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  • Published On : Dec 2021
  • Code : CMI4568
  • Industry : Biotechnology
  • Pages : 190
  • Formats :

The coronavirus (COVID-19) outbreak was first reported on December 31, 2019, in Wuhan, China. The World Health Organization declared COVID-19 as a pandemic on March 11, 2020. COVID-19 infection is caused by the novel SARS-CoV-2, which is a member of single stranded RNA coronavirus family. Some of the common symptoms observed in COVID-19 patients include dry cough, fever, and fatigue while some less common symptoms include muscle pain, nausea, diarrhea, loss of smell, vomiting, chills, and conjunctivitis. Sometimes, severe symptoms such as shortness of breath, loss of appetite, and others may be observed in the COVID-19 patients. The COVID-19 rapid test kits are either rapid antigen test kits or rapid antibody test kits.

The global COVID-19 rapid diagnostic test market is estimated to be valued at US$ 3,846.9 Mn in 2021 and is expected to exhibit a CAGR of 8.8% during the forecast period (2021-2028).

Figure 1.Global COVID-19 Rapid Diagnostic Test Market Share (%) in Terms of Value, by Sample Type, 2021

COVID-19 Rapid Diagnostic Test  | Coherent Market Insights

Increasing acquisition and collaboration among the key players is expected to drive the market growth during the forecast period

The increasing acquisition and collaboration among the key players is expected to drive the global COVID-19 rapid diagnostic test market growth during the forecast period. For instance, in February 2021, BD, a U.S.-based medical device company, collaborated with Scanwell Health, a California-based smartphone-enabled at-home medical tests manufacturer, to create an at-home lateral flow rapid antigen test for SARS-CoV-2 using a BD antigen test and the Scanwell Health mobile app.

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COVID-19 Rapid Diagnostic Test Market Report Coverage

Report Coverage Details
Base Year: 2020 Market Size in 2021: US$ 3,846.9 Mn
Historical Data for: 2017 to 2020 Forecast Period: 2021 to 2028
Forecast Period 2021 to 2028 CAGR: 8.8% 2028 Value Projection: US$ 6,952.3 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Product Type: Instruments, Reagents and Kits
  • By Sample Type: Nasopharyngeal swab, Oropharyngeal swab, Nasal swab, Osteosarcoma, Blood, Others
  • By Test Type: Molecular Testing, Antigen based testing, Antibody Testing, Others
  • By End User: Hospitals, Laboratories and Diagnostic Centers, Others
Companies covered:

Abbott Laboratories, F. Hoffmann-La Roche AG, Cardinal Health, Inc., Alfa Scientific Designs, Inc., Acon Laboratories, Inc., Thermo Fisher Scientific Inc., Danaher Corporation, PerkinElmer, Inc., Bio-Rad Laboratories, Inc., and Creative Diagnostics

Growth Drivers:
  • Increasing demand for COVID-19 rapid diagnostic test due to the COVID-19 outbreak
  • Increasing product launches and approvals
Restraints & Challenges:
  • Recalls of COVID-19 rapid diagnostic test kits
  • Lack of skilled healthcare professionals
  • Less efficacy of rapid COVID-19 diagnostic tests as compared to laboratory setting

Figure 2.Global COVID-19 Rapid Diagnostic Test Market Share (%), by Test Type, 2021

COVID-19 Rapid Diagnostic Test  | Coherent Market Insights

Increasing product launches and regulatory approvals is expected to drive the COVID-19 rapid diagnostic test market growth

Increasing product launches and regulatory approvals is expected to drive the COVID-19 rapid diagnostic test market growth during the forecast period. For instance, in September 2020, Laboratory Corporation of America Holdings, a U.S.-based testing laboratory company, launched a combined diagnostic test for flu, respiratory syncytial virus (RSV), and COVID-19.

Moreover, in September 2020, Mammoth Biosciences, a U.S.-based biotechnology company, received emergency use authorization from the U.S. FDA for its SARS-CoV-2 DETECTR Reagent Kit, which is based on CRISPR technology.

Global COVID-19 Rapid Diagnostic Test Market– Impact of Coronavirus (COVID-19) Pandemic

According to the Coronavirus (COVID-19) Weekly Epidemiological Update by the World Health Organization, over 245,403,909 cases and 4,981,395 deaths due to coronavirus (COVID-19) were reported till October 27, 2021, across the globe. During the COVID-19 pandemic, pharmaceutical business, and likewise biotechnology firms are facing difficulties due to the interruption in supply chains.

The global incidence of coronavirus is escalating demand for advanced diagnostic test kits, which is expected to boost growth of the COVID-19 rapid diagnostic test market.

Increasing demand of product launches for the diagnosis of COVID-19 is expected to drive the COVID-19 rapid diagnostic test market growth. For instance, in October 2020, Cipla Inc., an Indian pharmaceutical company, launched its new COVID-19 diagnostic test called ELIFast. ELIFast is based on ELISA (Enzyme linked immunosorbent assay), which detects the antibodies against SARS-CoV-2.

