Medical Device Testing Services Market Size, Share, Opportunities, COVID 19 Impact, And Trends By Type (Medical Device Testing Solutions, Certification & Auditing, Scientific Support Services, Others), By Services (Cardiovascular Device Testing, Orthopaedic Implant Testing, Microbiological Analysis, Shelf-Life Testing, Others), By Sourcing Type (In-House Testing, Outsourced Testing), And By Geography- Forecasts From 2022 To 2027

Published:  Jun 2022 Report Code: KSI061613783 Pages: 120

The global medical device testing services market is estimated to surge at a CAGR of 14.79% from a market value of US$32.434 billion in 2020, to achieve a market value of US$85.156 billion by the end of 2027. 

Medical device testing services are the most commonly utilized testing services and solutions performed within the medical industry. Hence, with the growing medical device industry globally, the market is projected to hold strong growth prospects during the forecast period. The growing prevalence of chronic diseases requiring state-of-the-art medical devices for testing and treatment purposes further augments the market demand during the forecast period. The presence of companies offering varied medical device testing services further fuels the market growth in the forecast period. For example, companies offer medical device testing services for biocompatibility testing, biological safety, chemical characterization, analytical chemistry, environmental monitoring, and long-term and accelerated shelf-life testing. Furthermore, with the growing need for testing the quality and reliability of medical devices, the market for medical device testing services holds strong growth opportunities during the forecast period.

Companies also offer medical device testing services that provide full support right from the device concept designing design to post-market applications. These services are highly beneficial due to stringent regulations for product development; hence, any defect in a medical device or inability of a medical device to serve the required medical purpose would lead to product disqualification. Therefore, strict regulations for device development and approval contribute to surging market demand during the forecast period. NAMSA, a medical organization based in Toledo, Ohio, USA, aids in the acceleration of product development for medical devices, in-vitro diagnostics, regenerative medicine, and combination products. For example, NAMSA, a medical organization based out of Toledo, Ohio, United States, helps speed product development for medical devices, In-Vitro Diagnostics, regenerative medicine, and combination products. By utilizing its MRO® approach, the company plays a significant role in translational research. By applying its unique combination of solutions that include medical device testing, regulatory, reimbursement, quality consulting, and clinical research services, the company offers support throughout the full development continuum, from bench to actual patient applications. The company’s offices are located across the Asian, European, and North American regions and support fast-track market introduction in the world's major markets. 

Geographically, North America is projected to hold a significant market share. At the same time, the Asia Pacific region is estimated to be the fastest-growing market in the global medical device testing services market during the forecast period.

The impact of COVID-19 on the medical device testing services market: COVID-19 impact on the medical device testing services market.

The sector for medical device testing is driven mainly by a growing percentage of COVID-19 cases, which leads to an increase in the quantity of ICU beds, which results in a higher trend for COVID-19 priority medical devices. Factors such as increased sales for PPE kits and N95 masks global level and growing preference for ventilators for the effective identification of critical COVID-19 patients are also driving the market. The COVID-19 disease has increased the demand for in-vitro diagnostic product lines due to market demand for rapid-test goods and a marked rise in the target patient population in a few countries. According to a study article published in May 2020 by A. Chandimal Nicholas, in Canada, throughout the COVID-19 pandemic 2020, the Minister of Health signed the Provisional Order Recognizing the Import and Sale of Medical Devices to be used in Regards to COVID-19, which permitted healthcare providers speeded up access to COVID-19 medical devices. Furthermore, according to Health Canada, the Provisional Order aided in the quick approval of importing goods and sale of COVID-19 medical devices. However, disruptions in non-urgent therapies and surgical techniques and the impact on the supply chain and logistics have been reported. It has been noticed at the global level that the novel coronavirus pandemic has severely affected medical device manufacturing. This is mainly because medical device manufacturers depend on healthcare facilities for their clinical trial data collection. It is required that almost every medical device must pass through different stages of clinical trials that include pre-market and post-market studies before the medical device certification is certified for market approval. As the COVID-19 pandemic continues to increase, medical device companies face difficulties making informed decisions regarding their products, supply chain, and regulatory obligations. Hence, the market is projected to be impacted in the current year compared to the previous years amid the novel coronavirus pandemic scenario.

The growing medical device industry will continue to surge and drive the market demand during the forecast period and the emergence of novel and innovative medical devices.

The global medical device industry is projected to grow steadily during the forecast period. Industrial growth is further supported by the growing demand for innovative medical devices, including wearables and innovative health services like health data. This is mainly because lifestyle diseases are gaining momentum with time due to the adoption of unhealthy living conditions. Hence, this is creating a high demand for the development of portable medical devices to keep a constant check on the vital parameters, further providing robust market growth prospects during the forecast period. The g Governments around the globe are working on cutting healthcare costs (especially on lowering the number of hospital visits) and demand greater value regarding improved patient outcomes. Companies are expected to step out of their traditional device manufacturing to achieve this. Instead, a need for integrating services and data intelligence coupled with their products is being realized to deliver holistic solutions, further bolstering the B2B activities and strengthening the creation of the new business-to-consumer (B2C) activities. This will further require the manufacturers to adopt different strategies in the form of mergers & and acquisitions and strategic partnerships and collaborations. The medical device companies will ultimately play a bigger role in the value chain and will get an opportunity to interact with the end consumers closely. This would further aid in increasing the company’s revenues and, in turn, would contribute to lowering the number of hospital visits. 

Additionally, with medical devices directly impacting human lives, these devices must deliver safe and effective healthcare services to patients. To achieve this, it is expected that all medical device manufacturers follow the proper medical device testing procedures, including verification and validation practices, and ensure that the quality and reliability of medical devices are maintained following the required medical needs.

By utilizing the various medical device testing strategies, it is expected of a medical device manufacturer that the company checks every functionality of its medical device right from the concept designing stage to the post-market applications. In the case of any defect being found, it would lead to huge losses to the company. Hence, with the growing medical device industry, medical device testing services hold importance to assist in properly manufacturing the device. Testing services can be provided in-house or can be outsourced. Furthermore, with the surging number of chronic diseases worldwide, the market is projected to hold strong growth prospects and develop novel medical devices through continuous innovations and technological advancements.

Key Development

January 2022, TÜV SÜD's medical device testing laboratory in New Brighton, Minnesota, has grown. The cutting-edge laboratory will perform biological and chemical testing on medical devices, supplementing TÜV SÜD's active service medical device probes.

January 2022, DNV, a global provider of assurance, certification and risk management, procured MEDCERT in addition to expanding its medical device assurance footprint.

Medical Device Testing Services Market Scope:

Report Metric Details
 Market size value in 2020  US$32.434 billion
 Market size value in 2027  US$85.156 billion
 Growth Rate  CAGR of 14.79% from 2020 to 2027
 Base year  2020
 Forecast period  2022–2027
 Forecast Unit (Value)  USD Billion
 Segments covered  Type, Services, Sourcing Type, And Geography
 Regions covered  North America, South America, Europe, Middle East and Africa, Asia Pacific
 Companies covered SGS SA, Intertek Group plc, Bureau Veritas, DEKRA, Eurofins Scientific, The British Standards Institution, Nelson Laboratories, LLC (A Sotera Health Company)
 Customization scope  Free report customization with purchase

 

Segmentation:

  • By Type
    • Medical Device Testing Solution
    • Certification & Auditing
    • Scientific Support Services
    • Others
  • By Services
    • Cardiovascular Device Testing
    • Orthopedic Implant Testing
    • Microbiological Analysis
    • Shelf-Life Testing
    • Others
  • By Sourcing Type
    • In-House Testing
    • Outsourced Testing
  • By Geography
    • North America
      • USA
      • Canada
      • Mexico
    • South America
      • Brazil
      • Argentina
      • Others
    • Europe
      • UK
      • Germany
      • France
      • Spain
      • Others
    • Middle East and Africa
      • UAE
      • Israel
      • Saudi Arabia
      • Others
    • Asia Pacific
      • Japan
      • China
      • India
      • South Korea
      • Thailand
      • Indonesia
      • Taiwan
      • Others

Frequently Asked Questions (FAQs)

Q1. What will be the medical device testing services market size by 2027?
A1. The global medical device testing services market is estimated to reach a market size of US$85.156 billion by 2027. 


Q2. What is the size of the global medical device testing services market?
A2. Medical Device Testing Services Market was valued at US$32.434 billion in 2020. 


Q3. What are the growth prospects for the medical device testing services market?
A3. The medical device testing services market is estimated to surge at a CAGR of 14.79% over the forecast period. 


Q4. What factors are anticipated to drive the medical device testing services market growth?
A4. The growing prevalence of chronic diseases requiring state-of-the-art medical devices for testing and treatment purposes is augmenting the market demand during the course of the forecast period. 


Q5. Which region holds the largest market share in the medical device testing services market?
A5. Geographically, North America is projected to hold a significant share in the medical device testing services market.

1. Introduction
1.1. Market Overview
1.2. COVID-19 Impact
1.3. Market Definition
1.4. Market Segmentation

2. Research Methodology
2.1. Research Data
2.2. Assumptions

3. Executive Summary
3.1. Research Highlights

4. Market Dynamics
4.1. Market Drivers
4.2. Market Restraints
4.3. Market Opportunities
4.4. Porters Five Forces Analysis
4.4.1. Bargaining Power of Suppliers
4.4.2. Bargaining Power of Buyers
4.4.3. Threat of New Entrants
4.4.4. Threat of Substitutes
4.4.5. Competitive Rivalry in the Industry
4.5. Industry Value Chain Analysis

5. Medical Device Testing Services Market Analysis, by Type
5.1. Introduction
5.2. Medical Device Testing Solution
5.3. Certification & Auditing
5.4. Scientific Support Services
5.5. Others

6. Medical Device Testing Services Market Analysis, by Services
6.1. Introduction
6.2. Cardiovascular Device Testing
6.3. Orthopedic Implant Testing
6.4. Microbiological Analysis
6.5. Shelf-Life Testing
6.6. Others

7. Medical Device Testing Services Market Analysis, by Sourcing Type
7.1. Introduction
7.2. In-House Testing
7.3. Outsourced Testing

8. Medical Device Testing Services Market Analysis, by Geography
8.1. Introduction
8.2. North America
8.2.1. North America Medical Device Testing Services Market, By Type, 2020 to 2027
8.2.2. North America Medical Device Testing Services Market, By Services, 2020 to 2027
8.2.3. North America Medical Device Testing Services Market, By Sourcing Type, 2020 to 2027
8.2.4. By Country
8.2.4.1. United States
8.2.4.2. Canada
8.2.4.3. Mexico
8.3. South America
8.3.1. South America Medical Device Testing Services Market, By Type, 2020 to 2027
8.3.2. South America Medical Device Testing Services Market, By Services, 2020 to 2027
8.3.3. South America Medical Device Testing Services Market, By Sourcing Type, 2020 to 2027
8.3.4. By Country
8.3.4.1. Brazil
8.3.4.2. Argentina
8.3.4.3. Others
8.4. Europe
8.4.1. Europe Medical Device Testing Services Market, By Type, 2020 to 2027
8.4.2. Europe Medical Device Testing Services Market, By Services, 2020 to 2027
8.4.3. Europe Medical Device Testing Services Market, By Sourcing Type, 2020 to 2027
8.4.4. By Country
8.4.4.1. UK
8.4.4.2. Germany
8.4.4.3. France
8.4.4.4. Spain 
8.4.4.5. Others
8.5. Middle East and Africa
8.5.1. Middle East and Africa Medical Device Testing Services Market, By Type, 2020 to 2027
8.5.2. Middle East and Africa Medical Device Testing Services Market, By Services, 2020 to 2027
8.5.3. Middle East and Africa Medical Device Testing Services Market, By Sourcing Type, 2020 to 2027
8.5.4. By Country
8.5.4.1. United Arab Emirates
8.5.4.2. Israel
8.5.4.3. Saudi Arabia
8.5.4.4. Others
8.6. Asia Pacific
8.6.1. Asia Pacific Medical Device Testing Services Market, By Type, 2020 to 2027
8.6.2. Asia Pacific Medical Device Testing Services Market, By Services, 2020 to 2027
8.6.3. Asia Pacific Medical Device Testing Services Market, By Sourcing Type, 2020 to 2027
8.6.4. By Country
8.6.4.1. Japan
8.6.4.2. China
8.6.4.3. India
8.6.4.4. South Korea
8.6.4.5. Thailand
8.6.4.6. Indonesia
8.6.4.7. Taiwan 
8.6.4.8. Others

9. Competitive Environment and Analysis
9.1. Major Players and Strategy Analysis
9.2. Emerging Players and Market Lucrativeness
9.3. Mergers, Acquisitions, Agreements, and Collaborations
9.4. Vendor Competitiveness Matrix

10. Company Profiles 
10.1. SGS SA
10.2. Intertek Group plc
10.3. Bureau Veritas
10.4. DEKRA
10.5. Eurofins Scientific
10.6. The British Standards Institution
10.7. Nelson Laboratories, LLC (A Sotera Health Company)

SGS SA

Intertek Group plc

Bureau Veritas

DEKRA

Eurofins Scientific

The British Standards Institution

Nelson Laboratories, LLC (A Sotera Health Company)

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