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

According to Mordor Intelligence, the immunohematology market size is expected to grow from USD 2.49 billion in 2025 to USD 2.64 billion in 2026 and is forecast to reach USD 3.51 billion by 2031 at 5.88% CAGR over 2026-2031.

This report is Segmented by Product (Immunohematology Analyzers [Semi-Automated and Fully Automated] and Immunohematology Reagents [Red-Cell Reagents, Antisera Reagents and More]), Application (Blood Grouping, Antibody Screening and More), End User (Hospitals, Diagnostic Laboratories and More), and Geography (North America, Europe and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Immunohematology Market Trends and Insights

Aging-related growth in surgical procedures

An expanding elderly cohort is raising the number and complexity of cardiovascular and orthopedic operations that rely on meticulous blood-compatibility checks. Hospitals anticipate longer inpatient stays and heavier transfusion needs from older patients, driving sustained reagent consumption and prompting investment in fully automated analyzers that can clear rising test volumes without compromising accuracy. Minimally invasive surgery, although reducing intra-operative blood loss, paradoxically increases per-case immunohematology workloads because surgeons demand tighter compatibility margins to minimize adverse events. Larger facilities have begun scaling AI-enabled analyzers to handle these workloads smoothly, ensuring consistent turnaround times for high-acuity geriatric cases.

Rising trauma & hemoglobinopathies incidence

Emergency departments are treating more complex trauma cases that require rapid cross-matching and massive transfusion protocols. Simultaneously, hemoglobinopathies such as sickle-cell disease necessitate specialized antibody screens for safe chronic transfusion support. University Hospitals reported a 7% rise in blood-bank samples and 12,000 additional tests in 2025, underscoring the growing need for fast, reliable immunohematology workflows. Field adoption of whole-blood programs and point-of-care testing is intensifying demand for portable analyzers capable of delivering accurate serologic or genotypic results in minutes, especially in rural areas that previously lacked transfusion services.

High capital & maintenance cost of automated analyzers

Fully automated platforms often exceed USD 500,000, with service contracts adding another 10-15% annually, stretching budgets of community hospitals and independent labs. Facilities struggling to justify such expenditure either delay upgrades or outsource testing, which can increase turnaround time and patient risk. Financial hurdles are steering procurement toward shared-service models and reagent-rental agreements where vendors bundle hardware with reagent commitments, attempting to balance initial outlay and long-term consumable spend.

Other drivers and restraints analyzed in the detailed report include:

1. Mandated universal antibody screening in transfusion services
2. AI-enabled fully automated analyzers cutting TAT
3. Short shelf-life of certain rare-cell reagents

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

Segment Analysis

Immunohematology reagents accounted for 56.68% of 2025 revenue, confirming the consumable core of every test procedure in the immunohematology market. Analyzers, though only a one-time capital purchase, are growing at an 11.05% CAGR because hospitals need automation to manage rising volumes. The immunohematology market size for reagents will continue to overshadow hardware spending yet is directly linked to analyzer penetration, since each automated test consumes multiple reagent vials. Red-cell reagents underpin routine ABO/Rh typing, while antisera panels increasingly rely on monoclonal specificity to minimize false-positive flags. Roche's 2025 FDA clearance for a highly sensitive lymphoma assay underscores the push for reagent innovation that pairs with sophisticated detection systems.

Laboratories in high-volume settings migrate toward fully automated analyzers that integrate barcode tracking, reflex testing, and LIS interfacing. Semi-automated instruments retain relevance in smaller labs looking to reduce manual pipetting without incurring premium maintenance contracts. Vendors offering reagent-rental structures bundle analyzer placement with guaranteed consumable purchases, shifting capital expenditure toward operating expenditure and smoothing adoption in resource-constrained environments.

Complete Report Scope:

• By Product
  • Immunohematology Analyzers
    • Semi-Automated
    • Fully Automated
  • Immunohematology Reagents
    • Red-Cell Reagents
    • Antisera Reagents
    • Enhancement & Control Solutions
• By Application
  • Blood Grouping (ABO/Rh)
  • Antibody Screening & Identification
  • Cross-Matching
  • Prenatal & Neonatal Testing
• By End User
  • Hospitals
  • Diagnostic Laboratories
  • Blood Banks & Transfusion Centers
  • Research & Academic Institutes
• Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America led with 35.50% revenue share in 2025 due to sophisticated healthcare infrastructure, stringent FDA oversight, and high adoption of AI-enabled analyzers. The United States accounts for the bulk of regional spending, while Canada contributes through Canadian Blood Services modernization programs. The FDA's 2025 draft guidances on communicable-disease risk underscore the region's influence on global transfusion standards.

