COVID-19 Saliva Collection Kits Market

COVID-19 Saliva Collection Kits Market Outlook (2023-2033)

Worldwide revenue from the COVID-19 saliva collection kits market stands at US$ 232.6 Mn in 2022, with the global market estimated to decline ahead at a CAGR of -2.3% and reach an estimated valuation of around US$ 157.7 Mn by the end of 2033.

As assessed by Persistence Market Research, COVID-19 diagnostics applications are expected to hold a market value of US$ 134.8 Mn in 2023. Overall, COVID-19 saliva collection kits market sales account for approximately 4.4% revenue share in the global antigen test market, which was valued at around US$ 5.3 Bn in 2022.

Sales Analysis of the Global Market from 2020 to 2022 Vs Market Outlook for 2023 to 2033

The global market for COVID-19 saliva collection kits recorded a historic CAGR of 10.7% in the last 2 years from 2020 to 2022.

In the early stages of a global crisis, businesses usually adjust to the new conditions in a way that assures company continuity and guards against short-term harm from emerging trends, such as a lack of liquidity, the loss of key clients, etc. This response could be seen in practically every business throughout the world.

The proactive and sustainable implementation of COVID-19 diagnostics capabilities has been a priority for medical and regulatory officials around the world in order to stop the spread of SARS-CoV-2. People who have COVID-19 symptoms or who have been around people who have the illness have been informed to undergo a diagnostic test for COVID-19.

Minimizing the harmful effects of SARS-CoV-2 on people's health and the economy has required significant investments in innovative diagnostic technology with rapid and decentralised testing. The U.S. National Institute of Health introduced the Rapid Acceleration of Diagnostics (RADx) Initiative in April 2020 to expedite COVID-19 testing technology research, commercialization, and application.

The RADx Initiative's objective was to create novel screening tests that are rapid, accurate, simple to use, and available at the point of care and at home, especially for COVID-19-vulnerable and most-affected population groups.

Despite such efforts, the pandemic still affects many areas of the world, particularly low and middle-income communities where testing facilities remain inadequate and testing kits are expensive or hard to come by. The equitable and sustainable deployment of COVID-19 testing resources is the present objective of governments and organisations globally for the long-term remediation of the virus.

The FDA has authorized numerous in vitro diagnostic tests for severe acute respiratory Emergency Use Authorization (EUA). According to their capability to detect the disease indicators from the inception of symptoms, these in-vitro diagnostic tests are divided into three categories: diagnostic testing, serological tests or antibody tests, and tests for the management of COVID-19 patients.

In order to determine whether a COVID-19 infection is active, the first category of IVD testing include diagnostic tests that look for specific SARS-CoV-2 virus components. Samples for diagnostic testing are obtained by swabbing the nose, throat, or by spitting saliva into a tube. Sputum and bronchoalveolar lavage fluids are examples of lower respiratory tract secretions that are occasionally used for confirmatory tests.

The global market is thus likely to show decline over the coming years at a CAGR of 2.3% and reach a global market size of US$ 157.7 Mn by 2033.

What Factors will Drive the Market Growth?

“Government Initiatives, Strategic Alliances, and Increasing Product Accessibility”

The second wave arrived much later in countries like India than it did in many other nations, which have already felt it. It has been stated that the second wave is far more grave compared to the first wave. While Brazil is preparing for the prospect of a third wave of COVID-19, spurred by vaccination delay and a deficiency of prevention strategies, the United States has so far experienced about three waves of coronavirus.

A third wave may hit the African continent, according to research findings. Furthermore, numerous nations are reporting a noticeable increase in COVID-19 cases. The third wave is currently affecting the continent, according to a dramatic increase in instances.

Many research institutions and businesses are forming strategic alliances to enhance their therapeutic and diagnostic domains in order to provide efficient diagnostic solutions which would satisfy the demands of the Americas in order to prevent the pandemic outbreak.

The United States and India decided in March 2020 to establish a long-term, fruitful relationship between their respective research organisations and industry in the fields of disease detection and treatment. The National Institute of Allergy and Infectious Disease in the United States shared the crucial reagents with the Translational Health Science Technology Institute in Gurgaon as part of the ongoing bilateral healthcare collaboration.

Such collaboration is anticipated to play a significant role in the development of novel medicines and COVID-19 diagnostic sectors that may present attractive market prospects for businesses.

Additionally, many nations have made a negative COVID-19 test a requirement for both local and international travel.

Government regulations have also mandated screening of those who may have come into contact with the sick people in attempt to break the cycle. Throughout the projected timeframe, these factors will continue to offer the COVID-19 saliva collection kits market significant growth prospects.

Can Demand for COVID-19 Saliva Collection Kits be Affected in Any Way?

“Threat of New Entrants and Shortage of Supplies”

Due to its ease of self-collection and clinical application, saliva is becoming an increasingly important specimen. However, alternative specimen testing kits that employ samples other than saliva, such as blood and nasopharyngeal swabs, are still driving the market today. Swab-based kits are projected to be introduced by many new players, although swabs are still the primary method of testing and their use has not decreased.

Additionally, even small businesses are receiving FDA authorization for their testing kits alongside major industry giants. This becomes a significant barrier when more small businesses enter the market, posing a threat to dominant players.

