The global medical device & IVD regulatory affairs outsourcing market size surpassed at US$ 1.4 Bn in 2020 and to reach US$ 3.5 billion by 2030 with a CAGR of 12.5% from 2021 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.
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.
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.
Market Drivers
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.
Subject Matter Experts Help Reduce Instances of RTR for Product Applications
Research design and full-outsourced support are being provided to med-tech companies in order to achieve fast growth in the market landscape. As such, the implementation of quality management services has become increasingly important for managing high-stake situations such as device filings. Companies in the medical device & IVD regulatory affairs outsourcing market are focusing on commercializing products of healthcare companies, whilst staying within budget. These companies understand that clients require maximum return on investment, while adhering to changing regulations of the FDA.
Most healthcare companies fear refusal to receive (RTR) for their application of a product, since this can lead to significant expenditures and may disrupt timelines for launching the product in the market. Hence, consultation firms are hiring experts that adapt to the multi-disciplinary and complex approach of the FDA.
Lucrative Business Opportunities in Asia Pacific and Middle East Bolster Market Growth
Recruiting of subject matter experts has become an important aspect for companies in the medical device & IVD regulatory affairs outsourcing market. Apart from North America, consulting firms are tapping into incremental opportunities in the Asia Pacific region, the Middle East, and the European Union. Companies are increasing their portfolio in regulatory audits, ISO (International Organization for Standardization) certification, and quality system validation. This is evident since the medical device & IVD regulatory affairs outsourcing market is slated to register a striking CAGR of ~11% from 2020 to 2030.
There is a growing demand for professional consultation services for FDA-regulated verticals. Healthcare companies are hiring specialists in health retail and life sciences projects. Comprehensive services in health retail and life sciences include market access strategy, which is very important to prevent resources from drying up before a product is launched in the market.
Leading players analyzed in the report are
Market Segmentation
By Service
By Software
By Region
Scope of the Report
VRR’s report on the global medical device & IVD regulatory affairs outsourcing market studies past as well as current growth trends and opportunities to gain valuable insights of these indicators for the market during the forecast period from 2021 to 2030. The report provides the revenue of the global medical device & IVD regulatory affairs outsourcing market for the period 2017–2030, considering 2020 as the base year and 2030 as the forecast year. The report also provides the compound annual growth rate (CAGR) of the global medical device & IVD regulatory affairs outsourcing market from 2020 to 2027.
The report has been prepared after extensive research. Primary research involved bulk of research efforts, wherein analysts carried out interviews with key opinion leaders, industry leaders, and opinion makers. Secondary research involved referring to key players’ product literature, annual reports, press releases, and relevant documents to understand the global medical device & IVD regulatory affairs outsourcing market.
Secondary research also included Internet sources, statistical data from government agencies, websites, and trade associations. Analysts have employed a combination of top-down and bottom-up approaches to study various attributes of the global medical device & IVD regulatory affairs outsourcing market.
The report includes an elaborate executive summary, along with a snapshot of the growth behavior of various segments and sub-segments included in the scope of the study. Moreover, the report sheds light on changing competitive dynamics in the global medical device & IVD regulatory affairs outsourcing market. These serve as valuable tools for existing market players as well as entities interested in participating in the global medical device & IVD regulatory affairs outsourcing market.
The report also delves into the competition landscape of the global medical device & IVD regulatory affairs outsourcing market. Key players operating in the global medical device & IVD regulatory affairs outsourcing market have been identified and each one of these has been profiled in terms of various attributes. Company overview, financial standings, recent developments, and SWOT are attributes of players in the global medical device & IVD regulatory affairs outsourcing market that have been profiled in this report.
Key Questions Answered in Medical Device & IVD Regulatory Affairs Outsourcing Report
Research Objectives and Research Approach
The comprehensive report on the global medical device & IVD regulatory affairs outsourcing market begins with an overview, followed by the scope and objectives of the study. Following this, the report provides detailed explanation of the objectives behind this study and key vendors and distributors operating in the market and regulatory scenario for approval of products.
For reading comprehensibility, the report has been compiled in a chapter-wise layout, with each section divided into smaller sections. The report comprises an exhaustive collection of graphs and tables that have been appropriately interspersed. Pictorial representation of actual and projected values of key segments is visually appealing to readers. This also allows comparison of market shares of key segments in the past and at the end of the forecast period.
The report analyzes the global medical device & IVD regulatory affairs outsourcing market in terms of service, software, and region. Key segments under each criteria have been studied at length, and the market share for each of these at the end of 2030 has been provided. Such valuable insights enable market stakeholders to make informed business decisions for investment in the global medical device & IVD regulatory affairs outsourcing market.
Table of Content
1. Preface
1.1. Market Definition and Scope
1.2. Market Segmentation
1.3. Key Research Objectives
1.4. Research Highlights
2. Assumptions and Research Methodology
3. Executive Summary: Global Medical Device & IVD Regulatory Affairs Outsourcing Market
4. Market Overview
4.1. Introduction & Overview
4.2. Product Overview
4.3. Market Dynamics
4.3.1. Drivers
4.3.2. Restraints
4.3.3. Opportunities
4.4. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast, 2018–2030
5. Market Outlook
5.1. COVID-19 Pandemics Impact on Industry
5.2. Technology/Product Roadmap
5.3. Market Channel Development Trends
5.4. Key Potential Customers
6. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast, by Service
6.1. Introduction & Definition
6.2. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
6.2.1. Regulatory Writing & Submissions
6.2.2. Regulatory Registration Service
6.2.3. Regulatory Consulting
6.2.4. Others
6.3. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Service
7. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast, by Software
7.1. Introduction & Definition
7.2. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
7.2.1. Cloud-based software
7.2.2. On-premises software
7.3. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Software
8. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast, by Region
8.1. Key Findings
8.2. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Region
8.2.1. North America
8.2.2. Europe
8.2.3. Asia Pacific
8.2.4. Latin America
8.2.5. Middle East & Africa
8.3. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Region
9. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
9.1. Introduction
9.2. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
9.2.1. Regulatory Writing & Submissions
9.2.2. Regulatory Registration Service
9.2.3. Regulatory Consulting
9.2.4. Others
9.3. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
9.3.1. Cloud-based software
9.3.2. On-premises software
9.4. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country, 2018–2030
9.4.1. U.S.
9.4.2. Canada
9.5. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
9.5.1. By Service
9.5.2. By Software
9.5.3. By Country
10. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
10.1. Introduction
10.2. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
10.2.1. Regulatory Writing & Submissions
10.2.2. Regulatory Registration Service
10.2.3. Regulatory Consulting
10.2.4. Others
10.3. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
10.3.1. Cloud-based software
10.3.2. On-premises software
10.4. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030
10.4.1. Germany
10.4.2. U.K.
10.4.3. France
10.4.4. Spain
10.4.5. Italy
10.4.6. Rest of Europe
10.5. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
10.5.1. By Service
10.5.2. By Software
10.5.3. By Country/Sub-region
11. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
11.1. Introduction
11.2. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
11.2.1. Regulatory Writing & Submissions
11.2.2. Regulatory Registration Service
11.2.3. Regulatory Consulting
11.2.4. Others
11.3. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
11.3.1. Cloud-based software
11.3.2. On-premises software
11.4. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030
11.4.1. China
11.4.2. Japan
11.4.3. India
11.4.4. Australia & New Zealand
11.4.5. Rest of Asia Pacific
11.5. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
11.5.1. By Service
11.5.2. By Software
11.5.3. By Country/Sub-region
12. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
12.1. Introduction
12.2. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
12.2.1. Regulatory Writing & Submissions
12.2.2. Regulatory Registration Service
12.2.3. Regulatory Consulting
12.2.4. Others
12.3. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
12.3.1. Cloud-based software
12.3.2. On-premises software
12.4. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030
12.4.1. Brazil
12.4.2. Mexico
12.4.3. Rest of Latin America
12.5. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
12.5.1. By Service
12.5.2. By Software
12.5.3. By Country/Sub-region
13. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
13.1. Introduction
13.2. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
13.2.1. Regulatory Writing & Submissions
13.2.2. Regulatory Registration Service
13.2.3. Regulatory Consulting
13.2.4. Others
13.3. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
13.3.1. Cloud-based software
13.3.2. On-premises software
13.4. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030
13.4.1. GCC Countries
13.4.2. South Africa
13.4.3. Rest of Middle East & Africa
13.5. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
13.5.1. By Service
13.5.2. By Software
13.5.3. By Country/Sub-region
14. Competition Landscape
14.1. Market Position Analysis, by Company, 2019
14.2. Company Profiles
14.2.1. REGIQ SOLUTIONS
14.2.1.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.1.2. Growth Strategies
14.2.1.3. SWOT Analysis
14.2.2. LORENZ Life Sciences Group
14.2.2.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.2.2. Growth Strategies
14.2.2.3. SWOT Analysis
14.2.3. AxSource Consulting Inc
14.2.3.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.3.2. Growth Strategies
14.2.3.3. SWOT Analysis
14.2.4. Freyr
14.2.4.1. Company Overview (HQ, Business Segments)
14.2.4.2. Growth Strategies
14.2.4.3. SWOT Analysis
14.2.5. Promedica International
14.2.5.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.5.2. Growth Strategies
14.2.5.3. SWOT Analysis
14.2.6. Covance
14.2.6.1. Company Overview (HQ, Business Segments)
14.2.6.2. Growth Strategies
14.2.6.3. SWOT Analysis
14.2.7. Assent Compliance Inc
14.2.7.1. Company Overview (HQ, Business Segments)
14.2.7.2. Growth Strategies
14.2.7.3. SWOT Analysis
14.2.8. MakroCare
14.2.8.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.8.2. Growth Strategies
14.2.8.3. SWOT Analysis
14.2.9. EMERGO
14.2.9.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.9.2. Growth Strategies
14.2.9.3. SWOT Analysis
14.2.10. ICON plc
14.2.10.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.10.2. Company Financials
14.2.10.3. Growth Strategies
14.2.10.4. SWOT Analysis
Cross-segment Market Size and Analysis for
Mentioned Segments
Additional Company Profiles (Upto 5 With No Cost)
Additional Countries (Apart From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers