생물학적 샘플 채취 키트 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the biological sample collection kits market size is projected to expand from USD 12.53 billion in 2025 and USD 13.41 billion in 2026 to USD 19.68 billion by 2031, registering a CAGR of 7.97% between 2026 to 2031.

This report is Segmented by Product (Blood, Swab/Viral Transport, Saliva, DBS, Buccal Swab DNA, and More), Application (Diagnostics, Research, Biobanking, and More), End User (Hospitals, Diagnostic Labs, Research Institutes, Biobanks, Pharma/Biotech, Telehealth Operators), and Geography (North America, Europe, Asia-Pacific, MEA, South America). Market Forecasts are in Value (USD).

Global Biological Sample Collection Kits Market Trends and Insights

Persistent Infectious-Disease Testing Volumes Sustaining Baseline Demand

Respiratory and sexually transmitted infection programs are still anchoring kit orders even after COVID-19 normalization. The CDC logged 2.2 million combined chlamydia, gonorrhea, and syphilis cases in 2024, a number higher than pre-pandemic levels despite a 9% yearly drop . Influenza H3N2 subclade K and the SARS-CoV-2 BA.3.2 lineage triggered regional testing surges in early 2025, boosting demand for swabs and viral-transport kits. WHO influenza networks rely on standardized swab protocols, and multiplex respiratory panels detecting influenza A/B, RSV, and SARS-CoV-2 require validated kits that protect nucleic acids across multiple targets. Sentinel laboratories feeding national databases are therefore expected to maintain mid-single-digit growth in swab kit volume through 2028. Manufacturers are balancing this steady demand with lean inventory practices to avoid the overstock cycles seen in 2021-2022.

Rapid Shift to At-Home and Remote Collection

Self-collection devices are reshaping diagnostic workflows. The FDA approved Teal Health's Wand for at-home HPV screening in May 2025, with 96% concordance with clinician samples, and the majority of users said home testing would keep them up to date with screening . The agency's September 2024 guidance formally permits fully decentralized trials for selected products, thereby reducing patient travel burdens and shortening enrollment timelines. European regulators endorse hybrid designs that mix site visits with remote sampling. Sponsors must still train participants to ensure specimen quality, yet cost savings from reduced site overhead and the ability to reach geographically dispersed patients outweigh the added complexity. Telehealth platforms now bundle collection kits with video guidance and prepaid returns, linking directly to CLIA laboratories for analysis.

IVDR and FDA Compliance Costs Creating Consolidation Pressure

Europe's In Vitro Diagnostic Regulation expanded notified-body oversight from roughly 10% of assays to 80%-90%, and certification now takes 13-18 months, with total fees often exceeding EUR 50, 000 (USD 58,800). The EUDAMED database becomes mandatory on 28 May 2026, compelling firms to upload labeling and surveillance data. A high number of manufacturers have already dropped some product lines after weighing the costs, leading to spot shortages of legacy kits.

Similar pressure exists in the United States, where 510(k) submissions for self-collection devices require human-factors data and post-market plans. Smaller vendors without dedicated regulatory teams are therefore pursuing mergers or exiting altogether, nudging industry concentration higher.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Genetic Testing
2. Ambient-Stable Nucleic-Acid Chemistries Reducing Cold-Chain Dependence
3. Raw-Material Volatility Compressing Margins

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

Segment Analysis

Blood-collection kits accounted for 33.48% of 2025 revenue, and this segment of the biological sample collection market is growing at an 8.34% CAGR through 2031. The biological sample collection kits market for blood-collection devices is expanding as hospitals mandate safety needles that reduce injuries by 71% compared with legacy designs. Swab and viral-transport kits remain core to respiratory and STI surveillance, yet face tender-driven price compression. Saliva kits are capitalizing on direct-to-consumer genomics and hormone assays; 23andMe relies on proprietary tubes for its FDA-cleared pharmacogenetics panel.

Specialty formats are moving up the value chain. Dried blood-spot cards, once confined to newborn screening, now support decentralized pharmacokinetic studies following the FDA's 2024 bioanalytical guidance. Buccal swab DNA kits continue to underpin forensics and paternity testing, while urine collectors support drug screening. Stool and fecal microbiome kits are emerging for colorectal cancer screening and inflammatory bowel disease monitoring, yet most offerings still target research use. Vendors that can obtain CLIA validation for these kits hold significant white-space potential.

Geography Analysis

North America accounted for 44.25% of global revenue in 2025, reflecting entrenched diagnostic infrastructure and high per capita healthcare spending. The U.S. Department of Health and Human Services earmarked USD 306 million for H5N1 preparedness in 2025, including USD 8 million for kit manufacturing. The CDC's Epidemiology and Laboratory Capacity program supplied USD 364 million in 2024 to upgrade specimen logistics across state labs. Regulatory approvals for at-home HPV screening and pharmacogenomics tests are further normalizing self-collection, while decentralized-trial sponsors lean heavily on ambient-stable tubes to sidestep frozen shipping.

