Report Ocean presents a comprehensive research report on Medical Device Regulatory Affairs, analyzing markets in 150+ countries. With access to 1,00000+ annual reports, subject matter experts ensure accuracy. Methods like S.W.O.T., P.E.S.T.E.L., and regression analysis forecast growth. The report covers regulations, research tech, innovation, and future trends in Medical Device Regulatory Affairs.
The global medical device regulatory affairs market size was US$ 6.8 billion in 2021. The global medical device regulatory affairs market is expected to grow to US$ 11.2 billion by 2030 by registering a compound annual growth rate (CAGR) of 5.9% during the study period from 2022 to 2030.
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Regulatory affairs play a prominent role in the medical sector in order to guarantee that safe and effective medical product are available globally. Experts in medical device regulatory affairs act as a bridge between the medical device industry and regulatory agencies around the world, such as the Japanese Pharmaceutical & Food Safety Bureau (PFSB), the Medicines and Healthcare Products Regulatory Agency (MHRA), the European Medicine Agency, the Central Drugs Standard Control Organization (CDSCO), etc.
COVID-19 Impact Analysis
The COVID-19 pandemic has positively affected the medical device regulatory affairs market as the companies were working on developing effective devices and medications to combat the disease risk. As a result, the role of medical device regulatory affairs remained active for longer than expected. However, supply chains and regulatory obligations in the midst of uncertainty challenged the medical device regulatory affairs market.
Factors Influencing the Market
The development of new devices and medications in the medical industry is expected to primarily drive the growth of the medical device regulatory affairs market during the analysis period.
A breakthrough medical equipment costs millions to produce, and single mistakes have a negative impact on the brand reputation of the business. The regulatory affairs expert is entirely responsible for maintaining items in conformance and keeping track of all documentation because medical devices play such a significant part in people’s lives and aid in the diagnosis, prevention, and treatment of numerous diseases. Thus, the global medical device regulatory affairs market is expected to spark unprecedented growth in the coming years.
On the contrary, the high cost of delivering regulatory services may limit the growth of the market during the analysis period.
Regional Analysis
In 2021, North America garners the largest market share for medical device regulatory affairs, thanks to rising R&D expenditures and government policies that encouraged the adoption of cutting-edge medical technology for the treatment of chronic illnesses.
The main drivers of market growth for medical device regulatory affairs include the aging population, R&D expenditures, and government programs that support the use of innovative medical devices for chronic conditions.
The market for regulatory affairs for medical devices in Asia-Pacific is anticipated to expand during the forecast period. Product approvals are increasing, clinical studies are being conducted more frequently, which is expected to surge the demand for cutting-edge medical equipment. As a result, it will bring untapped growth opportunities for the medical device regulatory affairs market during the analysis period.
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Competitors in the Market
Amerisource Bergen
Charles River
Clini expert
Emergo
Icbio cro
Icon plc
IQVIA Holdings Inc.
NKG
Parexel
Pepgra
Other Prominent Players
Market Segmentation
The global medical device regulatory affairs market segmentation focuses on Services, Service providers, Type, Indication, and Region.
By Services
Regulatory consulting /Strategic Services
Regulatory writing and publishing
Legal representation
Product Registration and Clinical trials
Others
By Service Provider
In-House
Outsourcing
By Types
Diagnostic
Therapeutics
By Indication
Infectious Diseases
Oncology and Hematology
Gynecology and Obstetrics
Musculoskeletal Disorders
Respiratory
Cardiovascular
Others
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By Region
North America
The U.S.
Canada
Mexico
Europe
Western Europe
The UK
Germany
France
Italy
Spain
Rest of Western Europe
Eastern Europe
Poland
Russia
Rest of Eastern Europe
Asia Pacific
China
India
Japan
Australia & New Zealand
ASEAN
Rest of Asia Pacific
Middle East & Africa (MEA)
UAE
Saudi Arabia
South Africa
Rest of MEA
South America
Brazil
Argentina
Rest of South America
FAQs:
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Any regional variations?
Projected market forecasts?
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Strategies for entry/expansion?
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