COVID 검사 키트 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the COVID testing kit market size was valued at USD 7.48 billion in 2025 and estimated to grow from USD 7.01 billion in 2026 to reach USD 5.06 billion by 2031, at a CAGR of -6.32% during the forecast period (2026-2031).

This report is Segmented by Product (RT-PCR Assay Kits, Immunoassay Test Strips/Cassettes, CRISPR-Based Molecular Kits, Next-Gen Sequencing Panels), Specimen (Nasopharyngeal Swab, Nasal Swab, and More), End User (Hospitals, Diagnostic Laboratories, and More), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global COVID Testing Kit Market Trends and Insights

High Incidence of COVID-19 Variants

The virus's evolution toward seasonal patterns similar to influenza reduces the urgency for mass testing but preserves baseline surveillance requirements. The WHO's advisory group now focuses on XBB-lineage strains, signaling a move to vaccinate and monitor rather than broadly screen entire populations. Labcorp reported a sequential fall in COVID testing revenue of 1.9% in Q1 2024 and 0.9% in Q2 2024, a pattern echoed across major laboratories as acute-phase demand subsides. Diagnostic companies must therefore balance lower volumes with the need to maintain sequencing capacity for variant detection. Platform flexibility and integrated data reporting become important differentiators as health agencies continue to rely on laboratories for genomic surveillance. Manufacturers that embed variant-specific primers into existing assays can capture ongoing institutional demand without incurring the cost of new kit development.

Expanding Governmental Stockpiling Programs

Government preparedness initiatives create a demand floor even as private-sector ordering wanes. The U.S. Department of Health and Human Services has invested more than USD 3 billion to maintain domestic rapid test production and procured 500 million at-home tests for strategic reserves. Similar procurement frameworks in the European Union guarantee manufacturers multi-year purchase commitments, offsetting margin erosion in retail channels. By stabilizing baseline production, these contracts help suppliers retain skilled labor and sustain quality systems required under ISO 13485 and FDA Quality System Regulation. In return, governments gain assured surge capacity for future outbreaks, supporting broader national security goals.

Declining Test Volumes as Pandemic Subsides

Diagnostic companies have reported 70-90% drops in COVID test orders compared with peak 2021 levels. Abbott cut 199 jobs at its Maine facility, and Cue Health reduced headcount by 170 as public funding pivoted toward vaccines and therapeutics. Fixed manufacturing overhead now spreads across smaller batches, intensifying cost pressures. Laboratories are rationalizing inventories, carrying just-in-time stocks rather than months of safety supplies. In this environment, suppliers are shuttering satellite plants, automating packaging lines, and renegotiating raw-material contracts to align capacity with new baseline demand.

Other drivers and restraints analyzed in the detailed report include:

1. Rapid Consumer Shift to Self-Testing
2. Commercialization of CRISPR-Based Diagnostics
3. Price Commoditization Squeezing Margins

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

RT-PCR assay kits sustained their lead with 73.42% COVID testing kit market share in 2025 as hospitals and reference labs trust their accuracy for regulatory and reimbursement compliance. However, the CRISPR-based molecular subgroup is projected to log the highest 1.90% CAGR through 2031, reflecting laboratory demand for rapid, point-of-care workflows. Immunoassay cassettes capture mass-screening orders yet face margin erosion, while next-generation sequencing panels remain confined to variant surveillance programs. Multiplex respiratory assays that detect SARS-CoV-2, influenza A/B, and RSV in a single run clock in at 97-100% accuracy with sub-hour turnaround, a capability that supports their premium pricing.

The segment reveals a split between commodity tests and higher-value specialized diagnostics. Companies that deploy modular cartridge systems can swap reagents to meet seasonal pathogen patterns, thereby shielding revenue. Columbia Engineering's 23-minute RT-PCR prototype hints at future benchmarks for emergency-department throughput. Simultaneously, CRISPR assays that distinguish active viral replication from residual fragments could guide quarantine decisions and antiviral prescriptions, carving out clinical niches even as total test numbers fall. Suppliers that merge these technical advances with automated result reporting stand to capture enduring demand in a downsized yet technology-savvy marketplace.

Complete Report Scope:

• By Product
  • RT-PCR Assay Kits
  • Immunoassay Test Strips / Cassettes
  • CRISPR-based Molecular Kits
  • Next-Gen Sequencing Panels
• By Specimen
  • Nasopharyngeal Swab
  • Nasal Swab
  • Oropharyngeal Swab
  • Saliva
  • Blood / Finger-prick
• By End User
  • Hospitals
  • Diagnostic Laboratories
  • Home Care Settings
  • Public Health Agencies
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America retained its leading 39.30% slice of the COVID testing kit market in 2025, buffered by USD 3 billion in federal funding for rapid-test procurement and manufacturing resilience. Yet commercial volumes shrank sharply after insurers curtailed blanket coverage, prompting manufacturers to streamline plants and prioritize higher-margin multiplex panels. Abbott Laboratories disclosed that lower COVID testing revenue and export tariffs will trim more than USD 1 billion from 2025 sales, illustrating the pressure on incumbents. FDA rulemaking on laboratory-developed-test oversight introduces new validation costs but promises a harmonized pathway for rapid approvals, benefitting firms that can meet stringent performance benchmarks.

