Product Code: GVR-2-68038-115-3
Medical Device Testing Services Market Growth & Trends
The global medical device testing services market size is expected to reach USD 16.29 billion by 2030, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 9.0% from 2023 to 2030. Increasing complexity in product design and stringent government regulations are driving demand for medical device testing services.
Significant rise in preclinical spending is a recent trend among pharmaceutical and medical device companies, which is expected to significantly contribute to market growth. According to the global health center, for pharmaceuticals, supporting preclinical research required 73 months and cost USD 7 million for biologics, it took 47 months and cost USD 6.3 million.
With modern medical devices offering a host of complex functions, the need for appropriate tests to check the compliance of the device with regulatory requirements is becoming vital. In order to meet the requirement of enhanced accuracy, ease of use, and durability, medical devices need to undergo extensive tests. This is expected to deliver competitive advantage to manufacturers.
On the other hand, an increase in the need for production efficiency and safety and rising regulatory requirements for medical devices are some of the major factors driving the market growth. Regulatory bodies such as the European Medicines Agency, U.S. Food and Drug Administration, Therapeutic Goods Administration, and other country regulatory bodies require documentation and testing to certify that medical devices meet efficacy and safety standards prior they can be sold and marketed to patients and healthcare providers.
The COVID-19 pandemic has created an unprecedented demand for medical device testing services. This is largely due to the increasing demand for COVID-10 related products such as masks, PPE, & respiratory equipments. Besides, countries such as Mexico, Spain, and France have published pertinent specifications and standards, namely the UNE 0064-1, UNE 0064-2, AFNOR-SPEC-S76 & UNE 0065, which must be met until a mask can be sold.
Medical Device Testing Services Market Report Highlights
- The microbiology and sterility testing was the leading segment in 2022 with a market share of 34.2% and is likely to remain dominant over the forecast period. Producing safe and effective products is a core goal of medical device manufacturers, and sterility assurance is a major component for achieving it
- The biocompatibility test segment held a significant share in the 2022. This is attributed to strict requirements for biocompatibility testing set by global regulatory bodies to ensure that their devices are safe to use before being made available in the market
- The clinical phase segment dominated the market in 2022 and accounted for 68.8% of the market share as this stage is mostly focused on assessing safety & biocompatibility of medical devices
- On the other hand, the preclinical phase segment is also expected to show significant growth over the forecast period. The preclinical phase of medical device includes determination of efficacy, safety, and biocompatibility of prosthesis, biomaterials, and medical devices
- Raw materials, packaging, and design all have an impact on a device's safety and compatibility, and preclinical testing of all of these factors is an important step in determining a device's market potential
- Asia Pacific held the maximum share of the global market and accounted for 41.0% of the revenue share in 2022. This is due to rising demand for medical devices in developing nations such as India and china
- North America is anticipated to register a significant CAGR over the forecast period. This can be attributed to the fact that it is one of the top manufacturing hubs of highly reliable, complex, and high-end medical devices
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. Country Market: CARG 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 Testing Services Market Snapshot
- 2.6. Medical Device Testing Services Market Segment Snapshot
- 2.7. Medical Device Testing Services Market Competitive Landscape Snapshot
Chapter 3. Medical Device Testing Services Market Variables, Trends, & Scope
- 3.1. Market Lineage Outlook
- 3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
- 3.2.1.1. Complexity in Product design
- 3.2.1.2. Intensifying competition
- 3.2.1.3. Increase in number of small medical device lacking in-house testing capabilities
- 3.2.1.4. Strict approval norms
- 3.2.2. Market Restraint Analysis
- 3.2.2.1. Legal and Regulatory Issues
- 3.2.2.2. Delays in contractual obligations
- 3.3. Medical Device Testing Services 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 Testing Services Market: Service Estimates & Trend Analysis
- 4.1. Segment Dashboard
- 4.2. Medical Device Testing Services Market: Service Movement Analysis, USD Billion, 2022 & 2030
- 4.3. Microbiology & Sterility Testing
- 4.3.1. Microbiology & Sterility Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 4.3.2. Bioburden Determination
- 4.3.2.1. Bioburden Determination Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 4.3.3. Pyrogen & Endotoxin Testing
- 4.3.3.1. Pyrogen & Endotoxin Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 4.3.4. Sterility Test and Validation
- 4.3.4.1. Sterility Test and Validation Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 4.3.5. Antimicrobial Activity Testing
- 4.3.5.1. Antimicrobial Activity Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 4.3.6. Others
- 4.3.6.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 4.4. Biocompatibility Tests
- 4.4.1. Biocompatibility Tests Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 4.5. Chemistry Test
- 4.5.1. Chemistry Test Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 4.6. Package Validation
- 4.6.1. Package Validation Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
Chapter 5. Medical Device Testing Services Market: Phase Estimates & Trend Analysis
- 5.1. Segment Dashboard
- 5.2. Medical Device Testing Services Market: Phase Movement Analysis, USD Billion, 2022 & 2030
- 5.3. Preclinical
- 5.3.1. Preclinical Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
- 5.4. Clinical
- 5.4.1. Clinical Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Billion)
Chapter 6. Medical Device Testing Services Market: Regional Estimates & Trend Analysis
- 6.1. Medical Device Testing Services Market: Regional Movement Analysis, 2022 & 2030
- 6.2. North America
- 6.2.1. North America Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.2.2. Regulatory Framework
- 6.2.3. U.S.
- 6.2.3.1. Key Country Dynamics
- 6.2.3.2. Competitive Scenario
- 6.2.3.3. U.S. Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.2.4. Canada
- 6.2.4.1. Key Country Dynamics
- 6.2.4.2. Competitive Scenario
- 6.2.4.3. Canada Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.3. Europe
- 6.3.1. Europe Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.3.2. Regulatory Framework
- 6.3.3. UK
- 6.3.3.1. Key Country Dynamics
- 6.3.3.2. Competitive Scenario
- 6.3.3.3. UK Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.3.4. Germany
- 6.3.4.1. Key Country Dynamics
- 6.3.4.2. Competitive Scenario
- 6.3.4.3. Germany Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.3.5. France
- 6.3.5.1. Key Country Dynamics
- 6.3.5.2. Competitive Scenario
- 6.3.5.3. France Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.3.6. Italy
- 6.3.6.1. Key Country Dynamics
- 6.3.6.2. Competitive Scenario
- 6.3.6.3. Italy Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.3.7. Spain
- 6.3.7.1. Key Country Dynamics
- 6.3.7.2. Competitive Scenario
- 6.3.7.3. Spain Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.3.8. Denmark
- 6.3.8.1. Key Country Dynamics
- 6.3.8.2. Competitive Scenario
- 6.3.8.3. Denmark Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.3.9. Sweden
- 6.3.9.1. Key Country Dynamics
- 6.3.9.2. Competitive Scenario
- 6.3.9.3. Sweden Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.3.10. Norway
- 6.3.10.1. Key Country Dynamics
- 6.3.10.2. Competitive Scenario
- 6.3.10.3. Norway Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.3.11. Netherlands
- 6.3.11.1. Key Country Dynamics
- 6.3.11.2. Competitive Scenario
- 6.3.11.3. Netherlands Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.3.12. Belgium
- 6.3.12.1. Key Country Dynamics
- 6.3.12.2. Competitive Scenario
- 6.3.12.3. Belgium Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.3.13. Switzerland
- 6.3.13.1. Key Country Dynamics
- 6.3.13.2. Competitive Scenario
- 6.3.13.3. Switzerland Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.3.14. Russia
- 6.3.14.1. Key Country Dynamics
- 6.3.14.2. Competitive Scenario
- 6.3.14.3. Russia Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.4. Asia Pacific
- 6.4.1. Asia Pacific Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.4.2. Regulatory Framework
- 6.4.3. Japan
- 6.4.3.1. Key Country Dynamics
- 6.4.3.2. Competitive Scenario
- 6.4.3.3. Japan Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.4.4. China
- 6.4.4.1. Key Country Dynamics
- 6.4.4.2. Competitive Scenario
- 6.4.4.3. China Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.4.5. India
- 6.4.5.1. Key Country Dynamics
- 6.4.5.2. Competitive Scenario
- 6.4.5.3. India Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.4.6. Australia
- 6.4.6.1. Key Country Dynamics
- 6.4.6.2. Competitive Scenario
- 6.4.6.3. Australia Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.4.7. Thailand
- 6.4.7.1. Key Country Dynamics
- 6.4.7.2. Competitive Scenario
- 6.4.7.3. Thailand Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.4.8. South Korea
- 6.4.8.1. Key Country Dynamics
- 6.4.8.2. Competitive Scenario
- 6.4.8.3. South Korea Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.4.9. Malaysia
- 6.4.9.1. Key Country Dynamics
- 6.4.9.2. Competitive Scenario
- 6.4.9.3. Malaysia Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.4.10. Indonesia
- 6.4.10.1. Key Country Dynamics
- 6.4.10.2. Competitive Scenario
- 6.4.10.3. Indonesia Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.4.11. Singapore
- 6.4.11.1. Key Country Dynamics
- 6.4.11.2. Competitive Scenario
- 6.4.11.3. Singapore Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.4.12. Philippines
- 6.4.12.1. Key Country Dynamics
- 6.4.12.2. Competitive Scenario
- 6.4.12.3. Philippines Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.5. Latin America
- 6.5.1. Latin America Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.5.2. Brazil
- 6.5.2.1. Key Country Dynamics
- 6.5.2.2. Competitive Scenario
- 6.5.2.3. Brazil Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.5.3. Mexico
- 6.5.3.1. Key Country Dynamics
- 6.5.3.2. Competitive Scenario
- 6.5.3.3. Mexico Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.5.4. Argentina
- 6.5.4.1. Key Country Dynamics
- 6.5.4.2. Competitive Scenario
- 6.5.4.3. Argentina Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.5.5. Colombia
- 6.5.5.1. Key Country Dynamics
- 6.5.5.2. Competitive Scenario
- 6.5.5.3. Colombia Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.5.6. Chile
- 6.5.6.1. Key Country Dynamics
- 6.5.6.2. Competitive Scenario
- 6.5.6.3. Chile Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.6. Middle East & Africa
- 6.6.1. Middle East & Africa Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.6.2. Regulatory Framework
- 6.6.3. South Africa
- 6.6.3.1. Key Country Dynamics
- 6.6.3.2. Competitive Scenario
- 6.6.3.3. South Africa Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.6.4. Saudi Arabia
- 6.6.4.1. Key Country Dynamics
- 6.6.4.2. Competitive Scenario
- 6.6.4.3. Saudi Arabia Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.6.5. UAE
- 6.6.5.1. Key Country Dynamics
- 6.6.5.2. Competitive Scenario
- 6.6.5.3. UAE Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.6.6. Kuwait
- 6.6.6.1. Key Country Dynamics
- 6.6.6.2. Competitive Scenario
- 6.6.6.3. Kuwait Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.6.7. Israel
- 6.6.7.1. Key Country Dynamics
- 6.6.7.2. Competitive Scenario
- 6.6.7.3. Israel Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
- 6.6.8. Egypt
- 6.6.8.1. Key Country Dynamics
- 6.6.8.2. Competitive Scenario
- 6.6.8.3. Egypt Medical Device Testing Services Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
Chapter 7. Competitive Landscape
- 7.1. Company Categorization
- 7.2. Company Market Share Analysis, 2022
- 7.3. Strategy Mapping
- 7.4. Company Profiles/Listing
- 7.4.1. SGS SA
- 7.4.1.1. Overview
- 7.4.1.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 7.4.1.3. Product Benchmarking
- 7.4.1.4. Strategic Initiatives
- 7.4.2. Toxikon, Inc
- 7.4.2.1. Overview
- 7.4.2.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 7.4.2.3. Product Benchmarking
- 7.4.2.4. Strategic Initiatives
- 7.4.3. American Preclinical Services
- 7.4.3.1. Overview
- 7.4.3.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 7.4.3.3. Product Benchmarking
- 7.4.3.4. Strategic Initiatives
- 7.4.4. Sterigenics International LLC
- 7.4.4.1. Overview
- 7.4.4.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 7.4.4.3. Product Benchmarking
- 7.4.4.4. Strategic Initiatives
- 7.4.5. Charles River Laboratories
- 7.4.5.1. Overview
- 7.4.5.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 7.4.5.3. Product Benchmarking
- 7.4.5.4. Strategic Initiatives
- 7.4.6. Element Minnetonka
- 7.4.6.1. Overview
- 7.4.6.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 7.4.6.3. Product Benchmarking
- 7.4.6.4. Strategic Initiatives
- 7.4.7. North American Science Associates, LLC
- 7.4.7.1. Overview
- 7.4.7.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 7.4.7.3. Product Benchmarking
- 7.4.7.4. Strategic Initiatives
- 7.4.8. Eurofins Scientific
- 7.4.8.1. Overview
- 7.4.8.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 7.4.8.3. Product Benchmarking
- 7.4.8.4. Strategic Initiatives
- 7.4.9. Pace Analytical Services LLC
- 7.4.9.1. Overview
- 7.4.9.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 7.4.9.3. Product Benchmarking
- 7.4.9.4. Strategic Initiatives
- 7.4.10. Intertek Group Plc
- 7.4.10.1. Overview
- 7.4.10.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 7.4.10.3. Product Benchmarking
- 7.4.10.4. Strategic Initiatives