市場調查報告書
商品編碼
1470777
醫療事務外包市場:按服務、業務模式和最終用戶分類 - 全球預測 2024-2030Medical Affairs Outsourcing Market by Services, Operational Model, End-User - Global Forecast 2024-2030 |
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預計2023年醫療事務外包市場規模為97.8億美元,2024年將達111.6億美元,預計2030年將達到253.9億美元,複合年成長率為14.59%。
醫療事務是生命科學產業的一項重要職能,涵蓋了連結臨床開發、商業化以及與醫療保健相關人員互動的廣泛活動。醫學事務外包是指將醫學寫作、醫學傳播、出版策劃、現場醫療參與、醫學資訊服務、衛生經濟學和結果研究(HEOR)等活動委託給具有專業知識點的外部組織。隨著治療方法變得更加複雜,對專業醫療事務服務的需求也增加。進入新市場的公司也會尋求當地醫療事務支持,以因應不同的監管環境。強大的製藥和生技公司通路正在擴大外包服務的可能性。然而,確保資料安全和維持品管等挑戰仍然是主要障礙。尋求開拓市場的製藥公司專注於提高服務合規性和交付,同時制定個人化醫療事務策略以支持個人化治療、展示產品價值並改善臨床結果。醫療事務的數位化和人工智慧也有潛力提供創新的外包服務。
主要市場統計 | |
---|---|
基準年[2023] | 97.8億美元 |
預測年份 [2024] | 111.6億美元 |
預測年份 [2030] | 253.9億美元 |
複合年成長率(%) | 14.59% |
服務:擴大採用醫療保健外包來提供策略指導,以應對複雜的監管途徑
使用醫療事務外包進行臨床試驗提交和產品註冊的組織可以獲得整體臨床研究和產品市場進入生命週期的全面支援。這包括準備和提交啟動臨床試驗所需的文件,與監管機構互動以確保所有臨床試驗通訊協定符合法律和安全標準,以及與醫療產品註冊相關的各個方面的管理。醫療保健和製藥領域的監管環境複雜且快速發展。醫療事務外包提供者提供監管諮詢和法律代表,以協助公司解釋和遵守管理這些行業的嚴格法規。這些服務包括監管策略、風險管理、合規評估以及與監管機構合作的建議。此外,我們還提供法律訴訟代理、代表公司進行談判以及公司與監管機構之間的持續溝通,以保持合規性並在出現法律問題時快速解決。複雜的溝通技巧對於清晰有效地傳達科學資料和監管訊息至關重要。監管文件準備醫療事務外包專業準備臨床試驗報告、監管備案和標準作業程式(SOP)等各種文件。這些服務確保所有材料均符合適當的準則並採用正確的格式以提交給監管機構。
業務模式:採用功能性服務模式,展現醫學寫作和資料分析重要領域的專業知識
醫療事務全方位服務外包是指由外部服務提供者管理企業整個醫療事務職能的綜合方式。希望利用第三方供應商的專業知識、基礎設施和全球影響力的公司選擇此模型。該模型涵蓋策略和營運方面,包括醫療資訊、醫療交流、醫藥學術專員(MSL) 活動、醫學教育和藥物安全檢測。職能外包涉及與外部合作夥伴簽訂合約來管理特定職能,而不是醫療事務部門的所有活動。這種業務模式使您能夠將專業知識集中在關鍵領域,例如科學寫作、資料分析和臨床試驗支持,同時管理公司內的其他職能。功能外包的模組化方法提供了彈性和擴充性,可滿足動態的市場需求,並使製藥和生物技術公司能夠有效地解決資源限制。部分或任務式的外包是一種選擇性方法,將醫療事務組合中的特定任務或計劃外包給專業供應商。該模型對於尋求管理短期需求、試點新舉措或處理需要內部不具備的特殊專業知識的業務的公司特別有用。這種形式的外包提供了高度的控制力和彈性,因為合約可以根據計劃要求和可用的內部資源擴大或縮小。
最終用戶:透過最終用戶之間的多樣化應用程式簡化營運成本
當生物技術和製藥公司需要臨床試驗、監管情況和市場准入的廣泛支援時,他們會轉向醫療事務外包服務。委外研發機構利用醫療事務外包來藥物安全檢測、監管支援和病患招募策略等專門業務,以擴大服務範圍並提高業務效率。作為重症加護提供者,醫院依靠醫療事務外包服務來簡化業務、改善病患治療效果並遵守醫療保健法規。外包使醫院能夠專注於患者護理,同時將臨床研究、醫療交流、繼續醫學教育等委託給專業提供者。醫療設備製造商透過外包醫療事務業務,走在產品核可和市場推廣的複雜道路上。療養院需要醫療事務外包服務來改善臨床實踐、患者照護標準並遵守醫療保健法規。
區域洞察
在美洲,尤其是美國和加拿大,製藥業務的合規性和透明度受到高度重視。這些地區的公司擴大將其醫療事務業務外包,以保持高水準的監管合規性並從外部專家那裡獲得策略見解。在醫藥產業高度發展的美洲,對於成熟的CRO和醫療事務服務提供者來說,有成熟的外包市場。亞太地區的特點是醫療保健市場多元化,各國製藥業處於不同的發展階段。由於本地企業的崛起和全球公司投資的增加,亞太地區的外包正在迅速擴張。臨床試驗數量的不斷增加、對專業醫療服務的需求不斷增加以及成本優勢極大地促進了亞太地區醫療事務外包的擴張。亞太地區的公司正在轉向外包,以獲得區域專業知識、擴大市場覆蓋範圍並滿足中國和印度等人口大國不斷成長的醫療保健需求。 EMEA(歐洲、中東和非洲)幅員遼闊,擁有多樣化的醫療保健系統和法規環境。醫療事務外包在歐洲已經很成熟,許多公司利用 CRO 和其他專業公司的服務,特別是在市場進入和健康經濟成果研究 (HEOR) 方面。中東和非洲是新興的外包市場,跨國公司正在尋求擴大在這些地區的業務。
FPNV定位矩陣
FPNV定位矩陣對於評估醫療事務外包市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市場佔有率分析
市場佔有率分析是一個綜合工具,可以對醫療事務外包市場中供應商的現狀進行深入而深入的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該行業競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、分散主導地位和合併特徵等因素。詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:提供有關新產品發布、開拓地區、最新發展和投資的詳細資訊。
4.競爭評估與資訊:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況、製造能力等進行全面評估。
5. 產品開發與創新:提供對未來技術、研發活動和突破性產品開發的見解。
1.醫務外包市場規模及預測如何?
2.在醫療事務外包市場的預測期間內,有哪些產品、細分市場、應用和領域需要考慮投資?
3. 醫療事務外包市場的技術趨勢和法規結構是什麼?
4.醫務外包市場主要廠商的市場佔有率如何?
5.進入醫事外包市場合適的形式或策略手段是什麼?
[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?