Global COVID-19 Rapid Diagnostic Test Market: Restraint

Product recalls, lack of skilled healthcare professionals, and less efficacy of rapid COVID-19 diagnostic tests as compared to laboratory setting are the factors that are expected to hinder growth of the global COVID-19 rapid diagnostic test market over the forecast period. For instance, in May 2020, India recalled rapid-antibody COVID-19 testing kits from two Chinese in-vitro diagnostics companies, namely Guangzhou Wondfo Biotech Co. and Zhuhai Livzon Diagnostics, Inc. due to low accuracy and inconsistent results delivered by the COVID-19 test kits.

Moreover, on October 1, 2021, Ellume Limited, an Australia-based digital diagnostics company, issued a recall of approximately 427,000 of its COVID-19 home tests. In total, approximately 42,000 affected tests were used and produced false positive results.

Key Players

Major players operating in the global COVID-19 rapid diagnostic test market include Abbott Laboratories, F. Hoffmann-La Roche AG, Cardinal Health, Inc., Alfa Scientific Designs, Inc., Acon Laboratories, Inc., Thermo Fisher Scientific Inc., Danaher Corporation, PerkinElmer, Inc., Bio-Rad Laboratories, Inc., and Creative Diagnostics.

A rapid diagnostic test of a sample of a person helps to detect the presence of viral proteins (antigens) related to the COVID-19 virus. This ensures an accurate and a speedy diagnosis, and its usage is Centers for Disease Control and Prevention CDC-approved. This test is a rapid diagnostic test based on antigen detection. The other test is rapid diagnostic test based on antibody detection. This test is used to detect the presence of antibodies in the blood of COVID-19 infected people. The strength of the antibody response depends on several factors like medications, age, infections, and the severity of disease, etc.

Molecular and antigen tests are types of diagnostic tests that can detect the infection if you have an active COVID-19 infection. Samples for diagnostic tests are normally collected with a throat or nasal swab, or saliva collected by spitting into a tube. Antibody tests look for antibodies in your immune system produced in response to SARS-CoV-2, the virus that is responsible for causing COVID-19. Antibody tests cannot be used to diagnose an active COVID-19 infection. Antibodies can take several days or weeks to develop after you get infected by the infection and may stay in your blood for several weeks or even after recovery from the infection. Samples for antibody tests are typically blood drawn by your doctor or other medical personnel.

Market Dynamics

The increasing number of approvals for new and advanced COVID-19 rapid diagnostic test kits by regulatory authorities is expected to propel the market growth over the forecast period. For instance, on May 12, 2020, Fujirebio Europe received CE mark for the molecular IVD assay iAMP COVID-19 detection kit, developed in partnership with Atila Biosystems, Inc., a U.S.-based company focused on developing products for nucleic acid amplification and detection of clinical diagnostic applications. Moreover, in September 2020, the U.S. FDA granted emergency use status to MiraDx, a U.S.-based molecular genetics company, for its SARS-CoV-2 RT-PCR assay used for detection of COVID-19.

Furthermore, development of cheaper COVID-19 detection kits is expected to drive the global COVID-19 rapid diagnostic test market growth over the forecast period. For instance, in January 2021, the World Health Organization approved a rapid antigen test developed by UNICEF (United Nations International Children’s Emergency Fund) for diagnosis of COVID-19 under emergency use. This COVID-19 diagnostic test is a low cost alternative to other more expensive COVID-19 test and is priced at US$ 2.55 per test. With the development of such low cost COVID-19 rapid diagnostic tests, low and middle income countries such as Bangladesh, Indonesia, and others would have more access to the COVID-19 diagnostic tests.

Key features of the study:

  • This report provides in-depth analysis of the global COVID-19 rapid diagnostic test market, and provides market size (US$ Mn) and compound annual growth rate (CAGR%) for the forecast period (2021–2028), considering 2020 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends,  regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global COVID-19 rapid diagnostic test market based on the following parameters – company highlights, products portfolio, key highlights, financial performance, and strategies
  • Key companies covered as a part of this study include Abbott Laboratories, F. Hoffmann-La Roche AG, Cardinal Health, Inc., Alfa Scientific Designs, Inc., Acon Laboratories, Inc., Thermo Fisher Scientific Inc., Danaher Corporation, PerkinElmer, Inc., Bio-Rad Laboratories, Inc., and Creative Diagnostics
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
  • The global COVID-19 rapid diagnostic test market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global COVID-19 rapid diagnostic test market

Detailed Segmentation:

