医疗器械验证和确认市场(主要地区、市场参与者、规模和份额)- 到 2031 年的预测

  • Report Code : TIPRE00016735
  • Category : Life Sciences
  • No. of Pages : 150
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医疗器械验证和确认市场预计在 2023 年至 2031 年期间的复合年增长率为 11.1%,市场规模将从 2023 年的 XX 百万美元扩大到 2031 年的 XX 百万美元。

报告按治疗领域(肾病学、呼吸、神经病学、肿瘤学、耳鼻喉、心血管、皮肤病学)、应用(诊断、治疗、植入)进行细分。报告进一步根据技术(机械测试、生物、电气安全测试)进行分析。全球分析进一步细分为区域和主要国家。报告以美元为单位提供上述分析和细分的价值。

报告目的

Insight Partners 发布的《医疗器械验证和确认市场》报告旨在描述当前形势和未来增长、主要驱动因素、挑战和机遇。这将为各种业务利益相关者提供见解,例如:

  • 技术提供商/制造商:了解不断变化的市场动态并了解潜在的增长机会,从而能够做出明智的战略决策。
  • 投资者:对市场增长率、市场财务预测以及整个价值链中存在的机会进行全面的趋势分析。
  • 监管机构:监管市场政策和警察活动,旨在最大限度地减少滥用行为,维护投资者的信任和信心,维护市场的完整性和稳定性。

 

医疗器械验证和确认市场细分

 

治疗领域

  • 肾脏科
  • 呼吸系统
  • 神经病学
  • 肿瘤学
  • 耳鼻喉
  • 心血管
  • 皮肤科

应用

  • 诊断
  • 治疗
  • 植入物

技术

  • 机械测试
  • 生物
  • 电气安全测试

地理

  • 北美
  • 欧洲
  • 亚太
  • 南美洲和中美洲
  • 中东和非洲

地理

  • 北美
  • 欧洲
  • 亚太
  • 南美洲和中美洲
  • 中东和非洲

 

定制此报告以满足您的需求

您可以免费定制任何报告,包括本报告的部分内容、国家级分析、Excel 数据包,以及为初创企业和大学提供优惠和折扣

医疗器械验证和确认市场:战略洞察

Medical Device Validation and Verification Market
  • 获取此报告的关键市场趋势。
    这个免费样品将包括数据分析,从市场趋势到估计和预测。

 

医疗器械验证和确认市场增长动力

  • 法规遵从性:医疗器械法规遵从性是验证和确认市场的主要驱动因素之一。这是因为 FDA、EMA 和其他机构要求对产品进行广泛的测试和验证,以确保其安全性和有效性,从而迫使制造商在整个产品生命周期内投资进行全面验证。
  • 质量保证需求不断增长:在医疗保健系统中,对患者安全和产品可靠性的更强有力的质量保证的需求正在增加。医疗器械必须符合已制定的标准,验证服务和验证需求的增加促使制造商依赖严格的测试协议。
  • 技术进步:软件集成和物联网设备等新发展使得验证和确认变得更加复杂。随着新技术的复杂性增加,公司必须确保这些设备的可靠性和安全性,这增加了对此类验证服务的需求。

医疗器械验证和确认市场未来趋势

  • 风险管理策略:最近有一种趋势是将风险管理策略纳入验证和确认流程。医疗器械制造商还采用 ISO 14971 等框架,以识别和解决可能与医疗产品性能相关的风险。这将确保合规性,甚至提高患者的安全性。
  • 引入数字化解决方案:在验证和确认过程中使用数字化工具和软件的趋势越来越明显。自动化、人工智能和数据分析技术在各个层面得到采用,使测试更轻松、更快速、更精确,从而缩短医疗器械的上市时间并提高运营效率。
  • 提高产品质量:制造商的思维方式已经发生改变,如今他们越来越多地在验证和确认过程中采用六西格玛和精益等持续改进方法。这一趋势旨在提高产品质量,同时减少浪费,推动医疗器械开发和合规方面的卓越文化。

医疗器械验证和确认市场机会

  • 医疗保健基础设施的扩张:医疗保健基础设施的不断扩张促进了新兴市场对验证和核查服务的需求增加。公司可以通过提供符合当地法规的专业服务并支持这些地区越来越多的医疗器械制造商来从这一发展中获益。
  • 与初创企业和创新者合作:在医疗技术领域,与初创企业和创新公司合作可以为那些将要验证和确认服务提供商的人带来机遇。通过合作最终成为前沿项目,应该能够推进他们的服务产品,从而始终紧跟行业进步。
  • 高级服务:越来越有可能的是,更复杂的医疗器械的验证或确认需要服务提供商专门从事这一细分市场。例如,专门从事软件验证、网络安全评估或生物相容性测试的公司可以开辟细分市场,并准确地满足医疗器械开发商的相关需求。

 

医疗器械验证和确认市场区域洞察

Insight Partners 的分析师已详细解释了预测期内影响医疗器械验证和验证市场的区域趋势和因素。本节还讨论了北美、欧洲、亚太地区、中东和非洲以及南美和中美洲的医疗器械验证和验证市场细分和地理位置。

Medical Device Validation and Verification Market
  • 获取医疗器械验证和确认市场的区域特定数据

医疗器械验证和确认市场报告范围

报告属性细节
2023 年的市场规模XX 百万美元
2031 年市场规模XX 百万美元
全球复合年增长率(2023 - 2031)11.1%
史料2021-2022
预测期2024-2031
涵盖的领域按治疗领域
  • 肾脏科
  • 呼吸系统
  • 神经病学
  • 肿瘤学
  • 耳鼻喉
  • 心血管
  • 皮肤科
按应用
  • 诊断
  • 治疗
  • 植入物
按技术分类
  • 机械测试
  • 生物
  • 电气安全测试
覆盖地区和国家北美
  • 我们
  • 加拿大
  • 墨西哥
欧洲
  • 英国
  • 德国
  • 法国
  • 俄罗斯
  • 意大利
  • 欧洲其他地区
亚太
  • 中国
  • 印度
  • 日本
  • 澳大利亚
  • 亚太其他地区
南美洲和中美洲
  • 巴西
  • 阿根廷
  • 南美洲和中美洲其他地区
中东和非洲
  • 南非
  • 沙特阿拉伯
  • 阿联酋
  • 中东和非洲其他地区
市场领导者和主要公司简介
  • 瑞士通用公证行
  • QuEST 全球服务私人有限公司
  • 天祥集团
  • 元素材料科技
  • 北美科学协会
  • 欧陆科技
  • 查尔斯河
  • 斯特林医疗设备公司
  • 太平洋生物实验室

 

医疗器械验证和确认市场参与者密度:了解其对业务动态的影响

医疗器械验证和确认市场正在快速增长,这得益于最终用户需求的不断增长,这些需求源于消费者偏好的不断变化、技术进步以及对产品优势的认识不断提高等因素。随着需求的增加,企业正在扩大其产品范围,进行创新以满足消费者需求,并利用新兴趋势,从而进一步推动市场增长。

市场参与者密度是指在特定市场或行业内运营的企业或公司的分布情况。它表明在给定市场空间中,相对于其规模或总市场价值,有多少竞争对手(市场参与者)存在。

在医疗器械验证和确认市场运营的主要公司有:

  1. 瑞士通用公证行
  2. QuEST 全球服务私人有限公司
  3. 天祥集团
  4. 元素材料科技
  5. 北美科学协会

免责声明上面列出的公司没有按照任何特定顺序排列。


Medical Device Validation and Verification Market

 

  • 获取医疗器械验证和确认市场顶级关键参与者概述

 

 

主要卖点

 

  • 全面覆盖:报告全面涵盖医疗器械验证和确认市场的产品、服务、类型和最终用户的分析,提供整体概况。
  • 专家分析:报告基于对行业专家和分析师的深入了解而编写。
  • 最新信息:该报告涵盖了最新信息和数据趋势,确保了其与业务的相关性。
  • 定制选项:此报告可以定制以满足特定客户要求并恰当地适应业务策略。

因此,医疗器械验证和确认市场研究报告有助于引领解读和了解行业情景和增长前景。尽管可能存在一些合理的担忧,但本报告的总体优势往往大于劣势。

  • 历史分析(2 年)、基准年、预测(7 年)及复合年增长率
  • PEST 和 SWOT 分析
  • 市场规模价值/数量 - 全球、区域、国家
  • 行业和竞争格局
  • Excel 数据集
medical-device-validation-and-verification-market-report-deliverables-img1
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Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

常见问题


What is the expected CAGR of the Medical device validation and verification market

The medical device validation and verification market is estimated to grow with a CAGR of 11.1% from 2023 to 2031

Which region is expected to witness the fastest growth rate by 2031

Asia-Pacific region is likely to witness the fastest growth rate during the forecast period

What are the driving factors impacting the Medical device validation and verification market

The market drivers include increasing regulatory scrutiny surrounding medical devices and innovations in medical device technology are driving the Medical device validation and verification market

Which are the leading players operating in the medical device validation and verification market

The medical device validation and verification market majorly consists of players such as SGS SA, QuEST Global Services Pte. Ltd, Intertek among others

What are the future trends of the Medical device validation and verification market

Use of digital tools and software for validation and verification processes is likely to remain the key trend during the forecast period

Which region dominated the Medical device validation and verification market in 2023

North America dominated the Medical device validation and verification market in 2023

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The List of Companies

1. SGS SA
2. QuEST Global Services Pte. Ltd
3. Intertek
4. Element Materials Technology
5. North American Science Associates, Inc
6. Eurofins Scientific SE
7. Charles River
8. Sterling Medical Devices
9. Pacific Biolabs
10. Toxikon Corporation
11. Steris Laboratories
medical-device-validation-and-verification-market-cagr

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.