헤모글로빈 검사 기기 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the hemoglobin testing devices market size was valued at USD 4 billion in 2025 and is estimated to grow from USD 4.28 billion in 2026 to reach USD 5.91 billion by 2031, at a CAGR of 6.67% during the forecast period (2026-2031).

This report is Segmented by Product Type {Laboratory Analyzers (3-Part Differential Analyzers and More), POC Analyzers (Handheld Analyzers and More), and More}, Technology (Photometric, and More), End User (Hospitals, Labs, and More), Application (Anemia Screening, Maternal Health, and More), and Geography (North America, Europe, Asia-Pacific, MEA, and More). Market Forecasts are in Value (USD).

Global Hemoglobin Testing Devices Market Trends and Insights

High And Rising Anemia Burden Across LMICs And Aging Populations

More than 1.9 billion individuals, or 24% of the world's population, were anemic in 2024, with prevalence exceeding 40% in children under five and women of reproductive age in South Asia and Sub-Saharan Africa . India's National Family Health Survey-5 data still show anemia in 57% of women and 67% of children, highlighting a vast underserved diagnostic need. In Latin America, the mean hemoglobin level among Mexican women declined amid cuts to nutrition programs, sustaining community-level demand for screening. Simultaneously, an aging OECD cohort grapples with renal and cardiac comorbidities that require frequent hemoglobin checks, cementing dual-track growth for the Hemoglobin testing devices market.

Shift Toward Point-Of-Care Hemoglobin Testing For Rapid Decisions

Emergency departments, operating suites, and mobile donor stations increasingly require sub-5-minute hemoglobin turnaround. The AABB standards, effective April 2026, mandate quantitative testing for all double-RBC collections, accelerating uptake of handheld analyzers over legacy copper-sulfate baths. Siemens Healthineers' epoc system delivers wireless results in under 1 minute from 92 µL of whole blood, easing workflow congestion . FDA guidance in 2024 on skin-tone bias in optical sensing is pushing vendors to validate their devices across diverse populations, improving trust in CLIA-waived platforms and widening the market for hemoglobin testing devices.

Accuracy And Bias Concerns For Noninvasive Hb At Low Hb And Varied Skin Tones

Multiple studies show Masimo SpHb can miss transfusion triggers when true hemoglobin is below 10 g/dL, while darker skin reduces optical signal quality, leading the FDA to tighten validation guidance in 2024 . Ugandan field data also reported capillary bias in several handheld devices, complicating anemia screening in resource-poor settings. The perception gap constrains near-term uptake of noninvasive monitors in the Hemoglobin testing devices market.

Other drivers and restraints analyzed in the detailed report include:

1. Strong Installed Base And Replacement Cycle Of Hematology Analyzers
2. Public Health Screening And Blood Donation Programs Mandate Hb Testing
3. Budget And Reimbursement Pressures Limiting Analyzer Upgrades In Mature Markets

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

Segment Analysis

Point-of-care invasive analyzers are set to post a 7.78% CAGR through 2031, the fastest clip among all product groups, as recent CLIA-waived clearances allow them into pharmacies, WIC clinics, dialysis units, and ambulatory surgical centers that lack full laboratory infrastructure. Portable benchtop units sit in dialysis suites and same-day surgery rooms, where staff need quantitative results before discharge or erythropoiesis-stimulating-agent dosing. The AABB's 35th edition standards, effective April 2026, mandate such readings for every double red-cell collection and are phasing out copper-sulfate drop tests in blood centers.

Laboratory hematology analyzers still held 42.09% of the Hemoglobin testing devices market share in 2025, buoyed by Sysmex's large global installed base and a gradual migration from 3-part to 5-part differentials that add parameters such as immature granulocytes and reticulocyte hemoglobin content. Sysmex's FDA-cleared XR-Series and HORIBA's IVDR-certified Yumizen H500 CRP layer advanced analytics onto familiar photometric engines, helping laboratories justify upgrades even as budget ceilings lengthen equipment life cycles to 10-15 years.

Photometric or spectrophotometric instruments controlled 45.67% of the Hemoglobin testing devices market share in 2025, a position cemented by low reagent expense and the International Council for Standardization in Hematology's endorsement of the cyanmethemoglobin reference method. HORIBA's six-reagent Yumizen H2500 demonstrates how cost trimming keeps this technology attractive for mid-volume hospitals. Independent work from Chile confirmed that such analyzers deliver reliable red-cell indices for B-thalassemia screening when paired with confirmatory HbA2 tests, reinforcing their frontline diagnostic role.

The sharpest growth line, however, belongs to noninvasive pulse CO-oximetry, projected at an 8.62% CAGR through 2031, even though multiple studies show the technology can overestimate by up to 2 g/dL when true values fall below 10 g/dL. Perioperative guidelines from ESAIC and EACTS/EACTAIC endorse continuous hemoglobin trending to fine-tune transfusion triggers, a recommendation that is placing Masimo's SpHb sensors into new cardiac and orthopedic theaters across Europe and North America.

Geography Analysis

North America commanded 49.54% of the Hemoglobin testing devices market share in 2025, supported by a dense installed base of laboratory analyzers and early adoption of CLIA-waived handheld platforms. The region's hospitals are embedding perioperative blood-management protocols that require near-real-time hemoglobin values, while retail pharmacies and WIC clinics widen device placement beyond acute-care environments. Despite a 1.3% cut to the 2025 Clinical Laboratory Fee Schedule, U.S. laboratories continue to upgrade middleware so that older analyzers can feed electronic medical records, lengthening hardware lifecycles but sustaining reagent demand. Canada mirrors this pattern, with provincial health authorities approving CLIA-waived analyzers for community dialysis centers, creating a parallel distribution channel that sidesteps hospital procurement committees.

Asia-Pacific is projected to post the fastest CAGR of 8.31% through 2031, reflecting large-scale public health screening in India, China, and Indonesia. India's Anemia Mukt Bharat initiative has already deployed digital hemoglobinometers at the village level, yet the National Family Health Survey-5 still shows anemia in the majority of women and children, underscoring unmet diagnostic needs. China is adding dual testing for neonatal G6PD and hemoglobin on Mindray BS-2800M platforms, accelerating deployment in county hospitals and maternal-child centers. While Japan faces fee pressures that extend analyzer lifespans to 15 years, reagent-saving models from local suppliers are still entering secondary hospitals, cushioning revenue erosion. Collectively, these trends will lift the Asia-Pacific Hemoglobin testing devices market size to rival Europe before the end of the forecast period.

Europe held the second-largest regional position in 2025, driven by perioperative guidelines that mandate real-time hemoglobin monitoring in Germany, France, and the United Kingdom. CE IVDR requirements are prompting analyzer software retrofits and new placements, exemplified by HORIBA's Yumizen H500 CRP certification that targets small laboratories seeking combined CBC + CRP workflows. In the Middle East and Africa, anemia prevalence above 40% among women of reproductive age is catalyzing procurement of ruggedized point-of-care devices for rural clinics. South America is expanding infant CBC mandates, with Brazil requiring confirmatory hemoglobin tests 30-45 days after iron therapy, generating repeat consumable revenue. Taken together, these developments sustain global geographic momentum even as mature markets focus on middleware upgrades over new hardware, ensuring balanced growth for the Hemoglobin testing devices market.

1. Abbott Laboratories
2. Acon Laboratories
3. Boule Diagnostics
4. Danaher
5. Diatron
6. EKF Diagnostics
7. Erba Mannheim
8. F.Hoffman La Roche
9. HORIBA Medical
10. Masimo
11. Nihon Kohden
12. Nonin Medical
13. Nova Biomedical
14. OrSense Ltd.
15. Mindray
16. Siemens Healthineers
17. Sysmex
18. Trinity Biotech
19. URIT Medical

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 And Rising Anemia Burden Across LMICs and Aging Populations
  • 4.2.2 Shift Toward Point-Of-Care Hemoglobin Testing for Rapid Decisions
  • 4.2.3 Strong Installed Base and Replacement Cycle of Hematology Analyzers
  • 4.2.4 Public Health Screening and Blood Donation Programs Mandate Hb Testing
  • 4.2.5 Perioperative Blood Management Programs Adopting Continuous SpHb in OR/ICU
  • 4.2.6 CLIA-Waived Hb Analyzers Enabling New Sites (Pharmacies, WIC, Dialysis)
• 4.3 Market Restraints
  • 4.3.1 Accuracy/Bias Concerns for Noninvasive Hb At Low Hb and Varied Skin Tones
  • 4.3.2 Budget And Reimbursement Pressures Limiting Analyzer Upgrades in Mature Markets
  • 4.3.3 Microcuvette/Consumable Costs and Supply Constraints Depress POC Utilization
  • 4.3.4 Data Integration/Middleware Gaps Hinder Scaling Across Decentralized Sites
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 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 Industry Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product Type
  • 5.1.1 Laboratory Hematology Analyzers
    • 5.1.1.1 3-part differential analyzers
    • 5.1.1.2 5-part and advanced differential analyzers
  • 5.1.2 Point-of-Care Hemoglobin Analyzers (invasive)
    • 5.1.2.1 Handheld analyzers
    • 5.1.2.2 Portable/benchtop analyzers
  • 5.1.3 Noninvasive Hemoglobin Monitors (pulse CO-oximetry)
    • 5.1.3.1 Spot-check monitors
    • 5.1.3.2 Continuous multi-parameter monitors
• 5.2 By Technology
  • 5.2.1 Photometric/Spectrophotometric (azidemethemoglobin/HiCN)
  • 5.2.2 Co-oximetry (invasive blood gas analyzers)
  • 5.2.3 Near-infrared/Pulse CO-oximetry (noninvasive SpHb)
• 5.3 By End User
  • 5.3.1 Hospitals & Clinics
  • 5.3.2 Diagnostic Laboratories/Reference Labs
  • 5.3.3 Blood Banks & Plasma Centers
  • 5.3.4 Ambulatory Surgical Centers
  • 5.3.5 Home Care & Community Health Programs
  • 5.3.6 Dialysis/Nephrology Centers
• 5.4 By Application
  • 5.4.1 Anemia Screening & Diagnosis
  • 5.4.2 Maternal & Child Health Screening
  • 5.4.3 Perioperative & Critical Care Monitoring
  • 5.4.4 Dialysis/CKD Anemia Management
  • 5.4.5 Other Applications
• 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 France
    • 5.5.2.3 United Kingdom
    • 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 India
    • 5.5.3.3 Japan
    • 5.5.3.4 South Korea
    • 5.5.3.5 Australia
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and 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 Diagnostics
  • 6.3.2 ACON Laboratories
  • 6.3.3 Boule Diagnostics
  • 6.3.4 Danaher Corporation
  • 6.3.5 Diatron
  • 6.3.6 EKF Diagnostics
  • 6.3.7 Erba Mannheim
  • 6.3.8 F.Hoffman La Roche
  • 6.3.9 HORIBA Medical
  • 6.3.10 Masimo
  • 6.3.11 Nihon Kohden
  • 6.3.12 Nonin Medical
  • 6.3.13 Nova Biomedical
  • 6.3.14 OrSense Ltd.
  • 6.3.15 Shenzhen Mindray Bio-Medical Electronics Co., Ltd
  • 6.3.16 Siemens Healthineers
  • 6.3.17 Sysmex Corporation
  • 6.3.18 Trinity Biotech
  • 6.3.19 URIT Medical

7 Market Opportunities & Future Outlook

• 7.1 White-space & unmet-need assessment