The global ANA test market is anticipated to grow significantly at a CAGR of 12.3% during the forecast period (2024-2031). 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.
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.
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Market Coverage
- Segment Covered-
o By Product Type
o By Test Type
o By Disease Type
o By End-User
- Regions Covered-
o North America
o Europe
o Asia-Pacific
o Rest of the World
- Competitive Landscape- Abbott Laboratories, ERBA Diagnostics, Inc., Trinity Biotech plc, Bio-Rad Laboratories, Inc., Thermo Fisher Scientific, Inc., and Antibodies, Inc., among others.
Key questions addressed by the report
- What is the market growth rate?
- Which segment and region dominate the market in the base year?
- Which segment and region will project the fastest growth in the market?
- How COVID-19 impacted the market?
o Deviation from the pre-COVID-19 forecast
o Most affected region and segment
- Who is the leader in the market?
- How players are addressing challenges to sustain growth?
- Where is the investment opportunity?
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
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