Medical device affairs outsourcing market to reach USD 8.1B by 2031

According to a new report, 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 experiencing cost pressures and workforce challenges, making it increasingly difficult to obtain new marketing authorizations, maintain regulatory compliance, and manage operating costs. As a result, decision-makers are exploring the option of outsourcing regulatory affairs services to service providers. Outsourced activities often include clinical and nonclinical overviews, summaries, expert reports, and preparation of various regulatory documents such as clinical trial protocols and investigator brochures.

Reasons for outsourcing include reducing the workload on in-house regulatory affairs departments and cost-effectiveness. Medical affairs outsourcing provides scalable solutions for OEM companies, allowing them to utilize healthcare resources efficiently. The growth in clinical trials is driven by the increasing prevalence of diseases, further boosting demand for medical affairs outsourcing.

However, the Covid-19 pandemic has negatively impacted the medical device affairs outsourcing industry, complicating decision-making processes for medical device companies due to uncertainty. Clinical trials have been particularly affected by travel bans and restrictions, leading to challenges in meeting corporate milestones and maintaining data integrity.

The market for regulatory affairs outsourcing is classified into various services such as regulatory writing, submissions, consulting, and others. Regulatory writing and submissions are expected to grow rapidly due to their benefits for medical technology companies.

Cloud-based software dominates the market due to its advantages and is projected to continue growing, especially with increased R&D activities in medical devices.

End users include pharmaceutical and medical technology companies, with the latter dominating the market share due to increased product development. However, pharmaceutical companies are expected to grow rapidly as they increasingly prefer outsourcing for regulatory compliance.

Europe leads in revenue, driven by the presence of clinical research organizations and key players, while Asia-Pacific is expected to grow at the highest rate due to increased clinical trials and awareness of regulatory affairs outsourcing benefits. Allied Market Research