혈액학 시장(2026-3031년)

Global Laboratory-Based and Point-of-Care Hematology Market Forecast Through 2031

The complete blood count is one of the most frequently ordered tests in medicine, and the instruments that run it are changing faster than the test itself. Hematology is a mature IVD segment, but competition no longer centers only on cell counting. Vendors now compete on automation, digital morphology, AI-assisted cell classification and the ability to put full CBC testing outside the central laboratory. Worldwide Market for Hematology, 2026–2031 from Kalorama Information looks at where that shift creates revenue and which suppliers are positioned to capture it.

What the Report Covers

The report sizes and forecasts the global hematology testing market across two segments: laboratory-based hematology and decentralized (point-of-care) hematology. The laboratory segment is examined by vendor share, reagent sales by test type, and region. The decentralized segment is split into lab-style compact instruments and handheld devices. It also separates hemoglobin and hematocrit testing from other routine hematology performed near the patient.

Regional analysis covers North America, Europe, Asia Pacific and the Rest of World. For each region, the report breaks out laboratory and point-of-care sales.

Technology and Market Trends

The report examines the forces shaping purchasing decisions, including:

• Digital morphology. The report covers the move from cell-gallery systems to full-field smear imaging, and the role of remote review in laboratory networks facing staffing shortages.
• AI in hematology. Applications include flagging, specimen triage, autoverification and longitudinal result analysis. The report also covers the regulatory and validation limits on how quickly this software can change.
• Decentralized testing. Cartridge-based and compact analyzers are taking CBC testing into oncology clinics, urgent care and physician offices. The report explains the practical difference between CLIA-waived and moderate-complexity systems.
• Combined testing. Some analyzers pair the CBC with CRP, ESR or HbA1c measurement from a single specimen.

Competitive Analysis

The report provides vendor market shares for both laboratory and point-of-care segments, company revenue estimates, and a tiered view of the supplier base. Leading suppliers are profiled, including Sysmex, Beckman Coulter/Danaher, Mindray, Roche, Siemens Healthineers, Abbott, HORIBA and Nihon Kohden.

A dedicated section on China examines centralized procurement, payment reform, import substitution and the rise of domestic manufacturers. FDA registration and CLIA categorization trends are also analyzed. Product tables cover recent analyzer introductions, digital morphology systems, quality control products and point-of-care platforms.

Scope and Methodology

Market estimates are presented in U.S. dollars for 2026, with forecasts through 2031. Values are based on factory sales to the end user rather than retail pricing or reimbursement. The market includes analyzers, instruments and reagents sold for commercial laboratory and hospital use, some research-use products used in clinical laboratories, and over-the-counter products. Test services are excluded.

The analysis draws on company, government and medical organization reports, supported by literature searches and interviews with industry professionals and IVD experts.

Who Should Read This Report

This report is written for diagnostics manufacturers, component and reagent suppliers, investors, business development teams and strategic planners. It is especially relevant to anyone evaluating opportunities in laboratory automation, digital morphology or near-patient hematology.

Table of Contents

Chapter 1: Executive Summary

• About Kalorama Information
• Hematology Overview
• Market Overview
  • Table 1-1: Global Hematology Testing Market, by Product Segment, 2026-2031 Est. (US$ millions) [Decentralized (POC) Hematology, Laboratory-based Hematology]
• Scope and Methodology

Chapter 2: Overview of Hematology and Trends

• Introduction
  • Figure 2-1: Hematology Analyzer Distribution of Sales by Menu Capability, 2026 Est. (%)
• Digital Image Analysis
  • Table 2-1: CellaVision Market Share Data by Hematology Vendor, 2026 Est. (%)
  • Table 2-2: Selected Hematology Image Analysis Innovations
• Digital Evolution
• Artificial Intelligence in IVD Hematology
• Quality Control Measurement Programs
  • Table 2-3: Selected Hematology Quality Control Products, 2026

Chapter 3: Laboratory-based Hematology Testing

• Overview
• Product Overview
  • Table 3-1: Selected Hematology Innovations, 2026
  • Table 3-2: Lab-Based Hematology Test and Instrument Market Share, by Vendor, 2026 Est. (%)
• Market Summary
  • Table 3-3: Global Laboratory-based Hematology Test and Instrument Market, 2026 and 2031 (US$ millions)
  • Figure 3-1: Lab-based Hematology Sales by Reagent, 2026 Est. (%)
• Regional Laboratory-based Hematology Test and Instrument Market
  • Table 3-4: Global Laboratory-based Hematology Test and Instrument Market, by Region, 2026 Est. (%)
  • Figure 3-2: Laboratory-based Hematology Test and Instrument Market, Regional Analysis, 2026 Est. (%)

Chapter 4: Decentralized Hematology Testing

• Overview
• Hemoglobin/Hematocrit at the POC
  • Table 4-1: POC Hematology Distribution by Specialty (Hematocrit/Hemoglobin vs. Other Routine Hematology), 2026 (%)
  • Table 4-2: Selected Hematocrit and Hemoglobin POC Systems, 2026
  • Table 4-3: Selected POC Hematology Analyzer Systems, 2026
  • Table 4-4: POC-Based Hematology Test and Instrument Market Share by Vendor, 2026 Est. (%)
• Decentralized (POC) Market Summary
  • Table 4-5: Decentralized Hematology Test and Instrument Market, 2026 and 2031 Est. (US$ millions)
• Regional Decentralized Hematology Test and Instrument Market
  • Table 4-6: Global Decentralized Hematology Test and Instrument Market, by Region, 2026 Est. (%)
  • Figure 4-1: Decentralized Hematology Test and Instrument Market, Regional Analysis, 2026 (%)

Chapter 5: Market Analysis & Leading Suppliers

• Summary
  • Figure 5-1: Laboratory Hematology Analyzer CLIA Categorizations by Year, 2000–2026 YTD
  • Figure 5-2: FDA Registration Distribution by Company for Hematology Analyzers/Instruments (%)
  • Table 5-1: Hematology Market Revenue Distribution, by Product Type, 2026 Est. (%) [Analyzers, Instruments and Reagents]
  • Figure 5-3: Global Hematology Market Value, by Segment, 2026 Est. (US$ millions) [Laboratory-based and Decentralized (POC)]
  • Table 5-2: Global Hematology (Laboratory-based and POC) Sales Distribution, by Region, 2026 (%)
  • Figure 5-4: Global Hematology Market, by Testing Platform (Laboratory-based, POC) and Region, 2026 (US$ millions)
  • Figure 5-5: North America Hematology Market Revenue, Laboratory-Based vs. POC, 2026 (US$ millions)
  • Figure 5-6: North America Hematology Market Share, Laboratory-Based and POC Segments, 2026 (%)
  • Figure 5-7: Europe Hematology Market Revenue, Laboratory-Based vs. POC, 2026 (US$ millions)
  • Figure 5-8: Europe Hematology Market Share, Laboratory-Based vs. POC, 2026 (%)
  • Figure 5-9: Asia Pacific Hematology Market Revenue, Laboratory-Based vs. POC, 2026 (US$ millions)
  • Figure 5-10: Asia Pacific Hematology Market Share, Laboratory-Based vs. POC, 2026 (%)
  • Figure 5-11: Rest of World Hematology Market Revenue, Laboratory-Based vs. POC, 2026 (US$ millions)
  • Figure 5-12: Rest of World Hematology Market Share, Laboratory-Based vs. POC, 2026 (%)
• Leading Suppliers
  • Table 5-3: Hematology, Company Revenues (laboratory and POC), 2026 Est. (US$ millions)
  • Table 5-4: Hematology Vendors (Laboratory, POC), 2026
• China and IVD Hematology
• The Commercial Outlook for Hematology Tests