수혈 진단 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, blood transfusion diagnostics market size in 2026 is estimated at USD 6.41 billion, growing from 2025 value of USD 5.97 billion with 2031 projections showing USD 9.14 billion, growing at 7.34% CAGR over 2026-2031.

This report is Segmented by Product Type (Instruments and Consumables), Technology (Serology, Nucleic Acid Tests, and More), Application (Disease Screening and Blood Group Typing), End-User (Hospitals, Diagnostic Laboratories, and More), Geography (North America, Europe, Asia-Pacific, The Middle East and Africa, and South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Blood Transfusion Diagnostics Market Trends and Insights

Rising Global Blood Donations and Transfusion Demand

Voluntary donor drives and hemovigilance programs stimulate steady growth for the blood transfusion diagnostics market. China's National Health Commission partners with youth organizations to broaden group donations, while India's Hemovigilance Program trains more than 15,000 clinicians to improve adverse-event reporting. In the United States, college competitions supported by Abbott Laboratories raise public awareness, and Cerus Corporation's INTERCEPT pathogen-reduction kits safeguard platelet and plasma components. Europe continues to call for 2 million extra donors to lessen import dependence, underscoring global supply challenges.

Growing Incidence of Trauma and Surgical Procedures

The blood transfusion diagnostics market benefits from rising trauma care complexity and higher surgical case loads. The 2025 Medicare Physician Fee Schedule recognizes pre-hospital transfusion as advanced life support, increasing reimbursement for ambulance providers that stock blood. A large Midwest academic center reported 323 massive transfusion activations in 2024, a 7% increase year on year. Point-of-care coagulation analyzers now guide intraoperative decisions, and machine-learning dashboards predict inventory surges, cutting wastage.

High Cost of Advanced Diagnostic Instruments

Price tags on high-throughput analyzers restrain adoption in resource-constrained settings, challenging broader penetration of the blood transfusion diagnostics market. Routine assay reimbursements continue to drop, forcing laboratories to cross-subsidize molecular test investments. The FDA estimates annual compliance costs up to USD 3.56 billion as laboratory-developed tests transition to full device oversight. Hospital outpatient departments still bill three times more for identical tests than independent labs, underscoring procurement asymmetries.

Other drivers and restraints analyzed in the detailed report include:

1. Technological Advancements in Transfusion Diagnostics
2. Integration of Point-of-Care Testing in Blood Banks
3. Stringent Regulatory Approval Processes

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

Segment Analysis

Consumables generated 53.62% of the 2025 blood transfusion diagnostics market. Continuous demand for reagents, calibrators, and quality-control materials provides steady cash flows, especially as test menus now include malaria, Babesia, and Zika screening. Integrated cartridge designs minimize pipetting errors while lowering hands-on time.

The instrument segment is expected to advance at a 8.95% CAGR through 2031. AI-enhanced vision systems within new centrifuge and reader platforms drive throughputs exceeding 400 samples per hour. Partnerships such as the Siemens Healthineers-Sysmex supply deal illustrate how manufacturers combine hemostasis, immunohematology, and NAT modules within single middleware ecosystems. The blood transfusion diagnostics market size attributable to new instrument placements is set to widen as leasing models and reagent-rent contracts lower upfront capital barriers.

Serology retained 45.12% of revenue in 2025, capitalizing on cost-efficient enzyme-linked and chemiluminescent assays that fit legacy analyzers. Reagent refinements cut false positives, preserving donation throughput.

Nucleic acid testing exhibits the highest growth at 8.63% CAGR, narrowing diagnostic windows and improving blood safety. Roche's cobas systems now screen tens of millions of donations annually for HIV, HBV, HCV, and malaria. The blood transfusion diagnostics market share associated with NAT platforms will expand further as regulators mandate multiplex screening for additional pathogens and as pooling protocols moderate per-donor costs.

Complete Report Scope:

• By Product Type
  • Instruments
  • Consumables (Reagents, Kits, Calibrators, Controls)
• By Technology
  • Serology (ELISA, CLIA, Agglutination)
  • Nucleic Acid Tests (PCR, TMA, NAT)
  • Microarray & Next-Generation Sequencing
  • Rapid / Lateral Flow Assays
• By Application
  • Disease Screening (TTIs, Emerging Pathogens)
  • Blood Group Typing (ABO/Rh, Extended Antigen)
• By End-User
  • Hospitals
  • Diagnostic Laboratories
  • Blood Banks
  • Plasma Fractionation Centers
• 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 held 39.12% of global revenue in 2025. FDA guidance on device regulation and Medicare's elevation of pre-hospital transfusion drive demand for high-sensitivity assays. Becton Dickinson's USD 10 million domestic expansion underscores efforts to shorten supply chains. Persistent price gaps-hospital outpatient departments bill three times what independent labs charge-shape purchasing strategies.

