Saliva Collection and Diagnostics Market to Reach US$ 1,260.5 Million by 2033 | Astute Analytica
Validated by technological leaps and strong patient preference for non-invasive methods, the saliva diagnostics market is rapidly expanding, shifting from specialized research to mainstream clinical and at-home use for diverse, early disease detection.
Chicago, Aug. 29, 2025 (GLOBE NEWSWIRE) — The global saliva collection and diagnostics market was valued at US$ 826.6 million in 2024 and is expected to reach US$ 1,260.5 million by 2033, growing at a CAGR of 4.8% during the forecast period 2025–2033.
A favorable regulatory environment is fundamentally reshaping the saliva collection and diagnostics market. The U.S. Department of Transportation (DOT) issued a pivotal final rule on November 5, 2024. It became effective on December 5, 2024. A key provision is a temporary exception for mock oral-fluid collection monitor qualifications. This grace period will last for one year after the Department of Health and Human Services (HHS) certifies the first lab.
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As of December 5, 2024, there are 0 HHS-certified oral fluid drug testing laboratories, indicating future growth potential. A previously published direct final rule on June 21, 2024, was withdrawn after adverse comments. At the state level, Minnesota amended its Drug and Alcohol Testing in the Workplace Act. The new rules, effective August 1, 2024, officially permit oral fluid testing. Furthermore, in New York, DiamiR Biosciences received Clinical Laboratory Evaluation Program (CLEP) test approval in August 2025, signaling growing acceptance.
Key Findings in Saliva Collection and Diagnostics Market
| Market Forecast (2033) | US$ 1,260.5 million |
| CAGR | 4.8% |
| Largest Region (2024) | North America (48%) |
| By Site of Collection | Submandibular/Sublingual Gland Collection (52%) |
| By Application | Saliva Collection (93%) |
| By End Use | Diagnostic Laboratories (78%) |
| Top Drivers |
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| Top Trends |
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| Top Challenges |
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Competitive Arena Sees Key Players Navigate Growth, Restructuring, and Financial Pressures in the Saliva Collection And Diagnostics Market
The competitive landscape shows a mix of strategic adjustments and financial realities. OraSure Technologies, a major player, reported having 501 employees as of December 31, 2024. This figure represents a decrease of 137 employees from the prior year. The company posted revenues of US$ 185 million for 2024. However, it also recorded a net loss of US$ 19.50 million for the year. Meanwhile, direct-to-consumer genetics company 23andMe had 582 employees as of March 31, 2024. It reported total assets of US$ 395 million for the same date. The company’s revenue for the fiscal year ending March 31, 2024, was $192 million. It simultaneously faced a substantial net loss of US$ 666 million. These figures underscore the challenging yet dynamic nature of the saliva collection and diagnostics market.
Direct-to-Consumer Segment Undergoes a Major Transformation Following Strategic Corporate Acquisition
A significant disruption has redefined the direct-to-consumer genetics space. 23andMe filed for Chapter 11 bankruptcy on March 23, 2025. The company listed both assets and liabilities within the range of $100 million to $500 million. During the proceedings, 23andMe secured a commitment for up to $35 million in debtor-in-possession financing. A costly class-action lawsuit settlement from a 2023 data breach amounted to $30 million. An auction for the company’s assets was scheduled for May 14, 2025. A final court hearing to approve the sale was set for June 17, 2025. TTAM Research Institute emerged as the winning bidder in June 2025, with a final price of $305 million. The acquisition was officially completed on July 14, 2025, marking a new chapter for a key segment of the market.
Rapid Product Innovation and Launches Expand Diagnostic Capabilities and Market Reach
Innovation is a primary growth engine in the saliva collection and diagnostics market. In August 2024, Lord’s Mark Microbiotech announced its plan to launch a saliva-based organ age test. The test is set to be priced between Rs 15,000 and 20,000. This is considerably lower than existing market options priced from Rs 30,000 to 40,000. The company is targeting a revenue of Rs 100 crore within the next two years from these tests.
In January 2024, Isohelix launched its SaliFix Saliva Swab DNA Collection Kit. Zymo Research gained FDA clearance in February 2024 for its DNA/RNA Shield SafeCollect Saliva Collection Kit. The FDA designated it a Class II in-vitro diagnostic (IVD) device. DiamiR’s new test is designed to identify 3 common variants of the APOE gene (ε2, ε3, and ε4).
Strategic Partnerships and High-Profile Collaborations Accelerate Research and Development Efforts
Strategic alliances are proving crucial for accelerating innovation across the global saliva collection and diagnostics market. On August 21, 2024, Pattern Computer, Inc. announced a research partnership with the Medical College of Wisconsin (MCW) Cancer Center. Their pilot study will assess the detection of head, neck, and lung cancers through saliva analysis. The study utilizes Pattern’s ProSpectral multi-disease hyperspectral diagnostics research platform. A powerful feature of the platform is its ability to detect diseases in just 3 seconds without reagents. The research is led by 1 world-renowned oncologist, Dr. Razelle Kurzrock, and will be conducted across 2 specialty clinics. In other moves, DiamiR Biosciences entered a merger agreement with Aptorum Group, expected to close in the fourth quarter of 2025. Lura Health partnered with Japan’s SCO Group, which serves over 17,000 dental clinics, to advance health monitoring.
