Medical Device Regulatory Affairs Market: Therapeutic Segment Accounted For The Larger Share

 Medical Device Regulatory Affairs Industry Overview

The global medical device regulatory affairs market size is expected to reach USD 12.1 billion by 2030, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 10.1% from 2023 to 2030. 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 an 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 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.


Medical Device Regulatory Affairs Market Segmentation

Grand View Research has segmented the global medical device regulatory affairs market based on services, type, service provider, and region:

Based on the Service Insights, the market is segmented into Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, and Other Services.

  • The regulatory writing and publishing segment dominated the market for medical device regulatory affairs with 36.4% of revenue share in 2020. This is largely attributed to the fact that these services are provided from the early stages of product development to premarket approval, as high-quality documentation is essential for regulatory affairs in order to escape delays in the approval process.

 

  • The segment of product registration and clinical trial services is anticipated to witness the fastest growth rate of 25.1% over the forecast period. The clinical trial for a medical device and regulations to manage the studies are very different. The medical device studies are complex that span across regulatory challenges, product types, and unique statistical analyses and study designs. 

 

Based on the Type Insights, the market is segmented into Diagnostics, and Therapeutics.

  • The therapeutics segment led the market for medical device regulatory affairs and accounted for the largest revenue share of more than 55.0% in 2020. The segment is also projected to witness the fastest CAGR of 8.9% during the forecast period. This may be attributed to the increasing prevalence of various chronic diseases such as cancer, diabetes, cardiovascular diseases, and respiratory disorders that create demand for advanced therapeutic products.

 

  • The pandemic has increased the demand for regulatory services. Due to a lack of supply, temporary approvals for expired therapeutic equipment such as respirators/ventilators and certification of similar equipment such as positive pressure breathing devices and anesthesia gas machines are permitted.

 

Based on the Service Provider Insights, the market is segmented into Outsource, and In-house.

  • The outsourcing segment dominated the market for medical device regulatory affairs with the largest revenue share of 60.0% in 2020. This is largely attributed to the lack of an in-house regulatory team. Besides, the advantages such as cost and time saving associated with the outsourcing of these services are contributing to the market growth.

 

  • New regulatory challenges, such as medical device regulation and in vitro diagnostic device regulation in Europe, as well as regulatory cybersecurity scrutiny, make market launch and recertification timelines difficult. It is incredibly challenging for businesses to manage regulatory hurdles with unskilled personnel which drives the demand of outsourcing these services.

 

Medical Device Regulatory Affairs Regional Outlook

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa (MEA)

 

Key Companies Profile & Market Share Insights

Market players are undertaking various strategic initiatives such as the launch of new services partnerships, collaborations, mergers and acquisitions, geographic expansion, aiming to strengthen their product portfolio, manufacturing capacities, and provide a competitive advantage. For example, in February 2020, Emergo has released 510(k) Builder, a new subscription-based software tool that can simplify and streamline the U.S. FDA’s submissions for the manufacturers of medical devices to get faster access to the market. 510(k) Builder comprises full integration with FDA databases that allows users to rapidly identify required data such as product codes and predicate devices; and automated formatting of documentation in accordance with FDA requirements. Some of the prominent players in the medical device regulatory affairs market include:

  • ICON Plc
  • Emergo
  • Covance
  • Freyr
  • Promedica International
  • Medpace
  • IQVIA Holdings
  • Intertek Plc
  • SGS SA
  • Integer Holdings

 

Order a free sample PDF of the Medical Device Regulatory Affairs Market Intelligence Study, published by Grand View Research.

 

About Grand View Research

Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research Helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.

 

Contact:

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Grand View Research, Inc.

Phone: 1-415-349-0058

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