신속 진단 키트 : 시장 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The Rapid Diagnostic Kits Market size is estimated at USD 23.24 billion in 2025, and is expected to reach USD 35.47 billion by 2030, at a CAGR of 8.83% during the forecast period (2025-2030).

The expansion reflects rising point-of-care adoption, tighter hospital budgets, and the global shift from episodic to preventive care. Technology upgrades that allow multiplex detection, alongside supportive reimbursement for chronic disease monitoring, keep demand elevated even after the acute pandemic wave. Manufacturers benefit from government funding that de-risks R&D, while ageing populations increase test volumes across primary and home-care settings. Competitive strategies now focus on scale, vertical integration, and data connectivity as hospitals and consumers both expect seamless integration with electronic health records.

Global Rapid Diagnostic Kits Market Trends and Insights

Government Funding Surge for Multiplex Respiratory Panels

Public agencies continue to bankroll multiplex respiratory panels that test for SARS-CoV-2, influenza A/B, and RSV in one cartridge, giving suppliers firm multiyear order books. BARDA's outlays have accelerated prototype-to-market timelines, exemplified by Roche's 20-minute cobas liat triple assay cleared in May 2024. Hospitals embrace the syndromic model because a single swab trims sample handling, shortens isolation decisions, and conserves personal protective equipment. Laboratories capture operational savings, while manufacturers secure volume commitments that justify further platform miniaturization. The model is now migrating to emerging pathogen panels, widening the rapid diagnostics kits market scope and solidifying a revenue floor for molecular suppliers.

Rising Consumer Adoption of Self-Testing for Chronic Diseases

Self-testing has moved beyond pregnancy kits into cardiometabolic and infectious disease monitoring. Labcorp's First-to-Know syphilis kit, the first FDA-authorized over-the-counter blood test for a bacterial STI, validated consumer readiness for capillary sampling at home. Digital health platforms that curate results for care teams reduce clinic visits and enable medication titration without laboratory delays. Payers also gain, as direct-pay kits lower claims associated with repeated phlebotomy. Regulatory draft guidance on digital detection of prediabetes underscores official support for non-invasive screening, and suppliers respond by embedding Bluetooth or NFC connectivity for instant data upload. The behavioural shift cements home-care as the fastest end-user channel in the rapid diagnostics kits market.

Supply-Chain Fragility for Critical Reagents

Specialized antibodies, enzymes, and buffers are often produced in single-facility clusters across East Asia. Trade friction or pandemics quickly halt exports, forcing allocation protocols that lengthen delivery times and inflate costs. The COVID-19 crisis exposed these choke points when enzyme shortages limited PCR kit output. Manufacturers now dual-source or internalize reagent production, but capital outlays lengthen payback horizons and squeeze smaller firms. Disruptions can starve public clinics of essential diagnostics, especially in low-income regions that lack inventory buffers, restraining the rapid diagnostics kits market until redundancy plans mature.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Decentralized Molecular PoC Platforms in LMICs
2. Integration of AI-Enabled Readers Improving Test Accuracy
3. Regulatory Uncertainty for Home-Use Multiplex Kits

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

Segment Analysis

Lateral flow immunoassay generated the largest slice of the rapid diagnostics kits market in 2024 with 42.76% revenue, underpinned by mature supply chains, low unit costs, and the ability to scale quickly during pandemic surges. The segment continues to thrive in resource-limited clinics, humanitarian missions, and mass-screening programs because it tolerates ambient temperatures and requires minimal training. Advances such as nanoparticle labels and improved membrane porosity are lifting analytical sensitivity, allowing lateral flow to defend share even as laboratory expectations rise. Immuno-chromatography, though smaller, logs the fastest 9.17% CAGR, fueled by growing physician demand for semi-quantitative output and by AI-assisted readers that unlock richer data layers. Microfluidic lab-on-chip systems inch forward in endocrinology and neonatal screening where microlitre volumes and high precision matter. Molecular rapid assays employing isothermal amplification or CRISPR editing record double-digit growth, capitalizing on syndromic panels that bundle respiratory and gastrointestinal targets. Biosensor platforms leverage electrochemical detection to capture continuous glucose or cardiac biomarker trends, expanding the total addressable rapid diagnostics kits market.

A steady pipeline of combination systems blends lateral flow cartridges with integrated nucleic-acid capture modules. Such hybrids promise lower reagent use, three-target detection in one strip, and smartphone readouts that sync to cloud dashboards. FDA's January 2025 validation guidance for emerging pathogen panels accelerates clearance of these designs. As hospitals rationalize suppliers, technology differentiation now hinges on throughput, sample type versatility, and embedded connectivity rather than solely on detection chemistry. Manufacturers that pair proprietary reagents with open-analytics software carve durable footholds within the rapid diagnostics kits market.

Infectious diseases contributed 36.03% of 2024 revenue, buoyed by perpetual influenza, RSV, and antimicrobial resistance surveillance. Yet oncology markers is advancing fastest at a 9.46% CAGR because policy makers back early detection to curb treatment costs. Point-of-care FIT tests, liquid biopsy cartridges for methylated DNA, and nucleosome assays such as VolitionRx's sepsis indicator keep oncology in the spotlight. Cardio-metabolic Monitoring gains as hypertension and diabetes management migrate to pharmacies and homes. Pregnancy & Fertility kits sustain baseline volume, expanded by later-life pregnancies and tele-reproductive services. Toxicology & Drugs-of-Abuse panels evolve in step with shifting opioid policies and upcoming federal workplace rule revisions.

Veterinary & zoonotic screening, though small today, benefits from One Health frameworks that integrate animal and human disease vigilance. The overall rapid diagnostics kits market size for infectious disease testing in LMICs is buttressed by multilateral grants, while oncology-focused start-ups secure venture capital to refine epigenetic targets. Application diversification thus cushions suppliers against cyclical demand swings and positions multipurpose platforms for cross-sector revenue.

The Rapid Diagnostics Kits Market Report is Segmented by Technology (Lateral Flow Immunoassay, Microfluidic Lab-On-Chip, and More), Application (Infectious Diseases, Cardio-Metabolic Monitoring, and More), Sample Type (Blood, Nasal, and More), End User (Hospitals & Clinics, and More), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America retained 38.17% of 2024 revenue, aided by favorable reimbursement codes, high digital literacy, and the BARDA pipeline that continuously seeds innovation. The United States accounts for a majority share, where CLIA waivers for Roche's 20-minute STI assays open wide deployment across 12,000 retail clinics. Canada follows through national tender programs for First Nations communities, adding HIV and hepatitis-C cartridges to primary-care tool kits. The region also leads in AI-reader pilots that integrate with electronic health records, creating first-mover advantages for early adopters within the rapid diagnostics kits market.

Asia-Pacific records the strongest 11.15% CAGR, spurred by public insurance expansion and government incentives for domestic IVD production. China's push for self-reliance lifted local suppliers who reverse-engineer reagents to undercut imports, while tier-2 city hospitals procure portable PCR analyzers to meet new respiratory surveillance mandates. India scales telemedicine through its Ayushman Bharat Digital Mission, embedding rapid metabolic panels into community health worker kits. Southeast Asian ministries deploy combination dengue-COVID cartridges during monsoon seasons, and Japanese geriatric clinics pilot saliva-based dementia biomarkers. The region's heterogeneity drives diverse demand patterns yet converges on a common need for low-maintenance, cloud-connected systems.

Europe sustains steady mid-single-digit growth undergirded by harmonized IVDR rules that assure cross-border device acceptance. Germany finances AI-assisted lateral flow platforms in nursing homes, while France subsidizes pharmacy-based cardiometabolic screens to shorten cardiologist queues. The Middle East & Africa sees accelerated tender activity for tuberculosis and mpox detection as petro-states upgrade lab infrastructure, though distribution remains hampered in remote zones. Latin America tackles arbovirus co-circulation with multiplex assays that differentiate dengue, Zika, and chikungunya. Cross-regional donor programs, such as the Global Fund, aggregate demand and smooth currency volatility, anchoring the rapid diagnostics kits market size across emerging geographies.

