The global medical equipment calibration services market size is expected to reach USD 2.2 billion by 2028, registering a CAGR of 9.4% over the forecast period. The market is majorly driven by the demand for refurbished medical equipment, stringent regulations and market strategies, such as total annual calibration service subscriptions, provided by service providers.
Calibration ensures the highest level of precision for medical devices while also lowering costs, making it an essential component of biomedical cGMP and FDA compliance. As medical equipment measurements have a significant impact on public health and safety, pharma and biotech businesses must adhere to ISO/IEC 17025:2005 regulations throughout testing, calibration and sampling.
The calibration requirements for equipment are defined in title 21 of the FDA's Code of Federal Regulations. As per section 820.72, manufacturers are required to inspect, measure and test equipment to ensure that it is adequate for its intended purpose and capable of producing correct findings. Noncompliance with FDA equipment calibration standards can result in significant financial fines. It ranges from $100,000 for individual errors that do not result in a patient's death to $500,000 for a noncompliance issue that results in a patient's death.
The COVID-19 pandemic has had a major impact on the market The healthcare sector has experienced unprecedented difficulty as a result of governments' clear social distancing attempts to prevent the virus from spreading. This has affected the sales reps, medical scientific liaisons and pharma personnel's face-to-face interactions.
Medical Equipment Calibration Services Market Report Highlights
The third-party calibration services segment dominated the market with a share of 40.2% in 2020. This is owing to the quickest turnaround time for equipment calibration results when using a third-party source on-site
The clinical laboratories segment is projected to witness the fastest CAGR of 11.2% over the forecast period, as these labs prefer to subscribe to annual or periodic service plans that cover the validation of all of the lab's instruments
North America account 3d for the maximum revenue share of 37.0% in 2020 due to factors, such as the increasing number of medical devices recalls as technology becomes more sophisticated
Asia Pacific is anticipated to register the fastest CAGR of 10.3% over the forecast period due to the strict regulatory regulations and increasing public awareness about the quality of services given in hospitals and laboratories
Key Topics Covered:
Chapter 1 Methodology and Scope
Chapter 2 Executive Summary 2.1 Market Outlook
Chapter 3 Medical Equipment Calibration Services Market: Variables, Trends, & Scope 3.1 Market Segmentation and Scope 3.2 Market Dynamics 3.2.1 Market Driver Analysis 220.127.116.11 Stringent regulations pertaining to calibration of devices 18.104.22.168 Rising awareness of preventative medical equipment maintenance 22.214.171.124 Increasing demand for refurbished medical equipment 3.2.2 Market Restraint Analysis 126.96.36.199 Limited Consciousness 3.3 Penetration & Growth Prospect Mapping 3.4 COVID-19 Impact on the Market 3.5 Major Deals and Strategic Alliances Analysis 3.6 Medical Equipment Calibration Services: Market Analysis Tools 3.6.1 Industry Analysis - Porter's 3.6.3 PESTEL Analysis
Chapter 4 Medical Equipment Calibration Services Market: Service Segment Analysis 4.1 Medical Equipment Calibration Services Market: Service Market Share Analysis, 2020 & 2028 4.2 In-House Calibration Services 4.2.1 In-House Calibration Services Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million) 4.3 Third Party Calibration Services 4.3.1 Third Party Calibration Services Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million) 4.4 Original Equipment Manufacturer (OEM) 4.4.1 Original Equipment manufacturer Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
Chapter 5 Medical Equipment Calibration Services Market: End User Segment Analysis 5.1 Medical Equipment Calibration Services Market: End User Market Share Analysis, 2020 & 2028 5.2 Hospitals 5.2.1 Hospitals Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million) 5.3 Clinical Laboratories 5.3.1.Clinical Laboratories Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million) 5.4 Others 5.4.1 Others Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
Chapter 6 Medical Equipment Calibration Services Market: Regional Analysis
Chapter 7 Company Profiles 7.1 Industrial Calibration and Service Co. Inc. 7.1.1 Company Overview 7.1.2 Service Benchmarking 7.1.3 Financial Performance 7.1.4 Strategic Initiatives 7.2 Tektronix 7.2.1 Company Overview 7.2.2 Financial Performance 7.2.3 Service Benchmarking 7.2.5 Strategic Initiatives 7.3 Fluke Biomedical 7.3.1 Company Overview 7.3.2 Service Benchmarking 7.3.3 Strategic Initiatives 7.4 Biomedical Technologies Inc. 7.4.1 Company Overview 7.4.2 Financial Performance 7.4.3 Service Benchmarking 7.5 NS Medical Systems 7.5.1 Company Overview 7.5.2 Financial Performance 7.5.3 Service Benchmarking 7.6 Transcat, Inc. 7.6.1 Company Overview 7.6.2 Financial Performance 7.6.3 Service Benchmarking 7.7 JM Test Systems 7.7.1 Company Overview 7.7.2 Financial Performance 7.7.3 Service Benchmarking 7.7.4 Strategic Initiatives 7.8 JPen Medical 7.8.1 Company Overview 7.8.2 Financial Performance 7.8.3 Service Benchmarking 7.9 TAG Medical 7.9.1 Company Overview 7.9.2 Financial Performance 7.9.3 Service Benchmarking 7.9.4 Strategic Initiatives 7.9.5 Strategic Initiatives 7.10 Hospicare Equipment Services Corporation 7.10.1 Company Overview 7.10.2 Financial Performance 7.10.3 Service Benchmarking 7.11 RS Calibration 7.11.1 Company Overview 7.11.2 Financial Performance 7.11.3 Service Benchmarking