COVID-19 Diagnostics Market Size, Share & Trends Analysis Report By Product & Service (Instruments, Reagents & Kits, Services), By Sample Type, By Test Type, By Mode, By End Use, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global COVID-19 diagnostics market size was valued at USD 97.4 billion in 2021 and is expected to decline at a compound annual growth rate (CAGR) of 7.7% from 2022 to 2030. The market is driven by rising government initiatives targeted toward the implementation of mass testing. On 1st September 2020, Hong Kong began voluntary mass testing with the help of healthcare personnel from mainland China. Around 1.78 million Hong Kong citizens were tested as of 15th September 2020. Moreover, despite the several criticisms over mass testing, on 11th September 2020, the British government announced its plan for mass coronavirus testing in the U.K. Additionally, increased traction gained by mobile testing market space is expected to open new avenues for market expansion.

Transitioning focus of new entrants toward at-home testing and integration of advanced software has been witnessed in the past few months. This is expected to increase patient convenience in regard to time-consuming laboratory-based testing. One such new entrant, namely, Switch Health, offers mobile services for at-home testing and business testing. The Switch Health mobile rapid testing units have deployed more than 30 mobile units for the diagnosis of individuals with coronavirus infection and have catered to more than 30 clients, including on-site factory workers and sports players, as of September 2020.

The considerable increase in patient population around the world, the enormous need for speedy diagnostics, and the lack of specific drug or vaccination are the primary factors driving the market for Covid-19 diagnostics. However, a lack of awareness among developing countries about the precautions that must be taken, as well as a scarcity of diagnostic kits and medical professionals with sufficient understanding about the use of diagnostic kits for new Covid-19, are expected to stymie market expansion. Leading diagnostic kit producers, on the other hand, can benefit from a number of profitable ventures by manufacturing rapid diagnostic kits. Moreover, several local players and small startups are producing diagnostic kits and assays to take advantage of huge prospects. For example, once the National Institute of Virology confirmed its test, Mylab, India gained permission from the Drug Controller of India for manufacturing the Covid-19 diagnostic kit.

The demand for COVID-19 diagnostic products is set to propel further with the increasing number of coronavirus-infected patients, particularly post the ease of lockdown across the globe. According to World meter, the total number of cases witnessed a spike with 33,556,252 patients testing positive as of 28^th September 2020 to 55,961,380 patients on 17^th November 2020. Despite the gradual decline expected in the number of positive patients in 2021, integration of COVID-19 tests in routine diagnostic protocols is expected to maintain the growth of the market for Covid-19 diagnostics.

Moreover, these testing programs are set to pave way for the travel industry to gear up, creating a favorable environment for the entities operating in the market for Covid-19 diagnostics. The tourism and travel industries have been most affected during this pandemic outbreak, which has led to an upsurge in COVID-19 testing initiatives post August 2020, particularly in tourism-based countries and regions. This is also expected to propel the PoC testing market penetration as these tests are able to overcome the limitations associated with traditional testing.

Complex and pure reagents, such as probes, enzymes, and primers, are crucial in conducting tests in clinical laboratories. A number of factors like a sudden increase in demand, export bans, and stockpiling have led to the shortage of these reagents. Additionally, these reagents are manufactured by limited companies, therefore leading to a shortage of supply due to insufficient production capacity. The inadequate demand-to-supply ratio of reagents worldwide is anticipated to negatively impact the overall diagnosis rate and hinder the growth of the market for Covid-19 diagnostics.

The market for Covid-19 diagnostics is divided into two segments based on technology: PCR and immunoassay. Because of the rising need for coronavirus patient diagnosis, the PCR segment is likely to rise rapidly in the near future. Furthermore, PCR is regarded as the gold standard for detecting COVID-19 infections. The immunoassay segment is expected to increase at the fastest rate throughout the forecast period, due to a rise in the need for quick serological testing for disease diagnosis. A plethora of serological kits is being developed to confirm Sars Cov 2 infections.

The sudden rise in the number of COVID-19 cases has increased demand for R&D in the diagnostics process, a rise in government funding, and diagnostics activities which fueled the market growth. With the increasing number of COVID-19 cases in 2020 and 2021, increased focus of government to prevent further spread of the disease, lack of therapeutic treatment and vaccines, and a rise in demand for timely diagnostics were observed which expanded the market for COVID-19 diagnostics. Key players shifted their focus on developing time-efficient and accurate diagnostics kits for detecting COVID-19. For instance, in December 2021 F-Hoffman LaRoche Ltd. announced that it would launch SARS-CoV 2 and Flu A/B antigen rapid test kit in the market with a CE mark. Since the start of the pandemic, FDA approved around 88 antibody-based tests and 256 molecular tests accounting for the total approval of over 350 diagnostics tests.

Product & Service Insights

The services segment is estimated to dominate the market for Covid-19 diagnostics and accounted for revenue share of 47.8% in 2021. Service providers are boosting their testing capabilities by expanding technological footprints in existing labs and diagnostic centers as well as by launching new, high-capacity laboratories, which has contributed to the segment growth. Collaborations between governments, test developers, public health organizations, and private laboratories accelerate the expansion of testing capacities. For instance, Novacyt, a France-based diagnostics company, formed a strategic alliance with GlaxoSmithKline, AstraZeneca, and the University of Cambridge to increase testing capacity in the U.K.

The reagents and kits segment is expected to register a CAGR of (7.2%) from 2020 to 2030. The reduction in the number of active COVID-19 cases is responsible for the declining market growth of this segment. In response to the pandemic, companies are implementing various strategic initiatives, such as new product development and collaborations. For instance, in September 2020, Veredus Laboratories Pte Ltd. launched an extraction-free RT-PCR suite that includes VereRT COVID-19 PCR kit for direct use either from a swab or human saliva.

Sample Type Insights

The nasopharyngeal swabs segment accounted for the largest revenue share of 43.9% in 2021. Nasopharyngeal swabs have been observed to exhibit a significantly higher SARS-CoV-2 sensitivity, detection rate, and viral load than other swab types. Thus, this swab type is primarily recommended when testing for COVID-19 and assessing SARS-CoV-2 load, resulting in the largest revenue share of this segment. With accelerated production and supply of nasopharyngeal swabs, this segment is anticipated to grow at a lucrative rate during the forecast period. In addition, the majority of molecular diagnostic tests utilized for the detection of infection use nasopharyngeal swabs specimen.

The major advantage of serology tests is their ability to detect asymptomatic symptoms of SARS-CoV-2 infection. The blood sample type segment is estimated to register a growth rate of (7.3%) from 2020 to 2030. This is attributed to the significant decrease in the COVID-19 incidence rate. The demand for blood-based serology tests/antibody detection tests for the detection of SARS-CoV-2 infection is likely to drop further during the forecast period.

Oropharyngeal swab samples are observed to be less sensitive than nasopharyngeal samples; however, using multiple types of samples help attain maximum sensitivity during infection screening. This has accelerated the use of OP swabs for COVID-19 diagnosis. The use of an OP swab sample alongside a nasopharyngeal swab increases the detection of viral illnesses in clinical settings or enables a thorough study of the etiology of lower respiratory tract infection.

Test Type Insights

The Molecular (PCR) testing dominated the market and accounted for a revenue share of 67.1% in 2021. Currently, the PCR technique is considered to be the most accurate for the detection of COVID-19, thereby leading to a tremendous increase in the adoption of PCR testing kits. Owing to the advantages of the PCR technique in detection, laboratories, hospitals, diagnostic centers and clinics, and research institutes are preferring this technique over others.

As the number of COVID-19 cases were rapidly increasing across the globe, many companies started developing PCR-based diagnostic tests for efficient diagnosis. In May 2020, more than 100 PCR-based diagnostic tests were either approved or in the development phase for clinical use. Such a high number indicates the dominance of this technology in the market, resulting in a large revenue share of this segment throughout the forecast period.

The antigen-based testing is expected to witness a CAGR of (6.1%) from 2020 to 2030. Antigen- and antibody-based tests are observed to be considerably more stable than RNA samples, which makes them less hazard-vulnerable during storage and transportation, thus minimizing the chances of false-negative results. Moreover, antigens and antibodies are more uniformly available in sputum and blood samples, thus improving testing accuracy. However, the most significant advantage of immunoassays is their capability in the detection of past infections.

Mode Insights

The non-POC (centralized) testing segment dominated the market and accounted for revenue share of 64.5% in 2021. Currently, most of the COVID-19 tests are carried out in the laboratory environment, thus centralized or laboratory testing is currently the key testing mode in the market. Incorporation of automated high throughput systems facilitates efficient processing of a high number of samples at a given point of time without hampering the quality and integrity of the result. These factors are making centralized testing a critical element in a viable COVID-19-response strategy to circumvent the spread.

As a result, hospitals have centralized their lab operations into one core facility, rather than sending specimens to multiple places. Several companies are launching products suitable for lab-based COVID-testing, including Quest Diagnostics and Perkin Elmer. In September 2020, Eurofins Diatherix launched the Flu Plus test that can be used across multiple end-use settings, such as hospitals, physicians’ offices, nursing homes, and reference labs nationwide for COVID-19 detection.

The development of point-of-care technology for the detection of COVID-19 infection is aimed at reducing the assay duration and scaling up the testing capacity to prevent further transmission of the disease. In September 2020, a Cambridge hospital demonstrated the combined use of antibody testing and rapid point-of-care nucleic acid to improve patient outcomes. This approach can be particularly useful in low resource settings as centralized testing capabilities are scarce.

End-use Insights

The laboratories segment dominated the market and accounted for the largest revenue share of 39.6% in 2021. An increasing number of laboratories are leveraging high-throughput technologies to process COVID-19 tests rapidly and effectively on a large scale. This is driven by the effective implementation of favorable reimbursement policies in developed economies. For instance, the Medicare reimbursement rate for high-throughput molecular tests pertaining to COVID-19 detection has been doubled by the Centers for Medicare and Medicaid Services.

With an alarmingly high number of COVID-19 cases worldwide, laboratories are inclined toward performing a large number of tests per day. Quest Diagnostics exhibits 200,000 test capacity for COVID-19 per day through its fully owned laboratories and has planned to roughly double the testing capacity as of September 2020. Whereas, LabCorp has performed over 11.2 million molecular tests from March 2020 to August 2020 and increased its molecular testing capacity to 200,000 tests per day.

The diagnostic centers and clinics segment is expected to register a growth rate of 6.9% from 2022 to 2030. According to NHS England, up to 20% of patients have hospital-acquired COVID-19 infection. This is encouraging many individuals to opt for diagnostics centers over hospitals for COVID-19 testing, which is a major factor contributing to revenue generation for this segment. Thus, the need to eliminate the risk of acquiring COVID-19 in hospitals is boosting the growth of the diagnostic centers and clinics segment.

Regional Insights

North America dominated the Covid-19 diagnostics market and accounted for a revenue share of 33.5% in 2021. This can be attributed to the rapid increase in COVID-19 cases and the local presence of key players engaged in the development and manufacturing of diagnostic tests incorporating various technologies. As a result of the pandemic, regulatory bodies such as the U.S. FDA and Health Canada are granting Emergency Use Authorizations (EUA) to COVID-19 test kits in order to boost testing. Such factors are anticipated to fuel regional market growth.

The U.S. has emerged as a key contributor to the regional revenue, primarily attributed to the effective scaling-up of COVID-19 tests by the local companies. Additionally, the presence of key laboratories, such as Quest Diagnostics and Laboratory Corporation of America (LabCorp), has strengthened the country’s market for COVID-19 diagnostics. As of September 28, 2020, Quest Diagnostics performed around 15.7 million COVID-19 molecular diagnostic tests and nearly 3.8 million COVID-19 antibody tests. Such initiatives are anticipated to enable large-scale testing in the country.

Asia Pacific is estimated to emerge as a lucrative regional market and is projected to witness a CAGR of 6.7% from 2020 to 2030. China and India made significant contributions to the revenue generated by this region. China is a major exporter of COVID-19 test kits; more than 100 companies from China are exporting these kits.

Key Companies & Market Share Insights

Key industry participants constantly accelerated the supply and production of diagnostic tests to address the rising need for the effective containment of the COVID-19 pandemic. For instance, in September 2020, LabCorp launched a combined test for RSV, flu, and COVID-19. The company has applied for U.S. FDA approval to use this test with its Pixel by LabCorp at-home test collection kit.

Companies such as Quest Diagnostics and Labcorpwere focused on the aggressive expansion of capacity and are also working toward the return-to-work testing market through employer-focused COVID testing offerings. For instance, in October 2020, Quest Diagnostics announced a pilot program for drone delivery of COVID-19 at-home self-collection kits to single-family homes in the Cheektowaga area. The company has collaborated with DroneUp and Walmart for the effective delivery of kits. Some of the prominent players in the COVID-19 diagnostics market include:

• Hologic Inc.

• Thermo Fisher Scientific, Inc.

• F. Hoffman-La Roche Ltd.

• Perkin Elmer, Inc.

• Veredus Laboratories

• 1drop Inc.

• ADT Biotech Sdn Bhd

• Laboratory Corporation of America Holdings

• bioMérieux SA

• Danaher

• Mylab Discovery Solutions Pvt. Ltd.

• Neuberg Diagnostics

• ALDATU BIOSCIENCES

• Quidel Corporation

• Quest Diagnostics

• altona Diagnostics GmbH

• Luminex Corporation

• Abbott

COVID-19 Diagnostics Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2020 to 2030. For the purpose of this study, Grand View Research has segmented the global COVID-19 diagnostics market report on the basis of product & service, sample type, test type, mode, end-use, and region:

• Product & Service Outlook (Revenue, USD Million, 2020 - 2030)

  • Instruments

  • Reagents & Kits

  • Services

• Sample Type Outlook (Revenue, USD Million, 2020 - 2030)

  • Nasopharyngeal (NP) swabs

  • Oropharyngeal (OP) swabs

  • Nasal swabs

  • Blood

  • Others

• Test Type Outlook (Revenue, USD Million, 2020 - 2030)

  • Molecular (PCR) Testing

  • Antigen-based Testing

  • Antibody (Serology) Testing

  • Others

• Mode Outlook (Revenue, USD Million, 2020 - 2030)

  • Point-of-Care (PoC)

  • Non-Point-of-Care (Non-PoC)

• End-use Outlook (Revenue, USD Million, 2020 - 2030)

  • Laboratories

  • Hospitals

  • Diagnostic Centers and Clinics

  • Others

• Regional Outlook (Revenue, USD Million, 2020 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • China

    • India

    • Japan

    • South Korea

    • Australia

  • Latin America

    • Brazil

    • Mexico

  • Middle East Africa (MEA)

    • South Africa

    • Saudi Arabia