市场调查报告书
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1470777
医疗事务外包市场:按服务、业务模式和最终用户划分 - 全球预测 2024-2030Medical Affairs Outsourcing Market by Services, Operational Model, End-User - Global Forecast 2024-2030 |
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预计2023年医疗事务外包市场规模为97.8亿美元,2024年将达111.6亿美元,预计2030年将达到253.9亿美元,复合年增长率为14.59%。
医疗事务是生命科学产业的一项重要职能,涵盖了连结临床开发、商业化以及与医疗保健相关人员互动的广泛活动。医学事务外包是指将医学写作、医学传播、出版策划、现场医疗参与、医学资讯服务、卫生经济学和结果研究(HEOR)等活动委託给具有专业知识点的外部组织。随着治疗方法变得更加复杂,对专业医疗事务服务的需求也增加。进入新市场的公司也会寻求当地医疗事务支持,以因应不同的监管环境。强大的製药和生技公司通路正在扩大外包服务的可能性。然而,确保资料安全和维持品管等挑战仍然是主要障碍。寻求开拓市场的製药公司专注于提高服务合规性和交付,同时制定个人化医疗事务策略以支持个人化治疗、展示产品价值并改善临床结果。医疗事务的数位化和人工智慧也有潜力提供创新的外包服务。
主要市场统计 | |
---|---|
基准年[2023] | 97.8亿美元 |
预测年份 [2024] | 111.6亿美元 |
预测年份 [2030] | 253.9亿美元 |
复合年增长率(%) | 14.59% |
服务:越来越多地采用医疗保健外包来提供策略指导,以应对复杂的监管途径
使用医疗事务外包进行临床试验提交和产品註册的组织可以获得整体临床研究和产品市场进入生命週期的全面支援。这包括准备和提交启动临床试验所需的文件,与监管机构互动以确保所有临床试验通讯协定符合法律和安全标准,以及与医疗产品註册相关的各个方面的管理。医疗保健和製药领域的监管环境复杂且快速发展。医疗事务外包提供者提供监管咨询和法律代表,以协助公司解释和遵守管理这些行业的严格法规。这些服务包括监管策略、风险管理、合规评估以及与监管机构合作的建议。此外,我们还提供法律诉讼代理、代表公司进行谈判以及公司与监管机构之间的持续沟通,以保持合规性并在出现法律问题时快速解决。复杂的沟通技巧对于清晰有效地传达科学资料和监管讯息至关重要。监管文件准备医疗事务外包专业准备临床试验报告、监管备案和标准作业程式(SOP)等各种文件。这些服务确保所有材料均符合适当的准则并采用正确的格式以提交给监管机构。
业务模式:采用功能性服务模式,展现医学写作和资料分析重要领域的专业知识
医疗事务全方位服务外包是指由外部服务提供者管理企业整个医疗事务职能的综合方式。希望利用第三方供应商的专业知识、基础设施和全球影响力的公司选择此模型。该模型涵盖策略和营运方面,包括医疗资讯、医疗交流、医药学术专员(MSL) 活动、医学教育和药物安全检测。职能外包涉及与外部合作伙伴签订合约来管理特定职能,而不是医疗事务部门的所有活动。这种业务模式使您能够将专业知识集中在关键领域,例如科学写作、资料分析和临床试验支持,同时管理公司内的其他职能。功能外包的模组化方法提供了弹性和扩充性,可满足动态的市场需求,并使製药和生物技术公司能够有效地解决资源限制。部分或任务式的外包是一种选择性方法,将医疗事务组合中的特定任务或计划外包给专业供应商。该模型对于寻求管理短期需求、试点新倡议或处理需要内部不具备的特殊专业知识的业务的公司特别有用。这种形式的外包提供了高度的控制力和弹性,因为合约可以根据计划要求和可用的内部资源扩大或缩小。
最终用户:透过最终用户之间的多样化应用程式简化营运成本
当生物技术和製药公司需要临床试验、监管情况和市场准入的广泛支援时,他们会转向医疗事务外包服务。委外研发机构利用医疗事务外包来药物安全检测、监管支援和病患招募策略等专门业务,以扩大服务范围并提高业务效率。作为重症加护提供者,医院依靠医疗事务外包服务来简化业务、改善病患治疗效果并遵守医疗保健法规。外包使医院能够专注于患者护理,同时将临床研究、医疗交流、继续医学教育等委託给专业提供者。医疗设备製造商透过外包医疗事务业务,走在产品核可和市场推广的复杂道路上。疗养院需要医疗事务外包服务来改善临床实践、患者照护标准并遵守医疗保健法规。
区域洞察
在美洲,尤其是美国和加拿大,製药业务的合规性和透明度受到高度重视。这些地区的公司越来越多地将其医疗事务业务外包,以保持高水准的监管合规性并从外部专家那里获得策略见解。在医药产业高度发展的美洲,对于成熟的CRO和医疗事务服务提供者来说,有成熟的外包市场。亚太地区的特点是医疗保健市场多元化,各国製药业处于不同的发展阶段。由于本地企业的崛起和全球公司投资的增加,亚太地区的外包正在迅速扩张。临床试验数量的不断增加、对专业医疗服务的需求不断增加以及成本优势极大地促进了亚太地区医疗事务外包的扩张。亚太地区的公司正在转向外包,以获得区域专业知识、扩大市场覆盖范围并满足中国和印度等人口大国不断增长的医疗保健需求。 EMEA(欧洲、中东和非洲)幅员辽阔,拥有多样化的医疗保健系统和法规环境。医疗事务外包在欧洲已经很成熟,许多公司利用 CRO 和其他专业公司的服务,特别是在市场进入和健康经济成果研究 (HEOR) 方面。中东和非洲是新兴的外包市场,跨国公司正在寻求扩大在这些地区的业务。
FPNV定位矩阵
FPNV定位矩阵对于评估医疗事务外包市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一个综合工具,可以对医疗事务外包市场中供应商的现状进行深入而深入的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4.竞争评估与资讯:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况、製造能力等进行全面评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1.医务外包市场规模及预测如何?
2.在医疗事务外包市场的预测期间内,有哪些产品、细分市场、应用和领域需要考虑投资?
3. 医疗事务外包市场的技术趋势和法规结构是什么?
4.医务外包市场主要厂商的市场占有率如何?
5.进入医事外包市场合适的形式或策略手段是什么?
[182 Pages Report] The Medical Affairs Outsourcing Market size was estimated at USD 9.78 billion in 2023 and expected to reach USD 11.16 billion in 2024, at a CAGR 14.59% to reach USD 25.39 billion by 2030.
Medical affairs is an essential function within the life sciences industry, encompassing a wide range of activities that bridge the gaps between clinical development, commercialization, and engagement with healthcare stakeholders. Medical affairs outsourcing refers to the practice of entrusting these activities, including medical writing, medical communications, publication planning, field medical engagement, medical information services, and health economics and outcomes research (HEOR) to external organizations with specialized expertise. As therapies become more complex, the demand for specialized medical affairs services grows. Companies entering new markets also seek local medical affairs support to navigate different regulatory landscapes. The robust pipeline of pharmaceutical and biotech companies broadens the potential for outsourcing services. However, challenges such as ensuring data security and maintaining quality control remain significant hurdles. While market players are focusing on improving service compliance and offerings, they are also developing tailored medical affairs strategies to support personalized therapies and are leveraging real-world evidence to demonstrate product value and inform clinical strategies. Digitalization and AI in medical affairs could also offer innovative outsourcing services.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 9.78 billion |
Estimated Year [2024] | USD 11.16 billion |
Forecast Year [2030] | USD 25.39 billion |
CAGR (%) | 14.59% |
Services: Rising adoption of medical affair outsourcing for strategic guidance to navigate the intricate regulatory pathways
Organizations engaging in medical affairs outsourcing for clinical trial applications and product registrations can expect comprehensive support that spans the complete lifecycle of clinical research and product market entry. This includes the preparation and submission of documents required for the initiation of clinical trials, interfacing with regulatory authorities to ensure all trial protocols meet legal and safety standards, and managing the various aspects related to the registration of a medical product. The regulatory landscape of the healthcare and pharmaceutical sectors is complex and ever-evolving. Medical affairs outsourcing providers offering regulatory consulting and legal representation assist companies in interpreting and adhering to the stringent regulations that govern these industries. These services encompass advice on regulatory strategies, risk management, compliance assessments, and liaising with regulatory agencies. Additionally, they may provide representation during legal proceedings, negotiate on behalf of the company, and ensure consistent communication between businesses and regulatory bodies to maintain compliance and promptly address any legal issues that arise. Sophisticated communication skills are essential in conveying scientific data and regulatory information clearly and effectively. Medical affairs outsourcing for regulatory writing and publishing offers expert crafting of various documents, including clinical study reports, regulatory submission dossiers, and standard operating procedures (SOPs). These services ensure that all materials adhere to the appropriate guidelines and are suitably formatted for submission to regulatory agencies.
Operational Model: Adoption of functional service model to attain targeted expertise in vital areas of medical writing and data analysis
Full-service outsourcing within medical affairs refers to a comprehensive approach in which an external service provider manages the entirety of a company's medical affairs functions. This model is chosen by organizations seeking to leverage the specialized expertise, infrastructure, and global reach of third-party vendors. It encompasses the strategic and operational aspects, including medical information, medical communication, medical science liaison (MSL) activities, medical education, and pharmacovigilance. Functional outsourcing involves contracting external partners to manage specific functions within the medical affairs department rather than the full spectrum of activities. This operational model allows for targeted expertise in critical areas such as scientific writing, data analysis, or clinical trial support while maintaining control over other in-house capabilities. The modular approach of functional outsourcing offers flexibility and scalability, catering to dynamic market needs and enabling pharma or biotech companies to address resource constraints effectively. Partial or task-based outsourcing is a selective approach where specific tasks or projects within the medical affairs portfolio are outsourced to specialized vendors. This model is particularly useful for companies looking to manage short-term needs, pilot new initiatives, or handle tasks that require special expertise not available in-house. This form of outsourcing provides a high degree of control and flexibility, as companies can scale their engagements up or down based on the project requirements and available internal resources.
End User: Diverse applications across end-users for operational cost efficiency
Biotechnology and pharmaceutical companies are primary consumers of medical affairs outsourcing services to fulfill requirements of extensive support in navigating clinical trials, regulatory landscapes, and market access initiatives. Contract Research Organizations utilize medical affairs outsourcing for specialized tasks such as pharmacovigilance, regulatory support, and patient recruitment strategies to expand their service offerings and improve operational efficiencies. As critical care providers, hospitals engage medical affairs outsourcing services to streamline operations, improve patient outcomes, and ensure compliance with healthcare regulations. Outsourcing allows hospitals to focus on patient care while entrusting aspects of clinical research, medical communications, and continuing medical education to specialized providers. Medical device companies outsource medical affairs functions to navigate the complex pathways to product approval and market adoption. Nursing homes require medical affairs outsourcing services to improve clinical practices, patient care standards, and adherence to healthcare regulations.
Regional Insights
In the Americas, particularly in the United States and Canada, there is a significant emphasis on compliance and transparency in pharmaceutical operations. Firms in these regions often outsource medical affairs activities to maintain high levels of regulatory compliance and to gain strategic insights from external experts. With a highly developed pharmaceutical industry, the Americas generally show a mature outsourcing market characterized by the engagement of sophisticated CROs and medical affairs service providers. The APAC region is marked by its diverse healthcare markets, with countries at different stages of pharmaceutical industry development. Outsourcing in APAC is rapidly growing, driven by the emergence of local players and increasing investments by global companies. The rise in the number of clinical trials, growing demand for specialized medical services, and cost advantages are significant factors contributing to the expansion of Medical Affairs outsourcing in APAC. Companies in APAC turn to outsourcing to gain access to regional expertise, expand their market reach, and capitalize on the growing healthcare needs of populous countries, including China and India. EMEA encompasses a vast region with a wide variety of healthcare systems and regulatory environments. In Europe, medical affairs outsourcing is well-established, with many companies leveraging the services of CROs and other specialized firms, particularly for market access and health economics outcomes research (HEOR). The Middle East and Africa are emerging markets for outsourcing, with multinational companies exploring these regions for expansion.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Medical Affairs Outsourcing Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Medical Affairs Outsourcing Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Medical Affairs Outsourcing Market, highlighting leading vendors and their innovative profiles. These include Accenture PLC, Ashfield Healthcare Communications by Inizio, Biomapas Group, Charles River Laboratories International, Inc., Comprehend Systems, Inc. by Saama Technologies, Inc., Excelya, Freyr Solutions, Genpact, Groupe ProductLife S.A., ICON PLC, Indegene, Inc., Insuvia, IQVIA Holdings, Inc., JSS Medical Research Inc, Medpace Holdings, Inc., MMS Holdings Inc., PAREXEL International Corporation, Pharmalex by BlueReg, PPD, Inc. by Thermo Fischer Scientific Inc., ProPharma Group, SGS S.A., Syneos Health, Inc., The Medical Affairs Company, Wuxi Clinical Development, Inc., and Zeincro Group.
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Medical Affairs Outsourcing Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Medical Affairs Outsourcing Market?
3. What are the technology trends and regulatory frameworks in the Medical Affairs Outsourcing Market?
4. What is the market share of the leading vendors in the Medical Affairs Outsourcing Market?
5. Which modes and strategic moves are suitable for entering the Medical Affairs Outsourcing Market?