COVID-19 Diagnostics Market 2020 and Forecast 2021-2027

                                          
Report Overview: COVID-19 Diagnostics Market


The global COVID-19 diagnostics market size was valued at USD 4.1 billion in 2020 and looks set to grow at a compound annual growth rate (CAGR) of 4.85% from 2021 to 2027. The COVID-19 diagnostic tests are critical in the management of the current pandemic for accurate diagnosis as well as to tackle the spread of the infection. As a result, with the growing demand, these tests are being made available with over 600 SARS-CoV-2 diagnostic tests either approved or in the development phase for clinical use. Therefore, an increase in the need for developing diagnostic tests is anticipated to drive market growth. For efficient and accurate COVID-19 diagnosis, clinicians need a portable or an on-site diagnostic test for real-time management of patients in minimal time. This has encouraged the adoption of Point-of-Care (POC) testing for diagnosis, primarily aimed at reducing the assay duration from hours to a few minutes.

In March 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) to the first POC test-Xpert Xpress test manufactured by Cepheid-for COVID-19 diagnosis. Abbott and Chembio Diagnostics are among the active market players operating in the point-of-care marketplace. The World Health Organization (WHO) has urged healthcare organizations to make COVID-19 diagnostic testing a top priority in response to this crisis. A combination of regulations and enthusiasm has allowed some nations, such as Singapore and South Korea, to rapidly deploy thousands of diagnostics tests to combat the current emergency situation. Several universities and research laboratories have also stepped in to develop tests to meet the growing demand.

In addition, integration of novel technologies and software solutions with COVID-19 testing is expected to open new avenues for market expansion. For instance, the companies are inclined toward incorporating artificial intelligence (AI) algorithms in COVID-19 tests for rapid and efficient diagnosis. As reported in March 2020, Surgisphere Corporation, a U.S.-based firm, introduced an AI-based rapid diagnostic tool for the detection of coronavirus. This diagnostic tool exhibits 93.7% sensitivity and 99.9% specificity, assisting accurate identification of virus and preventing transmission of the infection.

Robust funding and investments by public as well as private agencies are expected to propel molecular diagnostic companies to develop COVID-19 diagnostic products, thereby driving the market. For instance, in March 2020, the U.S. Department of Health and Human Services awarded USD 0.56 million funding to a U.S.-based private company, Mesa Biotech Inc. This monetary support was for the development of a POC rapid molecular diagnostic test for detection of SARS-CoV-2.

CRISPR-based nucleic acid detection serves as a reliable, sensitive, and specific approach. In addition, the method enables testing at a constant temperature eliminating the need for an expensive thermal cycler or PCR platform. The University of Connecticut Health Center has developed an All-In-One Dual assay method based on CRISPR-Cas12a (AIOD-CRISPR) for detection of SARS-CoV-2 in 20 mins. The one-pot reaction system principle implemented in this assay reduces the risk of cross-contamination and minimizes the turnaround time significantly by the elimination of manual steps. Ongoing efforts by the research center to integrate the aforementioned CRISPR technology into microfluidic diagnostic chips are expected to help introduce a novel POC product for diagnosis of SARS CoV-2 and are currently in clinical settings.

Product Insights: COVID-19 Diagnostics Market

In terms of revenue, the reagents and kits segment is estimated to dominate the COVID-19 diagnostics market with a revenue share of 72% in 2020 as they are critical components in testing of coronavirus infection. The WHO has urged nations to ramp up their diagnostics capacities, which is expected to increase the uptake of reagents and kits at a large scale. Several regulatory bodies have issued mass testing; however, laboratories are facing a shortage of reagents required for large batches of testing.

The Centers for Disease Prevention and Control (CDC) and the FDA are addressing the challenges surfacing due to the recent shortage of reagents in the U.S. To combat any hindrance caused by shortages of pivotal testing reagents and kits in the U.S., the FDA has granted Emergency Use Authorization (EUA) to various COVID-19 detection tests. This strategy is aimed at relaxing various ordinary standards enabling the market players to seek easy and rapid approval for their kits as well as reagents. This is expected to increase the supply of kits and reagents, contributing to the growth of this segment in the global market through 2020 to 2027.

