DUBLIN–(BUSINESS WIRE)–The “Medical Device Regulatory Affairs Market By Services, By Service Provider, By Types, By Indication: Global Opportunity Analysis and Industry Forecast, 2021-2031” report has been added to ResearchAndMarkets.com’s offering.
The global Medical Device Regulatory Affairs Market was valued at $6,969.7 million in 2021, and is projected to reach $12,247.7 million by 2031, registering a CAGR of 5.8% from 2022 to 2031.
Medical Device Regulatory Affairs are Regulatory affairs (RA), commonly known as government affairs, is a specialty in regulated industries such as pharmaceuticals, medical devices, and agrochemicals. Within the healthcare industry, regulatory affairs have a very specific connotation.
The regulatory function in the healthcare industry is critical in ensuring the availability of safe and effective healthcare products around the world. Regulatory professionals include individuals who ensure regulatory compliance and prepare submissions, as well as those whose primary job function is clinical affairs or quality assurance. Medical Device Regulatory Affairs experts serve as a link between the medical device industry and regulatory bodies around the world, including the United States, the United Kingdom, Canada, the European Union, India, Japan, and Australia.
As one of the most highly regulated industries, the healthcare industry needs more experts than ever before who are capable of resolving regulatory issues in a proficient way. Regulatory affairs experts are critical in ensuring that all medical devices comply with industry regulations. Industry regulatory specialists are involved with a wide range of medical devices manufactured in various nations. As regulatory processes become more sophisticated and broader, and as the area becomes more globalized, there will be a continued demand for personnel with a strong background in medical device regulatory affairs.
The advantages of medical device regulatory affairs are that it ensure that all GCP and ICH guidelines, as well as EU CTD and other applicable laws and regulations, are followed when conducting clinical trials for medical devices, it help in establishing, maintaining, and obtaining senior management approval for the Quality Management project and strategic audit programmed and also it help in setting up and maintaining clinical quality assurance papers, protocol deviations, investigations, and change management systems and tools wherever required for the approval of new medical device.
With the rapid changes taking place in medical technologies the regulations and quality requirements also need to keep pace and address the specific needs across different geographies. For Medical Devices, the Quality and Regulatory affairs requirements kick in and play a crucial role from the product design phase and provide guidelines across the product lifecycle.
The market is expected to witness a moderate growth during the forecast period, owing to rise in adoption and development of advanced medical devices for the treatment of various disease such as cardiovascular, cancer, and other infectious diseases, along with various technological advancements and their increasing applications in the healthcare sector. Furthermore, surge in geriatric population along with various technological advancements in the market to meet the unmet needs of patients provides significant opportunities for existing players and new entrants.
However, factors such as high cost of providing regulatory services and increase in number of cyber-attacks & concern related to cyber security are expected to hamper growth of the market up to some extent during the forecast period.
Key Benefits For Stakeholders
- This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the medical device regulatory affairs market analysis from 2021 to 2031 to identify the prevailing medical device regulatory affairs market opportunity.
- The market research is offered along with information related to key drivers, restraints, and opportunities.
- Porter’s five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
- In-depth analysis of the medical device regulatory affairs market segmentation assists to determine the prevailing market opportunities.
- Major countries in each region are mapped according to their revenue contribution to the global market.
- Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
- The report includes the analysis of the regional as well as global medical device regulatory affairs market trends, key players, market segments, application areas, and medical device regulatory affairs market growth strategies.
Key Market Segments
By Services
- Regulatory consulting /Strategic Services
- Regulatory writing and publishing
- Legal representation
- Product Registration and Clinical trials
- Others
By Service Provider
- In-House
- Out sourcing
By Types
- Diagnostic
- Therapeutics
By Indication
- Infectious Diseases
- Oncology and Hematology
- Gynaecology and Obstetrics
- Muscusloskeletal Disorders
- Respiratory
- Cardiovascular
- Others
By Region
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- France
- United Kingdom
- Italy
- Spain
- Rest of Europe
- Asia-Pacific
- Japan
- China
- India
- South Korea
- Malaysia
- Rest of Asia-Pacific
- LAMEA
- Brazil
- Israel
- Saudi Arabia
- South Africa
- Rest of LAMEA
Key Market Players
- Amerisource Bergen
- Charles river
- Clini expert
- Emergo
- icbio cro
- icon plc
- IQVIA Holdings Inc.
- NKG
- parexel
- Pepgra
For more information about this report visit https://www.researchandmarkets.com/r/8jcqxr
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