The global ANA test market is anticipated to grow significantly at a CAGR of 12.3% during the forecast period (2021-2027). The ANA test market is segmented based on the product type, test type, disease type, and end-users. Among the test type, the market is segmented into indirect immunofluorescence, enzyme-linked immunosorbent assay (ELISA), and multiplex testing. Besides, the key companies across the globe are adopting different business strategies including expanding their geographic presence, R&D activities, new product approvals, mergers & acquisitions, partnerships, and collaborations to increase market share.
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Further, in February 2019, Grifols, a producer of plasma-derived medicines and one of the leaders in the development of innovative diagnostic solutions, has announced that the US Food and Drug Administration (FDA) approved the Procleix Babesia assay, a qualitative assay for the detection of the ribosomal RNA from 4 Babesia species (B. microti, B. duncani, B. divergens, B. venatorum) in samples of individual or around 16 pooled lysed specimens from human donors, including donors of whole blood and blood components for transfusion. The assay is utilizing Nucleic Acid Testing (NAT) for blood screening.
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In Addition, in June 2018, Grifols’ latest diagnostic examinations for Antineutrophil Cytoplasmic Antibodies (ANCA)-associated vasculitis and lupus were approved by the US FDA. These tests enabled labs to use immunofluorescence assays to standardize and speed up diagnosis. The FDA’s recent approvals would enable laboratories to diagnose autoimmune diseases like lupus, scleroderma, and vasculitis more accurately and efficiently. Apart from it, in October 2020, ZEUS Scientific has announced the received approval from the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for its in vitro ELISA diagnostic test for the qualitative detection of IgG antibodies to the SARS-CoV-2 virus in human serum and plasma. This test is readily available in all clinical laboratories since it is in stock. However, the various approvals by the US FDA for the assays, diagnostics test, and others of the key players are to propel the growth of the global ANA test market.
Global ANA Test Market Report Segment
By Product Type
- Assay Kits & Reagents
- Antinuclear Antibody Test System
- Antinuclear Antibody Test Software
By Test Type
- Indirect Immunofluorescence
- Enzyme-Linked Immunosorbent Assay (ELISA)
- Multiplex Testing
By Disease Type
- Systemic Lupus Erythematosus
- Sjögren’s Syndrome
- Rheumatoid Arthritis
- Scleroderma
- Others (Addison Disease And Pulmonary Fibrosis)
By End-User
- Hospitals
- Clinical Laboratories
Global ANA Test Market Report Segment by Region
North America
- United States
- Canada
Europe
- UK
- Germany
- Italy
- Spain
- France
- Rest of Europe
Asia-Pacific
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Rest of the World
- Latin America
- Middle East & Africa
Company Profiles
- Abbott Laboratories
- Abbvie, Inc.
- Aerpio Pharmaceuticals, Inc.
- Antisense Therapeutics, Ltd.
- Astellas Pharma Europe, Ltd.
- AstraZeneca plc.
- Bayer AG
- Bristol-Myers Squibb Co.
- Cellmid, Ltd.
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