The at-home and handheld instruments segment is gaining immense popularity in the market space for their use in controlling coronavirus cases and is anticipated to witness lucrative growth over the forecast period 2021-2027. These portable instruments accelerate clinical decision-making in decentralized settings. In March 2020, Abbott received EUA for its molecular POC test based on a portable ID NOW platform. This platform delivers positive results in five minutes, which assists clinicians significantly.

End-Use Insights: COVID-19 Diagnostics Market

Laboratories segment is estimated to account for the largest revenue share of 40% in 2020. The laboratories are constantly increasing their testing capacities to address the rising demand. Moreover, private laboratories are also inclined toward coronavirus testing. As reported in April 2020, Orchard Laboratories is the first private laboratory in Michigan, U.S., to offer rapid COVID-19 testing by using RT-PCR technology. Initially, it would conduct 400 tests per day.

Moreover, laboratories have leveraged high-throughput technologies to process a large volume of coronavirus tests accurately and rapidly. This is propelled by robust reimbursement policies implemented effectively in the developed economies. For instance, the Centers for Medicare & Medicaid Services (CMS) has doubled the Medicare reimbursement rate for high-molecular tests pertaining to COVID-19 detection.

Government authorities and companies are undertaking efforts to develop tests that can be specifically deployed in diagnostics centers, clinics, or physician’s offices. The FDA has recently approved decentralized testing platforms to diversify testing capabilities across clinics. For instance, Abbott’s ID NOW platform is highly implemented in urgent-care clinics and doctors’ offices in the U.S. The small size makes it portable and, thus, its use would not be limited to only hospital settings.

Sample Type Insights: COVID-19 Diagnostics Market

The oropharyngeal and nasopharyngeal swabs segment is estimated to account for the maximum revenue share of 53% in 2020. Nasopharyngeal swabs are preferred choice for sample collection as recommended by the CDC. In case of unavailability of nasal swabs, oropharyngeal swabs are also acceptable. The combinatorial use of both swabs in a single tube maximizes the test sensitivity and limits the usage of testing resources, which drives their adoption rate in COVID-19 sample collection.

In addition, the FDA has recently allowed using a wide range of swabs, especially polyester swabs, for diagnosis of this infection. These synthetic swabs are easier to manufacture and address the challenges pertaining to a shortage of swabs. In response, in April 2020, the FDA announced that U.S. Cotton has planned to manufacture polyester-based swabs in large quantities that can also be put to use in sample collection for coronavirus testing. These initiatives are expected to further accelerate the adoption rate of swabs at a lucrative rate.

Blood sample-based tests are largely employed in antibody detection tests along with rapid detection tests. This sample type provides an assessment of both short- and long-term trajectories of antibody response, abundance, and diversity in the affected patients, which is difficult in viral RNA detection tests. Thus, the blood sample type is expected to gain traction across research and molecular studies.

Technology Insights: COVID-19 Diagnostics Market

The PCR segment is projected to dominate the market in 2020 with a 45% revenue share. PCR is expected to emerge as the dominant segment in 2020, as the majority of the COVID-19 detection tests rely on Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) for quantification of RNA in the samples of coronavirus patients. Large-scale employment of PCR across the CDC, commercial laboratories, hospitals, and public health laboratories have made significant contributions to the revenue generated by this technology.

Continuous approval of RT-PCR-based molecular diagnostic tests for early detection of the infection is anticipated to drive the growth of the segment. In March 2020, Roche’s Cobas SARS-CoV-2 test was the first test to receive EUA. Subsequently, the TaqPath COVID-19 Combo Kit of Thermo Fisher received EUA in March 2020. Other available tests are Lyra SARS-CoV-2 Assay by Quidel, SARS-CoV-2 Qualitative Real-Time RT-PCR by Quest, COVID-19 RT-PCR Test by LabCorp, and others.

Companies are validating and developing rapid POC immunodiagnostic tests to facilitate decentralized testing. In April 2020, the U.K.-based firms, GeneFirst and Rapid Diagnostics in an agreement validated a COVID-19 assay developed by the former company to be used on the Rapid’s Rapid Minilab RT-PCR Desktop Point of Care Platform. This agreement allowed the development of a POC test with an automatic sample-to-result workflow. Such initiatives are expected to fuel the demand for point-of-care tests in the near future.

Regional Insights: COVID-19 Diagnostics Market

Europe is estimated to dominate the market for COVID-19 diagnostics with a share of 40% in 2020. High awareness levels about the spread, diagnosis, and effective management of coronavirus infection have been encouraged by the regional government and regulatory authorities. This has ultimately accelerated the diagnostic product approvals that would contribute to Europe’s dominant revenue share in 2020. For instance, in March 2020, Novacyt Group, a French clinical diagnostics company, received the EUA for its 2-hour coronavirus test. Whereas, in April 2020, Abbott received CE approval for its IgG serology blood test for coronavirus.
In recent months, countries of Europe, such as the Czech Republic and Switzerland, have increased their testing capacity by two- and threefold, respectively. Switzerland has the highest per-capita rates of infection globally and has administered around 12,639 tests per million population as reported in March 2020. This large number of coronavirus testing increases the revenue generation in this region.
Asia Pacific is anticipated to witness the fastest growth rate during the forecast period. This region is witnessing an increase in the number of new entrants that provide COVID-19 diagnostic solutions. Mylab Discovery Solutions is the first India-based company to receive approval for its Mylab PathoDetect COVID-19 qualitative PCR kit in March 2020.

In May 2020, Fujirebio, Inc. received approval for its SARS-CoV-2 antigen test kit from the Japanese authorities. Additionally, profitable partnership initiatives between the Asian countries are expected to propel the penetration of COVID-19 diagnostic products throughout the region. For instance, India and China are key trading partners for each other, with China emerging as the second largest economy, while India is one of the fastest developing economies across the globe. This partnership is expected to strengthen further with the pandemic outbreak of COVID-19 across India and China.

Key Companies & Market Share Insights: COVID-19 Diagnostics Market

Key players are constantly accelerating the production and supply of diagnostic tests to keep pace with the increasing need for disease containment. For instance, in March 2020, Roche initiated shipment of the first allotment of the Cobas SARS-CoV-2 test for COVID-19 diagnosis. Approximately, 400,000 tests were shipped to targeted network of reference laboratories as well as hospitals across the U.S. The company further planned for a shipment of 400,000 additional tests to the laboratory testing facilities every week in the country.

The companies are also adopting profitable strategic moves to gain a competitive edge in the market. These include product development, collaborations and partnerships, and business expansion strategies to fulfill the demand for their customers in untapped regions. For instance, in May 2020, Quest Diagnostics announced its collaboration with Ortho Clinical Diagnostics aimed at expansion of COVID-19 antibody testing across more than 20 laboratories of Quest throughout the U.S. The company applied VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test of Ortho to ramp up the coronavirus testing in patients. Some of the prominent players in the COVID-19 diagnostics market include:

Key companies Profiled: COVID-19 Diagnostics Market Report

 	
Thermo Fisher Scientific, Inc.
 	
F. Hoffman-La Roche Ltd.
 	
Perkin Elmer, Inc.
 	
Neuberg Diagnostics
 	
1drop Inc.
 	
Veredus Laboratories
 	
ADT Biotech Sdn Bhd
 	
Altona Diagnostics GmbH
 	
bioMérieux SA
 	
Danaher
 	
Mylab Discovery Solutions Pvt Ltd.
 	
ALDATU BIOSCIENCES
 	
Quidel Corporation
 	
Quest Diagnostics
 	
Hologic Inc.
 	
Laboratory Corporation of America Holdings
 	
Luminex Corporation
 	
Cepheid
 	
Abbott

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the subsegments from 2020 to 2027. For the purpose of this study, Trusted Business Insights has segmented the global COVID-19 diagnostics market report on the basis of product, sample type, technology, end use, and region:

Product Outlook (Revenue, USD Million, 2020 - 2027)

 	
Instruments
 	
Reagents & Kits

Sample Type Outlook (Revenue, USD Million, 2020 - 2027)

 	
Oropharyngeal & Nasopharyngeal Swabs
 	
Blood
 	
Urine
 	
Others

Technology Outlook (Revenue, USD Million, 2020 - 2027)

 	
Polymerase Chain Reaction (PCR)
 	
Antibody or Enzyme-Linked Immunosorbent Assay (ELISA)
 	
Serology
 	
Portable or Point-of-Care (POC)
 	
Others

End-Use Outlook (Revenue, USD Million, 2020 - 2027)

 	
Laboratories
 	
Hospitals
 	
Diagnostic Centers and Clinics
 	
Research Institutes