Medical Device Regulatory Affairs Market Future Outlook: Analyzing Size, Share, and Growth Patterns

The global medical device regulatory affairs market size is expected to reach USD 11.66 billion by 2030, registering to grow at a CAGR of 9.55% from 2024 to 2030 according to a new report by Grand View Research, Inc. Technological advancements in medical devices, such as AI and machine learning, increasing trends toward portable and smaller devices, and strict government regulations for medical devices are driving the market.

Medical equipment regulation is a vast and rapidly changing field that is often complicated by legal challenges. Even within one regulatory framework, legal terms and their definitions are not always consistent. As technology expands, software, machine learning, and algorithms become essential component of an increasing number of digital health resources. This presents new challenges as an increasing number of instruments fall under the regulatory framework.

Medical Device Regulatory Affairs Market Report Highlights

  • The regulatory writing and publishing segment dominated the market with the largest revenue share of 36.4% in 2023. This is due to a rise in the number of clinical trials, government support, and an increasing need to launch the product quickly
  • Based on type, the therapeutic segment accounted for the larger market share in 2023, due to increasing demand for equipment as a result of technological advancements in developed countries
  • There is a huge demand for outsourcing these services. Hence, the segment contributed to 58.2% of the global market in 2023. This is largely owing to the lack of in-house capabilities and ever-changing regulations for medical devices across the globe
  • Asia Pacific dominated the market and accounted for 37.82% of the revenue share in 2023. This is largely due to the expanding medical device market in India as a result of increased health awareness, a growing middle class, and government health initiatives.

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Medical device companies have to deal with continuous changes in regulatory requirements, which can differ based on business activities and geographies. Noncompliance with the changing regulatory requirements can result in penalties and delays, which may lead to a loss of revenue. According to a survey sponsored by Genpact, 72.0% of executives from the life sciences industry consider regulatory compliance to be one of the top three challenges they face. Such factors are expected to support the demand for these services further.

Public organizations worldwide are providing funding to improve healthcare R&D. For instance, in March 2022, over USD 188.0 million was funded by the U.K. government to support NHS-led health research pertaining to diagnostics and treatments. Such investments in the future are expected to increase the number of new medical device launches, thus creating opportunities for medical device regulatory services. Such activities are expected to support the market in the forecasted period.

List of major companies in Medical Device Regulatory Affairs Market

  • ICON, Plc
  • Emergo
  • Freyr
  • Laboratory Corporation of America Holdings
  • IQVIA, Inc.
  • Intertek Group plc
  • SGS Société Générale de Surveillance SA
  • Promedica International
  • Integer Holdings Corporation
  • Medpace

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We have segmented the global medical device regulatory affairs market based on services, type, service provider, and region.

Research Methodology

We employ a comprehensive and iterative research methodology focused on minimizing deviance in order to provide the most accurate estimates and forecasts possible. We utilize a combination of bottom-up and top-down approaches for segmenting and estimating quantitative aspects of the market. Data is continuously filtered to ensure that only validated and authenticated sources are considered. In addition, data is also mined from a host of reports in our repository, as well as a number of reputed paid databases. Our market estimates and forecasts are derived through simulation models. A unique model is created and customized for each study. Gathered information for market dynamics, technology landscape, application development, and pricing trends are fed into the model and analyzed simultaneously.

About Grand View Research

Grand View Research provides syndicated as well as customized research reports and consulting services on 46 industries across 25 major countries worldwide. This U.S. based market research and consulting company is registered in California and headquartered in San Francisco. Comprising over 425 analysts and consultants, the company adds 1200+ market research reports to its extensive database each year. Supported by an interactive market intelligence platform, the team at Grand View Research guides Fortune 500 companies and prominent academic institutes in comprehending the global and regional business environment and carefully identifying future opportunities.

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Grand View Research, Inc.

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Web: https://www.grandviewresearch.com

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