의료장비 교정 : 시장 점유율 분석, 산업 동향 및 통계, 성장 예측(2025-2030년)

The Medical Equipment Calibration Market size is estimated at USD 1.77 billion in 2025, and is expected to reach USD 3.04 billion by 2030, at a CAGR of 11.42% during the forecast period (2025-2030).

Demand tracks three converging forces: stricter global quality mandates, rapid technology replacement cycles, and the steady spread of advanced healthcare infrastructure. New FDA Quality Management System Regulation amendments taking effect in 2026 will harmonize United States rules with ISO 13485:2016 and reinforce the need for traceable calibration records. Capital spending on AI-enabled imaging, ventilators, and networked monitors expands the medical equipment calibration market because every new device shipped carries a downstream calibration requirement. Hospitals also link reimbursement to device accuracy metrics under value-based care, further embedding calibration into operating budgets.

Global Medical Equipment Calibration Market Trends and Insights

Stringent Global Regulations Drive Calibration Standardization

Regulatory harmonization elevates the medical equipment calibration market by embedding calibration traceability into quality audits and device approvals. The FDA QMSR now mirrors ISO 13485:2016, eliminating dual compliance silos and expanding documentation depth. Europe's MDR and IVDR impose comparable file-keeping obligations that reach far beyond basic safety checks and push suppliers to maintain chain-of-custody records for every calibration event. China's NMPA reforms dovetail with the same standards while adding local clinical-trial demands, creating new accreditation work for domestic and multinational laboratories. Regulators also extend oversight to cybersecurity, with draft U.S. guidance requiring a software bill of materials for "cyber devices," so calibration routines increasingly include security-verification steps. Collectively, these intertwined rules reshape procurement, service contracting, and technician training.

Growing Installed Base of High-Value Imaging & Life-Support Systems

Hospital capital budgets now revolve around AI-ready CT, MRI, and ventilator platforms. Philips' helium-free MRI architecture trims running costs yet requires new calibration protocols for a 7-liter magnet in place of traditional 1,500-liter vessels. GE HealthCare's alliance with NVIDIA for autonomous x-ray and ultrasound adds another calibration layer because software models need the same traceability as mechanical parts. These innovations multiply device variants and expand the medical equipment calibration market by shifting the service mix toward algorithm validation, IoT sensor checks, and multi-modal performance tests. Emerging life-support systems embed real-time feedback loops that demand more frequent micro-calibrations to guard patient safety and maintain uptime guarantees negotiated in value-based service contracts.

High Cost & Scheduling Complexity in Emerging Markets

Healthcare systems in lower-income regions prioritize hardware acquisition over lifecycle services. Supply-chain disruptions raised logistics costs by up to 5% of manufacturer revenue in 2024, inflating calibration expenses for imported reference instruments. Geographic sprawl means a technician may spend two travel days for every service day, which deters routine visits and dampens the medical equipment calibration market. Currency swings further complicate multiyear contracts priced in hard currencies. Large providers respond by pooling demand or inviting global firms like Trescal to set up regional hubs, slowly easing cost burdens.

Other drivers and restraints analyzed in the detailed report include:

1. Preventive-Maintenance Contracts to Cut Device Downtime
2. IoT-Linked Self-Diagnostic Sensors Enabling Micro-Calibration
3. Scarcity of ISO/IEC 17025-Accredited Technicians

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

Segment Analysis

Imaging platforms accounted for 33.45% of the medical equipment calibration market in 2024, reflecting extensive calibration touchpoints from gantry alignment to dose calibration. Each software revision and hardware retrofit drives incremental service revenue and anchors long-term contracts. Algorithmic imaging methods add video-rate adjustments that go beyond classical geometric checks, enlarging scope. Vital-sign monitors, by contrast, post a 14.01% CAGR because home-care adoption multiplies unit volume. Every monitor shipped into a living room extends the medical equipment calibration market to non-institutional settings and triggers portable field-calibration kits. Gradient-free helium MRI, AI-enabled ultrasound, and connected infusion pumps all require bespoke procedures, locking in specialist demand.

Rapid uptake of networked devices means calibration now routinely covers sensors, embedded firmware, and cloud APIs. Infusion pumps rely on gravimetric calibration for flow accuracy, and any firmware patch resets the clock on compliance. Ventilator calibration gained visibility during the pandemic and remains a critical safety hedge in intensive-care units. Surgical tools and laboratory analyzers sustain steady growth, rounding out revenue diversity within the medical equipment calibration market.

The Medical Equipment Calibration Market Report Segments the Industry Into by Equipment Type (Vital Sign Monitors, Ventilators, Fetal Monitors, and More), Type of Service (In-House Calibration Services, and More ), End User (Clinical Laboratories, Hospitals, and More), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America generated 39.83% of global revenue in 2024, supported by early alignment with ISO 13485 and routine FDA surveillance audits. Procurement teams embed service clauses that mandate ISO/IEC 17025 accreditation, cementing a high-entry barrier and rewarding scale operators. Canada's regulatory modernization and Mexico's export-oriented device production add regional tailwinds. The medical equipment calibration market size for North America is projected to advance in lockstep with imaging overhauls, tele-ICU rollouts, and cybersecurity mandates.

Asia-Pacific grows at a brisk 12.52% CAGR, propelled by expanding manufacturer hubs in China, India, and South Korea and by fresh hospital construction across Southeast Asia. Government incentives to localize high-end production spur suppliers to build domestic calibration capability, stimulating cross-border joint ventures. Japan's aging population drives heavy imaging utilization, while the ASEAN Medical Device Directive trims paperwork across 10 countries and speeds vendor onboarding. These factors converge to embed the medical equipment calibration market across the region.

Europe commands a large installed base and a detailed regulatory playbook. MDR and IVDR updates extend calibration from radiology into in vitro diagnostics, inflating task lists and lengthening service contracts. Germany's export pipeline, France's hospital investments, and the United Kingdom's post-Brexit alignment efforts collectively keep demand high. Sustainability preferences open space for newer calibration methods-for instance, helium-free MRI-and render traditional cooling and cryogen checks obsolete. Elsewhere, the Middle East, Africa, and South America register quicker relative growth as they retrofit outdated fleets and build new tertiary centers, though limited technician pools and currency risk temper uptake.

1. Fortive
2. Trescal
3. GE Healthcare
4. Siemens Healthineers
5. Koninklijke Philips
6. Transcat
7. Tektronix
8. JM Test Systems
9. TAG Medical
10. BC Group International
11. Beamex
12. Keysight Technologies
13. JPen Medical
14. NS Medical Systems
15. Medserve Ltd
16. Godrej Biomed
17. Biomed Technologies (ISS Solutions)
18. TBS Group
19. Aramark Services
20. Pentax Medical Services
21. Rigel 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 Stringent Global Regulations
  • 4.2.2 Growing Installed Base of High-Value Imaging & Life-Support Systems
  • 4.2.3 Preventive-Maintenance Contracts to Cut Device Downtime
  • 4.2.4 IoT-Linked Self-Diagnostic Sensors Enabling Micro-Calibration
  • 4.2.5 Value-Based Procurement Tying Reimbursement to Accuracy KPIs
  • 4.2.6 Home/POC Devices Needing Field-Calibration Kits
• 4.3 Market Restraints
  • 4.3.1 High Cost & Scheduling Complexity in Emerging Markets
  • 4.3.2 Scarcity of ISO/IEC 17025-Accredited Technicians
  • 4.3.3 Cyber-Security Rules Limiting Remote Calibration Access
  • 4.3.4 AI Autocalibration Data-Integrity Concerns
• 4.4 Porter's Five Forces Analysis
  • 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 in USD)

• 5.1 By Equipment Type
  • 5.1.1 Vital Sign Monitors
  • 5.1.2 Ventilators
  • 5.1.3 Fetal Monitors
  • 5.1.4 Cardiovascular Monitors
  • 5.1.5 Imaging Equipment
  • 5.1.6 Infusion Pumps
  • 5.1.7 Other Equipment
• 5.2 By Type of Service
  • 5.2.1 In-house Calibration Services
  • 5.2.2 Third-party Calibration Services
  • 5.2.3 OEM Calibration Services
• 5.3 By End User
  • 5.3.1 Clinical Laboratories
  • 5.3.2 Hospitals
  • 5.3.3 Others (Home-care, Ambulatory, OEM Labs)
• 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 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East & 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 Fortive
  • 6.3.2 Trescal
  • 6.3.3 GE Healthcare
  • 6.3.4 Siemens Healthineers
  • 6.3.5 Philips Healthcare
  • 6.3.6 Transcat
  • 6.3.7 Tektronix
  • 6.3.8 JM Test Systems
  • 6.3.9 TAG Medical
  • 6.3.10 BC Group International
  • 6.3.11 Beamex
  • 6.3.12 Keysight Technologies
  • 6.3.13 JPen Medical
  • 6.3.14 NS Medical Systems
  • 6.3.15 Medserve Ltd
  • 6.3.16 Godrej Biomed
  • 6.3.17 Biomed Technologies (ISS Solutions)
  • 6.3.18 TBS Group
  • 6.3.19 Aramark Services
  • 6.3.20 Pentax Medical Services
  • 6.3.21 Rigel Medical

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment