基于(关键地区、市场参与者、规模和份额)的医疗保健监管事务外包市场 - 到 2031 年的预测

  • Report Code : TIPRE00007611
  • Category : Healthcare IT
  • Status : Published
  • No. of Pages : 192
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[研究报告]医疗监管事务外包市场规模预计将从2021年的72.7473亿美元增至2028年的149.9635亿美元;预计 2021 年至 2028 年复合年增长率为 10.9%。

医疗保健公司的监管压力不断增加,新产品快速批准的需求不断增加。然而,熟练专业人员的缺乏正在限制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行业提供的服务。监管事务外包服务有助于实现快速监管审批。监管事务外包行业正在帮助新产品获得批准、准备临床试验方案、发布报告等。对监管咨询、医学写作和监管文件发布、临床试验申请等各种服务的需求增加。监管咨询和法律代理、专利申请、产品注册和临床试验申请导致医疗监管事务外包业务的采用激增。


战略见解< /h3>

医疗监管事务外包市场利润丰厚的地区


市场洞察

医疗保健公司监管压力不断加大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正在给医疗保健行业带来重大挑战。制药公司和医学界面临着降低处方药成本的巨大压力,而运营成本却在飙升。监管要求的复杂性、重磅药物专利到期导致的收入下降以及政府和健康保险公司要求降低医疗成本的压力,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其资源以及专业外部资源提供的专业知识。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。监管事务外包可以使申办者获得经验、优化成本并提高生产力。监管外包公司能够更好地评估监管要求,这使他们能够选择最佳的解决方案。他们精通与实施、运营和维护监管发布系统相关的知识。大多数大型制药和生物技术公司都在寻找能够提供监管和药物警戒支持服务的咨询公司。

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规划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批准极为重要。如果在开发早期阶段未能解决合规问题,通常会因文件归档不当、制造疏忽、监管研究遗漏以及其他未能满足监管要求的情况而导致审批流程延迟。医疗保健公司现在专注于其核心能力,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和现有产品等核心职能的关注。

基于服务类型的洞察

根据服务类型,医疗保健监管事务外包市场分为监管和分销。科学战略发展、医疗保健科学写作、eCTD 和电子提交、数据管理服务、生命周期管理服务、药物警戒、化学制造和生产控制 (CMC) 服务、监管标签、监管艺术品服务。医疗与科学写作领域预计将在 2021 年占据更大的市场份额,药物警戒领域预计在预测期内将实现更高的复合年增长率。

医疗保健监管事务外包市场,按服务类型划分 – 2021年和2028年

基于最终用户的洞察

基于最终用户的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。制药公司细分市场将在 2021 年占据更大的市场份额。预计 2021 年至 2028 年制药公司细分市场将以更高的复合年增长率增长。

在医疗保健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声誉。

医疗保健监管事务外包市场 –按服务类型

  • 监管和监管科学战略发展
  • 医疗与医疗科学写作
  • eCTD 和 eCTD电子提交
  • 数据管理服务
  • 生命周期管理服务
  • 药物警戒
  • 化学制造和化学工业控制(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
  • 生物技术公司
  • 医疗器械公司
    • 医疗器械软件 (SaMD)
    • 医疗器械材料与技术生物材料
    • 医疗器械生物标志物和体外诊断(IVD)
    • 基于物质的医疗器械
    • 组合产品医疗器械(DDC)
    • < /ul>

    医疗保健监管事务外包市场 –按地理位置

    • 北美洲
      • 美国
      • 加拿大
      • 墨西哥
    • < li>欧洲
      • 法国
      • 德国
      • 意大利
      • 英国
      • 西班牙
      • 休息欧洲
    • 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
    • 中东和非洲非洲 (MEA)
      • 南非
      • 沙特阿拉伯
      • 阿联酋
      • 中东其他地区和地区非洲
    • 南部和非洲中美洲 (SCAM)
      • 巴西
      • 阿根廷
      • 南美洲和中美洲其他地区

    公司简介

    • KLIFO
    • ProPharma Group
    • Arriello Ireland Ltd.
    • DRA CONSULTING OY
    • Asphalion SL
    • Parexel International Corporation
    • IQVIA Inc.
    • Pharmalex Gmbh
    • ProductLife Group
    • Voisin 生命科学咨询 (VCLS)
    • Azierta 合同科学支持咨询
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 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.

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.

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.

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.

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.

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

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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