Saliva-based Screening Market
Global Market Study on Saliva-based Screening: Hospitals & Clinics to Remain Dominate End Users
Saliva-based Screening Market Segmented By Saliva Collection Kits, Saliva Nucleic Acid Purification Kits, Saliva-based Detection Kits Product for Research Use Only,, Diagnostics
Revenue from the sales of saliva-based screening products is around US$ 297 Mn this years, with the market slated to experience significant growth of 8% CAGR during 2021-2031 As per Persistence Market Research’s projections, saliva-based detection kits hold a substantial share of over 60% in the overall market.
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- Thermo Fisher Scientific
- Zymo Research Corporation
- DNA Genotek Inc.
- Invitek Molecular GmbH
- Salimetrics, LLC.
- BioChain Institute Inc.
- Mawi DNA Technologies LLC
- Cell Projects Ltd.
- Kyodo International, Inc.
- Spectrum Solutions
- NEOGEN Corporation
- Xiamen Zeesan Biotech Co., Ltd.
- Sedia Biosciences Corporation
- Biosynex SA
- Chembio Diagnostics, Inc.
- Creative Diagnostics
- OraSure Technologies
Key Insights Covered in Saliva-based Screening Industry Survey:
- Market Estimates and Forecasts (2016-2031)
- Key Drivers and Restraints Shaping Market Growth
- Segment-wise, Country-wise, and Region-wise Analysis
- Competition Mapping and Benchmarking
- Market Share Analysis By Key Players
- Key Product Innovations and Regulatory Climate
- COVID-19 Impact on Demand for Saliva-based Screening Products and How to Navigate
- Recommendation on Key Winning Strategies
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Demand Analysis of Saliva-based Screening for 2016 to 2031
The global saliva-based screening market is projected to surge at 8% CAGR during 2021-2031.
Saliva, over the last decade, has been emerged as an alternative to serum-based testing because of its non-invasive nature and ease of collection. Along with this, significant presence of diseases indicators/biomarkers such as genetic materials and proteins has driven its demand in identifying oral and systemic illness. Furthermore, saliva provides a cost-effective approach for the screening of larger population.
Apart from these, minimal risk of cross-contamination, commercial availability of screening assays, sample collection at convenience at home, ease in obtaining multiple samples, real-time diagnostic values, safe to administer as compared to serum sampling (no needles), and ease in recent drug detection owing to shorter detection window are some of the other benefits associated with saliva-based screening.
Due to these advantages, saliva-based screening is widely accepted and used for the diagnosis of autoimmune diseases, cardiovascular diseases, diabetes, HIV, cancer, caries, and periodontal diseases. This is likely to see increased utilization of saliva as a diagnostic fluid.
Also, as genomic research advances, a saliva-based diagnostic is expected to play an important role in the early detection, monitoring, and progression of systemic and oral diseases. Thus, growing adoption of saliva-based screening is expected to provide lucrative opportunities for market growth.
The market is expected to expand at a considerable growth rate over the next ten years and offer an absolute $ opportunity of US$ 343 Mn.
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How are Regulatory Approvals and New Product Launches Impacting the Saliva-based Screening Space?
Development and launch of technologically advanced new solutions to cater to the growing need for rapid detection for various diseases. This is one of the primary reasons for manufacturers in the global saliva-based screening market to become more competitive. Several established, as well as emerging companies, are releasing new products or obtaining approvals to increase their product sales and market share. Some of the recent approvals and launches include:
- In January 2021, OraSure Technologies, Inc. launched Oragene Dx (OGD-610), a saliva collection device as a component in the De Novo, and U.S. FDA granted authorization to Helix for its Helix Laboratory Platform1, a whole-exome sequencing platform.
- Zeesan Biotech, in June 2017, received China Food and Drug Administration (CFDA) approval for its MeltPro Del- HBA test. These kits are designed to detect three gene mutations common in the Chinese population, which were related to deletional α-Thalassemia.
- In October 2016, Good Start Genetics introduced VeriYou, a saliva-based screening test for the detection and diagnosis of two common inherited genetic disorders - cystic fibrosis (CF) and spinal muscular atrophy (SMA).
Availability of such innovative products with associated benefits will lead to market expansion. Approvals such as these are expected to increase adoption, thus fuelling growth of the global saliva-based screening industry during the forecast period of 2021-2031.
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What are the Key Opportunities on Offer for Saliva-based Screening Product Manufacturers?
To capitalize on the growth opportunities in this technology-driven market, manufacturers are focusing on expanding inorganically by entering into agreements, partnerships, and collaborations.
- Hologic, Inc., in June 2021, acquired Mobidiag Oy, an innovator in acute care molecular diagnostic testing, and near-patient, for a Value of around $808 million.
- QIAGEN N.V. in September 2020, announced the acquisition of the remaining 80.1% stake in NeuMoDx Molecular, Inc., a diagnostic instrument company, for $248 million in cash
- Chembio Diagnostics, Inc. acquired a Brazilian distributor and manufacturer, Orangelife Comercio e Industria Ltda., for the development of point-of-care diagnostic tests in infectious diseases.
Such developments not only strengthen a company’s existing portfolio but also helps increase its presence at the regional as well as global level, and also helps sustain the increasing competitive pressure.
How is Availability of Serum-Based Rapid Testing Restraining Demand for Saliva-based Screening?
The global market is facing challenges from substitute products owing to the range of technologies being introduced by key players such as serum-based rapid testing for the detection of diseases.
This trend is especially observed in the case of HIV testing kits, as a larger target population is to be screened. Though rapid or point-of-care test specimen collection is very simple, the accuracy of point-of-care tests is not always equal to that of laboratory tests. Also, when used in a population with a low prevalence of HIV, false-positive results can be a problem. The rapid oral fluid test is more likely to give a false-positive result than other tests.
Thus, owing to the risk of false-positive results, healthcare providers might suggest a blood test to confirm the diagnosis. Thus, the availability of serum-based rapid testing hampers the adoption of saliva-based screening kits and devices among hospitals, diagnostic laboratories, and academic & research institutes, which are the major end users of these products.
What Makes the U.S. a Lucrative Market for Saliva-based Screening?
The U.S. dominates the North American region with a total market share of 89% in 2021, and is projected to continue experiencing high growth throughout the forecast period.
Increasing demand for self-testing/home-based saliva-based screening is creating lucrative growth opportunities for the U.S. in saliva-based screening. Growing preference for self-testing home kits can be attributed to their user-friendly nature and accessibility through various distribution channels such as online pharmacies or drug stores.
Patients will be impacted even more as these point of care devices will make them adjusted to new settings where they can monitor their health at their convenience.
Self-test kits have displayed great potential for reaching into groups where there is a high risk of HIV, but a lower level of HIV testing. Also, there have been many advances in the introduction, implementation and scaling of HIV self-testing. Also, initiatives taken by governments worldwide for easy and rapid approval of self-test kits are increasing demand for HIV self-testing kits.
While public-sector HIV self-testing distribution has not played a great role in the U.S. market, health insurance schemes and government subsidies to reimburse customers who purchase these kits are gradually being developed and rolled out.
Hassle-free usage and portability that comes with these devices will increase the market penetration of self-testing kits even in remote areas where healthcare facilities are not adequate. This, along with the above-mentioned advantages will drive demand for saliva-based self-screening kits over the coming years.
Why is Germany a Prominent Market for Saliva-based Screening in Europe?
Germany dominates the European market for saliva-based screening with a share of 29%.
In May 2021, the European Centre for Disease Prevention and Control circulated concerns for the use of saliva as a diagnostic sample to diagnose COVID-19 infection. As per this report, commercial assays based on the use of saliva specimen are available in the European Union with CE marking.
The European Medicines Agency (EMA) has granted approvals to several key players for the promotion of their goods in Germany, thus driving market growth in Germany for saliva-based screening tests.
How is India Faring in the Saliva-Based Screening Industry?
India holds 72% share in the South Asia market and is projected to expand at a CAGR of 8.6% during 2021-2031.
In India, growing awareness due to government and non-profit organization initiatives is supplementing the growth of the market. Awareness about the need for early detection of infections will contribute to market growth in the country.
What is the Outlook for China Regarding Saliva-based Screening?
In 2020, China dominated the East Asia market with 46% share and is projected to expand at a CAGR of 9.4% from 2021-2031.
Increasing occurrence of viral infections in China and unawareness of the treatment options due to disordered urban growth and environmental changes owing to changing lifestyles create potential opportunities for saliva-based screening in the country.
Which Saliva-based Screening Product is Driving Market Growth?
By product, saliva-based detection kits will lead the market with a share of 60% over the forecast period. Growing acceptance of saliva-based screening by some developers contributes to the market growth.
For instance, e7 Health of Las Vegas deals with at-work or at-home COVID-19 tests authorized by the U.S. FDA.
What is the Future Outlook for Saliva-based Screening in Diagnostics?
The diagnostics segment dominates the market with 76% revenue among other purposes. Rising prevalence of infectious disease and availability of advanced screening tests are contributing to the large share of the segment.
Why is Saliva-based Screening Most Applicable in Infection Analysis/Detection (Non-COVID)?
Based on application, infection analysis/detection (non- COVID) holds a larger share of 60% in 2021. Although serum-based testing remains the gold standard for detecting HIV infections, in recent years, saliva-based HIV screening has been extensively used to diagnose diseases.
Which End User is Most Preferred for Saliva-based Screening?
Based on end user, the hospitals & clinics segment leads the way with 49% market share.
Advancements in healthcare methodologies in different countries such as the U.S. and Japan have brought about improved cost-effectiveness for different diagnostic tests, which has prompted more individuals to receive strategies for their diagnosis and treatment. This has prompted a rise in the need from hospitals.
What is the Impact of COVID-19 on the Saliva-based Screening Industry?
With the unprecedented COVID-19 crisis, the diagnostics industry has found itself at the frontline to deal with the global medical emergency, which has not only crippled economies worldwide but has also put immense pressure on healthcare facilities around the globe. The unanticipated level of demand for testing kits has pushed industry players into uncharted territories where their strengths are challenged on daily basis.
Adding to already existing challenges are closed transnational borders, lengthy customs procedures together with choked distribution channels and limited stock of supplies of raw materials. The other end of the market comprising of end-users like hospitals and diagnostic laboratories are facing challenges as the number of saliva-based tests have seen a drop and is given secondary importance. During the pandemic, the healthcare centers had been busy addressing the patients with COVID-19.
This trend is expected to have a short-term impact on saliva-based screening for other infectious diseases. However, owing to ongoing advancements in genomics and proteomics saliva-based screening will enable the market to provide significant growth opportunities for the market post-pandemic era.
What is the Impact of Market Consolidation on the Saliva-based Screening Business Space?
Many diagnostics manufacturing companies are making the significant focus on discovering a potential application of saliva-based screening for diagnosing various diseases, with oral diseases and lung cancer being yet another upcoming area of focus. In this regard, Spectrum Solutions, LLC in January 2021, entered into a sponsored research collaboration with the UCLA School of Dentistry for a study on using saliva in early lung cancer detection and analysis.
Research collaborations will support the development of new products and are expected to provide substantial growth opportunities for providers of saliva-based screening.
Key market players are focusing on their product portfolios through acquisition and collaboration activities.
- For instance, in January 2020, Salimetrics launches a new Salivary Human Total Immunoglobulin G (IgG) ELISA Kit to support multidisciplinary investigators in serological studies.
Saliva-based Screening Market Report Scope
Historical Data Available for
US$ Mn for Value
Key Regions Covered
Key Countries Covered
Key Market Segments Covered
Key Companies Profiled
Available upon Request
Key Segments Covered in Saliva-based Screening Industry Research
- Saliva Collection Kits
- Saliva Nucleic Acid Purification Kits
- Saliva-based Detection Kits
- Rapid Tests
- PCR-based Tests
- Research Use Only
- Infection Analysis/Detection (Non- COVID)
- Genomic Analysis
- Liquid biopsy
By End User
- Hospitals & Clinics
- Diagnostic Laboratories
- Academic and Research Institutes
- Biopharmaceuticals and CROs
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