SYSTEMIC AUTOIMMUNE TESTING MARKET

INTRODUCTION

 Systemic autoimmune diseases are a group of disorders that affect multiple organs and tissues in the body, causing chronic inflammation and damage. Some examples of systemic autoimmune diseases are rheumatoid arthritis, systemic lupus erythematosus, Sjögren’s syndrome, scleroderma, and vasculitis. 

Systemic autoimmune testing is the process of detecting autoantibodies in the blood or other body fluids that are produced by the immune system against the body’s own cells or tissues. Autoantibodies can cause inflammation and damage to various organs and systems, leading to symptoms and signs of autoimmune diseases.

Systemic autoimmune testing can help diagnose autoimmune diseases, monitor disease activity and response to treatment, and identify potential complications or comorbidities. Systemic autoimmune testing can also help differentiate between different types of autoimmune diseases that may have similar clinical features. 

There are different methods and techniques for systemic autoimmune testing, such as immunofluorescence assay (IFA), enzyme immunoassay (EIA), immunoblotting, and multiplex immunoassay.

Each method has its own advantages and limitations, depending on the type of autoantibody, the sample type, the sensitivity and specificity, the cost and availability, and the clinical utility.

Some of the common autoantibodies that are tested for systemic autoimmune diseases are:Antinuclear antibodies (ANA): These are antibodies that react with components of the cell nucleus, such as DNA, histones, ribonucleoproteins, and nuclear antigens.

ANA are detected by IFA using human epithelial cells (HEp-2) as substrate.ANA are present in about 95% of patients with systemic lupus erythematosus (SLE) and in various other autoimmune diseases, such as Sjögren’s syndrome, scleroderma, mixed connective tissue disease (MCTD), and polymyositis/dermatomyositis.

ANA can also be found in some healthy individuals, especially elderly people, and in some infections or malignancies. The pattern and titer of ANA can provide clues to the specific type of autoimmune disease. 

Anti-double stranded DNA (anti-dsDNA): These are antibodies that react with double stranded DNA (dsDNA), a component of the cell nucleus. Anti-dsDNA are detected by EIA or IFA using Crithidia luciliae as substrate.

Anti-dsDNA are highly specific for SLE and correlate with disease activity and renal involvement. Anti-dsDNA are present in about 70% of patients with SLE and rarely in other autoimmune diseases.

SYSTEMIC AUTOIMMUNE TESTING MARKET SIZE AND FORECAST

The Global Systemic Autoimmune Testing market accounted for $XX Billion in 2022 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2024 to 2030.

SYSTEMIC AUTOIMMUNE TESTING MARKETNEW PRODUCT LAUNCH

Bio-Rad, which offers immunofluorescence assay and enzyme immunoassay kits for detection of autoantibodies associated with rheumatoid arthritis, systemic lupus erythematosus, and other systemic autoimmune diseases.

Bio-Rad also offers the BioPlex® 2200 ANA Screen with MDSS, a multiplex assay for detection of clinically relevant antinuclear antibodies and predefined profiles correlated with systemic autoimmune diseases. 

Thermo Fisher Scientific, which offers EliA™ and Phadia™ systems, a range of automated immunoassays for detection of autoantibodies in serum or plasma samples. Thermo Fisher Scientific also offers NOVA Lite®, a line of immunofluorescence assays for detection of antinuclear antibodies and other autoantibodies. 

Inova Diagnostics, which offers QUANTA Flash®, a line of chemiluminescent immunoassays for detection of autoantibodies using the BIO-FLASH® instrument. Inova Diagnostics also offers QUANTA Lite®, a line of enzyme immunoassays for detection of autoantibodies using the QUANTA-Lyser® instrument. 

Euroimmun, which offers EUROLINE and EUROASSAY systems, a range of immunoblot and enzyme immunoassay kits for detection of autoantibodies using the EUROIMMUN Analyzer instruments.

Euroimmun also offers EUROPattern and EUROLabOffice systems, a range of immunofluorescence assays for detection of autoantibodies using the EUROPattern microscope and software. 

Werfen, which offers Alegria®, an automated system for detection of autoantibodies using immunofluorescence strips. Werfen also offers Zenit®, a line of immunoblot assays for detection of autoantibodies using the Zenit RA Analyzer instrument. 

BioLegend, which offers LEGENDScreen™ Human Autoimmune Profiling Kit, a multiplex bead-based assay for simultaneous detection of 90 human autoantibodies using flow cytometry.

BioLegend also offers LEGENDplex™ Human Autoimmune Panel, a multiplex bead-based assay for simultaneous detection of 13 human cytokines associated with autoimmune diseases using flow cytometry.

PRODUCT DEVELOPMENT AND INNOVATION

A diagnostic test called the Elecsys ANA Screen was created by Roche Diagnostics to help in the evaluation of autoimmune illnesses. Antinuclear antibodies, or ANAs for short, are a class of antibodies that specifically target the cell nucleus and are frequently linked to a number of systemic autoimmune diseases.

This examination is crucial in the early screening and assessment of patients who may have autoimmune diseases such systemic lupus erythematosus (SLE), systemic sclerosis, Sjögren's syndrome, and other connective tissue disorders. To find ANAs in patient blood samples, the Elecsys ANA Screen makes use of cutting-edge technologies.

The test is based on the ELISA concept, which immobilizes particular antigens produced from human cells on a solid surface. Any ANAs in a patient's serum, plasma, or whole blood sample will attach to the antigens, if any are present, when they are added to the test.

A labeled antibody directed against human immunoglobulin is then used to identify the binding response, enabling the quantification of ANAs in the patient's sample.

The results are given as a titer, which shows the patient's sample's dilution level at which the ANAs are still identifiable. The test also offers details on the pattern of nuclear staining, which may reveal clues about a possible autoimmune disease. Both healthcare professionals and individuals can benefit from using the Elecsys ANA Screen in a number of ways.

Its great specificity and sensitivity is one of its key benefits. It is extremely reliable for ruling out or confirming the presence of autoimmune illnesses since it can recognize ANAs even at low concentrations.

In order to avoid incorrect diagnoses, needless treatments, and delays in receiving proper care, the test's accuracy is essential. In addition, the quantitative character of the test enables improved disease monitoring and evaluation of disease activity over time.

Patients with known autoimmune illnesses who need continuing monitoring and treatment modifications should pay special attention to this. High-throughput testing in clinical laboratories is made possible by the Elecsys ANA Screen, a completely automated, quick, and reproducible assay.

Automation lowers the possibility of human error and improves efficiency in delivering results quickly, which is crucial for providing patients with timely care. The patient may not actually have an autoimmune disease, despite a positive ANA result, it is vital to remember.

ANAs may be present in healthy people, as well as in connection with a number of infections and other non-autoimmune diseases. The ANA Screen is therefore regarded as a screening test, and additional research is necessary for a certain diagnosis.

In the event that an ANA test is positive, medical professionals may request additional testing, such as anti-dsDNA, anti-Sm, or certain ANA subtyping, to better understand the patient's situation. Further testing may be guided by the ANA Screen's detected pattern of nuclear staining.

For instance, SLE is linked to a speckled pattern, whereas systemic sclerosis is frequently accompanied by a nucleolar pattern. Elecsy Ana A useful tool for the initial assessment and screening of autoimmune disorders is Screen from Roche Diagnostics.

Due to its high sensitivity, specificity, and quantitative character, it is crucial for healthcare professionals' diagnostic procedures. To establish an accurate diagnosis and the proper course of treatment, as with any diagnostic test, the results should be read in conjunction with the patient's clinical presentation and medical history. 

SYSTEMIC AUTOIMMUNE TESTING MARKETCOMPANY PROFILE

• Bio-Rad
• Thermo Fisher Scientific
• Inova Diagnostics
• Euroimmun
• Werfen
• BioLegend

SYSTEMIC AUTOIMMUNE TESTING MARKETTHIS REPORT WILL ANSWER FOLLOWING QUESTIONS

1. How many Systemic Autoimmune Testing are manufactured per annum globally? Who are the sub-component suppliers in different regions?
2. Cost breakup of a Global Systemic Autoimmune Testing and key vendor selection criteria
3. Where is the Systemic Autoimmune Testing manufactured? What is the average margin per unit?
4. Market share of Global Systemic Autoimmune Testing market manufacturers and their upcoming products
5. Cost advantage for OEMs who manufacture Global Systemic Autoimmune Testing in-house
6. key predictions for next 5 years in Global Systemic Autoimmune Testing market
7. Average B-2-B Systemic Autoimmune Testing market price in all segments
8. Latest trends in Systemic Autoimmune Testing market, by every market segment
9. The market size (both volume and value) of the Systemic Autoimmune Testing market in 2024-2030 and every year in between?
10. Production breakup of Systemic Autoimmune Testing market, by suppliers and their OEM relationship