Saliva Collection and Diagnostic Market

Market Overview

The global saliva collection and diagnostic market size was valued at USD 2.77 billion in 2022. It is estimated to reach USD 7.30 billion by 2031, growing at a CAGR of 11.37% during the forecast period (2023–2031)

Saliva is a translational research tool and a diagnostic medium utilized in cutting-edge techniques to find molecular biomarkers for several illnesses and conditions that impact the mouth and the body. A desirable goal for oral health improvement and research is the ability to deconstruct saliva to screen for diseases and health issues. Saliva tests have been used to diagnose illnesses of the salivary glands, hepatitis, HIV, periodontitis, breast cancer, oral cancer, and cancer risk. Technological progress has permitted a high level of studies to be performed at a previously unrealized scale and is serving to propel the discovery and approval of salivary disease biomarkers.

Market Dynamics

Market Drivers

• Growing Number of Approvals for Saliva Collection Devices

The increase in approvals for saliva collection and diagnostic devices is due to their growing need to diagnose life-threatening diseases rapidly. For example, in January 2015, DNA Genotek, an OraSure Technologies, Inc. subsidiary, received approval from the US Food and Drug Administration (USFDA) for genetic Oragene Dx saliva collection test kits. The saliva collected using these kits is used to screen for Bloom Syndrome, a genetic disorder.

Furthermore, 23andMe, Inc. works with DNA Genotek to manufacture a genetic Oragene Dx saliva collection test kit. Later, in February 2015, the USFDA approved the proposal of 23andMe, Inc. to market genetic Oragene Dx saliva collection test kits. The growing demand for salivary diagnostics has encouraged several companies to invest in the market and develop products, kits, and devices for saliva collection and testing resulting in an upsurge in the global growth of the saliva collection and diagnostic market.

• Cost-Effective Saliva Collection and Diagnostic Methods

Collecting saliva DNA is less costly for genetic research than other types of testing, such as blood and urine tests. As per the CRN Pharmacovigilance Project, the cost of a saliva collection kit of Oragene is around USD 20, while the price of a blood collection kit is nearly USD 100. However, according to DNA Genotek, saliva collection is 48% less costly than blood collection. There is no need for transportation and storage of saliva samples from collection to processing. In contrast, the blood samples require dry ice, overnight shipping, and freezers, while the saliva samples can be stored at room temperature and transported via traditional methods. Hence, the saliva collection method is less costly than blood collection, which is one of the factors fueling the market's growth.

Market Restraint

• Supply of Defective and Faulty Products

The supply of faulty and defective products is expected to hamper the global saliva collection and diagnostics market. In June 2018, Dante Labs delivered a faulty saliva collection kit in Switzerland. The tube portion where saliva was to be deposited had a bubbly liquid on its brim and was sealed in a biohazard bag. Furthermore, the kit did not contain any return instructions. This faulty device will likely cause a dip in the global saliva collection and diagnostics market.

Market Opportunities

• Technological Advancements like Saliva-Based POCT Devices

The salivary diagnostic is an evolving field for advancing the point of care technology (POCT). The need for the development of saliva-based POCT devices is due to the potential of saliva in the early detection of oral and systemic diseases such as bacterial and fungal infections, cancers, and genetic disorders. In addition, point of care technology is a medical device used to conduct testing outside the laboratory, including at the patient's bedside, the doctor's office, and the patient's home. The increasing research and development in disease prediction by saliva testing provide enormous opportunities for market players to enter the global saliva collection and diagnostics market.

Technological progress has permitted a high level of studies to be performed at a previously unrealized scale and is serving to propel the discovery and approval of salivary disease biomarkers. Miniaturization technology provides a new avenue for point-of-care diagnostics among the newly developed technologies. This will detect multiple biomarkers in parallel and allow simultaneous research and development studies for various disease conditions. Such new technologies would significantly change the landscape of point care diagnostic technology and boost the saliva collection and diagnostics market.

Regional Analysis

Americas Dominate the Global Market

By region, the global saliva collection and diagnostic market is divided into Americas, Europe, Asia-Pacific, and the Middle East and Africa.

Americas is the most significant shareholder in the global saliva collection and diagnostic market and is anticipated to grow at a CAGR of 11.36% during the forecast period. The Americas saliva collection and diagnostics is further segmented into North America and Latin America saliva collection and diagnostics market. North America is expected to lead the industry with the most significant market share, primarily because of the region's growing elderly population and access to cutting-edge healthcare facilities. Some of the critical factors leading to the growth of this market are the rising prevalence of cancers and the increasing number of companies investing significantly in the research and development of such diagnostic tests.

Furthermore, the presence of market leaders and increasing technological developments are also responsible for propelling market growth. In May 2020, the Food and Drug Administration granted emergency authorization for the first at-home saliva collection kit to test for the coronavirus. The high awareness rate and better healthcare facilities have increased the demand for saliva collection and diagnostics tests in this region. The growing recognition of the association between an individual's oral and overall health has led to renewed interest in using saliva as a diagnostic fluid. Two US-based companies, Epitope, Inc. and Saliva Diagnostic Systems, Inc, were early developers of oral diagnostics.

Europe is anticipated to grow at a CAGR of 11.19% over the forecast period. The increasing presence of major companies in European countries is a significant factor in the saliva collection and diagnostic market growth. For instance, SARSTEDT AG & Co. KG (Germany) has a presence in 36 countries in the Europe region. Furthermore, the company has tie-ups with distributors and importers, which aid the demand in the region. Moreover, many companies continuously strive to bring innovative products to this market. For instance, Bethlehem's OraSure Technologies Inc. is working to develop a rapid, oral-fluid self-test on the market by September, available over the counter and able to produce results within 20 minutes. It likely would sell for less than USD 50. The public and private firms' continuous support in light of the coronavirus outbreak to the companies operating in the market is expected to fuel growth in the region.

Asia-Pacific is anticipated to have the fastest-growing market for saliva collection and diagnostics due to increased funding for R&D, expanding healthcare infrastructure, government initiatives and support for bettering public health, significant investments by businesses, and government initiatives. The rising prevalence of respiratory infections is increasing the burden on the Asia-Pacific healthcare system. Being a large population base, an increasingly aging population, and growing use of technology in healthcare, the government authorities in Asian countries, such as India, China, and Japan, are actively involved in keeping infectious diseases at bay. Moreover, the growing awareness regarding the benefits of saliva-based tests in patients and healthcare professionals is likely to create demand, which is expected to increase the saliva collection and diagnostics market value in Asian countries.

Over the last few years, the Middle East and African saliva collection and diagnostic market are growing dramatically due increasing prevalence of various infectious diseases. This market is expanding significantly due to increased regional distributorship and subsidiaries. For instance, DNA Genotek Inc., an OraSure Technologies, Inc. subsidiary, operates in Israel, Saudi Arabia, and Saudi Arabia through Pronto, Integrated Gulf Biosystems (IGB), and Whitehead Scientific (Pty) Ltd, respectively. In addition, the Middle East region is growing significantly compared to Africa. Some factors affecting this region's saliva collection and diagnostic market include limited access to healthcare facilities, lack of knowledge of new collection techniques, less funding for R&D, limited availability of products, and others.

Segmental Analysis

The global saliva collection and diagnostic market is segmented into site of collection, application, and end-user.

Based on the Site of Collection

The global saliva collection and diagnostic market is divided into parotid glands collection, submandibular glands/sublingual glands collection, minor salivary glands collection, and others.

The submandibular glands/sublingual glands collection segment is the highest contributor to the market and is expected to grow at a CAGR of 11.62% during the forecast period. Just below the inferior border of the mandibular body is where the submandibular gland is located. It is best palpated bi-manually with one hand on the lateral floor of the mouth and the other on the submandibular gland. The sublingual glands are almond-shaped and lie on the bottom of the oral cavity. The submandibular gland produces around 70.0% of nonstimulated saliva. In addition, sialoliths or salivary stones are the most prevalent disorder affecting the salivary glands in middle-aged adults. Approximately 80% of salivary sialoliths originate in the submandibular gland, followed by the parotid gland, which accounts for 6–15%, and the minor or sublingual salivary glands, which account for 2%. The rising incidence of sialolithiasis may contribute to the segment's expansion over the forecast period.

The parotid gland lies on the lateral surface of the mandibular ramus and folds itself around the posterior border of the mandible. Cancer of the salivary glands is a rare tumor that originates in the salivary gland tissue. The parotid glands are home to the most benign salivary gland malignancies. Imaging tests or biopsies, such as CT scans, MRIs, and positron emission tomography scans, are used to diagnose this illness. The rising incidence of parotid carcinoma has contributed to expanding the saliva collection and diagnosis market. Later in May 2020, the U.S. Food and Drug Administration (FDA) authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing.

Based on Application

The global saliva collection and diagnostic market is divided into disease diagnosis, forensics, pharmaceutical and biotechnology companies, and others.

The disease diagnosis segment owns the highest market share and is expected to grow at a CAGR of 11.71% during the forecast period. Saliva is a non-invasive and safe source and could be used as a substitute for blood in diagnosing and prognosis of diseases. Oral diseases diagnosed by saliva are carries, periodontal diseases, oral cancer, and Sjögren's syndrome. The increased number of streptococcus mutans and lactobacilli in saliva has been associated with an increased prevalence of caries and root caries. In addition, periodontal diseases have been associated with increased levels of aspartate aminotransferase (AST) and alkaline phosphatase (ALP). Thus, salivary AST is used as a marker for monitoring periodontal disease. Therefore, the increasing diagnosis of diseases by saliva is boosting the global saliva collection and diagnostic market.

An increasing number of saliva collection device approvals and new launches by pharmaceutical companies, along with the availability of new tools for saliva collection and diagnosis, especially during the ongoing COVID-19 pandemic, is fueling the global saliva collection and diagnostic market. For instance, in Spectrum DNA, in April 2020, declared that the Spectrum DNA SDNA-1000 Whole Saliva Collection Device, researchers from RUCDR Infinite Biologics at Rutgers University successfully validated saliva as a viable biosample source for COVID-19 detection when compared to nasopharyngeal or oropharyngeal swabs.

Based on End-User

The global saliva collection and diagnostic market is divided into hospitals and dental clinics, diagnostic centers, investigation laboratories, and others.

The hospitals and dental clinics segment is the highest contributor to the market and is anticipated to grow at a CAGR of 10.93% over the forecast period. The hospitals and dental clinics segment market growth is majorly attributed to the increasing number of patients getting monitored with chronic diseases. Since advanced and complete treatments are available in the hospital, patients usually prefer to get treated at the hospital. Dental clinics are also medical care centers that provide dental services. Further, hospitals are rapidly adopting new technologies and procedures to provide effective treatments, which are expected to contribute to the market's growth.

A diagnostic center is a place that offers diagnostic services to medical professionals or the public. This segment's market growth is due to the increasing number of people diagnosed at diagnostic centers. Additionally, a growing number of diagnostic centers providing innovative diagnostic techniques contributes to the market's growth.

Recent Developments

November 2022- Quest Diagnostics announced that it had completed its previously announced acquisition of select assets of LabCare Plus, the outreach laboratory services business of Summa Health, an extensive integrated healthcare organization.

August 2022- LordsMed entered into an exclusive partnership with Singapore-based diagnostics kit manufacturer Sensing Self to bring one of the world’s first COVID-19 saliva-based rapid antigen test kits to India.