1. Abbott Laboratories
2. Roche
3. Danaher Corp. (Cepheid)
4. Beckton Dickinson
5. bioMerieux
6. Siemens Healthineers
7. QuidelOrtho Corp.
8. Thermo Fisher Scientific
9. QIAGEN
10. Hologic
11. SD Biosensor Inc.
12. Orasure Technologies
13. Access Bio
14. Alfa Scientific Designs
15. Acon Laboratories
16. BTNX
17. Artron Laboratories
18. LumiraDx Ltd.
19. Bio-Rad Laboratories
20. DiaSorin (Luminex)
21. SureScreen Diagnostics
22. Creative Diagnostics
23. Biopanda Reagents

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 Government Funding Surge for Multiplex Respiratory Panels
  • 4.2.2 Rising Consumer Adoption of Self-Testing for Chronic Diseases
  • 4.2.3 Expansion of Decentralized Molecular PoC Platforms in LMICs
  • 4.2.4 Integration of AI-Enabled Readers Improving Test Accuracy
  • 4.2.5 Emergence of CRISPR-Based Ultra-Rapid Assays
  • 4.2.6 Increasing Awareness of Diseases Driving Screening Demand
• 4.3 Market Restraints
  • 4.3.1 Supply-Chain Fragility for Critical Reagents
  • 4.3.2 Regulatory Uncertainty for Home-Use Multiplex Kits
  • 4.3.3 Reader-Device Data-Privacy Concerns
  • 4.3.4 Sustainability Pressure on Single-Use Plastics
• 4.4 Regulatory Landscape
• 4.5 Technological Outlook
• 4.6 Porter's Five Forces Analysis
  • 4.6.1 Bargaining Power of Buyers/Consumers
  • 4.6.2 Bargaining Power of Suppliers
  • 4.6.3 Threat of New Entrants
  • 4.6.4 Threat of Substitute Products
  • 4.6.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value in USD)

• 5.1 By Technology
  • 5.1.1 Lateral Flow Immunoassay
  • 5.1.2 Microfluidic Lab-on-Chip
  • 5.1.3 Immuno-chromatography
  • 5.1.4 Agglutination & Latex Tests
  • 5.1.5 Biosensor-Based Rapid Tests
  • 5.1.6 Molecular Rapid Tests
• 5.2 By Application
  • 5.2.1 Infectious Diseases
  • 5.2.2 Cardio-metabolic Monitoring
  • 5.2.3 Pregnancy & Fertility
  • 5.2.4 Toxicology & Drugs-of-Abuse
  • 5.2.5 Oncology Markers
  • 5.2.6 Veterinary & Zoonotic Screening
• 5.3 By Sample Type
  • 5.3.1 Blood
  • 5.3.2 Nasal
  • 5.3.3 Urine
  • 5.3.4 Saliva
  • 5.3.5 Stool
• 5.4 By End User
  • 5.4.1 Hospitals & Clinics
  • 5.4.2 Physician Offices & Urgent Care
  • 5.4.3 Home-care Setting
  • 5.4.4 Diagnostic Laboratories
  • 5.4.5 Other End Users
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 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 Laboratories
  • 6.3.2 F. Hoffmann-La Roche AG
  • 6.3.3 Danaher Corp. (Cepheid)
  • 6.3.4 Becton, Dickinson & Co.
  • 6.3.5 bioMerieux SA
  • 6.3.6 Siemens Healthineers
  • 6.3.7 QuidelOrtho Corp.
  • 6.3.8 Thermo Fisher Scientific
  • 6.3.9 Qiagen NV
  • 6.3.10 Hologic Inc.
  • 6.3.11 SD Biosensor Inc.
  • 6.3.12 OraSure Technologies Inc.
  • 6.3.13 Access Bio Inc.
  • 6.3.14 Alfa Scientific Designs Inc.
  • 6.3.15 ACON Laboratories Inc.
  • 6.3.16 BTNX Inc.
  • 6.3.17 Artron Laboratories Inc.
  • 6.3.18 LumiraDx Ltd.
  • 6.3.19 Bio-Rad Laboratories Inc.
  • 6.3.20 DiaSorin (Luminex)
  • 6.3.21 SureScreen Diagnostics
  • 6.3.22 Creative Diagnostics
  • 6.3.23 Biopanda Reagents

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment