Medical Device Testing Market by Service (Testing, Inspection, Certification), Sourcing (In-house, Outsourced), Technology (Active Implant, Active, Non-active, IVD, Ophthalmic, Orthopedic & Dental, Vascular), Class (I, II, III) – Global Forecast to 2028
[215 Pages Report] The global medical device testing market size is expected to be valued at USD 10.6 billion in 2023 and is projected to reach USD 13.5 billion by 2028; it is expected to grow at a CAGR of 4.9% from 2023 to 2028. The expansion of the global healthcare sector presents a substantial opportunity for stakeholders in the market. With healthcare accessibility improving, especially in emerging markets, the demand for advanced medical devices is on the rise due to factors such as a growing population, increased disposable incomes, and heightened awareness of healthcare and well-being.
Medical Device Testing Market Forecast to 2028
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Medical device testing market dynamics
Driver: The global expansion of the healthcare industry
The global expansion of the healthcare industry represents a significant opportunity for various stakeholders within the medical device testing market. As healthcare access improves across the world, particularly in emerging markets, there is a growing demand for advanced medical devices. This demand is fueled by an increasing population, rising disposable incomes, and a growing awareness of healthcare and wellness. Consequently, there is a need for robust testing services to ensure the safety, efficacy, and compliance of these devices with stringent regulatory standards. Testing facilities and services play a vital role in supporting the global expansion of the healthcare industry by providing the necessary assurance to manufacturers, healthcare providers, and patients, thus contributing to the overall growth and credibility of the medical device sector on a global scale.
Restraint: Quality concerns and product recalls for medical devices
Quality concerns and the associated risk of product recalls represent a critical restraint for the medical device testing market. Ensuring the quality and safety of medical devices is paramount, particularly for high-risk devices like pacemakers, coronary stents, and artificial heart valves. A lapse in quality control can have severe consequences, including injuries to end-users or even fatalities. Any compromised quality can lead to product recalls, causing financial losses and reputational damage for manufacturers. Moreover, the potential consequences of poor quality in medical devices, such as product recalls and harm to patients, intensify the need for meticulous testing. Inadequate testing or failure to meet regulatory standards can result in legal, financial, and reputational damage for manufacturers. The need to avoid these significant risks necessitates thorough and meticulous testing processes, adding complexity and costs to the development and testing phases of medical devices. Achieving optimal quality and reducing the risk of recalls are persistent challenges for companies in the market.
Opportunity: Connectivity of mobile devices with medical equipment
The merging of mobile technology with medical devices is revolutionizing healthcare. Through dedicated applications and connectivity, mobile devices seamlessly connect with medical equipment, empowering individuals to monitor and manage their health on-the-go. This integration improves accessibility and facilitates timely interventions, resulting in enhanced health outcomes. Rapid advancements in wireless technologies and sensor-based devices have given rise to a new wave of mobile medical devices, significantly enhancing patient quality-of-life while reducing healthcare costs for both providers and patients. The compact size and networking capabilities of these mobile medical devices offer considerable advantages, allowing patients to make fewer hospital visits and giving healthcare providers the benefit of reduced administrative overheads and care expenses.
Challenge: Intricate nature of supply chains in medical device testing
The medical device testing supply chains face rigorous regulatory demands, presenting a notable challenge. As components are often procured worldwide, ensuring a smooth supply chain while upholding stringent quality control and compliance standards proves difficult. The complexity arises from the need to manage multiple suppliers, coordinate logistics, and ensure consistent safety and quality standards throughout the testing process in today's interconnected global economy. In contemporary manufacturing, optimizing costs and profits involves sourcing components globally. However, this approach introduces heightened risks in managing intricate supply chains, further complicated by evolving international trade regulations. The ongoing reviews and frequent changes in trade agreements among nations add to the complexity, influenced by economic and geopolitical factors.
Medical Device Testing Market Ecosystem
The medical device testing market is dominated by established and financially sound manufacturers with extensive experience in the industry. These companies have diversified product portfolios, cutting-edge technologies, and strong global sales and marketing networks. Leading players in the market include Knowles Eurofins Scientific from Luxembourg, Intertek Group plc from the UK, SGS Société Générale de Surveillance SA. from Switzerland, Bureau Veritas from France, and TÜV SÜD from Germany.
Testing services segment is expected to hold the highest market share during the forecast period
Testing services hold a significant market share in the medical device testing industry due to their crucial role in ensuring regulatory compliance, safety, and quality of medical devices. The healthcare sector is highly regulated, necessitating comprehensive testing to meet stringent standards set by regulatory bodies like the Food & Drug Administration of US (FDA) and European Commission (EC). Through thorough evaluations, testing services confirm that devices function effectively, pose no risks to patients, and meet specified performance benchmarks. This instills confidence in healthcare professionals and end-users, facilitating market access and fostering trust. Outsourcing to specialized testing facilities grants access to expertise and advanced technology, further driving the prominence of testing services in the medical device testing market.
Based on device class, the class III to hold the highest market share during the forecast period
Class III medical devices, the highest risk category, require the most rigorous testing and scrutiny in the medical device testing market. These devices, such as pacemakers and implantable defibrillators, undergo extensive testing to ensure their safety, efficacy, and compliance with strict regulatory standards imposed by bodies like the FDA. The complexity and criticality of Class III devices necessitate comprehensive evaluation across multiple parameters, including biocompatibility, performance, sterility, and more. The growth of Class III devices in the market is propelled by their increasing complexity and critical nature, necessitating comprehensive and stringent testing procedures. Regulatory requirements for Class III devices are particularly demanding, driving the demand for rigorous testing to ensure compliance and safety. Additionally, the rising development and adoption of advanced medical technologies, such as implantable devices, contribute to the expanding market for Class III device testing. Manufacturers' emphasis on thorough testing to meet regulatory standards and deliver high-quality, innovative healthcare solutions further fuels the growth of Class III devices in the medical device testing sector.
IVD medical devices for medical device testing market to hold the highest market share
In Vitro Diagnostic (IVD) medical devices, ranging from diagnostic kits to molecular assays, hold a significant market share in medical device testing. These devices play a pivotal role in healthcare, aiding in disease diagnosis, monitoring, and treatment decisions. The demand for IVD medical device testing stems from the critical importance of accurate and reliable diagnostic results in healthcare decision-making. Stringent regulatory requirements necessitate rigorous testing to ensure precision, sensitivity, and specificity of these devices. Furthermore, the increasing prevalence of infectious diseases and chronic conditions fuels the demand for innovative IVD devices, driving the growth of testing services to validate their effectiveness and compliance with regulatory standards.
Medical device testing market in Asia Pacific to hold the highest CAGR during the forecast period
Rapid economic development and industrialization in countries like China and India are driving substantial investments in healthcare and technology, fueling the demand for medical device testing services. Moreover, evolving regulatory frameworks in the region are placing increased emphasis on quality and safety standards for medical devices, necessitating comprehensive testing. Additionally, the burgeoning middle-class population with higher disposable income is demanding superior healthcare services, boosting the need for advanced medical devices and, consequently, the testing thereof. Lastly, the surge in medical tourism and the aspiration to meet international market standards are further propelling the growth of the market in the Asia-Pacific region.
Medical Device Testing Market by Region
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Key Market Players
The medical device testing companies is dominated by players such as Eurofins Scientific (Luxembourg), Intertek Group plc (UK), SGS Société Générale de Surveillance SA. (Switzerland), Bureau Veritas (France), TÜV SÜD (Germany) and others.
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Report Metric |
Details |
Estimated Value |
USD 10.6 billion |
Expected Value |
USD 13.5 billion |
Growth Rate |
CAGR of 4.9% |
Market size available for years |
2019-2028 |
Base year considered |
2022 |
Forecast period |
2023-2028 |
Forecast units |
Value (USD Million/Billion) |
Segments Covered |
By Service Type, By Sourcing Type, By Device Class, By Technology |
Geographies covered |
North America, Europe, Asia Pacific, and RoW |
Companies covered |
The major market players include Eurofins Scientific (Luxembourg), Intertek Group plc (UK), SGS Société Générale de Surveillance SA. (Switzerland), Bureau Veritas (France), TÜV SÜD (Germany), (Total of 25 players are profiled) |
Medical Device Testing Market Highlights
The study categorizes the medical device testing market based on the following segments:
Segment |
Subsegment |
By Service Type |
|
By Sourcing Type |
|
By Device Class |
|
By Technology |
|
By Region |
|
Recent Developments
- In June 2023, TÜV SÜD has opened a laboratory in New Brighton, Minnesota, accredited to ISO 17025 for biological and chemical testing of medical devices. Staffed by experienced scientists and technicians, the lab will cater to both domestic and international medical device companies, aiding in research and development through microbiology, reusable device testing, chemistry, biocompatibility, and packaging testing services.
- In September 2022, Bureau Veritas has acquired Galbraith Laboratories Inc., known for advanced analytical solutions in healthcare. This acquisition amplifies Bureau Veritas' presence in Consumer Healthcare and Industrial Chemicals supply chains, bolstering support for research, development, and product testing. Galbraith Laboratories' expertise will enhance Bureau Veritas' service portfolio, particularly in medical device testing, expanding its reach and influence in the US.
- In July 2022, Eurofins Scientific acquired WESSLING (Hungary) to enhance its environmental, food, and BioPharma product testing offerings in the European region.
- In October 2021, SGS acquired Groupe IDEA TESTS (IDEA), a leading provider of clinical, microbiological, and in-vitro testing and regulatory services to cosmetic & personal care product manufacturers in France. The acquisition is likely to help SGS to offer enhanced services to customers from the strategic markets of cosmetics & hygiene.
Frequently Asked Questions:
What are the major driving factors and opportunities in the medical device testing market?
Some of the major driving factors for the growth of this market include Global expansion of healthcare industry, increasing need for stringent standards, increasing need for validation and verification of medical devices. Furthermore, the opportunities such as Connectivity of mobile devices, harmonization of standards, technological advancements including IoT and AI technologies are factors expected to boost the growth of medical device testing market.
Which region is expected to hold the highest market share?
The market in Asia Pacific will dominate the market share in 2023, anticipating strong demand for medical device testing in the region. The rapid growth of middle-class population with increased purchasing power fuels the demand for superior healthcare services, driving the need for comprehensive testing of advanced medical devices. Furthermore, the region's growth is amplified by medical tourism and a strong desire to meet global market standards.
Who are the leading players in the global medical device testing market?
Companies such as Eurofins Scientific (Luxembourg), Intertek Group plc (UK), SGS Société Générale de Surveillance SA. (Switzerland), Bureau Veritas (France), and TÜV SÜD (Germany) are the leading players in the market. Moreover, these companies rely on several strategies including new product launches and developments, collaborations and partnerships, and acquisitions. Such strategies provide these companies with an edge over other players in the market.
What are some of the technological advancements in the market?
3D printing technology allows for the rapid production of patient-specific personalized anatomical models, aiding in surgical planning and practicing. Additionally, it can be utilized in medical device testing to print medical devices like exoskeletons. This includes optimizing material parameters and consumption, selecting appropriate materials for the exoskeleton, and facilitating efficient testing and validation.
What is the size of the global medical device testing market?
The global medical device testing market was valued at USD 10.2 Billion in 2022 and is anticipated to reach USD 13.5 Billion at a CAGR of 4.9% during the forecast period.
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The study involved four major activities in estimating the current size of the medical device testing market. Exhaustive secondary research was done to collect information on the market, peer, and parent markets. The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the complete market size. After that, market breakdown and data triangulation were used to estimate the market size of segments and subsegments.
Secondary Research
Various secondary sources have been referred to in the secondary research process for identifying and collecting information important for this study. The secondary sources include annual reports, press releases, and investor presentations of companies; white papers; journals and certified publications; and articles from recognized authors, websites, directories, and databases. Secondary research has been conducted to obtain key information about the industry’s supply chain, the market’s value chain, the total pool of key players, market segmentation according to the industry trends (to the bottom-most level), regional markets, and key developments from market- and technology-oriented perspectives. The secondary data has been collected and analyzed to determine the overall market size, further validated by primary research.
List of major secondary sources
Sources |
Web Link |
International Organization for Standardization (ISO) |
https://www.iso.org/home.html |
Canadian Standards Association (CSA) |
https://www.csagroup.org/ |
International Safe Transit Association (ISTA) |
https://ista.org/ |
American Society for Testing Materials (ASTM) |
https://www.astm.org/ |
American National Standards Institute (ANSI) |
https://www.ansi.org/ |
Hong Kong Certification Body Accreditation Scheme (HKCAS) |
https://www.itc.gov.hk/ |
Hong Kong Inspection Body Accreditation Scheme (HKIAS) |
https://www.itc.gov.hk/ |
World Bank Group |
https://www.worldbank.org/ |
Primary Research
Extensive primary research was conducted after gaining knowledge about the current scenario of the medical device testing market through secondary research. Several primary interviews were conducted with experts from both the demand and supply sides across four major regions—North America, Europe, Asia Pacific, and RoW. This primary data was collected through questionnaires, emails, and telephonic interviews.
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Market Size Estimation
In the complete market engineering process, both top-down and bottom-up approaches have been used, along with several data triangulation methods, to perform market estimation and forecasting for the overall market segments and subsegments listed in this report. Key players in the market have been identified through secondary research, and their market shares in the respective regions have been determined through primary and secondary research. This entire procedure includes the study of annual and financial reports of the top market players and extensive interviews for key insights (quantitative and qualitative) with industry experts (CEOs, VPs, directors, and marketing executives).
All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources. All the parameters affecting the markets covered in this research study have been accounted for, viewed in detail, verified through primary research, and analyzed to obtain the final quantitative and qualitative data. This data has been consolidated and supplemented with detailed inputs and analysis from MarketsandMarkets and presented in this report. The following figure represents this study’s overall market size estimation process.
Bottom-Up Approach
The bottom-up approach was used to arrive at the overall size of the medical device testing market from the revenues of the key players and their shares in the market. The overall market size was calculated based on the revenues of the key players identified in the market.
- Identifying the entities in the medical device testing market influencing the entire market, along with the related component players
- Analyzing major providers of medical device testing services, studying their portfolios, and understanding different types of products based on features and functions
- Analyzing trends pertaining to the usage of medical device testing offerings, such as hardware, software, and services
- Tracking the ongoing and upcoming developments in the market, such as investments made, R&D activities, product launches, collaborations, and partnerships, and forecasting the market size based on these developments and other critical parameters
- Carrying out multiple discussions with key opinion leaders to understand the different types of medical device testing; and offerings, vertical, and recent trends in the market, analyzing the breakup of the scope of work carried out by major manufacturing companies
- Arriving at the market estimates by analyzing segment revenues of these companies generated by medical device testing offerings and then combining the same to get the market estimate by different segments
- Verifying and cross-checking the estimate at every level by discussing with key opinion leaders, such as Chief Experience Officers (CXOs), directors, and operations managers, and finally with the domain experts at MarketsandMarkets
- Studying various paid and unpaid sources of information, such as annual reports, press releases, white papers, Factiva, and databases
Top-Down Approach
In the top-down approach, the overall market size has been used to estimate the size of individual markets (mentioned in the market segmentation) through percentage splits from secondary and primary research.
The most appropriate immediate parent market size has been used to implement the top-down approach to calculate the market size of specific segments. The top-down approach has been implemented for the data extracted from the secondary research to validate the market size obtained.
Each company’s market share has been estimated to verify the revenue shares used earlier in the top-down approach. This study has determined and confirmed the overall parent market and individual market sizes by the data triangulation method and data validation through primaries. The data triangulation method in this study is explained in the next section.
- Focusing on top-line investments and expenditures being made in the ecosystems of various verticals, listing key developments, analyzing updated technology in the marketplace, and evaluating the market by further splitting it into different technology
- Building and developing the information related to the market revenue generated by key medical device testing tools manufacturers
- Conducting multiple on-field discussions with the key opinion leaders involved in the development of medical device testing products in various verticals
- Estimating geographic splits using secondary sources based on various factors, such as the number of players in a specific country and region, the offerings of medical device testing, and the level of solutions offered in different verticals
- The impact of the recession on the steps mentioned above.
Data Triangulation
After arriving at the overall market size from the estimation process explained above, the overall market has been split into several segments and subsegments. The data triangulation procedure has been employed wherever applicable to complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments. The data has been triangulated by studying various factors and trends from both the demand and supply sides. Additionally, the market size has been validated using top-down and bottom-up approaches.
Market Definition
Medical device testing services are provided to help manufacturers improve their productivity, meet the global standards, and enhance the quality of medical devices. Services such as audit, inspection, verification, certification, and testing can be applied to any medical device, service, or company, involved in medical devices. These services aim to assure the end users and consumers that the manufacturer has followed national and international regulations and industry standards to ensure quality, public health, and safety.
Key Stakeholders
- Raw material and testing equipment suppliers
- Research organizations
- Original equipment manufacturers (OEMs)
- Technology standards organizations, forums, alliances, and associations
- Technology investors
- Analysts and strategic business planners
- Government bodies, venture capitalists, and private equity firms
- Market Research and Consulting Firms
- Technology Investors
- Governments, Regulatory Bodies, and Financial Institutions
- Venture Capitalists, Private Equity Firms, and Startups
Report Objectives
- To describe and forecast the medical device testing market, in terms of value, based on service type, sourcing type, device class and, technology.
- To forecast the market size, in terms of value, for various segments with regard to 4 main regions, namely, North America, Europe, Asia Pacific (APAC), and the Rest of the World (RoW)
- To provide detailed information regarding the major factors influencing the growth of the medical device testing market (drivers, restraints, opportunities, and industry-specific challenges)
- To analyze the micromarkets1 with respect to individual growth trends, prospects, and contributions to the total market
- To study the complete value chain and allied industry segments, and perform a value chain analysis of the medical device testing landscape
- To analyze the opportunities in the market for various stakeholders by identifying the high-growth segments of the medical device testing market
- To profile the key players and comprehensively analyze their market position in terms of ranking and core competencies2, along with detailing the competitive landscape for the market leaders
- To analyze competitive developments, such as partnerships and joint ventures, mergers and acquisitions, new product developments, expansions, and research and development, in the medical device testing market
- To track and analyze competitive developments, such as partnerships, collaborations, agreements, joint ventures, mergers and acquisitions, expansions, product/service launches, and other developments in the market
Available Customizations
With the given market data, MarketsandMarkets offers customizations according to the specific requirements of companies. The following customization options are available for the report:
- Detailed analysis and profiling of additional market players (up to 5)
- Additional country-level analysis of the medical device testing market
Product Analysis
- Product matrix, which provides a detailed comparison of the product portfolio of each company in the medical device testing market.
Growth opportunities and latent adjacency in Medical Device Testing Market