Systemic Autoimmune Disease Diagnostics Market
Number of pages: 100 | Report Format: PDF | Published date: February 13, 2023
Historical Years – 2020 | Base Year – 2021 | Forecasted Years – 2022-2030
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Report Attribute |
Details |
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Market Size Value in 2021 |
US$ 987 million |
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Revenue Forecast in 2030 |
US$ 1,480 million |
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CAGR |
5.2% |
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Base Year For Estimation |
2021 |
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Forecast Year |
2022-2030 |
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Historical Year |
2020 |
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Segments Covered |
Product, Disease Type, Diagnosis, End-user, and Region |
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Regional Scope |
North America, Europe, Asia Pacific, and the Rest of the World (RoW) |
According to the deep-dive market assessment study by Growth Plus Reports, the global systemic autoimmune disease diagnostics market was valued at US$ 987 million in 2021 and is expected to register a revenue CAGR of 5.2% to reach US$ 1,480 million by 2030.
Systemic Autoimmune Disease Diagnostics Market Fundamentals
Systemic autoimmune diseases are characterized by immune system dysregulation, which causes immune cells to attack autoantigens, resulting in unsuitable inflammation and multi-tissue damage. They are an intriguing but poorly understood group of diseases that range from the common rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) to the relatively uncommon systemic sclerosis. The etiology of systemic autoimmune disease is still poorly understood. Genetic factors, infection, endocrine dysfunction, and environmental exposure are now thought to play a role in the pathogenesis of these diseases.
Systemic autoimmune diseases develop when the immune system targets the healthy tissue in joints, the vascular system, and other organ systems. This immune response results in inflammation, discomfort, decreased mobility, exhaustion, and other vague symptoms. Some systemic autoimmune diseases have many signs and symptoms, which can delay diagnosis and effective treatment. According to a survey by the Autoimmune Diseases Association, it can take up to 4.6 years and nearly five doctor visits to properly diagnose a systemic autoimmune disease. Clinical evaluation and laboratory tests are required for the differential diagnosis and classification of systemic autoimmune disorders. The antinuclear antibody (ANA) immunofluorescence assay (IFA) is a first-line screening test for individuals with a possible systemic autoimmune condition. Due to its exceptional sensitivity when compared to other assays, this test is considered the gold standard.
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Systemic Autoimmune Disease Diagnostics Market Dynamics
The global systemic autoimmune disease diagnostics market is expanding due to the rising prevalence of autoimmune diseases, increasing knowledge of disease diagnosis, and technological advancements. The market for systemic autoimmune disease diagnostics is anticipated to develop as systemic autoimmune disorders become more prevalent. Multiple sclerosis is more prevalent in women than in men. About 2 million people have RA, whereas 2% to 3% of the general population are considered to have psoriasis, one of the most common autoimmune conditions. The growing understanding of autoimmune disorders as a result of programs for research, education, support, and activism is one of the main factors influencing rising usage rates of systemic autoimmune disease diagnostics. Additionally, the burden of autoimmune illnesses is increasing worldwide. This, combined with expanding health and disease awareness, creates a need for early diagnosis diagnostics, which is expected to propel the market’s expansion. Furthermore, favorable government policies are expected to enhance the global market dynamics in the next few years. Various groups, such as the North American Rheumatoid Arthritis Consortium, Cooperative Study Group for Autoimmune Disease Prevention, and Autoimmunity Centers of Excellence, aggressively promote the appropriate diagnosis and treatment of autoimmune diseases. Moreover, the global market expansion is anticipated to be fueled by the increasing introduction of technological advances and rising adoption of lab automation. Clinicians are utilizing cutting-edge technology to run several tests simultaneously and produce faster, more accurate findings. For instance, in comparison to traditional diagnosis, one of the most intriguing new technologies, cytometry by time-of-flight mass spectrometry, and immune phenotyping are potential methods for systemic autoimmune disease diagnosis. Bead-based immunoassays, another cutting-edge method for analyzing soluble proteins, can measure up to 75 soluble analytes at once in a multiplexed array, making the diagnostic processes much more efficient and less time-consuming.
However, the high upfront cost for diagnosis centers, the lengthy turnaround times for test findings, and the requirement for several diagnostic tests may have a negative impact on the market’s expansion.
Systemic Autoimmune Disease Diagnostics Market Ecosystem
The global systemic autoimmune disease diagnostics market is analyzed from five perspectives: product, disease type, diagnosis, end-user, and region.
Systemic Autoimmune Disease Diagnostics Market by Product
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Based on the product, the global systemic autoimmune disease diagnostics market is segmented into consumables and assay kits, and instruments.
The consumables and assay kits segment accounted for the largest revenue share of the global systemic autoimmune disease diagnostics market in 2021. For producers and commercial vendors, the requirement for tools, reagents, and other consumables to carry out these assays has emerged as a key entry point for creating and distributing a broad range of diagnostic kits. Commercial assay kits have significantly increased their market share in various subfields of autoimmune serology; however, some diagnostic laboratories continue to use in-house created assays. Commercial kits are affordable, simple to use, and capable of meeting accreditation requirements. Most kits include all required reagents and a step-by-step guide for the assay. Commercial autoantibody assay kits use various technologies, including ELISA, addressable laser beads, immunodiffusion, immunoblotting, indirect immunofluorescence (IIF), and antigen arrays. Due to the ELISA’s sensitivity, high throughput, and relatively low cost, in addition to the assay’s minimal requirement for equipment, it is one of the more widely used technological platforms.
Systemic Autoimmune Disease Diagnostics Market by Disease Type
Based on the disease type, the global systemic autoimmune disease diagnostics market is segmented into rheumatoid arthritis, systemic lupus erythematosus, scleroderma, dermatomyositis, psoriasis, and others.
The rheumatoid arthritis segment dominated the global systemic autoimmune disease diagnostics market in 2021. RA primarily targets the synovial tissues found within the joints. Major elements influencing the segment’s revenue growth include the aging population and technological advancements. The ESR test, C-reactive protein test, rheumatoid factor test, cyclic citrullinated peptide (CCP) antibodies, antinuclear antibodies (ANA) test, and other imaging can be used to detect RA. The prevalence of RA has increased along with the burden of the geriatric population, which in turn has fueled market expansion.
Systemic Autoimmune Disease Diagnostics Market by Diagnosis
Based on the diagnosis, the global systemic autoimmune disease diagnostics market is segmented into antibody and immunologic tests, complete blood count (CBC), C-reactive protein (CRP), urinalysis, and others.
The antibody and immunologic tests segment is further sub-segmented into autoantibody tests and ANA tests. The ANA test had the largest revenue share of the global market. Antinuclear (or anti-cytoplasmic) antibodies bind to fixed cells on a slide in the ANA test. Under a fluorescence microscope, adding a secondary antibody (with an associated fluorescent dye) directed towards human antibodies may reveal staining of the cytoplasm or nucleus. It has high sensitivity and specificity, is affordable, and is easy to perform. A positive ANA test may help doctors diagnose an autoimmune disease and identify the particular type of autoimmune disease the patient is experiencing. Thus, this test is preferred for the diagnosis of systemic autoimmune disease.
Systemic Autoimmune Disease Diagnostics Market by End-user
Based on end-user, the global systemic autoimmune disease diagnostics market is segmented into clinical laboratory, hospitals, and others.
The hospital segment dominates the global systemic autoimmune disease diagnostics market. During the forecast period, the hospitals segment is anticipated to drive market expansion. This significant market share results from hospitals using more diagnostic methods for autoimmune diseases in conjunction with complex interventional surgery. Hospitals have high-tech laboratories that offer efficient physiotherapy sessions, better patient help and counseling, and other services that guarantee market expansion and stimulate demand for these facilities. The prevalence of several chronic diseases and neurological conditions that might lead to autoimmune disease is expected to fuel market revenue growth. Some major factors driving the segment revenue growth include the rising availability of highly experienced medical and healthcare experts and cutting-edge facilities.
Systemic Autoimmune Disease Diagnostics Market by Region
Based on the region, the global systemic autoimmune disease diagnostics market is segmented into North America, Europe, Asia Pacific, and the Rest of the World.
The Affordable Care Act, the existence of favorable regulations and activities conducted by the American Autoimmune Related Diseases Association (AARDA), and high disease prevalence in the region contribute to North America’s highest market revenue share. Nearly 50 million Americans suffer from an autoimmune condition, according to AARDA. A high prevalence of chronic diseases and rising healthcare costs have prompted government bodies and other organizations to introduce various programs that intend to reduce healthcare spending through early disease diagnosis and increased patient awareness.
The market in Asia Pacific is estimated to experience profitable growth due to the region’s high levels of unmet patient requirements, rising patient awareness levels, and continuously improving healthcare infrastructure. According to a June 2022 article by Janssen Asia Pacific, a branch of Johnson & Johnson, the prevalence of autoimmune, inflammatory, and pulmonary conditions, such as RA, psoriasis, and inflammatory bowel disease, is increasing across Asia Pacific. Chronic obstructive pulmonary disease (COPD) and systemic lupus erythematosus (SLE) are already prevalent at the highest rates in China and Southeast Asia, respectively, in this region. These factors are expected to boost the requirement for diagnostics in the years to come.
Systemic Autoimmune Disease Diagnostics Market Competitive Landscape
The key companies operating the global systemic autoimmune disease diagnostics market are:
Systemic Autoimmune Disease Diagnostics Market Strategic Developments
Systemic autoimmune diseases are characterized by immune system dysregulation, which causes immune cells to attack autoantigens, resulting in inflammation and multi-tissue damage. General laboratory tests can help in finding out the potential presence of underlying systemic autoimmune diseases. These include the comprehensive metabolic panel (CMP), complete blood count (CBC), urine analysis (UA), sedimentation rate (ESR), C-reactive protein (CRP), and muscle enzymes.
The technological advancements, increase in the prevalence of systemic autoimmune disorders, and rise in the adoption of lab automation are estimated to fuel the global market revenue growth.
Thermo Fisher Scientific, Siemens Healthcare Pvt. Ltd, Abbott Laboratories, Danaher Corporation, and Bio-Rad Laboratories are among the top market players.
The necessity for several diagnostic tests, poor turnaround times for test findings, and expensive startup costs for diagnosis centers can negatively impact the market’s expansion. Government regulations and other issues related to diagnostic centers may have a detrimental effect on the revenue growth of the market.
The global systemic autoimmune disease diagnostics market is expected to register a revenue CAGR of 5.2% during the forecast period from 2020-2030.
*Insights on financial performance are subject to the availability of information in the public domain