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“The Anti-nuclear Antibody (ANA) market is expected to generate around USD 14.7 billion by 2030, at a CAGR of around 9.7% between 2020 and 2030”, says Visiongain

30 October 2019

Anti-nuclear Antibody (ANA) Market Forecast 2020-2030: Forecasts and Analysis by type (immunofluorescence, enzymelinked, immunosorbent assay (ELISA) and others), by application (Rheumatoid arthritis, Systemic lupus erythematosus (SLE), Polymyositis, Scleroderma, Sjögren's syndrome, and others), by End User (Hospitals and clinics, research laboratories, and others) and Geography, with Profiles of Leading Companies, with Profiles of Leading Companies report provides impartial Anti-nuclear Antibody (ANA) sector analysis.

According to the report published by Visiongain, the Anti-nuclear Antibody (ANA) market was valued at approximately USD 987 million in 2019 and is expected to generate around USD 14.7 billion by 2030, at a CAGR of around 9.7% between 2020 and 2030.

Anti-nuclear antibodies (ANAs), also recognized as an anti-nuclear force or ANF, are blood-borne autoantibodies generated by the immune system that also invade the body's own tissues by working against one or more proteins in the body. Normally, the body generates antibodies to assault and kill objects or external objects such as viruses and bacteria. ANAs are unusual antibodies or autoantibodies with the ability to bind and work against the skin to different areas of the nucleus of the cells. The immune system's inclination to operate against its own tissue is called autoimmunity. Thus, when identified, AANAs may indicate the existence of autoimmune disease. Disorder is autoimmune diseases.

Autoimmune diseases are characterized by inflammation of different bodily tissues. ANAs are discovered in people with various autoimmune diseases, including systemic Lupus erythematosus, drug-induced lupus, Sjogren's syndrome, rheumatoid arthritis, scleroderma, vitiligo, Hashimoto thyroiditis, juvenile diabetes mellitus, additive illness, pernicious anemia, glomerulonephritis, and lung fibrosis. In addition, ANAs can be discovered in people with circumstances not deemed to be typical autoimmune diseases like cancer and acute infections. The ANA elisa test detects the serum autoantibodies. Autoantibody screening is useful in the diagnosis of autoimmune disorders and monitoring levels helps to predict the progression of diseases or assessing the efficacy of a treatment. 

The sample of antinuclear antibody (ANA) is commonly used as an autoimmune disease serological indicator. Antinuclear antibodies are immunoglobulins or antibodies that attach within the nucleus of natural cells to one or more antigens. The ANA test can be a helpful laboratory instrument used selectively to assist verify or exclude chronic rheumatic disease identification. However, as well as good people, the comparatively elevated incidence of ANAs in other inflammatory circumstances can render it hard to understand a favorable outcome.

A important stage in the diagnosis of chronic lupus erythematosus (SLE) and other chronic autoimmune rheumatic diseases (SARD) is testing for the existence of antinuclear antibodies (ANAs). The conventional slide-based external immunofluorescence (IIF) experiment is commonly used, but is restricted by a comparative absence of SLE specificity and is not identified by all SARD-ANAs. Alternative immunoassays that could provide improved data on diagnosis and prognosis have developed, some of which have joined clinical exercise. This analysis summarizes the present state of ANA screening and multiplexing methods to detect other autoantibodies, the potential for point-of-care testing, and application methods.

Anti-nuclear Antibody (ANA) Market is witnessing Growth due to factors such as

According to the American Autoimmune Related Disease Association (AARDA), in the United States, about 50 million individuals are suffering from autoimmune diseases and the incidence is increasing every year. It is one of the top 10 major triggers of mortality in all communities of females up to the era of 65. According to AARDA, females represent for 75% of all autoimmune disease clients.

Testing of antinuclear antibody (ANA) is an significant instrument for diagnosing and managing autoimmune diseases such as Systemic Lupus Erythematosus (SLE) and rheumatoid infection in both subspecialty and primary care environments. Repurposing ANA from a SLE exam to a study for any autoimmune illnesses has improved these trials ' acceptance.

The present increase in ANA supply may also be attributed to variables such as the extended and key position of primary care physicians in the delivery system for health care. In addition, increasing R&D operations and advances in medical facilities have caused requirement for ANA exams primarily in growing countries including Brazil and China.