  • Global COVID-19 Rapid Diagnostic Test Market, By Product Type:
    • Instruments
    • Reagents & Kits
  • Global COVID-19 Rapid Diagnostic Test Market, By Sample Type:
    • Nasopharyngeal (NP) Swabs
    • Oropharyngeal (OP) Swabs
    • Nasal Swabs
    • Blood
    • Others (others include Saliva)
  • Global COVID-19 Rapid Diagnostic Test Market, By Test Type:
    • Molecular Testing
    • Antigen-based Testing
    • Antibody Testing
    • Others (others include CRISPR and Biosensors)
  • Global COVID-19 Rapid Diagnostic Test Market, By End User:
    • Hospitals & Clinic
    • Laboratories & Diagnostics Centers
    • Others
  • Global COVID-19 Rapid Diagnostic Test Market, By Region:
    • North America
      • By Product Type
        • Instruments
        • Reagents and Kits
      • By Sample Type
        • Nasopharyngeal (NP) Swabs
        • Oropharyngeal (OP) Swabs
        • Nasal Swabs
        • Blood
        • Others (others include Saliva)
      • By Test Type
        • Molecular Testing
        • Antigen-based Testing
        • Antibody Testing
        • Others (others include CRISPR and Biosensors)
      • By End User
        • Hospitals and Clinic
        • Laboratories & Diagnostics Centers
        • Others
      • By Country
        • U.S.
        • Canada
    • Latin America
      • By Product Type
        • Instruments
        • Reagents and Kits
      • By Sample Type
        • Nasopharyngeal (NP) Swabs
        • Oropharyngeal (OP) Swabs
        • Nasal Swabs
        • Blood
        • Others (others include Saliva)
      • By Test Type
        • Molecular Testing
        • Antigen-based Testing
        • Antibody Testing
        • Others (others include CRISPR and Biosensors)
      • By End User
        • Hospitals and Clinic
        • Laboratories & Diagnostics Centers
        • Others
      • By Country
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Product Type
        • Instruments
        • Reagents and Kits
      • By Sample Type
        • Nasopharyngeal (NP) Swabs
        • Oropharyngeal (OP) Swabs
        • Nasal Swabs
        • Blood
        • Others (others include Saliva)
      • By Test Type
        • Molecular Testing
        • Antigen-based Testing
        • Antibody Testing
        • Others (others include CRISPR and Biosensors)
      • By End User
        • Hospitals and Clinic
        • Laboratories & Diagnostics Centers
        • Others
      • By Country
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Product Type
        • Instruments
        • Reagents and Kits
      • By Sample Type
        • Nasopharyngeal (NP) Swabs
        • Oropharyngeal (OP) Swabs
        • Nasal Swabs
        • Blood
        • Others (others include Saliva)
      • By Test Type
        • Molecular Testing
        • Antigen-based Testing
        • Antibody Testing
        • Others (others include CRISPR and Biosensors)
      • By End User
        • Hospitals and Clinic
        • Laboratories & Diagnostics Centers
        • Others
      • By Country
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Product Type
        • Instruments
        • Reagents and Kits
      • By Sample Type
        • Nasopharyngeal (NP) Swabs
        • Oropharyngeal (OP) Swabs
        • Nasal Swabs
        • Blood
        • Others (others include Saliva)
      • By Test Type
        • Molecular Testing
        • Antigen-based Testing
        • Antibody Testing
        • Others (others include CRISPR and Biosensors)
      • By End User
        • Hospitals and Clinic
        • Laboratories & Diagnostics Centers
        • Others
      • By Country
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Product Type
        • Instruments
        • Reagents and Kits
      • By Sample Type
        • Nasopharyngeal (NP) Swabs
        • Oropharyngeal (OP) Swabs
        • Nasal Swabs
        • Blood
        • Others (others include Saliva)
      • By Test Type
        • Molecular Testing
        • Antigen-based Testing
        • Antibody Testing
        • Others (others include CRISPR and Biosensors)
      • By End User
        • Hospitals and Clinic
        • Laboratories & Diagnostics Centers
        • Others
      • By Country/Region
        • South Africa
        • Central Africa
        • North Africa
  • By Company Profiles :
    • Abbott Laboratories*
      • Company Highlights
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • F. Hoffmann-La Roche AG
    • Cardinal Health, Inc
    • Alfa Scientific Designs, Inc
    • Acon Laboratories, Inc
    • Thermo Fisher Scientific Inc
    • Danaher Corporation
    • PerkinElmer, Inc
    • Bio-Rad Laboratories, Inc
    • Creative Diagnostics

 “*” marked represents similar segmentation in other categories in the respective section.

Frequently Asked Questions

The global COVID-19 rapid diagnostic test market size is estimated to be valued at US$ 3,846.9 Mn in 2021 and is expected to exhibit a CAGR of 8.8% between 2021 and 2028.
Increasing incidence of COVID-19 and increasing research and development activities for the development of novel diagnostics for the diagnosis of COVID-19 infection are expected to drive the market growth over the forecast period.
Nasopharyngeal swab sample type segment is the leading sample type segment in the market.
North America holds the largest market share in the global market.
Product recalls, lack of skilled healthcare professionals, and less efficacy of rapid COVID-19 diagnostic tests as compared to laboratory setting are the factors that are expected to hamper the growth of the market.
Major players operating in the market include Abbott Laboratories, F. Hoffmann-La Roche AG, Cardinal Health, InC., Alfa Scientific Designs, Inc., Acon Laboratories, Inc., Thermo Fisher Scientific Inc., Danaher Corporation, PerkinElmer, Inc., Bio-Rad Laboratories, Inc., and Creative Diagnostics.

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