Press Release

COVID-19 Diagnostics Market : Quidel Receives Emergency Use Authorization to Distribute Sofia 2 SARS Antigen FIA from FDA, reports Fortune Business Insights™

The global COVID-19 diagnostics market is set to gain momentum from the increasing research and development activities to create numerous compounds and combinations for the creation of novel coronavirus detection systems and therapies. Biopharma Reporter, for instance, mentioned that the U.S. experienced a surge of 255 therapies in March 2020 against this deadly virus. This information is given by Fortune Business Insights™ in a report, titled, “COVID-19 Diagnostics Market, 2021-2028.” As per the report, the market size was USD 16.05 billion in 2020. It is projected to drop from USD 20.05 billion in 2021 to USD 9.20 billion in 2028 at a CAGR of -10.5% in the forecast period.

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InstrumentsSegment to Remain at Forefront Stoked by Adoption of ELISA Instruments

Based on the product type, the market is bifurcated into instruments and reagents & kits. Out of these, the instruments segment remained dominant in 2020 by holding the largest COVID-19 diagnostics market share. This growth is attributable to the surging usage of ELISA instruments and polymerase chain reaction (PCR) analyzers for conducting R&D activities.

Increasing Prevalence of Communicable Coronavirus Diseases to Drive Growth

The rising prevalence of communicable coronavirus diseases has surged the demand for COVID-19 diagnostics across the globe. The Worldometer statistics, for instance, declared that the number of daily new cases is rising constantly. As of 18th May 2021, around 163,312,429 people were affected by COVID-19, according to the World Health Organization (WHO). Besides, the surging sales of reagents & kits for the detection of this virus are expected to drive the COVID-19 diagnostics market growth in the upcoming years. However, manufacturers have to undergo stringent regulatory restrictions for launching state-of-the-art kits. It may hamper growth.

Presence of Novel Diagnostic Equipment to Help North America Dominate

Geographically, in 2020, North America earned USD 5.28 billion in terms of revenue and would lead the market throughout the forthcoming years. The increasing testing rates to detect the coronavirus and the presence of adequate COVID-19 diagnostic equipment would bolster growth. On the other hand, Europe is anticipated to exhibit a significant CAGR fueled by the utilization of advanced COVID diagnostics technologies for preventing transmission of this deadly virus.

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Key Players Focus on Receiving Fast Track Approvals to Distribute Their In-house Products

The global market contains a large number of companies that are persistently striving to gain a competitive edge. To do so, they are trying to receive approvals from regulatory bodies for distributing their products in the market. Below are the two notable industry developments:

  • May 2020: Quidel received Emergency Use Authorization (EUA) from the U.S. FDA to distribute its rapid point-of-care test named Sofia 2 SARS Antigen FIA for the detection of COVID-19.
  • March 2020: The U.S. Food and Drug Administration approved the usage of the first point-of-care test for COVID-19 diagnosis. It will help Americans in providing results within hours, rather than days, unlike the other existing tests.

A list of renowned providers of COVID-19 diagnostics present in the global market:

  • Abbott (Illinois, U.S)
  • Danaher Corporation (Washington D.C, U.S)
  • Siemens Healthcare GmbH (Germany, Europe)
  • Hoffmann-La Roche Ltd (Switzerland, Europe)
  • Quidel Corporation (California, U.S)
  • bioMérieux SA (France, Europe)
  • Quest Diagnostics Incorporated (New Jersey, U.S)
  • Thermo Fisher Scientific Inc. (Massachusetts, U.S)
  • PerkinElmer Inc. (Massachusetts, U.S)
  • Other Prominent Players

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Detailed Table of Content:

  • Introduction
    • Market Scope
    • Market Segmentation
    • Market Methodology
    • Definitions and Assumptions
  • Executive Summary
  • Market Dynamics
    • Market Drivers
    • Market Restraints
    • Market Opportunities
  • Key Insights
    • Overview: Guidelines for COVID-19 Diagnosis
    • New Product Launch
    • Prevalence of COVID-19 Disease
    • Impact of COVID-19 on Diagnostics Market
    • Overview of Regulatory Scenario
    • Impact on Supply Chain of Diagnostics Amid the Pandemic
    • Key Industry Developments – Mergers, Acquisitions, and Partnerships
    • Recent Launches/Developments Pertaining to Mobile/On-site COVID-19 Testing
  • Global COVID-19 Diagnostics Market Analysis, Insights and Forecast, 2020-2028
    • Key Findings / Summary
    • Market Analysis, Insights and Forecast – By Product
      • Instruments
      • Reagents & Kits
    • Market Analysis, Insights and Forecast – By Technology
      • Polymerase Chain Reaction (PCR)
      • Enzyme-linked Immunosorbent Assay (ELISA)
      • Lateral Flow Immunoassay (LFIA)
      • Others
    • Market Analysis, Insights and Forecast – By Sample Type
      • Oropharyngeal & Nasopharyngeal Swabs
      • Nasal Swab
      • Blood
      • Others
    • Market Analysis, Insights and Forecast – By Setting
      • Lab-based
      • Point of Care
    • Market Analysis, Insights and Forecast – By End User
      • Hospitals & Clinics
      • Laboratories & Diagnostic Centers
      • Others
    • Market Analysis, Insights and Forecast – By Geography
      • North America
      • Europe
      • Asia Pacific
      • Latin America
      • Middle East & Africa
    • North America COVID-19 Diagnostics Market Analysis, Insights and Forecast, 2020-2028
      • Key Findings / Summary
      • Market Analysis, Insights and Forecast – By Product
        • Instruments
        • Reagents & Kits
      • Market Analysis, Insights and Forecast – By Technology
        • Polymerase Chain Reaction (PCR)
        • Enzyme-linked Immunosorbent Assay (ELISA)
        • Lateral Flow Immunoassay (LFIA)
        • Others
      • Market Analysis, Insights and Forecast – By Sample Type
        • Oropharyngeal & Nasopharyngeal Swabs
        • Nasal Swab
        • Blood
        • Others
      • Market Analysis, Insights and Forecast – By Setting
        • Lab-based
        • Point of Care
      • Market Analysis, Insights and Forecast – By End User
        • Hospitals & Clinics
        • Laboratories & Diagnostic Centers
        • Others
      • Market Analysis, Insights and Forecast – By Country
        • U.S.
        • Canada
      • Europe COVID-19 Diagnostics Market Analysis, Insights and Forecast, 2020-2028
        • Key Findings / Summary
        • Market Analysis, Insights and Forecast – By Product
          • Instruments
          • Reagents & Kits
        • Market Analysis, Insights and Forecast – By Technology
          • Polymerase Chain Reaction (PCR)
          • Enzyme-linked Immunosorbent Assay (ELISA)
          • Lateral Flow Immunoassay (LFIA)
          • Others
        • Market Analysis, Insights and Forecast – By Sample Type
          • Oropharyngeal & Nasopharyngeal Swabs
          • Nasal Swab
          • Blood
          • Others
        • Market Analysis, Insights and Forecast – By Setting
          • Lab-based
          • Point of Care
        • Market Analysis, Insights and Forecast – By End User
          • Hospitals & Clinics
          • Laboratories & Diagnostic Centers
          • Others
        • Market Analysis, Insights and Forecast – By Country/Sub-region
          • U.K.
          • Germany
          • France
          • Spain
          • Italy
          • Scandinavia
          • Rest of Europe

TOC Continued….

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