Asia-Pacific recorded the fastest regional expansion at a 1.98% CAGR and is expected to keep that momentum through 2031 as urban hospitals prioritize combined respiratory panels to manage overlapping flu and COVID seasons. Governments are channeling recovery funds into molecular-diagnostic capacity, including subsidies for domestic reagent manufacturing. Public-private partnerships in India and China are building centralized data platforms that connect test readers to cloud analytics, transforming discrete kits into surveillance assets for health ministries. Nevertheless, uneven insurance coverage and variable reimbursement slow widespread adoption outside tier-one cities.

Europe continues to emphasize institutional purchasing, guided by the European Medicines Agency's collaboration on global vaccine and diagnostic standards. Health systems are adding sustainability clauses to contracts, rewarding vendors that use recyclable plastics or supply take-back services. This environmental focus raises cost-of-goods for some suppliers but differentiates early movers in public tenders. In Latin America and Africa, donor-funded initiatives are improving laboratory networks, yet budget constraints keep average selling prices below global norms. Suppliers addressing these regions tailor stripped-down kits that retain core sensitivity while accommodating hot-chain shipping and minimal instrumentation.

1. Abbott Laboratories
2. Roche
3. Thermo Fisher Scientific
4. Danaher (Cepheid)
5. Beckton Dickinson
6. bioMerieux
7. QIAGEN
8. Randox Laboratories
9. DiaSorin
10. PerkinElmer
11. Laboratory Corporation of America (Labcorp)
12. QuidelOrtho
13. SD Biosensor
14. Siemens Healthineers
15. Acon Laboratories
16. LumiraDx
17. Cue Health
18. Seegene
19. Ellume
20. BGI

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 High Incidence of COVID-19 & Continuous Variant Emergence
  • 4.2.2 Expanding Governmental Stock-Piling Programs for Future Outbreaks
  • 4.2.3 Rapid Consumer Shift to Self-Testing & Tele-Health Integration
  • 4.2.4 Commercialisation of CRISPR-Based Ultra-Rapid Diagnostics
  • 4.2.5 Digital Connectivity/AI-Enabled Result Reporting Mandates
  • 4.2.6 Multiplex Respiratory Panels Replacing Single-Pathogen Tests
• 4.3 Market Restraints
  • 4.3.1 Declining Test Volumes as Pandemic Moves to Endemic Phase
  • 4.3.2 Price Commoditisation Squeezing Margins for Kit Makers
  • 4.3.3 Accuracy Concerns with Unsupervised Home Sample Collection
  • 4.3.4 Bio-Hazardous Plastic Waste & Disposal Compliance Costs
• 4.4 Regulatory Landscape
• 4.5 Porter's Five Forces Analysis
  • 4.5.1 Threat of New Entrants
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Bargaining Power of Suppliers
  • 4.5.4 Threat of Substitutes
  • 4.5.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value in USD)

• 5.1 By Product
  • 5.1.1 RT-PCR Assay Kits
  • 5.1.2 Immunoassay Test Strips / Cassettes
  • 5.1.3 CRISPR-based Molecular Kits
  • 5.1.4 Next-Gen Sequencing Panels
• 5.2 By Specimen
  • 5.2.1 Nasopharyngeal Swab
  • 5.2.2 Nasal Swab
  • 5.2.3 Oropharyngeal Swab
  • 5.2.4 Saliva
  • 5.2.5 Blood / Finger-prick
• 5.3 By End User
  • 5.3.1 Hospitals
  • 5.3.2 Diagnostic Laboratories
  • 5.3.3 Home Care Settings
  • 5.3.4 Public Health Agencies
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East & Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 Abbott
  • 6.3.2 F. Hoffmann-La Roche
  • 6.3.3 Thermo Fisher Scientific
  • 6.3.4 Danaher (Cepheid)
  • 6.3.5 Becton, Dickinson and Company
  • 6.3.6 bioMerieux
  • 6.3.7 Qiagen
  • 6.3.8 Randox Laboratories
  • 6.3.9 DiaSorin
  • 6.3.10 PerkinElmer
  • 6.3.11 Laboratory Corporation of America (Labcorp)
  • 6.3.12 QuidelOrtho
  • 6.3.13 SD Biosensor
  • 6.3.14 Siemens Healthineers
  • 6.3.15 ACON Laboratories
  • 6.3.16 LumiraDx
  • 6.3.17 Cue Health
  • 6.3.18 Seegene
  • 6.3.19 Ellume
  • 6.3.20 BGI Genomics

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment