Medical Device Testing Services Market Share, Size, Trends, Industry Analysis Report, By Service (Microbiology and Sterility Testing, Chemistry Test, Biocompatibility Test, Package Validation); By Phase; By Region; Segment Forecast, 2023 - 2032
The global medical device testing services market size is expected to reach USD 19.65 billion by 2032, according to a new study by Polaris Market Research. The report “Medical Device Testing Services Market Share, Size, Trends, Industry Analysis Report, By Service (Microbiology and Sterility Testing, Chemistry Test, Biocompatibility Test, Package Validation); By Phase; By Region; Segment Forecast, 2024 - 2032” gives a detailed insight into current market dynamics and provides analysis on future market growth.
Medical device testing is an essential process that guarantees the reliability and safety of a device when in use. In the course of new product development, comprehensive design validation testing is carried out, which includes toxicity tests, performance testing, chemical analysis, and sometimes even human factors or clinical testing.
The increasing popularity of wearable and portable medical devices is anticipated to be a key driving force behind this expansion. Furthermore, government programs dedicated to enhancing healthcare infrastructure and boosting healthcare resources are bolstering the demand for testing services within this industry.
Rigorous regulatory guidelines, represented by the FDA and EMA directive, in-depth medical device assessments to guarantee their safety and effectiveness. The imperative for ongoing advancements necessitates thorough testing protocols to mitigate emerging risks and amplify patient well-being. An increasing need for medical devices, propelled by the aging demographic and soaring healthcare expenses, has precipitated substantial expansion within the testing sector. Consequently, numerous medical device enterprises are now subcontracting their testing requirements to specialized organizations.
COVID-19 has impacted medical device testing. The healthcare system prioritized testing and validating COVID-19 medical devices, causing a rise in demand for rapid diagnostic tests, ventilators, PPE, and other essential devices. Telehealth and remote monitoring devices were also developed, requiring new testing protocols. However, traditional supply chains were disrupted, causing delays in testing non-COVID-19 devices. The pandemic is expected to lead to a more streamlined and technologically advanced approach to testing, with a focus on remote and virtual methods, as well as shaping the regulatory landscape for future health crises.
Additionally, a study published in the National Library of Medicine in June 2021 highlighted the significant impact of coronary artery disease (CAD) on global health. CAD alone is responsible for approximately 610,000 deaths annually, accounting for an estimated one in four deaths and making it the foremost cause of mortality in the United States. With the incidence of CAD rising, there is a growing demand for effective coronary stent devices to address this pressing medical need. Consequently, this factor is projected to drive the demand for coronary stents throughout the forecast period.
Medical Devices Testing Services Market Report Highlights
The microbiology and sterility test segment held the largest revenue share in the medical devices testing services market. Microbiology and sterility testing are essential in reducing contamination risks and preventing infections. These tests are necessary to avoid regulatory delays. The field includes Pyrogen and Endotoxin testing, sterility test validation, bioburden determination, and antimicrobial activity testing.
The clinical segment accounted for the highest market share during the forecast period. The clinical phase is crucial for medical device development. It involves testing the device on humans to evaluate its safety and effectiveness. Clinical trials gather data to support regulatory approval and commercialization. Precise data collection, management, and analysis are essential, and testing services play a pivotal role in maintaining data quality.
Asia Pacific dominated the largest market in the medical devices testing services market The area will see growth due to global interest in Chinese and Indian markets, driven by China's strict product approval standards and better healthcare infrastructure. There is also an increase in medical device testing services availability due to China's significant global exportation.
The North America region accounted for the fastest growth in the medical devices testing services market. The region's demand for TIC services is increasing, which will significantly boost regional market expansion. The sub-continent is well-positioned to penetrate the market due to increasing product design complexity and cost reduction pressure. The thriving pharmaceutical sector and substantial medical device manufacturing companies' presence will drive significant growth in the medical device testing industry across the region.
The global key market players include American Preclinical Services, Charles River Laboratories, Element Minnetonka, Eurofins Scientific, Intertek Group Plc., Labcorp (Toxikon, Inc), North America Science Associates Inc., Pace Analytical Services LLC, SGS S.A., and Sterigenics International LLC.
Polaris Market Research has segmented the medical devices testing services market report based on service, phase and region:
Medical Devices Testing Services, Service Outlook (Revenue - USD Billion, 2019 - 2032)
Microbiology and Sterility Testing
Bioburden Determination
Pyrogen & Endotoxin Testing
Sterility Test & validation
Antimicrobial testing
Others
Chemistry Test
Biocompatibility Test
Package validation
Medical Devices Testing Services, Phase Outlook (Revenue - USD Billion, 2019 - 2032)
Clinical
Pre-Clinical
Medical Devices Testing Services, Regional Outlook (Revenue - USD Billion, 2019 - 2032)
North America
U.S.
Canada
Europe
Germany
UK
France
Italy
Spain
Russia
Netherlands
Asia Pacific
China
India
Japan
South Korea
Indonesia
Malaysia
Latin America
Argentina
Brazil
Mexico
Middle East & Africa
UAE
Saudi Arabia
Israel
South Africa
- 1. Introduction
- 1.1. Report Description
- 1.1.1. Objectives of the Study
- 1.1.2. Market Scope
- 1.1.3. Assumptions
- 1.2. Stakeholders
- 2. Executive Summary
- 2.1. Market Highlights
- 3. Research Methodology
- 3.1. Overview
- 3.1.1. Data Mining
- 3.2. Data Sources
- 3.2.1. Primary Sources
- 3.2.2. Secondary Sources
- 4. Global Medical Device Testing Services Market Insights
- 4.1. Medical Device Testing Services Market – Industry Snapshot
- 4.2. Medical Device Testing Services Market Dynamics
- 4.2.1. Drivers and Opportunities
- 4.2.1.1. Amplification in Innovation & Technologies will drive the market growth
- 4.2.1.2. Increasing demand for verification and validation of medical devices will bolster market growth
- 4.2.2. Restraints and Challenges
- 4.2.2.1. Stringent rules and regulations across divergent regions
- 4.3. Porter’s Five Forces Analysis
- 4.3.1. Bargaining Power of Suppliers (Moderate)
- 4.3.2. Threats of New Entrants: (Low)
- 4.3.3. Bargaining Power of Buyers (Moderate)
- 4.3.4. Threat of Substitute (Moderate)
- 4.3.5. Rivalry among existing firms (High)
- 4.4. PESTLE Analysis
- 4.5. Medical Device Testing Services Industry trends
- 4.6. Value Chain Analysis
- 4.7. COVID-19 Impact Analysis
- 5. Global Medical Device Testing Services Market, by Service
- 5.1. Key Findings
- 5.2. Introduction
- 5.2.1. Global Medical Device Testing Services, by Service, 2019-2032 (USD Billion)
- 5.3. Microbiology and Sterility Testing
- 5.3.1. Global Medical Device Testing Services Market, by Microbiology and Sterility Testing, by Region, 2019-2032 (USD Billion)
- 5.3.2. Bioburden Determination
- 5.3.2.1. Global Medical Device Testing Services Market, by Bioburden Determination, by Region, 2019-2032 (USD Billion)
- 5.3.3. Pyrogen & Endotoxin Testing
- 5.3.3.1. Global Medical Device Testing Services Market, by Pyrogen & Endotoxin Testing, by Region, 2019-2032 (USD Billion)
- 5.3.4. Sterility Test & validation
- 5.3.4.1. Global Medical Device Testing Services Market, by Sterility Test & validation, by Region, 2019-2032 (USD Billion)
- 5.3.5. Antimicrobial testing
- 5.3.5.1. Global Medical Device Testing Services Market, by Antimicrobial testing, by Region, 2019-2032 (USD Billion)
- 5.3.6. Others
- 5.3.6.1. Global Medical Device Testing Services Market, by Others, by Region, 2019-2032 (USD Billion)
- 5.4. Chemistry Test
- 5.4.1. Global Medical Device Testing Services Market, by Chemistry Test, by Region, 2019-2032 (USD Billion)
- 5.5. Biocompatibility Test
- 5.5.1. Global Medical Device Testing Services Market, by Biocompatibility Test, by Region, 2019-2032 (USD Billion)
- 5.6. Package validation
- 5.6.1. Global Medical Device Testing Services Market, by Package validation, by Region, 2019-2032 (USD Billion)
- 6. Global Medical Device Testing Services Market, by Phase
- 6.1. Key Findings
- 6.2. Introduction
- 6.2.1. Global Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 6.3. Clinical
- 6.3.1. Global Medical Device Testing Services Market, by Clinical, by Region, 2019-2032 (USD Billion)
- 6.4. Preclinical
- 6.4.1. Global Medical Device Testing Services Market, by Preclinical, by Region, 2019-2032 (USD Billion)
- 7. Global Medical Device Testing Services Market, by Geography
- 7.1. Key findings
- 7.2. Introduction
- 7.2.1. Medical Device Testing Services Market Assessment, By Geography, 2019-2032 (USD Billion)
- 7.3. Medical Device Testing Services Market – North America
- 7.3.1. North America: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.3.2. North America: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.3.3. Medical Device Testing Services Market – U.S.
- 7.3.3.1. U.S.: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.3.3.2. U.S.: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.3.4. Medical Device Testing Services Market – Canada
- 7.3.4.1. Canada: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.3.4.2. Canada: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.4. Medical Device Testing Services Market – Europe
- 7.4.1. Europe: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.4.2. Europe: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.4.3. Medical Device Testing Services Market – UK
- 7.4.3.1. UK: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.4.3.2. UK: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.4.4. Medical Device Testing Services Market – France
- 7.4.4.1. France: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.4.4.2. France: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.4.5. Medical Device Testing Services Market – Germany
- 7.4.5.1. Germany: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.4.5.2. Germany: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.4.6. Medical Device Testing Services Market – Italy
- 7.4.6.1. Italy: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.4.6.2. Italy: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.4.7. Medical Device Testing Services Market – Spain
- 7.4.7.1. Spain: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.4.7.2. Spain: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.4.8. Medical Device Testing Services Market – Netherlands
- 7.4.8.1. Netherlands: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.4.8.2. Netherlands: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.4.9. Medical Device Testing Services Market – Russia
- 7.4.9.1. Russia: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.4.9.2. Russia: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.5. Medical Device Testing Services Market – Asia Pacific
- 7.5.1. Asia Pacific: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.5.2. Asia Pacific: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.5.3. Medical Device Testing Services Market – China
- 7.5.3.1. China: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.5.3.2. China: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.5.4. Medical Device Testing Services Market – India
- 7.5.4.1. India: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.5.4.2. India: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.5.5. Medical Device Testing Services Market – Malaysia
- 7.5.5.1. Malaysia: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.5.5.2. Malaysia: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.5.6. Medical Device Testing Services Market – Japan
- 7.5.6.1. Japan: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.5.6.2. Japan: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.5.7. Medical Device Testing Services Market – Indonesia
- 7.5.7.1. Indonesia: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.5.7.2. Indonesia: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.5.8. Medical Device Testing Services Market – South Korea
- 7.5.8.1. South Korea: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.5.8.2. South Korea: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.6. Medical Device Testing Services Market – Middle East & Africa
- 7.6.1. Middle East & Africa: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.6.2. Middle East & Africa: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.6.3. Medical Device Testing Services Market – Saudi Arabia
- 7.6.3.1. Saudi Arabia: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.6.3.2. Saudi Arabia: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.6.4. Medical Device Testing Services Market – UAE
- 7.6.4.1. UAE: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.6.4.2. UAE: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.6.5. Medical Device Testing Services Market – Israel
- 7.6.5.1. Israel: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.6.5.2. Israel: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.6.6. Medical Device Testing Services Market – South Africa
- 7.6.6.1. South Africa: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.6.6.2. South Africa: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.7. Medical Device Testing Services Market – Latin America
- 7.7.1. Latin America: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.7.2. Latin America: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.7.3. Medical Device Testing Services Market – Mexico
- 7.7.3.1. Mexico: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.7.3.2. Mexico: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.7.4. Medical Device Testing Services Market – Brazil
- 7.7.4.1. Brazil: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.7.4.2. Brazil: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 7.7.5. Medical Device Testing Services Market – Argentina
- 7.7.5.1. Argentina: Medical Device Testing Services Market, by Phase, 2019-2032 (USD Billion)
- 7.7.5.2. Argentina: Medical Device Testing Services Market, by Service, 2019-2032 (USD Billion)
- 8. Competitive Landscape
- 8.1. Expansion and Acquisition Analysis
- 8.1.1. Expansion
- 8.1.2. Acquisitions
- 8.2. Partnerships/Collaborations/Agreements/Exhibitions
- 9. Company Profiles
- 9.1. American Preclinical Services
- 9.1.1. Company Overview
- 9.1.2. Financial Performance
- 9.1.3. Product Benchmarking
- 9.1.4. Recent Development
- 9.2. Charles River Laboratories
- 9.2.1. Company Overview
- 9.2.2. Financial Performance
- 9.2.3. Product Benchmarking
- 9.2.4. Recent Development
- 9.3. Element Minnetonka
- 9.3.1. Company Overview
- 9.3.2. Financial Performance
- 9.3.3. Product Benchmarking
- 9.3.4. Recent Development
- 9.4. Eurofins Scientific
- 9.4.1. Company Overview
- 9.4.2. Financial Performance
- 9.4.3. Product Benchmarking
- 9.4.4. Recent Development
- 9.5. Intertek Group Plc.
- 9.5.1. Company Overview
- 9.5.2. Financial Performance
- 9.5.3. Product Benchmarking
- 9.5.4. Recent Development
- 9.6. Labcorp (Toxikon, Inc)
- 9.6.1. Company Overview
- 9.6.2. Financial Performance
- 9.6.3. Product Benchmarking
- 9.6.4. Recent Development
- 9.7. North America Science Associates Inc.
- 9.7.1. Company Overview
- 9.7.2. Financial Performance
- 9.7.3. Product Benchmarking
- 9.7.4. Recent Development
- 9.8. Pace Analytical Services LLC
- 9.8.1. Company Overview
- 9.8.2. Financial Performance
- 9.8.3. Product Benchmarking
- 9.8.4. Recent Development
- 9.9. SGS S.A.
- 9.9.1. Company Overview
- 9.9.2. Financial Performance
- 9.9.3. Product Benchmarking
- 9.9.4. Recent Development
- 9.10. Sterigenics International LLC
- 9.10.1. Company Overview
- 9.10.2. Financial Performance
- 9.10.3. Product Benchmarking
- 9.10.4. Recent Development
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