and the absence of skilled and knowledgeable healthcare workers in developing countries may impede business growth.

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.

High Start-up cost

The need for numerous diagnostic tests, the long wait times for test results, and the high startup costs for diagnosis centers may restrain the market's growth. The association of autoimmune disease diagnostic centers with stringent governmental requirements and diagnostic issues may significantly impact the company's ability to grow.

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.

Regional Analysis

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

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.

A large patient base and rising discretionary income in emerging markets are to blame for Asia-expected Pacific's significant growth over the projection period. The construction of new infrastructure and the earlier and increasing need for accurate diagnosis are two significant factors influencing regional market expansion.

Segmental Analysis

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.The subsegment rheumatoid holds a significant share in the market, The synovial tissues in the joints are primarily targeted by the autoimmune disease rheumatoid arthritis (R.A.). Patients who have the disease are primarily elderly. The segment is expanding mainly due to the aging population and technological advancements. Erythrocyte sedimentation rate (ESR), C-reactive protein, rheumatoid factor, cyclic citrullinated peptide (CCP), antinuclear antibodies (ANA), and other imaging tests can all be used to diagnose rheumatoid arthritis. For example, in the World Population Prospect, 2022, In 2022, there were 771 million people over the age of 65; this number is expected to rise to 994 million by 2030 and 1.6 billion by 2050. 

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.

Medical specialists who focus on particular organs, such as endocrinologists, gastroenterologists, neurologists, or rheumatologists, frequently treat these diseases. Localized autoimmune disease is further segmented into inflammatory bowel disease, type 1 diabetes, thyroid, and other localized autoimmune diseases.

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.

Impact of covid-19

Due to the pandemic, the lockdown made regulatory and governing bodies impose various restrictions and strict guidelines. Due to this, many manufacturing and production plants were shut down or stopped production, negatively influencing the supply chain. This had an adverse effect on the demand from various applications. The unexpected COVID outbreak decreased investment and/or is expected to postpone the ongoing projects for about 1-2 years in various related industries. The global GDP growth surged to -3.3% in 2020 compared to 2.8% in 2019. In 2021, according to the IMF forecasts, the global economy was estimated to recover in 2021 and register a growth of 6%.

The automotive industry was severely affected by the pandemic. This declined the market sales having a significant effect on the market. In 2020, the automotive production was USD 77.62 million, declining by 16%, compared to USD 91.79 million in 2019. The pandemic had the worst impact on the aerospace industry without a future view on its recovery. As a result, many competitors in the aerospace manufacturing industry stopped production, including Boeing.

Microspheres are used to produce manufacture lightweight construction composites. In the United States, 16% of projects had a shortage of equipment and raw materials, 11% faced a shortage of workers, laborers, and contractors, 18% of projects experienced shortages of government workers, and infected workers disrupted 8% of projects.

 Due to travel restrictions and other restrictions, the demand for petroleum-based products declined significantly. Reduced demand and new modern inventories severely affected the drilling exploration activities. The demand for petroleum fell from 100.7 million barrels per day in 2019 to 90.0 million barrels per day in 2020. By the COVID 19 outbreak, the global industries of beauty and grooming like cosmetics, fragrances, skincare, haircare, and personal care were affected significantly. Widespread store closure was observed. Also, various cosmetic and personal care manufacturers switched to manufacturing hand sanitizers and various cleaning agents.

Post COVID-19 Growth of Global Microspheres Market

The market concerning medical purposes is opening up owing to the need for innovation and advancement in technology for detection, diagnosis, and treatment. Also, other industries like cosmetics, paints, and automotive are witnessing a slight elevation in the market. The demand for microsphere is improving gradually, especially for drug delivery, diagnostics-based assays, and cosmetics. For instance, in January 2022, Diasorin released updated SIMPLEXA™ SARS-COV-2 variants direct molecular assay to detect mutations associated with the omicron variant. Such factors are anticipated to support market growth post-COVID-19 pandemic. 

Recent Developments

• In August 2022, KSL Beutner Laboratories (Beutner) introduced a blood test where The autoimmune blistering disease mucous membrane pemphigoid (MMP) frequently results in painful lesions in the oral cavity and is linked to an antigen.
• In May 2022, Thermofisher's new Phadia 2500+ series of instruments will be accessible in the U.S. for autoimmune testing. For both allergy diagnostics and autoimmune testing, it provides dependable and unmatched high throughput.
• In June 2022, At the 13th International Congress on Autoimmunity held in Athens, Greece, PEPperPrint GmbH presented a novel biomarker for the early diagnosis of rheumatoid arthritis (R.A.).
• In December 2022, In order to treat aortic stenosis, ABBOTT presents NAVITOR™, its newest generation Transcatheter Aortic Valve Implantation (TAVI) system in India.