全球监管事务外包市场 – 2030 年行业趋势和预测

监管事务外包市场分析和规模

用于法规事务和运营活动的内部资源（如培训、技术、专业知识和设施）的固定成本大幅增加是法规事务外包市场的主要驱动因素。临床试验数量的增加也是法规事务外包市场的一个驱动因素。专注于上市前和上市后活动的流程的改进以及法规服务成本的降低是法规事务外包市场的一个机会。

与数据安全和系统访问相关的风险是监管事务外包市场面临的一大挑战。然而，失控和技术进步导致的价格波动是预测期内监管事务外包市场增长的主要制约因素。          

Data Bridge Market Research 分析，监管事务外包市场规模从 2022 年的 93.892 亿美元飙升至 2030 年的 153.1219 亿美元，预计在预测期内的复合年增长率为 10.66%。由于癌症发病率上升，“肿瘤学”在监管事务外包市场的适应症领域占据主导地位。除了对市场价值、增长率、细分、地理覆盖范围和主要参与者等市场情景的洞察外，Data Bridge Market Research 整理的市场报告还包括深度专家分析、患者流行病学、渠道分析、定价分析和监管框架。

监管事务外包市场范围和细分

市场定义

监管事务外包是制药、生物技术和医疗器械制造公司利用的服务，用于从各种组织获得快速监管批准。监管主要涉及对特定产品的广泛测试，以确保保护公众健康、营销授权、进口和分销以及满足产品安全和性能，市场参与者确保产品符合所有监管要求。

监管事务外包市场动态

驱动程序

• 监管复杂性不断增加

制药、生物技术和医疗器械等行业的监管要求越来越复杂和多样化。这种复杂性促使公司寻求外包合作伙伴的专业监管知识，以确保合规性并有效应对不断变化的法规。

• 技术飞速进步

Industries such as pharmaceuticals and medical devices continuously introduce innovative products and technologies. To keep up with the pace of innovation, companies rely on outsourcing partners with specialized knowledge to navigate regulatory hurdles efficiently and bring new products to market faster.

• Focus on Core Competencies 

Companies are increasingly recognizing the importance of focusing on their core competencies, such as research and development, manufacturing, and marketing. By outsourcing regulatory affairs, they can delegate regulatory tasks to experts and allocate more resources to their primary business activities.

• Flexibility and Scalability

The outsourcing model provides flexibility and scalability to adapt to changing regulatory needs. Companies can scale their regulatory operations up or down based on project requirements, allowing for efficient resource allocation.  

Opportunities

• Expanding Pharmaceutical and Healthcare Industries

The pharmaceutical and healthcare sectors are experiencing rapid growth globally, driven by an aging population, increasing healthcare expenditures, and the development of innovative therapies and medical devices. This growth creates a substantial opportunity for regulatory affairs outsourcing as companies seek efficient ways to navigate complex regulatory landscapes and bring products to market faster.

• Adoption of Advanced Technologies

The adoption of advanced technologies, such as artificial intelligence (AI) and data analytics, can enhance regulatory affairs processes. Outsourcing providers can leverage these technologies to streamline regulatory data management, submissions, and compliance, offering innovative solutions to clients.

Restraints/Challenges

• Confidentiality and Data Security Concerns

Regulatory affairs often involve sensitive and confidential data, including proprietary product information and clinical trial data. Companies may be hesitant to outsource these activities due to concerns about data security, confidentiality breaches, and intellectual property protection.

• Quality Control Challenges

Maintaining consistent quality standards and oversight can be challenging when outsourcing regulatory affairs. Companies may worry about the level of control they have over regulatory processes and whether outsourced providers can maintain the same quality and compliance standards.

• Changing Regulatory Landscapes

Regulatory environments are constantly evolving, with new regulations and guidelines being introduced in various regions and industries. Keeping up with these changes and ensuring compliance across multiple jurisdictions can be a significant challenge for outsourcing providers and their clients.

• Data Privacy and Security

Handling sensitive regulatory data, including clinical trial information and patient data, requires strict adherence to data privacy regulations like GDPR in Europe. Ensuring the security and privacy of data across borders and during the outsourcing process is a complex challenge.

This regulatory affairs outsourcing market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the regulatory affairs outsourcing market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Development

• In February 2021, ICON plc acquired PRA Health Sciences, Inc. in a cash and stock transaction valued at approximately USD 12 billion. This acquisition has strengthened the medical affairs service offering of the company
• In August 2021, ProPharma Group acquired India-based iSafety Systems. This acquisition is expected to strengthen ProPharma Group’s position as the prime global provider of regulatory and compliance consulting, pharmacovigilance, clinical research services, and medical information

Global Regulatory Affairs Outsourcing Market Scope

The regulatory affairs outsourcing market is segmented on the basis of service outlook, size, category, indication, stage and end-user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Service Outlook

• Regulatory Consulting
• Legal Representation
• Regulatory Writing and Publishing
• Product Registration
• Clinical Trial Applications
• Other Services

Size

• Small
• Medium
• Large

Category

• Drugs
• Generics
• Innovators
• Biologics
• Biotech
• ATMPs
• Medical Devices
• Therapeutic
• Diagnostic

Indication

• Oncology
• Neurology
• Cardiology
• Immunology
• Others

Stage

• Preclinical
• Clinical
• PMA (Post Market Authorization)

End-User

• Medical Device Companies
• Pharmaceutical Companies
• Biotechnology Companies

Regulatory Affairs Outsourcing Market Regional Analysis/Insights

The regulatory affairs outsourcing market is analysed and market size insights and trends are provided by service outlook, size, category, indication, stage and end-user as referenced above.

The countries covered in the regulatory affairs outsourcing market report are U.S., Canada, Mexico, Germany, Italy, U.K., France, Spain, Netherlands, Belgium, Switzerland, Turkey, Russia, Rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia- Pacific, Brazil, Argentina, Rest of South America, South Africa, Saudi Arabia, U.A.E., Egypt, Israel, Rest of Middle East and Africa.

North America is likely to lead the regulatory affairs outsourcing market. The regional market has been driven by the low costs of labour increased availability of a skilled workforce and increasing number of clinical trials and a rising number of companies trying to enter markets. However, growing market with new players is the main factor propelling the growth of the regional market. The market in Asia-Pacific is expected to exhibit a substantial growth rate during the forecast period 2023 to 2030 due to growing number of regulatory affairs out-sourcing companies and availability of skilled workforce.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and up-stream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.   

Competitive Landscape and Regulatory Affairs Outsourcing Market Share Analysis

The regulatory affairs outsourcing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the company’s focus related to regulatory affairs outsourcing market.

Some of the major players operating in the regulatory affairs outsourcing market are:

• Accell Clinical Research, LLC (U.S.)
• Genpact (U.S.)
• CRITERIUM, INC. (U.S.)
• PRA Health Sciences (U.S.)
• Promedica International(U.S.)
• WuXiAppTec (China)
• Medpace (U.S.)
• PPD Inc. (U.S.)
• Charles River Laboratories (U.S.)
• ICON plc (U.S.)
• Covance (U.S.)
• Parexel International Corporation. (U.S.)
• Freyr, Navitas Clinical Research, Inc. (U.S.)
• Medelis, Inc. (U.S.)
• Sciformix (U.S.)
• Tech Tammina(U.S.)
• Acorn Regulatory Consultancy Services Ltd. (Ireland)
• BIOMAPAS (Lithuania)
• REGULATORY PROFESSIONALS (Australia)
• CompareNetworks, Inc.（美国），    

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