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市场调查报告书
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1467594

2024-2032 年医疗器材测试市场报告(按服务、类型、测试类型、设备类别、设备类型和地区)

Medical Device Testing Market Report by Service, Type, Testing Type, Device Class, Device Type, and Region 2024-2032

出版日期: | 出版商: IMARC | 英文 138 Pages | 商品交期: 2-3个工作天内

价格

IMARC Group年,全球医疗器材测试市场规模达125亿美元。严格的监管要求、重大的技术进步、对病人安全的日益重视、医疗器材製造商对新兴市场的渗透率不断提高、医疗器材的复杂性不断增加以及持续的竞争压力是推动市场的一些主要因素。

医疗器械测试是指检查各种有源和非有源医疗设备的设计和生产效率的过程。它涉及原型、生物相容性、化学、微生物学和无菌测试、包装验证、电气、机械和功能安全评估以及软体测试。这些测试针对心血管、神经和骨科设备、牙科植体和材料组件进行。服务提供者也向消费者提供内部或外包的测试、检验和认证服务。这些服务确保设备在临床或紧急情况下可靠且安全地使用。因此,医疗设备测试在医院、诊所以及其他医疗保健和诊断中心都得到了广泛的应用。

医疗设备製造商对新兴市场的渗透率不断提高,促进了测试需求,以符合多个司法管辖区的各种监管环境。此外,设备(包括多组件系统和软体整合设备)日益复杂,需要复杂的测试协议,这是另一个成长诱导因素。此外,持续的竞争压力促使公司获得与竞争对手区分开来的认证和标准,这有利于市场成长。除此之外,广泛采用测试作为主动风险管理策略,以保护公司免于支付因设备故障或失效而产生的高额诉讼费用,这正在支持市场成长。此外,全球医疗保健支出的激增扩大了对有品质保证的医疗设备的需求,对市场成长产生了积极影响。

医疗器材测试市场趋势/驱动因素:

施加严格的监管要求

不断变化的监管要求是推动市场成长的一个突出因素。全球各地的组织制定了严格的标准来维护医疗设备的安全性和有效性。此外,遵守这些标准和法规不仅是一项行政义务,而是直接影响公众健康的严格措施。此外,这些要求有助于确保任何设备在进入市场时都必须经过一系列严格的测试,以验证其安全性、有效性和整体品质。除此之外,不满足这些要求可能会导致经济处罚、法律后果以及对製造商声誉的不可逆转的损害。因此,监管合规性是医疗器材行业任何公司的一个重要关注点,导致他们分配大量资源进行测试。

重大技术进步

医疗器材产业技术进步的显着步伐是推动市场成长的一个突出因素。设备变得越来越复杂,包含从即时监控到人工智慧 (AI) 驱动的诊断等各种功能。这种复杂性促进了对专业测试服务的需求,以确保其有效性、安全性和可靠性。此外,穿戴式科技、远距医疗和个人化医疗的出现,结合了复杂的演算法、资料储存功能,甚至使用者介面元件,正在推动对一组特定测试的需求,以确保其稳健性和可靠性。此外,能够跟上新兴技术复杂性的新型测试方法的开发是另一个成长诱导因素。

对病人安全的日益重视

病人安全是医疗器材测试市场的关键驱动力。医疗机构和消费者越来越意识到设备故障的影响。有缺陷的医疗设备的影响可能是毁灭性的,从错误的诊断到潜在危及生命的併发症。医疗器材测试在确保病人安全方面发挥着至关重要的作用,因为它提供了额外的保证,减少了与器械相关的事件的可能性。此外,由于政府和监管机构对病人安全实施严格监管,医疗器材测试的重要性日益凸显,这也支撑了市场的成长。除此之外,患者本身也变得更加了解情况,并开始要求更高的护理标准。因此,医疗器材生产商面临越来越大的压力,需要投资严格和广泛的测试协议。

目录

第一章:前言

第 2 章:范围与方法

  • 研究目的
  • 利害关係人
  • 资料来源
    • 主要资源
    • 二手资料
  • 市场预测
    • 自下而上的方法
    • 自上而下的方法
  • 预测方法

第 3 章:执行摘要

第 4 章:简介

  • 概述
  • 主要行业趋势

第 5 章:全球医疗器材测试市场

  • 市场概况
  • 市场业绩
  • COVID-19 的影响
  • 市场预测

第 6 章:市场区隔:按服务

  • 测试服务
    • 市场走向
    • 市场预测
  • 检验服务
    • 市场走向
    • 市场预测
  • 其他的
    • 市场走向
    • 市场预测

第 7 章:市场区隔:按类型

  • 内部
    • 市场走向
    • 市场预测
  • 外包
    • 市场走向
    • 市场预测

第 8 章:市场区隔:按测试类型

  • 生物相容性测试
    • 市场走向
    • 市场预测
  • 化学测试
    • 市场走向
    • 市场预测
  • 生物负荷测定
    • 市场走向
    • 市场预测
  • 抗菌活性和无菌测试
    • 市场走向
    • 市场预测
  • 其他的
    • 市场走向
    • 市场预测

第 9 章:市场区隔:按设备类别

  • Ⅰ类
    • 市场走向
    • 市场预测
  • 二级
    • 市场走向
    • 市场预测
  • 三级
    • 市场走向
    • 市场预测

第 10 章:市场区隔:依设备类型

  • 植入式医疗器材
    • 市场走向
    • 市场预测
  • 被动医疗器材
    • 市场走向
    • 市场预测
  • 体外诊断医疗器材
    • 市场走向
    • 市场预测
  • 眼科医疗器材
    • 市场走向
    • 市场预测
  • 其他的
    • 市场走向
    • 市场预测

第 11 章:市场区隔:按地区

  • 北美洲
    • 美国
      • 市场走向
      • 市场预测
    • 加拿大
      • 市场走向
      • 市场预测
  • 亚太
    • 中国
      • 市场走向
      • 市场预测
    • 日本
      • 市场走向
      • 市场预测
    • 印度
      • 市场走向
      • 市场预测
    • 韩国
      • 市场走向
      • 市场预测
    • 澳洲
      • 市场走向
      • 市场预测
    • 印尼
      • 市场走向
      • 市场预测
    • 其他的
      • 市场走向
      • 市场预测
  • 欧洲
    • 德国
      • 市场走向
      • 市场预测
    • 法国
      • 市场走向
      • 市场预测
    • 英国
      • 市场走向
      • 市场预测
    • 义大利
      • 市场走向
      • 市场预测
    • 西班牙
      • 市场走向
      • 市场预测
    • 俄罗斯
      • 市场走向
      • 市场预测
    • 其他的
      • 市场走向
      • 市场预测
  • 拉丁美洲
    • 巴西
      • 市场走向
      • 市场预测
    • 墨西哥
      • 市场走向
      • 市场预测
    • 其他的
      • 市场走向
      • 市场预测
  • 中东和非洲
    • 市场走向
    • 市场细分:按国家/地区
    • 市场预测

第 12 章:SWOT 分析

  • 概述
  • 优势
  • 弱点
  • 机会
  • 威胁

第 13 章:价值链分析

第 14 章:波特五力分析

  • 概述
  • 买家的议价能力
  • 供应商的议价能力
  • 竞争程度
  • 新进入者的威胁
  • 替代品的威胁

第 15 章:价格分析

第16章:竞争格局

  • 市场结构
  • 关键参与者
  • 关键参与者简介
    • American Preclinical Services LLC
    • Charles River Laboratories International Inc.
    • Element Materials Technology
    • Eurofins Scientific LLC
    • Intertek Group Plc
    • North American Science Associates Inc.
    • Pace Analytical Services LLC (LAB Holdings Inc.)
    • SGS SA
    • Sterigenics US LLC (Sotera Health LLC)
    • Toxikon Corporation
    • TUV Rheinland Aktiengesellschaft
    • TUV SUD Aktiengesellschaft
    • WuXi AppTec
Product Code: SR112024A3343

The global medical device testing market size reached US$ 12.5 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 21.1 Billion by 2032, exhibiting a growth rate (CAGR) of 5.8% during 2024-2032. The imposition of strict regulatory requirements, significant technological advancements, growing emphasis on patient safety, increasing penetration of medical device manufacturer into emerging markets, rising complexity of medical devices, and ongoing competitive pressure are some of the major factors propelling the market.

Medical device testing refers to the process of inspecting the design and production efficiency of various active and non-active medical equipment. It involves prototype, biocompatibility, chemistry, microbiology and sterility testing, package validation, electrical, mechanical and functional safety assessments and software testing. These tests are conducted for cardiovascular, neuro and orthopedic devices, dental implants and material components. The service providers also offer in-house or outsourced testing, inspection and certification services to the consumers. These services ensure that the device is reliable and safe to use in clinical or emergency settings. As a result, medical device testing finds extensive applications across hospitals, clinics and other healthcare and diagnostic centers.

The increasing penetration of emerging markets by medical device manufacturers is facilitating the testing demand to comply with a diverse array of regulatory environments across multiple jurisdictions. Additionally, the rising complexity of devices, including multi-component systems and software-integrated devices, which calls for intricate testing protocols, is acting as another growth-inducing factor. Furthermore, the ongoing competitive pressure, which drives companies to achieve certifications and standards that distinguish them from competitors, is favoring the market growth. Besides this, the widespread testing adoption as a proactive risk management strategy to safeguard companies from paying high litigation costs arising from device malfunction or failures is supporting the market growth. Moreover, the surge in global healthcare expenditure, which amplifies the demand for quality-assured medical devices, is positively influencing the market growth.

Medical Device Testing Market Trends/Drivers:

The imposition of strict regulatory requirements

The evolving landscape of regulatory requirements is a prominent factor driving the market growth. Organizations across the globe have set forth stringent standards to maintain the safety and efficacy of medical devices. Furthermore, complying with such standards and regulations is not merely an administrative obligation but a strict measure that directly impacts public health. In addition, these requirements help to ensure that no device reaches the market without passing through a rigorous series of tests that verify its safety, effectiveness, and overall quality. Apart from this, the failure to meet these requirements can result in financial penalties, legal repercussions, and irreversible damage to the manufacturer's reputation. As a result, regulatory compliance is a significant focus for any company in the medical device sector, leading them to allocate substantial resources to testing.

The significant technological advancements

The significant pace of technological advancements in the medical device industry is a prominent factor contributing to the market growth. Devices are becoming more intricate, encompassing a variety of functionalities from real-time monitoring to artificial intelligence (AI)-driven diagnostics. This complexity is facilitating the demand for specialized testing services that ensure its efficacy, safety, and reliability. Furthermore, the advent of wearable technology, telemedicine, and personalized medicine, which incorporates complex algorithms, data storage capabilities, and even user interface components, is fueling the demand for a specific set of tests to ensure their robustness and reliability. Additionally, the development of novel testing methodologies that can keep pace with the complexity of emerging technologies is acting as another growth-inducing factor.

The growing emphasis on patient safety

Patient safety serves as a critical driver for the medical device testing market. Healthcare institutions and consumers are becoming increasingly aware of the implications of device malfunctions. The impact of a defective medical device can be devastating, ranging from incorrect diagnosis to potentially life-threatening complications. Medical device testing plays a critical role in ensuring patient safety as it provides an added layer of assurance, reducing the likelihood of device-related incidents. Furthermore, the heightened importance of medical device testing due to the imposition of strict regulation by governments and regulatory bodies regarding patient safety is supporting the market growth. Besides this, patients themselves are becoming more informed and are beginning to demand higher standards of care. As a result, medical device producers are facing increasing pressure to invest in rigorous and extensive testing protocols.

Medical Device Testing Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global medical device testing market report, along with forecasts at the global, regional and country levels for 2024-2032. Our report has categorized the market based on service, type, testing type, device class, and device type.

Breakup by Service:

Testing Services

Inspection Services

Others

Testing services dominates the market

The report has provided a detailed breakup and analysis of the market based on service. This includes testing services, inspection services, and others. According to the report, testing services represented the largest segment.

Testing services are dominating the market as medical device manufacturers must adhere to rigorous standards set by regulatory agencies, which necessitates comprehensive testing services to ensure compliance. Additionally, the increasing complexity of medical device design, integrating hardware, software, and sometimes bio-components, requires a broad range of specialized testing services. Furthermore, comprehensive testing is essential for mitigating risks associated with device malfunctions, which could lead to patient harm and legal consequences for manufacturers. Besides this, possessing a thoroughly tested product can serve as a competitive advantage, allowing manufacturers to differentiate themselves in a crowded market based on quality and reliability.

Breakup by Type:

In-House

Outsourced

In-house holds the largest share in the market

A detailed breakup and analysis of the market based on the type has also been provided in the report. This includes in-house and outsourced. According to the report, in-house represented the largest segment.

In-house testing allows manufacturers to maintain strict control over their intellectual property, reducing the risk of information leaks that could occur when outsourcing to third-party services. Additionally, manufacturers have the flexibility to develop customized testing protocols that are tailored specifically to their devices, enabling more precise and relevant evaluations. Besides this, conducting tests in-house often results in quicker turnaround times, allowing for faster iterations and shorter time-to-market for new products. Moreover, possessing an in-house testing facility provides greater control over the quality of testing procedures and equipment, ensuring consistency and reliability in results. Apart from this, in-house testing allows for easier integration of testing data with other internal systems, such as design and manufacturing, facilitating a more cohesive product development process.

Breakup by Testing Type:

Biocompatibility Testing

Chemistry Testing

Bio-Burden Determination

Anti-Microbial Activity and Sterility Testing

Others

Anti-microbial activity and sterility testing holds the largest share in the market

A detailed breakup and analysis of the market based on testing type has also been provided in the report. This includes biocompatibility testing, chemistry testing, bio-burden determination, anti-microbial activity and sterility testing, and others. According to the report, anti-microbial activity and sterility testing accounted for the largest market share.

Anti-microbial activity and sterility testing are dominating the market as it is a non-negotiable aspect of medical devices that come into contact with the human body. Any microbial contamination could lead to severe infections, making anti-microbial and sterility testing critical for patient safety. Furthermore, the imposition of stringent guidelines for sterility and anti-microbial properties by regulatory bodies is acting as another growth-inducing factor. Besides this, all categories of medical devices, from surgical instruments to implantable devices, require sterility. Hence, the applicability of this testing type is vast, driving its dominance in the market. Moreover, the rising demand for sterility and anti-microbial testing owing to the heightened awareness and concern about healthcare-associated infections (HAIs) is contributing to the market growth.

Breakup by Device Class:

Class I

Class II

Class III

Class II hold the largest share in the market

A detailed breakup and analysis of the market based on the device class has also been provided in the report. This includes class I, class II, and class III. According to the report, class II represented the largest segment.

Class II devices make up a large proportion of the medical devices produced and used. Their sheer volume drives a higher demand for testing services. Furthermore, they are often more complex than Class I devices, which necessitates a broad range of testing services, such as mechanical, electrical, and biocompatibility tests. Additionally, Class II devices carry moderate risks and, therefore, require more comprehensive testing compared to low-risk Class I devices, thus increasing the demand for specialized testing services. Besides this, the class II segment is a hotbed for technological innovation, which continually introduces new types of devices or updates to existing ones. Moreover, they have prolonged contact with patients, which imposes additional requirements for safety and effectiveness testing.

Breakup by Device Type:

Implantable Medical Devices

Non-Active Medical Devices

In-Vitro Diagnostic Medical Devices

Ophthalmic Medical Devices

Others

A detailed breakup and analysis of the market based on the device type has also been provided in the report. This includes implantable medical devices, non-active medical devices, in-vitro diagnostic medical devices, ophthalmic medical devices, and others.

Implantable medical devices often fall under the highest risk classification in regulatory frameworks due to their critical role in patient health. This necessitates rigorous and extensive testing to ensure safety and efficacy. Furthermore, the complexity of implantable devices, which often feature electronic components, biocompatible materials, and even software, requires a broader range of testing services. Moreover, implantable medical devices are designed to function over extended periods, sometimes for a lifetime. This long-term application requires exhaustive durability and reliability testing.

Non-active medical devices, such as surgical instruments, catheters, and syringes, are produced in higher volumes, which drives a substantial need for testing. Furthermore, they are used across various healthcare settings, including hospitals, clinics, and home care, making their market considerably large and diverse. The wide range of applications calls for versatile testing protocols. Additionally, non-active medical devices are subject to stringent regulatory guidelines concerning material safety, sterility, and mechanical reliability, which necessitates comprehensive testing.

Breakup by Region:

North America

United States

Canada

Asia-Pacific

China

Japan

India

South Korea

Australia

Indonesia

Others

Europe

Germany

France

United Kingdom

Italy

Spain

Russia

Others

Latin America

Brazil

Mexico

Others

Middle East and Africa

The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia-Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa.

North America has one of the most stringent regulatory environments that are pushing companies to invest heavily in comprehensive evaluation processes. This regulatory stringency naturally elevates the demand for advanced testing services. Furthermore, the region is a hub for technological innovation, housing numerous high-tech companies, research institutions, and startups focusing on medical devices. The fast-paced development of new technologies necessitates equally advanced testing services, creating a thriving market. Additionally, North America accounts for a significant proportion of global healthcare spending. The substantial investment in healthcare infrastructure and medical technology feeds into the need for extensive and specialized medical device testing.

Asia-Pacific is experiencing rapid economic growth, which translates into increased healthcare expenditure. This surge in healthcare spending fuels the need for a diverse array of medical devices and, consequently, their testing. Furthermore, the region is undergoing significant expansion in healthcare infrastructure, including hospitals and clinics, which creates a burgeoning demand for certified medical devices and testing services. Additionally, the imposition of various policies by regional governments to strengthen medical device regulations is propelling the market growth.

Competitive Landscape:

Top market players are developing cutting-edge testing technologies, such as automation and artificial intelligence (AI) algorithms, that increase testing efficiency and reliability. Furthermore, they are establishing new testing facilities or forming partnerships with local entities to broaden their geographical reach. Additionally, leading companies are working closely with regulatory agencies to ensure that their testing protocols meet or exceed current standards. Apart from this, they are offering specialized testing services, such as biocompatibility testing, electrical safety testing, and mechanical testing, to cater to the diverse needs of clients. Moreover, major players are obtaining international certifications and accreditations to enhance their credibility and build trust among consumers. Along with this, they are adopting a more customer-focused approach, offering tailored solutions that meet the specific needs of individual clients, including after-service support and consultancy.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

American Preclinical Services LLC

Charles River Laboratories International Inc.

Element Materials Technology

Eurofins Scientific LLC

Intertek Group Plc

North American Science Associates Inc.

Pace Analytical Services LLC (LAB Holdings Inc.)

SGS SA

Sterigenics U.S. LLC (Sotera Health LLC)

Toxikon Corporation

TUV Rheinland Aktiengesellschaft

TUV SUD Aktiengesellschaft

WuXi AppTec.

Recent Developments:

In June 2020, Intertek Group Plc announced that it is expanding its personal protective equipment (PPE) services to include pre-certification testing of N95 respirators.

In March 2021, American Preclinical Services LLC was acquired by NAMSA, a long-standing leader in the medical device testing industry, to expand its portfolio of preclinical solutions.

In July 2021, Charles River Laboratories International Inc. announced a site expansion plan in Ballina to facilitate batch release testing for Covid-19 vaccines.

Key Questions Answered in This Report

  • 1. What was the size of the global medical device testing market in 2023?
  • 2. What is the expected growth rate of the global medical device testing market during 2024-2032?
  • 3. What are the key factors driving the global medical device testing market?
  • 4. What has been the impact of COVID-19 on the global medical device testing market?
  • 5. What is the breakup of the global medical device testing market based on the service?
  • 6. What is the breakup of the global medical device testing market based on the type?
  • 7. What is the breakup of the global medical device testing market based on the testing type?
  • 8. What is the breakup of the global medical device testing market based on the device class?
  • 9. What are the key regions in the global medical device testing market?
  • 10. Who are the key players/companies in the global medical device testing market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Medical Device Testing Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Service

  • 6.1 Testing Services
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Inspection Services
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast
  • 6.3 Others
    • 6.3.1 Market Trends
    • 6.3.2 Market Forecast

7 Market Breakup by Type

  • 7.1 In-House
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Outsourced
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast

8 Market Breakup by Testing Type

  • 8.1 Biocompatibility Testing
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Chemistry Testing
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Bio-Burden Determination
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast
  • 8.4 Anti-Microbial Activity and Sterility Testing
    • 8.4.1 Market Trends
    • 8.4.2 Market Forecast
  • 8.5 Others
    • 8.5.1 Market Trends
    • 8.5.2 Market Forecast

9 Market Breakup by Device Class

  • 9.1 Class I
    • 9.1.1 Market Trends
    • 9.1.2 Market Forecast
  • 9.2 Class II
    • 9.2.1 Market Trends
    • 9.2.2 Market Forecast
  • 9.3 Class III
    • 9.3.1 Market Trends
    • 9.3.2 Market Forecast

10 Market Breakup by Device Type

  • 10.1 Implantable Medical Devices
    • 10.1.1 Market Trends
    • 10.1.2 Market Forecast
  • 10.2 Non-Active Medical Devices
    • 10.2.1 Market Trends
    • 10.2.2 Market Forecast
  • 10.3 In-Vitro Diagnostic Medical Devices
    • 10.3.1 Market Trends
    • 10.3.2 Market Forecast
  • 10.4 Ophthalmic Medical Devices
    • 10.4.1 Market Trends
    • 10.4.2 Market Forecast
  • 10.5 Others
    • 10.5.1 Market Trends
    • 10.5.2 Market Forecast

11 Market Breakup by Region

  • 11.1 North America
    • 11.1.1 United States
      • 11.1.1.1 Market Trends
      • 11.1.1.2 Market Forecast
    • 11.1.2 Canada
      • 11.1.2.1 Market Trends
      • 11.1.2.2 Market Forecast
  • 11.2 Asia-Pacific
    • 11.2.1 China
      • 11.2.1.1 Market Trends
      • 11.2.1.2 Market Forecast
    • 11.2.2 Japan
      • 11.2.2.1 Market Trends
      • 11.2.2.2 Market Forecast
    • 11.2.3 India
      • 11.2.3.1 Market Trends
      • 11.2.3.2 Market Forecast
    • 11.2.4 South Korea
      • 11.2.4.1 Market Trends
      • 11.2.4.2 Market Forecast
    • 11.2.5 Australia
      • 11.2.5.1 Market Trends
      • 11.2.5.2 Market Forecast
    • 11.2.6 Indonesia
      • 11.2.6.1 Market Trends
      • 11.2.6.2 Market Forecast
    • 11.2.7 Others
      • 11.2.7.1 Market Trends
      • 11.2.7.2 Market Forecast
  • 11.3 Europe
    • 11.3.1 Germany
      • 11.3.1.1 Market Trends
      • 11.3.1.2 Market Forecast
    • 11.3.2 France
      • 11.3.2.1 Market Trends
      • 11.3.2.2 Market Forecast
    • 11.3.3 United Kingdom
      • 11.3.3.1 Market Trends
      • 11.3.3.2 Market Forecast
    • 11.3.4 Italy
      • 11.3.4.1 Market Trends
      • 11.3.4.2 Market Forecast
    • 11.3.5 Spain
      • 11.3.5.1 Market Trends
      • 11.3.5.2 Market Forecast
    • 11.3.6 Russia
      • 11.3.6.1 Market Trends
      • 11.3.6.2 Market Forecast
    • 11.3.7 Others
      • 11.3.7.1 Market Trends
      • 11.3.7.2 Market Forecast
  • 11.4 Latin America
    • 11.4.1 Brazil
      • 11.4.1.1 Market Trends
      • 11.4.1.2 Market Forecast
    • 11.4.2 Mexico
      • 11.4.2.1 Market Trends
      • 11.4.2.2 Market Forecast
    • 11.4.3 Others
      • 11.4.3.1 Market Trends
      • 11.4.3.2 Market Forecast
  • 11.5 Middle East and Africa
    • 11.5.1 Market Trends
    • 11.5.2 Market Breakup by Country
    • 11.5.3 Market Forecast

12 SWOT Analysis

  • 12.1 Overview
  • 12.2 Strengths
  • 12.3 Weaknesses
  • 12.4 Opportunities
  • 12.5 Threats

13 Value Chain Analysis

14 Porters Five Forces Analysis

  • 14.1 Overview
  • 14.2 Bargaining Power of Buyers
  • 14.3 Bargaining Power of Suppliers
  • 14.4 Degree of Competition
  • 14.5 Threat of New Entrants
  • 14.6 Threat of Substitutes

15 Price Analysis

16 Competitive Landscape

  • 16.1 Market Structure
  • 16.2 Key Players
  • 16.3 Profiles of Key Players
    • 16.3.1 American Preclinical Services LLC
      • 16.3.1.1 Company Overview
      • 16.3.1.2 Product Portfolio
    • 16.3.2 Charles River Laboratories International Inc.
      • 16.3.2.1 Company Overview
      • 16.3.2.2 Product Portfolio
      • 16.3.2.3 Financials
      • 16.3.2.4 SWOT Analysis
    • 16.3.3 Element Materials Technology
      • 16.3.3.1 Company Overview
      • 16.3.3.2 Product Portfolio
      • 16.3.3.3 Financials
    • 16.3.4 Eurofins Scientific LLC
      • 16.3.4.1 Company Overview
      • 16.3.4.2 Product Portfolio
    • 16.3.5 Intertek Group Plc
      • 16.3.5.1 Company Overview
      • 16.3.5.2 Product Portfolio
      • 16.3.5.3 Financials
      • 16.3.5.4 SWOT Analysis
    • 16.3.6 North American Science Associates Inc.
      • 16.3.6.1 Company Overview
      • 16.3.6.2 Product Portfolio
    • 16.3.7 Pace Analytical Services LLC (LAB Holdings Inc.)
      • 16.3.7.1 Company Overview
      • 16.3.7.2 Product Portfolio
    • 16.3.8 SGS SA
      • 16.3.8.1 Company Overview
      • 16.3.8.2 Product Portfolio
      • 16.3.8.3 Financials
    • 16.3.9 Sterigenics U.S. LLC (Sotera Health LLC)
      • 16.3.9.1 Company Overview
      • 16.3.9.2 Product Portfolio
    • 16.3.10 Toxikon Corporation
      • 16.3.10.1 Company Overview
      • 16.3.10.2 Product Portfolio
    • 16.3.11 TUV Rheinland Aktiengesellschaft
      • 16.3.11.1 Company Overview
      • 16.3.11.2 Product Portfolio
      • 16.3.11.3 Financials
    • 16.3.12 TUV SUD Aktiengesellschaft
      • 16.3.12.1 Company Overview
      • 16.3.12.2 Product Portfolio
      • 16.3.12.3 Financials
    • 16.3.13 WuXi AppTec
      • 16.3.13.1 Company Overview
      • 16.3.13.2 Product Portfolio
      • 16.3.13.3 Financials

List of Figures

  • Figure 1: Global: Medical Device Testing Market: Major Drivers and Challenges
  • Figure 2: Global: Medical Device Testing Market: Sales Value (in Billion US$), 2018-2023
  • Figure 3: Global: Medical Device Testing Market Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 4: Global: Medical Device Testing Market: Breakup by Service (in %), 2023
  • Figure 5: Global: Medical Device Testing Market: Breakup by Type (in %), 2023
  • Figure 6: Global: Medical Device Testing Market: Breakup by Testing Type (in %), 2023
  • Figure 7: Global: Medical Device Testing Market: Breakup by Device Class (in %), 2023
  • Figure 8: Global: Medical Device Testing Market: Breakup by Device Type (in %), 2023
  • Figure 9: Global: Medical Device Testing Market: Breakup by Region (in %), 2023
  • Figure 10: Global: Medical Device Testing (Testing Services) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 11: Global: Medical Device Testing (Testing Services) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 12: Global: Medical Device Testing (Inspection Services) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 13: Global: Medical Device Testing (Inspection Services) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 14: Global: Medical Device Testing (Others) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 15: Global: Medical Device Testing (Others) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 16: Global: Medical Device Testing (In-House) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 17: Global: Medical Device Testing (In-House) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 18: Global: Medical Device Testing (Outsourced) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 19: Global: Medical Device Testing (Outsourced) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 20: Global: Medical Device Testing (Biocompatibility Testing) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 21: Global: Medical Device Testing (Biocompatibility Testing) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 22: Global: Medical Device Testing (Chemistry Testing) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 23: Global: Medical Device Testing (Chemistry Testing) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 24: Global: Medical Device Testing (Bio-Burden Determination) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 25: Global: Medical Device Testing (Bio-Burden Determination) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 26: Global: Medical Device Testing (Anti-Microbial Activity and Sterility Testing) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 27: Global: Medical Device Testing (Anti-Microbial Activity and Sterility Testing) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 28: Global: Medical Device Testing (Others) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 29: Global: Medical Device Testing (Others) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 30: Global: Medical Device Testing (Class I) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 31: Global: Medical Device Testing (Class I) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 32: Global: Medical Device Testing (Class II) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 33: Global: Medical Device Testing (Class II) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 34: Global: Medical Device Testing (Class III) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 35: Global: Medical Device Testing (Class III) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 36: Global: Medical Device Testing (Implantable Medical Devices) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 37: Global: Medical Device Testing (Implantable Medical Devices) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 38: Global: Medical Device Testing (Non-Active Medical Devices) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 39: Global: Medical Device Testing (Non-Active Medical Devices) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 40: Global: Medical Device Testing (In-Vitro Diagnostic Medical Devices) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 41: Global: Medical Device Testing (In-Vitro Diagnostic Medical Devices) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 42: Global: Medical Device Testing (Ophthalmic Medical Devices) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 43: Global: Medical Device Testing (Ophthalmic Medical Devices) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 44: Global: Medical Device Testing (Others) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 45: Global: Medical Device Testing (Others) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 46: North America: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 47: North America: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 48: United States: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 49: United States: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 50: Canada: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 51: Canada: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 52: Asia-Pacific: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 53: Asia-Pacific: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 54: China: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 55: China: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 56: Japan: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 57: Japan: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 58: India: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 59: India: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 60: South Korea: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 61: South Korea: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 62: Australia: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 63: Australia: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 64: Indonesia: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 65: Indonesia: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 66: Others: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 67: Others: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 68: Europe: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 69: Europe: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 70: Germany: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 71: Germany: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 72: France: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 73: France: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 74: United Kingdom: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 75: United Kingdom: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 76: Italy: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 77: Italy: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 78: Spain: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 79: Spain: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 80: Russia: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 81: Russia: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 82: Others: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 83: Others: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 84: Latin America: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 85: Latin America: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 86: Brazil: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 87: Brazil: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 88: Mexico: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 89: Mexico: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 90: Others: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 91: Others: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 92: Middle East and Africa: Medical Device Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 93: Middle East and Africa: Medical Device Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 94: Middle East and Africa: Medical Device Testing Market: Breakup by Country (in %), 2023
  • Figure 95: Global: Medical Device Testing Industry: SWOT Analysis
  • Figure 96: Global: Medical Device Testing Industry: Value Chain Analysis
  • Figure 97: Global: Medical Device Testing Industry: Porter's Five Forces Analysis

List of Tables

  • Table 1: Global: Medical Device Testing Market: Key Industry Highlights, 2023 and 2032
  • Table 2: Global: Medical Device Testing Market Forecast: Breakup by Service (in Million US$), 2024-2032
  • Table 3: Global: Medical Device Testing Market Forecast: Breakup by Type (in Million US$), 2024-2032
  • Table 4: Global: Medical Device Testing Market Forecast: Breakup by Testing Type (in Million US$), 2024-2032
  • Table 5: Global: Medical Device Testing Market Forecast: Breakup by Device Class (in Million US$), 2024-2032
  • Table 6: Global: Medical Device Testing Market Forecast: Breakup by Device Type (in Million US$), 2024-2032
  • Table 7: Global: Medical Device Testing Market Forecast: Breakup by Region (in Million US$), 2024-2032
  • Table 8: Global: Medical Device Testing Market: Competitive Structure
  • Table 9: Global: Medical Device Testing Market: Key Players