Clinical Research Validates Saliva as a Premier Sample for Disease Screening
Saliva is rapidly becoming a preferred sample type in critical clinical research. The Pattern Computer and MCW study focuses on 3 cancer types: head, neck, and lung. These cancers in the saliva collection and diagnostics market are projected to account for more than 305,000 new U.S. cases in 2024. In neurodegenerative disease, the stakes are high. Individuals with 1 copy of the APOE ε4 allele have a 3 to 4 times higher risk of developing Alzheimer’s. Those with 2 copies face an 8 to 12 times higher risk. A study with 60 participants was conducted to validate the SalivaDirect At-Home Collection Kit. The IBI Saliva Collection Kit can achieve a typical DNA yield of 100 µg from a 5ml saliva specimen. Its 10ml collection tube contains 2ml of stabilization buffer, keeping DNA samples stable for up to 1 month when refrigerated at +4°C.
Intellectual Property and Technological Breakthroughs Fortify Market Leaders and Innovators
A robust pipeline of intellectual property signals intense innovation in the saliva collection and diagnostics market. Life Technologies Corporation was granted U.S. patent D1010851 on January 9, 2024, for a saliva collection device. The application (29/770,074) was filed on February 9, 2021. A patent for a biofluid collection system (CN118717113A) applicable to saliva was also filed in 2024. Pfizer Inc. secured a European patent (EP3429543B1) on November 20, 2024. Another new patent describes a lateral flow test strip with a filter pad of at least 0.5 mm thickness for better sample flow. SalivaBio, LLC, and Johns Hopkins University received a U.S. patent for their Saliva Collection Aid. Looking ahead, Lura Health is targeting FDA approval for its microsensor technology by early 2027, promising future growth.
Direct-to-Consumer Segment Demonstrates Resilience and Dominant Market Share Position in Saliva Collection and Diagnostics Market
The direct-to-consumer (DTC) channel remains a powerful force. The North America DTC laboratory testing market was valued at $1.13 billion in 2024. It is estimated to reach $1.24 billion in 2025. Saliva-based testing was the largest segment, capturing 53.5% of the DTC market share in 2024. Globally, the at-home saliva testing kit market was valued at approximately $1.2 billion in 2024. In the DTC DNA test kits market, the saliva segment held a commanding share of over 56% in 2023. The falling cost of sequencing a human genome, down to about $600 in 2023, has increased accessibility. However, the sector faced challenges, including a 2023 data breach at 23andMe that affected nearly 7 million customer profiles.
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Global Market Expansion and Specialized Manufacturing Solidify Sector’s Bright Future
The saliva collection and diagnostics market is expanding globally while manufacturers refine their offerings. North America held the largest share of the at-home saliva testing kit market in 2024, with about 45% of the revenue. The U.S. market, estimated at $273.98 million in 2023, is projected to surpass $404.96 million by 2032. European expansion is also underway, with Thermo Fisher Scientific opening a new bioanalytical lab in Sweden in September 2024.
There are growing requirements for saliva testing in at least 3 major Asian countries: China, India, and South Korea. Manufacturers in the saliva collection and diagnostics market are catering to specific needs. Salimetrics offers a 25-pack of 2 mL Cryovials for $24.00, a 50-pack of its Saliva Collection Aid for $77.00, a 50-pack of its SalivaBio Oral Swab for $57.00, a 50-pack of its Children’s Swab for $110.00, and a 50-pack of its Infant Swab for $88.00. Zymo Research’s kits contain a tube with 2mL of its DNA/RNA Shield reagent.
Meanwhile, DNA Genotek’s Oragene•Dx and ORAcollect•Dx are the first 2 FDA 510(k) cleared saliva DNA collection devices for diagnostic use.
Saliva Collection and Diagnostics Market Major Players:
- Norgen Biotek Corp
- Takara Bio, Inc.
- OraSure Technologies, Inc
- Autogen, Inc.
- Meridian Bioscience, Inc.
- Zymo Research Corporation
- Neogen Inc
- Porex
- Thermo Fisher Scientific, Inc.
- Salimetrics, LLC.
- Sarstedt AG & Co.KG
- Spectrum Solutions, LLC.
- Wuxi NEST Biotechnology Co., Ltd
- ZRT Laboratory
- Abbott Laboratories
- Akonni Biosystems, Inc.
- Other Prominent Players
Key Market Segmentation:
By Site of Collection
- Parotid Gland Collection
- Submandibular/Sublingual Gland Collection
- Others
By Application
- Disease Diagnostics
- Forensic Applications
- Research
By End-Use
- Dentistry
- Diagnostic Laboratories
- Pharmaceutical and Biotechnology Companies
- Research Institutes
By Region
- North America
- Europe
- Asia Pacific
- Middle East
- Africa
- South America
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