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Anti-nuclear antibody test, also known as ANA or FANA (fluorescent anti-nuclear antibody) test is a blood test used to determine the presence of auto-antibodies in the serum, which are produced by the body against its own cells. In normal conditions, the immune system of the human body recognizes foreign entities such as bacteria, virus, fungus, etc. and generates an immune response against these foreign particles. This immune response involves production of a large number of antibodies, which bind and destroy any foreign particles in the body. However, in certain autoimmune disease conditions such as Systemic Lupus Erythematosus (SLE), Rheumatoid arthritis, Scleroderma, and Sjogren’s syndrome, the body recognizes its own cells as foreign bodies and produces anti-nuclear antibodies against its own cells. These anti-nuclear antibodies are specifically targeted at the nucleus of the cell, hence the body ends up damaging its own healthy proteins present within the cell nucleus. Some of the tests used to check the presence of anti-nuclear antibodies in serum include ELISA (Enzyme Linked Immunosorbent Assay), indirect immunofluorescence, multiplex assay, and others.

ANA testing is used as a preliminary technique in the diagnosis of systemic autoimmune disorders such as SLE and rheumatoid arthritis. For instance, the staining pattern and titre values of antinuclear antibodies obtained in the laboratory are reported as an indication for further testing specific to autoimmune disorders. However, ANA is tested positive even for certain other conditions such as cancer, viral infections, thyroid diseases- Grave’s disease, liver diseases- autoimmune hepatitis, lung diseases- idiopathic pulmonary fibrosis, in patients taking medications like hydralazine, isoniazid, procainamide, and several anticonvulsants or in patients with no health conditions.     

Global Anti-nuclear Antibody Testing market: Dynamics

An exponential rise in the demand for antinuclear antibody testing has been witnessed due to increase in prevalence of autoimmune disorders such as SLE and rheumatoid arthritis, which is expected to drive the market growth over the forecast period. For instance, the U.S. Centers for Disease Control and Prevention (CDC) estimated that around 54.4 million adults suffered from arthritis in the U.S. in 2017. In 2017, the Arthritis foundation of U.S estimated a rise in the number of cases of diagnosed arthritis in the U.S. by 49% over the next 20-25 years. In addition, the Lupus Foundation of America estimated that about 5 million people around the world suffered from SLE in 2017, which further indicated that the incidence rate of lupus is 16,000 new cases per year.    

Moreover, government healthcare insurance, increase in autoimmune disorders awareness programs, and reimbursement policies drive the market growth of anti-nuclear antibody testing. For instance, the World Lupus Federation (WLF) is a union of around 250 lupus organizations in 75 countries in six continents with the aim of providing assistance to patients suffering from Lupus. WLF helps to raise awareness about Lupus amongst public and also provide access to better healthcare for patients suffering from Lupus.

Technological advancements and increase in investments in R&D for development of novel products or methodology further propel the market growth of antinuclear antibody testing. For instance, in2019, European League against Rheumatism (EULAR) and the American college of Rheumatology established a classification criterion for systemic lupus erythematosus (SLE), which suggested that the immunofluorescence testing on solid-phase anti-nuclear antibody screening immunoassay and HEp-2 cells with equal performance was highly preferred.  

Global Anti-nuclear Antibody Testing market: Restraints

The major factors likely to restraint the growth of anti-nuclear antibody testing market globally include stringent U.S FDA regulations for product approval, lack of skilled labor, and diagnostic errors. For instance, according to the American College of Rheumatology, healthy people without any health conditions or people using medications like isoniazid and procainamide may show false positive anti-nuclear antibody test. Anti-nuclear antibody test is a highly sensitive diagnostic method but lacks specificity, which can hamper its market growth.

Global Anti-nuclear Antibody Testing market: Product Insights

The reagents and assay kits segment is expected to witness the maximum growth over the forecast period due to factors such as high adoption in clinical and research field and creating standardized workflows to help achieve accurate and reproducible results. High efficiency and reduced costs are believed to drive the market growth in the near future. Moreover, an increase in the number of reagent/assay rental agreements help this segment of anti-nuclear antibody testing market to hold up major shares. Few of the key players involved in reagent and assay kit production are Bio-Rad Laboratories, Zeus Scientific, and Thermo Fisher Scientific.

Global Anti-nuclear Antibody Testing market: Regional Insights

The largest market for anti-nuclear antibody testing is North America, followed by Europe while Asia Pacific is the fastest growing market. However, Middle East and Africa are expected to show limited market growth due to lack of awareness of medical advancements and treatments for diseases associated with anti-nuclear antibody. The dominance of North American anti-nuclear antibody testing market is attributable to several factors such as a rise in the geriatric population and increasing incidence of autoimmune disorders such as Rheumatoid arthritis, SLE, etc. For instance, the American Autoimmune Related Disease Association (AARDA) has declared a list of more than 100 types of autoimmune disorders prevailing in the U.S. The market growth of Asia Pacific is expected to continue at a fast pace as a result of rising population, rise in the incidence of autoimmune disorders, growing investments in R&D, and technological advancements in health infrastructure.

Global Anti-nuclear Antibody Testing market: Impact of COVID-19

The impact of COVID-19 pandemic is expected to be in favour of the anti-nuclear antibody testing market, as patients suffering from COVID-19 are at a high risk of developing autoimmune disorders, which requires early diagnosis using anti-nuclear antibody testing as a preliminary diagnostic tool. For instance, according to a study done by the Department of Laboratory Medicine and Pathology, University of Washington, USA in 2020, 30% of patients suffering from COVID-19 showed the presence of detectable anti-nuclear antibodies. Moreover, an intensive research and trials involving antinuclear antibody testing have been carried out for development of COVID-19 vaccine as well as treatment of COVID-19, which will further propel the anti-nuclear antibody testing market growth.

Global Anti-nuclear Antibody Testing market: Competitive landscape

Key players operating in the anti-nuclear antibody testing market include F. Hoffmann-La Roche Ltd., ERBA Diagnostics, Zeus Scientific, Inc., Alere Inc., Bio-Rad Laboratories, Inc., Becton Dickinson and Company, Antibodies, Inc., EUROIMMUN AG, Immuno Concepts, Inova Diagnostics, Thermo Fisher Scientific, Inc., and Trinity Biotech plc.

These key players focus on mergers, acquisitions, collaborations, product launches, R&D activities, and geographical expansion. For instance, in June 2018, Grifols, a European pharmaceutical and chemical manufacturer, received the U.S. Food and Drug Administration approval for its HELIOS Automated System for IFA, which is used for the diagnosis of autoimmune disorders such as Lupus, Scleroderma, and Antineutrophil Cytoplasmic Antibodies (ANCA)-associated vasculitis. HELIOS enables the laboratories to standardize and reduce time consumption of the diagnostic test, hence driving the growth of anti-nuclear antibody testing market.

Global Anti-nuclear Antibody Testing Market: Taxonomy

By Product

  • Reagents & Assay Kits
  • Systems & Software
  • Services

By Disease 

  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus
  • Sjögren’s Syndrome
  • Scleroderma
  • Other Diseases

By Technique

  • ELISA
  • Multiplex Assay
  • Immunofluorescence Assay

By End Users

  • Hospitals and Clinics
  • Diagnostic Laboratories
  • Others

By Region

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East
  • Africa
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