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

According to Mordor Intelligence, the bilirubin blood test market size is expected to increase from USD 1.42 billion in 2025 to USD 1.5 billion in 2026 and reach USD 2.02 billion by 2031, growing at a CAGR of 6.16% over 2026-2031.

This report is Segmented by Test Type (Total, Direct, Indirect), Product Type (Reagents, Calibrators, Analyzers), Technology (Lab-Based, POC Blood, Transcutaneous), Application (Neonatal Jaundice, Liver Function, and More), End User (Hospitals/NICUs, Diagnostic Labs, and More), and Geography (North America, Europe, Asia-Pacific, MEA, South America). The Market Forecasts are Provided in Terms of Value in USD.

Global Bilirubin Blood Test Market Trends and Insights

Rising Neonatal Jaundice Screening Intensity

The bilirubin blood test market is gaining a stable demand base because neonatal bilirubin screening has moved from a preferred practice to a routine care expectation in many hospital systems. The AAP technical report kept predischarge bilirubin measurement central to newborn care, which supports repeated total bilirubin testing and follow-up measurement in at-risk infants. Australia strengthened this pattern when NSW updated its neonatal jaundice guideline in January 2026 and mandated universal transcutaneous bilirubin screening with broader gestational coverage. The bilirubin blood test market also benefits from a second testing step because jaundiced infants often need conjugated bilirubin measurement when cholestasis must be ruled out early, and Swiss pediatric guidance formalized that pathway through Biliscreen.org in 2026. This means one clinical event can generate screening, confirmation, and fractionation rather than a single assay, which keeps per-patient test intensity structurally high.

Growing Liver Disease Diagnostic Volumes

The bilirubin blood test market is also supported by routine liver disease workups because total bilirubin remains a standard component of liver function testing across primary care and specialist pathways. MASLD affects 38% of adults worldwide, which sustains large panel volumes that include bilirubin alongside other liver markers. This demand is not displaced by newer fibrosis tools because bilirubin is built into multimarker algorithms such as FibroTest, Hepascore, and SteatoTest, which keep the assay tied to noninvasive liver disease assessment. The bilirubin blood test market is further supported by treatment monitoring and diagnostic expansion in MASH and MASLD workflows, including the 2025 acquisition by Fibronostics to broaden noninvasive liver diagnostics capacity. Hemolytic disease adds another recurring layer because 2025 clinical evidence continued to show that total bilirubin and related markers remain practical tools for monitoring intravascular hemolysis in sickle cell anemia.

High Cost of Analyzers and Noninvasive Devices

The bilirubin blood test market still faces a capital barrier because transcutaneous bilirubinometers from established suppliers remain expensive for smaller facilities. A 2025 Japanese study noted commercial device pricing of USD 5,000 to USD 10,000 per unit, which limits adoption in primary and community settings that screen newborns but do not have large equipment budgets. Public procurement data in China still showed that hospitals were budgeting carefully for neonatal transcutaneous units, with Longyan First Hospital tendering 3 units at RMB 13,000 each, equal to USD 1,790 per unit. These cost limits slow wider penetration across the bilirubin blood test market, especially where township hospitals and community clinics must choose between screening equipment and broader chemistry investments. At the same time, low-cost innovation is emerging, and the same Japanese research validated a wearable TcB prototype with a unit cost near USD 100 and clinically meaningful correlation with serum bilirubin, which suggests that pricing pressure could intensify over time.

Other drivers and restraints analyzed in the detailed report include:

1. Adoption of Point-of-Care Bilirubin Workflows
2. Remote Newborn Follow-Up and Digital Jaundice Monitoring
3. Assay Standardization and Interference Limitations

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

Segment Analysis

Within the bilirubin blood test market, total bilirubin tests held 61.68% of the bilirubin blood test market share in 2025. This segment remains the first-line assay in neonatal jaundice protocols, liver panels, and comprehensive chemistry testing. The AAP framework kept predischarge bilirubin measurement and repeat follow-up central to newborn care, which supports repeated ordering across multiple encounters. Direct bilirubin tests are projected to grow at 7.94% through 2031 because neonatal cholestasis workups, MASLD-related hepatobiliary assessment, and hemolytic disorder evaluation increasingly require bilirubin fractionation.

Indirect bilirubin remains important even though it is usually reported as a derived value rather than a separately ordered assay. It still shapes clinical classification because clinicians use it to separate pre-hepatic, hepatic, and post-hepatic patterns of jaundice. A 2025 thalassemia study showed that unconjugated bilirubin above 59.8 µmol/L predicted UGT1A1 variant carriage with an area under the curve of 0.90, which supports its relevance in more specialized follow-up pathways. The bilirubin blood test market is therefore shifting from a simple total bilirubin model toward a broader fractionation mix, especially where pediatric hepatology and neonatal referral systems are becoming more standardized.

Reagents and assay consumables accounted for 63.23% share of the bilirubin blood test market size in 2025. Their lead reflects the recurring revenue structure created by reagent-rental agreements, where platforms are tied to multiyear supply contracts rather than one-time analyzer sales. This model gives established vendors stronger switching protection and steadier revenue visibility across hospital laboratory accounts. Alberta Precision Laboratories reinforced this pattern in 2025 when it implemented Roche Cobas Pure analyzers across regional sites, which supported single-vendor chemistry standardization and locked in ongoing bilirubin reagent demand.

Calibrators and quality controls remain a smaller revenue category, but they are gaining strategic weight as traceability standards tighten and cross-platform comparability becomes a larger procurement issue. The bilirubin blood test industry is likely to see continued interest in pediatric control materials that can support multiple analyzer families and reduce method-to-method drift. Bilirubin analyzers and meters are the fastest-growing product type at 7.66%, supported by dedicated transcutaneous devices and portable serum analyzers. Beckman Coulter's 2025 study of the DxC 500i in India showed strong analytical performance with a within-lab CV of 1.13% for higher-concentration total bilirubin and an r of 0.984 against comparator systems, which supports deployment in large tertiary settings. The bilirubin blood test market is also seeing longer-term hardware pressure from low-cost wearable TcB development, which could expand neonatal screening access while narrowing the pricing advantage of incumbent device makers.

Geography Analysis

North America accounted for 48.21% share of the bilirubin blood test market size in 2025. The region leads because AAP newborn screening guidance is widely embedded in clinical practice and because Medicare reimbursement includes total and direct bilirubin within the hepatic function panel coding structure. The bilirubin blood test market in Canada is also supported by laboratory standardization programs, including Alberta's 2025 Roche Cobas Pure implementation across regional hospitals. Europe remains a more heterogeneous setting because country-specific protocols coexist with broader NICE-style screening approaches and active IFCC standardization work. Universal screening has still kept testing volumes durable across the region, and pediatric research showed that extreme hyperbilirubinemia-related infant mortality in select European countries fell from 21.4 per million live births in 1990 to 4.2 per million in 2019.

Asia-Pacific is the fastest-growing geography in the bilirubin blood test market, with forecast CAGR of 8.45% through 2031. China is driving part of that expansion through active hospital procurement of neonatal transcutaneous bilirubinometers, including the September 2025 Longyan First Hospital tender for 3 units at RMB 13,000 each, equal to USD 1,790 per unit. India is expanding through point-of-care serum testing, and the 2025 Chennai validation of Bilistick System 2.0 showed clinically useful performance in a high-volume public hospital environment. Japan and Australia add another growth layer because routine TcB use in maternity care and updated universal screening guidance continue to support frequent neonatal bilirubin checks.

The bilirubin blood test market in the Middle East and Africa and in South America remains smaller in absolute size, but both regions carry targeted growth potential. GCC countries benefit from concentrated neonatal care infrastructure, while tertiary hospital networks in South Africa continue to support laboratory-based testing volume. Parts of Sub-Saharan Africa and the Middle East also face elevated bilirubin monitoring need because G6PD deficiency prevalence can range from 15% to 26% in male populations, which increases demand for hemolytic jaundice workups. Latin America remains important for liver-related testing because MASLD prevalence is highest globally in the region at 44.37%, which sustains bilirubin demand within routine hepatology panels.

1. Abbott Laboratories
2. Beckton Dickinson
3. DiaSys Diagnostic Systems
4. Dragerwerk
5. Elitech Group
6. Fortress Diagnostics
7. Roche
8. FUJIFILM Wako Pure Chemical Corporation
9. HORIBA Medical
10. Konica Minolta
11. Koninklijke Philips
12. Mennen Medical Ltd.
13. Nova Biomedical
14. QuidelOrtho
15. Randox Laboratories
16. Reichert
17. SEKISUI Diagnostics, LLC
18. Mindray
19. Siemens Healthineers
20. Thermo Fisher Scientific
21. Werfen, S.A.

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 Neonatal Jaundice Screening Intensity
  • 4.2.2 Growing Liver Disease Diagnostic Volumes
  • 4.2.3 Expansion of Routine Hospital Chemistry Testing
  • 4.2.4 Adoption of Point-of-Care Bilirubin Workflows
  • 4.2.5 Increasing Use of Transcutaneous Pre-Screening
  • 4.2.6 Remote Newborn Follow-Up and Digital Jaundice Monitoring
• 4.3 Market Restraints
  • 4.3.1 High Cost of Analyzers and Noninvasive Devices
  • 4.3.2 Need for Serum Confirmation at Clinical Decision Thresholds
  • 4.3.3 Assay Standardization and Interference Limitations
  • 4.3.4 Cross-Platform Assay Bias and Preanalytical Interference Risk
• 4.4 Value / 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 Industry Rivalry

5 Market Size & Growth Forecasts

• 5.1 By Test Type
  • 5.1.1 Total Bilirubin Tests
  • 5.1.2 Direct Bilirubin Tests
  • 5.1.3 Indirect Bilirubin Tests
• 5.2 By Product Type
  • 5.2.1 Reagents and Assay Consumables
  • 5.2.2 Calibrators and Quality Controls
  • 5.2.3 Bilirubin Analyzers and Meters
• 5.3 By Technology
  • 5.3.1 Laboratory-Based Testing
  • 5.3.2 Point-of-Care Blood Testing
  • 5.3.3 Transcutaneous Screening Systems
• 5.4 By Application
  • 5.4.1 Neonatal Jaundice Screening and Monitoring
  • 5.4.2 Liver Function Assessment
  • 5.4.3 Hemolytic Disorder Assessment
  • 5.4.4 Pre-operative and Routine Health Screening
• 5.5 By End User
  • 5.5.1 Hospitals and NICUs
  • 5.5.2 Diagnostic Laboratories
  • 5.5.3 Maternity and Neonatal Clinics
  • 5.5.4 Outpatient and Ambulatory Care Centers
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East & Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East & Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 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, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Beckman Coulter, Inc.
  • 6.3.3 DiaSys Diagnostic Systems GmbH
  • 6.3.4 Dragerwerk AG & Co. KGaA
  • 6.3.5 ELITechGroup
  • 6.3.6 Fortress Diagnostics
  • 6.3.7 F. Hoffmann-La Roche Ltd
  • 6.3.8 FUJIFILM Wako Pure Chemical Corporation
  • 6.3.9 HORIBA Medical
  • 6.3.10 Konica Minolta, Inc.
  • 6.3.11 Koninklijke Philips N.V.
  • 6.3.12 Mennen Medical Ltd.
  • 6.3.13 Nova Biomedical
  • 6.3.14 QuidelOrtho Corporation
  • 6.3.15 Randox Laboratories Ltd.
  • 6.3.16 Reichert, Inc.
  • 6.3.17 SEKISUI Diagnostics, LLC
  • 6.3.18 Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
  • 6.3.19 Siemens Healthineers AG
  • 6.3.20 Thermo Fisher Scientific Inc.
  • 6.3.21 Werfen, S.A.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment