Medical Device Affairs Outsourcing Market By Service (Regulatory Writing and Submissions, Regulatory Registration Services, Regulatory Consulting, Others), By Software (Cloud Based Software, On Premise Software), By End User (Pharmaceutical Companies, Medical Technology Companies, Others): Global Opportunity Analysis and Industry Forecast, 2021-2031
The global medical device affairs outsourcing market was valued at $4,546.4 million in 2021, and is projected to reach $8,111.02 million by 2031, registering a CAGR of 6.0% from 2022 to 2031.
The medical affairs is a multi-faceted functional area with activities spread across regulatory affairs, pharmacovigilance, post-marketing studies, and brand sales & marketing. In all stages and at all aspects of a product’s lifecycle and commercial processes, medical affairs foster significant value. It helps build a company’s scientific & medical credibility, and even enhances their brand reputation. It originally emerged as a reaction to increasing pressures from regulators to separate product development and commercialization functions. Companies were experiencing increasing internal demands to focus the role of development on generating and developing new products rather than on managing products after FDA approval. Over the past 25 years, continued regulatory pressure shifted a number of commercial activities to people with medical expertise, most often to medical affairs groups.
The global medical device affairs outsourcing market is anticipated to show significant market growth during the forecast period, owing to increase in number of on-going R&D activities, surge in number of clinical studies conducted, and rise in demand for outsourcing regulatory affairs services. Furthermore, the medical device regulatory affairs outsourcing helps to augment the volume of product registrations and clinical trial approvals, which contribute toward the market growth.
However, high cost of clinical trials & product development and change in the regulations regarding medical device in different regions negatively impact the market growth. Conversely, the economic growth in emerging market offers the lucrative opportunities for the growth of the market.
The medical device affairs outsourcing market is segmented on the basis of service, software, end user, and region. By service, the market is classified into regulatory writing & submissions, regulatory registration services, regulatory consulting, and others. By software, the market is bifurcated into cloud-based software and on-premise software. By end user, the market is categorized into pharmaceutical companies, medical technology companies, and others. Furthermore, the pharmaceutical companies segment is subclassified into large and medium. The medical technology companies segment is further subsegmented into large and medium. Region wise, the market is studied across North America (U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and rest of Europe), Asia-Pacific (China, Japan, Australia, India, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and rest of LAMEA).
The major companies profiled in the report include Excelya, Icon plc, Indegene Private Limited, Inizio (UDG Healthcare plc.), IQVIA Holdings Inc., Parexel International Corporation, SGS SA, Syneos Health, Inc., Thermo Fisher Scientific, Inc. (PPD Inc.), and Wuxi AppTec.
Key Benefits For Stakeholders
This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the medical device affairs outsourcing market analysis from 2021 to 2031 to identify the prevailing medical device affairs outsourcing market opportunities.
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 affairs outsourcing 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 affairs outsourcing market trends, key players, market segments, application areas, and market growth strategies.
Key Market Segments
By Service
Regulatory Writing and Submissions
Regulatory Registration Services
Regulatory Consulting
Others
By Software
Cloud Based Software
On Premise Software
By End User
Pharmaceutical Companies
Company Size
Large
Medium
Medical Technology Companies
Company Size
Large
Medium
Others
By Region
North America
U.S.
Canada
Mexico
Europe
Germany
France
UK
Italy
Spain
Rest Of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest Of Asia-Pacific
LAMEA
Brazil
Saudi Arabia
South Africa
Rest Of LAMEA
Key Market Players
Charles River
Inizio
IQVIA Holdings Inc.
Parexel International Corporation
SGS SA
Syneos Health, Inc.
Thermo Fisher Scientific, Inc.
Wuxi AppTec
Excelya
Icon plc
Indegene Private Limited
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