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市場調查報告書

醫療設備檢驗服務的全球市場 (2021年∼2028年)

Global Medical Device Testing Services Market - 2021-2028

出版商 DataM Intelligence 商品編碼 1014764
出版日期 內容資訊 英文 180 Pages
商品交期: 約2個工作天內
價格
醫療設備檢驗服務的全球市場 (2021年∼2028年) Global Medical Device Testing Services Market - 2021-2028
出版日期: 2021年06月14日內容資訊: 英文 180 Pages
簡介

全球醫療設備檢驗服務市場主要促進因素是對醫療器械驗證和驗證的需求不斷增長。另一方面,限制醫療器械開發和製造本地化的過度監管會阻礙市場增長。從服務領域來看,微生物/滅菌檢測板塊佔有率最大,分階段(phase)來看,臨床前檢測佔有率最大。按地區劃分,亞太地區是最大的市場,預計未來將保持其地位。

本報告提供全球醫療設備檢驗服務的市場相關分析,提供市場規模趨勢預測,及各類服務·不同階段·各地區的詳細趨勢,主要的推動及阻礙市場要素,主要企業的簡介等相關調查。

目錄

第1章 全球醫療設備檢驗服務市場:分析方法·範圍

第2章 全球醫療設備檢驗服務市場:市場定義和概要

第3章 全球醫療設備檢驗服務市場:摘要整理

第4章 全球醫療設備檢驗服務市場:市場動態

  • 對市場的影響要素
    • 促進因素
    • 阻礙因素
    • 市場機會
    • 影響分析

第5章 全球醫療設備檢驗服務市場:產業分析

  • 波特的五力分析
  • 流行病學分析
  • 供應鏈分析
  • 價格分析
  • 法規分析
  • 醫療費償付分析
  • 未滿足需求

第6章 全球醫療設備檢驗服務市場:新型冠狀病毒感染疾病 (COVID-19)的分析

  • COVID-19對市場的影響分析
    • "COVID-19前" /過去的市場方案
    • "COVID-19中" /目前市場方案
    • "COVID-19後" /未來市場方案
  • COVID-19流行中的價格趨勢
  • 需求與供給的變動階段
  • 政府在COVID-19疫情下的市場相關措施
  • 各製造公司的策略展開情形
  • 結論

第7章 全球醫療設備檢驗服務市場:各類服務

  • 簡介
    • 市場規模的分析與與前一年同期相比成長率 (YoY):各服務領域
    • 市場向心力指數:各服務領域
  • 生物適合性實驗
    • 簡介
    • 市場規模 (以金額為準,2018年∼2028年)·與前一年同期相比成長率 (YoY) (2020年∼2028年)
  • 化學實驗
  • 微生物·殺菌實驗
    • 微生物附著量的決策
    • pirogen·終局毒素檢驗
    • 殺菌檢驗·檢驗
    • 抗菌作用實驗
    • 其他
  • 包裝檢驗

第8章 全球醫療設備檢驗服務市場:不同階段

  • 簡介
    • 市場規模的分析與與前一年同期相比成長率 (YoY):不同階段
    • 市場向心力指數:不同階段
  • 前臨床
  • 臨床

第9章 全球醫療設備檢驗服務市場:各地區

  • 簡介
    • 市場規模 (以金額為準,2018年∼2028年)·與前一年同期相比成長率 (YoY) (2020年∼2028年):各地區
    • 市場向心力指數:各地區
  • 北美
    • 簡介
    • 域內市場固有趨勢
    • 市場規模·與前一年同期相比成長率 (YoY):各類服務
    • 市場規模·與前一年同期相比成長率 (YoY):不同階段
    • 市場規模·與前一年同期相比成長率 (YoY):各國
  • 歐洲
  • 南美
  • 亞太地區
  • 中東·非洲

第10章 全球醫療設備檢驗服務市場:競爭情形

  • 主要趨勢與策略
  • 企業佔有率分析
  • 產品的互相比較
  • 值得注意的企業
  • 有顛覆性技術的企業
  • Start-Ups企業

第11章 全球醫療設備檢驗服務市場:企業簡介

  • Eurofins Advinus
    • 企業概要
    • 產品的組合/概要
    • 近幾年趨勢
    • 財務分析:概要
  • Charles River Laboratories International, Inc.
  • Pace Analytical Services LLC
  • Intertek Group Plc
  • Wuxi AppTec
  • SGS SA
  • North American Science Associates Inc.
  • Sterigenics International LLC
  • Toxikon
  • Element Materials Technology
  • Adico Inspection Service LTD.

第12章 關於DataM Intelligence

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目錄
Product Code: DMMD3433

Market Overview

The global medical device testing services market size was valued US$ XX billion in 2020 and is estimated to reach US$ XX billion by 2028, growing at a CAGR of XX % during the forecast period (2021-2028).

Medical device testing is a significant step in transforming an innovative design into a solid and marketable product. Moreover, testing puts the product through a comprehensive medical devices industry assessment and helps to show compliance with standards and regulations worldwide.

Market Dynamics

Increasing demand for validation and verification of medical devices is expected to drive the market's growth.

The companies manufacturing across the globe are planning to invest more in automation post-COVID-19. Moreover, the need for automated quality assurance has increased as industries have realized its importance in manufacturing processes. In addition, this need is further raised due to the COVID-19 outbreak due to less interference by humans required in the process. It has resulted in the widespread approval of machine vision as an integral part of long-term automation development processes. Hence, from the above statements medical device testing market is expected to drive growth.

Limitations to the local development of medical devices is expected to hamper the market's growth.

According to the Medical Journal, while the advancement of standards and control of medical devices is essential, excessive regulations, particularly in domestic circumstances, can also be a barrier to local innovation. Moreover, it can potentially hinder domestic innovation by subjecting new technologies to a lengthy and expensive licensing procedure after increasing the cost and the time that local manufacturers spend. The production cost of the medical equipment and few products, which are of significant value to low-income countries, may be extracted from the market due to the observed risks compared with their use. Hence Barriers to the local development of medical devices are expected to hamper the market's growth.

COVID-19 Impact Analysis

The COVID-19 pandemic has affected the healthcare systems globally. Also, it has a notable impact on the market, and this has happened in several businesses closing down their manufacturing plants and halting most of their operations. During this pandemic, the main objective of companies was to run the business by safety and to continue the operations to get their revenues. Moreover, the pandemic has increased the demand for TIC services in the medical sector. For instance, the COVID-19 outbreak has led to increased demand for hygienic masks. In few countries such as France, Spain, and Mexico, have published appropriate standards and specifications, i.e., the UNE 0065, UNE 0064-1, UNE 0064-2, and AFNOR-SPEC-S76 standards, which is met before a mask is sold.

Additionally, TIC market players who provide services to the medical industry have begun inspections of medical equipment to keep the continuity of health and safety compliance and avoid any possible physical contact.

Segment Analysis

Microbiology & Sterility Testing segment is expected to hold the largest market share in this market segment.

The microbiology and sterility testing segment commanded the medical device testing services market and accounted for the largest revenue share in 2020. According to the Journal, A sterile medical device is free from viable microorganisms. Medical devices produced under approved manufacturing conditions under the requirements for Quality Management Systems (QMS) may have microorganisms present and within them before sterilization (non-sterile products). Moreover, sterilization aims to inactivate the microbiological contaminants to modify the devices from non-sterilized to sterilized. Sterility testing of medical devices is needed during the sterilization validation process, and routine release testing as sterility assurance is very crucial for medical devices. Failure to conduct such tests might delay the regulatory process for devices. Hence, the microbiology & sterility testing segment is expected to hold the largest market share.

Preclinical Segment is expected to hold the largest market share in this segment

The preclinical phase has accounted for the largest revenue share of the medical device testing services market in 2020. Preclinical studies determine a starting, safe dose for the first-in-human study and evaluate the potential toxicity of the product, including new medical devices, prescription drugs, and diagnostics. According to the Journal(CBSET), they profile the safety and efficacy of implanted devices and combination products and develop novel testing and assessment procedures with multiple regulatory compliances. For instance, Full histology suite for all phases of embedding, sectioning, staining and imaging, Customizable mechanical testing of biomaterials and biological tissues. Hence, the medical device companies must follow the testing and verification & validation practices to ensure the quality & reliability of medical devices. Therefore, from the above statements, the preclinical segment is expected to hold the largest market share.

Geographical Analysis

Asia Pacific region holds the largest market share in the global medical device testing services market

The Asia Pacific held a maximum share in the medical device testing services market in 2020 because of the increasing per capita income among the middle class. Moreover, there is increasing consumer awareness about the importance of certification, the growing interest of international players in the China and India market, stringent product approval in countries such as China, and advancements in healthcare infrastructure. Additionally, China is the leading exporter for many companies worldwide, which has appeared to increase medical device testing services in the country to have agreement with international standards. Thus, there is a vast potential for the medical device testing services market during the forecast period.

For instance, WuXi PharmaTech (Cayman) Inc., on October 23, 2015, a leading R&D capability and technology platform company assisting the pharmaceutical, biotechnology, and medical device industries, announced its Laboratory Testing Division (LTD) had launched preclinical medical device testing services in China. Moreover, these services are being offered for Chinese and international clients for their product registration with the China Food and Drug Administration (CFDA) and Chinese clients for product registration in global markets.

Competitive Landscape

The medical device testing services market is moderately competitive with presence of local as well as global companies. Some of the key players which are contributing to the growth of the market Sterigenics International LLC, Charles River Laboratories International, Inc., Pace Analytical Services LLC, Intertek Group Plc , Wuxi AppTec, SGS SA, Eurofins, North American Science Associates Inc., Toxikon, Element Materials Technology and Adico Inspection Service LTD. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the Medical Device Testing Services market globally.

Key Companies to Watch

Eurofins Advinus:

Overview:

Eurofins Advinus is an R&D services company that supports the discovery and development of compounds for different industries, including Pharmaceuticals, Biologicals, Agrochemicals, Nutraceuticals and Cosmetics. Moreover, it is part of Eurofins Scientific, a EUR 4.5 Billion leading international group of laboratories that provides a unique range of analytical testing services to the pharmaceutical, food, environmental and consumer products industries and governments.

Additionally, for the pharma/biotech industries, the company offers end-to-end services in preclinical toxicology testing, chemical process development, analytical R&D, drug metabolism and pharmacokinetics for IND submission.

Besides, the company is also one of the pioneers in drug discovery services in India, with a track record that is well explained by its path-breaking collaborations with Takeda, Merck, J&J, Novartis, Celgene and DNDi.

Product Portfolio:

Eurofins Advinus is has continuously set new standards in the continuous manufacturing of biocompatibility testing services to medical devices for various regulatory and notified bodies. For instance, Medical Device testing involves the below category of testing:

Biocompatibility Testing (Cytotoxicity Testing, Sensitization Testing, Irritation Testing)

Material Mediated Pyrogenicity Testing (Systemic Toxicity Testing, Implantation Testing, Hemocompatibility testing) and includes other tests.

Recent Market Developments:

In June 2020, Intertek announced expanding its protective equipment services to include the pre-certification testing of N95 respirators to conditions set by the National Institute for Occupational Safety and Health (NIOSH). Intertek also expanded upon its solutions and resources to support customers and the global community during the COVID-19 pandemic with these new services.

In October 2019, TUV SUD signed a memorandum of understanding (MoU) with the NUS Centre for Additive Manufacturing (AM.NUS) at the National University of Singapore (NUS) to improve R&D projects in the area of 3D printed biomedical implants for clinical trials.

Why Purchase the Report?

  • Visualize the composition of the medical device testing services market segmentation by service and phase highlighting the key commercial assets and players.
  • Identify commercial opportunities in medical device testing services market by analyzing trends and co-development deals.
  • Excel data sheet with thousands of data points of medical device testing services market- level 4/5 segmentation.
  • PDF report with the most relevant analysis cogently put together after exhaustive qualitative interviews and in-depth market study.
  • Product mapping in excel for the key product of all major market players

The global medical device testing services market report would provide an access to an approx. 50market data table, 41 figures and 200pages.

Target Audience

  • Service Providers/ Buyers
  • Industry Investors/Investment Bankers
  • Education & Research Institutes
  • Research Professionals
  • Emerging Companies
  • Manufacturers

Market Segmentation

Global Medical Device Testing Services Market- By Service

  • Biocompatibility Test
  • Chemistry Test
  • Microbiology & Sterility Testing

Bioburden Determination

Pyrogen & Endotoxin Testing

Sterility Test & Validation

Antimicrobial Activity Testing

Other

  • Package Validation

Global Medical Device Testing Services Market - By Phase

  • Preclinical
  • Clinical

Global Medical Device Testing Services Market - By Region

  • North America
  • South America
  • Europe
  • Asia
  • Middle East & Africa

Table of Contents

1. Global Medical Device Testing Services Market Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Global Medical Device Testing Services Market - Market Definition and Overview

3. Global Medical Device Testing Services Market - Executive Summary

  • 3.1. Market Snippet by Service
  • 3.2. Market Snippet by Phase
  • 3.3. Market Snippet by Region

4. Global Medical Device Testing Services Market - Market Dynamics

  • 4.1. Market Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Increasing demand for validation and verification of medical devices is expected to drive the market's growth.
      • 4.1.1.2. Strict approval norms are expected to drive the market's growth.
    • 4.1.2. Restraints:
      • 4.1.2.1. Limitations to the local development of medical device are expected to hamper the market's growth.
      • 4.1.2.2. Legal & regulatory issues are expected to hamper the market's growth.
    • 4.1.3. Opportunity
    • 4.1.4. Impact Analysis

5. Global Medical Device Testing Services Market - Industry Analysis

  • 5.1. Porter's Five Forces Analysis
  • 5.2. Epidemiology Analysis
  • 5.3. Supply Chain Analysis
  • 5.4. Pricing Analysis
  • 5.5. Regulatory Analysis
  • 5.6. Reimbursement Analysis
  • 5.7. Unmet Needs

6. Global Medical Device Testing Services Market - COVID-19 Analysis

  • 6.1. Analysis of Covid-19 on the Market
    • 6.1.1. Before COVID-19 Market Scenario
    • 6.1.2. Present COVID-19 Market Scenario
    • 6.1.3. After COVID-19 or Future Scenario
  • 6.2. Pricing Dynamics Amid Covid-19
  • 6.3. Demand-Supply Spectrum
  • 6.4. Government Initiatives Related to the Market During Pandemic
  • 6.5. Manufacturers Strategic Initiatives
  • 6.6. Conclusion

7. Global Medical Device Testing Services Market - By Service

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Service Segment
    • 7.1.2. Market Attractiveness Index, By Service Segment
  • 7.2. Biocompatibility Test*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis, US$ Million, 2018-2028 and Y-o-Y Growth Analysis (%), 2020-2028
  • 7.3. Chemistry Test
  • 7.4. Microbiology & Sterility Testing
    • 7.4.1. Bioburden Determination
    • 7.4.2. Pyrogen & Endotoxin Testing
    • 7.4.3. Sterility Test & Validation
    • 7.4.4. Antimicrobial Activity Testing
    • 7.4.5. Others
  • 7.5. Package Validation

8. Global Medical Device Testing Services Market - By Phase

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Phase
    • 8.1.2. Market Attractiveness Index, By Phase
  • 8.2. Preclinical*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis, US$ Million, 2018-2028 and Y-o-Y Growth Analysis (%), 2020-2028
  • 8.3. Clinical

9. Global Medical Device Testing Services Market - By Region

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis, US$ Million, 2018-2028 and Y-o-Y Growth Analysis (%), 2020-2028, By Region
    • 9.1.2. Market Attractiveness Index, By Region
  • 9.2. North America
    • 9.2.1. Introduction
    • 9.2.2. Key Region-Specific Dynamics
    • 9.2.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Service
    • 9.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Phase
    • 9.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 9.2.5.1. U.S.
      • 9.2.5.2. Canada
      • 9.2.5.3. Mexico
  • 9.3. Europe
    • 9.3.1. Introduction
    • 9.3.2. Key Region-Specific Dynamics
    • 9.3.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Service
    • 9.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Phase
    • 9.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 9.3.5.1. Germany
      • 9.3.5.2. U.K.
      • 9.3.5.3. France
      • 9.3.5.4. Italy
      • 9.3.5.5. Spain
      • 9.3.5.6. Rest of Europe
  • 9.4. South America
    • 9.4.1. Introduction
    • 9.4.2. Key Region-Specific Dynamics
    • 9.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Service
    • 9.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Phase
    • 9.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 9.4.5.1. Brazil
      • 9.4.5.2. Argentina
      • 9.4.5.3. Rest of South America
  • 9.5. Asia Pacific
    • 9.5.1. Introduction
    • 9.5.2. Key Region-Specific Dynamics
    • 9.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Service
    • 9.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Phase
    • 9.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 9.5.5.1. China
      • 9.5.5.2. India
      • 9.5.5.3. Japan
      • 9.5.5.4. Australia
      • 9.5.5.5. Rest of Asia Pacific
  • 9.6. Middle East and Africa
    • 9.6.1. Introduction
    • 9.6.2. Key Region-Specific Dynamics
    • 9.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Service
    • 9.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Phase

10. Global Medical Device Testing Services Market - Competitive Landscape

  • 10.1. Key Developments and Strategies
  • 10.2. Company Share Analysis
  • 10.3. Product Benchmarking
  • 10.4. Key Companies to Watch
  • 10.5. Company with disruptive technology
  • 10.6. Start Up Companies

11. Global Medical Device Testing Services Market- Company Profiles

  • 11.1. Eurofins Advinus*
    • 11.1.1. Company Overview
    • 11.1.2. Product Portfolio and Description
    • 11.1.3. Key Highlights
    • 11.1.4. Financial Overview
  • 11.2. Charles River Laboratories International, Inc.
  • 11.3. Pace Analytical Services LLC
  • 11.4. Intertek Group Plc
  • 11.5. Wuxi AppTec
  • 11.6. SGS SA
  • 11.7. North American Science Associates Inc.
  • 11.8. Sterigenics International LLC
  • 11.9. Toxikon
  • 11.10. Element Materials Technology
  • 11.11. Adico Inspection Service LTD.

LIST NOT EXHAUSTIVE

12. Global Medical Device Testing Services Market - DataM

  • 12.1. Appendix
  • 12.2. About Us and Services
  • 12.3. Contact Us