Antinuclear antibody test is a sensitive screening test used to diagnose autoimmune disorders. The test is used in symptoms such as low-grade fever, skin sensitivity to light, persistent fatigue, weakness and inflammation, and damage to organs and tissues. The test gives two types of results: positive result and negative result. A positive test indicates the presence of autoantibody. Enzyme-linked immunosorbent assay (ELISA) and indirect fluorescent antibody (IFA) are the two types of tests commonly performed to detect antinuclear antibody test. ELISA test results are reported as arbitrary units, and IFA test results are reported as rations, for example 1:320, which indicates one part of blood sample was mixed with 320 parts of a diluting substance. About 95% of antinuclear test is used to test lupus autoimmune disease.
Lupus disease is followed by scleroderma (systemic sclerosis) and Sjögren’s syndrome which shows positive results in about 60% and 40% cases, respectively. The prevalence of antinuclear antibody in healthy individuals is about 3% to 15% and production of autoantibody is age dependent, which increases from 10% to 37% over age 65. The antinuclear antibody test further provides additional diagnostic and prognostic information about the nature of the autoimmune process based on the targeted antigens. Other therapeutic conditions with modest frequency of antinuclear antibody are thyroid, rheumatoid arthritis, HIV, and hepatitis C.
Factors such as growth in health care awareness among people and increase in prevalence of autoimmune diseases, such as rheumatoid arthritis and type I diabetes, are driving the global antinuclear antibody test market. According to WHO, the number of people suffering from diabetes has increased from 108 million in 1980 to 422 million in 2014, and it is expected to increase further in the near future. Other factors such as government health care insurance & reimbursement policies and increase in health care expenditure are projected to fuel the antinuclear antibody test market. However, factors such as stringent regulation for product approval, diagnostic errors, and unavailability of skilled labor are estimated to hinder the antinuclear antibody test market globally.
The antinuclear antibody test reagents market has been segmented by test type, product type, end-user, and geography. In terms of test type, the antinuclear antibody test market is classified into ELISA, IFA, and Dot Blot test. In terms of product type, the market is classified into assay kits and reagents. In terms of end-user, the antinuclear antibody test market is classified into hospitals, clinics, diagnostic centers, and research laboratories. The hospitals segment is expected to contribute a significantly large share due to developed infrastructure and safety test procedure. Geographically, the market is classified into North America, Latin America, Europe, Asia Pacific, and Middle East & Africa.
Geographically, North America dominates the market owing to early disease diagnosis, growth in number of autoimmune diseases such as lupus, developed health care infrastructure, and large number of geriatric population. These factors are estimated to drive the antinuclear antibody test market in the region. According to Lupus Foundation of America, 1.5 million Americans and approximately 5 million people are living with lupus disease. North America is followed by Europe with a large market for antinuclear antibody test. Asia Pacific is expected to grow at a higher rate during the forecast period due to rapid rise in population, high prevalence of autoimmune disorders, increase in public awareness, and improvement in health care infrastructure, which in turn boost the antinuclear antibody test market. Growing number of government awareness campaigns is the driving factor boosting patients to seek clinical diagnostics even for disease symptoms. Other emerging countries such as Brazil and South Africa are anticipated to create a large opportunity for the antinuclear antibody test market.
Major players operating in this market include Alere Inc., Thermo Fisher Scientific, Inc., Trinity Biotech PLC, Bio-Rad Laboratories, Inc., Becton Dickinson and Company, Biocom Biotech, Erba Diagnostics, ZEUS Scientific, Inc., and F. Hoffmann-La Roche Ltd.