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Medical Device Testing Market Size, Share & Growth Analysis

Report Code SE 5802
Published in Oct, 2023, By MarketsandMarkets™
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Medical Device Testing Market by Service (Testing, Inspection, Certification), Sourcing (In-house, Outsourced), Technology (Active Implant, Active, Non-active, IVD, Ophthalmic, Orthopedic & Dental, Vascular), Class (I, II, III) – Global Forecast to 2028

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Overview

The global medical device testing market size is expected to be valued at USD 10.6 billion in 2023 and is projected to reach USD 13.5 billion by 2028; growing at a CAGR of 4.9% from 2023 to 2028. Global medical device testing market is experiencing significant growth, driven by an increasing demand for high-quality and reliable medical devices amid stringent regulatory requirements. As healthcare providers and manufacturers prioritize patient safety and efficacy, comprehensive testing of medical devices—from concept development to post-market surveillance—has become essential. Key trends influencing this market include the rising adoption of advanced testing technologies, such as automation and digital solutions, which enhance testing efficiency and accuracy. Additionally, the integration of IoT and connected devices in healthcare is necessitating more rigorous testing protocols to ensure cybersecurity and data integrity. The ongoing emphasis on innovation in medical technology, particularly in areas like wearable health monitors and diagnostic devices, further fuels the demand for robust testing solutions. As regulatory bodies continue to tighten standards and the global focus on healthcare quality increases, the medical device testing market is poised for substantial growth, with investments in advanced testing methodologies and technologies becoming a top priority for manufacturers. The expansion of the global healthcare sector presents a substantial opportunity for stakeholders in the market. With healthcare accessibility improving, especially in emerging markets, the demand for advanced medical devices is on the rise due to factors such as a growing population, increased disposable incomes, and heightened awareness of healthcare and well-being.

Attractive Opportunities in the Medical Device Testing Market

ASIA PACIFIC:

Growing healthcare infrastructure and demand for advanced devices propels the growth of the market in Asia Pacific.

The rapid growth of healthcare infrastructure in the Asia-Pacific region necessitates comprehensive medical device testing for safety and compliance

Ongoing efforts by governments to enhance regulatory compliance and standards in the Asia-Pacific region

The increasing need for sophisticated medical devices in Asia-Pacific creates a substantial opportunity for thorough testing and validation to meet quality and safety standards.

Opportunity for robust testing services, enabling manufacturers to meet international regulatory standards

Global Medical Device Testing Market Dynamics

Driver: The global expansion of the healthcare industry

The global expansion of the healthcare industry represents a significant opportunity for various stakeholders within the medical device testing market. As healthcare access improves across the world, particularly in emerging markets, there is a growing demand for advanced medical devices. This demand is fueled by an increasing population, rising disposable incomes, and a growing awareness of healthcare and wellness. Consequently, there is a need for robust testing services to ensure the safety, efficacy, and compliance of these devices with stringent regulatory standards. Testing facilities and services play a vital role in supporting the global expansion of the healthcare industry by providing the necessary assurance to manufacturers, healthcare providers, and patients, thus contributing to the overall growth and credibility of the medical device sector on a global scale.

Restraint: Quality concerns and product recalls for medical devices

Quality concerns and the associated risk of product recalls represent a critical restraint for the medical device testing market share. Ensuring the quality and safety of medical devices is paramount, particularly for high-risk devices like pacemakers, coronary stents, and artificial heart valves. A lapse in quality control can have severe consequences, including injuries to end-users or even fatalities. Any compromised quality can lead to product recalls, causing financial losses and reputational damage for manufacturers. Moreover, the potential consequences of poor quality in medical devices, such as product recalls and harm to patients, intensify the need for meticulous testing. Inadequate testing or failure to meet regulatory standards can result in legal, financial, and reputational damage for manufacturers. The need to avoid these significant risks necessitates thorough and meticulous testing processes, adding complexity and costs to the development and testing phases of medical devices. Achieving optimal quality and reducing the risk of recalls are persistent challenges for companies in the medical device testing market.

 

Opportunity: Connectivity of mobile devices with medical equipment

The merging of mobile technology with medical devices is revolutionizing healthcare. Through dedicated applications and connectivity, mobile devices seamlessly connect with medical equipment, empowering individuals to monitor and manage their health on-the-go. This integration improves accessibility and facilitates timely interventions, resulting in enhanced health outcomes. Rapid advancements in wireless technologies and sensor-based devices have given rise to a new wave of mobile medical devices, significantly enhancing patient quality-of-life while reducing healthcare costs for both providers and patients. The compact size and networking capabilities of these mobile medical devices offer considerable advantages, allowing patients to make fewer hospital visits and giving healthcare providers the benefit of reduced administrative overheads and care expenses.

Challenge: Intricate nature of supply chains in medical device testing

The medical device testing supply chains face rigorous regulatory demands, presenting a notable challenge. As components are often procured worldwide, ensuring a smooth supply chain while upholding stringent quality control and compliance standards proves difficult. The complexity arises from the need to manage multiple suppliers, coordinate logistics, and ensure consistent safety and quality standards throughout the testing process in today's interconnected global economy. In contemporary manufacturing, optimizing costs and profits involves sourcing components globally. However, this approach introduces heightened risks in managing intricate supply chains, further complicated by evolving international trade regulations. The ongoing reviews and frequent changes in trade agreements among nations add to the complexity, influenced by economic and geopolitical factors.

Global Medical Device Testing Market Ecosystem Analysis

The medical device testing market share is dominated by established and financially sound manufacturers with extensive experience in the industry. These companies have diversified product portfolios, cutting-edge technologies, and strong global sales and marketing networks. Leading players in the market include Knowles Eurofins Scientific from Luxembourg, Intertek Group plc from the UK, SGS Société Générale de Surveillance SA. from Switzerland, Bureau Veritas from France, and TÜV SÜD from Germany.

Testing services segment is expected to hold the highest market share during the forecast period

Testing services hold a significant market share in the medical device testing industry due to their crucial role in ensuring regulatory compliance, safety, and quality of medical devices. The healthcare sector is highly regulated, necessitating comprehensive testing to meet stringent standards set by regulatory bodies like the Food & Drug Administration of US (FDA) and European Commission (EC). Through thorough evaluations, testing services confirm that devices function effectively, pose no risks to patients, and meet specified performance benchmarks. This instills confidence in healthcare professionals and end-users, facilitating market access and fostering trust. Outsourcing to specialized testing facilities grants access to expertise and advanced technology, further driving the prominence of testing services in the medical device testing industry.

Based on device class, the class III to hold the highest market share during the forecast period

Class III medical devices, the highest risk category, require the most rigorous testing and scrutiny in the medical device testing market. These devices, such as pacemakers and implantable defibrillators, undergo extensive testing to ensure their safety, efficacy, and compliance with strict regulatory standards imposed by bodies like the FDA. The complexity and criticality of Class III devices necessitate comprehensive evaluation across multiple parameters, including biocompatibility, performance, sterility, and more. The growth of Class III devices in the market is propelled by their increasing complexity and critical nature, necessitating comprehensive and stringent testing procedures. Regulatory requirements for Class III devices are particularly demanding, driving the demand for rigorous testing to ensure compliance and safety. Additionally, the rising development and adoption of advanced medical technologies, such as implantable devices, contribute to the expanding market for Class III device testing. Manufacturers' emphasis on thorough testing to meet regulatory standards and deliver high-quality, innovative healthcare solutions further fuels the growth of Class III devices in the medical device testing sector.IVD medical devices for medical device testing market to hold the highest market shareIn Vitro Diagnostic (IVD) medical devices, ranging from diagnostic kits to molecular assays, hold a significant market share in medical device testing. These devices play a pivotal role in healthcare, aiding in disease diagnosis, monitoring, and treatment decisions. The demand for IVD medical device testing stems from the critical importance of accurate and reliable diagnostic results in healthcare decision-making. Stringent regulatory requirements necessitate rigorous testing to ensure precision, sensitivity, and specificity of these devices. Furthermore, the increasing prevalence of infectious diseases and chronic conditions fuels the demand for innovative IVD devices, driving the growth of testing services to validate their effectiveness and compliance with regulatory standards.

ASIA PACIFIC Region Holds the Largest Share of the Medical Device Testing Market

Rapid economic development and industrialization in countries like China and India are driving substantial investments in healthcare and technology, fueling the demand for medical device testing services. Moreover, evolving regulatory frameworks in the region are placing increased emphasis on quality and safety standards for medical devices, necessitating comprehensive testing. Additionally, the burgeoning middle-class population with higher disposable income is demanding superior healthcare services, boosting the need for advanced medical devices and, consequently, the testing thereof. Lastly, the surge in medical tourism and the aspiration to meet international market standards are further propelling the growth of the market in the Asia-Pacific region.

Recent Developments of Medical Device Testing Market industry

  • In June 2023, TÜV SÜD has opened a laboratory in New Brighton, Minnesota, accredited to ISO 17025 for biological and chemical testing of medical devices. Staffed by experienced scientists and technicians, the lab will cater to both domestic and international medical device companies, aiding in research and development through microbiology, reusable device testing, chemistry, biocompatibility, and packaging testing services. In September 2022, Bureau Veritas has acquired Galbraith Laboratories Inc., known for advanced analytical solutions in healthcare. This acquisition amplifies Bureau Veritas' presence in Consumer Healthcare and Industrial Chemicals supply chains, bolstering support for research, development, and product testing. Galbraith Laboratories' expertise will enhance Bureau Veritas' service portfolio, particularly in medical device testing, expanding its reach and influence in the US.
  • In July 2022, Eurofins Scientific acquired WESSLING (Hungary) to enhance its environmental, food, and BioPharma product testing offerings in the European region. In October 2021, SGS acquired Groupe IDEA TESTS (IDEA), a leading provider of clinical, microbiological, and in-vitro testing and regulatory services to cosmetic & personal care product manufacturers in France. The acquisition is likely to help SGS to offer enhanced services to customers from the strategic markets of cosmetics & hygiene.

Key Market Players

KEY PLAYERS IN THE Medical Device Testing Market INCLUDE

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Scope of the Report

Report Attribute Details
Estimated Value USD 10.6 billion in 2023
Expected Value  USD 13.5 billion by 2028
Growth Rate CAGR of 4.9%
Market size available for years 2019-2028
Base year considered 2022
Forecast period 2023-2028
Forecast units Value (USD Million/Billion)
Segments Covered By Service Type, By Sourcing Type, By Device Class, By Technology
Geographies covered North America, Europe, Asia Pacific, and RoW
Companies covered The major market players include Eurofins Scientific (Luxembourg), Intertek Group plc (UK), SGS Société Générale de Surveillance SA. (Switzerland), Bureau Veritas (France), TÜV SÜD (Germany), (Total of 25 players are profiled)

 

Key Questions Addressed by the Report

What are the major driving factors and opportunities in the medical device testing market share?
Some of the major driving factors for the growth of this market include global expansion of the healthcare industry, increasing need for stringent standards, and increasing need for validation and verification of medical devices. Furthermore, opportunities such as connectivity of mobile devices, harmonization of standards, and technological advancements including IoT and AI technologies are factors expected to boost the growth of the medical device testing market.
Which region is expected to hold the highest market share?
The market in Asia Pacific will dominate the market share in 2023, anticipating strong demand for medical device testing in the region. The rapid growth of the middle-class population with increased purchasing power fuels the demand for superior healthcare services, driving the need for comprehensive testing of advanced medical devices. Furthermore, the region's growth is amplified by medical tourism and a strong desire to meet global market standards.
Who are the leading players in the global medical device testing market share?
Companies such as Eurofins Scientific (Luxembourg), Intertek Group plc (UK), SGS Société Générale de Surveillance SA. (Switzerland), Bureau Veritas (France), and TÜV SÜD (Germany) are the leading players in the market. Moreover, these companies rely on several strategies including new product launches and developments, collaborations and partnerships, and acquisitions. Such strategies provide these companies with an edge over other players in the market.
What are some of the technological advancements in the medical device testing market size?
3D printing technology allows for the rapid production of patient-specific personalized anatomical models, aiding in surgical planning and practicing. Additionally, it can be utilized in medical device testing to print medical devices like exoskeletons. This includes optimizing material parameters and consumption, selecting appropriate materials for the exoskeleton, and facilitating efficient testing and validation.
What is the size of the global medical device testing market?
The global medical device testing market was valued at USD 10.2 Billion in 2022 and is anticipated to reach USD 13.5 Billion at a CAGR of 4.9% during the forecast period.

 

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Table of Contents

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TITLE
PAGE NO
INTRODUCTION
22
RESEARCH METHODOLOGY
27
EXECUTIVE SUMMARY
39
PREMIUM INSIGHTS
43
MEDICAL DEVICE TESTING MARKET OVERVIEW
47
  • 5.1 INTRODUCTION
  • 5.2 MARKET DYNAMICS
    DRIVERS
    - Expansion of global healthcare industry
    - Need to meet stringent industry regulations with advancements in medical devices
    - Increasing emphasis on validation and verification of medical devices
    - Enforcement of stringent regulations by governments worldwide
    - Shift toward outsourcing of medical device testing services
    - Increased focus on testing of medical devices post emergence of COVID-19 pandemic
    - Integration of advanced technologies with medical equipment
    RESTRAINT
    - Lengthy and expensive licensing procedures hindering development of medical devices
    OPPORTUNITIES
    - Harmonization of standards in medical device industry
    - Technological advancements in medical device testing
    CHALLENGES
    - Complexities of managing global supply chains in medical device testing
    - Long lead times required for overseas qualification tests for medical devices
  • 5.3 VALUE CHAIN ANALYSIS
  • 5.4 MARKET: ECOSYSTEM MAPPING
    TIC STANDARDS AND REGULATORY BODIES
    TIC SERVICE PROVIDERS
  • 5.5 TRENDS/DISRUPTIONS IMPACTING CUSTOMER BUSINESS
  • 5.6 TECHNOLOGY TRENDS
    3D PRINTING AND PROTOTYPING
    INTERNET OF THINGS (IOT) AND CONNECTIVITY
    AUGMENTED REALITY (AR) AND VIRTUAL REALITY (VR)
    ARTIFICIAL INTELLIGENCE (AI)
    MACHINE LEARNING (ML)
MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE
62
  • 6.1 INTRODUCTION
  • 6.2 ELECTROMAGNETIC COMPATIBILITY
    PROLIFERATION OF WIRELESS TECHNOLOGIES TO NECESSITATE ELECTROMAGNETIC COMPATIBILITY TESTING OF MEDICAL DEVICES
  • 6.3 ELECTRICAL SAFETY
    STRINGENT SAFETY MEASURES TO DRIVE DEMAND FOR ELECTRICAL SAFETY TESTS
  • 6.4 WIRELESS CONNECTIVITY
    INTEGRATION OF CONNECTED HEALTH TECHNOLOGIES IN MEDICAL DEVICES TO FUEL DEMAND FOR WIRELESS CONNECTIVITY TESTING
  • 6.5 ENVIRONMENTAL TESTING
    INCREASING COMPLEXITY OF MEDICAL DEVICES TO NECESSITATE ENVIRONMENTAL TESTING
  • 6.6 MECHANICAL TESTING
    GROWING SOPHISTICATION OF MEDICAL DEVICES TO CONTRIBUTE TO DEMAND FOR MECHANICAL TESTING SERVICES
  • 6.7 CHEMICAL, PHYSICAL, AND BIOCOMPATIBILITY TESTING
    STRINGENT REGULATIONS ON MEDICAL DEVICES FOR PATIENT SAFETY TO FOSTER MARKET GROWTH
  • 6.8 CYBERSECURITY TESTING
    RISING CYBER ATTACKS ON MEDICAL DEVICES TO NECESSITATE CYBERSECURITY TESTING
MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE
68
  • 7.1 INTRODUCTION
  • 7.2 TESTING SERVICES
    RISING FOCUS ON ENSURING COMPLIANCE WITH REGULATORY STANDARDS TO DRIVE DEMAND FOR TESTING SERVICES
  • 7.3 INSPECTION SERVICES
    INCREASING EMPHASIS ON IMPROVING QUALITY OF MEDICAL DEVICES TO BOOST DEMAND FOR INSPECTION SERVICES
  • 7.4 CERTIFICATION SERVICES
    GROWING STRINGENCY OF NORMS AND REGULATIONS PERTAINING TO MEDICAL DEVICES TO BOOST DEMAND FOR CERTIFICATION SERVICES
  • 7.5 OTHERS
MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE
73
  • 8.1 INTRODUCTION
  • 8.2 IN-HOUSE
    CAPABILITY TO MEET CUSTOMIZED TESTING REQUIREMENTS FOR SPECIFIC DEVICES TO BOOST DEMAND FOR IN-HOUSE TESTING
  • 8.3 OUTSOURCED
    INCREASING FOCUS ON EXPEDITING PRODUCT DEVELOPMENT TO LEAD TO OUTSOURCING OF MEDICAL DEVICE TESTING
MEDICAL DEVICE TESTING MARKET, BY DEVICE CLASS
77
  • 9.1 INTRODUCTION
  • 9.2 REGIONAL CLASS DIFFERENTIATION
    US
    - Class I: General controls
    - Class II: General controls with special controls
    - Class III: General controls, special controls, and pre-market approval
    EUROPEAN UNION AND EUROPEAN FREE TRADE ASSOCIATION
    CANADA
    AUSTRALIA
  • 9.3 CLASS I
    RAPID INCREASE IN DEMAND FOR ESSENTIAL HEALTHCARE PRODUCTS TO DRIVE MARKET
  • 9.4 CLASS II
    GROWING DEMAND FOR MONITORING AND DIAGNOSTIC DEVICES IN HEALTHCARE TO DRIVE CLASS II MEDICAL DEVICE TESTING
  • 9.5 CLASS III
    ADVANCEMENTS IN IMPLANTABLE TECHNOLOGIES TO INDUCE DEMAND FOR TESTING OF CLASS III DEVICES
MEDICAL DEVICE TESTING MARKET, BY TECHNOLOGY
82
  • 10.1 INTRODUCTION
  • 10.2 ACTIVE IMPLANT MEDICAL DEVICES
    INCREASING PREVALENCE OF CHRONIC DISEASES TO NECESSITATE USE OF MEDICAL IMPLANTS
  • 10.3 ACTIVE MEDICAL DEVICES
    NEED FOR CONTINUOUS MONITORING OF PATIENTS WITH CHRONIC DISEASES TO DRIVE SEGMENT
  • 10.4 NON-ACTIVE MEDICAL DEVICES
    INCREASING NUMBER OF SURGICAL PROCEDURES TO FUEL DEMAND FOR TESTING OF NON-ACTIVE MEDICAL DEVICES
  • 10.5 IN VITRO DIAGNOSTIC (IVD) MEDICAL DEVICES
    NEED TO ENSURE ACCURACY OF DIAGNOSTIC INFORMATION TO CREATE DEMAND FOR TESTING OF IVD MEDICAL DEVICES
  • 10.6 OPHTHALMIC MEDICAL DEVICES
    INCREASING PREVALENCE OF EYE DISEASES TO INDUCE DEMAND FOR TESTING OF OPHTHALMIC MEDICAL DEVICES
  • 10.7 ORTHOPEDIC & DENTAL DEVICES
    NEED TO VALIDATE DURABILITY AND PROPER FUNCTIONING OF ORTHOPEDIC DEVICES TO FUEL DEMAND FOR TESTING SERVICES
  • 10.8 VASCULAR MEDICAL DEVICES
    RISING INCIDENCE OF CARDIOVASCULAR DISEASES TO PROPEL NEED FOR TESTING OF VASCULAR MEDICAL DEVICES
  • 10.9 OTHERS
MEDICAL DEVICE TESTING MARKET, BY REGION
102
  • 11.1 INTRODUCTION
  • 11.2 NORTH AMERICA
    US
    - Robust research & development activities to drive market
    CANADA
    - Increasing adoption of advanced technologies to propel market growth
    MEXICO
    - Rising demand for healthcare services to augment market growth
    RECESSION IMPACT ON MARKET IN NORTH AMERICA
  • 11.3 EUROPE
    GERMANY
    - Strong focus on quality of medical devices to foster market growth
    UK
    - Stringent regulatory standards pertaining to medical devices to contribute to market growth
    FRANCE
    - Consolidating trend of outsourcing testing services to fuel market growth
    ITALY
    - Rise in demand for testing of home healthcare devices to complement market growth
    SPAIN
    - Increasing burden of chronic diseases to provide growth opportunities to market players
    REST OF EUROPE
    RECESSION IMPACT ON MARKET IN EUROPE
  • 11.4 ASIA PACIFIC
    CHINA
    - Focus on increasing production of high-end medical devices to boost demand for testing services
    JAPAN
    - Growing concerns regarding product safety and regulatory compliance to support market growth
    INDIA
    - Increasing demand for medical devices to boost testing
    SOUTH KOREA
    - Increasing emphasis on basic medical care to favor market growth
    AUSTRALIA
    - Increasing need for robust testing procedures to foster market growth
    REST OF ASIA PACIFIC
    RECESSION IMPACT ON MARKET IN ASIA PACIFIC
  • 11.5 ROW
    SOUTH AMERICA
    - Development of advanced medical technologies to necessitate rigorous testing procedures
    MIDDLE EAST AND AFRICA
    - Growing concerns regarding product safety to accelerate demand for testing services
    RECESSION IMPACT ON MARKET IN ROW
COMPETITIVE LANDSCAPE
138
  • 12.1 INTRODUCTION
  • 12.2 STRATEGIES ADOPTED BY KEY PLAYERS
    PRODUCT/SERVICE PORTFOLIO
    REGIONAL FOCUS
    ORGANIC/INORGANIC GROWTH STRATEGIES
  • 12.3 MARKET SHARE ANALYSIS, 2022
  • 12.4 REVENUE ANALYSIS OF TOP PLAYERS IN MEDICAL DEVICE TESTING MARKET
  • 12.5 COMPANY EVALUATION MATRIX, 2022
    STARS
    PERVASIVE PLAYERS
    EMERGING LEADERS
    PARTICIPANTS
  • 12.6 COMPANY FOOTPRINT
    COMPANY FOOTPRINT, BY SERVICE TYPE
    COMPANY FOOTPRINT, BY REGION
    OVERALL COMPANY FOOTPRINT
  • 12.7 COMPETITIVE SCENARIOS AND TRENDS
    SERVICE LAUNCHES & DEVELOPMENTS
    DEALS
COMPANY PROFILES
153
  • 13.1 KEY PLAYERS
    SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA
    - Business overview
    - Products/Services/Solutions offered
    - Recent developments
    - MnM view
    EUROFINS SCIENTIFIC
    - Business overview
    - Products/Services/Solutions offered
    - Recent developments
    - MnM view
    BUREAU VERITAS
    - Business overview
    - Products/Services/Solutions offered
    - Recent developments
    - MnM view
    TÜV RHEINLAND
    - Business overview
    - Products/Services/Solutions offered
    - Recent developments
    - MnM view
    TÜV SÜD
    - Business overview
    - Products/Services/Solutions offered
    - Recent developments
    - MnM view
    DEKRA
    - Business overview
    - Products/Services/Solutions offered
    - Recent developments
    - MnM view
    UL LLC
    - Business overview
    - Products/Services/Solutions offered
    - Recent developments
    ASTM
    - Business overview
    - Products/Services/Solutions offered
    - Recent developments
    INTERTEK GROUP PLC
    - Business overview
    - Products/Services/Solutions offered
    - Recent developments
    SOTERA HEALTH
    - Business overview
    - Products/Services/Solutions offered
    - Recent developments
  • 13.2 OTHER PLAYERS
    ELEMENT MATERIALS TECHNOLOGY
    INOTIV
    GATEWAY ANALYTICAL
    MEDISTRI SA
    NORTH AMERICAN SCIENCE ASSOCIATES, LLC (NAMSA)
    PACE
    WUXI APPTEC
    LABORATORY CORPORATION OF AMERICA
    CHARLES RIVER LABORATORIES
    SOURCE BIOSCIENCE
    NSF
    BIOMEDICAL DEVICE LABS
    SURPASS, INC.
    THE BRITISH STANDARDS INSTITUTION
    MEASUR OY
APPENDIX
203
  • 14.1 DISCUSSION GUIDE
  • 14.2 KNOWLEDGESTORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL
  • 14.3 CUSTOMIZATION OPTIONS
  • 14.4 RELATED REPORTS
  • 14.5 AUTHOR DETAILS
LIST OF TABLES
 
  • TABLE 1 COMMON FRAMEWORK FOR MEDICAL DEVICE REGULARIZATION
  • TABLE 2 LIST OF STANDARDS RELATED TO WIRELESS MEDICAL DEVICES
  • TABLE 3 COMMON STANDARDS FOR MEDICAL DEVICE REGULARIZATION IN EUROPEAN NATIONS
  • TABLE 4 MEMORANDA OF UNDERSTANDING ON CYBERSECURITY IN MEDICAL DEVICES
  • TABLE 5 MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION)
  • TABLE 6 MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION)
  • TABLE 7 MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 8 MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 9 MARKET, BY DEVICE CLASS, 2019–2022 (USD MILLION)
  • TABLE 10 MARKET, BY DEVICE CLASS, 2023–2028 (USD MILLION)
  • TABLE 11 MARKET, BY TECHNOLOGY, 2019–2022 (USD MILLION)
  • TABLE 12 MARKET, BY TECHNOLOGY, 2023–2028 (USD MILLION)
  • TABLE 13 ACTIVE IMPLANT MEDICAL DEVICES: MARKET, BY REGION, 2019–2022 (USD MILLION)
  • TABLE 14 ACTIVE IMPLANT MEDICAL DEVICES: MARKET, BY REGION, 2023–2028 (USD MILLION)
  • TABLE 15 ACTIVE IMPLANT MEDICAL DEVICES: MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION)
  • TABLE 16 ACTIVE IMPLANT MEDICAL DEVICES: MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION)
  • TABLE 17 ACTIVE MEDICAL DEVICES: MARKET, BY REGION, 2019–2022 (USD MILLION)
  • TABLE 18 ACTIVE MEDICAL DEVICES: MARKET, BY REGION, 2023–2028 (USD MILLION)
  • TABLE 19 ACTIVE MEDICAL DEVICES: MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION)
  • TABLE 20 ACTIVE MEDICAL DEVICES: MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION)
  • TABLE 21 NON-ACTIVE MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2019–2022 (USD MILLION)
  • TABLE 22 NON-ACTIVE MEDICAL DEVICES: MARKET, BY REGION, 2023–2028 (USD MILLION)
  • TABLE 23 NON-ACTIVE MEDICAL DEVICES: MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION)
  • TABLE 24 NON-ACTIVE MEDICAL DEVICES: MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION)
  • TABLE 25 IVD MEDICAL DEVICES: MARKET, BY REGION, 2019–2022 (USD MILLION)
  • TABLE 26 IVD MEDICAL DEVICES: MARKET, BY REGION, 2023–2028 (USD MILLION)
  • TABLE 27 IVD MEDICAL DEVICES: MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION)
  • TABLE 28 IVD MEDICAL DEVICES: MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION)
  • TABLE 29 OPHTHALMIC MEDICAL DEVICES: MARKET, BY REGION, 2019–2022 (USD MILLION)
  • TABLE 30 OPHTHALMIC MEDICAL DEVICES: MARKET, BY REGION, 2023–2028 (USD MILLION)
  • TABLE 31 OPHTHALMIC MEDICAL DEVICES: MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION)
  • TABLE 32 OPHTHALMIC MEDICAL DEVICES: MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION)
  • TABLE 33 ORTHOPEDIC & DENTAL DEVICES: MARKET, BY REGION, 2019–2022 (USD MILLION)
  • TABLE 34 ORTHOPEDIC & DENTAL DEVICES: MARKET, BY REGION, 2023–2028 (USD MILLION)
  • TABLE 35 ORTHOPEDIC & DENTAL DEVICES: MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION)
  • TABLE 36 ORTHOPEDIC & DENTAL DEVICES: MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION)
  • TABLE 37 VASCULAR MEDICAL DEVICES: MARKET, BY REGION, 2019–2022 (USD MILLION)
  • TABLE 38 VASCULAR MEDICAL DEVICES: MARKET, BY REGION, 2023–2028 (USD MILLION)
  • TABLE 39 VASCULAR MEDICAL DEVICES: MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION)
  • TABLE 40 VASCULAR MEDICAL DEVICES: MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION)
  • TABLE 41 OTHERS: MARKET, BY REGION, 2019–2022 (USD MILLION)
  • TABLE 42 OTHERS: MARKET, BY REGION, 2023–2028 (USD MILLION)
  • TABLE 43 OTHERS: MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION)
  • TABLE 44 OTHERS: MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION)
  • TABLE 45 MEDICAL DEVICE TESTING MARKET, BY REGION, 2019–2022 (USD MILLION)
  • TABLE 46 MARKET, BY REGION, 2023–2028 (USD MILLION)
  • TABLE 47 NORTH AMERICA: MARKET, BY COUNTRY, 2019–2022 (USD MILLION)
  • TABLE 48 NORTH AMERICA: MARKET, BY COUNTRY, 2023–2028 (USD MILLION)
  • TABLE 49 NORTH AMERICA: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 50 NORTH AMERICA: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 51 NORTH AMERICA: MARKET, BY TECHNOLOGY, 2019–2022 (USD MILLION)
  • TABLE 52 NORTH AMERICA: MARKET, BY TECHNOLOGY, 2023–2028 (USD MILLION)
  • TABLE 53 US: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 54 US: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 55 CANADA: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 56 CANADA: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 57 MEXICO: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 58 MEXICO: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 59 EUROPE: MARKET, BY COUNTRY, 2019–2022 (USD MILLION)
  • TABLE 60 EUROPE: MARKET, BY COUNTRY, 2023–2028 (USD MILLION)
  • TABLE 61 EUROPE: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 62 EUROPE: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 63 EUROPE: MARKET, BY TECHNOLOGY, 2019–2022 (USD MILLION)
  • TABLE 64 EUROPE: MARKET, BY TECHNOLOGY, 2023–2028 (USD MILLION)
  • TABLE 65 GERMANY: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 66 GERMANY: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 67 UK: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 68 UK: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 69 FRANCE: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 70 FRANCE: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 71 ITALY: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 72 ITALY: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 73 SPAIN: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 74 SPAIN: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 75 REST OF EUROPE: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 76 REST OF EUROPE: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 77 ASIA PACIFIC: MARKET, BY COUNTRY, 2019–2022 (USD MILLION)
  • TABLE 78 ASIA PACIFIC: MARKET, BY COUNTRY, 2023–2028 (USD MILLION)
  • TABLE 79 ASIA PACIFIC: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 80 ASIA PACIFIC: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 81 ASIA PACIFIC: MARKET, BY TECHNOLOGY, 2019–2022 (USD MILLION)
  • TABLE 82 ASIA PACIFIC: MARKET, BY TECHNOLOGY, 2023–2028 (USD MILLION)
  • TABLE 83 CHINA: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 84 CHINA: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 85 JAPAN: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 86 JAPAN: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 87 INDIA: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 88 INDIA: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 89 SOUTH KOREA: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 90 SOUTH KOREA: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 91 AUSTRALIA: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 92 AUSTRALIA: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 93 REST OF ASIA PACIFIC: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 94 REST OF ASIA PACIFIC: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 95 ROW: MARKET, BY REGION, 2019–2022 (USD MILLION)
  • TABLE 96 ROW: MARKET, BY REGION, 2023–2028 (USD MILLION)
  • TABLE 97 ROW: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 98 ROW: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 99 ROW: MARKET, BY TECHNOLOGY, 2019–2022 (USD MILLION)
  • TABLE 100 ROW: MARKET, BY TECHNOLOGY, 2023–2028 (USD MILLION)
  • TABLE 101 SOUTH AMERICA: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 102 SOUTH AMERICA: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 103 MIDDLE EAST & AFRICA: MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)
  • TABLE 104 MIDDLE EAST & AFRICA: MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)
  • TABLE 105 OVERVIEW OF STRATEGIES ADOPTED BY KEY PLAYERS IN MARKET
  • TABLE 106 MARKET: MARKET SHARE ANALYSIS, 2022
  • TABLE 107 MARKET: SERVICE LAUNCHES/DEVELOPMENTS, 2020–2023
  • TABLE 108 MEDICAL DEVICE TESTING MARKET: DEALS, 2020–2023
  • TABLE 109 SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA: COMPANY OVERVIEW
  • TABLE 110 SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA: PRODUCTS/SERVICES/SOLUTIONS OFFERED
  • TABLE 111 SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA: DEALS
  • TABLE 112 SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA: OTHERS
  • TABLE 113 EUROFINS SCIENTIFIC: COMPANY OVERVIEW
  • TABLE 114 EUROFINS SCIENTIFIC: PRODUCTS/SERVICES/SOLUTIONS OFFERED
  • TABLE 115 EUROFINS SCIENTIFIC: DEALS
  • TABLE 116 BUREAU VERITAS: COMPANY OVERVIEW
  • TABLE 117 BUREAU VERITAS: PRODUCTS/SERVICES/SOLUTIONS OFFERED
  • TABLE 118 BUREAU VERITAS: DEALS
  • TABLE 119 TÜV RHEINLAND: COMPANY OVERVIEW
  • TABLE 120 TÜV RHEINLAND: PRODUCTS/SERVICES/SOLUTIONS OFFERED
  • TABLE 121 TÜV RHEINLAND: DEALS
  • TABLE 122 TÜV RHEINLAND: OTHERS
  • TABLE 123 TÜV SÜD: COMPANY OVERVIEW
  • TABLE 124 TÜV SÜD: PRODUCTS/SERVICES/SOLUTIONS OFFERED
  • TABLE 125 TÜV SÜD: OTHERS
  • TABLE 126 DEKRA: COMPANY OVERVIEW
  • TABLE 127 DEKRA: PRODUCTS/SERVICES/SOLUTIONS OFFERED
  • TABLE 128 DEKRA: OTHERS
  • TABLE 129 UL LLC: COMPANY OVERVIEW
  • TABLE 130 UL LLC: PRODUCTS/SERVICES/SOLUTIONS OFFERED
  • TABLE 131 UL LLC: DEALS
  • TABLE 132 ASTM: COMPANY OVERVIEW
  • TABLE 133 ASTM: PRODUCTS/SERVICES/SOLUTIONS OFFERED
  • TABLE 134 ASTM: PRODUCT/SERVICE LAUNCHES
  • TABLE 135 INTERTEK GROUP PLC: COMPANY OVERVIEW
  • TABLE 136 INTERTEK GROUP PLC: PRODUCTS/SERVICES/SOLUTIONS OFFERED
  • TABLE 137 INTERTEK GROUP PLC: PRODUCT/SERVICE LAUNCHES
  • TABLE 138 SOTERA HEALTH: COMPANY OVERVIEW
  • TABLE 139 SOTERA HEALTH: PRODUCTS/SERVICES/SOLUTIONS OFFERED
  • TABLE 140 SOTERA HEALTH: PRODUCT/SERVICE LAUNCHES
  • TABLE 141 SOTERA HEALTH: DEALS
  • TABLE 142 SOTERA HEALTH: OTHERS
LIST OF FIGURES
 
  • FIGURE 1 MEDICAL DEVICE TESTING MARKET: MARKET SEGMENTATION
  • FIGURE 2 MARKET: RESEARCH DESIGN
  • FIGURE 3 PROCESS FLOW OF MARKET SIZE ESTIMATION
  • FIGURE 4 MARKET SIZE ESTIMATION: BOTTOM-UP APPROACH
  • FIGURE 5 MARKET SIZE ESTIMATION: TOP-DOWN APPROACH
  • FIGURE 6 MARKET SIZE ESTIMATION: TOP-DOWN APPROACH (SUPPLY SIDE)—REVENUE GENERATED FROM MEDICAL DEVICE TESTING SERVICES
  • FIGURE 7 DATA TRIANGULATION
  • FIGURE 8 ASSUMPTIONS FOR RESEARCH STUDY
  • FIGURE 9 LIMITATIONS FOR RESEARCH STUDY
  • FIGURE 10 IVD MEDICAL DEVICES SEGMENT TO CAPTURE LARGEST SHARE OF MARKET IN 2028
  • FIGURE 11 TESTING SERVICES TO COMMAND LARGEST SHARE OF MARKET IN 2028
  • FIGURE 12 IN-HOUSE SEGMENT TO ACCOUNT FOR LARGER SHARE OF MARKET FROM 2023 TO 2028
  • FIGURE 13 NORTH AMERICA ACCOUNTED FOR LARGEST SHARE OF MARKET IN 2022
  • FIGURE 14 STRINGENT REGULATORY STANDARDS PERTAINING TO MEDICAL DEVICES TO BOOST MARKET GROWTH
  • FIGURE 15 TESTING SERVICES SEGMENT TO COMMAND LARGEST SHARE OF MARKET IN 2028
  • FIGURE 16 ACTIVE IMPLANT MEDICAL DEVICES SEGMENT TO REGISTER HIGHEST CAGR FROM 2023 TO 2028
  • FIGURE 17 IN-HOUSE SEGMENT TO ACCOUNT FOR LARGER SHARE OF MARKET FROM 2023 TO 2028
  • FIGURE 18 CLASS III SEGMENT TO REGISTER HIGHEST CAGR IN MARKET FROM 2023 TO 2028
  • FIGURE 19 IVD MEDICAL DEVICES AND US HELD LARGEST SHARE OF MARKET IN NORTH AMERICA IN 2022
  • FIGURE 20 MARKET IN INDIA TO GROW AT FASTEST RATE DURING FORECAST PERIOD
  • FIGURE 21 DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES: MEDICAL DEVICE TESTING MARKET
  • FIGURE 22 ANALYSIS OF IMPACT OF DRIVERS ON MARKET
  • FIGURE 23 ANALYSIS OF IMPACT OF RESTRAINT ON MARKET
  • FIGURE 24 ANALYSIS OF IMPACT OF OPPORTUNITIES ON MARKET
  • FIGURE 25 ANALYSIS OF IMPACT OF CHALLENGES ON MARKET
  • FIGURE 26 MARKET: VALUE CHAIN ANALYSIS
  • FIGURE 27 MARKET: KEY PLAYERS IN ECOSYSTEM
  • FIGURE 28 TRENDS/DISRUPTIONS IMPACTING CUSTOMER BUSINESS
  • FIGURE 29 CERTIFICATION SERVICES SEGMENT TO EXHIBIT HIGHEST CAGR IN MARKET DURING FORECAST PERIOD
  • FIGURE 30 OUTSOURCED SEGMENT TO REGISTER HIGHEST CAGR IN MARKET DURING FORECAST PERIOD
  • FIGURE 31 CLASS III SEGMENT TO DOMINATE MEDICAL TESTING MARKET DURING FORECAST PERIOD
  • FIGURE 32 IVD MEDICAL DEVICES SEGMENT TO DOMINATE MARKET DURING FORECAST PERIOD
  • FIGURE 33 ASIA PACIFIC TO EXHIBIT HIGHEST CAGR IN MARKET DURING FORECAST PERIOD
  • FIGURE 34 NORTH AMERICA: MARKET SNAPSHOT
  • FIGURE 35 EUROPE: MARKET SNAPSHOT
  • FIGURE 36 ASIA PACIFIC: MARKET SNAPSHOT
  • FIGURE 37 FIVE-YEAR REVENUE ANALYSIS OF TOP PLAYERS IN MARKET
  • FIGURE 38 MEDICAL DEVICE TESTING MARKET (GLOBAL): COMPANY EVALUATION MATRIX, 2022
  • FIGURE 39 SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA: COMPANY SNAPSHOT
  • FIGURE 40 EUROFINS SCIENTIFIC: COMPANY SNAPSHOT
  • FIGURE 41 BUREAU VERITAS: COMPANY SNAPSHOT
  • FIGURE 42 TÜV RHEINLAND: COMPANY SNAPSHOT
  • FIGURE 43 TÜV SÜD: COMPANY SNAPSHOT
  • FIGURE 44 DEKRA: COMPANY SNAPSHOT
  • FIGURE 45 INTERTEK GROUP PLC: COMPANY SNAPSHOT
  • FIGURE 46 SOTERA HEALTH: COMPANY SNAPSHOT

 

The study involved four major activities in estimating the current size of the medical device testing market. Exhaustive secondary research was done to collect information on the market, peer, and parent markets. The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the complete market size. After that, market breakdown and data triangulation were used to estimate the market size of segments and subsegments.

Secondary Research

Various secondary sources have been referred to in the secondary research process for identifying and collecting information important for this study. The secondary sources include annual reports, press releases, and investor presentations of companies; white papers; journals and certified publications; and articles from recognized authors, websites, directories, and databases. Secondary research has been conducted to obtain key information about the industry’s supply chain, the market’s value chain, the total pool of key players, market segmentation according to the industry trends (to the bottom-most level), regional markets, and key developments from market- and technology-oriented perspectives. The secondary data has been collected and analyzed to determine the overall market size, further validated by primary research.

List of major secondary sources

Sources

Web Link

International Organization for Standardization (ISO)

https://www.iso.org/home.html

Canadian Standards Association (CSA)

https://www.csagroup.org/

International Safe Transit Association (ISTA)

https://ista.org/

American Society for Testing Materials (ASTM)

https://www.astm.org/

American National Standards Institute (ANSI)

https://www.ansi.org/

Hong Kong Certification Body Accreditation Scheme (HKCAS)

https://www.itc.gov.hk/

Hong Kong Inspection Body Accreditation Scheme (HKIAS)

https://www.itc.gov.hk/

World Bank Group

https://www.worldbank.org/

Primary Research

Extensive primary research was conducted after gaining knowledge about the current scenario of the medical device testing market through secondary research. Several primary interviews were conducted with experts from both the demand and supply sides across four major regions—North America, Europe, Asia Pacific, and RoW. This primary data was collected through questionnaires, emails, and telephonic interviews.

Medical Device Testing Market Size, and Share

To know about the assumptions considered for the study, download the pdf brochure

Market Size Estimation

In the complete market engineering process, both top-down and bottom-up approaches have been used, along with several data triangulation methods, to perform market estimation and forecasting for the overall market segments and subsegments listed in this report. Key players in the market have been identified through secondary research, and their market shares in the respective regions have been determined through primary and secondary research. This entire procedure includes the study of annual and financial reports of the top market players and extensive interviews for key insights (quantitative and qualitative) with industry experts (CEOs, VPs, directors, and marketing executives).

All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources. All the parameters affecting the markets covered in this research study have been accounted for, viewed in detail, verified through primary research, and analyzed to obtain the final quantitative and qualitative data. This data has been consolidated and supplemented with detailed inputs and analysis from MarketsandMarkets and presented in this report. The following figure represents this study’s overall market size estimation process.

Bottom-Up Approach

The bottom-up approach was used to arrive at the overall size of the medical device testing market from the revenues of the key players and their shares in the market. The overall market size was calculated based on the revenues of the key players identified in the market.

  • Identifying the entities in the medical device testing market influencing the entire market, along with the related component players
  • Analyzing major providers of medical device testing services, studying their portfolios, and understanding different types of products based on features and functions
  • Analyzing trends pertaining to the usage of medical device testing offerings, such as hardware, software, and services
  • Tracking the ongoing and upcoming developments in the market, such as investments made, R&D activities, product launches, collaborations, and partnerships, and forecasting the market size based on these developments and other critical parameters
  • Carrying out multiple discussions with key opinion leaders to understand the different types of medical device testing; and offerings, vertical, and recent trends in the market, analyzing the breakup of the scope of work carried out by major manufacturing companies
  • Arriving at the market estimates by analyzing segment revenues of these companies generated by medical device testing offerings and then combining the same to get the market estimate by different segments
  • Verifying and cross-checking the estimate at every level by discussing with key opinion leaders, such as Chief Experience Officers (CXOs), directors, and operations managers, and finally with the domain experts at MarketsandMarkets
  • Studying various paid and unpaid sources of information, such as annual reports, press releases, white papers, Factiva, and databases

Medical Device Testing Market Size, and Bottom-Up Approach

Top-Down Approach

In the top-down approach, the overall market size has been used to estimate the size of individual markets (mentioned in the market segmentation) through percentage splits from secondary and primary research.

The most appropriate immediate parent market size has been used to implement the top-down approach to calculate the market size of specific segments. The top-down approach has been implemented for the data extracted from the secondary research to validate the market size obtained.

Each company’s market share has been estimated to verify the revenue shares used earlier in the top-down approach. This study has determined and confirmed the overall parent market and individual market sizes by the data triangulation method and data validation through primaries. The data triangulation method in this study is explained in the next section.

  • Focusing on top-line investments and expenditures being made in the ecosystems of various verticals, listing key developments, analyzing updated technology in the marketplace, and evaluating the market by further splitting it into different technology
  • Building and developing the information related to the market revenue generated by key medical device testing tools manufacturers
  • Conducting multiple on-field discussions with the key opinion leaders involved in the development of medical device testing products in various verticals
  • Estimating geographic splits using secondary sources based on various factors, such as the number of players in a specific country and region, the offerings of medical device testing, and the level of solutions offered in different verticals
  • The impact of the recession on the steps mentioned above.

Medical Device Testing Market Size, and Top-Down Approach

Data Triangulation

After arriving at the overall market size from the estimation process explained above, the overall market has been split into several segments and subsegments. The data triangulation procedure has been employed wherever applicable to complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments. The data has been triangulated by studying various factors and trends from both the demand and supply sides. Additionally, the market size has been validated using top-down and bottom-up approaches.

Market Definition

Medical device testing services are provided to help manufacturers improve their productivity, meet the global standards, and enhance the quality of medical devices. Services such as audit, inspection, verification, certification, and testing can be applied to any medical device, service, or company, involved in medical devices. These services aim to assure the end users and consumers that the manufacturer has followed national and international regulations and industry standards to ensure quality, public health, and safety.

Key Stakeholders

  • Raw material and testing equipment suppliers
  • Research organizations
  • Original equipment manufacturers (OEMs)
  • Technology standards organizations, forums, alliances, and associations
  • Technology investors
  • Analysts and strategic business planners
  • Government bodies, venture capitalists, and private equity firms
  • Market Research and Consulting Firms
  • Technology Investors
  • Governments, Regulatory Bodies, and Financial Institutions
  • Venture Capitalists, Private Equity Firms, and Startups

Report Objectives

  • To describe and forecast the medical device testing market, in terms of value, based on service type, sourcing type, device class and, technology.
  • To forecast the market size, in terms of value, for various segments with regard to 4 main regions, namely, North America, Europe, Asia Pacific (APAC), and the Rest of the World (RoW)
  • To provide detailed information regarding the major factors influencing the growth of the medical device testing market (drivers, restraints, opportunities, and industry-specific challenges)
  • To analyze the micromarkets1 with respect to individual growth trends, prospects, and contributions to the total market
  • To study the complete value chain and allied industry segments, and perform a value chain analysis of the medical device testing landscape
  • To analyze the opportunities in the market for various stakeholders by identifying the high-growth segments of the medical device testing market
  • To profile the key players and comprehensively analyze their market position in terms of ranking and core competencies2, along with detailing the competitive landscape for the market leaders
  • To analyze competitive developments, such as partnerships and joint ventures, mergers and acquisitions, new product developments, expansions, and research and development, in the medical device testing market
  • To track and analyze competitive developments, such as partnerships, collaborations, agreements, joint ventures, mergers and acquisitions, expansions, product/service launches, and other developments in the market

Available Customizations

With the given market data, MarketsandMarkets offers customizations according to the specific requirements of companies. The following customization options are available for the report:

  • Detailed analysis and profiling of additional market players (up to 5)
  • Additional country-level analysis of the medical device testing market

Product Analysis

  • Product matrix, which provides a detailed comparison of the product portfolio of each company in the medical device testing market.

Previous Versions of this Report

Medical Device Testing Market with COVID-19 impact, By Services (Testing, Inspection , Certification), Sourcing , Technology (Active Implant, IVD, Orthopedic & Dental, Opthalmic, Vascular), Class, Testing, Region) - Global Forecast to 2025

Report Code SE 5802
Published in Aug, 2020, By MarketsandMarkets™

Medical Device Testing Market with COVID-19 impact, By Services (Testing, Inspection , Certification), Sourcing , Technology (Active Implant, IVD, Orthopedic & Dental, Opthalmic, Vascular), Class, Testing, Region) - Global Forecast to 2025

Report Code SE 5802
Published in Dec, 2017, By MarketsandMarkets™
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