A Brief Look at the COVID-19 Saliva Testing Global Market
The recent FDA approval of an OTC test shows that COVID-19 saliva testing may be poised for bigger and better things in the years ahead.
Saliva-based COVID-19 kits first became a viable alternative test option early during the public health emergency (PHE) when the nasopharyngeal swabs used to collect tissue samples for conventional tests were in desperately short supply. To date, over 30 different saliva test kits and products have received emergency use authorization (EUA) from the FDA. But despite their advantages, saliva kits remain a marginal part of the COVID-19 diagnostic testing market, at least in the US. Even so, there are signs that saliva testing may be poised for bigger and better things in the years ahead.
Drivers of Saliva Testing Growth
Most current COVID-19 tests are performed on tissue samples collected by inserting a long nasopharyngeal swab deep into the nostril. The downside of swab collection is that it may:
- Be uncomfortable for patients and thus contribute to “testing fatigue”
- Not be suitable for young people or those with special needs
- Be susceptible to supply chain disruption
- Require trained lab personnel using PPE, either or both of which could be in short supply
Saliva-based testing eliminates these disadvantages. It’s noninvasive, suitable for all individuals, simple, can be performed at the point of care, and is largely impervious to supply chain disruptions. Saliva samples are also stable and can be preserved for at least 20 days, according to a Frontiers in Virology study.1
The Global Market for COVID-19 Saliva Tests
At the start of the pandemic in 2020, the consensus was that the global market for COVID-19 saliva screening was between $1.4 to $1.6 billion US. However, while some consulting firms project compound annual growth rates (CAGR) as high as 4.8 percent through 2030, others predict modest declines. According to a report from research and consulting firm Fact.MR and an article on the report in BioSpace, as of 2021:2,3
- By product, PCR-based kits constitute approximately 73.5 percent of the global market value share, almost three times greater than the share for point-of-care products;
- By technology, RT-qPCR has the highest global market share at 49 percent revenue;
- At 26.8 percent share, diagnostic labs are the largest end user, although academic and research institutes are expected to increase at a higher CAGR of 2.5 percent.
North America accounts for the largest share of global sales at 34 percent (with 91 percent of those sales coming from the US), followed by Europe and South Asia.
FDA Clearance of COVID-19 Saliva Products
Lab industry development of novel saliva-based diagnostics products in response to the PHE has been the primary driver of growth in the US and worldwide. In April 2020, less than three months into the PHE, Rutgers University secured the first EUA for a saliva COVID-19 test, the Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay test which runs on the Thermo Fisher Applied Biosystems QuantStudio 5 Real-Time PCR System.4 A month later, Rutgers’ RUCDR Infinite Biologics received an expanded EUA for a saliva assay performed on samples that users collected at home and send to a laboratory for testing. The test, developed by RUCDR in partnership with Spectrum Solutions and Accurate Diagnostic Labs, became the first saliva assay to not require any physical interaction with a healthcare professional.5
As of publication date, 35 different saliva-based kits have received EUA during the PHE, many for use at the point of care. That includes products from not only academic institutions, but also leading commercial laboratory companies, including Thermo Fisher Scientific, PerkinElmer, BioMérieux subsidiary BioFire, Ambry Genetics, Rheonix, and NeuMoDx Molecular.
On Oct. 18, the FDA broke some new ground by issuing the first EUA for an over-the-counter saliva-based COVID molecular test to Aptitude Medical for the Metrix COVID-19 Test, a single-use test that uses real-time loop-mediated isothermal amplification (RT-LAMP) with a fluorescence reader to detect the SARS-CoV-2 virus.6
COVID-19 Saliva Testing Infographic
SARS-CoV-2 Saliva Diagnostic Products Cleared by FDA (as of November 23, 2022)
Original EUA Date | Company | Product & Approved Uses |
---|---|---|
Nov 8, 2022 | Nanobiosym Precision Testing Services | The Nano Test for COVID-19, RT-PCR, Home Collection, Multiple Targets |
April 9, 2021 | Thermo Fisher Scientific | Amplitude Solution with TaqPath COVID-19 High-Throughput Combo Kit, RT-PCR, Multiple Targets |
Oct 18, 2022 | Aptitude Medical Systems Inc. | Metrix COVID-19 Test, RT-PCR, LAMP, OTC, Home Use, Screening, Multiple Targets |
April 29, 2020 | Rheonix | Rheonix COVID-19 MDx Assay, RT-PCR, Home Collection, Single Target |
March 24, 2020 | PerkinElmer | PerkinElmer New Coronavirus Nucleic Acid Detection Kit, RT-PCR, Pooling, Screening, Multiple Targets |
