Product Code: GVR-1-68038-366-9
Medical Device Analytical Testing Outsourcing Market Growth & Trends
The global medical device analytical testing outsourcing market size is expected to reach USD 10.57 billion by 2030, according to a new report by Grand View Research, Inc. The market is expected to grow at a CAGR of 8.2% from 2023 to 2030. Several medical device companies outsource analytical testing operations to decrease business risks, accelerate product market entrance, and lower expenses. As a result of this considerable rise in spending levels, medical device original equipment manufacturers (OEMs) quickly shift to outsourcing as a cost-cutting technique. The testing requirements of medical device manufacturers (MDMs) reflected variations in the medical/healthcare market as it recovered from the COVID-19 slowdown.
In 2021, the need for European Medical Device Regulation (MDR) remediation standards, as well as the ever-increasing regulatory demands in the leachables & extractables (E&L) arena, accounted for a significant portion of the testing effort. However, due to delays and a lack of external resources and labor, labs' ability to expand capacity has been limited. Regulatory authorities are focusing on testing technique validation, especially data quality, including repeatability and reproducibility. There is also a trend of more deterministic testing methods. This enables companies to acquire more statistically reliable data to determine if their products meet the criteria. For example, the medical device sector and testing labs confront considerable hurdles in adopting ISO 10993-18:2020 E&L testing regulations while still meeting FDA expectations.
The FDA had requested the use of conservative techniques to reduce areas of ambiguity or potential inaccuracy in E&L testing throughout 2021.Furthermore, intensifying competition in the medical device industry is expected to create growth opportunities for the market. In such an intensely competitive environment, companies must reduce the time to market. Considering that the approval processes for medical devices are not simple, companies need a better understanding of updated regulatory norms and protocols. Not all companies have such expertise; hence, outsourcing these functions to a specialized firm is a better option for medical device companies. Recent studies have shown significant opportunities for both suppliers and buyers in the medical device industry.
For smaller companies, outsourcing manufacturing, and development functions is an effective alternative to cut costs. For larger companies, outsourcing activities enable them to focus on core business activities and drive future growth. Based on end-uses, the hospital segment accounted for the largest revenue share in 2022 due to high patient volume and increased hospital management budget allocation for these surgeries. The reprocessed devices segment is projected to witness the fastest CAGR during the forecast period due to the low prices of these devices. They cost about 30 to 40% less than new devices; thus, the demand for such products is significant in price-sensitive low- and medium-income countries.
Medical Device Analytical Testing Outsourcing Market Report Highlights
- The material characterization services segment accounted for the largest share of the global revenue in 2022. Material characterization is crucial for maintaining quality, mitigating risks, ensuring regulatory compliance, and optimizing cost and time efficiency
- The cardiology therapeutic area segment held the largest revenue share in 2022 due to the high demand for cardiovascular devices as a result of the increased prevalence of related conditions
- Asia Pacific led the global market in 2022 and is projected to witness the fastest CAGR during the forecast period. This is owing to the region's large population base, low per capita income, and demand for accessible treatment solutions
- North America is also anticipated to witness considerable growth during the forecast period. This can be attributed to the presence of various multinational players, such as Charles River Laboratories, WuXi AppTec, and SGS SA
- Moreover, the increased need for scrutiny pertaining to the quality of devices and reorganizing of classes is a key factor expected to impose additional testing requirements on manufacturers. These requirements can be met by partnering with laboratories that perform tests at an affordable price rather than installing in-house analytical tools
Table of Contents
Chapter 1.Methodology and Scope
- 1.1.Market Segmentation and Scope
- 1.2. Research Methodology
- 1.2.1. Information Procurement
- 1.3. Information or Data Analysis
- 1.4. Methodology
- 1.5. Research Scope and Assumptions
- 1.6. Market Formulation & Validation
- 1.6.1.1. Country Market: CAGR Calculation
- 1.7. Country Based Segment Share Calculation
- 1.8. List of Data Sources
Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Outlook
- 2.3. Regional Insights
- 2.4. Competitive Insights
- 2.5. Medical Device Analytical Testing Outsourcing Market Snapshot
- 2.6. Medical Device Analytical Testing Outsourcing Market Segment Snapshot
- 2.7. Medical Device Analytical Testing Outsourcing Market Competitive Landscape Snapshot
Chapter 3. Medical Device Analytical Testing Outsourcing Market Variables, Trends, & Scope
- 3.1. Market Lineage Outlook
- 3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
- 3.2.1.1. Intensifying Competition
- 3.2.1.2. Increasing Number Of Small-Size Medical Device Manufacturers Lacking In-House Testing Infrastructure
- 3.2.1.3. Strict Approval Norms
- 3.2.2. Market Restraint Analysis
- 3.2.2.1. Regulatory And Legal Compliance
- 3.2.3. Industry Challenges
- 3.2.3.1. Managing Relationships
- 3.2.3.2. Pricing Analysis
- 3.3. Medical Device Analytical Testing Outsourcing Market Analysis Tools
- 3.3.1. Industry Analysis - Porter's
- 3.3.1.1. Bargaining power of the suppliers
- 3.3.1.2. Bargaining power of the buyers
- 3.3.1.3. Threats of substitution
- 3.3.1.4. Threats from new entrants
- 3.3.1.5. Competitive rivalry
- 3.3.2. PESTEL Analysis
- 3.3.2.1. Political landscape
- 3.3.2.2. Economic and Social landscape
- 3.3.2.3. Technological landscape
Chapter 4. Medical Device Analytical Testing Outsourcing Market: Service Estimates & Trend Analysis
- 4.1. Segment Dashboard
- 4.2. Medical Device Analytical Testing Outsourcing Market: Service Movement Analysis, USD Billion, 2022 & 2030
- 4.3. Extractable And Leachable
- 4.3.1. Extractable And Leachable Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 4.3.2. Material Characterization
- 4.3.2.1. Material Characterization Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 4.3.3. Physical Testing
- 4.3.3.1. Physical Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 4.3.4. Bioburden Testing
- 4.3.4.1. Bioburden Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 4.3.5. Sterility Testing
- 4.3.5.1. Sterility Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 4.4. Others
- 4.4.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
Chapter 5. Medical Device Analytical Testing Outsourcing Market: Therapeutic Areas Estimates & Trend Analysis
- 5.1. Segment Dashboard
- 5.2. Medical Device Analytical Testing Outsourcing Market: Therapeutic Areas Movement Analysis, USD Billion, 2022 & 2030
- 5.3. Cardiology
- 5.3.1. Cardiology Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 5.4. Diagnostic Imaging
- 5.4.1. Diagnostic Imaging Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 5.5. Orthopedic
- 5.5.1. Orthopedic Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 5.6. IVD
- 5.6.1. IVD Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 5.7. Ophthalmic
- 5.7.1. Ophthalmic Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 5.8. General & Plastic Surgery
- 5.8.1. General & Plastic Surgery Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 5.9. Drug Delivery
- 5.9.1. Drug Delivery Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 5.10. Endoscopy
- 5.10.1. Endoscopy Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 5.11. Dental
- 5.11.1. Dental Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 5.12. Diabetes Care
- 5.12.1. Diabetes Care Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 5.13. Others
- 5.13.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
Chapter 6. Medical Device Analytical Testing Outsourcing Market: Device Type Estimates & Trend Analysis
- 6.1. Segment Dashboard
- 6.2. Medical Device Analytical Testing Outsourcing Market: Device Type Movement Analysis, USD Billion, 2022 & 2030
- 6.3. Reprocessed Devices
- 6.3.1. Reprocessed Devices Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 6.3.2. Others
- 6.3.2.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
Chapter 7. Medical Device Analytical Testing Outsourcing Market: End-Use Estimates & Trend Analysis
- 7.1. Segment Dashboard
- 7.2. Medical Device Analytical Testing Outsourcing Market: End-Use Movement Analysis, USD Billion, 2022 & 2030
- 7.3. Hospitals
- 7.3.1. Hospitals Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 7.3.2. Others
- 7.3.2.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
Chapter 8. Medical Device Analytical Testing Outsourcing Market: Regional Estimates & Trend Analysis
- 8.1. Medical Device Analytical Testing Outsourcing Market: Regional Movement Analysis, 2022 & 2030
- 8.2. North America
- 8.2.1. North America Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.2.2. U.S.
