The global medical equipment calibration services market is projected to reach a valuation of USD 3.28 billion by 2030, expanding at a compound annual growth rate (CAGR) of 12.3% from 2024 to 2030, according to a newly published report by Grand View Research, Inc. This anticipated growth is primarily attributed to several key factors, including the rising demand for refurbished medical devices, the enforcement of stringent regulatory frameworks, and the implementation of strategic offerings by service providers, such as total annual calibration service subscriptions.
Calibration plays a critical role in ensuring precision and accuracy in medical devices. Not only does it optimize device performance, but it also contributes to cost-efficiency, making it an indispensable aspect of biomedical current Good Manufacturing Practice (cGMP) and U.S. Food and Drug Administration (FDA) compliance. Given that even minor deviations in medical equipment readings can significantly impact patient safety and public health, pharmaceutical and biotechnology companies are mandated to comply with ISO/IEC 17025:2005 standards throughout processes such as testing, calibration, and sampling.
The FDA’s Code of Federal Regulations Title 21 provides clear guidelines regarding calibration requirements. Specifically, section 820.72 obligates manufacturers to routinely inspect, measure, and test medical equipment to verify that it meets its intended use and delivers accurate results. Failure to adhere to these calibration standards can lead to severe financial penalties. These fines can vary based on the severity of the violation—from $100,000 for individual infractions that do not result in patient death, to $500,000 in cases where noncompliance results in a fatality.
The COVID-19 pandemic significantly disrupted the medical equipment calibration services market. The healthcare sector encountered unparalleled challenges due to government-mandated social distancing measures aimed at curbing virus transmission. These restrictions hindered traditional face-to-face engagements between sales representatives, medical science liaisons, and pharmaceutical personnel, directly affecting the efficiency of service operations and client interactions.
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Medical Equipment Calibration Services Market Report Highlights
• The third-party calibration services segment led the market in 2023, commanding a 41.1% share of total revenue. The dominance of this segment is largely due to its ability to provide fast turnaround times for calibration results, especially through on-site services rendered by third-party vendors.
• The Original Equipment Manufacturer (OEM) services segment is forecasted to grow at a CAGR of 12.4% during the forecast period, reflecting the increasing preference for brand-certified service solutions that ensure compliance and reliability.
• Among end users, hospitals held the largest revenue share at 42.8% in 2023, underscoring the sector's unwavering commitment to maintaining patient health and safety through routine calibration and maintenance of medical equipment.
• The clinical laboratories segment is expected to witness rapid expansion, with a projected growth rate exceeding 14.1% over the forecast period, driven by rising diagnostic testing demands and regulatory adherence requirements.
• North America emerged as the leading regional market in 2023, accounting for a 36.4% share of global revenue. The region is expected to continue its dominance and demonstrate robust growth throughout the forecast period, fueled by advanced healthcare infrastructure and strong regulatory oversight.
Medical Equipment Calibration Services Market Segmentation
Grand View Research has segmented global medical equipment calibration services market report based on service, end-use, and region:
Medical Equipment Calibration Services Service Outlook (Revenue, USD Million, 2018 - 2030)
• In-house
• Third-party Services
• Original Equipment Manufacturer (OEM)
Medical Equipment Calibration Services End-use Outlook (Revenue, USD Million, 2018 - 2030)
• Hospitals
• Clinical Laboratories
• Others
Medical Equipment Calibration Services Regional Outlook (Revenue, USD Million, 2018 - 2030)
• North America
o U.S.
o Canada
o Mexico
• Europe
o UK
o Germany
o France
o Italy
o Spain
o Denmark
o Sweden
o Norway
• Asia Pacific
o Japan
o China
o India
o Thailand
o Australia
o South Korea
• Latin America
o Brazil
o Argentina
• Middle East & Africa
o South Africa
o Saudi Arabia
o UAE
o Kuwait
List of Key Players of Medical Equipment Calibration Services Market
• TEKTRONIX, INC.
• Fluke
• Transcat Biomedical
• NS Medical Systems
• Transcat Inc.
• JM Test Systems
• Godrejenterprises.com
• NES GROUP MEDICAL
• Helix Pvt Ltd
• Angelus Medical and Optical
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