The global medical equipment calibration service market is expected to grow at a CAGR of around 10.6% from 2021 to 2028 and expected to reach the market value of around US$ 5.6 Bn by 2028.
Medical equipment calibration is done to reduce uncertainty in measurements, reduce errors, and bring precise measurements because a drift in measurement is absolutely unacceptable in the medical industry. Calibration is also required for medical equipment/industry used in hospitals for patient monitoring and treatment in order to have confidence in its functioning and operation.
Stringent regulations imposed by the authorized bodies bolster the growth of global market
As with any medical device or machine, wear and tear over time has a direct impact on accuracy and performance. Periodic calibration is required to maintain the equipment's effectiveness and reduce the risk of causing harm to a patient. The Food and Drug Administration (FDA) has imposed stringent regulations on medical device companies regarding the establishment of standard operating procedures (SOP) that include instructions and acceptable limits for accuracy and precision. According to the NHSRC report, medical equipment testing and calibration can be done in accordance with a variety of national and international standards, including IEC606.1, EN60601.2.4, EN61010, VDE0751, MDADB9801, HE95, ANSI/AAMI, and others. This is possible for nearly all medical equipment, including defibrillators, pulse oximeters, infusion pumps, patient simulators, ventilators, fetal monitors, and patient monitors.
Rising number of calibration of services due to calibration service subscriptions offered by the authorized bodies drive the global medical equipment calibration service market
According to a Food and Drug Administration (FDA) report, there is an accreditation scheme for conformity assessment (ASCA). The FDA grants ASCA Recognition to qualified accreditation bodies to accredit testing laboratories to perform premarket testing for medical device companies under the ASCA Pilot. The Pilot intends to increase consistency and predictability in the FDA's approach to assessing conformity with respect to FDA-recognized consensus standards and test methods eligible for inclusion in the ASCA pilot in medical device premarket by relying on international conformity assessment standards and a set of FDA-identified ASCA program specifications.
Impact of COVID-19 on medical equipment calibration service market
The COVID-19 pandemic has presented unique challenges to all businesses and industries. Maintenance and calibration of hospital equipment went for a toss in order to maintain regulatory compliance and ensure the health and safety of patients. Furthermore, the crisis has compelled the medtech industry to quickly recalibrate across the value chain in order to meet the critical needs of healthcare.
The global medical equipment calibration service market is segmented as service and end-user. Based on service, the market is segmented as in-house, third-party services, and original equipment manufacturer (OEM). By end-user, the market is segregated as hospitals, clinical laboratories, and among others.
In terms of service, the third-party calibration service segment dominated the overall market in 2020, with a reasonable share that is expected to continue throughout the forecast period. According to the IJEAT report, the academic hospital has both in-house and independent service provider (third party) contracts because it has a reasonable annual cost of medical equipment (US$433) and very low downtime and turnaround time (1.2 and 1.5) days. Such factors foster segmental growth ultimately contributing to the growth of the global medical equipment calibration service market.
According to end-user, the hospital segment has historically accounted for the highest revenue share and is expected to continue in this manner throughout the forecast period. When the downtime in the three hospitals is compared, the academic hospital has the lowest COSR (3.7%), the shortest downtime (1.2 days), and the shortest turnaround time (1.5 days). Such factors stimulate the segmental growth ultimately contributing growth of global medical equipment calibration service market.
North America takes a forefront lead in the medical equipment calibration service market
North America has dominated the equipment calibration service market in the past and is expected to do so again during the forecast period. As medical equipment maintenance is required in North American provinces due to stringent regulations, it is one of the major factors contributing to regional growth. For example, the regulations of the US Centre for Medicare and Medicaid Services (CMS), USFDA, and OEMs, as well as the accreditation requirements of the Healthcare Facilities Accreditation Program HFAP, Det Norske Veritas (DNV), and The Joint Commission (TJC) require hospitals in the region to adhere to equipment maintenance. Furthermore, rising awareness for preventive medical equipment maintenance stimulates the medical equipment calibration service market in the North America regional market, which is ultimately responsible for the market's overall growth.
Asia Pacific, on the other hand, is expected to have the fastest growing CAGR in the coming years. For example, according to a report released by the Australian Trade and Investment Commission, Australia's health and medical industry has grown dramatically in size and reputation over the last decade, thanks to strong R&D support, a robust healthcare system, professional skills, and other factors. The therapeutic goods administration regulates the medical device industry (TGA). Furthermore, Australia's medical device industry is listed as having distinct competitive advantages due to its shorter time to market when compared to other drug discovery; it has established a significant position within the APAC regional market.
Apart from that, China and India have already established a significant position and are growing at twice the rate of the overall market, owing to favourable healthcare reforms, local government incentives, and rising demand for healthcare. Furthermore, both countries are transforming into rapid innovation hubs by localising innovation and manufacturing, implementing country-specific distribution models and sales channels, investing in local technology infrastructure, and collaborating with domestic value chain stakeholders. Such factors have a positive impact on the growth of the APAC regional market, ultimately contributing to the overall growth.
The prominent players of the global medical equipment calibration service market involve Fluke, Spectrum Technologies (Transcat Company), Industrial Calibration and Service Company, Inc., Custom Calibration, Inc., Calibration Laboratory, LLC., Morehouse Instrument Company, Inc., Strainsert, Inc., Sierra Instruments, Inc., and among others
Market By Service
Original Equipment Manufacturer (OEM)
Market By End-user
Market By Geography
• Rest of Europe
• South Korea
• Rest of Asia-Pacific
• Rest of Latin America
Middle East & Africa
• South Africa
• Rest of Middle East & Africa
Medical equipment calibration service market is expected to reach a market value of around US$ 5.6 Bn by 2028.
The medical equipment calibration service market is expected to grow at a CAGR of around 10.6% from 2021 to 2028.
Based on service, third-party services segment is the leading segment in the overall market.
Stringent regulation imposed by the authorized body is one of the prominent factors that drive the demand for medical equipment calibration service market.
Fluke, Spectrum Technologies (Transcat Company), Industrial Calibration and Service Company, Inc., Custom Calibration, Inc., Calibration Laboratory, LLC., Morehouse Instrument Company, Inc., Strainsert, Inc., Sierra Instruments, Inc., and among others.
North America is anticipated to grab the highest market share in the regional market
Asia Pacific is expected to be the fastest growing market in the forthcoming years