Medical device regulatory affairs market to reach USD12.2B by 2031

Allied Market Research published a report, titled, “Medical device regulatory affairs market by services (Regulatory consulting/strategic services, regulatory writing and publishing, legal representation, product registration and clinical trials, others), by service provider (In-house, out sourcing), by types (Diagnostic, therapeutics), by indication (Infectious diseases, oncology and hematology, gynaecology and obstetrics, musculoskeletal disorders, respiratory, cardiovascular, others): Global opportunity analysis and industry forecast, 2021-2031” According to the report, the global medical device regulatory affairs industry was estimated at $7.0 billion in 2021, and is anticipated to hit $12.2 billion by 2031, registering a CAGR of 5.8% from 2022 to 2031.

Drivers, restraints, and opportunities
Rise in adoption and development of advanced medical devices for the treatment of various diseases such as cardiovascular, cancer, and other infectious diseases, along with various technological advancements and their increased applications in the healthcare sector drives the growth of the global medical device regulatory affairs market. On the other hand, factors such as high cost of providing regulatory services and increase in number of cyberattacks on software-based medical devices are expected to hamper the market growth to some extent.

However, surge in the geriatric population along with various technological advancements in the market to meet the unmet needs of patients are anticipated to pave the way for lucrative opportunities in the industry.

The legal representation segment to dominate by 2031
By application, the legal representation segment contributed to the major share in 2021, holding nearly one-fourth of the global medical device regulatory affairs market. Increase in demand for traditional and special 510(k) and pre-market approval (PMA) drives the segment growth.

The product registration and clinical trials segment, however, would cite the fastest CAGR of 6.8% during the forecast period. This is owing to surge in demand for faster approval processes.

The outsourcing segment to maintain the lion’s share
By service provider, the outsourcing segment accounted for the major share in 2021, holding nearly two-thirds of the global medical device regulatory affairs market. The same segment is also expected to grow at the fastest CAGR of 6.0% from 2022 to 2031.

This is attributed to the increasing complexity of medical devices and rise in demand for regulatory services required by small-scale industries to get their product approval globally.

Europe garnered the major share in 2021
By region, the market across Europe had the lion’s share in 2021, generating nearly one-third of the global medical device regulatory affairs market. The Asia-Pacific region, simultaneously, is projected to portray the fastest CAGR of 6.9% by 2031.

This is due to rise in number of product approvals, increase in number of clinical trials procedures, surge in demand for regulatory services.

Key players in the industry

• Charles River
• Cliniexpert
• Emergo
• Icbio
• Icon PLC
• Amerisource Bergen
• Pepgra
• IQVIA
• NKG
• Parexel

Allied Market Research