Medical Device & IVD Regulatory Affairs Outsourcing Market Size, Share, Trends, Growth, Consumption, Revenue, Company Analysis and Forecast 2021-2030

Published Date : Nov 2020 | No. of Pages : 200 Pages | Category : Healthcare

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

  • Health authorities continue to raise the bar on the documentation required for review to achieve regulatory approvals across the globe. The continuous track from the initial clinical trial throughout the pre-registration, registration, and post-approval lifecycle fuels the demand for regulatory professionals. A medical device or in vitro diagnostic (IVD) manufacturer, whether a start-up or an established multinational firm has to carefully balance the time its new or ongoing product development is taking against available resources.
  • Moreover, new upcoming changes in Medical Devices Regulation (MDR) and In-vitro Diagnostic Devices Regulation (IVDR) from regulators make it particularly difficult to meet market launch and recertification timelines. Hence, demand for regulatory outsourcing has increased in order to manage and understand new and ongoing regulatory demands. This, in turn, is estimated to boost the market.
  • Stringent regulatory framework of product development process compels the healthcare industry to streamline their respective operations by outsourcing regulatory support and services to CROs and CMOs. Hence, demand and preference for outsourcing regulatory affairs is significantly high considering the extensive documentation involved in the overall process, which in turn propels the market.

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

  • RegIQ Solutions,
  • LORENZ Life Sciences Group,
  • AxSource Consulting Inc.,
  • Freyr Solutions,
  • Covance,
  • Promedica International,
  • Assent Compliance Inc.,
  • MakroCare,
  • Emergo by UL,
  • ICON

Market Segmentation

By Service

    • Regulatory Writing & Submissions
    • Regulatory Registration Services
    • Regulatory Consulting
    • Others

By Software

    • Cloud-based Software
    • On-premises Software

By Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific          
    • China
    • India
    • Japan
    • Australia & New Zealand
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • Israel
    • Rest of Middle East & Africa

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

  1. What is the sales/revenue generated by medical device & IVD regulatory affairs outsourcing service providers across all regions during the forecast period?
  2. What are the opportunities in the global medical device & IVD regulatory affairs outsourcing market?
  3. What are the major drivers, restraints, opportunities, and threats in the global market?
  4. Which region is set to expand at the fastest CAGR during the forecast period?
  5. Which product segment is expected to generate the highest revenue globally in 2030? Which segment is projected to expand at the highest CAGR during the forecast period?
  6. What are the market positions of different companies operating in the global market?

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


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