Asia-Pacific is the fastest-growing region, with a 8.48% CAGR, accounting for a significant share of the biological sample collection kits market in 2025. India's PM-ABHIM allocated INR 4,770 crore (USD 570 million) in FY 2025 to build district laboratories, a major year-on-year rise. The Union Budget 2026 pledged INR 10,000 crore for Bio SHAKTI to seed 1,000 trial sites, while the Production Linked Incentive scheme steers INR 34.2 billion toward in-vitro diagnostic devices. China is rolling out regional genomics centers, and Japan's multiplex genetic point-of-care devices, launched in late 2023, are stimulating demand for saliva and blood kits across oncology and prenatal testing.

Europe remains sizable, but growth is tempered by IVDR-related overheads, which have driven significant number of firms to discontinue some products. Certification queues and limited notified-body capacity prolong market entry, tilting the share toward large incumbents. The Middle East and Africa, plus South America, are early in the adoption curve; government procurements for surveillance and donor-funded disease programs keep baseline volumes stable, with private diagnostic chains gradually adding molecular panels that require higher-grade collection kits.

1. Beckton Dickinson
2. Cardinal Health
3. COPAN Diagnostics
4. Cytiva
5. Exact Sciences
6. Roche
7. Greiner Bio-One
8. Hardy Diagnostics
9. HiMedia Laboratories
10. Hologic
11. Longhorn Vaccines & Diagnostics
12. Medical Wire & Equipment
13. Medline Industries
14. Norgen Biotek
15. OraSure Technologies / DNA Genotek
16. Puritan Medical Products
17. QIAGEN
18. Revvity
19. Sarstedt
20. Spectrum Solutions
21. Thermo Fisher Scientific
22. Zymo Research

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 Rapid Shift to At-Home/Remote Collection for Diagnostics and Decentralized Trials
  • 4.2.2 Expansion Of Genetic Testing (NIPT, Pgx, Oncology) Requiring Validated Collection Kits
  • 4.2.3 Ambient-Stable Nucleic-Acid Chemistries Reducing Cold-Chain Dependence
  • 4.2.4 Persistent Infectious-Disease Testing Volumes (Respiratory, STI) Sustaining Kit Demand
  • 4.2.5 Biobanking and Precision-Medicine Programs Standardizing Preanalytics
• 4.3 Market Restraints
  • 4.3.1 IVDR/FDA Compliance Costs and Documentation Complexity for Self-Collection Devices
  • 4.3.2 Post-Pandemic Inventory Normalization and Destocking Cycles
  • 4.3.3 Price Pressure and Tender-Driven Commoditization In Swabs/VTM
  • 4.3.4 Raw-Material Volatility (Medical-Grade Polymers, Flocking Fibers) Impacting Margins
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product
  • 5.1.1 Blood Collection Kits
  • 5.1.2 Swab And Viral Transport Kits
  • 5.1.3 Saliva Collection Kits
  • 5.1.4 Dried Blood Spot (DBS) Collection Cards/Kits
  • 5.1.5 Buccal Swab DNA Collection Kits
  • 5.1.6 Urine Collection Kits
  • 5.1.7 Stool/Fecal Microbiome Collection Kits
• 5.2 By Application
  • 5.2.1 Diagnostics
  • 5.2.2 Research & Academia
  • 5.2.3 Biobanking & Biorepositories
  • 5.2.4 Clinical Trials & Decentralized Trials
  • 5.2.5 Forensics & Law Enforcement
  • 5.2.6 Direct-To-Consumer Genomics & Wellness Testing
• 5.3 By End User
  • 5.3.1 Hospitals & Clinics
  • 5.3.2 Diagnostic Laboratories
  • 5.3.3 Academic & Research Institutes
  • 5.3.4 Biobanks & Biorepositories
  • 5.3.5 Other End Users
• 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 India
    • 5.4.3.3 Japan
    • 5.4.3.4 South Korea
    • 5.4.3.5 Australia
    • 5.4.3.6 Rest of APAC
  • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of MEA
  • 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 Becton, Dickinson and Company (BD)
  • 6.3.2 Cardinal Health
  • 6.3.3 COPAN Diagnostics
  • 6.3.4 Cytiva
  • 6.3.5 Exact Sciences
  • 6.3.6 F. Hoffmann-La Roche
  • 6.3.7 Greiner Bio-One
  • 6.3.8 Hardy Diagnostics
  • 6.3.9 HiMedia Laboratories
  • 6.3.10 Hologic
  • 6.3.11 Longhorn Vaccines & Diagnostics
  • 6.3.12 Medical Wire & Equipment
  • 6.3.13 Medline Industries
  • 6.3.14 Norgen Biotek
  • 6.3.15 OraSure Technologies / DNA Genotek
  • 6.3.16 Puritan Medical Products
  • 6.3.17 QIAGEN
  • 6.3.18 Revvity
  • 6.3.19 Sarstedt
  • 6.3.20 Spectrum Solutions
  • 6.3.21 Thermo Fisher Scientific
  • 6.3.22 Zymo Research

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment