Global Medical Device Regulatory Affairs Market (2024 Edition): Analysis By Type (Diagnostic, Therapeutic), By Services, By Service Provider, By Region: Market Insights and Forecast (2020-2030)

Global Medical Device Regulatory Affairs Market (2024 Edition): Analysis By Type (Diagnostic, Therapeutic), By Services, By Service Provider, By Region: Market Insights and Forecast (2020-2030)

Executive Summary

Azoth Analytics has released a research report titled “Global Medical Device Regulatory Affairs Market (2024 Edition)” which provides a complete analysis of the Global Medical Device Regulatory Affairs industry in terms of market segmentation By Type (Diagnostic, Therapeutic), By Services (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Other Services), By Service Provider (Outsource, In-house) for the historical period of 2020-2023, the estimates of 2024 and the forecast period of 2025-2030.

The report analyses the Medical Device Regulatory Affairs Market by Region (Americas, Europe, Asia Pacific, Middle East & Africa) and 10 Countries (United States, Canada, United Kingdom, Germany, France, Italy, China, Japan, India, South Korea). The Global Medical Device Regulatory Affairs market showcased growth at a CAGR of 12.98% during 2020-2023. The market was valued at USD 6.86 Billion in 2023 which is expected to reach USD 27.58 Billion in 2030. The Medical Device Regulatory Affairs Market is influenced by factors such as evolving regulatory requirements, technological advancements in medical device development, globalization of markets, and increasing focus on patient safety and product quality.

According to World Health Organization (WHO), Noncommunicable diseases (NCDs) kill 41 million people each year, equivalent to 74% of all deaths globally. Cardiovascular diseases, including coronary artery disease, peripheral artery disease, and cardiac arrhythmias, continue to be leading causes of morbidity and mortality globally. As the prevalence of risk factors such as obesity, diabetes, and hypertension increases, so does the incidence of cardiovascular diseases. Non-communicable diseases often require continuous monitoring and management to prevent complications and improve patient outcomes. As the prevalence of NCDs rises, there is an increasing demand for medical devices for diagnosis, monitoring, and management of these conditions. Regulatory affairs professionals play a crucial role in ensuring that these devices meet regulatory requirements for safety, efficacy, and performance before they can be marketed and used in clinical settings.

Recognizing the need to facilitate international trade and harmonize regulatory requirements, regulatory authorities around the world are working to align their standards and regulations for medical devices. Initiatives such as the International Medical Device Regulators Forum (IMDRF) aim to promote convergence and mutual recognition of regulatory requirements, reducing duplication of efforts and facilitating market access for medical devices across multiple jurisdictions.

Advances in genomics, biomarkers, and diagnostic technologies are driving the emergence of personalized and precision medicine approaches in therapeutic interventions. Regulatory affairs professionals collaborate with developers of personalized medical devices, such as genetic tests and companion diagnostics, to ensure regulatory compliance and evidence-based validation of clinical utility and effectiveness.

Automated authoring and publishing tools automate repetitive tasks in regulatory writing and publishing, such as document formatting, template creation, and generation of submission-ready documents. These tools improve productivity, accuracy, and consistency in regulatory document preparation, reducing manual errors and time-to-market for medical devices. Regulatory affairs professionals can focus on content creation and regulatory strategy, while automated tools handle formatting and publishing tasks efficiently.

Cloud-based collaboration platforms facilitate seamless communication, document sharing, and project management between medical device companies and outsource service providers. These platforms enable real-time collaboration on regulatory affairs projects, regardless of geographic location. Cloud-based collaboration platforms enhance transparency, efficiency, and accountability in outsourcing relationships. Medical device companies can securely share documents, track project progress, and communicate with outsource service providers, facilitating effective collaboration and project management.

Scope of the Report:

• The report analyses the Medical Device Regulatory Affairs Market by Value (USD Million).
• The report analyses the Medical Device Regulatory Affairs Market by Region (Americas, Europe, Asia Pacific, Middle East & Africa) and 10 Countries (United States, Canada, United Kingdom, Germany, France, Italy, China, Japan, India, South Korea).
• The report presents the analysis of Medical Device Regulatory Affairs Market for the historical period of 2020-2023, the estimated year 2024 and the forecast period of 2025-2030.
• The report analyses the Medical Device Regulatory Affairs Market by type (Diagnostic, Therapeutic).
• The report analyses the Medical Device Regulatory Affairs Market by services (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Other Services).
• The report analyses the Medical Device Regulatory Affairs Market by service provider (Outsource, In-house).
• The key insights of the report have been presented through the frameworks of SWOT and Porter’s Five Forces Analysis. Also, the attractiveness of the market has been presented by region, by type, by service, & by service provider.
• Also, the major opportunities, trends, drivers, and challenges of the industry has been analyzed in the report.
• The report tracks competitive developments, strategies, mergers and acquisitions and new product development. The companies analysed in the report include ICON Plc, Labcorp, IQVIA, Intertek Group Plc, SGS SA, Integer Holdings Corp, Medpace Holdings, Emergo, Freyr Solutions, and Promedica International.