医疗器械测试服务市场分析及预测(按规模、份额、增长、趋势)2027 年

  • Report Code : TIPRE00003011
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 131
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Medical Device Testing Services Market Share, Size Report, 2027

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2018 年医疗保健市场中的医疗器械测试服务价值为 55.054 亿美元,预计到 2027 年将达到 146.601 亿美元;预计 2019 年至 2027 年的复合年增长率为 11.7%。

医疗器械至关重要,因为它们直接影响患者的生活。为了给患者提供高质量和安全的体验,医疗器械制造商在将医疗器械推向市场之前对其进行测试。医疗器械制造商倾向于进行内部测试或将测试服务外包给合同研究组织 (CRO),以遵守严格的监管准则。医疗器械测试是为了确保医疗器械在开发和使用的所有阶段的服务安全、质量和一致性。医疗治疗高度依赖医疗器械,因此确保医疗器械测试以最熟练的方式完成非常重要。医疗保健市场中医疗器械测试服务的增长归因于创新产品开发、合作、并购、严格的医疗器械审批监管环境多年来推动了市场的增长。此外,医疗器械行业的发展可能会在预测期内对市场需求产生积极影响。然而,市场的增长受到合同义务中断等因素的制约。

医疗保健市场的医疗器械测试服务预计将在疫情后见证大幅增长,SGS SA、Eurofins、Toxikon、Pace Analytical Services, LLC、Intertek Group plc、NORTH AMERICAN SCIENCE ASSOCIATES INC.、Charles River、无锡药明康德、Element Materials Technology、TÜV SÜD AG mRNA 预计将出现并改变制药行业,未来几年市场也有望见证更多的垂直整合和合资企业。

 

市场洞察

 

 

医疗设备测试服务在医疗保健领域的应用日益广泛,推动医疗设备测试服务在医疗保健市场的持续增长

 

 

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医疗器械测试服务市场:

医疗器械测试服务市场
  • Medical Device Testing Services Market
    复合年增长率(2018 - 2027)
    11.7%
  • 2018 年市场规模
    55.1 亿美元
  • 2027 年市场规模
    146.6 亿美元

市场动态

增长动力
  • 財政部
  • 財政部
  • 財政部
未来的趋势
  • 財政部
  • 財政部
  • 財政部
机会
  • 財政部
  • 財政部
  • 財政部

关键人物;主力;重要一员

  •  
  • 瑞士通用公证行
  • 欧陆金融集团
  • 毒力康
  • Pace 分析服务有限公司
  • 天祥集团
  • 北美科学协会
  • 查尔斯河
  • 药明康德
  • 元素材料科技

区域概况

Medical Device Testing Services Market
  • 北美
  • 欧洲
  • 亚太
  • 南美洲和中美洲
  • 中东和非洲

市场细分

Medical Device Testing Services Market服务
  • 生物相容性测试
  • 化学测试
  • 微生物学和无菌测试
  • 包裹验证
Medical Device Testing Services Market阶段
  • 临床前
  • 临床
Medical Device Testing Services Market地理
  • 北美
  • 欧洲
  • 亚太地区
  • 中东和非洲
  • 南美洲和中美洲
  • 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。

 

医疗器械测试需要丰富的领域经验、本土和国家法规以及有关设备、基础设施和支持测试能力的信息。医疗保健和医疗器械行业由于不断发展和先进的解决方案而活跃。过去几十年来,医疗器械技术的进步显著提高了患者护理的效率。 

然而,各种医疗器械制造商在将产品投放市场时有时会面临挑战。法规有时很复杂,难以理解,尤其是在涉及创新和新型医疗器械的应用时。 

召回是消除或修改不符合美国食品药品管理局 (FDA) 法律的产品的过程。大多数医疗器械召回都是公司根据 21 CFR 7 自愿进行的。FDA 将产品召回分为不同的级别,例如 I、II 或 III,以表明被召回产品对健康的危害程度。

根据 FDA 在 2018 年的声明,自 2008 年以来,已发现 80,000 多起因医疗器械伤害而引发的事件。过去几年,医疗器械公司和医生发现脊髓刺激器帮助了患有疼痛障碍的患者。因此,脊髓刺激器已成为价值 4000 亿美元的医疗器械行业中增长最快的产品之一。因此,产品召回事件的增加和对优质产品的需求增加,增加了对医疗器械测试的需求。因此,它将推动医疗器械测试服务市场的发展。

医疗器械技术通过早期识别疾病、加强治疗、诊断和患者监测来改善生活。中国、智利、印度尼西亚、墨西哥、马来西亚、新加坡、菲律宾、秘鲁、俄罗斯和越南等国家已经实施了中小企业培训计划。2018年,英国医疗器械市场价值约为106亿美元。其中,英国约有2500家中小型医疗器械公司。此外,大量跨国公司在该国设立了总部或子公司。此外,每年,急性信托机构平均在包括医疗设备在内的临床用品上花费约66亿美元。 

此外,2018年,国际贸易管理局(ITA)表示,法国有1300多家医疗器械公司,其中三分之一的医疗器械公司是外国公司,但这些外国医疗器械公司却贡献了法国医疗器械总业务的三分之二左右。 

此外,在法国 1,300 家医疗器械公司中,约 92% 为中小型企业 (SME),其中 88% 专门生产医疗器械。中小企业将医疗器械测试外包,因为这需要高成本、时间和熟练劳动力。

此外,马德里和加泰罗尼亚占医疗器械销售额的 80% 以上。其中,90% 的医疗器械市场是中小型公司,它们从医疗器械总收入中产生约 40% 的收入。由于这些公司是初创公司,他们选择外包医疗器械测试以降低成本并节省时间。因此,行业日益增长的需求可能会在未来几年推动全球医疗器械测试服务市场的增长。为消费者带来先进的医疗器械技术是一项艰巨的任务

  • 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。

风险项目。因此,这些公司通过提供准确可靠的结果来满足医疗器械测试要求,从小型初创企业到大型成熟制造商,提供正确的测试。 

 

北美、欧洲和亚太地区的许多实验室都提供法规遵从知识和合格的 GMP/GLP/ISO 17025 测试,以确保使用最高水平的服务和最先进的技术快速改进微生物、分析化学、生物相容性和包装测试要求。

在其他国家,有各种监管机构来监管医疗器械。西班牙的医疗器械由西班牙药品和健康产品管理局 (AEMPS) 控制和许可。食品和药品法 (FDA) 为众多医疗器械制定了监管框架。医疗器械局是另一个负责医疗器械指南的机构,允许销售和进口医疗器械。

所有医疗器械都有美国食品药品监督管理局(FDA)、中国食品药品监督管理局(CFDA)、欧盟公告机构和其他监管机构规定的一套专有且系统的测试要求,必须在进入市场前遵守。

在加拿大,加拿大卫生部强制进口商和制造商报告医疗器械事故,并鼓励医护人员、医院和消费者/患者报告事故。在墨西哥,COFEPRIS 负责医疗器械的审批和注册。制造商应满足所有测试要求并遵守 COFEPRIS 的审批要求。

英国药品和保健产品管理局(MHRA)是管理医疗器械法律的指定机构,负责检查可能存在问题的医疗器械产品,确保其安全性和质量。在日本,日本厚生劳动省(MHLW)和药品和医疗器械管理局(PMDA)合作对上市申请医疗器械进行科学测试,以监控其上市后的安全性。 

因此,预计预测期内针对创新和精密设备的日益严格的监管将推动医疗器械测试服务市场的增长。

 

基于服务的洞察

 

就服务而言,医疗保健市场的医疗器械测试服务分为生物相容性测试、化学测试、微生物学和无菌测试以及包装验证。2018 年,按服务划分,微生物学和无菌测试占据了医疗器械测试服务市场的最大市场份额,为 53.55%。

 

医疗器械测试服务市场报告范围

报告属性细节
2018 年市场规模55.1亿美元
2027 年市场规模146.6亿美元
全球复合年增长率(2018 - 2027)11.7%
历史数据2016-2017
预测期2019-2027
涵盖的领域按服务
  • 生物相容性测试
  • 化学测试
  • 微生物学和无菌测试
  • 包裹验证
按阶段
  • 临床前
  • 临床
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
  • 欧陆金融集团
  • 毒力康
  • Pace 分析服务有限公司
  • 天祥集团
  • 北美科学协会
  • 查尔斯河
  • 药明康德
  • 元素材料科技
  • 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。

 

 

基于阶段的洞察

 

根据阶段,医疗保健市场中的医疗器械测试服务分为临床前和临床。2018 年,按阶段划分,临床前部分占据了医疗器械测试服务市场 68.17% 的相当大的市场份额。

医疗保健市场参与者的医疗器械测试服务正在采用产品发布和扩张策略来满足全球不断变化的客户需求,这也使他们能够在全球范围内维护自己的品牌名称。

 

 

医疗保健市场的医疗器械测试服务 – 按服务分类

  • 生物相容性测试
  • 化学测试
  • 微生物学和无菌测试
  • 包裹验证

 

医疗保健市场的医疗器械测试服务 – 按阶段

  • 临床前
  • 临床

 

医疗保健市场中的医疗器械测试服务 – 按地区划分

  • 北美

    • 我们
    • 加拿大
    • 墨西哥
  • 欧洲

    • 法国
    • 德国
    • 意大利
    • 英国
    • 西班牙
    • 欧洲其他地区
  • 亚太地区 (APAC)

    • 中国
    • 印度
    • 韩国
    • 日本
    • 澳大利亚
    • 亚太地区其他地区
  • 中东和非洲 (MEA)

    • 南非
    • 沙特阿拉伯
    • 阿联酋
    • MEA 其他地区
  • 南美洲和中美洲(SCAM)

    • 巴西
    • 阿根廷
    • 其余的骗局

 

 

公司简介

  • 瑞士通用公证行
  • 欧陆金融集团
  • 毒力康
  • Pace 分析服务有限公司
  • 天祥集团
  • 北美科学协会
  • 查尔斯河
  • 药明康德
  • 元素材料科技
  • TÜV 南德意志集团
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.

The List of Companies

  1. SGS SA
  2. Eurofins
  3. Toxikon
  4. Pace Analytical Services, LLC
  5. Intertek Group plc
  6. NORTH AMERICAN SCIENCE ASSOCIATES INC.
  7. Charles River
  8. WuXi AppTec
  9. Element Materials Technology
  10. TÜV SÜD AG

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.

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