Asia-Pacific is forecast to rise at an 8.31% CAGR, the strongest worldwide. China's Healthy China 2030 plan funds modern blood-collection centers and supports Terumo BCT's USD 15 million localization investment. India's nationwide hemovigilance program lifts clinician competence, while Southeast Asian countries pilot cloud-based donor registries. Heterogeneous reimbursement and fragmented supply chains remain barriers, yet urban hospitals continue to adopt NAT and automation platforms.

Europe retains a substantial position amid unique supply and regulatory challenges. The region needs 2 million additional donors to cut reliance on imported plasma, a gap that primes demand for donor-recruitment analytics. Implementation of the Regulation on Substances of Human Origin will harmonize oversight by 2027, but labs must bridge gaps created by the In Vitro Diagnostic Regulation's stricter evidence requirements. The blood transfusion diagnostics market continues to benefit from public-sector funding aimed at achieving self-sufficiency.

1. Grifols
2. Roche
3. Abbott Laboratories
4. Bio-Rad Laboratories
5. Immucor
6. Danaher (Beckman Coulter & Cepheid)
7. Siemens Healthineers
8. DiaSorin
9. Werfen (Instrumentation Laboratory)
10. Merck KGaA (MilliporeSigma)
11. Sysmex Corp.
12. QuidelOrtho Corp.
13. Fresenius
14. Haemonetics Corp.
15. Beckton Dickinson
16. Thermo Fisher Scientific
17. Terumo Corp.
18. Trinity Biotech
19. bioMerieux

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 Rising Global Blood Donations And Transfusion Demand
  • 4.2.2 Growing Incidence of Trauma And Surgical Procedures
  • 4.2.3 Technological Advancements in Transfusion Diagnostics
  • 4.2.4 Integration of Point-of-Care Testing in Blood Banks
  • 4.2.5 Expansion of Healthcare Infrastructure in Emerging Markets
  • 4.2.6 Adoption of Cloud-Based Blood Bank Information Systems
• 4.3 Market Restraints
  • 4.3.1 High Cost if Advanced Diagnostic Instruments
  • 4.3.2 Stringent Regulatory Approval Processes
  • 4.3.3 Limited Availability if Rare Blood Reagents
  • 4.3.4 Fragmented Donor Traceability Systems
• 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, USD)

• 5.1 By Product Type
  • 5.1.1 Instruments
  • 5.1.2 Consumables (Reagents, Kits, Calibrators, Controls)
• 5.2 By Technology
  • 5.2.1 Serology (ELISA, CLIA, Agglutination)
  • 5.2.2 Nucleic Acid Tests (PCR, TMA, NAT)
  • 5.2.3 Microarray & Next-Generation Sequencing
  • 5.2.4 Rapid / Lateral Flow Assays
• 5.3 By Application
  • 5.3.1 Disease Screening (TTIs, Emerging Pathogens)
  • 5.3.2 Blood Group Typing (ABO/Rh, Extended Antigen)
• 5.4 By End-User
  • 5.4.1 Hospitals
  • 5.4.2 Diagnostic Laboratories
  • 5.4.3 Blood Banks
  • 5.4.4 Plasma Fractionation Centers
• 5.5 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 Business Segments, Financials, Headcount, Key Information, Market Rank, Market Share, Products and Services, and analysis of Recent Developments)
  • 6.3.1 Grifols S.A.
  • 6.3.2 Roche Diagnostics
  • 6.3.3 Abbott Laboratories
  • 6.3.4 Bio-Rad Laboratories Inc.
  • 6.3.5 Immucor Inc.
  • 6.3.6 Danaher (Beckman Coulter & Cepheid)
  • 6.3.7 Siemens Healthineers
  • 6.3.8 DiaSorin S.p.A.
  • 6.3.9 Werfen (Instrumentation Laboratory)
  • 6.3.10 Merck KGaA (MilliporeSigma)
  • 6.3.11 Sysmex Corp.
  • 6.3.12 QuidelOrtho Corp.
  • 6.3.13 Fresenius Kabi AG
  • 6.3.14 Haemonetics Corp.
  • 6.3.15 Becton, Dickinson & Co.
  • 6.3.16 Thermo Fisher Scientific
  • 6.3.17 Terumo Corp.
  • 6.3.18 Trinity Biotech
  • 6.3.19 BioMrieux SA

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment