Medical Device Testing Market by Service Type, Test Type, Device Class, Phase, Device Type, Sourcing Type, End-Users

Description

List of Tables

[194 Pages Report] The Medical Device Testing Market size was estimated at USD 10.83 billion in 2023 and expected to reach USD 11.67 billion in 2024, at a CAGR 7.85% to reach USD 18.40 billion by 2030.

Medical device testing is the systematic, regulated process of assessing and validating medical devices' safety, reliability, and performance. This extensive process ensures that the device performs as intended and safeguards users, including healthcare professionals and patients, from potential device-related harm. This process often involves a series of rigorous tests adhering to international and national standards and regulations, including those established by organizations such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Innovations in medical device technologies, stringent regulatory compliances, and increasing awareness about patient safety primarily shape market growth. However, the medical device testing market faces challenges owing to high testing costs acting as a significant barrier for new entrants, and the lengthy approval process for new medical devices may hinder market growth. In addition, the increasing adoption of wearable medical devices, growth in home and remote patient care, and the rising application of AI, IoT, and other innovative technologies in the medical field offer tremendous opportunities for the medical device testing market.

KEY MARKET STATISTICS
Base Year [2023]	USD 10.83 billion
Estimated Year [2024]	USD 11.67 billion
Forecast Year [2030]	USD 18.40 billion
CAGR (%)	7.85%

Service Type: Growing requirement for inspection services driven by the ever-growing complexity and diversity of medical technologies

Certification services are vital to validate the reliability and viability of medical devices. For manufacturers requiring certification for their medical devices, such services are particularly beneficial for gaining international acceptance and ensuring patient safety. Inspection services guarantee medical devices' physical and functional integrity throughout their lifecycle. Inspection services are the preferred choice for manufacturers to ensure their devices work correctly with minimal potential for faults or malfunctions. Testing services play a pivotal role in assessing medical device performance, safety, and compliance with industry standards. This service type is crucial for manufacturers eager to ensure their products' efficacy and safety before entering the market.

Test Type: Emerging applications of cybersecurity testing with advent of advanced technologies in medical devices

Chemical testing checks for harmful chemicals, physical testing examines attributes including durability, and biocompatibility testing confirms devices won't adversely interact with human tissues or fluids. Cybersecurity testing is critical, owing to the increasing digital connectivity of medical devices, which checks for vulnerabilities that could allow unauthorized access or hacking. Electrical safety testing confirms medical devices meet standards for electric shock prevention, electromagnetic compatibility, and other metrics. Environmental testing evaluates medical devices' functions under extreme temperatures, humidity, vibration, or drop impact. Mechanical testing assesses medical device attributes such as tensile strength, hardness, and fatigue resistance.

Device Class: Requirement of rigorous PMA processes for class III devices to ensure safety and effectiveness before reaching the market

Class I medical devices are low-risk devices and are subject to the least regulatory control. These include tongue depressors, bedpans, and elastic bandages, among others. Class II medical devices pose a moderate risk and are subject to special controls to ensure safety and effectiveness. Devices, including powered wheelchairs, infusion pumps, and surgical drapes, fall under this category. Manufacturers must clear a 510(k) process to demonstrate substantial equivalence to a predicate device. Class III medical devices support life or pose a serious risk and are subject to the highest level of regulation. These include devices such as pacemakers, heart valves, and orthopedic implants. Manufacturers must undergo a laborious premarket approval application process to establish safety and effectiveness.

Technology: Escalating adoption of medical device testing services for mobile devices

Active implantable medical devices (AIMDs) are characterized by devices that remain active inside the human body. Such devices include defibrillators, cochlear implants, and neuro-stimulators. Extensive testing is needed to ensure safety, focusing on battery functionality, biocompatibility, and telemetry. Active medical devices (AMDs), such as pacemakers, infusion pumps, and monitors, require a power source for operation. AMD testing ensues rigorous regulatory requirements, focusing on aspects including electromagnetic compatibility, electrical safety, and software reliability. In-vitro diagnostic medical devices (IVDs) are used for testing samples outside the human body, particularly in a laboratory setting, such as blood glucose tests or pregnancy tests, and ensuring their accuracy, reproducibility & sensitivity is required for IVD testing. Mobile devices in healthcare include smartphones & tablets equipped with medical apps or wearable health monitors. Application functionality, data privacy, and battery life are critical testing areas to ensure such devices' safe and effective use. Non-active medical devices consist of tools that do not require power for operation, such as scalpels, sutures, or hospital beds. Testing for these devices focuses on mechanical safety, materials testing, and sterilization. Ophthalmic medical devices used in eye-related ailments include contact lenses, cataract implants, and laser vision correction equipment. Testing ensures precise optical and mechanical performance and maintains unique biocompatibility requirements. Orthopedic and dental medical devices encompass a wide range, such as artificial joints, dental implants, and braces. Functionality, durability, and biocompatibility testing are essential in these devices, given their long-term use inside the human body. Vascular medical devices treat conditions within blood vessels, such as stents, catheters, and vascular grafts. Critical testing areas are device performance under dynamic vascular conditions, the robustness of the device, and biocompatibility.

Phase: Significant penetration of medical devices testing in the clinical phase

A detailed evaluation of the safety and effectiveness of a medical device on human subjects characterizes the clinical phase. Clinical trials are primarily driven by healthcare regulations and the need to ensure patient safety while establishing a device's efficacy. Preceding the clinical phase, the preclinical phase is conducted in laboratories using in-vitro techniques and animal models. The goal is to assess the device's safety profile, biocompatibility, and functional attributes under controlled conditions. This phase is paramount to researchers and physicians for understanding devices' potential benefits and limitations before they reach patients. Preclinical trials are preferred when there's a need for initial safety checks, identifying major risks, feasibility, and efficacy analysis before exposing a device to humans. Clinical trials are performed to validate the findings in real-world settings and comply with regulatory needs.

Sourcing Type: Higher preferences for in-house testing for highly proprietary or sensitive devices

In-house testing is conducted within the medical device company's facilities using their employees and resources, which allows for tight control and oversight over the testing process but requires significant investments in infrastructure and personnel. Outsourced testing leverages third-party contract research organizations (CROs) and test labs specializing in medical device testing. Outsourcing reduces the burden on a company's resources but can be costlier and risk exposing intellectual property or trade secrets.

End-Users: Proliferating need from medical device manufacturers

Contract manufacturing organizations (CMOs) are critical in medical device testing as they provide various services, including device design and development, manufacturing, packaging, sterilization, and testing. In addition, CMO offers specialized medical device testing services, such as biocompatibility testing, performance testing, and packaging validation. CMOs prioritize accuracy, speed, and compliance with regulatory standards. Manufacturers primarily focus on the production of medical devices and rely heavily on testing services to ensure medical devices are safe, effective, and comply with regulatory standards. Manufacturers significantly prefer testing services that offer a quick turnaround time and cost-effectiveness. Research institutions favor testing services that offer detailed analyses and precise results, as these are essential in verifying and validating their research findings. Research institutions emphasize medical device testing services that provide comprehensive test results and analytical interpretations.

Regional Insights

In the Americas, the medical device testing market has exhibited resilience and growth in recent years, attributed to the region's stringent regulatory standards promulgated by the Food and Drug Administration (FDA) and the increasing need for high-quality medical devices. The healthcare sector has been poised for innovation fueled by critical factors such as the increasing aging population and the prevailing chronic diseases, including diabetes and cardiovascular disorders. The EMEA region presents an encouraging growth for the medical device testing market. The European market, driven by technological advancements, increased research funding, and high healthcare expenditure, has contributed heavily to medical device testing in the EMEA region. The Middle East and African regions have comparatively less market share but provide substantial growth potential owing to rapidly developing healthcare infrastructure and increasing healthcare spending.

Meanwhile, the APAC region encapsulates a vast diversity from mature markets, including Japan and Australia, to emerging ones, such as China and India. The increasing healthcare spending, aging population, and surge in health consciousness in the region fuel this growth. In addition, government policies' encouragement of local manufacturing is potentially stimulating market growth.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Medical Device Testing Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Medical Device Testing Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Medical Device Testing Market, highlighting leading vendors and their innovative profiles. These include 5D Health Protection Group Ltd., Alliance Technologies, LLC, Almac Group Limited, AMETEK, Inc., Applied Technical Services, LLC, Bioneeds India Pvt. Ltd., Boston Analytical, Bureau Veritas S.A., Cetecom Advanced GmbH, Charles River Laboratories, Inc., Clark Testing, DDL, Inc., DEKRA SE, Device Conformity and Testing, LLC, Element Materials Technology, Eurofins Scientific SE, ImpactQA, Innovatech Labs, LLC, Intertek Group PLC, iuvo BioScience, LLC, Laboratory Corporation of America Holdings, Maven Profcon Services LLP, Measur Oy, MED Institute Inc., Medical Engineering Technologies, Nemko Group, North American Science Associates, LLC, Pace Analytical Services, LLC, Q Laboratories, Inc., Qualitest Group, Qualizeal India LLP, Sanbor Medical Corporation, ScienceSoft Corporation, SGS S.A., STEMart, Sterigenics U.S., LLC by Sotera Health company, STERIS PLC, TA Instruments by Waters Corporation, Tentamus Group GmbH, Test Labs Ltd., The British Standards Institution, The Smithers Group Inc., TUV SUD AG, UL LLC, and WESTPAK, Inc..

Market Segmentation & Coverage

This research report categorizes the Medical Device Testing Market to forecast the revenues and analyze trends in each of the following sub-markets:

Service Type
- Certification Services
- Inspection Services
- Testing Services

Test Type
- Chemical, Physical, & Biocompatibility Testing
- Cybersecurity Testing
- Electrical Safety
- Environmental Testing
- Mechanical Testing

Device Class
- Class I
- Class II
- Class III

Phase
- Clinical
- Preclinical

Device Type
- Active Implant Medical Device
- Active Medical Device
- In-Vitro Diagnostic Medical Device
- Mobile Medical Devices
- Non-Active Medical Device
- Ophthalmic Medical Device
- Orthopedic & Dental Medical Device
- Vascular Medical Device

Sourcing Type
- In-House
- Outsourced

End-Users
- Contract Manufacturing Organization
- Medical Device Manufacturers
- Research Institutions

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Medical Device Testing Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Medical Device Testing Market?

3. What are the technology trends and regulatory frameworks in the Medical Device Testing Market?

4. What is the market share of the leading vendors in the Medical Device Testing Market?

5. Which modes and strategic moves are suitable for entering the Medical Device Testing Market?

Product Code: MRR-6611A5111648

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Increasing requirements for new medical devices to undergo rigorous regulatory standards
  - 5.1.1.2. Government initiatives to establish and strengthen medical device manufacturing and testing facilities
  - 5.1.1.3. Increasing trend of outsourcing medical device testing services
- 5.1.2. Restraints
  - 5.1.2.1. Extended lead time and costs associated with qualification tests
- 5.1.3. Opportunities
  - 5.1.3.1. Emerging potential for cybersecurity testing with the advent of smart medical devices
  - 5.1.3.2. Ongoing introduction of new medical device testing services and facilities
- 5.1.4. Challenges
  - 5.1.4.1. Complexities associated with medical device testing
5.2. Market Segmentation Analysis
- 5.2.1. Service Type: Growing requirement for inspection services driven by the ever-growing complexity and diversity of medical technologies
- 5.2.2. Test Type: Emerging applications of cybersecurity testing with advent of advanced technologies in medical devices
- 5.2.3. Device Class: Requirement of rigorous PMA processes for class III devices to ensure safety and effectiveness before reaching the market
- 5.2.4. Technology: Escalating adoption of medical device testing services for mobile devices
- 5.2.5. Phase: Significant penetration of medical devices testing in the clinical phase
- 5.2.6. Sourcing Type: Higher preferences for in-house testing for highly proprietary or sensitive devices
- 5.2.7. End-Users: Proliferating need from medical device manufacturers
5.3. Market Trend Analysis
- 5.3.1. Innovations and developments in smart medical devices creating need for medical device testing services in the Americas
- 5.3.2. Substantial focus on domestic production and exports of medical devices raising the need for robust medical device testing services in the APAC region
- 5.3.3. Presence of well-established regulations governing medical devices elevating the need for medical device testing services in the EMEA region
5.4. Cumulative Impact of High Inflation
5.5. Porter's Five Forces Analysis
- 5.5.1. Threat of New Entrants
- 5.5.2. Threat of Substitutes
- 5.5.3. Bargaining Power of Customers
- 5.5.4. Bargaining Power of Suppliers
- 5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework Analysis

6. Medical Device Testing Market, by Service Type

6.1. Introduction
6.2. Certification Services
6.3. Inspection Services
6.4. Testing Services

7. Medical Device Testing Market, by Test Type

7.1. Introduction
7.2. Chemical, Physical, & Biocompatibility Testing
7.3. Cybersecurity Testing
7.4. Electrical Safety
7.5. Environmental Testing
7.6. Mechanical Testing

8. Medical Device Testing Market, by Device Class

8.1. Introduction
8.2. Class I
8.3. Class II
8.4. Class III

9. Medical Device Testing Market, by Phase

9.1. Introduction
9.2. Clinical
9.3. Preclinical

10. Medical Device Testing Market, by Device Type

10.1. Introduction
10.2. Active Implant Medical Device
10.3. Active Medical Device
10.4. In-Vitro Diagnostic Medical Device
10.5. Mobile Medical Devices
10.6. Non-Active Medical Device
10.7. Ophthalmic Medical Device
10.8. Orthopedic & Dental Medical Device
10.9. Vascular Medical Device

11. Medical Device Testing Market, by Sourcing Type

11.1. Introduction
11.2. In-House
11.3. Outsourced

12. Medical Device Testing Market, by End-Users

12.1. Introduction
12.2. Contract Manufacturing Organization
12.3. Medical Device Manufacturers
12.4. Research Institutions

13. Americas Medical Device Testing Market

13.1. Introduction
13.2. Argentina
13.3. Brazil
13.4. Canada
13.5. Mexico
13.6. United States

14. Asia-Pacific Medical Device Testing Market

14.1. Introduction
14.2. Australia
14.3. China
14.4. India
14.5. Indonesia
14.6. Japan
14.7. Malaysia
14.8. Philippines
14.9. Singapore
14.10. South Korea
14.11. Taiwan
14.12. Thailand
14.13. Vietnam

15. Europe, Middle East & Africa Medical Device Testing Market

15.1. Introduction
15.2. Denmark
15.3. Egypt
15.4. Finland
15.5. France
15.6. Germany
15.7. Israel
15.8. Italy
15.9. Netherlands
15.10. Nigeria
15.11. Norway
15.12. Poland
15.13. Qatar
15.14. Russia
15.15. Saudi Arabia
15.16. South Africa
15.17. Spain
15.18. Sweden
15.19. Switzerland
15.20. Turkey
15.21. United Arab Emirates
15.22. United Kingdom

16. Competitive Landscape

16.1. Market Share Analysis, 2023
16.2. FPNV Positioning Matrix, 2023
16.3. Competitive Scenario Analysis
- 16.3.1. UL Solutions Rolls Out Medical Device Testing in Michigan, Helping the Industry Advance Safety of Healthcare Technology
- 16.3.2. Element Materials Technology Announces USD 8 Million Expansion in Cincinnati
- 16.3.3. Element Materials Technology Expands Connected Technology Testing Capabilities with Acquisition of CTK
- 16.3.4. New Microbiology and Chemistry Laboratory Opens to Accelerate Scientific Discovery
- 16.3.5. Industries and IT Minister Launches Three Made-In-Telangana Medical Devices
- 16.3.6. MedCrypt and Stratigos Security Partner to Offer Specialized Penetration Testing and Security Assessments for Life-Saving Medical Devices
- 16.3.7. New Alliance Enables Medical Device OEMs With End-To-End AM Solution
- 16.3.8. Molbio Diagnostics Partners with SigTuple To Build Next-Gen Point-Of-Care Diagnostic Testing Devices
- 16.3.9. Grand Opening of New Bioanalytical Laboratory in Pudong, China
- 16.3.10. DDL and Gateway Analytical Announce Joint Agreement
- 16.3.11. Element Materials Technology Acquires National Technical Systems
- 16.3.12. Clinimark Acquired by Element Materials Technology

17. Competitive Portfolio

17.1. Key Company Profiles
17.2. Key Product Portfolio