Medical Devices and IVD Regulatory Affairs Outsourcing Market By Service (Regulatory Writing & Submissions, Regulatory Consulting, Regulatory Registration Services, Others); By Software (Cloud-based Software, On-premises Software): Prospective Landscape, Size, Share, Growth, Opportunities and Industry Forecast 2019-2028

Market Insights:

The medical device industry is expanding at a significant growth rate from the last few years. Also, innovative technology and development in diagnosis, treatment, and delivery of services are boosting the market demand. The medical device industry has made technological evolution and rapid progress in the last decade due to rising government initiatives to enhance product access. Furthermore, the latest technological and scientific benefits, growing adoption of digital technologies, and expansion in emerging markets are propelling the global medical devices and IVD regulatory affairs outsourcing market. Additionally, increasing demand for technologically advanced products, owing to the increasing prevalence of different chronic diseases is likely to fuel market growth.

Latest Trends:

The following are the trending factors encouraging the global medical devices and IVD regulatory affairs outsourcing market growth over the coming years:

• Increasing prevalence of different chronic diseases across the globe.
• Innovative upcoming changes in Medical Devices Regulation (MDR).
• Growing government initiatives for product access.
• Technological advancements adopted by leading key players.
• Development in diagnosis, treatment, and healthcare infrastructure.

Driving Factors:

• Health authorities giving focus on documentation required for review to achieve regulatory approvals across the global regions. The continuous tracking from initial clinical trials throughout the pre-registration, post-approval lifecycle, and registration fuels the demand for the market.
• A medical device or in vitro diagnostic (IVD) manufacturer or established multinational companies has to carefully balance the time its new or ongoing product development in the market for driving the market growth.
• Furthermore, innovative upcoming changes in Medical Devices Regulation (MDR) and In-vitro Diagnostic Devices Regulation (IVDR) from regulators make it complex and difficult to meet market launch and recertification timelines. Hence, the demand for regulatory outsourcing has increased from the last few years to manage and understand new and ongoing regulatory demands.
• Also, the stringent regulatory framework of the product development process compels the healthcare and clinical sectors to streamline their business operations by outsourcing regulatory support and services to CROs and CMOS.

Restraining Factors:

The high costing structure of medical devices and the IVD regulatory affairs outsourcing market is hampering the market growth.

Segmentations:

The global medical devices and IVD regulatory affairs outsourcing market has been bifurcated into different global market segments by examining various perspectives such as services, software, and global geographies. Based on the market, it can be divided into Regulatory Writing & Submissions, Regulatory Consulting, Regulatory Registration Services, and Others. Based on software, it can be divided into Cloud-based Software and On-premises Software. Also, different global regions such as North America, Latin America, Middle East, Asia-Pacific, Africa, and Europe have been analyzed in the report.

Services Perspective (Revenue in USD Billion):

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

Software Perspective (Revenue in USD Billion):

• Cloud-based Software
• On-premises Software

Regional Perspective (Revenue in USD Billion):

North America

• U.S.A
• Canada

Europe

• Italy
• Germany
• France
• UK
• Spain
• Rest of Europe

Asia-Pacific

• China
• India
• Japan
• Rest of Asia-Pacific

Latin America

• Brazil
• Mexico

Middle East & Africa

• UAE
• Saudi Arabia
• Turkey
• Rest of Middle East & Africa

Regional Insights:

• The global medical devices and IVD regulatory affairs outsourcing market has been scrutinized into different global market regions such as North America, Asia-Pacific, Africa, and Europe, Latin America, and the Middle East based on different global market segments.
• Among the global regions, North America is marking the notable growth in the medical devices and IVD regulatory affairs outsourcing market owing to intense government regulations and the presence of large-scale research units in this region. Furthermore, increasing awareness regarding drug safety is also boosting the medical devices and IVD regulatory affairs outsourcing market growth in North America.
• North America dominated the global medical device & IVD regulatory affairs outsourcing market in 2019 and the trend is projected to continue over the forecast period. Moreover, an increase in clinical research, the presence of large-scale research units, and stringent government regulations are major factors driving the growth of the global market. Also, increasing patient awareness about cost savings and easy access to global expertise are propelling the demand for regulatory affairs outsourcing activities by medical device key players.
• Expansion of the medical devices and IVD regulatory affairs outsourcing market in the Asia Pacific is growing owing to a favorable business environment and rising government initiatives to improve healthcare infrastructure in emerging regions. Furthermore, a growing focus on research and development is likely to foster market growth.
• Additionally, increases in approvals of Asia-based CMOs by the U.S. FDA to pursue their regulatory services operations are augmenting the market growth. Also, preference for business expansion in emerging economies such as India and China by leading companies due to a favorable business environment is likely to boost the regulatory affairs outsourcing market in the Asia-Pacific region.

Key Industry Players:

Different leading key players have been examined to get informative insights for making well-informed business decisions in the market. It offers data on various parameters such as company overview, financial overview, leading marketing strategies, and revenue generation.

The following leading companies have been profiled to get detailed insights into leading key players in the medical devices and IVD regulatory affairs outsourcing market:

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

Key Industry Developments:

• Abbott completed the acquisition of St. Jude Medical, Inc. in 2017, this acquisition enabled the company to strengthen the medical device leadership and offer new products to address more areas of care.

The following key questions have been addressed through this research report:

• What are the global leading key players functioning in the medical devices and IVD regulatory affairs outsourcing market?
• What is the impact of the Covid-19 viral outbreak on the global medical devices and IVD regulatory affairs outsourcing market?
• What are the global medical devices and IVD regulatory affairs outsourcing market?
• Which factors are encouraging and driving the global medical devices and IVD regulatory affairs outsourcing market?
• What will be the global market size and market shares over the forecast period?
• Which are the major segments accounted for marking the impressive growth in medical devices and IVD regulatory affairs outsourcing market?
• What are the upcoming trends and evolution in the medical devices and IVD regulatory affairs outsourcing market?
• What are the challenges, threats, and issues faced by medical devices and IVD regulatory affairs outsourcing market key players?
• What will be the global medical devices and IVD regulatory affairs outsourcing market opportunities over the forecast period?
• What are the outcomes of SWOT and Porter’s five forces analysis?
• What are the technological advancements and trends in medical devices and IVD regulatory affairs outsourcing market?

Synopsis:

Alchemy Market Research has recently published a fully-fledged analysis on the global medical devices and IVD regulatory affairs outsourcing market to its humongous database. The Global Medical Devices And IVD Regulatory Affairs Outsourcing Market Size Was Estimated At US$ 1.4 Billion In 2019 And Is Expected To Register A CAGR Of 11.2 % Over The Forecast Period. A discussion on various factors such as affiliated trends, key drivers, opportunities, threats, challenges has been elucidated in the report. Also, this informative repository sheds light on a comprehensive analysis of the mergers and acquisitions that have been made by leading key players in the market.

Chapter 1.        Executive Summary

Chapter 2.        Market Introduction

Chapter 3.        Global Medical Devices and IVD Regulatory Affairs Outsourcing Market– Analysis and Revenue Forecast 2019-2028 – Key Industry Dynamics

3.1.   Key Market Drivers

3.2.   Key Market Restraints

3.3.   Market Opportunities

3.4.   Future Trends

3.5.   Impact Analysis of Drivers and Restraints

Chapter 4.        Global Medical Devices and IVD Regulatory Affairs Outsourcing Market– Analysis and Revenue Forecast 2019-2028

Chapter 5.        Global Medical Devices and IVD Regulatory Affairs Outsourcing Market– Analysis and Revenue Forecast 2019-2028 – By Services

5.1.   Regulatory Writing & Submissions

5.2.   Regulatory Consulting

5.3.   Regulatory Registration Services

5.4.   Others

Chapter 6.        Global Medical Devices and IVD Regulatory Affairs Outsourcing Market– Analysis and Revenue Forecast 2019-2028 – By Software

6.1.   Cloud-based Software

6.2.   On-premises Software

Chapter 7.        Global Medical Devices and IVD Regulatory Affairs Outsourcing Market– Analysis and Revenue Forecast 2019-2028 – By Region

7.1.   North America

7.2.   Europe

7.3.   Asia-Pacific

7.4.   Latin America

7.5.   Middle East & Africa

Chapter 8.        North America Medical Devices and IVD Regulatory Affairs Outsourcing Market– Analysis and Revenue Forecast 2019-2028

8.1.   North America Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Services

8.1.1.Regulatory Writing & Submissions

8.1.2.Regulatory Consulting

8.1.3.Regulatory Registration Services

8.1.4.Others

8.2.   North America Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Software

8.2.1.Cloud-based Software

8.2.2.On-premises Software

8.3.   North America Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Country

8.3.1.U.S.

8.3.2.Canada

Chapter 9.        Europe Medical Devices and IVD Regulatory Affairs Outsourcing Market– Analysis and Revenue Forecast 2019-2028

9.1.   Europe Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Services

9.1.1.Regulatory Writing & Submissions

9.1.2.Regulatory Consulting

9.1.3.Regulatory Registration Services

9.1.4.Others

9.2.   Europe Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Software

9.2.1.Cloud-based Software

9.2.2.On-premises Software

9.3.   Europe Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Country

9.3.1.  Germany

9.3.2.  France

9.3.3.  UK

9.3.4.  Spain

9.3.5.  Italy

9.3.6.  Rest of Europe

Chapter 10.    Asia Pacific Medical Devices and IVD Regulatory Affairs Outsourcing Market– Analysis and Revenue Forecast 2019-2028

10.1.            Asia Pacific Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Services

10.1.1.    Regulatory Writing & Submissions

10.1.2.    Regulatory Consulting

10.1.3.    Regulatory Registration Services

10.1.4.    Others

10.2.            Asia Pacific Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Software

10.2.1.    Cloud-based Software

10.2.2.    On-premises Software

10.3.            Asia-Pacific Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Country

10.3.1. China

10.3.2. India

10.3.3. Japan

10.3.4. South Korea

10.3.5. Rest of Asia-Pacific

Chapter 11.    Latin America Medical Devices and IVD Regulatory Affairs Outsourcing Market– Analysis and Revenue Forecast 2019-2028

11.1.            Latin America Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Services

11.1.1.    Regulatory Writing & Submissions

11.1.2.    Regulatory Consulting

11.1.3.    Regulatory Registration Services

11.1.4.    Others

11.2.            Latin America Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Software

11.2.1.    Cloud-based Software

11.2.2.    On-premises Software

11.3.            Latin America Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Country

11.3.1. Brazil

11.3.2. Mexico

11.3.3. Rest of Latin America

Chapter 12.    Middle East & Africa Medical Devices and IVD Regulatory Affairs Outsourcing Market– Analysis and Revenue Forecast 2019-2028

12.1.            Middle East & Africa Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Services

12.1.1.    Regulatory Writing & Submissions

12.1.2.    Regulatory Consulting

12.1.3.    Regulatory Registration Services

12.1.4.    Others

12.2.            Middle East & Africa Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Software

12.2.1.    Cloud-based Software

12.2.2.    On-premises Software

12.3.            Middle East & Africa Medical Devices and IVD Regulatory Affairs Outsourcing Market– By Country

12.3.1. UAE

12.3.2. Saudi Arabia

12.3.3. Turkey

12.3.4. Rest of Middle East & Africa

Chapter 13.    Competitive Analysis

13.1.1. Competition Dashboard

13.1.2. Company Profiles

13.1.2.1.          RegIQ Solutions,

13.1.2.2.          LORENZ Life Sciences Group,

13.1.2.3.          Covance,

13.1.2.4.          Promedica International,

13.1.2.5.          Emergo by UL,

13.1.2.6.          ICON

13.1.2.7.          AxSource Consulting Inc.,

13.1.2.8.          Assent Compliance Inc.,

13.1.2.9.          MakroCare,

13.1.2.10.      Freyr Solutions