市場調查報告書

全球醫療設備檢驗·認證市場:成長,趨勢,及預測

Medical Device Testing and Certification Market - Growth, Trends, and Forecast (2020 - 2025)

出版商 Mordor Intelligence LLP 商品編碼 925225
出版日期 內容資訊 英文 120 Pages
商品交期: 2-3個工作天內
價格
全球醫療設備檢驗·認證市場:成長,趨勢,及預測 Medical Device Testing and Certification Market - Growth, Trends, and Forecast (2020 - 2025)
出版日期: 2020年02月01日內容資訊: 英文 120 Pages
簡介

本報告提供全球醫療設備檢驗·認證市場的相關調查,提供市場機會和趨勢,成長及阻礙因素,各服務類型·採購類型·設備級·技術·地區的市場分析,競爭情形,主要企業的簡介等資訊。

目錄

第1章 簡介

  • 調查成果
  • 調查的前提條件
  • 調查範圍

第2章 調查方法

第3章 摘要整理

第4章 市場動態

  • 市場概況
  • 市場成長要素
    • 醫療設備的V&V(檢驗與有效性確認的)需求不斷增長
    • 規格的遵守
  • 市場阻礙因素
    • 法規的多樣性
  • 波特的五力分析

第5章 市場區隔

  • 各服務形式
    • 實驗服務
    • 檢驗服務
    • 認證服務
    • 其他
  • 各採購類型
    • 公司內部
    • 外包
  • 各級設備
    • 級I
    • 級II
    • 級III
  • 各技術
    • 活性植入
    • 活性
    • 非活性
    • In-Vitro診斷
    • 眼科
    • 整形外科及牙科
    • 血管
    • 其他
  • 各地區
    • 北美
    • 歐洲
    • 亞太地區
    • 中東·非洲
    • 南美

第6章 競爭情形

  • 企業簡介
    • BSI Group
    • Dekra Testing and Certification GmbH
    • Eurofins Scientific
    • Institute for testing and Certification Inc.
    • Intertek Group PLC
    • SGS SA
    • TUV Rheinland
    • UL LLC

第7章 市場機會及今後趨勢

目錄
Product Code: 62575

Medical devices are subjected to comply with strict regulatory protocols, as it is vital to ensure the efficacy and safety of medical devices. Therefore, it is compulsory for every device to comply with national and international standards before entering a market. The standard guidelines of medical devices vary from country to country, and it is mandatory for every manufacturer to follow these guidelines for marketing or selling of their products in a country. For example, the United States follows FDA guidelines, Europe considers CE approval, Canada needs Health Canada Registration, and India requires approval from CDSCO. This diverse range of regulatory landscape drives the testing and certification market for aesthetic devices.

Since regulations are different in every country, it is crucial for each medical device manufacturer to register or receive regulatory guidelines of that specific country, which, in turn, indicates the need for authorized third-parties to register their devices. National regulatory authorities of every country prefer that the manufacturers selling their products in that particular country should comply with standard guidelines, and get it checked by a third-party certification system. This can result in propelling the testing and certification market, as well as increase easy market access. The other factors, such as increasing need of validation and verification (V&V) for medical devices are driving the medical device testing and certification market.

Key Market Trends

Testing Services are Expected to Witness Rapid Growth

Medical devices are regulated by various regulatory authorities and compliances. This is mainly because the end-users of these devices expect outstanding performance, effectiveness, and safety from these medical devices. Therefore, it is mandatory for the manufacturers to properly define and implement medical device testing strategy which makes the device effective and production becomes easier due to the confirmation of quality.

An effective medical device testing strategy needs several sets of test requirements. These test requirements are based on the component specification, manufacturing process, and other critical functional specifications of the device. Test requirements define and describe setup conditions, actions, and expected response constraints for each experiment defined in the test steps.

These sets of requirements are required to smoothen test implementation as tests are carried out continuously at different stages of the complete manufacturing process, from component selection to a final assembly of a medical device, and each stage has different requirements and different parameters to be satisfied.

Thus, increasing medical devices will also increase these testing services, which is expected to augment the growth of the market.

North America Dominates the Market

North America dominates the medical device testing and certification market due to the increased focus on the quality of the medical devices and the presence of a large number of companies that serve the medical device industry. In the North America region, the United States is having the largest share in the market and the country is expected to witness a similar trend over the forecast period due to the presence of well-developed healthcare and the presence of top multinatiional medical device companies.

Competitive Landscape

The market is highly consolidated and there are few other companies that are providing the testing and certification services. It has been observed that with the growing medical device market, more companies are expected to enter the market in the near future. Substantial market share will be gained by the small to mid-sized companies in the coming years.

Reasons to Purchase this report:

  • The market estimate (ME) sheet in Excel format
  • Report customization as per the client's requirements
  • 3 months of analyst support

Table of Contents

1 INTRODUCTION

  • 1.1 Study Deliverables
  • 1.2 Study Assumptions
  • 1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Increasing Need of Validation and Verification (V&V) for Medical Devices
    • 4.2.2 Compliance of Standards
  • 4.3 Market Restraints
    • 4.3.1 Diversity in Regulation
  • 4.4 Porter's Five Force Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION

  • 5.1 By Service Type
    • 5.1.1 Testing Services
    • 5.1.2 Inspection Services
    • 5.1.3 Certification Services
    • 5.1.4 Other Services
  • 5.2 By Sourcing Type
    • 5.2.1 In-House
    • 5.2.2 Outsourced
  • 5.3 By Device Class
    • 5.3.1 Class I
    • 5.3.2 Class II
    • 5.3.3 Class III
  • 5.4 By Technology
    • 5.4.1 Active Implant Medical Device
    • 5.4.2 Active Medical Device
    • 5.4.3 Non-Active Medical Device
    • 5.4.4 In-Vitro Diagnostic Medical Device
    • 5.4.5 Ophthalmic Medical Device
    • 5.4.6 Orthopedic and Dental Medical Device
    • 5.4.7 Vascular Medical Device
    • 5.4.8 Other Technologies
  • 5.5 Geography
    • 5.5.1 North America
      • 5.5.1.1 United States
      • 5.5.1.2 Canada
      • 5.5.1.3 Mexico
    • 5.5.2 Europe
      • 5.5.2.1 Germany
      • 5.5.2.2 United Kingdom
      • 5.5.2.3 France
      • 5.5.2.4 Italy
      • 5.5.2.5 Spain
      • 5.5.2.6 Rest of Europe
    • 5.5.3 Asia Pacific
      • 5.5.3.1 China
      • 5.5.3.2 Japan
      • 5.5.3.3 India
      • 5.5.3.4 Australia
      • 5.5.3.5 South Korea
      • 5.5.3.6 Rest of Asia-Pacific
    • 5.5.4 Middle East and Africa
      • 5.5.4.1 GCC
      • 5.5.4.2 South Africa
      • 5.5.4.3 Rest of Middle East and Africa
    • 5.5.5 South America
      • 5.5.5.1 Brazil
      • 5.5.5.2 Argentina
      • 5.5.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 BSI Group
    • 6.1.2 Dekra Testing and Certification GmbH
    • 6.1.3 Eurofins Scientific
    • 6.1.4 Institute for testing and Certification Inc.
    • 6.1.5 Intertek Group PLC
    • 6.1.6 SGS SA
    • 6.1.7 TUV Rheinland
    • 6.1.8 UL LLC

7 MARKET OPPORTUNITIES AND FUTURE TRENDS