April 14, 2022 | MicroGEM U.S. | MicroGEM Sal6830 SARS-CoV-2 Saliva Test, RT-PCR, Multiple Targets |
Aug 27, 2021 | Yale School of Public Health, Department of Epidemiology of Microbial Diseases (Yale) | SalivaDirect DTC Saliva Collection Kit, DTC, Home Collection Kit, Screening |
April 9, 2021 | Yale | SalivaDirect At-Home Collection Kit, Home Collection Kit, Screening |
Aug 25, 2020 | Standard BioTools Inc. | Advanta Dx SARS-CoV-2 RT-PCR Assay, RT-PCR, Home Collection, Multiple Targets |
March 23, 2020 | BioFire Defense | BioFire COVID-19 Test, RT, Nested Multiplex PCR, Pooling, Multiple Targets |
Aug 27, 2021 | Yale | SalivaDirect for use with DTC Kits, RT-PCR, DTC, Home Collection, Screening, Pooling, Single Target |
Aug 15, 2020 | Yale | SalivaDirect, RT-PCR, Home Collection, Screening, Pooling, Single Target |
Feb 24, 2021 | University of Illinois | covidSHIELD, RT-PCR, Home Collection, Serial Screening, Pooling, Multiple Targets |
July 30, 2021 | Life Technologies Corporation (part of Thermo Fisher Scientific) | TaqPath COVID-19 Fast PCR Combo Kit 2.0, RT-PCR, Multiple Targets |
Nov 23, 2020 | Gravity Diagnostics | Gravity Diagnostics SARS-CoV-2 RT-PCR Assay, RT-PCR, Home Collection, Screening, Multiple Targets |
April 19, 2021 | Southern California Permanente Medical Group | Kaiser Permanente High Throughput SARS-CoV-2 Assay, RT-PCR, Home Collection, Multiple Targets |
Aug 23, 2021 | Mount Sinai Hospital | Mount Sinai SARS-CoV-2 Assay, RT-PCR, Home Collection, Screening, Multiple Targets |
April 10, 2020 | Infinity BiologiX | Infinity BiologiX TaqPath SARS-CoV-2 Assay, RT-PCR, Home Collection, Pooling, Multiple Targets |
Oct 8, 2020 | Spectrum Solutions | SDNA-1000 Saliva Collection Device |
Jan 22, 2021 | Ambry Genetics Laboratory | Ambry COVID-19 RT-PCR Test, RT-PCR, Home Collection, Multiple Targets |
June 18, 2020 | 3B Blackbio Biotech India Ltd. (subsidiary of Kilpest India Ltd.) | TRUPCR SARS-CoV-2 Kit, RT-PCR, Multiple Targets |
Aug 3, 2020 | WREN Laboratories | WREN Laboratories COVID-19 PCR Test, RT-PCR, Home Collection, Screening, Multiple Targets |
June 17, 2021 | WREN Laboratories | WREN Laboratories COVID-19 PCR Test DTC, RT-PCR, DTC, Home Collection, Screening, Multiple Targets |
June 17, 2021 | WREN Laboratories | WREN Laboratories COVID-19 Saliva Test Collection Kit DTC, Home Collection Kit, DTC, Screening, Multiple Targets |
June 4, 2020 | Phosphorus Diagnostics | Phosphorus COVID-19 RT-qPCR Test, RT-PCR, Home Collection, Screening, Multiple Targets |
May 17, 2021 | Phosphorus Diagnostics | Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC, Home Collection Kit, DTC, Screening, Multiple Targets |
Sept 22, 2020 | Quadrant Biosciences | Clarifi COVID-19 Test Kit, RT-PCR, Pooling, Multiple Targets |
Aug 28, 2020 | DxTerity Diagnostics | DxTerity SARS-CoV-2 RT PCR CE Test, RT-PCR, Home Collection, Multiple Targets |
May 21, 2020 | P23 Labs, LLC | P23 Labs TaqPath SARS-CoV-2 Assay, RT-PCR, Home Collection, Multiple Targets |
March 30, 2020 | NeuMoDx Molecular | NeuMoDx SARS-CoV-2 Assay, RT-PCR, Collection Kit, Multiple Targets |
May 22, 2020 | Express Gene LLC, DBA: Express Gene Molecular Diagnostics Laboratory | Express Gene 2019-nCoV RT-PCR Diagnostic Panel, RT-PCR, Collection Kit, Multiple Targets |
Aug 21, 2020 | DxTerity Diagnostics | DxTerity SARS-CoV-2 RT-PCR Test, RT-PCR, Multiple Targets |
Oct 28, 2020 | DNA Genotek Inc. | ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 Saliva Collection Devices, Saliva Collection Device |
Oct 14, 2020 | DNA Genotek Inc. | OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) Saliva Collection Devices, Saliva Collection Device |
July 30, 2020 | Clinical Reference Laboratory, Inc. | CRL Rapid Response, RT-PCR, Home Collection, Single Target |
Source: FDA “In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2” Webpage, accessed November 23, 2022.7
Leading companies in the larger global saliva testing market include Thermo Fisher Scientific, Hologic, Qiagen, ACON Laboratories, Assure Tech (Hangzhou), Arcis Biotechnology, Abacus, Nantong Diagnos Biotechnology, KYODO INTERNATIONAL, Takara Bio, GeneProof, Vitagene, Therma Bright, Salimetrics, and Zymo Research.
References:
- https://www.frontiersin.org/articles/10.3389/fviro.2021.778790/full
- https://www.factmr.com/report/covid-19-saliva-based-detection-kits-market
- https://www.biospace.com/article/demand-for-covid-19-saliva-based-detection-kits-experienced-significant-growth-with-an-estimated-market-value-of-around-us-1-6-bn-states-fact-mr/
- https://support.rutgers.edu/news-stories/new-rutgers-saliva-test-for-coronavirus-gets-fda-approval/
- https://www.rutgers.edu/news/fda-approves-first-home-saliva-collection-test-coronavirus
- https://www.fda.gov/media/162401/download
- https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
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