Asia-Pacific is the immunohematology market's fastest-growing arena, projected at 9.40% CAGR through 2031. China and India are scaling hospital networks and blood-bank capacity, while Japan and South Korea deploy cutting-edge automation. Resource differentials across the region create stratified adoption: urban tertiary centers champion AI analyzers, whereas district hospitals rely on semi-automated systems. Workforce shortages in specialized roles propel demand for walk-away instruments that require minimal human intervention.

Europe remains a mature market characterized by rigorous EMA and national regulations, comprehensive hemovigilance networks, and hospital consolidation. Germany, the United Kingdom, and France field advanced laboratory information systems and routinely pilot molecular immunohematology projects. Southern and Eastern European nations are modernizing, offering growth pockets for mid-range analyzers and reagent rental contracts.

The Middle East displays bifurcation: Gulf Cooperation Council states invest in state-of-the-art blood centers, while many North African and sub-Saharan nations still grapple with infrastructure shortfalls. International aid projects and public-private partnerships are expanding basic reagent availability, setting the stage for gradual analyzer deployment.

1. Abbott Laboratories
2. Beckton Dickinson
3. Becton Dickinson & Co.
4. Bio-Rad Laboratories
5. Cardinal Health
6. Roche
7. Grifols
8. Immucor
9. Merck
10. Ortho Clinical Diagnostics
11. Siemens Healthineers
12. Thermo Fisher Scientific
13. bioMerieux
14. DiaSorin
15. Quotient Limited
16. Fresenius
17. BAG-Diagnostics GmbH
18. Inno-Train Diagnostik
19. Tulip Diagnostics
20. HemoCue AB (Radiometer)

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 Aging-Related Growth In Surgical Procedures
  • 4.2.2 Rising Trauma & Hemoglobinopathies Incidence
  • 4.2.3 Mandated Universal Antibody Screening In Transfusion Services
  • 4.2.4 AI-Enabled Fully-Automated Analyzers Cutting TAT
  • 4.2.5 Transition From Polyclonal To Monoclonal Reagent Formulations
  • 4.2.6 Demand For Molecular Immunohematology (Genotyping)
• 4.3 Market Restraints
  • 4.3.1 High Capital & Maintenance Cost Of Automated Analyzers
  • 4.3.2 Short Shelf-Life Of Certain Rare-Cell Reagents
  • 4.3.3 Scarcity Of Certified Immunohematologists In Lmics
  • 4.3.4 Reimbursement Gaps For Advanced Antibody Panels
• 4.4 Porter's Five Forces
  • 4.4.1 Threat of New Entrants
  • 4.4.2 Bargaining Power of Buyers
  • 4.4.3 Bargaining Power of Suppliers
  • 4.4.4 Threat of Substitutes
  • 4.4.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product
  • 5.1.1 Immunohematology Analyzers
    • 5.1.1.1 Semi-Automated
    • 5.1.1.2 Fully Automated
  • 5.1.2 Immunohematology Reagents
    • 5.1.2.1 Red-Cell Reagents
    • 5.1.2.2 Antisera Reagents
    • 5.1.2.3 Enhancement & Control Solutions
• 5.2 By Application
  • 5.2.1 Blood Grouping (ABO/Rh)
  • 5.2.2 Antibody Screening & Identification
  • 5.2.3 Cross-Matching
  • 5.2.4 Prenatal & Neonatal Testing
• 5.3 By End User
  • 5.3.1 Hospitals
  • 5.3.2 Diagnostic Laboratories
  • 5.3.3 Blood Banks & Transfusion Centers
  • 5.3.4 Research & Academic Institutes
• 5.4 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 South Korea
    • 5.4.3.5 Australia
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and 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 Laboratories
  • 6.3.2 Beckman Coulter Inc. (Danaher)
  • 6.3.3 Becton Dickinson & Co.
  • 6.3.4 Bio-Rad Laboratories
  • 6.3.5 Cardinal Health
  • 6.3.6 F. Hoffmann-La Roche
  • 6.3.7 Grifols S.A.
  • 6.3.8 Immucor Inc.
  • 6.3.9 Merck KGaA
  • 6.3.10 Ortho Clinical Diagnostics
  • 6.3.11 Siemens Healthineers
  • 6.3.12 Thermo Fisher Scientific
  • 6.3.13 bioMerieux SA
  • 6.3.14 DiaSorin S.p.A.
  • 6.3.15 Quotient Limited
  • 6.3.16 Fresenius Kabi
  • 6.3.17 BAG-Diagnostics GmbH
  • 6.3.18 Inno-Train Diagnostik
  • 6.3.19 Tulip Diagnostics
  • 6.3.20 HemoCue AB (Radiometer)

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment