中东和非洲医疗保健监管事务外包市场预测至 2028 年 - COVID-19 影响和按服务类型划分的区域分析（监管和科学战略制定、医疗和科学写作、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、监管标签和监管图稿服务）和最终用户（制药公司、生物技术公司和医疗器械公司）
No. of Pages: 119 | Report Code: TIPRE00026213 | Category: Life Sciences
No. of Pages: 119 | Report Code: TIPRE00026213 | Category: Life Sciences
中东及中东地区非洲由三个主要国家组成，即阿拉伯联合酋长国（阿联酋）、沙特阿拉伯和南非。由于研发支出的增加，预计市场将增长。因此，贬值压力正在推动监管外包趋势。此外，合同分析组织提供价格高效的解决方案，并遵守卫生当局的要求、报销方案的变化以及沙特阿拉伯、阿拉伯联合酋长国和南非等国家医疗外包技术市场参与者的定价压力和发展。各国正在发展其卫生设施，大力投资新型药物治疗研究，并加强与外国公司的合作伙伴关系可能会在预测期内推动市场增长。市场整合活动的激增是推动MEA医疗保健监管事务外包市场增长的主要因素。
COVID-19对南非、以色列、阿联酋和沙特阿拉伯等国家产生了严重影响在中东和非洲。大流行增加了对家庭护理医疗设备的需求。该地区入住重症监护病房 (ICU) 的患者数量不断增加，药物数量不断增加，给紧张的卫生系统带来多重诊断和治疗挑战，导致医疗设备增加。与其他地区一样，中东和非洲也经历了三波疫情。由于大流行尚未结束，各国政府必须采取措施防止其传播，保护医院免受交通拥堵的影响，并确保为所有患者提供毫不妥协的护理。 MEA 地区各国已采取严格的预防措施来控制 COVID-19 的传播。阿联酋、沙特阿拉伯、约旦、伊拉克和伊朗等国家已严格实施封锁。中东和北非不同国家的药品市场经历着不同的动态。例如，沙特阿拉伯的高购买力和对昂贵外国品牌的文化偏好迫使他们进口大量（85%）的药品。近年来，南非对仿制药的兴趣有所增加。此外，各医疗保健公司在疫情后的恢复阶段可能会参考更多监管建议，特别是远程监控、远程医疗、数据保护等。此外，随着越来越重视加快产品开发和快速获得批准为了有效对抗 COVID-19 的疗法、疫苗和设备，公司可能会与监管机构更加密切地合作。医疗事务在克服接触医疗保健专业人员 (HCP) 的障碍方面发挥着核心作用。此外，出于合规要求，医疗事务部负责向MEA内的HCP实时提供公正、透明的医疗信息。
MEA的医疗监管事务外包市场预计将从2021年的2.9172亿美元增长到2028年的5.3837亿美元；预计 2021 年至 2028 年复合年增长率为 9.1%。医疗保健监管事务外包职能在全球范围内已变得充满挑战。在过去的十年中，对新产品获得批准、更多地关注核心优势、以最低的运营成本以及保持合规性的需求不断增加。医疗保健监管审批流程变得更加严格，耗时且市场参与者都在努力争取其产品的批准，以争取更大的市场份额。由于发达国家监管机构的严格以及发展中国家不断变化的监管环境，企业被迫建立内部监管部门，或者选择外包监管活动。对于大多数医疗保健公司来说，建立内部监管事务部门并不可行，因为这会增加运营成本并减少收入，因此公司越来越多地根据项目的规模和优先级采用外包模式。随后，对监管信息系统的投资大幅增加，以满足监管发布和运营等活动自动化的需求。在此背景下，外包已逐渐成为医疗监管事务的重要组成部分，预计将增加对医疗监管事务外包的需求，从而推动市场增长。
MEA 医疗保健监管事务外包市场已根据服务类型、最终用户和国家/地区进行细分。根据服务类型，MEA 医疗保健监管事务外包市场分为医疗和医疗服务。科学写作、药物警戒、数据管理服务、生命周期管理服务、eCTD 和电子提交、监管和科学策略开发、化学制造和控制 (CMC) 服务、监管标签和监管艺术品服务。医疗与科学写作领域在 2020 年占据市场主导地位，药物警戒领域预计将在预测期内增长最快。根据最终用户，市场分为制药公司、生物技术公司和医疗器械公司。制药公司细分市场在 2020 年占据主导地位，预计将在预测期内增长最快。同样，细分的医疗器械公司分为医疗器械材料和医疗器械。生物材料、医疗器械、生物标志物和体外诊断（IVD）、医疗器械软件（SaMD）、医疗器械机电、基于物质的医疗器械以及组合产品的医疗器械。
在准备本中东和非洲医疗保健监管事务外包市场报告时提到的一些主要一手和二手来源是公司网站、年度报告、财务报告报告、国家政府文件、统计数据库等。报告中列出的主要公司包括 Arriello Ireland Ltd.、IQVIA Inc.、PAREXEL INTERNATIONAL CORPORATION、PHARMALEX GMBH 和 ProductLife Group 等。
Strategic insights for Middle East and Africa Healthcare Regulatory Affairs Outsourcing involve closely monitoring industry trends, consumer behaviours, and competitor actions to identify opportunities for growth. By leveraging data analytics, businesses can anticipate market shifts and make informed decisions that align with evolving customer needs. Understanding these dynamics helps companies adjust their strategies proactively, enhance customer engagement, and strengthen their competitive edge. Building strong relationships with stakeholders and staying agile in response to changes ensures long-term success in any market.
| Report Attribute | Details |
|---|---|
| Market size in 2021 | US$ 291.72 Million |
| Market Size by 2028 | US$ 538.37 Million |
| Global CAGR (2021 - 2028) | 9.1% |
| Historical Data | 2019-2020 |
| Forecast period | 2022-2028 |
| Segments Covered |
By 服务类型
|
| Regions and Countries Covered | 中东和非洲
|
| Market leaders and key company profiles |
The regional scope of Middle East and Africa Healthcare Regulatory Affairs Outsourcing refers to the geographical area in which a business operates and competes. Understanding regional nuances, such as local consumer preferences, economic conditions, and regulatory environments, is crucial for tailoring strategies to specific markets. Businesses can expand their reach by identifying underserved regions or adapting their offerings to meet regional demands. A clear regional focus allows for more effective resource allocation, targeted marketing, and better positioning against local competitors, ultimately driving growth in those specific areas.
The Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market is valued at US$ 291.72 Million in 2021, it is projected to reach US$ 538.37 Million by 2028.
As per our report Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market, the market size is valued at US$ 291.72 Million in 2021, projecting it to reach US$ 538.37 Million by 2028. This translates to a CAGR of approximately 9.1% during the forecast period.
The Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market report typically cover these key segments-
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The Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market is populated by several key players, each contributing to its growth and innovation. Some of the major players include:
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Essentially, anyone involved in or considering involvement in the Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market value chain can benefit from the information contained in a comprehensive market report.
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