USD 7.43 billion
Medical Device Testing Services Market Size, Share, Growth Analysis, By Services(Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Testing, Bioburden Determination), By Phase(Preclinical, and Clinical), By Region - Industry Forecast 2024-2031
Report ID:
SQMIG35A2432 |
Region:
Global |
Published Date: February, 2024
Pages:
157
|Tables:
67
|Figures:
65
Medical Device Testing Services Market Insights
Medical Device Testing Services Market size was valued at USD 7.43 billion in 2021 and is poised to grow from USD 8.1 billion in 2022 to USD 16.14 billion by 2030, growing at a CAGR of 9.0% in the forecast period (2023-2030).
The Medical Device Testing Services market plays a pivotal role in ensuring the safety, efficacy, and compliance of medical devices before they reach the market. With the increasing complexity of medical devices and stringent regulatory requirements, the demand for comprehensive testing services has surged. These services encompass a wide range of activities, including performance testing, biocompatibility assessments, sterilization validation, usability testing, and regulatory compliance evaluations. Medical device testing services are essential to identify potential risks, validate product claims, and verify adherence to industry standards and regulations such as ISO 13485, FDA guidelines, and EU MDR. The market is driven by several factors, including the rapid advancement of medical technology, the growing emphasis on patient safety, and the need for manufacturers to navigate complex regulatory landscapes. Additionally, the increasing awareness of the importance of testing services among manufacturers and regulatory authorities contributes to market expansion. Key players in the medical device testing services market offer specialized expertise and state-of-the-art facilities to address diverse testing needs. These services cater to a wide spectrum of medical devices, including implantable devices, diagnostic equipment, surgical instruments, and electronic medical devices.
US Medical Device Testing Services Market is poised to grow at a sustainable CAGR for the next forecast year.
Market Snapshot - 2024-2031
Global Market Size
Largest Segment
Clinical
Fastest Growth
Clinical
Growth Rate
9.0% CAGR
Global Medical Device Testing Services Market ($ Bn)
Country Share for North America Region (%)
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Medical Device Testing Services Market Segmental Analysis
The global medical device testing services market is segmented on the basis of services, phase, and region. By services, the market is segmented into biocompatibility tests, microbiology & sterility testing, chemistry test, bioburden determination, pyrogen & endotoxin testing, sterility test and validation, antimicrobial activity testing, and others. By Phase, the market is segmented into Preclinical, and Clinical. By region, the market is segmented into North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.
Medical Device Testing Services Market Analysis By Services
In the Medical Device Testing Services market, the dominant segment is Microbiology & Sterility Testing. This service is critical for ensuring the safety and efficacy of medical devices by assessing their microbial contamination levels and sterility. It is a regulatory requirement for medical devices to undergo rigorous microbiology and sterility testing to prevent infections and ensure patient safety.
On the other hand, the fastest growing segment is Chemistry Testing. With the increasing complexity of medical devices and their components, chemistry testing plays a vital role in evaluating the chemical composition, stability, and compatibility of materials used in these devices. As medical devices become more advanced and diverse, the demand for comprehensive chemistry testing services is on the rise to meet regulatory standards and ensure device performance.
Medical Device Testing Services Market Analysis By Phase
In the medical device testing services market, the Clinical Phase segment holds a dominant position. Clinical Phase 1 involves initial human trials to evaluate the safety and tolerability of medical devices. It is a critical step in the regulatory approval process, driving demand for specialized testing services to ensure patient safety and compliance.
On the other hand, the fastest-growing segment is the Preclinical phase, which encompasses rigorous testing on animals and in vitro models before human trials. With increasing emphasis on thorough preclinical testing to expedite regulatory approvals and minimize risks, the demand for comprehensive testing services in this phase is rapidly expanding. This growth is fueled by advancements in technology, increased outsourcing of testing services, and stringent regulatory requirements to ensure the safety and efficacy of medical devices before progressing to clinical trials.
Global Medical Device Testing Services Market By Phase
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Medical Device Testing Services Market Regional Insights
The global medical device testing services market is analyzed based on its regional presence, which includes North America, Europe, Asia Pacific, Middle East and Africa, and Latin America. In the medical device testing services market, North America stands as the dominant region. With a mature healthcare infrastructure, stringent regulatory standards, and a strong emphasis on patient safety, North America has a substantial share in the market. The region's well-established medical device industry and regulatory bodies drive the demand for comprehensive testing services.
In terms of the fastest growing segment, Asia-Pacific is witnessing remarkable growth. The increasing healthcare investments, expanding medical device manufacturing sector, and growing awareness about quality and safety standards contribute to the rapid growth of medical device testing services in this region. As countries in Asia-Pacific work to enhance their regulatory frameworks, the demand for testing services is expected to surge, making it the fastest growing segment.
Global Medical Device Testing Services Market By Geography
- Largest
- Fastest
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Medical Device Testing Services Market Dynamics
Medical Device Testing Services Market Drivers
Regulatory Compliance and Quality Assurance:
- The increasing stringency of regulatory standards and requirements for medical devices has driven the demand for comprehensive testing services. Manufacturers are seeking to ensure their products meet safety and efficacy criteria to gain regulatory approvals and market acceptance.
Rapid Technological Advancements:
- The continuous innovation in medical device technologies, such as wearable devices, telemedicine tools, and minimally invasive surgical equipment, necessitates rigorous testing to validate their performance, accuracy, and safety. This drives the demand for specialized testing services to keep pace with evolving industry trends.
Medical Device Testing Services Market Restraints
High Testing Costs:
- The intricate nature of medical device testing, often involving complex protocols and specialized equipment, can lead to significant expenses. Smaller manufacturers, startups, and those with limited resources may face challenges in affording comprehensive testing services, potentially slowing down product development and market entry.
Lengthy Regulatory Approval Process:
- Medical devices undergo thorough testing and evaluation as part of the regulatory approval process, which can be time-consuming. Delays in obtaining necessary approvals can prolong time-to-market, hindering manufacturers' ability to capitalize on emerging opportunities and impacting overall market growth.
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Medical Device Testing Services Market Competitive Landscape
The global medical device testing services market is characterized by intense competition among key players offering comprehensive testing solutions to ensure regulatory compliance, safety, and quality of medical devices. Prominent companies such as SGS SA, Eurofins Scientific, Intertek Group plc, and TÜV SÜD AG dominate the market with their extensive expertise in various testing domains including biocompatibility, sterility, electrical safety, and performance testing. These players focus on expanding their service portfolios, global presence, and strategic collaborations to cater to the evolving regulatory landscape and increasing demand for reliable testing services. The market also witnesses the emergence of specialized niche players catering to specific device segments. As innovation continues, competition in the medical device testing services market is anticipated to remain fierce, driving advancements and quality assurance across the industry.
Medical Device Testing Services Market Top Player’s Company Profile
- SGS SA - Switzerland
- Toxikon, Inc - United States
- American Preclinical Services - United States
- Sterigenics International LLC - United States
- River Laboratories International Inc - United States
- Medical Device Testing Services - United States
- North America Science Associates Inc - United States
- Eurofins Scientific - Luxembourg
- Pace Analytical Services LLC - United States
- Intertek Group Plc - United Kingdom
Medical Device Testing Services Market Recent Developments
- In May 2022, Labcorp introduced a novel at-home collection kit through Labcorp OnDemand. This innovative solution gauges hemoglobin A1c (HbA1c) levels from a provided blood sample, aiming to identify potential diabetes or prediabetes risks in individuals.
- In May 2022, Sterigenics announced the initiation of processing operations at its expanded electron beam facility situated in Indiana. The facility's electron beam accelerator is employed for sterilizing medical and pharmaceutical products. By utilizing electron beam irradiation, the facility effectively eliminates microorganisms and potential contaminants from these products, ensuring their safety for utilization in medical environments.
- In January 2023, Eurofins Scientific declared the acquisition of resources for establishing a cutting-edge laboratory campus in Hyderabad (Genome Valley). The campus's primary objective is to support prominent global pharmaceutical clients, as well as emerging biotech enterprises, across a range of domains including analytical R&D, bioanalytical services, in-vivo pharmacology, synthetic organic chemistry, formulation R&D, and safety toxicology.
- In February 2023, The company Eurofins Viracor LLC, which is a division of Eurofins Scientific, announced the availability of a novel test that will assess the efficacy and durability of Chimeric Antigen Receptor T-Cell (CAR-T) therapy in people with B cell lymphomas and pre-B cell acute lymphoblastic leukaemia. CAR-T therapy, a cutting-edge type of immunotherapy that employs genetically modified T cells to target cancer cells, has shown encouraging results for a number of cancer types.
- In June 2023, NAMSA established a collaborative partnership with Terumo Aortic to aid in the market introduction of Terumo Aortic's advanced aortic disease solutions. Under this strategic arrangement, NAMSA aimed to provide Terumo Aortic with access to clinical specialists and its proficient teams specializing in cardiovascular matters.
Medical Device Testing Services Key Market Trends
Rising Emphasis on Regulatory Compliance and Quality Assurance:
- With increasing scrutiny from regulatory bodies, such as the FDA and European Medicines Agency, medical device manufacturers are placing a higher importance on ensuring their products meet stringent quality and safety standards. This has led to a growing demand for comprehensive testing services to validate the performance, safety, and effectiveness of medical devices. Companies offering testing services are expanding their capabilities to cover a wide range of regulatory requirements, including pre-market and post-market testing, to help manufacturers navigate complex regulatory landscapes.
Advancements in Testing Technologies:
- The medical device testing services market is witnessing a rapid evolution of testing methodologies and technologies. This includes the adoption of cutting-edge techniques such as artificial intelligence (AI), machine learning, and simulation models to enhance the accuracy, speed, and efficiency of testing processes. Additionally, the use of virtual and augmented reality in testing environments is becoming more prevalent, allowing for realistic simulations of device interactions within the human body. These technological advancements are enabling more precise and comprehensive testing, reducing development time and costs for medical device manufacturers.
Medical Device Testing Services Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Component types team that Collects, Collates, Correlates, and Analyzes the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
According to our global Medical Device Testing Services market analysis, the market is witnessing substantial growth as regulatory requirements become stringent and the complexity of medical devices increases. These services encompass safety, performance, and quality assessments to ensure compliance and mitigate risks. The market is driven by rising demand for reliable and accurate testing, driven by the growing number of medical devices and innovations. Outsourcing testing services by medical device manufacturers to specialized firms is a common practice, propelling market expansion. North America dominates the market due to established healthcare infrastructure and stringent regulations. However, Asia-Pacific displays considerable growth potential due to a burgeoning medical device industry and increasing regulatory harmonization efforts. The market's trajectory remains upward as safety and quality remain paramount in the medical field.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 7.43 billion |
| Market size value in 2031 | USD 16.14 billion |
| Growth Rate | 9.0% |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Medical Device Testing Services Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Medical Device Testing Services Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Medical Device Testing Services Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Medical Device Testing Services Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Medical Device Testing Services Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Medical Device Testing Services Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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