- 8.2.2.1. Key Country Dynamics
- 8.2.2.2. Competitive Scenario
- 8.2.2.3. Medical Device Clinical Trials Scenario
- 8.2.2.4. Regulatory Framework
- 8.2.2.5. U.S. Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.2.3. Canada
- 8.2.3.1. Key Country Dynamics
- 8.2.3.2. Competitive Scenario
- 8.2.3.3. Medical Device Clinical Trials Scenario
- 8.2.3.4. Regulatory Framework
- 8.2.3.5. Canada Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.3. Europe
- 8.3.1. Europe Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.3.2. UK
- 8.3.2.1. Key Country Dynamics
- 8.3.2.2. Competitive Scenario
- 8.3.2.3. Medical Device Clinical Trials Scenario
- 8.3.2.4. Regulatory Framework
- 8.3.2.5. UK Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.3.3. Germany
- 8.3.3.1. Key Country Dynamics
- 8.3.3.2. Competitive Scenario
- 8.3.3.3. Medical Device Clinical Trials Scenario
- 8.3.3.4. Regulatory Framework
- 8.3.3.5. Germany Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.3.4. France
- 8.3.4.1. Key Country Dynamics
- 8.3.4.2. Competitive Scenario
- 8.3.4.3. Medical Device Clinical Trials Scenario
- 8.3.4.4. Regulatory Framework
- 8.3.4.5. France Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.3.5. Italy
- 8.3.5.1. Key Country Dynamics
- 8.3.5.2. Competitive Scenario
- 8.3.5.3. Medical Device Clinical Trials Scenario
- 8.3.5.4. Regulatory Framework
- 8.3.5.5. Italy Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.3.6. Spain
- 8.3.6.1. Key Country Dynamics
- 8.3.6.2. Competitive Scenario
- 8.3.6.3. Medical Device Clinical Trials Scenario
- 8.3.6.4. Regulatory Framework
- 8.3.6.5. Spain Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.3.7. Denmark
- 8.3.7.1. Key Country Dynamics
- 8.3.7.2. Competitive Scenario
- 8.3.7.3. Medical Device Clinical Trials Scenario
- 8.3.7.4. Regulatory Framework
- 8.3.7.5. Denmark Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.3.8. Sweden
- 8.3.8.1. Key Country Dynamics
- 8.3.8.2. Competitive Scenario
- 8.3.8.3. Medical Device Clinical Trials Scenario
- 8.3.8.4. Regulatory Framework
- 8.3.8.5. Sweden Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.3.9. Norway
- 8.3.9.1. Key Country Dynamics
- 8.3.9.2. Competitive Scenario
- 8.3.9.3. Medical Device Clinical Trials Scenario
- 8.3.9.4. Regulatory Framework
- 8.3.9.5. Norway Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.4. Asia Pacific
- 8.4.1. Asia Pacific Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.4.2. Japan
- 8.4.2.1. Key Country Dynamics
- 8.4.2.2. Competitive Scenario
- 8.4.2.3. Medical Device Clinical Trials Scenario
- 8.4.2.4. Regulatory Framework
- 8.4.2.5. Japan Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.4.3. China
- 8.4.3.1. Key Country Dynamics
- 8.4.3.2. Competitive Scenario
- 8.4.3.3. Medical Device Clinical Trials Scenario
- 8.4.3.4. Regulatory Framework
- 8.4.3.5. China Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.4.4. India
- 8.4.4.1. Key Country Dynamics
- 8.4.4.2. Competitive Scenario
- 8.4.4.3. Medical Device Clinical Trials Scenario
- 8.4.4.4. Regulatory Framework
- 8.4.4.5. India Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.4.5. Australia
- 8.4.5.1. Key Country Dynamics
- 8.4.5.2. Competitive Scenario
- 8.4.5.3. Medical Device Clinical Trials Scenario
- 8.4.5.4. Regulatory Framework
- 8.4.5.5. Australia Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.4.6. Thailand
- 8.4.6.1. Key Country Dynamics
- 8.4.6.2. Competitive Scenario
- 8.4.6.3. Medical Device Clinical Trials Scenario
- 8.4.6.4. Regulatory Framework
- 8.4.6.5. Thailand Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.4.7. South Korea
- 8.4.7.1. Key Country Dynamics
- 8.4.7.2. Competitive Scenario
- 8.4.7.3. Medical Device Clinical Trials Scenario
- 8.4.7.4. Regulatory Framework
- 8.4.7.5. South Korea Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.5. Latin America
- 8.5.1. Latin America Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.5.2. Brazil
- 8.5.2.1. Key Country Dynamics
- 8.5.2.2. Competitive Scenario
- 8.5.2.3. Medical Device Clinical Trials Scenario
- 8.5.2.4. Regulatory Framework
- 8.5.2.5. Brazil Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.5.3. Mexico
- 8.5.3.1. Key Country Dynamics
- 8.5.3.2. Competitive Scenario
- 8.5.3.3. Medical Device Clinical Trials Scenario
- 8.5.3.4. Regulatory Framework
- 8.5.3.5. Mexico Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.5.4. Argentina
- 8.5.4.1. Key Country Dynamics
- 8.5.4.2. Competitive Scenario
- 8.5.4.3. Medical Device Clinical Trials Scenario
- 8.5.4.4. Regulatory Framework
- 8.5.4.5. Argentina Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.6. Middle East & Africa
- 8.6.1. Middle East & Africa Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.6.2. South Africa
- 8.6.2.1. Key Country Dynamics
- 8.6.2.2. Competitive Scenario
- 8.6.2.3. Medical Device Clinical Trials Scenario
- 8.6.2.4. Regulatory Framework
- 8.6.2.5. South Africa Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.6.3. Saudi Arabia
- 8.6.3.1. Key Country Dynamics
- 8.6.3.2. Competitive Scenario
- 8.6.3.3. Medical Device Clinical Trials Scenario
- 8.6.3.4. Regulatory Framework
- 8.6.3.5. Saudi Arabia Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.6.4. UAE
- 8.6.4.1. Key Country Dynamics
- 8.6.4.2. Competitive Scenario
- 8.6.4.3. Medical Device Clinical Trials Scenario
- 8.6.4.4. Regulatory Framework
- 8.6.4.5. UAE Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 8.6.5. Kuwait
- 8.6.5.1. Key Country Dynamics
- 8.6.5.2. Competitive Scenario
- 8.6.5.3. Medical Device Clinical Trials Scenario
- 8.6.5.4. Regulatory Framework
- 8.6.5.5. Kuwait Medical Device Analytical Testing Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
Chapter 9. Competitive Landscape
- 9.1. Company Categorization
- 9.2. Company Market Share Analysis, 2022
- 9.3. List of Private Players
- 9.4. Strategy Mapping
- 9.5. Company Profiles/Listing
- 9.5.1. SGS Sa
- 9.5.1.1. Overview
- 9.5.1.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.5.1.3. Product Benchmarking
- 9.5.1.4. Strategic Initiatives
- 9.5.2. Toxikon, Inc
- 9.5.2.1. Overview
- 9.5.2.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.5.2.3. Product Benchmarking
- 9.5.2.4. Strategic Initiatives
- 9.5.3. Eurofins Scientific
- 9.5.3.1. Overview
- 9.5.3.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.5.3.3. Product Benchmarking
- 9.5.3.4. Strategic Initiatives
- 9.5.4. Pace Analytical Services Llc.
- 9.5.4.1. Overview
- 9.5.4.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.5.4.3. Product Benchmarking
- 9.5.4.4. Strategic Initiatives
- 9.5.5. Intertek Group Plc
- 9.5.5.1. Overview
- 9.5.5.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.5.5.3. Product Benchmarking
- 9.5.5.4. Strategic Initiatives
- 9.5.6. Wuxi Apptec
- 9.5.6.1. Overview
- 9.5.6.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.5.6.3. Product Benchmarking
- 9.5.6.4. Strategic Initiatives
- 9.5.7. North American Science Associates, Inc.
- 9.5.7.1. Overview
- 9.5.7.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.5.7.3. Product Benchmarking
- 9.5.7.4. Strategic Initiatives
- 9.5.8. Envigo
- 9.5.8.1. Overview
- 9.5.8.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.5.8.3. Product Benchmarking
- 9.5.8.4. Strategic Initiatives
- 9.5.9. Charles River Laboratories International, Inc
- 9.5.9.1. Overview
- 9.5.9.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.5.9.3. Product Benchmarking
- 9.5.9.4. Strategic Initiatives
- 9.5.10. Medical Device Testing Services
- 9.5.10.1. Overview
- 9.5.10.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.5.10.3. Product Benchmarking
- 9.5.10.4. Strategic Initiatives