医疗保健监管事务外包市场概况、增长、趋势、分析、研究报告(2021-2028 年)

  • Report Code : TIPRE00007611
  • Category : Life Sciences
  • Status : Published
  • No. of Pages : 192
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[研究报告] 医疗监管事务外包市场预计将从 2021 年的 72.7473 亿美元增至 2028 年的 149.9635 亿美元;预计从 2021 年到 2028 年的复合年增长率为 10.9%。

 

医疗保健公司面临的监管压力不断增加,对新产品快速审批的需求不断增加。然而,缺乏熟练的专业人员制约了医疗保健监管事务外包市场的增长。监管事务外包是为制药、生物技术和医疗器械制造业提供的服务。监管事务外包服务有助于快速获得监管批准。监管事务外包行业正在帮助获得新产品的批准、制定临床试验方案、发布报告等。对监管咨询、监管文件的医学撰写和发布、临床试验申请、监管咨询和法律代理、专利申请、产品注册和临床试验申请等各种服务的需求增加,导致医疗保健监管事务外包业务的采用激增。

 

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医疗保健监管事务外包市场:

Healthcare Regulatory Affairs Outsourcing 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。

 

 

市场洞察

医疗保健公司面临的监管压力不断增加 医疗保健监管事务外包市场增长

传统药物开发方法的不断升级和进步给医疗保健行业带来了重大挑战。制药公司和医疗界面临着降低处方药成本的巨大压力,而他们的运营成本却在飞涨。监管要求的复杂性、畅销药专利到期导致的收入下降以及政府和医疗保险公司要求降低医疗成本的压力,都给医疗保健行业带来了额外的挑战。鉴于这些困难,制药公司已经意识到需要利用自己的资源以及外部专家提供的专业知识。许多高端监管咨询公司正在提供整个产品生命周期的专业知识。监管事务的外包可能使赞助商能够获得经验、优化成本并提高生产力。监管外包公司更有能力评估监管要求,这使他们能够选择最佳解决方案。他们精通与实施、运营和维护监管发布系统相关的理解。大多数大型制药和生物技术公司都在寻找能够提供支持性监管和药物警戒服务的咨询公司。

监管备案的复杂性日益增加,凸显了对专业 CRO 专业知识的需求。在产品开发的早期阶段,制定针对特定产品的监管建议和策略以及医疗保健监管合规措施,对于产品的监管审批极为重要。在开发早期阶段未能解决合规问题,往往会导致审批流程延迟,原因是文件提交不当、制造疏忽、遗漏监管研究以及其他未能满足监管要求的情况。医疗保健公司现在专注于其核心竞争力,并将非核心职能外包,以提高生产力和运营效率。他们通常将监管职能外包给在亚太地区和中东和非洲等新兴市场运营的 CRO,这也使他们能够降低运营成本,并加强对研发活动、现有产品的销售和分销等核心职能的关注。

基于服务类型的洞察

根据服务类型,医疗监管事务外包市场细分为监管和科学战略开发、医学和科学写作、eCTD 和电子提交、数据管理服务、生命周期管理服务、药物警戒、化学制造和控制 (CMC) 服务、监管标签、监管图稿服务。预计医学和科学写作部分将在 2021 年占据更大的市场份额,而药物警戒部分预计在预测期内将实现更高的复合年增长率。

基于最终用户的洞察

根据最终用户,医疗监管事务外包市场分为制药公司、生物技术公司和医疗器械公司。制药公司部门将在 2021 年占据更大的市场份额。预计制药公司部门的市场将在 2021 年至 2028 年期间以更高的复合年增长率增长。

在医疗监管事务外包市场运营的公司采用产品创新战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市场上保持自己的品牌名称。

 

医疗保健监管事务外包市场区域洞察

Insight Partners 的分析师已详细解释了预测期内影响医疗监管事务外包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监管事务外包市场细分和地理位置。

Healthcare Regulatory Affairs Outsourcing Market
  • 获取医疗保健监管事务外包市场的区域特定数据

医疗保健监管事务外包市场报告范围

报告属性细节
2021 年市场规模72.7 亿美元
2028 年市场规模150亿美元
全球复合年增长率(2021 - 2028)10.9%
史料2019-2020
预测期2022-2028
涵盖的领域按服务类型
  • 监管和科学战略发展
  • 医学与科学写作
  • eCTD 和电子提交
  • 数据管理服务
  • 生命周期管理服务
  • 药物警戒
  • 化学制造和控制服务
  • 监管标签
  • 监管艺术品服务
按最终用户
  • 制药公司
  • 生物科技公司
  • 医疗器械公司
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
  •  
  • 克里夫
  • ProPharma集团
  • Arriello 爱尔兰有限公司
  • DRA 咨询公司
  • 阿斯法利昂 SL
  • 精鼎国际公司
  • IQVIA 公司
  • 法玛莱克斯有限公司
  • 产品生活集团

 

医疗保健监管事务外包市场参与者密度:了解其对业务动态的影响

医疗保健监管事务外包市场正在快速增长,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的需求,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。

在医疗保健监管事务外包市场运营的主要公司有:

  1. 克里夫
  2. ProPharma集团
  3. Arriello 爱尔兰有限公司
  4. DRA 咨询公司
  5. 阿斯法利昂 SL

免责声明上面列出的公司没有按照任何特定顺序排列。


Healthcare Regulatory Affairs Outsourcing Market

 

  • 获取医疗监管事务外包市场顶级关键参与者概览

 

医疗保健监管事务外包市场 – 按服务类型

  • 监管和科学战略发展
  • 医学与科学写作
  • eCTD 和电子提交
  • 数据管理服务
  • 生命周期管理服务
  • 药物警戒
  • 化学制造与控制 (CMC) 服务
  • 监管标签
  • 监管艺术品服务

医疗保健监管事务外包市场 – 按最终用户划分

  • 制药公司
  • 生物科技公司
  • 医疗器械公司
    • 医疗设备软件 (SaMD)
    • 医疗器械材料和生物材料
    • 医疗器械生物标志物和体外诊断 (IVD)
    • 基于医疗器械物质
    • 组合产品医疗器械(DDC)

医疗保健监管事务外包市场 – 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
    • 亚太其他地区
  • 中东和非洲 (MEA)
    • 南非
    • 沙特阿拉伯
    • 阿联酋
    • 中东和非洲其他地区
  • 南美和中美洲(SCAM)
    • 巴西
    • 阿根廷
    • 南美洲和中美洲其他地区 

公司简介

  • 克里夫
  • ProPharma集团
  • Arriello 爱尔兰有限公司
  • DRA 咨询公司
  • 阿斯法利昂 SL
  • 精鼎国际公司
  • IQVIA 公司
  • 法玛莱克斯有限公司
  • 产品生活集团
  • 沃辛咨询生命科学公司(VCLS)
  • Azierta 合同科学支持咨询
  • Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
  • PEST and SWOT Analysis
  • Market Size Value / Volume - Global, Regional, Country
  • Industry and Competitive Landscape
  • Excel Dataset
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.

Frequently Asked Questions


What is the regional market scenario of healthcare regulatory affairs outsourcing?

Global healthcare regulatory affairs outsourcing market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa and South & Central America. In North America, the U.S. is the largest market for anatomic pathology. The US is estimated to hold the largest share in the healthcare regulatory affairs outsourcing market during the forecast period. The growth of the market can be because of rise in cases of chronic diseases such as cancer, and increase in healthcare expenditure in the country. In addition, presence of major market players coupled with large number of funding programs by the public agencies in the region stimulate the growth of healthcare regulatory affairs outsourcing market in North America. On the other hand, enormous number of ongoing developments and innovations in healthcare, and rising spending capabilities in the Asia Pacific is expected to account for the fastest growth of the region during the coming years.

Who are the key players in the healthcare regulatory affairs outsourcing market?

The healthcare regulatory affairs outsourcing market majorly consists of the players such as Parexel International Corporation, IQVIA Inc., KLIFO, ProPharma Group, Arriello Ireland Ltd., DRA CONSULTING OY, Asphalion S.L, Pharmalex Gmbh, ProductLife Group, Voisin Consulting Life Sciences (VCLS), Azierta Contract Science Support Consulting among others.

Which end user held the largest share in the healthcare regulatory affairs outsourcing market?

The pharmaceutical companies segment dominated the global healthcare regulatory affairs outsourcing market and accounted for the largest revenue share of 43.0% in 2021.

What are the restraining factors for the healthcare regulatory affairs outsourcing market across the globe?

Key factors that are restraining the growth of this market are dearth of skilled professionals and data breach and lack of calibration.

What are healthcare regulatory affairs outsourcing?

Healthcare regulatory affairs mainly deal with the safety and efficacy of the product and other pharmaceutical agents. Medical writing and publishing of regulatory documentation prepared by experienced medical writers, quality control (QC) auditors, and publishers to develop high-quality documents for research projects regulatory submissions are among the services offered by healthcare regulatory affairs outsourcing. In addition, other regulatory outsourcing services include regulatory consulting, clinical trial applications, legal formalities, and guidelines, along with quality assurance and compliance.

What are the driving factors for the healthcare regulatory affairs outsourcing market across the globe?

Key factors that are driving the growth of this market are increasing regulatory pressure on healthcare companies and escalating demand for speedy approval of new products.

Which service type segment led the healthcare regulatory affairs outsourcing market?

The medical & scientific writing segment dominated the global anatomic pathology market and held the largest revenue share of 29.0% in 2021.

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The List of Companies - Healthcare Regulatory Affairs Outsourcing Market

  1. KLIFO
  2. ProPharma Group
  3. Arriello Ireland Ltd.
  4. DRA CONSULTING OY
  5. Asphalion S.L.
  6. Parexel International Corporation
  7. IQVIA Inc.
  8. Pharmalex Gmbh
  9. ProductLife Group
  10. Voisin Consulting Life Sciences (VCLS)
  11. Azierta Contract Science Support Consulting

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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.