Medical Device & IVD Regulatory Affairs Outsourcing Market: FDA-regulated Companies Create Incremental Opportunities for Consultation Firms

Medical Device & IVD Regulatory Affairs Outsourcing Market: Introduction

According to the report, the global medical device & IVD regulatory affairs outsourcing market was valued at US$ 1.03 Bn in 2019. It is projected to expand at a CAGR of ~11% from 2020 to 2030. Regulatory affairs (RA) play a critical role in the medical device & IVD industry, as it is concerned about the lifecycle of the healthcare product, provides strategic, tactical, and operational direction and support to work within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world.

In terms of service, the global medical device & IVD regulatory affairs outsourcing market has been classified into regulatory writing & submissions, regulatory registration services, regulatory consulting, and others. Based of software, the market has been divided into cloud-based software and on-premises software. Increase in regulatory requirements and expansion of the medical device industry boost the global medical device & IVD regulatory affairs outsourcing market.

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North America dominated the global medical device & IVD regulatory affairs outsourcing market in 2019, and the trend is anticipated to continue during the forecast period. Stringent government regulations, presence of large-scale research units, and increase in clinical research are key factors attributed to the prominent share held by North America in the global market. Furthermore, increase in patient awareness regarding cost savings and easy access to global expertise resulted in enhanced adoption of regulatory affairs outsourcing activities by medical device companies.

Asia Pacific is expected to be a highly lucrative market for medical device & IVD regulatory affairs outsourcing during the forecast period. This can be ascribed to increase in approvals of Asia-based CMOs by the U.S. FDA to pursue their regulatory services operations and rise in completion of good manufacturing practice (GMP) certification. Preference for business expansion in countries such as India and China by companies due to favorable business environment is likely to boost the regulatory affairs outsourcing market in these countries.

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Expansion of Medical Device Industry and Increase in Regulatory Requirements to Drive Global Market

The medical device industry is expanding at a rapid pace, driven by innovative technology, and improvement in diagnosis, treatment, and delivery. The medical device industry has made rapid progress in the last decade, owing to government initiatives to increase product access. Moreover, recent technological and scientific advantages with adoption of digital technologies and expansion in emerging markets further boost the medical device industry. A surge in the demand for technologically advanced products, owing to rise in prevalence of various chronic diseases is likely to fuel industry growth. Hence, the expansion of the medical device industry is leading to the requirement for regulations on newly launched products, and regulatory affair paper submission and registration process.\

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Regulatory Writing & Submissions to be Main Services

In terms of service, the global medical device & IVD regulatory affairs outsourcing market has been classified into regulatory writing & submissions, regulatory registration services, regulatory consulting, and others. The regulatory writing & submissions segment dominated the global medical device & IVD regulatory affairs outsourcing market in 2019. The segment dominated the market due to increase in clinical trials, government support, and investment by players toward regulatory affair outsourcing. However, the regulatory consulting segment is estimated to expand at a notable CAGR during the forecast period.

Medical device manufacturers commonly outsource various regulatory consulting services, owing to increase in regulatory pressure. This, in turn, is projected to propel the segment.

Low Cost of Cloud-based Software to Drive Demand

Based on software, the global medical device & IVD regulatory affairs outsourcing market has been classified into cloud-based software and on-premises software. The cloud-based software segment dominated the global medical device & IVD regulatory affairs outsourcing market in 2019. Low cost of cloud-based technology and rapid implementation are key factors likely to augment the segment.

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Competition Landscape

Freyr, Covance, ICON plc, and Emergo are the four major companies operating in the global medical device & IVD regulatory affairs outsourcing market. The global medical device & IVD regulatory affairs outsourcing market is fragmented in terms of number of players. Key players in the global market include RegIQ Solutions, LORENZ Life Sciences Group, AxSource Consulting Inc., Freyr Solutions, Covance, Promedica International, Assent Compliance Inc., MakroCare, Emergo by UL, and ICON. New product development through robust R&D activities and merger & acquisitions are key strategies adopted by these players to operate business in the global medical device & IVD regulatory affairs outsourcing market.

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