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 $100,000for 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.
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 $100,000for 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
Table of Contents
Chapter 1 Methodology and Scope1.1 Market Segmentation & Scope
1.1.1 Estimates And Forecast Timeline
1.2 Research Methodology
1.3 Information Procurement
1.3.1 Purchased Database
1.3.2 Internal Database
1.3.3 Secondary Sources
1.3.4 Primary Research
1.4 Information or Data Analysis
1.4.1 Data Analysis Models
1.5 Market Formulation & Validation
1.6 Region Wise Market Calculation
1.6.1 Region Wise Market: Base Estimates
1.6.2 Global Market: CAGR Calculation
1.7 List of Secondary Sources
1.8 Objectives
1.8.1 Objective - 1: Understanding market dynamics
1.8.2 Objective - 2: Understanding market estimates and forecasts
1.8.3 Objective - 3: Understanding attributes such as strategy framework and competitor categorization
1.8.4 Objective - 4: Understanding the key service and application scopes to conclude on the market size.
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
3.2.1.1 Stringent regulations pertaining to calibration of devices
3.2.1.2 Rising awareness of preventative medical equipment maintenance
3.2.1.3 Increasing demand for refurbished medical equipment
3.2.2 Market Restraint Analysis
3.2.2.1 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
6.1 Medical Equipment Calibration Services Market: Regional Market Share Analysis, 2020 & 2028
6.2 North America
6.2.1 North America Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.2.2 The U.S.
6.2.2.1 The U.S. Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.2.3 Canada
6.2.3.1 Canada Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.3 Europe
6.3.1 Europe Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.3.2 The U.K.
6.3.2.1 The U.K. Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.3.3 Germany
6.3.3.1 Germany Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.3.4 France
6.3.4.1 France Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.3.5 Italy
6.3.5.1 Italy Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.3.6 Spain
6.3.6.1 Spain Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.4 Asia Pacific
6.4.1 Asia Pacific Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.4.2 Japan
6.4.2.1 Japan Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.4.3 China
6.4.3.1 China Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.4.4 India
6.4.4.1 India Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.4.5 Singapore
6.4.5.1 Singapore Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.4.6 Thailand
6.4.6.1 Thailand Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.5 Latin America
6.5.1 Latin America Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.5.2 Brazil
6.5.2.1 Brazil Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.5.3 Mexico
6.5.3.1 Mexico Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.5.4 Argentina
6.5.4.1 Argentina Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.5.5 Colombia
6.5.5.1 Colombia Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.6 MEA
6.6.1 MEA Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.6.2 South Africa
6.6.2.1 South Africa Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.6.3 Saudi Arabia
6.6.3.1 Saudi Arabia Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
6.6.4 UAE
6.6.4.1 UAE Medical Equipment Calibration Services Market, 2016 - 2028 (USD Million)
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
List of Tables
Table 1 List of Secondary Sources
Table 2 List of Abbreviations
Table 3 Global Medical Equipment Calibration Services Market, by Region, 2016 - 2028 (USD Million)
Table 4 Global Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 5 Global Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 6 North America Medical Equipment Calibration Services Market, by Country, 2016 - 2028 (USD Million)
Table 7 North America Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 8 North America Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 9 The U.S. Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 10 The U.S. Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 11 Canada Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 12 Canada Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 13 Europe Medical Equipment Calibration Services Market, by Country, 2016 - 2028 (USD Million)
Table 14 Europe Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 15 Europe Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 16 The U.K. Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 17 The U.K. Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 18 Germany Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 19 Germany Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 20 France Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 21 France Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 22 Italy Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 23 Italy Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 24 Spain Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 25 Spain Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 26 Asia Pacific Medical Equipment Calibration Services Market, by Country, 2016 - 2028 (USD Million)
