Medical Device Affairs Outsourcing Market Expected to Reach $8.1 Billion by 2031—Allied Market Research

According to a new report published by Allied Market Research, titled, “Medical Device Affairs Outsourcing Market," The medical device affairs outsourcing market was valued at $4.6 billion in 2021, and is estimated to reach $8.1 billion by 2031, growing at a CAGR of 6% from 2022 to 2031.

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.

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.

By service, the market is classified into regulatory writing & submissions, regulatory registration services, regulatory consulting, and others. The others segment is anticipated to acquire the largest medical device affairs outsourcing market size. This is attributed to the increase in the use of regulatory affairs outsourcing services in the clinical research organization. Recent increase in the demand of the regulatory services have contributed to improve the preference for these services, thus driving the market growth.

On the other side, the regulatory writing and submissions segment is projected to exhibit the fastest market growth during the forecast period due to its increased number of benefits for the medical technology companies.

By software, the market is bifurcated into cloud-based software and on-premise software. The cloud based software segment acquired the largest medical device affairs outsourcing market size in 2021, and is anticipated to continue this trend during the forecast period, due to increase in the advantages of the cloud based software. In addition, the cloud based software segment is expected to exhibit the fastest market growth during the forecast period due to increase in R&D activities concerning medical devices.

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 acquired the largest medical device affairs outsourcing market share in 2021, and is anticipated to continue this trend during the forecast period. This is attributed to the increase in number of medical technology companies globally and increase in the number of product development. On the other side, the pharmaceutical companies segment is projected to exhibit the fastest market growth during the forecast period, owing to rise in preference of the market players for using the outsourcing services for the regulatory affairs compliance.

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.

KEY FINDINGS OF STUDY

• By service, the others segment accounted for major share of the global medical device affairs outsourcing industry in 2021.
• By software, the cloud based software segment is anticipated to grow with the highest CAGR during the medical device affairs outsourcing market forecast period.
• By end user, the pharmaceutical companies segment is anticipated to grow with the highest CAGR during the forecast period.
• Asia-Pacific is anticipated to grow at the highest rate during the medical device affairs outsourcing market analysis period.