As they race to receive federal emergency use authorization, laboratories that are developing their own tests for the COVID-19 pathogen detection are hitting unanticipated roadblocks. Nationally, some laboratories undertaking assay validation studies require complex and pure reagents, including probes, enzymes, and primers, which are essential in clinical lab testing.

Several events may occur throughout the assay validation process, including a rapid surge in demand, export restrictions, stockpiling, restricted access to equipment, and increased personnel requirements. This can result in a lack of the reagents specified above.

As a result, it is projected that the insufficient financial demand-to-supply ratios of reagents will have a negative effect on the overall diagnostic rates and impede the market's expansion.

Country-wise Insights

Why is the U.S. Market Booming?

“Rising R&D and Presence of Key Players”

The U.S. accounted for around 91.2% market share in the North America COVID-19 saliva collection kits market in 2022. This is because the sector has significant R&D investment and important players who are focused on developing diagnostic tests using a variety of technologies. Manufacturers are attempting to release and obtain certification for new products due to the increased popularity of COVID-19 test kits that are practical and easy to use.

• For instance, Therma Bright Inc. reported in April 2021 that its AcuVidTM COVID-19 rapid antigen saliva test had acquired CE clearance from an EU-competent authority of Belgium.

Will U.K. Be a Lucrative Market for Global Manufacturers?

“Recommendations for Sample Selection by Regulatory Body”

U.K. held around 18.8% value share of the Europe COVID-19 saliva collection kits market in 2022. The European Center for Disease Prevention and Control (ECDC) reaffirmed in September 2021 that for symptomatic cases, saliva-based RT-PCR tests produce similar sensitivities to nasopharyngeal swabs and attributed variations to different variants in populations tested, sampling methods, and time of sample collection.

The ECDC recommended saliva as a means to broaden testing adoption among younger groups in August 2020. The ECDC had not yet approved saliva for use in rapid antigen tests as of October 2021. However, a great deal of research on saliva as a flexible sample, for detection utilising a variety of platforms on a wide range of populations, has emerged quickly throughout Europe, thus propelling the market within the region.

How is China a Prominent Market?

“Growing Studies on Saliva as a Specimen for Rapid Disease Diagnostics”

China held a market share of about 89.1% of the East Asia COVID-19 saliva collection kits market in 2022. Early research from China has shown the value of saliva for tracking SARS-CoV-2 infection dynamics, and in 2022, China has started numerous new saliva-based diagnostic projects.

Amplification of nanoparticles for the quick detection of SARS-CoV-2 in saliva, the establishment of an enhanced substrate to be used saliva samples, the development and testing of a Matrix Assisted Laser Desorption Ionization-time of Flight Mass Spectrometry assay combined with isothermal gene amplification from saliva, as well as the proposal of an electrochemical sensor that can interpret viral targets in samples that contain only 10% saliva are a few of the above.

These efforts will continue to propel market demand within the region.

Category-wise Insights

Which Application is Driving Growth of the Global Market?

“Growing Burden of SARS-COV-2 Infection Proliferation”

The COVID-19 diagnostics segment held around 62.4% share of the total COVID-19 saliva collection kits market in 2022. While nasopharyngeal swabs (NPS) continue to be the gold standard substrate, salivary diagnostics for SARS-CoV-2 has been advocated as a substitute and non-invasive approach in susceptible patients.

The lack of NPS as collecting agents has a significant impact on RT-PCR testing sensitivity, culminating to approximately 30% of false - negative. There is abundant indication that saliva can be used as an alternative and non-invasive bio fluid appropriate for SARS-Cov2 genetic testing. With growing burden of COVID-19 infection proliferation, COVID-19 diagnostics using saliva as specimen has gained traction.

Which End User Offers the Global Market a Profitable Outlook?

“Standard Operating Procedures Recommended by Regulatory Authorities”

Diagnostic laboratories held a larger share of about 27.7% with a market value of around US$ 64.4 Mn in 2022. Currently, the WHO recommends using real-time reverse transcriptase polymerase chain reaction (RT-PCR) to detect specific viral RNA sequences in order to diagnose COVID-19 in laboratories (rRT-PCR).

In a similar vein, the Ministry of Health and Family Welfare (MHFW) and Drug Controller General of India (DCGI) were informed by the Indian Council of Medical Research (ICMR) that rRT-PCR-based assays authorized by the US FDA EUA/CE-IVD recognized kits should be used. With the presence of several regulatory interventions, the segment holds a larger share within the overall market.

Competition Landscape

Manufacturers mostly use partnerships, launches, expansion, mergers, and acquisitions to boost product sales across various geographies. To increase their capacity for production, manufacturers in the marketplace are expanding their manufacturing facilities.

Key instances include:

• Thermo Fisher Scientific launched the Thermo Scientific SpeciMAX Saliva Collection Kit in June 2021 to enable extensive research and surveillance programmes.
• In February 2021, Zymo Research launched their COVID-19 variant sequencing service. This new international service increased Zymo Research's end-to-end SARS-CoV-2 solutions, which included SARS-CoV-2 detection, RNA extraction, and sample collection.

Industry Report Scope

Key Segments Covered in COVID-19 Saliva Collection Kits Industry Research

Application:

• COVID-19 Research
• COVID-19 Diagnostics

End User:

• Diagnostic Laboratories
• Hospitals & Clinics
• Academic and research Institutes
• Biopharma Companies
• Long Term Care Facilities
• Home Care Settings
• Others

Region:

• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East & Africa

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