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

According to Mordor Intelligence, the bilirubin meters market size is expected to increase from USD 377 million in 2025 to USD 402.60 million in 2026 and reach USD 562.40 million by 2031, growing at a CAGR of 6.89% over 2026-2031.

This report is Segmented by Product Type (Transcutaneous Bilirubinometers, Bench-top/Serum Bilirubinometers), End User (Hospitals, Neonatal Clinics & Birth Centers, Diagnostic Laboratories, Home Care), Application (Screening, Diagnosis & Monitoring), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America). Market Forecasts are Provided in Terms of Value (USD).

Global Bilirubin Meters Market Trends and Insights

High Neonatal Jaundice Prevalence and Universal Predischarge Screening Momentum

Six of every ten term newborns and eight of every ten preterm infants exhibit visible jaundice during the first week of life, prompting guideline bodies to press for routine testing across delivery wards. India's Mission ANMOL shows how middle-income health systems can operationalize the mandate at scale by integrating bilirubin with 55 other newborn screens in a single visit. This regulatory alignment transforms discretionary testing into a standard-of-care expectation, driving multiyear budget allocations for capital devices and consumables. As screening becomes universal, vendors that can bundle equipment financing and staff training into turnkey contracts stand to gain.

Shift to Non-Invasive TcB Screening Reduces Blood Draws and Readmissions

A heel-stick serum draw averages eight minutes of staff time versus two minutes for a transcutaneous scan, creating an immediate 40% labor saving per screening episode . A 2024 JAMA Pediatrics cohort study tied universal TcB adoption to a 32% drop in jaundice-related readmissions within one year. Workflow efficiency is magnified in U.S. maternity wards processing up to 5,000 deliveries each year, where the switch frees nursing teams for lactation support and discharge education. Device makers have responded by embedding barcode scanners and HL7 FHIR data exchange so readings auto-populate the electronic health record and trigger alerts when phototherapy thresholds loom. Yet the necessity for serum confirmation near treatment cutoffs tempers the total addressable volume, keeping laboratory assays in play.

TcB Requires Confirmatory TSB Near Thresholds and Post-Phototherapy Limits

Optical bilirubinometry underestimates values above 15 mg/dL and becomes unreliable after phototherapy, when skin reflectance changes foil algorithms. NICE guidelines, therefore, impose serum confirmation whenever TcB readings fall within 3 mg/dL of treatment cutoffs. In Ghana, this double-testing pushed per-infant costs to USD 8.50, versus USD 3.20 for TcB-only workflows, eroding the economic case in public hospitals . Laboratories equipped with Radiometer ABL90 FLEX or Siemens RAPIDPoint 405 platforms already measure bilirubin alongside blood gases, enabling clinicians to bypass standalone devices in critical-care settings. Unless TcB vendors can lift post-phototherapy accuracy, serum assays will retain a foothold.

Other drivers and restraints analyzed in the detailed report include:

1. APAC Birth Volumes and Neonatal Capacity Expansion Raise Device Demand
2. EHR/HIS Connectivity and Workflow Automation Drive Hospital Procurement
3. High Upfront Cost and Patchy Reimbursement in Emerging Markets

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

Segment Analysis

Transcutaneous devices captured 61.30% of 2025 revenue, validating hospital preference for non-invasive workflows that cut collection time by 75% and integrate smoothly with electronic records. The bilirubin meters market size for transcutaneous systems is projected to climb steadily as universal screening makes a device mandatory for every delivery ward. Bench-top serum analyzers, however, are forecast to post the brisker 8.36% CAGR through 2031, buoyed by laboratory consolidation onto multi-parameter blood-gas instruments that can process bilirubin alongside six other chemistries. Correlation coefficients between transcutaneous and serum values still range from 0.76 to 0.92, so one in three infants screened will need serum confirmation, safeguarding residual demand.

Clinicians weigh accuracy against workflow: Dragerwerk's JM-105 embeds five-wavelength optics and barcode scanners that flag near-threshold values for confirmatory draws, while QuidelOrtho's Vitros BuBc Slide delivers conjugated and unconjugated fractions vital for biliary atresia diagnosis. As algorithmic advances lift transcutaneous precision, remaining differentiation may hinge on consumable costs and calibration stability. Vendors that wrap disposable probe tips and cloud analytics into subscription bundles could lock accounts before AI-based smartphone apps disrupt the entry-level tier of the bilirubin meters market.

Geography Analysis

North America held 37.18% share in 2025, underpinned by 3.6 million annual U.S. births, comprehensive insurance coverage, and guideline alignment that embeds bilirubin measurement into every discharge checklist. Device penetration is now replacement-cycle driven; hospitals upgrade to Wi-Fi-enabled models or pursue consumable-saving alternatives. Canada mirrors this maturity, while Mexico's uneven facility coverage leaves rural clinics reliant on visual assessment.

Asia-Pacific is the growth epicenter, projected at a 7.98% CAGR to 2031 as China and India scale NICU beds and national screening programs. Although the bilirubin meters market size in the region is smaller than North America's today, sheer birth volumes and rising institutional deliveries create outsized upside. Reimbursement gaps persist; fewer than 30% of South Asian public hospitals have ring-fenced diagnostic budgets, but state schemes and philanthropic grants offer episodic boosts.

Europe trails in volume growth, restrained by NICE's caution that discourages blanket TcB adoption. Germany and France retain targeted protocols, while Spain seeks EU funds to pilot universal screening in 2027. Middle East & Africa and South America suffer infrastructure deficits; only a few of Sub-Saharan public hospitals own a TcB meter. Brazil's SUS reimburses screening in public maternity wards but not in private clinics, splitting the market. Novel low-cost interventions such as filtered-sunlight phototherapy could allow these regions to bypass traditional meters altogether.

1. Advanced Instruments, LLC
2. APEL Co., Ltd
3. Beijing M&B Electronic Instruments Co., Ltd
4. BIOBASE Group
5. Delta Medical International
6. Dragerwerk
7. Roche
8. GINEVRI srl
9. Heal Force Bio-meditech Holdings
10. Konica Minolta
11. Koninklijke Philips
12. Labotronics Scientific
13. Mennen Medical Ltd
14. Ningbo David Medical Device
15. QuidelOrtho (Ortho Clinical Diagnostics)
16. Radiometer Medical
17. Reichert Analytical Instruments (AMETEK)
18. Siemens Healthineers

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 Neonatal Jaundice Prevalence; Universal Predischarge Screening Momentum
  • 4.2.2 Shift To Non-Invasive TcB Screening Reduces Blood Draws and Readmissions
  • 4.2.3 APAC Birth Volumes and Neonatal Capacity Expansion Raise Device Demand
  • 4.2.4 EHR/HIS Connectivity and Workflow Automation Drive Hospital Procurement
  • 4.2.5 Algorithmic/Sensor Advances (Multi-Wavelength, AI) Improve Accuracy
  • 4.2.6 Remote/Community TcB Programs for Post-Discharge Monitoring
• 4.3 Market Restraints
  • 4.3.1 TcB Requires Confirmatory TSB Near Thresholds; Post-Phototherapy Limits
  • 4.3.2 High Upfront Cost; Patchy Reimbursement in Emerging Markets
  • 4.3.3 Divergent Guidelines (NICE Vs AAP) Dampen Universal Screening Adoption
  • 4.3.4 Substitution By Multi-Parameter Blood-Gas/Chemistry Analyzers in Labs
• 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 Type
  • 5.1.1 Transcutaneous Bilirubinometers
  • 5.1.2 Bench-top/Serum Bilirubinometers
• 5.2 By End User
  • 5.2.1 Hospitals
  • 5.2.2 Neonatal Clinics & Birth Centers
  • 5.2.3 Diagnostic Laboratories
  • 5.2.4 Home Care
• 5.3 By Application
  • 5.3.1 Screening
  • 5.3.2 Diagnosis & Monitoring
• 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 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
  • 6.3.1 Advanced Instruments, LLC
  • 6.3.2 APEL Co., Ltd
  • 6.3.3 Beijing M&B Electronic Instruments Co., Ltd
  • 6.3.4 BIOBASE Group
  • 6.3.5 Delta Medical International
  • 6.3.6 Dragerwerk AG & Co. KGaA
  • 6.3.7 F. Hoffmann-La Roche Ltd
  • 6.3.8 GINEVRI srl
  • 6.3.9 Heal Force Bio-meditech Holdings
  • 6.3.10 Konica Minolta, Inc.
  • 6.3.11 Koninklijke Philips N.V.
  • 6.3.12 Labotronics Scientific
  • 6.3.13 Mennen Medical Ltd
  • 6.3.14 Ningbo David Medical Device Co., Ltd
  • 6.3.15 QuidelOrtho (Ortho Clinical Diagnostics)
  • 6.3.16 Radiometer Medical
  • 6.3.17 Reichert Analytical Instruments (AMETEK)
  • 6.3.18 Siemens Healthineers

7 Market Opportunities & Future Outlook

• 7.1 White-space & unmet-need assessment