The Increasing Approvals by the FDA Along With the Launching of New Products to Support the Global Antinuclear Antibody (ANA) Test Market

Published: May 2022

The global ANA Test market is anticipated to grow at a considerable CAGR of 12.3% during the forecast period. The increasing approvals for the various advanced treatments by the FDA and other organizations are contributing to the growth of the global market. For instance, in January 2022, Paracrine, Inc. announced that the FDA has granted full approval of its Investigational Device Exemption (IDE) to conduct a pivotal trial titled Scleroderma Treatment with Celution Processed Adipose-Derived Regenerative Cells: A Randomized, Double-blind, and Placebo-Controlled Study - the “STAR II Trial.” The STAR II Trial is a Pivotal Trial designed to provide a robust data set on the safety and efficacy of adipose-derived regenerative cells (ADRCs) in the treatment of patients with hand dysfunction due to diffuse cutaneous scleroderma.

  • For instance, in December 2021, Navidea Biopharmaceuticals, Inc., a company focused on the development of precision immunodiagnostic agents and immunotherapeutics announced the launch of the NAV3-33 Phase 3 clinical trial titled “Evaluation of Tc99m Tilmanocept Imaging for the Early Prediction of Anti-TNF? Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA).”
  • For instance, in August 2021, AstraZeneca’s Saphnelo (anifrolumab-fnia) was approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. The approval by the Food and Drug Administration (FDA) was based on efficacy and safety data from the Saphnelo clinical development program, including two TULIP Phase III trials and the MUSE Phase II trial. 
  • For instance, in December 2020, GlaxoSmithKline plc announced the US Food and Drug Administration (FDA) has approved BENLYSTA (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. Lupus nephritis is a serious inflammation of the kidneys caused by systemic lupus erythematosus (SLE), the most common form of lupus, which can lead to end-stage kidney disease, requiring dialysis or a kidney transplant. The approval extends the current indication in the US to include both SLE and LN for both the intravenous and subcutaneous formulations.
  • For instance, in February 2019, Grifols, a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, announced that the U.S. 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 individual samples or up to 16 pooled lysed specimens from human donors, including donors of whole blood and blood components for transfusion.

Browse the full report description “Global Antinuclear Antibody (ANA) Test Market Size, Share & Trends Analysis Report by Product Type (Assay Kits & Reagents, Antinuclear Antibody Test System, and Antinuclear Antibody Test Software), by Test Type (Indirect Immunofluorescence, Enzyme-Linked Immunosorbent Assay (ELISA), and Multiplex Testing), by Disease Type (Systemic Lupus Erythematosus, Sjogren’s Syndrome, Rheumatoid Arthritis, Scleroderma, and Others), and by End-User (Hospitals and Clinical Laboratories) Forecast Period (2022-2028)” at https://www.omrglobal.com/industry-reports/antinuclear-antibody-ana-test-market 

Market Coverage

  • The market number available for – 2021-2028
  • Base year- 2021
  • Forecast period- 2022-2028

Segment Covered- 

  • By Product Type
  • By Test Type
  • By Disease Type
  • By End-User

Regions Covered-

  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World

Competitive Landscape- including Abbott Laboratories, and AESKU. GROUP GmbH, Antibodies Inc., Bio-Rad Laboratories, Inc., Hycor Biomedical, MBL International Corp., Thermo Fisher Scientific Inc., ZEUS Scientific, Inc., and 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 has COVID-19 impacted the market?

oDeviation from the pre-COVID-19 forecast

oMost 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
  • Multiplex Testing

By Disease Type

  • Systemic Lupus Erythematosus 
  • Sjögren’s Syndrome
  • Rheumatoid Arthritis
  • Scleroderma
  • Others

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

To learn more about this report request a free sample copy @ https://www.omrglobal.com/industry-reports/antinuclear-antibody-ana-test-market