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COVID-19 Diagnostics Market Size, Share & Industry Analysis, By Product (Instruments and Reagents & Kits), By Technology (PCR (Polymerase Chain Reaction), ELISA (Enzyme-linked Immunosorbent Assay), Lateral Flow Immunoassay (LFIA)), By Sample Type (Oropharyngeal and Nasopharyngeal Swabs, Nasal Swabs, Blood), By Setting (Lab-Based, Point of Care) By End-User (Hospitals & Clinics, Laboratories & Diagnostic Centers), and Regional Forecast, 2021-2028

Region : Global | Format: PDF | Report ID: FBI103291



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The global COVID-19 diagnostics market size was USD 16.05 billion in 2020. The global impact of corona has been unprecedented and staggering, with COVID-19 diagnostics witnessing a positive demand shock across all regions amid the pandemic. Based on our analysis, the market will exhibit a stellar growth share of 24.9% in 2021. The market 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 2021-2028 period. The sudden fall in CAGR is attributable to factors such as growth in vaccination rates and decline in infections.

Coronavirus outbreak was declared by the World Health Organization (WHO) as a Public Health Emergency in January 2020. Since then, the number of cases in many countries has surged exponentially. According to Worldometer, as of May 2021, the U.S. recorded the highest corona cases in the world, accounting for around 96.2% in the North American region. The sudden emergence of the crisis has brought increased COVID-19 diagnostic activities, treatment procedures, and a rise in R&D activities for the development of diagnostics, such as molecular tests and point-of-care tests, among others.

Countries are racing to slow down the spread of the disease by implementing necessary measures and increasing sample testing. The growing demand for COVID-19 diagnostic procedures and products has created immense opportunities in the healthcare industry, thus augmenting the market value. Diagnostic companies in this industry, such as Thermo Fisher Scientific, Roche, and Bio-Rad, among others, have developed various technologies to improve detection and treatment against COVID-19 infection. Therefore, the increasing prevalence of infectious disease, coupled with the demand for accurate diagnostic procedures, is anticipated to give momentum to the market growth


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Introduction of Novel Therapies for COVID-19 Treatment is a Prominent Trend

The emergence of the COVID-19 pandemic has led to an explosion of research on various combinations of compounds in laboratories to develop COVID-19 diagnostics and therapies. Multiple pharmaceutical and biotechnology companies have registered their preclinical as well as clinical studies for testing novel therapies against the deadly virus. Plasma therapy, immunotherapy, and stem therapy trials are currently in the pipeline. This trend is likely to increase the potentiality of the coronavirus detection market during the forecast period.

According to the Biopharma Reporter, as of March 2020, the U.S. holds the highest position by registering 255 therapies against this highly infectious disease. Additionally, the first epicenter of the virus, China, has 39 therapies in the pipeline. Other countries, such as the U.K., Switzerland, Germany, France, and India, also have their therapies in the pipeline. Such extensive research projects and investments are likely to boost the market growth during the forecast period.


Rising Prevalence of Coronavirus Disease to Fuel Demand for Diagnostic Devices & Kits

The sudden rise in the communicable coronavirus disease leading to a global pandemic has resulted in the escalating demand for COVID-19 diagnostic procedures and products. According to the Worldometer statistics, there has been a continuous rise in new daily cases across the globe. According to the World Health Organization (WHO), as of 18th May 2021, 163,312,429 people globally are affected with COVID-19. Such rapid daily rise in cases has surged the adoption of COVID-19 diagnostic tests so as to provide early treatment to patients.

Moreover, a surge in coronavirus infection has also been recorded in growing economies. For example, Brazil’s total number of cases stands at 15.9 million as of May 2021. This is likely to increase the sales of reagents & kits used in the detection of the virus. Additionally, rising R&D activities are likely to drive market growth during the forecast period. Also, higher investments are being made by several companies to support the development of diagnostic solutions. For instance, in July 2020, the National Institutes of Health (NIH) invested USD 248.7 million in new technologies to address challenges associated with COVID-19 diagnostics (which detects SARS-CoV-2 coronavirus).

Launch of Innovative Products to Propel Market Growth

Protecting human lives is the most crucial element of the healthcare system during a pandemic situation. The need of the hour is to have accurate diagnostic procedures so as to receive early treatment. This has led pharmaceutical and medical device companies to invest in R&D to launch novel testing kits and assays. Large and small companies, as well as startups, are introducing new products for patients and healthcare personnel.

For example, in May 2021, Cipla Limited, in partnership with Ubio Biotechnology Systems Pvt. Ltd announced the launch of the test kit ViraGen in India for corona diagnosis. This serology test is performed by collecting and analyzing saliva samples for detection of the coronavirus antigen. Also, in May 2021, Precipio announced the launch of the COVID-19 rapid antibody test that is capable of testing IgG and IgM antibodies. The POC device gives results within 20 minutes and has been launched on Amazon.


Stringent Regulatory Framework to Develop New Test Kits May Limit Growth

Though the COVID-19 diagnostic market has tremendous potential and upcoming opportunities, there are some challenges that are likely to hinder the growth of the global market. Owing to the continuous rise in COVID-19 infections worldwide, the demand for better, safer, and faster detection kits to provide successful treatment to patients has created havoc in the diagnostics market.

However, despite the dire need for these diagnostic tools, manufacturers have to pass through stringent regulatory restrictions to launch novel kits and maintain the supply chain. For instance, every country has its own regulatory authority implementing different regulations and guidelines for manufacturers. To ensure the safety of products, the U.S Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and other regulatory bodies have updated their guidelines. Moreover, increasing budgetary constraints are also likely to impact the market growth during the forecast period.


By Product Analysis

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Increased R&D among Diagnostic Companies to Surge Sales of Reagents & Kits

On the basis of product, the market includes instruments and reagents & kits. The instruments segment held a dominant COVID-19 diagnostics market share in 2020 on account of the increased adoption of polymerase chain reaction (PCR) analyzers and ELISA instruments to conduct R&D for diagnostics purposes. Moreover, the use of instruments for the detection of COVID disease in hospitals, clinics, and laboratories has gained traction, thereby fueling sales of the segment.

The reagents & kits segment is projected to register a higher CAGR by 2028 due to the increasing demand for the products with respect to the increasing R&D in the companies coupled with the growing need for detection of the diseases. As these kits are one-time use, they need to be bought in bulk quantities and need to be supplied regularly. This is likely to aid the segment in registering a higher growth rate during the forecast period.

By Technology Analysis

Higher Rate of Accurate Output through PCR Technique to Increase Their Adoption

By technology, the market is classified into PCR, ELISA, LFIA, and others.

The PCR technique segment dominated the market in 2020. The dominance is attributable to the increased quantification of patient samples by the use of PCR. According to a news article published by The Hindu in June 2020, researchers from the Center for Cellular and Molecular Biology (CCMB) said that they find the PCR method to be less expensive than others. Hence, patient samples are largely quantified using PCR. PCR adoption has also contributed to the considerable growth of the segment. Moreover, the launch of new PCR-based detection techniques is likely to surge the demand for PCR instruments in the upcoming years.

The ELISA segment holds the second-leading position in the market owing to the U.S FDA and other regulatory authorities' approvals for ELISA-based tests. The LFIA segment is anticipated to show the highest CAGR during the forecast period. Such tests identify the existence of the novel coronavirus antigens through nasal or nasopharyngeal samples and provide results within 15 minutes.

By Sample Type Analysis

Surging Number of Tests to Drive Oropharyngeal & Nasopharyngeal Swabs Segment

By sample type, the market for COVID-19 Diagnostics is segmented into oropharyngeal & nasopharyngeal swabs, nasal swabs, blood, and others.

The oropharyngeal & nasopharyngeal swabs segment marked the higher position in the market owing to the increased COVID-19 testing by the conductance of such swab tests. Swab tests are easy, convenient, and can be carried out within a short time. Owing to the increased pressure of testing patients with coronavirus infections, these swab tests are friendlier and can deliver results within a few hours. For example, in June 2020, as stated in a news article in the Global Times, Beijing sampled 2.29 million people using swab tests for screening COVID cases between June 11 and June 20.  

The nasal swabs sample type holds the second-leading position in the market owing to the higher collection of samples for diagnostic purposes. The blood samples segment is anticipated to register the highest CAGR during the forecast timeframe. Additionally, researchers have been collecting blood samples of patients to carry out exhaustive research activities to bring novel therapies, such as plasma therapy, for treatment. On the other hand, the others segment is anticipated to register a smaller market share and CAGR owing to the lesser frequency of this sample type collected for detection purposes.

By Setting Analysis

Rigorous Diagnosis of COVID-19 at Lab-based Setting to Help with its Dominance

By setting, the market is segmented into lab-based and point of care. The lab-based setting segment dominated the market in 2020 owing to the growing number of laboratories offering high-throughput technologies to speed up the process of COVID-19 tests effectively. For instance, in June 2020, the Indian Institute of Technology, Hyderabad, announced the development of an Artificial Intelligence-powered COVID-19 test, which can be performed at an affordable cost.

Besides, the point of care testing (POC) segment is estimated to exhibit the highest CAGR during the forecast timeframe. The growth is attributable to the rising number of COVID-19 POC testing, coupled with the surging rate of U.S. FDA approvals for efficient and highly sensitive POC tests for the disease. For instance, in July 2020, BD received the Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Veritor System indicated for the rapid detection of SARS-CoV-2. This can be used in point-of-care settings.

By End-User Analysis

Availability of Necessary COVID-19 Diagnostic Equipment to Drive Hospitals & Clinics Segment

In terms of end-users, the market segments include hospitals & clinics, laboratories & diagnostic centers, and others.

The hospitals & clinics segment is expected to have a dominant share in the market during the forecast period. The dominance is due to a sudden increase in hospital stays of patients suffering from COVID-19. For instance, according to the Worldometer statistics, as of May 2021, there were more than 15 million coronavirus active cases in the world.

The laboratories & diagnostic centers segment is expected to grow at a significant CAGR during the forecast period due to the increasing diagnostic procedures, coupled with the sales of diagnostic products in developed and emerging economies. Moreover, the others segment, which includes research institutes, is also likely to register a comparatively higher CAGR owing to the extensive research activities carried out for the development of the COVID vaccine.


North America COVID-19 Diagnostics Market Size, 2020 (USD Billion)

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The market size in North America stood at USD 5.28 billion in 2020. The dominance of this region in terms of the market growth is attributable to the increasing prevalence of coronavirus infections and higher testing rates for the detection of the virus. For instance, according to the Worldometer statistics, the U.S. recorded more than 33 million cases as of May 2021 and conducted over 470 million tests. This, along with the presence of adequate COVID-19 diagnostic equipment and higher sales of reagents & kits for conducting these tests, is responsible for the dominance of North America in the global coronavirus diagnostics market.

The market in Europe is expected to grow at a significant CAGR owing to the rising prevalence of coronavirus infections, coupled with the adoption of advanced technologies to fight the deadly virus.

The market in Asia Pacific is expected to exhibit healthy growth owing to the launch of innovative testing kits (ELISA, POC, and so on). In addition to this, market players and governmental organizations in this region are making heavy investments in establishing diagnostic facilities, which, in turn, will fuel the demand for COVID-19 diagnostics products.

Latin America & the Middle East & Africa accounted for a comparatively lower share of the market owing to the presence of a huge underpenetrated market but are likely to witness comparatively higher growth during the forecast period. This growth is attributable to the adoption of coronavirus detection kits and instruments.


Higher Investments in R&D and Novel Product Launches to Accelerate Competition

The global market for COVID-19 diagnostics has a fragmented structure with the presence of numerous players. Among them, few players, such as Roche, Abbott, and Danaher Corporation, are likely to have the maximum share in the market. Having advanced technologies and a broad diagnostic portfolio, Roche is likely to have the highest market share. Significant investments in R&D for the launch of diagnostic kits and therapies against COVID-19 are helping these players in contributing to maintain their positions in the market.

For example, in February 2021, Visby Medical announced the FDA emergency use authorization for its single-use, rapid point-of-care COVID-19 polymerase chain reaction test. Visby's PCR test provides results in 30 minutes and is performed without the need for additional instruments or readers. It is authorized for point-of-care use.


  • Abbott (Illinois, U.S.)

  • Danaher Corporation (Washington D.C, U.S.)

  • Siemens Healthcare GmbH (Germany, Europe)

  • F. 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


  • May 2021– Quest Diagnostics Incorporated announced its collaboration with Ginkgo Bioworks to provide COVID-19 testing to K-12 schools across the U.S.

  • June 2021 - Trivitron Healthcare, a medical technology company announced the launch of mobile laboratory for covid-19 testing to enable diagnostics in urban, rural areas and distant geographies to bring quality healthcare and diagnostic services close to the patients.

  • July 2021 – Abbott announced the launch of Panbio COVID-19 rapid antigen tests which will be available for self-testing to get easy and accurate results.

  • March 2020 – MyLab, Pune received NIV approval for its diagnostic kit intended for the use of COVID-19 detection.


An Infographic Representation of COVID-19 Diagnostics Market

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The COVID-19 diagnostics market research report provides a detailed analysis of the market and focuses on key aspects, such as leading companies, product types, and leading applications of the product. Besides this, it offers insights into the trends of the market and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the advanced market over recent years.

Report Scope & Segmentation



Study Period


Base Year


Forecast Period



Value (USD billion)


Product; Technology; Sample Type; Setting, End User and Geography

By Product

  • Instruments

  • Reagents & Kits

By Technology

  • Polymerase Chain Reaction (PCR)

  • Enzyme-linked Immunosorbent Assay (ELISA)

  • Lateral Flow Immunoassay (LFIA)

  •  Others

By Sample Type

  • Nasopharyngeal & Oropharyngeal Swab

  • Nasal Swab

  • Blood

  • Others

By Setting

  • Lab-based

  • Point-of-care

By End-User

  • Hospitals & Clinics

  • Laboratories & Diagnostic Centers

  • Others

By Geography

  • North America (the U.S. and Canada)

  • Europe (U.K., Germany, France, Italy, Spain, Scandinavia, and the Rest of Europe)

  • Asia-Pacific (Japan, China, India, Australia, Southeast Asia, and the Rest of Asia- Pacific)

  • Latin America (Brazil, Mexico, Rest of Latin America)

  • The Middle East & Africa (GCC, South Africa, Rest of the Middle East & Africa)

Frequently Asked Questions

Fortune Business Insights says that the global market size was USD 16.05 billion in 2020 and is projected to reach USD 9.20 billion by 2028.

In 2020, the North American market value stood at USD 5.28 billion.

Registering a CAGR of -10.5%, the market will exhibit steady growth in the forecast period (2021-2028).

The PCR segment is expected to lead this market during the forecast period.

The increasing prevalence of coronavirus infections and the introduction of novel diagnostics tests by key players are the major factors driving the markets growth.

F. Hoffmann-La Roche Ltd, Abbott, and Danaher Corporation are the major players in the global market.

North America dominated the market in terms of share in 2020.

The launch of advanced technologies by market players, such as rapid detection kits and COVID-specific diagnostic reagents, are expected to drive the adoption of diagnostics products.

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COVID-19 Diagnostics Market Size, Share and Global Industry Trend Forecast till 2026
  • Aug, 2021
  • 2020
  • 2020 - 2027
  • 157


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