Table 27 Asia Pacific Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 28 Asia Pacific Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 29 Japan Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 30 Japan Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 31 China Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 32 China Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 33 India Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 34 India Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 35 Thailand Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 36 Thailand Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 37 Singapore Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 38 Singapore Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 39 Latin America Medical Equipment Calibration Services Market, by Country, 2016 - 2028 (USD Million)
Table 40 Latin America Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 41 Latin America Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 42 Brazil Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 43 Brazil Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 44 Mexico Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 45 Mexico Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 46 Argentina Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 47 Argentina Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 48 Colombia Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 49 Colombia Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 50 Middle East & Africa Medical Equipment Calibration Services Market, by Country, 2016 - 2028 (USD Million)
Table 51 Middle East & Africa Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 52 Middle East & Africa Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 53 South Africa Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 54 South Africa Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 55 South Arabia Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 56 South Arabia Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)
Table 57 UAE Medical Equipment Calibration Services Market, by Service, 2016 - 2028 (USD Million)
Table 58 UAE Medical Equipment Calibration Services Market, by End User, 2016 - 2028 (USD Million)List of Figures
Fig. 1 Market research process
Fig. 2 Information procurement
Fig. 3 Primary research pattern
Fig. 4 Market research approaches
Fig. 5 Value-chain-based sizing & forecasting
Fig. 6 QFD modeling for market share assessment
Fig. 7 Market formulation & validation
Fig. 8 Medical Equipment Calibration Services Market snapshot (2020)
Fig. 9 Medical Equipment Calibration Services Market segmentation
Fig. 10 Market driver relevance analysis (Current & future impact)
Fig. 11 Market restraint relevance analysis (Current & future impact)
Fig. 12 Penetration & growth prospect mapping
Fig. 13 Porter’s five forces analysis
Fig. 14 PESTEL analysis
Fig. 15 Medical Equipment Calibration Services Market service outlook: Segment dashboard
Fig. 16 Medical Equipment Calibration Services Market: service movement analysis
Fig. 17 In-House Calibration Services, 2016 - 2028 (USD Million)
Fig. 18 Third Party Calibration Services, 2016 - 2028 (USD Million)
Fig. 19 Original Equipment Manufacturer (OEM), 2016 - 2028 (USD Million)
Fig. 20 Medical Equipment Calibration Services Market End User outlook: Segment dashboard
Fig. 21 Medical Equipment Calibration Services Market: End User movement analysis
Fig. 22 Hospitals based Medical Equipment Calibration Services market, 2016 - 2028 (USD Million)
Fig. 23 Clinical laboratories based Medical Equipment Calibration Services market, 2016 - 2028 (USD Million)
Fig. 24 Others based Medical Equipment Calibration Services market, 2016 - 2028 (USD Million)
Fig. 25 Regional market: Key takeaways
Fig. 26 Regional outlook, 2020 & 2028
Fig. 27 North America market, 2016 - 2028 (USD Million)
Fig. 28 The U.S. market, 2016 - 2028 (USD Million)
Fig. 29 Canada market, 2016 - 2028 (USD Million)
Fig. 30 Europe market, 2016 - 2028 (USD Million)
Fig. 31 The U.K. market, 2016 - 2028 (USD Million)
Fig. 32 Germany market, 2016 - 2028 (USD Million)
Fig. 33 France market, 2016 - 2028 (USD Million)
Fig. 34 Italy market, 2016 - 2028 (USD Million)
Fig. 35 Spain market, 2016 - 2028 (USD Million)
Fig. 36 Asia Pacific market, 2016 - 2028 (USD Million)
Fig. 37 Japan market, 2016 - 2028 (USD Million
Fig. 38 China market, 2016 - 2028 (USD Million)
Fig. 39 India market, 2016 - 2028 (USD Million)
Fig. 40 Singapore market, 2016 - 2028 (USD Million)
Fig. 41 Thailand market, 2016 - 2028 (USD Million)
Fig. 42 Latin America market, 2016 - 2028 (USD Million)
Fig. 43 Brazil market, 2016 - 2028 (USD Million)
Fig. 44 Mexico market, 2016 - 2028 (USD Million)
Fig. 45 Argentina market, 2016 - 2028 (USD Million)
Fig. 46 Colombia market, 2016 - 2028 (USD Million)
Fig. 47 MEA market, 2016 - 2028 (USD Million)
Fig. 48 South Africa market, 2016 - 2028 (USD Million)
Fig. 49 Saudi Arabia market, 2016 - 2028 (USD Million)
Fig. 50 UAE market, 2016 - 2028 (USD Million)
Companies Mentioned
- Industrial Calibration and Service Co. Inc.
- Tektronix
- Fluke Biomedical
- Biomedical Technologies Inc.
- NS Medical Systems
- Transcat, Inc.
- JM Test Systems
- JPen Medical
- TAG Medical
- Hospicare Equipment Services Corporation
- RS Calibration
Methodology
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 100 |
| Published | June 2021 |
| Forecast Period | 2021 - 2028 |
| Estimated Market Value ( USD | $ 1.16 billion |
| Forecasted Market Value ( USD | $ 2.2 billion |
| Compound Annual Growth Rate | 9.6% |
| Regions Covered | Global |
| No. of Companies Mentioned | 11 |
