Medical Device Regulatory Affairs Market Size, Share & Trends Analysis Report By Service (Legal Representation, Regulatory Consulting), By Type (Diagnostics, Therapeutics), By Service Provider, By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global medical device regulatory affairs market size was estimated at USD 4.5 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 8.6% from 2021 to 2028. This growth can be attributed to rising demand for faster approval processes, a shifting regulatory landscape, and expansion in emerging fields such as therapeutics and diagnostics. Besides, the increasing complexity of medical devices and favorable government initiatives are also supporting the growth of the market for medical device regulatory affairs.

Right now, every aspect of the medical industry has been dominated by the COVID-19 pandemic. While the decline in economic activity has reduced revenue streams, demand for products such as ventilators and Personal Protective Equipment (PPE) has increased, mitigating the financial impact. As a result, regulatory agencies granted exemptions and emergency use authorizations quickly.

The global regulatory landscape is changing rapidly, making it a complicated scenario for medical device firms. The conventional regulatory affairs are proving relatively unstable, with rules that might be changing for various products depending on what a manufacturer is selling. Exemptions related to COVID-19 have been issued by several countries around the globe. For instance, Australia issued an exemption for devices involved in diagnosis, confirmatory testing, prevention, monitoring, treatment, or alleviation of COVID-19.

Artificial intelligence and machine learning technologies have the potential to transform health by extracting a massive amount of data during healthcare delivery. Recently, numerous pre-market approvals have been granted through the FDA's pre-market pathway. One such example is the algorithm used in the Apple Watch's AF detector and diabetes management support tools that provide personalized treatment plans. The FDA has signified a different strategy that shifts the center of mass for certification, particularly for AI-related technologies, aside from a complete focus on the device or its performance and toward the company and its processes.

Besides, increasing cybersecurity threats and the financial impact of data breaches are making manufacturers of medical devices implement strategies to ensure that their products remain secure. This is being accompanied by government support. For instance, in October 2018, the FDA collaborated with the U.S. Department of Homeland Security to improve information sharing and collaboration to address cybersecurity risks, including less secure communication as well as prevention of unauthorized access when it comes to data transfer to and from the device.

Service Insights

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. Hence, with the increasing number of products in development, the demand for these services is likely to increase, thereby contributing to the growth of the market for medical device regulatory affairs.

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. Hence, this creates more demand for the services supporting market growth.

Service Provider Insights

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.

Besides, 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.

Type Insights

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.

For instance, increasing demand for technologically advanced products such as auto-injectors or pen needles for effective and efficient delivery of insulin in diabetic patients is driving the segment. As there are multiple modalities involve in the combination product, more than one regulatory agency office reviews the submission. Due to the complexity of combination products, it is difficult to understand which regulatory requirements apply to combination products. Hence, this creates demand for these services.

Besides, with the increasing cases of COVID-19 around the world, there is a growing need for respiratory devices such as oxygen tanks, nebulizers, pulse oximeters, and spirometers, and ventilators for patients with severe COVID-19 infection, which is contributing to market growth. Furthermore, 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.

Regional Insights

Asia Pacific dominated the medical device regulatory affairs market and accounted for the largest revenue share of 37.1% in 2020. The region is also expected to grow at a significant rate during the forecast period. This is due to the highly evolved regulatory systems in countries like Australia and Japan. For instance, in 2018, Australia's Therapeutic Goods Administration took a significant step toward broadening recognition of international approvals and embracing the Medical Device Single Audit Program, giving manufacturers significantly more options for entering the market for medical device regulatory affairs. Furthermore, government efforts to simplify the regulatory system for foreign investors, expedited approval for innovative products, and procurement control relaxation are some of the key factors driving the market for medical device regulatory affairs.

Regional regulatory initiatives in Africa, Asia, and the Americas are evolving to promote the harmonization of regulatory requirements across countries, lowering market entry barriers for manufacturers that can lead to lower product prices, encourage manufacturers to register their products in more countries, and contribute to a more sustainable total market for health products.

North America and Europe are also expected to be key markets for medical device regulatory affairs owing to the presence of two major international regulatory agencies — the European Medicines Agency (EMA) and the U.S. FDA respectively, which regulate more than half of medical devices worldwide. The U.S. FDA issues various guidelines for medical device manufacturers to help in the process.

Key Companies & 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

Medical Device Regulatory Affairs Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global medical device regulatory affairs market report on the basis of service, type, service provider, and region:

• Services Outlook (Revenue, USD Million, 2016 - 2028)

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Applications

  • Other Services

• Type Outlook (Revenue, USD Million, 2016 - 2028)

  • Diagnostic

  • Therapeutic

• Service Provider Outlook (Revenue, USD Million, 2016 - 2028)

  • Outsource

  • In-house

• Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE