Medical Device Testing Services Market Share, Size Report, 2027

Medical Device Testing Services Market to 2027 - Global Analysis and Forecasts By Service (Biocompatibility Test, Chemistry Test, Microbiology & Sterility Testing, and Package Validation), Phase (Preclinical, Clinical), and Geography

  • Report Code : TIPRE00003011
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 131
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The Medical Device Testing Services in healthcare market was valued at US$ 5505.4 million in 2018 and it is projected to reach US$ 14,660.1 million by 2027; it is expected to grow at a CAGR of 11.7% from 2019 to 2027.

Medical devices are very critical as they have a direct impact on patient's life. To deliver high-quality and safe experiences to the patients’ medical device manufacturers test the medical devices before delivering it to the market. Medical device manufactures prefer to do in-house testing or outsource the testing services to the contract research organizations (CROs) to comply with the stringent regulatory guidelines. The testing of the medical devices is to ensure the service safety, quality and consistency during all stages of development and usage of medical device. The medical treatment is highly dependent on medical devices, hence it's important to ensure that the testing of medical devices is done with the outmost proficiency. The growth of the Medical Device Testing Services in healthcare market is attributed to the innovative product development, collaborations, mergers and acquisitions, stringent regulatory scenario for medical device approval are boosting the growth of the market over the years. Also, the developments in the medical device industry is likely to have a positive impact on the demand for the market during the forecast period. However, the growth of the market is restrained by factors such as interruptions in contractual obligations.

The Medical Device Testing Services in healthcare market is expected to witness substantial growth post-pandemic SGS SA, Eurofins, Toxikon, Pace Analytical Services, LLC, Intertek Group plc, NORTH AMERICAN SCIENCE ASSOCIATES INC., Charles River, WuXi AppTec, Element Materials Technology, TÜV SÜD AG mRNA is expected to emerge and shift the pharmaceutical industry and market is also expected to witness more vertical integration and joint ventures in coming years.

Lucrative Regions for Medical Device Testing Services in Healthcare Market

Lucrative Regions for Medical Device Testing Services in Healthcare Market
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Market Insights

Growing Applications of Medical Device Testing Services in Healthcare to Drive Medical Device Testing Services in Healthcare Market Growth

Medical device testing needs strong experience of the domain, native and national legislations, and information about the devices, infrastructure, and ability to support the testing. The healthcare and medical device industry is an active one due to continuous development and advanced solutions. The enhancements in medical device technology have significantly enhanced the efficiency of patient care in the last few decades. 

However, manufactures of various medical devices sometimes face challenges in making products ready for the market. The regulations are occasionally complex and challenging to understand, majorly when relating to applications of innovative and novel medical devices. 

A recall is a process of eliminating or modifying products that are not as per the laws administered by the Food and Drug Administration (FDA). Mostly the medical device recalls are conducted voluntarily by the company under 21 CFR 7. The product recalls are classified into various designation, such as I, II, or III by the FDA for indicating the comparative degree of health hazard offered by the product being recalled.

As per the FDA in 2018, stated that there are above 80,000 incidents identified since 2008, due to the medical device injury. Since, last few years, medical device companies and doctors have observed that spinal-cord stimulators have helped the patients who suffer from pain disorders. Due to this, it has become one of the most rising products in the $400 billion medical device industry. Therefore, the increasing incidences of product recall and higher demand for quality products are growing the need for testing of medical devices. Hence, it will boost the market for medical device testing services.

The medical device technology is improving life by identifying diseases at an early stage and enhancing treatment, diagnosis, and patient monitoring. The small and medium-sized enterprises (SMEs) training programs have been implemented in the countries such as China, Chile, Indonesia, Mexico, Malaysia, Singapore, Philippines, Peru, Russia and Viet Nam and others. In 2018, the medical device market in the U.K. was valued approximately US$10.6 billion. Among which, around 2,500 are small to medium-sized medical device companies in the U.K. Moreover, a large number of multinational companies have established their head offices or subsidiaries in the country. Furthermore, every year, the acute trusts spend around an average of US$ 6.6 billion on clinical supplies, which include medical equipment. 

Furthermore, in 2018, the International Trade Administration (ITA) mentioned that there are above 1,300 medical device firms in France, of which one-third of the entire medical device companies are overseas companies. However, these foreign medical device companies bring around two-third of the total business. 

Additionally, among the 1,300 medical device companies in France, approximately 92% are small and medium-sized enterprises (SMEs), out of which 88% produce entirely medical devices. SME’s outsource the medical device testing as it requires high cost, time, and skilled labor.

Additionally, in Madrid and Catalonia accounts for more than 80 percent of medical device sales. Among that, 90% of the medical device market is small and medium-sized companies that generate around 40% revenue from the total medical device revenue. Since these companies are start-ups, they choose to outsource the medical device testing for reducing the cost and saving time. Thus, the growing need in the industry is likely expected to drive the growth of the global medical device testing services market over the coming years. Bringing advanced medical device technology for the consumers is a high

  • Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
risk project. Therefore, the companies offer correct tests by providing accurate and reliable results for the medical device testing requirement, from small, start-up ventures till large, established manufacturers. 

Many laboratories across North America, Europe, and the Asia Pacific offer regulatory compliance knowledge and qualified GMP/GLP/ISO 17025 testing for ensuring fast improvement times using the highest level of service, and most advanced technologies for the microbiological, analytical chemical, biocompatibility, and package testing requirements.

In other countries, various regulatory bodies are present to regulate medical devices. The medical devices in Spain are controlled and permitted by the Spanish Agency of Medicines and Health Products (AEMPS). The Food and Drugs Act (FDA) set out a regulatory framework for numerous medical devices. The Medical Devices Bureau is another body responsible for medical devices guidelines that allow sale and import of medical devices.

All medical devices have an exclusive and systematic set of testing necessities imposed by the FDA, China Food and Drug Administration (CFDA), EU Notified Bodies, and other regulatory bodies, which should be followed before entering the market.

In Canada, Health Canada implemented mandatory reporting of medical device incident reports by importers and manufacturers and also inspires reporting from healthcare practitioners, hospitals, and consumers/ patients. In Mexico, COFEPRIS is responsible for approval and registration of the medical device. The manufacturer should fulfill all the testing requirements and comply with seeking COFEPRIS approval.

Medicines and Healthcare products Regulatory Agency (MHRA) is the selected authority that administers the law on medical devices in the UK. It inspects the medical devices products with potential problems and ensures their safety and quality. In Japan, its Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) that works together to conduct scientific tests of marketing application medical devices to monitor their post-marketing safety. 

Thus, the growing strict regulations for innovative and precise devices are expected to drive the growth of the medical device testing services market during the forecast period.

Service-Based Insights

In terms of service, the Medical Device Testing Services in healthcare market is segmented into biocompatibility test, chemistry test, microbiology & sterility testing, and package validation. In 2018, the microbiology & sterility testing held the most significant market share 53.55% of the medical device testing services market, by service.

Medical Device Testing Services in Healthcare Market, by Service – 2018 and 2027

Medical Device Testing Services in Healthcare Market, by Service – 2018 and 2027
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Phase-Based Insights

Based on phase, the Medical Device Testing Services in healthcare market is segmented into preclinical, and clinical. In 2018, the preclinical segment held a considerable market share of 68.17% of the medical device testing services market, by phase.

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Medical Device Testing Services Market: Strategic Insights

Market Size Value inUS$ 5505.4 Million in 2018
Market Size Value byUS$ 14,660.1 Million by 2027
Growth rateCAGR of 11.7% from 2019-2027
Forecast Period2019-2027
Base Year2019
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The Medical Device Testing Services in healthcare market players are adopting the product launch and expansion strategies to cater to changing customer demands worldwide, which also allows them to maintain their brand name globally.


Medical Device Testing Services in Healthcare Market – by Service

  • Biocompatibility Test
  • Chemistry Test
  • Microbiology & Sterility Testing
  • Package Validation

Medical Device Testing Services in Healthcare Market – by Phase

  • Preclinical
  • Clinical

Medical Device Testing Services in Healthcare Market – by Geography

  • North America

    • US
    • Canada
    • Mexico
  • Europe

    • France
    • Germany
    • Italy
    • UK
    • Spain
    • Rest of Europe
  • Asia Pacific (APAC)

    • China
    • India
    • South Korea
    • Japan
    • Australia
    • Rest of APAC
  • Middle East & Africa (MEA)

    • South Africa
    • Saudi Arabia
    • UAE
    • Rest of MEA
  • South America and Central America (SCAM)

    • Brazil
    • Argentina
    • Rest of SCAM

Company Profiles

  • SGS SA
  • Eurofins
  • Toxikon
  • Pace Analytical Services, LLC
  • Intertek Group plc
  • Charles River
  • WuXi AppTec
  • Element Materials Technology
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Service , Phase , and Geography

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States

The List of Companies

  1. SGS SA
  2. Eurofins
  3. Toxikon
  4. Pace Analytical Services, LLC
  5. Intertek Group plc
  7. Charles River
  8. WuXi AppTec
  9. Element Materials Technology
  10. TÜV SÜD AG

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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