COVID-19 Saliva-Based Detection Kits Market to reach US$ 1.2 Bn by 2031 | Thermo Fisher Scientific Inc; Qiagen; Hologic; Takara Bio In

The global COVID-19 Saliva-Based Detection Kits Market reached a valuation of US$ 1.6 billion in 2021, with PCR-based kits commanding a dominant 73% share, according to Fact.MR. Despite significant growth during the pandemic, the market is projected to decline at a CAGR of -2.8% from 2021 to 2031, reaching US$ 1.2 billion by 2031, driven by increased vaccination rates and a shift to alternative testing methods. This press release explores the key drivers, projections, and opportunities in this evolving healthcare sector.

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Why Did the Market Grow in 2021?

The surge in COVID-19 cases, with over 96.8 million confirmed cases in the U.S. alone by November 2022, fueled demand for saliva-based detection kits due to their non-invasive, patient-friendly nature. Saliva tests, like Yale's SalivaDirect authorized by the FDA in 2024, eliminated the need for nasopharyngeal swabs, reducing healthcare worker exposure by 10% and patient discomfort. Innovations such as Qiagen's 2021 CE-marked artus Prep&Amp test improved turnaround time by 15%. Government support, like the U.S.'s US$ 248.7 million NIH investment in diagnostics in 2020, boosted adoption, though declining cases and vaccination campaigns, covering 70% of the global population by 2024, temper future growth.

What Are the Key Market Projections?

The market, valued at US$ 1.6 billion in 2021, is expected to decline from US$ 1.4 billion in 2020 to US$ 1.2 billion by 2031, reflecting a -2.8% CAGR, resulting in a US$ -400 million opportunity loss. PCR-based kits, with a 73% share in 2021, are projected to maintain dominance due to their 95% sensitivity, though their share may decline to 70% by 2031 as rapid antigen tests gain traction. North America, holding a 91% share in the U.S. market in 2021, leads due to robust healthcare infrastructure, while Asia-Pacific grows at a 2.5% CAGR, driven by India's 909.9 million tests by 2022. Historical growth from 2019 to 2020 saw a 9.9% CAGR, but future declines are expected due to vaccination success.

How Can Stakeholders Leverage Opportunities?

Stakeholders in diagnostics and healthcare can focus on niche markets, such as saliva-based kits for detecting SARS-CoV-2 variants, like Thermo Fisher Scientific's 2021 acquisition of Mesa Biotech for rapid testing. Partnerships, such as Molbio Diagnostics' 2023 collaboration with Testi Technologies for saliva-based tests, enhance accessibility. Targeting Asia-Pacific, with India's growing self-testing market, and North America offers potential. Diagnostic labs and homecare, accounting for 26.8% and 10% of revenue in 2021, respectively, provide scalability. Compliance with FDA and CE standards ensures market trust, despite declining demand.

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What Does the Report Cover?

Fact.MR's report combines primary research across 30+ countries and secondary analysis, covering segments by product (rapid test kits, PCR-based kits), technology (direct sample to PCR, RT-qPCR, lateral flow assay), application (COVID-19 diagnosis, research), end user (diagnostic labs, hospitals, clinics, academic institutes, homecare), and region (North America, Latin America, Europe, East Asia, South Asia & Oceania, Middle East & Africa). It highlights trends like at-home testing, cost-effective kits, and variant detection, providing actionable insights for stakeholders.

Who Are the Market Leaders?

Key players include Thermo Fisher Scientific Inc., Qiagen NV, ACON Laboratories Inc., Hologic Inc., and Zymo Research Corporation. Therma Bright Inc.'s 2021 CE-approved AcuVid rapid antigen test and Lenexa's 2020 FDA-approved saliva test strengthened portfolios. These companies, holding over 50% of the market, drive innovation through R&D and regulatory approvals, focusing on rapid, accurate diagnostics.

What Are the Latest Market Developments?

In 2024, saliva-based testing adoption grew by 10% in schools and workplaces due to its non-invasive nature. RT-qPCR technology, holding a 49.2% share in 2021, remains dominant for its accuracy. North America's 91% U.S. share reflects high testing rates, while Asia-Pacific's growth is driven by India's Angcard saliva test launch in 2021. Regulatory advancements, like the FDA's 2024 SalivaDirect EUA, reduced reagent dependency by 15%. However, a shift to nasal swab-based rapid antigen tests, growing 20% in 2024, restrains saliva-based market growth.

What Challenges and Solutions Exist?

Declining COVID-19 cases, with global vaccinations reaching 70% by 2024, and competition from nasal swab kits, holding a 48.2% share in 2023, challenge market growth. High production costs, averaging US$ 10 per kit, and reagent shortages affect scalability. Solutions include cost-effective rapid tests, like Vatic Health's 2021 CE-marked saliva antigen test, and open-source protocols like SalivaDirect, reducing costs by 20%. Localized production in Asia-Pacific, adopted by 15% of manufacturers, mitigates supply issues. Compliance with WHO and EMA standards ensures market resilience.

Conclusion:

The Global COVID-19 Saliva-Based Detection Kits Market, valued at US$ 1.6 billion in 2021, faces a projected decline to US$ 1.2 billion by 2031 at a -2.8% CAGR. Despite challenges from vaccinations and nasal swab tests, opportunities remain in variant detection and self-testing markets. Stakeholders can leverage Fact.MR's insights to target high-growth regions like Asia-Pacific, invest in innovative diagnostics, and address cost and supply challenges to sustain relevance in this evolving healthcare industry.

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