Global Medical Device Regulatory Affairs Outsourcing Market – Industry Trends and Forecast to 2031

Global Medical Device Regulatory Affairs Outsourcing Market, By Services (Regulatory Affairs Services, Quality Consulting, Regulatory Writing and Publishing, Regulatory Submissions, Clinical Trial Applications, Product Registrations, Legal Representation, and Medical Writing), Product (Finished Goods, Electronics and Raw Material), Device Type (Class I, Class II and Class III), Category (Biologics, Drugs, and Medical Devices), Application (Cardiology, Diagnostic Imaging, Orthopedic, IVD, Ophthalmic, General and Plastic Surgery, Drug Delivery, Dental, Endoscopy, Diabetes Care and Others), End User (Small Medical Device Company, Medium Medical Device Company, Pharmaceutical and Biotechnology Companies, Medical Devices Manufacturer, and Large Medical Device Company) – Industry Trends and Forecast to 2031.

Medical Device Regulatory Affairs Outsourcing Market Analysis and Size

The medical device regulatory affairs outsourcing market is thriving, as highlighted by a Global Observatory on Health R&D analysis in February 2022. This growth aligns with the escalating recruitment of trials registered on the WHO ICTRP worldwide, reflecting a steadfast global dedication to advancing healthcare research and development, underpinning market expansion.                                

Data Bridge Market Research analyses that the global medical device regulatory affairs outsourcing market, which was USD 6.53 billion in 2023, is expected to reach USD 17.12 billion by 2031, and is expected to undergo a CAGR of 12.8% during the forecast period of 2024 to 2031. This indicates that the market value. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Report Scope and Market Segmentation

Market Definition

Medical device regulatory affairs outsourcing involves hiring external experts or firms to handle regulatory compliance tasks such as submissions, documentation, and compliance strategies for medical devices. This allows companies to navigate complex regulations efficiently, ensure compliance, and focus on core business activities while leveraging specialized expertise.            

Global Medical Device Regulatory Affairs Outsourcing Market Dynamics

Drivers

• Changing Healthcare Landscape to Ensure Adaptability

The evolving healthcare landscape, including policy shifts, reimbursement criteria adjustments, and heightened patient safety concerns, constantly reshapes regulatory requirements. This dynamic environment underscores the ongoing need for regulatory support to ensure compliance and adaptability within the medical device industry, driving demand for specialized expertise and regulatory affairs outsourcing services.

• Demand for Faster Time-to-Market for Quick Approval Process

Outsourcing regulatory affairs accelerates approval processes, enabling medical device firms to rapidly launch products, gaining competitive advantages. Through leveraging specialized expertise and resources, companies navigate complex regulatory landscapes efficiently, reducing time-to-market. This strategic approach ensures timely market entry, maximizing opportunities and enhancing competitiveness in the dynamic medical device industry.

Opportunities

• Mergers and Acquisitions for Better Efficiency

Mergers and acquisitions in the medical device sector necessitate regulatory harmonization and product portfolio integration. This fuels demand for outsourced regulatory expertise to navigate transitional phases efficiently, ensuring compliance and accelerating time-to-market for newly consolidated entities.

• Rapid Technological Advancements for Better Effects

Rapid advancements in medical device technologies necessitate continuous adaptation to regulatory standards. This dynamic landscape demands specialized regulatory expertise to navigate complex requirements effectively. Companies stay well-informed of evolving regulations to ensure compliance and expedite product development, highlighting the crucial role of specialized regulatory knowledge in facilitating innovation within the industry. 

Restraints/Challenges

• Difficulty in Vendor Selection and Management

The difficulty in identifying reputable outsourcing partners with required expertise and managing multiple vendor relationships adds complexity to the medical device regulatory affairs outsourcing market. This challenge can hinder efficiency, increase costs, and potentially compromise regulatory compliance, impacting the overall effectiveness and growth potential of the outsourcing market. 

• Resource Constraints Delays in Regulatory Submissions

Resource constraints in medical device regulatory affairs outsourcing impede market growth as firms grapple with challenges in recruiting and retaining qualified personnel. This scarcity results in delays in regulatory submissions, escalating costs, and risk compliance. The inability to effectively meet client demands and uphold high-quality services undermines the overall efficiency and competitiveness of the market.   

This global medical device 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 global medical device 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 Developments

• In 2022, PharmaLex Group merges with DRA Consulting, a Finland-based firm specializing in pharmacovigilance, market access, quality, regulatory services, and comprehensive solutions for over 300 clients, enhancing PharmaLex's global offerings
• In 2022, AmerisourceBergen Corporation finalizes acquisition of PharmaLex Holding GmbH, a key player in life sciences services, from AUCTUS Capital Partners AG, strengthening AmerisourceBergen's presence and capabilities in the industry
• In 2021, ProTom International partnered with Guohong Guokang Health Technology Development Co., LTDGHGK in China to distribute the Radiance 330 Proton Therapy system, marking a significant move in its global expansion strategy, focusing on mainland China
• In 2020, Mevion Medical Systems collaborated with Hermes Advanced Therapy Systems Corp. (HATS) to distribute the Mevion S250i proton therapy system in Taiwan and Southeast Asia, including Thailand, Malaysia, and Singapore, aiming to boost business and facilitate further expansion in these regions

Global Medical Device Regulatory Affairs Outsourcing Market Scope

The global medical device regulatory affairs outsourcing market is segmented on the basis of services, product, device type, category, application 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.

Services

• Regulatory Affairs Services
• Quality Consulting
• Regulatory Writing and Publishing
• Regulatory Submissions
• Clinical Trial Applications
• Product Registrations
• Legal Representation
• Medical Writing

 Product

• Finished Goods
• Electronics
• Raw Material

 Device Type

• Class I
• Class II
• Class III

 Category

• Biologics
• Drugs
• Medical Devices

 Application

• Cardiology
• Diagnostic Imaging
• Orthopedic
• IVD
• Ophthalmic
• General and Plastic Surgery
• Drug Delivery
• Dental
• Endoscopy
• Diabetes Care
• Others

 End User

• Small Medical Device Company
• Medium Medical Device Company
• Pharmaceutical and Biotechnology Companies
• Medical Devices Manufacturer
• Large Medical Device Company

Global Medical Device Regulatory Affairs Outsourcing Market Regional Analysis/Insights

The global medical device regulatory affairs outsourcing market is analysed and market size insights and trends are provided by country, services, product, device type, category, application and end user as referenced above.

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

Asia-Pacific dominates the medical device regulatory affairs outsourcing market due to increasing research and development activities and demand for regulatory affairs services. The region's rapid adoption of advanced technology further accelerates market growth, reflecting its pivotal role in the global landscape.

Europe dominates the medical device regulatory affairs outsourcing market, with Germany at the forefront. The country's dominance stems from an increased allocation of healthcare expenditure towards the regulatory affairs services segment, solidifying its leading position in shaping the regional outsourcing landscape.

North America dominates the medical device regulatory affairs outsourcing market, with U.S. at the forefront. The region is poised for substantial growth from 2024 to 2031, driven by a rising trend in adopting outsourcing models for the regulatory affairs services segment, solidifying the U.S.'s position as a key market driver.

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 upstream 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.   

Healthcare Infrastructure growth Installed base and New Technology Penetration

The global medical device regulatory affairs outsourcing market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for global medical device regulatory affairs outsourcing market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the global medical device regulatory affairs outsourcing market. The data is available for historic period 2016-2021.

Competitive Landscape and Global Medical Device Regulatory Affairs Outsourcing Market Share Analysis

The global medical device 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 companies' focus related to global medical device regulatory affairs outsourcing market.

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

• Parexel International (MA) Corporation. (U.S.)
•  North American Science Associates, LLC U.S.)
• SGS Société Générale de Surveillance SA. (Switzerland)
• Pace (U.S.)
•  Trilogy Writing & Consulting GmbH (Germany)
•  Creganna (Ireland)
•  Intertek Group plc (U.K.)
• WuXi AppTec (China)
•  Charles River Laboratories (U.S.)
•  Celestica Inc. (Canada)
•  Freyr (U.S.)
•  Cactus Communications (India)
•  In.Corp Indonesia (Indonesia)
•  Eurofins Scientific (Luxembourg)
•  Plexus Corp. (U.S.)
•  Sanmina Corporation (U.S.)
•  OMRON Corporation (Japan)