Global Medical Device Affairs Outsourcing Market Size Was Valued at USD 4.6 billion in 2021 and is projected to Garner USD 8.1 billion by 2031, with a registered CAGR of 6% from 2022 to 2031.
What is the Medical Device Affairs Outsourcing?
Many pharmaceutical companies are facing cost pressures and workforce spin. Recent trends show that it is much more challenging to obtain new marketing authorization approvals, maintain regulatory compliance, and ensure competitive staff operating costs. Hence, the key decision-makers of companies consider the possibility to obtain external regulatory affairs services from regulatory affairs service providers. The most often outsourced medical affairs activities in the group of regulatory services are clinical & nonclinical overviews & summaries, addendums to clinical overview, expert reports, scientific publications, preparation of clinical trials protocols, investigator’s brochure, PSURs, clinical study reports (CRSs).
Some of the reasons to consider the outsourcing of the regulatory affairs services include reduction of excessive workload in pharmaceutical companies’ regulatory affairs department and cost effectiveness of the services. Medical affairs outsourcing services assist the original equipment manufacturing (OEM) companies with scalable and flexible solutions that support them to use healthcare personnel resources, resource components, and strategic management. The growth in the number of clinical trials being conducted is principally linked to the rising cases of many non-communicable and communicable diseases, which is boosting the demand for the development of medical devices or new drugs, which in turn increases the need for medical affairs outsourcing services. The major end users like medical technology companies those with established quality assurance/ regulatory affairs departments, often seek the assistance to supplement their in-house expertise, allowing them to overcome staffing shortages, accommodate a parental leave of absence, provide training, or obtain independent auditor assistance.
How big is Medical Device Affairs Outsourcing Market?
By region, 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). Europe accounted for the largest share of revenue in 2021, and is anticipated to maintain its dominance from 2022 to 2031, owing to presence of large number of clinical research organizations, strong presence of key players, increased healthcare expenditure, higher number of research, development, & innovation activities, and higher adoption of advanced technologies. Moreover, Asia-Pacific is expected to grow at the highest CAGR, owing to medical device affairs outsourcing market trends like increase in number of clinical trials conducted and rise in awareness related to regulatory affairs services outsourcing benefits.
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- CAGR: 6%
- Current Market Size: USD 4.6 Billion
- Forecast Growing Region: APAC
- Largest Market: North America
- Projection Time: 2021 – 2031
- Base Year: 2021
(𝐈𝐧 𝐭𝐨𝐝𝐚𝐲’𝐬 𝐜𝐨𝐦𝐩𝐞𝐭𝐢𝐭𝐢𝐯𝐞 𝐦𝐚𝐫𝐤𝐞𝐭, 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐚𝐧𝐚𝐥𝐲𝐬𝐢𝐬 𝐢𝐬 𝐚 𝐜𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐬𝐭𝐞𝐩 𝐢𝐧 𝐢𝐝𝐞𝐧𝐭𝐢𝐟𝐲𝐢𝐧𝐠 𝐭𝐡𝐞 𝐜𝐨𝐫𝐫𝐞𝐜𝐭 𝐭𝐚𝐫𝐠𝐞𝐭 𝐜𝐨𝐧𝐬𝐮𝐦𝐞𝐫𝐬 𝐚𝐧𝐝 𝐩𝐫𝐨𝐯𝐢𝐝𝐢𝐧𝐠 𝐜𝐮𝐬𝐭𝐨𝐦𝐢𝐬𝐞𝐝 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐟𝐨𝐫 𝐭𝐡𝐞𝐢𝐫 𝐛𝐮𝐬𝐢𝐧𝐞𝐬𝐬 𝐧𝐞𝐞𝐝𝐬. 𝐖𝐡𝐢𝐥𝐞 𝐟𝐨𝐫𝐦𝐮𝐥𝐚𝐭𝐢𝐧𝐠 𝐭𝐡𝐞𝐬𝐞 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬, 𝐞𝐯𝐞𝐫𝐲 𝐟𝐚𝐜𝐞𝐭 𝐚𝐧𝐝 𝐬𝐩𝐞𝐜𝐢𝐟𝐢𝐜 𝐩𝐫𝐨𝐛𝐥𝐞𝐦 𝐩𝐫𝐞𝐬𝐞𝐧𝐭𝐞𝐝 𝐛𝐲 𝐭𝐡𝐞 𝐩𝐚𝐫𝐭𝐢𝐜𝐮𝐥𝐚𝐫 𝐬𝐞𝐜𝐭𝐨𝐫 𝐢𝐬 𝐭𝐡𝐨𝐫𝐨𝐮𝐠𝐡𝐥𝐲 𝐜𝐨𝐧𝐬𝐢𝐝𝐞𝐫𝐞𝐝. 𝐈𝐭 𝐚𝐥𝐬𝐨 𝐜𝐨𝐧𝐬𝐢𝐝𝐞𝐫𝐬 𝐧𝐮𝐦𝐞𝐫𝐨𝐮𝐬 𝐠𝐨𝐯𝐞𝐫𝐧𝐦𝐞𝐧𝐭 𝐫𝐞𝐟𝐨𝐫𝐦𝐬, 𝐭𝐡𝐞 𝐜𝐨𝐦𝐩𝐞𝐭𝐢𝐭𝐢𝐯𝐞 𝐞𝐧𝐯𝐢𝐫𝐨𝐧𝐦𝐞𝐧𝐭, 𝐜𝐮𝐬𝐭𝐨𝐦𝐞𝐫 𝐛𝐞𝐡𝐚𝐯𝐢𝐨𝐮𝐫, 𝐜𝐮𝐫𝐫𝐞𝐧𝐭 𝐚𝐧𝐝 𝐟𝐮𝐭𝐮𝐫𝐞 𝐛𝐮𝐬𝐢𝐧𝐞𝐬𝐬 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐞𝐬, 𝐚𝐧𝐝 𝐫𝐚𝐩𝐢𝐝𝐥𝐲 𝐜𝐡𝐚𝐧𝐠𝐢𝐧𝐠 𝐭𝐞𝐜𝐡𝐧𝐢𝐜𝐚𝐥 𝐛𝐫𝐞𝐚𝐤𝐭𝐡𝐫𝐨𝐮𝐠𝐡𝐬. 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐚𝐧𝐚𝐥𝐲𝐬𝐢𝐬 𝐚𝐢𝐝𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐟𝐨𝐫𝐦𝐮𝐥𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐛𝐮𝐬𝐢𝐧𝐞𝐬𝐬 𝐩𝐥𝐚𝐧𝐬 𝐚𝐧𝐝 𝐩𝐨𝐥𝐢𝐜𝐢𝐞𝐬.)
Impact of COVID-19 on the Medical Device Affairs Outsourcing Market-
- The impact of COVID-19 remains negative on medical device affairs outsourcing industry, as medical device companies are finding it difficult to make informed decisions about their products, supply chains, and regulatory obligations in the midst of uncertainty. Medical device professionals have the unenviable task of asking for a pause amid the panic. For instance, the impact of COVID-19 on clinical trials has been hampered, due to challenges posed by travel bans, hospital/clinic visit restrictions, and social distancing precautions, just to name a few. These factors have translated into multiple issues that pose challenges related to corporate milestones, budgets, and data integrity. IRB meetings and processes are not impacted by any restrictions on travel. As a standard practice, the IRB meets remotely via video conference technology.
Get detailed COVID-19 impact analysis on the Medical Device Affairs Outsourcing Market
VALUE PROPOSITIONS RELATED TO THE REPORT:
- 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.
Medical Device Affairs Outsourcing Companies:
• Charles River
• IQVIA Holdings Inc.
• Parexel International Corporation
• SGS SA
• Syneos Health, Inc.
• Thermo Fisher Scientific, Inc.
• Wuxi AppTec
• Icon plc
• Indegene Private Limited
Each segment of the global medical device affairs outsourcing market is extensively evaluated in the research study. The segmental analysis offered in the report pinpoints key opportunities available in the global medical device affairs outsourcing market through leading segments.
The regional study of the global medical device affairs outsourcing market included in the report helps readers to gain a sound understanding of the development of different geographical markets in recent years and also going forth. We have provided a detailed study on the critical dynamics of the global medical device affairs outsourcing market, which include the market influence and market effect factors, drivers, challenges, restraints, trends, and prospects. The research study also includes other types of analysis such as qualitative and quantitative.
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