However, worries about the unreliability of ANA exams have been growing. Not all individuals identified with lupus stay favorable for ANA exams, according to a research undertaken by the Lupus Research Alliance. Furthermore, the research indicated that whether a person with long-standing ANA adverse or favorable lupus exams may vary extensively based on the specific diagnostic procedures being used. Hence, inconsistency of antinuclear antibody tests can be a restraining factor for the market.

 Shift in Trends

The antinuclear test market is classified into reagents and assay sets, technologies, and software and facilities based on products. It was reported that the reagents and assay sets were the biggest population in 2019. Due to elevated item acceptance in clinical and study environments, it is probable to experience the highest development over the forecast period.  Reagents and assay packages affect an assay's general efficiency. They assist produce uniform workflows in multiple areas to support scientists. Standard reagents enable precise and effective outcomes to be achieved. Improved effectiveness, uniform outcomes, and cost-effectiveness are expected in the close future to further promote market growth. In addition, increasing number of reagent rental agreements is anticipated to help the segment maintain its market position. The key market players providing reagents and assay kits are Thermo Fisher Scientific, Bio-Rad Laboratories, and Zeus Scientific.


The antinuclear test market is divided into ELISA, immunofluorescence assay, and multiplex assay based on method. Due to their elevated acceptance, immunofluorescence assay dominated the industry in income in 2019. Immunofluorescence assay is regarded the gold standard for ANA screening as it provides a higher sensitivity relative to other methods accessible. It can also recognize models that indicate related autoantibodies and inherent illnesses such as nucleolar, spotted, homogeneous, and others. Because of its increasing acceptance, ELISA is probable to experience the highest development over the forecast period. These tests are easily automated and do not need a high level of operator skill to perform. This factor is anticipated to bode well for market growth over the forecast period. Furthermore, ELISA provides higher specificity than immunofluorescence assay. It is generally used but as a screening tool for profiling an ANA positive.

The sector is categorized as rheumatoid arthritis, generalized lupus erythematosus (SLE), Sjogren illness, scleroderma, and other implementation-based diseases. The rheumatoid arthritis segment is expected to maintain the largest market share, mainly due to the increasing incidence of the disease. According to the U.S. In March 2017, Centers for Disease Control and Prevention (CDC) had diabetes in about 54.4 million adolescents in the U.S. about 25 percent of the workers. Approximately 78 million (26 percent) people in the U.S. living 18 years or older are expected to have arthritis diagnosed by the doctor by 2040. The most prevalent kinds of disease are rheumatoid arthritis and osteoarthritis. SLE is estimated to be the fastest growing segment owing to rising awareness coupled with government initiatives and number of tests approved by the U.S. Food and Drug Administration (FDA) to diagnose the disease.

Based on end-use, the antibody test market is segmented into clinics, clinical laboratories, and laboratories of the physician's department. It has been predicted that hospitals will be the biggest sector in 2017. Hospitals perform maximum amount of diagnostic tests, primarily owing to simple entry. It is projected that the hospital sector will retain the biggest proportion of the worldwide industry during the forecast period. During the forecast period, the section of physician office labs is anticipated to experience significant development. It is expected that the physician's expanded and vital function in the healthcare delivery system will boost section development in the coming years.

Regional Market Analysis

North America, accompanied by Europe, was the biggest national income sector in 2017. Geographically, the most well-established industries in North America and Europe are ANA screening, healthcare infrastructure, customer consciousness, and sophisticated test placement. They therefore create up most of ANA's current industry. Due to unmet clinical requirements and the need for stronger diagnosis, Asia Pacific is expected to be the highest growing region during the forecast period. During the forecast period, unmet autoimmune disease diagnostic demands are expected in nations such as India to increase national supply.

Competition in the market

Key businesses are embracing various company approaches such as extending their geographical existence, R&D operations, fresh item approvals and increasing partnerships. For example, Grifols received the U.S. in 2018. FDA approval for their fresh therapeutic tests for vasculitis and lupus associated with Antineutrophil Cytoplasmic Antibodies (ANCA). These experiments will allow laboratories to standardize and accelerate diagnosis using immunofluorescence testing. The U.S. has recently approved FDA will provide a secure and effective manner for laboratories to diagnose autoimmune diseases such as lupus, scleroderma, and vasculitis.

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